cyrilzakka/clinical-trials huggingface dataset:
PreTerm RNA in Maternal Serum

Preterm birth is defined as a birth occurring before the completion of 37 weeks gestation. The incidence of preterm birth in Israel in the last years is around 7-8%.

Despite various diagnostic modalities as well as newly therapeutic approaches the incidence of preterm birth remains unchanged and is considered to be the leading cause of neonatal morbidity and mortality.

In the last decade, small RNAs have emerged as an important player in both physiological and pathophysiological responses. These single strands, non-coding regulatory RNA molecules are responsible for post transcriptional regulation of target genes. Hence, may provide a new opportunity for biomarkers discovery in the field of preterm birth.

The main objective of this study is to identify a distinctive expression profile of maternal circulating RNAs that will be used as biomarkers for preterm birth.


Eligibility Criteria:
Inclusion Criteria:

1. Women with singleton pregnancy at 26-32 week of gestation with no clinical symptoms of preterm labor.
2. Women with singleton pregnancy 24-34 week of gestation who present to the labor suite with symptoms suspected for preterm labor.
3. Women with singleton pregnancy in term active labor (weeks 37-40).

Exclusion Criteria:

Exclusion criteria will include:

1. multiple gestation,
2. major fetal anomalies,
3. IUFD,
4. severe preeclampsia,
5. chronic steroid or immunosuppressive drug use,
6. active immunological illness,
7. and/or pregestational and gestational DM.
The Stool Microbiome of Treated and Untreated IBS (Irritable Bowel Syndrome) Patients

Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. The two main mechanisms invoking IBS development and flares include 1) an increase in luminal water content due to malabsorption of small molecules and 2) incrementation of colon gas production generated by the fermentation of small molecules by gut bacteria.Yet to date, a person-specific elucidation of the specific small molecules and bacteria driving IBS, and their downstream effects on the human gut epithelium remain unknown.

Over the past years, it became evident that dietary regimes, and their interactions with the intestinal microbiome, are at the center of IBS symptom generation and alleviation. The most widely used dietary intervention is a highly restrictive diet, the low-Fermentable Oligo-saccharides Di-saccharides Mono-saccharides And Polyols (FODMAP) diet, based on avoidance of multiple food items that contain available fermentable molecules.

The low-FODMAP diet remains an effective line of treatment for IBS patients, yet due to its complexity and unhealthy nature, it remains a last line of treatment and fails to impact the majority of IBS patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female
* Age - 18-70

Exclusion Criteria:

* Consumption of antibiotics 2 months prior to the first day of the experiment.
* Consumption of probiotic supplements 1 month prior to the first day of the experiment.
* Type 1 or type 2 diabetes diagnosis.
* Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the study.
* Chronic disease - to the discretion of the study doctor.
* Cancer and recent anticancer treatment.
* Psychiatric disorders - to the discretion of the study doctor.
* IBD (inflammatory bowel diseases).
* Alcohol or substance abuse.
* BMI \> 35.
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia

This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study.

This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States from Phase 2 (ABP-19000) trial. Study subjects who had their initial dose of study drug in the Phase 2 trial, irrespective of treatment allocation, will be eligible to enroll in this OLE study. Study subjects will receive a predetermined dose of ABP-450 between the Low Dose and High Dose, based on the investigator's discretion and clinical judgment.

Eligibility Criteria:
Inclusion Criteria:

1. Qualified for and had their initial dose of study drug in the ABP-19000 study.
2. Provided written informed consent to being treated for cervical dystonia with ABP-450.
3. Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000 study.
4. Stated willingness to comply with all study procedures, including attendance at the study center for all study visits as scheduled and have technological capabilities to have tele visits.

Exclusion Criteria:

1. Participated in another interventional study during participation in this study.
2. Were a pregnant or lactating female, or female of child-bearing potential not willing to use an acceptable method of contraception (ie, intrauterine device, barrier methods with spermicide, or abstinence).
3. Would not benefit from treatment with ABP-450 for their cervical dystonia, in the investigator's opinion.
4. Viral or other active infection or any medical condition that, in the opinion of the investigator, classifies the patient as unsuitable for participation in the study or patients who do not seem to be in good general health at the time of Day 0 "rollover", and prior to any investigational study drug administration.
Safety of a Single, Intravitreal Injection of Human Retinal Progenitor Cells (jCell) in Retinitis Pigmentosa

This study evaluates the safety and potential activity of a single dose of live human retinal progenitor cells (jCell) administered to adults with retinitis pigmentosa. Four different dose levels of cells will be assessed in each of two groups of patients.

The primary purpose of this study is to test the safety and tolerability of the administration of a single dose of jCell to adults with retinitis pigmentosa.

The goal of jCell therapy is to preserve vision by intervening in the disease at a time when host photoreceptors can be protected and potentially reactivated.

Human allogeneic retinal progenitor cells will be injected into adults with advanced RP to see if the procedure is safe, if the cells survive, and whether they have any impact on the visual status of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of RP confirmed by electroretinogram (ERG) and willing to consent to mutation typing, if not already done
* Best corrected visual acuity (BCVA) 20/63 or worse and no worse than hand motions (HM)
* Adequate organ function and negative infectious disease screen
* Female of childbearing potential must have negative pregnancy test and be willing to use medically accepted methods of contraception throughout the study

Exclusion Criteria:

* Eye disease other than RP that impairs visual function
* Pseudo-RP, cancer-associated retinopathies
* History of malignancy or other end-stage organ disease, or any chronic disease requiring continuous treatment with system steroids, anticoagulants or immunosuppressive agents
* Known allergy to penicillin or streptomycin
Numerical Standard of Anthropomorphicity of Prosthetic Feet for Improvement of Amputee Performance

The study concerns the testing of methodology of attachment of external foot prothesis based on anthropomorphism criteria


Eligibility Criteria:
Inclusion Criteria:

* Unilateral lower transtibial amputation
* Prosthetic user with socket type attachment (Cohort 1) or with direct skeletal attachment (Cohort 2) and be able to walk 50 meters independently,
* Between 18-60 years of age,
* Able to follow instructions,
* Able to provide consent.

Exclusion Criteria:

* problems on the residuum,
* Non-prosthetic user,
* Bilateral amputation,
* Self-reported pain levels greater than 4 out of 10 at study outset,
* Experienced a fall within the last 8 weeks before assessment,
* Mental illness or intellectual impairment compromising participant's ability to give informed consent,
* Injuries involving contralateral (intact) limb,
* Major uncorrected visual deficit,
* History of epilepsy or recurrent dizziness,
Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -

The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.

This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.

Eligibility Criteria:
Inclusion Criteria:

-Participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets

Exclusion Criteria:

* Participants with contraindications to Rozerem Tablets.
* Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets.
* Participants with severe liver dysfunction.
* Participants taking fluvoxamine maleate
Frequency of ICAM-1 Polymorphisms in Obese Subjects

The genetic contribution to the development of obesity is now well recognized. However obesity is a polygenic disease and thus many genes are likely to be involved. This study aims to investigate the possible association between specific variants of the gene coding for the Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian population

Severely obese subjects referred to our institution will be evaluated. For the aim of the study, a venous blood sample will be obtained from these subjects and from a group of normal weight volunteers. Genomic DNA will be extracted from the blood samples and analysed by standard molecular biology techniques.The allelic and genotype frequencies of the two ICAM-1 variants will be calculated in the obese and control groups. The statistical significance of possible differences will be determined

Eligibility Criteria:
Inclusion Criteria:

* Obesity

Exclusion Criteria:

* Associated inflammatory diseases
How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan

Shared decision-making helps patients to establish a treatment plan with clinicians together. Our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea.

Shared decision-making helps patients to establish a treatment plan with clinicians together. Our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea.

Inclusion criteria: include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese.

Exclusion criteria: dementia, mental illness, language difficulties.

Eligibility Criteria:
Inclusion Criteria:

* Include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese

Exclusion Criteria:

* Exclude dementia, mental illness, language difficulties
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 or older
* CP or AD CML or Ph+ ALL
* Intolerant of resistant to imatinib
* ECOG PS 0-2 (CP CML)
* ECOG PS 0-3 (AD CML and Ph+ ALL)
* Adequate hepatic and renal function

Exclusion Criteria:

* Pregnant or breastfeeding females
* History of significant cardiac disease
* History of significant bleeding disorder (not CML)
Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas

This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline

Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.

Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.

Subjects will be blindly randomized to receive one of three different types of IV fluids:

1. 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
2. Normal saline (a solution containing sodium and chloride) at 250 mL/hr
3. 2.5% dextrose Normal saline at 125 mL/hr

   * Management of labor will be at the discretion of the attending physician(s).
   * Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
   * Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.

Eligibility Criteria:
Inclusion Criteria:

* • Primiparous

  * Singleton gestation
  * Vertex presentation
  * Spontaneous active labor with or without pitocin augmentation
  * Gestational age \> 36 weeks
  * Cervical dilation 3 to 5 cm with or without ruptured membranes

Exclusion Criteria:

* • Multiparous

  * Pregestational or gestational diabetes mellitus
  * Preeclampsia at admission
  * Previous cesarean section
  * Non-vertex presentation
  * Multiple gestation
  * Chorioamnionitis at admission
  * Intrauterine growth restriction (\< 10th percentile)
  * Patients admitted for induction
  * BMI \> 50
Prevalence of Dynamic Instability Among Football Players in the UAE: A Cross-sectional Study

the purpose of this study is to determine dynamic instability prevalence in United Arab Emirates football players.


Eligibility Criteria:
Inclusion Criteria:

* male
* 16-24 years .

Exclusion Criteria:

* previous injury in lower extremities
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction

Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra, Dioscorea tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna Linn, Honey, improved the erectile function by preserving the smooth muscle content and inhibiting the fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this study, the researchers investigated the efficacy and safety of the herbal formula (KBMSI-2) in the treatment of ED.

Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy variable was the change in the EF domain scores of the IIEF questionnaire from baseline. Secondary efficacy measures included change in all domain scores of the IIEF from baseline, change in question 2 and 3 of the SEP2,3, from baseline.


Eligibility Criteria:
Inclusion criteria were as follows:

* men with history of ED for at least 6 months according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance);
* erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire ≤ 25;
* age range between 19 and 40 years old;
* patients were required to be involved in a stable, monogamous relationship with a female sexual partner and having failed \>50% of at least four sexual attempts during the run-in period.

Exclusion criteria were as follows:

* Men with the following conditions were excluded from the study:
* penile anatomical defects,
* spinal cord injury,
* radical prostatectomy,
* and radical pelvic surgery;
* a primary diagnosis of another sexual disorder;
* uncontrolled DM (HBA1C\> 12%);
* serum creatinine\>2.5mg/dL;
* major uncontrolled psychiatric disorder;
* history of major hematological, renal, or hepatic abnormalities;
* recent (within the previous 6 months) history of cardiovascular disease, stroke or myocardial infarction, cardiac failure, unstable angina, life-threatening arrhythmia and a history of alcoholism or substance abuse.
* Patients having taken PDE5 inhibitors and testosterone replacement therapy within 2 weeks were excluded in the study. Concomitant use of ED treatment was forbidden.
Evaluation of Healing Following Open Gluteus Medius Repair with Biointegrative Implant

This is a prospective, single-center study design with enrollment of 15 subjects. The 15 subjects will all undergo standard gluteus medius repair that includes augmentation with the biointegrative implant. This is a small observational study. As such, we expect that the results from 15 subjects will give an adequate understanding of post surgical healing.

Surgical gluteal tendon repair is a procedure performed regularly in operating rooms everywhere. This procedure is normally recommended to address gluteal tendon tears after nonoperative treatment options have been exhausted. However, less than satisfactory long-term outcomes can be common after open gluteal tendon repair. The augmentation of tendon repairs via various biointegrative implants is becoming more common in clinical practice, however very little, if any, of the literature details the healing after surgical intervention.

Biointegrative implants have been studied for the use of augmenting other tendon repairs, such as rotator cuff tears. Successful complete rotator cuff repairs augmented with a collagen-based implant have indicated that biointegrative implants are a safe option that may provide greater rates of healing and more positive long-term outcomes (Thon SG, 2019). Rates of healing and long-term outcomes when using a patch of this sort in other tendons such as the gluteal tendon in the hip show promise and demonstrate that there is a need for this area of study.

A 2016 study evaluated augmenting gluteus medius repair with a bioinductive implant, but the surgery was performed using endoscopic technique. There is no literature studying the healing of collagen-based implants for open gluteal tendon repairs. Although clinical outcomes show similar level of improvement for endoscopic and open gluteal tendon tear repair (Maslaris A, 2020), open repair technique with more anchors may be required for larger or more intricate tears.

This is a prospective, single-center study design with enrollment of 15 subjects. The 15 subjects will all undergo standard gluteus medius repair that includes augmentation with the biointegrative implant. This is a small observational study. As such, we expect that the results from 15 subjects will give an adequate understanding of post surgical healing.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years of age
2. Patients healthy enough to undergo procedure
3. Large partial tear and full thickness gluteal tendon tear requiring augmentation
4. Willing and able to make all required visits
5. Able to read and write in English

Exclusion Criteria:

1. Hypersensitivity or objection to using bovine derived materials
2. Significant atrophy or major retraction of gluteal tendon
3. Women who are pregnant or nursing
4. History of poor compliance with medical treatment
5. Patients who are incarcerated
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis

The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of cobitolimod maintenance treatment compared to placebo in inducing or maintaining clinical remission at week 52, in participants with clinical response at week 6 after induction treatment with cobitolimod.

This phase III study protocol includes an induction study for 6 weeks and a maintenance study for an additional 45 weeks.

In the induction study there will be an initial phase to explore the best dose, between cobitolimod 250 mg and cobitolimod 500 mg using adaptive design.

Eligibility Criteria:
Inclusion Criteria Induction:

* Male or female ≥ 18 years of age.
* Established diagnosis of UC.
* Moderate to severe active left-sided UC assessed by central reading.
* Have inadequate response, loss of response or be intolerant of at least one of the following treatments: Oral GCS, AZA/6-MP, Biologics, JAK-inhibitors, or other approved advanced therapies for UC.
* Allowed to receive a therapeutic dose of the following UC drugs during the study: Oral GCS therapy (≤20 mg prednisone or equivalent/day) , Oral 5-ASA/SP compounds, AZA/6-MP.
* Ability to understand the treatment, willingness to comply with all study requirements, and ability to provide informed consent.

Exclusion Criteria Induction:

* Suspicion of differential diagnosis.
* Acute fulminant UC and/or signs of systemic toxicity.
* UC limited to the rectum or extending beyond the splenic flexure.
* Have failed treatment with more than three advanced therapies of two different therapeutic classes.
* Have had surgery for treatment of UC.
* History of malignancy, unless treated with no relapse of the disease and ≥ 5 years since last treatment (cured).
* History or presence of any clinically significant disorder.
* Concomitant treatment with cyclosporine, methotrexate, tacrolimus, or advanced therapies or similar immunosuppressants and immunomodulators.
* Treatment with rectal GCS, 5-ASA/SP or tacrolimus.
* Long-term treatment (\>14 days) with antibiotics or NSAIDs .
* Serious known active infection including history of latent or active tuberculosis.
* Gastrointestinal infections including positive Clostridium difficile stool assay.
* Females who are lactating or have a positive serum pregnancy test.
* Women of childbearing potential not using highly effective contraceptive methods.
* Concurrent participation in another clinical study.
* Previous exposure to cobitolimod.

Inclusion Criteria Maintenance:

* Participants are eligible to be included in the maintenance study if they have achieved clinical response at week 6 and have adhered to the protocol procedures of the induction study.

Exclusion Criteria Maintenance:

* Participants will not be eligible for the maintenance study if they are not willing to comply with all further study requirements.