cyrilzakka/clinical-trials huggingface dataset:
Influence of Diet on Pregnancy With Polyhydramnios

To evaluate the effect of a diet that is suited for gestational diabetes mellitus on amniotic fluid index in women with idiopathic polyhydramnios.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24-37 pregnancy weeks, singleton pregnancy, diagnosed with AFI at 95% or more by gestational age
* Express their consent to participate in the study and try to make the recommended dietary change for at least two consecutive weeks from the moment the guidelines are given.
* Without a medical indication for an immediate delivery

Exclusion Criteria:

* Medical recommendation for delivery within two weeks of diagnosis
* Condition of non-idiopathic amniotic fluid: gestational or pre-gestational diabetes, fetal malformation, proof of fetal infection
* Premature rupture or membranes
* Twins pregnancy
Phase I/II Study of Monoclonal Factor IX Concentrate for Factor IX Deficiency

OBJECTIVES:

Assess the safety and long-term efficacy of monoclonal factor IX concentrate in patients with factor IX deficiency.

PROTOCOL OUTLINE:

Patients receive monoclonal factor IX replacement therapy as inpatients. Patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Patients with factor IX deficiency.
Cardiovascular Lifestyle Study: Effects and Expense of a Cardiovascular Risk Reduction Clinic in Primary Care

The purpose of this trial is to study the effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment.

Background: Uncontrolled hypertension, hyperlipidemia, hyperglycemia, smoking and other cardiovascular risks remain at epidemic proportions despite known efficacious treatments. Issues of both provider and patient behavioral non-adherence to guidelines and therapeutic regimes, respectively, are key factors in non-control. Few interventions aimed at reducing cardiovascular risk factors are based on sound theories of behavior change.

Objective: To assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease. The three treatment approaches are usual care, usual care plus nurse telephone calls, and usual care plus clinic visits to a nurse and/or physician.

Design: Patients will be randomized to a 1) specialized proactive, and holistic cardiovascular risk management clinic using principles of behavior change; 2) nurse telephone calls as an attention placebo, yet a low dose, health promotion intervention; and 3) usual primary care. A random sample of 670 patients with cardiovascular risks identified in the past five years will be selected. Patients will be excluded if they do not speak English, are cognitively impaired or live in a nursing home. Interview questionnaires will measure cardiovascular risk, intention to change, social support, depression, coping and health services use. In addition, patients will be required to give a blood sample to measure cholesterol and glucose levels. Patients will then be randomized to one of three treatment groups.

Significance: The expected findings of this study is that the cardiovascular clinic, with nurse and physician, will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* A random sample of all persons with visits to their primary care physician for cardiovascular risks in past year. Cognitively intact (mini-mental state) or living with a carer who is cognitively intact. All other co-morbidities

Exclusion Criteria:

* Presently in a nursing home or in-patient long-term care facility (already receiving medications and diets as prescribed). No available family/friend interpreter if non-English speaking.
Healthy Networks Water Treatment Study

This study is a non-randomized double cohort study evaluating the impact of social network-based water treatment education on sustained household water treatment behaviors over 12 months of follow up. A three-session curriculum was developed on the spread of water borne illness, water treatment methods, and the role of social support in water treatment. Participants in the intervention arm will receive this curriculum in a group setting, where group members are self-selected members of the study participants' social networks. Participants in the comparison arm will receive the same curriculum taught at the individual household level. All participants will receive CeraMaji ceramic filters for use in household water treatment after participating in the three sessions. Research staff will conduct surveys and water quality testing over a period of 12 months to determine whether participants continue to use the ceramic filters. Investigators hypothesize that social network-based training on household water treatment will result in a higher proportion of households using ceramic filters at 6- and 12-months as compared to households receiving individual training.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the Mfangano Island Healthy Networks Impact Study
* Resident of Mfangano Island in the East or North sub-locations
* 18 years of age or older
* Conversant in DhoLuo or English

Exclusion Criteria:

* none
Placebo-controlled Trial of 5-hydroxytryptophan and Creatine for SSRI or SNRI Augmentation in Treatment Resistant Depression in Females

The investigators propose to determine if 8 weeks of dietary augmentation with oral 5g creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (5-HTP) twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI- or SNRI-resistant depression, combined with the examination of changes in functional connectivity based on resting-state fMRI and changes in brain metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.

Serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. Therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. Thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-HTP) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Eligibility Criteria:
Inclusion Criteria:

* Female gender, ages 25-40 years inclusive
* Current diagnosis of Major Depressive Disorder identified by the SCID-I
* Current HAM-D17 score of \> 16
* Adequate adherence to any FDA approved SSRI or SNRI for at least 8 weeks
* Right-handed

Healthy Controls Inclusion criteria:

* Female gender, ages 25-40 inclusive
* No current or past DSM-5 diagnosis, as determined by clinical and structured interviews

Exclusion Criteria:

* Any non-MDD and non-anxiety psychiatric diagnosis, as identified by the SCID-I
* History of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease
* Diabetes type I or II
* Current colitis or diverticulitis
* History of or current pulmonary disease
* History of cardiac disease or QTc \> 500ms
* History of fibromyalgia, lupus, eosinophilia-myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition
* History of or current seizure disorder
* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
* Current treatment with an antipsychotic, mood stabilizer, or non-SSRI antidepressant
* Positive pregnancy test, pregnancy, failure to use adequate birth control method
* Previous diagnosis of serotonin syndrome or evidence of serotonin syndrome
* Use of any excluded drugs or medications including serotonergic drugs or medications (Table 2)
* Pre-existing eosinophilia (absolute eosinophil count \> 500/uL)
* Contraindications to MRI: ferromagnetic implants, implanted devices, claustrophobia
Trial to Evaluate the Safety and Effectiveness of Vagus Nerve Stimulation for Children With Refractory Epilepsy

Children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. Vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age 3-6
2. At least 6 seizure per month
3. Refractory Epilepsy
4. In good health except epilepsy
5. Patients or his(her) familyscould understand this method and sign the informed consent
6. Patients with good compliance and could complete postoperative follow-up

Exclusion Criteria:

1. Results of MRI remind epilepsy caused by intracranial space-occupying lesions
2. The vagus nerve lesion and damage
3. Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication
4. Cann't write the epilepsy diary
5. Participating other clinical trial
6. Cann't complate the operation
7. Complete the postoperative follow-up
8. Cann't complete the promgramming
10-year Follow-up of the Ponto Wide-implant

The goal of this single center, prospective study is to investigate the survival of the Ponto Wide Implant at least 10 years after implantation.

Secondary objectives are:

1. To determine the amount and causes of implant loss and implant and/or abutment removal.
2. To establish the stability of the implant.
3. To assess skin complications.
4. To investigate daily usage and the number of hours of use of the sound processor.
5. To determine the quality of life.

During a check-up of the implant at the outpatient clinic, the skin around the implant will be assessed, the stability of the implant will be measured, and the patient will be asked to complete two questionnaires.

Patients who participated in the previous studies concerning the Ponto Wide implant from Oticon (3 years after implantation) will be approached. If consent is given, they will be added to the database of the already completed studies, and new data will be stored in the same database. The patients were already pseudonymized in the previous studies, and the database is secured with a code that is only accessible to individuals directly involved in the research

Eligibility Criteria:
Inclusion Criteria:

* Implantation with Ponto Wide implant (diameter 4.5 mm, length 4.0 mm)
* Ten or more years of post-operative follow-up.
* Valid informed consent

Exclusion Criteria:

* No specific exclusion criteria have been set for the study.
Safety/ Feasibility of Percutaneous Administration of Vonapanitase as Monotherapy for Peripheral Artery Disease (PAD) of the SFA and Popliteal Arteries

The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years.
2. Clinical diagnosis of PAD secondary to atherosclerosis affecting a lower limb.
3. ABI \<0.90 at rest or with exercise, or a toe-brachial index (TBI) \<0.70 if ABI value is \>1.30 (non-compressible), or radiographic evidence of PAD that correlates with clinical symptoms.
4. Rutherford category 2-4.
5. Screening duplex Doppler ultrasound with a SFA or PA lesion with a PSVR \>2.4.
6. De novo lesion, not previously treated by angioplasty, atherectomy, or stent.
7. If female and of childbearing potential (premenopausal and not surgically sterile) must have a negative pregnancy test at the screening visit and be willing to use contraception from the time of the screening visit to 1 week following study drug administration. Acceptable methods of birth control include abstinence, barrier methods with spermicide, implants, injectables, oral contraceptives, intra-uterine device, or a vasectomized partner.
8. Ability to understand and comply with the requirements of the entire study and communicate with the study team.
9. Ability to provide written informed consent using a document that has been approved by the required institutional review board.

Exclusion Criteria

1. Patients in whom arterial insufficiency in the lower extremity is the result of an immunologic or inflammatory non-atherosclerotic disorder (e.g., Buerger's disease, vasculitis).
2. Total occlusion of the SFA or PA in the index leg.
3. Planned surgical or endovascular procedures to the affected leg on the day of or within 28 days of study drug administration.
4. Deep vein thrombosis within the past 3 months.
5. Known bleeding disorder.
6. Presence of any arterial aneurysm in the index leg.
7. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation).
8. Platelet count \<130K, hematocrit \<30%, bilirubin or ALT \>3.0 times the upper limit of normal.
9. Arterial systolic BP \>200 mmHg or diastolic BP \>100 mmHg at screening or day of procedure.
10. Pregnancy, lactation or plans to become pregnant during the course of the study.
11. Presence of any significant medical condition that might significantly confound the collection of safety and efficacy data in this study.
12. Malignancy or treatment for malignancy within the previous 12 months with the exception localized basal cell or squamous cell skin cancer, or any cancer in situ.
13. Treatment with any investigational drug within the previous 30 days or investigational antibody therapy within 90 days prior to signing informed consent.
14. Known allergy to contrast media, iodine, lidocaine, prilocaine, or EMLA Cream (lidocaine 2.5% and prilocaine 2.5%).
Intravenous Lidocaine and Postoperative Pain Management

This study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. Half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.

Postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this patient population. However, opioid administration can exacerbate postoperative ileus and further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects.

Studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. Therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Open surgery;
* Patients allergic to lidocaine or other local anesthetics;
* Drug abuser.
Adjunctive Effect of Pulsed Electromagnetic Field on Quadriceps Muscle Strength After Burn Injury

The aim of this study is to examine whether Pulsed Electromagnetic Field therapy combined with strengthening exercises will have a positive effect on quadriceps muscle strength in lower limb burn .

• Subjects: Sixty patients with lower limb burn, subdivided into two groups each one has 30 patients.

* Group (A) = Pulsed Electromagnetic Field therapy and quadriceps strengthening exercises group.
* Group (B) = quadriceps strengthening exercises group. • Equipment and tools:

  1. Measurements tools:

     Isokinetic dynamometer : to measure the quadriceps muscle peak torque before the treatment and after 8 weeks of treatment for both groups.
  2. Therapeutic tools:

Pulsed Electromagnetic Field therapy device and free weights for strengthening of quadriceps muscle.

Eligibility Criteria:
Inclusion Criteria:

* - Patients are males.
* Their age will range from (25-40) years.
* Patients will suffer from second-degree burn ( Partial thickness of thermal injury).
* Total body surface area (TBSA) for the burns will be ranged from 20% to 35% .
* They will be selected from Outpatient Clinic of Faculty of Physical Therapy and Burn Unit at Om El-Obour Hospital.
* Patients will begin the training program after complete wound healing.
* All patients will receive traditional physical therapy program in the form of range of motion exercise, stretching, splinting, massage, functional training for ambulation and activities of daily living.
* Patients will be given their informed consent.

Exclusion Criteria:

* - Patients who participate in any rehabilitation program to improve muscle strength prior to the study.
* Musculoskeletal disorders that will impair performance during training and tests.
* Equilibrium disorders.
* Uncontrolled cardiovascular or pulmonary diseases .
* Neurological and renal disorders.
* metabolic or vascular disease with a neurological component such as diabetes,
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders.
* Subjects with burn to the posterior thigh with knee flexion contracture, which affected the function of the quadriceps muscle.
* Lower limb lymphedema or lipoedema.
* Athletic subjects.
* Subjects with morbid obesity.
A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11

This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.

The investigators recently developed a mutant form of rhIL-11 with improved stability. In in vitro experimental systems, mIL-11 was shown to endure chemical and proteolytic stresses more effectively, while retaining the biological activity of the original rhIL-11. The improved stability of mIL-11 was also demonstrated in the comparative pharmacokinetic study of subcutaneously delivered mIL-11 and rhIL-11 in the rodent and primate models. Based on its improved pharmacokinetic and pharmacodynamic features. In Phase II study shows that mIL-11 is well tolerated and has thrombopoietic activity equivalent to one third of the clinical dose of rhIL-11, indicating the potential of mIL-11 for use in the treatment of CIT. This study is a phase III, single-blinded, randomized,multicenter,cross-over study designed to evaluate optimal dosing dose and efficacy and safety of mIL-11 on CIT patients receiving suitable chemotherapeutic regimen for treating cancer.

Eligibility Criteria:
Inclusion Criteria:

* histological verification of malignancy at the time of initial diagnosis；
* Patients (age,18-75 years) receiving chemotherapy, who had experienced platelet counts below 75×10\^9/L；
* patients were required to have adequate bone marrow,hepatic, and renal functions at the time of study entry；
* ECOG ≤2；
* patients to have normal laboratory findings:while white blood count \>3.0×10\^9/L,platelet count ≥100×10\^9/L, and AST and/or ALT lesser than 2.5 times the upper limit of the normal value；
* The estimated life expectancy of the patient was more than 3 months.

Exclusion Criteria:；

* patients who received total body irradiation；
* patients with childbearing potential；
* patients who were breast-feeding or pregnant
Mesenchymal Stem Cells in Critical Limb Ischemia

This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

* Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.
* Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
* Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot
* Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications
* Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits
* Normal liver and renal function
* On regular medication for hypertension if any

Exclusion Criteria:

* Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
* CLI patient requiring amputation proximal to trans-metatarsal level
* Patients with gait disturbance for reasons other than CLI.
* Type I diabetes
* Patients having respiratory complications/left ventricular ejection fraction \< 25%f) Stroke or myocardial infarction within last 3 months
* Patients who are contraindicated for MRA
* Have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
* Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year
* Patients already enrolled in another investigational drug trial or completed within 3 months.
* History of severe alcohol or drug abuse within 3 months of screening.
* Hb% \< 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c \> 8%
* Women with child bearing potential, pregnant and lactating women.
* Patients tested positive for HIV 1, HCV, HBV,