cyrilzakka/clinical-trials huggingface dataset:
Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma

The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and Beclomethasone in pediatric asthma control.

Cost-effectiveness study, of cohorts, observational, analytic, prospective, from health institution perspective. Based on published data related to percentage of patients free of crisis for both molecules, it was estimated that the sample size to detect significant differences between the two alternatives was 20 patients per alternative. Medical records of 94 patients with diagnosis of uncontrolled asthma were included, aged between 6 and 15 years, 47 received Beclomethasone randomly, and 47 received Ciclesonide randomly, treatment physician was blind related to this assignation, both cohorts were followed for 6 months, and primary effectiveness variable was defined as number of patients free of crisis with each alternative. Cost generating variables were defined as medication use, and hospital stay. Decision analysis was based on a decision tree.

Eligibility Criteria:
Inclusion Criteria:

* Patients with uncontrolled asthma diagnosis
* Patients with only one controller medication

Exclusion Criteria:

* Patients without lung infection
* Patients without antibiotic use
Supervised Group-based Walking Intervention Among Inactive Older Adults in Saudi Arabia

The purpose of the proposed study is to compare the effects of supervised group-based walking and non-supervised individual-based walking interventions on frailty, cognitive function and quality of life among inactive older adults in Saudi Arabia.

Objectives

1. To compare the difference of effects between supervised group-based walking and non-supervised individual-based walking on the primary outcomes, including frailty, cognitive functions, and health-related quality of life among inactive older adults in Saudi Arabia.
2. To compare the difference of effects between supervised group-based walking and non-supervised individual-based walking on the secondary outcomes, including physical activity enjoyment, health parameters consisting of resting heart rate, resting blood pressure, and body composition, as well as walking performance among inactive older adults in Saudi Arabia.
3. To formulate guidelines for achieving an effective walking intervention for inactive older adults in Saudi Arabia.
4. To recommend the government of Saudi Arabia on guidelines and policies for promoting walking and active ageing among the older adults in the country.

Eligibility Criteria:
Inclusion Criteria:

* 60-70 years old
* capable of walking without assistive device
* healthy and live independently in communities
* being physically inactive

Exclusion Criteria:

* with cardiovascular or related diseases that prevent from intensive walking
* fail the PAR-Q screening or without physician's advice on readiness of participation in exercise training
* diagnosed with cognitive impairment
Induction Chemotherapy for Advanced Head and Neck Cancer

Over the last 30 years, induction chemotherapy (IC) has become important for the management of patients with locally advanced HNSCC (LAHNSCC), particularly since the introduction of taxanes. The results reported in the TAX 323 and TAX 324 trials indicate that the TPF regimen (docetaxel, cisplatin and 5-fluorouracil) improves overall survival comparing with the PF regimen (cisplatin and 5-fluorouracil), and the TPF regimen is globally the most accepted induction regimen for the treatment of LAHNSCC.

However, the TPF regimen has been associated with high toxicity rates, and patients frequently decline cisplatin during concurrent radiotherapy and require the use of infusion pumps and a central venous catheter.

Extensive efforts are ongoing to identify alternative schemes that are less toxic than the TPF regimen but are as effective for LAHNSCC and safely allow the use of definitive concurrent treatment based on cisplatin and radiotherapy.

This non-randomized phase II trial evaluated the safety, feasibility and response rates of concurrent therapy (cisplatin and radiotherapy) after three cycles of an IC regimen based on the combination of cisplatin plus paclitaxel without 5-fluorouracil (5FU) (thereby avoiding infusion pumps and a central venous catheter) in LAHNSCC patients with a high tumor burden.

The patients were stratified by tumor subsite (oropharynx and hypopharynx/larynx) and by tumor resectable status (resectable or irresectable advanced squamous cell).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced squamous cell carcinoma of head and neck (stage III and IV) eligible to chemoradiotherapy.
* Presence of measurable disease
* ≥ 18 year
* ECOG performance status: 0-2
* Adequate bone marrow functions evidenced by: absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L and hemoglobin ≥ 90 g/L
* Adequate renal function.
* Adequate hepatic function.
* Patients or their legal representatives must be able to read, understand and provide written informed consent to participate in the study.

Exclusion Criteria:

* Any previous chemotherapy or radiotherapy
* Patients who have known hypersensitivity to paclitaxel or cisplatin
* Patients who are receiving concurrent investigational, biological or immune therapies
* Concomitant administration of high doses of systemic corticosteroids
* Known HIV or Hepatitis B or C (active, previously treated or both; testing is not required)
* Uncontrolled CNS disease (e.g., seizures not controlled with standard medical therapy)
* Clinically significant cardiovascular disease.
Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics

The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.

The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as \<80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.

Consented patients who are diagnosed with gestational diabetes will be randomized to either 1-hour or 2-hour postprandial blood glucose monitoring. A retrospective chart review from July 2020 until study commencement for patients from the same clinic will be used as a historical control group. This study will assess differences in adherence to testing.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with singleton gestation who are ≥ 18 years of age.
* Diagnosis of GDM after 24 0/7 weeks.
* For diagnosing GDM, a two-step screening algorithm will be performed according to the American College of Obstetrics and Gynecologists.4 Specifically, a 1-hour 50-g glucose-loading test is given first. Plasma glucose levels between 140 and 200 mg/dL will be considered elevated. Confirmatory testing will then be performed using a 3-hour 100-g glucose tolerance test. Diagnosis was made when two of the four values were elevated. Abnormal glucose value thresholds are established via the criteria suggested by Carpenter and Coustan: fasting value ≥ 95 mg/dL, 1-hour ≥ 180 mg/dL, 2-hour ≥ 155 mg/dL, and 3-hour ≥ 140 mg/dL.9 Patients with a blood glucose level greater than 200 mg/dL after 1-hour 50-g glucose-loading test will be diagnosed with GDM without requirement for the 3-hour 100-g glucose tolerance test.

Exclusion Criteria:

* Type 1 pre-gestational diabetes
* Type 2 pre-gestational diabetes
* GDM diagnosed prior to 24 0/7 weeks gestation.
Evaluation of the Metrological Reliability of Connected Objects in the Measurement of Medical Physiological Parameters

Many connected objects available over-the-counter to the general public claim to measure physical quantities that may have a medical application. Examples include heart rate, oxygen saturation, respiratory rate, blood pressure, body composition between body fat, lean mass and bone mass, and motion analysis. .

The continuous collection of these quantities by a cheap and easily accessible device opens important medical perspectives in the areas of home monitoring of chronic diseases or preventive medicine in general. Nevertheless, the medical decisions that could be made on the basis of the information provided by these objects require that the measurement be reliable, which is not always the case.

The evaluation of the accuracy of measurements made by these objects therefore seems to be a prerequisite for future use in a medical context. This study therefore proposes to test the adequacy between "gold-standard" measurements carried out in consultation in the department of functional explorations of the Bichat Claude-Bernard hospital and the measurements of the same parameters by connected objects, under the conditions of intended uses by their manufacturer.

Primary objective : Evaluate, in patients consulting for polysomnography, respiratory functional explorations or osteodensitometry, or as part of a day hospital cardiology. The accuracy of the measurement provided by a connected object in relation to the "gold standard" measurement made during the visit. The parameters studied will be:

* For polysomnography, pulse oxygen saturation (SpO2), heart rate (HR) and respiratory rate (RF), sleep quality (efficacy, duration of mild slow sleep, deep slow sleep and REM sleep)
* For bone densitometry, body composition in lean mass, fat mass and bone mass, weight • For respiratory function tests, pulse oxygen saturation (SpO2) and heart rate (HR)
* For day hospitalization in cardiology, blood pressure (BP), heart rate (HR) and heart rate, existence of rhythm disorders or conduction

Secondary objectives:

* Evaluate the ease of use of the device (evaluated by an ad-hoc questionnaire completed by the nursing staff)
* Describe the temporal evolution of the recorded parameters (excluding osteodensitometry for which the measurement is unique)
* For day hospitalization in cardiology, evaluate the diagnostic performance of objects tested on the existence of cardiac rhythm disorders (sinus bradycardia, sinus tachycardia, atrial fibrillation, presence of extrasystoles) or conduction disorders (atrioventricular block). -ventricular, branch block)

Eligibility Criteria:
Inclusion criteria :

* Patient over 18 years old
* Patient sent to the functional exploration department of Bichat hospital to perform one of the following exams: polysomnography, bone densitometry, respiratory function tests, cardiology day hospital assessment
* Patient agreement to participate in the study,
* Affiliated to a social security scheme (benefiting or entitled)

Exclusion criteria :

No defined
Effects of Home-Based Emotional Disclosure in Rheumatoid Arthritis

The purpose of the study is threefold: 1) to develop a home-based emotional disclosure intervention inducing core elements of change (emotional engagement, cognitive restructuring, and positive future directedness); 2) to examine in a randomized controlled trial in patients with rheumatoid arthritis the induction of the core elements and the feasibility of the intervention for home application; and, 3) to examine the psychological, clinical, and physiological effects of the adapted emotional disclosure intervention and the modulating role of cognitive-emotional change and individual differences in emotion regulation.

Emotional disclosure has been suggested to alleviate psychological and physical stress in chronically ill people. Emotional engagement, cognitive restructuring, and positive future directedness are considered core elements to induce change in emotional disclosure interventions. The aim of our randomized controlled trial in patients with rheumatoid arthritis is to examine the psychological, clinical, and physiological effects of an emotional disclosure intervention adapted for home application and the modulating role of cognitive-emotional change and individual differences in emotion regulation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis according to the criteria of the American College of Rheumatology (Arthritis Rheum 1988;31:315-24
* Written informed consent
External Oblique Intercostal Plane Block for Patients Undergoing Upper Abdominal Surgeries

Ithe study will evaluate the analgesic efficacy of external oblique intercostal block for patients undergoing upper abdominal surgeries

Patients will be randomly divided into two equal groups using SPSS. Group A: will receive US-guided external oblique intercostal block after induction Group B: will receive postoperative morphine on patient request. Study design: prospective controlled randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Selected patients will be more than 21 years old with ASA physical status I \& II scheduled for upper abdominal surgeries

Exclusion Criteria:

Uncooperative patients.

* Patients who have allergy to any of the used drugs.
* Patients who are on opioids.
* Known abuse of alcohol or medication.
* Local infection at the site of injection or systemic infection.
* Pregnancy
* Patients with coagulation disorders or on anticoagulation therapy
Evaluation of the Safety and Immunogenicity of Autologous Thrombosomes® in Healthy Human Subjects; A Microdose Escalation Study (Cohorts 1 - 4) and Repeat Microdose Immunogenicity Study (Cohort 5)

This "first-in-human" exploratory IND, single-center study will assess the safety, toxicity, hematology, and immunogenicity of sub-therapeutic "microdoses" of autologous Thrombosomes® in healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Minimum weight 110 pounds (50 kg)
2. Age 18-45 years
3. Able and willing to provide informed consent
4. Has permanent address and phone/e-mail for contact and notification, and able to come to the research site for scheduled study visits for up to 60 days after their last study infusion
5. Understands, speaks and reads standard English language
6. Normal healthy subject able to pass the universal blood donor history questionnaire and screen

Exclusion Criteria:

1. Breast-feeding female
2. At any time, previously pregnant female
3. Participation in an experimental drug/device study within the past 30 days.
Effect of Growth Hormone on Bone Mineral Density in Young Adults With Child-hood Onset Growth Hormone Deficiency

This trial is conducted in Europe. Growth Hormone in young adults with growth hormone deficiency in childhood. This trial compares a treated group of patients with an untreated group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Child-hood onset growth hormone deficiency
* Subjects received growth hormone replacement therapy during pre-puberty and puberty

Exclusion Criteria:

* GH treatment during the month preceding randomisation
* Treatment within the previous 6 months with medication that may affect bone mineral density
* Diseases which may affect bone metabolism
Impact of Low-fat and Full-fat Milk on Lipids and Cardiac Function in Patients With Coronary Artery Disease

This trial aimed to investigate the effects of low-fat and full-fat milk on patients with coronary artery disease (CAD).

The effects of low-fat and full-fat milk on lipid profiles and sphingolipid profiles in CAD patients are not well understood. In addition, milk intake is at a low level in the Chinese population compared with developed countries. Therefore, we aimed to conduct a randomized controlled trial to investigate the effects of low-fat and full-fat milk on lipid profiles, sphingolipid profiles, and cardiac performance in Chinese CAD patients.

Eligibility Criteria:
Inclusion Criteria:

(1) Patients with CAD

Exclusion Criteria:

(1) patients \<18 years of age; (2) patients with systemic active infection; (3) patients with severe hepatic and renal dysfunction \[alanine aminotransferase (ALT) \> 135mmol/L, creatinine \> 200umol/L), or chronic lung disease; (4) patients with a life expectancy ≤ 6 months due to bleeding tendency and hematological diseases, malignant tumors, and end-stage diseases; (5) patients with valvular heart disease or left ventricular aneurysm who needed simultaneous surgeries; (6) patients with cerebrovascular disease (cerebral infarction or cerebral hemorrhage within 6 months before enrollment); (7) patients who enrolled in other drug intervention trials; (8) patients who received emergency percutaneous coronary intervention (PCI); and (9) patients who reported intolerance to lactose.
Canagliflozin in Patients With Acute Decompansted Heart Failure

The study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I.V loop diuretic during the hospitalization period.

The study will focus on the role of adding canagliflozin to I.V loop diuretic therapy early in unstable hospitalized acute heart failure patients regardless of diabetic state, patients who will be included in the study will continue on canagliflozin for 3 months after hospital discharge to evaluate the incidence of re-hospitalization, mortality rate and other benefits related to HF symptoms will be investigated.

Eligibility Criteria:
Inclusion Criteria:

Randomized within 24 of presentation during hospital admission for hypervolemic ADHF with evidence of congestion defined by the presence of any of the following signs or symptoms:

Peripheral edema Ascites Jugular venous pressure \> 10 mmHg Orthopnea Paroxysmal nocturnal dyspnea 2.5 kg weight gain Signs of congestion on chest X-ray or lung ultrasound If pulmonary artery catheterization is available pulmonary capillary wedge pressure \> 19 mmHg plus a systemic physical examination finding of hypervolemia.

Planned use of intravenous (IV) loop diuretic therapy during the current hospitalization Estimated glomerular filtration rate (e-GFR) \> 30 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.

Exclusion Criteria:

Type 1 diabetes Serum glucose \< 80 mg/dL Systolic blood pressure \< 90 mmHg Requirement of IV inotropic therapy History of hypersensitivity to any SGLT-2 inhibitors Already receiving therapy with an SGLT2 inhibitor Women who are pregnant or breastfeeding Severe anemia (Hemoglobin \< 7.5 g/dL)(24) Severe uncorrected aortic or mitral stenosis Inability to perform standing weights or measure urine output accurately Signs of ketoacidosis and/or hyperosmolar hyperglycaemic syndrome (pH \>7.3 and glucose \> 250 mg/dL and HCO3 \> 18 mmol/L) in diabetic patients at the time of inclusion to the study.

The use of other diuretic therapies including; ≥100 mg/day spironolactone doses, ≥ 100 mg/day eplerenone, metolazone, hydrochlorothiazide, or other thiazides, systemic acetazolamide for the indication of diuretics, triamterene, or amiloride therapy.

The use of other medications possessing natriuretic effect as nesiritide, or arginine vasopressin antagonists.

Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 18 kg. Severe hepatic impairment (Child-Pugh class C). Patients on hemodialysis Acute myocardial infarction with symptoms of acute ischemia or changes on electrocardiogram
Effect of Ultrasound Acupoints on Patients With Polycystic Ovary Syndrome

This study will be conducted to evaluate the effect of ultrasound acupoints on menstrual irregularity and hormone levels on polycystic ovary syndrome (PCOS) patient.

PCOS is a life-long condition and although the exact cause is yet to be identified, it is believed to have epigenetic origins. It is the main gynecological endocrinopathy of reproductive age. It is the most common cause of infertility due to anovulation. In many countries, it represents the leading cause of female infertility.

Signs and symptoms are mediated by hormonal disorder including elevated androgens and fasting insulin, and abnormal relative ratio of the gonadotropins luteinizing hormone (LH) and follicle stimulating hormone (FSH). Endocrine imbalances occur within the framework of disordered ovarian folliculogenesis, chronic anovulation, clinical signs of hyperandrogenism and metabolic syndrome.

The standard treatment of PCOS includes oral medications, lifestyle changes, and surgery. Pharmacology-based treatments are effective in only 60% of patients. Therefore, acupuncture provides an alternative.

Acupuncture therapy in female with PCOS and ovulatory disorder has been known to bring enduring useful results on the endocrine system and menstrual cycle, without complications.

In women with PCOS and IR, acupuncture was superior to metformin in improving glucose metabolism and had a lower incidence of gastrointestinal adverse effects.

There were no studies using ultrasound acupoint to improve symptoms of PCOS patients, so this study will discuss this method to describe its effect on PCOS patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults range between 18 and 35 years.
* All patients will be stopped drugs that affect the result during study period.
* body mass index (BMI) not exceeding 30 kg/m2.
* have the symptoms of oligomenorrhea or amenorrhea (appendix I).
* No documented or observable psychiatric or neurological disorders that would interfere with study participation (eg, dementia or psychosis).
* Not having any type of cancer.

Exclusion Criteria:

* Any malignancy
* Patients with severe or unstable cardiorespiratory or musculoskeletal diseases that may influence the accuracy of quantitative sensory testing results.
* Participants who refuse to stop the drugs that affect the study during study period.
* Contraindications to therapeutic ultrasound including active cancer in region of hands or feet, presence of deep vein thrombosis, complete numbness in hands or feet, metal or plastic implantation.
Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Health Staff

The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 50 health staff smokers. This pilot multi-method study will combine the methodology of clinical trial with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a health staff audience.

The participants will be recruited at the Clinical Investigation Center (CIC) of the University Hospital of Poitiers. At baseline visit, they will be randomly 1:1 assigned to receive either music therapy and NRT or NRT alone for 3 months.

During the 3 months after Target Quit Date (TQD) , 3 visits will be performed by practitioners and nurses at the CIC. They will register smoking status of the participant, exhaled carbon monoxide concentration, body weight and all adverse events. Participants will answer questionnaires (FTCQ-12,Hospital Anxiety and Depression Scale ( HAD), Minnesota Nicotine Withdrawal Scale (MNWS), Impulsive Behavior Scale (UPPS), State-trait Anxiety Inventory Forme Y (STAI-Y)).

Eligibility Criteria:
Inclusion Criteria:

* Health staff,
* Age \>= 18 years
* Smoking more than 10 cigarettes per day for at least 6 months
* motivated to quit smoking
* without legal tutors or subordination
* affiliated to a health insurance system as required by the French law on biomedical research
* written informed consent for participation in the study

Exclusion Criteria:

* Roommates and couples
* NRT contraindication
* unstabilised depression
* psychosis and/or cognitive disorder and/or mental retardation
* substance misuse or alcohol dependence
* smoking-cessation medication (NRT, bupropion) or undergoing cognitive-behavioral therapy or hypnotherapy for smoking cessation in the last 3 months
* electronic cigarette for smoking cessation in the last 3 months
* participating in a study up to visit 4
* Persons benefiting from enhanced protection, i.e.persons deprived of their liberty by a judicial or administrative decision, adults under legal and finally patients in a vital emergency situation.