cyrilzakka/clinical-trials huggingface dataset:
Metabolic Syndrome and Obstructive Sleep Apnea

Background:Metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood glucose. Accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the characteristics of metabolic syndrome. Studies indicate that sleep apnea may be a manifestation of the metabolic syndrome.

Subjects and methods:This study was conducted in the pulmonology department at kasrelainy hospital. It included 80 patients who came to the sleep lab unit for polysomnography. Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck\&hip circumference and blood pressure measurements,Laboratory investigations including :Lipid profile\& Diabetic profile(HBA1C).In addition to ESS and stop bang score questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilled the criteria of OSA ( obstructive sleep apnea) in the form of symptoms suggestive of OSA (daytime sleepiness/daytime fatigue/headache/snoring)and with AHI ( apnea-hyponea index) ≥5.

Exclusion Criteria:

1. Cerebro-vascular accident within the preceding 30 days.
2. Patients on sedatives.
3. Patients on anti-psychotics
The Effect of Web-Based Education in Patients With Type 2 Diabetes

This research was designed as a randomized controlled study to develop a web-based training program and evaluate the program's impact on diabetes management. This research was carried out on 89 patients diagnosed with type 2 diabetes in the Department of Endocrinology and Metabolic Diseases of Akdeniz University. The preparation of the web page and its content has benefited from the latest literature, national and international websites, and expert opinions. Individuals in the survey scope have been stratified random method with as intervention group (n=44) and control group (n=45). Individuals who were taken in the initiative group were informed by web page, SMS, e-mail prepared for a period of three months. Personal information forms Metabolic Control Variable Form, Diabetes Self-Care Activities Questionnaire, Self-Efficacy Scale for Type 2 Diabetic Individuals, Diabetes-Specific Quality of Life Scale and Web Site Analysis and Measurement Inventory were used as the data tools. The informed consent was obtained from the patients and all data were collected by author during face-to-face interviews.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65
* Diagnosed with type 2 diabetes at least six months ago
* Not have communication disabilities
* Used insulin
* Phone and internet connection

Exclusion Criteria:

* Have a physical, cognitive or mental disability to answer questions
Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System

The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.

Up to 400 children, ages 2 months through 14 years

1. To assess measures of injection performance, including estimates of injection completeness by collecting residual surface moisture with filter paper that will be circled with indelible ink; the volume will be compared to a reference set of moisture recordings.
2. To document completeness of injections; completeness is defined as \<10% of 0.1 ml volume remaining on the skin surface immediately after injection. Measurement of the bleb size following injection will recorded in millimeters.
3. To ensure device is well received by subjects. Subject's response to the injection will be noted by the subject and/or family members after the procedure for up to 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children between ages 2 months and 14 years
* Outpatient, expected to go home day of surgery
* Written consent and assent when appropriate
* Willing to complete and return pain diary (postcard) after 48 hours

Exclusion Criteria:

* Presently have skin rash at the intended injection site
* Have a history of use of any topical or systemic medications at the intended injection site that could have potentially altered the normal physical properties of the skin (i.e. atrophy from chronic steroid use, thinning of the skin from topical or systemic retinoids).
* Have a permanent physical change in the skin at the intended injection site, such as burns, scars or prior radiation therapy.
* Skin disorders that may predispose them to develop skin lesions at sites of trauma.
* Present use of any blood thinning medications.
* In the 10-11 year old cohort, none of the participants can have started puberty.
Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management

The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and more
* Index event of non-ST or ST segment elevation ACS
* Provision of signed informed consent

Exclusion Criteria:

* Hypersensitivity to aspirin or ticagrelor
* Oral anticoagulation therapy that cannot be stopped
* Treated with thrombolysis within 24hrs
* Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
* Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
* Any life-threatening condition with life expectancy less than 6months
* Mental condition (dementia, alcohol or drug abuse) which may be affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study
* High risk due to malignant hypertension
* The conditions associated with increased risk of bradycardiac events
* Subjects with severe liver disease
* Subjects requiring dialysis
* Increased bleeding risk
* History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days
* Thrombocytopenia or leukopenia
* Positive pregnancy test or is known to be pregnant
Validation of in Vitro Method for Anti-MCPyV Immunotherapy on Patients With Cutaneous Merkel Cell Carcinoma

The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years old;
* Diagnosed with Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or an active follow-up;
* Informed for the study and no-opposed for participation;
* Affiliated with a social security scheme or in an equivalent situation.

Exclusion Criteria:

* Patients ongoing another interventional clinical trial;
* Patients under guardianship or trusteeship;
* Pregnancy or breastfeed;
* Patients refusal.
Comparison Efficiency of Oral Etoricoxib Versus Intravenous Fentanyl on Post Operative Pain in Curettage Under TIVA

Comparison of the efficiency of oral Etoricoxib versus intravenous Fentanyl on post operative Pain in curettage under TIVA: A randomized controlled trial

Fractional Curettage is the most widely used for diagnostic and treatment abnormal uterine bleeding. The patient categorize post-operative pain as mild to moderate. Therefore, the effective analgesic added on intraoperative and post-operative is the most important factor in patient's satisfaction, patient well co-operation, shortness time of operation, decrease unpleasant symptoms and rapid recovery. However, there are many anesthetic technique that can be used to relive pain in the operation such as local anesthesia, total intravenous anesthesia, regional anesthesia or oral analgesic drugs.

Intravenous Fentanyl is an short acting opioid. It has a fast onset of action within 2 minutes and short duration of action 30-60 minutes. Respiratory depression, hypotension and bradycardia are adverse effects that might delayed discharge especially in one day surgery e.g. fractional curettage. Etoricoxib is an oral COX-2 specific inhibitor which can be used to relieve the pain. The onset of analgesia can be occurred within 24 minutes which peak plasma level within 60 minutes. There are many empirical evidences to support the results of post-operative pain after used oral Etoricoxib or intravenous Fentanyl. However, there are less evidences to support efficiency of oral Etoricoxib versus intravenous Fentanyl on post-operative Pain in fractional curettage under TIVA

Eligibility Criteria:
Inclusion Criteria:

* Women who having abnormal uterine bleeding undergoing fractional curettage under TIVA

Exclusion Criteria:

* Women who have opioid or NSAIDs allergy
* Women who disagree to participate in this study
* Women who have history of gastrointestinal bleeding or ulcer
* Women who have abnormal kidney function
* Women who can't understand Thai language
* Women who have American Society of Anesthesiologists \[ASA\] above 2
* Women who have been used NSAIDs in 48 hours or often used NSAIDs
Relationship Between Preoperative Subcutaneous Trochanteric Fat Thickness and Postoperative Infection Risk

The effect of preoperative subcutaneous trochanteric fat thickness and trochanteric soft tissue thickness on postoperative infection risk in patients undergoing hemiarthroplasty for femoral neck fracture

Obesity is a growing problem for healthcare systems and orthopaedic surgeons, with 29% of the adult population in the UK and 40% in the US affected by obesity. The most commonly used measure of obesity in healthcare is body mass index (BMI), and the World Health Organisation defines obesity as a BMI ≥ 30 kg/m2. Much of the arthroplasty literature has also focused on the use of BMI as a measure of obesity.

BMI-defined obesity is associated with an increased risk of perioperative complications (including infection and dislocation) in total hip arthroplasty. It has also been shown that there is a gradual increase in anaesthetic time, operative time and length of hospital stay as BMI increases in obese patients.

BMI is an imperfect measure because it does not take into account age, sex, race, fat distribution or muscle mass. Previous studies have shown that subcutaneous fat depth (FD) is an independent risk factor for wound infection in cervical and lumbar spine surgery and after laparotomy. It is not known whether increased subcutaneous fat and soft tissue mass are associated with an increased risk of complications after arthroplasty for femoral neck fractures.

The aim of this study was to investigate whether preoperative measurement of subcutaneous adipose tissue by radiography and computed tomography (CT) and muscle thickness in the gluteus medius/minus, gluteus maximus, anterior and medial compartments by computed tomography (CT) in femoral neck fractures correlate with infection rates at postoperative follow-up.

Hypothesis: In patients with high body mass index (BMI) with femoral neck fractures, the investigators believe that the relationship between increased subcutaneous adipose tissue on radiographs and CT sections and wound infection is as effective as the relationship between increased muscle thickness in the gluteus medius/minimus, gluteus maximus, anterior and medial compartments measured on CT sections and wound infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years of age
* Femoral neck fractures
* Female patients
* Patients undergoing hemiarthroplasty

Exclusion Criteria:

* Patients younger than 65 years
* Male patients
* Patients with immunosuppressive conditions
* Intertrochanteric fractures
* Patients with revision surgery
* Pathological femoral neck fractures
A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis

This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis

The purpose of this NIS was to gather data from the daily clinical practice of the Jakavi®-treatment in a broad patient population. In order to evaluate the direct effect of Jakavi®, only JAK inhibitor naive patients were documented in the first study arm; patients pretreated with JAK inhibitors were documented in the second study arm to evaluate the long-term efficacy of Jakavi® in this subpopulation.

The documentation of all patients was carried out prospectively and began after the baseline visit. The medical decision on which therapeutic and diagnostic measures to take was made solely by the responsible physician. The observational period per patient was 36 months. The visit schedule after the baseline visit was set by the responsible physician according to standard clinical care, the clinical condition of the respective patients and the SmPC.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with Primary Myelofibrosis (PMF), post-Polycythemia Vera-Myelofibrosis (PPV-MF), or post-Essential Thrombocythemia-Myelofibrosis (post-ET-MF), for whom Jakavi® therapy is indicated.
* Patients that were informed about all aspects of this NIS and provided written informed consent.

Exclusion Criteria:

-
Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.

After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.

Eligibility Criteria:
Inclusion Criteria:

1. Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;
2. Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion;
3. Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional;
4. ECOG score is 0-2;
5. The interval time between surgery and radiotherapy is no more than 8 weeks;
6. The routine blood examination was normal;
7. Compliance is good and informed consent is voluntarily signed.

Exclusion Criteria:

1. The patients receive chemotherapy;
2. History of previous malignant disease;
3. Previous diagnosis of Crohn's disease or ulcerative colitis.
Study Evaluating DVS-233 SR to Treat Vasomotor Systems Associated With Menopause

The purpose of this study is to assess the safety and efficacy of desvenlafaxine succinate (DVS) for treatment of moderate to severe vasomotor symptoms (VMS) that are associated with menopause, and also to assess the effects of DVS on sleep parameters and health outcomes indicators.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women who seek treatment for hot flushes
* Minimum of 7 moderate to severe hot flushes per day or 50 per week recorded for 7 consecutive days during screening
* Body Mass Index (BMI) less than or equal to 40 kg/m2

Other inclusions apply.

Exclusion Criteria:

* Hypersensitivity to Venlafaxine
* History of seizure disorder
* History of myocardial infarction or unstable angina within 6 months

Other exclusions apply.
A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer.

The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated.

The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated.

The third dose group receives SH003 for 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* Patients with histologically and cytologically confirmed solid tumor
* Patients who have failed standard treatments, such as previous chemotherapy or radiotherapy, or who are inoperable, refractory, or progressive.
* ECOG score 0-2
* Patients with a minimum life expectancy of 12 weeks at the scheduled starting date of the study drug
* Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects.
* Patients who can swallow pills.
* Patients who provide written informed consent for participation in the trial

Exclusion Criteria:

* Known hypersensitivity to any study drug component, including Astragalus membranaceus, Angelica gigas, or Trichosanthes Kirilowii Maximowicz
* Patients with pre-existing cardiac conditions:
* Prior documented myocardial infarction within the last 6 months
* Pre-existing cardiac failure (NYHA class III-IV)
* Atrial fibrillation on anti-coagulants
* Unstable angina
* Severe valvulopathy
* Cardiac angioplasty or stenting with in the last 6 months
* Pregnant or lactating females
* Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety
* Active uncontrolled infection, including known history of AIDS or hepatitis B or C
* Any psychological, sociological, or geographical condition that could potentially interfere with compliance with the study protocol
* Concurrently receiving any other investigational agents while on study
A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial.

In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent has been obtained.
* The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at the end of follow-up visit (month 14) of that trial.

Exclusion Criteria:

* The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area .
* The subject is enrolled in any other interventional clinical trial.

For subjects where there is a gap between end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:

* The subject has been treated with ingenol mebutate or ingenol disoxate in the selected treatment area after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
* The subject has been enrolled in any other interventional clinical trial after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
Remote Monitoring of Chronic Illness Patients With a IHAP Home Wireless Hub and Vitals Measurements

This is planned as a feasibility study.

The primary objective is to evaluate a specially designed patient monitoring software Vitalbeat and standard mobile device hub termed Intel Health Application Platform (IHAP) in terms of its reliability, seamless data transmission and early data availability to the physician to improve patient physician interaction.

The second objective is assessing patient response to use of mobile device monitoring and patient self-monitoring skills to transmit vital signs data using the IHAP wireless home hub device

The proposed study is a prospective single-center clinical feasibility study. All patients shall be monitored for a total period of 30 days from their date of recruitment. A total of 10 patients will be recruited from one center. The center will be provided with mobile devices which would be activated by a local mobile service provider. Additionally a tablet computer will be provided to the local investigator for monitoring patient's data, providing portability and immediate access of information. An automated blood pressure (BP) monitoring apparatus and a weighing scale will be provided to the patient.

Vitalbeat software, with a mobile device home hub having a specially designed patient personalized software application ("Vitalbeat" from Aventyn, USA) for remote monitoring and a clinician monitoring software will be tested in the proposed study. The software has been developed in a manner which provides easy navigation and use, with provision of regular data entry of basic parameters used in chronic illness monitoring. The entered data is instantaneously available on the software monitored at the physician's end.

This study is targeted towards chronic patients. A "chronic" patient is defined as a patient who has had within the last six months symptoms of chronic illness before enrollment.

All patients above 18 years hospitalized and discharged alive with a primary diagnosis of a chronic illness shall be considered for recruitment. Upon enrollment into the study, patients will have mobile device monitoring along with existing standard care monitoring available at the local center.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of either gender and 18 years or older
* The subject is able and willing to provide written informed consent prior to enrollment in the study
* Symptoms of chronic illness.

Exclusion Criteria:

* Disability of fingers or upper limbs (unable to use devices)
* Visually impaired
* Those unable to read and write
* Hearing dysfunction
* Significant cognitive disabilities / mental illness
* Those who are unable to handle electronic devices
* Those residing in places outside mobile phone coverage
* Patients who may not come for follow up or likely to drop out of the study
* Any illness which may preclude regular follow up
An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven diagnosis of non-small cell lung cancer
* positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
* may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
* Tumors can be measurable or non measurable

Exclusion Criteria:

* prior treatment with PF-02341066
* received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
* current enrollment in another therapeutic clinical trial