cyrilzakka/clinical-trials huggingface dataset:
Optimizing Vitamin D Status During Initial Military Training

The primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin D and calcium supplementation (800IU and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during Army basic combat training (BCT) and Air Force basic military training (BMT).

The investigators hypothesize that daily supplementation with vitamin D and calcium during military training will improve vitamin D status, stabilize PTH levels, and result in improvements in markers of bone health. As a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin D in blood necessary to stabilize PTH levels and to optimize bone formation during initial military training.

Vitamin D is an essential nutrient for maintaining bone health. Previous work from our laboratory indicates that vitamin D status may decline in Soldiers during BCT, even during the summer months in the Southeastern United States. Stress fractures may affect up to 5% of male and 21% of female Soldiers during training, resulting in attrition in up to 60% of affected personnel, but a recent report indicates that vitamin D and calcium supplementation may attenuate stress fracture risk by up to 20% in female Navy recruits. However, biochemical measures of nutritional status and associated markers of bone health were not collected in that study, leaving questions regarding the vitamin D and calcium requirements for military personnel during periods of elevated bone turnover.

Eligibility Criteria:
Inclusion Criteria:

* Female or male US Army or US Air Force Recruits
* Participating in Basic Combat Training or Basic Military Training, respectively

Exclusion Criteria:

* Pregnant or breastfeeding
* History of kidney stones or kidney disease
Smoking Cessation Using Motivational Therapy and Varenicline

People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.

HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age and older;
2. diagnosis of HIV;
3. self-reported smoking on a daily basis;
4. provide informed written consent

Exclusion Criteria:

1. persons with active psychosis or impaired mental status as judged by the clinic staff and confirmed with a Mini-Mental Status Exam)
2. unable to understand spoken English
3. age less than 18 years.
4. pregnant women
ZAP, US. Zomig for Appropriate for Primary Care

The purpose of this study is to determine how useful and effective the use of ZOMIG-ZMT™ (zolmitriptan) 5.0 mg and ZOMIG® Nasal Spray (zolmitriptan) 5.0 mg is for patients, in treating migraine over a period of 6 months


Eligibility Criteria:
Inclusion Criteria:

* Have an established diagnose of migraine as with an age at onset of less than 50 years
* Have experienced an average of at least 1 migraine headache per month in the previous three months
* Be able to differentiate between migraine and non-migraine headaches

Exclusion Criteria:

* Use of any triptan within the last 12 months or use of MAO-A inhibitors, methysergide or methylergonovine in the 2 weeks before entering the study.
* History of basilar, ophthalmoplegic or hemiplegic migraine headache or any potentially serious neurological condition that is associated with headache
* History, symptoms, or significant risk factors for ischaemic heart or other cardiovascular disease, including coronary vasospasm, cardiac accessory conduction pathways or arrhythmias or uncontrolled hypertension.
Treatment of Rheumatoid Arthritis With Roxithromycin

The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of roxithromycin in patients with rheumatoid arthritis.

This was 6-month, monocentre, randomized, double-blind, placebo-controlled study. We treated 100 patients with rheumatoid arthritis with either once-daily oral roxithromycin (300 mg) or daily oral placebo for 6 months. The primary efficacy variable was the percentage of patients who had a 20 percent improvement according to American College of Rheumatology (ACR) criteria (an ACR 20 response) at six months. Secondary outcome measures were 50 percent improvement and 70 percent improvement according to ACR criteria (an ACR 50 response and an ACR 70 response, respectively).

Eligibility Criteria:
Inclusion Criteria:RA according to the 1987 American Rheumatism Association criteria19, age between 18 and 70 years. Patients were required to have had an inadequate response to one to four DMARDs (such as azathioprine, methotrexate, sulfasalazine, penicillamine, hydroxychloroquine, or oral or injectable gold); an inadequate response was defined as discontinuation of therapy because of lack of effect. If patients were receiving DMARDs, they were required to complete a DMARD washout period that lasted at least 1 month before starting study drug treatment; no DMARDs were permitted during the study. Patients who were receiving nonsteroidal antiinflammatory drugs, prednisone (at 10 mg daily or less), or both were eligible if the doses had been stable for at least four weeks before the study period and continued to be stable during the study period. Patients were not allowed to receive intra-articular corticosteroids.

Patients had to have active disease at enrollment (before the DMARD washout period), defined as 12 or more tender joints, 10 or more swollen joints, and at least one of the following: erythrocyte sedimentation rate(ESR) of at least 28 mm/hr, C-reactive protein(CRP) level greater than 2.0 mg/dL, or morning stiffness for at least 45 minutes.

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Exclusion Criteria:

* A negative pregnancy test result was required for non-menopausal female patients. In female patients of childbearing potential a urine pregnancy test was done at baseline and any pregnant women were excluded. Other exclusion criteria included impaired hepatic enzyme tests, impaired renal function, chronic/recurrent infection (e.g., chronic bronchitis, recurrent sinusitis), other infections(e.g., Borrelia burgdorferi, Chlamydia trachomatis, Ureaplasma) , history of adverse reactions to macrolides, roxithromycin, or similar antibiotics.

A patient could be withdrawn from the trial at any time after enrollment for the following reasons: the patient's request, severe or life-threatening adverse event, or inadequate control of arthritis symptoms (\>50 percent increase in the total number of swollen or tender joints) necessitating an increase in the systemic corticosteroid dosage or reinstitution of therapy with disease-modifying antirheumatic drugs.
The Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation

To study the Influence of Different Preoperative Decision Schemes on the Visual Quality After Toric Intraocular Lens Implantation


Eligibility Criteria:
Inclusion Criteria:

1. Age-related cataract (age 55-80)
2. Corneal astigmatism is greater than 1.0D
3. Patients who are willing to implant Toric IOL

Exclusion Criteria:

1. Previous or present eye diseases, such as glaucoma, eye trauma, etc
2. High refractive error
3. Previous eye surgery
4. Irregular astigmatism of the cornea
Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥ 18 years of age
* Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4
* HCV RNA viral load ≥ 10,000 IU/mL
* Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)
* Body Mass Index (BMI) of 18 to 35 kg/m2
* Seronegative for Hepatitis C virus (HIV) and Hepatitis B

Exclusion Criteria:

* Evidence of decompensated liver disease
* Evidence of medical condition contributing to chronic liver disease other than HCV
Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke

1. Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of chronic stroke patients
2. Subjects chronic stroke patients with gait impairment
3. Methods

   * Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
   * Group 2: Robotic-assisted gait training with sham tDCS (45 min)
   * Duration of treatment: 2 weeks, 5 times a week
   * Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
* Hemiplegic patients due to unilateral lesion
* Patients in chronic stage after 6 months from stroke onset
* Patients with gait impairment (FAC \<= 4)
* Adult (Age \>= 18)

Exclusion Criteria:

* Unstable vital sign
* History of seizure or cranial operation
* unable to walk before stroke
* bilateral hemispheric lesions
* metalic implant (cardiac pacemaker, artificial cochlear, etc.)
* severe cognitive deficit, MMSE \< 10
* severe aphasic patient who cannot communicate at all
Educational Program and Schoolchildren's Energy Expenditure

The aim of this study was to evaluate the impact of a classroom teachers' educational intervention on 1st and 2nd grades children's physical activity level and energy expenditure during physical education classes in elementary public schools, in São Paulo, Brazil.

This study is a School-based Randomized Controlled Trial. Three-step cluster sampling was used for subject selection. In the first step, 8 schools in the Vila Mariana district - São Paulo were selected and assigned randomly to physical activity intervention (3 schools) or control condition (5 schools). In the second step, all 48 classes from the 1st and 2nd grades were selected. In the third step, 352 children were randomly selected compose the observational group. In both groups, questionnaire data and SOFIT's observation were collected two times: "pre" (immediately before the intervention), and "post" (immediately after the intervention), with a six weeks interval between them. No educational intervention was taken place in the control schools while the project was running. Afterwards control schools received training.

Eligibility Criteria:
Inclusion Criteria:

* children from 7 to 10 years of age, enrolled at 1st or 2nd grades of selected schools in Vila Mariana - Sao Paulo.

Exclusion Criteria:

* Not have both observations.
Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments.

To investigate the effects of hUC-MSC treatment for Pneumoconiosis, 10 patients with Pneumoconiosis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility Criteria:
Inclusion Criteria:

* The patient who have signed the informed consent document;
* Clinical and radiological evidence of liver cirrhosis.

Exclusion Criteria:

* Pregnant women or lactating mothers;
* History of neurological disease, head injury or psychiatric disorder;
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
* With malignant tumors;
* Abnormal blood coagulation, combine other tumor or special condition;
* Patients who had participated in other clinical trials within three months prior to this study.
Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV

Investigators propose to develop methods to improve early identification of acute exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize that earlier identification of acute exacerbations through in-home monitoring of respiratory symptoms, lung function and medication usage will allow appropriate intervention to reduce the morbidity associated with AECOPD. Therefore, the investigators propose using innovative mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly under-recognized among HIV-infected persons. In this application, among HIV-infected individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden of AECOPD.


Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* Has an established longitudinal care provider in Baltimore, MD
* Confirmed COPD defined as post-bronchodilator FEV1/FVC\<0.70
* Stable residence for duration of 6 month intervention

Exclusion Criteria:

* Age \< 18 years
* Unable/unwilling to provide informed consent
* Failure to present to randomization visit
Prospective Assessment of TBDx Feasibility

The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.

This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx.

Eligibility Criteria:
Inclusion Criteria:

* Persistent cough (\>2 weeks) and at least one other typical symptom of pulmonary TB (fever, night sweats, malaise, recent weight loss, contact with active case, hemoptysis, chest pain, loss of appetite)
* Provision of informed consent (FIND TB Reference Materials)
* Provision of sputum for adequate testing

Exclusion Criteria:

* Patients receiving any anti-TB medication, in the 60 days prior to testing.
* Patients with only extra-pulmonary disease
Phase 2 Study With SNF472 in Calciphylaxis Patients

To evaluate the effect of SNF472 on top of standard of care on promoting wound healing and other parameters of therapeutic response in haemodialysis patients with calciphylaxis (calcific uraemic arteriolopathy, CUA).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with either newly diagnosed CUA OR recurrent CUA that has been dormant with no skin lesion involvement for at least 90 days from study start (new or recurrent diagnosis must be made within 5 weeks of study start)
2. Patients who signed the written informed consent to participate in this clinical trial (prior to any clinical trial-related procedures being performed), after reading the Patient Information Sheet and Informed Consent Form (ICF), and who had the opportunity to discuss the clinical trial with the Investigator or designee
3. Males or females aged ≥18
4. Patients on maintenance haemodialysis (HD)
5. Patients with at least a minimum level of pain on Visual Analog Scale (VAS) scale or on pain-killers stronger than non-steroidal anti-inflammatory drugs (NSAIDs)
6. Females of child-bearing potential should use a highly effective contraceptive measure throughout the study and have a negative serum pregnancy test at entry. Male patients having sexual relationship in which pregnancy can occur should take adequate contraceptive precautions (wear a condom)

Exclusion Criteria:

1. Body weight above 150 kg
2. BMI \>35 and central(abdominal) ulcers
3. History of bisphosphonate treatment within 12 months before entering into the study
4. Severely ill patients without reasonable expectation of survival for \> 6 months according to the treating physician
5. Patients with scheduled parathyroidectomy during the run-in or study period
6. Female patients who are either intending to get pregnant or are undergoing treatment to get pregnant, as well as breast-feeding females
7. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion
8. Any psychological, emotional problems, any disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the patient to comply with the Clinical Trial Protocol requirements
9. Patients who, in the opinion of the Investigator, are considered unsuitable for any other reason
Development of Automated Real-time Algorithms for Detection of Dislocation of the Carpus

Perilunate dislocation of the carpus is a serious lesion of the wrist which is defined by a total loss of contact of the articular surfaces capito-lunar, scapholunate and lunate-triquetral. Rare by its frequency, it represents 5 to 10% of traumatic injuries of the wrist.

Perilunate wrist dislocation is a rare injury that goes unnoticed in 25% of cases. Even with surgical treatment, 50-100% of patients will develop radiocarpal and/or midcarpal osteoarthritis.


Eligibility Criteria:
Inclusion criteria :

* Major subjects (≥18 years old)
* Treated at the University Hospitals of Strasbourg for a carpal dislocation
* Presence of carpal radiographs that may indicate the presence of a lesion
* Subjects who have not expressed their opposition, after information, to the re-use of their data for the purposes of this research

Exclusion criteria :

* Subject having expressed his opposition to participate in the study
* Subject under legal protection, guardianship or curatorship
DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting

The goal of the clinical trial is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic loosening in patients with a knee prosthesis. The main question it aims to answer is:

Does the use of the AtMoves Knee System reduce the percentage of failed outcomes? A "failed outcome" is defined as a change in the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS-PS) that is lower than the minimal clinically important difference at 12 months.

Researchers will compare two groups: The first group will undergo an additional CT scan using the AtMoves Knee System. The second group will not undergo these scans. Both groups are allowed to undergo additional diagnostic measures. Researchers will compare the percentage of "failed outcomes" between these groups.

During the one-year follow-up, participants in both groups will be asked to fill out questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Subjects must have underwent either unilateral or bilateral TKA surgery.
* Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon
* The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.
* The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment.
* Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.

Exclusion Criteria:

* A clear other cause for complaints other than aseptic loosening (e.g. septic loosening, neuropathic pain, non-consolidated peri-prosthetic fracture of the bone around the TKA)
* Surgical interventions of the index knee in the year prior to the start of the complaints associated with TKA loosening.
* Posttraumatic or congenital deformation of the leg for which the loading device does not fit.
* Pregnancy or suspected pregnancy.
* Unable or unwilling to understand or sign the informed consent for this study and to undergo examination with the AtMoves Knee System.
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease

This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening
* On a gluten-free diet for at least 12 months
* Negative celiac serology
* Avoidance of pregnancy

Exclusion Criteria:

* Severe complications of celiac disease, such as refractory celiac disease
* Celiac symptoms
* Other concomitant autoimmune disease
* Chronic, active gastrointestinal disease
* Infections, concomitant diseases
* Prohibited medications