cyrilzakka/clinical-trials huggingface dataset:
Stabilometry Changes After Dry Needling in Flexor Digitoum Brevis

The aim of this clinical trial is to check the balance effects of dry needling in the Flexor digitorum Brevis

Eighteen healthy subjects wil be recruited for a quasi-experimental study. Participants will be from 18 to 40 years old, not obese. Participants will be measured before and after bilateral dry neddling in Flexor digitorum Brevis. The investigators will measure stabilometry variables with eyes open and closed.

Measures. Stabilometry will be measured by displacement of the center of pressures in X and Y with eyes open and closed , center of pressure (COP) with eyes open and closed, COP area with eyes open and closed, COP antero-posterior (a-p) and medio-lateral (m-lat) directions with eyes open and closed, and COP speed. Two trials will be recorded for each condition and the order of the conditions will be randomized across subjects, eyes open and eyes closed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Must have latent trigger point in Flexor Brevis Digitorum muscles

Exclusion Criteria:

* Previous lower extremities surgery.
* History of lower extremities injury with residual symptoms (pain, "giving-away" sensations) within the last year.
* Leg-length discrepancy more than 1 cm
* Balance deficits (determined by oral questionnaire regarding falls)
Effect of Prebiotics on Blood Glucose Management

This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood glucose, gut microbiota and cardiovascular risk fators in subjects with hyperglycemia.

Highland barley β-glucan belongs to the group of prebiotics and has been found to be associated with multiple health benefits. However, its protective role in subjects with hyperglycemia are remain unclear. This study aims to examine the effect of 8-week prebiotics supplementation on glucose management in subjects with hyperglycemia. By understanding the mechanism by which prebiotics exert the beneficial effects, we can better control the rising prevalence of hyperglycemia, which is a major risk factor for cardiovascular diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 30-65 years old
2. Fasting venous plasma glucose ≥5.6mmol/L OR plasma glucose 2 h after an oral glucose load ≥7.8mmol/L OR glycosylated hemoglobin ≥5.7% OR newly diagnosed diabetes without hypoglycemic drugs using
3. BMI≥18 kg/ m2

Exclusion Criteria:

1. Receiving or have been treated with hypoglycemic drugs or insulin.
2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.
3. Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR\<30ml/min/1.73m2).
4. Autoimmune diseases or thyroid diseases.
5. Women who are pregnant, nursing, or prepare to give birth during the trail.
6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease.
7. Mental or intellectual abnormalities, unable to sign informed consent.
8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.
9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.
10. Major operations were performed within six months of screening visit, or will be made during the trial.
11. Alcohol abuse (alcohol intake\>60g/d for male and alcohol intake\>40g/d for female)
Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery

Assess the efficacy of 2 Cervical Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous birth before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted during weeks 16th and 24th and removed at 36 weeks and 6 days in pregnant women at high risk of premature birth.

Participant selection will be performed by screening the general population of pregnant women with single fetus monitored by the Hospital Healthcare Network, to investigate by serial transvaginal ultrasound performed between gestation weeks 16 (0 day to 7 days) and 24 (0 day to 7 days) those patients who have a cervical length between 10 mm and 25 mm, and/or women with a single fetus and cervical length ≥10 mm presenting one or more of the following risk factors:

1. preterm birth prior to 35 (34 weeks and 6 days) weeks of gestation;
2. premature rupture of membranes prior to 35 (34 and 6 days) weeks of gestation.

After insertion of the pessary or beginning of the administration with vaginal progesterone capsules and until 28 weeks of gestation, participants in the 3 treatment groups will be monitored every 4 weeks at the most or more often, if the site has established so as a control standard. After 28 weeks, patients should be monitored every 2 weeks.

The proportions of spontaneous preterm delivery before gestation weeks 32 and 34 will be compared between the control group and the 2 groups with the pessaries containing different doses of progesterone.

Eligibility Criteria:
Inclusion Criteria:

* Women with a single pregnancy and a cervical length of 10 mm - 25 mm between 16 and 24 weeks of gestation, without any previous factors.
* Women with a single pregnancy with 10 mm or more cervical length between 16 and 24 weeks of gestation, and pre-existing risk factors risk factors for preterm birth:
* Previous preterm birth before week 35.
* Previous rupture of membranes before week 35

Exclusion Criteria:

* Pregnancies with:

  * Major fetal abnormalities, such as lethal malformations or malformations requiring pre- or post-natal surgery; and fetal death before inclusion into the study.
  * History of rupture of membranes or prophylactic cerclage before study entry.
* Cervical or vaginal injuries prior to insertion of the pessary (e.g., cervical erosion secondary to trauma, infection, or carcinoma; vesicovaginal or rectovaginal fistulas).
* Unconscious, severely ill or mentally disabled patients, or under 16 years of age.
* Patients for whom use of progesterone is contraindicated.
* Patients with history of thrombosis.
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY

This study will assess tolerability, safety, and pharmacodynamics (PD) of twice daily (BID) administration of PF- 06882961 in adult participants with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and in non-diabetic adults with obesity


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between the ages of 18 and 75 years, inclusive, at Visit 1 (screening).

Exclusion Criteria:

* Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes.
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, New York Heart Association Functional Class II IV heart failure, or transient ischemic attack within 6 months of screening (Visit 1).
* Participants with a known medical history of active liver disease (other than non alcoholic hepatic steatosis), including chronic active hepatitis B or C, or primary biliary cirrhosis.
* History of major depressive disorder or history of other severe psychiatric disorders (eg, schizophrenia or bipolar disorder) within the last 2 years.
* Any lifetime history of a suicide attempt.
Acceptance and Commitment Therapy for Smoking Cessation in the Primary Care Setting

The purpose of this study is to evaluate the feasibility and potential efficacy of Acceptance and Commitment Therapy (ACT) in enhancing smoking cessation among attendees in primary healthcare settings.

The program is preventive and corrective, and carries brief messages by approaching and influencing services attendees who may not be able to reach in traditional reactive approach method of service users. Those traditional approaches are, for example, quitline and smoking cessation clinic. It can therefore benefit a larger population at low cost.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years and older
* currently smoking at least one cigarette per day in the past 30 days
* Hong Kong residents
* able to communicate in Cantonese
* currently residing in Hong Kong and expecting to continue to do so for the next 6 months
* have access to a telephone

Exclusion Criteria:

* currently undergoing another smoking cessation or similar program
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse

The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.

.Aims/Objective The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, we will evaluate the short and long-term clinical outcomes after this new procedure.

Primary Outcomes

1. Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance
2. Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)
3. Sedation and local anesthesia feasibility: surgery completed without patient intubation
4. Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications
5. Long Term Clinical Outcomes: Rectal Prolapse Recurrence

Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected prospectively before, during, and after surgery.

Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Age, 75 years and older, Male and Female
* BMI above 18 and ≤30
* ASA class 1-3
* willing to participate in the study

Exclusion Criteria:

* ASA class 4-5
* Previous Abdominal Surgeries including abdominal wall repair with mesh
iDropper Usability in Glaucoma

The purpose of this study is to evaluate the usability of a medication management support system for glaucoma patients self-administering eye drops named iDropper. The iDropper system is a home-based ocular medication management system that reminds, instructs, dispenses, and records eye drop medication usage. The iDropper system will be evaluated among a cohort of glaucoma subjects self-administering eye drops for 4-weeks.

Glaucoma is a leading cause of vision loss in the United States, impacting the lives of \~4 million people. Left untreated or inadequately managed, it causes blindness -- the second ranking cause of blindness in the world as well as the leader among African Americans. Estimates project 79.6 million glaucoma diagnoses worldwide by 2020; of these, 74% will have open-angle glaucoma (OAG), which occurs virtually without symptoms. The explanation for such strikingly high disease prevalence and blindness rates is partially due to the asymptomatic nature of glaucoma. However, deficient adherence to glaucoma ocular hypotensive drops is a significant and escalating health care problem.

Glaucoma eye drops are often the first therapeutic choice and very effective at controlling intraocular pressure (IOP) to prevent eye damage. However, glaucoma is a chronic condition and daily dosing regimens for medications can be complex and difficult to manage with impaired vision. Consequently, adherence and persistence to glaucoma eye drop regimens over time becomes quite poor. Overwhelming research brings the unwelcome conclusion that long term persistence with glaucoma medication is 33-39% at one year and positively contributes to blindness.

Currently, no mechanism exists for supporting and monitoring glaucoma eye drop compliance.

The purpose of this study is to evaluate the usability of a medication management support system for glaucoma patients self-administering eye drops named iDropper. The iDropper system is a home-based ocular medication management system that reminds, instructs, dispenses, and records eye drop medication usage. The iDropper system will be evaluated among a cohort of glaucoma subjects self-administering eye drops for 4-weeks.

At study conclusion usability and satisfaction assessments will be performed to evaluate iDropper system performance.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age;
* Physician diagnosis of: open angle glaucoma, angle-closure glaucoma, glaucoma suspect, or ocular hypertension
* Responsible for self-administration of eye drops.
* No surgery within the prior 3 months;
* Able to speak and read English;

Exclusion Criteria:

* Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
* Cognitive or visual impairment that would interfere with completing a self-administered questionnaire.
RC2S+: Remediation of Social Cognitive Impairments

Background:

Difficulties in social interactions are a central characteristic of people with schizophrenia, and can be partly explained by impairments of social cognitive processes. According to renown researchers, three to five social cognitive processes are usually altered in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional style; and (4 and 5) social perception and knowledge. The components of social cognition appear to be related to both symptomatology and functioning in everyday life.

New strategies of cognitive remediation have been recently developed to target these deficits and few meta analyses have assessed the extent to which social cognitive remediation programs have led to multiple improvements for schizophrenia patients. Overall, it seems that such therapies showed encouraging results in both patient interest and motivation, and social cognitive processes.

The RC2S therapy is the first individualized and partly computerized program through which patients practice social interactions and develop social cognitive abilities with simulation techniques in a realistic environment.

Methods:

This is a randomized controlled trial to establish the validity of the RC2S+ program in schizophrenia.

The project's main objective is to assess the impact of RC2S+ on social cognitive impairments in schizophrenia compared with a cognitive remediation program (control therapy) focusing on neurocognition, equivalent in terms of number, duration and rhythm of sessions.

The study has four other objectives:

1. To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive processes
2. To assess the impact of the RC2S+ therapy versus control therapy on social functioning
3. To assess the impact of the RC2S+ therapy versus control therapy on both positive and negative symptoms
4. To study the maintenance of benefits 3 months forward

Outcomes:

To treat social cognitive impairments in people with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45 years old
* Diagnosis of schizophrenia assessed with DSM5 criteria (APA, 2013)
* No modification of psychotropic treatment during the month before inclusion (variation of 20% of the dose is tolerated
* French native language or education in a French school since the first year of primary school
* Consent to participate to the study and agreement of the legal guardian
* Patients who have not benefited from cognitive remediation during the three months before inclusion

Exclusion Criteria:

* Substance use disorder (criteria of DSM-5), except for caffeine and tobacco
* Neurologic disorders (vascular, infectious or neurodegenerative)
* Uncorrected visual deficit
* Medical drugs with cerebral or psychological effect (e.g, corticosteroids)
* Patients resistant to antipsychotic medication
* Pregnancy
Clinical Trial for the Application of Tirobot System

The object of this study was to evaluate the accuracy and safety of the Tirobot system.

Tirobot system is a new-type medical robot-assisted surgery system that designed for spine and traumatic orthopaedic surgeries. This system has been certified by CE. The accuracy and safety of pedicle screw placement using this system will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* traumatic or degenerative thoracolumbar disease required for pedicle screw fixation surgery

Exclusion Criteria:

* severe osteoporosis
* old thoracolumbar fracture
* deformity of pedicle
* combined with coagulation disorders
* combined with other systematic disease
A Phase 1 Study of Tegoprazan on Healthy Male Volunteers

A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects

* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
* To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
* To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males aged ≥ 19 years and ≤ 50 years
* Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening

Exclusion Criteria:

* Presence or history of clinically significant diseases
* Presence or history of gastrointestinal disorder (gastric ulcer, GERD, - Crohn's disease, etc.)
* Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
* Serologic test positive
* Abnormal obstacle to insertion and maintenance of pH meter catheter
* History of drug abuse
* Excessive caffeine intake or persistent alcohol intake
* Not use of a medically acceptable method of contraception
Pathological Characteristics of Basal Cell Carcinoma

A hospital based cross-sectional study was conducted from 2017 to February 2021. Clinical history, examination and histopathological variants were collected from medical files and pathology reports. Confirmation of pathology was done in all the patients visiting skin and plastic surgery department with suspected lesions.

Some cases may be tested for immunohistochemistry on the tissue block

Eligibility Criteria:
Inclusion Criteria:

* Excised lesion
* Confirmed basal cell carcinoma pathologically

Exclusion Criteria:

* Incision biopsy
* Incomplete follow up
Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease

This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .

In the gastrointestinal (GI) tract live wide spectrum of bacteria, in this study we are trying to find if there is a relation between the GI tract bacteria and the development of non alcoholic fatty liver disease, the results of the this study may help us identify the stage of liver disease in noninvasive means and enables us to adopt methods to reduce morbodity.

Eligibility Criteria:
Inclusion Criteria:

* patients with non alcoholic fatty liver disese.
* patients who give approval to participate in the study

Exclusion Criteria:

* liver failure
* acute or chronic kidney failure
* heart failure ( NYHA 3-4)
* active cancer
* fatty liver due to non alcoholic etiology.
* patients who consume drugs from the estrogen/methotrexate family, or chloroquine.
* history of hypothyrodism or cushing.
* patients who used TPA in the last 6 months .
* pathients with chronic liver disease like A1AT, hemochromatosis, wilson, toxic damage and autoimmunity .
* special population like - children, pregnant women and patients who lack the ability to make judgment.
* infectious liver disease - viral hepatitis or HIV.
* inflammatory bowel disease.
* patients who underwent surgery of the gastrointestinal trant.
Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection.

* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
* Cohort B: post-liver transplant, with or without cirrhosis;
* Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
* Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Chronic genotype 1 and/or 4 HCV infection
* Normal ECG
* Negative serum pregnancy test for female subjects
* Male subjects and female subjects of childbearing potential must agree to use contraception
* Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Exclusion Criteria:

* Serious or active medical or psychiatric illness
* HIV or hepatitis B viral (HBV) infection
* Stomach disorder that could interfere with the absorption of the study drug
* Treated with an anti-HCV medication in the last 30 days
* Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
* Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
* History of clinically significant medical condition associated with other chronic liver disease
* Active spontaneous bacterial peritonitis at screening
* Females who are breastfeeding
* Infection requiring systemic antibiotics
* Participated in a clinical study with an investigational drug or biologic within the last 30 days
* Active or history (last 6 months) of drug or alcohol abuse
* History of organ transplant other than liver, kidney, or corneal.