cyrilzakka/clinical-trials huggingface dataset:
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Elderly Patients With Generalized Anxiety Disorder

The primary objective of this study is to demonstrate the efficacy of SR58611A 350 mg twice a day compared to placebo in elderly patients with Generalized Anxiety Disorder (GAD), as assessed by the 14-item Hamilton Anxiety rating Scale (HAM-A).

Secondary objectives are to evaluate the tolerability and safety of SR58611A in elderly patients with GAD, to evaluate the efficacy of SR58611A compared to placebo on disablility and quality of life in elderly patients with GAD and to evaluate the tolerability and safety of 24 weeks of additional treatment with SR58611A in elderly patients with GAD.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Generalized Anxiety Disorder (GAD) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and supported by the Mini International Neuropsychiatric Interview (MINI) plus Generalized Anxiety Disorder module

Exclusion Criteria:

* Minimum total score of less than 22 on the 14-item HAM-A scale
* Total score of 18 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS)
* Mini-Mental State Examination (MMSE) score of 22 or less

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Impact of Preoxygenation Time on End-tidal Oxygen Concentration and on Hypoxic Events Occurring After Intubation in the Intensive Care Unit.

Preoxygenation is recommended before performing tracheal intubation. In intensive care units (ICU) patients, there is no specific recommendation regarding the duration of preoxygenation, which usually is applied for 3 to 5 minutes. Monitoring the effectiveness of preoxygenation with end-tidal oxygen concentration (EtO2) is strongly recommended in the operating room but it is never used in ICUs. The first aim of this pilot study is to assess the effect of the preoxygenation duration on EtO2, and secondarily, as an exploratory objective, to determine whether targeting a given value of EtO2 during preoxygenation might insure a safer intubation than when targeting pulse oximetry (SpO2).

This is a multicenter randomized controlled pilot study. 110 patients who require intubation in the ICU will be randomly assigned, with a 1:1 ratio, to 3 or 5 minutes of preoxygenation duration. EtO2 will be continuously measured but hidden to the clinician. The primary outcome measure will be the obtention of an optimal preoxygenation defined by an EtO2 \>90%. Secondary outcomes include the occurrence of hypoxia and complications during the procedure.

A pulse oximetry (SpO2) greater than or equal to 96% (SpO2 ≥ 96%) at the end of preoxygenation will be the target in each group. If at the end of the preoxygenation, SpO2 is still lower than 96%, clinician will be allowed to extend the duration of preoxygenation (up to 5 minutes in the 3 minutes period of preoxygenation group and up to 8 minutes in the 5 minutes period of preoxygenation group).

End-tidal oxygen concentration (EtO2) will be measured during preoxygenation and will be hidden to the clinician in order to not influence the duration of preoxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Requiring intubation in ICU
* Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not present

Exclusion Criteria:

* Intubation for cardiac arrest
* End-tidal oxygen concentration monitoring not available
* Preoxygenation with high-flow nasal oxygenation
* Previous participation to the study
* Patient known, at time of inclusion, as being under guardianship, tutorship or curator
* Pregnancy or breastfeeding
* Lack of social security number
Plasma Transthyretin Levels and Risk of Type 2 Diabetes Mellitus and Impaired Glucose Regulation

Objective: To investigate the association between plasma transthyretin levels and risk of newly diagnosed type 2 diabetes mellitus (T2DM) and impaired glucose regulation (IGR) in a Chinese population.

Design: We performed a case-control study, including 1,244 newly diagnosed T2DM patients, 837 newly diagnosed IGR patients, and 1,244 individuals with normal glucose tolerance (NGT). The diagnostic criteria were recommended by World Health Organization in 1999. All cases were recruited from patients who, for the first time, received a diagnosis of T2DM in the Department of Endocrinology, Tongji Hospital, Tongji Medical College, Wuhan, China, from December 2010 to December 2016. Concomitantly, general population undergoing a routine health checkup in the same hospital were enrolled as controls. The inclusion criteria were age ≥ 30 years, BMI \< 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia. Participants with clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases, were excluded from the present study. Written informed consent was obtained from each participant. Besides, cases were stringently matched to controls in a 1:1 ratio, based on sex and age (± 3 years). All participants enrolled were of Han ethnicity, and gave a commitment of taking no medication known affecting glucose tolerance or insulin secretion before participating in the study. Fasting blood samples were collected in EDTA-anticoagulative tubes and separated for plasma within 1 h. Then plasma was kept at -80℃ prior to analyses. Plasma transthyretin levels were measured by BS 200 Autoanalyser (Mindray, Shenzhen, China) using immunoturbidimetric method.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30 years, BMI \< 40 kg/m2, and no history of diagnosis of diabetes or receiving pharmacological treatment for hypertension and hyperlipidemia

Exclusion Criteria:

* Clinically significant neurological, endocrinological, psychological or other systemic diseases, as well as acute illness or chronic inflammatory or infectious diseases.

Incomplete basic information.
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
* For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)

Exclusion Criteria:

* Contraindicated for PAP (CPAP or AutoCPAP) therapy
* Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
* Persons with obesity hypoventilation syndrome or congestive heart failure.
* Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
* Persons with implanted electronic medical device (e.g cardiac pacemakers)
* Persons who are pregnant or think they might be pregnant.
Effect of Combined Music and Taekwondo Training for Children with Autism Spectrum Disorder

The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder. Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder.


Eligibility Criteria:
Inclusion Criteria:

* Chinese children aged 7 to 9 years who have been clinically diagnosed as ASD by developmental paediatricians or clinical psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ASD.

Exclusion Criteria:

* children who have experience in Taekwondo training;
* children who have received music therapy within the previous 12 months;
* those who have severe sensory disorders (blindness or deafness);
* those who have underlying congenital abnormalities or other diseases that limit their ability to engage in physical activities.
Effects of Telmisartan on Ischemic Cardiovascular Events in High-risk Hypertensive Patients

This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.

This study is aimed to investigate whether treatment with Telmisartan is more effective than Candesartan in reducing the ischemic cardiovascular events in high-risk patients with cardiovascular disease.

Study design: PROBE(Prospective, Randomized, Open-labeled Blind Endpoints)

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria are set by at least one of the three following risk factors:

1. Coronary artery disease documented by at least one of the following:

   * Myocardial infarction at least 12 months before enrollment and not planned for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
   * Angina pectoris or asymptomatic myocardial ischemia undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at least 12 months before enrollment and not planned for further percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
2. Peripheral arterial disease undergoing percutaneous transluminal angioplasty (PTA) or peripheral artery bypass grafting at least 6 months before enrollment
3. Symptomatic cerebral infarction or cerebral hemorrhage at least 6 months before enrollment

Exclusion Criteria:

The exclusion criteria are set as follows:

1. History of worsening of heart failure within the preceding 6 months
2. Planned elective percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the anteceding 3 months
3. History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within the preceding 12 months
4. History of percutaneous hind limb angioplasty (PTA) or bypass grafting within the preceding 6 months
5. History of cerebral infarction, cerebral hemorrhage within the past 6 months
6. Congenital heart disease
7. Uncontrolled hypertension on treatment (eg, BP\>180/110 mmHg)
8. Pregnant women or women of childbearing potential
9. Hepatic dysfunction (AST or ALT \>100IU/L)
10. Renal impairment (serum creatinine level \>2.0 mg per 100 ml)
11. Known hypersensitivity or intolerance to ARB
QUALIOR Feasibility and Efficacy of a Supervised Home-based Standard Physical Exercise Program

This phase II-III study will be randomized (2:1) patients starting first-line oral targeted therapies (OTT) for metastatic cancer between an individualized supervised physical exercise programs (SPEP) by a personal coach, and recommended physical exercises via a booklet. Eligible patients will have received ≤2 lines of metastatic chemotherapy, Eastern Cooperative Oncology Group Performance status (ECOG PS) ≤2, controlled pain (visual analogue scale (VAS) \<3/10), and life expectancy ≥3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Patient's ≥18 years old.
2. Patient treated for a metastatic solid tumour within the following 4 cohorts: breast cancer, kidney cancer, lung cancer, and other tumours treated with oral targeted therapies (including melanomas, sarcomas, hepatic sarcomas, and colon cancers).
3. Patients starting first-line oral targeted therapy, with market authorisation. The targeted therapy may be associated with hormonal therapy.
4. Patients may have been treated with immunotherapy.
5. Patients may have received chemotherapy (≤2 lines) for their metastatic disease.
6. Life expectancy of ≥3 months.
7. ECOG performance status ≤2.
8. Patients able to comply with the constraints of the SPEP protocol.
9. Pain under control (VAS ˂3; 0-10 scale).
10. Haemoglobin level ≥9 g/dL.
11. Patient must have signed the informed consent form before any study-related procedures.
12. Patients must have public health insurance coverage.

Exclusion Criteria:

1. Patient receiving an injectable targeted therapy.
2. Patient previously treated by more than 2 lines of treatment (previous treatment with cytokines are allowed)
3. Patient to be treated with chemotherapy associated with the oral targeted therapy (hormonal therapy is allowed).
4. Patient with known risk of fracture, symptomatic cardiac insufficiency (NYHA-3), respiratory insufficiency (grade 3), intense pain not controlled with analgesic treatment, and/or neuropathy (grade 3).
5. Patients with a history of cancer in the last 5 years (except basal cell carcinoma adequately treated and in situ cervical cancer treated and cured).
6. Patient treated with corticotherapy (˃1 month) before randomisation at a dose ˃1 mg/kg.
7. Bone metastases with risk of fractures.
8. Geographical, sociological, or psychological reasons that could potentially hampering compliance with the study protocol and follow-up schedule.
9. Patients with a history of non-compliance to medical treatment, reluctance or incapable to conform to the study protocol.
10. Persons deprived of liberty or under guardianship.
Impact of Tripolar Radiofrequency on Acne Scar

The aim of this study is to investigate the therapeutic efficacy of tripolar radiofrequency on acne scar

Acne scarring is a very troublesome complication associated with acne and is reported in as high as 95% of the patients, sometimes even with proper and prompt treatment. The visible depressed scars have been known to have a negative impact on patient's psychological well-being and quality of life. Post acne scarring can pose as a risk factor for depression, anxiety, and even suicide (Villani, 2020).

There are a multitude of treatment options that are traditionally used for the treatment of acne scars including many ablative and non-ablative methods (Dogra, 2014).

Furth more, the need of this study is developed from the lack in quantitative knowledge and information in the published studies which investigate the effect of tripollar RF This study will be designed to provide guidelines about the effect tripollar Radiofrequency on acne scars.

Eligibility Criteria:
Inclusion Criteria:

* Forty patients having acne scar, from both genders their ages will be ranged from 20 to 40 years old
* Both genders will participate in this study as the following distribution 17 male and 23 female.
* They diagnosed as acne scar by their physicians and referred for physical therapy management.
* Medically and psychologically stable patients.
* All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients

Exclusion Criteria:

* Patients who suffer from hypertrophic and/or keloidal scars and a skin condition in the area of acne scars that would interfere with study procedures (e.g., plaque psoriasis, tattoo, birthmark, facial hair).
* Patients with medical red flags as severe psychiatric disorder or cognitive deficits.
* Medically unstable and uncooperative patients.
* Untreated and active/ongoing acne vulgaris.
* Immunocompromised status.
* History of skin cancer.
* Recurrent herpes viral infection.
* Pregnancy or breastfeeding status.
* Females take contraceptive pills
* Hormonal disturbance
Metabolic Adaptations to Chronic and Acute Exercise in Overweight Adults (ATX-Study)

The primary purpose of this study is to examine the effects of chronic exercise training and an acute session of exercise on key risk factors associated with Metabolic Syndrome (e.g., glucose tolerance, blood lipid profile, and blood pressure) and alterations in subcutaneous adipose tissue structure and metabolic function in overweight adults.

Subjects will be asked to complete the Substrate Metabolism Laboratory General Screening Questionnaire and American Heart Association Health/Fitness Questionnaire to determine if they are eligible to complete the preliminary testing procedures. If eligible, subjects will be asked to visit the Substrate Metabolism Laboratory to participate in the preliminary testing procedures (listed below) before participating in the experimental trial.

PRELIMINARY TESTING PROCEDURES:

* Blood pressure, height and weight measurements
* Body Composition Assessment (\~20 min)
* Exercise Fitness Test (\~10 min)
* Resting Metabolic Rate (RMR) measurement (\~30 min)
* 3 hour Oral Glucose Tolerance Test (OGTT)

EXPERIMENTAL TRIAL:

The evening before the experimental trial, subjects will eat a standardized dinner meal and snack. The meal and snack must be eaten at specific times as indicated by the research staff. After eating the snack, subjects will need to fast (no food or beverages - besides water) overnight.

Participants who exercise regularly will be instructed to exercise exactly 3 days before the experimental trial, and then abstain from their exercise training program until after the study is complete.

In the morning, subjects will return to the Substrate Metabolism Laboratory. The research team will collect a blood sample from the subject's hand or forearm and a small sample of fat tissue in the subject's abdomen with a needle. Next, subjects will exercise on a treadmill at a moderate intensity for about 1 hour. Immediately after exercising the research team will collect a second blood sample. Subjects will remain in the laboratory for 1 hour after exercising, and then the research team will collect another blood and fat tissue sample. Upon completion of the experimental trial, subjects will be provided a snack before leaving the laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Body Mass Index: 25-35 kg/m2
* Regular exercisers: (≥4 days/wk of aerobic exercise; 30-60min/session at moderate and vigorous intensities)
* Non-exercisers: no regularly planned exercise/physical activity
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Blood pressure \> 140/90 mm Hg
* Pregnant or lactating
* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism
Postoperative Adjuvant Therapy of HCC Based on PD-1

For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.

We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.

Eligibility Criteria:
Inclusion Criteria:

* 1. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain
* 2. Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery
* 3. Aged18-75
* 4. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
* 5. Child-Pugh grade A or B
* 6. The patient knows, and informed consent was obtained

Exclusion Criteria:

* 1. Any history of other malignant tumors or recurrent HCC
* 2. Any preoperative treatment for HCC including local and systemic therapy
* 3. Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* 4. Any persistent serious surgery-related complications
* 5. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
* 6. Inability or refusal to comply with the treatment and monitoring