cyrilzakka/clinical-trials huggingface dataset:
Mobile Health App to Reduce Diabetes in Latina Women With Prior Gestational Diabetes II

The investigators will conduct a pre-post study to evaluate the effectiveness of the Hola Bebe intervention on improving self-efficacy for healthy eating and physical activity, and on weight loss among Hispanic women with recent GDM. The Hola Bebe app provides a unique opportunity to provide an effective, culturally tailored lifestyle modification program. The investigators will provide training to health educators at the two participating sites to ensure consistency and fidelity of implementation.

The study builds on the investigators' previous research in which the investigator developed a culturally-tailored Spanish and English app for Latinas with recent GDM based on Social Cognitive Theory and Behavioral Economics.

The app-based program included 12 audio/visual behavioral and educational modules on healthy eating and physical activity, motivational texts, weight tracking, personalized action plans, tiered badges, videos (easy at-home exercises, user-friendly, easy-to-follow recipes, and building a balanced plate), and an online community to communicate with other participants. All content was in plain-language Spanish and English, with Spanish and English audio voice-over. Graphics were dynamic and incorporated culturally sensitive.

Eligibility Criteria:
Inclusion Criteria:

* Female;
* Self-identify as Latina;
* Overweight or obese (BMI \> or =25);
* Age 18 to 45;
* Having had a pregnancy complicated by GDM within the prior 5 years.

Exclusion Criteria:

* Currently has a diagnosis for diabetes (type 1, type 2 or secondary form);
* Has underlying disease or treatment that might interfere with participation in or completion of the protocol (e.g., cancer, moderate or severe cardiovascular disease, HIV positive, active tuberculosis, lung disease, significant gastrointestinal conditions, renal disease, major psychiatric disorders, and other at the discretion of the study clinician);
* Has diseases associated with glucose metabolism;
* Takes certain medications (e.g., glucocorticoids) which interfere with glucose metabolism.
Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.

Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC).

Secondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care.

To evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study
* If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score / Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months

Exclusion Criteria:

* Currently receiving biologic therapies
* Known allergy to hymecromone
* Cholangiocarcinoma
* Pregnancy
* Serious liver disease
Effect of n-3 Polyunsaturated Fatty Acids Supplementation on Human Milk Composition of Lactating Women

We propose to measure the LCPUFA human milk (linolenic acid, linoleic acid, docosahexaenoic acid, arachidonic acid) according to fatty acids nature and quantities consumed by lactating women

n-3 and n-6 long chain polyunsaturated fatty acids (LCPUFA) are essential particularly to neurodevelopment of newborn infants. Many variations in essential PUFA and LCPUFA content of human milk are observed according to countries and dietary habits of the mothers.

Maternal diet supplementation of LCPUFA of lactating women may increase LCPUFA human milk according to consensus recommendations.

This clinical trial is performed to evaluate the effect of different of consumption of n-3 fatty acids (linolenic acid) in different forms (oils or margarine) in the human milk composition.

Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will be randomised into four groups : one group will receive olive oil (standard group), one group supplemented in rapeseed oil, one group with n-3 margarine and one group with diet associating rapeseed oil and n-3 margarine.Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.

Eligibility Criteria:
Inclusion Criteria:

* Lactating women more than 1 month and less than 4 month with neonate whom term is between 37 and 42 gestational age
* Women who agree to consume fatty fish two times per week
* Free consent

Exclusion Criteria:

* Women with multiple infants
* Chronic treatments more than 8 days
* Women with treatment during supplementation period
* Women with maternal pathology not compatible with breastfeed
Investigate Role of Metabolic Imaging in Predicting Tumor Response/Outcome After Pancreatic CA Tx

To test the ability of new imaging techniques to monitor and predict response of pancreatic cancer to radiation and/or chemotherapy.


Eligibility Criteria:
Inclusion Criteria:- Adult patients (\>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery.

* Negative urine pregnancy test if a woman of child-bearing potential (WOCBP).
* WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study period.
* All patients will be evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board to determine eligibility. Exclusion Criteria:1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

  2. Any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. Patients with a previous malignancy without evidence of disease for \>5 years will be allowed to enter the trial.

  3. WOCBP who is pregnant or breastfeeding. 4. Inability to sign written consent.
LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema

Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.

The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.

Eligibility Criteria:
Inclusion Criteria:

* lymph node + breast cancer requiring dissection

Exclusion Criteria:

* previous lymphedema
* BMI \>35
Ph IIA Study (SOC +/- NS5B)

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects


Eligibility Criteria:
Inclusion Criteria:

* Subjects chronically infected with HCV genotype 1 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
* HCV RNA ≥ 10\*5\* IU/mL at Screening
* Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
* Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
* Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² at Screening

Exclusion Criteria:

* Liver transplant recipients
* Documented or suspected HCC by imaging or liver biopsy
* Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
Living Organ Donor Recovery Enhancement Program

The purpose of the study is to test if using these living donor-specific pre-transplant resources would lead to a better and faster recovery post-transplant.

Donor safety and outcomes are the chief concerns of programs performing living donor liver and kidney transplantation. The protection of donors from physical and emotional harm has been a fundamental principle in living donor liver and kidney donation from the beginning. The safety of living donor hepatectomy and nephrectomy has been established. The risks associated with the donation have been deemed acceptable by the transplant community.

The investigators would like to move beyond the safety of the operation and address the most important post-operative issues that potentially cause donors physical and emotional stress: these include pain control, appropriate nutrition for optimal liver regeneration and physical/functional recovery, fatigue, time to return to normal physical and work activity, and difficulties coping with recovery and any possible complications. The goal of conducting this study is to create a program of pre- and post-operative interventions to enhance recovery so that patients can return to their normal quality of life as soon as possible. Currently there is no literature on programs to enhance living donor care and recovery.

This study will be conducted to determine if interventions during the pre-operative (a minimum of four weeks in an exercise program), intra-operative (anesthesia), and post-operative (pain management) stages have an effect on liver and kidney donor patients' quality of life and return to baseline functional status.

Eligibility Criteria:
Inclusion Criteria:

1. Ages ≥ 18 years
2. Cleared by a physician to participate in an exercise program
3. Approved for evaluation to be a living liver or kidney donor
4. Subjects willing and able to comply with the protocol procedures for the duration of the study, including the exercise regimen and scheduled follow-up visits
5. Subjects who have given IRB-approved written informed consent, prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care

Exclusion Criteria:

1. Any co-morbidity restricting the subject's ability to walk alone
2. Pregnant or breast-feeding women
Regional Variation in the Primary Medical Care of Northern Germany

The study explores the variation in the patient populations and describes regional differences regarding the reasons for consultations in the primary medical care in Germany. The data collection will be stratified by rural and urban areas as well as environs. The data set will include a large variety of data about physicians, patients and health care utilization.

Inappropriate supply and the increasing demand on the health care system have been of concern for health policy in Germany for the last 15 years. Concerning primary care, this especially relates to an undersupply of rural GPs (general practitioners). But there also seem to be other relevant regional differences, e.g. a lower number of house calls in larger cities, a greater number of psychiatric (co-)morbidities in the cities, a greater spectrum of services offered by rural doctors, and a difference in accessing primary and secondary care between the rural and the urban areas. Despite these results, differences between rural and urban areas have not been studied extensively in Germany. Therefore this study aims to explore regional variation of patient populations and their reasons for accessing primary care.

The study is based on standardized interviews with 240 GPs and approximately 1.200 patients in Northern Germany. Questionnaires are based on a preliminary qualitative study and were pretested. The GP's questionnaire comprises characteristics of the GP and the practice, patient types, reasons for consultation and services offered. The patient's questionnaire includes sociodemographic data and past medical history, quality of life, access to the GP, specialists and hospitals, perceived social support, health behaviour and the reasons for their consultations. Data will be analysed by descriptive statistics and different regression modelling strategies adjusted for possible confounders and the GP-induced cluster structure.

Eligibility Criteria:
Inclusion Criteria:

* having consulted the practice within the last 3 months and
* being patient of the practice since at least 36 months (i.e. at least one consultation before 36 or more months)

Exclusion Criteria:

* no capacity to consent (e.g. because of dementia)
* insufficient German language skills to conduct interview
* not able to participate in the interviews (e.g. because of deafness or major depression)
A Study of BGB-R046 as Monotherapy and in Combination With Tislelizumab in Solid Tumors

This is a first-in-human (FIH) study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-R046 as a single agent and in combination with tislelizumab (BGB-A317) in participants with advanced or metastatic immune-sensitive solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
* Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom standard treatment is not available, not tolerated, or determined not appropriate based on the investigator's judgement
* ≥ 1 measurable lesion per RECIST v1.1
* Able to provide an archived tumor tissue sample
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Adequate organ function
* Life expectancy \>12 weeks as determined by the investigator

Exclusion Criteria:

* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
* Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s)
* History of interstitial lung disease, noninfectious pneumonitis (including immune mediated), or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases.
* Experienced ≥ Grade 3 imAE(s) on prior immuno-oncology agent (anti-PD-1, anti CTLA4, or other experimental drugs)
* Uncontrolled diabetes \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or ≥ Grade 3 hypoalbuminemia ≤ 14 days before the first dose of study drug(s).
* Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s)
* Immunodeficiency as assessed by the investigator to be not suitable for treatment with immune modulating anticancer agents

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious


Eligibility Criteria:
Key Inclusion Criteria:

* Subjects chronically infected with hepatitis C virus (HCV) genotype 1
* HCV RNA viral load ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening
* The current standard of care naïve or non-responder

Key Exclusion Criteria:

* Cirrhosis
* HCC
* Co-infection with hepatitis B virus (HBV), HIV-1 or HIV-2
Support Needs and Preferences of Family Caregivers of Lung Cancer Patients

This study is being done to learn what the needs are in relation to the family members. Some family members seek counseling; others do not. The institution wants to try to understand why and wants to see if they can improve our support services for family members.


Eligibility Criteria:
Inclusion Criteria:

* Primary family caregiver identified by a patient who is approximately within 4 to 6 weeks of a new visit to a thoracic clinic and receiving cancer care at Memorial Sloan-Kettering Cancer Center or Queens Cancer Center
* Caregiver is at least 18 years of age.
* Caregiver has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
* Clinically meaningful distress defined as a score of 8 or greater on the Anxiety or Depression subscale of the HADS (see Bjelland et al., 2002; Zigmond \& Snaith, 1983).

Exclusion Criteria:

* Patients or caregivers exhibiting significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation
* Patient has lung cancer recurrence
* Currently participating in a psychosocial intervention trial
Study of Leukocyte Populations in Patients With Chronic Inflammatory

Exploration of pathophysiological mechanisms in chronic inflammatory rheumatism and rare systemic autoimmune diseases with the objective of identifying therapeutic targets.

The primary objective is to characterization of the quantitative and qualitative specificities of the different leukocyte sub-populations in patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases. We will perform an exploratory descriptive study whom primary endpoint will be to assess by FACS the phenotype of the specific leukocyte subsets. In addition, we will characterize the protein and transcriptomic signature associated with the conditions for which we have obtained preliminary data showing their potential involvement in autoimmunity (i.e: IL7 pathway, IFN signature).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patient who did not express his opposition
* Patients with chronic inflammatory rheumatism and rare systemic autoimmune diseases (pSS, lupus, scleroderma, myositis, unclassified connectivitis) diagnosed according to the usual criteria.
* Weight\> 35 kg

Exclusion Criteria:

* Corticosteroid treatment\> 10 mg / day
* Pregnant patient
* Patients under legal protection
* Beneficiary of the state medical aid
Quantitative Determination of Brain Water Content in Patients During and After Hepatic Encepalopathy

There is increasing evidence that the pathophysiology of hepatic encephalopathy (HE) is tightly associated with low-grade cerebral edema. Uptake of ammonia in astrocytes leads to osmotic swelling caused by glutamine formation. Previous studies were performed in covert HE patients or used indirect methods.

Methods: The investigators wish to describes quantitative measurement of localized water content using MRI water mapping in a cohort of patients with cirrhosis during an episode of overt HE type C and again after recovery. Furthermore patients with cirrhosis and no history of HE and healthy subjects will be investigated as controls.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type C HE during and after HE,
* Patients with stable cirrhosis and
* Healthy subjects

Exclusion Criteria:

* Patients with pace-maker
* Metal implants
Expanded Access Protocol for an Intermediate Size Population - RAVICTI for Byler Disease

Byler Disease is the result of a homozygous missense (G308V) mutation in the ATP8B1 gene. The disease is typically manifest in the first year of life on the basis of complications of cholestasis; common presentations include jaundice, poor growth, bleeding related to vitamin K deficiency, and/or weak bones related to vitamin D deficiency. Early management of Byler Disease is directed at nutritional issues which tend to be responsive to medical intervention, unlike the pruritus/scratching which remains a devastating problem. Progressive liver disease develops in Byler Disease and can lead to cirrhosis and end-stage liver disease. This is an open label expanded access protocol of RAVICTI in children with Byler Disease. The primary hypothesis is that the administration of RAVICTI in these children is feasible, well tolerated and safe. It is also hypothesized that RAVICTI treatment leads to an improvement in biochemical markers of liver disease and it may ameliorates or prevents the development of scratching behavior as a manifestation of pruritus attributed to the liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Byler Disease as identified by a homozygous mutation in ATP8B1 predicted to yield a G308V missense mutation
* Total serum bile acid \> 100 µM
* Male or female subjects of age greater than 130 days to begin screening procedures
* Male or female subjects of age greater than 180 days to begin RAVICTI therapy
* Ability and willingness to adhere to all study protocols
* Access to intermittent phone contact
* Written informed consent

Exclusion Criteria:

* Prior surgical interruption of the enterohepatic circulation (including but not limited to partial biliary diversion and/or ileal exclusion)
* Liver transplantation
* Other diagnosed concomitant liver disease
* Evidence of portal hypertension

  * Platelet count \< 150,000 and
  * Spleen palpable \> 2 cm below the costal margin, or
  * History of a clinical complication/feature c/w portal hypertension
* esophageal or gastric varix or variceal hemorrhage
* ascites
* hepatic encephalopathy
* Coagulopathy (PT \> 15 seconds or INR \> 1.5) despite vitamin K therapy
* ALT \> 10 X ULN
* Allergy/hypersensitivity to RAVICTI or 4-phenylbutyrate
* Severe concurrent illnesses, such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders, that would interfere with the conduct and results of the study
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Cancer or history of cancer
* Any female who is pregnant or lactating or who is planning to become pregnant with 1 year of enrollment
* Any known history of alcohol or substance abuse