cyrilzakka/clinical-trials huggingface dataset:
Double-Blind, Randomized, Placebo-Controlled Study of Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived) in ARC Patients

To conduct a parallel-group, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of an orally administered low dose interferon alfa-n3 as an immunomodulator in the treatment of mild to moderate symptomatic HIV+, AIDS-related complex (ARC) patients.

The study has been extended to offer 52 weeks of maintenance therapy after the 10 weeks of the placebo controlled period are concluded successfully.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).

Patients must have:

* Diagnosis of AIDS related complex (ARC).
* Given written informed consent.
* Been receiving a dose of = or \< 600 mg/day of zidovudine (AZT) at least 90 days prior to study entry IF they are currently taking AZT.

Prior Medication:

Allowed:

* Zidovudine (AZT) at a dose = or \< 600 mg/day at least 90 days prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* History of AIDS-defining condition or evidence of AIDS dementia.
* Evidence of chronic hepatitis with severe liver dysfunction, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular or psychiatric disorder that would limit the subject's ability to complete the 12 weeks of the study period.

Concurrent Medication:

Excluded:

* Ketoconazole.
* Trimethoprim / sulfamethoxazole (TMP/SMX).
* Experimental medications.

Patients with the following are excluded:

* Absolute CD4 count of \< 100 or \> 350 cells/mm3.
* Any disease or disorder listed in Patient Exclusion Co-existing Conditions.
* Unlikely or unable to comply with the requirements of the protocol.
* Unwilling or unable to give informed consent.
* Development of antibodies to interferon during prior interferon therapy that occurred \> 3 months prior to study entry.

Prior Medication:

Excluded within 45 days of study entry:

* Immunomodulators (e.g., BCG vaccine, isoprinosine).
* Chemotherapy.
* Steroids.
* Excluded within 3 months of study entry:
* Interferon therapy. Active IV drug abuse.
Ultrasound Guided Bilateral Superficial Cervical Block for Post-operative Pain Therapy in Thyroid Surgery

Ultrasound Guided Bilateral Superficial Cervical Block for Postoperative Pain Therapy in Thyroid Surgery


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I and II

Exclusion Criteria:

* allergy to local anesthetics, bleeding diatheses, and local infection or sepsis thyrotoxicosis and , malignancy.
Motivating Campus Change Study

The study evaluates the relative merit of a multi-component PFI presented in the traditional simultaneous delivery (i.e., all components at once) versus a sequential format, wherein individual PFI components are delivered one at a time over several weeks to minimize time and attention demands for each component.

This study builds upon the latest alcohol intervention literature to develop and test the next wave of personalized feedback interventions (PFIs) to address harmful alcohol use among college students. The purpose of this research is to determine optimal configuration of PFIs to take advantage of the clarity and initial impact of single-component PFIs and greater effect size and duration of personalized multi-component PFIs. The Investigators seek to increase and evaluate engagement with the PFI and text-message materials and boost innovation of both content and process of the intervention. In addition to PFI content and delivery, the investigators will use qualitative and quantitative methods to determine personal relevance of the chosen high-risk events among a sample of students who engage in heavy episodic drinking to better understand duration of PFI effects impacted by fluctuations in drinking associated with high-risk events. Prior interventions have targeted drinking in general or a single high-risk drinking event (e.g., Spring Break), but have not targeted both general and event-specific drinking together. These enhanced intervention effects, could have a significant impact on risks associated with college student drinking, and can be rapidly disseminated and implemented on campuses nationwide to address the public health problem posed by heavy episodic drinking among college students.

Eligibility Criteria:
Inclusion Criteria:

* at least 1 heavy episodic drinking episode in the past month
* at least 3 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past 3 months for cohort 1
* at least 2 negative alcohol related consequences on Rutgers Alcohol Problem Index/ Young Adult Alcohol Problems Screening Test in the past month for cohort 2 - 5
* Indicate they own a cell phone with text message capabilities and consent to receiving text messages

Exclusion Criteria:

* Doesn't meet inclusion criteria
* Unwillingness to participate
* Failure to provide consent
* Plan to travel internationally in the next 12 months (for intervention text purposes)
Can Fecal Calprotectin Be Used as a Biomarker of Non-alcoholic Fatty Liver Disease In Obese Adolescents?

The incidence of non-alcoholic fatty liver disease (NAFLD) is increasing with obesity, and it is believed that ongoing inflammation in obesity and alterations in the enterohepatic axis contribute to this process. This study aimed to determine the role of fecal calprotectin (FCP) as an inflammatory biomarker in course of obesity and NAFLD.

Obesity is a significant public health issue worldwide. With the increasing prevalence of obesity, the prevalence of metabolic syndrome in adolescents is also on the rise. Non-alcoholic fatty liver disease (NAFLD), a major cause of chronic liver disease, is the hepatic component of metabolic syndrome. The prevalence of NAFLD is not precisely known, but in some studies, it is between 22.5% and 52.8% in children with obesity, constituting 2.6% of all children. Although the mechanisms involved in the development of obesity-related metabolic complications and NAFLD are not well understood, it is believed that intestinal inflammation, changes in the microbiota, and alterations in the gut-liver axis (GLA) may play a role in the development of low-grade chronic inflammation in NAFLD associated with obesity. Fecal calprotectin (FCP), which has become increasingly important in demonstrating intestinal inflammation in recent years, is a widely used test, particularly in the diagnosis and monitoring of inflammatory bowel disease and various gastrointestinal disorders. In our study, the utility of FCP as an inflammatory biomarker in the course of NAFLD in obese adolescents has been investigated. The study was approved by our hospital's ethics committee in 15.11.2022 and another ethics committee approval was taken in 08.06.2023 for title change of study. This study conducted under the Helsinki Declaration.

Eligibility Criteria:
Inclusion Criteria:

* 10-18 years old healthy adolescents for control group
* Children aged 10-18 years without any additional diseases, BMI\>2 SD, no hepatosteatosis detected by ultrasonography (USG), and alanine aminotransferase (ALT) levels within normal limits were included in the obese group
* Children aged 10-18 years without any additional diseases, BMI\>2 SD, Hepatosteatosis detected by ultrasonography (USG), and alanine aminotransferase (ALT) levels higher than normal limits adjusted for gender were included in the obese + NAFLD group

Exclusion Criteria:

* Diseases other than obesity and NAFLD
Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years

During general anesthesia, objective monitoring for analgesia is still lacking. The administration of opioids relies on the experience of the anesthesiologist. There are some monitors, e.g., Analgesia Nociception Index (ANI), showing that they can evaluate analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor was released for assessing analgesia in children with age less than 2 years. The investigators aim to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.

During balanced anesthesia, hypnosis can be monitored with BIS, muscle relaxation can be monitored with a train-of-four, however, analgesia lacks precise monitoring. The anesthesiologist administers narcotics according to clinical signs and experience. Analgesia Nociception Index (ANI) has been introduced as an objective monitor for analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor has been introduced to assess analgesia in children under 2 years, however, clinical studies regarding its clinical efficacy are scarce.

The objective of this study is to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Newborn up to 2 years old
* ASA Status 1-2
* Undergoing elective surgery of upper part of body

Exclusion Criteria:

* Premature
* Arrhythmia
* Concomitant use of regional anesthesia
* Plan for ICU admission
Ultrasound-detectable Endotracheal Tube: a Feasibility Study

The researchers are studying whether special features make it easier to see if the breathing tube is in the correct place. It is hoped that the investigational device will enable more accurate placement (depth and trachea vs. esophagus).

The participant will have a breathing tube where the balloon (cuff) at the end of the tube has two special features: 1) The balloon will have a divot in it, rather than be round in shape, and 2) The balloon will be filled with saline (salt water), rather than air. The breathing tube is called an ultrasound detectable cuffed endotracheal tube (USD-ETT).

The USD-ETT has not been tested or used in humans previously.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing scheduled or planned diagnostic or interventional cardiac catheterization with planned general anesthesia requiring endotracheal intubation.

Exclusion Criteria:

* Patient has a known airway abnormality, including tracheal stenosis, previous tracheal stenosis, or tracheobronchomalacia.
* Patient has a tracheostomy.
* Patient is ventilator-dependent.
* Patient has an anticipated difficult intubation based upon airway exam and/or history of difficult intubation.
* Patient is unlikely (in opinion of anesthesia team) or is unable to be intubated with 3.5 mm, 4.0 mm, or 4.5 mm Inner Diameter USD-ETT due to the size of the patient or their airway.
* Patient is already intubated prior to the scheduled procedure.
* It is anticipated that the patient will not be extubated after the catheterization procedure.
* Concurrent enrollment in another clinical trial with an intervention during the cardiac catheterization procedure or 30 days afterwards.
* Allergy to plastic/materials in USD-ETT
Childhood Activities Nutrition and Development Oversight

The overall goal of this study is to understand how common conditions in childhood develop and if by providing specific health education and resources to parents/caregivers we can promote healthy development. This study will provide information and instruction on several aspects of infant care including, sleep, nutrition, building a healthy relationship with your baby, and healthy screen time use.

This study is a randomized controlled trial that will recruit parents/caregivers and infants infants living in the Greater Chicago area . The study will follow these infants until they are three years old.

The intervention arm will receive education about nutrition, resources, and specific instructions on feeding and caring for their infants. The control arm will receive education about infant development and helpful tips about infant sleep, screen time, and building healthy relationships. In addition, all caregivers will be asked to fill out surveys and come to research visits during the study period. There will be a total of 4 study visits during the three years of the study. There will be optional blood, stool, and skin testing of the child at each study visit. Two visits will take place during the first year of life, followed by visits around the child's 2nd and 3rd birthdays.

Eligibility Criteria:
Inclusion Criteria:

* Parent/guardian(s) must understand and provide informed consent
* Infant \<26 weeks of age at enrollment
* Willing to be randomized to either intervention or control
* In good general health as evidenced by medical history
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Child assigned male or female sex at birth

Exclusion Criteria:

* Infant completed less than 28 weeks gestation
* Co-morbid medical diagnoses that would prevent caregivers from initiating solid foods per protocol, such as dysphagia, chronic aspiration, malformations, etc.
* Co-morbid medical diagnoses that would require specialized diet/nutritional needs, such as congenital heart disease, genetic/metabolic disorders, malignancy, etc.
* Caregivers who express unwillingness to introduce peanut, milk, egg, or cashew
* Caregivers who cannot provide informed consent in English or Spanish
* Parents planning to move away from study sites before child is 12 months of age
* Investigator or designee considers that the participant or parent/guardian would be unsuitable for inclusion in the study
* Infant with a sibling enrolled in the study
Cobra (Severe Asthma)Medical-economic

The severe asthma is a major source of expenses in term of public health, while it concerns no more than 5 % of the asthmatics. The expenses is direct (medicines, hospitalizations, care) but especially indirect (absenteeisms, etc.). The forward-looking follow-up of cohort of more than 500 severe asthmatic patients multicentrique in an already widely established cohort (COBRA, at present in Visit 9 (one every 6 months) is an once-in-a-lifetime opportunity, coupled with the data of the CPAM, to identify well the evolution in time of a real medical economic variable. The possibility of dynamic follow-up of the expenses compared to the medical data offers perspectives of evaluation cost-efficiency of the informed therapeutic procedures. It is possible to couple in a forward-looking and dynamic way the data of health stemming from a cohort with the economic data stemming from the CPAM. This variable included in a Cluster's algorithm has to allow to identify the interventions the more and the less cost effective. The main objective of this study is to realize a cost estimate of care of the severe asthma. The variation of the costs will be also studied. The recruited patients are patients already included in the cohort COBRA in the centers of Marseille, Montpelier or Nice, classified GINA 4 and agreeing to participate.

The following direct medical costs will be collected according to the point of view of the Social Security on a duration of 2 years:

* Hospitalizations (valuation from the GHS + medicines except GHS)· Consultations (valuation AM)
* Complementary(additional) examinations except hospitalization (valuation AM)
* Pharmacy (valuation AM)
* Transport (valuation AM)The estimate of average costs will be made with a reliable interval for 95 %.

The average cost by patient of the care will be calculated for every year of the follow-up. Relationship individual cost-efficiency: by analogy with the studies cost-efficiency comparative clauses, the investigators shall calculate a relationship cost-efficiency at the individual level as follows: (cost-year2 - cost-year1) / (efficiency-year2 - efficiency-year 1). Differences in these relationships will be looked for between various groups by tests of comparisons of averages.The construction of patients' clusters will be made according to the algorithm of the study SARP but also by using techniques statistics of classification non supervising to define our own algorithm. Variables used on our algorithm will include the relationship cost efficiency individual in addition to the clinical variables. The temporal stability of the relationship cost efficiency will be analyzed. The risk factors of a modification of this relationship will be looked for.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the observationnal cohort COBRA for at least 6 months
* Patient members in one of the partner health insurance funds

Exclusion Criteria:

* The patient refusing his participation to the research
Efficacy Comparison of Warfarin Versus Rivaroxaban CVT

With regard to Cerebral Venous Thrombosis (CVT) importance as a life threatening disease, specific care is necessary, Known anti-coagulants have limitations.Vitamin K antagonists such as Warfarin, require laboratory monitoring and exact administration starting and maintenance dose. although Rivaroxaban(selective and direct Xa factor antagonist ) has no monitoring and no drug interaction. This study aim to focus on efficacy of Warfarin versus Rivaroxaban.


Eligibility Criteria:
IInclusion Criteria:

* Patients of both gender
* Age 18 years and higher
* proven CVT on neuro imaging ( MRI-MRV)

Exclusion Criteria:

* Patients suffering from renal failure(GFR\<30) Patients
* Patients with contraindications for oral anticoagulation
* Patient who having pregnancy
* Uncooperative patient for completing the course of treatment
The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease.

BACKGROUND: Previous studies of short-term surgical outcomes after preoperative exposure to anti-TNF therapy in ulcerative colitis (UC) patients who have undergone IPAA have been conflicting. We sought to determine whether preoperative exposure to anti-TNF therapy affects histological measures of fibrosis in the colorectum, which may be a potential factor in adverse anastomosis complications following IPAA surgery.

METHODS: Individuals who received infliximab as maintenance therapy and who received their last dose within 180 days of the first stage of IPAA were selected. The control group comprised UC patients who were not exposed to anti-TNF therapy, matched by age, sex, BMI, disease duration, albumin levels, and post-operative leak outcome. Hematoxylin and eosin- (H\&E) and trichrome-stained slides from the most distal, well-oriented, full-thickness section of colorectum from each patient's total colectomy specimen were evaluated. Blinded assessment of the degree of fibrosis in the lamina propria, the submucosa, the submucosa immediately adjacent to the muscularis propria, and the subserosa was performed by a single observer using a semi-quantitative pictorial scale.


Eligibility Criteria:
Inclusion Criteria:

* all individuals with IBD who underwent IPAA from January 2002 to June 2013 were reviewed .

Exclusion Criteria:

* Patients with CD
* Patients without adequate clinical records documenting the 30-day postoperative clinical outcomes .
STrategies for AntithRombotic Treatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant

Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients who have an indication for OAC.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had undergone successful TEER (Defined as techinal success according to MVARC );
* Need for long-term oral anticoagulation;
* Ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures;
* Providing written informed consent form；
* Women of childbearing potential must use an acceptable method of contraception from signing the informed consent form until the date of the last dose of antithrombotic drug;
* The heart team agrees on the antithrombotic strategies.

Exclusion Criteria:

* Severe renal impairment (creatinine clearance rate\<15ml/min or on dialysis)；
* Postoperative persistent bleeding (overt bleeding either associated with a drop in the hemoglobin of 3.0 g/dl or requiring transfusion of 3 U of whole blood or packed red blood cells) or occurrence of vascular complications；
* Platelet count ≤ 30 ×10\^9/L；
* Need for reoperation；
* History of intracranial or intracerebral hemorrhage；
* History of gastrointestinal ulcers or hemorrhage；
* Any hepatic disease associated with coagulopathy (Child-Pugh B or C);
* Allergy, intolerance or contraindication to oral anticoagulation or antiplatelet drug;
* History of cerebrovascular event or transient ischemic attack within the past 6 weeks;
* Current antiplatelet therapy；
* Patients who have participated in another drug or device investigational study within the past 30 days；
* Life expectancy \<12 months；
* Pregnant or breastfeeding women。
Precise Stratification of Genetic Risk of Ovarian Function Impairment

Aging is a common problem in human society at present. The fertility decline, perimenopausal symptoms and senile diseases caused by ovarian aging seriously affect women's own health, offspring's health, family and social stability, and endanger national population security. Accurate stratification of genetic risk of ovarian aging has practical significance. Early and accurate identification of high-risk groups of premature ovarian aging can help such women to start early protection of ovarian function, preserve fertility to a greater extent, improve fertility quality, and also be conducive to early prevention and treatment of other systemic diseases and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Women who meet the diagnosis of premature ovarian insufficiency (POI), diminished ovarian reserve (DOR) or early menopause and hope to find out the risk of premature ovarian impairment and clarify the cause of premature ovarian impairment;

   1. premature ovarian insufficiency (POI): the age of female is less than 40 years old, with menopause or sparse menstruation for 4 months, and basal FSH \> 25IU / L for two consecutive times with an interval of more than 4 weeks.
   2. Diminshed ovarian reserve (DOR): before the age of 40, the number of antral follicles in both ovaries is less than 6, or AMH is less than 1.1ng/ml, or basal FSH is greater than 10 IU/L.
   3. Early menopause: women who enter menopause between the age of 40 and 45.
2. Informed consent, voluntary test.

Exclusion Criteria:

1. Chromosome karyotype abnormality;
2. Iatrogenic ovarian injury: history of radiotherapy, chemotherapy (reproductive toxic drugs such as alkylating agents) and ovarian surgery;
3. Ovarian mass: there is abnormal echo in the ovary under ultrasound, and the maximum diameter is greater than 4cm.
4. Pregnant and lactating women;
5. Polycystic ovary syndrome, hyperprolactinemia, hyperandrogenemia, hypothyroidism, adrenal dysfunction and other endocrine diseases affect ovulation;
6. Patients with cardiovascular, liver, kidney, hematopoietic system and other serious primary diseases and psychosis;
7. Patients who are participating in other clinical trials or have participated in other clinical trials in the past month;
8. Other patients determined by the investigator to be unsuitable for participation in this study.