cyrilzakka/clinical-trials huggingface dataset:
How to Optimally Train Emotional and Social Skills

The goal of this clinical trial is to compare different well-being intervention components in healthy individuals. The main question it aims to answer is how an optimal emotional and social learning program should be composed. Participants will participate in one of 16 courses over 14-weeks which will have a varying combination of four components:

* emotion regulation,
* mindfulness,
* self-acceptance and
* resource activation.

For each of these components there will be a control component. Further, there will be a waitlist-control-group included.

Background: Social-emotional skills are of great importance for academic and professional success and are a huge protective factor of mental health.

Objectives: The aim of the study therefore is to examine the optimal combination of different well-being intervention components to foster mental health and subjective well-being in a student and trainee population. The investigators draw on current concepts like mindfulness which already proved to be empirically effective and try to compare their effectiveness and understand how they work together, whether they strengthen or complement each other.

Methods: In a factorial design trial with 16 different intervention conditions, up to 240 students or trainees will participate in a 14-week well-being-intervention. This intervention with a maximum of 15 participants per course consists of weekly 1,5h sessions plus 3 full-day appointments using psycho-educational elements, practical exercises and group discussion on various topics. Participants will complete online surveys on subjective and psychological well-being, mental health, and several resilience factors pre-, during and post-intervention as well as 5 months after completion as follow-up assessments.

Implications: The study will contribute to an evidence-based and easily accessible and scalable well-being intervention, supporting health promotion and stress prevention in the general population.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Fluent in German language
* Student at a German university or trainee in vocational training

Exclusion Criteria:

* Acute mental health crisis (e.g., suicidality)
Variations of High Sensitivity Troponin T in Neonates

Troponin T-us is a cardiac marker for myocardial infarction. Its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as High sensitivity cardiac troponin T test. This study is an observational study designed to determine biological normal values of High sensitivity cardiac troponin T test (troponin T -us) in newborns.

* Approximately 400 subjects will be recruited over a planned recruitment period of 2 months. During labour, or pre natal hospitalization, information about the study will be given to every mothers by the midwife or the pediatrician. Absence of opposition will be notified in the medical file.
* At birth, every child born alive is possibly eligible for this study, if he doesn't meet the exclusion criteria.
* After clamping the umbilical cord, the midwife realizes the systematic sample for assessment of pH and lactate. If the mother did not object to the study, the midwife will use 200µl of this very same sample to assess Troponin T blood level. This sample goes to the same laboratory to be analyzed. The blood sample for troponin T measurement must be brought to the laboratory within 2 hours, just as pH and lactate must be. The midwife in charge of this patient also fills a form with informations from the patient's medical file. This form is anonymized for the study.
* Samples will not be stored, remaining swab after analysis will be destructed.
* Before discharge, all children undergo a medical exam by a pediatrician, whether they are in maternity or in neonate. The pediatrician who examines the child fills a second form that summarizes the noteworthy events of his hospital journey.

Subjects have the right to withdraw from the study at any time for any reason. If one of the parents wishes to withdraw from the study after the first Troponin T measurement is made, we will ask for their permission to use the collected data.

Eligibility Criteria:
Inclusion Criteria:

* Every newborn, born alive in René Dubos maternity, without regarding the way of birth.
* Absence of malformative syndromes or genetic abnormalities in prenatal echographies
* Absence of parental opposition

Exclusion Criteria:

* Multiple pregnancies
* Post natal discovery of malformative syndromes or genetic abnormality. All congenital heart diseases will be excluded.
* Parental opposition at any time of the study
Aminophylline for Patients With Post-Dural Puncture Headache

Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Its clinical manifestations are pain in the forehead and the occipital region, or diffuse headache. The pain is dull or fluctuating, becoming worse when standing and better when lying down, and is often accompanied by symptoms including a stiff neck, tinnitus, hearing loss, photophobia, and nausea, which cause great suffering to the patients1. According to epidemiological data, approximately 10% to 30% of the patients who undergo lumbar puncture suffer from PDPH within 48 hours of the procedure.Currently, commonly used treatments for PDPH include rehydration, the administration of corticotropin, caffeine, or sumatriptan, and the application of an epidural blood patch. The efficacy of theophylline has been proven in a placebo-controlled study in which 17 PDPH patients received an intravenous (IV) injection of 200 mg theophylline. The Visual Analogic Scale scores 4 hours after treatment were significantly different compared with those of the placebo group5. At present, the clinical application of theophylline has been replaced by aminophylline and doxofylline, and it is difficult to purchase theophylline in most hospitals in China and other countries.

The Aminophylline for Patients With Post-Dural Puncture Headache trial, is a prospective,randomized,double-blind,placebo-controlled trial to evaluate the efficacy and safety of an IV injection of aminophylline on post-dural puncture headache.Eligible patients were randomized in a blinded fashion(1:1) to receive IV injection of aminophyllineor or sterile isotonic saline.The investigators estimate that this trial will demonstrate that an IV injection of aminophylline could be the preferred method for the clinical treatment of PDPH.


Eligibility Criteria:
Inclusion Criteria:

* headache has developed after the dural puncture;
* PDPH was defined according to the International Classification of Headache Disorders III (ICHD-3) criteria;
* The VAS score of the headache was 5 or more than 5;
* age between 18 and 70 years old.

Exclusion Criteria:

* a previous history of headache that could interfere with PDPH diagnosis;
* a history of central nervous system diseases including intracranial hemorrhage, seizures, intracranial hypertension, and hydrocephalus;
* a history of cardiovascular system diseases including coronary heart disease, arrhythmias, and hypertension;
* a history of peptic ulcer.
* women who were pregnant, nursing, or planning a pregnancy.
Transoral Robotic Surgery in Treating Patients with Benign or Malignant Tumors of the Head and Neck

This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery

To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Eligibility Criteria:
Inclusion Criteria:

* Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
* Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
* Written informed consent and/or Consent waiver by institutional review board (IRB)

Exclusion Criteria:

* Unexplained fever and/or untreated, active infection
* Patient pregnancy
* Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm.
* The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
* Inability to grant informed consent
* INTRAOPERATIVE EXCLUSION CRITERIA:
* Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Study of the Pathogenesis and Pathophysiology of Familial Neurohypophyseal Diabetes Insipidus

OBJECTIVES: I. Determine whether diverse mutations of the vasopressin-neurophysin II (AVP-NPII) gene cause autosomal dominant familial neurohypophyseal diabetes insipidus by directing the production of an abnormal preprohormone.

II. Determine whether the AVP-NPII gene-directed preprohormone accumulates and destroys magnocellular neurons because it cannot be folded and processed efficiently.

PROTOCOL OUTLINE: This project involves 2 clinical studies. Members of known kindreds participate in Study I; members of kindreds who have not been surveyed, genotyped, or phenotyped participate in Study II.

In Study I, participants undergo clinical, hormonal, radiologic, and biochemical studies. Assessment on unrestricted fluid intake includes body weight, urine volume, osmolality, creatinine, sodium, potassium, urea, glucose, arginine-vasopressin (AVP), oxytocin, and aquaporin-II.

Participants with diabetes insipidus (DI) undergo a standard fluid deprivation test; those without DI undergo standard water load and hypertonic saline testing.

Previously untreated DI patients may be given intranasal or subcutaneous desmopressin or oral chlorpropamide (adults only) for 2 or 3 days.

Magnetic resonance imaging of the pituitary-hypothalamic area is performed on all patients with and without gadolinium.

Infants and children are studied annually for the first 5 years or until they develop DI. Affected adults are studied every 2-5 years. Unaffected adults are re-tested only if they subsequently report de novo symptoms suggestive of DI.

In Study II, participants undergo similar genotype and phenotype testing. Kindreds demonstrating the familial neurohypophyseal diabetes insipidus phenotype and genotype are added to Study I. Kindreds found to have a different type of DI are directed into a companion protocol.

Eligibility Criteria:
* Verified or suspected familial neurohypophyseal diabetes insipidus with or without an identified mutation of the vasopressin-neurophysin II gene Affected and unaffected members of kindreds entered
A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

The purpose of this study is to evaluate the efficacy of 40 mg a day of istradefylline (KW-6002) for reducing the percentage of awake time spent in the OFF state in patients with advanced Parkinson's disease treated with levodopa.

Parkinson's disease (PD) is a progressive motor disease characterized by bradykinesia or akinesia, rigidity, and resting tremor. Levodopa is still the most widely used treatment for PD, but as the disease progresses the drug tends to become less helpful. This is because of the development of motor response complications such as end-of-dose deterioration or wearing-off, peak dose dyskinesias, and ON-OFF phenomenon.

Comparison(s): The safety of 40 mg/d istradefylline and the efficacy for reducing the percentage of OFF time in patients with advanced PD treated with levodopa will be compared to placebo. The safety and efficacy of Entacapone will also be compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

Patients selected for this study will be at least 30 years of age and will have been diagnosed with advanced Parkinson's disease as determined by UK Parkinson's Disease Society (UKPDS) criteria and the Modified Hoehn and Yahr Scale. The patients will have been receiving levodopa treatment for at least one year, may be taking other antiparkinsonian drugs, will have an average of at least three hours OFF time as recorded in two 24-hour ON/OFF diaries, and if female, must be non-pregnant and non-nursing.

Exclusion Criteria:

Patients may not be enrolled if they are taking certain medications excluded by the protocol, have been treated with any investigational drug within 30 days prior to randomisation (or five half-lives if longer), have ever received istradefylline or been treated with a COMT inhibitor, are psychotic, have clinically significant illness or laboratory values at screening, have insufficient mental capacity to comply with protocol requirements or certain psychiatric or neurological conditions.

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Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter

Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Using image analysis software, measurements summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent (CRVE).

Null Hypothesis: There is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye


Eligibility Criteria:
Inclusion Criteria:

• Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease

Exclusion Criteria:

* History of previous systemic or ocular Anti-VEGF therapy
* History of previous intravitreal injection with any drug
* Intraocular pressure ≥ 22
* Glaucoma
* History or presence of thromboembolic events
* Un-controlled blood pressure
* Blood donation during the previous 3 weeks
* Relevant media opacity of the lens
Raltitrexed in HIPEC

To evaluate the tolerance of patients with colorectal cancer to hyperthermic intraperitoneal chemotherapy with Raltitrexed, to determine the dose limiting toxicity and maximum tolerated dose.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-75 (including 18 and 75), regardless of gender;
2. ECOG score ≤1;
3. Patients with colorectal adenocarcinoma/mucinous adenocarcinoma/signet ring cell carcinoma/mucinous tumor confirmed by histopathology;
4. The laboratory test results within 1 week before treatment meet the following conditions:

   White blood cell (WBC) ≥ 4.0×109 /L;Neutrophil count (ANC) ≥ 1.8×109 /L;Platelet (PLT) ≥ 100×109/L;Hemoglobin (Hb) ≥ 80 g/L;Serum total bilirubin (TB) ≤ 1.5×ULN;Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT)≤ 2.5×ULN;Blood urea nitrogen (BUN) and blood creatinine (Cr) ≤ 1.5×ULN;
5. Patients voluntarily participate in this study, sign written informed consent, have good compliance and are willing to cooperate with the follow-up.

Exclusion Criteria:

1. Patients with severe complications were considered to be intolerant of postoperative chemotherapy;
2. Previous or concurrent malignancy, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;
3. Patients with peptic ulcer, gastrointestinal dynamic obstruction, severe active bleeding of the digestive tract, and perforation of the digestive tract;
4. Those with a history of allergy to the drug components or metabolites in the program;
5. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
6. had any heart disease, including :(1) angina;(2) Arrhythmia requiring medical treatment or clinically significant;(3) Myocardial infarction;(4) Heart failure;(5) any other heart disease deemed unfit to participate in this study by the researcher;
7. Female patients during pregnancy and lactation, female patients with fertility and positive test of baseline pregnancy or female patients of childbearing age who are unwilling to take effective contraceptive measures during the whole test period;
8. The accompanying diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that, according to the judgment of the researcher, seriously endanger the safety of the patient or affect the completion of the study;
9. A past history of neurological or mental disorders, such as major depression, epilepsy, or dementia, that clearly affect study disclosure or follow-up evaluation;
10. Participate in other clinical trials within 30 days of enrollment and receive research drugs and any concomitant treatment containing research drugs;
11. Other conditions in which the investigator considers it inappropriate to participate in this study.
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Latrunculin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,


Eligibility Criteria:
Inclusion Criteria:

* All ICSI cycles

Exclusion Criteria:

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Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn

Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late preterm infants.

The recommendations from the recently published Latin American Society of Gastroenterology, Hepatology and Pediatric Nutrition guidelines are substantially different in this area, and surveys have reported variations in clinical practice.

The aim of this randomised controlled trial (RCT) is to evaluate the benefits and risks of PNC AND parenteral nutrition total (NPT) in term and late preterm infants.

Methods/design:

This study is a single-centre, non-blinded RCT in the NICU of Pediatric Hospital of Sinaloa, Northwest, Mexico.

A total of 66 infants born ≥34 weeks of gestation who have a high likelihood of intolerance to enteral nutrition (EN) for at least 10 days will be randomised to PNC o PNT after informed parental consent. In both groups, EN will be commenced as early as clinically feasible.

Primary outcomes Incidence of colestasis on Day 28 of admission.

Secondary outcomes are total plasma bilirrubine profiles, the incidence of hypoglycemia, hospital-acquired infections, length of hospital/NICU stay, in-hospital all-cause mortality, weight, height and head circumference.

Discussion: This RCT will examine the effects of NPTC versus late PNT in term and late preterm infants by comparing key biochemical and clinical outcomes and has the potential to identify underlying pathways for beneficial or harmful effects related to both treatments.

Trial registration: 2022.HPS.DI.434 (3rd March 2024)

Keywords: Parenteral nutrition cycling, Incidence of colestasis, incidence of hypoglycaemia, hospital-acquired infections, Randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Chylothorax
* Intestinal obstruction
* Intestinal malrotation
* Intestinal intussusception
* Gastroschisis
* Intestinal volvulus
* Duodenal atresia
* Enterocolitis
* Sepsis
* Septic shock
* Prolonged fast
* Authorization of the study by parents

Exclusion Criteria:

* Presence of liver diseases or malformations that cause cholestasis.
* All patients who have received medical treatment for cholestasis are excluded.
Registry Evaluation of a Double Balloon Accessory Device

This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for endoscopic removal of suspected adenomatous benign polyps(s)
2. Patients capable of giving informed consent in English
3. No medical contraindication to endoscopic mucosal resection or endoscopic submucosal disection

Exclusion Criteria:

1. No patients less than 18 years of age.
2. Any contraindication to colonoscopy with due to subject's colon anatomy (i.e. stricture)
3. History of open or laparoscopic colorectal surgery
4. History of Inflammatory Bowel Disease
Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologic diagnosis of malignant melanoma (MEL)
* Measurable unresectable Stage III or IV MEL
* ECOG performance status score of 0 or 1
* Life expectancy ≥4 months
* For those enrolled in amendment 5 and later, tumor tissue (archival or recent acquisition) must be available
* For Cohorts 1-5, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma not including any post-incisional adjuvant therapy. Subjects may be treatment naïve. All metastatic melanoma regardless of primary site of disease will be allowed
* For Cohorts 6-7, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma; this does not include any post-incisional adjuvant therapy. Specifically, subjects must have received ≥3 doses of Ipilimumab therapy and the last dose having been administered within 4-12 weeks of initiation of study treatment

Exclusion Criteria:

* History of severe hypersensitivity reactions to other mAbs
* Prior malignancy active within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the investigator present a low risk for recurrence
* Active autoimmune disease or a history of known or suspected autoimmune disease
* History of recently active diverticulitis or symptomatic peptic ulcer disease and history of adrenal insufficiency
* Regular narcotic analgesia
* Active, untreated central nervous system metastasis
* For subjects enrolled in Cohorts 1-5, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody
* For subjects enrolled in Cohorts 6-7, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CD137 antibodies
* Any non-oncology vaccine therapy used for prevention of infectious disease
* Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs
* Positive tests for human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B, hepatitis C
* Subjects weighing ≥125 kg are excluded from Cohort 5
* Subjects in Cohorts 6 and 7 must have received Ipilimumab monotherapy immediately prior to study entry, but must not have received that Ipilimumab as part of a clinical trial
* Subjects with ocular melanoma are excluded from Cohort 8