cyrilzakka/clinical-trials huggingface dataset:
Ketogenic Diet in Rheumatoid Arthritis (RA)

This is a 6-week ketogenic diet (KD) intervention where participants with rheumatoid arthritis (RA) will follow a KD plan, supervised and monitored by a dietician. Participants will be provided extensive educational and ongoing support on the KD, including personalized coaching with the ability to text a dietitian at any time and expect a response within 12 hours. Diet adherence and progress will be assessed daily using at-home blood ketone/glucose monitors, along with diet records. Participants will fill out health related questionnaires and undergo assessments of body composition, RA disease activity. This study also includes blood draws and fat biopsy of the abdominal region.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA according to the ACR/EULAR 2010 criteria for RA.
* On stable doses of DMARDs and/ or biological agents (≥ 2 months prior to study enrollment)

Exclusion Criteria:

* Chronic inflammatory/ autoimmune disease other than RA (e.g. gout, inflammatory bowel disease such as Crohn's disease or ulcerative colitis, lupus, myositis, etc.)
* Prednisone or other glucocorticoid use in the last 4 weeks (exception: intra-articular glucocorticoid injections)
* Insulin use
* Hospitalization in the 30 days prior to study enrollment
* Acute or uncontrolled disease (e.g. cirrhosis, COPD, CKD)
* Malignancy
* Chronic infection (HIV, hep B/C, etc.)
* Heavy drinking
* On a ketogenic diet or exogenous ketone supplement (lses than 3 months prior to study enrollment)
* Recent weight loss (\>5% in the last 2 months)
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

Up to 5% of patients in the United States have a postpartum hemorrhage. "Postpartum hemorrhage" means excessive bleeding after delivery. The majority of these bleeds occur immediately with delivery.

The current study focuses on hemorrhages that occur in the "medium-term" (1.5-24 hours after delivery). Investigators are examining whether ultrasound exams performed at the beginning of this period 1.5 to 2 hours after birth can identify markers that predict a medium-term bleed. Data collected for this study will include medical and obstetrical history, details about the course and outcomes of patients' labor and delivery, and particulars about postpartum bleeding. This information will be collected through the end of the patients' delivery admission and will allow correlation with the results of the ultrasound exam. If patients are re-admitted to the hospital after the delivery discharge, investigators may also collect relevant information about those admissions up to 6 weeks postpartum.

All patients after term delivery (≥ 37 weeks' gestation) will be eligible to participate. Patients will be approached to provide consent for participation as early as feasible during a prenatal visit (≥ 36 weeks' gestation) or during the delivery admission. No subjects will be consented while in significant pain, \>6cm dilated without an epidural, or \>8cm dilatated with an epidural.


Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant and planning to deliver at Endeavor Health \>37 weeks gestational age
* English speaking
* Labor \<6cm dilated at time of consent without epidural
* Labor \<8cm dilated at time of consent with epidural

Exclusion Criteria:

* Preterm delivery
* Non-English speaking
* Any conditions that impairs potential participants decision making
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin

To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.

Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia.

Methods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection.

Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.

Eligibility Criteria:
Inclusion Criteria:

* infantile esotropia and acquired esotropia

Exclusion Criteria:

* exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.
A Randomized Study of Polarity or Massage Therapy to Reduce Fatigue in Breast Cancer Patients During Radiation Therapy

This research study is being conducted to compare the effectiveness of two types of complimentary medicine treatments to see if they will reduce the fatigue experienced by breast cancer patients receiving radiation therapy. The treatments being studied are Polarity Therapy and Massage Therapy.

The primary study hypothesis is that Polarity Therapy will be efficacious in relieving fatigue in breast cancer patients receiving radiation treatments.

The secondary hypothesis is that Polarity Therapy will be efficacious in improving health-related quality of life in breast cancer patients receiving radiation treatments.

This is a randomized three-arm clinical trial of an intervention examining the efficacy of Polarity Therapy for the relief of fatigue associated with radiation treatments in breast cancer patients. Patients who meets the eligibility criteria and who have signed the consent form will be randomized to one of three trial arms: 1) Polarity Treatment 2) Massage treatment 3) Standard Care. Three treatments will be administered in the 4th, 5th, and 6th calendar weeks of radiation treatment. There will be weekly blood draws to assess cytokine levels. In addition, 6 saliva samples will be gathered per day for 2 days during each of the 4 study weeks to assess cortisol levels. Saliva samples will be completed by the participant at home. An actigraph will be worn for the 28 day study period to assess activity and sleep. Patients randomized to the Standard Care Arm will receive a Polarity or Massage treatment gratis following the completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer
* Fatigue of 2 or greater on Symptom Inventory
* Received at least 8 radiation treatments
* Able to read English

Exclusion Criteria:

* Be receiving concurrent chemotherapy
* Have bone metastasizes
* Be taking methylphenidate, modafinil, sedatives, or anxiolytics
* Have a hemoglobin \<11g/dL.
A Pharmacokinetic Evaluation Study in Healthy Volunteers

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous, intranasal, and inhalation administration and to calculate the relative bioavailability of INS37217 when administered via oral or nasal inhalation.


Eligibility Criteria:
Inclusion Criteria:

* Are current nonsmokers or previous smokers who have not smoked within 6 months and who do not have greater than or equal to a 10 pack-year history of tobacco use
* Are within 20% of their ideal body weight
* Are healthy on the basis of a pre-trial physical examination

Exclusion Criteria:

* History or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
* History of cardiac arrhythmias, any pathological abnormality on the ECG, bronchospasm, diabetes mellitus, thyrotoxicosis, Parkinsonism, asthma, COPD or cardiovascular disease significant drug allergy
* Subject with a physical obstruction in the nose
* Use of concomitant medication other than hormonal contraceptives and multi-vitamins
* Subjects with a current upper respiratory illness or infection for the 2 weeks prior to screening or any chronic respiratory illness
Prospective Study Evaluating the Use of PROSPECT to Reduce Insomnia in Patients With Early Stage Breast Cancer

Women with early stage breast cancer may experience difficulty falling asleep or staying asleep. If this occurs for more than 4 weeks, these participants may have chronic insomnia. Chronic insomnia can lead to difficulty coping with stress, changes in mood, increased use of medications for sleep and an overall decrease in quality of life.

The investigators have developed an internet-based website that is designed to help people manage symptoms typically experienced by breast cancer survivors, including insomnia, fatigue, pain and overall poor quality of life. The investigators want to learn whether this type of treatment can reduce chronic insomnia and improve the way subjects feel using both questionnaires and a special form of a wrist watch. This information may help the investigators better manage sleep difficulties in subjects who experience these symptoms after diagnosis of their breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score \>14
2. Insomnia present for \> 30 days per patient report
3. Female gender
4. Histologically proven stage 0-III invasive carcinoma of the breast

   a. Patient's must have completed primary surgical resection at least 2 weeks prior to enrollment, radiation at least 2 weeks prior to enrollment and/or cytotoxic chemotherapy at least 6 weeks prior to enrollment in the study
5. ECOG performance status 0-2
6. Ability to operate the accelerometer (Actiwatch Spectrum Pro)
7. The patient is aware of the nature of her diagnosis, understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent document

Exclusion Criteria:

1. Subjects who do not have access to the internet to use the internet-based module, PROSPECT
2. Initiation of hormone therapy \<4 weeks prior to enrollment in the study
3. Initiation of sleep aids, including over-the-counter or prescription medications taken for insomnia (melatonin, benzodiazepines, antihistamines, etc.) for \< 4 weeks prior to enrollment in the study
4. Use of medication for treatment of another sleep disorder, such as restless leg syndrome or narcolepsy
5. History of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (Rheumatoid Arthritis, Systemic Lupus Spondyloarthropathy, Psoriatic Arthritis, Polymyalgia Rheumatica), Parkinson's disease and cancer involving the bone
6. Second or third shift workers or others with non-traditional sleep schedules
7. Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation
Comparison of Rosuvastatin With Atorvastatin in Chronic Periodontitis

The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical and radiographic efficacy of two local drug delivery systems containing 1.2% RSV gel and 1.2% ATV gel in treatment of intrabony defects in patients with chronic periodontitis as an adjunct to SRP.

Background: Rosuvastatin (RSV) and Atorvastatin (ATV) are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of 1.2% RSV and 1.2% ATV gel as local drug delivery systems in adjunct to scaling and root planning (SRP) for the treatment of intrabony defects in patients with chronic periodontitis (CP).

Methods: A total of 90 intrabony defects were treated with either 1.2% RSV, 1.2% ATV or placebo gel LDD after SRP. Clinical parameters (plaque index, modified sulcus bleeding index, probing depth and clinical attachment level) were recorded at baseline and 6 months. Radiographic intrabony defect depth change was calculated on standardized radiographs by using image analysis software at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients with PD ≥5mm or CA loss ≥4mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included

Exclusion Criteria:

* Patients with a known systemic disease;
* known or suspected allergy to statin group;
* on systemic statin therapy;
* with aggressive periodontitis;
* who used tobacco in any form;
* alcoholics;
* immunocompromised patients;
* pregnant or lactating females were excluded from the study
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma

This study investigates how seizures can vary over time with changes in low grade gliomas and its treatments. This study may help doctors find symptoms or triggers of seizures earlier than normal, and ultimately earlier care or treatment for seizures.

PRIMARY OBJECTIVE:

I. To evaluate the rate of change of seizure frequency and the status of the tumor at each data collection point.

SECONDARY OBJECTIVES:

I. To obtain sufficient number of patients' data in order to power the analysis to determine whether a change in seizure frequency correlates with tumor control.

II. Evaluate progression free survival and overall survival when compared with seizure control.

OUTLINE:

Patients complete a seizure assessment survey over 5 minutes at each clinic visit.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Primary brain tumors (separated by World Health Organization \[WHO\] grade I-IV)
* History of seizures secondary to brain tumor
* On tumor directed treatment
* Magnetic resonance imaging (MRI) within 2 weeks of clinic visit where seizure assessment takes place

Exclusion Criteria:

* Patients without seizures
* Patients with intracranial lesions other than primary brain tumor
* Patients not undergoing tumor directed treatment
* Absence of recent (within 2 weeks) MRI
Efficacy of BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study

The purpose of this study is to evaluate the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing restless legs syndrome (RLS) severity in persons with multiple sclerosis (MS) and RLS. The study includes a proposed sample of 20 persons with MS and RLS that will be randomized into either a 16-week behavioral intervention arm aimed at increasing physical activity or a 16-week wait-list control arm.

The primary aim of the proposed pilot RCT involves examining the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing RLS severity in persons with MS and RLS. Secondarily, the investigators will be assessing changes in sleep quality and daytime sleepiness following the behavioral intervention. The study includes a proposed sample of 20 persons with MS and RLS that will complete a baseline testing session for measures of physical activity, restless legs syndrome severity, sleep quality, and daytime sleepiness. Participants will then be randomized into one of two study arms: (1) a 16-week Social Cognitive Theory-based behavioral intervention aimed at increasing physical activity; or (2) 16-week waitlist control with the option of completing the intervention upon completion of the study. All participants will complete a follow-up testing session at the conclusion of each 16-week arm.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Relapse free in the past 30 days
* Positive screen for restless legs syndrome
* Non-active (not engaging in 30 minutes of activity per day on more than 2 days per week in the previous six months)
* Ambulatory without assistance
* Internet and email access

Exclusion Criteria:

* Diagnosis of radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia) renal disease, or diabetes
* Screen at moderate or high risk for undertaking strenuous or maximal exercise
Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic

This study is a multisite ,grouped test-negative case-control , phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to estimate the protective effectiveness of complete vaccination (measured ≥14 days after the second dose) of CoronaVac against symptomatic SARS-COV-2 infections ,COVID-19 hospitalizations and severe cases.

This study is a multisite,grouped test-negative case-control , phase Ⅳ clinical trial in population aged 18 years and older. The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in ten (10) selected hospitals and their catchment communities in five provinces of the Dominican Republic (DR): National District, La Altagracia, Puerto Plata, Santiago, and Santo Domingo from July 1, 2021 to April 30, 2022 . A total of 1400 subjects will be enrolled with 700 estimated clinic cases who are diagnosed as SARS-CoV-2 infection by real-time polymerase chain reaction (RT-PCR); and 700 estimated clinic controls who have a negative RT-PCR test.And subjects will receive two doses of vaccine for primary immunization .

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years;
* Permanent residents of study provinces;
* Able and willing to provide informed consent to participate in the study;
* Able and willing to provide nasopharyngeal swab and venous blood sample;
* Able and willing to complete a questionnaire survey for collecting information on histories of COVID-19 vaccination and disease;
* Considered as suspected cases of SARS-CoV-2 infections by the physicians in the study clinics according to DR national protocol.

Exclusion Criteria:

-
Operation Worth Living Project With Suicidal Soldiers at Ft. Stewart

This is a randomized controlled trial comparing the use of new clinical intervention (the "Collaborative Assessment and Management of Suicidality--CAMS") versus enhanced care as usual for suicidal Soldiers who are seen at outpatient mental health clinics at Ft. Stewart GA.

This is a randomized controlled clinical trial of 148 suicidal active-duty US Army Soldiers. Participants were randomized to on-site providers who were trained in the Collaborative Assessment and Management of Suicidality (CAMS) vs. providers doing their own routine care--referred to as Enhanced Care as Usual (E-CAU) within an outpatient military treatment center. The CAMS Rating Scale (CRS) was used to reliably verify fidelity between treatment conditions and the adherence by CAMS providers to the model. Participants received informed consent to be randomly assigned to treatment arm and were ask to complete study assessments at baseline, 3 months, 6 months, and 12 months after the start of treatment. Recruitment is complete and all study assessments were completed as of March 2016. The study is in a second year of no cost extension; outcome data analyses and moderator analyses are currently underway to develop manuscripts for submission to peer-review scientific journals.

Eligibility Criteria:
Inclusion Criteria:

* Active duty Army personnel at FSGA
* Significant suicidal ideation
* Soldier is appropriate under FSGA policies
* Consent at baseline and follow up
* Consent to randomization and being digitally recorded

Exclusion Criteria:

* Significant psychosis, cognitive or physical impairment to not give consent
* Judicially ordered treatments
Internet Treatment for Patients With Obesity

There is a strong link between obesity and reduced quality of life as well as serious sequelae of diseases. Step by step is a treatment model that has been developed at the Obesity Unit, Orebro County Region and includes six group meetings over 6-8 months. The aim is to increase patients' knowledge about the disease obesity, to provide support for lifestyle changes and weight control, and to reduce stigma-related psychosocial disorders. A 1-year pilot study aimed at evaluating the Internet-based Step by Step treatment has recently been completed. Results after 6 months of treatment show that the participants who completed the treatment were mainly satisfied with the program and the content. However, the dropouts from the treatment were more than expected.

Based on the experience from the pilot study, a new randomized study is planned with the aim of evaluating a revised treatment program. People 25-69 years with a BMI 30-44.9 kg / m2, or with a BMI 28-29.9 kg / m2 and co-occurrence of hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidemia, hepatic steatosis, sleep apnea or polycystic ovary syndrome can be included. The intervention group receives increased therapist support with physical or digital meetings before and during the treatment as well as individualized feedback from the therapist. Feedback takes place after 6, 12 and 18 weeks. The other group, the control group, implements the program without meetings with the therapist and receives general feedback during the treatment. The purpose is to evaluate whether increased therapist contact compared to less therapist contact leads to improved weight reduction, quality of life, eating habits and increases physical activity at follow-up after 12 months

Eligibility Criteria:
Inclusion Criteria:

* BMI 30-44.9 kg / m2
* BMI 28-29.9 kg / m2 and hypertension
* BMI 28-29.9 kg / m2 and prediabetes
* BMI 28-29.9 kg / m2 and type 2 diabetes
* BMI 28-29.9 kg / m2 and coronary heart disease
* BMI 28-29.9 kg / m2 and hyperlipidemia
* BMI 28-29.9 kg / m2 and hepatic steatosis
* BMI 28-29.9 kg / m2 and sleep apnea
* BMI 28-29.9 kg / m2 and polycystic ovary syndrome

Exclusion Criteria:

* Severe mental illness
* Ongoing or suspected eating disorder
* Pregnancy
* Breastfeeding
* Cancer in active treatment
* Use of drugs for weight loss
* Weight loss treatment during the past 6 months
* Active abuse of alcohol or drugs
* Not being able to express themselves in Swedish in speech and writing
* If the study supervisor deems that participation in the study is inappropriate for another reason.
Sleep Well for Healthy Brain

The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment.

Exclusion Criteria:

* pregnant women
* cognitively impaired subjects not able to provide consent
* prisoners
* Subjects 55 years of age and older that meet criteria for mild cognitive impairment.
* Subjects with any neurological disorder.
* Any other condition that in the opinion of the investigator may affect the participation in this study