cyrilzakka/clinical-trials huggingface dataset:
Telerehabilitation Exercise: Effects on Maternal Psychological Health and Delivery Outcomes

Gestational diabetes occurs when the body can't make enough insulin to manage high blood sugar during pregnancy, usually developing between the 24th and 28th weeks. It affects about 14% of pregnancies worldwide. Women with gestational diabetes often feel more anxious and stressed and have a higher risk of depression during and after pregnancy. This study will explore how telerehabilitation can reduce anxiety and depression and show how exercise can improve the health of pregnant women with gestational diabetes.

The diagnosis of GDM can be unexpected and distressing, leading to feelings of sadness and hopelessness.Women with GDM are at a higher risk of experiencing prenatal and postnatal depression, which can affect their overall well-being and ability to care for their newborn. Regularly checking blood sugar levels, changing diet, and possibly using medication or insulin can be overwhelming. This constant effort and worry about complications can cause a lot of anxiety and stress. Many pregnant women with GDM might not fully understand how exercise can help control their blood sugar levels and improve their overall well-being. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve psychological symptoms in participants with GDM.

The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving psychological health.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 20 to 35 years
* Gestational age between 20-28weeks
* diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
* Primigravida and multigravida
* able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
* Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
* Who signed informed consent

Exclusion Criteria:

* Previously diagnosed T1DM or T2DM
* High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
* Patients taking insulin regularly.
* Patients with fetal anomalies diagnosed at 20 th week.
* Multiple gestation (twin or triplets).
Chest X-Ray Image Diagnosis and Report Generation Dedicated Model Based on Deepseek

The global shortage of radiologists is a pressing issue, particularly in regions with limited medical resources. Against this backdrop, making report generation the core objective of radiology AI systems not only aligns with the practical needs of radiologists but also better serves patient requirements. With the development of multimodal large models, it has become possible to develop automatic report generation systems for medical images. Although ChatGPT 4o has demonstrated certain capabilities in multiple medical sub - fields, as a closed - source system, it has limitations. Its model generation mechanism is opaque, and issues such as hallucination exist. Recently, Deepseek's open - source multimodal large model, Janus - Pro, an "any to any" model, has the advantages of high performance, low cost, and open - source. Nature published three consecutive articles introducing its stunning features. After training and fine - tuning, Janus - Pro shows great potential in medical image diagnosis and report generation. However, currently, the application of Janus - Pro in image diagnosis has not been evaluated. Most existing models are highly versatile but lack optimization for specific domains, and there is a lack of systematic and multi - dimensional evaluation methods to determine the pros and cons of multimodal large models in medical radiology. Based on these current situations, the purpose of our research is to develop and verify the application value of large models dedicated to medical images in image diagnosis and radiology report generation.


Eligibility Criteria:
Inclusion Criteria:

1. Type of examination: standard digital orthopantomogram of the chest during the study period.
2. Completeness of information: Medical records containing basic information, medical history, etc.
3. Informed consent: written consent form signed by the patient or legal representative.

Exclusion Criteria:

1. Anatomical abnormalities: congenital abnormalities of chest development, history of chest surgery, or severe scoliosis that interfere with image interpretation.
2. Poor image quality: chest radiographs with severe artifacts, exposure abnormalities, or incomplete images.
3. Acutely ill: life-threatening and unable to cooperate with the study process.
4. Mental cognitive problems: suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
5. Pregnant: Fetus is radiosensitive and physiological changes during pregnancy affect the images.
6. Participation in other studies: concurrent participation in other programs that affect the results of this study.
Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)

This research is being done to better understand the pulmonary consequences of completing an ultra marathon at altitude and a sea level city.

Subjects will be asked to undertake three (3) sets of assessments at prescribed time intervals: Baseline (at 72-24h prior to each event), immediately post (within 2h of race completion) and during recovery (within 24-48h of race completion). Each assessment will consist of 1)lung function tests; 2) a saliva and blood sample; 3) a lung and cardiac ultrasound. Subjects will be recruited from a range of age groups and fitness levels, before being divided into a sham or therapy group. Groups will use Pulsed Electromagnetic Field (PEMF) therapy or related sham before the event and during recovery.

Eligibility Criteria:
Inclusion Criteria:

Healthy endurance trained individuals participating in the Ultra Trail du Mont Blanc (UTMB) and/or Hong Kong 100 ultramarathons

Exclusion Criteria:

\> 65 years age
BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo


Eligibility Criteria:
Inclusion Criteria:

* Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
* At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

* Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
* Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
* Unstable angina pectoris.
* History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
* Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate \>100 BPM).
ATM Variants in Radiotherapy Patients

The purpose of this study is to compare the baseline incidence of variant alleles in the ATM and/or other DNA repair genes present in the Native American population versus the non-Native American population. It is thought that a higher baseline incidence of the variant alleles in the ATM gene may correlate to higher rates and higher grades of radiation toxicities noted in the Native American population.


Eligibility Criteria:
Inclusion Criteria:

* Indication for radiotherapy.
* Ability or desire to donate a blood sample and be followed closely for radiation toxicities
Diet and Estrogen Metabolism in Postmenopausal Women

RATIONALE: The amount of dietary fat or fiber may affect estrogen metabolism in postmenopausal women, and this may affect the risk of developing cancer.

PURPOSE: Randomized dietary intervention to study the effectiveness of a low-fat diet combined with either high fiber or low fiber on estrogen metabolism in healthy postmenopausal women.

OBJECTIVES: I. Determine the effect of a low fat diet combined with either high fiber (25-35 grams per day) or low fiber (10-15 grams per day) intake on estrogen metabolism in healthy postmenopausal women.

OUTLINE: This is a randomized study. Patients are randomized to one of 2 arms (dietary fat reduction with and without increased fiber). All patient must successfully complete a dietary run-in phase for 4 weeks before randomization. During the run-in phase, patients are asked to maintain a food record for days 7-14. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28. Patients are given 3 prepackaged meals a day for 12 weeks. Patients must maintain a record of all food eaten and return all food containers to the center for documentation. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. At the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low fat, high fiber diet for the second phase of the study.

PROJECTED ACCRUAL: 40 women will be accrued over 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Healthy postmenopausal female between the ages of 50 and 69 with diet of greater than 32% of total calories from fat and less than 15 grams of fiber

PATIENT CHARACTERISTICS: Age: 50 to 69 Sex: Female Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: At least 2 years since menopause In general good health Increased body fat (125%-175% of ideal body weight) Increased upper body fat (waist-to-hip circumference ratio greater than 0.85) Serum estradiol greater than 13 picograms per milliliter

PRIOR CONCURRENT THERAPY: No concurrent medication that can interfere with blood test results No hormone replacement therapy or thyroid hormones
Pharmacodynamics Study of Enoxalow Compared to Clexane in Healthy Subjects After Subcutaneous Single Dose

The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single subcutaneous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.

In addition other pharmacodynamic tests such as Tissue Factor Pathway Inhibitor (TFPI) activity, as well as the ratio of anti-FXa and anti-FIIa activity will be compared as secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* Agree to all the purposes of the study by signing and dating the Informed Consent;
* Male, aged between 18 and 55 years, clinically healthy;
* BMI between 18.5 and 30;

Exclusion Criteria:

* Participation in clinical trials in the 12 months preceding the trial;
* Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
* Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
* Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
* Hemoglobin \< 13 g/dL;
* Continuous use of oral anticoagulants, platelet inhibitors or anti-inflammatory drugs;
* Use of medications that interact with enoxaparin;
* History of gastrointestinal bleeding, deep vein thrombosis or pulmonary embolism that may interfere with the clinical outcome of the study;
* History of coagulopathy and bleeding diathesis;
* Presence of changes in physical examination suggestive of coagulation disorders (bruising, petechiae, or bruising);
* Changes in the skin or subcutaneous tissue of the place of drug administration(eg liposuction in the abdomen);
* Absolute platelet count below 100 x 109 / L;
* History of chronic bleeding;
* History of acute haemorrhage in the past 30 days;
* History of sensitivity to mammalian-derived biological products, albumin or any component of the formulation;
* History of allergy or Steven Johnson disease;
* Current or previous history (under 12 months) use of illicit drugs and tobacco;
* History of alcohol abuse, current or previous (within 12 months);
* At the discretion of the Principal Investigator of the study.
Cardiac Rehabilitation for Cardiovascular Risk Reduction in People With Severe and Persistent Mental Illness

The goal of this prospective, randomized trial is to explore the link between cardiovascular disease and mortality in individuals with severe and persistent mental illness (SPMI). The main question it aims to answer is: Is a primary prevention cardiac rehabilitation intervention feasible and effective at reducing cardiovascular risk in people with a primary psychotic disorder or bipolar disorder?"

Participants will undergo a multi-component primary prevention intervention program. Researchers will compare with a control group to see if cardiovascular risk reduction is attained.

This prospective, randomized study aims to recruit 46 adults with schizophrenia, schizoaffective disorder, or bipolar disorder, who are classified as intermediate or high 10-year risk for a cardiovascular event, into a multi-component cardiac rehabilitation intervention program. The aim is to explore the feasibility and efficacy of this multi-component primary prevention intervention program in reducing cardiovascular risk in individuals with SPMI.

Evidence supports a high burden of cardiovascular disease and mortality in individuals with SPMI. In link, multiple studies outline disparities in access to quality cardiovascular care in people with SPMI. Given the high CV risk factor burden in people with SPMI and the disparity in access and quality of care, there is a need to screen for CV risk factors and initiate and monitor guideline-directed therapies in people with SPMI.

Intervention outcomes will be measured using the Framingham 10-year cardiovascular risk score, the Framingham 30-year cardiovascular risk score, the PRIMOSE BMI and Lipid risk scores, the EQ-5D-5L scale and the CGI score. Continuous variables will be displayed as means, with associated standard deviations. Categorical variables will be represented as frequencies and percentages. Subsequent comparative analysis will take place, where the overall cohort will be characterized into high risk (top quartile) and low risk (bottom quartile) cohorts. This will be accomplished using the chi-squared test or the Fisher exact test, along with the student's t test and the Mann-Whitney U test when appropriate. SPSS 24.0 will be the statistical software used.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30 to 59 years old
* Psychiatric diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
* 2 or more cardiac risk behaviors or conditions: smoking, obese, hypertension, diabetes, metabolic syndrome, dyslipidemia, obstructive sleep apnea
* 10-year Framingham cardiovascular risk score of ≥ 10% (intermediate risk)
* Willing to participate in cardiac rehabilitation program

Exclusion Criteria:

* Psychiatric instability, as judged by treating psychiatrist
* Distance from cardiac rehabilitation centre that would preclude participation
* Unsafe to participate in the cardiac rehabilitation intervention, as judged by the cardiology assessment
* Pregnant
* Known coronary artery disease, cerebrovascular disease, or peripheral vascular disease
* Court ordered mandatory or tutor
Netosis in Determination of Respiratory Infection Severity

The study aims to evaluate the prognostic value of alveolar and blood NETosis in patients under mechanical ventilation and treated for an acute low-respiratory tract infection. The main outcome is the occurrence of an acute respiratory distress syndrome (ARDS) according to the Berlin definition.

Neutrophils are the first line of defense against infectious injury. Among the numerous mechanisms involving the immune system, neutrophil extracellular traps (NETs) have been recently described as an additional way neutrophils are able to use to fight against bacteria. NETs are made of DNA and antimicrobial proteins. In the other hand, NETs promote coagulation and may contribute to evolution of severe pneumonia into acute respiratory distress syndrome.

The secondary objectives of the study include the research of the relation between blood NETosis and alveolar NETosis with:

* the documentation of invasive pulmonary infection based on microbiological analysis criteria (which would be bacteria or viral) of LBA at admission to ICU;
* the diagnosis value of usually used biomarkers: procalcitonin and C-reactive protein;
* marbrure score at admission to ICU;
* arterial lactatemia;
* scores of gravity at admission IGSII and SOFA;
* all-cause mortality at day-28;
* duration of mechanical ventilation at day-28;
* duration of amines at day-28;
* developement of hemodynamic failure;
* developement of pulmonary circulatory failure.

The study will include 1) 60 patients under mechanical ventilation admitted to the intensive care unit for acute respiratory failure, 2) 10 control patients admitted to the ICU after a planned vascular surgery and 3) 10 healthy subjects.

Eligibility Criteria:
Inclusion criteria:

A/ For all subjets:

* Be \>/= 18 years of age on day of signing informed consent;
* Affiliated to the french social security - welfare system in France.

B/ Inclusion criteria for acute respiratory failure patients:

admitted to the ICU for acute respiratory failure requiring mechanical ventilation within the first 24 hours after admission and suspected to suffer from an infectious pneumonia, according to the following criteria:

* recent fever;
* acute respiratory failure signs (dyspnea, polypnea \> 30 cycles/min, hypoxemia PaO2\<65 mmHg);
* pulmonary focal signs of auscultation;
* evocative signs in chest radiography or chest TDM.

C/ Inclusion criteria for control patients:

- admitted to the ICU for post-operative management of vascular surgery.

Exclusion Criteria:

A/ For all subjets:

* pregnancy,
* nosocomial pneumonia,
* no social health insurance,
* neutropenia of any cause;
* patient refusal.

B/ Exclusion criteria for acute respiratory failure patients:

- no mechanical ventilation within the first 24 hours after admission to the ICU.
Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder

This is a pilot, open trial of trauma-focused psychodynamic psychotherapy for LGBT-identifying individuals who meet for DSM-5 defined post-traumatic stress disorder and are interested in receiving a research psychotherapy intervention. A sample of at least 15 therapy completers will be collected.

Despite high prevalence of PTSD among LGBT individuals, there are no data characterizing the disorder in this population, nor its treatment. This represents an important under-researched area in LGBT care and treatment. The purpose of this study is: (a) to preliminarily characterize PTSD within an LGBT sample; and (b) to test out the preliminary effects and acceptability of a novel PTSD psychotherapy, trauma-focused psychodynamic psychotherapy, in this group. Participants identifying as LGBT and meeting DSM-5 criteria for PTSD per a structured, reliable clinical interview for PTSD will receive 20-24 sessions of twice-weekly TFPP at no cost. Participants will receive four detailed clinical research assessments, at baseline/study entry, Week 5 of treatment, treatment termination/end (Week 12), and 3-months after the end of treatment.

TFPP is adapted from the only empirically supported, non-exposure focused psychodynamic therapy for panic disorder and anxiety disorders, panic-focused psychodynamic psychotherapy. TFPP aims to improve patients' ability to understand and manage strong, intense emotions that appear seemingly "out of the blue," which links to their tendency to reexperience traumatic events in the here-and-now. TFPP addresses the psychological meanings of symptoms and their relationship to traumatic events to help the patient understand underlying emotions triggering their symptoms and the ways in which trauma influences their current experiences. TFPP was developed for patients with complex PTSD, who often have multiple prior trauma exposures with no clear "index" trauma. Moreover, TFPP also explicitly considers opportunities for patients to explore the broader context of their symptoms and difficulties, including but not limited to LGBT identity or experiences of oppression.

Eligibility Criteria:
Inclusion Criteria:

* Identify as LGBTQ
* CAPS-5 diagnosed PTSD per DSM-5 criteria
* Stable medication for \>=2 months and ongoing during treatment

Exclusion Criteria:

* Psychosis or bipolar disorder
* Primary substance use disorder
* Severe suicidality
* Severe depression per a reconstructed Hamilton Rating Scale for Depression score of \>=24
* Organic mental syndromes interfering with trial demands
The Effect of Probiotics on the Improvement of Intestinal and Immune Function

Evaluate the effectiveness and safety of Lactobacillus delbrueckii subsp. bulgaricus LB42 as a food supplement compared to a placebo in improving intestinal and immune functions in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45 years
2. Willing to undergo 3 follow-up visits during the intervention period
3. Willing to provide 2 blood, urine, and stool samples during the intervention period
4. Willing to self-administer one of the probiotics/placebo once daily during the intervention period
5. Good eyesight, able to read and write, and can wear glasses
6. Have good hearing and be able to hear and understand all instructions during the intervention

Exclusion Criteria:

1. Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease)
2. Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia)
3. Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder
4. Take medication for depression or low mood
5. Suffering from internal organ failure (heart, liver, or kidney failure, etc.)
6. Radiotherapy or chemotherapy in the past
7. Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial
8. Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past