cyrilzakka/clinical-trials huggingface dataset:
Could Dietary Algae Affect Immunity and Viral Counts in People With HIV?

Drawing inferences from epidemiologic studies of HIV/AIDS as well well as cell culture and animal studies of HIV inhibition by algae, we propose algal consumption as one unifying characteristic of countries with anomalously low rates. HIV/AIDS incidence and prevalence in Eastern Asia (\<1/10,000 adults in Japan and Korea), compared to Africa (≈1/10 adults) strongly suggest that differences in IV drug use and sexual behavior are insufficient to explain the 1000-fold variation. Even in Africa, AIDS/HIV rates vary. Spirulina is part of the daily diet for many people living in Chad, where prevalence of HIV has remained at less than 4% for more than 20 years. Average daily algae consumption in Asia and Africa ranges between 1 to 2 tablespoons (3 - 13 grams).

HIV viral load is the main indicator of infection, however CD4 helper cell counts are most predictive of morbidity and mortality.We hypothesized that the consumption of algae could be important in diminishing the risk of HIV infection, and subsequent progression, possibly by enhancing the immune response.

Twelve HIV+ patients not on antiretroviral therapy were clinically evaluated and enrolled in the three-week study. Subjects received 10 algae capsules/d. Laboratory tests of CD4 counts and HIV RNA were performed at baseline, week 1, week 2, and week 3, and then once a month. Six subjects continued for between 4 and 14 months. In addition to CD4 lymphocyte counts and viral loads, subjects were evaluated monthly for Complete Blood Counts (CBC), Liver profile, Basic Metabolic Panel, and some subjects were evaluated for thyroid function and cholesterol. All subjects completed standard HIV Quality of Life questionnaires at each clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV
* Able to swallow pills

Exclusion Criteria:

* Allergy to iodine/seafood
* Thyroid disease
* Not taking antiretroviral therapy
Phase 1 Study of Mesothelin-ADC

The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have histological confirmation of advanced and/or metastatic solid

tumors which are expected to express mesothelin

* Must have received and either progressed or been intolerant to the standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
* Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

* Cancer metastases in the brain
* Uncontrolled or significant cardiovascular disease
* Moderate eye disorders
* Moderate peripheral neuropathy
* Known past or active hepatitis B or C infection

Other protocol defined inclusion/exclusion criteria could apply
Evaluation of Hearing Protection Fit Testing Program

The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force (USAF) employees. Currently, Public Health provides informal, subjective training to employees; this practice may be altered by the results of this study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. Subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction.

Exclusion Criteria:

* Not enrolled in the hearing conservation program. Not using in-the-ear hearing protection device on a regular basis. Ear canals containing cerumen, infection, or other obstructions.
Structured Exercise Prescription Program in Obese Children

This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.

The parameters that will be evaluated between groups are physical fitness, anthropometry, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage, inflammatory biomarkers, anxiety and depression scores, and allelic variants related to physical fitness.

This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity (study group) with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.

The parameters that will be evaluated between groups are physical fitness (measured by VO2max, ECG at rest, biomechanics and dynamometry), anthropometric measurements (weight height, BMI, plicometry, bioimpedance, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage (carotid intima-media thickness, atherogenic dyslipidemia), inflammatory biomarkers (leptin, adiponectin, IL-17, IL-10, INF-gamma, IL-6, IL-12, y TNF-alpha), anxiety and depression scores evaluated with Child Depression Inventory (CID) and -Trait Anxiety Inventory for Children (STAI-CH), and allelic variants related to physical fitness (ACTN, TRH2 y FTO).

Eligibility Criteria:
Inclusion Criteria: Patients with BMI ≥ Pc 95 and \< 35kg/m2 Both sexes Accepts to participate and signs informed consent

Exclusion Criteria:

Presence of endocrine disease including type I and II diabetes mellitus Presence of arterial hypertension Presence of primary dyslipidemia Presence of infections at moment of enrollment Presence of systemic disease Presence of genetic disorder Medical treatment that may interfere with lipid or glucose metabolism Prolonged or acute immobilization Participated in a previous similar intervention
A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation

The study will evaluate the impact of smart adherence technology for monitoring on lumacaftor/ivacaftor (LUM/IVA) adherence rates among subjects 16 years of age and older with Cystic Fibrosis (CF) who are homozygous for the F508del Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutation.


Eligibility Criteria:
Inclusion Criteria:

* Subject (or his or her legally appointed and authorized representative) will sign and date an informed consent form (ICF).
* Willing and able to comply with scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
* Confirmed diagnosis of CF and homozygous for the F508del-CFTR mutation
* Forced Expiratory Volume in one second/forced vital capacity (FEV1) ≥40% of predicted normal for age, sex, and height

Exclusion Criteria:

* Presence of moderate or severe hepatic impairment (Child-Pugh Class B or C)
* Subjects currently receiving invasive mechanical ventilation
* Known history of alcohol or drug abuse in the past year
* Clinically significant abnormal laboratory values during screening
* Pregnant or nursing females
* Female subjects and female partners of male subjects who plan to become pregnant during Treatment Period or within 90 days following the last dose of study drug
* History of solid organ or hematological transplantation
* Ongoing or prior participation in an investigational drug study within 30 days of screening
* Current use of commercial LUM/IVA combination therapy
Antibody and Safety Study of 6 Doses of NicVAX in Smokers

Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.


Eligibility Criteria:
Inclusion Criteria:

* Healthy smoker, ≥10 cigarettes per day for 6 months, exhaled carbon monoxide ≥10 ppm
* Written informed consent
* Negative urine pregnancy test, and willing to use birth control during the study, if applicable

Exclusion Criteria:

* Prior exposure to nicotine vaccine
* Clinically significant allergic reactions, especially to components of the vaccine
* Serious or unstable clinical disease within the past 6 months
* Use of any smoking cessation therapy within 30 days preceding 1st dose
* Immunosuppression, due to: steroids or other immunosuppressants in the last 30 days, history of cancer or cancer treatment in the last 60 months, known HIV infection, or congenital or acquired immunodeficiency
* Use of any vaccine other than influenza vaccine within 30 days prior to each study dose
* Use of another IND drug or device within 30 days preceding 1st dose
* Inability to follow the protocol, or illicit drug use in the past 12 months, or psychiatric disorder in the past 3 months
AMH and Functional Hypothalamic Amenorrhea

The purpose of this study is to analyze AMH levels in patients with prolonged FHA (more than 2 years). Based on previous studies, we can assume that prolonged FHA may mimic a condition of primary hypogonadotropic hypogonadism, due to a lasting interruption of gonadotropin release. Furthermore, after the resumption of the spontaneous menstrual cycle, we will reanalyze AMH levels, which we hypothesize to find higher. If our hypotheses are confirmed correct, we could support the thesis that AMH is not a good index of ovarian reserve in patients with functional hypothalamic amenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 15-34 years.
* Diagnosis of functional hypothalamic amenorrhea (for at least 2 years).
* Signature of informed consent.

Exclusion Criteria:

* Polycystic ovary syndrome
* Taking oral contraceptives in the previous three months
* Other clinically relevant endocrinopathies
* positive MAP-test (Medroxyprogesterone acetate test)
* Estroprogestin replacement therapy
* Autoimmune disorders
* Failure to sign informed consent
A Randomised,Multi-Center Study of Docetaxol Plus Capecitabine or Cisplatin in Anthracycline-Pretreated Patients With Advanced Breast Cancer

Docetaxol plus capecitabine regimen is the standard treatment for the anthracycline-pretreated patients with advanced breast cancer. Cisplatin is an important drug for advanced breast cancer and potential effective drug for triple negative breast cancer.The study primary objective:Assess ORR,TTP,TTF and 2 year PFS rate between docetaxol+capecitabine and docetaxol+cisplatin.

The second objective:Assess the safety and QOL.

The study main inclusion criteria are:1.age≥18,KPS\>70.2.anthracycline-pretreated patients with advanced breast cancer.3.at least 1 measurable lesion as defined by modified RECIST criteria.4.screening laboratory values within the following parameters:ANC ≥1.5×109/L,Hemoglobin≥10.0 g/dl，Platelet≥100×109/L. 5. signed ICF The patients will be randomised two group: docetaxol+capecitabine and docetaxol+cisplatin. According to AE, the dose will be adjusted.

Eligibility Criteria:
Inclusion Criteria:

* age≥18y
* KPS≥ 70
* pathologic diagnosis of breast cancer
* at least 1 measurable lesion as defined by modified RECIST criteria
* screening laboratory values with the following parameters: hemoglobin:≥10.0 g/dl absolute neutrophils count:≥1.5×109/L platelet:≥100×109/L creatinine clearance rate: ≥60ml/min total bilirubin: ≤1.5 ×upper limits of normal Alkaline phosphatase,Aspartate aminotransferase and Alanine aminotransferase:≤ 2.5×upper limits of normal（≤5×upper limits of normal if liver metastasis are present)
* signed ICF
* for women of child bearing potential,a negative serum or urine pregnancy test result before study entry.

Exclusion Criteria:

* More than 2 cytotoxic chemotherapy treatment regimens for metastatic disease.
* prior exposure to 5-Fluorouracil continuous infusion.
* prior exposure docetaxol for metastatic disease
* Any other cancer within 5 years prior to screening with the exception of contralateral breast cancer,adequately treated cervical carcinoma in situ,or adequately treated basal or squamous cell carcinoma of skin
Tobacco Control Policy-related Survey 2020

Aim: to collect further information on issues related to tobacco control which should be addressed and advocated in further tobacco control measures in Hong Kong

The objectives of this policy-related survey by landline and mobile telephone are as follows:

1. to update information on prevalence of conventional cigarettes, e-cigarettes, heat-not-burn tobacco products and waterpipe tobaccos ;
2. to investigate the effects of new pictorial health warning policy in the public;
3. to investigate the level of public support on current and future tobacco control measures and taxation;
4. to address the timely impacts of smoke-free policies, public support for further tobacco control measures and assist COSH in shaping policy direction for government;

Current study is a cross-sectional retrospective landline and mobile telephone survey based on questionnaires. The target sample size is planned to be 5,100 Hong Kong residents, including 1,700 current, ex and never smokers respectively. All three smoking status are to be evenly sampled by landline and mobile telephone. All data will be collected using a Computer Assisted Telephone Interview (CATI) system, which allows real-time data capture and consolidation. All interviews shall be conducted anonymously except for those who are willing to participate subsequent studies pictorial warning opinion. Analysis of survey data will aim to identify current opinion on tobacco control policies and implications for future policies. All eligible subjects who complete the telephone survey will be included in the analysis. Comparison with past trends conducted by previous landline and mobile phone surveys and, where possible, extrapolation of future trends will be explored. Weightings will be applied to adjust for the sex and age of Hong Kong population, and to handle the over-sampling issues of ex- and current smokers. The data analysis will be conducted by experienced statisticians in the applicants' team.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong resident aged 15 and above
* Cantonese speakers

Exclusion Criteria:

* Unable to provide a consent
* Speak language other than Cantonese
Acute Effects of Beetroot Juice and Caffeine Co-ingestion on Lower-limb Strength and Muscular Endurance in Females

The aim of this study is to evaluate the acute effects of beetroot juice and caffeine, consumed individually or in combination, on lower-limb strength and muscular endurance in physically active women. The main questions it aims to answer are:

* Does the co-ingestion of beetroot juice and caffeine enhance lower-limb strength and muscular endurance more than either substance alone or a placebo?
* How do the acute effects of beetroot juice interact with caffeine on physical performance?

The study was conducted using a randomized, crossover design to evaluate the following four conditions:

Beetroot juice with placebo Caffeine with placebo Beetroot juice with caffeine Placebo only

Each participant completed all conditions, with a sufficient washout period between sessions to eliminate potential carryover effects. This design allowed for a direct comparison of the acute effects of each supplementation strategy on lower-limb strength and muscular endurance.

Participant Protocol

Participants consumed their assigned supplement on a single testing day for each condition. After supplementation, they performed standardized tests to measure lower-limb strength and muscular endurance. Progress was monitored, and data from all conditions were collected to assess the acute effects of each intervention.


Eligibility Criteria:
Inclusion Criteria:

* Minimal experience of six months of strength training
* Be familiarized with the exercise test: counter movement jump (CMJ), barbell back squats, leg press and knee extension.

Exclusion Criteria:

* Supplementation consumption
* Sports injuries
Short Term Outcome of Acute Heart Failure in Diabetic and Non Diabetic Patients

Around 26 million people suffer from heart failure (HF) globally, and the prevalence is increasing with an increasing longevity, prevalence of risk factors, and improved survival in patients with cardiovascular diseases In Egypt, HF is the primary cause of hospitalization among patients aged \> 65 years . Hospitalization for HF is associated with a high mortality and rate of re-hospitalization . Around 75% patients with HF have ≥ 1 comorbidity, and these comorbidities make overall clinical outcomes worse . In a recent meta-analysis, patients with diabetes mellitus (DM) were suggested to have a two-fold increase in the risk of HF . DM is present in \~ 35% patients hospitalized with acute HF . Multiple factors such as ischemia, hypertension, and extracellular fluid volume expansion are involved in the pathogenesis of HF in DM.

The prevalence of both heart failure (HF) and diabetes has increased over the last decades and is expected to do so in the upcoming decades . Therefore, the presence of diabetes in patients with HF is also likely to increase and this is anticipated to become a major health concern. The actual prevalence of diabetes in patients with acute HF in different registries has varied but may be as high as 45% . Because the structure and function of the heart is directly influenced by the presence of diabetes, diabetes is to be considered to represent more than just a co morbid condition in HF .

Diabetes has been shown to be an independent risk factor for the development of HF . Moreover, this risk has been shown to be age and sex dependent. Compared with patients without diabetes, the presence of diabetes doubles the risk of HF in men, and the risk of developing HF in women may be as much as four times higher . These associations may even be stronger in younger patients. Furthermore, the presence of diabetes has been associated with a longer duration of hospitalization and higher rates of rehospitalization among patients with acute HF. Importantly, in patients with HF, it has been established that the presence of diabetes is not only associated with an increased cardiovascular morbidity but also with an increased mortality

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or older .
* Admitted to the Coronary Care Unit with acute HF.
* Patients with new onset heart failure.
* Decompensated chronic HF.

Exclusion Criteria:

* Aged under 18 years old.
* Patients with chronic HF
Adequate Dairy Intake on Weight Change in Girls

SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .

HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less.


Eligibility Criteria:
Inclusion Criteria:

* Age 13-14 years old (must be this age when consent is signed)
* Above the 50th percentile for BMI
* Above the 85th percentile for BMI with approval from their primary physician
* At least one and one- half years post menarche
* Habitual dietary calcium intake of 600mg/d or less as assessed by 3 day diet diary. This will be inclusive of supplemental calcium and dietary intake.
* Willingness to increase dietary calcium (low fat \[skim, 1%, 2%\] milk or yogurt) for one year

Exclusion Criteria:

* Menarche prior to age 10
* History of lactose intolerance or milk allergy
* Weight \>300 pounds
* BMI \> 97 percentile for age and gender
* Pregnancy
* Chronic disease or disorder like diabetes, polycystic ovarian syndrome, thyroid disease, seizures or cancer (cancer is ok if it has been \>10 years)
* Use of steroids like prednisone, prednisolone, hydrocortisone, Flovent, Advair, or Nasonex
* Use of weight reducing medications like Meredia, alli, Dexatrim or Xenical
* Use of contraceptives like Yasmin, Ortho Tri-Cyclen, Apri, Aviane or Depo-Provera for any reason, including acne (see inclusive list)
* Use of acne medications like Accutane or high dose Vitamin A
* Use of ADHD medications like Adderall, Ritalin, Concerta. (Per Dr. Ramaswamy-Straterra OK) (see inclusive list)
* Use of seizure medications like Lamictal or Phenobarb (see inclusive list)
* Use of anti-depressants like Prozac or Effexor (see inclusive list)
* Diagnosed eating disorder
* Dieting behavior with weight loss \> 10 pounds in the last 3 months (IF YES, consult with Project Manager)
* Metal in the skeleton (pins, rods, etc)
* Sibling of a child who is or has been on a dietary study in the last 5 years
* Total body BMC Z-score below -2.0 at baseline
* Participating in other ongoing research protocols
Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.

New algorithms for the automation of insulin delivery (AID) are showing great benefit on glucose control in people with type 1 diabetes. Indeed, Hybrid closed loop (HCL) systems can improve HbA1c levels, percentage of time in defined glucose range, time below range and time over range, according to RCT and observational studies results. However, scientific evidences demonstrating potential benefits on the reduction of diabetes complications are limited regarding CSII or SAP with demonstrated reduction of cardiovascular mortality, improvement of albuminuria and peripheral nerve damage.

Data on AID effects on complications of diabetes are missing. In this study intermediate damage markers will be measured to assess potential effects of AID in comparison to sensor augmented pumps.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* T1D patients above 18 years in CSII treatment for at least 3 months
* HbA1c values between 6.0% and 9.5%
* Disease duration ≥ 2 years
* Written informed consent obtained from the patient

Exclusion Criteria:

* Pregnancy
* Participation to other clinical trials
* A history of alcohol or drug abuse
* Advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or eGFR \< 60 ml/min/1,73m2
* Proliferative Diabetic retinopathy or macular edema
* Established Atherosclerotic Cardiovascular Disease (ASCVD) or history of heart failure
* Presence of serious diseases or conditions which in the opinion of the Investigator makes patient non-eligible for the study
* Hypoglycemia Unawareness (Clarke score \> 4)
* Patients unable to understand spoken and written Italian language