louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00457353: ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children
Official title: Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroenteritis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 264
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary:

* To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

* To evaluate the safety of Enterogermina® in acute diarrhea in Indian children


Eligibility criteria: Inclusion Criteria:

* Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (\>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration

Exclusion Criteria:

* History of presence of blood, pus, or mucus in stools
* Severe dehydration (World Health Organization criteria)
* Severely malnourished patients
* Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
* History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
* Known hypersensitivity to Bacillus clausii or other probiotics.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Reduction in duration of diarrhea
timeFrame: Throughout the treatment period
measure: Incidence of adverse events
timeFrame: Throughout the study period
Secondary outcomes:
measure: Mean number of stools per day
timeFrame: Throughout the treatment period
measure: Effect on consistency of stools
timeFrame: Throughtout the treatment period
measure: Vomiting episodes per day
timeFrame: Throughout the treatment period
measure: Requirement of unscheduled intravenous transfusion
timeFrame: Throughout the study period
measure: Need for hospitalization
timeFrame: Throughout the treatment period
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Shah Pratik
role: STUDY_DIRECTOR
References:
Clinical trial NCT00493753: Feasibility and Safety of Acupuncture for Systemic Lupus
Official title: Feasibility and Safety of Acupuncture for Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-06-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (SLE). Twenty-four SLE patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. It was hypothesized that acupuncture would be safe for people with SLE, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.


Eligibility criteria: Inclusion Criteria:

* diagnosed with SLE, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand English, and provide informed consent.

Exclusion Criteria:

* known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets \< 100,000, previous course of acupuncture treatment.

Primary outcomes:
measure: Safety (side effect and adverse event rates), protocol adherence (expected 80% of sessions completed on time)
timeFrame: 6 weeks
Secondary outcomes:
measure: pre-post treatment effect size estimates for self-reported pain and fatigue
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC General Clinical Research Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Center for Integrative Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Carol M Greco, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04660253: Feasibility and Acceptability of Culturally Adapted Group Psychosocial Intervention for Depressed Fathers
Official title: A Group Parenting Intervention for Depressed Fathers (LTP+ Dads): A Feasibility Study From Pakistan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This integrated intervention is called LTP Plus Dads consisting of 10 group sessions delivered weekly by trained professionals who received weekly supervision by LTP Plus master trainers.
Primary purpose: TREATMENT

Brief summary: The study is a feasibility trial with a pre and post-experiment design in Karachi, Pakistan's most populous city. The intervention comprises of twelve sessions of learning through play (LTP) plus during the three month period.


Eligibility criteria: Inclusion Criteria:

* Depressed fathers of children 0-30 months
* Given written informed consent

Exclusion Criteria:

* Not willing to participate
* Out of trial catchment area

Primary outcomes:
measure: Intervention feasibility
timeFrame: Baseline to 3rd month
measure: Intervention acceptability
timeFrame: Baseline to 3rd month
Secondary outcomes:
measure: Change in severity of symptoms measured using Hamilton Depression Rating Scale (Hamilton, 1960)
timeFrame: Changes in severity of symptoms from baseline to 3rd month
measure: Changes in severity of symptoms measured using Edinburgh Postnatal Depression Scale (EPDS; Cox et al. 1987),
timeFrame: Changes in severity of symptoms from baseline to 3rd month
Other outcomes:
Locations:
Study officials:
References:
citation: Husain MI, Chaudhry IB, Khoso AB, Wan MW, Kiran T, Shiri T, Chaudhry N, Mehmood N, Jafri SF, Naeem F, Husain N. A Group Parenting Intervention for Depressed Fathers (LTP + Dads): A Feasibility Study from Pakistan. Children (Basel). 2021 Jan 6;8(1):26. doi: 10.3390/children8010026.
Clinical trial NCT01613053: Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination
Official title: Continuation of Drug Supply in Chinese Patients After CAMN107DBR01study Termination
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Gastrointestinal Stromal Tumor
Keywords: Gastrointestinal Stromal Tumor, GIST
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-06-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Continuation of drug supply in Chinese patients after CAMN107DBR01study termination.

Detailed description: Five patients who are on treatment of imatinib and deriving clinical benefit after CAMN107DBR01 study termination and written informed consent obtained will enter the trial, all five patients will receive Glivec (8oomg per day) treatment until tumor progression \[by RECIST guidelines, version 1.0\], unacceptable toxicity, death or withdrawal of consent.

Eligibility criteria: Inclusion Criteria:

* Five patients who are on treatment of imatinib and deriving clinical benefit after CAMN107DBR01 study termination and written informed consent obtained.

Exclusion Criteria:

* N/A.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
city: Guang zhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Ruijin Hospital of Shanghai Jiaotong University
name: Jie Zhong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184353: Clinical MR Spectroscopy of Brain Metastases at 1,5T and 3T.
Official title: In Vivo Proton MR Spectroscopy of Brain Metastases Obtained at 1,5T and 3T.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Metastases
Keywords: brain metastasis
signal to noise ratio
spectral resolution
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
First posted: 2005-09-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain metastases

Brief summary: Increasing magnetic field is known to give improvements in signal-to-noise-ratio (SNR) and spectral resolution. To investigate this, spectra from different subjects were examined using two clinical MR instruments operating at 1.5T and 3T respectively.


Eligibility criteria: Inclusion Criteria:

* brain metastases

Exclusion Criteria:

* children
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Cancer Clinic, St.Olavs Hospital Trondheim University Hospital
name: Steinar Lundgren, MD PhD
role: STUDY_DIRECTOR
affiliation: Norwegian University of Science and Technology, Faculty of Medicine
name: Ingrid S Gribbestad, PhD
role: STUDY_CHAIR
References:
citation: Sjobakk TE, Lundgren S, Kristoffersen A, Singstad T, Svarliaunet AJ, Sonnewald U, Gribbestad IS. Clinical 1H magnetic resonance spectroscopy of brain metastases at 1.5T and 3T. Acta Radiol. 2006 Jun;47(5):501-8. doi: 10.1080/02841850600644808.
Clinical trial NCT00297453: Smoking Treatment in HIV Clinical Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nicotine Dependence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-02-28
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate and compare the efficacy and cost effectiveness of 3 smoking cessation treatments with HIV-positive cigarette smokers. The treatments include face-to-face individual counseling, a computer-Internet-based self-help treatment and a self-help manual treatment.


Eligibility criteria: Inclusion Criteria:

* HIV positive
* 18 years or older
* smoking "most days" during the past month
* must be able to read English

Exclusion Criteria:

* any contraindications for over-the-counter nicotine replacement treatment
* active psychotic symptoms
* severe cognitive deficits/dementia

Primary outcomes:
measure: 7 day point prevalence biochemically verified abstinence rates
timeFrame: 3, 6, 9, and 12 months following treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gary Humfleet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04060953: Quality of Life in Managing Chronic Pain
Official title: Health-Related Quality of Life Measures to Optimize Chronic Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.

Detailed description: The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain.

Eligibility criteria: Inclusion Criteria:

Chronic Low Back Pain based on criteria established by the NIH Task Force on Research Standards for Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

Exclusion Criteria:

Absence of Chronic Low Back Pain OR SPADE Cluster Score \< 55

Primary outcomes:
measure: PROMIS-29 Quality of Life Measures
timeFrame: 3 Months Post-Randomization
Secondary outcomes:
measure: Low Back Pain Intensity
timeFrame: 3 Months Post-Randomization
measure: Back-Related Disability
timeFrame: 3 Months Post-Randomization
Other outcomes:
measure: Utility of the Health-Related Quality of Life Report
timeFrame: 1 Month Post-Randomization
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: John C Licciardone, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382753: Impact of Periodontal Supportive Therapy in Patients With Gingivitis and Periodontitis
Official title: Impact of Periodontal Supportive Therapy Number of Sessions in Patients With Gingivitis and Periodontitis in Order to Evaluate Disease Evolution.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gingivitis
Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients with diagnosed gingivitis

Brief summary: The study evaluated the number of sessions of periodontal supportive treatment in patients with gingivitis in order to evaluate the risk of periodontitis development.

Detailed description: Patient with gingivitis were retrospectively evaluated. The number of periodontal supportive therapy were recorded other than gingivitis periodontal parameters over 5-years follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Gingivitis

Exclusion Criteria:

* Diagnosis of Periodontitis
* Pregnancy
* Systemic diseases

Primary outcomes:
measure: Bleeding on Probing
timeFrame: 5-years
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518453: Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Formulation 2007-2008
Official title: A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine Ph.Eur, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO and CPMP recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly adults and elderly subjects (CPMP/BWP/214/96).


Eligibility criteria: Inclusion Criteria:

* Healthy Subjects eligible for enrollment into this study are male and female adult volunteers

Exclusion Criteria:

* Any serious disease

Primary outcomes:
measure: evaluate the antibody response to each influenza vaccine antigen
timeFrame: 21 days post-immunization
Secondary outcomes:
measure: Safety and tolerability of the study vaccine in the study population
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Suffolk
country: United Kingdom
facility: The Health Centre
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT05640453: Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
Official title: Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pregabalin
Delirium Treatment
Coronary Artery Bypass Grafting
Dexmedetomidine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.

Detailed description: Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.

Eligibility criteria: Inclusion Criteria:

* CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD).

Exclusion Criteria:

* Patients who had history of psychiatric diseases; inability to communicate;
* previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate \<50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency.
* Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.

Primary outcomes:
measure: Percent of delirium treatment
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: Level of sedation
timeFrame: 24 hour postoperatively
measure: Incidence of weaning from mechanical ventilation
timeFrame: 1 week postoperatively
measure: Length of hospital stay
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Islam Morsy
state: El-Gharbia Governorate
Study officials:
References:
Clinical trial NCT02011477: Hypoalgesic Effects Neural Mobilization Techniques
Official title: Comparison of Hypoalgesic Effects of Neural Stretching Versus Neural Gliding: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperalgesia
Keywords: Neural mobilization
Physical therapy
Asymptomatic subjects
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Madrid
First posted: 2013-12-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the immediate mechanical hypoalgesic effect of neural mobilization in asymptomatic subjects. We also compared neural gliding versus neural stretching to see which produced greater hypoalgesic effects in asymptomatic subjects.

Detailed description: Asymptomatic subjects will be randomly allocated into three groups: the neural glide group; the neural stretch group; and the placebo group. Each subject will receive one treatment session. Outcome measures included bilateral pressure pain threshold measured at the trigeminal, cervical, and tibialis anterior points, which will assess pre-treatment and immediately post-treatment by a blinded assessor. Three-way repeated measures analysis of variance was used to evaluate changes in pressure pain threshold, with group (experimental or control) as the between-subjects variable and time (pre-, post-treatment) or side (dominant, nondominant) as the within-subjects variable.

Eligibility criteria: Inclusion Criteria:

* Asymptomatic subjects who met the inclusion criterion of being between 18 and 30 years old.

Exclusion Criteria:

* rheumatologic diseases or any type of cancer, cervical surgery in the past, whiplash trauma and undergoing any type of treatment like physical therapy, manual therapy, osteopathy, chiropraxis, acupuncture during the last three months. All patients recruited for the study complained of pain localized in the neck and/or head region. Initial screening was accomplished by telephone and eligible persons attended a evaluation appointment.
* development of systemic or degenerative diseases
* subjects with symptoms of depression according Beck's questionnaire
* pain in any area between the lower back and head in the last 9 months
* traumatic event in the past 12 months
* history of neck or face pain in the last 6 months

Primary outcomes:
measure: Pressure pain threshold assessment
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro superior de Estudios Universitarios La Salle
state: Aravaca
Study officials:
affiliation: Centro de estudios La Salle. Universidad Autonoma de Madrid
name: Hector Beltran, MSc
role: PRINCIPAL_INVESTIGATOR
References: