cyrilzakka/clinical-trials huggingface dataset:
Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea

The aim of this trial is to compare two different ways of CPAP titration:

CAP titration with fixed pressure vs. auto-titrating CPAP.

Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.

Eligibility Criteria:
Inclusion Criteria:

* moderate OSA (obstructive AHI 15-30/u on initial PSG)

Exclusion Criteria:

* Presence of hypoventilation
* Presence of central sleep apnea (central AHI ≥ 15)
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)

This is the long-term extension of a phase III, efficacy and safety open-label (protocol PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the administration of progestin or placebo tablets after end of PGL4001 treatment.

This extension study consists of three periods of 3 months open-label PGL4001 treatment, each followed by ten days of double-blind treatment with progestin or placebo and then a period without treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed visit 6 of PGL09-026 study, 10 to 18 days after menstruation following end of treatment with PGL4001, and did not take medications forbidden by the protocol.

Exclusion Criteria:

* Subject has a large uterine polyp (\> 2cm).
* Subject has one or more ovarian cysts ≥ 4cm diagnosed by ultrasound during PGL09-026 study.
* Subject has abnormal hepatic function at re-test.
* Subject has clinically significant abnormal findings at visit A or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or interfere with study evaluations.
* Subject has a positive pregnancy test or is planning a pregnancy during the course of the study.
Preference of Genetic Polymorphism and Pharmacokinetics

Genetic polymorphism affects plasma concentration of antiretroviral therapy in HIV patients. The investigators investigate the prevalence of genetic polymorphism affecting efavirenz metabolism and the corresponding pharmacokinetics of different genotypes.

Eligible patients are invited to donate blood samples for pharmacokinetic study and genotype analysis

Eligibility Criteria:
Inclusion Criteria:

* Southern Chinese HIV patients on efavirenz

Exclusion Criteria:

* Refuse to sign consent, HIV patients not on efavirenz
A Phase I Trial of Donor- Derived 19-28z CAR T Cells Following Allogeneic Transplant for the Treatment of CD19 Malignancies

The purposed of this study is to determine whether an infusion with specialized 'modified T cells' (or CD19 chimeric antigen T cells, also called CD19 CAR T cells) that target the B cell marker will reduce the risk of relapse after transplant.


Eligibility Criteria:
Inclusion Criteria:

The following criteria must be met prior to the allogenic transplantation:

1. ALL in second remission or greater (≥ CR2)

   * Please refer to section 3.0 for more discussion of ALL in CR1 versus CR2
2. CLL

   1. High risk in any remission status as defined by 17p deletion or Richter's transformation, or
   2. All other patients eligible after at least 2 lines of standard or investigational chemotherapy
3. B-NHL

   1. Refractory or stable disease to last line of therapy per ICML 2014. Patients should have at least 2 lines of prior therapy.
   2. Relapsed disease in patients who are not candidates for autologous transplant
4. Patient's age is ≥ 18 and ≤ 60.
5. KPS ≥ 70%
6. Patients must have CD19 expression (by any detection method) demonstrated on their malignant cells at the time of enrollment on the protocol.
7. Patients relapsed after prior CD19 CAR T cell or blinatumomab are eligible for enrollment as long as CD19 expression is still prese on the malignant cells.
8. Patients who have a matched related donor willing to donate HSC for allograft and PBMC for CAR T cell generation
9. Patients must have adequate organ function measured by:

   1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50%
   2. Hepatic: \< 3x ULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
   3. Renal: serum creatinine \<1.3 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 60 ml/min (measured or calculated/estimated)
   4. Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
   5. Negative serum pregnancy test for women of child-bearing potential is required

Exclusion Criteria:

1. Active and uncontrolled infection at time of transplantation. Please note that patients being actively treated for a viral reactivation may be enrolled on the protocol at the discretion of the investigators.
2. Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
3. Pregnant or breast feeding
4. HIV infection
5. Progressive disease at time of transplant
6. Patients with known autoimmune disease.
7. Patients with active or clinically significant neurological disorders, such as seizure disorders.
Beta2-mimetic and Central Nervous System

Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Some data suggest that Salbutamol may have some effects on the central nervous system which may explain the improved exercise and neuromuscular performances. The present study aims to assess the effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using neurostimulation techniques and magnetic resonance imaging.

The effects of Salbutamol intake will be assessed by using transcranial magnetic stimulation on one hand and magnetic resonance imaging on the other hand. Maximal voluntary activation and cerebral activation will be measured during motor tasks performed until exhaustion after acute inhaled slabutamol intake, acture oral salbutamol intake or oral placebo intake.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without respiratory and cordiovascular diseases
* Male
* Age between 18 and 35
* Trained subjects (\>6 hours of physical activity per week)
* Non- or ex-smoker (smoking cessation since at least 1 year)

Exclusion Criteria:

* Respiratory, cardiovascular and metabolic diseases
* Neuromuscular diseases
* thyrotoxicosis, or diabetes treated with insulin
* alcoholism
* MRI contraindication
* TMS contraindication
Effect of COVID-19 Infection on the Performance of Adolescent Professional Overhead Athletes

COVID-19 is known to also cause damage outside the pulmonary system, particularly the cardiovascular and the musculoskeletal system. The studies on the effects of COVID-19 infection on different populations may provide valuable information for health professionals. Derangements in the cardiorespiratory and musculoskeletal systems which normally direct effect on the sports performance of athlete together with physical inactivity during COVID-19 infection are the main factors that may decrease the performance of the professional athletes. Although it may be well anticipated that COVID-19 will reduce sports performance; there are scarce studies in the literature. The aim of this study is to compare the sports performance of adolescent athletes that has COVID-19 infection with those did not.

Extensor muscle endurance, flexor muscle endurance and the lateral core muscle endurance were evaluated. All tests were performed by a chronometer and test was terminated as the position was lost and the time passed was recorded. Hand grip strength was measured by Jamar hand dynamometer. Health ball throwing test was used to evaluate upper extremity open kinetic chain and explosive power. Pro-agility test was used to evaluate the agility. Step test was performed for 3 minutes with a 30 cm high step board.

Eligibility Criteria:
Inclusion Criteria:

* Basketball, volleyball, handball, tennis and American football players
* Between 12 to 20
* Performing sports-specific training more than two times a week at least for 1 year

Exclusion Criteria:

* Vertebral, upper or lower extremity injury within the last 6 weeks or had undergone a surgery
GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC

This study aimed to preliminarily evaluate the clinical efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of gemcitabine and oxaliplatin (GEMOX) plus systemic gemcitabine chemotherapy (GEM-SYS) combined with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor in patients with large unresectable intrahepatic cholangiocarcinoma (uICC). Large uICC patients who underwent GEMOX-HAIC (Day 1) and GEM-SYS (Day 8) (3w/cycle) combined with lenvatinib and PD-1 inhibitor between November 2019 and December 2022 were enrolled. Clinical data were retrospectively collected to analyze local tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. AEs were evaluated by the common terminology criteria for adverse events (CTCAE) version 5.0. In this study, OS was the primary endpoint, and progression-free survival (PFS) was the secondary endpoint.


Eligibility Criteria:
Inclusion Criteria:

(a) age of 18-70 years; (b) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; (c) diagnosis of ICC by histopathological examination of tissue biopsy specimens; (d) unresectable ICC confirmed by a multidisciplinary staff including at least one experienced liver surgeon; (e) tumor size larger than 5 cm in maximum diameter; (f) adequate liver function (total bilirubin \< 3 times the upper limit of normal and aspartate/alanine transaminases \< 5 times the upper limit of normal), adequate renal function (serum creatinine concentration of no more than 1.5 times the upper limit of the normal level), adequate bone marrow function (white blood cell count\>3,000/mm3, hemoglobin\>9.0g/dl and platelet count \>100,000/mm3 ) and adequate coagulation function (prothrombin activity \> 40% and international normalized ratio (INR) \< 1.26); (g) patients received at least two cycles of GEMOX-HAIC + GEM-SYS combined with lenvatinib and PD-1 inhibitor; (h) patients with regular clinical data for evaluating the clinical efficacy and safety.

Exclusion Criteria:

(a) combined with other malignancies; (b) patients underwent any other chemotherapy regimens before, including gemcitabine and oxaliplatin; (c) patients received previous surgical resection or any other interventional procedures besides HAIC, such as transarterial chemoembolization (TACE), 125I seed implantation, radiofrequency ablation, microwave ablation, cryoablation, or percutaneous ethanol injection, etc.; (d) drug (chemotherapy drugs, lenvatinib, or PD-1 inhibitors) allergy; (e) patients with a history of autoimmune diseases; (f) patients with gastrointestinal bleeding of any grade within 4 weeks prior to the integrated treatment; (g) patients with uncontrolled comorbidities (e.g. general infection, serious dysfunction of heart or kidney, acute hepatitis or pneumonia, chronic obstructive pulmonary disease, or recent stroke).
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Healthy Subjects.

The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard to its total and to its maximum serum insulin concentrations.

The purpose of this study is the comparative evaluation of the Pharmacodynamics and Pharmacokinetics of two recombinant regular human insulin injections administered intravenously in healthy volunteers under the conditions of euglycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subject
2. Age between 18 and 45 years (both inclusive)
3. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
4. Body Mass Index (BMI) between 18.0 and 35.0 kg/m2 (both inclusive)
5. Non-smoker, defined as no nicotine consumption for at least one year.
6. Signed and dated informed consent obtained before any trial-related activities.

Exclusion Criteria:

1. Previous participation in this trial or other clinical trials within the last 3 months.
2. Pregnant, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
3. Clinically significant abnormal hematology or biochemistry screening tests, as judged by the Investigator.
4. Any serious systemic infectious disease during the four weeks prior to the first dose of test drug, as judged by the Investigator.
5. History of any illness that, in the opinion of the Investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. In particular, subjects with significant cardiovascular disease, anemia (below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
6. History of alcohol or drug abuse within the past 5 years and/or any positive test for drugs of abuse at screening.
7. Positive test for hepatitis B or C or HIV positive at screening or in the past.
8. Use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for oral contraceptives/hormonal implants.
9. Use of any insulin product in the past.
10. Use of non-prescription drugs, except routine vitamins, within 2 weeks prior to the first dose of the test drug. Occasional use of acetaminophen will be permitted.
11. Blood donation of more than 500 mL (or considerable blood loss) within the last 12 weeks.
12. History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
13. Known or suspected allergy to trial products or related products.
14. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
Effects of Liuzijue Exercise Versus Tai Chi Chuan Exercise in Asthma

To analyze either Liuzijue exercise or Tai Chi Chuan exercise is effective in improving dyspnea index and pulmonary function in patients with asthma. In the general population, the rate of asthma is increasing day by day because of environmental and occupational risk factors which is becoming a burden. It causes shortness of breath, decreases lung volume, and disturbs quality of life. This study aims to improve dyspnea index, lung volume and quality of life of the patients with asthma.

Liuzijue Exercise is the most popular exercise in ancient Chinese literature which is compiled by the Chinese Qigong Management Centre. Liuzijue exercise includes inhalation and exhalation through various mouth patterns to manage and control the rise and fall of the breath in the body. It is performed by delivering 6 distinct sounds, ("xū", "hē", "hū", "sī", "chuī", and "xī") through termination along with comparing body activities. It is very helpful to improve pulmonary functions, exercise capacity, and quality of life of patients with pulmonary disease.

Liuzijue exercise takes on the backward abdominal breathing technique joined with physical exercises, which can practice the diaphragm and chest auxiliary respiratory muscles. Hence, the patient's breathing time is extended, and the breathing profundity increments. To accomplish the reason for expanding the gas exchange rate of the lungs and enhancing the lung capacity. Tai Chi Chuan is a traditional Chinese Exercise that is significant in improving the pulmonary functions of asthmatic patients.

Tai Chi (10 forms of yang style ) significantly improves the exercise capacity of patients with lung disease. Tai Chi seems to have physiologic and psychosocial benefits and appears to be protected and viable in advancing balance control, adaptability, and cardiovascular fitness for older adults.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed case of Asthma for last 6 months
* Patients with mild to moderate asthma
* On spirometry FEV1/FVC ratio less than 70%
* MRC- Grade 2 and 3

Exclusion Criteria:

* Refusal to consent.
* Unstable vitals.
* Diagnosed with any lung disease.
* Uncontrolled Hypertension.
* Diagnosed Tumor.
* Patient with Stroke and other neurological conditions.
* Patient with active Tuberculosis or other infectious disease.
* Patients with history of heart failure or any other cardiovascular condition
Erector Spinae Block in First Rib Resection: a Monocentric Before-after Study

First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.

In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.

In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* First rib resection for thoracic outlet syndrome
Study of Fluconazole in Children With Autism Spectrum Disorder

Antifungal therapy is widely used for individuals with Autism Spectrum Disorders (ASD). The current investigation will examine the effects of fluconazole on behavioral functioning among children with ASD. This is a double-blind, randomized, placebo-controlled study of oral fluconazole in children who meet criteria for ASD. Pre- and post-treatment behavioral ratings will be used to evaluate the efficacy of fluconazole therapy. In addition, children will undergo comprehensive medical history, physical examination, and laboratory analyses.

Our objective is to quantify differences in behavioral functioning between the fluconazole treatment and a placebo. Our primary hypothesis is that, on average and relative to the placebo, children with ASD who receive fluconazole will show greater improvements in symptoms of autism.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants, three to ten years of age.
2. Meets clinical criteria for an autism spectrum disorder.
3. No antifungal use in the preceding 3 months.
4. Results of pyrosequencing analysis that have identified yeast
5. Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study and must provide written consent to study protocol.

Exclusion Criteria:

1. History of allergic reaction to fluconazole or other azole antifungal agents
2. Current use of terfenadine, cisapride, phenytoin, cyclosporine, rifampin, theophylline, terfenadine, cisapride, astemizole, rifabutin, or tacrolimus
3. History of uncontrolled epilepsy
4. Weight less than 15 kg at screening
5. Presence of a chronic medical condition that might interfere with study participation or where study participation would be contraindicated or clinically significant abnormal baseline laboratory results.
6. Recent (less than two months prior to study entry) initiation of behavior therapy

A child will be excluded at any point during the study if it is revealed that a major change (either addition or deletion) of treatment or service provision has occurred.
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents

We will conduct a randomized trial to compare differences in sexually transmitted infection (STI) treatment adherence between patients receiving text messages versus those receiving usual care (e.g. no text messages). We hypothesize that STI treatment adherence will be 20% higher among patients randomized to receipt of two-way text messaging services.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent patients seen in the Emergency Department who test positive for gonorrhea, chlamydia, or pelvic inflammatory disease and are prescribed outpatient antibiotic treatment.

Exclusion Criteria:

* Patients will be excluded if they are unable to understand English, are critically ill, have cognitive impairment or if they do not have access to a cellular telephone with text messaging capabilities.
Triglyceride-Glucose Index in Diabetic Nephropathy in Type 2diaberes Mellitus Patients

The aim of the present study is to investigate the associations between the TyG index and diabetic nephropathy in patients with type2 DM .

the triglyceride-glucose (TyG) index was proposed as a simple and reliable surrogate marker of IR, and it has been reported to be closely correlated with the HOMA-IR index. The TyG index has the advantage of being applicable in clinical practice since both triglyceride and glucose levels are routinely measured and the cost of these measurements is low.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 DM

Exclusion Criteria:

- (1) Individuals with obstructive uropathy, severe heart failure, stroke, liver disease, cancer, autoimmune disease (2) Pregnant woman. (3)End stage renal disease patients on dialysis ( glomerular filtration rate \<15 mL/min/1.73 m2) or renal transplantation.

(4) Type 1 Diabetic patient. (5) Albuminuria due to non-diabetic renal disease
Ivabradine Versus Propranolol for Induced Hypotension in Endoscopic Sinus Surgery

the study is designed to compare the effect of addition of oral Ivabradine, propranolol to general anesthesia aimed reduction in blood loss during functional endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 60 years.
* Patients of both genders.
* ASA grade I - II .

Exclusion Criteria:

* Patient refusal.
* Any contraindication to medication included in the study .
* Patients with allergy to medication included in the study.