cyrilzakka/clinical-trials huggingface dataset:
Daily Step Count and Achieving Goal Gestational Weight Gain

The purpose of this voluntary research study is to determine an optimal step count that aids in achieving the recommended weight gain during pregnancy and to use this count in future studies.

The goal of this study is to contribute to the growing data that show a clear benefit in activity during pregnancy over sedentary behavior. Uniquely, this study looks to determine an optimal step count for achieving goal gestational weight gain. In doing so, this will enable clinicians to better counsel patients on a low cost, at home activity that can aid in improved maternal and fetal outcomes. This optimal step count would be used in future randomized clinical trials to determine whether this goal step count could be used to benefit other maternal and fetal outcomes such as gestational diabetes, preeclampsia, preterm labor, cesarean section rates, and birth weight.

Participation will begin at the patients 18-22 week clinic visit and will last until delivery. At the 18 - 22 week clinic visit a pedometer will be given to the patient. Patient will be instructed by a study team member to wear the pedometer on a hip for 7 days every 4 weeks and will submit daily step count for the day via a link to an online submission form which will arrive in the email once a day for 7 days in a row. An email reminder will be received every four weeks to prepare the patient for the reporting of daily step count, if no response is received electronically via the online submission form after 14 days a second reminder will be received. No change in normal activity will be required, instructions will be given to maintain normally activity during the week. The pedometer will be returned when patient arrives to labor and delivery to deliver.

The risks of this study are minimal as there will be no diversion from normal daily routine.

The results of this research may guide the future studies in walking in pregnancy in relation to maternal, fetal, and neonatal morbidity.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years and older
2. Pregnant women
3. A singleton pregnancy
4. Gestational age at inclusion 18-22 weeks
5. Ability to read and speak English
6. Access to a computer
7. Cell phone

Exclusion Criteria:

1. Multiple pregnancy
2. Pregestational diabetes
3. Diseases limiting level of physical activity
4. Previous bariatric surgery
5. Current alcohol use
6. Current drug abuse
7. Currently in a opioid treatment program
8. History of eating disorder
9. Non-English speaking
Blood Pressure During Rate Control in Patients With Tachycardic Atrial Fibrillation at the Emergency Department

The aim of this study is to analyse blood pressure during rate control therapy in patients with tachycardic atrial fibrillation in a real-world emergency cohort.

Atrial fibrillation (AF) is the primary clinical problem in 3.3% to 10.0 % emergency department (ED) admissions. Rate control is an integral part of the management of symptomatic tachycardic AF patients.

According to the recent guidelines beta-blockers, digoxin, the calcium channel blockers diltiazem and verapamil, amiodarone or combination therapy should be considered for rate control. Haemodynamic side-effects in particular hypotension may occur. Heart rate and blood pressure behavior in an ED population during rate control therapy in patients with tachycardic atrial fibrillation will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Atrial fibrillation or atrial flutter and heart rate ≥ 110 bpm
* Indication for rate control
* Informed consent

Exclusion Criteria:

• Inclusion criteria not met
Epidemiological Study of Vulvovaginal Candidiases Strain Types and Risk Factors Among Gynecological Outpatients in China

We has proposed to conduct a national epidemiological study on the pathogenic strains and high risk factors of Vulvovaginal Candidiasis in China , and conduct drug resistance analysis.

Vulvovaginal Candidiasis is a mucosal infectious disease, which rarely occurs fatal infection, but has high recurrence rate. Vulvovaginal Candidiasis often leads to decreased life quality and serious economic burden. However, we known little about the pathogenesis of Vulvovaginal Candidiasis. So better diagnosis and treatment methods are needed to decrease the impact on women's health.

In 2017, the national Vulvovaginal Candidiasis epidemiological survey led by Professor Liao showed that 543 strains of fungi were isolated from different patients from 12 hospitals in 10 cities in China, of which Recurrence Vulvovaginal Candidiasis strains accounted for 15.7%. The most common pathogenic strain was Candida albicans (460 species, 84.71%), and the most common non-albicans was Candida glabra (47 species, 8.66%). In addition, 92 isolates (20.4%) belonged to the new branch endemic to North China. Vaginal symptoms of Vulvovaginal Candidiasis caused by non-albicans are usually milder compared to Vulvovaginal Candidiasis caused by Candida albicans. However, inherent resistance to azoles, as well as acquired resistance mechanisms, can complicate the treatment of non-albicans and often requires a long-term antifungal treatment or other treatments to clear non-albicans.

Given that the resistance rate of different types of candida to antifungal drugs changes over time, common antifungal drugs have selective induction of resistance to fungi, and fungi have cross-induction of resistance to antifungal drugs, it is very important to evaluate the distribution and resistance of Candida species in a long-term . Accurate and effective acquisition of candida epidemiological data to understand the recent status and drug resistance of Candida infection can effectively guide clinical treatment to improve the therapy, and play a very important role in clinical diagnosis and treatment. Therefore, Professor Liao has proposed to conduct a national epidemiological study on the pathogenic strains and high risk factors of Vulvovaginal Candidiasis in China once again, and conduct drug resistance analysis, in order to guide clinicians to better Vulvovaginal Candidiasis treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients of gynecology
2. Age≧18 years
3. Signed informed consent form voluntarily
4. With diagnosis and symptomatology of Vulvovaginal Candidiasis (all types of Vulvovaginal Candidiasis can be included)
5. History of sexual life

Exclusion Criteria:

1. Antifungal medication was used within 7 days (oral or topical)
2. With contraindications of vaginal sampling
3. Other conditions deemed unsuitable for inclusion by clinicians
Clinical Evaluation of the Application of the FilmArray GI Panel in Post-HSCT Diarrhea Patients

This is a prospective single arm study with the study period from June 1st, 2019 to May 31st, 2020. An historical control group will be used in the study, which includes all patients received HSCT but not GI panel detection between June 1st, 2018 to May 31st, 2019. All patients receiving HSCT within the year at SCMC will be enrolled in the study. The stool samples will be collected from each patient at 2-3 time points, including the day before pre-conditioning (T1), 28+-3 days after HSCT (T2), and the day severe diarrhea present (T3). All the stool samples will be detected by the FilmArray GI panel, and the results as well as other clinical information including the laboratory examinations will be recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 18 years old;
* Receiving HSCT;
* Legal guardians fully understand and sign informed consent.

Exclusion Criteria:

* Receiving secondary transplantation;
* Cannot give informed consent or not willing to enroll the study.
A Prospective, Randomized Trial of Intravenous Pulse Versus Sequential Steroid Therapy for Patients With Graves' Orbitopathy

This study was designed to compare the efficacy and safety of 4.5g iv MP administered in 12 weeks and 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Patients should meet the criteria of either a or b and together with c, d and e to include into the study.

  a. Lid retraction with any one of the following: i) Thyroid dysfunction ii) Proptosis iii) Optic nerve involvement iv) Extraocular muscle involvement b. Thyroid dysfunction with any one of the following: i) Proptosis ii) Optic nerve involvement iii) Extraocular muscle involvement c. Exclude cases with such ophthalmological signs caused by other diseases. d. Moderate to severe patients defined by EUGOGO. e. Clinical activity score (CAS)≥3/7 f. Normal function of heart, liver and kidney.

Exclusion Criteria:

* Orbital decompression surgery needed immediately
* History of chronic recurrent or active infection
* History of peptic ulcer
* Patients with a history of chronic liver disease or liver disorders； ALT or AST above 2.5 times upper limit of normal
* History of HIV, hepatitis C or hepatitis B Positive
* Cardiovascular or cerebrovascular disease clinically significant
* Uncontrolled diabetes mellitus
* Use of corticosteroids during 12 weeks before to inclusion period
* Pregnant patient or patient who is planning to become pregnant during the study
Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study

Since the first implant in September 1982, the Medtronic Hancock® II has provided more than 20 years of excellent hemodynamic performance and durability. Design improvements over the past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6 anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A critical issue is the size of the prosthesis in relation to the patient's annulus.

The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus diameter.


Eligibility Criteria:
Inclusion Criteria:

* Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of atrial fibrillation or mitral valve repair.
* Patients who are able to provide informed consent.

Exclusion Criteria:

* Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial fibrillation or mitral valve repair.
* Patients indicated for receiving a mechanical prosthesis.
* Patients who will have a replacement of existing valve prosthesis.
* Patients refusing or not able to provide informed consent.
* Patients requiring emergency surgery.
* Patients unable to participate in follow-up
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan

The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.

The study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant NHB women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. Consenting participants will be randomized to the intervention or an active control. The intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the IP3, 2) structured encouragement via text messages and 3) employment law education sheet. The powerpoints will also be available for review on our you-tube channel for intervention patients. The active control arm includes: 1) a narrated powerpoint describing the Duke Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e. it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index.

The team will collect feedback on the intervention based on an intake questionnaire and an exit interview.

Information will also be collected on adherence to the IP3 based on review of the participant's medical record. The primary aim of the study is to evaluation feasibility and acceptability. These endpoints will be measured via enrollment and participant feedback during the exit interview.

Eligibility Criteria:
Inclusion Criteria:

* self described race as Non-Hispanic Black
* history of prior singleton preterm delivery (before 37 weeks gestation)
* current singleton gestation

Exclusion Criteria:

* women with anomalous fetuses
* age below 18\]
* non-English speaking
Caffeinated Chewing Gum on 400-meter Performance

20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. The outcomes are Running-Based Anaerobic Sprint Test and 400-meter sprint test was performed.

The purpose of this study was to investigate the effect of caffeinated chewing gum on 400-meter sprint performance. 20 trained sprinter were divided into caffeine Gum trial (CAF) and Placebo trial (PL) with a randomized, double-blind study design. The participants chewing either caffeine Gum (CAF trial, containing 3 mg/kg of caffeine) or Placebo Gum (PL) for 10 minutes. After rested for 15 minutes, the participants underwent a Running-Based Anaerobic Sprint Test. After a 30-minute break, a 400-meter sprint test was performed. The blood lactate concentration were collected before and after 400-meter sprint from finger. Saliva samples were predicted to be collected before chewing gum, before the RAST, and after a 400-meter sprint. Saliva samples will be analyzed for caffeine and α-amylase concentrations in saliva.

Eligibility Criteria:
Inclusion Criteria:

* 6 years of professional short sprinting training
* 6 months of ongoing training, and
* 3 months of recovery from sports injuries such as strains and sprains.

Exclusion Criteria:

* Non-specialized sprinters.
* has not trained regularly for the past 6 months.
* has recovered from an athletic injury.
* less than 3 months of recovery from a sports injury, or participants with epilepsy, hypertension, hyperlipidemia, heart disease, arthritis, osteoporosis, brain injury, or a history of caffeine allergy.
Stem Cell Therapy in Limb Girdle Muscular Dystrophy

The purpose of this study was to study the effect of stem cell therapy on the course of the disease in patients with Limb Girdle Muscular Dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* age group of 15 years and above
* limb girdle muscular dystrophy diagnosed on the basis of clinical presentation
* Electromyographic and Nerve Conduction velocity findings

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding
Rehabilitation After Intensive Care

Patients with critical illness loose bodymass, mainly muscle. The purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6MWT), muscle strength, body weight, body composition and quality of life after intensive care. This is a single center randomised controled study comprising patients ≥45 years of age staying 5 days or more in the intensive care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving the ICU.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients ≥45 years with LOS ≥ 5days

Exclusion Criteria:

* Patients \< 45 years, Cerebral function that make cooperation impossible, Fractures in the spine, pelvis and/or lower extremities, Unable to perform the intervention LOS \< 5 days
Safety of Repaircell in Healthy Volunteers

Allogenic differentiated adipocytes (ANT-adip-AL) is produced by well-established techniques including cell harvesting from lipoaspirates obtained from healthy donors, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label study. Subjects were received subcutaneous injection of ANT-adip-AL and followed for 8 weeks according to the clinical trial protocol.


Eligibility Criteria:
Inclusion Criteria:

* male, 19 years of age or older
* volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening
* informed consent form signed

Exclusion Criteria:

* volunteers who have participated in other clinical studies related cell therapy within 30 days before this clinical trial
* volunteers who received any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
* volunteers who have tattoo or scar which disturb assessment of study at injection site
* volunteers who have Creutzfeldt Jacobs disease or related disease or family history
* volunteers who have allergy to bovine-derived materials
* volunteers who have infectious disease such as hepatitis B virus (HBV), hepatitis C virus (HCV)and HIV
* volunteers who have a symptom of septicemia or diagnosis of active Tuberculosis
* volunteers who have a clinically relevant history of abuse of alcohol or drugs
* volunteers who are considered not suitable for the study by investigator
* volunteers who have history of surgery for malignant cancer in the past 5 years
* volunteers who have congenital or acquired immunodeficiency syndrome
* volunteers who have horrible anemia or thrombopenia
* volunteers who have chronic disease such cardiovascular,renal and respirometer disease
* volunteers who were immunosuppressed by disease (ex: chronic heart failure)
* volunteers who were immunodepressed by treatment of medication
* volunteers who is being treated with blood derivatives/who is going to get a blood derivatives
* volunteers who have abnormal rage of CD4/CD8 ratio
Comparing Efficacy of PRP Combined With Different Hyaluronan for the Treatment of Knee Osteoarthritis

Either PRP or HA is each effective for treating knee OA. However, the efficacy of combined PRP and HA injections remains unknown clinically.

Intraarticular plasma-rich platelet (PRP) or hyaluronic acid (HA) was each effective for knee osteoarthritis(OA). The efficacy of combined injections remains unknown. This study aimed to evaluate the efficacy of PRP combined with different hyaluronan for treating knee OA. In a prospective, randomized-controlled trial, 95 patients with Kellgren-Lawrence grade 2 knee OA were randomized to receive a single intraarticular Artz (10mg/ml) followed by PRP (N=48) into target knee or single HYAJOINT Plus (20mg/ml) injection followed by PRP (N=47). Primary outcome was the change from baseline in the visual analog scale (VAS) pain at 6 months. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, single leg stance test (SLS), use of rescue analgesics and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Age of 20-85 years Symptomatic knee osteoarthritis for more than 6 months despite analgesics, NSAIDs, or physical therapy Kellgren-Lawrence grade-2 knee osteoarthritis seen on radiographs made within previous 6 months Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.

Exclusion Criteria:

* Previous orthopedic surgery on spine or lower limb Disabling osteoarthritis of either hip or foot Knee instability, apparent joint effusion, or marked valgus/varus deformity Known allergy to avian proteins or hyaluronan products Confirmed or suspected pregnancy, or lactating Intra-articular injections into knee in previous 6 months Any specific medical conditions (rheumatoid arthritis, active infection, hemiparesis, neoplasm, hematological etc.) that would interfere with assessments
An Open Label Study to Evaluate the Efficacy of Airgent in Treating Damaged and Wrinkled Skin

The primary objective of this study is to Evaluate the effectiveness of treatment of wrinkles or damaged skin with the Airgent device.

The secondary objective of this study are to:

* Evaluate subjects' satisfactory of the treatment.
* Demonstrate the safety of the Airgent treatment by evaluation of adverse events.

Each subject will attend the clinic for the screening visit, 3 or 4 treatment visits 3-4 weeks apart, and number of follow-up visits (three at least). Evaluation of results of the performed treatments will be performed in course of the next treatment visit (prior to performance the next treatment) and at follow-up visits at 1, 3 and 6 months after the last treatment in session. Additional evaluation visits at 9 and 12 months after completion the treatment session can be performed upon decision of the investigator in case when considerable improvement is recorded during the 6-months evaluation visit.

Biopsies from up to five subjects treated for stretch marks will be collected at the time of 3-months evaluation visit, from treated and untreated zone (one of each).

Subjects will be requested to refrain from using any other method of skin rejuvenation for the entire duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Females and males in good general health 18-65 years old
* Subject that are capable of reading, following directions, and understanding the procedure to be applied and that are obligated to forgo any other method of skin rejuvenation treatment for the entire study period.

Exclusion Criteria:

* Medical or psychiatric conditions that can affect the subject's ability to give informed consent, or complete the study.
* Pregnant or lactating females.
* Other known diseases including diabetes, autoimmune disorders, epilepsy, severe migraines chronic liver or kidney
* Disease or contagious diseases, such as HIV or hepatitis
* Participation in a clinical trial within the last 30 days.
* Subjects on any medication (chronic use) that would affect the characteristic of the skin (medical or hormonal), such as NSAID, blood thinning medications, immunosuppressive drugs, steroids, vitamin E supplements and Isotretinoins within one month prior to enrollment.
* Subjects who have any form of suspicious lesion on the treatment area.
* Subjects with history of keloid formations or hypertrophic scarring.
* Subjects with permanent makeup/ tattoo (in the treated area).
* Subjects with any cutaneous inflammation on the treatment area such as herpes or acne.
* Subjects with known sensitivity to hyaluronic acid or to egg products.
* Subjects with clotting disorders.
* Subjects addicted to drug or alcohol.
* Subjects who underwent any aesthetic procedure in the treated area or adjacent to it.