cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Standardized Stroke Upper Limb Rehabilitation Program with Shortened Fugl-Meyer Assessment Stratification

The objective of the study was to investigate the effectiveness of a standardized stroke upper limb rehabilitation program with stratification using Shortened Fugl-Meyer Assessment (S-FM). The standardized program was compared with conventional training based on the hospital protocol.


Eligibility Criteria:
Inclusion Criteria:

* first stroke, able to attend gym training and give written consent

Exclusion Criteria:

* unstable medical condition, any musculoskeletal conditions or other diseases restricted upper limb training, unfit mental state and unable to follow command
Efficacy of Trial-Based Cognitive Therapy and Behavioral Activation in Treatment of Depression

Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world. The treatments of choice are the psychotropic drugs of the class of antidepressants and Behavioral or Cognitive Behavior Therapy (CBT). The aim of this study is to compare the efficacy of Trial Based Cognitive Therapy with the Behavioral Activation and pharmacotherapy in the treatment of MDD in a randomized clinical trial witch 96 patients with MDD,

Major Depressive Disorder (MDD) is a mood disorder, highly prevalent in Brazil and in world. MDD is associated with an impaired quality of life and socio occupational functions. The treatments of choice are the psychotropic drugs of the class of antidepressants and Cognitive Behavior Therapy (CBT). Some of the patients with pharmacotherapy alone still symptomatic. This explains the association between psychotherapy and pharmacotherapy. The CBT seek to modify thoughts, emotions and behaviors and have shown efficacy in several mental disorders, including MDD. Among the CBT models, there is an emphasis on interventions that emphasize: 1) the modification or restructuring of thoughts and beliefs. In this point, the Trial based cognitive Therapy (TBCP) is an approach with a particular emphasis on the modification of core beliefs ; 2) the direct modification of behavior, such as the behavioral activation (BA) that analyzes contingencies and encourages the implementation of activities to improve mood. This project aims to compare the efficacy of TBCP with the BA in the treatment of MDD. For this, a randomized clinical trial will be conducted to treat 96 patients with MDD who are in drug treatment, which will be drawn to the interventions of TBCP most psychiatric drugs, BA more psychiatric drugs or pharmacotherapy alone, each group with 32 patients. Patients will be evaluated with scales and inventories to assess depression, quality of life and social functioning, and the data will be statistically compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder
* Both Genres
* Minimum of 20 in BDI Score
* Refractory depressive disorder

Exclusion Criteria:

* Bipolar disorder
* High risk of suicide
* Borderline personality
RCT: Effectiveness of a Microscope During Dental Root Apical Surgery

An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The overall success rate for this treatment is high; 97% of the treated teeth are retained in the oral cavity after 8 years (Salehrabi \& Rotstein, 2004). However, there are teeth that have a persistent granuloma because of various reasons and need endodontic retreatment or apical surgery. Overall results in literature for an endodontic retreatment show a success rate of 77%-89% (Ng, Mann, \& Gulabivala, 2008; Salehrabi \& Rotstein, 2010), the results of apical surgery are more or less similar (von Arx, 2005). Which of the two methods is preferred for failed root canal treatments is dependant on a variety of reasons. (For example an amount of gutta-percha outside the apex of the root is better corrected by apical surgery. Persistent infection as a result of insufficient gutta-percha amounts in a treated root is best treated with an endodontic retreatment.) The overall results in apical surgery have increased the past years due to better preparation of the apical end of the root by the use of an ultrasonic device (de Lange, Putters, Baas, \& van Ingen, 2007) and new materials that are used for filling of the rootend e.g. MTA (von Arx, Hanni, \& Jensen, 2010)

Objective of the study:

The objective of this study is to assess whether or not apical surgery that is carried out with the help of a microscope has a higher success rate than apical surgery without the use of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi, \& Weinstein, 2009).


Eligibility Criteria:
Inclusion Criteria:

* Peri-apical lesion on one of the teeth, confirmed on radiograph.
* Previous endodontic treatment was more than 6 months earlier.

Exclusion Criteria:

* Root fracture.
* Periodontal origin of apical infection or absence of marginal buccal bone after flap elevation.
* Root perforation.
* No previous endodontic treatment.
* Previous endodontic surgery.
Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery

The purpose of this study is to determine if patching the eye or a bandage contact lens along with Tylenol #3 is more effective for pain control following pterygium surgery.


Eligibility Criteria:
Inclusion Criteria:

* Primary pterygium (no previous surgeries or radiotherapy) requiring excision due to ocular discomfort or disruption in vision
* Size of pterygium greater than 2.5 mm over the cornea (pterygia smaller than this do not result in much postoperative eye pain)
* Ability to understand the nature of the procedure and to complete all measurement requirements
* Adults (age greater than 18)

Exclusion Criteria:

* Ocular surface disease apart from pterygium (such as severe dry eye, corneal disease, scarring from previous infection, radiotherapy, inflammatory diseases or trauma)
* Patients who have had previous ocular surface surgery
* Contraindications to local anesthetics (such as known allergy)
* Pregnancy (as the risk to the fetus with the use of topical antibiotic drops and local anesthetics are not known)
* Patients already on systemic analgesics for any other reason (such as rheumatoid arthritis)
* Allergy to codeine (in order to standardize the systemic analgesic used so that we can compare the effect of bandage contact lens versus 24 hour patching)
Evaluation of Thoracic Tumors With 18F-FMT and 18F-FDG PET-CT A Clinicopathological Study

L-\[3-18F\]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid transporter 1 (LAT1).


Eligibility Criteria:
Inclusion Criteria:

* Patients with indeterminate pulmonary nodule suspicious of lung cancer

Exclusion Criteria:

* Patients with other malignancies and those who had received cancer treatment within the past 5 years were excluded.
Genetic and Immunity in Heart Failure

Heart failure is a major health problem with serious consequences on mortality and morbidity worldwide. In chronic heart failure an alteration of the inflammatory state occur. The aim of this study will be to describe the relationship between markers of inflammation in patients with heart failure with preserved ejection fraction, gender differences and advanced age.

The study sample will include patients hospitalized in the Unit of General Medicine and Aging with a diagnosis of heart failure based on the guidelines. Clinical and demographic data will be collected from the electronic records of our hospital system. A complete history will be obtained, including the possible etiology of heart failure, cardiac and noncardiac comorbidities, all medications, intracardiac devices, and chronic oxygen treatment. All patients will be documented for peripheral edema, pulmonary rales and jugular vein distension. NYHA (New York Heart Association) class will be identified at discharge. In addition, a blood sample will be taken to obtain a complete panel including total blood count, glycemia, renal function, electrolytes and liver function tests, as per standardized clinical practice. NT-proBNP (Amino-terminal pro Natriuretic Peptide B) will be measured at admission and discharge from the hospital, as per standardized clinical practice.

Echocardiograms will be performed by experienced operators of the echocardiography service of our Polyclinic, according to the American Society of Echocardiography guidelines.

A single additional blood sample will be collected during one of the normal routine blood draws for all immunological tests. Plasma from each participant will be isolated to determine the concentrations of several cytokines. Circulating lymphocytes will be separated according to Ficoll gradient (peripheral blood mononuclear cells, PBMC) into the two different components of immunity (B and T lymphocytes) with different inflammatory phenotypes Evaluation of enhancer (HS)1,2 polymorphisms and estrogen levels: DNA purifications and amplifications will be performed from an aliquot of the single whole blood sample collected for the evaluation of the inflammatory profile. Genomic DNA will be isolated and 9 SNPs in four specific polymorphic regions of the 3'-1 Regulatory Region (3'RR-1) of the human immunoglobulin (IgH) heavy chain locus will be sequenced. Follow-up will be performed by telephone contacting the patients or their caregivers 90 days after discharge.


Eligibility Criteria:
Inclusion criteria:

* Adult patients (age ≥18 years) with exacerbation of chronic heart failure with reduced or preserved ejection fraction,
* stable haemodynamic conditions, without the need for inotropic support at the time of admission to the ward,
* signature of the informed consent.

Exclusion criteria:

. age \<18 years;

* pregnancy;
* acute coronary syndromes;
* end-stage renal failure (clearance \<30 mL/min) or dialysis;
* ongoing sepsis;
* bed rest syndrome;
* any concomitant neoplasm,
* congenital and acquired immunodeficiencies (HIV, immunosuppressive drugs).
Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.

Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy

Eligibility Criteria:
3.1 Inclusion Criteria

* Women with a breast cancer diagnosis (Stage I-IIIC)
* Sedentary (\< 75 min/wk of moderate intensity exercise over the past month)
* No previous history of anthracycline based chemotherapy
* Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
* Absence of contraindications for neoadjuvant chemotherapy
* Scheduled to receive neoadjuvant chemotherapy
* Primary attending oncologist approval

3.2 Exclusion Criteria

* Absolute contraindications for exercise stress testing

  * acute myocardial infarction (3-5 days)
  * unstable angina
  * uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  * syncope
  * acute endocarditis
  * acute myocarditis or pericarditis
  * uncontrolled heart failure
  * acute pulmonary embolus or pulmonary infarction
  * thrombosis of lower extremities
  * suspected dissecting aneurysm
  * uncontrolled asthma
  * pulmonary edema
  * room air desaturation at rest ≤85%
  * respiratory failure
  * acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
  * mental impairment leading to inability to cooperate
  * decisional impairment
* Non-English speaking
* Women only diagnosed with ductal carcinoma in situ
* Women diagnosed with stage 4 metastatic breast cancer
* Pregnant women
* Men
* Children
Bioavailability of Dipyridamole of Asasantin p.o. in Three Experimental Formulations Relative to the Standard Formulation in Healthy Male Subjects

The objective of this study was to compare the pharmacokinetics of dipyridamole in three different Asasantin ER batches (test) containing different amounts of retarding lacquers to the existing commercial product at steady state with BID treatment


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age \>=50 years
* BMI \>=18.5 and \<=29.9 kg/m2
* Able to communicate well with the investigator and to comply with study requirements
* Laboratory values within a clinically defined reference range

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 3 months prior to administration (at least 10 times the relevant elimination half-life) or during trial)
* Having had prescription medication 2 weeks prior to study drug administration or over the counter medication 1 week prior to study drug administration (at least 10 times the relevant elimination half-life)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation or loss \> 400 mL (\< 1 month prior to administration or during the trial)
* Excessive physical activities (\< 5 days prior to administration or during the trial)
* Any ECG value outside of the reference range of clinical relevance including, but not limited to QTcB \> 480 ms or QRS interval \> 110 ms
* History of any familial bleeding disorder
* Inability to comply with dietary regimen of study centre
* Inability to comply with investigator's instructions
Change in Biting Force After Botox Injection

Implant rehabilitation is a successful treatment option for edentulous patients. Decreasing bone loss around implants is an important target for all implantologists. It has been shown that pathological forces, such as bruxism, may in fact result in bone loss and eventual implant failure.

Botilinium Toxin is a material of many clinical uses. Beside its cosmetic applications, it has been used in the treatment of masseter muscle hypertrophy.

Purpose: To investigate the effect of botilinium toxin injection on biting forces, and its ultimate effect on peri-implant bone changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a partially edentulous mandible, Kennedy Class I configuration, who are indicated for rehabilitation with partial implant overdenture prostheses, and who complained of Bruxism.

Exclusion Criteria:

* The presence of notable facial asymmetry.
* Severe malocclusion
* Pregnancy
* A history of any serious medical illness
* Drug allergy.
Breast Reconstruction With External Pre-expansion and Autologous Fat Transfer Versus Standard Therapy

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT (intervention group) or reconstruction with implants (control group). AFT will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age of 18 years and older
* History or in candidate for a mastectomy procedure in the near future
* Patients' choice to undergo a breast reconstruction
* Wanting to participate in this study
* Patient is able to wear the BRAVA device

Exclusion Criteria:

* Active smoker or a history of smoking 4 weeks prior to surgery
* Current substance abuse
* History of lidocaine allergy
* History of silicone allergy
* 4 weeks or less after chemotherapy
* History of radiation therapy in the breast region
* Oncological treatment includes radiotherapy after mastectomy
* Kidney disease
* Steroid dependent asthma (daily or weekly) or other diseases
* Immune-suppressed or compromised disease
* Uncontrolled diabetes
* BMI\>30
* Large breast size (i.e. larger than cup C), unless the patient prefers reduction of the contralateral side towards Cup C
* Extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction
* The treating plastic surgeon has strong doubts on the patient's treatment compliance
* Claustrophobia for an MRI-scan
Safety & Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients

Patients who are legally blind, caused by retinal degeneration of photoreceptor rods \& cones (e.g. Retinitis pigmentosa), receive a subretinal implant to restore vision partially.


Eligibility Criteria:
Inclusion Criteria:

* Hereditary retinal degeneration of the outer retinal layers i.e. photoreceptor rods \& cones.
* Pseudophakia
* Angiography shows retinal vessels adequately perfused, despite pathological RP condition.
* Age between 18 and 78 years.
* Blindness (at least monocular) i.e. visual functions not appropriate for localization of objects, self sustained navigation and orientation (impaired light localization or worse).
* Ability to read normal print in earlier life, optically corrected without magnifying glass.
* Willing and able to give written informed consent in accordance to EN ISO 14155 (section 6.7) and local legislation prior to participation in the study. Able to perform the study during the full time period of one year

Exclusion Criteria:

* Period of appropriate visual functions \< 12 years / lifetime.
* Optical Coherence Tomography (OCT) shows significant retina edema \&/or scar tissue within target region for implant.
* Retina detected as too thin to expect required rest-functionality of inner retina as shown via Optical Coherence Tomography (OCT).
* Lack of inner-retinal function, as determined by Electrically Evoked Phosphenes (EEP).
* Heavy clumped pigmentation at posterior pole
* Any other ophthalmologic disease with relevant effect upon visual function (e.g. glaucoma, optic neuropathies, trauma, diabetic retinopathy, retinal detachment).
* Amblyopia reported earlier in life on eye to be implanted
* Systemic diseases that might imply considerable risks with regard to the surgical interventions and anaesthesia (e.g. cardiovascular/ pulmonary diseases, severe metabolic diseases).
* Neurological and/or psychiatric diseases (e.g. M. Parkinson, epilepsy, depression).
* Hyperthyroidism or hypersensitivity to iodine
* Women who are pregnant or nursing, or women of childbearing potential who are not willing to use a medically acceptable means of birth control for the duration of the study, or women unwilling to perform a pregnancy test before entering the study.
* Participation in another interventional clinical trial within the past 30 days.
Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery

The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes in the morbid obese patients after laparoscopic sleeve gastrectomy.

In this study four groups including: Group I - Morbid Obese Diabetics, Group II - Morbid Obese Non Diabetics, Group III - Lean Diabetics, and Group IV - Lean Non Diabetics will be studies. The bariatric surgical procedure should include Laparoscopic Sleeve Gastrectomy (LSG). All participants will be assessed by members of a multidisciplinary obesity team including a surgeon, endocrinologist, dietician, and nurse specialist who will usually have input into patient selection.

Briefly the study will be explained to the each participant, and after his/her agreement, the informed Consent Form will be deliver to him/her for completion and signature. Within a week before surgery each enrolled participant of group I and II will be subjected to a medical questionnaire and other routine laboratory analyses before surgery such as fasting glucose, liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT) will be performed and blood samples will be collected for further analysis as it is described in the protocol.

Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and 360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from these participants will be harvested during of the LSG (days 0). Participants in group I will be asked to monitor their fasting blood glucose level everyday at early morning and the dose of anti-hyperglycemia medications will be adjusted by the recommendation provided by the physician member of team. This data will be recorded as their continuous blood glucose monitoring.

Group III and IV participants, as control groups with no surgical intervention, will be subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just one visit.

All demographic and clinical information collected from the participants will be recorded in the information form identified by identification number (ID number). Only samples from the cases that do not have any post-surgery related complications or not have any emergency clinical condition will be used for genomics and proteomics analysis.

Eligibility Criteria:
Inclusion Criteria:

* adults
* Type 2 diabetes \<5 years
* male and female,
* resident of Kuwait,
* who agreed to participate in the study

Exclusion Criteria:

* pregnancy,
* malignancy,
* type 1 diabetes,
* type 2 diabetes with more than 5 years,
* and history with overt heart and/or kidney failure