cyrilzakka/clinical-trials huggingface dataset:
Post-Prandial Liver Glucose Metabolism in PCOS

The Investigators will measure if hepatic metabolism is upregulated in obese girls with PCOS and hepatic steatosis (HS), compared to PCOS without HS and obese controls without HS.

This will be a cross-sectional study with 4 groups of youth. A 6 hour OSTT (Oral Sugar Tolerance Test) with an oral U-C13 glycerol tracer will be paired with nuclear magnetic resonance spectroscopy (NMR) isotopomer analysis of serum samples to describe flux through the hepatic pentose phosphate pathway, TCA cycle and FAS pathways in girls with PCOS receiving lifestyle only, metformin or oral contraceptive treatment, and obese girls with regular menses receiving lifestyle therapy. Hepatic steatosis will be measured with MRI.

Please note that 3 study groups: PCOS on metformin, PCOS on oral contraceptive treatment, and obese girls with regular menses were not funded in the study, so no participants were enrolled in these 3 arms of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Ages 12-21
3. Sedentary- less than 2.5 hours of moderate (jogging, swimming etc) exercise a week.
4. BMI equal or greater than the 90th percentile for age and gender
5. For PCOS groups:

   * (NIH definition) irregular menstrual cycles at least 1.5 years after menarche, and
   * either clinical evidence of hyperandogenism, or
   * elevated Testosterone (above the norms for age/tanner stage) at time of screening, or documented prior to initiation of therapy for OCP and metformin groups.
6. For PCOS groups:

   * patients un-treated or currently treated with either Metformin 1500-2000 mg a day, or
   * oral contraception (30-35 mcg ethynyl estradiol a day) for at least 6 months, with \> 80% adherence confirmed via refill frequency from pharmacy.
7. For non-PCOS groups:

   * regular menstrual cycles at least 1.5 years after menarche, and
   * no clinical evidence of hyperandrogenism.

Exclusion Criteria:

1. Use of medications known to affect insulin sensitivity:

   * oral glucocorticoids within 10 days,
   * atypical antipsychotics,
   * immunosuppressant agents,
   * HIV medications.
   * Nexplanon, Depo-Provera or Mirena progesterone only contraceptives.
   * Dermal patch or vaginal ring contraception methods.
   * For controls only: metformin or oral contraception.
2. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.
3. Severe illness requiring hospitalization within 60 days
4. Diabetes, defined as Hemoglobin A1C \> 6.4%
5. BMI percentile less than the 90th percentile for age and sex.
6. Weight \>325 lbs or \<84 lbs.
7. Anemia, defined as Hemoglobin \< 10 mg/dL
8. Diagnosed major psychiatric or developmental disorder limiting informed consent
9. Implanted metal devices that are not compatible with MRI
10. Use of blood pressure medications
11. Known liver disease other than NAFLD or AST or ALT \>150 mg/mL

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Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Multicenter, open-label Phase 1b/2 study of ripretinib in combination with binimetinib in patients with gastrointestinal stromal tumor (GIST). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2).


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age with advanced GIST (unresectable or metastatic).
2. Must have at least progressed on imatinib or have documented intolerance to imatinib.
3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
4. Patients must have a histologic diagnosis of GIST.
5. If a female of childbearing potential, must have a negative pregnancy test.
6. Adequate organ function and bone marrow function

Exclusion Criteria:

1. Received prior anticancer therapy within 14 days or 5× the half-life whichever is longer) prior to the first dose.
2. Ongoing or prior participation in the DCC-2618-03-002 study.
3. Prior therapy with ripretinib.
4. Prior therapy with MEK inhibitor.
5. History of certain ocular disorders.
6. History of clinically significant hepatobiliary disease.
7. Known active central nervous system metastases.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. Systemic arterial or venous thrombotic or embolic events within 6 months of first dose.
10. History of acute or chronic pancreatitis
11. History of chronic inflammatory bowel disease or Crohn's disease requiring intervention within 12 months of first dose.
12. Gastrointestinal abnormalities including but not limited to:

    * inability to take oral medication,
    * malabsorption syndromes
Consolidation Whole Abdominal Intensity-Modulated Radiation Therapy (IMRT) in Advanced Ovarian Cancer

The primary objective of this phase-II study is to assess the toxicity of consolidation intensity-modulated whole-abdominal radiotherapy using tomotherapy in patients with advanced optimally debulked stage International Federation of Gynecology and Obstetrics (FIGO) III ovarian cancer with a complete remission after adjuvant chemotherapy.

36 patients will be treated to a total dose of 30 Gy in 1.5 Gy fractions. The planning target-volume includes the entire peritoneal cavity and the pelvic and para-aortal node regions. Intensity-modulated whole-abdominal radiotherapy allows an effective sparing of liver, kidneys and bone-marrow (vertebral bodies and pelvic bones).


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed ovarian cancer or tube cancer or primary peritoneal carcinoma stage FIGO III
* primary optimal debulking surgery
* postoperative gross residual tumor ≤ 1cm ( R0, R1 oder R2 \< 1cm situation)
* adjuvant chemotherapy with platin and taxane
* complete remission after chemotherapy
* Karnofsky performance score \> 60
* patients \>18 years of age
* written informed consent

Exclusion Criteria:

* stage FIGO I or II
* stage III with postoperative gross residual tumor \> 1cm
* stage FIGO IV
* recurrence situation
* delayed wound healing post laparotomy
* leucopenia \<2000/ml before radiotherapy
* thrombocytopenia \<75000/ml before radiotherapy
* clinically active renal, hepatic, cardiac, metabolic, respiratory, coagulation or hematopoietic disease
* status post pelvic or abdominal radiotherapy
* status post other cancer disease in the past 5 years (cervical cancer in situ, basal cell carcinoma, squamous cell carcinoma of the skin are excluded)
* participation in another clinical trial
Macrolide in Pregnancy and Adverse Child Outcomes

Over the last 20 years, concerns have been raised about rare but serious adverse outcomes associated with macrolide use during pregnancy. The strongest evidence comes from a large randomised controlled trial (RCT, ORACLE Child Study II) of women with spontaneous preterm labour (SPL), which reported an increased risk of cerebral palsy in children whose mothers received erythromycin compared with no erythromycin. A recent systematic review on macrolides prescription during pregnancy showed consistent associations with miscarriage, and less consistent associations with adverse child outcomes such as congenital malformations, cerebral palsy and epilepsy. In this study, the investigators will evaluate associations between macrolide antibiotics prescription during pregnancy and a range of adverse child outcomes.

The investigators compare children whose mothers were prescribed an only monotherapy of macrolides or penicillins during pregnancy (from 5 gestational week (GW) to delivery and by trimesters). The investigators estimate the risk ratios of major malformation (overall and five system-specific) and hazard ratios of four neurodevelopmental disorders (cerebral palsy, epilepsy, attention-deficit/hyperactivity disorder, and autism spectrum disorder) with control for potential confounders. The associations will also be examined by subtype of macrolides and treatment duration.

Mother-child pairs will be analysed in a cohort selected from the UK Clinical Practice Research Database (CPRD) between 1990 and 2016.


Eligibility Criteria:
Inclusion Criteria:

* Children whose mother was prescribed an only monotherapy of macrolides or penicillins during pregnancy (between 5 GW and delivery).
* Children born from Jan 1st 1990 to June 30th 2016 in the CPRD Mother Baby Link.
* Children who registered with the GP within 6 months of birth
* Children whose mother was aged 14 to 50 years and had been registered with GP at least 50 weeks before estimated conception date until after delivery

Exclusion Criteria:

* Children with known chromosomal abnormalities and pregnancies with exposure to known teratogenic medications (warfarin, angiotensin-converting enzyme (ACE) inhibitors, antineoplastic agents, isotretinoin, misoprostol, and thalidomide)
Acceptability and Feasibility of Human Papilloma Virus Vaccine

The overall program goal is to determine the Acceptability and Feasibility of introducing a population based Human Papilloma Virus (HPV) Vaccination programme and understanding the key individual and community factors that would determine the potential acceptability of the vaccine.

The eligible participant will be chosen by door-door household visit. Each participant will be given information regarding the study and written informed consent will be obtained from them. Their participation will be entirely voluntary and no pressure or coercion will be used. Our team will help them with questions that are not well understood by them or are ambiguous for them. The questionnaire is in 2 sections. Section one will try and ascertain the mother's Knowledge, Attitude and Perception regarding cervix cancer, HPV infection and HPV Vaccination.

Section 1 will be interviewed for a period of 5-10 minutes followed by an information sheet providing details on HPV infection, its association with cervix cancer and HPV Vaccination against cervix cancer. The information sheet available will be explained to them for a period of 10-15 minutes. Our social workers will be available at all times to allay their misinterpretations. This will be followed by section 2 which will be a post intervention questionnaire comprising of questions regarding their attitude towards HPV vaccination and identifying barriers and motivators for these women towards vaccination.

The post-intervention questionnaire would be interviewed for a period of 10-15 minutes, thus a total of 25-40 minutes will be made available to every participant for the entire session. The team is expected to cover 15 women per day totaling to 300 women per month considering the monthly holidays and time lost in certain administrative issues.

Patients will be recruited for 4 months which will be followed by data entry, data analysis, formulation of results and write -up. Thus the entire study will last for eight months. The questionnaire consists of mostly close ended questions with options in the form of yes/no/do not know. Some questions which require definitive answers have been provided with plausible options. Some questions have been left open ended so as to avoid ambiguity. The questionnaire is simple, in continuity and is translated into Hindi and Marathi languages so as to meet the needs of the local population.

Eligibility Criteria:
Inclusion Criteria:

All married women bearing daughters of the age group 10-18 years and are conversant in either Marathi, Hindi or English will be included in the study.

Exclusion Criteria:

Women with no children or with daughters outside the 10-18 yrs age group have been excluded.
Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin

RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma.

PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma.

OBJECTIVES:

* Determine whether computer-assisted, higher-order analysis of participant low molecular weight serum proteins can detect distinctive proteomic patterns in participants with normal skin vs mycosis fungoides/cutaneous T-cell lymphoma vs psoriasis.
* Determine whether these proteomic patterns can distinguish between various stages of cutaneous T-cell lymphoma.

OUTLINE: This is a pilot study.

Participants complete a general and skin health questionnaire and undergo a whole-body skin examination. Blood samples are taken and analyzed for low molecular weight serum proteins by mass spectroscopy.

PROJECTED ACCRUAL: A total of 141-423 participants (47-94 each of healthy volunteers, psoriasis patients, and T3 cutaneous T-cell lymphoma patients and 141 T1, T2, and T4 mycosis fungoides patients) will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets criteria for 1 of the following categories:

  * Healthy skin volunteer

    * No significant inflammatory or neoplastic disease of the skin or internal organs
  * Diagnosis of 1 of the following skin diseases\*:

    * Psoriasis

      * Plaque-type disease
      * Psoriasis Area and Severity Index score at least 12
    * Mycosis fungoides/cutaneous T-cell lymphoma

      * Clinical diagnosis of T1-T4 skin disease with a compatible pathologic diagnosis NOTE: \*Stable or worsening disease on no therapy or topical therapy only within the past 2 weeks

PATIENT CHARACTERISTICS:

Age

* 18 to 85

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant
* No known HIV-1-related diseases
* No known HTLV-1-related diseases
* Willing to undergo brief skin examination and fill out a questionnaire regarding skin and general health

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* More than 2 weeks since prior systemic therapy for skin disease
Role of the Isomerase Pin-1 in the Development and Treatment of Asthma

Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal pathways in multiple cells in asthma.

The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after house dust mite allergen challenge. The investigators will perform segmental allergen challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later and activation of Pin1 and related pathways will be examined.

Eligibility Criteria:
Inclusion criteria:

* Subjects 18-55 years of age, diagnosed with asthma for at least 1 year;
* And FEV1 \> 70% predicted on only short acting beta agonists e.g albuterol
* And methacholine PC20 \< 8 mg/ml
* Positive skin prick test to Dermatophagoides pteronyssinus(DerP)
* No prior history of intubation for asthma
* No use of inhaled corticosteroids for 1 month prior to entry

Exclusion criteria:

* Current smoking or smoking history of greater than 10 pack-years
* Any other clinically important comorbidity determined by the principal investigator to affect subject safety, including uncontrolled diabetes, uncontrolled coronary artery disease, acute or chronic renal failure, and uncontrolled hypertension that would increase the risk of significant adverse events during bronchoscopy,
* Worsening of asthma symptoms requiring treatment with steroids within 4 weeks of screening
* Respiratory infection within four weeks
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant or who are currently pregnant or lactating.

Unless they:

* Are women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
* Are women whose partners have been sterilized by vasectomy or other means
* Use one acceptable birth control method. Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
* Pre-existing lung disease other than asthma
* History of coagulation disorders or abnormal PT/PTT testing at screening
* History of immunodeficiency diseases, including HIV
* A disability that may prevent the patient from completing all study requirements
* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Diagnosis of Hepatitis B or C.
* History of alcohol abuse (as determined by the principal investigator) within 6 months of screening.
* History of illicit drug abuse (as determined by the principal investigator) within 6 months of screening.
Three Protocols for Phenylephrine Administration in Cesarean Delivery

The investigators will compare variable infusion of phenylephrine (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop of reactive hypertension occurred) and single shot (1.5 mcg/Kg) phenylephrine.

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Phenylephrine (PE) is the most popular vasopressor for prevention of post-spinal hypotension (PSH) during CD; however, the most appropriate protocol for PE administration is still unknown. The most common PE protocols used for prophylaxis against PSH are: single shot, fixed infusion, and variable infusion. A recent study reported that a dose of 1.5 mcg/Kg is the most suitable single-shot dose for prophylaxis. Another randomized controlled trial compared four doses of PE infusion and reported that 25 mcg/Kg/min and 50 mcg/Kg/min doses were the best doses for fixed infusion with accepted incidence of both PSH as well as reactive hypertension. Using variable infusion rate of PE had been recently introduced in another study with a starting dose of 0.75 mcg/Kg/min. The variable rate infusion showed very good results regarding PSH. In this study, the investigators will compare variable infusion of PE (at a starting rate of 0.75 mcg/Kg/min) with fixed rate (0.75 mcg/Kg/min which will stop if reactive hypertension occurred) and single shot protocol (1.5 mcg/Kg).

Eligibility Criteria:
Inclusion Criteria:

* Full term
* Pregnant women
* Scheduled for cesarean delivery

Exclusion Criteria:

* Pre-eclampsia
* Eclampsia
* Hemorrhage
* Cardiac dysfunction
* Baseline low heart rate (below 60 bpm)
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus with inadequate glycemic control

Exclusion Criteria:

* Patients with Type 1 Diabetes Mellitus
Effect of Pulse Width With Spinal Cord Stimulation

The primary objective of this study is to assess the effects of varying pulse width in suprathreshold dorsal column stimulation in patients with low back pain.

This study will generate data which may allow Precision SCS devices to be used or programmed in such a way as to relieve pain while minimizing any uncomfortable sensations. This study will extend anecdotal reports into a prospective analysis of outcome data.

Patients invited to participate in this study will have recently been implanted with the Precision system, or will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.

Eligibility Criteria:
Inclusion Criteria:

* Have chronic low back pain following spine surgery (Failed Back Surgery Syndrome), which is primarily located in the low back, with minimal lower extremity pain.
* Have been permanently implanted with a Precision spinal cord stimulation (SCS) system within 6 months, or be an appropriate candidate for SCS and for the surgical procedures required for SCS as determined by the physician and have independently selected SCS with Precision for treatment.
* Be 18 years of age or older.
* Be willing and able to comply with all study related procedures and visits.
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
* Have any other chronic pain condition likely to confound evaluation of study endpoints.
SMARTease Trial: Evaluating Stroke Help Distance Interventions to Improve Cognitive Performance Post-Stroke

The purpose of this study is to provide evidence for the feasibility and initial effectiveness of a manualized, telephone-based (telehealth) approach to the delivery of cognitive interventions (SMARTease) targeted to improve cognitive performance in daily activities after stroke.

An initial brief screening interview will be completed with the potential participant by telephone to determine whether or not the individual meets the criteria for the study.

In an initial onsite visit, informed consent will be obtained from both the stroke survivor and their study partner and baseline evaluations will be completed with the stroke survivor, including a baseline cognitive assessment and setting goals to work on during the study period. Then the introductory section of the study Handbook (Making the Most of Your Memory) which includes procedural information on the Stroke Help Program will be reviewed with the stroke survivor and study partner. A study Handbook and a large button speaker phone will be provided to the stroke survivor/partner pair to ensure that both members of the participant-caregiver team can listen to the rehabilitation coach without having to be concerned with holding a handset (an action that may be difficult for some stroke survivors).

Telephone contact by the rehabilitation coach will be organized and the 16-week Stroke Help Cognitive Strategy Training Intervention will proceed. In general the topics or strategies to be discussed will be used to achieve one or more of the following rehabilitation strategies: 1) Understanding cognitive deficits that may result from stroke; 2). Reinforcing, strengthening or re-establishing previously learned patterns of behavior; 3) Establishing new patterns of compensatory mechanisms; 4) Enabling persons to adapt to their cognitive disability.

Following the 16-week Cognitive Strategy Training Intervention participants will have an on-site visit to provide qualitative and quantitative data related to the feasibility and efficacy of the program.

Eligibility Criteria:
Inclusion Criteria:

* history of one or more strokes;
* living in the community;
* subjective concerns about cognitive function;
* ability to give informed consent;
* fluent in written and spoken English.

Exclusion Criteria:

* unstable medical conditions or a co-morbid neurological disorder that could additionally impact cognitive or daily function, such as Parkinson's disease or Multiple Sclerosis;
* no available caregiver or significant other willing to participate in approximately one hour of telephone contact per week with coach and stroke survivor;
* current symptoms of severe depression (Geriatric Depression Scale\>20), global aphasia, or dementia (determined by baseline testing).