cyrilzakka/clinical-trials huggingface dataset:
Study of the Effectiveness of Central Line Placement Using an Ultraportable Ultrasound Device

The placement of a catheter in a large-caliber vein is sometimes necessary for the administration of treatments or the monitoring of a patient. This may be associated with complications during its realization, such as the puncture of an adjacent artery with possible formation of a hematoma or the puncture of the pleura with creation of a pneumothorax. These complications may be favored by variations in the anatomy. The use of ultrasound allows visualization of the vessels, its adjacent structures and the puncture needle along its path.

The contribution of ultrasound with the technique of venipuncture under ultrasound guidance is to date the best means of preventing complications by reducing the risk of early mechanical complications by a factor of 5 to 10 according to the studies. The retrospective, multicenter, observational study recently published by Björkander et al reported the experience of 8 Swedish hospitals with 14243 central venous catheter placements, 58% of which were in the internal jugular vein. Nearly one catheter in two was placed with the use of ultrasound (49%). One hundred and eighteen mechanical complications were recorded, of which 23 were considered serious, including 21 pneumothoraxes and 2 severe hemorrhages. Lack of ultrasound use was found to be an independent risk factor for complications in multivariate analysis by logistic regression. Despite a high level of evidence in the scientific literature on the contribution of ultrasound guidance for the placement of central venous catheters, and the recommendations of national and international learned societies published before the start of this study, almost one patient in two had not yet benefited from this technique, which could nevertheless greatly reduce the incidence of early mechanical complications.

The recent introduction of ultra-portable ultrasound scanners could encourage the generalization of the use of ultrasound, given their reduced cost. The hypothesis of the research is that the placement of a central venous catheter is similar whether the ultrasound machine is an ultra-portable ultrasound machine or a conventional ultrasound machine


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients scheduled to have a right or left jugular central venous line placed preoperatively or in the ICU .
* Patient with free, informed and express consent or emergency procedure

Exclusion Criteria:

* Absolute emergency not allowing randomization
* Pregnant woman
* Patient with suspected or proven jugular thrombosis at the insertion site
* Change of central venous line on guidewire
* Operator with no experience in central venous line placement under ultrasound
* contraindication to the placement of a jugular central venous line
Low Glycemic Index Diet in Patients With Type 1 Diabetes

The purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.

The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A meta-analysis of randomised controlled trials of the effect of low GI diets in the management of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI foods. However, several critical points concerning the GI concept remain, for instance, how to apply it in practical every day life, how to calculate GI in mixed meals, how to find relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue, however, is the fact that studies on the long-term effects of a low GI diet in type 1 diabetes are lacking. In this study, the critical issue of finding palatable low GI foods will be solved in close collaboration with the food industry. This may lead to the development of new commercial products with low GI, which is necessary if low GI diets are to be advocated for diabetics in the future.

Comparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.

Eligibility Criteria:
Inclusion Criteria:

* Type I diabetes, durability \>5 years
* Age 20-65 years
* Normal weight (BMI 19-26 kg/m2)
* Diabetic treatment with mealtime and bedtime insulin.
* HbA1c ≤10 %
* Informed consent to participate in the study.

Exclusion Criteria:

* Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
* A known food intolerance of gluten, leguminous plants, nuts or almonds.
* Pregnancy or breast-feeding.
* Concurrent participation in another research study with metabolic effects.
* Previously regular follow-up with a dietician at SDC during the last year.
* Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
* Non acceptance of the study diet or food products that are recommended in the study.
* Disability to read and understand the Danish language.
* Unable to receive and/or store the test products.
* Place of residence \>1 hr drive from SDC.
Weight Loss Interventions for Black Adults of Faith

This trial compares the effect of intermittent fasting versus continuous caloric reduction for the reduction of body weight in Black adults of faith. Intermittent fasting and continuous caloric reduction interventions may help Black adults of faith lose weight, improve their health, and help reduce cancer risk.

PRIMARY OBJECTIVES:

I. Partner with the First Ladies of Western New York (FLOW) to engage 10 community stakeholders from Black churches in the Roswell Park Catchment area in a four-stage process involving information gathering, discussion groups, and mock intervention delivery to create Fasting WORD for Black adults of faith.

II. Implement and determine the initial comparative effectiveness of Fasting WORD with The WORD to reduce body weight, and biomarkers of obesity, inflammation, insulin, and insulin resistance.

SECONDARY OBJECTIVES:

I. Examine the interventions' effects on diet and physical activity. II. Examine participants' adherence and satisfaction with both interventions.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive the Fasting WORD intermittent fasting weight loss intervention consisting of 16 small-group lessons over 1.5 hours each once a week (QW) for 2 months and then once every 2 weeks (Q2W) for 4 months.

ARM II: Participants receive The WORD continuous energy restriction (CER) weight loss intervention consisting of 16 small-group lessons over 1.5 hours each QW for 2 months and then Q2W for 4 months.

After completion of study, participants are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* African American/Black
* Body mass index (BMI) \> 25 kg/m\^2
* Associated with a participating church through membership or participation in a church activity
* Cleared by a Primary Care Provider (PCP-Doctor) to be a part of the study
* Not currently on weight loss medications
* Not pregnant or lactating
* Has not lost at least 10% of their body weight in the last 6 months
* Has not had bariatric surgery in the last 10 years
* Able to walk unassisted and continuously for 10 minutes

Exclusion Criteria:

* Adults unable to consent
* Adults unable to complete study measures in English
* Individuals who are not yet adults (infants, children, teenagers)
* Individuals who are pregnant or lactating
* Adults who have had a myocardial infarction (heart attack) or stroke without medical clearance from their primary care physician to participate in the study
* Adults who currently have type 1 or type 2 diabetes without medical clearance from their primary care physician to participate in the study
Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)

The purpose of this research study is to assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory and diarrheal) outcomes. A randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.


Eligibility Criteria:
Inclusion Criteria:

* All healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of Santa Lucia, Magdalena and San Antonio who do not present any of the medical conditions listed in the exclusion criteria.
* Mothers have understood and signed consent forms to enable their children to participate in the study. They were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. As well as the additional data assessments necessary to be considered active participants in the study.

Exclusion Criteria:

* Children with congenital anomalies, mental retardation, severe physical handicap, under-nutrition caused by medical conditions that contribute to under-nutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, chronic diseases such as tuberculosis, etc.
* Children with a known allergy to peanuts and eggs will also be excluded from the study, 30% of children with known allergies to nuts also have an allergy to eggs.
* Plans to move or change their place of residence outside of the study region in the next 2 months would make them ineligible.
* Mothers who are younger than 16 years of age will be excluded from the study. Women younger than 16 might not understand the consent process and the importance of following the guidelines established in the research, therefore we chose not to include this group as "eligible" participants.
* Children who are \<= -2 standard deviations below the norm for z score for weight for age. These children are severely malnourished and need to be carefully followed under the supervision of a qualified health care provider.
Risk Factors of Shoulder Injuries in Youth Volleyball Players

Shoulder injuries are usual in volleyball players. Nowadays, few prospective studies assessed risk factors of shoulder injuries in this sport. So, the objective of this study is to assess the risk factors of injuries in youth volleyball players. For that purpose, the following factors will be taken into consideration : shoulder internal/external rotators strength, shoulder range of motion, scapular dyskinesis, functional tests (medicine ball throw and upper quarter Y balance test), training load and psychosocial factors (POMS questionnaire).

About 100 youth volleyball players (13-20 years), playing at least 8 hours volleyball in a week will be included in the study.

At the beginning of the 2019-2020 season, they will have to take part at the following evaluations :

1. Clinical evaluation :

   * Scapular dyskinesis assessment (normal, subtle abnormality and obvious abnormality)
   * Scapular upward rotation at 0°, 45°,90° and 120° with an inclinometer.
   * Rounded shoulder posture
   * Posterior shoulder stiffness
   * Internal/external rotation range of motion (at 90° of abduction)
2. Medicine ball throw :

   From a cocking position, players have to throw a 800g medicine ball as far as possible (3 trials). Only the best result will be retained for analysis. Volunteers have 2 minutes of rest between trials.
3. Upper Quarter Y Balance Test :

   In a facial drop position, the purpose of this test is to bring the plastic board as far as possible in the 3 directions (supero-lateral, infero-lateral, medial). 3 trials are performed by each subject and only the best test is kept for analysis. A rest period of one minute is provided between tests to avoid fatigue.
4. Strength assessment (isokinetic test) :

   Internal and external rotators strength (concentric 60°/s, eccentric 60°/s and concentric 240°/s) are measured with an isokinetic device (Cybex Norm) at 90° of abduction.
5. Psychosocial factors assessment :

Players will have to fill in POMS questionnaire (65 questions), that give information about stress and well-being.

After that, players will be followed during all the 2019-2020 season and will have to fill in a form each month about the potential injuries they had during the previous month.

Eligibility Criteria:
Inclusion Criteria:

* age between 13 and 20
* to play volleyball at least 8 hours in a week

Exclusion Criteria:

There are no exclusion criteria
Modulation Of Airway Reactivity With Chronic Mechanical Strain

The purpose of this study is to see if the use of a machine called CPAP will help children with asthma breathe better. CPAP is a machine that produces airflow to help people with breathing problems. To use it, you will wear a mask connected by a hose to the CPAP machine. We believe that use of CPAP may be a treatment for children with asthma.

During the previous funding period of this project, our laboratory demonstrated that chronic mechanical strain imposed on the airways in vivo using continuous positive airway pressure (CPAP) results in a dramatic reduction in airway reactivity in vivo in mice, ferrets and rabbits1-3. Lungs, airways and airway smooth muscle (ASM) tissues isolated from CPAP-treated animals studied in vitro exhibited lower responsiveness to bronchoconstrictors1-3. We also observed this suppression of airway responsiveness by chronic mechanical strain in a rabbit model of allergic asthma5. These animal studies led to a small clinical trial in which adults with asthma were treated with nocturnal CPAP for 1 week. CPAP caused a significant reduction in airway reactivity in these patients6. This novel approach for treating airway hyper-reactivity is currently being evaluated in a NIH multi-center Phase II clinical trial of adults with mild to moderate asthma (U01 HL108730).

Eligibility Criteria:
Inclusion Criteria:

* Children 8-17 yrs olds with severe asthma (N=120) will be recruited from the Pediatric High Risk Asthma Clinic and Pulmonary Clinics at Riley Hospital for Children at Indiana University Health.
* Severe asthma will be defined by the need for medication therapies following steps 4-6 according to the National Institutes of Health's Asthma Care Quick Reference, September 2012 or high dose of inhaled corticosteroids
* On a stable regimen of asthma medications for at least 8 weeks prior to enrollment without systemic corticosteroids for ≥ 4 weeks

Exclusion Criteria:

* Obese (\>95% predicted BMI)
* Congenital heart disease or chronic lung disease
* History of pneumothorax
* Inability to perform pulmonary function testing
* Oxygen saturation \<93%
* forced expiratory volume at one second (FEV1) \<70% predicted
* Provocative concentration causing a 20% drop in FEV1 from baseline (PC20) ≥16 mg/ml of methacholine.
Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension

AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, "A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension".


Eligibility Criteria:
Inclusion Criteria:

* Must have completed Visit 14/Week 24 of the NCT00046319 study.
* Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for \>=4 weeks following their final study visit.
* Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria:
* Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment.
* Must be stable on conventional therapy for PAH for \>=4 weeks prior to the Screening Visit.

Exclusion Criteria:

* Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit.
* Intravenous inotrope use within 2 weeks prior to the Screening Visit.
* Females who are pregnant or breastfeeding.
* Contraindication to treatment with an endothelin receptor antagonist (ERA).
The Effects of Daily Ginger Tea Consumption in Reducing Discomfort During Menstruation

The purpose of our graduate student research study is to observe the effect of drinking ginger tea daily on period discomfort.

* Day 1: Subjects will sign informed consent and will go over the introduction, purpose, procedures, and compliance with student investigators. Subjects will then be given a sample of ginger tea that will be used for the study and will be asked if they think they can drink this daily for a month. They will also be asked if they have regular menstrual cycles and agree to stop home remedies and stop taking pain medications or herbal supplements for a period of three menstruation cycles.
* Start/During the first menstruation cycle: Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given visual analog pain scales and symptom checklists that need to be completed during their second menstruation cycle.
* End of the first menstruation cycle - Start of the second menstruation cycle: Subjects will not take ginger tea, avoid home remedies, and refrain from taking pain medications or supplements.
* Start of the second menstruation cycle - End of the second menstruation cycle: Subjects will rate discomfort using the visual analog pain scales and symptom checklist during menstruation. Subjects will meet with student investigators at a convenient location to the subject and will complete surveys and questionnaires. Subjects will be given daily logs, visual analog pain scales, symptom checklists, and supplies for the ginger tea.
* End of the second menstruation cycle - Start of the third menstruation cycle: Subjects will take ginger tea daily, avoid home remedies, refrain from taking pain medications and supplements, and keep track of ginger tea intake by placing a check mark each day in the daily log checklist.
* Start of the third menstruation cycle - End of the third menstruation cycle: Subjects will rate discomfort using the visual analog pains scales and symptom checklist during menstruation.
* After the third menstruation cycle ends: Subjects will meet with student investigators at a location convenient to the subject to turn in daily logs, visual analog pain scales, and symptom checklists.

Eligibility Criteria:
Inclusion Criteria:

1. female within age range
2. regular menstrual cycles
3. experiencing period cramps
4. agrees to refrain from taking any pain medications, herbal supplements, or use home remedies such as heating pads that are known to alleviate menstrual cramps during the study period
5. after sampling the ginger tea, the subject must agree to drink ginger tea daily.

Exclusion Criteria:

1. women who take oral contraceptives
2. work night shifts
3. allergic to ginger
4. lactating
5. female-related uterine problems such as fibroids and polycystic ovarian syndrome who suffer from secondary dysmenorrhea
Infection After Free Fibula Flap Reconstruction of the Mandible: a Retrospective Cohort Study

Mandibular osteitis after flap reconstruction is rare but is a serious infection with significant sequelae.

The aim of this study is to describe this type of infection


Eligibility Criteria:
Inclusion Criteria:

* patients having had infection after a free bony flap reconstruction of the mandibule treated as an osteomyelitis at the CRIOAc between 2014 and 2020

Exclusion Criteria:

* non-bony flap
Patient Positioning and Airway Management During ERCP

The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography \[(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas\] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.


Eligibility Criteria:
Inclusion Criteria:

1. Patient undergoing ERCP without preceding endoscopic ultrasound (EUS)
2. At least one of the following risk factors for adverse events during sedation:

   1. STOP-BANG score of 3 or higher
   2. Abdominal ascites on either physical exam or imaging within the last 14 days
   3. BMI greater than or equal to 35
   4. Chronic lung disease
   5. ASA class 4
   6. Mallampati Class 4 airway (only hard palate visible)
   7. Concurrent moderate to heavy alcohol use (≥4 drinks/day for men and ≥3 drinks/day for women)

Exclusion Criteria:

1. EUS preceding the ERCP
2. Emergent indication for ERCP (eg cholangitis with septic shock)
3. Presence of a tracheostomy
4. Unstable airway
5. Gastric outlet obstruction
6. Altered foregut anatomy (eg Roux-en-Y gastric bypass, Billroth II)
7. Inability to give informed consent
Mechanisms of Inflammation, Immunity, Islet Cell and Intestinal Hormone Changes in Youth at Risk for Diabetes

This study intends to assess the role of inflammation in insulin resistant conditions (i.e., obesity and pre-diabetes) and the subsequent development of disease, such as type 2 diabetes (T2D) and cardiovascular disease (CVD), in the adolescent population.

This study proposes to characterize inflammatory biomarkers, insulin resistance and fecal microbiome composition in obese/pre-diabetic adolescents after glucose ingestion, followed by an oral fat tolerance test on a separate visit. Lipoprotein abnormalities and intestinal biomarkers, post-lipid ingestion, will also be evaluated. The primary aim is to assess the role of inflammation in insulin resistant conditions (i.e., obesity and pre-diabetes) and the subsequent development of disease, such as type 2 diabetes (T2D) and cardiovascular disease (CVD), in the adolescent population.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents aged 12 - 18 years old with obesity (defined as body mass index (BMI) \>97th percentile based on their age- and sex-specific World Health Organization growth chart)

Exclusion Criteria:

1. Known type 2 diabetes
2. Diabetes secondary to medication or surgery
3. Antibodies suggestive of type 1 diabetes
4. Pregnancy
5. Were born by C-section
6. Developmental delay precluding assent/consent
7. Acute illness within the past 3 days (chills, fever, vomiting \> 1x, or diarrhea \> 3x)
8. Taking medications that influence glucose (e.g., steroids, metformin) or lipids (e.g., statins)
9. Have taken prescribed medicine/antibiotics in the three months prior to clinic or study visit
10. Significant chronic illness (e.g., Cushing's Disease, Craniopharyngioma, Hypothalamic Obesity, etc.)
11. Lactose intolerance and/or milk allergy (Study Visit Day 2 Only)
12. Bariatric surgery