cyrilzakka/clinical-trials huggingface dataset:
Developing an Artificial Intelligence System to Detect Cognitive Impairment

Alzheimer's disease dementia (AD) is a debilitating and prevalent neurodegenerative disease in older adults globally. Cognitive impairment, a hallmark of AD, is assessed through verbal tests that require high specialization, and while accepted as screening tools for AD, general practitioners seldom use them. AD can be diagnosed with expensive, invasive neuroimaging and blood tests, but these are usually conducted when cognitive functioning is already severely impaired. Thus, finding a novel, non-invasive tool to detect and differentiate mild cognitive impairment (MCI) and AD is a prime public health interest. Self-figure drawings (a projective tool in which individuals are asked to draw a picture of themselves), are easy to administer and have been shown to differentiate between healthy and cognitively impaired individuals, including AD. Convolutional Neural Network (CNN) (a type of deep neural network, applied to analyze visual imagery) has advanced to assess health conditions using art products. Therefore, the proposed study suggests utilizing CNN-based methods to develop and test an application tailored to differentiate between drawings of individuals with MCI, AD, and healthy controls (HC) using 4,000 self-figure drawings. This


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60 and above with subtle signs of risk of future cognitive decline, residing in the community or in nursing homes with a minimum of 10 years of education.

Exclusion Criteria:

* Current or past psychiatric illness, the presence of congenital/organic cognitive condition, severe visual or motor impairment, and terminal illness (to avoid the effect of comorbidities).
Safety and Tolerance of a Nutritional Intervention Program- In.Form 1.2

The study evaluated and the safety, tolerance and acceptability of a lifestyle modification program with nutritional supplementation in generally healthy overweight subjects with cardiometabolic risk factors. Experience will be compared to a historical controls.

To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined with exercise and lifestyle modification education and a meal replacement formula and targeted nutraceuticals (PROG 2) in generally healthy, overweight subjects, fifty subjects with two or more cardiometabolic risk factors, aged 18 to 69 will be randomized into different arms, 13-week intervention trial. To evaluate safety and tolerability, questionnaires were collected weekly. Additionally, baseline, week 9 and 13 fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and additional cardiovascular risk factors. Vitals signs, weight and body composition were monitored weekly.

Eligibility Criteria:
Inclusion Criteria:

Generally healthy subjects (men and women ≥ 18 and ≤ 69 years old) were required:

* to be overweight or obese (BMI ≥ 27 kg/m2 and ≤ 50 kg/m2),
* to exhibit visceral obesity (waist circumference ≥ 35 inches for women and ≥ 39 inches for men),
* and demonstrate signs of cardiometabolic dysfunction. Specifically, subjects were required to have:
* elevated LDL cholesterol ≥ 130 mg/dl
* and/or elevated TG defined as TG ≥ 130 mg/dl. Additionally, subjects were required to have at least one of the following criteria (unless subject had both elevated LDL and TG):
* HDL \< 50 mg/dl for women and \< 40 mg/dl for men,
* blood glucose ≥ 100 mg/dl, HbA1C ≥ 5.7%,
* or Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) score defined as ≥ 2.0.

Exclusion Criteria included:

* Pregnancy
* Lactation
* Recent changes in prescription medications, over-the-counter medications, medical foods, and nutritional supplements
* Recent or regular use of narcotics, investigational drugs, corticosteroids, anticoagulants, neuroactive medications, or medication or supplements relevant to hyperglycemia or hyperlipidemia
* Chronic use of over-the-counter medication which would interfere with study endpoints including NSAIDS, laxatives and antacids
* Allergy or intolerance to study products
* Serious, unstable medical conditions including known infection with HIV, tuberculosis or hepatitis; cardiovascular disease; Diabetes Mellitus; autoimmune diseases; malignancy; psychiatric disease; substance abuse;
* Abnormal laboratory findings
* Participating in or planning to begin a weight loss diet during the study period
* Difficulty in swallowing pills
* Lifestyle or schedule incompatible with the study protocol.
Effects of Banned Substances on Some Metabolic Functions in Male Amateur Athletes

The aim of this study was to investigate the effects of banned substances on some metabolic functions in male athletes in order to raise awareness among individuals who use these substances by highlighting the potential harms of using banned substances to draw attention to the issue and raise awareness. 2) Methods: The study is a randomised cross-sectional study. The study included 20 male amateur athletes who had actively practised bodybuilding, arm wrestling, powerlifting and weightlifting in the last 5 years and had not participated in competitions. The study group consisted of 10 adult male amateur athletes who had used banned substances at least once a year in the past 5 years, while 10 male amateur athletes who had not used banned substances with similar qualifications formed the control group. Participants were included in the study on a voluntary basis. Participants' age, sports age, height, weight and BMI variables were selected and parameters related to liver, kidney, hormone and lipid profiles were determined. The Shapiro-Wilk test was used to test the normality of the values obtained from the data. The independent t-test was used for the data showing a normal distribution and the Mann Whitney U- test was used for the data not showing a normal distribution.


Eligibility Criteria:
Inclusion Criteria:

1. Amateur athlete who has been actively involved in bodybuilding, arm wrestling, powerlifting and weightlifting for the last 5 years
2. Adult male amateur athletes who use banned substances in at least 1 period each year

Exclusion Criteria:

1. with chronic illness
2. receiving continuous medication
3. heavy labor
4. who has recently had an infection
5. amateur athletes who performed heavy exercise in the last 72 hours
Pudendal Assessment in Erectile Dysfunction

The study will address the role of internal pudendal artery disease in erectile dysfunction (ED), and whether it might eventually be amenable to intervention with stenting. There is currently a small trial investigating the potential benefit of stenting for erectile dysfunction, but the relationship between pelvic arterial stenoses and erectile dysfunction is not yet proven. The investigators intend to perform angiography on patients both with and without erectile dysfunction, to see whether internal pudendal artery disease is more common in the population with erectile dysfunction. In addition to angiography, stenoses will be examined using fractional flow reserve. The degree of internal pudendal artery disease will then be correlated with the degree of erectile dysfunction using a validated questionnaire, the International Index of Erectile Function (IIEF). Patients will then complete IIEF questionnaires for 5 years to assess the relationship between internal pudendal artery disease and progression of erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* As above, men with one risk factor for ED such as age\>55, diabetes, hyperlipidemia, smoking, hypertension, coronary disease or peripheral arterial disease

Exclusion Criteria:

* Patients with ED from a non-arterial cause, including hormonal, neurological, or trauma-related (as determined by past medical history routinely performed prior to catheterization)
* Patients requiring urgent catheterization (e.g. acute coronary syndrome or cardiogenic shock)
* Patients with a creatinine \>1.5 mg/dL and those deemed at increased renal risk (such as from receiving \>200 mL of dye during the primary procedure, post renal transplant or single kidney), as the additional contrast dye required for angiography would pose an undue risk of progressive kidney disease
* Patients with other illnesses that reduce their life expectancy to less than one year
VOCs in Patients With Acute Cardiogenic Chest Pain

The goal of this observation study is to compare VOCs in cardiogenic chest pain population/health conditions, to answer：Establishment and promotion of the application system of emergency rapid detection of expiratory Volatile Organic Compounds (VOCs) in patients with acute cardiogenic chest pain

1. VOCs levels were measured at baseline in healthy people, and markers of VOCs that could be used to identify acute cardiogenic chest pain were sought.
2. The relationship between abnormal VOCs (mainly aldehydes) and prognosis of patients and the correlation with Super-score for early warning of acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

Observation group inclusion criteria:

1. Over 18 years old, male or female;
2. Patients with acute cardiogenic chest pain (see diagnostic criteria);
3. Patient\&#39;s informed consent.

Inclusion criteria of healthy control group:

1. Over 18 years old, male or female;
2. Centerless cerebrovascular disease, lung disease, no abnormal liver and kidney function, no acute infection recently;
3. Informed consent.

Exclusion Criteria:

1. The patient had difficulty in collecting breath;
2. Patients with terminal illness or receiving palliative care;
3. Have participated in other clinical studies or consider it inappropriate to participate in this study.
EORTC Quality of Life Measurement Strategies in Progressive Cancer

Rationale: Health-related quality of life (HRQOL) in people diagnosed with cancer is of increasing interest as an endpoint in clinical care and research. It helps keep track of patients' functioning and wellbeing, and informs the net clinical benefit of treatment. However, gathering HRQOL information becomes increasingly harder when patients experience disease progression. Therefore we need to develop measurement strategies of HRQOL within the progressive disease setting. Objective: The overall aim of the project is to develop recommendations to optimise the measurement and analysis of HRQOL outcomes of cancer patients within the progressive disease setting. The aim of this sub-study is to identify the preferences of patients, their carers as proxies, and health-care professionals (HCPs) about the research objectives, how often and how we should assess HRQOL, and how we might limit dropout over time.

Sub-study design: An international, multi-centre study using semi-structured interviews.

Procedures: Across Europe, we aim to interview adult people diagnosed with cancer who experience progressive disease (N=30), their carers as proxies (N=30), and HCPs involved in cancer care and/or research (N=15). The UK site will aim to recruit a maximum of 10 patients and 10 proxies. Patients and carers will be interviewed twice to evaluate whether preferences change over time. Study outcomes: Findings can help in optimising the measurement and analysis of HRQOL outcomes of cancer patients in the progressive disease setting. This will help to better inform both clinical decision-making and regulatory processes.


Eligibility Criteria:
Inclusion Criteria:

PATIENT- Adult (\> 18 years of age)

* Histologically proven or radiologically diagnosed cancer
* Clinical and/or radiological progressive disease according to RECIST criteria
* Poor prognosis, i.e. expected survival time \<3 years according to the treating physician PROXIES - Adult (\> 18 years of age)
* Partner, relative or close friend of a patient who is eligible according to the criteria specified above

Exclusion Criteria:

* Participants without understanding of the official language of the country in which they live
* Participants with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper providing informed consent for research participation
Safety Study of Liver Regeneration Therapy Using Cultured Autologous BMSCs

Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is \<3.0 mg/dL, patients who are still deemed unsuitable as a candidate for general anesthesia. About 30 mL of autologous bone marrow was collected from the bilateral iliac crests under local anesthesia, heparin was added after collection. In addition, at the Center for Regenerative and Cell Therapy at Yamaguchi University Hospital, a nucleated cell fraction was prepared. Next, a cell suspension was prepared by adding culture medium, and this was inoculated into a culture flask. After subculturing for 3 weeks, the cells were infused through a peripheral vein. The primary endpoint is the incidence of adverse events up to 24 weeks after ABMSC infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for this study include those with decompensated liver cirrhosis with a Child-Pugh score ≥7 (Child-Pugh B) in whom further improvement with current medical treatment is not expected. Other inclusion criteria are age 20 to 75 years and a serum total bilirubin of 3.0 to 5.0 mg/dL, or if the total bilirubin is \<3.0 mg/dL,
* Patients who are still deemed unsuitable as a candidate for general anesthesia.
* Patients must provide informed consent for study participation.

Exclusion Criteria:

* Patients with a current history of malignant neoplasm.
* Patients with gastroesophageal varices at risk of rupture.
* Patients with renal insufficiency and a serum creatinine ≥2 mg/dL.
* Patients with a hemoglobin \<8 g/dL, a platelet count \<50,000/μL, or a prothrombin time \<40%.
* Patients with a performance status of 3 or 4.
* Patients who refuse to consent to allogeneic blood transfusion.
* Women who are pregnant.
* Patients whom their attending physician deems are not suitable candidates for general anesthesia.
* Patients with a current or previous severe allergic reaction to a contrast agent, beef, cow milk, and anesthesia.
* Any patient deemed unsuitable for study inclusion by their attending physician.
Retina is a Marker for Cerebrovascular Heath

Cerebral small vessel disease (SVD), present in 80-94% of adults over age 65 years, increases the risk of stroke by 2-fold, and dementia by 2.3-fold. There is currently no treatment to slow SVD progression. This study aims to test whether impaired cerebral and retinal vasoreactivity may serve as biomarker for SVD progression, and to evaluate the safety and efficacy of cilostazol (antiplatelet agent with vasodilatory and anti-inflammatory properties) for the treatment of SVD.

This is a prospective, observational nested pilot randomized controlled study to discover retinal biomarkers that would predict cerebral small vessel disease progression, and evaluate the safety/efficacy of cilostazols in slowing SVD progression. Twenty CADASIL, 40 sWMD, 20 lobar CMB, and 20 age-matched healthy controls from the Mayo Clinic Florida Familial Cerebrovascular Disease Registry and neurology clinic will be recruited. All participants will undergo OCTA retinal scan, MRI-BOLD brain scan, cognitive battery evaluation, and blood sample at baseline and a 12-month follow-up visit. Key outcome measures are: RVR, CVR, cognition, WMH volume, and CMB volume. The 40 patients diagnosed in the course of routine clinical care with sWMD will be randomized in 1:1 ratio to receive cilostazol 100mg bid (or 50 mg bid if taking medications known to affect metabolism of cilostazol) or no cilostazol, and followed for WMD progression, and secondarily for changes in cognition, RVR and CVR. Flow diagram below outlines the study design. Note that in addition to what is shown in the trial flow diagram, patients will have telephone visits between baseline and 12 month clinic visits biweekly for 3 months and then monthly thereafter. These visits will consist of a survey for adverse events and at the 1-, 3-, 6- and 9-month telephone visits patients will also get a modified Rankin scale assessment, a Six-item screener (cognitive assessment) and a PHQ-2 (depression screen).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 yo.
* Diagnosis of CADASIL, sporadic WMD or lobar CMB and age-matched healthy controls (eg. patient's spouse or unrelated friends without SVD)

Exclusion Criteria:

* Age\<18yo
* Pregnant
* Breast feeding
* Unable to follow commands
* Unable to tolerate MRI
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* WOCBP who are using acceptable method of contraception
* Women who are not nursing

Exclusion Criteria:

* History of GI disease
* Any GI surgery that could impact study drug absorption
* Glucosuria at screening or Day -2
* Abnormal liver function tests (ALT, AST or total bilirubin \> 10% above ULN)
* History of current or recurrent UTI
* History of Diabetes Mellitus
* History of chronic or recurrent vulvovaginal mycotic infections
* Estimated creatinine clearance (ClCr) \< 80 mL/min using Cockroft-Gault formula
* History of allergy to SGLT2 inhibitors or related compounds
Thyroxin in Subclinical Hypothyroidism

Subclinical hypothyroidism(SCH) is the elevated thyroid stimulating hormone (TSH) with normal free Thyroxine levels and it is a mild or compensated form of primary hypothyroidism. It has been suggested that SCH is more prevalent in infertile women (especially in women with ovulatory disorders.Various rates of SCH was reported in infertile women in different populations

Despite well-established recommendations on screening and treatment of overt hypothyroid in infertile women, there is a controversy regard the treatment of SCH in infertile women .

There are few published data on the prevalence of SCH and the outcome of treatment of SCH in infertile women, many were conducted during IVF cycles . Moreover there are inconsistent results in these studies being authors advised to treat SCH before IVF and some other articles find out no any benefit regarding treatment with Thyroxine in SCH

Eligibility Criteria:
Inclusion Criteria:

1. Unexplained infertility
2. TSH more than 2.5 and normal T3,T4 levels
3. Negative for Anti-thyroid antibodies

Exclusion Criteria:

1. current history of overt hypo or hyperthyroidism
2. recurrent pregnancy loss
3. women having franked causes for infertility like tubal blockage, pelvic inflammatory disease, endometriosis , ,uterine factor
4. Ovarian dysfunction or decreased ovarian reserve
5. abnormal seminal fluid analysis or male factor
Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer

This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.

This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.

For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.

Eligibility Criteria:
Inclusion Criteria:

1. subjects had voluntarily given written informed consent
2. subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
3. subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
4. subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC
5. subjects' ECOG performance status ≤ 2
6. subjects with life expectancy ≥ 3 months

Exclusion Criteria:

1. subjects with medical history of gout
2. subjects who had participated other clinical trials within 4 weeks before the screening visit
3. subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
4. subjects with clinically significant diseases other than cancer
5. subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
6. female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception
7. subjects with history of alcohol, drug or other substance abuse
8. subjects with disease of bacteremia
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combinations (FDC) tablets containing empagliflozin, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.


Eligibility Criteria:
Inclusion criteria:

* Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
* Age of 18 to 55 years (incl.)
* BMI of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
* Male subjects, or female subjects who meet any of the following criteria starting from at least 30 days before the first administration of trial medication and until 30 days after trial completion:

Use of adequate contraception, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device Sexually abstinent A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment) Surgically sterilised (including hysterectomy) Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria:

* Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply