cyrilzakka/clinical-trials huggingface dataset:
PERmixon® in LUTS Evaluation Study (PERLES)

The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male subject
* Between 45 and 85 years old
* Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream
* Subject naive to any prior treatment for LUTS due to BPH
* Prostate enlargement at digital rectal examination (DRE) suggestive of BPH
* I-PSS \> 12 at enrolment visit and at inclusion visit
* QoL I-PSS score ≥ 3 evaluated at enrolment visit and at inclusion visit

Exclusion Criteria:

* Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra)
* Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle
* Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus
* Known severe renal insufficiency or creatinine clearance \< 30 ml/mn
* Known liver insufficiency or clinically significant abnormal liver function tests
* History of, or concomitant, cardiac arrhythmia or angina pectoris
* Orthostatic hypotension at enrolment or inclusion visit
* Known hypersensitivity to one of the constituents of the study drugs
* Is participating in another clinical trial
Acetylsalicylic Acid and Colorectal Cancer Prevention: Exploring the Platelet Function of Its Mechanism of Action

In a preliminary study in healthy subjects, the investigators determined the pharmacokinetic and pharmacodynamic of enteric-coated acetylsalicylic acid (ASA) (Adiro 100 mg, Bayer), and the variability (coefficient of variation), accuracy and precision of a novel biomarker of ASA action, i.e., quantification of the extent of COX-1 acetylation at serine-529, using a stable isotope dilution liquid chromatography multiple reaction monitoring/mass spectrometry (LC-MS) technique.

Now, the investigators will perform a clinical study in individuals undergoing Colorectal cancer (CRC) to validate the hypothesis that that low-dose ASA given once daily is acting primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout the 24-hour dosing interval. In contrast, it is expected that the inhibitory effect on extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially COX-1, and this effect will be completely reversed at 24 hours after dosing. This is an important point which will strengthen the platelet hypothesis underpinning the apparent adequacy of a 24-hour dosing interval of ASA administration for the anticancer effect detected in cardiovascular trials.

These patients will be stratified into individuals with adenomas/carcinomas (20 to 30%) and patients without clinically detected adenomas/carcinomas (about 70 to 80%).


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged ≥ 18 and ≤ 69.
2. Patients should have an indication for screening colonoscopy

   1. First degree relative of patient with CRC.
   2. Personal history of adenomas.
   3. People older than 50 and FOBT positive
3. Routine hematological and biochemical parameters within the normal range.

Exclusion Criteria:

1. Allergy to ASA or other NSAIDs.
2. Previous use of ASA, NSAIDS, antiplatelet agents, corticosteroids or misoprostol in the previous 15 days and/or anticipated need for these drugs during the study period.
3. Peptic ulcer history or any other gastrointestinal disease that could be considered a contraindication for ASA use without the concomitant use of a proton-pump inhibitor.
4. Subjects with coagulation disorder or serious comorbid condition.
5. Malignancies, excluding CRC, diagnosed in the previous 5 years
6. Cigarette smoking, history of drug or alcohol abuse
7. Pregnant women or breast feeding
Effects of Gum Chewing on Recovery of Bowel Function Following Benign Gynecologic Surgery

Gum chewing can promotes the return bowel function after gynecologic surgery.

Following abdominal surgery for treatment of benign gynecologic surgery, paralytic ileus may be develops. Gum chewing can promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion. This study will be evaluate effects of adding gum chewing to the conventional postoperative feeding protocol on the return of bowel function, its related complication, and patients's satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing abdominal surgery for benign gynecologic conditions at Maharaj Nakorn Chiang Mai hospital

Exclusion Criteria:

* Perioperative hyperalimentation
* Recent chemotherapy (within 3 weeks before surgery)
* Previous bowel surgery
* Inflammatory bowel disease
* Previous abdominal or pelvic radiation
* Need for immediate postoperative endotracheal intubation
* Need for postoperative admission to intensive care unit
* Undergoing emergency surgery with oral intake of fluid or food with in 4 hours before surgery
Assessment of the Effect of an Implant System With a Novel Abutment Attachment Design on Crestal Bone Preservation

Integration success rates and the preservation of crestal bone will be higher for the experimental device than for the control implants.

In this study patients are randomized to receive either the experimental implant system or the control Nanotite Certain Tapered (standard abutment connection) and assessed for integration success measured by lack of implant mobility and lack of bone loss obtained at various study time points

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching
Gait Assessment Via Telephone Application

The evaluation of human gait is a crucial component of the clinical assessment and decision-making process. The gold standard in gait analysis is computerized gait analysis, which allows for three-dimensional digital data acquisition through computers (3D Computerized Gait Analysis). However, this technology is not readily accessible in routine analyses, as it proves to be a time-consuming and expensive endeavor in terms of infrastructure and human resources. The utilization of smartphones in clinical applications is on the rise, facilitated by the increasing accessibility of low-cost or free "applications," thereby addressing the limitations associated with traditional gait analysis methods. The Gait-Analyzer application is among the mentioned applications. However, in the literature, no evidence has been found regarding the validity and reliability of Gait-Analyzer application compared to the gold standard 3D computerized gait analysis systems within the context of gait analyses.

The aim of this study is to comparatively examine the effectiveness of the Gait-Analyzer smartphone application with established 3D Computerized Gait Analysis systems, which have proven validity and reliability in gait analyses. Through this research, the study intends to elucidate the validity and reliability of spatiotemporal parameters of walking within the Gait-Analyzer smartphone application.

Voluntary healthy participants will be included in the study. Signed voluntary consent will be obtained from participants. Participants will be divided into two groups. 3D Computerized Gait Analysis will be applied to one group first, and Gait-Analyzer smarthphone application will be applied to the other group first.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 26 years.
* Body Mass Index (BMI) within normal limits (18.5-24.9 kg/m2)

Exclusion Criteria:

* Presence of lower extremity rotational problems (such as high femoral anteversion, internal tibial torsion, metatarsus adductus).
* History of Botulinum Toxin Type A (BoNT-A) application or surgery within the last 6 months.
* History of lower extremity injury within the last 6 months.
* Leg length discrepancy.
* Presence of third-degree pes planus.
* Any neurological, rheumatic, musculoskeletal, metabolic, or connective tissue diseases.
* History of pain, deformity, or surgery related to the vertebral column and upper extremities.
* Presence of cognitive, mental, and/or severe psychiatric disorders
MRI Detection of Microbleeds in Glioma Patients

Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Diagnosed with brain glioblastoma
* Receiving treatment with cranial radiotherapy and/or chemotherapy
* Having at least one follow-up MRI conducted that used a susceptibility weighted imaging sequence

Exclusion Criteria:

* Underage
* Absence of formal diagnosis of glioblastoma
* No available medical imaging file with MRI susceptibility weighted imaging sequence
Evaluation of Individual Health Coaching Sessions Provided by a Patient Expert As Part of Therapeutic Education for Patients Registered At the Chronic Pain Consultation

Chronic pain is defined as a persistent sensory and emotional experience, lasting for more than three months, and often resistant to treatment. It can result from various conditions, including life-threatening diseases, accidents, or therapeutic procedures like surgery or chemotherapy. Chronic pain significantly impacts a patient's physical and psychological well-being, often leading to body image issues and functional deterioration in daily activities, both at home and at work or school. The World Health Organization recognized chronic pain as a disease in 2019. Chronic pain patients must adapt to their condition, acquiring new skills and knowledge through therapeutic education. Group sessions, a key part of therapeutic education, help break the isolation felt by many patients, fostering shared experiences and mutual support. Since 2015, the Saint-Joseph Hospital's chronic pain consultation has offered group education workshops, inspired by those at the Pitié-Salpêtrière hospital in Paris. However, many patients struggle to apply new skills independently after these workshops. In response, individualized coaching was introduced in 2020. This approach, led by a health coach who is also an expert patient, provides personalized support to help patients set and achieve realistic goals, fostering active engagement in their lives through tailored strategies and ongoing support.

The main aim of this pilot study is to assess the quantitative and qualitative contribution of personalized support by an "expert patient" chronic pain coach (individual coaching), on the functional and emotional impact and emotional impact of their pain, in patients followed up in a chronic pain consultation and having group therapeutic education workshops.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Patients followed in chronic pain consultations referred to the therapeutic education workshops
* Patient affiliated with a health insurance plan
* French-speaking patient
* Patient capable of giving oral, informed, and explicit consent

Exclusion Criteria:

* Patient with psychiatric disorders making inclusion in group workshops impossible
* Patient unwilling to participate in individual coaching sessions Patient under guardianship or curatorship Patient deprived of liberty Patient under legal protection Pregnant or breastfeeding patient
Novel Home Care Device for High-Risk Diabetic Patients

More than half of all lower extremity amputations are in persons with diabetes. These patients suffer from severe, diabetes-induced, peripheral, sensory neuropathy and, thus they frequently do not protect their feet from repetitive shear stress or traumatic episodes and ulceration often ensues. We have previously shown that the temperature profile of the plantar aspects of the foot provides a reliable warning of tissue injury and can be effectively used as a preventive modality. In this study we propose to further develop and clinically test a novel infrared-based temperature instrument (TempTouchRM®) that is intended for home use by high-risk diabetic patients. This step-on remote monitoring device will serve as an early warning system for impending ulcers and Charcot fractures. The study's central hypothesis is that the TempTouchRM device will reduce the incidence of ulcers by providing an accurate, simple, and effective approach to monitor changes in foot temperatures.

The study's central hypothesis is that the TempTouchRM device will reduce the incidence of ulcers by providing an accurate, simple, and effective approach to monitor changes in foot temperatures. To study this hypothesis, the following specific aims are proposed:

Aim 1: To develop, validate and implement software and protocols for the following: (i) data acquisition and processing, and (ii) the physician-TempTouchRM communications interface. A state-of-the-art web interface will be developed to allow clinicians to view the stored data for their patients.

Aim 2: To evaluate the effectiveness of the TempTouchRM in reducing the incidence of diabetic foot ulcers among high-risk patients. Our hypothesis is that patients monitored with the TempTouchRM will have fewer foot ulcers and that the ulcers will be less severe. The 110 patient study will comprise two treatment arms: the standard therapy group and the enhanced therapy group The latter will receive standard care plus infrared temperature monitoring using the TempTouchRM daily for 12 months. Elevated temperatures will provide information to the physician that prevention practices should be initiated, such as off-loading, skin care, etc.

Aim 3: To determine the normal range of temperature variations for each individual foot for patients in the Enhanced Therapy and to correlate deviations from this range to the incidence of ulcers. Our previous studies have used the contralateral foot as the control to detect abnormal temperatures. We will investigate the hypothesis that with proper trending of normal foot temperatures, the individual foot can serve as its own control for predicting ulcers.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of diabetes by WHO criteria, ability to provide informed consent, 18-80 years of age.

Exclusion Criteria:

* patients with open ulcers or open amputation sites, active Charcot arthropathy, severe peripheral vascular disease, active foot infection, dementia, impaired cognitive function, history of drug or alcohol abuse within one year of the study, or other conditions based on the PI's clinical judgment.
Microfracture in Rotator Cuff Injury Repair

The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.


Eligibility Criteria:
Inclusion Criteria:

- Patients over the age of 18 with a full thickness rotatorcuff rupture.

Exclusion Criteria:

* Isolated rupture of the subscapularis
* Tendon atrophia
* Goutallier grade 3-4 fatty degeneration
* Fracture surgery in same shoulder
* Inflammatory or neurologic affection of shoulder
* Other disabling disease
* Unwilling to participate in study
Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery

The objective of this study is to collect in a prospective registry all cases of French patients undergoing an assessment for percutaneous treatment of mitral valve disease on a native valve or due to deterioration after surgical valve repair or replacement. In these patients, valvular surgery should be considered contra-indicated or at prohibitive risk. This registry will evaluate the morbidity and mortality up to 24 months for those patients with severe mitral valve disease who are not included in a clinical trial. The association of demographic, clinical, laboratory, echocardiographic variables and treatment options with morbidity and mortality will be evaluated by univariate and multivariate analyses.

Patients with symptomatic severe mitral valve disease will have a medical evaluation visit (physical examination, ECG, biology) with transthoracic ± transesophageal echocardiography in each center. If the patient is considered not eligible for surgery by the heart-team and is not included in a clinical trial, the investigator informs the patient of the existence of the registry and verifies that it does not express opposition to the use of its clinical data.

In each participating center, demographic information, clinical, laboratory, echocardiographic and treatment options will be collected and reported in an electronic case report form (e-CRF). Each center will be responsible of patient monitoring, including phone call at 6 months and a medical visit at 1 and 2 years. Transthoracic echocardiography will also be performed at 1 year and 2 years.

Eligibility Criteria:
* Aged over 18 years
* Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification)
* Symptomatic (NYHA functional class II-IV) despite optimized medical therapy
* Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
* Having received information about the study and not expressing opposition to the use of their data
* Patient not included in a clinical trial

Exclusion Criteria:

* Asymptomatic patients
* Absence of severe mitral regurgitation or stenosis
* Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist.
* Pregnant or breastfeeding women
* Having not received information about the study or having expressed opposition to the use of their data
The Intracept Global Registry ( TIGR ) - Pilot Study

The Intracept Global Registry is a prospective, noninterventional, observational global post market independent data collection of the ongoing effectiveness, safety, and satisfaction outcomes for patients treated with the Intracept Procedure. This registry will be conducted according to Good Clinical Practice (GCP) guidelines, including participant verbal informed consent and Independent Review Board (IRB) / Ethics Committee (EC) approval and oversight.

Registry design, conduct, analysis, and reporting are overseen by the Principal Investigator (PI) and the cross-specialty TIGR Physician Steering Committee.

Participants in the registry will have seven study visits over a period of five years (one prior to procedure and 6 post their procedure). Study visits will be conducted via telephone by a third-party CRO and independent clinical research coordinators. Participants will be verbally consented and then evaluated via telephonic study visits at baseline (prior to procedure) and at 3, 12, 24, 36, 48, and 60 months post their Intracept Procedure.

Primary and secondary objectives are based on patient reported outcomes for functional improvement, pain reduction, and physical and mental health pre and post procedure. The study will also look at utilization of injections and pain interventions/surgery for treatment of low back pain post Intracept.

Eligibility Criteria:
Inclusion Criteria:

All patients scheduled for the Intracept procedure and whose treating physician is referring to the registry

Exclusion Criteria:

* No exclusion criteria
Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain

to check the effects of Mckenzie intervention \& Pilates intervention on power looms workers having nonspecific chronic low back pain

The purpose of this study is to check and compare the effects of McKenzie back extension exercise and Pilates pelvic tilt exercise on power looms workers having nonspecific chronic low back pain. To check the effects of these interventions on pain, disability, and anterior pelvic tilt angle.

In this study pain intensity of the subjects will be noted via a numeric pain rating scale. Pain will be measured at baseline, after 2 weeks and 4 weeks of intervention.

In this study disability of the patients will be measured via Quebec back pain disability scale. Disability will be measured at baseline, after 2 weeks and 4 weeks of intervention.

In this study, a goniometer will be used to measure the anterior pelvic tilt angle. Anterior pelvic tilt angle will be measured at baseline, after 2 weeks and 4 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age of the participants between 35-45 years.
* Only male workers diagnosed with nonspecific chronic low back pain.
* Power looms workers; Operator of power looms, working 12 hours per day.
* Low back pain for more than three months.
* Power looms workers with pain intensity on NPRS ranges from mild to moderate.
* Anterior pelvic tilt angle more than normal 13º±4.9º, anteriorly tilt to 18º to 25º.

Exclusion Criteria:

* Serious spinal pathology like tumors.
* Any inflammatory diseases.
* History of spinal surgery.
* Neurological disorder.
* Pain due to any systemic diseases.