cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).


Eligibility Criteria:
Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. Participants with IDA defined as having:

   1. Hemoglobin \<10.0 g/deciliter (dL)
   2. Transferrin saturation (TSAT) \<20%
3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron
2. Allergy to two or more classes of drugs
3. Participants on dialysis or with an estimated glomerular filtration rate \<30 mL/minute(min)/1.73 square meter (m\^2)
4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin \>600 nanogram/mL
Ultrasonic Bone Scalpel in BSSO

The conventional saw compared with the piezo surgery in BSSO to evaluate cutting time, surgery duration, amount of bleeding. The purpose of this study was to answers following clinical questions: Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? and 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO.

The purpose of this study was to answers following clinical questions:

1) Is ultrasonic bonescalpel effective osteotomy like conventional bur in BSSO? 2) Does it reduce operative parameter like bleeding, duration, lingual split pattern? 3) Does it reduce postoperative morbidity after BSSO. Hypotheses of this study that ultrasonic bone scalpel can improve BSSO and its postoperative results due to strong cutting efficiency and soft tissue protective effect.

Surgical procedure; After removing the full thickness mucoperiosteal flap lingula was localized. In ultrasonic device group, osteotomies one side of the mandible were performed unilaterally using an ultrasonic bone scalpel (BoneScalpel; Misonix, Farmingdale, NY) with a serrated standard blade. In conventional group, contralateral side mandibular osteotomies were performed with Lindeman and round bur. Groups are selected randomly.

c- Follow up

The predictor variable was the type of instrument used for bone osteotomy. The instruments were ultrasonic bone scalpel and Lindeman bur. The main outcome variable are the cutting time and NSD. All patients were followed for 6 months.The authors used the 3dMD imaging system (3dMD, Atlanta, GA) and 3dMD Vultus software to evaluate the amount of postoperative edema.

Eligibility Criteria:
Inclusion Criteria:

* Patients are included with older than 18 years old,
* normal hemoglobin level, international normalized ratio in the average range,
* American Society of Anesthesiologists status of ASA I and II.

Exclusion Criteria:

* The exclusion criteria are neuropathic disease,
* recent use of nonsteroidal anti-inflammatory drugs and opioid derivatives,
* having preoperative signs of inflammation in the maxillofacial region,
* presence of excessive bleeding in the previous surgery,
* and allergy to drugs. All patients have given written informed consent.
Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia

The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral inguinal hernia
* suitable for open mesh repair in local anesthesia as well as laparoscopic repair
* ASA score I-III
* informed consent

Exclusion Criteria:

* ASA score IV (not suitable for TEP)
* bilateral hernias (laparoscopic repair preferable)
* recurrent hernia (primary repair affects preferable treatment)
* large scrotal hernias (not suitable for local anesthesia)
* earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)
Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder

In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches children to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance. This form of CBT has been well-studied in typically developing children with disruptive behavior and we are investigating if this treatment can be feasible and helpful, with appropriate modifications, for irritability and disruptive behavior in ASD.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS
* presence of disruptive behaviors such as irritability and anger outbursts
* IQ above 80
* Unmedicated or on stable medication

Exclusion Criteria:

* medical or psychiatric condition that would require alternative treatment
Carboplatin in Castration-resistant Prostate Cancer

Open label, non-randomised phase II clinical pilot study

Pilot Study of weekly Carboplatin in Patients with Advanced Metastatic Castration-Resistant Prostate Cancer (CRPC) and DNA repair defects

Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent
2. Adult patients with histological diagnosis of adenocarcinoma of the prostate.
3. Metastatic Castration-Resistant Prostate Cancer (mCRPC)
4. Progression after at least one taxane-based chemotherapy (or contraindication against taxanes) and at least one therapy with a newer hormonal agent (Cyp17 inhibitor or a new generation AA like enzalutamide).
5. DNA repair defects as per central assessment
6. Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0 - 2
7. Progression of disease by any of the criteria listed here:

   * PSA utilizing PCWG 2 criteria
   * Bone scan
   * RECIST 1.1
8. Adequate organ and bone marrow function as evidenced by:

   * Haemoglobin ≥8.0 g/dL
   * Absolute neutrophil count ≥1.5 x 109/L
   * Platelet count ≥ 100 x 109/L
   * AST and/or ALT \< 2.5 x ULN, in the presence of liver metastases: AST ≥5 x ULN, ALT \<5 x ULN
   * Total bilirubin \< 2.0 x ULN (except for patients with Gilbert's disease)
   * Creatinine Clearance ≥30ml/min
9. Patient must agree in the biomarker studies including the fresh tumour biopsies

Exclusion Criteria:

1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product Carboplatin
2. Prior treatment with any prior platinum based chemotherapy,
3. Major surgery within 4 weeks prior to planned start of treatment
4. Known brain or leptomeningeal involvement unless clinically stable and on stable dose of steroids
5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
6. Previous enrolment into the current study
7. Active secondary malignancy that requires systemic therapy.
Cerebral Amyloid Imaging Using Florbetapir (AV-45)

This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia

This study is aimed at examining the interest of amyloid radiotracer Florbetapir (18F-AV-45) for the etiological diagnosis of poststroke cognitive impairment and dementia. This study stems from two converging objectives: (1) the need to refine characteristics of vascular cognitive impairment (VCI) and dementia (VD) in order to propose diagnosis criteria of VCI and of mixed dementia and to improve diagnosis criteria of VD and (2) the need to improve the etiological diagnosis of poststroke cognitive impairment and dementia. It will take advantage from the ongoing GRECOG-VASC study (which determines the cognitive status 6 months poststroke in consecutive patients according to a standardized international battery) coordinated by the Amiens University Hospital center, the opportunity to perform amyloid imaging in vivo using Positron Emission Tomography (PET) and Florbetapir (a production site is located in the city of Amiens) and the collaboration between neurology and imaging departments of Amiens University hospital.

Eligibility Criteria:
Inclusion Criteria:

1. patients suffering of parenchymal stroke visualized by imaging (MRI),
2. patients suffering from cognitive impairment on the 6 months assessment (including GRECogVASC patients),
3. age between 40 and 80 years,
4. French-speaking,
5. reliable informant,
6. agreeing to participate in the study,
7. affiliation to a social security system,

Exclusion Criteria:

1. women of childbearing potential (defined as pre-menopausal, less than 2 years postmenopausal, or not surgically sterile), or who are breast-feeding
2. history of relevant severe drug allergy or hypersensitivity,
3. patient receiving any investigational medications at least in the 30 last days,
4. stroke affecting the cerebellum,
5. mental retardation,
6. illiteracy,
7. dementia diagnosed before stroke,
8. history of schizophrenia or psychiatric illness requiring a stay for \> 2 days in a psychiatry unit,
9. persons placed under judicial protection,
10. comorbidities affecting cognition (respiratory, renal, liver, heart failure),
11. persistent disturbance of consciousness defined by a score to item 1a of the National Institute of Health Stroke Scale (NIHSS) ≤ 1,
12. contraindication to MRI.
Effectiveness of ES and MT VS ES and PNF Technique Among Bells Palsy Patients

To determine the effectiveness of electrical stimulation with MIME therapy versus electrical stimulation with PNF technique for improving strength \& restoring lost motor function in the patients of Bell's palsy


Eligibility Criteria:
Inclusion Criteria:

* • Acute, unilateral, lower motor neuron bells palsy patient with house-backmann scale 4

  * Acute onset 1-3 weeks
  * Age group 20-40 years
  * Who were are willing to be a part of the study
  * Patients with the Bell's palsy (Facial paralysis , idiopathic facial paralysis and the herpetic facial paralysis)

Exclusion Criteria:

* • Patient who had the autoimmune disorder, tumors, recent head injury

  * The subject long with the surgery for ear and the fascial nerve palsy
  * Metal dental implants, and pregnant women
  * The patient with any peripheral vascular diseases
  * Central fascial palsy
Bowel Dysfunction and HoLEP Outcomes

The objective of this prospective study is to examine the correlation and effects of bowel dysfunction on outcomes for patients undergoing holmium laser enucleation of prostate (HoLEP) for lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH).The investigator hypothesizes that patients who have more bowel dysfunction based on higher severity scores on patient-reported validated questionnaires will experience more symptoms in the immediate post-operative period and may have slower recovery of urinary control. Assessment of pre, peri, and post-procedural bowel dysfunction via the Constipation Severity Score (CSS) and Vaizey Incontinence Questionnaire will aid the analysis.


Eligibility Criteria:
Inclusion Criteria:

* Males18-89 undergoing HoLEP
* Able to read, understand, and complete patient questionnaires
* Willing to sign the informed consent form

Exclusion Criteria:

* Patients with bowel diversion (colostomy, ileostomy)
* Patients with known neurogenic bowel
* Patients having concurrent ureteroscopy+/-laser lithotripsy, percutaneous nephrolithotomy, or non-urologic surgery at time of HoLEP
* Anticipated need for perineal urethrostomy at time of HoLEP
* Prior pelvic radiation or patients with history of bladder cancer with or without Bacillus Calmette-Guerin (BCG) therapy
* Patients who lack decisional capacity
Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population

The aim of this study is to confirm the difference in ovarian reserve markers and serum vitamine D levels between infertile indian, arabian and caucasian population.

200 caucasian, indian, and arab patients

Eligibility Criteria:
Inclusion Criteria:

WOMEN BETWEEN 21-43 YEARS FIRST OR SECOND IN VITRO FERILIZATION TREATMENT DUE TO TUBAL, MASCULINE OR PREVIOUS INTRAUTERINE INSEMINATION FAIL TREATMENT

Exclusion Criteria:

POLYCYSTIC PATIENTS ENDOMETRIOSIS GRADE III OR IV INFLAMMATORY PELVIC DISEASE
Effect of Music Listening on Stress in Acute Stroke

Investigation on changes in the neurochemical stress parameters in acute stroke. 30 patients are recruited in the stroke unit, blood samples are collected at fixed intervals during the first two days. Patients are randomized to music listening and control.Neuropsychological testing is performed in the acute phase and 6 months post-stroke.

Outcome measures: NIHSS, stress hormone levels, questionnaires on mood and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Hemispheric infarction
* Neurologically stable

Exclusion Criteria:

* Previous neurological disease affecting the outcome
* Previous psychiatric disease affecting the outcome
* Substance abuse
The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.

Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain \>= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* At least six months of prior cumulative ZDV therapy.
* Qualifying plasma HIV RNA count of \>= 4 log10 copies/ml obtained within 2 weeks of randomization.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
* Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days).
* Signs and symptoms of bilateral peripheral neuropathy \>= grade 2 at the time of screening.
* Inability to tolerate oral medication.
* Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.

Concurrent Medication:

Excluded:

* Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
* Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole at any time while on indinavir therapy.

Patients with any of the following prior conditions or symptoms are excluded:

* History of acute or chronic pancreatitis.
* Prior history of bilateral peripheral neuropathy.
* Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days) within 30 days prior to study entry.

Prior Medication:

Excluded:

* Any prior antiretroviral therapy except for ddI, ddC, 3TC or ZDV (for ZDV, as specified in inclusion criteria).
* Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
* Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.
* Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.

Risk Behavior:

Excluded:

* Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.

Required:

At least 6 months of prior cumulative ZDV therapy.
Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

The purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent before any assessment was performed.
2. Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study.
3. Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study.
4. Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.

Exclusion criteriat:

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
2. Patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse.
3. Patients that received immunomodulating or immunosuppressive MS treatments other than fingolimod since completion of study CFTY720DDE01 as for example: Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental immunomodulating-immunosuppressive therapies.
Deep Brain Stimulation of the Nucleus Accumbens as a Novel Treatment in Severe Opioid Addiction

The main objective of this study is to assess the efficacy of bilateral deep brain stimulation (DBS) of the Nucleus accumbens (NAc) as a novel treatment in severe opioid addiction. The included patients have been treated so far with a substitute in form of methadone.

Our hypothesis is that bilateral DBS of the NAc will significantly reduce the craving for heroin and thus enable the patients to decrease their Levomethadone-dosage substantially.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Proficiency in the German language
* Long lasting heroin addiction (fulfilled diagnostic-criteria according to DSM-IV,ICD-10)
* At least one detoxication-treatment without a long-term period of abstinence has already taken place
* Long-term inpatient treatment to support abstinence have occurred
* Free patient's decision / Informed Consent (existing comprehensive ability in meaning, methodology and execution of the study and ability of acceptance)
* If prior medication, stable dosage of psychopharmacological drugs over the last three months, which shall, after checking be retained during the study
* Substitution treatment with constant dose within the last three months before study inclusion

Exclusion Criteria:

* Hospitalization by PsychKG
* Clinical relevant psychiatric comorbidity (schizophrenic psychoses, bipolar affective diseases, severe personality disorder)
* Contraindications of a MRI-examination, e.g. implanted cardiac pacemaker/ heart defibrillator
* Current and in the last six months existent paranoid-hallucinated symptomatology
* Foreign aggressiveness in the last six months
* Verbal IQ \< 85 (evaluated with the German Mehrfachauswahl-Intelligenz-Test (MWT-A/B))
* Stereotactic respectively neurosurgical intervention in the past
* Neoplastical neurological diseases
* Contraindications of a stereotactic operation, e.g. increased bleeding-disposition, cerebrovascular diseases (e.g. arteriovenous malfunction, aneurysms, systemic vascular diseases)
* Serious and instable organic diseases (e.g. instable coronal heart disease)
* tested positively for HIV
* pregnancy and/or lactation
Spinal Manipulative Therapy for Low Back Pain

Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work.

Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.

Design: Randomised controlled parallel-group trial comparing standard care plus spinal manipulative therapy with standard care alone. Intention-to-treat analysis.

Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern University Hospital and a primary care practice network.

Eligibility Criteria:
Inclusion criteria:

1. Age between 20 and 55 years
2. Duration of acute low back pain less than 4 weeks
3. Informed consent

Exclusion criteria:

1. Pregnancy
2. Radicular origin of back pain (with irradiation)
3. Cauda equine syndrome
4. Neurologic deficit
5. Epidural glucocorticoid injections in the preceding three months
6. Previous low back surgery
7. Severe osteoporosis
8. Blood-coagulation disorder
9. Allergy to planned rescue medications
10. Suspicion of a specific cause of low back pain (fracture, tumor, infection, inflammatory disease of the spine, HIV-infection) in the patient's history or by physical examination
11. History or signs of severe dysfunction of the liver or kidney
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect.

The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
* Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
* Congenital FXIII A-subunit deficiency
* Actual or planned exposure to rFXIII