cyrilzakka/clinical-trials huggingface dataset:
Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease

The primary purpose of this study is to measure the efficacy of solifenacin succinate (VESIcare) on treating urinary incontinence in Parkinson's disease patients.

The secondary objective of this study is to examine the effect of solifenacin succinate (VESIcare) on symptoms of PD and the patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
2. Age 30 years to 80 years.
3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
4. Patients must score 18 or higher on the UPDRS scale and 1.0 to 2.5 on the Modified Hoehn and Yahr scale.
5. Women of child-bearing potential must use a reliable method of contraception.
6. Must be experiencing symptoms of urinary incontinence (voiding 8 or more times/day or episodes of incontinence 5 or more times per week).
7. Patients must have evidence of normal PSA and urodynamic tests within the last 12 months.
8. Clearance from the patient's urologist or internist who has examined the patient within the last 12-months.

Exclusion Criteria:

1. Any illness that in the investigator's opinion preclude participation in this study.
2. Pregnancy or lactation.
3. Concurrent participation in another clinical study.
4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24).
5. Legal incapacity or limited legal capacity.
6. Presence of severe renal disease (BUN 50% greater than normal).
7. Presence of major hepatic impairment.
8. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor.
9. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
10. History of controlled narrow angle glaucoma.
The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery

The purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.

Fifty patients underwent total knee replacement were included in the study. The patients (11 male and 39 female) were classified into two equal groups:- The patients received 15 mL plain bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups was 17 ml.

Postoperative records:

1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.
2. Frequency of rescue analgesia.
3. Postoperative side effects like nausea, vomiting, and over sedation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for total knee replacement surgery.
2. ASA Physical status I,II,III.

Exclusion Criteria

1. Patients' refusal.
2. Uncooperative patients / Not able to understand pain assessment test.
3. Patients with history of allergy to the used drugs.
4. Significant liver disease.
5. Pregnancy.
6. Any contraindication for epidural anesthesia
7. Failed technique.
Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment

The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 35kg/m2
* MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)
* Negative TMD diagnosis (according to RDC/TMD)

Exclusion Criteria:

* DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE
* SLEEP DISORDERS OTHER THAN OSAS
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus

The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.

System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels \>80 mg/dL and ±20 mg/dL at YSI glucose levels \<80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly.

Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants.

Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).


Eligibility Criteria:
Inclusion Criteria:

* Ages 2 to 17 years ;
* Diagnosis of diabetes mellitus;
* Willing to participate in one 7-day Sensor wear period;
* Willing to wear 2 systems simultaneously;
* Willing to take a minimum of 7 fingersticks per day during home use with a blood glucose meter provided;
* Willing to attend one in-clinic session of up to 6 hours duration. Clinic procedures where blood sampling via SMBG and/or venous YSI method, depending on age;
* Subject or guardian is able to speak, read, and write English.

Exclusion Criteria:

* Extensive skin changes/diseases at sensor wear site that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis);
* Known allergy to medical-grade adhesives;
* Require a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, or diathermy during the wear period. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their continuous glucose monitoring (CGM) session, and remove their sensor.
Effect of Reminders on Adherence

The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence.

The investigators seek to increase medication adherence of subjects. The investigators will send mailings to customers of an insurance company, asking them to predict or commit to a certain level of behavior. The investigators will measure whether this increases medication adherence. The investigators will send mailings to subjects once per month, and elicit responses via mail, phone, and web surveys.

Eligibility Criteria:
Inclusion Criteria:

* customers of the investigators' insurance company partner

Exclusion Criteria:

* none
The Chemopreventive Effect of Metformin in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study

Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Metformin, a biguanide, which is widely used for treating diabetes mellitus, has recently been suggested to have a suppressive effect on tumorigenesis via mTOR-inhibiting pathway, and have no significant safety issues in long term use. The investigators devised a double-blind randomized controlled trial to evaluate the effect of metformin on polyps of colorectum and duodenum in non-diabetic FAP patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age.
2. FAP patients who have colonic or duodenal polyp
3. FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination.

Exclusion Criteria:

1. FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization.
2. FAP patients with malignant disease, including colorectal cancer.
3. FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. 4. FAP patients with diabetes mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test) and significant infectious or respiratory diseases.
Effects of TOA Versus PNF Techniques on Trunk Control in Children With Hemiplegic Cerebral Palsy

Cerebral palsy occurs in 2-2.5 per 1000 live births, seems to be the most common cause of lifelong physical disability, and has an impact on the child, caregivers, and society. The incidence of cerebral palsy continues to rise owing to the large numbers of premature and high-risk infants who survive. Task-oriented arm approaches promote intensive, meaningful, and goal-oriented training in subjects, and the voluntary functional activities of these subjects possibly reduce their motor disabilities.

The study will be randomized clinical trial used to evaluate the effectiveness of TOA and PNF on trunk control in children with hemiplegic cerebral palsy. Subjects with hemiplegic cerebral palsy meeting the inclusion and exclusion criteria will be divided into two groups using non- probability sampling techniques. Assessment will be done using trunk control measuring scale and pediatric reach test . Group A will receive TOA and conventional therapy and Group B will receive PNF and conventional therapy.

Eligibility Criteria:
Inclusion Criteria:

* The level of gross motor function between I and III in accordance with the Gross Motor Function Classification System (GMFCS)
* The degree of spasticity in the affected lower extremity between grade 1 and 1+ in accordance with the Modified Ashworth scale
* 6-12 years of age
* Ability to understand and follow verbal instructions

Exclusion Criteria:

* Surgical procedures within the past 6 months
* Botox injection within 6 months
* Unstable Seizures
* Other comorbidity condition (Multiple Disabilities)
Research Accelerated by You Lupus Registry

The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is an ongoing, voluntary, longitudinal study gathers data from adults with lupus and legally authorized representatives of children with lupus to better understand diagnosis, treatment, care, and quality of life. Participants provide informed consent and complete electronic surveys every six months. The LFA uses the data to address constituent needs, share clinical research opportunities, and advance lupus research by sharing de-identified data with approved third-party investigators. The LFA will promote participation via its website and email outreach to around 200,000 people connected to lupus. Participants may also be resurveyed to assess clinical trial eligibility and other factors related to trial participation. Types of self-reported data will include: demographics, diagnoses, treatment information and patient reported outcomes, including quality of life reports, which have been increasingly recognized as essential for assessing health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* For adults with lupus, the individual who completes the Registry:

  * is 18 years of age or older
  * has a self-reported diagnosis of lupus by a physician or health care provider
  * is willing and able to provide informed consent
  * is able to read and understand English sufficiently to complete the survey questions
  * has access to a computer with an internet connection

For children under 18 with lupus, the individual who completes the Registry is:

* 18 years of age or older
* the parent/legal guardian/legally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider
* willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age
* able to access a computer with an internet connection
* able to read and understand English sufficiently to complete the survey questions

For adults with lupus unable to provide consent, the individual who completes the Registry is:

* 18 years of age or older
* the legally authorized representative of an adult 18 or older who is unable to provide consent and has a diagnosis of lupus by a physician or health care provider
* willing and able to provide consent for the adult with lupus
* able to access a computer with an internet connection
* able to read and understand English sufficiently to complete the survey questions

Exclusion Criteria:

-
The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease

Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups.

The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.


Eligibility Criteria:
Inclusion Criteria:

* all patients fulfilling the classification criteria of the International Study Group for Behçet's disease

Exclusion Criteria:

* smoking,
* diabetes mellitus,
* hypercholesterolaemia,
* hypertension,
* cardiac insufficiency,
* coexisting hepatic and renal diseases
* inflammatory diseases.
Research on the Localization Accuracy of PICC Guided by EDUG in Real World

This study is a multi-center clinical study, 3000 cases, 25 centers in the country involved, carry out the guidance of EDUG PICC standardized operation at the same period. Each center assists to use app to collect research data.The experimental data will be collected, processed and analyzed by the sponsor and the researchers, and the clinical effect of EDUG will be evaluated according to the results (like the rate of once in place, the number of adjustment times before X-ray, the length of time during the whole catheter placement, the ectopic incidence during PICC first implantation and so on, the special content can be seen in the next indicator section)


Eligibility Criteria:
Inclusion Criteria:

1. Patient≥18 years old
2. Follow the doctor's advice,patients who need to be placed PICC for the first time.
3. No serious cardiovascular diseases, such as atrial fibrillation,pulmonary heart disease and other P wave abnormalities, severe heart block, etc.
4. Patients who did not participate in other clinical studies；
5. Patients who volunteer to participate the clinical study, sign the informed consent and cooperate with the clinical follow-up.

Exclusion Criteria:

1. Patients who have partial deformity or scar formation
2. Patients whose puncture site were infected or damaged
3. Patients who have sclerosis or the cord like change of the vein
4. Patients have compressed vessel by tumor
5. Patients who are confirmed or suspected having infection, bacteremia, or sepsis related to the catheter
6. Patients whose size are not fit to insert the PICC
7. Patients who are confirmed or suspected sensitive to silica gel
8. Patients who have history of radiotherapy in the pre-insertion section
9. Patients who have history of venous thrombosis, trauma, or vascular surgery
10. Patients who have superior vena cava syndrome
11. Patients who were always not following up with the doctors
12. Patients who have severe peripheral edema
13. Patients who may be required a high flow of fluid infusion, hemodialysis, pacemaker, crutches or A-V fistulation

    -
Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

Chronic obstructive lung disease (COPD) is a common disease that is frequently complicated by hyperinflation. The resulting increase in lung volume impairs the diaphragmatic function because of a shortening of the diaphragmatic fibers and an increase in the radius of curvature of the diaphragmatic domes. Lung volume reduction surgery (LVRS) has already shown an improvement in diaphragmatic function that could be explained by a change of the diaphragm conformation. More recently, endoscopic lung volume reduction (ELVR) has shown benefits in terms of respiratory function, exercise capacity and quality of life, but the mechanisms of these improvements are poorly understood. Therefore, we aim to evaluate the evolution of the diaphragmatic function and the changes in diaphragmatic conformation after unilateral ELVR.


Eligibility Criteria:
Inclusion Criteria:

* valves insertion

Exclusion Criteria:

* TLVR \< 50 %
Low-Volume Interval Training and Resistance Exercise in Individual With Stroke

To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.

Prescribing aerobic and resistance training in concurrence is proposed as an optimum strategy to target cardiovascular as well as musculoskeletal functions in individuals with post-stroke. Lower limb's resistance training alone in chronic stroke produces a large effect on muscle strength. However, it has shown uncertainty results on walking performance. Therefore, it is suggested that to prescribe mix training (treadmill training and strength training) in order to improve muscle strength, gait performance and quality of life in stroke survivors. Previous studies have shown the effect of mixed training on walking performance and endurance in other populations such as multiple sclerosis and coronary artery disease. However, there is a lack of study that conducted mixed training among chronic post-stroke. Therefore, the feasibility study on the effectiveness of combining LV-ITT and RE in post-stroke should be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 45-65 years' old
* At least 3-months post-stroke
* Gait speed ≤1.0 m·s -¹ measured by the 10 m walk test.
* Able to walk 10 m overground with assistive devices as needed and no physical assistance.
* Able to walk for 3 min on the treadmill at ≥0.17 m·s -¹ (0.4 mph) with no aerobic exercise contraindications.
* Modified Rankin Score (mRS) of \<4 at the screening
* American Heart Association class B (2), allowing for aerobic capacity \<6 metabolic equivalent (MET)

Exclusion Criteria:

* Significant resting ECG abnormalities
* Hospitalization for cardiac or pulmonary disease within 3 months
* Using Pacemaker
* Aphasia
* Significant musculotendinous or bony restrictions of the affected limb, or any serious chronic disease independently causing disability or profound atrophy of the affected limb that will comprise further indications to participation significant.
Probiotics in Pulmonaty Rehabilitation for COPD

This study aims to investigate various aspects of patients with chronic respiratory diseases undergoing pulmonary rehabilitation supplemented with probiotics. The focus will be on clinical physiological responses, functional performance, respiratory status assessments, nutritional status evaluations, body composition analyses, and biochemical blood parameters, with a primary emphasis on the anti-inflammatory response.

Background： Patients with chronic obstructive pulmonary disease (COPD) often suffer from malnutrition and weight loss, which negatively impact mortality rates. Research indicates that insufficient intake of fiber, vitamins, and folic acid is associated with airflow limitation in COPD. Malnutrition affects lung function and muscle strength, leading to difficulty in breathing and reduced exercise tolerance. Nutritional support interventions, such as probiotics, are valuable in improving the nutritional status, lung function, and pulmonary rehabilitation in COPD patients.

Study Design： This is a one-year, single-center, prospective randomized controlled trial.

Methods： This study is a randomized controlled trial targeting COPD patients undergoing pulmonary rehabilitation. The plan is to recruit 60 participants, randomly assigned to either the probiotic intervention group or the conventional pulmonary rehabilitation group. The study includes physiological parameters, functional tests, questionnaires, and blood biochemical analyses. Data will be analyzed using SPSS, with statistical significance set at p \< 0.05.

Effect： The trial expects that COPD patients receiving probiotic supplementation will achieve significant muscle gain and fat loss, reduce inflammation, and exhibit changes in body composition and functional performance.

Key words： Chronic obstructive pulmonary disease; probiotics; nutritional supplementation; inflammation markers; body composition

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign a written informed consent form.
* Diagnosed with pre-COPD or COPD stage I-IV according to the 2023 GOLD guidelines.
* Undergoing pulmonary rehabilitation therapy for more than three months.

Exclusion Criteria:

* Under 18 years old.
* Diagnosed with neuromuscular diseases.
* Experienced respiratory disease exacerbation requiring emergency care or hospitalization in the past three months.
* Unable to cooperate with cardiopulmonary exercise testing.
* Has other diseases or behavioral restrictions preventing participation in exercise training for over one year.
* Assessed by a physician to have severe malnutrition or a significantly low BMI.
Study Evaluating Etanercept in Moderate to Severe Asthma

The primary objective of the study is to assess the efficacy and safety of etanercept 25 mg given twice weekly in subjects with moderate to severe persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe persistent asthma for at least 1 year
* Demonstrated reversibility of at least 9% and (FEV1) 50% to 80% predicted
* Subjects must be on a high-dose inhaled corticosteroid (ICS)

Exclusion Criteria:

* Previous treatment with etanercept
* Current use of cigarettes
* Significant concurrent medical conditions at the time of screening