cyrilzakka/clinical-trials huggingface dataset:
The Effect of Exercise on Disease Activity and Cardiovascular Risk for Patients With Axial SpondyloArthritis

The overall aim of this multicenter randomised controlled trial (RCT) is to investigate if exercise can modify the disease course and prevent comorbidity in patient with spondyloarthritis (SpA).

International guidelines recommend exercise as a cornerstone in the management of SpA. Due to the typical features of SpA with reduced spinal mobility, the main focus for exercise has been flexibility exercise. Exercise trials for this patient group have mainly aimed at improving spinal mobility and there is limited evidence of the potential effects of exercise on disease pathogenesis and CVD risk factors.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of axial SpA (the Assessment of SpondyloArthritis International Society classification criteria) confirmed by a rheumatologist
2. Age, 18-70 -years
3. Steady medication for ≥3 months
4. Moderate disease activity defined as a BASDAI score of ≥3.5 or a patient global score ≥3.5
5. Not participated in a structured endurance and strength exercise program during the last 6 months (\>1 hour/week)

Exclusion Criteria:

1. Severe co-morbidity which involves reduced exercise capacity and/or contraindications for physical activity as per American College of Sports Medicine guidelines for exercise testing
2. Not able to participate in weekly exercises sessions
3. Pregnancy
Oncological Surgery in Times of COVID-19: Effectiveness of Preoperative Screening for Sars-Cov-2

To evaluate the incidence of patients with a positive test for SARS-CoV-2, performed in the preoperative screening for patients treated at the institution

Cohort, prospective, observational study to evaluate the incidence of asymptomatic patients with a positive SARS-CoV-2 test detected in the preoperative screening program of the institution.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elective surgery scheduled at the IBCC, including those diagnosed with any type of cancer;
* Patients who will undergo the screening test for SARS-COV-2 by RT-PCR (nasal swab), according to the guidelines and protocol of the hospital

Exclusion Criteria:

* Urgent or emergency surgery;
* Screening test for SARS-COV-2 not performed
* Incomplete data in the institutional database
Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Colonosopy

Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Propofol Versus the Use of Dexmedetomidine as a Sedative Agent for Patients Presented for Lower Gastrointestinal Endoscopy

Eligibility Criteria:
Inclusion Criteria:

* aged 25-45 years,
* ASA class I or II,
* who are scheduled for elective outpatient colonoscopy

Exclusion Criteria:

* refused to give informed consent
* if they had known hypersensitivity to the used drugs
* patients with morbidly obese patients
* patients with increased risk for airway obstruction as obstructive sleep apnea,
* Liver diseases
Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates. 47 participants received oral nystatin and 48 participants received sterile water as part of oral hygiene.

Oral nystatin is an effective and safe alternative fungal prophylaxis. Some previous studies (1 randomized controlled trial and 4 observational studies) showed that oral nystatin prophylaxis reduce fungal colonization and decrease risk of systemic fungal infection in very low birth weight infants.

Nystatin is a non-absorbable antifungal agent with minimal side effects that works by binding on the major component of fungus cell membrane and causes death of the fungus. Its efficacy as fungal prophylaxis is comparable with Fluconazole but does not linked to drug-induced liver injury.

To determine this effectivity, we recruit eligible neonates who are admitted in our neonatal intensive care unit and randomly assign them into 2 groups once noted written parental consent. One group is given nystatin via oral and/or orogastric tube and the other group only receives sterile water as part of oral hygiene. Weekly fungal surveillance cultures (oropharyngeal and rectal) are done to evaluate colonization. Further examinations (blood/cerebrospinal fluid/deep tissue/urine culture) are done once noted clinical signs of systemic fungal infections.

Data analysis is conducted with intent-to treat approach. Significance testing is done by chi-square or fisher's exact test as needed.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \<= 32 weeks and/or birth weight \<=1500 grams
* 1 or more systemic fungal infection risk factors (antibiotic therapy, intravenous access, endotracheal tube, orogastric tube, urinary catheter, corticosteroid therapy, parenteral nutrition, theophylline therapy)

Exclusion Criteria:

* Suspected of having necrotizing enterocolitis within 72 hours after birth, cyanotic congenital heart disease, chromosomal defects, or critical conditions whom were not expected to live more than 72 hours after birth
Management of Recurrent Croup

Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric population: 6 months to 15 years of age
* 2 or more episodes of croup in 12 month period

  * croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.

Exclusion Criteria:

* Grade 3 or 4 subglottic stenosis
* Subglottic hemangioma
* Posterior laryngeal cleft
* Recurrent respiratory papillomatosis
* External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)
* Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body
* Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress
* Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.
* Other medical conditions necessitating chronic steroid utilization
Coordination-based Exercise Intervention in Preschool Children

This study intended to assess the impact of coordination-based exercise interventions on physical fitness, motor competence, and executive function among preschoolers aged 4 to 6 years.

Forty-four preschool children (22 boys and 22 girls), with a mean age of 5.90 years (SD = 0.28). Participants will be randomly assigned to an Exercise Group (n = 19) or a Control Group (n = 25). The Exercise Group will engage in 20-minute, fun, and game-based sessions focusing on foundational movement patterns appropriate for preschoolers, conducted twice weekly over eight weeks. In contrast, the Control Group continued with their regular unstructured school activities. Physical fitness was evaluated using agility tests, static-dynamic balance, and vertical jumping. Motor competence was assessed through the KTK3+ test battery, and inhibition control was measured using the Go/No-Go test. The study concluded that coordination-based exercises, structured around fun and engaging activities suitable for preschoolers, potentially enhance physical fitness, motor skills, and executive functions. These areas are essential for early childhood development, suggesting that integrating such exercises into preschool activities could be beneficial. However, specific results regarding the effectiveness of the interventions on the tested competencies would need to be detailed to confirm these hypothesized benefits fully. The study highlights the importance of structured physical activity in early childhood education settings for promoting essential developmental skills.

Eligibility Criteria:
Inclusion Criteria:

* typically preschoolers between the aged between 4-6 years old
* not taking any medication
* absence of cardiovascular, neurological, orthopedic, or psychiatric illnesses.

Exclusion Criteria:

• children with physical disabilities or other conditions that might significantly impact their ability to participate in the physical activity interventions might be excluded,
Effectiveness of Green Color Exposure on Dental Anxiety

The investigator's aim in this study was to evaluate the preoperative anxiety and the pain felt during the operation due to exposure to green light. For this purpose, the participants will wear green or translucent glasses before the operation. The investigator will evaluate the patient's anxiety change and the pain she/he feels during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and ASA 2 patient population
* not having had a third molar surgery before
* volunteer to participate in the study

Exclusion Criteria:

* dental phobia
* patients who will be treated under general anesthesia
* refusing the measurements
* not filling the VAS
Repair of Infected or Contaminated Hernias

This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.


Eligibility Criteria:
Inclusion Criteria:

* is an adult ≥18 years old.
* has need of open abdominal incisional repair of a contaminated or infected site
* has an estimated hernia size of \>9cm2 by physical exam

Exclusion Criteria:

* has a nidus of chronic colonization
* has a systemic infection at the time of repair.
* has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.
* requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.
* is bedridden or otherwise non-ambulatory.
* is ASA Class 4 or 5.
* has a BMI \>40.
* has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma

This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma
* Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter or nodal lesion greater than or equal to 15 mm in shortest axis)
* ECOG performance status of 0 or 1
* May be untreated or have previously received treatment for pancreatic adenocarcinoma or must have relapsed or refractory disease following 1 prior systemic therapy for metastatic gastric adenocarcinoma. For patients who have previously received treatment, it must be at least 2 weeks since the last systemic therapy or radiation, and at least 4 weeks since treatment with any monoclonal antibody (other than bevacizumab).

Exclusion Criteria:

* Evidence or history of central nervous system metastases
* History of another primary malignancy that has not been in remission for at least 3 years
* Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class III-IV within 6 months prior
Efficacy of Laflavon in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL)

A trial of LaFlavon in Patients with Metabolic Syndrome to Evaluate its Effectiveness in Lowering Triglycerides and Raising High-Density Lipoprotein (HDL).


Eligibility Criteria:
Inclusion Criteria:

1. Men and Women with Metabolic Syndrome
2. Elevated Triglycerides (\> 150)
3. Low High-Density Lipoprotein (HDL) (\< 35)
4. Willingness to take study nutritional supplement once a day for 3 months

Exclusion Criteria:

1. Women who are pregnant, nursing, or who intend pregnancy during the period of treatment
2. Known milk, soy or whey allergy
Therapy for Pediatric Hodgkin Lymphoma

With the success of current chemotherapy for Hodgkin's disease, the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity. The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls.

This study will evaluate the following objectives:

Primary Objectives:

1. To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkin's disease who achieve a complete response after 2 cycles of VAMP chemotherapy.
2. To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkin's disease who achieve a partial response after 2 cycles of VAMP chemotherapy.
3. To evaluate the efficacy of 2 alternating cycles of VAMP/COP chemotherapy (total 4 cycles of chemotherapy) plus low-dose, involved-field RT in children with intermediate risk Hodgkin's disease.
4. To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose, involved-field RT in children with unfavorable risk Hodgkin's disease.

Secondary Objectives:

1. To evaluate patient quality of life during and after treatment from the patient and parent perspective.
2. To compare patient and parental ratings of treatment-related symptoms and patient physical, psychological, social and cognitive functioning before the first treatment (T1 - baseline); after Cycle 2 or after 8 weeks of Stanford V (T2 - Evaluate Response); after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation (as applicable) (T3); at the conclusion of radiation or within a few days following the end of radiation (as applicable) (T4); and at 3 to 6 months after completion of therapy follow-up evaluation (T5).

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must have histologically confirmed previously untreated Hodgkin's disease (Patients receiving limited emergent RT or steroid therapy because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
* Patients must be 21 years of age or younger
* Ann Arbor stages IIB-IV
* No prior treatment.
* No pregnant or lactating women.
* Signed informed consent
* If re-evaluation of a patient's disease shows favorable risk features or intermediate risk features, the patient will be removed from the HOD99 study and consented to the respective HOD08 or HOD05 study.

Inclusion: treatment of favorable risk features:

* Ann Arbor IA or IIA with:

  1. Non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x ray)
  2. Ann Arbor stage IA or IIA with any of the following features: (1) "E" lesions (s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)

     Inclusion: unfavorable risk features:
* Stage must be classified as one of the following:

  1. Ann Arbor stage IIB, IIIB, or any IV
A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants

This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib while it is still in the body. Healthy participants will get one dose of tucatinib by mouth. Patients will be monitored for 8-14 days after they take the dose of tucatinib.

This study will examine the absorption, metabolism, and excretion of tucatinib in healthy individuals. Participants will receive one oral dose of tucatinib and will be followed for 8-14 days after the dose is received.

Eligibility Criteria:
Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, or lab evaluations
* Body mass index (BMI) between 18 and 32 kg/m²
* Weight between 50 and 100 kg
* Females must be of non-childbearing potential
* Males must agree to use contraception

Exclusion Criteria:

* History of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Any condition affecting drug absorption
* History of hypersensitivity or allergy to any drug compound, food, or other substance
* History of alcoholism or drug/chemical abuse within 2 years
* Use of prescription products within 28 days prior to check in
* Use of tobacco- or nicotine-containing products within 3 months prior to check in
Impact of Covid-19 in Congenital Heart Disease

The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (\> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer.

The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients.

CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today.

The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population.

This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France


Eligibility Criteria:
Inclusion criteria:

* Patient with CHD as defined in the international classification ACC-CHD
* Covid-19 infection over the study period

Exclusion criteria:

- Patient with genetic heart disease (cardiomyopathy, hereditary rhythmic disease).
Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?

The overall objective of this three-arm randomized controlled trial is to compare a dietary fiber-focused behavioral intervention to standard weight loss education for improving eating-related behavior and cognition, weight, and metabolic markers of chronic disease risk in a population of adults with obesity.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Dietary fiber intake ≤25 grams/day
* Self-reported BMI ≥30 kg/m2
* Willingness to attend in-person education sessions
* Willingness to avoid taking supplemental digestive aids (e.g., alpha-galactosidase (Beano®),
* Willingness to provide informed consent.

Exclusion Criteria:

* Metabolic, digestive, or allergic conditions or reactions that preclude consumption of whole food or food groups (e.g., irritable bowel syndrome, diverticulosis)
* History of gastric bypass surgery
* Currently taking glucagon like glucagon-like peptide-1 (GLP-1) Receptor Agonists
* Self-reported history of a diagnosed eating disorder
* Chronic disease (other than obesity)
* Pregnancy or lactation
* Use of tobacco or electronic smoking products
* Taking a pre-, pro-, or syn-biotic supplement
* Enrollment in another weight loss or diet intervention
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management

This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.

Project Summary

Justification for the project

One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. Elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. The management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. Patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year.

Proposed research

This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.

New features

Gabapentin as an adjunct o pain management has proven beneficial in gynecological surgery. Its use in similar surgical settings as an adjunct to pain management regiments has proven to be beneficial. It is generally well tolerated, inexpensive, has minimal side effects, and few contraindications.

Problems anticipated

The high volume at the study clinic will benefit recruitment efforts, however, as the coordination of this study may potentially disrupt clinic flow there will be limits on daily recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to follow-up, most of the outcomes are measured on the same day as the procedure. Further, multiple contact approaches will be employed and a second incentive offered after completion of the postoperative assessment.

Eligibility Criteria:
Inclusion Criteria:

* Women \>=18 years-old
* Presenting for a surgical abortion
* Fluency in English and able to provide informed consent
* Has a driver to take them home following the procedure

Exclusion Criteria:

* Allergy, sensitivity or contraindication to gabapentin
* Severe renal disease
* Currently using gabapentin or pregabalin
* Contraindication to outpatient abortion under local anesthesia