cyrilzakka/clinical-trials huggingface dataset:
To Compare the Efficacy of I.V 200 mg Iron Sucrose and 500 mg Iron Sucrose to Treat Anemia in Pregnancy

This study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.

Anemia is common during pregnancy. It is associated with maternal and neonatal complications. It is acceptable to prescribe oral iron supplements. However, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. In those cases, as well as in severe anemia it is recommended to give iron sucrose. This drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. The two methods of giving iron sucrose is (1) to give I.V 200 mg iron sucrose 2-3 times/week or (2) to give I.V 500 mg iron sucrose once a week In the present study we aim to compare between the efficacy of those 2 protocols.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Iron deficiency anemia
* Intolerance or low compliance for oral iron

Exclusion Criteria:

* Known allergy for iron supplements
* Anemia not due to iron deficiency
* Acute infection
* Liver failure or viral hepatitis
* Thalassemia or hemoglobinopathies
* Asthma
* Multiple pregnancy
Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy

This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Decompression therapy differs from traction-based therapy in that the traction applied to the spine in decompression therapy is typically alternated between lower and higher levels of tension for predetermined periods of time. In either therapy, spinal tension is maintained for the period's typically extending 30-minutes or longer. This study will provide evidence about how much dose of decompression more effective for the treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of decompression in literature till now.

Eligibility Criteria:
Inclusion Criteria:

* Both Genders
* Age between 30 to 50 years
* Unilateral Radiculopathy
* Limited SLR (Less than 60 degree)
* Pain on Numeric Pain Rating Scale \< 7
* BMI ≤ 30

Exclusion Criteria:

* Severe paraspinal Muscle Spasm
* Acute prolapse intervertebral disc
* Bilateral Positive SLR
* Osteoporotic
* H/O Spinal Fracture
Effect of Emergency Department Bedside Compression Ultrasonography on Door-to-Disposition Time in Patients Suspicious for Lower Extremity Deep Venous Thrombosis

Comparing the disposition time of point of care ultrasound (POCUS) versus formal lower extremity doppler in emergency department patients.


Eligibility Criteria:
Inclusion Criteria: Emergency Department patients presenting for lower extremity swelling concerning Deep vein thrombosis.

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Exclusion Criteria: n/a

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Brief Interventions for Short-Term Suicide Risk Reduction in Military Populations

The purpose of the proposed study is to identify the most effective brief interventions for reducing short-term risk for suicide attempts in "real world" military triage settings, and to identify potential mechanisms of change underlying the interventions' impact on subsequent suicide attempts. We will randomize 360 patients to one of three commonly-used crisis interventions delivered as routine care in the mental health triage system: (1) Treatment As Usual (TAU); (2) Standard Crisis Response Plan (S-CRP); or (3) Enhanced Crisis Response Plan with Reasons For Living (E-CRP). The following hypotheses will be tested:

1. The enhanced crisis response plan (E-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to the standard crisis response plan alone (S-CRP) and treatment as usual (TAU).
2. The standard crisis response plan (S-CRP) intervention will contribute to significantly decreased risk for suicide attempts and hospitalization during follow-up relative to treatment as usual (TAU).
3. Greater ambivalence about suicide and faster recall of reasons for living will mediate the relationship between intervention and reduced risk for suicide attempt during follow-up.

The CRP has been proposed as an alternative to TAU for the short-term management of suicidal patients and is now in widespread use, but has never been empirically tested. The CRP is purported to reduce suicide risk via unique mechanisms that directly suicide risk, notably suicidal ambivalence (i.e., the relative balance between the wish to live and the wish to die) and problem solving. Because suicidal ambivalence has gained support as an active mechanism for reducing suicide risk, the present study will also seek to augment this underlying mechanism by directly engaging the suicidal patient in a discussion about their reasons for living, thereby potentially increasing the potency of the CRP.

The present study therefore entails a component analysis of crisis interventions. As such, we anticipate ordered effects, whereby the S-CRP and E-CRP conditions will show significantly better outcomes than TAU, and E-CRP will demonstrate significantly better outcomes than the standard CRP condition.

Eligibility Criteria:
Inclusion Criteria:

* Active duty
* 18 years of age or older
* Reporting current suicidal ideation with intent to die, or a suicide attempt within the past two weeks
* Able to speak and understand the English language
* Able to complete the informed consent process

Exclusion Criteria:

* Severe psychiatric or medical conditions that preclude the ability to provide informed consent or participation in outpatient treatment
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)

This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft

Eligibility Criteria:
Inclusion Criteria:

* All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.

Exclusion Criteria:

* pregnancy
* No consent to participate in the study
* Previous enrollment in the study
* follow-up is not possible
Studies of In Vitro B Lymphocyte Responses in Subjects Receiving Tetanus Toxoid Booster Immunization

One of the major interests of this laboratory is the characterization of the cellular subpopulations involved in the triggering and immunoregulation of B lymphocytes to produce antibodies. We are assessing the responses of individuals to produce antibodies against newly encountered antigens such as keyhole limpet hemocyanin (KLH) (approved project number 77-I-0130) and propose to assess the amnestic responses to the previously encountered antigen, tetanus toxoid. The purpose of this protocol is to add this recall antigen to our repertoire of antigens used to evaluate the immune response in man.

Booster immunization with tetanus/diphtheria toxoid has now been used for several years by a number of clinical immunology laboratories throughout the country to assess B cell related immunologic profiles in patients and control normal subjects. We have recently developed a sensitive ELISA assay for IgM and IgG in vitro specific antibody responses against tetanus toxoid. This will allow us to carefully and precisely monitor the evolution and immunoregulation of the human B cell responses to this recall antigen. This is of particular importance and relevance to us in our ongoing studies of a number of diseases characterized by abnormalities of immunologic reactivity, including those treated with various regimens of immunosuppressive agents.

One of the major interests of this laboratory is the characterization of the cellular subpopulations involved in the triggering and immunoregulation of B lymphocytes to produce antibodies. We are assessing the responses of individuals to produce antibodies against newly encountered antigens such as keyhole limpet hemocyanin (KLH) (approved project number 77-I-0130) and propose to assess the amnestic responses to the previously encountered antigen, tetanus toxoid. The purpose of this protocol is to add this recall antigen to our repertoire of antigens used to evaluate the immune response in man.

Booster immunization with tetanus/diphtheria toxoid has now been used for several years by a number of clinical immunology laboratories throughout the country to assess B cell related immunologic profiles in patients and control normal subjects. We have recently developed a sensitive ELISA assay for IgM and IgG in vitro specific antibody responses against tetanus toxoid. This will allow us to carefully and precisely monitor the evolution and immunoregulation of the human B cell responses to this recall antigen. This is of particular importance and relevance to us in our ongoing studies of a number of diseases characterized by abnormalities of immunologic reactivity, including those treated with various regimens of immunosuppressive agents.

Eligibility Criteria:
Male and female patients 18 years and older.

Patients admitted to the Clinical Center under other approved research protocols designed to investigate immune mediated or inflammatory diseases and who have not been immunized to tetanus toxoid within 6 months.

No pregnant women.
Impact of Hysterectomy on Quality of Life and Urethral Length

To establish the impact of hysterectomy on sexual function, urethral length and quality of life

The investigators evaluate impact of total hysterectomy (abdominal, by laparoscopy and vaginal) and supracervical hysterectomy (abdominal and by laparoscopy) on quality of life, sexual function, urethral length and urinary incontinence. The patients fulfill questionnaires (UDI 6, IIQ7, FSFI and ICIQ) before operation and 6 months after. Additionally the investigators measure urethral length before procedure and 6 months after.

Eligibility Criteria:
Inclusion Criteria:

* patients qualified to hysterectomy due to benign condition

Exclusion Criteria:

* serious health condition
* previous vaginal operations
Effects of Breezy Candy on Halitosis

Users of Breezy candy will utilize the candy's abrasiveness to scrape tongue surface. The scraping action together with the release of compounds contained inside the abrasive microcapsules will result in significant reduction of oral halitosis.


Eligibility Criteria:
Inclusion Criteria:

* adult
* healthy
* male
* female
* bad breath

Exclusion Criteria:

* subject suffering from Diabetes
* subject suffering from renal disease
* pregnant women
* cigarette smokers
* any illness of oral cavity for the last 3 months
* subjects undergoing chemotherapy
* treatment by antibiotic
* treatment by anti-inflammatory
Cavernous Sinus Dissection and Bleeding in Meningiomas

The blood loss will be compared in middle fossa meningiomas which will receive pealing of the outer layer of the lateral wall of the cavernous sinus and those which will not revive pealing before the dura is opened

Cases with middle fossa meningiomas will be randomised to one of two surgical techniques. The first technique will involve pealing of the outer layer of the lateral wall of the cavernous sinus before the dura is opened and the tumour attacked, and the second group of cases will be operated by a standard technique, where the tumour will be directly attacked with out pealing of the outer layer of the lateral wall of the cavernous sinus. Blood loss will be monitored in each case by calculating the amount of blood in the suction container and subtracting it from the amount of fluids used for irrigation during surgery. The number of cotton patties and dressings will be also counted with each case as well as the number of gauzes used. The pre-operative complete blood picture will be documented particularly the haemoglobin , hematocrits and others. The same lab data will be also monitored after surgery. The amount of blood transfusion required will also be calculated in each case.

Eligibility Criteria:
Inclusion Criteria:

* Meningiomas of the middle cranial fossa

Exclusion Criteria:

* Meningiomas outside the middle cranial fossa
Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH


Eligibility Criteria:
Inclusion Criteria:

* Male/female patients, 18 years or older
* Written informed consent
* Presence of NASH by histologic evidence (liver biopsy) and elevated alanine aminotransferase (ALT), OR phenotypic diagnosis of NASH based on elevated ALT, BMI and diagnosis of Type 2 diabetes mellitus

Exclusion Criteria:

* Current use of obeticholic acid (OCA)
* New initiation GLP-1 agonists such as liraglutide, exenatide , lixisenatide, albiglutide or dulaglutide within 3 months of screening
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 5 days after stopping study medication
* Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
* Clinical evidence of hepatic decompensation or severe liver impairment
* Previous diagnosis of other forms of chronic liver disease
* Uncontrolled diabetes mellitus
* History or current diagnosis of ECG abnormalities
* Patients with contraindications to MRI imaging
Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD

To compare the efficacy and safety of photodynamic therapy (PDT) combined with intravitreal bevacizumab versus combination of photodynamic therapy , intravitreal bevacizumab and intravitreal triamcinolone for neovascular AMD.


Eligibility Criteria:
Inclusion Criteria:

* Cases of active neovascular AMD with visual acuity of 20/400- 20/40

Exclusion Criteria:

* History of glaucoma or ocular hypertension
* Disciform scar
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®

The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.


Eligibility Criteria:
Inclusion Criteria:

* children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray, vaccinated five times by MenBVac
* parental authority(ies)assent

Exclusion Criteria:

* no parental authority(ies)assent
* no blood sample during the third vaccination
* impossibility of third vaccination
* children with guardianship
* children yet vaccinated or non eligible for vaccination
Efficacy/Safety of HCP1306 Tablet Versus HGP0816 Tablet in Patients With Primary Hypercholesterolemia

The purpose of this study is to evaluate efficacy and safety of HCP1306 in patients with primary hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 19 years
* Signed informed consent
* At visit 1, LDL-C ≤ 250mg/dL and Triglyceride \< 400 mg/dL
* After 4 weeks more TLC, At visit2, LDL-C ≤ 250mg/dL, Triglyceride \< 400 mg/dL and satisfied criteria according to Risk of cardiovascular disease

Exclusion Criteria:

* Current or past history of hypersensitivity to HMG-CoA reductase inhibitors and component of Ezetimibe
* Has an active liver disease and severe liver disorder (continous elevation of AST, ALT level or exceeds more than 3 times of normal upper limit)
* Has a severe renal failure and kidney injury (Creatinine level exceeds more than 2 times of normal upper limit)
* CK level exceeds more than 5 times of normal upper limit
* Uncontrolled hypertension patient (SBP≥ 180 mmHg or DBP ≥ 110 mmHg)
* Uncontrolled diabetes mellitus patient (HbA1c ≥ 9%)
* Uncontrolled malfunctional thyroidism (or at pre-visit 2, TSH level exceeds more than 1.5 times of normal upper limit)
Comparing Autologous Peripheral Blood Stem Cell to Bone Marrow Transplantation for Recurrent Non-Hodgkin's Lymphoma

The purpose of this study is to evaluate the difference in relapse rates and long term event free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with intermediate grade NHL with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our transplant program.

These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be stratified according to good and poor prognosis category and relapsed vs. first partial response categories. The patients will have bone marrow or peripheral stem cells collected according to standard protocols. A standardized hematopoietic growth factor will be used for mobilization and post-transplant. The patients' PSC or bone marrow (BM) product will be assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays. The patients' outcome for transplantation will be evaluated with response to transplantation, relapse rates and event free survival being the measured end points.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-65
* Intermediate grade non-Hodgkin's lymphoma (International Working Formulation - Follicular large cell, Diffuse Small Cleaved, Diffuse Mixed, Diffuse Large Cell, and Immunoblastic) with histologic negative bone marrow who would otherwise meet all eligibility criteria for high-dose therapy and ABMT. These criteria are in each specific high-dose therapy protocol (i.e. Karnofsky performance status \> 70, adequate organ function, HIV and Hepatitis B negative, etc.). These patients would be enrolled in a high-dose protocol using carmustine, etoposide, cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue.

Exclusion Criteria:

* Patients with bone marrow histologically involved with tumor or with a bone marrow abnormality making bone marrow harvest not possible.
* Patients whose tumor is rapidly growing which may preclude the extra time involved with the PSC collection process.
* Patients who do not otherwise meet high-dose therapy and transplantation entry criteria.
Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth

The objective of this prospective randomized clinical trial is to assess clinically and radiographically, the effect of NeoPutty as a pulp medicament following coronal pulp amputation in human primary molars with carious pulp exposure in comparison to Formocresol (FC).


Eligibility Criteria:
Inclusion Criteria:

* primary teeth which requires pulpotomy.

Exclusion Criteria:

* not healthy patients,
* teeth which requires pulpectomy.
Electroacupuncture Therapy for Treating Postherpetic Neuralgia

Postherpetic neuralgia (PHN) has a high incidence rate and severely impact on quality of life and health care costs, interfering with physical, emotional and social functioning of affected patients. Current therapeutic options for PHN mainly include analgetic and local anaesthesia for selective nerve blockade. Nevertheless, the efficacy of analgetic is always limited by inevitable side effects, in which patients have poor compliance. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite the administration of complex combinations. As a non-pharmarceutical therapy, acupuncture is widely use for a wide range of pain conditions. Thus, it might be an alternative treatment for PHN. The aim of this multicenter randomized controlled trial is to investigate the efficacy and safety of electroacupuncture therapy in patients with postherpetic neuralgia.

This randomized controlled trial will enroll 132 patients with postherpetic neuralgia. All patients will be randomly assigned to either the EA combined with medication group or the medication group via a computerized central randomization system in a 1:1 ratio. Primary outcomes will be change in sensory thresholds and pain intensity. Secondary outcomes will be change in dosage of analgetic, quality of life, anxiety and depression severity and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

1. Patients have a medical history of herpes zoster;
2. Skin lesion has healed in the region of herpes zoster, but the duration of postherpetic neuralgia persist for more than 30 days.
3. 20 ≤ age ≤80 years, male or female
4. Participants can fully understand the study protocol and written informed consent is signed.

Exclusion Criteria:

1. Acute herpes zoster, herpes zoster has not disappeared;
2. Herpes zoster belongs to a special type, such as ophthalmic herpes zoster, auricular herpes zoster, HZ that involves internal organs, meningeal herpes zoster, and disseminated herpes zoster.
3. Pregnant or lactating women;
4. Patients have severe complications in cardiovascular, cerebrovascular, liver, kidney, hematopoietic and other systems,or have malignant tumor, mental illness, immune deficiency, hemorrhagic disorders and other diseases;
5. Patients have severe cognitive impairment and can not understand the study protocol;
6. Patients can not receive electroacupuncture treatment due to any reasons.
Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients

The study consists of 3 phases (enrollment, infiltrative procedure, and controls):

* Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires.
* infiltrative procedure
* Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients, both sexes, with symptomatic knee osteoarthritis with:
* Age: 18-40 years;
* Unilateral involvement;
* Signs and symptoms of knee osteoarthritis;
* Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
* Ability and consent of patients to actively participate in clinical follow-up;
* Signature of informed consent;
* Pain ≥ 4 on VAS s

Exclusion Criteria:

* Patients unable to express consent;
* Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
* Patients undergoing knee surgery in the previous 12 months;
* Patients with malignant neoplasms;
* Patients with rheumatic diseases;
* Patients with uncontrolled metabolic diseases;
* Patients with hematological diseases (coagulopathies);
* Patients abusing alcoholic beverages, drugs or medications;
* Knee trauma treated in the previous 6 months.
* Other conditions that may interfere with the evaluation of OA treatment.