cyrilzakka/clinical-trials huggingface dataset:
GLucobay M OBservation Study for Efficacy and Safety in Treatment of Type-2 Diabetes Patients

An observational and multicenter study to assess the effectiveness and safety of Glucobay®- M under daily life treatment of type-2 diabetes patients.The study objectives are to investigate the effectiveness and safety of Glucobay® -M on blood glucose and patients body - weight. Glucobay®- M is taken 1-3 times daily. All patients with type 2 diabetes mellitus, where investigator feels that addition of Glucobay®-M would be beneficial to patients will be included in non- interventional study. The routine investigation suggested by the attending physician will be done in diabetic patients. No additional investigation will be done for the study purpose. The uncontrolled diabetic patient on existing treatment and prescribed Glucobay®-M will be included in study after taking the informed consent. The patient will be asked to attend 2 follow up visit each after 6 weeks. All patients receiving at least one tablet will be included in the safety analysis.The study is planned to be carried out in 10000 patients from 320-350 trial sites in India.


Eligibility Criteria:
Inclusion Criteria:

* Female and male patients ≥ 18 years of age with Type 2 Diabetes where investigator feels that addition of Glucobay®-M would be beneficial to patients.
* The diagnosis will be made based on the ADA criteria by the attending physician.
* Patients will be defined as included in the study if they have a documented prescription of Glucobay-M by the physician.
* Patients willing to provide signed \& dated informed consent.
* Patients willing to comply with study requirements.

Exclusion Criteria:

* According to the local product information
Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

The purpose of this study is to determine if modafinil is more effective than placebo in the treatment of posttraumatic stress disorder (PTSD) in male combat veterans who have been deployed to Iraq or Afghanistan.

There is a high rate of posttraumatic stress disorder (PTSD) in soldiers exposed to combat in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF). Unfortunately, currently available treatments for combat-related PTSD have produced modest treatment gains at best. New treatment strategies that can be directed toward objectively measured correlates of PTSD are urgently needed.

Specific Aims: 1) To determine if there is evidence for the effectiveness and tolerability of adjunctive modafinil in the treatment of combat-related PTSD. We hypothesize that OEF/OIF veterans with PTSD randomized to modafinil 100mg/day for four weeks will experience more improvement in PTSD symptoms than OEF/OIF veterans with PTSD randomized to placebo treatment for four weeks. 2) To determine if PTSD symptom severity is associated with electrophysiological and neuropsychological measures of pre-attention and attention and if these measures change to a greater degree in participants randomized to modafinil versus those randomized to placebo. We hypothesize modafinil treatment will result in greater changes in electrophysiological and neuropsychological measures of pre-attention and attention than placebo treatment.

Eligibility Criteria:
Inclusion Criteria:

* OEF/OIF Veteran with a history of deploying to Afghanistan or Iraq
* right-handed
* male 20-60 years of age
* meets Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for PTSD
* competent to give informed consent
* access to a telephone
* stable psychotropic medication regimen for a minimum of four weeks prior to enrollment
* able and willing to complete the required schedule of evaluations (Baseline in person, 1 week by phone, 2 week in person, 4 week in person)

Exclusion Criteria:

* diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
* current substance abuse or dependence
* history of seizure disorder or severe traumatic brain injury
* history of attempted suicide within the previous two years or active suicidal ideation within the past month
* currently taking benzodiazepines except for bedtime dosing only
* currently taking stimulant medication
* known allergic reaction to modafinil or currently taking medication
* that may have altered metabolism if taken with modafinil: Tricyclic antidepressants (amitriptyline; nortriptyline; desipramine; imipramine; CNS stimulants (amphetamine; d-ampthetamine; atomoxetine); Carbamazepine; Phenytoin; Phenobarbitol; Rifampin; Ketaconazole; MAO Inhibitors (isoniazid; selegiline); Warfarin; Diazepam; Mephenytoin; Cyclosporine; Theophylline
Rock Steady Boxing: A Community Based In Person Class

The purpose of this study is to evaluate the feasibility and effectiveness of a non-contact Rock Steady Boxing class delivered to participants with Parkinson's Disease via an in-person community-based program. The study will also assess the overall feasibility of integrating an in-person community program within a neuromuscular course in a Doctor of Physical Therapy program.

Specific Aim: To examine the effects of an in-person community-based Rock Steady Boxing class on the functional mobility, functional endurance, cardiovascular capacity, visual-motor reaction times, quality of life, mood/affect and overall physical activity completion and fear of falling on individuals with Parkinson's Disease.

Participants will be recruited directly from the the Brain Center (non-for-profit neurology clinic). Participants will be educated on the study but advised that their participation is voluntary and researchers will not coerce boxers to participate in the study. Once a participant agrees to participate, the Informed consent will be completed. During this time, participants will be told their participation is voluntary and they can quit at any time. he primary interventions being assessed in this study include the in-person Rock Steady Boxing Class offered at USAHS once per week. Prior to attending the Rock Steady Boxing classes, all participants must be provided with medical clearance from a referring medical doctor. The Rock Steady Boxing classes are 60-90 minutes in duration and include the following 4 components: (1) active warm up (2) functional mobility exercises (3) whole body strengthening exercises and (4) non-contact boxing exercises. During the classes, boxers' vitals are assessed using health rate monitors.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Age Range: 18 years or older
3. History of Parkinson's Disease between Hoehn and Yarh stages I and IV
4. Medical clearance from a referring medical doctor
5. Able to complete all assessments
6. Willing to complete a weekly exercise log

Exclusion Criteria:

1. Unable to complete the assessments.
2. Pregnant or is expected to become pregnant during study
3. Other reasons that may limit participation in exercises. -
AI in Hypertension Treatment Education: Comparing GPT and Traditional Methods

Educational Trial: GPT-Based Training vs. Traditional Teaching for Hypertension Management

The goal of this educational trial is to determine whether a Generative Pre-trained Transformer (GPT)-based training system is more effective than traditional teaching methods in helping medical students master hypertension management plans. It will also evaluate the educational effectiveness and engagement of the GPT-based system. The main questions it aims to answer are:

Does the GPT-based training improve the ability of students to develop effective hypertension management plans compared to traditional methods? How do students perceive the use of the GPT system in their learning process? Researchers will compare the GPT-based training system to traditional teaching methods to see if the innovative AI approach enhances learning outcomes in medical education.

Participants will:

Engage with either the GPT-based system or traditional teaching materials. Visit the educational facility periodically for assessments and feedback sessions.

Keep a diary of their learning experiences, noting any difficulties or advantages they observe in the training method they are assigned.


Eligibility Criteria:
Inclusion Criteria:

* Graduate or regulatory trainee, currently rotating in cardiology and willing to participate in research.
* Age between 18-30 years old, gender not limited.
* No specialized training experience in hypertension diagnosis and treatment, only possessing basic medical theoretical knowledge.
* Able to accept a 4-week teaching intervention (2 hours of study per week).
* Sign the informed consent form and be aware of the research purpose and process.

Exclusion Criteria:

* Graduate students or trained interns who have received specialized training in hypertension medication treatment.
* Students unable to complete the full course of study (e.g., rotations shorter than four weeks or potential mid-course withdrawal).
* Unable to consistently participate in educational interventions (e.g., conflicts with study schedule).
* Have severe physical or mental health issues that may affect the learning process.
* Have language comprehension barriers or cognitive impairments, making it difficult to complete learning tasks.
A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 2
* Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria:

* Severe Asthma, severe COPD
* Smoking
Celebrex In Acute Gouty Arthritis Study

This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that will include an 8-day treatment period followed by a 1-week follow-up period in patients experiencing symptoms of an acute exacerbation of gouty arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for acute arthritis of primary gout;
* Onset of pain from an acute gouty arthritis attack within 48 hours prior to Screening/Baseline (Visit 1);
* A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's assessment of pain intensity in the index joint (5-point scale:0-4) at Screening/Baseline.

Exclusion Criteria:

* Diagnosis of any other type of arthritis including those types suspected of being infectious in origin in the index joint or presence of any acute trauma of the index joint. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator's criteria) and it does not affect the index joint;
* Acute polyarticular gout involving greater than 4 joints or chronic gout.
The Hypotensive Effects of Home-Based Isometric Handgrip Training in Older Adults With Pre-Hypertension and Hypertension - The HoldAge Trial

New data suggests that isometric handgrip training (IHT) might become a novel tool in the treatment of hypertension. The main purpose of this research project is to evaluate the effects of home-based IHT on ambulatory blood pressure in older adults with pre-hypertension and hypertension. Eighty-four older adults with pre-hypertension and hypertension will be randomly distributed to one of three groups: home-based IHT, home-based aerobic exercise training (AET), or attention-control group (CON). Each intervention will have a total duration of 8 weeks. At baseline and after completing the intervention, patients will undergo the following evaluations: 24-hour ambulatory blood pressure, cardiorespiratory fitness, endothelial function, damage and repair, arterial stiffness, inflammatory biomarkers, autonomic function, physical activity levels, dietary intake and quality of life. A qualitative analysis will also be applied to enhance the understanding of the efficacy of this intervention from the patient's perspective.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Secondary Hypertension
* Target Organ Damage
* Coronary Artery Disease
* Heart Failure
* Any Previous Cardiovascular Event
* Peripheral Artery Disease
* Renal Failure
* Chronic Obstructive Pulmonary Disease
* Insulin Dependent Diabetes
* Change of Antihypertensive Medication in the Past 4 Weeks Before Inclusion in the Study
* Smokers
* Those Participating in Regular Physical Activity
Observational Study of Safety and Efficacy of Levemir® in Type 2 Diabetes

The study is conducted in Asia. The aim of this observational study is to evaluate the weight change from baseline while using Levemir® in subjects with type 2 diabetes mellitus under normal clinical practice conditions in India.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with type 2 diabetes

Exclusion Criteria:

* Subjects with a hypersensitivity to insulin detemir or any of its excipient
* Children below 6 years
* Subjects who are pregnant, lactating or planning to become pregnant
Testosterone Treatment for Hypogonadal Men

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men


Eligibility Criteria:
Inclusion Criteria:

* Low T males 18 - 80 years of age

Exclusion Criteria:

* Normal T levels
* Elevated Prostatic Specific Antigen (PSA)
Fast Track Module Based Colonoscopy Training Programme for Surgical Trainees at North Jutland Surgical Departments

Specially educated trainers will be responsible for colonoscopy training of junior doctors. The educated trainers will have attended seminars held by Valori et al.

The following fast track colonoscopy training program for junior doctors will consist of: 1) Endoscopy simulation training and theory course 2) supervised and partly supervised lower endoscopy. 3) Directly observed practical skills according graded by MCSAT (Mayo Clinical Skills Assessment Tool) .

Initially a "train the trainers" program will begin with 3 sessions held by Valori et al. at Aalborg University Hospital. 6 Trainers are expected to be trained during the "train the trainers" program. The doctors selected for the "train the trainers" program are doctors specialized in abdominal surgery with an extensive lower GI-endoscopy experience and who is considered to have an excellent teaching ability to educate junior doctor.

The training program for junior doctors consist of the following:

* Initial 1 day endoscopy simulation and theory at Nordsim. Endoscopy simulation scores will be monitored.
* 20 days of fully supervised colonoscopies (max booking of 6 colonoscopies pr day). Trainer is always present in the endoscopy room
* MCSAT (Mayo Clinical Skills Assessment Tool) will be used to grade the trainee multiple times and planned at day 0,5,10,15 and 20. Multiple graders will be used.
* Simulator test will be held at day 0, 10 and 20 colonoscopies to validate progress and compare simulator generated measures with MCSAT. Both the AccuTouch and Symbionix simulator will be used,

Eligibility Criteria:
Inclusion Criteria:

* Doctors currently enrolled in PGY1, 2 and 3 - Danish equivalents: introduktionsstilling, hoveduddannelse 1, 2.
* Able to arrange colonoscopy training in such a way that the total program can be completed in 12 weeks.
* Able to perform supervised upper endoscopy.

Exclusion Criteria:

* Less than 4 months left at current job position.
Pediatric Intubation During CPR

We hypothesized that the video-laryngoscopes are beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of two video-laryngoscopes (the Coopdech video Laryngoscope portable VLp-100 and the Flexible Videoendoscope: ATMOS Scope) and optical-laryngoscope (the AirTraq) during resuscitation with uninterrupted chest compressions using an child manikin.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (physicians, nurses, paramedics)

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases
INS, B Cells and Microbiota

Idiopathic nephrotic syndrome (NIS) is a clinical entity defined by the association of selective albuminuria, hypoalbuminemia, and nonspecific glomerular lesions (lesions minimal glomerular (LGM) or segmental and focal hyalinosis (HSF). The complication of this kidney disease is the progression towards chronic renal failure and in case of kidney transplantation, its immediate recurrence on the graft . The origin of this syndrome is unknown but a number of clinical observations tend to show an involvement of immune system. A link has been highlighted between atopy, diet and nephrotic flare-ups. The speed of recurrence of this initial disease on the graft and the observation of remissions obtained after treatment by plasma exchange or immunoadsorptions support the presence of a pathogenic plasma factor. Anti-CD20 treatments depleting B lymphocytes has made it possible to favorably treat a number of patients. Dysfunction of regulatory T cells has also been shown in SNI patients. This modification seems linked to allergies and could be due to an aberrant microbiota. The hypothesis of causality between dysbiosis, alteration lymphocyte and triggering of an SNI was mentioned recently. Two studies have shown intestinal dysbiosis in pediatric SNI/LGM, with reduction of T circulating regulators


Eligibility Criteria:
Inclusion Criteria :

* Patient treated in participating centers
* In nephrotic attack, defined biologically by:

Proteinuria \> 3g 24h or A proteinuria/creatinuria ratio \> 3 or Defined at the discretion of the clinician

Non inclusion Criteria :

* Patient with a history of NIS flare-ups resistant to corticosteroid therapy
* Patient treated with immunosuppressant
* Patient treated with corticosteroids \> 10 mg/d
* Weight \<50 kg
* Pregnant woman
* Patient under guardianship / curatorship
Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients

The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score

Eligibility Criteria:
Inclusion Criteria:

* type 2diabetes
* Non proliferative diabetic retinopathy

Exclusion Criteria:

* Uncontrolled glycemic level
* proliferative diabetic retinopathy
Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer

RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known which vitamin E regimen is more effective in preventing prostate cancer.

PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how well they work in preventing cancer in patients at risk of prostate cancer or who have prostate cancer.

OBJECTIVES:

* Determine the effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E_2 by comparing the blood and urine samples collected before and after the supplementation in patients with prostate cancer.
* Test the hypothesis that the supplementation reduced oxidative and nitrosative stress by measuring plasma levels of F_2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG).
* Determine the levels of α-, γ-, and δ-tocopherols in prostate tissues and analyze immunohistochemically (IHC) for cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels in prostate cancer/tissue slides.

OUTLINE: Patients are randomized into 1 of 3 arms.

* Arm I: Patients receive no supplementation.
* Arm II: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.
* Arm III: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.

Blood, urine, and tissue samples are collected periodically and analyzed for oxidative/nitrosative stress and other markers (i.e., F2-isoprostane, 8-OHdG, 3-nitrotyrosine, prostaglandin E2, C-reactive protein, and PSA), biomarkers in prostate tumors and nontumorous tissues (i.e., 8-OHdG, 3-nitrotyrosine, and cyclooxygenase-2) by IHC, and pharmacokinetics by high-performance liquid chromatography.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Abnormal digital rectal examination or abnormal prostate specific antigen (\> 4.0 ng/mL)
  * Obstructing prostate
  * Biopsy-proven prostate cancer
* Scheduled to undergo prostate surgery (i.e., transurethral prostatectomy or prostatectomy)

PATIENT CHARACTERISTICS:

* No uncontrolled diabetes, uncontrolled blood pressure, chronic congestive heart failure, or history of renal insufficiency
* No personal or family history of a bleeding disorder
* No known history of problems absorbing dietary fats (e.g., Crohn's disease, cystic fibrosis)

PRIOR CONCURRENT THERAPY:

* More than 2 weeks since prior NSAIDs or corticosteroids
* No concurrent supplementation of vitamin E (a multivitamin containing ≤ 60 IU of vitamin E is allowed)
* No concurrent colestipol or orlistat
* No concurrent warfarin or dicumarol
Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.


Eligibility Criteria:
Inclusion Criteria:

* 1 to 10 years of age
* ASA I-II
* Undergoing elective hypospadias surgery

Exclusion Criteria:

* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* ASA III-IV
* Patients with neurological disorders
ICCRT vs. CRT for Locally Advanced Nasopharyngeal Carcinoma

This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether concurrent chemoradiotherapy is not inferior to induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old;
2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);
4. No distant metastasis;
5. Have not received anti-cancer treatment in the past;
6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
7. Adequate hematologic, hepatic and renal function.

Exclusion Criteria:

1. The purpose of treatment is palliative;
2. Diagnosed with other malignant tumors at the same time;
3. Malignant tumor history;
4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period;
5. Combined serious illness.