cyrilzakka/clinical-trials huggingface dataset:
Growth Trial: Study of the Renata Minima Stent

The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.


Eligibility Criteria:
Inclusion criteria include:

* The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent
* Requiring treatment\* of:

  * native, acquired, or recurrent aortic coarctation, or
  * native, acquired, or recurrent pulmonary artery stenosis \*As defined by the patient's medical team
* Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system
* Adjacent vessel to stenosis measuring \> or equal to 4 mm

Exclusion criteria include:

* Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
* History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
* Aortic or pulmonary artery aneurysm in the location targeted for treatment
* Body weight \< 1.5 kg
* Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
* Target vessels larger or smaller than the Minima System balloon size ranges
* Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
* Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
* Currently participating in an investigational drug study or another device study
* Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
* Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
* Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately pre-medicated
PENG Block for Arthroscopic Hip Surgery

This randomized, double-blinded, placebo-controlled trial seeks to evaluate the analgesic efficacy of the pericapsular nerve group block in the setting of outpatient hip arthroscopy.

The pericapsular nerve group, or PENG block, has been recently described and shows promise in providing analgesia to the hip joint. The analgesic value of this block in the setting of hip arthroscopy is unknown. This study aims to compare a preoperative PENG block to placebo block prior to outpatient hip arthroscopy under general anesthesia. The primary outcome measure is immediate postoperative pain as measured by numerical rating score in the post-anesthesia care unit (PACU). Secondary outcomes include opioid consumption, opioid-related adverse events, patient satisfaction, chronic opioid usage, and pain scores at other time points.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old undergoing unilateral hip arthroscopy at the outpatient surgery center.

Exclusion Criteria:

* refusal to participate
* \< 18 yo
* Chronic opioid use
* localized infection
Laparoscopic Management of Gastrointestinal Stromal Tumor of Stomach

Gastric GISTs are rare neoplasms that require excision for cure. Although the feasibility of laparoscopic resection of gastric GIST less than 2cms has been established, the feasibility, safety and long-term efficacy of these techniques for larger lesions are unclear. Investigators hypothesized that laparoscopic resection of gastric GISTs even for larger lesions is feasible \& results in low perioperative morbidity and an effective long-term control of the disease.

Open surgical resection was the standard of treatment until two decades ago, but with advent laparoscopy and experienced gained over the years, the safety \& feasibility of laparoscopic resections of gastric GISTs has been proven but for tumors less than 2 cm. However, with gain of experience and skill in laparoscopic surgery, many surgeons have reported a safety \& feasibility excision of tumors greater than 5 cm. Our current study demonstrates the oncologic safety of the laparoscopic approach even with tumour size range up to 12cm, with efficacy and recurrence rates similar or superior to historical open surgical controls, however, it requires considerable expertise for safe manipulation of the tumour. All these resections were accomplished with minimal morbidity, no perioperative mortality, and short post-operative stay and comparable long term oncological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Gastric GIST\>2cm size

Exclusion Criteria:

* Metastatic GIST, not fit for GA
Physical Activity, mHealth and Intellectual Disability - a Pilot Study

The main objective of this pilot study is to assess distant procedures, study experiences and feasibility of a planned randomized controlled trial investigating the use of a mHealth support tool on physical activity for individuals with intellectual disability.

For individuals with intellectual disability (ID) with low physical activity (PA) levels, new methods to increase participation in physical activity are needed. Motivation for participation in PA should include both individuals with ID, family members and staff, and it should work in a supportive way to strengthen mastery experiences. Technology-based interventions have not yet been explored extensively.

The study objective is to assess feasibility of procedures for a distant, COVID-19-secure intervention, study pre-treatment expectations and experiences of participants and their caregivers. In addition, the study will explore the effectiveness of an individually tailored PA program with motivational mobile health support on everyday levels of PA, goal setting and self-efficacy in a PA setting for youth and adults with intellectual disabilities.

The current protocol concerns the conducting of a mixed method pilot study to test intervention procedures of a planned complex randomised controlled trial, with steps per day as main outcome. Ten participants with intellectual disability are included. Assessment are at baseline, follow-up after 4 weeks and 12 weeks. Goal attainment scale will be used together with the introduction of an activity planner application named Active Leisure as the intervention. Feasibility and acceptance of procedures, activity measures and questionnaires are assessed.

The present trial will investigate how modern technology and e-health can be used in the promotion of PA in individuals with IDs. The study has potentially important implications for both individuals with IDs and their support networks. If successful, the project will provide a simple and accessible solution for promoting PA in individuals with IDs.

Eligibility Criteria:
Inclusion Criteria:

* Low physical activity levels: determined with the question "How much of your leisure time have you been physically active in the last year?"
* Diagnosis of intellectual disability (mild, moderate, severe, or profound)
* Aged 16-60 years old
* Ability to participate in the intervention
* Ability to walk with or without support
* Able to provide written informed consent or written informed consent can be obtained from a representative

Exclusion Criteria:

* Medical contraindications for participation in programs with increased exercise, as advised by the primary care or ID specialist physician
* High level of physical activity
* Inability to provide written informed consent and written informed consent cannot be obtained from a representative
The Impact of Telemonitoring in the Management of Hypertension

Rater blinded, multi-center, prospective, randomized controlled study comparing mean 24 hour systolic blood pressure of eligible hypertensive patients in the TELEMONITORIN group versus the USUAL CARE group, at 6 months after inclusion.


Eligibility Criteria:
Inclusion Criteria:

Included are patients with:

* age ≥ 35 years old
* newly diagnosed hypertention
* uncontrolled hypertention

Exclusion Criteria:

Excluded are patients with:

* orthostatic hypotension
* chronic renal failure (serum creatinine \> 200 micromol / L)
* acute coronary syndrome
* coronary revascularization or stroke within the past 3 months
* known secondary causes of hypertension
* pregnancy
* New York Heart Association Class III or IV heart failure or left ventricular ejection fraction \< 30%
* dementia or another cause that prevents the application of remote monitoring
Letrozole in Patients With Hepatopulmonary Syndrome

The purpose of this study is to assess the safety, tolerability and possible benefit of letrozole compared to placebo in patients with Hepatopulmonary Syndrome.

This study is a phase II randomized, double-blind, placebo-controlled parallel trial of 20 subjects with hepatopulmonary syndrome designed to assess the effect of letrozole 2.5 mg orally daily or placebo for 6 months on the alveolar-arterial oxygen gradient (AaPO2).

Subjects at each site will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained baseline values will be established and subjects will begin letrozole with follow-up clinic visits and testing at 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of moderate to very severe hepatopulmonary syndrome which consists of having all 3 of the following conditions:

  * Presence of liver disease or portal hypertension
  * Intrapulmonary shunting on contrast-enhanced echocardiogram
  * Hypoxemia \[A-a gradient ≥15mmHg (or ≥20mmHg if age \>64) and PaO2\<80mmHg on arterial blood gas testing\]
* Child-Pugh class A or B liver disease
* MELD score \< 20
* ≥ 18 years old
* Female subjects must be post-menopausal (defined as 12 months of spontaneous amenorrhea or 6 weeks postsurgical bilateral oophorectomy without or without hysterectomy)
* Ability to provide informed consent

Exclusion Criteria

* Enrollment in a clinical trial or concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 28 days of baseline
* Current hepatic encephalopathy
* Expectation of liver transplant within six months of randomization
* Concomitant lung disease defined as restriction (TLC \< 70%) or obstruction (FEV1 \< 80% \& FEV1/FVC \< 70%)
* Inability to comply with the study protocol
* Osteoporosis
* Premenopausal women (those who have not reached 1 year absence of menarche)
* Vulnerable study population, including imprisoned individuals, or those who cannot consent on their own.
The Relationship of Hand Sensory and Strength Assessments with Functionality and Kinesiophobia in Individuals with Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid arthritis, hand and wrist involvement is seen from the early stages of the disease. Pain, stiffness and swelling in the joint are accompanied by decreased range of motion and muscle strength.Hand functions have a very important place due to the fact that the hand must be used in countless daily life activities.Kinesiophobia is defined as a state of fear and avoidance of activity and physical movement caused by painful injury and sensitivity to repeated injury.The aim of this study was to investigate the relationship between hand sensory and strength assessment, functionality and kinesiophobia in individuals with rheumatoid arthritis.

Rheumatoid arthritis (RA) is a systemic inflammatory disease that can involve all tissues with synovium. The wrist and hand, which are of great importance in our daily activities, are involved early and specifically because they are rich in synovium, which is the target tissue in RA.In many patients with rheumatoid arthritis, hand and wrist involvement is seen from the early stages of the disease. Pain, stiffness and swelling in the joint are accompanied by decreased range of motion and muscle strength.Hand functions have a very important place due to the fact that the hand must be used in countless daily life activities.Kinesiophobia is defined as a state of fear and avoidance of activity and physical movement caused by painful injury and sensitivity to repeated injury.The aim of this study was to investigate the relationship between hand sensory and strength assessment, functionality and kinesiophobia in individuals with rheumatoid arthritis.Thirty patients who were followed up in the Rheumatology outpatient clinic of Fırat University Hospital and diagnosed with RA according to the American College of Rheumatology (ACR) criteria will be included. SPSS program will be used in statistical analysis. Descriptive statistics will be used for the demographic characteristics of the groups. Qualitative variables will be defined by number and quantitative variables will be defined by mean and standard deviation.

Eligibility Criteria:
Inclusion Criteria:

* Female patients between 18-65 years of age
* Patients whose medical treatment has been stable for the last 3 months

Exclusion Criteria:

* Patients who have undergone surgery on the hand and wrist
* Patients with prosthesis
* Patients with neurological or orthopedic diseases
* Patients with another accompanying rheumatic disease
* Patients with malignancy
* Pregnant patients
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control

Evaluate the safety and effectiveness of experimental group by comparing with the control group

Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged 6-13,with written consent of his/her guardian,regardless of gender;
* Objective cycloplegic spherical equivalent refractive between -1.00D and 5.00D,and best corrected vision acuity of right and left eyes are better than or equal to 1.0;
* Astigmatism less than or equal to -1.50D;
* Voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

* Those with a history of ocular trauma or intraocular surgery;
* Clinical significant slit-lamp findings;
* Abnormal IOP(\<10 mmHg , \>21 mmHg or difference between two eyes \>5mmHg);
* Patient with other eye diseases,such as uveitis and other inflammation,glaucoma,cataract,fundus disease,eye tumors,eye trauma,strabismus and any lesions that affect vision function;
* Patient with systemic diseases causing immunosuppression,such as acute or chronic sinusitis,diabetes,Down syndrome,rheumatoid arthritis,psychosis and other conditions that the investigator considers inappropriate for wearing glasses;
* Those who have participated in other drug clinical trials within 3 months;
* Only one eye meets the inclusion criteria;
* Those who cannot have regular eye examinations;
* Those who have been involved in any myopia control clinical trials,previously used or are using RGP,contact lens and glasses or atropine drugs to control myopia in the past year;
* The candidates determined by the investigator are not eligible.
Clinical Investigation of Refraction Techniques

Prospective, multi-center, non-interventional, randomized, comparative clinical study to identify an optimal refractive technique that provides maximum plus refractive endpoint for best corrected distance visual acuity (BCDVA).


Eligibility Criteria:
Inclusion Criteria:

1. Participant in PCOL-102-AHSF who were bilaterally implanted with TECNIS IOL, Models C1V000, C2V000 or ICB00 and have completed and are at least 30 days postoperative from their second eye surgery;
2. At least one implanted eye with clear ocular media;
3. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in Australia and New Zealand;
4. Availability, willingness and sufficient cognitive awareness to comply with examination procedures.

Exclusion Criteria:

1. Best-corrected distance visual acuity (BCDVA) worse than 0.66 decimal (6/9 or 20/30 Snellen);
2. Subjects with ongoing adverse events that might impact outcomes during the study visit as determined by the investigator.
Evaluate Long-Term Safety and Efficacy WC3011 (Estradiol Vaginal Cream)

This is an open-label extension study evaluating the long-term safety and efficacy of WC3011 in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Completed Study PR-04409.3 (NCT01400776)

Exclusion Criteria:

Developed any of the following during Study-PR04409.3 or has begun taking hormone therapy other than WC3011:

* Hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease (except successfully treated skin cancers)
* Manifestation of or treatment for significant cardiovascular disease, stroke or ischemic attack
* Insulin-dependent diabetes mellitus
* Smoking ≥ 15 cigarettes daily
* Uncontrolled hypertension - systolic blood pressure (BP) ≥ 160 mmHG or diastolic ≥ 95 mmHg
Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neoadjuvant Therapy

The standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single vs. combined breast tissue markers in localizing non-palpable breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. female patients, age≥18 year
2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
3. Patients pathologically diagnosed with breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment.
4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery

Exclusion Criteria:

1. Inflammatory breast cancer or Paget's disease
2. Breast deformities and other conditions that impact breast conservation success rate
3. Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded.
4. Pregnancy or lactation
5. Patients with hook-wire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
6. Patients with stage IV diseases or unresectable lesions in either breast
7. Patients combined with other diseases that may affect survival
8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations
9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
10. Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy
Comparison of Perioperative Outcome Between Monopolar and Bipolar Hysteroscopic Myomectomy

Objective:

To evaluate clinical outcome between monopolar and bipolar hysteroscopic myomectomy.

Methods:

Hysteoscopic myomectomy is a safe and effective procedure to remove submucosal myoma. Distension media is needed to distend the uterine cavity during the procedure. The electric cutting loops included monopolar and bipolar electrodes, and have their corresponding distension media. Medical records, including outpatient and inpatient records, operation note, and laboratory data, of all consecutive women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.

Expected result: The investigatorscan get the differences between monopolar and bipolar hysteroscopic myomectomy, and the result can be used as a reference in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* women who received hysteroscopic myomectomy between July 2008 and April 2022 will be reviewed.

Exclusion Criteria:

* \< 20 years old women
* Cervical fibroids were excluded.
Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility Criteria:
Inclusion Criteria:

* Mixed dyslipidemia

Exclusion Criteria:

* Known hypersensitivity to fenofibrate or simvastatin
* Pregnant or lactating women
* Contra-indication to fenofibrate or simvastatin
* Unstable or severe cardiac disease
Study to Evaluate the Efficacy and Safety of Temozolomide in Subjects With Brain Metastases of Either Malignant Melanoma, Breast, or Non-small Cell Lung Cancer (P02064)

The study implies a 2 step study design. Patients are enrolled into 3 separate groups for melanoma, breast, and non-small cell lung cancer. In the first step, 21 patients per disease group are enrolled. If \>=2 objective responses (SD, PR, or CR) out of 21 evaluable patients are observed, enrollment continues for other 45 patients as a whole, where response will be positively evaluated if \>=10 patients will respond. If \<2 objective responses out of 21 evaluable patients per disease group are observed, this(ese) group(s) will no longer be treated with temozolomide.


Eligibility Criteria:
Inclusion Criteria:

* Cytological/histological diagnosis of either melanoma, non-small cell lung cancer and breast;
* Brain metastases \>=1 cm presenting or in progression following \>=4 weeks time interval free from previous malignancy-specific chemotherapy, hormone therapy, or other medical therapies;
* Magnetic resonance imaging suspected brain metastases; patients with brain lesion(s) not univocal as brain metastases must have negative radiolabeled leukocyte brain scan to rule out infectious non-malignant disease; all neuroradiological studies (baseline and treatment outcome evaluation), except for emergency exams must be performed after 10 days of unchanged schedule of dexamethasone, and obtained in the axial-coronal-sagittal planes in T1 and T2 before and after gadolinium enhancement.
* Presence of al least one bidimensionally measurable and not previously irradiated metastasis.
* Age \<=70 years.
* Performance status 0-2 (ECOG-WHO scale).
* Blood leukocytes \>=3.5 x 10\^9/L and platelets \>=100 x 10\^9/L.
* Bilirubin \<=25 M/L.
* Seric transaminases \<=2 x upper limit of normal values.
* Creatinine \<=150 M/L, creatinine clearance \>=60 mL/min.
* Signed written informed consent.

Exclusion Criteria:

* Diabetes not allowing administration of adequate doses of dexamethasone at least during the first 2 months of treatment.
* Previous whole brain irradiation.
* Brain metastases eligible to neurosurgery or stereotactic radiation therapy.
* Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
* Pregnant or nursing women.
* Acute infection requiring intravenous antibiotics.
* Severe vomiting or medical condition which could interfere with oral medication intake.
* Anticonvulsant chronic therapy.