cyrilzakka/clinical-trials huggingface dataset:
Analyzing Gait Parameters Among Women With and Without Stress Urinary Incontinence

This study will contribute to the existing body of knowledge on stress urinary incontinence and its impact on gait. The findings may have implications for the development of targeted interventions and rehabilitation strategies to improve mobility and quality of life in women with stress urinary incontinence

Use the provided software or tools to analyze the recorded data, including (cadence, velocity, swing, and double limb support, stride time, step length, and stride length) of gait. The software measures the cadence as total number of steps per minute, and it measures the stride time as the time (in sec) from heel strike of one limb to the next heel strike of the same limb. Also, the software measures the duration of stance, swing, and double limb support as percentage of stride time. Also, the software measures the step and stride length (in cm).

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-60 years old.
* Women with BMI ≥30.
* Women are free from any other gynecological disorders or symptoms that may affect the results of the study.
* All participants who will be enrolled in the study sign the informed consent form.
* All participants will be of multiparas.
* All participants will be diagnosed with a mild degree of stress urinary incontinence.

Exclusion Criteria:

* Pregnancy
* Neurological Disorders: such as Parkinson's disease , multiple sclerosis, or any neurological dysfunction that may affect the gait parameters
* Musculoskeletal disorders: such as severe osteoarthritis or lower limb amputations
* Significant cognitive impairment: or dementia
* Previous pelvic surgery as pelvic organ prolapse repair or anti-incontinence procedures.
* Other significant medical conditions that could affect gait include severe cardiovascular disease or severe respiratory conditions.
* Walking pain.
Feasibility Study: Evaluation of the Ulthera® System for Treatment of the Knees

Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.

This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged 30 to 65 years.
* Subject in good health.
* Mild to moderate skin laxity around the knees.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Excessive subcutaneous fat around the knees.
* Excessive skin laxity around the knees.
Comprehensive Assessment in a Longitudinal Study on Young Men Who Have Sex With Men Attracting to chemseX

The study is a two-phase observational study that assess multiple aspects of study and young men who have sex with men (YMSM).

Phase I of the study will be a cross-sectional descriptive study using a mixed methods data collection (focusing on qualitative data collection) to acquire information necessary for developing a more extensive study on the same matter.

Phase II of the study will be a prospective cohort study using a quantitative data collection.

Findings from phase I will guide the development of phase II which consist of a larger number of YMSM, important baseline and follow-up questionnaires and comorbidities assessments, sexually transmitted infections testing, and integration to care.

This protocol exclusively addresses the phase I of the study.

Once the phase I findings are finalized, the principal investigator will submit the phase II to the IRB of the Faculty of Medicine, Chulalongkorn University.


Eligibility Criteria:
Inclusion Criteria:

Group 1A: Current chemsex users

1. Men who have sex with men
2. Aged 16-35 years
3. Able to communicate in Thai fluently
4. Current chemsex users
5. Provide informed consent

Inclusion Criteria:

Group 1B: Former chemsex users (discontinued ≥90 days)

1. Men who have sex with men
2. Aged 16-35 years
3. Able to communicate in Thai fluently
4. Former chemsex users (discontinued ≥90 days)
5. Provide informed consent

Exclusion Criteria:

No exclusion criteria for all groups of participants
SLNM in Endometrial Cancer Combined With OSNA

The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with histological ultrastaging examination in the sentinel lymph node assessment in patients with endometrial cancer.

The molecular biologic method OSNA is a modern way of metastatic spread detection in lymphatic nodes using quantitative reverse transcription polymerase chain reaction. Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker (detected by OSNA).

The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could help to improve the standards of care in endometrial cancer patients.

Method:

After the sentinel lymph node detection (ICG, 99m Tc or Bleu Patente) and sentinel node/nodes removal is performed, the node/nodes is/are cut in 2-mm slices parallel to short axis of the node. The odd-numbered blocks will be examined by the OSNA method and the even-numbered blocks will be examined by conventional histopathological methods including immunohistochemistry.

Statistical analysis to identify differences will be performed subsequently.

Eligibility Criteria:
Inclusion Criteria:

* Endometrial cancer
* Signed informed consent

Exclusion Criteria:

* Inclusion criteria not met
* Pregnant patients
* Patients participating in other clinical studies
* Patients who have been judged to be an inappropriate candidate by any medical care provider
Abdominal Breathing for Depression, Anxiety, Heart Rate Variability in Obstructive Sleep Apnea Patients

The research topic is to explore the effectiveness of abdominal breathing on improving of depression, anxiety, and heart rate variability in obstructive sleep apnea patients with depressive symptoms. This study method adopts an experimental research design and divided into experimental group and control group by random sampling. Experimental group receives abdominal breathing training, whereas control group without receiving abdominal breathing training.

Obstructive Sleep Apnea (OSA) is a common chronic disease with frequent comorbidity of depression. When we use sedatives, antidepressants or hypnotics for the treatment of depression, these drugs may worsen symptoms of OSA leading to aggravation of original depressed moods. Therefore, the research topic is to explore the effectiveness of abdominal breathing on improving of depression, anxiety, and heart rate variability among obstructive sleep apnea patients with depressive symptoms. This study method adopts an experimental research design and divided into experimental group and control group by random sampling. Experimental group receives abdominal breathing training, whereas control group without receiving abdominal breathing training. The research is conducted with experimental and control groups. The effectiveness assessment will use the Beck Depression Inventory (BDI) Beck Anxiety Inventory (BAI) and check the heart rate variability (HRV). Both groups received the pre-test before the abdominal breathing training. The post-test was carried out at the fourth and eighth weeks of training. The experimental group is given abdominal breathing training for a total of 8 weeks, with the training in the hospital once a week, 15 minutes for each time, in combination with self-training at home under videos guidance for 10 minutes per day (10 minutes, for one time or several times accumulated) .The expected result is through abdominal breathing, the depression, anxiety, and heart rate variability of OSA patients with depressive symptoms can improve, and even with less use of medication.

Eligibility Criteria:
Inclusion Criteria:

* aged 20-64 years old.
* Be able to communicate with Chinese and Taiwanese, and who can express themselves without barriers.
* A person who is clearly conscious and can perform breathing exercises autonomously.
* Patients diagnosed with obstructive sleep apnea (AHI≧5) according to polysomnography and depression score ≧14 points measured by Beck Depression Inventory-II (Chinese version).

Exclusion Criteria:

* Patients with COPD.
* Patients with suicidal ideation.
* Obstructive sleep apnea AHI≧60.
* Those who have learned abdominal breathing.
The Light Sword Lens for Presbyopia Compensation

Clinical assessment of a new optical element for presbyopia compensation - the Light Sword Lens.

Healthy dominant eyes of presbyopes were examined for visual performance. The examination was performed in the ophthalmic trial frame, which included assessment of 3 trials: reference (with lens for distance correction); stenopeic (distance correction with a pinhole ϕ=1,25 mm) and Light Sword Lens (distance correction with a Light Sword Lens). In each trial, visual acuity was assessed in 7 tasks for defocus from 0.2D to 3.0D while contrast sensitivity in 2 tasks for defocus 0.3D and 2.5D.

Eligibility Criteria:
Inclusion Criteria:

* emmetropic or hyperopic eyes with a spherical error of maximum +1.75D and astigmatism of ≤ 0.5D.
* Corrected distance visual acuity (CDVA) had to be better than 0.1 logMAR (20/25) and at the same time contrast sensitivity (CS) could not be less than 1.9 logCS. -Uncorrected near visual acuity was required to be worse than 0.4 logMAR (20/50), as a proof of presbyopia.

Exclusion Criteria:

* any history of ophthalmic surgeries
* evidence of serious ocular or brain pathologies affecting visual acuity (VA)
* clinically active inflammation.
Feeding America Intervention Trial for Health--Diabetes Mellitus

The Feeding America Intervention Trial for Health-Diabetes Mellitus (FAITH-DM) is a randomized, controlled study of the implementation of a diabetes intervention in food pantry settings.

For adults with diabetes mellitus, diabetes self-management education (DSME) is critical to achieving long-term control of blood sugar levels (glycemic control) and preventing diabetes-associated complications. This education is often difficult to access for highly vulnerable and marginalized adults in the United States. Furthermore, foods for a diabetic diet are often out of reach for food insecure households. The purpose of this study is to determine the extent to which food banks and food pantries can help reach this population with effective DSME, food, and access to primary health care. The investigators' primary outcome of interest is HbA1c improvement in the intervention group compared to a wait-listed control group of food pantry clients living with uncontrolled type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Food pantry client at one of three participating food banks: Alameda County Community Food Bank (Oakland, CA), Gleaners Community Food Bank of Southeastern Michigan (Detroit, MI), Houston Food Bank, (Houston, TX)
* Type II diabetes mellitus with HbA1c ≥ 7.5% using food bank point-of-care testing
* Reliable mode of contact (either phone or address)
* English or Spanish verbal fluency
* 18 years of age or older
* Intent to remain in the study area for at least the next 12 months
* Willingness to participate in intervention

Exclusion Criteria:

* Type 1 diabetes
* Pregnant or less than 6 weeks post-partum
* Cognitively impaired: dementia, mental illness, or active substance abuse severe enough to interfere with administration of the survey or participation in the intervention
* Household member already enrolled in the study
Identifying MSI Status From ctDNA in Chinese Patients With Refractory Advanced Solid Tumors

This is a molecular epidemiological investigation aiming to identify microsatellite instability status from circulating tumor DNA in Chinese patients with refractory advanced solid tumors.

This study is conducted in Chinese patients with advanced refractory metastatic solid tumors. A total of 8-10 mL of blood will be collected from eligible patients and used for extracting circulating tumor DNA. Blood-MSI status will be tested based on SPANOM technique developed by 3D Medicines Inc. Shanghai, China. Patients are encouraged to provide tissues collected from progressive disease for tissue-MSI testing (not required for inclusion).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age≥18 years old.
2. Confirmed malignant solid tumor by histopathology or cytopathology.
3. Colorectal cancer: progression after second-line therapy. Non-colorectal cancer: progression after first-line therapy.
4. Time duration from the last time of anti-cancer treatment to blood sample collection for MSI testing ≥ two weeks or five times half-life period of anti-cancer drugs
5. Signed the informed consent with name and time.

Exclusion Criteria:

1. Hematological malignancy
2. Patients who received immuotherapies.
3. Patients who received blood transfusion within one month before blood collection.
4. Pregnancy.
NOV120401 (CKD-516 Tablet) for Advanced Solid Tumors

The purpose of this open-label, dose-escalation phase I trial is to evaluate the safety, tolerability and pharmacokinetic profiles and to assess the efficacy of NOV120401 (CKD-516 Tablet), a novel vascular disrupting agent, in patients with advanced refractory solid tumors.

Vascular disrupting agents are expected to kill cancer cells located in core of tumor tissues by disrupting microvascular structure of tumor. To assess the safety and tolerability of NOV120401 (CKD-516 Tablet), patients with advanced refractory solid tumors will be enrolled in this study. Initial dose of NOV120401 (CKD-516 Tablet) is 5 mg/day, which will be escalated until at least 2 of 6 subjects show dose-limiting toxicities (DLTs). Pharmacokinetic profiles and efficacy by tumor response and vascular disrupting activities will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 19 years or older
2. Patients who failed existing anti-cancer therapies
3. ECOG performance status ≤ 2
4. Life expectancy of ≥ 12 weeks
5. Adequate hematological, hepatic and renal functions:
6. Patients who give written informed consent voluntarily

Exclusion Criteria:

1. Prior systemic chemo-, radiochemo-, radio-, immuno-, hormonal and/or biological therapy within 2 weeks before study participation (in case of nitrosoureas and/or mitomycin, within 6 weeks before study participation)
2. Patients who received major surgery within 4 weeks before study participation (in case of VATS and/or ONC surgery, within 2 weeks before study participation)
3. Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
4. NYHA class III or IV heart failure, uncontrolled hypertension (SBP/DBP \> 140/90 mm Hg), other clinically significant cardiovascular abnormalities at investigator's discretion (e.g., LVEF \< 50%, clinically significant cardiac wall abnormalities or cardiac muscle damages)
5. Acute coronary syndrome (unstable angina or myocardial infarction) within 6 months
6. Uncontrolled arrhythmia
7. Significant cerebrovascular diseases including stroke within 6 months
8. Significant vascular diseases including aortic aneurysm requiring treatment or peripheral arterial diseases
9. Patients with known active hepatitis, HIV infection, or other uncontrolled infectious disease
10. Patients who cannot receive IP by mouth and have a history of clinically significant gastrointestinal disorders which can impede administration, transit or absorption of the IP
11. A history of severe drug hypersensitivity or hypersensitivity to analogs of the IP
12. Pregnancy or breast-feeding
13. Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
14. Patients who received other investigational products or used other investigational devices within 3 weeks before participation
15. Patients who cannot participate in this trial by investigator's discretion
Effects of Ketogenic Diet in Divers Breathing Enriched Air Nitrox

Overweight divers face a challenging activity such as immersions, starting from a higher levels of circulating cytokines and oxidative stress. Ketogenic Diet (KD) is described as effective in weight loss, in countering inflammation and oxidative stress, and used in the control of drug-refractory seizures.

The aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary regime, may have a protective effect on oxidative stress damages and inflammatory status, that accompanies both overweight and diving activities.

Blood and urine samples from six overweight divers were obtained a) before (CTRL) and after a dive breathing Enriched Air Nitrox and performing light underwater exercise (NTRX), b) after a dive (same conditions) performed after 7 days of KD (K-NTRX). We measured urinary 8-isoprostane and 8-OH-2-deoxyguanosine evaluating lipids peroxidation and DNA oxidative damages. Plasmatic IL-1beta, IL-6 and TNF-alpha levels were measured to investigate the inflammatory status.


Eligibility Criteria:
Inclusion Criteria:

* to be in an overweight state (BMI ≥ 25 kg/m2) and no history of orthopedic, cardiovascular, renal or metabolic disorders.

Exclusion Criteria:

* not to be in an overweight state (BMI ≥ 25 kg/m2) and a history of orthopedic, cardiovascular, renal or metabolic disorders.
Trial Comparing Laparoscopic Sacropexy and Vaginal Mesh Surgery for Women Cystocele Repair.

The primary objective of this study is to compare with PFDI-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery.

The secondary objectives of this study are the following:

1. to compare the two techniques for anatomical results based on the clinical evaluation of patients with POP-Q.
2. to overall quality of life assessment and expectations of patients.
3. to compare the two techniques for the long-term safety. The evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain.
4. to compare the improvement of the functional outcome assessed by PFDI-20 questionnaire (matched-analysis before versus after).


Eligibility Criteria:
Inclusion Criteria:

* All the patients included in the PROSPERE study will be included in the PROSPERE-4 study. The inclusion criterias for the PROSPERE study are:
* Written informed consent
* insured under the French social security system

Exclusion Criteria:

* Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol
* Participation in another trial
Respiratory Muscle Function in COPD Exacerbations

There is evidence that noninvasive mechanical ventilation (NIV) is effective in the treatment of severe exacerbations of COPD presenting respiratory acidosis.

The aim of the study is to evaluate the benefit of adding NIV to conventional treatment in patients with COPD exacerbation and hypercapnic respiratory failure without acidosis requiring hospital admission. It is known that NIV improves respiratory mechanics, so the primary outcome will be respiratory muscle function.

All patients admitted to the hospital for COPD exacerbation and hypercapnic respiratory failure without acidosis will be included for a period of 12 months. The patients will be randomized into two groups (conventional treatment or conventional treatment plus NIV). Clinical data, blood gases, muscle strength parameters will be collected at the inclusion time and 24h after starting NIV. Quality of life and hospital stay will be measured at discharge. All patients will be followed for a year.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD according to international guidelines ( GOLD)
* COPD exacerbation requiring hospitalization
* Initial blood gases: PaCO2\> 50 mm Hg and pH\> 7.35.
* If the patient does not have COPD diagnosis at the time of inclusion, it could be included if the diagnosis is confirmed within three months after the exacerbation.

Exclusion Criteria:

* Patients with a pH below 7.35
* Patients with intubation criteria
* Other chronic respiratory diseases (fibrothorax, cystic fibrosis, significant ribcage alterations)
* Neuromuscular Diseases
* Significant associated chronic systemic diseases (severe liver disease, chronic renal failure requiring dialysis, severe heart disease and active neoplasia)
* COPD exacerbation secondary to pulmonary embolism, pneumonia or pneumothorax
* Patients in active treatment with CPAP or home ventilation
PRospective Multiple Myeloma Impact Study

This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.

This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.

Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.

A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Potentially multiple myeloma according to IMWG criteria
* Candidates for systemic treatment

Exclusion Criteria:

* ECOG Performance Status \> 3
* Tumor sample that fails QA or QC criteria for MMprofiler