cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Cancer Biospecimen Collection Study

This study will collect de-identified tumor samples, with correlated clinical/demographic data and tissue histology, from patients selected or scheduled for pre-treatment tumor biopsy or who have had a recent pre-treatment tumor biopsy. These specimens and clinical data may be used in subsequent studies for the development and validation of a diagnostic test.

This study will establish a prospective cohort of pre-treatment tumor specimens with correlated de-identified clinical and demographic data and tissue histology from cancer patients who are undergoing treatment with PD-1/PD-L1 inhibitors. Patients who have undergone pre-anti-PD-1/PD-L1-treatment tumor biopsy or who are scheduled for tumor biopsy prior to anti-PD-1/PD-L1 treatment will be enrolled.

The study will not require a study-specific tumor biopsy; any biopsies taken prior to treatment as part of standard of care are eligible for this study. Biopsies must not have been taken after immunotherapy treatment began.

Participants will be asked to provide their consent for the potential use of their biospecimens in subsequent studies for the development and validation of a diagnostic test.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have a disease of interest. Specifically, subject must have one of:

   1. head and neck squamous cell carcinoma (HNSCC)
   2. non-small-cell lung cancer (NSCLC)
   3. small cell lung cancer (SCLC)
   4. urothelial carcinoma (UCC)
   5. gastric or gastroesophageal junction adenocarcinoma
   6. cervical cancer
   7. esophageal squamous cell carcinoma (ESCC)
   8. triple-negative breast cancer (TNBC)
   9. hepatocellular carcinoma (HCC)
   10. renal cell carcinoma (RCC)
   11. colorectal cancer (CRC)
2. Subject must have received, or be scheduled to receive, at least one dose of anti-PD-1/PD-L1 immunotherapy for treatment of their cancer.
3. Subject must have had, or will have, a tumor biopsy prior to treatment with anti-PD-1/PD-L1 immunotherapy.
4. Subject must have undergone, or will undergo, medical imaging (e.g. CT or MRI) of the tumor prior to treatment with anti-PD-1/PD-L1 immunotherapy.
5. Willing to provide electronic informed consent per IRB-approved protocol.
6. Able to speak, read, and comprehend English fluently.
7. Subject is 18 years of age or older.
8. Subjects must have sufficient tissue available to fulfill the specimen requirements of the study.

Exclusion Criteria:

1. Inability or unwillingness to provide informed consent.
2. Subject who does/did not have one of the cancers listed above (other histologies).
3. Subject has already participated in this trial.
Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans

Postprandial effects of Nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* non-smokers
* diet accordance with the Nordic Nutrition Recommendations
* BMI: 18.5-25 kg/m2

Exclusion Criteria:

* metabolic disorders
* food allergies
* no probiotics or other food /supplement which may interfere with the study
ChiCGB vs BEAM in High-risk or R/R Lymphomas

High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
* Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.
* Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
* Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \</= 2 x upper limit of normal.
* Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) \>/= 50% of expected corrected for hemoglobin.
* Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
* Performance status 0-1. 10. Negative Beta diffusing capacity of the lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

* Central nervous system lymphoma
* Patients relapsed after autologous stem cell transplantation
* Bone marrow was involved by lymphoma
* Patients with active hepatitis B or C(HBV DNA \>/=10,000 copies/mL).
* Active infection requiring parenteral antibiotics
* HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts
* Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.
* Patients with a corrected QT interval(QTc) longer than 500 ms
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge

This study will compare glucose and simple carbohydrate sensitivity. The hypothesis is that rapid emptying of high-glycemic index foods after Roux-En-Y gastric bypass (RYGB) causes reactive hypoglycemia. It is believed that the controlled release offered by an intact pylorus will be advantageous for long term results in bariatric surgery. This study can provide a scientific rationale, in a short duration of time, for why pylorus sparing surgery, such as the sleeve gastrectomy or duodenal switch, may offer therapeutic advantages, as compared to non-pyloric sparing surgery, namely the gastric bypass.

Clinical Trial Objective:

The objective of this clinical trial is to determine whether an intact pylorus prevents reactive hypoglycemia following challenge with liquid glucose preparation and/or solid load made of refined flour product that is a simple carbohydrate.

Clinical Trial Design:

This is a prospective, non-randomized, clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* The patient is greater than 18 years old;
* The patient has a BMI \> 35;
* Patient meets standards for bariatric surgery;

Exclusion Criteria:

* The patient has an incurable malignant or debilitating disease;
* The patient has been diagnosed with a severe eating disorder;
* The patient is currently pregnant (pregnancy test required for confirmation for those of child bearing years);
* The patient is unable to comply with the study requirements, follow-up schedule, or to give valid informed consent
Genetics of EGFR (Epidermal Growth Factor Receptor) Mutation Study

The investigators wish to document the distribution of EGFR somatic mutations, and assess the relationship between specific genotype, clinical demographic, therapy, and survival, in a large cohort of EGFR mutant NSCLC.

The investigators also wish to comprehensively investigate the relationship between germline DNA and risk of EGFR mutant NSCLC developing, through a GWAS (Genome-Wide Association Studies) and candidate gene approach, and explore the relationship between germline DNA and clinical outcome, in order to potentially identify germline genetic modifiers of EGFR TKI (Tyrosine Kinase Inhibitor) outcome.

Objective 1: To identify germline allelic DNA variation associated with somatic EGFR mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival in EGFR somatic mutant NSCLC.

Objective 3: Study germline allelic DNA variation associated with never /ex light smoking NSCLC.

Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant NSCLC cases and describe their relationship to clinical outcome.

Eligibility Criteria:
* Histologically or cytologically diagnosed NSCLC, all histologies are acceptable.
* Patients can be included in the study with any disease stage and at any time during the disease course.
* Any type (surgery, RadioTherapy, chemotherapy, targeted agents) of previous treatment and any line of treatment are eligible.
* Age ≥18 years.

Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.

Before patient registration, written informed consent must be given according to ICH/GCP (International Conference on Harmonisation/Good Clinical Practice), and national/local regulations.
Effects of a Comprehensive Weight Management Program on Obese Adolescents and Children

To compare anthropometric and metabolic effects of a comprehensive weight management program on obese adolescents and children in comparison to regular clinical weight management visits.

Patients are randomized (2:1) to either the intensive or standard treatment (control). Those who get randomized into the intensive group go to a family-based weight management program, including exercise, nutrition, behavior modification, and parenting classes. The intensive group is further randomized into a diet or non-dieting class to compare the outcomes of two different nutrition intervention methods. These classes meet twice per week (exercise twice per week and nutrition/behavior modification once per week)for first six months and then only twice per month during last six months. An exercise physiologist supervises the exercise component, which involves 45 minutes of aerobic activity (targeted at 65 to 80 percent of the subject's estimated maximum heart rate. A registered dietitian facilitates the nutrition and behavior component. A social worker facilitates parent classes when the children have a behavior modification topic in their class (parents only attend nutrition sessions). Those who get randomized into the control group go to clinic visits every 6 months. Intervention subjects go to clinic, as well, every 6 months to obtain the same measurements as the controls (weight, BMI, % fat, fasting insulin, fasting glucose, lipids, blood pressure).

Eligibility Criteria:
Inclusion Criteria:

* Ages 8-16 years old
* BMI \>95th percentile for age/gender based on CDC
* Both primary caregiver/parent and child must agree to participate in the nutrition classes

Exclusion Criteria:

* endocrinopathies, including hypothyroidism and diabetes
* Psychiatric disorders that will interfere with ability to complete follow-up and adherence to protocol
* Any behavioral or psychosocial issue that will interfere with subject's completion of program, including eating disorder.
* Any use of medication (steroids, for ex.) that contributes to excess adiposity.
* Any use of pharmacological intervention for weight management, including prescription medications, over-the-counter medications, or herbal supplements.
* Any concurrent membership in a weight management program.
* Inability or unwillingness of parent to accompany the child to nutrition classes.
* Pregnancy
Optimizing Cardiac Rehabilitation by Integrating Sleep Therapeutics

The study aims are to: 1) optimize the Transdiagnostic Sleep and Circadian Intervention (TranS-C) for delivery to Veterans in cardiac rehabilitation, 2) test and refine the adapted TranS-C treatment manual and protocol, and 3) conduct a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures.

Aim 1 will involve formative work to optimize the TranS-C manual and protocol for delivery in Cardiac Rehabilitation, with input from Veterans and provider stakeholders. Aim 2 will involve a preliminary test and refinement of the adapted TranS-C manual and protocol with a small sample of Veterans who are participating in cardiac rehabilitation and report sleep disturbance and/or sleep-related impairment. Aim 3 will involve a pilot randomized trial to establish the feasibility, acceptability, and plausibility of the intervention protocol and study procedures. Veterans in cardiac rehabilitation with sleep disturbance and/or sleep-related impairment will be randomized to TranS-C + Usual Care or Usual Care. Treatment satisfaction will be assessed at 3-months; sleep disturbance and sleep-related impairment, disability and functioning, and health-related quality of life will be assessed at baseline, 3-months, and 6-months to determine measure responsiveness and provide preliminary insight into treatment effects.

Of note, information provided in this entry (e.g., design, eligibility criteria, outcomes, etc.) pertains only to Aim 3 which includes the pilot randomized trial. Consistent with Stage I of the NIH stage model of behavioral intervention development research, results from Aim 1 and 2 activities may lead to modifications to the pilot protocol and procedures in Aim 3.

Eligibility Criteria:
Inclusion Criteria:

* Veteran
* Age 18 years or older
* Referred for VAPHS cardiac rehabilitation
* Self-reported sleep disturbance or sleep-related impairment, determined by PROMIS Sleep Disturbance T-score at least 55 (raw score at least 25) or PROMIS Sleep-Related Impairment T-score at least 55 (raw score at least 20)
* English language fluency
* Willing and able to voluntarily participate in a behavioral sleep intervention clinical research study
* Willing to permit study personnel access to VA EHR
* Willing to permit study personnel to communicate with routine VA healthcare providers
* Willing and able to participate in outpatient cardiac rehabilitation at VAPHS

Exclusion Criteria:

* Moderate to severe cognitive impairment
* Active suicidal ideation, plan, or intent
* Current moderate to severe alcohol or substance use disorder
* Current severe symptoms of depression, anxiety, mania/hypomania, psychosis, or PTSD
* Currently engaged in a non-pharmacological intervention for sleep
* Currently working night shifts
* Currently pregnant and/or breast-feeding
ECT Schizophrenia Serotonin Study

We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT

We suggest to investigate serotonin uptake in schizophrenia patients receiving ECT

Eligibility Criteria:
Inclusion Criteria:

Participants must meet DSM-IV criteria for schizophrenia, as assessed by the Structured Clinical Interview - Patient Version (SCID) (First et al., 1995).

Ages 18 -55 Men and/or women -

Exclusion Criteria:

1. History of neurological disorders, active substance abuse in the previous 3 months.
2. Estimated IQ less then 70.
3. SSRIs treatment 4 weeks prior to the study.
4. Any subject suffering from inflammatory fever disease will be excluded from the study.

   -
Colombian Screening Mammography Project

A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to evaluate the effects of an opportunistic (hospital-based) screening program (intervention) vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or control arm (N=13). At intervention clinics general practitioners were instructed to perform clinical breast examination (CBE) on all women aged 50-69 years attending clinics for non-breast health related issues, and to refer them for mammographic screening. Physicians from control clinics were not specifically instructed to perform breast-screening or refer women for mammography, but could do so if they thought it appropriate ('usual care'). Women were followed for 2 years post-randomization.


Eligibility Criteria:
Inclusion Criteria:

Female Aged 50-69 Resident in Bogotá, Colombia or surrounding cities; Had not had a mammogram in the previous two years; No history of breast cancer Attending health-centers for reasons unrelated to breast health

Exclusion Criteria:

* see above
Frankfurt Thrombophilia Registry

Consecutive patients with acute or previous venous thromboembolism are enrolled in this registry. Using a standardized questionnaire, clinical data detailing venous thromboembolism and contributing VTE risk factors are recorded. Results of technical and laboratory investigations including screening for thrombophilic disorders were additionally entered into the database.


Eligibility Criteria:
Inclusion Criteria:

* Acute or previous VTE

Exclusion Criteria:

* None
DMT310-005 Topical in the Treatment of Acne Rosacea

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne rosacea.


Eligibility Criteria:
Inclusion Criteria:

Patient is male or non-pregnant female at least 18 years of age.

Clinical diagnosis of moderate to severe papulopustular acne rosacea as determined by:

Investigator's Global Assessment (IGA) at Randomization score of 3 or 4. Patient has at least 15 inflammatory lesions on the face

Patient is willing to apply the Investigational Product as directed

Patient is willing and able to comply with the protocol

Exclusion Criteria:

Patient is pregnant or planning to become pregnant Patient is taking a topical therapy on the face which may affect the patient's rosacea
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumors for which standard treatment does not exist or is no longer effective.
* For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
* Relatively good overall health other than cancer.

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Serious heart conditions
* History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition
A Study of Immunological Biomarkers as Predictors of Cardiovascular Events

Cardiovascular disease linked to atherosclerosis (e.g. infarcts, cerebro-vascular accidents) are one of the main causes of mortality in the general population. The recruitment of macrophages from the walls of the arterial lumen followed by unregulated capture of oxidated LDL (LDLox) leads to the accumulation of cholesterol esters and the formation of foamy cells characteristic of fatty streaks, the first phase of atherogenesis. These fatty streaks are rarely followed by clinical events, but can progress to complicated atheromatoses (calcification, rupture) resulting in the occurrence of various clinical events such as myocardial infarction and cerebro-vascular accidents (CVA). Once oxidated, LDL becomes immunogenic and induces anti-LDLox antibody production that could be markers of progression of atherosclerosis. During LDL oxidation, a multitude of specific oxidative epitopes (SOE) such as oxidated phospholipids (PLox) and malondialdehyde-lysine epitopes (MDA) are generated. In order to measure the level of markers in the blood, researchers developed a series of immunologic levels in vitro, using specific antibodies directed against well-defined epitopes. Recently, it was shown that Lp(a ) would be the preferred transporter of these PLox. In fact, several clinical studies show a strong correlation between PLox/apoB concentrations and Lp(a). This marker (PLox/apoB) predicts future morbidity and mortality due to cardiovascular diseases, including CVA, up to 15 years in advance, independent of all other known risk factors. CD36 is a scavenger receptor that recognizes LDLox, but more specifically PLox present in these lipoproteins .One soluble form of inflammatory CD36 (sCD36) was recently identified. In this study, only healthy volunteers were recruited in order to be able to establish normal serum ranges of different immunologic biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* Persons providing signed informed consent
* Persons with healthcare coverage

Exclusion Criteria:

* Renal disease
* Cardiovascular disease
* Auto immune disease
* Pregnancy in progress
* Infection
* Dementia
* Persons under legal protection
* Malnutrition
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression

This is a randomized, multi-center, open-label study in which patients with depression who responded to an open-label treatment with intermittent theta burst stimulation (iTBS) will receive this procedure as maintenance therapy. The patients will be randomized to two study arms. The arms differ in the frequency of stimulation (standard iTBS (5 treatments every working day for one week) vs. accelerated iTBS (5 treatments in one day)). For purposes of effect size estimation an interim analysis will be done after half of the patients.


Eligibility Criteria:
Inclusion Criteria:

* adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31)
* moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 \>16 points)
* response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment \<11 points)
* no concomitant psychotic symptoms.
* no other relevant psychiatric disorder as assessed by the study physician
* residence in Germany and German speaking that allows understanding of the information provided
* patient is capable of giving consent

Exclusion Criteria:

* fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps).
* severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history)
* current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates
* acute suicidality
* pregnancy
* current participation in another study