cyrilzakka/clinical-trials huggingface dataset:
Extraperitoneal Versus Transperitoneal Cesarean Section

The aim of the study is to compare post operative morbidity between extra peritoneal cesarian and trans peritoneal cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* elective cesarean (primary or repeated up to four)

Exclusion Criteria:

* emergent cesarean
* macrosomia (fetal weight \> 4500 g)
* history of major abdominal surgery
* suspected abnormal placentation
* placenta previa
eTMS for Veterans and First Responders With PTSD

A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

Veterans and first responders diagnosed with PTSD will be studied to evaluate safety and efficacy of an EEG personalized TMS paradigm. All participants will undergo 2 days of extensive testing prior to eTMS application and 2 days of testing after. Testing will include MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study.

Eligibility Criteria:
Inclusion Criteria:

* Veteran or first responder
* diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above

Exclusion Criteria:

* Claustrophobia
* Contraindications to MRI
* Pregnant
* Uncontrolled medical, psychological, or neurological conditions
* Unable to calculate EEG alpha frequency
* History of ECT or rTMS
* History of intracranial lesion or increased intracranial pressure
* History of stroke
* History of other neurologic conditions
* Family history of epilepsy
* Personal history of epilepsy
* certain medications
A PhaseI/IIa Study to Determine the Safety and Tolerability of MA09-hRPE Cells in Patients With Advanced Dry AMD

To evaluate the safety and tolerability of MA09-hRPE cellular therapy in patients with advanced dry AMD To evaluate the safety of the surgical procedures when used to implant MA09-hRPE cells To assess the number of hRPE cells to be transplanted in future studies To evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of MA09-hRPE cellular therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female over 55 years of age. Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
* Clinical findings consistent with advanced dry AMD
* GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
* No evidence of current or prior choroidal neovascularization in the treated eye
* The visual acuity (BCVA) of the eye to receive the transplant found to be eligible for trial based on study protocol
* Electrophysiological findings consistent with advanced dry AMD.
* Medically suitable to undergo vitrectomy and subretinal injection.
* Medically suitable for general anesthesia or waking sedation, if needed.
* Medically suitable for transplantation of an embryonic stem cell line

Exclusion Criteria:

* Presence of active or inactive CNV in the eye to be treated.
* Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy or other retinal vascular or degenerative disease other than ARMD.
* History of optic neuropathy.
* Macular atrophy due to causes other than AMD.
* Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
* Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
* History of retinal detachment repair in the study eye.
* History of myocardial infarction in previous 12 months.
* History of diabetes mellitus.
* History of cognitive impairments or dementia which may impact the patients ability participate in the informed consent process and to appropriately complete evaluations.
* Any immunodeficiency.
* Any abnormalities in laboratory test result.
* Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
* Current participation in any other clinical trial.
* Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
* Any other sight-threatening ocular disease.
* Ocular lens removal within previous 3 months.
* Ocular surgery in the study eye in the previous 3 months
* If female, pregnancy or lactation.
* Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
Thalidomide for the Treatment of Primary Sclerosing Cholangitis (PSC)

The purpose of this study is to determine the safety and benefit of Thalidomide with primary sclerosing cholangitis (PSC). This is a six month study.

At entry, patients will have a complete history and physical, blood tests, ultrasound, and will complete questionnaires. Eligible patients will take Thalidomide 400 mg once a day in the evening. Patients will start a dose of 100 mg per day for two weeks, increasing by 100 mg per day every two weeks to a maximum dose of 400 mg per day for 6 months. Patients will return at 6 months for an evaluation, blood tests and completion of questionnaires. Blood tests will be performed by mailed-in kits at 3 months. Patients will receive weekly phone calls for the first 2 months and bi-monthly thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of primary sclerosing cholangitis as defined by: serum alkaline phosphatase level greater than or equal to 1.5 times the upper limit of normal, negative serum antimitochondrial antibody test, cholangiography diagnostic of PSC without other etiology for biliary obstruction, and liver histology consistent with or diagnostic of PSC
* Patients must give written informed consent.
* Patients must be willing and able to comply with the most recent version of the FDA-mandated System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.®) program.

Exclusion Criteria:

* Pregnant and/or lactating female
* Inability or unwillingness to practice contraceptive measures for the prevention of pregnancy
* History of hypersensitivity reaction to thalidomide
* Inability to provide consent
* Findings suggestive of liver disease of other etiology such as primary biliary cirrhosis, chronic alcoholic liver disease, chronic hepatitis B and C infection, hemochromatosis, Wilson's disease, alpha-1-antitrypsin deficiency, autoimmune hepatitis, and cryptogenic liver disease
* Anticipated need for liver transplantation in one year from decompensated chronic liver disease or recurrent variceal bleeding, spontaneous hepatic encephalopathy, or refractory ascites
* Treatment with tacrolimus, cyclosporine, sirolimus, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, nicotine, silymarin, vitamin E or pirfenidone in the preceding three months
* History of peripheral neuropathy
* Use of medications with significant drug-drug interactions with thalidomide
* History of Human Immunodeficiency Virus (HIV) positive status or Acquired Immunodeficiency Syndrome (AIDS)
* History of coexistent advanced malignancy
* History of coexistent severe cardiovascular disease
* History of coexistent severe renal disease
* History of current excessive or recent (within 6 months) alcohol use
* Any condition that, in the opinion of the investigators, would interfere with the patient's ability to complete the study safely or successfully
* History of thrombolytic events. Combination use with corticosteroids increases risk of deep vein thrombosis.
Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining cisplatin and irinotecan in treating patients who have ovarian, fallopian tube, or peritoneal cancer.

OBJECTIVES: I. Evaluate the antitumor effect of weekly cisplatin and irinotecan in patients with suboptimally debulked ovarian, fallopian tube, or peritoneal cancer and persistently elevated serum values of CA125 after 3 courses of standard therapy with paclitaxel and either carboplatin or cisplatin. II. Evaluate the toxicity, both qualitative and quantitative, of this regimen in this patient population. III. Evaluate the quality of life of these patients.

OUTLINE: Patients receive cisplatin IV over 30 minutes followed by irinotecan IV over 90 minutes. Treatment is administered weekly for 4 weeks (days 1, 8, 15, and 22) followed by 2 weeks of rest. Patients receive at least 3 courses (18 weeks) of therapy in the absence of disease progression or unacceptable toxicity. If patients demonstrate complete response to treatment, they are encouraged to undergo second-look laparoscopy or laparotomy. Quality of life is assessed before treatment, after the first course, and then after every 2 courses of therapy. Patients are followed 30 days after the last treatment and then for survival.

PROJECTED ACCRUAL: There will be 12-35 patients accrued into this study over 18-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of the ovary, fallopian tube, or peritoneum At least 3 prior courses of standard platinum-paclitaxel regimen Patients with taxane allergy may enter this study after 3 courses of platinum based treatment CA125 at least 35 measured within 30 days of commencement of treatment Measurable disease not required No CNS metastases, carcinomatous meningitis or interstitial pulmonary fibrosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Calcium less than 12.0 mg/dL Cardiovascular: No unstable angina No New York Heart Association grade III or IV cardiac disease Pulmonary: See Disease Characteristics Other: No active or uncontrolled infection No history of seizures No known Gilbert's Disease No medical or psychiatric conditions that makes patient a poor risk for participation in this study Not pregnant or lactating Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior irinotecan or topotecan Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: At least 4 weeks since prior surgery and recovered Other: No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
Functional Electrical Stimulation for Facial Muscles

Partial or complete facial paralysis is the weakness of muscles of facial expression. Facial paralysis causes physical, social and emotional problems. Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is designed to help patients with facial nerve weakness.


Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing unilateral facial nerve paralysis Brackmann 5/6 or 6/6.

Exclusion Criteria:

* History of epilepsy or seizures.
* Individuals with metal orthopedic implants in the mouth (e.g. plates or screws).
* Individuals suffering from fibromyalgia.
* Individuals currently receiving any form of transcranial brain stimulation (e.g. rTMS, ECT, or MST).
Penthrox in Rezūm BPH

Open-labeled, single-centre study

Patients who have elected Convective Thermal Therapy using Rezūm System for the management of their BPH and fulfilled inclusion and exclusion criteria will sign informed consent form for the study. Patient will use Methoxyflurane inhaler (Penthrox™) on top of standard oral analgesia including oral lorazepam, oral Percocet® (oxycodone and acetaminophen) or oxycodone immediate-release, and intra-urethral lidocaine gel (Xylocaine®). Intravenous propofol will be used as rescue analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects of ≥ 18 years of age
* Patient who has elected Convective Thermal Therapy using Rezūm System for the management of their benign prostatic hyperplasia.
* No contra-indication on using Methoxyflurane inhaler (Penthrox™).
* Willing and able to accurately complete the required questionnaires.
* Willing and able to provide signed and dated informed consent.

Exclusion Criteria:

* Ongoing use of analgesic agents for chronic pain.
* Concomitant use of nephrotoxic agents.
* INR \> 4.
* Use of Methoxyflurane inhaler (Penthrox™) within the previous 3 months.
* Known allergy to Lorazepam, Percocet/ Oxycodone, or Xylocaine® gel.
* Known personal or familial hypersensitivity to Methoxyflurane inhaler (Penthrox™) or other halogenated anesthetics.
* Clinically significant respiratory depression, cardiovascular instability, renal or hepatic impairment.
* An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol.
* Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives.
* A history of liver dysfunction after previous Methoxyflurane inhaler (Penthrox™) use or other halogenated anesthetics.
A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers

This is an open-label (volunteers will know the names of treatments they are assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM). Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth \[PO\] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

The current study compares the efficacy of glass ionomer fissure sealant versus topical application of 5% sodium fluoride varnish in prevention of occlusal caries among preschool children.

Topical fluoride varnish (TFV) with 5% sodium fluoride in its content has proven effective in preventing caries among children and adolescents. Its reduction in DMFT is well supported by Cochrane reviews and clinical trials. However, its effect in preventing pit and fissure caries in primary dentition has not been assessed.

Pit and fissure sealants have been a recommended procedure in preventing caries development in permanent molars. Multiple systematic reviews and clinical trials have concluded that fissure sealants are significantly more effective than topical fluoride varnishes in preventing occlusal caries in permanent molars. However, a recent Cochrane review suggested that there was still insufficient evidence to determine superiority of resin or glass ionomer fissure sealants over topical fluoride varnishes for occlusal caries prevention, due to the lack of reliable results and low quality of evidence.

Also, most studies were conducted on permanent first molars among school children, whom cooperation and moisture control can be easily achieved. However, application of fissure sealants, especially resin-based sealant, in very young children can be a technique-sensitive procedure. Compared with a mean treatment time of less than 3 minutes for varnish application, application of resin-based sealants required over 15 minutes. Moisture control is also of paramount importance for the retention and success of resin-based sealants, which may be difficult among young preschool children.

Glass-ionomer sealants can chemically bond to enamel and are more tolerable to inadequate moisture control. As its application requires less clinical steps, glass-ionomer sealant is comparatively more acceptable to younger patients and can be used in outreach settings with a large number of participants. The fluoride releasing ability is also beneficial in preventing caries especially at adjacent tooth surfaces. However, its retention rate is significantly lower than that of resin-based sealants, its success rate in preventing fissure caries in very young patients is still unknown.

Eligibility Criteria:
Inclusion Criteria:

Generally healthy children aged between 3-5 years with no remarkable medical history.

Exclusion Criteria:

1. Children with the presence of caries of ICDAS code 3, 4, 5, or 6 on other primary teeth.
2. Children who had received professional fluoride application in the past 6 months.
3. Children with serious systemic disease or taking long term medication.
4. Children who are uncooperative or refuse the treatment.
5. Second primary molars that are (i) with caries in dentin indicated by ICDAS code 4, 5 or 6; (ii) partially erupted; (iii) with fillings and/or sealants; and (iv) hypoplastic or hypomineralized.
PPARγ Agonist Treatment for Cocaine Dependence

The purpose of this research study is to determine whether a medication called pioglitazone (trade name Actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients.


Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for cocaine dependence
* At least one cocaine positive urine during screening
* Female subjects: a negative pregnancy test
* Be in acceptable health on the basis of interview, medical history and physical exam
* Be able to understand the consent form and provide written informed consent
* Be able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine
* Any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk
* Significant current suicidal or homicidal ideation
* Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by Framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
* Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications)
* Currently being treated for substance misuse with medication
* Conditions of probation or parole requiring reports of drug use to officers of the court
* Impending incarceration
* Pregnant or planning to become pregnant during the course of the trial or nursing for female patients
* Inability to read, write, or speak English (many of the research instruments in this study only exist in English)
* Having plans to leave the immediate geographical area within 3 months
* Unwillingness to sign a written informed consent form
* Unwillingness to use a barrier method of birth control during the study for female patients
* History of pacemaker or metal implants or welding or metal work without protective eyewear (for risk of MRI scans).
Modulation of Immunity by Hormonal Contraceptives

Clinical study to determine if hormonal contraceptive use effects cells that fight infection (i.e., immune cells).

Feminization of the HIV pandemic is impetus for better understanding of the risk factors promoting male to female sexual transmission. One putative risk factor is hormonal contraceptive use. Our laboratory recently reported that dendritic cell activation, virus-specific T cell expansion, and memory T cell development were impaired among female mice administered depot-medroxyprogesterone acetate (DMPA) prior to viral infection of mucosal tissue, and we now are enrolling women into a clinical investigation exploring the immunomodulatory effects of several common hormonal contraceptive forms. Completion of this research will provide important comparative evaluation of the capacity of these drugs to modulate host defenses combating genital tract infection, eventually supplying healthcare providers more informed recommendations regarding appropriate hormonal contraceptive choices among women at risk for acquisition of HIV.

Eligibility Criteria:
Inclusion Criteria:

* not pregnant
* regular menstrual cycle

Exclusion Criteria:

* use of oral contraceptive or Mirena in 3 months prior to enrollment
* use of depot-medroxyprogesterone acetate in 6 months prior to enrollment
* diagnosis of sexually transmitted infection in 30 days prior to enrollment
* history of cervical malignancy
Hyperbilirubinemia After Cardiac Surgery

This study aims to evaluate the incidence and risk factors of hyperbilirubinemia following major cardiac or thoracic aorta surgery, and to determine the clinical impacts of the hyperbilirubinemia on postoperative mortality and morbidity.

Patients receiving elective cardiac or thoracic aorta surgery will be monitored for the development of postoperative hyperbilirubinemia. Collection of data will include patient baseline demographic characteristics, laboratory and echocardiographic findings, procedural factors of the surgery, and early postoperative variables. Serial postoperative liver function testings will be done during the hospitalization. Postoperative hyperbilirubinemia is defined as serum bilirubin level of 3mg/dL.

Eligibility Criteria:
Inclusion Criteria:

Patients aged over 18 years who are scheduled to undergo elective major cardiac or thoracic aorta surgery. Major cardiac surgery includes coronary artery bypass grafting, pericardiectomy and corrections of cardiac diseases using cardiopulmonary bypassing (valve surgery, tumor excision, arrhythmia surgery, heart transplantation, ventricular reconstruction, pulmonary thromboembolectomy, and atrial or ventricular septal defects closure).

Exclusion Criteria:

1. univentricular or one-and-half ventricle repairs
2. presence of known liver cirrhosis or hepatic cancer
3. history of liver transplantation
4. Genetic diseases that affects bilirubin metabolism (i.e. Gilbert syndrome)
5. preoperative bilirubin level of 3mg/dL or more.