cyrilzakka/clinical-trials huggingface dataset:
Muscle Energy Metabolism and Metabolic Flexibility in Older Men and Women

This study will explore differences in energy metabolism and metabolic flexibility under various conditions in older men and women.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>20.0 and \<39.0 kg/m2
* Ambulatory (may use assistance device e.g., cane, walker)
* Not a current smoker (within past 10 years)
* Low or moderate risk based on the responses from the AHA/ACSM Health/Fitness Facility Preparticipation Screening Questionnaire
* Normal muscle mass and strength/performance or sarcopenia included in low muscle mass and low grip strength
* If on thyroid medication or hormone replacement therapy, has been on a constant dosage for at least 2 months prior to Screening Visit
* Willingness to follow protocol as described
* Voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) prior to any participation in the study

Exclusion Criteria:

* Active/treated disease, under the care of a physician, for the following: metabolic/endocrine (diabetes), hepatic, or renal disease, myocardial infarction, peripheral vascular disease, respiratory or neuromuscular disease
* Participates in a resistance exercise program
* Poor appetite with recent unexplained weight loss over the past 6 months
* Current infection (requiring medication or which might be expected to require hospitalization); has had inpatient surgery, or corticosteroid treatment (excluding topical creams) in the last 3 months or antibiotics in the last 3 weeks.
* Active malignancy, excluding carcinoma in-situ of the cervix, cutaneous malignancies (basal cell carcinoma, squamous cell carcinoma, except melanoma)
* Chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis A, B or C, or HIV
* Taking medications/dietary supplements or substances that could profoundly modulate metabolism in the opinion of the principal investigator or study physician, Exceptions for multi-vitamin/mineral supplement, topical or optical steroids and short-term use (less than two weeks) of dexamethasone
* Allergy or intolerance to any foods
* History of gastrointestinal disease, or surgeries, gastroparesis, or taking medications that are known in the opinion of the PI or study physician to interfere with consumption/digestion/absorption of nutrients
* Eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with compliance with study protocol procedures in the opinion of the principal investigator or study physician
* Participant in a concomitant AN trial or trial of a non-registered drug (or is within the 30 day follow-up period for such a trial) or that otherwise conflicts with this study unless otherwise approved
Vitamin D, Insulin Sensitivity, and Vascular Associations in Adolescents

The overall objectives of this study are to examine the relationships between circulating vitamin D, insulin sensitivity, and multiple indices of vascular function and to examine whether vitamin D deficiency in AA is responsible for ethnic differences in insulin sensitivity and hypertension in AA and EA, as well as mechanisms underlying the association between insulin resistance and blood pressure. We hypothesize that 1) serum 25(OH)D is associated with insulin sensitivity and vascular functioning, independent of adiposity, 2) lower insulin sensitivity and vascular functioning in AA relative to EA is due to lower circulating 25(OH)D in AA, and 3) the relationship between insulin resistance and vascular dysfunction is mediated by 25(OH)D.

Acronyms: African American (AA), European American (EA), Serum 25-hydroxy vitamin D (25()H)D, Body mass index (BMI), Alabama (AL).


Eligibility Criteria:
Inclusion Criteria:

* African American or Caucasian ethnicity
* Ages 14-18 yrs
* Healthy

Exclusion Criteria:

* BMI-for age and -sex higher than 95th centile on the Centers for Disease Control and Prevention Growth Charts
* Use of medication(s) known to influence body composition, vascular function, or glucose metabolism
* Pregnancy
* Diabetes or any chronic diseases
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Colitis in Patient With Ulcerative Colitis

Consequences of latent cytomegalovirus (CMV) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. Theoretically, CMV-specific cell-mediate immune response will further categorize the patients into high or low risk of CMV colitis. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patient with ulcerative colitis flare to assess the the impact of CMV colitis on ulcerative colitis flare.

Moderate to severe ulcerative colitis patients admitted in Inflammatory Bowel Disease (IBD) center will be enrolled in this study. Eligible patients had active UC with a Mayo score of 6-12 points (moderate or severe disease activity). The investigators will evaluate whether CMV-specific cell-mediated immune response at admission will predict the risk of active cytomegalovirus infection (true pathogen versus bystander).

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe UC require hospitalization
* age 16 or more
* agree with written informed consent

Exclusion Criteria:

* pregnancy
* foreign
* immunosuppressed patients
Pathogenic Variants in Genes Associated With Lung Adenocarcinoma

The goal of this observational study is to describe the prevalence of germ line-pathogenic variants in Mexican patients with lung adenocarcinoma.

The main questions it aims to answer are:

1. What is the prevalence of pathogenic variants in genes associated with lung adenocarcinoma in Mexican patients younger than fifty?
2. Which clinical-pathological characteristics are associated with germ-line pathogenic variants in patients with lung adenocarcinoma?
3. How actionable somatic mutations are associated with germ line-pathogenic variants of patients with lung adenocarcinoma?

Participants will be asked to sign an informed consent; after that, they will be instructed to donate 10 ml of peripheral blood by venipuncture in the morning and before the patient has taken morning medication and the first meal, following a period of 8-12 hr fasting.

This is an observational, descriptive, and longitudinal study.

The sample size was calculated with a proportion difference formula for a known population, considering the Local Institutional Personalized Medicine Laboratory tests 100 blood samples per year from patients with non-small cell lung cancer (NSCLC). It was considered a 95% confidence level and an 80% power. In addition, a 10% loss in follow-up was estimated.

After reviewing the inclusion and exclusion criteria, signing the informed consent, and peripheral blood sampling. Total DNA (tDNA) will be extracted using the DNAeasy Blood \& Tissue (Qiagen) kit.

Likewise, for the determination of pathogenic variants, the Sophia HCS Community panels (Sophia genetics) will be used to carry out Next-generation (NGS) sequencing in a NextSeq 550 (Illumina) platform.

To determine the clinical significance of genomic variants, the data analysis will be performed on the SOPHiA Alamut™ Visual Plus which is a comprehensive, full genome browser for efficient and user-friendly variant interpretation.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* ≥ 16 years old, according the institutional protocols for new patients admittances.
* histologically confirmed lung adenocarcinoma (LUAD)
* Signed written informed consent form
* A life expectancy greater than 8 weeks.
* Histologically confirmed LUAD and one of the following conditions: i) LCFH, defined as having one first-degree relative (FDR) or two or more second-degree relatives with LC, irrespective of the age at diagnosis. ii) Age at diagnosis ≤50 years, or ≤60 with a pack-years index. iii) Presence of ≥1 AGAs (EGFR, ALK, ROS1, KRAS, BRAF, MET exon 14 skipping, or RET).

Exclusion Criteria:

* A sample of peripheral blood that is not accessible.
* Insufficient clinical pathological information in the electronic clinical record.

Elimination Criteria:

* Withdrawal
* Insufficient DNA quality and quantity for genomic sequencing analyses.
* Lost of follow up
A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus

This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥18 years old, ≤70 years old;
* 2. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
* 3. Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.
* 4. Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
* 5. SLEDAI-2K score≥7.
* 6. BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems
* 7. PGA \> 1.0;

Exclusion Criteria:

* 1. Severe lupus nephritis within 8 weeks before screening;
* 2. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
* 3. uncontrolled lupus crisis within 8 weeks before screening;
* 4. clinically significant central nervous system diseases or pathological changes other than lupus before screening;
* 5. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;
* 6. complicated with other autoimmune diseases;
* 7. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，
* 8. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;
* 9. participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period;
* 10. participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,
* 11. active bacterial, fungal, or viral infection within 2 weeks before apheresis;
Tobacco Cessation Care for Cancer Patients by Automated Interactive Outreach

This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) delivering cancer-targeted educational messages to support referral to smoking cessation resources for patients with cancer.

PRIMARY OBJECTIVE:

I. To evaluate CareConnect's efficacy on referring patients to tobacco cessation resources.

SECONDARY OBJECTIVE:

I. To evaluate patients' acceptance of referrals.

II. To evaluate the acceptability of CareConnect.

EXPLORATORY OBJECTIVES:

I. In-depth semi-structured qualitative interviews of 20 selectively chosen participants who completed the 3-month follow-up survey or finished the automated CareConnect or Auto-Reach call but may have refused to complete the 3-month follow-up survey (10 from each group).

II. Smoking cessation with verification.

OUTLINE:

Eligible participants, identified through the Cancer Center Tobacco Registry will be randomized to either the Intervention or Control arm on a 1:1 ratio. Participants who complete the first call of CareConnect or AutoReach will be considered enrolled. Participants will complete a baseline assessment, a 3-month assessment, and have option to provide a saliva sample.

For those who are selected to participate in an in-depth interview, this will take place within 1 month after the 3-month assessment. Data from the participants medical record may be accessed at 6 months post follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older.
2. Able to understand study procedures and to comply with them for the entire length of the study.
3. Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
4. English, Spanish, Cantonese, or Mandarin speaking.
5. Self-reported current use of tobacco, including e-cigarette on EHR.
6. Has a diagnosis of cancer.
7. Has been seen by a prescribing provider within a UCSF Cancer Center-affiliated clinical department within the past 3 months.

Exclusion Criteria:

1. Contraindication to any study-related procedure or assessment.
2. No valid contact telephone number.
3. Currently hospitalized or having been discharged from inpatient setting within the past month (according to EHR).
The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder

Examination of the effects of short-term use of TENS and t-NMES on passive pain-free ROM of the painful post-stroke shoulder. Treatments are compared with no stimulation.

Single cohort, cross-over study. Subjects undergo passive pain-free ROM of the painful post-stroke shoulder under 3 stimulation conditions. The stimulation was delivered by a trained occupational therapist under three conditions: 10 seconds of TENS, 10 seconds of t-NMES, and 10 seconds of no stimulation. Each subject was exposed to each of the three stimulation conditions three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation. This protocol is repeated for each of the two passive movements tested, shoulder abduction and shoulder external rotation.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 months post-stroke
* worst shoulder pain in the last week at least 4 on the 0-10 numerical rating scale,
* adequate cognitive ability to be able to rate their pain in the past week

Exclusion Criteria:

* history of tachyarrhythmia with decreased blood pressure
* uncontrolled seizures (defined as more than one per month)
* an implanted electrical device
* uncompensated hemi-neglect
Negative Pressure Wound Therapy for Prevention of Groin Infection Following Vascular Surgery

Surgical site infection in vascular surgery is a relatively common event with reported incidence as high as 43%. When considering the groin alone, the incidence is around 20% (30% when considering any wound complication). This complication may sometimes lead to heavier complication (leg amputation, longer hospital stay, high costs...) and affects the early postoperative quality of life of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Every high-risk patient (meeting one of the criteria of table I) undergoing vascular surgery with groin incision (without ongoing infection)

Exclusion Criteria:

* Patients who need a transverse incision before EndoVascular Aortic Repair procedure, considering that in our experience surgical site infection almost never occurs after these procedures and patients with mental incapacities.
Thalidomide Plus Dexamethasone as Maintenance Therapy for Multiple Myeloma

This multicenter, prospective, randomized trial was designed to evaluate the role of thalidomide with or without dexamethasone as a maintenance therapy for multiple myeloma patients after a single autologous stem cell transplantation.

Patients were recruited prior to receiving induction therapy, and randomization in a 1:1 ratio occurred on day 60 post-autologous stem cell transplantation. The treatment consisted of the following four phases:

1. induction with 3-5 cycles of vincristine plus doxorrubicin and dexamethasone (VAD) every 21-28 days: vincristine 0.4 mg , doxorubicin 9 mg/m² and oral dexamethasone 40 mg daily for 4 days;
2. cyclophosphamide (4 g/m2 ) plus filgrastim (G-CSF) (5 μg/kg twice a day) for stem cell mobilization;
3. melphalan (200 mg/m2 ) and one autologous stem cell transplant (ASCT);
4. Sixty days (D +60) after ASCT: RANDOMIZATION in two arms of maintenance: Arm A (oral dexamethasone alone 40 mg/d for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg daily by mouth) for 12 months or until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic multiple myeloma in accordance with the International Myeloma Working Group criteria;
* age 18-70 years;
* Performance status 0-2 by the Eastern Cooperative Oncology Group (ECOG) criteria;
* normal hepatic function, defined as serum bilirubin \<3 mg/dl and alanine aminotransferase(ALT) and asparagin aminotransferase (AST) \<4x normal.

Exclusion Criteria:

* evidence of disease progression after ASCT;
* cardiac dysfunction (systolic ejection fraction \<50%);
* chronic respiratory disease (carbon monoxide diffusion \<50% of normal).
Imaging Multiparametric/Multimodality for Lungcancer

1. To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank...), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
2. To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
3. To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years
* High suspicion of lungcancer confirmed
* Tumor \> 2 cm
* Incomplete cerebral staging or not yet realized in the initial consultation of screening

Exclusion Criteria:

* Lungcancer medical history
* During Pregnancy
* Contraindications to MRI
* Patient not able to understand the information of the protocol, taking into account the state of the brain
* Patient unable to keep lying in MRI the necessary time
Exercise Effect on Chemotherapy-Induced Neuropathic Pain

Chemotherapy-induced peripheral neuropathy (CIPN) continues to be a serious healthcare concern. It is painful, persistent, resistant to conventional pain therapies, and results in long-term suffering and decreased quality of life for many cancer survivors. The role of exercise to decrease CIPN-related neuropathic pain (CIPN-NP) will be investigated, with the goal of identifying the mechanisms associated with this therapeutic approach to manage CIPN-NP.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with cancer, stage I-IV
* History of treatment with oxaliplatin, docetaxel, or paclitaxel, either alone or in combination with other agents
* Completion of chemotherapy \> 6 months \< 1 year
* Ability to walk on a treadmill
* Medical clearance from oncologist or primary care provider
* Presence of CIPN per National Cancer Institute Common Toxicity Criteria grade 1-3 (0-no signs/symptoms, 1-minor loss of function, 2-increased symptoms not interfering with activities of daily living (ADLs), 3-severe symptoms interfering with ADL, 4-disabling, and 5 is death)
* Score on Neuropathic Pain Scale \>1
* Age 21-70

Exclusion Criteria:

* Denial of CIPN
* Other motor/sensory neuropathy caused by other than chemotherapy (i.e.alcohol-related, autoimmune diseases, diabetes)
* Coronary artery disease
* History of \>1 chemotherapy regimen
* Musculoskeletal conditions which preclude participation in an exercise training program
* Pregnancy
* Regular exerciser, defined as \>90 minutes per week of aerobic exercise and any resistive training
Maternal DHA Supplementation and Offspring Neurodevelopment in India (DHANI-2)

DHANI-2 is an extension to DHANI (NCT01580345) which proposes to extend maternal supplementation (DHA or Placebo) from \<20 weeks of gestational age through 6 months postpartum and infant follow-up through 12 months. Leveraging the Randomized Controlled Trial (RCT) design, DHANI-2 aims to assess the role of maternal DHA supplementation on infant neurodevelopment and body growth. It also intends to enhance the mechanistic understanding by the addition of repeated biochemical measures from mother-child dyads.

A double-blinded, randomized, placebo controlled trial would be conducted among pregnant women in India to test the effectiveness of supplementing pregnant Indian women with 400 mg/d algal DHA compared to placebo from mid-pregnancy through delivery. Eligible participants would be randomized to receive either 400 mg of DHA or a placebo baseline measures would be taken before the enrollment of the participant in the study. The mother-child dyads would be followed through infant age 1 year and anthropometric measurements and biochemical investigations would be used to assess the effect of maternal DHA supplementation on infant neurodevelopment at ages 6- and 12-months using validated the Development Assessment Scale for Indian Infants (DASII).

Eligibility Criteria:
Inclusion Criteria:

* Willing, healthy singleton gestation of ≤ 20 weeks (scan report must)
* 18-35 years
* Hb \> 7 g/dL
* Non-fasting glucose as per Diabetes in Pregnancy Study Group of India (DIPSI) criteria (\<140mg/dL)
* No history of chronic diseases (heart disease, diabetes, liver disorders, cancer, epilepsy, HIV, thyroid) or
* High risk pregnancy (short stature\*\*, molar pregnancy++, HBsAg positive, as advised by physicians)

  * \<143 cm ++ A molar pregnancy starts when an egg is fertilized, but instead of a normal, viable pregnancy resulting, the placenta develops into an abnormal mass of cysts.

Exclusion Criteria:

* Women allergic (if aware) to any of the test products.
* Women at high risk for hemorrhagic bleeding, clotting (if aware).
* Women with high-risk pregnancies (history and prevalence of pregnancy complications, including abruptio placentae, preeclampsia, pregnancy-induced hypertension, any serious bleeding episode in the current pregnancy, and/ or physician referral); and/or diagnosed chronic degenerative disease(s) such as diagnosed heart disease, cancer, stroke or diabetes (as omega-3 could raise blood sugar and lower insulin production).
* Women consuming omega-3 supplements or having used these in 3 months preceding the intervention period.
* Reported participation in another biomedical trial 3 months before the start of the study or during the study (not to get the results of the present study contaminated).