cyrilzakka/clinical-trials huggingface dataset:
Diet-Induced Variability in Appetite (DIVA)

The aim of this study is to test the hypothesis that dietary weight loss (WL) through alternate day fasting (ADF) will enhance appetite control, health markers and wellbeing following WL compared to standard daily calorie restriction (CR).

This is a proof of concept randomized controlled trial in which overweight/obese females will be randomised to a dietary weight loss intervention (ADF or CR) to achieve ≥5% WL. Behavioural measures of appetite control including ad libitum intake after a fixed meal, body composition, resting metabolic rate, measured physical activity and daily energy expenditure, sleep quality, hedonic food reward and eating behaviour traits will be assessed before, during and after the WL intervention in those who reach the target weight loss within 12 weeks. After weight loss phase, participants will be given standard healthy eating and physical activity advice for weight maintenance and body weight will be followed up after weight loss at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Female participants aged between 18 and 55 years at the time of signing informed consent
* BMI of 25.0 - 34.9 kg/m2

Exclusion Criteria:

* Significant health problems which in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol
* Currently enrolled in a weight loss programme or following a specific diet plan.
* History of eating disorders including binge eating.
* Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
* Pregnant, planning to become pregnant or breastfeeding
* History of anaphylaxis to food
* Known food allergies or food intolerance
* Smokers and those who have recently ceased smoking (\< 6 months)
* BMI \< 24.9 kg/m2 or \> 35 kg/m2
* Volunteers having lost significant amount of weight in the previous 6 months (± 4kg)
* Volunteers who exercise \> 3 days per week or have significantly changed their physical activity patterns in the past 6 months or who intend to change them during the study
* Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
* Participants who work in appetite or feeding related areas.
* Participants who do shift work
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

In this study, subjects will take a regimen of hydroxychloroquine, vitamin C, vitamin D, and Zinc to test if this combination can prevent COVID-19. Treatment with hydroxychlorquine will last 1 day. Treatment with vitamin C, vitamin D, and and zinc will last 12 weeks. The study will last 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study
2. Male or female patients 18 years of age or older that are considered to be high-risk individuals.

   a. High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.
3. Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)

Exclusion Criteria:

1. Refusal to provide informed consent
2. Any previous positive test for COVID-19 by RT-PCR
3. Symptomatic for COVID-19
4. Diarrhea prior to the start of treatment
5. Type I or II diabetes
6. Atherosclerotic Coronary Artery Disease
7. Any contraindication for treatment with hydroxychloroquine including:

   1. Hypoglycemia
   2. G6PD deficiency
   3. Porphyria
   4. Anemia
   5. Neutropenia
   6. Alcoholism
   7. Myasthenia Gravis
   8. Skeletal muscle disorder
   9. Maculopathy
   10. Changes in the visual field
   11. Liver disease, with ALT/AST \> 2.5 upper limit normal and total bilirubin \>2.5 upper limit normal
   12. Psoriasis
   13. Any contraindicated medications found in Appendix 2
8. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
9. Vaccination for SARS-CoV-2
Shock Wave vs. On-demand Tadalafil for Erectile Dysfunction

The objective of this study is to evaluate the effectiveness and safety of focused Li-ESWT on 25 participants complaining of ED compared to 25 participants complaining of ED on medical treatment on a prospective clinical trial for 12 weeks.

Penile erection is a very complex process which requires a delicate and coordinated equilibrium among the neurological, vascular and the tissue compartments. It also includes arterial dilation, trabecular smooth muscle relaxation, and activation of the corporeal veno occlusive mechanism.Erectile dysfunction is defined as persistent inability to achieve or maintain the erection that is sufficient to permit satisfactory sexual intercours. It has a multifactorial pathogenesis, one of them is vasculogenic ED that occurs due to diseases such as diabetes mellitus, hypertension, hyperlipidemia, smoking, or vascular occlusive disease.

ED is also the most commonly treated sexual disorder and it affects approximately 20% of adult males over the age of 20. Nowadays, there are several treatment solutions for patients with ED, either non-invasive or invasive but the phosphodiesterase 5 inhibitors are still the first-line therapy for ED.

However, PDE5-Is effect is limited due to their inability to improve penile blood flow for a time period that is sufficient to allow optimal oxygenation and recovery of Cavernosal vasculature. Also, they cannot improve spontaneous erections. Moreover, several patients ranging from 40% to 50% will not respond to drug therapy even after optimization approaches such as treatment combinations have been implemented.

Also, it was proven that the effect of long-term daily use of PDE5-Is on endothelial function has induced a short-term improvement in erectile function but probably not a longstanding one.

Another option for ED patients is the use of intracavernosal injections which is considered the second line of treatment. Although PDE5-Is and intracavernosal injections are effective and safe vasodilating agents, they are unable to alter the underlying predominant pathology in patients with vasculogenic ED (eg, cavernosal artery insufficiency).

Other options include the use of intraurethral injections, or vacuum constrictive devices that could serve as salvage therapy for patients who failed to respond to PDE5-Is. If the previous options failed or not preferred by the patient, penile prosthesis implantation would be the last resort treatment for ED.

Many trials were done to find a new treatment modality that would provide a rehabilitative or curative effect for ED. This modality should affect the endothelial function and improve penile hemodynamics. One of these modalities was low-intensity extracorporeal shockwave therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male patients
* ED at least for 6 months
* vasculogenic ED
* from 25-60 years old

Exclusion Criteria:

* psychological patents
* neurological patients
* younger than 25 years old
* older than 60 years old
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150

This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male adult subjects.

To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.

Eligibility Criteria:
Inclusion Criteria:

* Body weight: ≥50.0 kg, \<80.0 kg
* BMI: ≥17.6, \<26.4
* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and lab tests

Exclusion Criteria:

* Received any investigational drugs within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 7 days before the study
* A deviation from the assessment criteria of physical examinations or laboratory tests
* A deviation from the normal reference range of coagulation test \[PT or aPTT\]
* History of drug allergies
* Upper gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Concurrent or previous malignant tumor
* Previous treatment with YM150
Magnetic Resonance Imaging (MRI) Assessments of the Heart and Liver Iron Load in Patients With Transfusion Induced Iron Overload

This study will evaluate the change in cardiac iron load over a 53 week period measured by MRI in 2 cohorts of patients


Eligibility Criteria:
Inclusion criteria:

* Male or female WITH haemoglobinopathy, Myelodysplastic Syndromes or other inherited or acquired anaemia (e.g. MPD, Diamond-blackfan anaemia and other rare anaemias) patients ≥ 18 years and weighing \>40kg.
* Lifetime minimum of \> 20 units of packed red blood cell transfusions
* Normal or minimally abnormal cardiac function

Exclusion criteria:

* Contraindication to MRI scans
* High risk myelodysplastic syndromes patients and patients with other haematological and non-haematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease
* Patients with uncontrolled high blood pressure
* An organ transplant less than 3 months previously

Other protocol-defined inclusion/exclusion criteria may apply.
Evaluation of Platelet Function in Pregnancy With Multiple Electrode Aggregometry

Establishment of a range of normal values in pregnancy with the Multiple Electrode Aggregometry (Multiplate@) device, a device that allows measurement of not only platelet count but platelet function. This has not been studied in ths special patient group. Results from this trial will be used as a basis for further investigation of abnormal platelet function in pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* Rejection of informed consent
Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.

Upon determination of eligibility, patients will receive:

Paclitaxel + Estramustine + Carboplatin

Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the prostate not curable with local treatment
* Disease progression while receiving hormonal therapy
* Measurable or evaluable disease
* Previous treatment with a maximum of one prior chemotherapy regimen
* ECOG performance status 0, 1, or 2.
* Adequate bone marrow, liver and kidney function
* Able to comprehend the nature of this study and give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* History of treatment for an invasive malignancy within five years
* Significant heart disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Beta-carotene and Oxidative Stress in Pediatric Second Generation Antipsychotic Use

Weight gain, hypertension, high cholesterol and sugar abnormalities in childhood are strongly linked and predict the risk of further complications and early death in adulthood. The newer antipsychotics, called the second generation antipsychotics are commonly used to treat mood disorders in adult and pediatric populations. Their use has substantially increased (up to 5-fold) in the past 15 years in children due to their approved use by the Food and Drug Administration and higher acceptance in the general medical community. However, second generation antipsychotics are known to have very damaging side effects that cause children to gain substantial amounts of weight, have high cholesterol, high blood pressure and high sugar levels. Despite the known risks their use is still needed and may be contributing to the high rates of obesity-related diseases in childhood and ultimately shorter life-spans in adulthood. How second generation antipsychotics cause these side effects is still not well known. Preliminary evidence has identified a novel pathway that may be associated with second generation antipsychotic side effects. This pathway has not been studied, is involved in vitamin A metabolism and is called the beta-carotene pathway. Beta-carotene is an important part of our diet because it acts as an anti-oxidant (fights harmful oxidative stress in the body) and it produces the active form of vitamin A which is essential for several processes in our body. The investigator's work has identified a backup in this pathway which the investigators hypothesize is due to genetic variation of the enzymes found within this pathway.

The investigators hypothesize that genetic variation in the beta-carotene pathway is responsible for the side effects associated with second generation antipsychotics. The investigators want to complete a cross-sectional, pilot study in the pediatric population that will be used for future prospective, extramural applications.

The investigators propose two aims for this study:

Aim 1: Determine how second generation antipsychotics change beta-carotene metabolism. For this aim, the investigators hypothesize that high beta-carotene:retinoic acid ratios will be due to genetic varition in the beta-carotene pathway.

Aim 2: Define the relationship between beta-carotene metabolism, oxidative stress and second generation antipsychotic induced insulin resistance. For this aim the investigators hypothesize that low beta-carotene levels will be associated with high oxidative stress levels and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 10 to 17 years currently treated with one or more antipsychotics as determined by a physician
2. No changes in antipsychotic dosage for the past 6 weeks.

Exclusion Criteria:

1. Guardian or child unwilling or unable to participate.
2. A diagnosis of diabetes or dyslipidemia prior to starting an antipsychotic.
3. Abuse or dependence diagnoses
Comparison Between Amniotic Fluid Lamellar Body Count and Fetal Pulmonary Artery Doppler Indices in Predicting Fetal Lung Maturity

The investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal pulmonary artery Doppler will be correlated with fetal outcome

Neonatal respiratory distress syndrome (RDS) remains a major cause of neonatal morbidity and mortality. A recent epidemiologic study in the United States estimates that there are 80,000 cases of neonatal RDS each year, resulting in 8500 deaths and hospital costs in excess of $4.4 billion.

A number of biochemical tests have been developed to predict the risk of RDS and assist obstetric care providers in delivery timing. Amniotic fluid lamellar body count (LBC) is an important biophysical test, based on measuring the concentration of pulmonary surfactant in amniotic fluid. It can be effectively used to assess fetal lung maturity. A noninvasive test for fetal lung maturity (FLM) would be useful to minimize the need for invasive testing and would be more acceptable to women. Fetal pulmonary artery Doppler waveform acceleration/ejection time may provide a noninvasive means of determining fetal lung maturity with relatively acceptable levels of sensitivity, specificity, and predictive values.

The investigators will study 200 women with singleton pregnancies presented with prelabor preterm rupture of membranes or undergoing cesarean section (CS). Amniotic fluid lamellar body count (LBC) and fetal pulmonary artery Doppler will be done to all women. LBC and fetal pulmonary artery Doppler will be correlated with fetal outcome.

Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using Mann Whitney U test for independent samples while categorical data will compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies without any major congenital anomalies.
* Gestation between 32-36 weeks
* Women presenting preterm pre-labour ruptured membranes or undergoing a cesarean section.

Exclusion Criteria:

* Patients with major fetal anomalies.
* Bloody or meconium stained amniotic fluid
* preexisting maternal medical conditions (eg, diabetes, renal disease, hypertensive disorders, vaginal bleeding
Effect of Stuttering Remediation Exercises on Cortical Auditory Evoked Potentials

studying how the cortical auditory evoked potentials differ in children who stutter from who do not stutter and how these potentials change with therapy

Measuring amplitude and latency of P1, N1, P2 N2 between a group with developmental stuttering and a control group with no stuttering at baseline. Recording the potentials through passive listening to a 60dB stimulus and active speaking, describing pictures and rapid naming.

Assigning the group with stuttering to remediation exercises using fluency shaping program for 2 to 4 months then remeasuring amplitude and latency of the previously mentioned potentials.

Eligibility Criteria:
Inclusion criteria:

* Patients with developmental stuttering
* Normal hearing and vision.
* Adequate language for age.

Exclusion criteria:

* Known history of epileptic fits.
* Intellectual disability and other neurological deficits.
* Cluttering
Analysis of the Results Obtained in the Regular Clinical Practice of a Clinical Ultrasound Classroom For Primary Care Physicians As a Formative Intervention System

The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit obtained by patients over 60 years of age included in the program, analyzing the degree of satisfaction, resolution time of the reason for consultation and decrease in the number of referrals to the second level of care, analyzing the differences by gender.

The objectives of the project are to evaluate the theoretical-practical knowledge acquired and the degree of satisfaction of a methodology based on theoretical-practical training in abdominal and thyroid clinical ultrasound of family doctors, in the urban area of Primary Health Care, and to evaluate the benefit obtained by patients over 60 years of age included in the program, analyzing the degree of satisfaction, resolution time of the reason for consultation and decrease in the number of referrals to the second level of care, analyzing the differences by gender.

The expected impact is that the doctors participating in the project learn to perform abdominal and thyroid ultrasound and continue to perform them during the year that their participation in the project lasts, and independently thereafter. In addition, this will allow the reduction of interconsultations to the specialized care and emergencies of their patients whose primary care physicians perform ultrasound scans in their health center.

Its application in clinical practice will be reflected because doctors who perform ultrasound scans in their primary care centers will increase their diagnostic certainty in real consultation time on many occasions, thereby reducing interconsultations at the second level of care, and when they have to refer a patient at this level, they will do so in a more documented manner.

Eligibility Criteria:
Inclusion Criteria:

* To work in selected health centers.
* To have assigned to more than 800 patients.
* Not have previous training in regulated clinical ultrasound.
* Sign a commitment to Attendance at least 80% of the training program sessions.
* Sign the informed consent.

Exclusion Criteria:

* Not meeting any of the inclusion criteria.
* Not signing the informed consent.
ENB-GS-TBLB for the Diagnosis of PPLs

The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .

The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope department, Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University, China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray group.Each subject will be randomized to each group.The study is expected to enroll 60 patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).

Eligibility Criteria:
Inclusion Criteria:

1. clinical and imaging characteristics suggestive of maligancy
2. CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.

Exclusion Criteria:

1. The lesion is close to the pleural membrane
2. Refusal of participation
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
Reliability of Light Induced Fluorescence Intraoral Camera Versus Visual-Tactile Method in Assessment of Marginal Integrity of Resin Composite Restorations: Diagnostic Invivo Study

This study will be conducted to assess diagnostic predictive values of a light induced fluorescence intraoral camera versus those of the visual-tactile assessment method according to FDI criteria in clinical evaluation the margins of resin composite restorations

Each patient should have at least one resin composite restoration. The restoration will be evaluated by two diagnostic methods.

Each examiner will record the dental findings using both the visual- tactile assessment method and the fluorescent-aided identification method. The visual-tactile assessment method includes the use of mirror, FDI probe under good illumination condition, while the fluorescent-aided identification method will be performed by light induced fluorescence intraoral camera then the reliability of each diagnostic tool will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be over 18 years of age.
* Patients should have an acceptable oral hygiene level.
* Patients must have at least one posterior resin composite restoration.

Exclusion Criteria:

* Patients with a compromised medical history.
* Severe or active periodontal disease.
* Heavy bruxism or a traumatic occlusion.