cyrilzakka/clinical-trials huggingface dataset:
Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age

The primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).

As secondary objectives, the study aims to:

* argue the clinical predicted markers (neuropsychological) transition toward psychosis.
* test the feasibility and the acceptability of a early diagnosis for a potential applicable guidance for different referent centers of learning in French territory.
* have a better classification of patients with learning disorders in order to target a prospective primary prevention of risk of psychosis via the questionnaires (AQ of Baron-Cohen: Autism-spectrum quotient auto-questionnaire; Inventory of Beck Anxiety Inventory, auto-questionnaire for panic disorder and general anxiety; Liebowitz Social Anxiety Scale).
* improve identification of the early signs and the early emerging psychological diseases intervention management (schizophrenia).
* Psychic disability: prevent and reduce non-seeking care and accompaniment situations, and risk of rupture of care.
* permitting better care of psychosocial rehabilitation with cognitive evaluation.

This study will be conducted in Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP, in France.

Eligibility Criteria:
Inclusion Criteria:

* Patients born between 1990 and 2005, have been cared by Dr Schlumberger in 2014 in the center of language and learning disorders at Raymond Poincaré hospital;
* With severe learning disorders: deficiency in school work, need at least one medical appointment and long-term rehabilitation in the center of language and learning disorders at Raymond Poincaré hospital;
* Affiliated to a social protection schema;
* Written informed consent signed.

Exclusion Criteria:

* Absence of learning disorder;
* Intellectual deficiency;
* Epilepsia;
* Patients who will performed follow-up at Chartres city;
* Patients under guardianship or curatorship;
* Foreign patients under AME schema, a medical help from the state in France.
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care

High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care.

The main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.

This is a open-label multicentre randomised controlled trial conducted in two parallel groups.

The primary endpoint is the success rate at Day 7, with success defined as "definitive" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.

The weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.


Eligibility Criteria:
Inclusion Criteria:

* Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2/FiO2 ratio \<300 mmHg)
* Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, flow rate and FiO2 having to be stable (i.e. not increased) in the 24 hours prior to inclusion
* With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88
* Had a blood gas test under HFNO within 24 hours of inclusion
* Participant covered by or entitled to social security
* Informed consent signed by the patient or its relatives if the patient is incapable; this consent must then be confirmed by the patient as soon as possible

Exclusion Criteria:

* Presence of a patient included in the study and not weaned off HFNO in the sector managed by the nurse of the patient assessed for eligibility
* Concomitant non-invasive ventilation treatment
* Use of HFNO within 7 days of extubation
* Chronic obstructive pulmonary disease (Gold grade 3 or 4)
* Cardiogenic acute pulmonary oedema as the main cause of acute respiratory failure
* Diffuse interstitial lung disease as a medical history
* Patient with long-term non-invasive ventilation with external positive pressure
* Patient on long-term oxygen therapy at home
* Pregnant women, women in labour and breastfeeding mothers
* Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
* Minor
* Adult subject to a legal protection measure (guardianship, curators, person under court protection)
* Patient with a medical decision not to intubate
* Patients already included in the study, neither for the same stay if they were to present the inclusion criteria again, nor for subsequent stays
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and CS-866 in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and CS-866 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male volunteers aged 20 to 50 years
2. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints

Exclusion Criteria:

1. A subject who had any allergic history to any drug.
2. A subject with sign or symptoms or previously diagnosed disease of liver, kidney, neurology, respiratory, endocrinology, hematology, cardiovascular, genitourinary, psychology, ophthalmic, dermatology and gastrointestinal function or other significant diseases
3. History or suspicion of current drug abuse
4. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication

   * Within 1 month: drug known CYP inducer or inhibitor
   * Within 2 weeks: Prescribed or herbal medicine
   * Within 1 weeks: OTC medicine
   * Within 2 days: Consumption of caffeine
5. A subject who had participated in any other clinical study within the last 2 weeks
6. A subject from whom over 400mL of blood was sampled(whole blood donation) within last 2 weeks or plasma/platelet donation within 1 month.
Feasibility Study of Laparoscopy-assisted D2 Distal Gastrectomy to Treat Advanced Gastric Cancer

The purpose of this study is to evaluate the oncological feasibility of laparoscopy-assisted distal gastrectomy with D2 lymph node dissection for advanced gastric cancer.

To test oncological feasibility, compliance of nodal dissection was selected as a primary end point. When there are more than two missing nodal station(no lymph nodes in dissected area), it is defined as a non-compliant nodal dissection. Other secondary outcomes will be supplementary to evaluate feasibility of D2 dissection.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven primary gastric adenocarcinoma
* T2 or T3 or T4a, N0 or N1 or N2 or N3a (AJCC 7th), which is assessed by computed tomography (CT) scan - mid 1/3 or low 1/3 location
* No evidence of other distant metastasis
* not stump carcinoma,(vi) aged 20-80 year old
* performance status (PS) of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
* no prior treatment of chemotherapy or radiation therapy against any other malignancies, and no prior treatment for gastric cancer including endoscopic mucosal resection
* adequate organ functions defined as indicated below:

  * WBC 3000/mm3, WBC 12 000/mm3
  * Hb 8.0 g/dl without any transfusion 2 weeks before enrollment
  * Plt 100 000/mm3
  * AST 100 IU/l
  * ALT 100 IU/l
  * T.Bil 2.0 mg/dl
  * written informed consent

Exclusion Criteria:

* active double cancer (synchronous double cancer and metachronous double cancer within five disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer)
* pregnant or breast-feeding women
* severe mental disorder
* systemic administration of corticosteroids
* unstable angina or myocardial infarction within 6 months of the trial
* unstable hypertension
* severe respiratory disease requiring continuous oxygen therapy
* previous upper abdominal surgery except laparoscopic cholecystectomy
A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery

Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy.

The purpose of this project is to evaluate whether there is a difference in outcome measures (length of stay, occurrence of readmission, and patient satisfaction) with the addition of a post-operative evidence-based bundle/standard pre-operative education compared to standard pre-operative education alone that is given to patients prior to a hysterectomy (open, vaginal, or laparoscopic).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are admitted for all hysterectomies from October 1, 2017 through December 31, 2017, who speak English, and who are discharged home.
A Longitudinal Study in 1st Degree Relatives of Parkinson's Disease (PD) Patients

This is a longitudinal study in healthy 1st degree relatives of patients with Parkinson's Disease (PD) carriers of a genetic mutation in genes that are known to increase the risk for PD. The purpose of this study is to explore the association between genetic mutations in the known genes and early preclinical symptoms such as motor, sensory, autonomic, behavioral and cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* healthy 1ST degree relatives of PD patients with known genotype that participated in an earlier genetic study at the sourasky medical center.

Exclusion Criteria:

* subjects with cognitive decline by the parameters defined in DSM- IV
* subjects with psychiatric disorder
* subjects unable to sign a consent form
Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

A single-centered randomized controlled trial with a parallel-groups design is utilized, comprised of mindfulness-based group therapy (MBGT) in the experimental condition, and treatment as usual (TAU) in the control condition. Participants in the experimental condition continued their regular psychiatric treatment (TAU) next to the participation in the MBGT. In order to evaluate possible psychotherapeutic effects, self-report and other clinical questionnaires including interviews and app-based assessments are evaluated before (T0), and after the four-week intervention (T1).

Ward psychiatrists identify eligible participants and invite them to participate in the study. An eligibility screening is held by the study assistant at baseline, introducing the study, providing informed consent in written form, as well as conducting the self-report measures and app-based assessments. A blinded psychiatrist who works independently of the (co-) therapist conducts the remaining rater-questionnaires. Due to the psychotherapeutic nature of the study, information about the treatment allocation had to be shared with the co-therapist and the participants. Randomization was conducted by the Random Group Generator (pubmed, 2018). The data management plan includes standard procedures for data-handling such as using anonymized identification codes for patient data. The participants have the right to access their data, and the right to claim an annihilation. The data is being stored in locked cupboards, only allowing researchers involved in the study to access the data.


Eligibility Criteria:
Inclusion criteria:

* male and female participants
* treated as psychiatric inpatients at the psychosis - or social-psychiatric day ward
* between 18 and 65 years of age
* diagnosis of a schizophrenia-spectrum disorder according to the Diagnostical and Statistical Manual 5th edition) and the International Statistical Classification of Diseases and Related Health Problems(ICD-10) code F2
* ability to give informed consent
* willingness and ability to engage in psychotherapeutic group therapy
* low to moderate psychotic state indicated with a score of 6 \< for each item at the Positive scale of the Positive and Negative Syndrome Scale (PANSS, Peralta \& Cuesta, 1994)

Exclusion criteria:

* a score ≥ 6, suggesting an acute psychotic episode with severe psychotic symptoms (Peralta\& Cuesta, 1994)
* acute suicidality, assessed by item eight of the Calgary Depression Scale for Schizophrenia \> 1 (Addington, Addington, Maticka-Tyndale, \& Joyce, 1992)
* any neurological disorders that may affect cognitive functioning
* acute substance abuse other than nicotine and prescribed medication
Pectoralis and Serratus Muscle Blocks

The overall research plan is PECS/SAP blocks with liposomal bupivacaine improve the Overall Benefit Analgesia Score averaged over the postoperative days 1, 2, and 3. A 20% reduction on geometric means (i.e., true ratio of geometric means of 0.80) in OBAS will be considered the minimal clinically important benefit.

The primary aim is to determine whether a PECS/SAP block, using a mixture of bupivacaine and liposomal bupivacaine, provides superior recovery compared to routine parenteral and enteral analgesia in patients recovering from MICS. The primary outcome will be the simple multi-dimensional quality assessment, Overall Benefit Analgesia Score (OBAS score).53 Our secondary aims are to: 1) compare cumulative postoperative opioid consumption (pain medications administered over one-day periods quantified as morphine equivalents and provided by the EMR for the day of surgery and postoperative days 1, 2, and 3; 2) evaluate respiratory mechanics (forced expiratory volume in first minute (FEV1), forced vital capacity (FVC) and peak flow) after extubation on the postoperative days 1, 2 and 3 while patients remain hospitalized; and, (3) evaluate the Quality-of-Recovery-15 score on the postoperative days 1, 2 and 3.

Eligibility Criteria:
Inclusion Criteria:

1. 18-85 years old;
2. Elective minimally invasive robotically-assisted mitral valve repair via anterolateral thoracotomy

Exclusion Criteria:

1. Weight less than 50 kg;
2. Pregnancy or lactation;
3. Emergency surgery and patients transferred from the ICU to the operating room;
4. Redo cardiothoracic surgery or post-operative reoperation within 72 hours of index procedure (including minor chest wall procedures including tube thoracostomy, thoracentesis or percutaneous drain placement);
5. Anticipated endotracheal intubation \> 24 hours;
6. Anticipated non-study nerve block that provides analgesia to the intercostal nerves;
7. Active systemic or cardiopulmonary infection;
8. Mechanical circulatory support;
9. Allergy or contraindication to study local anesthetics;
10. Current chronic pain or routine opioid use (patients on chronic enteral opioids like Percocet or Vicodin) in a dose of \> 30 mg of morphine-milligram-equivalents for at least 10 days in last 30 days;
11. Poorly controlled psychiatric disorders;
12. Clinically important current neurologic deficit;
13. Active liver disease or cirrhosis;
14. Pacemaker generator or breast implants ipsilateral to surgery;
15. Previous participation in this study.
Move to Music Video Intervention for ICU Survivors

The purpose of this study is to determine if exercising with a music video program will improve physical functions of patients who have been discharged from an Intensive Care Unit (ICU).


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old;
2. length of ICU stay \>5 days (excludes patients with less comorbidity);
3. recruitment within 48 hours of ICU discharge (standardizes time to begin intervention);
4. able to independently move upper and lower extremities (required to participate in intervention);
5. cognitively able to complete the assessments and comply with physical testing instructions;
6. able to speak English or Spanish; and
7. reside at home prior to ICU admission.

Exclusion Criteria:

1. documented mental incompetence;
2. dependent status pre-ICU admission (assessed by the Katz Index of Independence in Activities of Daily Living);
3. evidence of delirium assessed using the Confusion Assessment Method;
4. hearing impairment;
5. documented "comfort measures only" or impending death;
6. prior residence in a long-term care facility; and
7. unstable clinical measures defined as Heart Rate (\>140 beats/minute) or Respiratory Rate (\>35 breaths/minute), blood pressure (systolic blood pressure \>180 mmHg or \< 90mmHg), ventilation problems, agitation, or perspiration. We will not enroll adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, and prisoners.
Allergen Provocations- HCA Children's Hospital

A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.

The purpose of the study is to investigate the impact of co-morbidities, history, and allergen tests on the outcome of allergen provocation tests.

Subjects are children aged 0-18 years old investigated for allergy to foods or antibiotics. Data entered in the database are demographics, co-morbidities, symptoms, SPT, specific IgE and details of the allergen provocations.

Eligibility Criteria:
Inclusion Criteria:

clinical suspicion of allergy to foods or antibiotics informed concent -

Exclusion Criteria:

-
A Efficacy and Safety Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-line Treatment in Subjects With Advanced Non-squamous Cell Non-small Cell Lung Cancer

This is a randomized, double-blind, multicenter phase III clinical study to evaluate efficacy and safety of anlotinib hydrochloride capsule combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in subjects with advanced non-squamous cell non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 1. Local advanced (stage IIIB / ⅢC), metastatic or recurrent (stage IV) non-squamous cell non-small cell lung cancer, has at least one measurable lesion.

  2. EGFR, ALK, and ROS1 test results are negative. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, life expectancy≥ 12 weeks.

  4. Has not received systemic anti-tumor treatment for advanced disease. 5.Adequate organ system function. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

  7. Understood and signed an informed consent form.

Exclusion Criteria:

* 1.Other histopathological types of non-small cell lung cancer. 2.Has received VEGF pathway targeted therapy including anlotinib and bevacizumab.

  3. Has multiple factors affecting oral medication. 4. Has symptomatic brain metastases. 5. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

  6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

  7. Has any severe and / or uncontrolled diseases. 8. Has any bleeding symptoms or treated with anticoagulants or vitamin K antagonists.

  9.Has received surgery, or unhealed wounds within 4 weeks before the first administration.

  10. Has hemoptysis within 28 days before randomization. 11. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.

  12. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis and pulmonary embolism.

  13. Has psychotropic substances abuse or a mental disorder. 14. Have a history of immunodeficiency. 15. Has received allogeneic organ transplantation, hematopoietic stem cell transplantation or bone marrow transplantation.

  16. Has other malignancy. 17.Has participated in other anticancer drug clinical trials within 4 weeks. 18.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Clinical Diagnosis of Teenagers Admitted to Pediatric Departments

This study intends to analyze the clinical characteristics of teenagers admitted to pediatric wards due to organic illness and non organic diagnosis, including patients suffering from chronic diseases and comorbidity.

The intention is to summarize the data from year 2000 to 2007 af all the teenagers aged 14 ys to 20 yes admitted to the pediatric wards at the Ha'Emek Medical Center. The demographic and clinical date will be summarized.

Eligibility Criteria:
Inclusion Criteria: All the patients ages 14 to 20 ys admitted to the pediatric ward.

Exclusion Criteria: No exclusion criteria relevant.
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis

The present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP)

OBJECTIVE: The present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP).

DESIGN: Sixty five subjects presenting at least twelve teeth with probing depth (PD) ≥4 mm were selected. 33 subjects were randomly assigned to full-mouth SRP + Septilin (group 1) and 32 subjects were assigned to full-mouth SRP + Placebo (group 2). The clinical outcomes evaluated were plaque index (PI), gingival index (GI), clinical attachment level (CAL), PD and % of sites with bleeding on probing (%BOP) at baseline (B\\L), 10 days, 1, 3 and 6 months interval and percentage of sites positive for A. actinomycetemcomitans, P. gingivalis and T. forsythia were recorded at B/L, 3 and 6 months using polymerase chain reaction.

Eligibility Criteria:
Inclusion Criteria:

* age 30 to 50 years
* atleast 12 scorable teeth with a probing depth (PD) ≥ 4 mm not including third molars
* teeth with orthodontic appliances bridges, crowns, or implants
* radiographic evidence of bone loss.

Exclusion Criteria:

* pregnancy or lactation
* smokers
* systemic diseases like diabetes mellitus, immunocompromised patients
* systemic antibiotics taken within the previous 6 months
* use of non-steroidal anti-inflammatory drugs
* sub-gingival SRP or surgical periodontal therapy in the previous year.