cyrilzakka/clinical-trials huggingface dataset:
Hypoxia Intolerance in Preterm Individuals

Reduced Hypoxic Ventilatory Response (HVR) and systemic O2 saturation subsequently leading to blunted aerobic capacity as well as decreased overall physical and cognitive performance are the main physiological challenges faced by prematurely born individuals in hypobaric hypoxia (i.e. during high altitude sojourn). While these phenomena have been described previously, the underlying mechanisms are currently unresolved. Given that the reduction in altitude-performance and its underlying mechanisms are not well understood, it is currently impossible to give evidence-based recommendation for altitude sojourns in this cohort. It is also of note, that even hypobaric hypoxia exposure during long-haul flights might be detrimental to well-being of pre-term born individuals.

The present project aims to comprehensively investigate physiological responses to altitude/hypoxia during rest and exercise in prematurely born, but otherwise healthy adults. Specifically, the investigators aim to elucidate the underlying mechanisms of the altered resting and exercise cardiovascular, respiratory, cerebral and hematological responses to hypoxia in prematurely born individuals. The obtained results from this cohort will be compared to the data from a control groups consisting of healthy, age and aerobic capacity-matched individuals born at full-term. While acute hypoxic effects will be the focus of the project's first phase, the researchers will test the effect of prolonged terrestrial (real) or simulated (normobaric hypoxia) altitude exposures in the second part. This phase will, in addition to the insight into the prolonged altitude acclimatization modulation in prematurely born individuals, also enable the potential differences between the effects of normobaric (simulated) and hypobaric (terrestrial) hypoxia in this cohort to be investigated.


Eligibility Criteria:
Inclusion Criteria:

* prematurely born (gestational age: ≤ 32 weeks; gestational weight ≤ 1500g)
* full-term born
* healthy individuals
* male

Exclusion Criteria:

* presence of any medical risk factors to exercise and/or exposure to altitude
* presence of any medical condition that would make the protocol unreasonably hazardous for the patient
* smokers
* exposure to altitude above 1000m in the last 2 months
A Study to Evaluate the Effect of Food, Formulation, and a Proton Pump Inhibitor (PPI) on MK-1084 in Healthy Adult Participants (MK-1084-003)

The purpose of this study is to evaluate the effect of food, formulation, and a PPI on the levels of MK-1084 in a person's body over time.


Eligibility Criteria:
Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
* Medically healthy with no clinically significant medical history.

Exclusion Criteria:

* Has a history of cancer.
* Has had major surgery and/or donated or lost significant volume of blood.
Effects of Probiotic Mixture Supplementation and Evaluation of Intestinal Mucosal Tolerance and Gut Microbiome in Newborns With Perinatal Asphyxia Receiving Hypothermic Treatment

The VISNAT trial is a PILOT STUDY due to absence of previous evidences in literature on using probiotic in newborns with perinatal asphyxia.

It is designed as a randomized, placebo-controlled, blinded, multicentre superiority trial with two parallel groups and a primary outcome of mortality and/or disability at 18 months of age.

After informed consent is obtained from both parents, randomization will be performed as block randomization with a 1:1 allocation using a computer-generated allocation sequence, while the allocation concealment will be performed using locked bags.

Randomization data and allocation list will be stored in a secure place and will not be available to any of the components of the study apart of data collectors.

Participant files will be stored for a period of 10 years after completion of the study.

All the components of the study will be blinded including: participants and their parents, healthcare providers, outcome assessors, data collectors, data analysts.


Eligibility Criteria:
Inclusion Criteria:

* o Newborns with gestational age \>/= 35 weeks and birth weight \>/= 1800 grams

  o Intrapartum asphyxia defined according at least one of the following:
* APGAR index at 10 minutes \</=5;
* Resuscitation with endotracheal tube or mask IPPV for more then 10 minutes;
* pH \</= 7 or excess of base \>/= 12 mmol/l on arterial blood gas (ABG) analysis within the first 60 minutes of life

  * Moderate/severe Hypoxic-ischemic encephalopathy assessed between 30 and 60 minutes of life according to Sarnat \& Sarnat definition
  * Hypothermic treatment. According to the Italian national guidelines on Perinatal Asphyxia and Therapeutic Hypothermia, the hypothermic therapy will be started in the first six hours of life and will last 72 hours.

Exclusion Criteria:

* Inability to obtain the informed consent from both parents
* Congenital major malformations or syndromes o Surgical diseases
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis

This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients

Patients with acute sinusitis were randomly assigned (1:1) to receive either cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group) and corresponding placebo t.i.d. or b.i.d. for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with sinusitis (accompanied with otitis media) at screening, and whose first symptoms occurred within the past 3 weeks
* Symptoms or signs of acute sinusitis persist without improvement for 10 days after onset or symptoms or signs of acute sinusitis initially improve and then worsen within 10 days

Exclusion Criteria:

* Those who have a history of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics
* Those with a history of allergic rhinitis or other rhinitis
* Those who have been diagnosed with sinusitis more than 3 times within a year
* Have had or scheduled sinus surgery within 1 month
* Creatinine Clearance \< 40 mL/min at screening
* Those whose AST, ALT, and total bilirubin are more than 3 times the upper limit of normal at screening
* Cystic fibrosis patients
Laxative Effectiveness of a Phytotherapeutic Tea

The aim of this study is to evaluate the efficacy and safety of a phytotherapeutic laxative tea, composed by Pimpinella anisum, Foeniculum vulgare, Sambucus nigra and Cassia angustifolia, in a randomized crossover placebo-controlled clinical trial in patients with chronic constipation.

The Klein Laxative Tea is a pharmaceutical phytotherapeutic product that's been used for several years in Brazil for the treatment of constipation. This product contains fruit of Pimpinella anisum (green anises), fruit of Foeniculum vulgare (fennel), flowers of Sambucus nigra (elder tree) and flowers of Cassia angustifolia (senna). In spite of the beneficial effects of its components, separately demonstrated in vitro, it never had its effectiveness appraised in a randomized clinical trial.The purpose of this study was to evaluate the efficacy and safety of this product in a randomized crossover placebo-controlled clinical trial. Twenty patients presenting with the criteria of the American Association of Gastroenterology for chronic constipation were included, and concluded a two-phase crossover study. The primary endpoint was the evaluation of the intestinal transit time measured through radiological technique. The secondary endpoints were the number of evacuations, subjective impression of the quality in the intestinal habit, quality of life appraised through WHOQOL-brief and adverse effects.

Eligibility Criteria:
Inclusion criteria:

* patients with 18 to 55 years old with chronic constipation according to the criteria of the American Association of Gastroenterology (AAG);
* patients should present good understanding and collaboration capacity, an not be in use of other medications with effects on the intestinal habit;
* patients with no abnormalities in the exams;
* willing to sign a written informed consent;
* women in fertile age should make use of appropriate anti-conception.

Exclusion Criteria:

* pregnant or breast feeding women;
* patients with history of abuse of alcohol or use of drugs;
* significant or not-controlled disease, except constipation.
Genetic Polymorphisms Associated With Cigarette Smoking and Risk of Graves' Disease

Cigarette smoking is a well-recognized risk factor of Graves' disease and, particularly, Graves' ophthalmopathy. Hence, germline polymorphisms of detoxification genes and genes belonging to the major DNA repair/apoptosis pathways might have an important role in disease susceptibility. In addition, as some of these genes are regulated by thyroid hormones, they could affect the outcome of these patients. Our objective was to assess the influence of the GST, CYP and TP53 gene polymorphisms in the risk of Graves' disease and its outcome.

Although the role of many polymorphisms of genes related to toxins' metabolism has been extensively investigated regarding the susceptibility to thyroid cancer, their influence in thyroid autoimmune diseases risk is still largely unknown. Hence, this study was designed to assess the influence of GSTT1, GSTM1, GSTP1, CYP1A1 and 72TP53 polymorphic inheritance on the susceptibility to Graves' disease and to its response to the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Graves' disease patients
Bruxism Xeomin® Intervention Trial

The purpose of this study is to test whether severe masticatory muscle spasms during sleep (e.g. teeth clenching and grinding, known as "bruxism" in technical jargon) demonstrably decrease after application of botulinum toxin type A (Xeomin®). Xeomin® has so far been used to relieve spasms of other muscles and is an approved drug in Switzerland. This study is now intended to test the suitability of this drug for relaxation of the masseter muscle.

Bruxism is a prevalent condition that differentially burdens individuals. The overall objective of this pilot study is to measure the effects of BTX-A (Xeomin®) injections into bilateral masseter muscles for the management of sleep bruxism and associated symptoms. The hypothesis is that BTX-A reduces masticatory muscle activity. The aim of this study is to instrumentally monitor subjects closely over an extended time period of three months before and after application of BTX-A.

Botulinum toxin type A ( BTX A; Xeomin ® ) temporarily blocks neuromuscular synapses. It is successfully and safely used therapeutically in various types of movement disorders and in chronic migraineurs. The mechanism of action of this treatment is related to a reduction of neurotransmitter release leading to reduced muscle activity.

The following Null hypothesis will be tested:

Injections of Xeomin® into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle) have no effect on bruxism measured by A) Masticatory muscle activity (1° objective) B) Subjects' well-being (2° objective) C) Sensitivity of masticatory muscles and jaw joints (2° objective) D) Anxiety over tooth wear (2° objective) E) Disturbed sleep by bed partner (2° objective)

Following instruments will be used:

1. WISE questionnaires. A comprehensive web-based interdisciplinary symptom evaluation tool.
2. Algometer for sensitivity measure of masticatory muscles and jaw joints.
3. Bio-signal recorder. Parallel to the Electromyography (EMG) of the masseter muscles, other bio-signals such as a number of electroencephalographic (EEG) derivations, electrooculogram (EOG ) as well as an electrocardiogram (ECG) will be recorded, in order to detect sleep stages and better identify bruxism episodes. The device used in this study has been approved for projects NIH #2R01DE016417-05A1 and #1 R01DE028548-01.
4. Ultrasound for masseter muscle thickness measure
5. Dual-color chewing gum for chewing efficiency measure.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years;
* patients complaining of bruxism and/or bruxism-related symptoms.
* Sufficient knowledge of German to understand the patient information and the trial arrangement.

Exclusion Criteria:

* Contraindications for Xeomin® treatment such as generalized disorders of muscle activity (myasthenia gravis, Lambert-Eaton-Rooke syndrome);
* documented hypersensitivity to one of the components,
* local infection of the injection sites;
* intake of anticoagulants or muscle relaxing medications;
* recreational drugs.
Treatment Resistant Depression in America Latina

The purpose of this study is to estimate the prevalence of Treatment Resistant Depression (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American countries: Argentina, Brazil, Colombia and Mexico; and to evaluate all and depression-related healthcare resource utilization in TRD participants.


Eligibility Criteria:
Inclusion Criteria:

Phase 1:

* Major depressive disorder (MDD) diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), that was confirmed by MINI International Neuropsychiatric Interview, 5.0 version (MINI)
* Treated or untreated participants with a new or continued episode of depression at the time of the enrolment
* Participants must be capable of completing the corresponding assessments in the study
* Participants must be capable of signing the informed consent form

Phase 2:

* Diagnosis of Treatment Resistant Depression (TRD), to be described by the investigator, based on the criteria:

  1. Adequate follow-up and treatment with at least 2 antidepressants
  2. Without complete response to treatment (based on Montgomery-Asberg Depression Rating Scale \[MADRS\])

     Exclusion Criteria:
* Participants diagnosed of psychosis, schizophrenia, bipolar disorder, schizoaffective disorder, or dementia
* Participants with substance dependence considered serious by the investigator
* Participant currently participating in another clinical study
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.


Eligibility Criteria:
Inclusion Criteria

* Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
* Have moderate to severe SjS ESSDAI ≥ 5.
* Short duration of disease (≤ 10 years) before screening.
* A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
* Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.

Exclusion Criteria

* Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis).
* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
* Medical condition associated with sicca syndrome.
* Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Validation of K-DVPRS

This study aimed to validate Korean version of Defense and Veterans Pain Rating Scale for the assessment of postoperative pain.

Defense and Veterans Pain Rating Scale (DVPRS) is translated into the Korean version through forward-back translation. The K-DVPRS is reviewed by the Korean expert and finally verified by the investigator of this study.

On a day before surgery, postoperative pain at rest and during cough is investigated using K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted. At 24 hours after surgery, postoperative pain of surgical site at rest and during cough is investigated using NRS and K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted. At this time, to assess the reliability of K-DVPRS, postoperative pain of surgical site at rest and during cough is re-investigated using K-DVPRS after 30-60 minutes. At 48 hours after surgery, postoperative pain of surgical site at rest and during cough is investigated using NRS and K-DVPRS, and K-DVPRS supplementary questions and EQ-5D-5L are conducted.

In order to verify the reliability of the K-DVPRS, the internal correlation coefficient (ICC) and Cronbach's alpha coefficient are calculated to evaluate the test-retest reliability. Convergent validity and construction validity are calculated to verify the validity of the K-DVPRS. Spearman correlation analysis between pain intensity at rest and during cough using NRS and K-DVPRS is performed to verify convergent validity. In addition, an inter-item correlation analysis is conducted between pain intensity at rest and during cough using K-DVPRS, scores of K-DVPRS supplemental questions, pain intensity at rest and during cough using NRS, and EQ-5D-5L scores. To verify the construct validity, K-DVPRS score is analyzed by age, sex, operation time, and the severity of surgery. Finally, the Mann-Whitney U test is used to compare the difference in postoperative during at rest and during cough evaluated by K-DVPRS before and 24 hours after surgery. The difference in postoperative pain between 24 and 48 hours after surgery is also compared in the same way. The evaluation success rates of NRS and K-DVPRS are also compared at postoperative 24 and 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparoscopic surgery or robot abdomen surgery (duration ≥ 1 hour) under general anesthesia

Exclusion Criteria:

* Patients with ASA PS ≥ III
* Patients with a difficulty to answer postoperative pain-related questions or K-DVPRS
* Patients with red-green color blindness or difficulty distinguishing colors
* Patients who are inappropriate for this clinical trial based on the investigator's opinionr
Safety and Efficacy Study of a Food Supplement for Pregnant and Lactating Women

The purpose of this study is to determine whether a food supplement consisting of vitamins, minerals and fish oil taken during and after pregnancy can decrease the need for additional iron supplementation due to anemia during pregnancy, and optimize levels of nutritional markers such as vitamin D and docosahexaenoic acid (DHA, an omega 3 fatty acid) in maternal blood and breast milk, compared to placebo.

200 healthy, pregnant women will be randomized to receive either active or placebo at their first visit to the pre-natal centres. They will be monitored at regular intervals, blood samples will be taken and they will be asked about compliance and any adverse reactions.

Approx 8 weeks after delivery, the women will come to the pre-natal centres for a check-up. During this visit, a blood sample will be drawn and a breast milk sample will be collected.

The blood samples will be analysed for haemoglobin, serum ferritin, vitamin D and DHA. The breast milk samples will be analysed for vitamin D and DHA.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women aged 18-40 years with a body mass index (BMI) above 18.5 and below 35 kg/m2 who visit pre-natal clinics (midwife centres) to register.
* Nulliparous and multiparous women.
* The women must be able to understand verbal and written information in Swedish to give an informed consent to participate in the study.

Exclusion Criteria:

* Women below the age of 18 or above 40 years old.
* Women with a BMI below 18.5 or above 35 kg/m2.
* Women with any form of anaemia as diagnosed at the first visit to the prenatal clinic.
* Women expecting two or more babies.
* Women who have undergone bariatric surgery.
* Women on medication with pharmaceuticals that could affect the result of the study, e.g., vitamin K antagonists.
* Women who are allergic to any of the components of WellnessPack mama, e.g., fish.
* Women who suffer from drug or alcohol abuse.
* Women who suffer from known severe eating disorders.
* Women who suffer from chronic diseases that could affect gastrointestinal absorption and metabolism.
* Women who want to continue or start using similar food supplements in addition to WellnessPack mama/placebo, unless recommended by a physician or midwife, will be excluded from the study.
* Upon miscarriage or transfer to prenatal care specialist, the subject is excluded from the study.
The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia.

The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center.

The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary unilateral open Inguinal Hernia Repair .
* patients undergoing elective surgery.
* above the age of 18 years old

Exclusion Criteria:

* patients having repeated Inguinal Hernia.
* patients having bilateral Hernia.
* patients undergoing laparoscopic surgery.
* patients undergoing non-elective surgery.
Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.

Development of hepatic encephalopathy in a patient with cirrhosis is associated with poor survival rate of 10-70% at one year depending upon hepatic and renal functions. Treating patients to prevent development of first episode of hepatic encephalopathy is classified as primary prophylaxis of hepatic encephalopathy and preventing recurrence of hepatic encephalopathy in patients who had previous episode of hepatic encephalopathy is secondary prophylaxis of hepatic encephalopathy

Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients(18-70yrs) who never had encephalopathy

Exclusion Criteria:

* history of taking lactulose in the past 6 weeks
* alcohol intake during the past 6 weeks
* hepatocellular carcinoma
* previous TIPS or shunt surgery
* significant co morbid illness such as heart, respiratory, or renal failure
* neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
* patients on psychoactive drugs such as antidepressants or sedatives
* who restarted alcohol during follow up