cyrilzakka/clinical-trials huggingface dataset:
The Role of Non-Alcoholic Fatty Liver Disease in Gestational Diabetes

The thought is that Non-Alcoholic Fatty Liver Disease (NAFLD) plays a key role in the progression to prediabetes/T2DM in those with a history of Gestational Diabetes (GDM). The investigators want to know if having a fatty liver will be connected with more glucose abnormalities (higher fasting/oral glucose tolerance test glucose, more insulin resistance) and that a history of GDM will be common in those with NAFLD.

A liver ultrasound will be completed during the last trimester of pregnancy along with a questionnaire. The questionnaire includes baseline maternal characteristics, age, race, ethnicity, parity, blood pressure, pulse, medications, activity level, sociodemographic and behavioral risk factors, pregravid BMI, previous obstetric history, medical and family history.

The subject will come in person to clinic two times after the subject has had her baby (at 6 weeks postpartum, and at 6 months postpartum).

The subject will give blood samples during the 6 weeks postpartum visit and 6 months postpartum visit, and an Oral Glucose Tolerance Test will be done at these visits. Blood samples will be drawn by putting a small needle or IV catheter (a small plastic tube) into a vein in the subject's arm. Blood samples will be obtained at timed intervals both before and after the subject is given a glucose beverage to drink, to see how well the subject's body deals with sugar in the blood over time. The total amount of blood to be drawn for each Oral Glucose Tolerance Test and research blood work will be approximately 90 ml (about 6 tablespoons). The total volume of blood taken over the course of the study for each subject will be approximately 180 ml (about 12 tablespoons).

The subject will have their blood pressure measured with a blood pressure cuff during each clinic visit. The height, weight and pulse rate will also be measured. This will take about five minutes.

The subject will have an ultrasound of her liver at the 6 week postpartum visit and 6 month postpartum visit. This will take about 30 to 60 minutes each time.

The investigator's study coordinator will call the subject to do a questionnaire over the phone at 3 months after the subject has had the baby. During the phone call, the study coordinator will ask the subject how the baby is being fed. The study coordinator will also update information about development of any new medical problems and medications the subject's doctor might have started, activity levels, and health habits. Subjects will be asked questionnaires to update this information during their 6 week postpartum and 6 month postpartum clinic visits as well.

The subject's understanding and approval of these procedures is required if she is to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* a pregnant female
* age between 18-50 years.

Exclusion Criteria:

* pregravid diabetes mellitus
* inability to understand and speak English
* inability to provide consent
* plans to relocate out of the area within 12 months postpartum
Effects of FTY720 on Heart and Lung Functions in Healthy Volunteers

This study is designed to assess the effects of two doses of FTY720 on lung (pulmonary) and cardiac (heart) functions in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking,(ie. 6 months w/o the use of nicotine or nicotine containing products), male or female subjects.
* Female subjects must be either surgically sterilized (including bilateral tubal ligation) at least 6 months or post-menopausal. Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion and menopause will be confirmed by a plasma FSH level of \>40 IU/L.
* Male subjects agree to refrain from sperm donation from check-in until 30 days beyond the conclusion of all study events.
* Male subjects must agree to the use of condoms with spermicide with sexual intercourse from 14 days prior to check-in until 30 days beyond the last dose of study drug.
* Resting heart rate ≥ 50 beats per minute (bpm)

Exclusion Criteria:

* History or presence of any clinically significant events, which in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
* Subjects with systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 50 mmHg
* Male subjects with a QTcB \> 450 msec
* Female subjects with a QTcB \> 470 msec
* Subjects with pulmonary symptoms, history of exercise-induced asthma, asthma or chronic obstructive pulmonary disease (COPD)
* Use of any prescription drug within 1 month of starting the study
* Positive urine screen for alcohol or drugs at screening, unless the test is shown to be falsely positive on confirmation testing.
* Hemoglobin \< 12g/dL
* Donation of blood or significant blood loss within 56 days prior to check in.
* Donation of plasma within 7 days prior check in.
* Participation in an investigational study within 30 days prior to check in.
* Positive screening test for HIV or Hepatitis B or C.
* A past history of cigarette smoking of \> 10 pack-years or use of nicotine or nicotine-containing products 6 months prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply
Single Modality Trans Oral Robotic Surgery for Primary Oropharyngeal Cancer: Exploring the Impact of Surgical Margins on Local Disease Recurrence

Retrospective observational cohort study investigating Single modality Trans Oral Robotic surgery for primary oropharyngeal cancer: exploring the impact of surgical Margins on local disease recurrence.

The STORM study will examine transoral surgery performed before 31st July 2019. STORM is a retrospective observational cohort study, involving international centres performing TORS for primary OPSCC.

The main aim of this study is to explore the impact of surgical margins on local disease recurrence in primary oropharyngeal squamous cell carci-noma treated with transoral robotic surgery (TORS) without adjuvant therapy.

The primary objective is to report local recurrence-free survival. The primary endpoint will be Local recurrence-free survival time.

The secondary objectives are to report overall survival, disease-specific survival and disease-free survival, and to report post-operative haemor-rhage rates. The secondary endpoints include Overall survival time, Dis-ease-specific survival time, Disease-free survival time, Post-operative haemorrhage time.

Exploratory objective to identify a clinically relevant cut-off for surgical margins as a predictor of local disease recurrence.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older.
* Primary OPSCC.
* Index cancer treated with TORS without adjuvant therapy.
* Any post-operative TNM classification.
* TORS performed on or before 31st July 2019.

Exclusion Criteria:

* TORS preformed for diagnostic or palliative intentions.
* Known distant metastasis at time of TORS.
* Nasopharyngeal and thyroid cancers.
* Patients undergoing neoadjuvant or adjuvant chemotherapy, biotherapy, immunotherapy or radiotherapy to either the neck or primary site.
Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)

Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.


Eligibility Criteria:
Inclusion Criteria:

* Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2

Exclusion Criteria:

* Serious systemic problems
* Other ocular problems Except ROP
Comparative Effects of High and Moderate Intensity Resistance Training in Young Football Players

Football playing is an intermittent sport requiring high intensity dynamic movements, such as acceleration, sprinting and jumping. Higher levels of strength and power are crucial for young football players. Overuse includes using a muscle too much, too soon before warming up, or too often in gym, Tension or stress can cause muscle soreness. DOMS is thought to be due to temporary muscle damage and inflammation for which the most common trigger appears to be eccentric exercises. Exercise induced muscle damage DOMS is considered a type1 muscle strain injury that has a pain free period of one day. Muscle soreness peaks between one to two days. The objective of this study is to compare the effects of high intensity-low volume (HRT) versus moderate intensity-high volume resistance training (MRT) on strength, power and muscle soreness in young football players.

Study will be a randomized clinical trial, conduct at Pakistan football federation Lahore through convenient sampling techniques. Sample size will be calculated by using G-power. Randomization will be done by Lottery method. Participants will be divided into two groups. Group A will receive High intensity resistance training and Group B will receive moderate intensity resistance training Strength will be calculated by 1RM and sprint test . Power will be measured by vertical and horizontal jump. Muscle soreness and fatigue will be measured by Hooper and MacKinnon questionnaire. Data will be analyzed by SPSS version 25

The objective of my study is to compare the effects of high and moderate intensity resistance training on strength, power and muscle soreness in young football players

Eligibility Criteria:
Inclusion Criteria:

* Male and female players

  * Age 18-24yrs
  * Player with minimum 1-year experience of football
  * Muscle soreness value shouldn't be below normal.
  * Value on Hooper and Mackinnon Questionnaire should be from 1-3.
  * A minimum score of 3-4 in lower extremity functional scale
  * Fatigue shouldn't regress the normal.(45)

Exclusion Criteria:

* History of lower limb musculoskeletal injuries in last 3months

  * Fracture since last 6months
  * Taking drugs or ergogenic supplement
  * Neurological systems are not intact(dermatomes and myotomes)
  * A minimum score of in lower extremity functional scale.(65, 66)
LEPU Renal Denervation System for Resistant Hypertension

The purpose was to evaluate 6-month outcomes of renal denervation(RDN) for the treatment of resistant hypertension in Chinese patients in a prospective cohort study.

Currently, considerable data on RDN have been obtained from Western populations, while the clinical outcomes of RDN in East Asian populations are seldom reported. Therefore, the purpose was to evaluate 6-month outcomes of RDN for the treatment of resistant hypertension in Chinese patients.In a prospective single-center cohort study, 50 Chinese patients with resistant hypertension would be recruited to undergo RDN by LEPU Renal denervation system, which was similar to Symplicity the Symplicity renal-denervation system (Medtronic). The primary effectiveness endpoint was change in systolic and diastolic blood pressure at six months as measured by office-based blood pressure assessment and 24-hour ambulatory blood pressure monitoring following therapeutic renal denervation compared to baseline. The primary safety endpoint was the incidence of Major Adverse Event (MAE) through 6 months , including severe renal artery dissection/stenosis(\>60%) that required stenting or surgery, cerebrovascular accident, myocardial infarction, death.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Stable medication regimen including ≥3 antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to RDN)
* 1) Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour mean SBP and/or DBP ≥140 and/or 90 mmHg
* Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
* eGFR ≥45 mL/min/1.73 m2
* Written informed consent

Exclusion Criteria:

1. Clinical Exclusion Criteria:

   * Known secondary hypertension
   * Type 1 diabetes mellitus
   * Has an implantable cardioverter defibrillator (ICD) or pacemaker
   * Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
   * Widespread atherosclerosis with documented intravascular thrombosis or unstable plaques
   * Has hemodynamically significant valvular heart disease
   * Pregnant, nursing, or planning to be pregnant
   * Any serious medical condition that may adversely affect the safety of the participant or the study
   * Currently enrolled in another investigational drug or device trial
2. Anatomic Exclusion Criteria

   * Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
   * History of prior renal artery intervention including balloon angioplasty or stenting
   * Multiple renal arteries where the main renal artery is estimated to supply \<75% of the kidney
   * Main renal arteries with \<4 mm diameter or with \<20 mm treatable length (by visual estimation)
   * Renal artery abnormalities
Cognitive Behavioral Therapy Group for Older Adults Delivered by Telethealth

The present aim of the study is to to adapt an established, manualized enhanced Group CBT (CBT-E) for seniors to a telehealth format, which will allow us to offer the group virtually during the COVID-19 pandemic.

The goal of this project is to adapt an established, manualized enhanced Group CBT (CBT-E) for seniors to a telemedicine format. Currently the Geriatric Psychiatry service associated with the Nova Scotia Health Authority offer two CBT-E groups every year. They are usually facilitated by psychiatry residents, under the supervision of a staff psychiatrist. Due to the risk of COVID-19, we will not be holding in-person groups this year. Instead we will offer the group in a smaller, telemedicine format. For this project, we will change the group structure and activities to allow it's delivery in a virtual format. This study will assess feasibility, tolerability of the telehealth format by using the System Usability Scale and Group Satisfaction Survey. It will also assess response to online therapy buy using pre- and post-group questionnaires including the Beck Depression Inventory, Beck Anxiety Inventory and Perceived Quality of Life Questionnaire. Paired t-tests will be used to analyse the data and determine whether there has been an improvement in participant's symptoms and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* People over the age of 65
* Diagnosis of either or both Major Depressive Disorder (MDD) of mild or moderate severity and an anxiety disorder, including generalized anxiety disorder, social anxiety disorder or panic disorder.

Exclusion Criteria:

* Patients with psychosis
* Patients with dementia
* Patient with severe Major Depressive Disorder or Anxiety Disorder
* Patients with antisocial or borderline personality disorder
* Patients with acute suicidal ideation.
* Older adults who do not have access to the technology required for group; computer, phone or tablet with a webcam and access to Internet

These are also exclusion criteria for the CBT group outside of the study. People younger than 65 are also excluded from the group because it is offered to older adults only.
Obesity, Sleep Apnea, and Insulin Resistance

Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Individuals
* Age 30-70 years old
* BMI- 25-40 kg/m2
* Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography

Exclusion Criteria:

* Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
* Must not have previously received treatment for OSA, including CPAP.
* Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
* Pregnancy/lactation is also an exclusion.
Systemic and Local Inflammatory Biomarkers in the Treatment of Refractory Diabetic Macular Edema

The current study aims to investigate the relationship between systemic inflammatory biomarkers and local inflammatory biomarkers on OCT in patients with treatment resistant diabetic macular edema(DME) and further explore the associations with treatment outcomes.

This study was designed as a prospective open-label non rondomised observational study. The study was registered between April 18, 2022 and October 18, 2023. It is planned to include 80 volunteer patients over the age of 18 who are being followed up with the diagnosis of naive DME in the Retina Department of Prof Dr Cemil Tascioglu City Hospital and had poor response to the 3 consecutive initial monthly intravitreal bevacizumab loading dose. It was planned to evaluate systemic and local(OCT biomarker) inflammatory biomarker levels before swiching intravitreal agents, which may include intravitreal ranibizumab or intravitreal dexamethasone implant. The markers planned to be checked in blood samples are: IL-6, IL-8, TNF-a, ICAM-1, MCP-1, VEGF, HbA1c, CRP, ESR, haemogram, creatinine, AST, ALT, cholesterol. Patients were followed up monthly for 3 months after the switching. It was aimed to evaluate the level of systemic inflammatory biomarkers and the associations with treatment effectiveness. In addition, local OCT biomarkers (serous macular detachment and hyperreflective foci, etc.) and their relationship with treatment results were examined.

Eligibility Criteria:
Inclusion Criteria:

* who had refractory DME after 3 consecutive initial bevacizumab therapy
* treatment-naive

Exclusion Criteria:

* who had underwent anti-vegf treatment previously
* systemic inflammatory disease
* who had ocular surgery 6 months prior to enrollment
* uncontrolled hypertension
* \<18 years old
Marker Guided Breathhold Radiotherapy in NSCLC

Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with locally advanced non-small cell lung cancer (NSCLC)


Eligibility Criteria:
Inclusion criteria

* Age \> 18 years old
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Stage T1-4N1-3M0
* Performance status ≤ 2
* Inoperable
* FEV1 ≥ 1 l
* Ability to hold deep inspiration breathhold for \> 15 seconds
* Accepting treatment at Rigshospitalet
* Eligible for concomitant chemo-radiotherapy
* If a woman is of childbearing potential, a negative pregnancy test must be documented
* Ability to understand the given information
* Signed written consent for inclusion into the study

Exclusion criteria

* Prior thoracic radiotherapy
* Allergy to Iodine or iodine based contrast
* In the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons
Comparison of Different Weight Loss Methods in Obese Individuals

Although obesity is a rapidly increasing epidemic worldwide, it is associated with many health-related comorbidities. As a result of the developments in social life and observes the sedentary life in individuals, an effect of the age of technology the fact that this epidemic will cause even massive health problems in the coming period affecting the health systems of countries and indirectly their economies that, This situation necessitates the creation of alternative treatment methods for the prevention of obesity. This study aims to determine the effect of a therapy approach that can be applied to the vagus nervous system, which is associated with many organs and systems, on weight loss and general health. As an alternative treatment against lifestyle changes such as diet and exercise, individuals have made for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Age range 18 - 65
* Being in the stage I, II and III obesity class

Exclusion Criteria:

* Those with unstable DM
* Those with stage II hypertension
* Those who have had cardiovascular disease (especially those who have had an attack)
* Those with pulmonary disease
* Those with kidney disease
* Orthopedic restrictions
* Those with MND
* Those tied to the chair
A Nurse-led Theory of Planned Behavior Based Physical Activity Intervention Among Turkish Adults

The Theory of Planned Behavior has been successfully used in several programs to improve physical activity behavior. In this project, it is aimed to assess the effectiveness of Theory of Planned Behavior based physical activity intervention applied to 55-74 years old people living in nursing home in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study
* Aged 55 to 74
* Cognitive function of a score of greater than 24 on the Mini Mental State Examination
* Sedentary (Omaha system physical activity status ratings 1 or 2 score)
* To know Turkish literacy
* Time and go test score \<14 seconds
* Approval of the resident's General Practitioner to participate

Exclusion Criteria:

* Uncontrolled cardiovascular, musculoskeletal or neurological disorders.
* Pain in motion or acute
* Communication barrier (due to hearing/vision impairment )
* \> 3 falls in the previous year
* Need an walking aid (walkers, cane, crutches, walking sticks, etc.)