cyrilzakka/clinical-trials huggingface dataset:
RCT of Pulp Capping Over Carious Exposure in Adults

This multicentre study was a randomized, controlled, parallel, patient-blinded, two-arm superiority trial with a 1:1 allocation ratio that followed the CONSORT guidelines.The aim of this study was to investigate whether MTA is more effective than a conventional calcium hydroxide liner (Dycal®) as a direct pulp capping material in mature molar teeth with a carious pulpal exposure.

Calcium hydroxide (CH) is considered the standard material for pulp capping with good results in cases with pulpal exposure as a result of dental trauma both in animal and clinical studies. However, in carious exposures, follow-up studies of direct pulp capping performed with CH based materials have shown increasing failure rates and the outcome has been considered uncertain. Direct capping of carious exposures still remains a controversial treatment for mature teeth.

A new material, mineral trioxide aggregate (MTA) was introduced for root end filling material almost two decades ago. It is also suggested for pulp capping. MTA cement has showed good sealing ability and bio-compatibility in animal studies. Results from studies in humans corroborate the results from animal studies.

Although the overall results of pulp capping in human studies using MTA are very positive, well designed and controlled clinical studies, especially involving carious exposures on adult teeth are lacking.At the time the present study was launched, there were no RCTs comparing MTA and CH as DPC materials and the histological evaluations have primarily been based on healthy teeth, thus undermining the generalizability of the results to adult patients with carious exposures.

Eligibility Criteria:
Inclusion criteria:

* Age 18-55 years
* 1st and 2nd permanent molars
* Proximal caries to inner 1/3 of dentin (bite-wing)
* Apex closed, no periapical changes (apical radiograph)
* No periodontal pockets deeper than 4mm
* Medical history non-contributory (incl.pregnancy)
* No medication (no antibiotics during last month)
* No signs or symptoms more severe than reversible pulpitis
* Positive response to electrical pulp test(EPT) or cold test
* Written consent Inclusion requires compliance with all the criteria listed

Exclusion criteria:

* During the treatment there will be no pulpal exposure
* The bleeding of the exposed pulp cannot be controled in 10 minutes
Feasibility and Safety of In-bed Self-exercise in Patients With Subacute Stroke

The goal of this to investigate the feasibility and safety of in-bed self-exercises based on EMG-sensor feedback in subacute stroke patients. The main question is feasibility and safety. It aims to answer are:

\[Pittsburgh Rehabilitation Participation Scale\] \[The number and percentage of participating sessions\] \[The number and percentage of completed sessions\] \[The number and percentage of successful sessions\] \[The mean amplitude of muscle contractions in a session\] \[The duration and percentage of participating sessions during self-exercise\] \[Rivermead motor assessment\] \[Manual muscle test\] \[brunnstrom stages of motor recovery\] \[Fugl Meyer assessment of lower extremity\] \[Berg balance scale\] \[Functional ambulation category\] \[modified Rankin scale\] \[modified Barthel index\] \[Short-form Health Survery 36 version 2\]

The intervention group is provided with graded exercise using the in-bed self-exercises based on EMG-sensor feedback according to muscle strength of the hemiplegic lower extremity and Brunnstrom stages of motor recovery in addition to conventional rehabilitation whereas the control group is provided with only conventional rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* 19 years and older
* the onset of the stroke is less than 3months ago
* Lower extremity weakness due to stroke (MMT =\< 4 grade)
* Modified Rankine Scale 2-5 points
* Cognitive ability to follow commands

Exclusion Criteria:

* stroke recurrence
* other neurological abnormalities (e.g. parkinson's disease).
* severely impaired cognition
* serious and complex medical conditions(e.g. active cancer)
* cardiac pacemaker or other implanted electronic system
Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation

There are very few level 1 or level 2 evidence studies that examine postoperative rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that found only four studies that examined rotator cuff repair rehabilitation.

The current study was performed to determine if there is a significant difference in passive glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins' exercises.

Null Hypothesis: There will be no significant difference in passive range of motion, active range of motion, scapular substitution, and subject measured outcomes scores in subjects who undergo rotator cuff repair when treated with pulley exercises compared to Jackins' exercises.

Scapulothoracic substitution for forward elevation is seen clinically when patients have shoulder pain. The patient uses the trapezius musculature to superiorly elevate the upper extremity instead of using the deltoid and the rotator cuff for upper extremity elevation. Scapulothoracic substitution does not occur in healthy shoulders. Excessive scapular movement can be due to an attempt to substitute for poorly functioning shoulder musculature or tightness of the capsular structures of the glenohumeral joint.

Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. Jackins described a series of exercises that are used to improve active range of motion and develop strength without the use of pulleys. The use of pulleys in the post-operative care for patients who have had shoulder surgery is thought to contribute to excessive scapular motion. To date, there has not been any study that compares the use of pulleys and Jackins' exercises with respect to active range of motion, scapulothoracic substitution, and objective patient outcomes measures. Due to the lack of level 1 or 2 evidence postoperative rehabilitation studies, a prospective randomized study should be performed on patients that have underwent rotator cuff repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing post-operative rehabilitation for a rotator cuff repair

Exclusion Criteria:

* Patients who do not have permission from their treating surgeon to enroll in this study.

Patients who have undergone a previous rotator cuff repair on the non-operated side.

Patients who have undergone a previous rotator cuff repair on the ipsilateral shoulder.

Patients who have a history of adhesive capsulitis. Patients who are unwilling to participate in all aspects of the study. Patients who are cognitively impaired. Patients with known axillary or suprascapular neuropathy. Patients with a painful or dysfunctional contralateral shoulder.
Long-term Urodynamics in Individuals With Neurogenic Lower Urinary Tract Dysfunction

The long-term changes of bladder function in individuals with lower urinary tract dysfunction will be investigated. Patients presenting for regular urodynamic examination of bladder function will be included. Bladder diary details and urodynamic data will be collected in order to investigate bladder function.


Eligibility Criteria:
Inclusion Criteria:

* neurogenic lower urinary tract dysfunction
* urodynamic data

Exclusion Criteria:

* duration of neurogenic lower urinary tract dysfunction \< 10 years
* \< 5 urodynamic follow-ups
Effect of Transcranial Direct Current Stimulation Associated With Aerobic Exercise Training for Patients With Fibromyalgia

This study consists of a randomized, double-blind, clinical trial with two months' duration of follow-up. The variable used was the VAS for pain, considering the values of any difference between the data before and after stimulation.

The average between the analyzed values was 1.20, with a standard deviation of 0.84, taking into account a type I error of 5%, a type II error of 10% and a power of 80%. From the sample calculation was found an n = 10 for each group. The sample is amplified in order to avoid possible effects of dropout ending with a n = 15 in each group with a total N = 45.

Randomization was performed by a blinded therapist using sealed envelopes for each individual. The subjects will be divided into three intervention groups: tDCS (tDCS - DC stimulator, Neurocom, Germany) / AE Group, in which will receive active intervention of aerobic exercise training and active tDCS intervention. AE group, which will receive active intervention of aerobic exercise and placebo tDCS. And tDCS group, which will receive placebo AE and active intervention for tDCS.

Participants will be blinded to the intervention groups as well as therapists involved in the evaluation process.

The evaluation methods were carried out one week before the beginning of the intervention (baseline) for all variables. After the first week of intervention (neuromodulatory period) was performed ratings for level of cortical excitability (T1), and after the end of the one month period of intervention for all variables (T2). Follow-up evaluations were conducted one month (T3) and two months (T4) after the end of the intervention period."

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with Fibromyalgia according to the American College of Rheumatology
2. Have completed high school
3. Age between 18 and 65 years old

Exclusion Criteria:

1. Were on medication for pain control for less than two months
2. In treatment of depression for less than two months
3. Patients with epilepsy, psychiatric disorders or who have any recent episode of neurologic disorders such as idiopathic syncope
4. Pregnant women and infants
5. Possessing metallic implant in the brain
6. In use of illicit drugs
7. That were in some kind of physical treatment for less than two months
Effect of MCT Emulsification on Ketogenesis in Human Adults

Lower brain glucose uptake is present before the onset of cognitive deterioration and may increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to incomplete absorption so the investigators examined whether homogenisation into a skim milk matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken without homogenisation into a matrix (bulk MCT \[MCT-B\]).

Hypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and MCT-H on ketogenesis will be dose-dependent.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or more

Exclusion Criteria:

* smoker
* pregnancy or breastfeeding
* diabetes or insulin resistance
* uncontrolled thyroid disease, hepatic or renal disease
* uncontrolled high blood pressure
* medical treatment influencing lipid or glucide metabolism
* ongoing or past severe drug or alcohol abuse
* dementia or psychiatric difficulties or depression
* chronic immune condition or inflammation
Neural Mechanisms of Motor and Cognitive Networks

This study investigates the neural mechanisms of motor and cognitive networks using cognitive assessment, reaction time measurement, high-density EEG and fMRI.


Eligibility Criteria:
Inclusion Criteria (for healthy people):

* right handed,
* no history of psychological/psychotic problems,
* no history of important diseases.

Exclusion Criteria (for healthy people):

* Being Pregnant or breast feeding
* having any non-MRI compatible conditions

Inclusion Criteria (for patients):

* right handed
* in a stable condition
* ability to follow complex commands

Exclusion Criteria (for patients):

* having any non-MRI compatible conditions
* inability to perform required tasks
A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users

Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.


Eligibility Criteria:
Inclusion Criteria:

* Active smoker

Exclusion Criteria:

* Enrollment in smoking cessation protocol
* Current use of nicotine replacement therapy
Sequential, Multiple Assignment, Double Randomized Preference, Migraine Behavioral Trial

This study will unpack the behavioral intervention for migraine and determine the optimum combinations. In addition, the study will test preference and self-selection effects during the trial.

After a 4-week screening period, eligible candidates (14 headache days in 4 week period, with 8 days being migraine) will be randomized into 2 arms -

* Choice Arm: allowed to choose from a menu of migraine behavioral treatment options
* Random: randomized to migraine behavioral treatment options.

After 6 weeks, all participants will be assessed for their migraine frequency. Patients will be considered Responders if the migraine frequency is reduced to 50%. The Non-responders (NR) of the Choice Arm will be again given a chance to pick any of the 3 arms. The NR of the randomized arm will be randomized to any of the 3 arms. The responders will continue for 6 more weeks in their original arms. By the end of the 12 weeks, all participants will complete the study, and migraine frequency will be compared between the different groups. All behavioral interventions will be delivered virtually.

Eligibility Criteria:
Inclusion Criteria:

* have chronic migraine for a minimum of 1-year
* aged 18 years and older

Exclusion Criteria:

* secondary headache disorders
* children younger than 18 years old
Contrast Enhanced Ultrasound for Renal Obstruction

This research is studying Definity ultrasound contrast agent, which is already approved by the Food and Drug Administration (FDA) for the ultrasound evaluation of the liver and heart. This research will investigate the ability to use ultrasound imaging with ultrasound contrast agents to evaluate kidney obstruction.

Eligible participants that are enrolled will have two visits (one before and one after the planned surgery to relieve the kidney obstruction).


Eligibility Criteria:
Inclusion Criteria:

* Unilateral renal obstruction confirmed by Nuclear Medicine MAG3 Dynamic Renal Scan (diuretic t (time) ½ \>20 minutes)
* Obstructed kidney with differential function \>15% confirmed by Nuclear Medicine Mercaptoacetyltriglycine (MAG3) Dynamic Renal Scan within less or equal (\<=) 6 months from enrollment
* Patient has elected to move forward with pyeloplasty or proximal ureteroureterostomy to correct the obstruction

Exclusion Criteria:

* Solitary kidney
* Any abnormalities of contralateral collecting system (for example (e.g.) hydronephrosis, renal calculi, duplicated collecting system)
* Known vesicoureteral reflux
* Ureteral stent in place in the obstructive kidney
* Patients without a Nuclear Medicine MAG3 Dynamic Renal Scan
* Previous history of hypersensitivity to Ultrasound Contrast Agents or Definity (perflutren lipid microspheres))
* Previous sensitivity to polyethylene glycol
* Pregnant or breastfeeding females
* Body mass index (BMI) \>=40 without prior ultrasound confirming ability to adequately visualize the kidneys (Elevated BMI is known to decrease ability to image the kidneys)
* Global renal function with a Glomerular Filtration Rate (GFR) \<30 (chronic kidney disease Stage 4 \& 5 excluded)
* Unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias, presence of a cardiac shunt)
A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse

Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.

Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.

Eligibility Criteria:
Inclusion Criteria:

* Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology

Exclusion Criteria:

* Recurrent vaginal prolapse, wault prolapse
Effect of PRP Injection in Releiving of Symptoms of Senile Vaginitis

30 postmenopausal females with senile vaginitis will be enrolled with score of \<15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.

30 postmenopausal females with senile vaginitis will be enrolled with score of \<15 on the Gloria Bachman Vaginal Health Index (VHI) intramucosal injections of PRP will be adminstered and perform clinical evaluations at 0, 1, 3, and 6 months.

The patients will be seen in Ain shams university gynecological clinic and will not be paid either to receive the procedure or to complete the survey. All patients were fully informed of the innovative therapeutic and experimental nature of the localized PRP injection and consented to the procedure.

The materials and equipment included the following:

1. 5 cc syringes.
2. 27 gauge needles.
3. Centrifuge with proprietary collection system.
4. Calcium chloride 10% (for activation of PRP).
5. and a topical anesthetic cream compounded with a base that prevents irritation and promotes absorption through the vaginal mucosa. Active ingredients will be as follows: bupivicaine, lidocaine, and tetracaine with percent concentrations of 20/8/8 respectively.

First, a topical anesthetic cream will be applied to the posterior vaginal wall. Delaying the PRP injection for 20 minutes after anesthetic application achieved complete or near complete analgesia for the procedure. Peripheral blood will be drawn from the arm and centrifuged to yield 5 cc of PRP. The Regen® system concentrates 5ml of PRP from 10 ml of whole blood using a gel separator.

Study Interventions:

After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal for at least 3 years.
* Vaginal health index \<15.
* Any parity.

Exclusion Criteria:

* Women with vaginal infection.
* Women taking estrogen therapy for senile vaginitis.
* Any patient with medical disorder especially diabetes mellitus.
* Previous vaginal surgery as fistula repair or classical repair.
* Vaginal prolapse
* Any patient taking chemo or radiotherapy.
Clinical Study to Investigate Visual Performance of IOL: FineVision HP

This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.

Eligibility Criteria:
Inclusion Criteria:

* Cataracteous eyes with no comorbidity
* Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Unrealistic expectation
* Irregular astigmatism
* Regular corneal astigmatism \>0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Complicated surgery