louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00431262: Antabuse in Severe Alcoholism: an Open Controlled Study
Official title: Antabuse in Severe Alcoholism: an Open Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alcoholism
Keywords: alcoholism
antabuse
disulfiram
abstinence
cognitive behavioural therapy
Lead sponsor: Psykiatrisk Center Gentofte
Sponsor class: OTHER
First posted: 2007-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. The hypothesis to be tested is that more of the patients who receive antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to the control group. The trial is open.


Eligibility criteria: Inclusion Criteria:

* Alcoholism
* Living in the departments catchment area

Exclusion Criteria:

* Pregnancy
* Schizophrenia
* Bipolar disorder
* Other substance abuse
* Dementia
* Anorexia

Primary outcomes:
measure: The number of patients in each group who have not been drinking alcohol after 6 months of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Psykiatrisk Center Gentofte
Study officials:
affiliation: Psykiatrisk Center Gentofte
name: Jakob Ulrichsen, MD, ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00591162: Bone Disease in Severely Burned Children
Official title: Bone Disease in Severely Burned Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Burn
Keywords: Bone, Dexa, Parathyroid, Diuretic, Tetracycline
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 254
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bone metabolism is adversely affected by severe burns in children for a period of time.

Detailed description: More closely monitored biochemical and radiologic parameters of bone and mineral metabolism will increase the likelihood of earlier detection of abnormalities and possible therapeutic interventions.

Eligibility criteria: Inclusion Criteria:

* Children age 5-18 years old with at least 40% or more of their body burned.

Exclusion Criteria:

* Anyone with a burn covering less than 40% of the body or whose burn covers the front of both hipbones.
* Anyone younger than 5 years old, anyone with a history of cancer or other metabolic disease process, or anyone who is pregnant or has an allergy to Tetracycline will also be excluded.
* Anyone who has participated in an investigational drug trial within the past 60 days from date of admission will be excluded from this study.

Primary outcomes:
measure: Determine Bone Health(bone growth,strength,and content) in burn injured patients.
timeFrame: Admission to Burn Unit up to eighteen years old.
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: U.T.M.B.
state: Texas
Study officials:
affiliation: U.T.M.B.
name: Klein Gordon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05519462: Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?
Official title: Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar, a Feasible Choice?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Teeth; Lesion
Tooth Diseases
Keywords: CBCT
Lead sponsor: Malmö University
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adults

Brief summary: Low-Dose CBCT Protocol for Pre-Surgical Evaluation of the Mandibular Third Molar.

CBCT investigations with standard and low dose protocol for evalutation of the mandibular third molar.

Detailed description: Two CBCT scans were acquired of each examination site: one scan using the standard clinical protocol (90kV, 5mA, 9.4s) and one, the low-dose protocol (90kV, 2mA, 9.4s). All exposures were made with a Veraviewepocs 3D F40 (J Morita Corp.; Kyoto, Japan) using a field of view (FOV) of 4.0 x 4.0 cm and a rotation mode of 180°, voxel size of 0.125 mm.

Eligibility criteria: Inclusion Criteria:

* a need for a CBCT investigation of the mandibula third molar

Exclusion Criteria:

* been involved in radiographic examinations for science beforer.

Primary outcomes:
measure: evaluation of radiographic images
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Kristina Hellen-Halme
Study officials:
affiliation: Malmö University
name: Kristina Hellen-Halme, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00177762: Dose-Response of Exercise on Long-Term Weight Loss
Official title: Dose-Response of Exercise on Long-Term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Obesity
Weight Loss
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to examine varying durations and intensities of exercise on long-term weight loss.


Eligibility criteria: Inclusion Criteria:

1. Female
2. 21-45 years of age
3. BMI = 27-40 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 24 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Primary outcomes:
measure: weight loss
Secondary outcomes:
measure: fitness
measure: dietary intake
measure: physical activity
measure: mediators
measure: body composition
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsbugh
name: John M Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365962: Biomarker in Tumor Tissue Samples From Patients With Rhabdomyosarcoma
Official title: A Study to Assess and Quantify Surface Insulin-like Growth Factor I Receptor (IGF-IR) in Rhabdomyosarcoma (RMS) Tumor Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: alveolar childhood rhabdomyosarcoma
embryonal childhood rhabdomyosarcoma
previously treated childhood rhabdomyosarcoma
previously untreated childhood rhabdomyosarcoma
recurrent childhood rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of rhabdomyosarcoma.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:

* To determine and quantify the degree of surface insulin-like growth factor I receptor (IGF-IR) expression in rhabdomyosarcoma (RMS) tumor tissue.
* To assess the feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue.

OUTLINE: Paraffin-embedded tumor tissue slides are analyzed for insulin-like growth factor I receptor (IGF-1R) expression by mass spectrometry and correlated with the results obtained by IHC assay.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of rhabdomyosarcoma

  * Alveolar or embryonal rhabdomyosarcoma
* Available samples from the Cooperative Human Tissue Network (CHTN) bank

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Degree of surface IGF-IR expression in RMS tumor tissue
measure: Feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Doernbecher Children's Hospital at Oregon Health and Science University
name: Suman Malempati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06359262: Evaluating the Hope@School Prevention Program
Official title: Feasibility, Effectiveness and Overall Impact of the Hope@School Universal Prevention Program Promoting Child and Adolescent Mental Health in Schools: A Two-arm Randomized Controlled Trial Across Seven European Countries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Wellness 1
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 3220
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This multi-center cluster-randomized controlled trial aims to evaluate the feasibility, effectiveness and overall impact of the Hope@School (H@S) program by comparing mental health outcomes in students participating in the H@S program with students having only access to regular student health care (treatment as usual - TAU).

The primary objectives of the study are:

To determine if the H@S program is feasible, acceptable, usable and safe for students, families, teachers and school leaders To establish if the H@S program is associated with improvements in quality of life, everyday functioning, peer relations and general mental health.


Eligibility criteria: Inclusion Criteria:

* Age between 8 and 18 years
* Attends school included in the study
* Consents to participate

Exclusion Criteria:

- Younger than 8 and older than 18 years

Primary outcomes:
measure: KIDSCREEN-27 Child version
timeFrame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Secondary outcomes:
measure: KIDSCREEN-27 Parent version
timeFrame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
measure: Mental Health-Promoting Knowledge (MHPK-10)
timeFrame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 1
timeFrame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
measure: Digital Addiction Scale for Children (DASC)
timeFrame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
measure: Healthy Behaviours in School-aged Children survey protocol (HBSC) part 2
timeFrame: Baseline, 3 month and 6 month (the 6 month assessment is the primary endpoint)
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Jens Högström, Ass prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06130462: Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
Official title: Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Granuloma
Aluminum Allergy
Keywords: aluminum
allergy
contact dermatitis
vaccination granuloma
LPT
SCIT
Lead sponsor: National Allergy Research Center, Denmark
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce itching granulomas at the injection site. This is usually diagnosed by patch testing. Another way of detecting metal allergy is by investigation metal-specific cells in the blood.

We include participants both with and without granulomas, all have a blood test taken where we investigate if any participants have aluminium-specific cirkulation cells, and whether we can detect a difference between participants with and without granulomas.

Detailed description: Aluminium-adsorbed vaccines and subcutaneous immunotherapy may induce vaccination granulomas at injection site. Most children have concormitant aluminium contact allergy diagnosed by path testing, but in adults the allergy can rarely be detected by patch tests.

An alternative to patch testing is the blood in vitro lymphocyte proliferation test (LPT), which we investigated using a well-established LPT protocol. This has previously been shown to detect and characterize metal-specific cells and was used to detect circulating aluminium-specific proliferation. The LPT test is based on a single blood sample and has mostly been used to detect drug hypersensitivity. Still, its role in detecting metal allergy is expanding, with recent studies suggesting using the test as a supplement to the patch test when only a few allergens are to be investigated.

Eligibility criteria: Inclusion Criteria:

* Indivicuals with vaccination granulomas
* controls without granulomas and no suspected contact allergies

Exclusion Criteria:

* pregnancy, breastfeeding, recent vaccination, skin diseases

Primary outcomes:
measure: LPT
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: National Allergy Research Centre, Gentofte Hospital
Study officials:
affiliation: Allergy clinic, Gentofte Hospital
name: Lars Blom, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00665262: The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in the Elderly
Official title: The Effect of the Combined Use of Naloxone and Tramacet on Postoperative Analgesia in Elderly Patients Having Joint Replacement Surgery: a Prospective Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthroplasty
Keywords: analgesia
hip arthroplasty
knee arthroplasty
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 10
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ten patients 70 years and older having elective total hip/knee replacement surgery will be recruited to receive a continuous IV infusion of naloxone and oral tramacet for analgesia. Postoperative analgesia, satisfaction, side effects, need for rescure analgesia, and length of stay.


Eligibility criteria: Inclusion Criteria:

* aged 70 years or older able to give consent able to communicate in English having elective hip/knee arthroplasty ASA physical status 1-3

Exclusion Criteria:

* allergies to any of the following: naloxone, tramacet, NSAIDs, sulpha, or local anesthesic contraindication to spinal anesthesia contraindication to use of tramacet or celebrex ASA physical status4 chronic opiod use chronic pain syndrome

Primary outcomes:
measure: opoid use post knee/hip arthroplasty
timeFrame: post-op period
Secondary outcomes:
measure: incidence of visual analogue scale scores greater than 4
timeFrame: post-op period
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ngozi Imasogie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592162: Comparison of Different Propofol Formulations With or Without Remifentanil
Official title: Dose-effect of Propofol for Anesthetic Induction: Double-blind Comparison of Different Propofol Formulations Administered Alone or With Remifentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 409
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 objective of this study is to evaluate the influence of different propofol formulations (plain or with remifentanil) on anesthetic induction. Propofol plain or with remifentanil is administered using a closed-loop algorithm in order to reach a Bispectral Index target of 50.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for an intravenous induction of anesthesia with propofol

Exclusion Criteria:

* Age under 18
* Pregnancy or breastfeeding
* Allergy to propofol, soya or peanuts,
* Allergy to remifentanil,
* History of central neurological disorder or brain injury,
* Patients receiving psychotropic drugs,
* Patient with a pacemaker

Primary outcomes:
measure: necessary dose of propofol to obtain the induction of anesthesia (defined by a bispectral index < 60 over 30 continuous seconds)
timeFrame: one hour after anesthesia
Secondary outcomes:
measure: calculated concentrations of propofol at the end of the anesthetic induction
timeFrame: one hour after anesthesia
measure: pain at injection
timeFrame: one hour after anesthesia
measure: heart rate modifications induced by anesthetic induction
timeFrame: one hour after anesthesia
measure: patient's satisfaction
timeFrame: one day after anesthesia
measure: arterial pressure modifications induced by anesthetic induction
timeFrame: one hour after anesthesia
measure: Disappearance of the eyelash reflex
timeFrame: One hour after anesthesia
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile de France
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00809562: A Study of RO4917523 in Patients With Treatment Resistant Depression
Official title: An Exploratory Fixed Dose Randomized Double Blind Parallel-group Placebo-controlled Study of the Safety and of the Therapeutic Effects of Ro 4917523 in Patients With Treatment- Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 46
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: This study will evaluate the safety, tolerability and efficacy of RO4917523, in comparison to placebo, in patients with treatment-resistant depression. Following a washout period from existing anti-depressant medication, cohorts of patients will be randomized to receive daily oral RO4917523 at up to five different doses (according to the safety and tolerability observed at the lower doses during the study), or placebo. The anticipated time on study treatment is 10 days (in an inpatient unit), and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-65 years of age;
* recurrent major depressive disorder, without psychotic features;
* at least 3 lifetime treatment failures, at least 2 of which must have occurred within the current depressive episode;
* baseline minimal severity defined by a HAM-D score of 18 or above;
* willing to be hospitalized for at least 16 consecutive days.

Exclusion Criteria:

* history of bipolar disorder, schizoaffective disorder or schizophrenia;
* history of psychosis, including psychotic depression;
* significant past or present neurological disorder, including seizures, stroke and/or head trauma.

Primary outcomes:
measure: Safety and tolerability: Adverse events, ECGs, laboratory parameters,vital signs
timeFrame: Throughout study
Secondary outcomes:
measure: Efficacy: MADRS score
timeFrame: From baseline to day 10
measure: Symptoms of treatment-resistant depression
timeFrame: Throughout study
Other outcomes:
Locations:
city: Oceanside
country: United States
state: California
city: San Diego
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Shreveport
country: United States
state: Louisiana
city: Flowood
country: United States
state: Mississippi
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Pittsburgh
country: United States
state: Pennsylvania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: