cyrilzakka/clinical-trials huggingface dataset:
BEN-2001 in Parkinson Disease Patients With Excessive Daytime Sleepiness

This phase 2b study is designed as multicentre, multinational, randomized, double blind, parallel group and placebo controlled with three doses of Bavisant (0.5, 1, and 3 mg/d) in subjects with excessive daytime sleepiness with Parkinson's disease.

Phase 2b study will be conducted with the aim of investigating the efficacy and safety of three fixed doses of Bavisant (0.5, 1 and 3 mg/d) compared to placebo for the treatment of excessive daytime sleepiness (EDS) in subjects with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either sex aged 50 to 80 years \*Subjects with previous diagnosis of Parkinson's disease (following the UK Parkinson's disease society brain bank clinical diagnostic criteria)\*
* Subjects capable of understanding and complying with protocol requirements
* Subjects with medical history of excessive daytime sleepiness

Exclusion Criteria:

* Subjects with excessive daytime sleepiness due to conditions other than Parkinson's disease (including narcolepsy)
* Subjects with clinical evidence of depression with significant psychiatric comorbidities (Hamilton Rating Scale for Depression - HAM-D score greater than or equal to 17; with or without treatment)
* Subjects with evidence of significant fatigue (Fatigue Severity Scale - FSS greater than or equal to 36
* Subjects with known history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
* Subjects with known allergies or hypersensitivity to Bavisant or any of its excipients.
* Subjects who are pregnant or lactating.
Renal Denervation in Refractory Hypertension

Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Refractory hypertension with office SBP \> 140 mmHg
* SBP \> 130 during 24-hours Holter blood pressure monitoring
* Treatment with the least 3 antihypertensive medications including diuretics in optimal doses
* Age \> 18 years
* Signed informed consent

Exclusion Criteria:

* Secondary forms of hypertension
* Chronic renal disease (serum creatinine \> 200 umol/l)
* Pregnancy
* History of myocardial infarction or stroke in last 6 months
* Severe valvular stenotic disease
* Anatomic abnormalities and variants of renal artery including aneurysms, severe stenosis, reference diameter \< 4 mm or length \< 20 mm
* Increased bleeding risk (thrombocytopenia \< 50, INR \> 1.5)
Occipital Nerve Stimulation in Fibromyalgia

The aim of this study is to investigate whether greater occipital nerve stimulation is effective in the treatment of fibromyalgia related pain. The study uses sub sensory threshold stimulation and placebo stimulation in order to investigate whether sub-threshold stimulation is feasible in a placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed according to the criteria of the American College of Rheumatology (ACR-90)
* Minimally treated with adequate trials during 3 months
* Insight of the patient in her disease and capable of understanding and signing an informed consent

Exclusion Criteria:

* History of severe illness or suffering from severe chronic disease
* History of substance abuse, unless treated and in remission during 6 months
* Cardiac disease
* History of epileptic insults
* Psychiatric disorders with psychotic symptoms
* Pace maker / defibrillator
* Pregnancy
Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals

The purpose of this study is to evaluate the impact of a structured package (bundle) in reducing the use of antimicrobials and hospital stay of patients with community-acquired pneumonia (CAP), and no increase in mortality of these patients in different hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CAP at hospital admission .
* Age: 18 years or more.

Exclusion Criteria:

* Patients with nosocomial pneumonia or criteria related to health care.
* Patients with severe immunosuppression (HIV infection with \<200 CD4+ lymphocytes / mm3), neutropenia (\<500 neutrophils / mm3).
* Patient treated with immunosuppressive drugs.
Plasma Citrulline Concentration in Tropical Enteropathy

Citrulline is an amino acid produced in the intestine and in the liver, but the liver does not contribute significantly to circulating citrulline concentrations. The intestine is thus the only organ that normally releases significant amounts of citrulline into the blood stream. The investigators have designed a study looking at the value of measuring plasma citrulline concentration in patients with tropical enteropathy of mixed HIV status. The focus will be on the ability of the intestine to sustain the individual concerned from a nutritional standpoint. The investigators hypothesise that plasma citrulline concentration is a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.

Preliminary studies reported that plasma citrulline concentrations may be a reliable biochemical marker for intestinal dysfunction and absorptive enterocyte mass. The relationship between citrulline concentration and intestinal function has been supported in other studies including those examining rejection in small bowel allografts. Concentrations of citrulline are dramatically reduced in cases of mucosal damage (e.g. moderate graft rejection or viral enteritis)and strongly correlate (inversely) with severity on biopsy. Plasma citrulline concentration is lower also in patients with villous atrophy (24±13µmol/L)than in healthy subjects (40±10µmol/L)and patients with anorexia nervosa (39±9µmol/L).Experimental studies have been carried out also in assessing the value of citrulline as a marker for severity of small bowel epithelial damage from radiation and viral infections. The plasma citrulline was shown to be a simple, non invasive and sensitive essay to monitor and quantify radiation and/or chemotherapy induced small bowel damage in mice and humans. Otherwise, the literature on citrulline as a potential marker of intestinal and nutritional integrity is young and consistent data for specific conditions as for HIV enteropathy are missing.We hypothesise that plasma citrulline concentration is a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.

Eligibility Criteria:
Inclusion Criteria:

* histologically ascertained Tropical enteropathy
* Mixed HIV status
* Body mass index within normal range

Exclusion Criteria:

* Patients with surgical resection of stomach, duodenum or pancreas; or (UGI) bypass.
* Patients with other important disease, which may interfere with the study (especially diabetes and renal impairment). Alcoholism, drug abuse or any other circumstances, which may compromise the patient's ability to comply with the study requirements.
* Pregnancy
* Patients experiencing diarrhoea within one month since enrolment date
* Use of glucagon-like peptide 2 (GLP2), growth hormone (GH) or glutamine or triglycerides
* Coeliac Disease, Crohn's disease or infectious intestinal disease
* Patients on steroids or FANS
* Oral feeding\>1.0-fold the estimated basal metabolic rate as assessed using Harris and Benedict equation
Benefits of Traditional and Golf-specific Resistance Training in Amateur Female Golfers

Amateur female golfers were randomized to either a functional weight lifting group or a traditional weight lift group. Testing, consisting of performance measures and golf measures, was performed at baseline and after 10 weeks of weight lifting.

A randomized control trial to compare the effects of 10 weeks of two different types of training in recreationally active female golfers was performed. Participants were recruited through postings at local country clubs and public golf courses, as well as through emails to state and local women's golf associations. Following written informed consent approved by the university's institutional review board, participants completed a medical and golf history questionnaire. Golf-specific information gathered via the history form included self-reported number of years playing golf, handicap, frequency of play, frequency of practice. Baseline testing followed, consisting of measurement of height and weight using a stadiometer, bone density and body composition using dual energy X-ray absorptiometry (DXA), 7-iron and driver club speed and total ball distance using a golf simulator (High Definition Golf, Interactive Sports Technologies, Vaughan, Ontario), and physical performance tests. Participants were then randomly assigned, using a random number generator, to either a traditional resistance training group (TRAD) or a golf-specific resistance training group (GSRT). Resistance training was conducted 3 days per week for 10 weeks. Each training session was directly supervised by at least one of the researchers, such that correct technique and appropriate resistance could be monitored. Following the 10 weeks of training, participants repeated the testing procedures under similar conditions as baseline testing.

Eligibility Criteria:
Inclusion Criteria:

* females ≥18 years of age,
* and an official handicap or completion of at least 5 rounds of golf within the last year

Exclusion Criteria:

* Exclusion criteria were current episode of musculoskeletal pain,
* unable to stand and swing a golf club independently,
* systemic disease including but not limited to rheumatologic disease or cancer,
* or psychological or other cognitive impairment.
Physical Therapy Intervention in Pleural Effusion

To know the effects of a physical therapy intervention in patients hospitalized with pleural effusion. The investigators will study the effects of the intervention in hospital stay, health status, psychologica distress and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were pleural effusion patients hospitalized.

Exclusion Criteria:

* Inability to provide informed consent.
* Presence of psychiatric or cognitive disorders.
* Progressive neurological disorders, organ failure, or inability to cooperate.
* Patients who had experienced another pleural effusion in the previous month.
Molecular Markers and Genetic Markers in Patients Undergoing Radiation Therapy for Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at molecular markers and genetic markers in patients undergoing radiation therapy for cancer.

OBJECTIVES:

Primary

* Determine local-regional control in patients undergoing radiation therapy for cancer, as a function of expression of specific molecular/genetic markers.

Secondary

* Determine complications of radiation therapy for patients undergoing radiation therapy for cancer.

OUTLINE: Previously collected tissue samples are analyzed using immunohistochemical staining and other molecular/genetic study methods to detect markers, including p53, cyclin D1, HER-2-neu, bcl-2/BAX, and EGFR. Patient charts are also reviewed with emphasis on local-regional relapse.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Undergoing radiation therapy for malignant disease

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Postprandial Triglyceride Impact on Coronary Atherosclerosis in Non-Diabetic Patient in Sohag University Hospital

INTRODUCTION Cardiovascular diseases, including coronary artery disease (CAD), are the leading cause of mortality worldwide. Despite remarkable advancements in diagnostic and therapeutic approaches, CAD continues to pose formidable challenges. Atherosclerosis, characterized by the deposition of lipids, inflammatory cells, and fibrous tissue within the arterial walls, is the fundamental pathology underpinning CAD. Atherosclerosis development and progression are closely intertwined with lipid metabolism, particularly elevated levels of low-density lipoprotein cholesterol (LDL-C) and reduced levels of high-density lipoprotein cholesterol (HDL-C) \*1+. However, emerging evidence suggests that postprandial triglyceride levels, the transient increase in triglycerides following a meal, may play a pivotal role in atherosclerotic processes \*2+. Postprandial hypertriglyceridemia has been linked to various cardiovascular risk factors, including inflammation, endothelial dysfunction, oxidative stress, and altered hemostasis \*3+. cardiovascular disease (CVD) causes death for 4 million subjects in Europe every year. It causes death for women \*2.2 million (55%)+ than men \*1.8 million (45%)+, and cardiovascular (CV) deaths under 65 years more prevalent in men (490 000 versus 193 000) \*4+. Endothelial dysfunction was the main cause of vascular atherosclerosis. The damage of Endothelium cause lipids and macrophages accumulation (mostly lowdensity lipoprotein) in vessel injury site \*5+. Lipids considered the major cause of atherosclerosis \*6+. The increase of blood cholesterol (especially LDL) considered the main cause of the disease. High levels of triglycerides could be independent risk factor for coronary artery disease (CAD), particularly in women. Although, it was suggested that high level of density lipoproteins (HDLs) can prohibit these risk factors. Extensive examinations showed that lipid decrease the prevention of CAD in primary and secondary cases \*7+. The level \> 90% of total glyceride and/or LDL and level \> 10% of HDL confirm dyslipidemia \*8+


Eligibility Criteria:
Inclusion criteria includes CAD based on coronary angiography, laboratory and ECG evidence.

Exclusion criteria:

Patients with other co-morbidities diseases, such as liver and kidney disorders and thyroid diseases. Diabetic patients.
Comparison of Stress Reduction Techniques

There are many ways to reduce stress. This study will compare 2 different programs for reducing stress. In addition to looking at how well the programs reduce stress, we will also ask questions about how these programs may be working.


Eligibility Criteria:
Inclusion Criteria:

* 25-50 years of age
* Able to engage in moderate physical activity
* Interested in being treated for stress

Exclusion Criteria:

* Use of psychotropic medications within 6 months prior to study.
* History of extreme physical or psychological trauma.
* Medical conditions that would interfere with study procedures or confound results, such as diabetes, pregnancy, or paralysis.
* Axis I psychiatric diagnosis; e.g., history of substance use disorder, psychotic disorder, bipolar disorder, or eating disorder.
Guided Surgery for Horizontal Bone Augmentation

The aim of the research project is to develop a novel protocol for guided bone regeneration (GBR) and assess whether such a patient specific 3D printed guide can improve the accuracy of the resulting bone augmentation when compared to conventional freehand protocols.

This study will be an open, prospective, randomized controlled clinical trial. A total of 28 healthy adult patients requiring bone augmentation of an edentulous site with adjacent teeth prior to implant placement will be included in a clinical trial.

All patients have to fulfill all inclusion criteria and none of the exclusion criteria. The total study duration for the patient will be around 7 months, from inclusion to final follow-up.

A virtual plan representing the ideal shape of the augmentation will be prepared. Bone augmentation guides (molds) will be designed and 3D printed for each case. These molds will encompass the defect and the desired augmentation (including the overfill compensating for the expected resorption) on the buccal aspect, leaving a small access space on the coronal aspect of the defect which will be used to insert the grafting material. Additionally, they will have holes near the mesial, distal and apical edges allowing for fixation of the barrier membrane using pin placement when the mold is in position. Finally, they will extend to the occlusal surface of teeth adjacent to the defect site in order to allow precise positioning and will have a protrusion (handle) on the buccal aspect allowing for easier handling and positioning.

The trial will have two groups, a freehand group where conventional bone augmentation surgery will be performed and the clinician will determine the shape of the graft manually, and a guided group where the guide described above will be used. A 50:50 mixture of DBBM and autogenous bone will be used for both groups, resulting in a composite graft. The graft will be covered by a resorbable collagen membrane.


Eligibility Criteria:
Inclusion Criteria:

* presence of at least one site requiring bone augmentation prior to or simultaneously with implant placement;
* the above mentioned site should have adjacent teeth both mesially and distally;
* a history of edentulism in the area of implant treatment of at least 3 months;
* provision of informed consent.

Exclusion Criteria:

* unlikely to be able to comply with the study procedures, as judged by the investigator;
* untreated periodontal disease;
* known or suspected current malignancy;
* history of chemotherapy within 5 years prior to study;
* history of radiation in the head and neck region;
* history of other metabolic bone diseases;
* a medical history that makes bone augmentation or implant insertion unfavorable;
* need for systemic corticosteroids;
* current or previous use of intravenous bisphosphonates;
* current or previous use of oral bisphosphonates;
* history of bone grafting and/or sinus lift in the planned implant area;
* present alcohol and/or drug abuse;
* involvement in the planning and conduct of the study;
* previous enrolment in the present study.
A Phase2 Clinical Trial of Trafermin in Patients With Marginal Periodontitis in Japan

This study is designed to evaluate the efficacy and the safety of Trafermin(recombinant human basic fibroblast growth factor: rhbFGF) in Japanese patients with marginal periodontitis, in order to verify the superiority of Trafermin to placebo, and to determine the recommended therapeutic dose.


Eligibility Criteria:
Inclusion Criteria:

The patient with marginal periodontitis intend to conduct a flap operation(modified Widman) must meet the following criteria:

* Alveolar bone defect diagnosed by radiography.
* Mobility of teeth must be \<=2 and the width of attached gingiva is suitable for GTR(guided tissue regeneration) method.
* Males and females, \>=20 years of age.

Exclusion Criteria:

Patients will be excluded from the study if any of the following conditions are present:

* Concomitant administration of adrenal cortical steroid within 4weeks of treatment in the trial.
* Current or previous history of gingival overgrowth by drugs.
* Current or previous history of cancer or malignant tumour.
* Presence of diabetes mellitus(HbA1c\>=6.5%)
* Presence of malnutrition(serum albumin\<=2g/dL)
* Pregnancy or lactation
Sensory-Motor Integration for Sensory Processing and Balance in ASD

This randomized controlled trial evaluates the effectiveness of a 16-week structured sensory-motor integration exercise program compared to conventional therapy (Applied Behavior Analysis and massage therapy) in improving sensory processing abilities and balance in children aged 6-12 years diagnosed with Autism Spectrum Disorder (ASD). Outcomes are measured using the Short Sensory Profile and Berg Balance Scale at baseline and after 16 weeks of intervention. Findings aim to demonstrate the clinical utility of sensory-motor integration exercises in enhancing functional outcomes for children with ASD.

Children with Autism Spectrum Disorder often experience significant sensory processing issues and motor coordination challenges, particularly balance deficits. This study evaluates a sensory-motor integration intervention aimed at improving sensory modulation and motor abilities. Participants aged 6 to 12 years are randomized into two groups: an intervention group participating in structured sensory-motor exercises (64 sessions, 4 times weekly, 45 minutes per session), and a control group receiving conventional therapy (primarily Applied Behavior Analysis and massage therapy). Outcomes are assessed using standardized measures: the Short Sensory Profile (SSP) for sensory processing and the Berg Balance Scale (BBS) for balance, at baseline and immediately following the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years
* Diagnosed with Autism Spectrum Disorder (DSM-5 criteria)
* Mild-to-moderate ASD severity (CARS score ≤ 39.5)
* Ability to participate in structured sessions

Exclusion Criteria:

* Significant physical impairments or medical conditions affecting participation
* Recent (within 6 months) participation in sensory integration therapy
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects

A study to examine the effect of daridorexant on the way the body absorbs, distributes, and gets rid of dabigatran and rosuvastatin in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
2. Healthy male subject aged between 18 and 45 years (inclusive) at Screening.

Exclusion Criteria:

1. Known hypersensitivity to daridorexant, rosuvastatin, and/or dabigatran etexilate, or treatments of the same class, or any of its/their excipients.
2. Any history of hemorrhagic disease, whether or not hereditary.
3. Any history of complications with bleeding after surgery or tooth extractions and/or frequent nasal, hemorrhoidal, or gingival bleeding.
4. Activated partial thromboplastin time (aPTT) and/or thrombin time (TT) \< 0.8 or \> 1.2 at Screening.
5. Clinically relevant findings on the physical examination at Screening.
6. Clinically relevant findings on 12-lead ECG, recorded after 5 min in a supine position at Screening.
7. Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at Screening.