cyrilzakka/clinical-trials huggingface dataset:
Effects of Intranasal Oxytocin in Patients With Central Diabetes Insipidus

This is a randomized, double-blind, placebo-controlled crossover pilot study of single-dose intranasal oxytocin (4 IU and 24 IU) in 18-60-year-old men and women with central diabetes insipidus to evaluate the effect of oxytocin on anxiety, depression and socioemotional functioning.

Following a screening visit to determine eligibility, participants will return for three main study visits. During the main study visits, study participants will receive either oxytocin or placebo, followed by assessments of emotional behavior.

Thirty participants will be equally randomized to one of six possible drug orders:

1. 4 IU oxytocin - 24 IU oxytocin - placebo
2. 4 IU oxytocin - placebo - 24 IU oxytocin
3. 24 IU oxytocin - 4 IU oxytocin - placebo
4. 24 IU oxytocin - placebo - 4 IU oxytocin
5. placebo - 4 IU oxytocin - 24 IU oxytocin
6. placebo - 24 IU oxytocin - 4 IU oxytocin


Eligibility Criteria:
Inclusion Criteria:

* Central diabetes insipidus (based on routine clinical practice, e.g., clinical symptoms, serum and urinary sodium and osmolality levels or the water deprivation test)
* Normal FT4 or T4
* Stable hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline)

Exclusion Criteria:

* Active substance use disorder within the last 6 months
* History of psychosis
* Current suicidal ideation
* Medication changes within 4 weeks of enrollment or during the study
* History of cardiac disease, including arrhythmias, coronary heart disease, coronary artery spasms, valvular heart disease, hypertrophic cardiomyopathy (hypertension is not exclusionary)
* Hyponatremia
* Creatinine \>1.5mg/dL.
* ALT or AST \>2.5x upper limit of normal
* Hematocrit less than 2% below the norm
* Pregnancy or breastfeeding within the last 8 weeks
* Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
* Received an investigational drug or medical device in the past 30 days or within 5 half-lives of main study visit or be concurrently enrolled in another investigational product clinical trial.
* Any significant illness or condition that the Investigator determines could interfere with study participation, data collection, or safety
EYESHOT (EmploYEd Antithrombotic Therapies in Patients With Acute Coronary Syndromes HOspitalized in iTalian Coronary Care Units)

This register will evaluate the use of different antithrombotic therapies, combinations of different drugs routinely used during any stage of hospital admission, with their timing, dosage and mode of administration, in patients with a diagnosis of Acute Coronary Syndrome in the Italian Coronary Care Unit during a study period of three weeks


Eligibility Criteria:
Inclusion criteria:

* All consecutive patients discharged with a diagnosis of Acute Coronary Syndrome ( Non ST elevation or ST Elevation) undergoing myocardial revascularization or conservative treatment , admitted to the Coronary Care Unit during the observation period established.
* Age ≥ 18 years
* Signed informed consent

Exclusion criteria:

* Patients enrolled in clinical trials of intervention
* Diagnosis of Acute Coronary Syndrome caused by confounding comorbidities (eg . Trauma or surgery after non- cardiac )
* Patients already enrolled in eyeshot from another center.
Altered Faecal Microbiome and Metabolome in CT1D, AT1D and T2D

To elucidate the characteristics of global gut microbiota and fecal/serum metabolites in patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes.

Type 1 diabetes is caused by autoimmune destruction of pancreatic beta cells, leading to severe insulin deficiency and requiring insulin therapy. It is typically considered a disease of childhood and adolescence, but recent epidemiological data have shown that over half of all new-onset type 1 diabetes cases occur in adults worldwide. There are genetic, immune and metabolic differences between adult- and childhood-onset type 1 diabetes, revealing the underlying molecular basis of type 1 diabetes onset at diverse ages may differ. Accurate diagnosis is of great importance because the best treatment for different types of diabetes is divergent. Misdiagnosing type 2 diabetes as type 1 diabetes can lead to unnecessary initial insulin therapy, resulting in higher costs and more side effects. Thus, it is critical to identify the molecular basis and new diagnostic biomarkers for adult-onset type 1 diabetes.

Nonetheless, environmental exposures, in particular the immense intestinal microbiota and its derivatives, have been widely investigated. Indeed, patients with childhood-onset type 1 diabetes or type 2 diabetes exhibit compositional alterations in gut microbiota. However, gut microbiota in adult-onset type 1 diabetes has not been elucidated, and little is known about the shared and distinct microbial characteristics in adult-onset type 1 diabetes versus childhood-onset type 1 diabetes or type 2 diabetes.

Thus, this study is a cross-sectional study. 4 groups of subjects were recruited for metagenome and metabolome analysis, including healthy controls and patients with childhood-onset type 1 diabetes, adult-onset type 1 diabetes or type 2 diabetes. All subjects recruited meet the inclusion or exclusion criteria and written informed consent was obtained from each participant at enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Diabetes diagnosed according to the report of WHO in 1999；
2. Aged between 5 and 70 years old;

Exclusion Criteria:

1. Severe chronic cardiovascular or cerebrovascular disease；
2. Severe abnormalities in liver or renal function;
3. Hyperthyroidism; or other autoimmune diseases;
4. Tumors, surgery or pregnancy;
5. Treatments with oral hypoglycemic agents or immunomodulators;
6. Subjects who had taken probiotics, prebiotics within one week or antibiotics within one month.
The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

This study is designed to observed prospectively the efficacy and safety of 6 months treatment of iguratimod alone, or with methotrexate (MTX), hydroxychloroquine (HCQ) and prednisone step by step on Chinese rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients who were naïve or shown insufficiency response or intolerance to DMARDs. If volunteered, patients who completed the 6-month study can continue to follow our plans for 24 months.

This study will enroll 200 cases of rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients in China, who are naïve or shown insufficiency response or intolerance to DMARDs. The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX)/ hydroxychloroquine (HCQ) / prednisone (Pred) step by step for 6 months if participants are in medium or high disease activity (DAS28≥3.2). Participants can choose to continue the study up to 24 months.The efficacy and safety of 6 months and 24 months Iguratimod treatment in RA and ERA patients will be evaluated with DAS28-ESR and other disease activity indices.

Eligibility Criteria:
Inclusion Criteria: -

1. RA: Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis(RA);
2. ERA: Subjects diagnosed by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR); or by 2012 Chinese classification criteria of early rheumatoid arthritis (ERA), and not match the 1987 ACR criteria for RA.
3. Age ≥16 years;
4. Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
5. Patients can be naïve to any DMARDs, or relapse due to DMARDs drug suspended;
6. Patients have a history of using csDMARDs including csDMARDs（methotrexate，leflunomide, hydroxychloroquine, sulfasalazine, tacrolimus) , any biologic DMARDs（TNFi，tocilizumab or Tofacitinib），glucocorticoid (prednisone，methylprednisolone) or Chinese traditional Medicine（including tripterygium Glycosides, sinomenine）for 3 months, but couldn't achieve clinical remission or intolerance；

Exclusion Criteria:

1. Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
2. Platelet counts(PLT) \<80 x 10\^9 / L, or white blood cell (WBC) \<3 x 10\^9 / L;
3. Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
4. Renal insufficiency: serum Cr ≥ 176 umol / L;
5. Pregnant or nursing women (breastfeeding) ；
6. Patients has a history of malignancy (cure time in less than 5 years);
7. Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
8. Other comorbidities that cannot be treated with immune suppressants. In addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.
Continuous Vital Sign Monitoring in Newborns

This study evaluates the feasibility and usability of continuous wireless vital sign monitoring of well newborns during their birth hospitalization.

This study is conducted for the purposes of understanding the feasibility and acceptability of routine wireless continuous monitoring on healthy newborns as a standard practice \& its effect on existing workflows and as a future tool for the early detection of undiagnosed problems. All infants will receive routine newborn nursing care .

Once alarm limits have been determined, the monitoring data will be analyzed in real time and out of range vital signs will alert the nurse to perform standard assessment of the newborn.

Nurse and parents will complete surveys regarding their experience with continuous vital sign monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infants \<12 hours of age
* Expected to be admitted to the Well Baby Nursery
* 36 or more weeks gestation at birth
* Mother at least 18 years of age

Exclusion Criteria:

* Infants requiring any non-routine medical care or observation
* Neonatal Intensive Care Unit (NICU) or Special Care Nursery admission
* Multiple birth
Continuous Measurement of Activity in Patients with Muscle Pathology and in Control Subjects. ActiSLA Part.

ActiSLA is a monocentric academic study. Patients with amyotrophic lateral sclerosis may be included on a voluntary basis. The investigators plan to include a group of approximately 20 patients with ALS.

The investigators have planned to assess patient every three months for a year. On each visit, participants will undergo a clinical examination with MRC sum score and Ashworth scores.

They will perform few tests ( 6-minutes walk test (6MWT), dynamometric measure, electromyography, Edinburgh Cognitive and Behavioural ALS Screen ) and will answer to some questionaires (dysphagia handicap scale, ALS-SFR-r).

After each visit, participants will wear Actimyo for one month daily.


Eligibility Criteria:
Inclusion Criteria:

* Clinically defined or probable diagnosis of ALS according to El Escorial criteria revised with Awaji's electro-diagnostic algorithm.
* Over 18 years old.
* Signed informed consent
* If patient on Riluzole, the dosage should be stable for 1 month and continued throughout the study period.

Exclusion Criteria:

* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
* Any other previous or present pathology having an impact on motor function.
* Recent surgery or trauma (less than 6 months) in the upper or lower limbs.
* Prior neurological, endocrine, infectious, allergic, or chronic or acute inflammatory pathology in the three weeks preceding inclusion.
* Patients participating in an interventional clinical trial.
Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms

The purpose of this pilot study is to investigate the use of minocycline and doxycycline as medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and giant aneurysms.

Arteriovenous malformations (AVMs) are a treatable cause of stroke in young adults. The processes by which AVMs and giant aneurysms grow in size and spontaneously bleed are unknown. The primary reason to treat AVMs and aneurysms is to guard against intracranial bleeding.

This pilot study will examine the use of two common antibiotics-minocycline and doxycycline-as medical therapy for inoperable or partially treated AVMs and giant aneurysms. These drugs, which are tetracycline derivatives, can reduce the levels of a family of enzymes, called matrix metalloproteases, that degrade tissue and thereby cause a reduction in the risk of spontaneous bleeding from AVMs or aneurysm-which is the main cause of stroke associated with these disorders. The enzymes can contribute to weaknesses in the wall of blood vessels and may increase the risk of the vessel wall rupturing and causing spontaneous bleeding.

This trial also will show that taking minocycline and doxycycline over an extended period in this patient population is safe and well tolerated. Results from this study could help plan future studies to benefit patients with abnormal blood vessels prone to bleeding in their brains.

Eligibility Criteria:
Inclusion Criteria:

* Giant aneurysms or brain arteriovenous malformations (BAVM)
* Female patients of child bearing age using effective birth control, males
* Creatinine no greater than 2.0 mg/dl
* ALT no greater than 2 times upper limit of control

Exclusion Criteria:

* Unstable medical illness
* Contraindications to Tetracycline
* History of vestibular disease, (except benign positional vertigo)
* Prior tetracycline use within 2 mos of baseline visit.
* History of noncompliance with treatment or other protocols
* History of systemic lupus
* Patients not eligible for MRI
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of MHAB5553A in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics (PK) of MHAB5553A.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF)
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive
* Weight 40-100 kg
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations should be within reference range for the test, unless deemed not clinically significant by the investigator and sponsor at screening
* Willing to abstain from using drugs of abuse while enrolled in the study
* Willing and able to comply with protocol-specified criteria in regard to contraceptive protection
* Able to comply with the study protocol, in the investigator's judgment

Exclusion Criteria:

* History or clinically significant manifestations of metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
* History of anaphylaxis, hypersensitivity or drug allergies, unless approved by the investigator and sponsor
* History or presence of an abnormal ECG, which, in the investigator's or sponsor's opinion, is clinically significant (including evidence of previous acute myocardial infarction, complete left bundle branch block, second-degree heart block, or complete heart block)
* History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit
* History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], and crack) within 1 year prior to screening
* Current tobacco smokers (positive history within 3 months before initiation of dosing on Day 1), or those with positive cotinine test at check-in
* Positive drug screen at screening or at check-in
* Positive pregnancy test result at screening or Day -1 or breast feeding during the study
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe enrollment in and completion of the study
* Unwillingness to comply or other conditions that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol
Evaluation of the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program

A retrospective review of body composition outcomes of participants of a comprehensive visceral-fat focused anti-obesity program. Data from approximately 2000-2500 participants are expected to be included in the study.

This is a retrospective, multi-center clinical study to evaluate the efficacy of the 20Lighter comprehensive anti-obesity program in reducing body composition measures including body weight, body fat, visceral adiposity, intracellular fluid, and other metrics of interest. Anecdotal evidence on reductions of prescription medication, chronic health issues, and improvements in quality of life will be gauged via review of patient assessment forms and surveys.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>25
* ability to stand on platform for body composition analysis

Exclusion Criteria:

* Pregnant at time of enrollment
* Breastfeeding at time of enrollment
* Undergoing treatment for cancer at time of enrollment
* History of major organ transplant with immunosuppressant medication
* Over the 70 years of age with diagnosis of three cardiovascular comorbidities at time of enrollment
* Adult with a vegetarian diet
* Diagnosis of psychiatric conditions including: schizophrenia, bipolar disorder, manic depression
Guided and Unguided Therapeutic Game to Improve Emotional Abilities of Students

The aim of the study is to investigate the efficiency of a therapeutic online game, with and without coaching, in training emotional abilities of students.

The study is a randomized control trial with three groups. We will perform measurements before the intervention, after the intervention and at one month follow-up.

Participants will be students and will be randomized into three groups using a randomization program. The first group will be the gaming with coaching group, the second group will bw the gaming without coaching group and the third group will be the control group.

Measurements will be performed before receiving the game, after the intervention and at one month follow-up. We will measure depression, anxiety, stress and well-being as primary outcomes, solution focus orientation as secondary outcome and rational and irrational cognitions as mechanism outcome. All questionnaires will be completed online in a Google Form.

The intervention will consist of the Rethink game. Rethink is a therapeutic game developed and tested to improve emotional abilities in children. Participants in our study will test two levels of Rethink as well as a trial version of the game. Each level of the game is focused on a component:

* Level 1: recognition of emotions
* Level 2: relaxation and mindfulness
* Level 3: rational and irrational cognitions
* Level 4:changing the cognitions
* Level 5: problem-solving
* Level 6: positive emotions
* Level 7: summary of previous aqusitions

Eligibility Criteria:
Inclusion Criteria:

* being a student in a public or private university from Romania

Exclusion Criteria:

* not being enrolled as a student in a university from Romania
Genotype-Driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy

This is a prospective phase II trial, in patients with unresectable or metastatic NSCLC using chemotherapy regimens which will be defined according to the mRNA expression of ERCC1 and RRM1 of the tumor cells.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC) (stage IIIB or IV)
2. Chemotherapy naïve patient (Previous adjuvant or neoadjuvant chemotherapy allowed if the last dose was administered equal to or greater than 6 months ago.)
3. Age \> 18
4. Performance status 0 to 2 by Eastern Cooperative Oncology Group (ECOG) criteria
5. At least one measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST)
6. Adequate organ functions (assessed within 14 days of starting treatment) 1) Bone marrow: Absolute neutrophil count ≥ 1,500/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9.0 mg/dL 2) Liver: Total bilirubin ≤ 1.5 x ULN; aspartic transaminase (AST) and alanine transaminase (ALT), alkaline phosphatase(ALP) ≤ 2.5 x ULN 3) Kidney: Serum creatinine ≤ 1.5 x ULN
7. Signed informed consent document

Exclusion Criteria:

1. Clinically significant serious illness or medical condition (infection)
2. Prior systemic chemotherapy or immunotherapy for advanced NSCLC.
3. Presence of uncontrolled brain or leptomeningeal metastases
4. Prior radiotherapy within 3 weeks of starting treatment
5. Peripheral neuropathy equal to or greater than grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
6. Pregnant or lactating
7. Absolute contraindication of corticosteroid use
8. Patients with a history of severe hypersensitivity reaction to docetaxel, carboplatin, vinorelbine or gemcitabine
Effect of Diet on Intestinal Microbiota and Obesity Markers in Adults

This study aims to investigate the direct effect of high amounts of dietary fibre and high amounts of red meat in daily diet on intestinal microbiota, anthropometry and obesity markers in healthy adults.

Human gut microbiota composition and its bacterial pathways are involved in many metabolic processes, including digestion of actually indigestible food components and fat storage. Due to that it may contributes to the developement of obesity being one of the most important risk factors for many chronic diseases. Gut microbiota is under the influence of nutrition, consumption of pro- and prebiotics can promote the growth of certain bacterial strains. In a cross over dietary intervention this work will investigate the effect of defined diets on the intestinal microbiota in 20 healthy adults. The diets contain either high amounts (more than 40g/d) of dietary fibre and low red meat (less than 30g/d) or low amounts (less than 20g/d) of dietary fibre and high amounts of red meat (200g/d). Intervention periods last 3 weeks each interrupted by a 3 weeks wash out period. Examination of participants will happen at the beginning and at the end of both interventions and will contain anthropometry, blood sample, faecal sample, urine sample and saliva sample.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 60
* obtained informed consent
* willing and able to consume defined diets
* willing and able to collect all intended samples

Exclusion Criteria:

* prevalent chronic disease, i.e. diabetes (type 1 and 2), cardiovascular diseases, cancer
* Antibiotic treatment within the last three month before start of studies
* Prevalent gastrointestinal diseases, disorders and surgeries
* Pregnancy and breastfeeding