cyrilzakka/clinical-trials huggingface dataset:
Analgecine for the Treatment of Neuropathic Pain

A randomized, open-label , positive drug controlled (Neurotropin,Japan organs Pharmaceutical Co., Ltd. ), multi-center study to evaluate Analgecine's efficacy and safety for the treatment of neuropathic pain.

The study was designed to evaluate the efficacy and safety of Analgecine for the treatment of neuropathic pain for 2 weeks. It was a randomized, open-label , positive drug controlled, multi-center study phase III clinical trial. Patients were recruited with age between 18 and 80 and visual analysis scale (VAS) between 3 and 8. After randomization, subjects were divided into 2 groups: 1) Treatment with Analgecine as experiment group; 2) Treatment with Neurotropin as positive control group. There are 3 measurement time points on day 0, 7, 14 after treatment to score patients pain with VAS. The changes of the VAS score at day 14 were compared between groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with the established medical records;
2. Patients with age of 18 years to 80 years old.
3. Patients with neuropathic pain
4. Patients at child-bearing age with negative pregnancy tests and contraceptive measures ( oral or injectable contraceptives) taken throughout the course of the experiment
5. Patients with signed informed consent.

Exclusion Criteria:

1. Patients younger than 18 years old or older 80 years old
2. Patients of dementia who can not determine efficacy
3. Patients who was pregnant, nursing or who may become pregnant in the study course and did not take effective contraceptive measures.
4. Patients with the history of allergic reactions
5. Patients suffering from tuberculosis, cancer and other organic disease
6. Patients who are alcoholics and drug addicts
7. Others who were determined by physician not to be a candidate for this clinical observation
Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

1. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR

* Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score \<-1 and \>2.5) at the lumbar spine (L1 to L4) or total hip.

Exclusion Criteria:

1. Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score \<-3.5) at the lumbar spine (L1 to L4) or total hip.
2. Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
3. Osteopenia patients (T-score \<-1 and \>-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR

   * Osteopenia patients (T-score \<-1 and \>-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
4. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
5. Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
6. Other exclusion criteria as specified in the study protocol.
Binding and Effects of Lu AG06466 in the Brain of Healthy Men

This study is being done to learn about the binding of Lu AG06466 and its major breakdown product (Lu AG06988) in the brain of healthy men having received multiple doses of Lu AG06466. As the binding will result in inhibition of an enzyme in the endocannabinoid system called monoacylglycerol lipase (MAGL), the effects on this system will be evaluated both in the blood and cerebrospinal fluid and compared to the binding in the brain.


Eligibility Criteria:
Inclusion Criteria:

* The participant has a body mass index (BMI) ≥18 and ≤30 kilograms (kg)/square meter (m\^2) at the screening visit.
* The participant has a weight of ≥60 kg at the screening visit and baseline visit.
* The participant has a waist circumference ≤94 centimeters (cm) at the screening visit.

Exclusion Criteria:

* The participant has taken disallowed medication \<2 weeks prior to the first dose of study drug or \<5 half-lives prior to the screening visit for any medication taken.
* The participant has received a COVID-19 vaccination within the last 30 days before receiving first dose of study drug.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

Note: Other inclusion and exclusion criteria may apply.
A Single-Session Intervention for Adolescents and Young Adults with Internalizing Problems

With the increasing number of adolescents and young adults (AYA) experiencing depression and anxiety, paired with the lack of time, access, and funding towards social services, AYA need a mental health intervention that is affordable and easily accessible. A single-session intervention (SSI), Project Personality, was developed to improve youth growth mindset and reduce symptoms of internalizing problems, such as anxiety and depression. The purpose of this pilot study is to determine the feasibility of an SSI in adolescents and young adults at a reproductive community health center.

The mental health of adolescents and young adults (AYA) has greatly been impacted since the beginning of the pandemic. With the increasing number of AYA experiencing depression and anxiety, paired with the lack of time, access, and funding towards social services, AYA need a mental health intervention that is affordable and easily accessible. A single-session intervention (SSI) focused on cultivating an AYA's growth mindset has potential to overcome common barriers to care, such as cost, transportation and stigma related to psychological treatment. Furthermore, research shows having a fixed mindset correlate and can predict higher depressive and anxiety symptoms. Teaching adolescents about growth mindsets could decrease the risk of internalizing symptoms. The SSI, Project Personality, was developed to improve youth growth mindset and reduce symptoms of internalizing problems, such as anxiety and depression. The purpose of this pilot study is to determine the feasibility of an SSI in adolescents and young adults at a reproductive community health center.

Eligibility Criteria:
Inclusion Criteria:

* The adolescent or young adult is between the ages of 13 and 24.
* The adolescent or young adult has a score above 5 on either PHQ-9 (Patient Health Questionnaire-9) or GAD-7(General Anxiety Disorder-7).
* The adolescent and their parent participating in the study, or the young adult can read and comprehend English.

Exclusion Criteria:

* The adolescent or the young adult has severe current suicidal/homicidal ideation and/or self-injury requiring medical intervention as defined by the ASQ (Ask Suicide-Screening Questions).
* The adolescent and their parent participating in the study, or the young adult cannot read or comprehend English.
* The adolescent and their parent participating in the study, or the young adult cannot travel to the Baylor College of Medicine (BCM) Teen Health Clinic to receive the single-session intervention.
Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD

Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. Hyperinflation and affection of the small airways are two components that are not represented in current diagnostic concepts and may relate to early stages of the disease. Moreover, optimal therapeutic interventions in patients with these distinct features remain unclear. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and initiating therapeutic strategies in early stage COPD within the GOLD recommendations.


Eligibility Criteria:
Inclusion Criteria:

* known or first diagnosis of COPD
* lung function testing consistent with hyperinflation or peripheral obstruction
* emphysema in imaging
* symptoms (dyspnea, cough, sputum) and risk factors (\>= 10 pack years)
* indication for bronchodilator therapy

Exclusion Criteria:

* GOLD stages 3 and 4 (spirometric)
* indication for dual bronchodilator therapy, triple therapy or inhaled steroid
* contraindication for cardiopulmonary exercise testing
* unwilling to participate
The Effects of Inspiratory Muscle Training in Patients With Heart Failure and Obstructive Sleep Apnea Syndrome

This research aims to evaluate the effects of inspiratory muscle training (IMT) on apnea hypopnea index, sleepiness, sleep quality, cognitive function, motor task, executive function, quality of life, chemoreflex sensitivity and vagal modulation of heart rate in patients with heart failure and obstructive sleep apnea syndrome.

Patients with heart failure will be selected through the Outpatient of the Rio Grande do Sul, for convenience. Subsequently, patients will be subjected to test respiratory muscle strength (manometer), respiratory muscle endurance, portable polysomnography, sleepiness, sleep quality, cognitive function (mini-mental state examination), motor task (execution of a sequence of digital movements), executive function, quality of life (SF-36), maximum exercise testing, chemoreflex sensitivity (peripheral chemoreflex by transient hypoxia and central chemoreflex by hypercapnic hyperoxia) and vagal modulation of heart rate (spectral analysis) before the start of the training protocol. Patients will be randomized to inspiratory muscle training or control group. Inspiratory muscle training will be performed for 30 minutes a day, 7 days a week, for 12 weeks with muscle training device (PowerBreathe). There will be a weekly monitoring in the Clinical Research Center of the institution where the maximal inspiratory pressure (MIP) and respiratory training techniques will be reassessed and readjusted (30% of MIP). The control group will be submitted to respiratory training techniques with muscle training device (PowerBreathe) without load. After this period, all initial tests will be reassessed. A group study with 15 heart failure patients without obstructive sleep apnea syndrome will be included.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with obstructive sleep apnea- hypopnea
* Heart failure patients without sleep apnea
* Left ventricle fraction ejection \< 51 % for men and \< 53% for woman
* Must be clinically stable
* New York Heart Association I, II and III
* Without changes in medication for the last three months.

Exclusion Criteria:

* Unstable angina
* Atrial fibrillation
* Acute myocardial infarction (\<6 months)
* Recent heart surgery (\<6 months)
* Chronic metabolic disease
* Infectious disease
* Anemia
* Severe hypoxemia
* Neuromuscular disease
* Diabetes mellitus
* Obesity
* Use of continuous positive airway pressure
* Smoking
* Pulmonary disease (forced vital capacity \<80% of predicted and / or forced expiratory volume in one second \<70% predicted).
Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140

The purpose of this study is to determine eligibility for one of three treatment studies of the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational treatment will be administered through this study.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected.
* Screening viral load at least 5000copies/mL.
* Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
* Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
* Women of childbearing potential must use specific forms of contraception.

Exclusion criteria:

* Acute laboratory abnormalities.
* History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
* Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment or observational studies.
* Pregnancy or breastfeeding women.
* Recent participation in an experimental drug trial.
* Prior use of a CCR5 or CXCR4 antagonist.
* Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
* Current use of certain medications may exclude participation in this study.
* Additional qualifying criteria and laboratory test requirements to be assessed by study physician.
Fluid-dynamics in Bifurcation PCI

Investigator-initiated, international, multicentre, observational study with two cohorts.

The two study cohorts will be:

Cohort A: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with bifurcated coronary lesions treated by PCI.

Cohort B: to understand if the local blood flow patterns (associated with low WSS), as evaluated by computational fluid dynamic tools from combined angiographic and OCT invasive images, may better predict the clinical outcome of patients with sub-critical bifurcated lesions managed conservatively.

Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the time-averaged WSS at the bifurcated lesion level by using computational fluid dynamics software.

Baseline (in patients both managed conservatively and treated by PCI) and post-PCI (in patients treated by PCI) images will be processed.


Eligibility Criteria:
Inclusion Criteria

* Patients with stable or unstable coronary artery disease;
* TIMI 3 on both MV and SB;
* MV visual diameter \> 2.5 mm;
* SB visual diameter \> 2.0 mm;
* Documentation of angiographically-critical (visually estimated percentage diameter stenosis ≥80% \<100%) coronary lesion treated by PCI and underwent post-PCI OCT assessment or angiographically-intermediate (visually estimated percentage diameter stenosis ranging between 30-80%) lesion in the MV considered suitable for conservative management (myocardial revascularization not planned).

Exclusion Criteria

* Age \< 18 years or impossibility to give informed consent.
* Female sex with child-bearing potential.
* Life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc.).
* Ascertained or suspected contraindications to prolonged (up to 6 month) double antiplatelet therapy.
* Known hypersensitivity to aspirin, heparin, contrast dye, sirolimus, everolimus, zotarolimus, cobalt, chromium, nickel, tungsten acrylic, and fluoro-polymers.
* Poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
* Recent (\< 48 hours) ST-segment elevation myocardial infarction.
* Severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ECG Sokolow's criteria fulfilled).
* Severe valvular heart disease.
* Significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3).
* Gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks.
* History of clotting pathology.
* Advance renal failure with glomerular filtration rate \< 30 ml/min (Cockcroft-Gault equation)
* Left main lesion.
* Target bifurcation located on a distal coronary segment.
StrongWomen- Healthy Hearts: A Community Based Program for Midlife and Older Women

Cardiovascular disease (CVD) is the leading cause of death for women in the United States. CVD disproportionately affects underserved populations, specifically low-income, minority, and rural women who have higher obesity rates and experience other health disparities. There is a need for replicable, evidence-based programs that target women, particularly midlife and older women who represent an increasing proportion of the U.S. population, to reduce their CVD risk . StrongWomen - Healthy Hearts is a 12-week, community-based program that has demonstrated effectiveness at improving CVD risk factors, including body weight, diet quality, and physical activity in a controlled, randomized trial conducted with midlife and older overweight and obese subjects in Arkansas and Kansas.

The central objective is to rigorously evaluate dissemination of the StrongWomen - Healthy Hearts Program using the RE-AIM framework to achieve maximal public health impact. Expanded dissemination will occur through the Cooperative State Research, Education and Extension Service (CSREES) This partnership will leverage a long and successful collaboration between Tufts University and CSREES that provides strength training programs to older women in 41 states.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 40 years of age
* Female
* BMI greater than 24
* sedentary (not doing any type of exercise more than once per week)

Exclusion Criteria:

* unstable medical condition that would preclude participation in an exercise program
* current participation in another lifestyle modification program
* cognitive impairment
* pregnancy.
Effect of Modified Mesh on Surgical Success in Transobturator Tape Surgery

This study is a single-blind, randomized controlled trial evaluating whether changing the width of the surgical tape (mesh) used in transobturator tape (TOT) surgery improves treatment results in women with stress urinary incontinence (SUI). Two mesh widths are being compared: a 1.2 cm mesh (new method) and a 1.0 cm mesh (standard method). The main goal is to find out if the wider mesh leads to better urinary control and fewer complications. Participants will be followed for one year to measure cure rates, symptom improvement, and satisfaction.

This is a prospective, single-blind, randomized controlled trial evaluating the effect of mesh width on surgical outcomes in transobturator tape (TOT) procedures for women with stress urinary incontinence (SUI). A total of 106 participants will be randomized using a computer-generated allocation into two groups receiving either a 1.2 cm mesh (intervention group) or a 1.0 cm mesh (standard procedure).

The procedures will be conducted by a single experienced surgeon using a monofilament polypropylene mesh to ensure standardization. Surgical technique, anesthesia protocols, and perioperative management will be identical in both groups.

Primary outcome is objective cure, defined as negative stress test at 6 months. Secondary outcomes include symptom improvement (ICIQ-SF), mesh-related complications (erosion, infection, retention), and patient satisfaction assessed via structured Likert survey.

Follow-up visits are scheduled at 1 week, 1 month, and 1 year. Postoperative assessments will be conducted by a blinded evaluator. The study aims to evaluate whether wider mesh width provides superior anatomical support and reduces complication rates in comparison to standard mesh.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18 years or older
* Clinical diagnosis of stress urinary incontinence (SUI), confirmed by:
* Positive stress test (urine leakage on coughing with a comfortably full bladder)
* Q-tip test showing urethral hypermobility (\>30 degrees)
* Inadequate response to conservative therapy (e.g., pelvic floor muscle training, behavioral therapy)
* Eligible for transobturator tape (TOT) surgery
* Body mass index (BMI) less than 35 kg/m²
* Able to provide informed consent and follow postoperative instructions

Exclusion Criteria:

* History of prior midurethral sling surgery
* Mixed urinary incontinence or urge-dominant symptoms
* Pelvic organ prolapse stage \> II according to the POP-Q system
* Neurological disorders affecting bladder function (e.g., multiple sclerosis, spinal cord injury)
* Active urinary tract infection or recurrent UTI (defined as ≥3 infections within the past 12 months)
* Pregnant or planning to become pregnant within the next 12 months
* Severe comorbid conditions (e.g., uncontrolled diabetes mellitus, active malignancy, pelvic radiotherapy)
* Use of medications that significantly affect bladder function (e.g., anticholinergics, diuretics)
* Inability or unwillingness to attend follow-up visits or comply with postoperative care plan
A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After Laser Hair Removal in the Groin and Intimate Area

In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure for hair removal (laser depilation) in the groin and intimate area in adult women.

After the hair removal procedure, participants will return within 3 weeks for 3 visits to the study center to investigate the skin condition such as redness, irritation, softness of skin and possible side effects. Study participants will also be asked about their general acceptance of dexpanthenol dermal spray.

The primary objective is to evaluate the efficacy of the test product to aid skin recovery after lasering depilation in the intima and inguinal region.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Eligibility Criteria:
Inclusion Criteria:

* Phototypes I and II according to the Fitzpatrick scale
* Participants willing to have a dermatological procedure (laser depilation) in the inguinal region to remove hairs in the region

Exclusion Criteria:

* Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
* Hyperpigmentations in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
* Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area
Mesotherapy Versus Systemic Therapy in Treating Neck Pain Related to Herniated Disc

Introduction: Neck pain is a global public health concern, that ranked 4th highest health condition in terms of disability as measured by years lived with disability. The aim of this study is to compare the efficiency of one-session mesotherapy application with systemic therapy in treating neck pain related to cervical disk herniation.

Methods: This is a prospective parallel randomized controlled trial conducted with patients admitted to our emergency department with neck pain related to cervical disc herniation. A mixture of thiocolchicoside, lidocaine and tenoxicamwas administered via mesotherapy in one group, and intravenous administration of dexketoprofen was applied to the other group. We compared the changes in pain intensity at 60thminute, 120thminute and 24th hours after treatment using Visual Analogue Scale (VAS),and adverse effects of the treatment methods among the study groups.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older age
* Admission to Emergency Department (ED) with acute cervical pain related to cervical disk herniation.

Exclusion Criteria:

* Taking analgesic drugs before admission
* Having VAS score of lower than 4 on admission
* Having diabetes mellitus
* Body mass index\>30 kg/m2
* Pregnancy
* Lactation
* Having active bleeding or bleeding disorder
* Having active or recurrent gastrointestinal hemorrhage or ulcer, or history of these conditions
* Having a serious or life-threatening condition (stroke, intracranial hemorrhage, heart attack, cardiac tamponade, pneumothorax, hemothorax, flail chest, etc.).