cyrilzakka/clinical-trials huggingface dataset:
Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector

Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device that can detect an intracranial bleed at an early stage.

This prospective study determines the usability of CEREBO® to detect the intracranial hematoma. The operators will receive a training session before the study and will be evaluated at the end of the study through a survey questionnaire for ease of use, ease of learning and satisfaction. Each operator will examine at least 10 subjects with CEREBO®.

Eligibility Criteria:
Inclusion Criteria:

Operators -

Medical health professionals \>18 years of age with a valid medical license to practice medicine belonging to one of the following categories and have given a written consent to participate in the study.

1. MBBS with Specialisation
2. MBBS
3. Nursing Staff
4. Others

Subjects -

1. Subjects with suspected traumatic brain injury and GCS \> 13
2. Of all ages and gender, have understood the study and gave a written informed consent.

Exclusion Criteria:

Subjects -

1. Subjects with active bleeding or scalp laceration
2. Subjects with large extracranial lesions
Preventing Cognitive Decline With Alternative Therapies

Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). The study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (MCI), a precursor to dementia. Because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of GBE in this age group will also be tested in this study. The study is randomized, placebo controlled and double blind. Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to MCI. This pilot study is viewed as a necessary first step in order to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. The study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. The magnitude of biological effect of the treatments will also be assessed with volumetric quantitative MRI, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). Peripheral markers of oxidation status will measure possible anti-oxidant effects of GBE.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Can identify a collateral informant who has frequent contact with the subject
* No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition
* Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised
* Mini-Mental State Examination Score \>23
* Clinical Dementia Rating (CDR) of zero
Cardiac Rehabilitation in Chagas Heart Failure

Due to the lack of information in the literature about the role of cardiac rehabilitation on Chagas heart failure, the aim of the present study was to evaluate the effects of a cardiac exercise program on functional capacity, cardiac function, respiratory muscle strength, body composition, biomarkers and quality of life among Chagas heart failure patients.

The present study consisted in a pre/post single-arm intervention study conducted at the Evandro Chagas National Institute of Infectious Disease (INI), located on Rio de Janeiro, Brazil. INI is a national reference center for treatment and research in infectious diseases and tropical medicine in Brazil, which follows a large cohort of patients with Chagas disease, all of them diagnosed by two simultaneously positive serological tests (enzyme-linked immunosorbent assay and indirect immunofluorescence). Patients included in the study were submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during an 8-month period. Nutritional and pharmaceutical counseling were also monthly provided during the follow-up and consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.Patients included in the study were followed during an 8-month period in which evaluations of functional capacity (maximal progressive cardiopulmonary exercise test), muscle respiratory strength (manovacuometry) and body composition (anthropometry and skinfolds) were performed at baseline, after four months and at the end of follow-up. Assessments of cardiac function (bidimensional echocardiography), biomarkers (lipid profile, glucose and glycated hemoglobin) and quality of life (Minnesota Living with Heart Failure questionnaire) were taken at baseline and after eight months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients at the stages C or D of Chagas cardiomyopathy
* Patients receiving standard optimized medical therapy
* Patients with good adherence to outpatient treatment within the last three months.

Exclusion Criteria:

* Those who were not able to attend three weekly training sessions,
* Those who had neuromuscular limitations, cardiopathies from non-Chagasic etiology (e.g ischemic), systemic conditions that limits exercise practice (e.g chronic obstructive pulmonary disease)
* Practitioners of regular exercise.
Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.

This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.

Eligibility Criteria:
Inclusion Criteria:

* Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
* Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash

Exclusion Criteria:

* Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
* Have worn contact lenses within 7 days of Screening or be unwilling to forego contact lens wear during the study
* Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
* Pregnancy or lactation
Low Dose Cyclosporin A in Primary Sjögren Syndrome

Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome

NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren Syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a primary Sjögren´s Syndrome
* Liver values above 1,5 ULN
* uncontrolled arterial hypertension
* intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
* begin with Study medication

Exclusion Criteria:

* pre-treatment with Cyclosporine A
* Infection
* Neoplasia
* relevant cardiac, pulmonary, neurologic or psychiatric disease
* life-Vaccination within 4 weeks before begin with study medication
* pregnant or breast-feeding
* weight under 45kg or more than 110kg
Clinical Trial of Intravitreal Injection of Autologous Bone Marrow Stem Cells in Patients With Retinitis Pigmentosa

The purpose of this study is to evaluate the safety of intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa by a prospective, single-center, randomized, parallel, double-blind, phase I placebo-controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Retinitis Pigmentosa bilateral diagnosis.
* Visual acuity (measured with ETDRS) less than or equal to 20/70 and visual field below 30° central in both eyes.
* Signed informed consent
* Warranty sufficient adherence to protocol. It must fulfill all inclusion criteria.

Exclusion Criteria:

* Concurrence of any systemic or ocular disease that precludes or affects tracking study variables. Specifically retinal involvement with diabetes mellitus, glaucoma, macular degeneration or age.
* Eye surgery in the previous 6 months.
* Patients who are pregnant.
* Patients with active lactation.
* Physically fertile patients, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle or sexual orientation excludes sexual intercourse with a man and women whose partners have been sterilized by vasectomy or other methods, UNLESS tHEY are using a reliable contraceptive method. This birth control method can be:
* Complete abstinence from sexual intercourse
* Surgical sterilization (tubal ligation)
* Surgical sterilization partner (vasectomy)
* Implanted or injectable hormonal contraceptives and oral.
* Patients with cardiac disease, renal, hepatic, systemic, immune that might influence the survival of patients during the test.
* Positive serology for hepatitis B, hepatitis C or HIV.
* Clinical criteria or anesthetics that contraindicate the sedation or the extraction of BM (Altered coagulation system or anticoagulated patient with inability to withdraw anticoagulation, hemodynamic instability, altered skin in the puncture site, etc.)
* Participation in other clinical trials.
* Inability to sign informed consent or understanding.
Feasibility and Efficacy of Brief Behavior Change Counseling on Lifestyle in Hypertensive and Diabetics Participants

The purpose of this study will be to assess the feasibility and the preliminary efficacy of brief behavior change counseling on lifestyle among diabetic and hypertensive patients

1. BACKGROUND Noncommunicables diseases (NCDs) are on the rise globally as well as in Malawi, alongside their behavioral modifiable risk factors. Behavioral intervention such as brief behavior change counseling using 5A's and a guiding style (BBCC + 5As +GS) has shown an effect on reducing these lifestyles risk factors. Their effectiveness varies between the behavioral technique used. But So far, available evidences of this effect are from western countries. Even implementation of these techniques has been done in some countries, but so far there is no information about their implementation in noncommunicable diseases field in Mangochi, even Malawi. Therefore, a really need to conduct this study in Mangochi, Southern Malawi.
2. OBJECTIVES

   1. Overall objective: The primary objective of the study is to test the feasibility of the brief behavior change counseling using 5 A's and a guiding style from motivational interviewing which will be used for NCDs 'patients and assess its efficacy in improving lifestyle risk factors in NCDs' patients.
   2. Specific objectives for this study are

1. to evaluate the feasibility of participating in a future quasi-experimental study of BBCC + 5A's + GS ; 2. to estimate the efficacy of BBCC + 5A's + GS from MI on lifestyle risk factors, theory constructs, quality of life domains; 3. to provide data on which to estimate the sample size required to detect a statistically significant difference between experimental and control groups; 4. and to explore experience of participants and care providers during the brief behaviour change counseling sessions to NCDs' patients in Mangochi

4. Methodology:

1. Design: mixed methods (pilot quasi-experimental and qualitative study)
2. Settings: The study will take place at two sites: Mangochi District Hospital and Monkey Bay Community Hospital; Malawi.
3. sample size: Purposeful sampling and successive eligible patients. Sample size: Efficacy study will be conducted on 50 patients.
4. Intervention: brief behaviour change using 5A's and a Guiding style from motivational interviewing will be administered to participants in the intervention group by trained counsellors (nurses).

Eligibility Criteria:
Inclusion Criteria:

* aged between 18-65 years old,
* registered in the clinic at least for 6 months,
* been screened for at least 1 lifestyle risk factor,
* express willingness to participate in the study,
* being permanent resident in Mangochi District for at least 12 months from recruitment, and
* Fluent in Chichewa and/or Yao

Exclusion Criteria:

* - present with any concomitant severe disease,
* being pregnant
* patient with an active Psychiatrics' comorbidity
The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial.

The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.


Eligibility Criteria:
Inclusion Criteria:

1. Age more than15 years.
2. Gender; male or female.
3. Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
4. Mild crowding in the upper arch (≤ 4 mm).
5. Absence or previous extraction of the upper third molars.
6. Good compliance during the treatment

Exclusion Criteria:

1. Transversal dental or skeletal discrepancies.
2. Extraction treatment (except for the third molar).
3. Periodontal disease. .
4. Prosthodontics rehabilitation of the maxillary molars.
Evaluation of Decreased Usage of Betablockers After Myocardial Infarction in the SWEDEHEART Registry (REDUCE-SWEDEHEART)

Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with myocardial infarction and normal heart function. The aim of this study is to determine whether long-term treatment with oral beta-blockade in patients with myocardial infarction and preserved left ventricular systolic ejection fraction reduces the composite of death of any cause or new myocardial infarction..

REDUCE-SWEDEHEART is designed as a registry-based, randomized, parallel, open-label, multicenter trial.

Patients, day 1-7 after myocardial infarction, who have undergone a coronary angiography and with preserved left ventricular systolic ejection fraction will be randomized to either oral beta-blockade (see "Intervention" for detailed description) at a dose according to the treating physician, or no beta-blockade. To allow quick inclusion the randomization module will be accessible by a simple web-based log-in procedure. Concomitantly, all baseline data about each individual patient will be collected from the SWEDEHEART registry. Patients will then be followed regarding all-cause mortality, myocardial infarction, heart failure, atrial fibrillation, and patient-related outcome measures (for a subgroup of patients). Patients that are eligible but not included in REDUCE-SWEDEHEART will also be followed regarding chosen treatment and the primary and secondary endpoints.

Follow-up will continue until 379 primary endpoints have been observed (endpoint driven). All analyses will be performed on the intention-to-treat set, defined as all intentionally randomized patients, by randomized treatment. The primary endpoint is death or new MI. Information about death will be obtained from the Swedish population registry. Information regarding new myocardial infarction during hospitalization and readmission because of myocardial infarction or other outcome (secondary outcomes, see section below), will be obtained from the SWEDEHEART-registry (for myocardial infarction) and the patient registry of the National board of health and welfare.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years.
2. Day 1-7 after MI as defined by the universal definition of MI, type 1, included in the SWEDEHEART registry.
3. Undergone coronary angiography during hospitalization.
4. Obstructive coronary artery disease documented by coronary angiography, i.e. stenosis ≥ 50 %, FFR ≤ 0.80 or iFR ≤ 0.89 in any segment at any time point before randomization.
5. Echocardiography performed after the MI showing a normal ejection fraction (EF≥50%).
6. Written informed consent obtained.

Exclusion Criteria:

1. Any condition that may influence the patient's ability to comply with study protocol.
2. Contraindications for beta-blockade
3. Indication for beta-blockade other than as secondary prevention according to the treating physician.
Efficacy and Safety of Ofatumumab Retreatment and Maintenance Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

The purpose of the trial is to investigate the efficacy and safety of ofatumumab retreatment and maintenance in patients with chronic lymphocytic leukemia who have previously responded or had disease stabilization after ofatumumab in an ongoing trial (Hx-CD20-406).


Eligibility Criteria:
Inclusion Criteria:

* Has responded to ofatumumab treatment (CR, nPR, PR) or has had SD at least up to and including visit number 14 (24 weeks after first infusion) in the Hx-CD20-406 trial.
* Has disease progression after visit number 14 (24 weeks after first infusion) in the Hx CD20 406 trial.
* Received at least eight ofatumumab infusions.
* Has active CLL with an indication for treatment.
* Has Eastern Cooperative Oncology Group (ECOG) performance status grade 0, 1 or 2.
* Provides signed informed consent, following receipt of verbal and written information about the trial, before any trial related activity is carried out.
* If previously treated in GEN416 (this trial), the patient must have achieved CR with subsequent disease progression 24 weeks or later after the first infusion in the GEN416 trial.

Exclusion Criteria:

* The disease has transformed to more aggressive B-cell malignancies (e.g. diffuse large B-cell lymphoma, Richter's syndrome or prolymphocytic leukemia).
* Has a suspected treatment requiring malignancy other than CLL.
* Has received treatment other than ofatumumab within two weeks prior to visit 2.
* Has clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from visit 1, congestive heart failure (NYHA III IV), and arrhythmia requiring therapy, with the exception of clinically non-significant extra systoles or minor conduction abnormalities.
* Has significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
* Has a history of significant cerebrovascular disease.
* Is known HIV positive.
* Has positive serology for hepatitis B, defined as a positive test for HBsAg and/or positive tests for both anti-HBs and anti-HBc.
* Has known or suspected hypersensitivity to components of the IMP.
* Has received treatment with any non-marketed drug substance or experimental therapy other than ofatumumab within four weeks prior to visit 2.
* Currently participates in any other interventional clinical trial other than Hx-CD20-406.
* Known or suspected to not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychiatric disorder).
* Is breast feeding (women only).
* Has a positive pregnancy test at screening (women only).
* Is not willing to use adequate contraception during the trial and one year after last dose of ofatumumab (women only). Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the US the use of double barrier method is considered adequate.
Pain Assessment Via Force Measurement Using eEgg After Blockade of the Lumbar Facet Joints

The emotion Egg, or "eEgg" for short, is a sample series of a device for testing a new pain measurement method that is not yet on the market. The aim is to investigate whether the trial device and the eEgg method (eEgg plus software) are suitable for supporting, improving or even replacing the communication between doctor and patient, which still takes place via the numerical rating scale (NRS) and the pain diary. Issues of acceptability in comparison to the pain diary and the NRS are to be considered. Measurements should be recorded in real time; no orientation to the previous value is possible for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Elective interventional blockade of lumbar facet joints due to lumbar facet osteoarthritis
* Chronic pain (\>3 months, most severe pain on motion in the last three months ≥3 (NRS))
* Age ≥18 years
* Legal capacity
* Proficiency in the German language
* Presence of a written informed consent from the patient
* Inpatient pain patient

Exclusion Criteria:

* Participation in other interventional trials
* Individuals who have a dependent/employee relationship with the sponsor or investigator
* Cognitive impairment that could affect the use of the eEgg
* Impaired fist closure and/or reduction of gross strength in the hand area
* mono- or poly-neuropathy in the hand area
* Allergy to plastics