cyrilzakka/clinical-trials huggingface dataset:
Study Of PHarmacogenetics in Ethnically Diverse Populations (SOPHIE Study)

Collect DNA from well-characterized healthy volunteers.

DNA and plasma will be used to identify and determine allele frequencies of genetic variants in membrane transporters and other genes relevant to human disease or drug response, including drug metabolizing enzymes, collagen, race/ethnicity, neurovascular disease, asthma/allergy/lung disease, and cardiovascular disease. This phase of the study will serve as the hypothesis-generating phase for future studies by identifying genetic variants and determining allele frequencies among an ethnically diverse cohort of healthy volunteers. Future investigations (separate IRB applications) will attempt to correlate genotypes to phenotypes among this cohort of volunteers. The allele identification and frequency data from this group of healthy volunteers will also be used to design association studies in relevant disease populations.

Determine if identified sequence variants are associated with gain or loss of in vitro biologic function using lymphocytes obtained from patients.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects of both genders and specified ethnic groups
* Subjects must be between 18-40 years of age

Exclusion Criteria:

* Smokers
* Drink \> 2 alcoholic beverages/day
* Take any chronic medication
Descriptive and Risk Factors Analysis of All-cause Postoperative Death in Patients Undergoing Cardiovascular Surgery

The investigators are aimed to develop and externally validate a prediction model of clinical risk factors that quantifies postoperative death after cardiac and vascular surgery.

The investigators identify all patients treated with cardiovascular surgery, between 2000 and 2020, within the Wuhan Union hospital and all collaborators. The surgical patient cohort will be matched with the National Death database to determine the patient's postoperative death data.

60% patients were randomly selected to the development cohort. Logistic regression analysis for prediction of postoperative death adjusted for different covariates. The model was externally validated in the remaining 40% patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients Undergoing Cardiovascular Surgery

Exclusion Criteria:

* Patients with incomplete electronic medical record information
Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia

This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.

To assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.

Eligibility Criteria:
Key Inclusion Criteria:

1. Males or females 20-80 years of age
2. Significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area
3. CCS Angina Functional Class II-IV and/or NYHA Stages of Heart Failure Class II or III
4. On maximal medical therapy for anginal symptoms and or heart failure symptoms
5. Hemodynamic stability (Systolic Blood Pressure ≥ 90 mm/Hg, Heart Rate \< 110; Pulse-Oxygen \> 95)
6. Ejection fraction ≤ 45
7. Left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2D contrast echo within 4 weeks prior to enrollment, free of thrombus

Key Exclusion Criteria:

1. Atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate
2. Unstable angina
3. LV thrombus, as documented by echocardiography
4. Planned staged treatment of CAD or other intervention on the heart
5. Platelet count \< 100,000/mm3
6. WBC \< 2,000/mm3
7. TIA or stroke within 90 days prior to randomization
8. ICD shock within 30 days of randomization
9. Any condition requiring immunosuppressive medication
10. A high-risk acute coronary syndrome (ACS) or a myocardial infarction within 60 days prior to randomization
11. Revascularization within 60 days prior to randomization
12. Inability to walk on a treadmill except for class IV angina patients who will be evaluated separately
13. Hepatic dysfunction, as defined as aspartate aminotransferase (AST) and /or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal range (x ULN) prior to randomization
To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes Mellitus

This observation study is designed as a prospective, multi-organ observation study to confirm the blood sugar control effect and safety of ENVLO tablet or Envlomet SR Tablet administration for 24 weeks in patients with type 2 diabetes who are scheduled to administer ENVLO tablet in the actual treatment environment.

This observational study planned recruit population of type 2 diabetes patients who are scheduled to administer ENVLO tablet or Envlomet SR Tablet according to the medical judgment of the researcher (doctor in charge) based on permission (efficacy \& effect, usage \& dose, usage precautions, etc.) in the actual treatment environment.

This observational study will be conducted in an actual treatment environment regardless of whether ENVLO tablet or Envlomet SR Tablet was administered or not.

Information such as demographic information, body measurement, and vital signs performed will be collected up to 24 weeks after ENVLO tablet or Envlomet SR Tablet administration.

Data will be collected based on medical records recorded in the actual treatment environment, and there is no mandatory visit, examination, or treatment in this observation study.

Eligibility Criteria:
Inclusion Criteria:

1. an adult male and female over 19 years of age
2. A person who is a type 2 diabetic and is planed to take Envlo Tab or Envloment SR Tab for the first time according to the medical judgment of the Investigator based on the permit
3. A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied

Exclusion Criteria:

1. Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.)
2. A person who is prohibited from administering in accordance with the permission of Envlo Tab.'s

   * Patients who overreact to Envlo Tab. or Envlo Tab. components and have a history of it
   * eGFR (estimated global filtration rate) patients below 30 mL/min/1.73 m2, end-stage renal disease or on dialysis
   * Patients with moderate and severe liver failure (AST or ALT \> 3x normal upper limit, Total Bilirubin \> 2x normal upper limit, hepatitis or liver failure)
   * Class III or IV by classification of the New York Heart Association (NYHA)
3. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment
4. Pregnant women and lactating women
5. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices
6. A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators
Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery

This study was conducted to compare the effectiveness of care based on the "Accelerated Recovery After Surgery (ERAS) Protocol" and the traditional method in bariatric surgery and demonstrate the difference the two methods based on evidence.

The population of the study consisted of 700 patients over the age of 18 who underwent bariatric surgery in the Obesity Surgery Clinic of a private hospital in 2022. The sample of the study included 128 patients who were willing to undergo bariatric surgery between April 15-July 31, 2022, were in compliance with the research criteria and were voluntarily over the age of 18, 64 in the control and 64 in the experimental group. 128 patients in the sample were assigned to 2 groups using a computer program that generates random numbers. For the purpose of the research, groups were coded as groups A and B, and two different surgical preparations and surgical procedures were applied to the patients in the group. The effects of two different surgical method preparations and the surgical process on the patient's recovery were compared. In the study, the data were collected with the personal introduction form introducing the characteristics of the patients, the Rhodes Nausea-Vomiting and Regurgitation Index (WPI), the Mcgill Pain Scale and the Postoperative Evaluation Form created within the scope of the ERAS Accelerated Care Protocol. Permission was obtained for the scales, and the content validity calculation of the Postoperative Evaluation Form was made in line with the evaluations of the field experts consisting of physicians and nurses experienced in the ERAS Rapid Care Protocol. The data were analyzed in SPSS Package Program. While calculating frequency, percentage and standard deviation in the evaluation of the data, comparisons between groups were made with the independent sample t-test, and p≤ 0.05 was taken as the significance value of the findings.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age who underwent bariatric surgery
* Open to communication and collaborative,
* Patients who volunteered to take part in the study

Exclusion Criteria:

* Patients with major visual, hearing and speech impairments
* Patients who want to withdraw from the study at any stage of the study
The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses

The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.

In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
* Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
* Willing to stop wearing habitual contact lenses for the duration of study participation.
* Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

* Any eye infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator.
* Habitual wear of AOHP contact lenses.
* Habitual wear of any daily disposable contact lenses.
* Other protocol-specified exclusion criteria may apply.
CERAB Technique for Aortoiliac Occlusive Disease

To evaluate the safety and efficacy of the CERAB technique as an alternative to surgical reconstruction for treatment of aorto-iliac occlusive disease.

According to the Trans-Atlantic Inter-society Consensus (TASC-II), bypass grafting is the treatment of choice for extensive aortoiliac occlusive disease (AIOD) due to the good long-term patency rates. However, surgical reconstruction is associated with peri-operative morbidity and mortality.

Kissing stent technique was introduced as an endovascular treatment alternative for bilateral aortoiliac occlusive disease in 1991. Reported technical success rates varied with the use of bare metal stents in extensive AOID.

The COBEST trial showed that covered balloon expandable stents (CBES) have a superior primary patency rate and clinical improvement outcome at 24 months when compared with bare metal stents. CBES may immediately reduce the risk of procedural complications such as dissection, perforation, in-stent stenosis, and embolization.

In 2013, CERAB technique was introduced to improve endovascular treatment results by a more anatomical and physiological reconstruction, with a subsequent better clinical outcome.

The CERAB technique was developed to overcome the anatomical and physiological disadvantages of kissing stents such as flow disturbances leading to turbulence and stasis of blood, which may cause thrombus formation and intimal neohyperplasia.

The early results of the CERAB configuration are promising at 1-year follow up in a group of 130 patients with AOID and the 30-day major complication rate was 7.7%.

CERAB and Chimney CERAB (C-CERAB) techniques may change the treatment algorithm of AIOD and juxta-renal occlusive disease. It appears to be a safe and feasible alternative with promising results, being a valid alternative for surgery and/or kissing stents.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years and older patients.
2. Patient presented with disabling claudication pain.
3. Patient presented with rest pain.
4. Patient presented with gangrene or atrophic changes.
5. Provided written informed consent.
6. Eligible anatomy for CERAB technique.
7. TASC- (II) classification as assigned in the study protocol (specified type B, C and D lesions).

Exclusion Criteria:

1. Age less than 18 years old.
2. Patients with acute limb ischemia.
3. Patients treated with open surgery and other endovascular techniques such as kissing stenting.
4. CERAB configuration extending into aneurysmatic infrarenal aorta.
5. Patient's life expectancy \<2 years as judged by the investigator.
6. Patient has a psychiatric or other condition that may interfere with the study.
7. Patient has a known allergy to any device component.
8. Patients with a systemic infection who may be at increased risk of endovascular graft infection.
9. Patient has a coagulopathy or uncontrolled bleeding disorder.
10. Patient had a recent cerebrovascular accident (CVA) or a myocardial infarction (MI) within the prior three months.
11. Patient is pregnant (Female patients of childbearing potential only).
Abdominoplasty Under Spinal Anesthesia

100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing abdominoplasty under general anesthesia

200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II, were enrolled in this feasible study. All patients were subjected to abdominoplasty operation under spinal anesthesia or general anesthesia. Any intraoperative complications like hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and the need for analgesia to be administered.

Eligibility Criteria:
Inclusion Criteria:

* All patients between 18-55 years
* ASA I and II

Exclusion Criteria:

* BMI more than 35 years
* Contraindications for regional anesthesia
Finding Barriers and Designing Solutions to Promote Women s Cancer Screening in South Africa

The primary aim of the study explore drivers of cervical cancer screening and barriers contributing to low screening coverage among women in South Africa. Secondary aims are determining preferences for cervical cancer prevention services using a discrete choice experiment and developing a multi-level package of interventions that will address barriers to cervical cancer screening and improve engagement in care among women.

Cervical cancer is a leading cause of cancer death among South African women. Despite a comprehensive national cancer control policy, cervical screening coverage is low and attrition during on-ward referrals for diagnostic confirmation and treatment remains common.

This study uses a sequential mixed-methods design:

Phase 1) A qualitative exploratory phase using focus groups and in-depth interviews with women, men, other stakeholders will inform our design and interpretation of quantitative findings from a multi-cohort DCE.

Phase 2) Women will be recruited to participate in the DCE and determine their preferences for cancer screening services.

Phase 3) Design Thinking to co-create an intervention package for cervical cancer screening and enhanced linkage between screening, diagnosis, and treatment will be created.

Eligibility Criteria:
Inclusion Criteria

Focus Groups with HIV-positive Women

1. HIV-positive
2. Women 18 years and older
3. Participants should be willing and able to provide written informed consent

Focus Groups with HIV-negative Women

1. HIV-negative
2. Women 18 years and older
3. Participants should be willing and able to provide written informed consent

Focus Groups with Men

1. Male partners who are 18 years and older
2. Participants should be willing and able to provide written informed consent

In-depth Interviews with Key Stakeholders

1. Healthcare providers working within the public health system and other key stakeholders
2. Individuals 18 years and older
3. Participants should be willing and able to provide written informed consent

Exclusion Criteria:

Focus Groups with HIV-positive Women

1. Women younger than 18 years
2. Unwilling or unable to provide written informed consent

Focus Groups with HIV-negative Women

1. Women younger than 18 years
2. Unwilling or unable to provide written informed consent

Focus Groups with Men

1. Male partners younger than 18 years
2. Participants unwilling or unable to provide written informed consent

In-depth Interviews with Key Stakeholders

1. Providers who do not work in the public health system
2. Individuals younger than 18 years
3. Participants unwilling or unable to provide written informed consent
Assessment of Pink Esthetic Score After Using Two Papilla Reconstruction Exposure Techniques Versus Mid-Crestal Sulcular Incision in Second Stage Implant Surgery: a Randomized Controlled Clinical Trail

The purpose of this randomized clinical trial is to assess the pink esthetic score with three different techniques in second-stage implant surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who already received implants in the anterior and premolar region
2. All implants were placed 4 months prior to uncovering in the mandible and 6 months prior to uncovering in the maxilla.
3. Patients with good oral hygiene
4. Medically free patients
5. Adequate keratinized tissue

Exclusion Criteria:

1. Acute infection
2. Occlusal trauma
3. Smokers
4. Pregnancy and lactation
5. Severe gag reflex
Diabetic Ketoacidosis Diagnosis and Management

This is the first and only study conducted on the use of capnography in children diagnosed with DKA to evaluate the initial clinical grading of DKA, monitor clinical improvement, and predict complications such as brain edema.

Purpose: In this study, the contribution of this non-invasive follow-up method to the management of DKA and the reduction of the frequency of invasive procedures was investigated in patients diagnosed with diabetic ketoacidosis (DKA) in the pediatric emergency department and followed up with capnography

Method: This study is a prospective clinical study. Between October 2020- November 2022, EtCO2 and IPI follow-up of 0-18 year-old pediatric patients diagnosed with DKA in the Pediatric Emergency Service of Akdeniz University Medical Faculty Hospital was performed by capnography. DKA diagnosis, grading, clinical follow-up and treatment termination criteria of the patients were determined according to the ISPAD 2018 Diagnosis and Treatment Guidelines. In the study; During the clinical follow-up, changes in GCS, blood glucose, vital, blood gas and capnograph parameters were examined. Demographic data were analyzed in all patients and in groups of patients who underwent DKA grading. GCS, blood gas and capnograph parameters were compared in the patient groups with DKA grading. Diagnostic test performances of blood gas and capnograph parameters were compared to detect low GCS

Eligibility Criteria:
Inclusion Criteria:

* The study group consisted of pediatric patients aged 0-18 years who were diagnosed with Diabetic Ketoacidosis and applied to Akdeniz University pediatric emergency department.
* Written consent was obtained.

Exclusion Criteria:

• Who did not give written consent were not included in the study.
A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.

The main aim of this study is to learn how safe TAK-360 is and how well adults with NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that.

Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.


Eligibility Criteria:
Key Inclusion Criteria:

1. The participant weighs greater than equal or to (≥)40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
2. The participant has a documented, current diagnosis of NT2.

Key Exclusion Criteria:

1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
2. The participant has medically significant thyroid disease.
3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor).
4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus (HCV) antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
7. The participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.