cyrilzakka/clinical-trials huggingface dataset:
Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

The purpose of this study is to determine if the use of routine transvaginal cervical length ultrasound can be used to prevent preterm deliveries in twin gestations.

This is a randomized controlled trial to determine whether there is a difference in the rate of preterm birth among women with twin pregnancies whose clinicians are aware of transvaginal ultrasound cervical length measurements compared to those managed without this information. The study group had transvaginal cervical length ultrasound monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage depending on the cervical length. The control group had digital cervical exams and routine transvaginal cervical length ultrasound was not utilized. The primary outcome was the mean length of gestation. Secondary outcomes included percentage of deliveries \< 35 weeks, maternal and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Twin pregnancy
* Gestational age \< 20 weeks

Exclusion Criteria:

* History of incompetent cervix with plans to place a cerclage
* History of possible cervical incompetence with preexisting plans to monitor cervical length
* Prior preterm birth at \< 28 weeks gestational age
* Plans to leave the area before delivery
* Known major fetal anomaly
* Known diagnosis of twin-twin transfusion syndrome
* Age \< 18
* Monoamniotic twins
Effects of Maintaining Steady Albumin Levels (TAT 4) on Survival and Liver Related Complications in Cirrhosis With Ascites

Investigators intend to assess the utility of regular albumin infusions to maintain a targeted serum albumin level of 4.0 g/dl in newly detected cirrhotic patients with low albumin levels (\<2.8g/dl) with ascites.

Cirrhosis is characterized by progressive deterioration in liver functions. Liver's synthetic functions are inferred by serum albumin and INR estimation. Lower albumin level is a marker of severe liver disease and probability of worsening ascites, hepatorenal syndrome with increased risk for infections. Of the three recent RCTs on utility of long-term administration of albumin, two showed improvement in survival. The studies had included different patient populations (diuretic refractory ascites, high dose diuretics and patients on liver transplant waiting list) with different albumin infusion protocols and different end-points. These studies were done in advanced cases of cirrhosis. There is limited data on the utility of regular albumin infusions in early hepatic decompensation (albumin levels-\<2.8g/dl with ascites) and the effect of maintaining a targeted albumin level on survival or liver related side effects. Investigators are trying to address this issue by starting regular albumin infusions at an earlier stage of liver decompensation.

Eligibility Criteria:
Inclusion Criteria:

* Newly detected cirrhotic patients aged more than 18 years
* Cirrhosis deﬁned by standard clinical, analytical and/or histological criteria
* Serum albumin level \< 2.8g/dl with or without ascites
* Who would agree to give written informed consent

Exclusion Criteria:

* Uncontrolled HTN (sys\>150/ dis \>90 mmHg) or h/o any drug therapy for HTN
* Prior h/o Transjugular Intrahepatic Portosystemic Shunt (TIPS)
* Hepatocellular Carcinoma
* Active alcohol abuse within 3 months
* Patients presenting as Acute on Chronic Liver Failure
* Extrahepatic organ failure
* Known case of chronic heart failure or respiratory failure
* Diagnosed Chronic Kidney Disease
* Patients with hydrothorax
* Prior liver transplant recipient
* Human Immunodeficiency Virus infection
* Use of albumin infusion in the last one month
* CTP\>12, MELD\>28
* Total Bilirubin \>3 g/dl
* Overt Hepatic Encephalopathy at Presentation
Physical Telerehabilitation in Multiple Sclerosis

The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated Telemanagement) System as an adjunct to the current standard of medical care for patients with MS (PwMS). The individual patient with MS will be the unit of analysis. For each participant, the investigators will assess the effect of Home Automated Telemanagement (HAT) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.

People with multiple sclerosis may develop severe disability over the time. Physical therapy including regular exercise helps patients with severe disability to maintain muscle strength, reduce disease symptoms and improve quality of life. However physical therapy programs at clinical settings require constant travel which may limit access of patients with mobility disability to these services on continuous basis.Technology can allow patients with mobility disability exercise at home under supervision of their rehabilitation team. Currently it is unclear how effective this approach is. The study aims to demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, less symptoms and better quality of life. If so, other patients with significant mobility disability will be able to take advantage of this technology. This approach can be extended to people with different diseases causing mobility impairment and it can be used not only for physical but also for cognitive and occupational rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Age \>21
* Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria
* EDSS range 5.0-8.0
* Mini-Mental State Examination (MMSE) \> 22 or presence of a caregiver to assist in daily exercise regimen

Exclusion Criteria:

* Coronary artery disease
* Congestive Heart Failure
* Uncontrolled hypertension
* Epilepsy
* Pacemaker or implanted defibrillator
* Unstable fractures or other musculoskeletal diagnoses
The Experience of Living With Polycystic Ovary Syndrome in the Military

The purpose of this study is to understand the experience of living with polycystic ovary syndrome (PCOS) as an active duty Service Woman. As part of a budding research program, this proposed study will lay the groundwork for future intervention studies targeting the management of PCOS in a military population.

Using a qualitative descriptive approach with focus groups (FG) and individual interviews (II), the investigators will seek to describe the experience of living with PCOS as an active duty service woman (ADSW). This method will allow the investigators to obtain a comprehensive summary of living with PCOS in the every day terms of ADSW. The discussion in the (FG) meetings will be an effective way to supply information about what people think, or how they feel, or on the way they act. Advantages of this method include: (a) it can cover a large number of people in one session, (b) it is an efficient way of gaining a large amount of information in a short time, (c) it is comparatively easier to drive or conduct, and (d) it generates an opportunity to collect data from the group interaction, which concentrates on the topic of the researcher's interest \[64, 65\].

This proposed study will focus on six primary areas of inquiry: (a) experience of receiving PCOS diagnosis (b) symptoms experienced and methods of coping with them, (c) military-specific experience of managing and living with PCOS, (d) access to/availability of information related to PCOS and how they have applied it, (e) experience of support, and (f) present and future concerns about having PCOS.

Eligibility Criteria:
Inclusion Criteria:

* Women, active duty or prior (within 5 years) in the Army, Navy, Air Force or Marine Corps
* Diagnosed with PCOS
* 18 years of age or over

Exclusion Criteria:

* Reservist, Coast Guard, women who have separated or retired \> 5 years ago
Podcasting HIV Prevention Within African American Communities

Given the continued impact of HIV among African Americans, there is still an urgent need to expand prevention efforts and HIV testing in African American communities. Heterosexual individuals may acquire and spread infection directly through heterosexual contact, bi-sexual sexual contact, and/or indirectly through homosexual sexual contact. Evidence-based interventions (EBIs) have been shown to increase consistent condom use, decrease sexual partners, and increase HIV testing; however, traditionally-implemented EBIs may not be accessible to communities given the resources and expertise needed to implement them. This project seeks to: 1) assess feasibility for the development of two theory- based, video podcast-delivered, HIV prevention interventions for self-identified heterosexual African American males and females; and 2) evaluate their feasibility \& effectiveness (pilot). The investigators will develop the two (male and female) video podcasts that maintain the theoretical integrity of two established Centers for Disease Control evidence-based behavioral HIV prevention interventions. The assessment phase will consist of leveraging African American community stakeholders and experts in the development of the podcast content. The effectiveness phase will consist of broadcasting the podcasts for participants and evaluating psychosocial factors related to HIV prevention at 1 and 3 month follow-ups. This intervention is the first of its kind and has the potential to increase HIV protective behaviors in this hard-to-reach and medically underserved population. The resulting interventions are expected to be easily disseminated throughout the African American communities, with the potential to reduce HIV- related disparities within this population. This study will impact and advance the field by demonstrating feasibility and effectiveness for a novel mode of intervention engagement within HIV prevention science, serve as valuable preliminary data for a larger R01 trial, and foster HIV prevention awareness within the African American community.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American
* speak and read English
* 18 years old or older
* not currently or previously diagnosed with HIV

Exclusion Criteria:

• currently or previously diagnosed with HIV
Treatment of Facial Flushing with Botulinum Toxin a Injections

The purpose of this study is to find out if botulinum toxin A (botox®) can be used to treat facial flushing.

This study is a pilot study designed to determine feasibility of these procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 18-65 years of age with persistent facial flushing
2. Willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the study staff.

Exclusion Criteria:

1. Unable to understand the protocol or give informed consent
2. Younger than 18 or older than 65 years of age
3. Females who are pregnant or lactating
4. Known hypersensitivity to BTX-A
5. Subjects using medications that interfere with neuromuscular functions (such as aminoglycoside antibiotics)
6. Subjects who have a history of congestive heart failure, carcinoid syndrome, mastocystosis, or renal cell carcinoma
7. Botulinum toxin injections in the past 6 months
8. Ablative laser procedure in the past 6 months
9. Radiofrequency device treatment in the past 6 months
10. Ultrasound device treatment in the past 6 months
11. Medium to deep chemical peel in the past 6 months
12. Temporary soft tissue augmentation material in the area to be treated in the past year
13. Semi-permanent soft tissue augmentation material in the area to be treated in the past 2 years
14. Permanent soft tissue augmentation material in the area to be treated
15. Is planning to receive within the next 6 months, any cosmetic procedure (such as any chemical peels, botulinum toxin injections, ablative or non-ablative laser procedures, filler injections, radiofrequency procedures, dermabrasion, ultrasound and face lifting procedures) in the forehead or glabellar region.
16. Is planning to use tretinoin or retinoic acid in the next 6 months
17. Has an active infection in the forehead or glabellar region (excluding mild acne)
18. Is allergic to cow's milk protein
19. Is allergic to albumin
20. Is currently using anticoagulation therapy
21. Has a history of bleeding disorders
Geriatric Health Exam Osteoporosis Screening

BACKGROUND: The World Health Organization Fracture Risk Assessment Tool (WHO FRAX®) Taiwanese calculator is freely available on line to help osteoporosis management. However, its clinical utility for improving osteoporosis awareness and patient acceptance has not been validated in Taiwanese population.

OBJECTIVES: This 11-month FRAX® based screening and referral program enrolling older adults participating in the geriatric health examinations (GHEs) at the National Taiwan University Hospital (NTUH) aiming at determine the patient acceptance of the tool and the program and to improve patient awareness in osteoporosis. The second aim is to look for the recommendations from the participating physicians to improve the FRAX® -based osteoporosis management model.

METHODS: The NTUH GHE program is a two stage process to serve 3,000 older adults collecting annually from Mar. to Dec. Subjects will be enrolled to the current study at the stage 1 GHE visits after informed consent. Baseline questionnaires including the FRAX® tools will be distributed and expected to be returned at the stage 2 visits. Research assistants will calculate the 10-year predicted fracture risks for the participants during the waiting periods and present the numbers to the GHE physicians. High risks individuals will be referred to general geriatric clinic for further managements. All participants will be provided with osteoporosis and fracture educational material. Patient acceptance and awareness will be assessed. The study is to be started from Feb., to Oct., 2013 to enroll roughly 1,800 older adults assuming refusal rate about 40%.

Qualitative interviews will be used to obtain recommendations from study geriatricians in Jul., 2013 to optimize the FRAX® based screening and management model.

ANTICIPATED RESULTS:

To estimate the 10 year fracture risks for GHE participants. To understand the acceptance of this FRAX® based model from GHE participants and the impacts on patient osteoporosis awareness.

To calculate the economic benefits of this model on geriatric outpatient service.

To obtain recommendations from study geriatricians to optimize the FRAX® based model for further disseminations.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the NTUH GHE program
* Can complete the study questionnaire
* Willingness to join in the researchers

Exclusion Criteria:

* NA
Central Sensitization in Familial Mediterranean Fever (FMF)

Familial Mediterranean Fever (FMF) is an autosomal recessive inherited disease with a course of autoinflammation, which is characterized by the episodes of fever and serositis. Central sensitization (CS) is defined as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with many rheumatological diseases has been demonstrated in several studies. However, there are no data on the frequency of CS in FMF patients.

Familial Mediterranean fever (FMF) is a self-limiting autoinflammatory disease with well-defined genetic and clinical features. Recurrent episodes of fever and serositis accompanied by increased acute phase reactants and good response to colchicine are the core components of the disease. The frequency of this disease, which is common in Eastern Mediterranean countries, is variable according to regions, but it is reported as 1/1000. In the pathogenesis of the disease, the mutation of the MEFV (Mediterranean Fever) gene, which is located on the 16th chromosome and encodes the pyrin protein, is known as the basic mechanism.In rheumatic diseases, inflammatory mediators cause CS by first creating changes in the regulation of pain in peripheral neurons and then in spinal and supraspinal pathways. Stimulation of peripheral nerves by mediators released during inflammation results in neurogenic inflammation, which is among the peripheral sensitization (PS) mechanisms. PS is defined as the increased sensitivity of nociceptive neurons to normal or below-threshold stimuli and constitutes the first step in the development of CS.Similar to other autoimmune diseases, it is possible that the neuroinflammatory process triggers peripheral and central sensitization mechanisms in FMF patients and affects pain pathways.

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study

Exclusion Criteria:

* Had another systemic inflammatory rheumatic diseases
* Using centrally acting pain medications (e.g., pregabalin, duloxetine, opioids) or glucocorticoids (\>10 mg prednisone or its equivalent)
Biorhythms in Metabolic Tissues

Metabolism is increasingly recognized as being highly regulated by anticipatory biological rhythms (circadian rhythms or "biorhythms"), which are driven by molecular feedback loops, and which are approximately 24 hours long ("circa diem"). These circadian rhythms exist both centrally, in the brain, but also in the periphery, and are specific to many tissues depending on their main biological function or functions. Whereas these circadian rhythms have been thoroughly characterized in other organisms, their role in humans remain poorly understood, partly because of the difficulty in studying these rhythms in peripheral tissues. The investigators therefore aim to characterize these rhythms in primarily skeletal muscle and adipose tissue in healthy young volunteers (using the so-called constant routine paradigm), and how these rhythms interact with one another at various genetic and molecular levels. At the same time, the investigators aim to study how an unhealthy vs. healthy diet can alter these circadian rhythms, and how they interact with circadian rhythms in other tissue compartments such as those expressed by blood cells.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-33 yr
* Healthy (self-reported) and not on medication
* BMI 18-28 kg/m2 (and waist circumference \<102 cm), and weight stable (±5% body weight in past 6 months)
* Non-smoker and non-nicotine user
* Regular sleep-wake pattern, with sleep duration of 7-9.25 hrs per night
* Sedentary to moderately active with regular exercise habits the last 2 months
* Regular daily meal pattern with 3 main meals

Exclusion Criteria:

* Major or chronic illness, e.g. diabetes, renal disease or inflammatory bowel disease
* Current or history of endocrine or metabolic disorders
* Psychiatric or neurological disorders (e.g. bipolar disorder, epilepsy)
* Frequent gastrointestinal symptoms
* Chronic medication
* Any sleep disorder (e.g. irregular bedtimes, symptoms of insomnia)
* Any issues with or allergies against the provided food items or utilized anesthesia
* Shift work in the preceding three months or for a long duration
* Time travel over two time zones in the preceding month
* Too much weight gain or weight loss in the preceding 6 months
* Pregnancy
The Impact of Time Restricted Feeding in Crohn's Disease

Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Subjects has active Crohn's disease of the ileum and/or colon. The diagnosis should be confirmed by endoscopic or radiological evidence.
* Active inflammation on colonoscopy performed as evidenced by an SES-CD ≥ 6 (or ≥ 4 for isolated ileal disease) OR C-Reactive protein ≥ 1.0 mg/L OR fecal calprotectin ≥ 250 μg/g. Any or all of these results must be from within 180 days of study entrance.
* Subject should have BMI of \>18.5 and \<40

Exclusion Criteria:

* Subjects who decline to provide informed consent
* Subject with a history of an eating disorder, major gastrointestinal surgery within the past 3 months.
* Subject with a history of antibiotic use within 4 weeks.
* Subject with a history of bowel obstruction within the past 12 months
* Subject with a history of diabetes requiring medication
* Subject who is currently pregnant or breastfeeding will be excluded
* Subjects with current antibiotic use. In order to participate, subjects will be required to have a 2-week wash-out period.
Teledermatology Solution Through Mobile Phone in Rural Mongolia

Objective This study is aimed to estimate the distance, time and the cost of travel saved by patients who are seeking tele-dermatology (TD) service though smart mobile phones in the resource poor settings at the rural clinics of Mongolia.

Methods A cluster-randomised trial was conducted for six months at the 20 rural health clinics selected from three districts in Mongolia. With a computer-generated sequence, health clinics were randomly allocated either to the intervention group, in which all general practitioners (GPs) received TD consultation through Sana system, or the control group, in which GPs referred patients to the dermatologist at district hospital whenever needed. The primary outcome was to estimate the distance traveled, times spend and the cost of travel required in receiving dermal care for patients in rural Mongolia. Analysis was done to estimate the difference between the aforementioned parameters among intervention and control groups.

The investigators used Sana system, that is a mobile phone-based, open source software platform for telemedicine services. The Android-based system supports multimedia, location-based data, and text. In the village health clinic, a healthcare worker will interact with a patient and collects data through a step-by-step clinical questionnaire on a smart mobile phone. As patients' data is uploaded to an open source electronic medical record system (OpenMRS) with a diagnosis-specific information and images. The consultant can access the clinical information about the patient and make appropriate diagnoses and treatment recommendations from the secondary hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-98 years visiting with dermal problem.

Exclusion Criteria:

* Patients who do not need dermal care.
* Patients who are already under treatment for dermal problem.