cyrilzakka/clinical-trials huggingface dataset:
An 18-month Trial of a Low Glycemic Load Diet

The primary aim of this study is to compare the effects of an experimental low-glycemic load diet with those of a conventional low-fat diet among obese young adults in an 18-month randomized-controlled trial.

The prevalence of obesity has risen dramatically among children in the U.S. since the 1960s. Effective treatment of childhood obesity is widely recognized as instrumental to public health efforts to combat type 2 diabetes and heart disease. Evidence from animal studies, short-term human studies and epidemiology suggests that diets designed to minimize the rise in postprandial blood glucose, that is low glycemic index, may be useful in the treatment of obesity and related complications. This project proposes an month RCT comparing a low glycemic load diet to a conventional low fat diet. Both diet groups will receive identical treatment intensity, behavioral modification and physical activity recommendations. The primary endpoint will be change in percent body fat by dexa-scan at 18 months; other outcomes include insulin resistance and CVD risk factors. Compliance will be assessed by interviewer-administered, 24-hour dietary recalls.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 35 years
* Body mass index (BMI) ≥ 30 kg/m2
* Access to a working telephone
* Conversant in English
* Written medical clearance from a primary care physician or nurse practitioner, ruling out any pre-existing or complicating medical condition

Exclusion Criteria:

* Body weight \>300 lbs
* Major medical illness (heart, kidney or liver disease; diabetes; cancer; endocrinopathy; psychiatric illness) or other active medical problem
* An obesity-associated genetic syndrome (e.g., Prader-Willi)
* An abnormal screening laboratory test (ALT, creatinine, BUN, hematocrit)
* Fasting blood glucose ≥ 126 mg/dl)
* Taking any prescription medication that affects body weight (glucocorticoids, neuropsychiatric agents), blood pressure, or serum cholesterol concentrations
* Currently smoking (1 cigarette during any of the last 7 days)
* Previous diagnosis of an eating disorder (anorexia nervosa, bulimia, binge-eating disorder)
* If female, not pregnant or planning to become pregnant in the next 18 months and not lactating
* Failure to complete the pre-enrollment visits
Correlation of Pelvic Sentinel Lymph Node with Superficial Vein

Pelvic Sentinel Lymph Node (SLN) biopsy is an important integral part of endometrial surgery. Although SLN is usually found on internal iliac artery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac vessel locations). Since it is accepted that the lymphatic channel formation during embryologic life follows venous system formation investigators hypothesized that the presence or absence of superior or deep uterine vein may determine the location of sentinel lymph node

Endometrial cancer is the most common gynecologic cancer. Treatment and prognosis depends on the surgical staging of the apparently early stage disease including the evaluation of lymphatic status of the disease. Detection of positive lymph node upstages the apparently early stage endometrial cancer. However, systematic lymphadenectomy carries immediate and long term risks for patients including bleeding, massive transfusions, prolongation of operation time, serious major vessel and major abdominal organ injury and death.

Sentinel lymph node biopsy (SLNB) procedure is the biopsy of one or two lymph node(s) which represents the lymph node basin draining the area of malignancy. This biopsy may potentially eliminate the need systemic pelvic / para-aortic lymphadenectomy which harbours potential complications. Although SLNB became an standard procedure in endometrial cancer, available data on the SLNB in endometrial cancer is variable. The relevant literature suggests that the detection rate of sentinel lymph node using various tracer agents are between %70-98, even with lower for bilateral pelvic detection and para-aortic sentinel lymph node(s). The most commonly used tracer agent is fluorescent indocyanine green (ICG). Although SLN is usually found on internal iliac artery during surgery, location is variable. Lymphatic pathways in pelvis determines the location (Obturator, internal iliac or external iliac locations). Since it is accepted that the lymphatic channel formation during embryologic life follows venous system formation investigators hypothesized that the presence or absence of right or left superior (SUV) or deep uterine vein (DUV), which actually are highly variable, may determine the location of sentinel lymph node.

So investigators aims to find any correlation between the location of SLN (obturator, external iliac and internal iliac) and the presence of SUV or DUV unilaterally or bilaterally.

Eligibility Criteria:
Inclusion Criteria:

* all women with early stage endometrial cancer who will be operated for staging

Exclusion Criteria:

Previous radiotheraphy Previous pelvic retropelvic LN dissection Women with any disease that precludes pelvic retropelvic LN dissection (such as peritoneal dialysis)

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Parent Perceptions of Weight Status: Impact of a Pilot Intervention

This pilot study is a randomized controlled trial with an embedded cross sectional study exploring parental perceptions of their weight status and how it affects their perceptions of their child's weight status. This study uses an educational intervention in which parents are informed of their actual weight status and how it affects their child's health. We will study the effect of this intervention on the parent's perceptions of and level of concern for their own and their child's weight status.

Pediatric obesity has tripled in the past 20 years. Obesity prevention early in life is important and parental participation is essential. Parents must recognize overweight in their child so health providers may engage them in a dialogue to change their child's diet and physical activity patterns, yet a large proportion of parents do not recognize that their child is overweight. Parents' misperception of their overweight child's weight status presents a barrier to treating obesity.

This pilot study is a randomized controlled trial with an embedded cross sectional study exploring parental perceptions of their weight status and how it affects their perceptions of their child's weight status. This study uses an educational intervention in which parents are informed of their actual weight status and how it affects their child's health. We will study the effect of this intervention on the parent's perceptions of and level of concern for their own and their child's weight status.

Our goal is to develop a primary care intervention that will enhance parental perceptions of overweight and motivation to make changes for their family. Pilot data collected here will support an R21 Exploratory/Developmental Clinical Research Grant in Obesity or a Centers for Disease Control (CDC) or Robert Wood Johnson Foundation (RWJ) grant submission.

Eligibility Criteria:
Inclusion Criteria:

1. Boys and girls ages 3 to 13 years old presenting with at least one biological parent for a routine health maintenance exam (WCC) at the Child Health Continuity Clinic will be eligible. Parents must be able and willing to have their height and weight measured at the clinic

Exclusion Criteria:

1. Child has previously been referred to a nutritionist/dietician or specialized clinic/program for weight management
2. Child is currently being treated for failure to thrive
3. Child is on parenteral nutrition
4. Child is on chronic systemic steroid therapy
5. Child is non-mobile/wheelchair bound
6. The family has previously enrolled into the study with a prior sibling
7. Family is unable to be contacted at home
8. Presenting parent cannot speak and read English or Spanish at at least a 5th grade level
TNS for Treating Major Depressive Disorder in the Elderly

This is a phase II, open-label clinical trial. This clinical trial has as primary objective to evaluate changes in EEG of a Trigeminal Nerve Stimulation (TNS) treatment protocol for elderly patients with moderate / severe depressive episode.


Eligibility Criteria:
Inclusion Criteria:

1. patients between 65 and 99 years
2. patients with a diagnosis of depression according to the SCID
3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
4. agreement to participate in the study as recommended in the IC.

Exclusion Criteria:

1. patients with psychiatric indication for hospitalization
2. patients with psychiatric comorbidity
3. patients with a diagnosis of personality disorder
4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
Santeon-CAP; Dexamethasone in Community-acquired Pneumonia

The present study is designed to investigate the beneficial effects of adjunctive dexamethasone therapy in patients admitted with community-acquired pneumonia, additionally aiming at assessing what patients benefit from dexamethasone treatment mostly. A large multicenter study will be conducted comparing a 4 days dexamethasone 6 mg per os course with placebo in 600 patients and with predefined subgroup analyses planned.

Community-acquired pneumonia (CAP) is a common infection. Approximately 20 percent of all episodes of pneumonia result in hospitalization. It is the leading cause of community-acquired infection requiring intensive care unit (ICU) admission. In pulmonary infections, the release of cytokines and other inflammatory mediators from alveolar macrophages serves as a mechanism by which invading pathogens are eliminated. However, this reaction of the innate immune system can be potentially harmful when excessive release of circulating inflammatory cytokines causes damage to the patient, particularly the lung. Interest in the role of corticosteroids in the pathophysiology of critical illness has existed since the early part of the 20th century. On ICU, early treatment with corticosteroids to attenuate systemic inflammation is widespread. At the same time, outside the ICU little evidence is available on the effect of treatment with corticosteroids in patients diagnosed with CAP. Theoretically, early initiated administration of corticosteroids in the course of a CAP can lower systemic and pulmonary inflammation. This may lead to earlier resolution of pneumonia and a reduction of complications (sepsis, mortality).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Chest radiograph showing new opacities.

In combination with two of the following findings:

* Cough
* Production of sputum
* Temp \>38,0 °C or \<36,0 °C
* Audible abnormalities by chest examination compatible with pneumonia
* Leukocytosis (\>10.000 cells/mm3), leftward shift (\>10%) or leucopenia (\<4000 cells/mm3)
* C-reactive protein \> 15 mg/l (three fold higher than the upper limit of normal)

Exclusion Criteria:

* Immunocompromised patients:
* Patients with a known congenital or acquired immunodeficiency.
* Patients who received chemotherapy less than 6 weeks ago.
* Patients who received corticosteroids in the last 6 weeks.
* Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine).
* Patients with chronic obstructive pulmonary disease who are on systemic corticosteroids.
* Patients who require intensive care unit treatment.
* Patients with tropical worm infection.
* Patients with dexamethasone intolerance.
* Pregnant and breastfeeding women.
Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation

Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to monitor oxygen saturation in older people with COPD. A finger wearable device has been developed to measure oxygen saturation and heart rate variability. The investigators therefore will perform a cross sectional study to evaluate the clinical application of this finger wearable device in the detection and management of COPD in older people.

Subject and method: 100 COPD subjects and 200 community dwelling older people without diagnosis of COPD will be recruited. Physical functioning and lung function test will be performed. Subjects will wear a finger wearable device to monitor heart rate variability and oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical activity and sleep for 6 days at the same time.

Statistical analysis: Statistical analysis will be made to examine the potential association between oxygen saturation and physical activity and sleep, and the association between heart rate variability and physical activity and sleep.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years old or more with or without COPD

Exclusion Criteria:

* Current smokers
Protective Assets Reinforced With Integrated Care and TechnologY (PARITY) Feasibility Trial

This study will determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness.

The overall objective of this study is to determine the feasibility and acceptability of the Protective Assets Reinforced with Integrated care and TechnologY (PARITY) program, to test the clinical, behavioral, and strength building efficacy of the PARITY program and explore how it achieves its outcomes in pregnant Black women. PARITY is a program that provides community-based doula support, community resources, and a mobile technology platform that reinforces individual strengths (referred to as protective assets) through positive messaging and by promoting wellness (sleep, physical activity, nutrition, prenatal care adherence) in Black pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Black race
* Pregnant with gestational age 20-28 weeks at enrollment
* Ability to read and write in English language
* Planning to give birth at a healthcare facility \& receive obstetrical care with a healthcare record
* Reside within 20 minutes of the Lincoln/Omaha, NE metro area
* Owns a smartphone with internet access

Exclusion Criteria:

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Exercise in Patients With Post-Concussion Symptoms

Physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got advice to rest until they were free from symptoms. This approach, however, is challenged, and complete rest should probably be discouraged after the first 24-72 hours. Moderate aerobic exercise has been found promising in the early phase after sports-related concussion, and in the treatment of patients with headache. This study is an open pilot-study of guided, home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. The study will result in data about the feasibility and possible effects of exercise as treatment for prolonged postconcussion symptoms and posttraumatic headache.


Eligibility Criteria:
Inclusion Criteria:

* having sustained a minimal head injury (according to the Head Injury Severity Scale, HISS) or mild traumatic brain injury (TBI) (according to the TBI definition and the WHO criteria for mild TBI) within the last three years).
* post-concussion symptoms of at least moderate degree (according to the Rivermead postconcussion symptom questionnaire RPCSQ) occurring within the first week after the head injury and/or posttraumatic headache according to the International Classification of Headache Disorders 3 (ICHD-3) criteria.
* outpatients at St Olavs Hospital Clinic of Physical Medicine and Rehabilitation, Department of Acquired Brain Injury

Exclusion Criteria:

* Symptoms better explained by other conditions.
* Severe communication problems, typically due to language problems.
* Severe psychiatric, neurological, somatic or substance abuse disorders that will complicate follow-up and outcome assessment.
* Orthopedic injury or other disability too severe for performing the test or the intervention.
* Cardiovascular conditions or risk factors that are not compatible with testing or safe unsupervised exercise.
Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)

The original American-European Consensus Conference (AECC) definition of Acute Respiratory Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR using this definition among intensivists and radiologists.

As a result, the newly published Berlin definition of ARDS specified that the CXR criterion should include bilateral opacities consistent with pulmonary edema not fully explained by effusions, lobar/lung collapse, or nodules/masses on CXR.

In order to improve inter-observer agreement, the panel have also developed a set of CXRs judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.

The objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ARDS.

The study is composed of 3 phases:

Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as provided by the consensus panel. The possible radiographic interpretations include consistent, inconsistent, or equivocal for the diagnosis of ARDS.

Phase 2: Training materials adapted according to the recently published Berlin definition of ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all participants.

Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for interpretation for the second time.

Eligibility Criteria:
Inclusion Criteria:

* intensivists working in the participating ICUs

Exclusion Criteria:

* those who could not participate both questionnaire surveys
* those who have read the reference with the training set of CXRs before the study
* those who have already known the objective of the study
DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC

Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance.


Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
* Terminated curative radiotherapy treatment with/without chemotherapy;
* No metastases
* Complete tumour remission
* No current or previous malignancies that could prevent participation and training
* No excessive alcohol intake (men \> 21 and women \> 14 units/wk)
* No recent systematic resistance training or creatine ingestion (within 2 months)
* If woman, not pregnant
* WHO performance status of 0-1
* No psychological, social or geographical conditions that could disturb participation
* Written consent
Girls for Health: Empowering Rural Girls' Transition From School to Employment as Health Workers

Girls for Health (G4H) will promote the economic empowerment, agency, and voice of rural adolescent girls by supporting their transition from secondary school to tertiary training in midwifery, medicine, nursing and other health careers, and in so doing, will address the acute shortage of female health workers in rural Northern Nigeria. G4H will integrate proven girls' education strategies with innovative vocational interventions to build 1350 girls' career aspirations and academic achievement and will significantly increase the number of rural girls entering health training institutions (HTI) in four northern states. The program will include: 1) a bridge program offering accelerated academic instruction in science, math and English; 2) vocational counseling and practicums at local health facilities; 3) safe spaces to enhance critical life skills; 4) four month science immersion courses for girls accepted for admission to a health training institution; and 5) HTI capacity building to cultivate a rural female-friendly learning environment. G4H will work towards sustainability from the start by using existing secondary school and HTI infrastructure, and feeding into government rural health worker employment schemes.

G4H will be evaluated using a rigorous cluster randomized controlled trial design, randomizing at the school level to assess its impact on key outcomes of interest that include rural girls' secondary school graduation and subsequent HTI enrollment, retention and completion, as well as delayed marriage and improved agency and voice. Process monitoring and costing analysis will be conducted to support quality implementation and dissemination efforts. The design will ensure that high quality evidence is available to guide the field regarding the effectiveness and costing of in-school bridge programming in broadening rural girls' participation in education and career opportunities in the context of low resource settings characterized by low rates of female participation in education and income generation.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in secondary school at selected study schools, in her final two years of secondary school

Exclusion Criteria:

* low attendance (\<60%) at participating schools.
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.

As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with primary immunodeficiency
* Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

Key Exclusion Criteria:

* Allergic reactions to immunoglobulins or other blood products
* Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
* History of cardiac insufficiency
* Epilepsia