louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02150174: Testing Effect and Schizophrenia
Official title: Retrieval Practice in Patients With Schizophrenia : an Exploratory Study Using Word Pairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Episodic Memory Deficits
Keywords: Schizophrenia
Episodic memory deficits
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When people are tested on a previously learned material, they will latter remember it better even when compared to a condition where they can re-study it. This phenomenon is called retrieval practice and is supported by an extensive research literature mostly carried out in normal students. This paradigm begins to be used in cognitive remediation programs in patients suffering from memory difficulties.

The objective of this study is to investigate whether retrieval practice is spared in patients with schizophrenia.

If effective, this method could be used in cognitive remediation programs.

Since episodic memory difficulties are supposed to be secondary to deficits in the initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that retrieval practice is spared in schizophrenia


Eligibility criteria: Inclusion Criteria:

* French is the native language, or acquired before 5 years old
* People must be able to understand and follow the trial instructions

Specific inclusion criteria (for patients) :

* Diagnostic of schizophrenia, according to the DSM -5, clinically stable
* The treatment must remain unchanged during the trial

Exclusion Criteria:

* Severe or acute cerebral disease
* Other actual psychiatric disorder
* Use of drugs with high anticholinergic effect
* Irregular use of benzodiazepines medication, or high dose of benzodiazepin (more than 2 mg of lorazepam per day or equivalent)
* Inappropriate use of drugs

Specific exclusion criteria (for healthy subjects) :

- Diagnostic of schizophrenia of a relative up to the third degree

Primary outcomes:
measure: Number of word pairs properly recalled
timeFrame: Final test : 2 days after the first experimental session
Secondary outcomes:
measure: Difference between final performance recall and memory span score
timeFrame: Final test : 2 days after the first experimental session
Other outcomes:
Locations:
city: Laxou Cedex
country: France
facility: Centre Psychothérapique de Nancy
city: Strasbourg
country: France
facility: Service de psychiatrie - Hôpital Civil - CHRU Strasbourg
Study officials:
References:
Clinical trial NCT01273974: The Immunogenicity of Intradermal Influenza Vaccination in Hemodialysis Patients
Official title: The Comparison of Serum Antibody Response to Standard Intramuscular and Half Dose Intradermal Influenza Vaccine in Hemodialysis Patients in Shiraz City in 1388.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hemodialysis Patients
Keywords: intradermal influenza vaccine
hemodialysis patients
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether half-dose intradermal influenza vaccine is as immunogenic as standard dose intramuscular vaccine in hemodialysis patients.

Detailed description: Hemodialysis patients are at high risk of influenza infection due to suppress immune status.It is recommended to immunize them against influenza annually.in intradermal vaccination antigens directly present to the large numbers of antigen-presenting cells in the skin and it may cause greater immunogenicity than in the intramuscular method. Reduced-dose intradermal influenza vaccine is immunogenic in healthy adult, patients with solid cancer and three groups of immunocompromized patients including Rheumatologic patients treated with anti-TNF, HIV-infected and stem cell transplanted patients.

In this study we compare the efficacy of influenza vaccines in half dose intradermal and standard intramuscular methods among hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* Patients under chronic hemodialysis

Exclusion Criteria:

* history of flu infection in last month
* history of flu vaccination in 2009
* hospitalization in last month
* taking immune suppressants drugs
* hemodialysis less than twice weekly

Primary outcomes:
measure: vaccine effectiveness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University Of Medical Science
Study officials:
affiliation: Shiraz University Of Medical Science
name: Mohammad mahdi Sagheb
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University Of Medical Science
name: Samira Saeian
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University Of Medical Science
name: Jamshid Roozbeh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01927874: Subarachnoid or Infiltration for Hemorrhoidectomy
Official title: Comparative Study of the Analgesic Effect of Subarachnoid or Infiltration for Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoid
Keywords: infiltration
hemorrhoidectomy
Postoperative pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy

Detailed description: This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2.

Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side.

Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.

Eligibility criteria: Inclusion Criteria:

* Will be included 50 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form

Exclusion Criteria:

* There will be excluded patients with associated diseases (fistula, fissure), infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.

Primary outcomes:
measure: Pain intensity
timeFrame: 24 hours
Secondary outcomes:
measure: Time to discharge
timeFrame: 24 hours
Other outcomes:
measure: Duration of motor blockade
timeFrame: 24 hours
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Rioko K Sakata, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00310674: Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age
Official title: A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prevention of Meningococcal Infection
Keywords: Prevention of Meningococcal Meningitis
meningococcal vaccines
conjugate
Immunology
infant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age


Eligibility criteria: Inclusion Criteria:

* Healthy children of 11 to 15 weeks of age

Exclusion Criteria:

* Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth
* Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping
* Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days

Primary outcomes:
measure: antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
measure: safety and tolerability
Secondary outcomes:
measure: antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
measure: antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto di Pediatria, Università degli Studi di Milano
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis - Information Services
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05539274: Cervical Carcinoma in Shatby University Hospital and Its Relation to Human Papilloma Virus
Official title: Cervical Carcinoma in Shatby University Hospital and Its Relation to Human Papilloma Virus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cervical cancer cases

Brief summary: incidence of detection of carcinogenic types of human papilloma virus in 60 cases of cervical cancer


Eligibility criteria: Inclusion Criteria:

* cervical cancer

Exclusion Criteria:

* none

Primary outcomes:
measure: Detection of human papilloma virus infections and genotyping using real time PCR
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Hossam Hassan El Sokkary
Study officials:
References:
Clinical trial NCT01180374: The Effects of Cannabidiol and ∆-9-THC in Humans
Official title: Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Cannabis
Marijuana
Cannabidiol
CBD
THC
Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.


Eligibility criteria: Inclusion Criteria:

* Exposed to Cannabis at least once in lifetime

Exclusion Criteria:

* Cannabis Naive

Primary outcomes:
measure: Behavioral Measures
timeFrame: Baseline, +15, +80, +240
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University Medical School
name: Mohini Ranganathan, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ganesh S, Cortes-Briones J, Schnakenberg Martin AM, Skosnik PD, D'Souza DC, Ranganathan M. Delta-9-Tetrahydrocannabinol, Cannabidiol, and Acute Psychotomimetic States: A Balancing Act of the Principal Phyto-Cannabinoids on Human Brain and Behavior. Cannabis Cannabinoid Res. 2023 Oct;8(5):846-856. doi: 10.1089/can.2021.0166. Epub 2022 Mar 18.
Clinical trial NCT03019874: Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections
Official title: Observational Study With Mode of Action-Analysis of Cystorenal Cranberry Extract in Patients With Recurrent Urinary Tract Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic recurrent Urinary Tract Infections

Brief summary: The main focus of this observational study is to analyze the possible effects of cranberry dietary supplements on the intestinal microbiota in women with recurrent uncomplicated urinary tract infections. In a secondary analysis the possible influence of the microbiota changes on the recurrence frequency in the follow-up should be analyzed.


Eligibility criteria: Inclusion criteria:

• chronic recurrent urinary tract infections (≥3 infections per year or 2 infections in the last 6 months)

Exclusion Criteria:

* renal insufficiency (GFR \<60),
* anatomical or known structural causes of urinary tract infections
* regular consumption of probiotics or probiotic yogurts (at least 5x / week)
* intake of antibiotics in the last 4 weeks
* intake of Marcumar
* simultaneous participation in another study

Primary outcomes:
measure: Number of urinary tract infections
timeFrame: In the 6-month prospective observation period compared to a 6-month retrospective period
Secondary outcomes:
measure: Quality of life (SF-36)
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months
Other outcomes:
measure: Stool analysis: Intestinal microbiome by sequencing 16S rRNA
timeFrame: Baseline, 4 weeks, 8 weeks, 6 months
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
affiliation: Charité University Medical Center
name: Andreas Michalsen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04617574: Endostapler Sleeve Gastrectomy Study
Official title: A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Lexington Medical Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 subjects

Brief summary: The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.

Detailed description: Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing planned laparoscopic sleeve gastrectomy
* Informed consent for study obtained and signed from each subject

Exclusion Criteria:

* Planned open surgical approach
* Use of staple line reinforcement material (buttress)
* Revision or other bariatric procedure
* Patients with a bleeding disorder: known coagulopathy, or Platelets \<100,000, or Partial Thromboplastin Time (PTT) \>45sec, or Prothrombin Time (PT) \>15sec, or International Normalized Ratio (INR) \>1.5
* Patients with active HIV or Hepatitis B
* Patients under the age of 18 on the date of the surgery
* Patients who are pregnant
* Patients using tobacco products within the last 2 weeks prior to surgery date
* Patients using cortisone or related products within the last 2 weeks prior to surgery date

Primary outcomes:
measure: Intraoperative Endoscopic Staple Line Bleeding Score
timeFrame: Within surgery, after the last stapler firing
measure: Intraoperative Laparoscopic Staple Line Bleeding Score
timeFrame: Within surgery, images captured 10 seconds after the last stapler firing
Secondary outcomes:
measure: Number of Participants With Postoperative Leakage Requiring Intervention
timeFrame: Within 30-day post-operative period
measure: Number of Participants With Intraoperative or Postoperative Blood Transfusion
timeFrame: Within 72 hours of surgery start time
measure: Number of Participants With Reported Device-related Adverse Events
timeFrame: Within 30-day post-operative period
measure: Number of Participants With Product Malfunction
timeFrame: Within surgery
Other outcomes:
Locations:
city: Holyoke
country: United States
facility: Holyoke Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT05355974: Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure
Official title: Vasopressor Utilization to Support Mean Arterial Pressure During Rapid Sequence Intubation: A Clinical Trial (Rapid-Press Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Failure
Hypotension and Shock
Hypotension on Induction
Intubation Complication
Anesthesia Intubation Complication
Keywords: mean arterial pressure
Rapid Sequence Intubation
vasopressor
Norepinephrine
Hypotension from Intubation
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 42
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: The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events.

The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Detailed description: Aim: Prevent 25-46 percent reduction in systolic blood pressure associated with rapid sequence intubation with norepinephrine compared to isotonic fluids alone.

Eligibility criteria: Inclusion Criteria:

* Respiratory Failure Requiring Intubation

Exclusion Criteria:

* Pregnancy
* Patients intubated during code blue clinical scenarios
* Requiring surgical airway
* Failed intubations
* MAP less than 65 or Systolic Blood Pressure (SBP) less than 90mmHg pre-intubation
* Systolic blood pressure greater than 150mmHg
* Prisoners

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: 1 hour after Rapid Sequence Intubation
Secondary outcomes:
measure: Change in serum creatinine (Acute Kidney Injury)
timeFrame: 24 hours after Rapid Sequence Intubation
measure: Acute Kidney Injury
timeFrame: 24 hours after Rapid Sequence Intubation
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Miami Valley Hospital Premier Health
state: Ohio
Study officials:
affiliation: Wright State University
name: Matthew Koroscil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wright State University
name: Yonatan Dollin, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01350674: Role of EBUS-TBNA in Diagnosing TB in Mediastinal/Hilar Lymph Nodes
Official title: Role of EBUS-TBNA (Endobronchial Ultrasound Transbronchial Needle Aspiration- in Diagnosing Tuberculosis in Mediastinal and/or Hilar Lymph Nodes
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Tuberculosis
Keywords: mediastinal tuberculosis
endoscopy
EBUS
tuberculous lymphadenopathy
endobronchial ultrasound
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2011-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an observational prospective study. Role of EBUS-TBNA (endobronchial ultrasound transbronchial needle aspiration) is evaluated to diagnose tuberculosis in mediastinal and/or hilar lymph nodes.

The investigators analyse the specificity and sensibility of this technique to diagnose tuberculosis in mediastinal and/or hilar lymph nodes.

Patients with mediastinal and/or hilar lymph nodes on X-ray or CT thorax where a tuberculosis is the most probable cause and who have no parenchymal lesions suspected for tuberculosis and without other lymph nodes that are more easily accessible or palpable will be included in this study.


Eligibility criteria: Inclusion Criteria:

* patients with enlarged mediastinal and/or hilar lymph nodes on chest CT highly suspicious of tuberculosis (suggestive clinical history, suggestive echographic findings ...) without pulmonary lesions suspicious for tuberculosis or in whom the first evaluation with sputum examination, classical bronchoscopy, induced sputum didn't result in any diagnosis.
* patients aged 18 years or older
* patients need to sign the consent form after reading the information form

Exclusion Criteria:

* synchronic pulmonary lesions suspicious for tuberculosis or already proven tuberculosis by microscopic exam, PCR-technique and/or culture
* other affected ganglionary sites more easily accessible (cervical, supraclavicular, axillary ... region)

Primary outcomes:
measure: The ratio of tuberculosis in mediastinal lymph nodes
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St. Pierre; pulmonology department
Study officials:
affiliation: CHU St. Pierre Brussels
name: Inge M Muylle, MD
role: PRINCIPAL_INVESTIGATOR
References: