cyrilzakka/clinical-trials huggingface dataset:
Assessment of Chiropractic Treatment: Strength and Balance

This study is a randomized controlled trial designed to compare the effects of 4 weeks of chiropractic care to a waitlist control group on measures of strength, balance, and endurance in military personnel experiencing non-surgical low back pain.

This study will assess three functional outcomes (strength, balance and endurance) and patient-reported outcomes in participants with low back pain (LBP) treated with chiropractic care, providing evidence that may enhance our understanding of the relationship between functional outcomes and chiropractic care. The findings from this study may support the use of chiropractic care for military personnel as an effective, conservative treatment for low back pain that may also help preserve or improve functional outcomes and thus, allow active duty personnel to better perform the physical demands required of them.

Eligibility Criteria:
Inclusion Criteria:

1. Age range 18 - ≤ 40, inclusive
2. Able to provide written informed consent
3. Self-reported acute, subacute or chronic LBP at initial screen and baseline visit 1. Pain intensity of ≥ 2 on NRS within the past 24 hours.
4. Active duty status

Exclusion Criteria:

1. Any chiropractic care within 30 days of informed consent
2. Any LBP confirmed or suspected to arise from a visceral source
3. Spinal pathology or any other condition(s) contraindicating SM
4. LBP for which specific treatments outside those available within study parameters are indicated
5. Any spinal fracture within the past 6 months
6. Any spinal surgery within the past 6 months
7. LBP with positive neurologic signs indicating spinal nerve root compression, or LBP with presumptive or confirmed spinal nerve root compression
8. Imaging evidence of neuroforaminal or spinal canal stenosis or the clinical presentation of neurogenic claudication
9. Chronic pain syndrome diagnosis
10. Diagnosis or suspected systemic inflammatory arthropathy of the spine
11. Referral needed to evaluate or treat an urgent or emergent condition or to determine the status of a condition that pertains to eligibility
12. Unable to safely perform strength, balance, or endurance tests, or the ability to assess health status
13. Pregnant or planning to become pregnant within the next 6 weeks
14. Knowledge of impending transfer or absence during study period
15. Seeking or referred for Medical Evaluation Board / Physical Evaluation Board disability status (to ensure safety while performing study tests and to avoid confounding due to the potential for competing recovery goals)
16. Unable or unwilling to comply with study protocols
17. Patellar height is \<15 inches or \>25.5 inches
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.

The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.

Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must provide written informed consent.
* Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.

Exclusion Criteria:

* Subjects who require additional treatments in either leg within 30 days before or after the study procedure.
* Subjects who are participating in another investigational study.
Using Parent Engagement to Improve the Wellbeing of Black Premature Infants With Lung Disease

The goal of this pilot study is to test the feasibility and acceptability of a collaborative goal setting intervention to improve parent engagement of Black preterm infants with chronic lung disease in primary care. Preliminary impact on child and parent outcomes will also be explored.

The main questions it aims to answer are: 1) Will parents complete a pre-visit questionnaire that asks about goals for the child? 2) Does use of the pre-visit questionnaire help parents to achieve self-identified goals?

Participants will fill out a pre-visit questionnaire prior to the child's well visit. The participants will then complete two surveys after the visit (1 week and 2 months after).


Eligibility Criteria:
Inclusion Criteria:

* Parent/legal guardian of child born prior to 37 weeks gestational age
* Parent/legal guardian of child with diagnosis of chronic lung disease or bronchopulmonary dysplasia, as defined by the child's clinical team at the time of hospital discharge
* Parent/legal guardian of child who identifies that child's race as Black
* English speaking

Exclusion Criteria:

* Parent/legal guardian of child enrolled in palliative care or hospice services at time of hospital discharge
* Parent/legal guardian of child older than 12 months chronological age
Treatment Response to Different Lymphoedema Compression Programs Using a Pneumatic Compression Device

Proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.

This is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. Each intervention arm will include 10 completed subjects for a total of 30 completed subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be ≥ 18 years old
* Subjects must have a diagnosis of primary or secondary Stage 2 unilateral or bilateral lower extremity lymphoedema
* Must currently be using adequate compression garment(s) as determined by the clinician: (Garments must be at least 20mmHg and no more than 3 months old and must be worn upon rising and removed at bedtime)
* Subjects must have clinically relevant excess limb swelling as determined by clinician "pitting test"
* Must be able to attend all required in-clinic treatment visits

Exclusion Criteria:

* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy, or primary surgery for the treatment of cancer
* Active infection or inflammation
* Active thrombophlebitis (within the last 2 months)
* History of pulmonary embolism (within the last 2 months)
* Documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of \> 2 second in the deep system or any history of deep vein thrombosis (DVT)
* History of pulmonary edema
* History of congestive heart failure
* History of chronic kidney disease with a glomerular filtration rate (GFR) of less than 30 mls per minute
* Poorly controlled asthma
* Symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia)
* Presence of an open wound or ulcer of any etiology
* Diagnosis of lipoedema and lipolymphoedema
* Currently using an in-home pneumatic compression device
* Metal implant(s) that would interfere with bioimpedance equipment
* Pacemaker or other implanted electronic device(s)
* Unable or unwilling to remove bandaging from treatment regimen while participating in the study
* Pregnant
* Any condition where increased venous and lymphatic return is undesirable
* Unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent
* Currently participating in another clinical trial
* Currently using diuretics
* BMI \> 40
A Multi-Risk Factor Strategy vs a Guideline-Based Approach in Achieving Blood Pressure and Lipid Goals in Hypertensives at Extra Risk

The purpose of this study is to investigate whether an aggressive multi-risk factor management strategy (Caduet plus therapeutic lifestyle changes (TLC) regimen) will result in greater percentage of patients achieving blood pressure and low density lipoprotein cholesterol (LDL-C) goals compared with a Joint National Committee 7/ National Cholesterol Education Program Adult Treatment Panel III (JNC 7/NCEP ATP III) guideline-based approach (Norvasc plus TLC regimen) after 6 weeks of treatment in primary prevention subjects with hypertension and additional risk factors, including dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with diagnosed hypertension receiving treatment with Norvasc 5 or 10 mg and who also have 3 additional cardiovascular risk factors, including dyslipidemia.

Exclusion Criteria:

* Subjects who are taking the following prohibited medications within 14 days of screening: lipid-lowering therapy, calcium channel blocker other then Norvasc, \>3 antihypertensive agents (including Norvasc)
* Subjects that have not been on a stable dose of Norvasc for at least 4 weeks
* Subjects with a history of coronary heart disease, stroke, or Pulmonary Vascular Disease (PVD)
Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies

Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs.

Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year.

Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.


Eligibility Criteria:
Inclusion Criteria:

* Commitment to participate voluntarily.
* Signing informed consent to participate in the research, according to the Helsinki Declaration, updated at the 64th General Assembly, Fortaleza, Brazil, October 2013.

Exclusion Criteria:

* Babies who are born with a gestational age of less than 30 weeks.
* Baby changes that prevent physical activity.
Mortality Reduction After Oral Azithromycin: Mortality Study

Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood mortality. We propose a single multi-site (multi-country), cluster-randomized trial comparing communities randomized to oral azithromycin with those randomized to placebo. We hypothesize that mass azithromycin treatments will reduce childhood mortality.

We will assess childhood mortality over three years, comparing communities where children aged 1-60 months receive biannual oral azithromycin ("Azithromycin" arm) for two years, to communities where the children receive biannual oral placebo ("Control" arm) for two years. During the third year at the Niger site only, everyone will receive azithromycin.

This is a cluster-randomized trial; at each site, communities within a contiguous area of 300,000 to 600,000 individuals will be randomized to azithromycin or placebo using simple random sampling.

Niger contingency study: In the event that mass distributions of oral azithromycin are proven to reduce mortality in 1-60 month-old children, then we will treat all communities in Niger with mass azithromycin distributions to test whether the intervention continues to reduce childhood mortality after the initial 2 years of mass treatments.

Eligibility Criteria:
Inclusion Criteria:

Communities

* The community location in target district.
* The community leader consents to participation in the trial
* The community's estimated population is between 200-2,000 people.
* The community is not in an urban area.

Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census.

Exclusion Criteria:

Individuals

- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response

Heterogeneity of 18F-fluorodeoxyglucose (FDG) uptake is a promising marker for predicting response to treatment. This study aimed to evaluate the ability of pretreatment positron emission tomography/computed tomography (PET/CT) 18F-FDG-based heterogeneity to predict the response to pyrotinib in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed HER2 positive breast cancer
* Treated with Pyrotinib in the metastatic settings
* Underwent whole-body FDG PET/CT within 4 weeks before the initiation of pyrotinib and capecitabine were included in this study

Exclusion Criteria:

* Incomplete medical history
* Loss of follow up
The Alberta Diet: Effectiveness Study

The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA intervention, will have improved compliance with the nutritional therapy recommendations of the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a) to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention program that promotes the individual factors required for effective self-management practices AND that explicitly incorporate strategies to improve food availability, accessibility and acceptability and (b) to use these interventions as a means to examine the relationships between food availability, accessibility, acceptability, adherence to Nutrition Therapy Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, and speak/write English.
* Have attended a diabetes education session delivered by their healthcare provider.

Exclusion Criteria:

* Participants with type 1 diabetes, and those who are unable to speak English.
* People with end-stage renal disease or gastrointestinal diseases that require specialized diets will also be excluded.
Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients

To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.


Eligibility Criteria:
Inclusion Criteria:

Groups 1 and 2:

1. Written informed consent from all subjects.
2. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
3. Non-smokers.
4. Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of \> 90 mL/min/1.73 m2 .
5. Subject reenrollment.
6. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of BMS-986142.
7. Male subjects must be willing to refrain from sperm donation during the entire study plus 5 half-lives of BMS-986142.

Group 1 only:

1. Healthy male and female (not of childbearing potential) subjects as determined by medical history, and clinical assessments.
2. Women must have documented proof that they are not of childbearing potential and must not be breast feeding.

Group 2 only:

1. Healthy male subjects as determined by medical history, and clinical assessments.

Exclusion Criteria:

1. Administration of live vaccine including polio vaccine during the course of the study, 12 weeks prior to the first dose of study drug, or 30 days after the last dose of study drug.
2. Active tuberculosis (TB) requiring treatment within the previous 3 years.
3. History of herpes zoster.
4. Subjects who have experienced recent infection, upper respiratory infection,.
Human Outreach to Improve Adherence With Scheduled Pain Clinic Appointments

Patients tend to miss their scheduled appointments in chronic pain clinics for unknown reasons. This study will test the hypothesis in a prospective pragmatic trial that a human telephone call in the primary language of the patient, promising a clinical encounter in this language improves attendance at scheduled appointments in an academic inner city pain clinic.

Language barriers may lead to poor attendance at pain clinic appointments, especially in underserved patients. Targeted interventions can help overcome barriers and significantly improve adherence, but have rarely been rigorously investigated in randomized clinical trials. Our objective is to investigate if (1) making a telephone call in the patient's preferred language increases adherance with scheduled appointment in an inner city academic pain clinic or at least reduces failure to attend without a prior cancellation call and (2) if this intervention is more effective in Spanish speakers.

After institutional review board approval and waiver of informed consent, we enroll all adult patients (18 years and up) with a scheduled first appointment at our outpatient Pain Center at Montefiore Medical Center located in the Bronx, New York from October 2014 through October 2015. Participants are randomized to receive a phone call in their preferred language before their appointment, or not. We recorded if participants attended as scheduled and/or called to cancel. We fit stratified and multivariate multinomial logistic regression models.

In a methodologically rigorous randomized design, we seek to demonstrate that a human phone call in the patient's primary language increases adherence with scheduled appointments in an ethnically diverse, poor population, typical for an inner city pain clinic. Our targeted intervention may provide considerable cost savings to the institution while bolstering the patient-doctor relationship and overcoming barriers to access much needed care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* have scheduled appointment at Montefiore Medical Center

Exclusion Criteria:

* None
Probiotics on Immune Function and Intestinal Microbiota in Astronauts Under Closed Microgravity Environment

Human immune function and intestinal microbiota are suggested to be altered within long-duration stay in space. Accumulated evidences on earth support that Lactobacillus casei strain Shirota (LcS) is a promising probiotic strain on improvement of immune function and intestinal microbiota. This study aims to investigate the impact of long-duration spaceflight as well as intake of LcS on the international space station (ISS), on immune system and intestinal microbiota in astronauts.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are scheduled to stay on the ISS for at least 3 months
* Individuals who fully understand the study protocol and provide written informed consent for the study participation

Exclusion Criteria:

* Individuals who routinely use antibiotic, laxative, and/or bowel regulating medicine
* Individuals who participate in other research that competes with this study in terms of the purpose and field, e.g., study with dietary management or intake of bifidobacteria/lactic acid bacteria, oligosaccharides, antibiotic, laxative, and/or bowel regulating medicine
First Human Dose Trial for a New Medication to Potentially Treat Liver Diseases

This study will assess the safety, tolerability, the pharmacokinetics from single injection (under the skin) of NNC0581-0001 and explores the pharmacodynamics in healthy participants and participants with hepatic steatosis (increased liver fat). Participants will either get NNC0581-001 or Placebo (dummy treatment). Which treatment participants get is decided by chance.NNC0581-0001 is a new medicine which cannot be prescribed by doctors. The study will last about 58 weeks.


Eligibility Criteria:
Inclusion Criteria, for healthy participants in Part A:

* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) from 18.5 to 30.0 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Inclusion criteria for participants with hepatic steatosis in Part B:

* Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body Mass Index (BMI) from 25.0 to 34.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
* Hepatic steatosis identified by a score above 248 dB/m by Fibroscan® (Controlled Attenuated Parameter, CAP) at screening.

Exclusion Criteria

* Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* For Part A: Any laboratory safety parameters at screening outside the below laboratory ranges, see laboratory provided reference ranges for specific values (re-screening or re-sampling is NOT allowed if the participant has failed one of the exclusion criteria related to laboratory parameters):
* Alanine aminotransferase (ALT) greater than upper normal limit (UNL) plus 10 percent
* Aspartate aminotransferase (AST) greater than UNL plus 10 percent
* Bilirubin greater than UNL plus 10 percent
* Estimated glomerular filtration rate (eGFR) below 90 milliliters per minute per 1.73 square meters (90 mL/min/1.73m\^2)
* Glycated haemoglobin (HbA1c) greater than or equal to 5.7 percent (39 millimole per mole \[mmol/mol\]) at screening.
Ketorolac in Palatoplasty

The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively


Eligibility Criteria:
Inclusion Criteria:

-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral

Exclusion Criteria:

* Syndromic Cleft Palate patients
* Previous palatoplasty
* Major unrepaired cardiac malformation
* History of GI complications (GI Bleed, Gastric Ulceration)
* History of Renal disorder
* History of coagulopathy (As contraindication to NSAID use)
* Feeding tube dependency
* Patients whose parents refuse to consent to randomization