cyrilzakka/clinical-trials huggingface dataset:
The Effect of Brochure-Based Education on Patients Planned for Nose Surgery

The study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is planned to collect research data in Hatay Mustafa Kemal University Hospital otorhinolaryngology clinic between June 2022 and June 2023.The population of the research will be the patients who are hospitalized in the otorhinolaryngology clinic of the aforementioned hospital and are planned for nasal surgery. The sample of the study, on the other hand, will consist of 52 patients who meet the inclusion criteria and agree to participate in the study verbally and in writing.The data of the study were collected by using the Personal Information Form, the Surgical Fear Scale and the Surgical Anxiety Scale, which were prepared in line with the literature.The data will be analyzed with the SPSS package program.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and over, 65 years and under,
* Being literate,
* To be able to understand and speak Turkish
* First time nose surgery,
* Agreeing to participate in the research.

Exclusion Criteria:

* Having any psychiatric disorder that may reduce the ability to comprehend and understand
* The surgery was canceled for some reason.
Comparison Between the Axillary Bilateral-breast Approach (ABBA) and Bilateral Axillo-breast Approach (BABA) for Robotic Thyroidectomy

The purpose of this study is to compare the therapeutic effects between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy.To explore the efficacy, safety, cosmetic results and clinical value by the two approaches.

Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of between the axillary bilateral-breast approach (ABBA) and bilateral axillo-breast approach (BABA) for robotic thyroidectomy have been described. The investigators therefore designed a prospective trial comparing outcomes, including surgical outcomes and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

1. the initial surgery
2. preoperative needle aspiration biopsy of thyroid cancer, and the diameter of no more than 1cm, no lateral neck lymph node metastasis
3. the tumor is confined to the thyroid membrane, not invading trachea and recurrent laryngeal nerve
4. intraoperative frozen section diagnosis of thyroid cancer
5. the patient informed consent.

Exclusion Criteria:

1. high-frequency ultrasound preoperative tumor diameter greater than 1cm, or lateral neck lymph node metastasis in patients
2. there had been a history of thyroid surgery or neck radiation therapy
3. pregnant or lactating women
4. with severe Hashimoto's thyroiditis, thyroid volume greater than II °
5. coagulation disorders, hyperthyroidism or hypothyroidism patients
6. sternal goiter.
Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).

The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Type 2 diabetes mellitus
* obese
* postmenopausal
* HbA1c \>6.49 and \<14.1

Exclusion Criteria:

* use of tobacco
* substance abuse
* impaired cognitive function
* renal disease
* abnormal liver function
* gastrointestinal diseases
* use of exogenous insulin
* use of hormone replacement therapy currently or within past 6 months
* pacemaker/defibrillator
Effects of Nocturnal Nasal Oxygen on Biomarkers in Sleep Apnea Patients With Heart Failure

Sleep apnea syndrome is clinically defined by frequent pauses in breathing during sleep and symptoms, such as being tired. It can decrease the restfulness of sleep and decreases the level of oxygen in the blood. Sleep apnea patients suffer from daytime sleepiness, hypertension, coronary artery disease (CAD), stroke, ischemic heart disease, arrhythmias, pulmonary hypertension, heart failure, and premature death. There is significant evidence suggesting that nighttime decreases in blood oxygen levels are the primary cause of many of the abnormalities associated with this disease.

Epidemiological studies have demonstrated a surprisingly high prevalence of sleep apnea. Mild sleep apnea is present in 17% of adults in the general population and moderate to severe sleep apnea is present in 5.7% of adults. Among patients with heart failure the prevalence skyrockets. Multiple studies have found the prevalence of moderate to severe sleep apnea to be anywhere from 11-53% in heart failure patients.

Continuous positive airway pressure (CPAP) therapy is currently the standard of care for sleep apnea sufferers regardless of the severity of their disease. In patients without heart failure, CPAP therapy has numerous benefits and several long term studies have reported that CPAP causes less cardiovascular disease as well as a long term improvement in cardiovascular symptoms and mortality among patient with severe sleep apnea.

In heart failure patients, CPAP has shown some beneficial short term effects but evidence of long term improvements in symptoms and mortality are lacking. Compliance with CPAP therapy reduces systolic blood pressure, improves cardiac function, raises oxygen levels, and increases exercise tolerance. On the other hand, CPAP has not been shown to affect survival or number of hospitalizations in heart failure patients. Moreover, compliance with CPAP is often poor and many people cannot tolerate it. This further limits the therapeutic effectiveness of this intervention.

The purpose of this study is to assess whether nocturnal oxygen administration via nasal cannula alone can improve outcomes in congestive heart failure patients with moderate to severe sleep apnea. The effects of nocturnal oxygen administration will be assessed by using biomarkers of heart stress and markers of whole body inflammation.


Eligibility Criteria:
Inclusion Criteria:

* RDI \> 15
* Symptomatic Heart failure
* Oxygen saturation \< 88% during apnea
* Not currently be on nocturnal oxygen therapy, CPAP, or other PAP therapy

Exclusion Criteria:

* Hypoxemia requiring oxygen supplementation
* serum creatinine \> 2.5 or on chronic dialysis
* blood pressure \> 160
* pregnant
* chronic physical disability that would prevent subjects from participating in any aspect of the trial
Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation.

Left Iliac Vein Compression Syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar vertebra. It is also called Cockett syndrome or May-Thurner syndrome. Recently, left iliac vein balloon dilatation with stent implantation have been used to treat patients with LIVCS, and have achieved good results. However, no matter the iliac vein stenosis or occlusion, interventional therapy can directly cause local trauma and intimal injury, which is a clear inducement of local thrombosis. Therefore, high intensity anticoagulation therapy is still needed to prevent secondary thrombosis in stent after left iliac vein balloon dilatation with stent implantation. At present, the postoperative anticoagulation regimen of these patients is early heparin anticoagulant therapy, and later warfarin anticoagulant therapy. However, due to the narrow therapeutic window of the drug, patients need to adjust the dosage according to coagulation function under the guidance of doctors. Rivaroxaban can simplify treatment, and is safe. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism. However, Rivaroxaban lacks sufficient clinical data for adjuvant anticoagulation therapy after balloon dilatation with stent implantation. Therefore, this study should be carried out to provide the basis for LIVCS treatment guidelines and explore the clinical indications of rivaroxaban.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation

Exclusion Criteria:

* Age \< 18 years or age \> 75 years
* With history of pelvic surgery, left iliac vein trauma and pelvic radiotherapy
* With obvious contraindications for anticoagulation therapy
* Allergic to iodine contrast agents in the past
* With concomitant diseases that need high-intensity anticoagulation, and the anticoagulation intensity is clearly higher than that of the patients with iliac vein therapy alone
* Active bleeding or potential bleeding risk
* Pregnant or breastfeeding women
* With pelvic tumors causing compression of left iliac vein,
* With chronic venous insufficiency of lower extremities caused by K-T syndrome
* With malignant tumors and life expectancy \< 1 year
* Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers
A Crossover Study of the Acute Effects of Olanzapine in Healthy Volunteers

The purpose of this clinical research study is to examine the acute hormonal and metabolic effects of the drug olanzapine, as well as appetite effects, in healthy volunteers. The hypotheses to be tested are that: (1) Olanzapine rapidly attenuates plasma leptin and (2) rapidly alters glucose tolerance in healthy volunteers. These questions will be answered by having volunteers undergo two glucose tolerance tests in a crossover study design.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer
* Body Mass Index of 18.5-25 kilograms per square meter
* Must be able to swallow tablets
* Able to give informed consent

Exclusion Criteria:

* Any DSM-IV TR Axis I psychiatric disorder (except nicotine dependence)
* Presence of any medical disorder that may confound the assessment of relevant biologic measures, including: significant organ system dysfunction, metabolic diseases, type 1 diabetes mellitus, type 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, clinically significant anemia, or acute infection
* Subjects who have taken any antipsychotic medication within the last 6 months
* Personal or family history of seizures and/or cardiac arrhythmias
A Phase II Study on Recombinant Botulinum Toxin Type a (YY001) for Injection in the Treatment of Upper Limb Spasticity in Adults

This is a randomized, double-blind, dose escalation, placebo- and active-controlled parallel-group multi-center phase II study to evaluate the efficacy and safety of Recombinant Botulinum Toxin Type A (YY001) for injection in the treatment of upper limb spasticity in adults


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years old inclusive, at the time of signing the informed consent, regardless of gender.
2. Weight ≥ 50 kg.
3. Subjects with unilateral hemiplegia due to stroke (with a time interval of ≥ 3 months from stroke onset to randomized enrollment) exhibiting upper limb spasticity.
4. Subjects with Disability Assessment Scale score of at least 2 on the Principal Target of Treatment (one of four functional domains: hygiene, dressing, limb position and pain).
5. If taking oral antispasticity, the dosage must be stable for at least 1 month prior to randomized enrollment.
6. If the study limb receives physical therapy or occupational therapy, the frequency, type, and intensity must be stable for at least 3 weeks prior to randomized enrollment.

Exclusion Criteria:

1. History of allergy to any component of the experimental drugs.
2. Previous use of any botulinum toxin within 6 months prior to randomized enrollment, or plan to use other botulinum toxins not specified in the study protocol during the study.
3. Fixed contractures of the studied limb.
4. Any medical condition that may increase the risk to the subject when using Botulinum Toxin Type A.
5. Need for treatment with drugs that interfere with neuromuscular function during the study.
6. Plan or anticipate to use new antispasticity drugs during the study.
7. History of epilepsy.
8. Pregnant or breastfeeding women. Participation in other drug/device clinical trials within 1 month prior to randomized enrollment.
Interfascial Infiltration for Acute Unspecific Low Back Pain in the Emergency Department

Pain relief and functional impairment have been shown to remain poor to moderate over weeks after emergency department discharge, in patients who seek ED management for acute nontraumatic, nonradicular low back pain.

The investigators made the hypothesis that ultrasound-guided interfascial infiltration of local anesthesics and corticoid is efficient and safe in treating patients presenting to the ED with acute non specific low back pain. The investigators aimed to compare early and short term functional impairment and pain relief one day and 1 week after interfacial infiltration, as compared to standard medical treatment

This is a single center observational feasibility study enrolling ED patients presenting with acute unspecific low back pain.

Ultrasound-guided interfascial infiltration is proposed to eligible patients presenting to our ED with low back pain and disability, as part of routine care. Patients receive standard medical treatment if they refuse interfascial infiltration or in case of absence or unavailability of a trained operator.

Patients were followed-up at 1 day and 7-days pots ED discharge by telephone interview conducted by an independent member of our research team not involved in patient's management

Eligibility Criteria:
Inclusion Criteria:

* adults aged between 18 and 70 years old
* presenting to the ED for low back pain from musculoskeletal origin, with symptoms evolving for less than 6 weeks,
* a score of 3 or more in the numeric pain scale (0-10)
* a score of 5 or greater on the Rolland Morris Disability Questionary (scale 0-24, RMDQ).

Exclusion Criteria:

* Traumatic or radicular pain or low back pain from alternative etiology
* allergy to local anesthetics
* Blood coagulation disorders
* Patients for whom follow-up by telephone interview was not possible
* Patients already enrolled in the study
Clenbuterol to Target DUX4 in FSHD

The purpose of this study is to determine if Clenbuterol is a therapeutic option for FSHD by determining the safety and tolerability of the medication at three different dose levels.

Clenbuterol is an EMA approved drug for COPD that three independent patient derived screens identified as suppressing DUX4 expression in cultured FSHD muscle. Prior clinical studies with related beta2-agonists showed some activity in FSHD but did not meet their primary endpoint, although the prior studies would likely have been designed differently with current knowledge. Target FSHD is a 6-month open-label multiple ascending dose study of clenbuterol for safety and tolerability to determine the best dose for a future trial of efficacy. In addition, this study will collect secondary outcome data on muscle function, MRI changes (lean muscle volume, fat infiltration, STIR-rating) and molecular markers of disease activity (histopathology and pre-determined baskets of DUX4-target, inflammation, and ECM genes) at the beginning and end of the study to assess and power their utility as measures of drug activity in a future interventional study of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of FSHD type 1 or 2, or have a clinical diagnosis of FSHD type 1 with a first degree relative with confirmed mutation
* between 18 and 75 years of age
* with a clinical severity score between 1 and 4
* Able to walk 30ft without support of another person
* Showing anti-gravity strength on at least one of the tibialis anterior muscles or having an MRI eligible muscle in the leg for needle biopsy
* willing and able to provide informed consent

Exclusion Criteria:

* Pregnant or planning to become pregnant during the conduct of the study
* have a poorly controlled medical condition
* Were involved in a study of an experimental agent within 3 months of enrollment
* Are taking beta-blockers or anabolic agent or potassium wasting diuretics
* have any condition or contraindication which would interfere with testing or preclude use of beta-agonist
* Are taking blood thinners or medications which make a needle muscle biopsy contra-indicated
* Are taking any medications or therapies with a contraindication to Clenbuterol
Effectiveness of Knee Sync Partner and Strengthening Exercises Versus Strengthening Exercises in Knee Osteoarthritis.RCT

This study explores the effectiveness of a novel treatment approach for knee osteoarthritis (OA) by comparing the combined use of a new device, "Knee Sync Partner," which provides electrical knee traction with stimulation and strengthening exercises, to traditional strengthening exercises alone. Knee osteoarthritis is a leading cause of chronic pain and disability worldwide, significantly impacting the quality of life for many individuals, especially with the growing elderly population.

While strengthening exercises are a well-established treatment for improving joint stability and mobility in knee OA patients, the potential benefits of integrating electrical stimulation and traction therapy remain underexplored. This research addresses the gap by conducting a randomized controlled trial to assess whether this combined approach leads to superior outcomes in terms of pain relief, functional improvement, and joint health. The findings could provide valuable insights into more effective, non-invasive management strategies for knee OA, expanding therapeutic options in physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* having pain in knee for more than 3 months in most days of week
* age between 40 and 70 years
* patient who filled Kellgren-Lawrence radiographic criteria

Exclusion Criteria:

* joint injection in the previous three months.
* The exclusion criteria were patients who had inflammatory arthritis
* osteoarthritis of the hips.
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers only

  * Males/females ≥ 50 years and ≤ 65 years of age
* Cancer patients and inflammation patients (inflammation patients in study part 2 = optional, in study part 3 mandatory)

  * Males/females ≥ 30 and ≤ 80 years of age
  * patients had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass with high certainty, for

    1. NSCLC (non small cell lung cancer), or
    2. adenocarcinoma of the breast (female patients) or
    3. squamous cell cancer of head and neck and the cancer disease is histologically confirmed.
    4. Patients with confirmed/known inflammatory focus/foci after FDG-PET/CT imaging

Exclusion Criteria:

* Exclusion criteria for all healthy volunteers and patients:

  * any concomitant disease (for healthy volunteers) and for patients any concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY86-9596, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  * For healthy volunteers and patients: known sensitivity to the study drug or components of the preparation.
  * tumor patients with known inflammatory disease, where images overlap inflammatory lesions with tumor lesions
The Effects of Aerobic Exercise During the Different Phases of Menstural Cycle

The menstrual cycle is a term to describe the sequence of events that occur in body as it prepares for the possibility of pregnancy each month. The average length of a menstrual cycle is 28 days. However a cycle can range in length from 21 days to about 35 days and still normal. The menstrual cycle is the time from the first day of your menstrual period until the first day of your next menstrual period. Every person's cycle is slightly different, but the process is the same. Menstruation is the monthly shedding of the lining of the uterus. Menstrual blood which is partly blood and partly tissue from the inside of the uterus flows from the uterus through the cervix and out of the body through vagina. Some people experience symptoms of menstruation and others don't. The intensity of these symptoms can also vary. The most common symptom is cramps. The cramping you feel in your pelvic area is your uterus contracting to release its lining. Menstrual cycle have four phases, menses phase (3 to 7 days of your periods), follicular phase (during the 10 to 14 days), ovulation phase (14 day if cycle is 28 days) and luteal phase (15 to 28 days).These will a Randomized control trial conduct on 42 participants. The data will be collected ffrom ladies gym and muscle work gym by using non-probability convenience sampling technique. The age between 18-25 years participants will perform the aerobic exercises during the different phases of menstrual cycle. A sample will be divided into two groups each group have 21 participants. The Group A control group will Education and Self-Management about health and fitness and perform the walk. Group B intervention group will be given the Aerobic exercise (cycling, treadmill and running). The participants assessed with Borg scale for rate perceived exertion, berg balance questionnaire use for performance test parameters and menstrual stress questionnaire use for behaviour. Data will be analyzed by using SPSS version 26.0.


Eligibility Criteria:
Inclusion Criteria:

* Age ranged 18 - 25 years
* Physical active women
* Weight 40 to 60
* Normal BMI ( 18 to 24)

Exclusion Criteria:

* Contraceptive pills
* Perimenupause
* Ammnorehic women
* Pregnant female
* Irregular menstrual cycle
* Non-smokers to minimize confounding cardiovascular effects