louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00576550: A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
Official title: A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Eczema
Keywords: Hand eczema
Prevention
Lead sponsor: ACO Hud Nordic AB
Sponsor class: INDUSTRY
Collaborators: name: Smerud Medical Research International AS
First posted: 2007-12-19
Enrollment: 53
Sex: ALL
Minimum age (years): 18
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 investigate whether a moisturizing cream can prevent hand eczema.Patients with previous hand eczema will be studied. In the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.


Eligibility criteria: Inclusion Criteria:

* Clinically proven history of hand eczema
* At inclusion controlled state of hand eczema (≤3 on Hand Eczema Extent Score, HEES)
* Daily use of moisturising treatment
* Either gender
* Age 18 or above
* Written Informed Consent

Exclusion Criteria:

* Possible allergy to ingredients in the study medications
* At study start active psoriatic lesions or active atopic eczema lesions on the hands. Active bacterial, fungal or viral infection of the hands
* Patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study
* Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy
* Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse)
* Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results
* Inclusion in a study of an investigational drug within 60 days prior to start of treatment

Primary outcomes:
measure: Time to relapse of hand eczema
timeFrame: Up to 6 months
Secondary outcomes:
measure: The number of patients showing clearance of hand eczema after betamethasone treatment once versus twice daily
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Hamar
country: Norway
facility: Medi 3 Innlandet
city: Oslo
country: Norway
facility: Colosseumklinikken
city: Oslo
country: Norway
facility: Dr Funks hudklinikk
Study officials:
affiliation: Rikshospitalet, Oslo
name: Gro Moerk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517450: Effectiveness of an Adventure-based Training Programme
Official title: Effectiveness of an Adventure-based Training Programme in Promoting the Psychological Well-being of Primary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Subjects
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study tested the effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren. A randomised controlled trial was conducted, with 56 primary school pupils randomly assigned to the experimental group participating in the adventure-based training programme and 64 to the attention placebo control group.


Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese primary pupils from forms 5 and 6 of two schools were invited to participate in the study.

Exclusion Criteria:

* those with a chronic illness or identified cognitive and learning problems were excluded.

Primary outcomes:
measure: The Center for Epidemiologic Studies Depression Scale for Children at baseline
timeFrame: baseline
measure: change of The Center for Epidemiologic Studies Depression Scale for Children at 9 months from baseline
timeFrame: 9 months
measure: change of The Center for Epidemiologic Studies Depression Scale for Children at 12 months from baseline
timeFrame: 12 months
Secondary outcomes:
measure: The Chinese version of the State Anxiety Scale for Children at baseline
timeFrame: baseline
measure: change of The Chinese version of the State Anxiety Scale for Children at 9 months from baseline
timeFrame: 9 months
measure: change of The Chinese version of the State Anxiety Scale for Children at 12 months from baseline
timeFrame: 12 months
measure: The Rosenberg Self-esteem Scale at baseline
timeFrame: baseline
measure: change of The Rosenberg Self-esteem Scale at 9 month from baseline
timeFrame: 9 months
measure: change of The Rosenberg Self-esteem Scale at 12 month from baseline
timeFrame: 12 months
measure: The Pediatric Quality of Life Inventory Generic at baseline
timeFrame: baseline
measure: change of The Pediatric Quality of Life Inventory Generic at 9 months from baseline
timeFrame: 9 months
measure: change of The Pediatric Quality of Life Inventory Generic at 12 months from baseline
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: School of Nursing, The University of Hong Kong
name: William, Ho Cheung LI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04373850: Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.
Official title: Reducing Readmission Rates by Providing a Comprehensive Transition Plan From Hospital to Home for Cardiac Surgery Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Reducing readmissions
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who undergo cardiac surgery will be screened by a team member with the risk score once the patient has been admitted to the Cardiovascular Progressive Care Unit (CVPCU) after surgery. Participants will be randomized to the intervention or the control group. Both groups will receive standard discharge planning. In addition, the intervention group will have a nurse practitioner (NP) who will be responsible to verify that each essential step of the discharge process has been completed and will visit the patient in patient's home after discharge to complete a physical, review medications, titrate medications as needed, prescribe any necessary treatments, and perform education. The primary outcome variable will be a decrease in the 30 day readmission rate comparing high risk patients at pre and post intervention.


Eligibility criteria: Inclusion Criteria:

* All patients 18 years of age or greater who have had cardiac surgery procedures including coronary artery bypass surgery (CABG), valve replacement, aortic aneurysm repair, and combined CABG and valve procedures.

Exclusion Criteria:

* Patients who have undergone orthotopic heart transplantation, orthotopic lung transplantation, or orthotopic heart-lung transplantation
* Patients who have undergone ventricular assist device placement
* Patients who do not reside in Maryland
* Non English speaking patients
* Patients discharged to a facility.

Primary outcomes:
measure: 30-Day readmission rate
timeFrame: Up to 30 days post discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Sharon Owens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02379650: Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Official title: RCT Assessing Hydroxychloroquine for Unexplained Recurrent Pregnancy Loss
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Recurrent Pregnancy Loss
Miscarriage
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Intermountain Health Care, Inc.
First posted: 2015-03-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.


Eligibility criteria: Inclusion Criteria:

* Women ages 18 and older
* Planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth

Exclusion Criteria:

* Documented antiphospholipd antibodies
* Uterine malformation or parental chromosomal abnormality
* Known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol
* Any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy

Primary outcomes:
measure: Live Birth
timeFrame: Duration of gestation (up to 42 weeks)
Secondary outcomes:
measure: Adverse Pregnancy Outcomes
timeFrame: Duration of gestation (up to 42 weeks)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Robert Silver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515450: Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Official title: A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Generalized Myasthenia Gravis
Keywords: Myasthenia Gravis
Lead sponsor: Benesis Corporation
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 46
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as generalized myasthenia gravis
* Patients who are not controlled by current therapy and need plasmapheresis therapy
* Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent
* Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment

Exclusion Criteria:

* Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment
* Patients who had undergone thymectomy within 24 weeks prior to enrollment
* Patients with 3 points item in bulbar symptom of MG-ADL scale
* Patients with severe hepatic disorder, severe renal disorder or severe heat disorder
* Patients who have received treatment of malignant tumors
* Patients who have the anamnesis of shock or hypersensitivity to this drug
* Patients who have been diagnosed as hereditary fructose intolerance
* Patients who have the anamnesis of cerebral infarction or symptom of these diseases
* Patients who have been diagnosed as IgA deficiency in their past history
* Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant
* Patients who were administered other investigational drug within 12 weeks before consent

Primary outcomes:
measure: Changes in QMG score
timeFrame: at 4 weeks
Secondary outcomes:
measure: Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels
timeFrame: from beginning of the treatment through 4th week
Other outcomes:
Locations:
city: Nagasaki
country: Japan
facility: Nagasaki University
Study officials:
affiliation: Neurological Center Kanazawa-Nishi Hospital
name: Masaharu Takamori, Director
role: STUDY_CHAIR
References:
Clinical trial NCT01303250: Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery
Official title: Balanced 6 % HES 130/0.4 vs. Balanced Crystalloid-based Infusion in Patients Undergoing Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Surgery, Colorectal
Keywords: goal-directed fluid optimization
hemodynamic optimization
crystalloid
colloid
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
First posted: 2011-02-24
Enrollment: 31
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 primary purpose of this study is to determine the effect of a balanced 6%hydroxyethyl starch 130/0.4 vs. a balanced crystalloid in colorectal surgery. The intraoperative fluid management will be given to optimize the stroke volume variation \<= 12%.

The investigators hypothesize that patients in the intervention group will need less fluid administration be optimal hemodynamic stabilized.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective colorectal surgery
* minimum age 18 years
* informed consent

Exclusion Criteria:

* patients with severe cardiomyopathy or severe heart failure
* history of coagulation disorders
* intracranial hemorrhage
* patients with severe cardiovascular or respiratory disorders
* renal insufficiency
* severe liver diseases

Primary outcomes:
measure: Total amount of administered fluids
timeFrame: intraoperatively
Secondary outcomes:
measure: Incidence of surgery related complications
timeFrame: day 28 and 90 postoperatively
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: Department of Anesthesia and Intensive Care, University Hospital Muenster
name: Hugo Van Aken, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02509650: Identification of Mutations Responsible for Rare Familial Skin Diseases by Next Generation Sequencing
Official title: Identification of Mutations Responsible for Rare Familial Skin Diseases by Next Generation Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Familial Lipomatosis
Very Rare Dermatologic Diseases
Keywords: Exome sequencing
Skin disease
Familial lipomatosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Familial lipomatosis

Brief summary: The primary purpose of the protocol is to use next generation sequencing to identify pathogenic variants in genes involved in very rare skin diseases.

The secondary purpose will be to study the genotype-phenotype correlation in order to re-evaluate the classification of these disorders. This work could help in the understanding of the physiopathology of very rare skin disorders.


Eligibility criteria: Inclusion Criteria:

* patients affected by familial lipomatosis
* patients with rare dermatologic disease without molecular diagnosis
* written informed consent is obtained from the patient and his/her family

Exclusion Criteria:

* the patient does not want to participate to the protocol
* the patient is already included in another study using next generation sequencing technologies

Primary outcomes:
measure: Number of patients with a deleterious mutation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Fédération de Génétique, Service de Génétique Médicale, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Dermatologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Salima EL CHEHADEH, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03563950: An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
Official title: A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-06-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening

Exclusion Criteria:

* Women of childbearing potential
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986224
timeFrame: 5 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
timeFrame: 5 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
timeFrame: 5 days
Secondary outcomes:
measure: Biomarker plasma concentrations of BMS-986224
timeFrame: 5 days
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986224
timeFrame: 5 days
measure: Terminal elimination half-life (T-HALF) of BMS-986224
timeFrame: 5 days
measure: Metabolite of BMS-986224 Cmax
timeFrame: 5 days
measure: Metabolite of BMS-986224 AUC(0-T)
timeFrame: 5 days
measure: Metabolite of BMS-986224 AUC(INF)
timeFrame: 5 days
measure: Incidence of nonserious adverse events (AE)
timeFrame: 17 days
measure: Incidence of serious adverse events (SAE)
timeFrame: 30 days
measure: Incidence of AEs leading to discontinuation
timeFrame: 17 days
measure: Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests
timeFrame: 18 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03335150: Cognitive Rehabilitation for PD
Official title: Cognitive Rehabilitation for Individuals With Parkinson's Disease and MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Rehabilitation
Cognition
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-11-07
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with Parkinson's disease (PD) and mild cognitive impairment (MCI).

Detailed description: Eligible study participants will be randomly assigned to one of two interventions: 1) Cognitive Rehabilitation (Cognitive Symptom Management and Rehabilitation Therapy for Parkinson's disease; CogSMART-PD) or 2) Supportive Care. Interventions are held within a group format consisting of approximately 5 individuals with PD. Groups will meet once per week for 1.5 hours over a 10-week period. Neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Parkinson's disease
2. Mild Cognitive Impairment
3. Over 40 years of age
4. Fluent English speaker

Exclusion Criteria:

Other neurological conditions (e.g., stroke) besides Parkinson's disease

Primary outcomes:
measure: Wechsler Adult Intelligence Scale-IV (WAIS-IV) Matrix Reasoning Test Total Scaled Score
timeFrame: Baseline and Week 10
Secondary outcomes:
measure: Delis-Kaplan Executive Functioning System (D-KEFS): 20 Questions Test Total Questions Asked Scaled Score
timeFrame: Baseline and Week 10
measure: Informant Questionnaire on Cognitive Decline in the Elderly-Self Report (IQCODE-SR) Total Score
timeFrame: Baseline and Week 10
measure: Cognitive Problems and Strategies Assessment (CPSA) Memory Strategies Use Score
timeFrame: Baseline and Week 10
measure: Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Total Score
timeFrame: Baseline and Week 10
measure: Memory for Intention Test (MIST) Total Score
timeFrame: Baseline and Week 10
measure: World Health Organization Quality of Life (WHOQOL)-BREF Psychological Domain Transformed Score
timeFrame: Baseline and Week 10
measure: Parkinson's Disease Questionnaire-39 (PDQ-39) Total Score
timeFrame: Baseline and Week 10
measure: Neuropsychiatric Inventory-Questionnaire (NPI-Q) Total Month Score
timeFrame: Baseline and Week 10
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Dawn M. Schiehser, PhD
role: PRINCIPAL_INVESTIGATOR
References: