louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06530212: Sleeve Gastrectomy With Jejuno-ileal Bypass Versus Single Anastomosis Sleeve Jejunal Bypass
Official title: Sleeve Gastrectomy With Jejuno-ieal Bypass
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: sleeve gastrectomy with jejunoileal bypass (SGJIB) is a novel technique for the surgical treatment of obesity. The aim of the study is to compare this maneuver with single anastomosis sleeve jejunal bypass (SAS-JB)

Detailed description: 200 patients will be randomly divided into to equal . Group 1 will be operated by sleeve gastrectomy with jejunoileal bypass with the anastomosis between the jejunum at about 100 cm from the duodeno-jejunal flexure and the ileum at 250 cm from the ileocaecal junction. and group 2 will be operated by single anastomosis sleeve jejunal bypass (SAS-JB) with biliary limb equal one third of total intestinal length.

Eligibility criteria: Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 60
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures

Primary outcomes:
measure: Stoma complications
timeFrame: one year
Secondary outcomes:
measure: weight loss at one year
timeFrame: one year
measure: improvement of comorbidities
timeFrame: one year
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Minia University, faculty of medicine
name: Alaa Sewefy, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Minia University, faculty of medicine
name: Taha Kayed, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01894412: Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male Volunteers
Official title: A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanwha Chemical
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection


Eligibility criteria: Inclusion Criteria:

* 20 to 40 years of healthy volunteers

Exclusion Criteria:

* Subject who had been treated with Etanercept before

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
timeFrame: up to 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04682912: Blood Types in Children With COVID-19
Official title: ABO-Rh Blood Types and COVID-19 Infection in Children: Is There a Link?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Keywords: COVID-19
ABO blood group
infection risk
Lead sponsor: Mersin Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Mersin University
name: Dicle University
name: Bezmialem Vakif University
name: Uludag University
First posted: 2020-12-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective multicenter trial in five major hospitals in Turkey to determine whether ABO and Rh blood types carry any risk/beneficial factor among children with COVID-19 infection.

Brief summary: It is speculated that in adult patients with COVID-19 blood type A is associated with the worst outcome, while blood type O is associated with mild symptoms.To our knowledge, there has been no such a study investigated ABO and Rhesus (Rh) blood group types in children with COVID-19 infection yet. Therefore, the study aimed to examine if such a correlation exists in children infected with COVID-19.


Eligibility criteria: Inclusion Criteria:

* The study period consisted between March 2020 and December 2020
* Children with a documented positive COVID-19 nasal smear real-time reverse-transcriptase polymerase chain reaction (PCR) assay were included.

Exclusion Criteria:

* Patients who had a past medical history of any chronic illness (related to respiratory, cardiology, immunology, neurology, metabolic, etc) were excluded.

Primary outcomes:
measure: Patient medical files
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mersi̇n
country: Turkey
facility: Mersin City Training & Research Hospital
Study officials:
affiliation: Mersi̇n Şehi̇r Eği̇ti̇m Ve Araşti̇rma Hastanesi̇
name: Ali̇ Özdemi̇r, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersi̇n Şehi̇r Eği̇ti̇m Ve Araşti̇rma Hastanesi̇
name: Ali̇ Özdemi̇r
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00273312: Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma
Official title: An Open-label, Phase II Trial of Patupilone (EPO906) as Monotherapy to Evaluate Activity of Patupilone in Patients With Advanced Unresectable and/or Metastatic Hepatocellular Carcinoma (HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Advanced unresectable metastatic hepatocellular carcinoma
Liver cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, efficacy, and activity of patupilone in patients with advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response using modified RECIST criteria.


Eligibility criteria: Inclusion criteria:

- Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable lesion without any systemic single agent or combination chemotherapy. Previous local therapy is allowed.

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: at screening and at completion of every 6 weeks prior to the next dose administration
Secondary outcomes:
measure: Time to progression
timeFrame: at screening and at completion of every 6 weeks prior to the next dose administration
measure: Overall survival
timeFrame: at screening and at completion of every 6 weeks prior to the next dose administration
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
state: Shatin, NT
city: Hong Kong
country: Hong Kong
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Tai Chung Municipality
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Zhou Q, Wong CH, Lau CP, Hui CW, Lui VW, Chan SL, Yeo W. Enhanced Antitumor Activity with Combining Effect of mTOR Inhibition and Microtubule Stabilization in Hepatocellular Carcinoma. Int J Hepatol. 2013;2013:103830. doi: 10.1155/2013/103830. Epub 2013 Feb 20.
Clinical trial NCT01548612: Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia
Official title: Randomised Double Blind Placebo Controlled Study of Sodium Nitroprusside Added to Treatment as Usual in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Nitric oxide
Sodium nitroprusside
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO is a gas with unique chemistry and influences the release of neurotransmitters, learning, memory and neurodevelopment. Recent studies that investigated the role of NO in patients with schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO donor, will ameliorate schizophrenia symptoms.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia
* Patients in an acute psychotic episode requiring full hospitalization

Exclusion Criteria:

* Significant medical conditions (heart, kidney, liver, thyroid or neurological diseases, hypovitaminosis B12, hyponatremia)
* Pregnancy
* Breastfeeding
* Previous hypersensitivity to sodium nitroprusside
* DSM-IV diagnosis of drug abuse or dependence

Primary outcomes:
measure: Change in BPRS score
timeFrame: baseline and up to 4 weeks
measure: Change in PANSS negative subscale score
timeFrame: Every hour for 4 hours, then at +12h, then daily for 7 days, then weekly for 4 weeks
Secondary outcomes:
measure: Cognitive assessment
timeFrame: Baseline and after 12 h
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University General Hospital of the Ribeirao Preto Medical School
state: SP
Study officials:
affiliation: Ribeirao Preto Medical School, University of Sao Paulo
name: Jaime EC Hallak, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hallak JE, Maia-de-Oliveira JP, Abrao J, Evora PR, Zuardi AW, Crippa JA, Belmonte-de-Abreu P, Baker GB, Dursun SM. Rapid improvement of acute schizophrenia symptoms after intravenous sodium nitroprusside: a randomized, double-blind, placebo-controlled trial. JAMA Psychiatry. 2013 Jul;70(7):668-76. doi: 10.1001/jamapsychiatry.2013.1292.
Clinical trial NCT02965612: Specific Immunotherapy for Allergic Child
Official title: Tolerability and Side Effects for a New Device in Specific Immunotherapy for Allergic Child
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Allergic Asthma
Grass Allergy
Keywords: Grass Allergy
Allergic Rhinitis
Allergic Asthma
Paediatric
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: Bial Aristegui Italia srl
name: OPBG Contract and Research Organization
First posted: 2016-11-17
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive potential role that could be played, in particular in the forms of allergic asthma, because this method constitute the only intervention (unlike that pharmacologic) able to act on the same causes of the disease, altering the natural history. To achieve this the investigator has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies that, with scientific rigor, have demonstrated the benefits.

Detailed description: The Investigator proposes to compare, in children with allergic rhinitis and / or allergic asthma to grasses, the pain caused by the administration of the Specific Immunotherapy (ITS) via epicutaneous with autoinjector (INJEX) pressure without needle vs. the traditional subcutaneous immunotherapy (SCIT).

Eligibility criteria: Inclusion Criteria:

* Written informed consent from both parents / legal guardian;
* Of both sexes;
* Between the ages of 5 to 18 sensitized to grasses Awareness for grasses will be established with prick test;
* Rhinitis established according to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and / or stage 1 or 2 Asthma according to GINA classification (Global Initiative for Asthma)
* It may, or not, be going on ITS with s.c. administration

Exclusion Criteria:

* Children under age 5 and age\> 18 years;
* Autoimmune diseases and immunodeficiencies;
* Neoplasms;
* Severe psychological problems;
* Treatment with β-blockers;
* Poor compliance, including language training;
* Severe asthma uncontrolled by medication or irreversible airway obstruction (FEV1 less than 70% of the predicted value);
* Severe cardiovascular diseases in which may be hazardous in the administration of adrenaline

Primary outcomes:
measure: prevalence of pain
timeFrame: monthly for 6 month
Secondary outcomes:
measure: prevalence of pain
timeFrame: 20 minutes after every administration
measure: Incidence of procedure adverse events
timeFrame: within 24-48 hours after every administration
measure: Incidence of procedure adverse events
timeFrame: 6 month
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Operating unit of Allergology
Study officials:
affiliation: Bambino Gesù Hospital and Research Institute
name: Alessandro Fiocchi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725746: Feasibility of Remote Data Collection With a Point of Care Device to Measure HbA1c
Official title: Enhancing Cardiovascular Health Equity in Mothers and Children Through Home Visiting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant
Postpartum
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant or postpartum women who are currently or have recently participated in the Parents as Teachers home visiting program.

Brief summary: Conduct a pilot study to test feasibility of doing remote data collection with a point of care device that measures HbA1c.

Detailed description: The foundation for cardiovascular health (CVH) is laid in early life by intergenerational interactions, passed from parent to child, that have long-lasting biological and behavioral consequences. Lifestyle interventions can promote CVH among mothers and their children over time. Academic partnerships with home visiting organizations that reach families experiencing health disparities advance intergenerational CVH equity. For this pilot study we are testing the feasibility of doing remote data collection with a point of care device that measures HbA1c to use in the main study.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Screened or participating in NCT04253977
* Able to give informed consent for participation

Exclusion Criteria:

-

Primary outcomes:
measure: Feasibility to obtain HbA1c through remote data collection
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Debra Haire-Joshu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Victor G Davila-Roman, MD,FACC,FASE
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Rachel G Tabak, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05533112: Binaural Beat Stimulation to Improve Patient Outcome After Surgery and Anesthesia
Official title: Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preoperative Anxiety
Perioperative Complication
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.


Eligibility criteria: Inclusion Criteria:

* Fluent in German (Munich) or Portuguese (Porto)
* Scheduled for elective minor or intermediate risk procedure

Exclusion Criteria:

* ASA status 4
* History of drug abuse
* Pre-existing neurocognitive or psychiatric disorders
* Auditory Impairments, vision diseases or other diagnosed cognitive impairments

Primary outcomes:
measure: Reduction of preoperative anxiety
timeFrame: Assessments will take place one day before surgery as well as before administration of the intervention
Secondary outcomes:
measure: Increase of EEG alpha-band power during anesthesia emergence
timeFrame: Analysis will include the last 20 minutes of surgical procedure until patients are responsive again
measure: Lower incidence of perioperative neurocognitive disorders
timeFrame: Incidence of perioperative neurocognitive disorders will be assessed during the patients stay in the PACU as well as one day post surgery
Other outcomes:
Locations:
city: München
country: Germany
facility: Technische Universität München
state: München (Stadt)
Study officials:
affiliation: Klinik für Anästhesiologie und Intensivmedizin
name: Stephan Kratzer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Anästhesiologie und Intensivmedizin
name: Gerhard Schneider, Prof.
role: STUDY_CHAIR
affiliation: Klinik für Anästhesiologie und Intensivmedizin
name: Matthias Kreuzer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01577446: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy (NARROW CRT)
Official title: Narrow QRS Ischemic Patients Treated With Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: CRT
heart failure
narrow QRS
dyssynchrony
Lead sponsor: Ospedale Santa Maria di Loreto Mare
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current recommendations require a QRS duration of ≥120ms as a condition for prescribing cardiac resynchronization therapy (CRT). This study was designed to test the hypothesis that patients with heart failure of ischemic origin, current indications for defibrillator implantation and QRS \<120ms may benefit from CRT in the presence of marked mechanical dyssynchrony.


Eligibility criteria: Inclusion Criteria:

* NHYA class II-III heart failure
* ischemic cardiomyopathy
* ejection fraction of 35% or less
* QRS interval of 120ms or less
* evidence of mechanical dyssynchrony as measured on echocardiography

Exclusion Criteria:

* conventional indication for cardiac pacing
* persistent atrial fibrillation
* life expectancy lower than 1 year

Primary outcomes:
measure: heart failure clinical composite score
timeFrame: 12 months
Secondary outcomes:
measure: time to the first heart failure hospitalization or death
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Ospedale Santa Maria di Loreto Mare
Study officials:
affiliation: Ospedale Santa Maria di Loreto Mare
name: Carmine Muto, MD
role: STUDY_CHAIR
References:
citation: Muto C, Solimene F, Gallo P, Nastasi M, La Rosa C, Calvanese R, Iengo R, Canciello M, Sangiuolo R, Diemberger I, Ciardiello C, Tuccillo B. A randomized study of cardiac resynchronization therapy defibrillator versus dual-chamber implantable cardioverter-defibrillator in ischemic cardiomyopathy with narrow QRS: the NARROW-CRT study. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):538-45. doi: 10.1161/CIRCEP.113.000135. Epub 2013 Apr 16.