cyrilzakka/clinical-trials huggingface dataset:
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).


Eligibility Criteria:
Inclusion Criteria:

* Meets current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for AD and demonstrates serious behavioral problems; diagnosis confirmed by Autism, Diagnostic Interview-Revised (ADI-R).
* CGI score \> = 4 AND an ABC Irritability/Agitation subscale score \> = 18 at screening and baseline (randomization)
* Mental age of at least 18 months
* Male or female 6 to 17 years of age inclusive, at the time of randomization

Exclusion Criteria:

* Patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each
* Patients previously treated and not responding to aripiprazole treatment
* The patient is currently diagnosed with another disorder on the autism spectrum, including PDD-NOS, Asperger's Disorder, Rett's Disorder, Fragile-X Syndrome or Childhood Disintegrative Disorder
* Current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression
* A seizure in the past year
* History of severe head trauma or stroke
* Non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study
Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia

The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure.

Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut).

Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence

Eligibility Criteria:
Inclusion Criteria:

* Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.
* singleton pregnancy
* Age: 20 \~ 40 years;
* ASA physical status II \~ III;

Exclusion Criteria:

* parturient less than 20 years and more than 40 years.
* History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease.
* parturients who had allergy to any medication in the study.
* parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity)
* parturient who has history of alcohol intake.
* parturient received any medication likely to affect thermoregulation or Veno dilation.
* Refusing to sign informed consent.
Clinical Trial of Nebulized Hypertonic Saline to Attenuate Post-Traumatic Acute Lung Injury

This study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ALI). Both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.

Despite over 40 years of investigation, acute lung injury (ALI) remains a leading cause of morbidity in critically ill patients, and a disease for which there is no effective pharmacologic therapy. Our group and others have focused on the anti-inflammatory effects of intravenous hypertonic saline (HTS) acting on the injured endothelium with promising results experimentally, but failed to confirm the benefit clinically. Recent work, however, has shown that inhaled or nebulized HTS targeted at the epithelium is safe and effective in treating cystic fibrosis, COPD, and neonatal bronchiolitis. Recognizing the central role of the pulmonary epithelium in ALI, nebulization has the advantage of achieving high concentrations of the therapy without producing systemic side effects. Thus, we hypothesize that nebulized hypertonic saline will attenuate acute lung injury following trauma.

Eligibility Criteria:
Inclusion Criteria:

* adult 18 ≤ age ≤ 65
* trauma with a 9 ≤ NISS ≤ 36
* ≤10 units of RBC in the first 6 hours (as this is a major risk factor for ARDS and MOF in this population)

Exclusion Criteria:

* Direct or indirect lung injury
* Elevated intracranial pressure requiring treatment, including but not limited to mannitol, intravenous hypertonic saline, and ventricular drainage
* History of severe chronic respiratory disease
* Child-Pugh Class C liver failure
* Prisoners
* Pregnant women
Impact of Boostrix™ Maternal Vaccination on Morbidity and Mortality of Pertussis Disease in Infants ≤6 Weeks of Age, in Bogota, Colombia.

This study is being conducted to assess impact of maternal immunisation against pertussis in infants ≤12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January 2005-December 2014.

An observational, retrospective, ecological database study which involves systematic screening of the national databases of Bogota, to study pertussis related morbidity and mortality in infants ≤ 12 months of age before and after introduction of pertussis maternal immunisation in Bogota, Colombia from January 2005-December 2014.

Eligibility Criteria:
Inclusion Criteria:

• Not applicable as since this retrospective database study will include all the available aggregated data of pertussis cases, pertussis related hospitalisations and deaths, ALRTI cases, primary pertussis vaccination coverage and Boostrix vaccination coverage.

Exclusion Criteria:

• Not applicable as since this retrospective database study will include all the available aggregated data of pertussis cases, pertussis related hospitalisations and deaths, ALRTI cases, primary pertussis vaccination coverage and Boostrix vaccination coverage.
Narrow Band Imaging Bronchoscopy During SARS-CoV2 Infection

Vascular modifications have been described during SARS-CoV2 infection, especially a dilatation of the bronchial arteries. Within the airway wall, small branches of the bronchial arteries cross the muscle layer to develop a submucosal network. The Narrow Band Imaging technique is used during bronchoscopy to achieve a maximum contrast of vessels and the surrounding mucosa. Therefore, it enables to observe the microvessel structure and its distribution in the bronchial mucosa. The aim of this study is to describe the vasculature pattern of the bronchial tree during infection with SARS-CoV2.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo bronchoscopy with image and/or videos recording of NBI aspect of the proximal bronchial tree (carina, right and left upper lobe).
* Patients hospitalized with SARS-CoV2 infection proven by RT-PCR test
* patients hospitalized with lower respiratory tract infections unrelated to SARS-CoV2 (RT-PCR negative for SARS-CoV2)
* Patients who have had bronchoscopy performed as part of the assessment of a distal pulmonary nodule (RT-PCR negative for SARS-CoV2).

Exclusion Criteria:

* Patients under legal protection
* Patients who refuses the use of his personal medical data
Regional vs General Anesthesia in Patients With Hip Fracture Under Treatment With Clopidogrel

This study compares general to regional anesthesia concerning morbidity and mortality in patients older than or equal to 65 years old who receive clopidogrel and are to be submitted in hip fracture surgery. Half of participants will receive general anesthesia the first 48 hours and the other half will receive regional anesthesia after 5 days of the discontinuation of clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than or equal to 65 years old with hip fracture
* Native language greek and capable of speaking and writing
* Primary school graduated
* Is about to undergo in orthopedic surgery
* Participants should be available until the end of the prefixed end date of the research

Exclusion Criteria:

* Severe hearing impairment and visual acuity
* Major cognitive impairment (Mini Mental State Examination \<24)
* Medical history of central nervous system disease including stroke with neurological deficit
* Medical history of alcohol or drug abuse
* Dementia, Parkinson disease, Alzheimer disease
* Contraindication for general or regional anesthesia
* Severe contraindication for antiplatelet agent discontinuation
* Multiple failures
* Receiving other coagulants
* No written consent
Trental & Vitamin E for Radiation-Induced Fibrosis

This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.

Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.

Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental \& Vitamin E has been used with success in Europe and at the University of Iowa.

The focus of this study is to prevent fibrosis through intervention with Trental \& Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
* No evidence of metastatic disease.
* Minimum life expectancy of at least 12 months.
* Aged greater than 20 years.
* If female, pregnancy excluded.
* No documented history of collagen vascular disease.

Exclusion Criteria:

* Cognitively impaired patients
* Prisoners
* No histology available
* Documented metastatic disease
* Allergy to Trental
* Life expectance of less than 12 months.
* Aged less than 20 years
* Collagen vascular disease present
* Pregnant
* History of liver disease
* Use of anticoagulants
Cerebral Changes Following CTS Treated With Guided Plasticity

70 patients with mild to moderate Carpal tunnel Syndrome (CTS) including 24 patients with unilateral CTS were randomized to treatment with ipsilateral cutaneous forearm deafferentation with an anesthetic cream (EMLA®) or placebo during 8 weeks. Patient-rated outcomes was assessed using the symptom severity scale from the Boston carpal tunnel syndrome questionnaire (BCTQ) and the disability of arm, shoulder and hand questionnaire(Quick-DASH). Clinically patients were assessed for tactile discrimination and dexterity and nerve conduction studies (NCS). Cortical activation during sensory stimulation was evaluated with functional magnetic resonance imaging (fMRI) at 3T. Assessments were performed at baseline, after 90 min of initial treatment, and after 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* symptoms of CTS for more than 3 months
* classic or probable CTS according to Katz' hand diagram (2, 27)
* clinical signs of unilateral CTS with a positive Tinel's and Phalen's test
* age between 18 and 70 years
* nerve conduction studies (NCS) with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less on the affected side and of more than 43 m/s on the contralateral side
* no contraindications for MR examinations.

Exclusion Criteria:

* bilateral symptoms
* having been operated for CTS previously
* prior wrist or carpal fracture
* diabetes
* thyroid disease
* rheumatoid arthritis
* neurological disease
* drug abuse
* complete conduction block on electroneurography or prior regular exposure to hand-held vibrating tools.
Feasibility and Effectiveness of Nutritional Telemonitoring in Community-dwelling Elderly.

An optimal nutritional status is essential for healthy ageing. Telemonitoring might contribute to maintaining or improving nutritional status in elderly people.The objectives of this effect study are to test the feasibility and effectiveness of telemonitoring of nutritional parameters in community-dwelling older adults.


Eligibility Criteria:
Inclusion Criteria:

Having a care referral for at least one of the following types of care:

* Domestic care
* Personal care
* Nursing care
* Individual or group support
* Living in a sheltered home or service flat

Exclusion Criteria:

* Severe cognitive impairment (Mini Mental State Examination (MMSE) \< 20)
* Receiving terminal care
* Not having a television at home
* Clients with a visual impairment (not able to watch the television screen)
* Clients with a physical impairment in such a way, that they are not able to use the telemonitoring system
* Clients with nursing home care
Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) in the Treatment of Adolescent Depression

This trial is a single-center, single-blind, randomized, sham-stimulation controlled clinical trial. The primary objective of the trial is to detect the targeted effect of tTIS on the nucleus accumbens of adolescent depression patients using functional magnetic resonance imaging (MRI). The secondary objective is to evaluate the potential therapeutic efficacy of TIS treatment for adolescent MDD by assessing changes in clinical characteristics of participants, electrophysiological outcomes, and providing feasibility and tolerance estimates for large-scale efficacy trials. Thirty adolescent MDD participants aged 13 to 17 will be recruited and randomly assigned to receive 10 TIS treatments or sham stimulation treatments (15 participants per group). The trial includes pre-treatment and post-treatment MRI brain scans, clinical assessments, and resting-state EEG, fNIRS acquisition. Follow-ups will be conducted at baseline, after the 10th day of treatment, at the 4th week, and the 8th week. The Montgomery-Åsberg Depression Rating Scale (MADRS), the 17-item Hamilton Depression Rating Scale (HAMD-17), and the Self-Rating Depression Scale (SDS) will be used to assess changes in depressive symptoms of the subjects. The Hamilton Anxiety Rating Scale (HAMA) and the Self-Rating Anxiety Scale (SAS) will be used to assess anxiety symptoms of the subjects. The Wechsler Adult Intelligence Scale-Revised China (WAIS-RC) will be used to assess cognitive function of the subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age 13 - 17 years old; 2)Meet the DSM-5 criteria for MDD with a current MDE without psychotic features, as confirmed by the MINI 3) HAMD-17 total score of ≥20 4) No change in treatment regimen in the 4 weeks prior to screening 5) No severe mental disorders or intellectual disabilities; 6)Can cooperate actively with the experimental process and subsequent follow-up.

Exclusion Criteria:

* 1) serious diseases such as heart, liver, kidney and hematopoietic system disorders; 2) abuse drugs or are addicted to alcohol or suffer from uncontrollable mental illnesses; 3) Active suicidal intent, confirmed by the MINI Module B (Suicidality) or HAMD-17 item #3 score ≥3; 4) Pregnant or lactating; 5) Those who have identified definite organic lesions such as infarction foci, softening foci, hemorrhage foci, and space-occupying lesions through plain scan of cranial MRI; 6) Those with implanted objects in the brain (such as aneurysm clips, shunt devices, stimulators, cochlear implants or electrodes) or any other metal objects in or near the head, and cannot be safely removed; 7) Change in medication or psychotherapy treatment regimen before screening 8) Could not cooperate with fMRI examination or tTIS treatment; 9)Have received other forms of brain stimulation treatment in the past 3 months.
Diagnostic Value of Portable Ultrasound for Dyspneic Patient Support in the Emergency Department

The main objective of our study is to compare the effects of two care strategies for dyspneic patients on the length of hospital stay: (1) standard care (=contextual analysis + conventional clinical chest radiography) versus (2) standard care + pleuropulmonary ultrasound.

The secondary objectives of this study are to assess the following for both arms:

A-fatality rate, B-degree of concordance between the diagnosis orientation in the emergency department and final diagnosis determined by an expert committee using patient records one month later (blind evaluation by a panel of experts) C-clinical improvement between early emergency care and later care outside the emergency department (clinical parameters = blood gases and other biological parameters) D-imaging parameters.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Patient consulting in the emergency department for dyspnea

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot read French
* The patient is pregnant, parturient, or breastfeeding
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin

The results of studies conducted until now does not determine what the best way to treat infertility in the first line with patients with Polycystic ovary syndrome (PCOS). This study objective is to determine the best treatment for such patients. The long-term consequence health of women with PCOS are multiple. The woman with PCOS has a risk of developing metabolic diseases, heart diseases, diabetes Type II or anovulatory infertility. The insulin resistance plays an important role in all this medical condition. Clomiphene Citrate (CC) remains the first line treatment to induce ovulation in women with PCOS and anovulatory infertility.


Eligibility Criteria:
Inclusion Criteria:

* Women aged from 18 to 35
* Infertility for a period of a year or more or 6 month of irregular menstrual cycle
* PCOS under the Rotterdam criteria
* Insulin resistance HOMA-IR \> 2.5
* Normal semen analysis values
* Normal values of the following blood analysis: FSH, LH, Estradiol, AMH, TSH, Prolactine, Fasting glucose level, hemoglobin A1C, AST, ALT, alkaline phosphatase, SHBG, 17OH progesterone, DHEAS, Androstenedione, total testosterone, LDL, HDL, total cholesterol, Triglycerides, oral glucose tolerance test

Exclusion Criteria:

* Tubular factor
* Normal ovarian reserve
* Prior use of CC or Metformin, hypoglycemic agents, glucocorticoids, anti-androgen, weight-loss agent or oral contraceptives in the past 6 months
* Neoplasia
* BMI \> 35
* Renal, hepatic or cardiac failure
* Lactic, acidosis antecedent
A Novel Target Delineation Scheme in High-grade Glioma Patients: a Randomized Single-blind Clinical Trial

The main question it aims to answer are:

1. whether the new target delineation scheme can improve Progression-free Survival
2. whether it can reduce the incidence of radiation complications in high-grade glioma patients.

Participants in trial group will be performed radiotherapy of new target delineation method after the completion of the operation within 4-6 weeks., while participants in the control group be performed radiotherapy of EORTC(European organisation for research and treatment of cancer) target delineation method.Temozolomide 75 mg / ( m² · d ) will be given to both groups of patients during radiotherapy. After radiotherapy, its dose changes to 150 \~ 200 mg / ( m² · d ) for 5 days and stopped for 23 days as a cycle. There are 6 cycles in total.


Eligibility Criteria:
Inclusion Criteria:

1. High-grade glioma (2021 WHO grade III or IV)
2. Age between 18-65 years old, Karnofsky performance status (KPS) score ≥ 70
3. result of pregnancy test being negative within 7 days before enrollment, only applicable to women with reproductive potential
4. The patient voluntarily joined this study and signed an informed consent form
5. Willing to return for follow-up
6. Willing to provide tissue and blood samples for this research
7. Surgical treatment was completed without any postoperative complications (such as consciousness disorders, hematomas, lung infection and cardiac insufficiency)
8. Radiotherapy within 4-6 weeks after surgery
9. No contraindications for taking temozolomide

Exclusion Criteria:

1. Low-grade glioma(2021 WHO grade I or II)
2. had or having other type of malignant cancers
3. not having been performed gross total resection of tumor
4. Severe active comorbidities, systemic diseases or other serious comorbidities that would render the patient unsuitable for participation in this study or seriously interfere with the appropriate evaluation of the safety and toxicity of the prescribed regimen in the judgment of the investigator, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, or mental illness；
5. Baseline MRI indicates a previous or recent risk of cerebral hemorrhage or hernia;
6. Pregnancy or lactation, or pregnancy or childbirth during the expected trial period(from pre-screening or screening visits until 120 days after the last trial treatment)
7. Unable to perform brain magnetic resonance imaging;
8. Allergic to CT contrast agent, unable to perform enhanced CT examination;
9. Remote transfer;
10. Medical contraindications for receiving radiation therapy, such as active systemic lupus or scleroderma