cyrilzakka/clinical-trials huggingface dataset:
Effectiveness Study of Community-Based, Peer-Led Education on Weight Loss and Diabetes

The purpose of this study is to compare the effectiveness of a peer-led community-based lifestyle intervention, versus usual care, in achieving weight loss and prevention of diabetes among overweight adults with pre-diabetes in East Harlem.

Weight loss can prevent diabetes and eliminate racial and ethnic disparities in incident diabetes among overweight adults with pre-diabetes. However, proven effective interventions have not been sustained or disseminated in community settings. A community-academic partnership aims to employ community-based participatory research to conduct a randomized controlled trial to test the effectiveness of a culturally tailored, peer-led diabetes prevention intervention that promotes weight loss.

People who develop diabetes go through a period when they have "pre-diabetes". In clinical settings, overweight adults with pre-diabetes who reduce their weight by 5-10% can reduce their risk of developing diabetes by 55-60%. To date, there are no studies testing the effectiveness of peer-led, community-based programs in achieving diabetes prevention through weight loss.

We will identify and enroll 400 overweight (BMI \> 25) adults with pre-diabetes in East Harlem and randomized half into a community-based, peer-led lifestyle education program that teaches simple ways to lose weight.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Residents of East Harlem or members of an East Harlem Institution in zip codes 10029, 10035, OR in the section of 10037 east of Fifth Avenue
* BMI ≥ 25 AND pre-diabetes glucose values, defined as fasting fingerstick glucose of 100-125mg/dl and/or glucose 2 hours after an oral glucose load of 140-199 mg/dl
* Able to communicate verbally to participate in a group education class
* English or Spanish speaking

Exclusion Criteria:

* \< 18 years
* Previous diagnosis of diabetes
* BMI \<25
* Fingerstick glucoses outside pre-diabetes level ranges
* Currently pregnant
* On medications that may raise or lower blood glucose
* Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak)
* Self-reported terminal illness with life expectancy of less than 1 year
* Plans to relocate from New York City within one year of enrollment
Effects of Cryotherapy on Upper Limb Balance Test

The shoulder joint is commonly used and also stricken by high loads and injuries in sports. One technique in emphasis is cryotherapy, a physiotherapeutical intervention characterized by the use of low temperatures for tissue trauma's rehabilitation. Several studies analysed the effects of cryotherapy and brought important results related to pain and strength reduction, also to muscle contraction speed reduction. Although, considering the risk-benefit from de intervention it's pertinent to observe the presence of deleterious effects, especially the ones that impact on motor function. This scenario has been brought by scientists and currently the main gap from this theme resides on the repercussions of the technique application on functional answers

Eighty participants will receive control (rest) and the experimental condition (cryotherapy), with an interval of 48 hours. The intervention group will undergo: i) assessment, ii) 20 minutes of cryotherapy, iii) reassessment, iv) 20 minutes of rest and v) reassessment, while the control group remains at rest for 20 minutes. Assessments will be composed of shoulder function by the upper quarter y balance test, muscle tone by the myoton pro, skin temperature by a thermographic camera, thermic comfort, perception of balance and beliefs in cryotherapy. Data will be described using mean and standard deviation and compared by Mixed ANOVA (time x intervention) with post Bonferroni tests, with significance level of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 28 years old
* healthy
* no musculoskeletal complaints

Exclusion Criteria:

* failure to follow protocol
* complaints of injury or pain during the assessments
Effects of Two Packing Type in Maxillofacial Surgery

Operations of oral maxillofacial surgery cause the blood escape into stomach and trachea. Therefore, throat packing is applied. Endotracheal tube cuff is not protective from aspiration. While packing is preventing blood leakage, it may cause postoperative pain due to the pressure. Packing placed between oropharynx and hypopharynx before surgery to prevent leakage to stomach and trachea. The aim of this study is to compare the efficacy of two packing types in throat pain.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent oral maxillofacial surgery (maxillary and mandibular cysts, orthognathic surgery, palate and alveolar clefts, mandibular and maxillary fractures and reconstruction surgeries) under general anesthesia between the ages of 18-60
2. ASA 1-2 groups of patients
3. Patients who have completed growth and development
4. Patients who are willing to comply with the requirements of the study
5. Patients with complete medical records
6. Operations expected to last at least 2 hours

Exclusion Criteria:

1. Patients with severe systemic disease other than ASA 1-2
2. Difficult entubation story
3. Patients with BMI\> 35 kg / m2
4. Contraindications for the use of NSAIDs
5. Patients with diclofenac sodium and metoclopramide allergy
6. Patients whose medical records are inadequate
7. Patients with major tranquilizer or opiate addiction
8. Patients with mental and physical anxiety that would interfere with cooperative operation
Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain

Low back pain is a common health problem where over than half a billion people worldwide suffers from it. In Malaysia, back pain is among the top ten reasons why people see a doctor. Although there are many guidelines available, healthcare professionals still find managing low back pain as challenging.

The Decision Support System for Low Back Pain (DeSSBack) has been developed by adopting and re-packaging STaRT system, incorporate with the local clinical practice guidelines and feedback from local experts. It aims to aid healthcare professionals in managing low back pain through a stratified approach.

The objective of the study is to evaluate the effectiveness of DeSSBack in improving the management of patients with low back pain in a primary care clinic. We hypothesise that the implementation of DeSSBack will improve the outcomes of low back pain patients including quality of life, emotional state and level of pain.

This study protocol presents the rationale and design of a cluster randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient seeking care for low back pain at the primary care clinic in UMMC
* Male and female
* Age 18 years and above
* Can understand Malay and English

Exclusion Criteria:

* Potentially serious pathology (eg: cauda equina compression, inflammatory arthritis, malignancy and etc)
* Serious co morbidity
* Psychiatric illness or personality disorder
* Spinal surgery in the last 6 months
* Pregnant
* Already receiving treatment other than primary care for this episode of back pain
* Inability to attend regular physiotherapy appointments.
Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty

To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.

The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.

Eligibility Criteria:
Inclusion Criteria:

* The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.

Exclusion Criteria:

-
An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies

The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS.

The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.


Eligibility Criteria:
Inclusion Criteria:

PERSEUS

* Patients with wet AMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC)
* Documentation of at least one Aflibercept (Eylea) injection
* Assessment of at least one visual acuity measurement with available VA letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available VA letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection RAINBOW
* Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
* Patient who meet the local indication criteria for Eylea treatment
* At least one BCVA after the 1st Eylea injection
* BCVA at baseline
* Patient with no history of retinal disease
* Patient not previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye (for fellow eye allowed).
* For patients with both eyes treated, the eye firstly treated at initial visit will be considered as study eye. If both eyes are treated during initial visit, the treated eye with worst Best-Corrected Visual Acuity (BCVA) at M0 will be retained. If the two conditions are similar the study eye is the Right eye by convention
* Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled Exclusion criteria PERSEUS
* Exclusion criteria as listed in the local SPC
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
* All patients previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye will additionally be excluded for this integrated analysis
* Any concomitant therapy with another agent to treat wet AMD in the study eye RAINBOW
* Patient who does not meet the local indication criteria for Eylea treatment. Contraindications listed in the SmPCs must be taken into account
* Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
* Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
* Patient taking part in an interventional study at the time of enrolment
Non-invasive Negative Pressure Treatment for Pectus Excavatum

The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment


Eligibility Criteria:
Inclusion Criteria:

* absence of co-morbidities that may interfere with proper placement or function of the apparatus
* test negative for pregnancy in women of childbearing age

Exclusion Criteria:

* skeletal diseases like osteogenesis imperfecta or osteoporosis
* clotting disorders such as hemophilia or thrombopathia
* skin diseases or infections of the anterior chest wall
* angiopathies or vascular fragility
* obesity important with BMI greater than 30
* precarious commitment to the prolonged use of the device protocol
Functional and Morphological Characteristics of Neck Muscles in Acrobatic Skydivers

An observational cohort study, following the Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) guidelines.

Two groups will be examined, a group composed by spanish acrobatic skydivers and a control group composed by general physically active population(GPAP).

Two groups will be examined for veryfing the morfology and the function of neck muscles.

The profesional group composed by spanish acrobatic skydivers and a general group composed by general physically active population(GPAP). Both groups are matched at known confounder outcomes such as: physical activity level, age, sex, body weight and history of neck pain. Frequency matching will be carried out, subjects will be matched on known confounders.

Eligibility Criteria:
Inclusion Criteria:

* pain-free in the neck area in the last three months
* didn't actually take any drugs that can interfere with muscle strength

Exclusion Criteria:

* participants that not mached with the skydivers caracteristics
Study ADI-PEG 20 Plus Pembrolizumab in Advanced Solid Cancers

This is a phase 1b, open label trial of ADI-PEG 20 (36 mg/m2) weekly in combination with pembrolizumab (1 and 2 mg/kg or 200 mg) every three weeks. Assessment of safety and tolerability of drug combination

This is an open-label, phase 1b trial of ADI-PEG 20 in combination with pembrolizumab in subjects with advanced cancers. Dose escalation will occur using a 3 + 3 + 3 design.

The first subject in a dose escalation cohort must have had treatment with ADI-PEG 20 + pembrolizumab with a week of follow up) before the next 2 subjects are enrolled. Thus subjects 2 and 3 may be enrolled on day 8 if there is no dose limiting toxicity (DLT) in subject 1. No additional delay is required between treating subjects 4 to 6 or 7 to 9 in an expanded cohort. Before proceeding to the next cohort dose level, the first 3 eligible subjects in each cohort will have received at least 21 days of treatment (i.e. at least 2 of the expected 3 doses of ADI-PEG 20 + one dose of pembrolizumab).

Eligibility Criteria:
Select Inclusion Criteria:

1. Histologically confirmed diagnosis of advanced solid tumor.
2. Prior failure of a systemic treatment approved by the health authority in the country where the study will be enrolling. Such subjects may also have been treated with radiotherapy, local therapy or surgery.
3. Measurable disease using RECIST 1.1 criteria.
4. Age ≥ 18 years.

Select Exclusion Criteria:

1. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present or in the opinion of the investigator will not affect patient outcome.
2. Subjects who had been treated with ADI-PEG 20 previously.
3. History of seizure disorder not related to underlying cancer.
4. Known allergy to pegylated compounds.
5. Known allergy to E. coli drug products (such as GMCSF).
Effectiveness of Auto-adjusted Continuous Positive Airway Pressure for Long-term Treatment of Sleep Apnea

Hypothesis: Computer controlled continuous positive airway pressure (autoCPAP) is equally effective in improving obstructive sleep apnea syndrome symptoms, breathing disturbances, objective vigilance, and it is cost-effective compared to conventional fixed continuous positive airway pressure.

1. To investigate whether computer controlled continuous positive airway pressure (autoCPAP) improves subjective sleepiness, quality of life, objective vigilance, and nocturnal respiration to a similar degree as conventional fixed continuous positive airway pressure in the initial phase of treatment and over the subsequent 2 years during home therapy
2. To investigate the cost of autoCPAP compared to fixed CPAP therapy

Eligibility Criteria:
Inclusion Criteria:

* Excessive sleepiness, and Epworth Sleepiness Score \> or = 8
* Apnea- Hypopnea-Index (AHI) \> or = 10/hour
* Age 18-75

Exclusion Criteria:

* Psychophysiological incapacity to perform questionnaires
* Other sleep disorders
* Psychiatric disease requiring treatment
* Previous CPAP therapy
* Previous uvulopalatopharyngoplasty
* Chronic nasal obstruction that required treatment for more than 1 month
* Cancer
* COPD, with FEV1 \< 50% predicted
* Symptomatic cardiovascular disease requiring treatment defined as congestive heart failure \> NYHA II
* Previous stroke with neurological residuum
* Cheyne-Stokes respiration
* Chronic pain syndromes, fibromyalgia
* Drug or alcohol addiction
Evaluation of Exenatide in Patients With Diabetic Neuropathy

This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.

This study will look at the effects of the medication exenatide on peripheral neuropathy in people with type 2 diabetes. Exenatide (trade name, BYETTA®) is an injectable medication used by people with type 2 diabetes to control blood sugar. Peripheral neuropathy is a complication of diabetes that can cause symptoms such as numbness, tingling or burning sensations in the feet and hands. Controlling blood sugars levels in type 2 diabetes is thought to prevent, delay or improve the damage to the nerve fibers that causes peripheral neuropathy. There is also some evidence that exenatide may have additional beneficial effects on the peripheral nerves, beyond the benefits of blood sugar control alone. In this study, about half of the participants will take exenatide by injection twice daily and the other half will take insulin glargine (Lantus®) by injection once daily. Both groups are expected to have similar improvement in blood sugar control. This study will show whether exenatide has beneficial effects on neuropathy beyond the benefits of better blood sugar control alone.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes treated with one or more oral agents
* Persistent fasting glucose \> 140 mg/dl or HbA1c \> 7%
* Stable and maximally effective doses of one or more oral agents for 3 months
* Presence of diabetic peripheral neuropathy
* Age between 18 and 70 years
* No risk factors or other causes of neuropathy
* Willingness and capacity to sign the Institutional Review Board approved consent form and cooperate with the medical procedures for study duration

Exclusion Criteria:

* Nursing mothers or pregnant women
* A history of previous kidney, pancreas or cardiac transplantation
* A past history of neuropathy (independent of diabetes) or with a disease known to be associated with neuropathy (e.g., hepatitis C, end stage renal disease, lupus)
* Amputation of any part of either lower extremity for any reason or traumatic loss of any part of either lower extremity or congenital absence or severe deformity of lower extremity
* HbA1c \> 10%
* Participation in an experimental medication trial within 3 months of starting the study.
* Undergoing therapy for malignant disease other than basal- or squamous cell carcinoma
* Requiring long-term glucocorticoid therapy
* Inability or unwillingness to comply with the protocol
Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus

The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus

open labelled, multi-centric, parallel, randomized control trial

In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus vildagliptin (50 mg once or twice daily) assessed for Efficacy \& safety parameters to be measured at both the baseline and 24-week visits.

Background:

Diabetes is a rampant disease that keeps on getting more and more people affected each year. Over 200 million people have been affected worldwide due to this disorder, and many have contracted various cardiovascular complications due to uncontrolled diabetes. Though an easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is necessary to have drugs available which control diabetes and also limit the progression of complications that could arise due to it.

Objective:

The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin and vildagliptin in patients with Type 2 Diabetes Mellitus

Methods:

open labelled, multi-centric, parallel, randomized control trial to be conducted at the Department of Diabetes \& Endocrinology of two tertiary care hospitals in Karachi, Pakistan.

The Participants will undergo screening and then were randomized into two groups. The first group received empagliflozin (10 mg once or twice daily), and the second group received vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels., Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the baseline and 24-week visits.

Eligibility Criteria:
Inclusion Criteria:

Female and Male Patients of age 30-65 years with confirmed diagnosis of "type 2 diabetes mellitus".

Uncontrolled type 2 diabetes mellitus (\> 7% HbA1c patients on monotherapy of metformin for the past three months on a fixed dose of 1500 mg /day along with lifestyle modifications were included in this study.

BMI ranges from 18-45 kg/m2 were considered fit for this study. eGFR ≥ 60 ml/min/1.73 m2

Exclusion Criteria:

Pregnant female or female patients planning to conceive during the study period were excluded from this study.

"Type 1 diabetes" or "secondary diabetes" resulting from specific causes Patients with advanced diabetic complications. Patients with any other terminal disease(s) requiring long-term medications. Patients involved in other trials on therapy with SGLT-2i or DPP4-I 3 months before study enrollment Patients on insulin or any other oral hypoglycemic drugs except metformin. Serum creatinine levels ≥ 1.3 mg/dl in women and ≥ 1.4 mg/dl in men
Renal HYPODYSPLASIA : Genetic and Familial Assessment

Evaluation of the frequency of familial cases of renal HYPODYSPLASIA

DNA collection from the propositus and its family. A questionnaire will be filled by the parents to seek other affected individual in the family.With another affected member, DNA collection will be collected from the whole family.

A renal ultrasound will be prescribed for the parents, brothers and sisters.

Eligibility Criteria:
Inclusion criteria :

- Children aged more than 3 months and less than 18 years old with a renal bilateral HYPODYSPLASIA set by renal ultrasound examination :

* renal size \< -2DS
* with/or hyperechogenicity or lack of cortical-medullary differentiation
* with/or renal cysts

Exclusion criteria :

* Bladder uropathy or sus-bladder uropathy
* Recessive or dominant renal polycystic disease
* Bardet-Biedl syndrome and other malformative syndromes except renal coloboma syndrome, Renal cysts and diabetes syndrome RCAD
* Lack of written informed consent