cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial

Fecal incontinence is frequent and has a significant impact on the quality of life of individuals. Its therapeutic management is based primarily on transit regulation and rehabilitation and secondarily on neuromodulation of the sacral roots. However, this strategy is insufficient in more than one patient out of three. The patient and the clinician are often at a loss and the therapeutic possibilities are limited to the use of evacuating enemas and/or a colostomy.

The practice of autologous fat injections was initially developed in plastic surgery. The studies that have evaluated the efficacy of autologous fat injections in fecal incontinence in men are preliminary and old isolated observations. However, they have shown an improvement in episodes of fecal incontinence and in sphincter parameters. In the field of proctology and autologous fat injections, 2 recent small open studies have evaluated the efficacy and morbidity of this therapy in the treatment of anal fistulas related to Crohn's disease.

The primary hypothesis of the work is that autografting adipose tissue into the intersphincteric space can decrease episodes of fecal incontinence in patients with severe fecal incontinence due to sphincter failure. The secondary hypotheses are that autograft of adipose tissue in the intersphincter space improves resting anal pressures, is a well-tolerated technique for patients, and may improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. severe fecal incontinence characterized by at least one episode of weekly fecal incontinence
3. failed rehabilitation and dietary management strategies
4. who have failed/contraindicated/refused sacral root neuromodulation (in the indication of fecal incontinence)
5. having, for women of childbearing age, effective contraception throughout the study
6. having given free, informed and written consent

Exclusion Criteria:

1. unable or unwilling to undergo follow-up or symptomatic evaluation
2. contraindication to general anesthesia
3. contraindication to metronidazole (hypersensitivity and wheat allergy)
4. significant pelvic static disorder
5. active anal suppuration
6. anal stenosis
7. externalized rectal prolapse
8. chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)
9. on anticoagulants or antiaggregants
10. history of anal or rectal neoplasia
11. coagulation anomaly, curative anticoagulation
12. history of rectal surgery
13. history of pelvic radiotherapy
14. previous treatment with inert materials (hyaluronic acid, biosilicones, coaptitis) in the 5 years preceding inclusion
15. allergy to lidocaine or contraindication to adrenaline
16. protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant or breast-feeding woman, minor)
17. participating in another interventional trial concurrently
18. not covered by a social security system
Perception of Facial Expressions Following Correction of Wrinkles and Folds

The purpose of this study is to evaluate the perception of facial expressions following correction of wrinkles and folds in the lower face using Emervel Classic Lidocaine and Emervel Deep Lidocaine.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* NLFs assessed as moderate of severe using the WSRS
* Intent to undergo optimal correction of both NLFs
* Intent to undergo correction of at least one other wrinkle or fold in the lower face

Exclusion Criteria:

* Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction
* Subject who presents with severe midface volume loss
* Subject who presents with facial hair, e.g. beard, moustache, in the treatment area
* Woman who is pregnant or breast feeding or plans to become pregnant during the study
* Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three (3) months before study treatment
* Previous surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area
* Previous tissue augmenting therapy or contouring with permanent filler or fat-injection below the zygomatic arch
* Previous tissue augmenting therapy, contouring or revitalisation treatment with non-HA filler, e.g. Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), below the zygomatic arch within 24 months before treatment
* Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler below the zygomatic arch within 12 months before treatment
* Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch within six (6) months before treatment
* Previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment
* Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting

The goal of this study is to test the feasibility and acceptability of tethered capsule Optical Coherence Tomography (OCT) endomicroscopy as a device for population-based screening in the primary care practice environment.

60 healthy volunteers scheduled for a routine primary care visit will be recruited and asked to swallow the OCT capsule while being awake and unsedated. The capsule is attached to a tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired and later analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be scheduled for non-urgent appointment at primary care practice including annual wellness visits and routine follow-up appointments.
* Subjects must be over the age of 18
* Subjects must be able to give informed consent
* Subjects must have no solid food for 4 hours prior to the procedure, and only clear liquids for 2 hours prior to the procedure.

Exclusion Criteria:

* Subjects with current symptoms of dysphagia
* Subjects with any history of intestinal strictures, prior GI surgery, or history of intestinal Crohn's disease.
* Subjects with current symptoms of fever, nausea or sore throat at the time of the appointment.
* Pregnancy
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis

The primary objectives of this study are to assess the safety and efficacy of MS1819 in enteric capsules vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The exploratory objective of the extension phase (EP) is to find a dose of MS1819 in immediate release capsules that is safe and results in CFA values in a therapeutic range.

This is a Phase 2, open-label, multicenter, 2, 2x2 crossover study assessing the safety and efficacy of MS1819, 2240 mg/day vs porcine PERT, and 4480 mg/day vs porcine PERT given at the same dose and dosing regimen that was being administered during the pre-study period. MS1819 will be administered in enteric capsules.

MS1819 will be assessed in a 2x2 crossover including approximately 30 patients completing both periods. Fifteen patients will be randomized to the MS1819 2240 mg/day vs PERT arm, and 15 patients will be randomized to the MS1819 4480 mg/day vs PERT arm. Patients in each arm will further be randomized to receive either the sequence consisting of MS1819 for 3 weeks followed by PERT for another 3 weeks or the opposite sequence of treatments, PERT for 3 weeks followed by MS1819 for another 3 weeks.The coefficient of fat absorption (CFA) will be measured at the end of each 3 week study period. Patients enrolled into the extension phase (EP) will be composed of patients who have completed the crossover phase of OPTION 2.

Eligibility Criteria:
Inclusion Criteria:

1. Cystic fibrosis, based on 2 clinical features consistent with CF, plus either a new/historic sweat chloride ≥60 mmol/L (measured while not on a CFTR modulator) or genotype.
2. Under stable dose of porcine PERT
3. A fair or better nutritional status
4. Fecal elastase \<100 µg/g
5. Standard-of-care medications including CFTR modulators are allowed

Exclusion Criteria:

1. History or diagnosis of fibrosing colonopathy
2. Any chronic diarrheal illness unrelated to pancreatic insufficiency
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥5 ×upper limit of normal (ULN), or total bilirubin level ≥1.5 ×ULN at the Screening visit
4. Feeding via an enteral tube during 6 months before screening
5. Forced expiratory volume ≤30% at the Screening visit
EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye

The aim of the EAGLE Study is to compare the efficacy of conservative medical treatment and local intraarterial fibrinolysis in patients with central retinal artery occlusion and to evaluate benefit and risk for the patient of both therapies.


Eligibility Criteria:
Inclusion Criteria:

* Subtotal central retinal artery occlusion or central retinal artery occlusion with choroidal hypoperfusion not lasting longer than 20h
* Patients aged from 18 years to 75 years (in case of pre-existing blindness of other eye also older than 75 years)
* Informed consent of the patient

Exclusion Criteria:

* Central retinal artery occlusion lasting longer than 20h
* Eye diseases, namely branch retinal artery occlusion, cilioretinal arteries supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy and elevated intraocular pressure (over 30 mmHg)
* Systemic diseases, namely severe general diseases, systemic arterial hypertension (systolic pressure \> 200 mmHg), despite medical therapy, acute systemic inflammation (erythrocyte sedimentation rate \> 30 mm within the first hour/ C-reactive protein \> 1,0 mg/dl), antithrombin-III deficiency in case of thrombocytopenia (\< 100000 per ml): pathologic clotting time, acute pancreatitis with elevated pancreas enzymes
* Medical History: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with marcumar/warfarin, allergic reaction to contrast agent, haemorrhagic diathesis, aneurysms, inflammatory vascular diseases (e.g., giant cell arteritis, Wegener´s granulomatosis), endocarditis, gastric ulcer
* Patient participation in other studies during the prior 4 weeks
* No willingness and ability of the patient to participate in all follow-up examinations
* Pregnancy
* Written consent not given
* Patient is not mobile (bedridden)
* Other conditions/ circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, no fixed abode)
Influence of Maternal Postioning on Spread of Local Anesthetic After Epidural Analgesia

The purpose of this study is to determine if a lateral positioning of the pregnant woman after epidural analgesia increases the incidence of unilateral functioning epidurals.

Pregnant women requesting epidural analgesia will be randomized to either left lateral or semi-recumbent position for 30 minutes after the first epidural bolus-injection.

After 30 minutes, the clinical effect of the analgesia will be evaluated by an anesthesiologist if available or by a midwife if the anesthesiologist is unavailable. The study-period is concluded thereafter and further positioning is optional.

Maternal and fetal wellbeing are continuously being monitored during the study period and complications/interventions registered. APGAR and CTG results during the intervention will be registered and evaluated at a later stage.

Eligibility Criteria:
Inclusion Criteria:

* all adult pregnant women recieiving epidural analgesia

Exclusion Criteria:

* participation refused
* inability to understand study purpose/instructions
* study postition could not be maintained for 30 min
* ineffective epidural
Different Home Exercise Programs in Neck Pain

Purpose: The aim of this study was to compare the effects of two different home exercise methods on exercise compliance, neck pain and neck disability in individuals with neck pain.

Material and metods: The study, carried out between February 2018 and May 2018 at Istanbul Arel University Vocational School, was performed with 60 people aged 25-60 years who were suffering from neck pain in academic and administrative staff. The cases were randomly divided into two groups. In Group 1, the case was given home exercise method (B.M.E.Y) with printed materials whereas Group 2 was given exercise with home exercise method (V.H.E.Y) with video phone reminder. Pain intensity was evaluated before and after exercise with 'Visual Analog Scale' (VAS), whereas the level of neck disability was evaluated before and after exercise with 'Neck Pain and Disability Score' (NPDS). The obtained results were analyzed using appropriate statistical methods.

Both groups were prescribed the same type of exercise, duration of exercise and number of repetitions. group 1 completed the exercise program and marked the exercise attendance schedule. At the end of the program, these charts were collected from the subjects and the continuity was evaluated. The group marked the exercises completed with 2 phone app. In the program used, exercise continuity of the cases was evaluated as days.

Exercises were given at least 3 times a week for 10 weeks and 1 set per day for a total of 6 weeks. individuals; normal joint movement exercises; neck flexion, lateral flexion, rotation, extension and retraction movements, isometric exercises; neck flexion, extension, lateral flexion and rotation movements and stretching exercises; neck lateral flexion, neck rotation and flexion movements were given.

Eligibility Criteria:
Inclusion Criteria:

* complaint of neck pain,
* Being between 25-60 years of age

Exclusion Criteria:

* taking painkillers regularly,
* undergoing any neck surgery and severe trauma,
* presence of any diagnosed neck disease
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records.

Eligibility Criteria:
Inclusion Criteria:

* 1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
* 2. Male or female patients of any age (interest is given to children to compare with mothers).

Exclusion Criteria:

* 1. Refusal to sign informed consent form
* 2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
* 3. Postoperative stoma, ostomy, or ileoanal pouch
* 4. Participation in any experimental drug protocol within the past 12 weeks
* 5. Treatment with total parenteral nutrition
* 6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
* 7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents

The objective of the study is to compare the efficacy of gabapentin and amitriptyline for treating neuropathic pain in children in a randomized controlled trial.

Clinical experience and case reports suggest that both amitriptyline and gabapentin are effective treatments for neuropathic pain in children; however we do not know which drug is more effective for specific pain conditions or for specific children. This study will be the first prospective, randomized double-blind controlled trial directly comparing gabapentin and amitriptyline for the treatment of neuropathic pain in a paediatric population. We will also study the time course for pain reduction and evaluate changes in children's physical function, mood, and sleep. This information is needed to determine which drug is better for which children and which pain conditions.

Eligibility Criteria:
Inclusion Criteria:

* 8 - 17 years of age
* Diagnosis of neuropathic pain

Exclusion Criteria:

* Additional health problems
* Lactose intolerant
* Unable to swallow size 0 gelatin capsules
* Pregnant
* Unable to speak English
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)

S-ICD avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death. The long-term safety and feasible of S-ICD system in Asian population with a smaller body size remain unclear. The investigators propose to perform a prospective study in Korean population to investigate the safety and feasibility of S-ICD for primary or secondary prevention of sudden cardiac death.

The investigators propose to prospectively recruit 300 patients who are qualified to receive the EMBLEM S-ICD system by following the proposed BSC Patient Screening Steps in 10 sites in Korea. All patients will be follow-up as standard of care to collect acute procedural and device related complications as well as long-term, device related, clinical and patient reported outcomes. Follow up data will be systematically collected over 24 months post-implant.

Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years of age
2. Patients with conventional indications for ICD and;
3. Ability to provide informed consent and to complete the study and required follow-up

Exclusion Criteria:

1. planned cardiac surgery within 3 months of enrollment;
2. pregnancy;
3. life expectancy \<3 months;
4. indication for CRT-D or permanent ventricular pacing for new implant;
5. incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and
6. patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain

The aim of this study will be to investigate the effect of functional exercise on pain, functional disability and core strength in patients with chronic mechanical low back pain .

To our knowledge, there has been not enough studies that investigated the effect of core strengthening by functional exercise on pain, functional disability and core muscle strength in patients with chronic mechanical low back pain. Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.

the finding of this proposed work may help patients with chronic mechanical low back pain by addressing their pain, functional limitation, and/or participation restrictions. Consequently, this can speed up their recovery, return to work, decrease cost of treatment, improve psychological status, decrease level of irritability, and improve overall quality of life.

Patients with chronic mechanical low back pain will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form.

The subjects will be randomly assigned into one of two groups:

* Group I (control) will receive advices only.
* Group II (experimental) will receive a suggested functional exercise program plus advises.

the measurments will take before and after treatment programe .

Eligibility Criteria:
Inclusion Criteria:

* Chronic mechanical low back pain and their age will be ranged from 20 -45 years.
* History of chronic low back pain (≥3 months).
* Patients with Body Mass Index (BMI) between 18-28

Exclusion Criteria:

* Age younger than 20 or older than 45 years of age.
* History of any surgical procedure in the back or the lower extremities
* Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
* Patient with lumbar instability including spondylolisthesis.
* Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
* Pregnancy.
Efficacy and Safety of TwHF and MTX in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium Wilfordii has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a multicenter ,double Blind, randomized study to evaluated the efficacy and safety of Tripterygium Wilfordii in treating of patients with rheumatoid arthritis (RA) and establish a prediction model for Tripterygium Wilfordii response of rheumatoid arthritis (RA).

Two arms were included in this study. Active Comparator: treatment of MTX Patients were treated with methotrexate (MTX)and Tripterygium wilfordii Hook F（TwHF）placebo.Experimental: treatment of TwHF Patients were treated with methotrexate (MTX) and Tripterygium wilfordii Hook F（TwHF).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis as determined by the 1987 or 2010 ACR classification criteria;
* No male or female fertility requirements, or around menopause women;
* Patients with mild-to-moderate activity, 2.6 \< DAS28≤5.1;
* No serious system involved, such as severe pericardial effusion, interstitial lung disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc;
* Within a month before the selected participants did not attend any drugs

Exclusion Criteria:

* Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
* Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
* Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
* Previous treated with Tripterygium Wilfordii or MTX
* Patients with retinopathy.
Pyrocarbon Clinical Follow-up Study

The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort.

Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).


Eligibility Criteria:
Inclusion Criteria:

* Subject in the Pyrocarbon IDE Study and has not had the device explanted.
* Patient informed, willing, and able to sign an informed consent form approved by IRB or EC
* Willing and able to comply with the requirements of the study protocol

Exclusion Criteria:

• Subjects who are not able to comply with the study procedures based on the judgment of the assessor will be excluded (e.g. cannot comprehend study questions, inability to keep scheduled assessment times)