cyrilzakka/clinical-trials huggingface dataset:
WALK Study: Women's Active Living for Koreans Study

The prevalence of metabolic syndrome (MetS) is a health concern among Asians. Growing evidence indicates that Korean Americans had higher MetS prevalence compared to non-Hispanic Whites, but a culturally and linguistically appropriate lifestyle intervention has not been developed for Korean American middle-aged and older women. Thus, the investigators propose to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women.

The purpose of this pilot study is to develop a 4-week lifestyle intervention (Women's Active Living for Koreans (WALK) Study) to increase physical activity (PA) and reduce sedentary behavior for Korean American women. The investigators will assess feasibility and acceptability of the WALK Study and potential efficacy of the WALK Study on outcomes including sedentary behavior and PA.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified Korean-speaking Korean American women
* Sedentary lifestyle at work and/or during leisure time
* Aged between 40 and 69; 4) intention to be physically active
* KakaoTalk user

Exclusion Criteria

* Medical conditions or physical problems requiring a special care exercise program
* Known bone or join problems that impair the ability to do moderate physical activity
* Participating in a lifestyle modification program or research study
* Planning a trip out of the U.S. during the next 2 months
* Pregnancy.
Stress Relief Effect of Korean Red Ginseng

The purpose of this study is to examine clinical and neuropsychiatric effects of Korean Red Ginseng and examine changes in brain structure, function and metabolites. A total of 60 healthy volunteers will be recruited and will be assigned to either Korean Red Ginseng group or placebo group. Individuals will be examined through clinical assessment, neuropsychological function tests and neuroimaging.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18\~65

Exclusion Criteria:

* Current or past medical history, medical illnesses that are detected during clinical and physical evaluations
* Current Axis 1 diagnosis or past history of schizophrenia, bipolar, or psychotic disorders assessed by SCID-IV
* Current diagnosis of substance abuse assessed by SCID-IV
* Taking or have taken psychiatric medication in the past 2 months
* Head trauma accompanied by loss of consciousness or seizure
* IQ 80 or below
* Planning pregnancy, currently pregnant, or breastfeeding
* Claustrophobia or other fMRI incompatible factors such as pace makers
* Taking drugs, including over the counter drugs
Exercise Training Effects in Patients With Heart Failure

Chronic heart failure (CHF) is a common syndrome characterized by several central hemodynamic and peripheral vascular and muscle abnormalities including autonomic imbalance, neuro-hormonal over-activation and decreased oxidative status.

In patients suffering from CHF, exercise confers several beneficial effects on the cardiovascular and peripheral systems, mainly by continuous aerobic training. However, interval aerobic training has also been validated as an alternate form of training that increases the exercise capacity of patients who are in CHF.

Recent studies have suggested that resistance training alone or as a complementary program besides the traditionally aerobic continuous training might exert favorable effects. However, little it is known about the combined effects of interval and strength training in CHF patients.

Aim of this prospective randomized controlled study was to investigate the effects of combined interval and strength training comparing to interval training alone in CHF patients.


Eligibility Criteria:
Inclusion Criteria:

* Stable systolic heart failure
* NYHA functional class ≤ III
* Optimal medical treatment

Exclusion Criteria:

* Contraindications for a maximal cardiopulmonary exercise testing (CPET) according to the American Thoracic Society/American College of Chest Physicians Statement
* Moderate to severe COPD
Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction

Erectile dysfunction.

The intima media thickness is increasingly used as a surrogate end point of vascular outcomes in clinical trials aimed at determining the success of interventions that lower risk factors for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral artery diseases, like disease of cavernosal artery). The investigators hypothesized that the IMT of cavernosal artery would add to the predictive value of vasculogenic erectile dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings for discriminating patients with vasculogenic erectile dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction patients

Exclusion Criteria:

* Penile trauma.
Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL

Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.

This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL.

After being informed about study and potential risks, all patient giving written informed consent with undergo a mini-PCNL operation. Patient who meet the eligibility requirements will be randomized in a single-blind manner (patient) in a 1:1 ratio to total tubeless mini-PCNL or tubeless mini-PCNL.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with kidney stones with a size ranging from 20 to 40 millimeters.
* Patients have undergone mini-PCNL, unilateral
* Absence of urinary tract infections before surgery.
* No urological congenital abnormality
* No coagulopathy

Exclusion Criteria:

* Presence of residual stones after the surgery, fragments larger than 4 millimeters.
* Patients with a single functioning kidney
* Complicated cases, including:

  1. massive bleeding in the upper tract during surgery
  2. Severe collecting systems injury during surgery
  3. Severe UPJ mucosa swelling considered unsafe by the physician, requiring the placement of a DJ stent or nephostomy tube
* Participants who decline or request withdrawal from the research study.
Biomarkers in Stored Tumor Samples From Younger Patients With Liver Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in stored tumor samples from younger patients with liver cancer.

OBJECTIVES:

* To characterize, at a molecular level, archived samples of tissue from young patients with fibrolamellar carcinoma and hepatocellular carcinoma in non-cirrhotic livers matched for age and sex.
* To perform genomic analysis on these tissue samples using array comparative genomic hybridization.
* To perform targeted gene mutation analysis on these samples by PCR.
* To perform proteomic profiling on fixed tissues in these samples by various proteomic methods, including IHC and mass spectrometry.
* To look for association between molecular aberrations and clinicopathologic features in these samples.

OUTLINE: Archived tissue samples are collected from the pathology department at Vanderbilt University Medical Center and from the Mayo Clinic in Rochester, Minnesota. Tissue samples are analyzed by genomic analysis using array comparative genomic hybridization, target gene mutation analysis by PCR, and proteomic profiling on fixed tissues using various proteomic methods, including IHC and mass spectrometry. Samples are also examined for association between molecular aberrations and clinicopathologic features found in each disease.

Clinical patient data (i.e., age, sex, race, date of diagnosis, risk factors, histology, surgical staging, follow-ups, date of death, and adjuvant therapy) are also collected.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis of fibrolamellar carcinoma or hepatocellular carcinoma in a non-cirrhotic liver
* Archived tumor specimens available for analysis from Vanderbilt University or Mayo Clinic

Exclusion Criteria:

* Not specified

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Comparison of Laryngeal Mask and I-gel to Laryngoscope by Novice Operators in Simulated Difficult Airway

The use of laryngeal mask airway or i-gel to manage airway may improve success rates, especially in difficult situations more than tracheal intubation.

This study compares the insertion success rate and insertion time among the proceal laryngeal mask airway, i-gel, and tracheal tube. Following a short lecture, airway novices try to insert proceal laryngeal mask airway, i-gel, and tracheal tube into manikin with difficult laryngoscopy scenarios.

Eligibility Criteria:
Inclusion Criteria:

* medical student
* nurse
* no experience of insertion using tracheal tube, i-gel, and laryngeal mask airway

Exclusion Criteria:

* experience of insertion using tracheal tube, i-gel, and laryngeal mask airway
Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA

The objectives of this study are:

1. The investigators plan to evaluate and validate the use of a novel wireless insole device (Loadsol) that provides real-time biofeedback on post-operative mobility and weight bearing following total joint arthroplasty.
2. The investigators plan to utilize the wireless insole device to determine if biofeedback is sufficient for improving gait symmetry following total joint arthroplasty.
3. The investigators plan to determine if there is a correlation between patient reported outcomes and measured postoperative weight bearing.

In orthopaedic and trauma surgery post-operative mobility is very important. Six-month mortality and patient satisfaction has been associated with mobility. Elderly patients may suffer from severe complications caused by immobility due to a high prevalence of comorbidities.

Measuring postoperative mobility has primarily been based on advanced technology and complicated gait laboratories (treadmill, force plate, videoanalysis). The recent introduction of mobile insole force devices, such as the pedoped loadsol® (Novel) may allow for a cost-effective and clinically relevant use of providing biofeedback.

Using video analysis to evaluate the insole device will allow for measurements in realistic situations like walking stairs, stand up from a chair, sit down, turning and walking. The investigators had previously completed this in the lab setting and further the feedback mode of the loadsol will be used for training the patients in terms of symmetry after a total knee replacement.

This study may have an important influence on the aftercare of the investigators patients. Determining the postoperative mobility and evaluating gait analysis in real time will allow the investigators to compare between different operative approaches, operative techniques, Implants and more. If the feedback mode is working as expected the investigators might use it in the close future in the investigators standard aftercare for all patients.

Eligibility Criteria:
Inclusion Criteria:

* Planned or recently underwent (up to 8 weeks postoperatively) primary total joint arthroplasty
* Free walking before surgery, no devices needed
* Age \>/=18 years
* Preoperative outcomes scores (PF CAT, PROMIS Global Health, KOOS JR)
* Written informed consent

Exclusion Criteria:

* Index procedure is a revision total joint arthroplasty
* Total knee or hip arthroplasty on the contralateral side within 1 one year of index procedure
* Severe medical comorbidity (ASA\>/=3)
* Participant is planning TJA on another joint within next 12 months
* Significant symptoms on contralateral knee/hip/ankle that could impede performance on study
Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)

Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.


Eligibility Criteria:
Inclusion Criteria:

1. Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)
2. A history of knee injury not more than 4 weeks prior to inclusion
3. Agreement and informed consent to participate in the study

Exclusion Criteria:

1. Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
2. Pregnancy
3. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
4. General disease that effects physical function or systemic medication/abuse of steroids
5. Any other condition or treatment interfering with the completion or assessment of the trial.
The Role and Mechanism of TCR-T Cells in Immunotherapy for Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is the main type of leukemia, accounting for about 60% of all leukemia, with complex pathogenesis and great clinical heterogeneity. Effective targets for AML need to be further developed. We performed next-generation sequencing analysis of the TCR sequence of an AML patient to find the patient's specific TCR clone for leukemia. The rearranged TCR gene stimulated by leukemia antigens was transduced into the patient's own T cells, and the TCR gene-modified T cells (TCR-T) that could specifically recognize leukemia antigens and kill leukemia cells were constructed. Enhancing the specificity and killing activity of T cells can truly achieve individualized treatment for patients. In addition, through TCR sequencing, the TCR sequence database of leukemia patients can be constructed to find the common specific TCR clones for AML among different patients, which can realize the precise treatment of AML.

Acute myeloid leukemia (AML) is the main type of leukemia, accounting for about 60% of all leukemia, with complex pathogenesis and great clinical heterogeneity. Effective targets for AML need to be further developed. T cell receptor (TCR) is a characteristic marker on the surface of T cells. Stimulated by leukemia cell antigens, TCR can produce specific rearrangement and produce specific T cell clones for leukemia. However, immunosuppressive cells and immunosuppressive molecules in the leukemia microenvironment have inhibitory effects on T cells, which reduce the activity of T cells with specific clone proliferation. The anti-tumor effect was weakened. In order to solve this clinical problem, we performed next-generation sequencing analysis of the TCR sequence of an AML patient to find the patient's specific TCR clone against leukemia. The rearranged TCR gene stimulated by leukemia antigen was transduced into the patient's own T cells. To construct TCR gene-modified T cells (TCR-T) that can specifically recognize leukemia antigens and kill leukemia cells, enhance the specificity and killing activity of T cells, and truly realize the individualized treatment of patients. In addition, through TCR sequencing, the TCR sequence database of leukemia patients can be constructed to find the common specific TCR clones for AML among different patients, which can realize the precise treatment of AML.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 (≥ 18 years old, ≤ 65 years old)
2. gender is not limited
3. Acute myeloid leukemia patients
4. CR(remission phase, white blood cell count \> 2×10\^9/L after blood picture recovery)
5. After 3-4 courses of chemotherapy (the number of courses is not absolute)
6. Before the next chemotherapy

Exclusion Criteria:

1. Transformed acute myeloid leukemia
2. Secondary acute myeloid leukemia
3. Post-transplantation acute myeloid leukemia
4. AML-M3
5. white blood cell count \<2×10\^9/L
6. More than 8 courses of chemotherapy
7. Combined with other immune-related diseases
8. Pregnancy
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)

This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Wrinkle Severity Rating Scale ( WSRS ) as per ATLAS photographic grading at rest and on full smile and Global Aesthetic Improvement Scale (GAIS). The secondary endpoints are improvement in photographic assessment, Physician's assessment scores, Patient's assessment scores form enrollment to end of study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (male and female), aged 18 to 40 years (both inclusive).
* Subjects willing to refrain from any other treatment for Nasolabial Folds.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects receiving any aesthetic facial therapy 6 months prior to enrolment e.g. Botox, Fillers etc
* Subjects with history of Connective tissue disease
* Subjects with autoimmune diseases
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)


Eligibility Criteria:
Inclusion Criteria:

Patients aged 18-70 years, with inoperable locally advanced or metastatic squamous cell carcinoma of the head and neck (stage III-IV) histologically proven, no prior chemo and/or hormone therapy for metastatic disease or local recurrence (adjuvant or neo-adjuvant chemotherapy or radio-chemotherapy was allowed if finished since more than 6 months before inclusion and cisplatinum total dose used \< or=to 300 mg/m² or carboplatinum total dose used \< or=to 200mg/m²), at least 1 target lesion (measurable in 2 dimensions \> or=to 20 mm on computed tomography (CT) or magnetic resonance imaging (MRI) evaluated \< 15 days before start of study treatment, outside of irradiated fields),performance status (PS) \< or =to 2 World Health Organization (WHO), weight loss \< 5% normal weight,hemoglobin \> or =to 10 g/dL, neutrophils \> or =to 2000/mm3, platelets \> or =to 100,000/mm3 , creatinine \< or =to 1.5 x upper limit of normal (ULN), bilirubin \< or =to .5 x ULN, alanine amino-transferase (ALT)/aspartate amino-transferase (AST)\< or =to 2.5 x ULN (5 x ULN if liver metastases), clotting: prothrombin time (PT) \> or =to 60%. Written informed consent signed by patient and doctor prior to all study procedures -

Exclusion Criteria:

-
Anesthetic Management for TA-BSM in HOCM

To retrospectively analyze the preoperative, intraoperative and postoperative anesthesia management of patients with hypertrophic cardiomyopathy undergoing TA-BSM in the investigators' hospital, and to provide clinical basis for the development of reasonable and standardized perioperative anesthesia program for these patients.

Hypertrophic obstructive cardiomyopathy is an inherited cardiomyopathy. Such patients have significantly reduced mobility and quality of life, and are prone to sudden death in severe cases. According to conservative estimates, there are about 2 to 5 million patients with hypertrophic heart disease in China, and about 15 to 20 million patients in the world, which seriously threatens human health. The traditional surgical treatment is partial ventricular septal myectomy through thoracotomy, which is traumatic and difficult, with poor efficacy and high operative mortality in hospitals with little experience.

In order to solve this problem, professor Wei's team invented and developed a beating-heart myectomy device, and established the first transapical beating-heart septal myectomy (TA-BSM) with the aid of this device through the apical minimally invasive incision under the guidance of esophageal ultrasound. With the help of echocardiography, the position of the rotator can be monitored in real time, and the angle and thickness of the rotator can be determined to ensure the safe removal of the hypertrophic ventricular septum, so as to solve the problem of left ventricular outflow tract obstruction.

The team firstly completed 47 clinical trials from April to September 2022, with a surgical success rate of 97.9%. At 3-month follow-up, the median maximum pressure gradient of left ventricular outflow tract decreased from perioperational 86 mmHg to postoperational 19 mmHg , and 45 participants (95.7%) had complete remission of mitral regurgitation. All patients showed significant improvement or even disappearance of symptoms, and exercise capacity and quality of life were significantly improved.

Since TA-BSM is a new surgical method, there is no unified standard for anesthesia management and lack of evidence-based evidence. Therefore, the aim of this study is to retrospectively analyze the preoperative, intraoperative and postoperative anesthetic management of participants with hypertrophic cardiomyopathy undergoing TA-BSM, so as to provide clinical basis for formulating reasonable and standardized perioperative anesthesia programs for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hypertrophic cardiomyopathy
* American Society of Anesthesiologists (ASA) physical status classification I-III
* Undergoing TA-BSM

Exclusion Criteria:

* Cardiopulmonary bypass was used to assist the surgery.
Observational Usage Study of Statins in Primary Care in France

To describe the way statins are used in France in primary care, that is to determine patients profile (particularly CV risk factors), to determine the way statins are initiated by general practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin


Eligibility Criteria:
Inclusion Criteria:

* Patients to whom a statin was initiated or switched between 3 and 6 months before consultation
Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan

A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with OSA with AHI\>5

Exclusion Criteria:

* Patients with central sleep apnea (CSA).
* Patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc.
* Patients with loose teeth or advanced periodontal disease.
* Patients with pathologically low blood pressure.