cyrilzakka/clinical-trials huggingface dataset:
Chess Training as add-on Intervention for Adolescents With Psychiatric and Psychosomatic Disorders

In the planned study, the effect of chess training on the cognitive abilities of children and adolescents with psychiatric and psychosomatic illnesses will be investigated in a naturalistic setting. Furthermore, the effects on therapy success and quality of life will be determined.Despite the thoroughly positive results, CRT has not yet been included in the official guidelines as an intervention in standard therapy; this is due, among other things, to too few studies and too little knowledge in the field of child and adolescent psychiatry. The planned study aims to fill the research gap in the field of chess training as an adjunctive intervention in children and adolescents and to provide further evidence on the relevance of CRT in child and adolescent psychiatry.

The hypotheses of the proposed study are:

1. chess training as a six-week add-on intervention will improve cognitive functioning in adolescents with psychiatric/psychosomatic disorders compared to standard treatment.
2. chess training as a six-week add-on intervention improves quality of life in adolescents with psychiatric/psychosomatic disorders compared to standard treatment.
3. chess training as a six-week add-on intervention positively influences the course of therapy in adolescents with psychiatric/psychosomatic illnesses compared to standard treatment.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient treatment at the Clinic for Psychiatry and Psychotherapy of Childhood and Adolescence, ZI Mannheim
* Age between 13 and 17 years
* Sufficient ability to answer questions verbally and in written form
* Ability to give consent by patients and their parents after detailed verbal and written explanation
* Consent of patients and parents must be given in paper form

Exclusion Criteria:

* Date of inpatient admission more than 3 weeks ago
* Withdrawal of informed consent
* Severe psychiatric, neurological and internal medical comorbidities
Intestinal Microbiota: Immunity, Recovery and Metabolic Health

The aim of this intervention study is to investigate the effect of a specific postbiotic (Lacticaseibacillus rhamnosus GG = LGG) and whey protein on immunity, recovery, and weight management in young adults. The objective is based on previous knowledge about the health-promoting effects of these factors. A new goal is to study the combined effect of the postbiotic and whey protein. The results of the study can be utilized to promote the health of the young adults.

The study is a randomized, double-blind, 3-arm intervention involving young adults (n=160). Participants are randomized into three groups to receive different study product, and differences among the groups will be compared, for example, in terms of gut microbiota, weight changes, and inflammatory markers derived from blood samples.

Eligibility Criteria:
Inclusion Criteria:

- healthy

Exclusion Criteria:

* medicines and diseases that significantly affect the functioning of the stomach and intestines (e.g. irritable bowel syndrome)
* antibiotic treatment within 3 months
* asthma medication
* milk allergy (protein); the study product is lactose-free
* the participant must adhere to avoid the use of foods or nutritional supplements containing probiotics, and high-protein products, e.g. whey protein powders and high-protein snack bars
Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets Versus Desvenlafaxine Succinate Sustained-release Tablets Targeting Anhedonia in Patients With Major Depression Disorder

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of anhedonia in patients with major depression disorder compared to desvenlafaxine succinate sustained-release tablets, to provide evidence-based basis for clinical rational drug use.

The study included 80 patients with major depression disorder (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Eligible patients were randomly assigned (1:1) to 8-week treatment with toludesvenlafaxine hydrochloride sustained-release tablets (n=40) or desvenlafaxine succinate sustained-release tablets(n=40), followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Subjects meet the diagnostic criteria for major depression disorder in the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5);
* Male or female aged ≥18 and ≤65 years;
* Subjects who have a Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥24 points;
* Subjects who have a total score of Snaith-Hamilton Pleasure Scale (SHARPS) ≥3 points;
* Subjects voluntarily participate in the study and sign the informed consent form.

Exclusion Criteria:

* Allergic or known to be allergic to toludesvenlafaxine hydrochloride sustained-release tablets and desvenlafaxine succinate sustained-release tablets;
* Subjects have a severe self-injury/clear suicide attempt or behavior; Scores on MADRS items factor 10 ≥4 points;
* Subjects who meet the diagnostic criteria for any other psychotic disorders (except for major depression disorder) in DSM-5, or those who have substance disorders or drug abuse within the past six months;
* Individuals with severe and unstable physical diseases such as cardiovascular disease, liver disease, kidney disease, blood disorders, and endocrine disorders;
* Hypertensive patients with poor blood pressure control (systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg at screening);
* Total bilirubin (TBIL) values 1.5 times / alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal, or Thyroid-stimulating hormone (TSH) outside the normal range at screening;
* Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval \>450 ms in men and QTc interval \>460 ms in female;
* Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period;
* Other conditions that the investigator considers the participant is not suitable for the study.
A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets

This will be a randomized, open-label, single-center, 3-way crossover study in healthy subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will consist of 3 study periods separated by a washout period of at least 7 days. Subjects will receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be discharged from the study on Day 6 of Period 3 after completion of discharge procedures.


Eligibility Criteria:
Key inclusion:

* Healthy male and female subjects, including women of child-bearing potential, aged 18 to 55 years, inclusive
* Subjects who are able to tolerate the insertion and placement of a pH probe on 2 occasions per study period (Day -1 and Day 5)

Key Exclusion:

* Subjects who are H. pylori-positive
* Subjects who have a history of any gastrointestinal disorder or surgery likely to influence drug absorption (e.g., history of gastric resection)
* Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any ingredient in the formulations
* Other standard clinical pharmacology exclusion criteria for healthy volunteers
Serum Rennin Kinetics Versus Serum Lactate Kinetics as Predictors of Mortality in Septic Shock Patients

Whole blood lactate concentration is widely used in shock states to assess perfusion. We aimed to determine if the change in plasma renin concentration over time would be superior to the change in lactate concentration for predicting in-hospital mortality in septic shock patients.

Resuscitation in the ICU was traditionally based on blood pressure (1, 2). An assumption that adequate tissue perfusion cannot be made at pressures of 65 mm Hg, and the number itself has been challenged in other investigations (1, 3, 4). Lactate has long been regarded as an adequate indicator of tissue perfusion and prognosis. Most critical care resuscitation are guided by serial lactate levels as a mean to understand the flow and perfusion side of resuscitative aims (2, 5). Not all high lactate levels are indicators of poor tissue perfusion (6).In 2017, Khanna et al (7) reinvigorated the interest in the renin-angiotensin-aldosterone system (RAAS) as a significant biochemical hormonal axis and feedback mechanism in vasodilatory shock after they published the results of the Angiotensin II in High Output Shock Trial. Gleeson et al (8) showed in 2018 that renin appeared to be a much stronger and significant predictor of ICU mortality compared with lactate in a heterogenous shock population Jeyaraju et al (9) reported that renin kinetics are superior to lactate kinetics for predicting in-hospital mortality in critically ill patients with hypotension, with most being vasodilatory shock (most common diagnosis sepsis, also vasoplegia, acute respiratory distress syndrome \[ARDS\], liver failure) and those who had hypotension more than 6 hours while of vasopressors included. The bottom line in the previous investigations is that renin was a better marker of poor outcomes in comparison with concurrently measured lactate levels in critically ill ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* anticipated stay \>24 hours
* signed informed consent by patient or next-of-kin.
* Septic shock patients, septic shock was defined as persistent hypotension (defined as the need for vasopressors to maintain mean arterial pressure ≥ 65 mm Hg, and a serum lactate level \> 18 mg/dL \[2 mmol/L\] despite adequate volume resuscitation

Exclusion Criteria:

* chronic kidney disease stage IV/V (baseline eGFR (estimated glomerular filtration rate) \<30ml/min/1.73m2),
* do not resuscitate order.
Effects of Sleep Duration and Architecture on Insulin Sensitivity

This pilot clinical trial will test the hypotheses that sleep restriction (for 5 nights), in comparison to "normal sleep", will:

1. Decrease peripheral insulin sensitivity and glucose tolerance, as measured by the hyperinsulinemic-euglycemic clamp and oral glucose tolerance test.
2. Decrease hepatic insulin sensitivity, as assessed by stable isotope studies of endogenous glucose production, gluconeogenesis and glycogenolysis.

Over the past 50 years, the incidence of diabetes has increased dramatically, while sleep duration in the US has decreased significantly. Epidemiological studies and small clinical trials suggest that these trends are causally related. In this study, our goal is to determine the mechanisms by which decreased sleep duration directly affects insulin sensitivity. The investigators will perform a clinical study in 20 healthy volunteers to determine whether 5 nights of sleep restriction decreases insulin sensitivity in the peripheral tissues (ie, skeletal muscle) or liver.

Peripheral insulin sensitivity will be measured by the hyperinsulinemic-euglycemic clamp, and hepatic insulin sensitivity will be quantified by measurement of hepatic glucose production, gluconeogenesis and glycogenolysis (using stable isotope tracer methods). Subjects will be randomized to an initial period of "normal sleep" or sleep restriction and will be admitted to the Clinical Research Center (CRC) for 9 days to undergo comprehensive metabolic studies and sleep assessments under the assigned sleep condition. After a 1-month washout period, subjects will be re-admitted to the CRC to undergo these same assessments under the opposite sleep condition.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Regular work hours (ie, no night-time or shift work within the past 6 months)
* Pittsburgh Sleep Quality Index (PSQI) Score \<5
* Average nightly sleep duration 6-9 hours (per screening actigraphy)

Exclusion Criteria:

* Current or prior diabetes, gestational diabetes, impaired glucose tolerance or impaired fasting glucose
* Type 2 diabetes in biological parents
* BMI \>=25
* Pregnancy
* Chronic medical condition, including: psychiatric disorders, heart disease, pulmonary disease, infectious diseases, rheumatological and neurological disorders
* Use of prescribed medications on a regular basis.
* History of disorder involving hypothalamic, pituitary or adrenal glands
* History of or current sleep disorders (insomnia, restless leg syndrome, sleep disordered breathing, narcolepsy, etc)
* Anemia
* Cognitive impairment
Prevalence of ESBL-producing Enterobacteriaceae as Carbapenem-resistant Enterobacteriaceae in Nursing Homes.

This study evaluates individual and collective factors of ESBL and CRE carriage in nursing homes.

Epimiological data concerning ESBL an CRE, may differ between nursing home and hospital or community but poor data are available.

Multi-drug resistant bacteria carriage is associated with individual and collective factors wich have to be defined in nursing homes.

Eligibility Criteria:
Inclusion Criteria:

* voluntary residents present in the institution on the study day

Exclusion Criteria:

* dement-wandering resident
* unlikely to cooperate
Effects of SIT Combined with Remote Ischemic Preconditioning on Vascular Function in Young Women with Masked Obesity

Comparison of the effects of combined Sprint Interval Training (SIT) with Remote Ischemic Preconditioning (RIPC) and SIT on vascular function in young women with masked obesity.

This is a randomized clinical trial of single-blind with 3 arms (control group, SIT group and SIT with RIPC group), in which a pre-treatment-posttest design has been used.

Eligibility Criteria:
Inclusion Criteria:

* Females aged between 18 and 30 years;
* BMI within the normal range (18.5～24.9 kg/m²), BF% \> 30%;
* Participants with no clinically diagnosed contraindications for exercise, in good health, and not engaged in regular exercise, as determined by the health and physical activity questionnaire (based on the American College of Sports Medicine's guidelines for exercise testing and prescription).

Exclusion Criteria:

* History of cardiovascular diseases, including coronary heart disease, stroke, or peripheral arterial disease diagnosed through vascular imaging techniques;
* Currently participating in other intervention studies, including dietary, nutritional, or psychological education programs;
* Those with regular professional training;
* Musculoskeletal disorders that make long-term exercise interventions unsuitable.
Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma

This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. Evidence for cell membrane BCMA expression；
4. All genders, ages: 18 to 75 years；
5. The expect time of survive is above 12 weeks;
6. KPS\>60；
7. No serious mental disorders ;
8. Left ventricular ejection fraction ≥50%
9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
10. Sufficient renal function defined by creatinine clearance≤2 x ULN;
11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
12. With single or venous blood collection standards, and no other cell collection contraindications;
13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Have received CAR-T therapy or other genetically modified cell therapy before screening；
2. Participated in other clinical research within 1 month before screening；
3. Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
4. Live attenuated vaccine within 4 weeks before screening;
5. Convulsion or stoke within past 6 months;
6. Previous history of other malignancy;
7. Presence of uncontrolled active infection;
8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
9. Pregnant or breasting-feeding women;
10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
Use of Omics Methods to Classify Variations of Uncertain Significance and Improve Diagnosis of Neurogenetic Diseases

Many neurological disorders show a strong genetic basis, from hereditary diseases caused by a single mutation in a given gene, to diseases caused by combinations of strong genetic risk factors. However, even after the sequencing of the appropriate genes, a large proportion of patients remains undiagnosed, either because there is no candidate mutation observed, or in case of identification of a candidate mutation with insufficient knowledge to consider it as pathogenic or not.

The aim of this project is to identify the cause of neurogenetic diseases in patients in situations of diagnostic wandering or dead ends by proposing the analysis of RNA and/or proteins from different tissues.


Eligibility Criteria:
Inclusion Criteria:

For this project, the inclusion of 3 participant profiles is required:

* 1a. Patient, major or minor, with a neurological disease affecting the central nervous system, who has already benefited from a genomic analysis (panel, exome or genome sequencing) as part of routine care, with inconclusive analysis because the result was either a variation of uncertain significance or the absence of a variant of interest (patients with inconclusive genomic results).
* 1b. Patient with neurological disease affecting the central nervous system, of confirmed monogenic or probable oligogenic cause (positive controls).
* A relative of a type 1a. or 1b. patient with no symptoms of the disease, after the expected age of onset of symptoms in the patient's own family (healthy relatives).

For all 3 groups:

* Affiliation with a social security scheme
* Agreement to take part in the study with signature of a specific informed consent form for the study.

Exclusion Criteria:

For patients with inconclusive results: Patient with a neurological disease not suspected of a monogenic or oligogenic cause

For healthy relatives: existence of a neurological disease (other than uncomplicated migraine) or psychiatric disease (other than simple anxiety stable under treatment).

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A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic renal anemia, with no need for dialysis expected in next 3 months;
* adequate iron status.

Exclusion Criteria:

* previous epoetin therapy within 12 weeks prior to treatment;
* transfusion of red blood cells during 2 months prior to screening;
* significant acute or chronic bleeding such as overt gastrointestinal bleeding;
* hemolysis;
* folic acid and vitamin B 12 deficiency.
Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.


Eligibility Criteria:
Inclusion Criteria:

* social insurance
* signed informed consent
* solar urticaria (SU) confirmed with photoexplorations
* SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU
* SU with altered quality of life
* SU resistant to photoprotection
* SU resistant to the association of two different antihistaminics during 3 months

Exclusion Criteria:

* Pregnancy
* Heat triggered urticaria
* Contra-indications to IVIG
Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Both females and males

Exclusion Criteria:

* Central processing disorder
* Impaired vision without corrective lenses (max 20/60 uncorrected)
* Moderate to severe hearing loss (\>55 decibels (dB) pure tone audiometry (PTA), \<50% word identification)
* Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
* History of ear surgery other than myringotomy with or without tube placement
* Pregnant women
* Prisoners
* Adults unable to consent