cyrilzakka/clinical-trials huggingface dataset:
PNF in Subacromial Impingement Syndrome

Although proprioceptive neuromuscular facilitation (PNF) techniques have been used in the treatment of different shoulder problems, PNF techniques in scapular and upper trunk patterns with extremity pattern have not been considered as a possible option for the treatment of Subacromial Impingement Syndrome (SIS). The aim of this study was to evaluate the effects of different PNF patterns in SIS.

This randomized controlled trial was conducted in the Outpatient Clinic of a Physiotherapy and Rehabilitation Department in Ankara, Turkey. The demographic and clinical characteristics of the patients were recorded. Voluntary patients with SIS were regarded as eligible for the study if they met the inclusion criteria. Pain, posture and functionality were assessed before and after intervention. Patients who met the inclusion criteria and agreed to participate were randomly allocated to Group 1 \[Conventional therapy (CT)\], Group 2 \[CT+ PNF in extremity pattern\] and Group 3 \[CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns\]. A simple randomization method was used with opaque sealed envelopes containing "A", "B" or "C". Group allocation was performed by an independent therapist, not involved in the study. All patients received physiotherapy for approximately 60 mins each session, 3 sessions per week for 6 weeks. Conventional therapy consisted of cold pack (15 minutes); pulsed ultrasound therapy (1 watt/cm², 3 MHz, 1:2 pulsed mode; 3 minutes); transcutaneous electrical nerve stimulation (60-120 Hz; 20 minutes) and exercises (20 minutes). The exercises included stretching, strengthening and posture exercises. The exercises, and the duration and intensity of conventional physiotherapy were selected according to previous studies which showed that a physiotherapy program 3 times a week for 6 weeks was effective in improving function and relieving pain in SIS. The physiotherapy program was applied to all patients at the same intensity by the same physiotherapist and patients did the exercises every day throughout the 6-week period. The patients were also advised to avoid overhead activities.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with SIS,
* aged between 18 and 65 years,
* shoulder pain ongoing for more than four weeks,
* loss of active shoulder motion or painful ROM,
* no treatment related to the shoulder in the last 6 months.

Exclusion Criteria:

* history of frozen shoulder,
* disorders of the acromioclavicular joint,
* possession of a curved or hooked acromion,
* shoulder instability,
* degenerative arthritis of the glenohumeral joint,
* calcifying tendonitis,
* post-traumatic disorders,
* shoulder surgery and/or elbow, hand, wrist and cervical spine disorders,
* diseases that can cause positional vertigo.
Impact of Prebiotics in Ulcerative Colitis

The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.

Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 85 years old
* History of biopsy-proven ulcerative colitis (UC)
* Active symptoms (SCCAI \>2)
* Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
* Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
* Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial

Exclusion Criteria:

* Prior colectomy
* Hospitalization
* Urgent need for abdominal surgery
* Unstable major medical condition
* Active malignancy under treatment
* Active alcohol or non-cannabinoid substance abuse
* Pregnancy or lactation
* Concerns for non-compliance
The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis.

Qualified subjects will be enrolled and randomly assigned to either of the two study groups based on their initial Plaque and Gingivitis scores. During the first visit, subjects will undergo three key procedures: 1) evaluation for baseline plaque and gingivitis, 2) brushing with the assigned regimen products for two minutes, and 3) assessment for post-brushing plaque only. Subjects will be provided with clear instructions for regimen product usage and will be expected to adhere to these instructions. Follow-up evaluations for plaque and gingivitis will be conducted at one week, six weeks, and three months after initiation of regimen product use. Throughout the study period, continuous monitoring for adverse events will be carried out for all subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the three-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars). 5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one-month period prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects
Comparison of the Change in Fat Distribution in Overweight and Obese Subjects With Type 2 Diabetes After Insulin Treatment

This trial is conducted in Europe. The aim of this clinical trial is to compare the change in trunk fat mass, assessed by Double Energy X-ray Absorptiometry (DEXA) after 26 weeks of treatment with insulin detemir or insulin NPH (Neutral Protamine Hagedorn) (both combined with insulin aspart at the main meals) in overweight and obese subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes who have been treated with 2 or 3 doses of insulin (one of them must be a premix) for at least 3 months prior to inclusion in trial
* Glycosylated haemoglobin (HbA1c) between 7.0-11.0 %
* Body Mass Index (BMI) between 27.5-40 kg/m\^2

Exclusion Criteria:

* Treatment with any oral antidiabetic drugs (OADs) in the last 6 months except metformin (subjects currently treated with metformin within the interval of 1000 - 2550 mg daily may be included in the trial. The dose should have remained unchanged for a period of 2 months prior to randomisation and should be expected to remain unchanged throughout the trial period)
* Use of approved weight lowering pharmacotherapy (e.g. orlistat, sibutramin, rimonabant) or obesity induced by drug treatment (e.g. corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), tricyclic anti-depressants, atypical anti-psychotics)
* Previous or planned surgical treatment of obesity
* Total daily insulin dose higher or equal 2 IU/kg
* Proliferative retinopathy or maculopathy that has required acute treatment within the last six months
* Receipt of any investigational drug within 1 month prior to this trial
* Cardiac disease defined according to New York Heart Association (NYHA) class III or IV, unstable angina pectoris and/or myocardial infarction within the last 6 months previous to the selection
Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease

Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)
2. Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks
3. Male or female patients aged 20 and over
4. In or out-patients
5. Patient's severity characterized as Stage 1 - 5 by Modified Hoehn \& Yahr scale
6. Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law

Exclusion Criteria:

1. History of hypersensitivity of pramipexole
2. Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior
3. Subjective symptom derived from orthostatic hypotension
4. Hypotension (systolic blood pressure; 100 mmHg or less)
5. Complication such as clinically significant cardiac, renal and hepatic diseases
6. Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities
7. Pregnant, possibly pregnant or female in lactation
8. Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study
9. Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study
A First-In-Human Clinical Trial to Evaluate the Safety, Effectiveness and Surgical Characteristics of CADENCE in Patients With Refractory Glaucoma

To evaluate safety, effectiveness, and the surgical performance of CADENCE in patients with refractory glaucoma.

CADENCE a single use implantable glaucoma drainage device used for the surgical treatment of refractory glaucoma. The device is implanted in the eye using an ab-externo approach

Eligibility Criteria:
Inclusion Criteria:

* 22-80 years of age.
* moderate to severe refractory glaucoma
* Able to consent

Exclusion Criteria:

* Women of child-bearing potential
* Intraocular surgery or laser within the last 3 months
* Ocular infection or inflammation within the last 6 months or currently active
* Current use of anti-coagulant therapy
* History of bleeding disorder or coagulopathies
* Subject plans to undergo any ocular surgery (including cataract surgery) during the study period
* History of corneal transplantation
* History of ICE Syndrome or epithelial ingrowth/downgrowth
* History of congenital glaucoma
* Elevated episcleral venous pressure

  -. Persistent angle closure-
* Previous glaucoma filtration surgery- -Presence of conjunctival scarring -
* neovascular glaucoma
* AC lens or scleral sutured IOL
* Aphakia
* inability to DC contact lenses
* Presence of intraocular silicone oil
* Vitreous in AC
Clinical Evaluation of Subgingival Open Sandwich Restorations

This study was designed to evaluate and compare the 3-year periodontal responses and clinical performance of proximal subgingival open sandwich restorations using three different glass ionomer-based restorative materials and flowable composite.

The description of the experimental design followed the Consolidated Standards of Reporting Trials (CONSORT) statement. The present study was a double-blinded (patients and examiner) randomized clinical trial anticipating the parallel design. Ninety-five adult patients seeking dental treatment in the Operative Department clinic at the Faculty of Dentistry, University of Mansoura were enrolled in the current study with a total of 120 Class II restorations. No advertisement was made for participant recruitment, forming a sample of convenience. Each patient must signs a consent form before participating in the current study. The study was conducted from January 2020 to January 2023 as a part of the Doctoral dissertation. Mansoura University institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated based on the clinical success rate (100% success rate at 2 years) of posterior class II restorations restored with open sandwich and deep margin elevation techniques observed in previous studies. According to several parameters including a significance level of 5%, the power of the test was calculated to be 80%, and equivalent limit of 15%. Upon these data, a sample size of 120 subjects was appropriate to allow for a 20% drop-out.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one proximal sub gingival carious lesion ICDAS 4, or 5 in posterior teeth
* Patients must have a good oral hygiene;
* Patients with tooth gives positive response to testing with an electric pulp tester
* Patients with normal and full occlusion,
* Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria:

* High caries risk patients with extremely poor oral hygiene,
* Patients involved in orthodontic treatment or periodontal surgery,
* Patients with periodontally involved teeth (chronic periodontitis)
* Patients with abutments should be excluded.
* Patients with heavy bruxism habits and clenching
Digoxin Withdrawal in Stable Heart Failure

Heart failure is a chronic condition in which the heart fails to function as a pump to move blood around the body. This sets up a complex physiologic response to compensate, which include activation of many hormonal mechanisms which result in fluid accumulation.

In recent years, medications to block the hormonal response to heart failure are given as standard drugs, and these include ACE inhibitors, and beta blockers. Mortality is reduced with these medications, as well as symptoms improved.

Medications that were traditionally used in heart failure include diuretics, which cause fluid loss, and digoxin, which causes the heart to pump harder. These medications were introduced before clinical trials as we know them now were run. Since the introduction of ACE inhibitors and beta blockers, it is not clear whether there is still a role for digoxin.

In this study, we plan to withdraw digoxin from patients with stable heart failure in normal rhythm, taking stable doses of ACE inhibitors and beta blockers, in a closely monitored environment and watch for the effect of this on heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Over the age of 18 years
2. In sinus rhythm at the time of randomisation
3. Have a LVEF \<0.45 and a left ventricular end-diastolic dimension \>60 mm or \>34 mm/m2
4. Are receiving ACE inhibitor, β-blocker and diuretic therapy at the optimal doses.
5. Has been receiving digoxin therapy for at least 3 months at a dose that results in digoxin plasma levels of 0.4-0.8 on 2 consecutive blood tests (at least 1 weeks apart) prior to randomisation. The dose of digoxin must remain stable for at least 2 weeks prior to randomisation.
6. Documented, stable heart failure. Must have at least 1 of the following:

   * Hospitalised with a discharge diagnosed of heart failure in the last 6 months
   * Evidence of pulmonary congestion on chest X-ray
   * Evidence of heart failure on echocardiogram
   * Evidence of heart failure on ECG
7. Willing and able to provide informed consent

Exclusion Criteria:

1. Systolic BP \>160mmHg or \<90mmHg
2. Diastolic BP \>95mmHg
3. Uncorrected primary valvular disease
4. Active myocarditis
5. Obstructive or restrictive Cardiomyopathy
6. Exercise capacity limited by other factors not including dyspnoea
7. Myocardial infarction within the previous 6 months
8. Stroke within the previous 12 months
9. Hospitalisation within one month of randomisation
10. A history of supraventricular arrhythmia or sustained ventricular arrhythmia
11. Claudication
12. Severe primary pulmonary (VC \<1.5L), renal or hepatic disease
Occupational Therapy for Cancer Patients: a Randomised, Controlled Study

The aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.

Background

Cancer patients often experience serious dysfunctions leading to problems with activities of daily living (ADL) and reduced quality of life. Occupational therapy is believed to be effective in handling many of the problems with ADL experienced by patients with cancer, but the evidence is sparse.

Aim

The purpose of this study is to analyse the effects of an occupational therapy intervention targeting cancer patients.

Outcome measures are the patients self-reported quality of life and the patients ability to perform ADL.

Methods

Randomised controlled trial with 288 patients with cancer treated at Naestved hospital in Denmark. Occupational therapy intervention programme for the intervention group (N=144) and standard treatment and care for the controls (N=144).

A systematic review including studies of ADL intervention for cancer patients will be carried out. Feasibility of the recruitment and the intervention will be analysed and published.

The patients need for occupational therapy will be analysed using baseline information from the randomised controlled trial.

The effects of the intervention will be analysed using patient validated questionnaires including EORTC QLQ-C30 and the ADL taxonomy questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
* Able to read and understand Danish

Exclusion Criteria:

* Referred to occupational therapy before study start
Workshops for Children With Global Developmental Delays

To investigate the therapeutic effects of family workshops on children with global developmental delays and their parents by the analysis of the previously conducted workshops.

To evaluate the effects of family workshops for children aged 18-36 months old with language developmental delays conducted from Jan 2014 Jan to Dec 2018, by the data analysis.

The participants were children with global developmental delay (language delay with at least one delay in motor, cognitive function, or emotional and social functioning) and their parents in the workshops.

The family workshops were conducted with 5 courses, with 6-7 families in one course, a 2-hour session per week, for 6 weeks.

Effects:

1. Investigate the therapeutic effects of workshops for children with global developmental delays
2. Investigate the therapeutic effects of workshops for the parents of children with global developmental delays

Eligibility Criteria:
Inclusion Criteria:

* Children aged 18-36 months old with global developmental delays (language developmental delay, with motor, cognition, or social and emotional developmental delays) Parents and children attended the one 2 hour-session of workshop per week for 6 weeks

Exclusion Criteria:

* Less than 18 months old or older than 36 months old
Reliability and Reproducibility of the Eye Check Tonometer

To investigate whether the new applanation tonometer (EyeCheck monitor) can provide intraocular pressure (IOP) measurements comparable to those of traditional tonometers such as the Goldmann applanation tonometer and the Tonopen.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older,
* Any glaucoma patient or glaucoma suspect patient
* Presents for an appointment wearing their own soft contact lens.

Exclusion Criteria:

* Arthritis affecting the upper extremity in the patient or caregiver
* Patient unwilling or assessed to be unable to comply with the study protocol
* Any corneal abnormalities such as opacities, scars, Fuchs dystrophy, map dot fingerprint dystrophy, history of recurrent corneal abrasion, corneal surgery such as Lasik, PRK, DSAEK, transplant or implant
* History of any ongoing ocular symptoms such as eye pain or redness or discharge
* History of recent ocular surgery (done in the past 3 months)
* History of a any filtering or tube surgery for glaucoma (to reduce risk of infection associated complications)
* Recent eye infection (within the past 3 months)
* History of diabetes for \> 5 years duration
* Monocular patient
* Best corrected visual acuity\< 20/70
* Head or hand tremors
Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention

To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially available Foley catheters.

A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter.

Neurogenic bladder is commonly managed with indwelling catheters (urethral or suprapubic). Indwelling catheters are associated with multiple complications, including recurrent urinary tract infections and catheter obstruction. A randomly assigned catheter will be inserted using standard techniques. The assigned catheters will either be the SILQ ClearTract 100% Silicone 2-Way Foley Catheter or the current standard of care catheter. Subjects will continue to use the assigned catheter for a period of approximately 3 months following regular standard of care. Subjects will then be assigned the alternative catheter for an additional 3 month period after which they will be exited from the study

The purpose of the study is to compare the incidence of catheter-related complications between the SILQ treated catheter and the current standard of care catheter(s). Because these complications lead to more frequent interventions and associated treatment costs, the study will also calculate the economic impact of the use of SILQ treated catheters compared to standard of care catheters. Patient-reported outcomes will also be measured via questionnaires upon each study visit. Explanted catheter samples will also be sent to a core lab for quantification of the calcification present on the catheter surface.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Requirement of a 14 Fr, 16Fr, or 18Fr indwelling urethral or suprapubic urinary catheter (for at least 6 months) for bladder drainage.
* Able and willing to comply with study procedures
* Able and willing to give informed consent.

Exclusion Criteria:

* History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma.
* Cognitive deficit limiting the ability to respond to clinical questionnaires.
* Allergy or sensitivity to any catheter material used in this study.