cyrilzakka/clinical-trials huggingface dataset:
PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI \</= 32).
3. Metformin improves fertility outcomes in women with BMI \> 32 with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* Women between the age of 18 and 39 years inclusive.
* Anovulatory infertility of duration at least 12 months.
* Polycystic ovary syndrome, based on Rotterdam consensus criteria.
* Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
* Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;

Exclusion Criteria:

* Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
* Already taking oral hypoglycaemics.
* Diabetics receiving treatment.
* Renal impairment
* Chronic hepatic disease
* Cardiac Disease
* Alcohol dependency
* Pre-disposition to lactic acidosis
* Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation).
* For those women who have had previous fertility treatment, the following would be excluded:

  * Women who have had \> 5 cycles of clomiphene citrate
  * Women who have had \> 5 months metformin treatment previously
  * Women who have proven to be resistant to 100mg or more of clomiphene citrate.
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors

This trial collects feedback from patients to develop a video game in improving the outcomes in stem cell transplant survivors. A video game may help to improve health behaviors for leukemia or lymphoma patients after stem cell transplant.

PRIMARY OBJECTIVES:

I. Develop a prototype intervention electronic game that implements a baseline testable feature set, including features for social networking within a virtual game space, managing an intermittent mediated reward cycle, goal setting and tracking, and collaborative problem solving.

II. Evaluate the technical merit, feasibility, user perception and acceptance of the prototype system with adolescents and young adults (AYAs) allogeneic hematopoietic stem cell transplantation (HSCTs) patients in recovery.

III. Based on the results of the prototype evaluation, enhance and complete development of the Stempowerment on-line intervention.

IV. This is a single arm study with no comparison group; therefore, the purpose is to evaluate the impact of the Stempowerment intervention on

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients attend a focus group for up to 1.5 hours and provide feedback on design elements, specific desirable features, and preferences for the initial prototype.

GROUP II: Patients have access to the game for 3 weeks and then provide feedback on problems or questions regarding the use of the prototype.

Eligibility Criteria:
Inclusion Criteria:

Phase I

The target population for this study will consist of:

1. Individuals ages 15-29
2. Able to read and speak English
3. Diagnosis of leukemia or lymphoma
4. First time allogeneic SCT recipient

Phase II

The target population for this study will consist of:

1. Individuals ages 18-39 (in phase I, we recruited only individuals age 15-29. For phase II, we will recruit young adults, and will expand the eligible age range up to 39 years. This expansion in age eligibility to 39 years is consistent with the National Cancer Institute definition of adolescents and young adults with cancer, and is consistent with the age range of patients seen at MD Anderson in the Adolescent and Young Adult Center.
2. Able to read and speak English
3. Diagnosis of leukemia or lymphoma (including Myelodysplastic Syndrome - MDS) or lymphoma
4. HSCT recipient

Exclusion Criteria:

Phase I

The target population will be excluded if:

1. They do not speak English
2. They have vision problems
3. They have cognitive problems
4. They have psychological difficulties

Phase II

The target population will be excluded if:

1. They do not speak English
2. They have vision problems that would preclude them from viewing a computer screen.
3. They have an intellectual deficiency that would prevent the potential participant from understanding information delivered on the computer platform or as defined by the DSM-V Diagnostic and Statistical Manual of Mental Disorders that would prevent them from understanding information delivered on the computer platform.
HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV

The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.

Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16, 18, 31, 45). Around 50-80% of women are infected by HPV within their whole lives. The current treatment of HPV-positive mainly includes drug, cryotherapy, laser, microwave, surgery and so on. Some treatments are convenient, but easy to cause pain or infection and there is still a greater risk of recurrence after treatment.

Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of HPV specific cytotoxic T lymphocytes cells in patients.

Eligibility Criteria:
Inclusion Criteria:

1. Written, informed consent obtained prior to any study-specific procedures.
2. Evidence of HPV virus activation (viral DNA) or high risk of HPV infection.
3. Not suitable for routine treatment or invalid to antiviral drugs.
4. Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA.
5. Age less than 75 years.
6. Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
7. Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000/mm\^3, platelet (PLT) ≥ 1,000/mm\^3.
8. Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): Creatinine ≤ 2\*ULN, Bilirubin ≤ 2\*ULN, SGOT/ SGPT ≤ 3\*ULN.
9. If HPV-CTL is not from the patient's own, then the provider of HPV-CTL needs to meet the following criteria:

   * did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
   * white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl.
10. Human immunodeficiency virus (HIV) test was negative.

Exclusion Criteria:

1. Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
2. Subject is albumin-intolerant.
3. Subject with life expectancy less than 8 weeks.
4. Subject participated in other investigational somatic cell therapies within past 30 days.
5. Subject with positive pregnancy test result.
Effects of Human Leptin Replacement

This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.

The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin.

Eligibility Criteria:
Inclusion Criteria:

* Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far).

Exclusion Criteria:

* Pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception.
* Subjects with hemoglobin levels below 12 g/dl.
* Subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI.
Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus

To evaluate the efficacy of empagliflozin administered orally once daily in postprandial glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic control on no antidiabetic treatment.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus prior to informed consent
* Male and female patients on diet and exercise regimen for 12 weeks prior to informed consent who are:

  * drug-naïve, defined as no antidiabetic drugs for at least 12 weeks prior to informed consent or,
  * pre-treated with one oral antidiabetic drug (except sulfonylurea and thiazolidinedione); the present antidiabetic therapy has to be unchanged for at least 12 weeks prior to the informed consent. (Sulfonylurea is permitted as pre-treatment drug only if the dose is equal or less than a half of daily maximum approval dose.)
* Glycosylated haemoglobin (HbA1c) at Visit 1 (screening)

  * for patients without antidiabetic therapy : HbA1c \>=7.0 to =\<10.0%
  * for patients with one oral antidiabetic drug : HbA1c \>=7.0 to =\<9.5%

Exclusion criteria:

* Uncontrolled hyperglycaemia with a glucose level \>240 mg/dL (\>13.3 mmol/L)
* Impaired renal function, defined as estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 (moderate and severe renal impairment, modification of diet in renal disease (MDRD) formula)
* Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks prior to informed consent
* Indication of liver disease, defined by serum levels of either alanine transaminase (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper limit of normal (ULN)
The Effects of a Structured Hand Exercise Program on Trigger Finger: A Randomized Controlled Trial

To explore the effectiveness of a structured hand exercise program as a conservative treatment for trigger finger.


Eligibility Criteria:
Inclusion Criteria:

* Adults with aged \> 18 years old who are diagnosed with trigger finger
* The Green classification grade 2 or grade 3
* Pain (NPRS) equal or more than 4/10, during active triggering

Exclusion Criteria:

* Pediatric or congenital trigger finger
* Previously received physiotherapy, corticosteroid injection or surgery for trigger finger
* Hand trauma, local infection or using systemic steroids due to other diseases
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial

Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Eligibility Criteria:
Inclusion Criteria:

* non-blanchable erythema above a bony prominence
* Informed consent

Exclusion Criteria:

* Pressure ulcers grade 3 or 4
* Turning contra-indicated based on medical grounds
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

Experienced soft contact lens wearing subjects will be enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses may be trialed. Once vision and lens fit are determined to be acceptable, eligible subjects will wear study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses should be worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements will be taken at the insertion visit and at the 7-day follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
Consultation in the Emergency Department

This study intends to evaluate consultation in the Emergency Department. The purpose is to demonstrate that standardizing communication in the Emergency Department may lead to improved consultation.


Eligibility Criteria:
Inclusion Criteria:

* Emergency medicine residents (PGY1-5)

Exclusion Criteria:

* Did not want to partake in the study
Pharmacokinetics and Safety, Tolerability of DWJ211in Healthy Volunteers

This is a randomized, open-label, parallel design Phase I clinical trial to evaluate the safety/tolerability and pharmacokinetic of DWJ211 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult aged between 19 and 65 at screening
* Those whose BMI is less than 40kg/m2
* Subject who will agree with the no treatment(liposuction or surgery, obesity treatment)
* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc

Exclusion Criteria:

* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
* History of any intervention to treat Submental fat or abdominal fat
* History or current symptoms of dysphagia
* History of trauma associated with the chin or neck or abdominal areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment
Hypnosis for Smoking Relapse Prevention

A majority of smokers who quit return to smoking within three months of their quit date. This study is a randomized trial to investigate the effectiveness of hypnosis versus behavioural counseling to promote maintenance of abstinence or relapse prevention in quitting smokers. The hypothesis is that hypnosis will be at least as effective as behavioral counseling in preventing relapse to smoking in smokers who are able to quit for at least three days.

We will enroll 520 current smokers in the study. All subjects will participate in an initial smoking cessation intervention involving brief counseling and nicotine replacement therapy. Participants who are able to achieve at least 3 consecutive days of abstinence will be randomized to one of two relapse prevention interventions. The participants in Study Arm 1 will receive a hypnosis intervention designed to facilitate relapse prevention. Participants in Study Arm 2 will participate in empirically-supported behavior relapse prevention counseling, utilizing the National Cancer Institute's Forever Free materials. Both interventions will be conducted in two 60-minute individual sessions scheduled one week apart in addition to counseling phone calls on their quit date and after relapse prevention treatment.

Outcomes for the two study arms will be compared by assessing biochemically-validated point-prevalence smoking status at 9 weeks(end of treatment), 26 weeks and 52 weeks. Hypnosis for relapse prevention is designed to sustain the ex-smokers commitment to remain abstinent, to provide a review of behavioral skills to resist the temptations to smoke, and to encourage attempts to quit again if relapse occurs.

Eligibility Criteria:
Inclusion Criteria:

* currently smoking at least 5/cigarettes per day during the past week
* willingness to participate and give informed consent
* aged 18 and above

Exclusion Criteria:

* contraindications to nicotine replacement
* pregnancy, lactation
* unstable psychiatric disorders
* current (last 3 months)substance use disorder
* terminal illness
* current use of smoking cessation medication
The Relationship Between Brain Injury Biomarkers in Cerebrospinal Fluid and Blood of Patients After Cardiac Arrest and Prognosis

This study is a single-center, prospective, observational study. After successful cardiopulmonary resuscitation for patients with cardiac arrest, they will be transferred to the emergency intensive care unit for further standardized targeted temperature management. When evaluating that the patient meets the indications for lumbar puncture and there are no contraindications for lumbar puncture, lumbar puncture examinations will be completed immediately after return of spontaneous circulation (ROSC), at 24 hours of hypothermia, at 72 hours of hypothermia, and after rewarming. Routine cerebrospinal fluid examinations such as cerebrospinal fluid routine, cerebrospinal fluid biochemistry, and cerebrospinal fluid lactate will be sent for inspection. At the same time, 6 ml of cerebrospinal fluid will be retained and stored in a refrigerator at -80°C. After sample collection is completed, enzyme-linked immunosorbent assay (ELISA) will be used to detect markers such as NSE, HCH-L1, NFL, tau, MBP, GFAP, and S100β. While performing the lumbar puncture examination, peripheral blood will be collected. After centrifugation for 10 minutes (4000 revolutions), serum will be retained and stored in a refrigerator at -80°C to complete the examination of the above markers. After 3 months, the patient\&#39;s neurological function prognosis will be followed up according to the Pittsburgh Cerebral Performance Category (CPC) scale.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Still lack of directive movements after restoration of spontaneous circulation through cardiopulmonary resuscitation.
* Advanced life support and targeted temperature management are carried out within 6 hours after return of spontaneous circulation (ROSC).

Exclusion Criteria:

* Patients with contraindications for lumbar puncture (severe cerebral edema indicated by brain imaging, disappearance of basal cisterns or occult intracranial mass lesions, receiving antiplatelet and anticoagulant therapy, and those with coagulation disorders).
* Pregnant patients.
* Patients with concomitant traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
* Patients whose families do not agree to be enrolled.
Therapeutic Epidural Patch Versus Pain Block in the Midface for Headache

The purpose of this study is to compare a pain block in the midface, versus the traditional, more invasive, therapeutic epidural patch for the treatment of headaches

The sphenopalatine nerve block has been used to treat headaches. Patients have headaches after epidural access from post dural puncture. We need to know if sphenopalatine nerve block will help the patient with the headache.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 13-92
* Subjects have medical diagnosis of PDPH and require treatment
* Subjects who signed consent/assent

Exclusion Criteria:

* \<13 years of age
* Pregnancy
* Subjects with heart failure
* Subjects already being treated with lidocaine patch or other vehicle for chronic pain
* Non-english speaking subjects
* Subjects with platelets \<100,000
* Subjects that are septic
* Subjects with an allergy to lidocaine
* Subjects with known nasal polyps
* Subjects with recent neurological event
* Subjects on anticoagulant therapy
* Subjects that received prior therapy with SPG block or EBP
Sarcosine (N-Methylglycine) Monotherapy for Schizophrenia

The etiology of schizophrenia remains unclear. Schizophrenia patients reveal positive symptoms, negative symptoms, and cognitive impairments. In addition to dopamine system hyperactivity, hypofunction of N-methyl-D-aspartate (NMDA) receptor plays a role in the pathophysiology of schizophrenia. Consequently, enhancing NMDA receptor neurotransmission has been considered as a novel treatment approach. To date, there have been several trials on NMDA enhancers reported. For example, sarcosine (N-methylglycine, a glycine transporter I inhibitor) showed therapeutic effects not only in chronically stable patients but also in acutely exacerbated ones when added-on to antipsychotics. In addition, sarcosine yields excellent safety profiles, in comparison to current antipsychotics.

It remains unclear whether NMDA enhancers, such as sarcosine, can serve as monotherapy for schizophrenia. The aims of this project are to examine the efficacy and safety of sarcosine monotherapy for acutely-ill schizophrenic patients, and to compare the effects of 2 grams/day, effective dose, with 1 gram/day, ineffective lower dose.

In the study, 20 schizophrenic patients are recruited into the 6-week trial and randomly assigned into the two groups (1 g/d and 2 g/d) with a double-blind manner. Clinical manifestation (Positive and Negative Syndrome Scale; Scale for the Assessment of Negative Symptoms), side effects and quality of life are evaluated every two weeks during the trial. The efficacies of two groups are compared, and the characteristics of better responders are analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Fulfill the criteria of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV).
* Free from antipsychotics for at least 7 days before enrollment.
* Agree to participate in the study and provide informed consent

Exclusion Criteria:

* Meet DSM-IV criteria of major mood disorder, current substance dependence or mental retardation
* History of epilepsy, head trauma or CNS diseases
* Major, untreated medical diseases
* Pregnancy or lactation
* Receiving psychotropic agents or depot within three months prior to study entry
Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major

The purpose of the study is to assess the safety and efficacy of haploidentical hematopoietic stem cell transplantation for patients with thalassemia major.

The only curative therapy for thalassemia major remains the replacement of the defective erythropoiesis by allogeneic hematopoietic stem cell transplantation(HSCT). However, this option is unavailable to many patients as a result of a lack of compatible donors.Haploidentical transplantation has been certified as a valuable alternative for hematological malignancy patients lacking a well-matched donor, with results comparable matched HLA-identical sibling donors or unrelated donors.The objective of this study is to test the feasibility of haploidentical HSCT for patients with thalassemia major.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with thalassemia major
2. Lacking of a HLA-identical sibling donor or unrelated donor
3. Indication of haploidentical hematopoietic stem cell transplantation
4. No restrictions for transplantation

Exclusion Criteria:

1. Any restriction for transplantation
2. No indication of haploidentical hematopoietic stem cell transplantation