louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01172106: Impact of Family Psychoeducation on Psychosis
Official title: The Role of Psychoeducation on Perceived Social Support of Postpartum Others With a Psychotic Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postpartum Psychosis
Keywords: Postpartum psychosis
Perceived social support
Family psychoeducation
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2010-07-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is currently no clear involvement of families/caregivers in the care for postpartum mothers that develop postpartum psychosis. The lack of knowledge on causes of postpartum psychosis may influence the nature of perceived social support that mothers receive from caregivers. It is hoped that the provision of a culturally adapted version of family psychoeducation will bridge the knowledge gap and provide the much needed information. We therefore hypothesized that the involvement of a family member of a postpartum mother with a psychotic illness in a weekly session of family psychoeducation.

Detailed description: Postpartum psychosis causes distress to the mother, baby, spouse and other primary caregivers. This is especially true for Uganda where cultural beliefs for the causation of the illness place blame on supposedly the postpartum mother's promiscuity during pregnancy (COX, 1979). Cultural perceptions on the causes of postpartum psychosis may affect the nature of social support the mothers perceive from their families when they develop the illness. Other perceptions regarding postpartum psychosis in Uganda lay blame on supernatural causes like witchcraft.

Family psychoeducation which sets out to inform families of the nature of the illness is called for so as to demystify the illness.

Eligibility criteria: Inclusion Criteria:

* Postpartum mothers with a psychiatric illness in the current postpartum period.
* Must have been admitted to the mental health facility for the current episode.

Exclusion Criteria:

* Mothers residing out of a radius of 50 km away from the health facility.
* Mothers that do not have caregivers.
* Mothers who are not fluent in the language in which the study will be conducted.

Primary outcomes:
measure: perceived social support of mothers
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of psychological distress of the caregivers
timeFrame: 3 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University College of Health Sciences
city: Kampala
country: Uganda
facility: Makerere University College of Health Sciences
Study officials:
affiliation: Karolinska Institutet
name: Eija Airaksinen
role: STUDY_DIRECTOR
References:
Clinical trial NCT02840006: Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Revascularization
Spinal Anesthesia
Postoperative Care
Fentanyl
Keywords: Vasoconstrictor Agents
Vasodilator Agents
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: CONTEXT: In patients eligible for coronary artery bypass surgery, anesthesia should provide a number of conditions that exceed the limits of cardiovascular stability, myocardial protection and other organs. Moreover, the combination of general anesthesia and spinal anesthesia lessens the homeostatic, metabolic, hormonal and immunosuppressive changes. The goal of this research was to evaluate the consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting (CABG) surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.

METHODS: Clinical, prospective, randomized and double covered study, approved by the Research Ethics Committee. Fifty-six patients candidates for CABG with CPB, after signing the Terms of consent, were randomized and divided into two groups: GI - General and GII - General + subarachnoid. General anesthesia was induced according to the weight of each patient and maintenance with isoflurane and fentanyl. Spinal anesthesia was induced with 20 mg of 0.5% hyperbaric bupivacaine and 200 mcg of morphine, the patient is placed in cephalo-position slope of 45 degrees for 10 minutes in Group II. In the statistical study was performed using the Mann-Whitney test; the level of statistical significance was set at 5%.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders
* Underwent cardiac artery bypass surgery with cardiopulmonary bypass, with
* No restriction on age
* No restriction on ethnicity
* No restriction on education or social class

Exclusion Criteria:

* Patients with sternotomy provided; those
* Urgent surgery and/or emergency
* Patient was with signs of shock
* Patients with chronic renal failure
* Patients with liver disorders
* Tracheostomy patients
* Patients with presence of use of mechanical ventilatory support;
* Patients with physical disabilities; bedridden and wheelchair users.
* Patients to withdraw the Consent and Informed
* Patients who eventually had to be re-operated in the presence also of the mechanical ventilatory support.

Primary outcomes:
measure: consumption of fentanyl citrate in intra-operative in Coronary Artery Bypass Grafting surgery with cardiopulmonary bypass under spinal anesthesia associated with general anesthesia.
timeFrame: in 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clinicas Samuel Libânio
state: Minas Gerais
city: Pouso Alegre
country: Brazil
facility: Univas
state: Minas Gerais
Study officials:
References:
Clinical trial NCT04528706: A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)
Official title: An Open-label, Multicenter Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cerebral Adrenoleukodystrophy
Lead sponsor: Minoryx Therapeutics, S.L.
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 13
Sex: MALE
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open-Label, multicenter study in male pediatric patients with cerebral x-linked adrenoleukodystrophy (cald) to assess the effects of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)


Eligibility criteria: Inclusion Criteria:

* Males aged ≥2 and ≤12 years with a diagnosis of X-linked ALD
* White matter involvement as determined by cerebral MRI lesions without Gd enhancement at baseline (Population 1), or with Gd enhancement at baseline (Population 2).
* Major Functional Disabilities (MFD) score of 0.
* Baseline Loes score \>0 and ≤10
* Gadolinium Intensity Score \>2

Exclusion Criteria:

* Previous HSCT
* Too far progressed inflammatory brain lesions

Primary outcomes:
measure: evaluate whether MIN-102 can halt disease progression of cALD if administered prior to hematopoietic stem-cell transplantation (HSCT), as determined by serial clinical and MRI investigations in pediatric subjects.
timeFrame: 6 months- 2 years
measure: "arrested disease" will be assessed at 24 weeks and at 96 weeks
timeFrame: at 24 weeks and 96 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bueno Aires
country: Argentina
facility: Hernan Amartino
state: Buenos Aires
city: Paris
country: France
facility: CHU Kremlin Bicêtre
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik für Kinder- und Jugendmedizin
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
References:
Clinical trial NCT06935006: Erector Spinae Block vs Conventional Analgesia for Postoperative Analgesia in PCNL
Official title: Sonographic Guided Erector Spinae Plane Block Versus Conventional Analgesia After Percutaneous Nephrolithotomy a Comparative Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Percutaneous Nephrolithotomy (PCNL)
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 50
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: 50 adult patients scheduled for percutaneous nephrolithotomy in Sohag university hospitals will be devided in two groups one of them will receive Sonographic guided erector spinae plane block using 20 ml volume of bupivacaine 0.25 percent and the other will receive conventional analgesia of 0.1 mg/kg IV morphine


Eligibility criteria: Inclusion Criteria:

* ASA 1 to ASA 2 18 to 60 years

Exclusion Criteria:

* patient refusal Significant neurological , psychiatric or neuromascular disease Drug abuse Pregnant or lactating women Suspected coagulopathy Morbid obesity Known allergy to some medications Septicaemia and local infection at block site

Primary outcomes:
measure: Reduction of postoperative pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00013806: CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study
Official title: CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: Relapsed and refractory neuroblastoma
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2001-03-30
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma. This is a dual institution, Phase II study of 131I-MIBG administered at the previously defined maximum practical dose of 18 mCi/kg to children with relapsed or refractory neuroblastoma.


Eligibility criteria: Inclusion criteria: Refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine VMA with typical tumor cells in the bone marrow.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06845306: The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
Official title: Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Colo-rectal Cancer
Colonic Neoplasms Malignant
Keywords: ICG-guided quantitative assessment of bowel perfusion
Lead sponsor: the BELOOSTROV Clinic of High Technologies
Sponsor class: NETWORK
First posted: 2025-02-25
Enrollment: 1268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentre randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.

An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.

Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.


Eligibility criteria: Inclusion Criteria:

* Patients aged over 18 years old
* ECOG status 0-2
* Written informed consent
* histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)
* Scheduled for colorectal resection with primary anastomosis

Exclusion Criteria:

* Pregnancy or breast feeding
* Colon obstruction, perforation or bleeding complicating the tumor
* Medical contraindications for surgical treatment
* Known allergy or history of adverse reaction to ICG, iodine or iodine dyes

Primary outcomes:
measure: 30-days Anastomotic Leakage (AL) rate
timeFrame: 30-days
Secondary outcomes:
measure: complication rate
timeFrame: 30-days
measure: mortality
timeFrame: 30-days
measure: days in hospital stay
timeFrame: 90-days
Other outcomes:
Locations:
city: Vsevolozhsk District
country: Russian Federation
facility: BELOOSTROV Clinic of High Technologies
state: Leningrad Region
Study officials:
affiliation: BELOOSTROV Clinic of High Technologies
name: Victor Kashchenko, Doctor of Medical Sciences
role: STUDY_DIRECTOR
References:
Clinical trial NCT03768206: The PATH Study to Promote Physical Activity After Knee Replacement
Official title: Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: knee arthroplasty
behavioral intervention
physical activity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Prisma Health-Midlands
First posted: 2018-12-07
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.

Detailed description: Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.

Eligibility criteria: Inclusion Criteria:

* Be 40-79 years of age
* Have had a knee replacement in the last 2 months
* Be willing to wear and accelerometer for 7 days during assessments
* Be English speaking

Exclusion Criteria:

* Have any contraindications to activity
* Have a mobility limiting comorbidity
* Have a scheduled surgery within the next 6 months

Primary outcomes:
measure: Number of Participants Enrolled
timeFrame: Baseline
measure: Percentage of Participants Who Complete the 12 Week Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Moderate-Vigorous Intensity Physical Activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Palmetto Health- USC Orthopedic Center
state: South Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Christine Pellegrini, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00236106: Short Term Growth in Children With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: Children´s Clinic, Randers
Sponsor class: OTHER
First posted: 2005-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Main objective:to assess short term growth in children with atopic dermatitis during treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and run out)


Eligibility criteria: Inclusion Criteria: age 5-14, atopic dermatitis, normal current growth, Tanner 1, informed consent by the parent or guardian, willing and able to comply with study procedures

Exclusion Criteria: Tanner 2-5, treatment of atopic dermatitis with anti-inflammatory agent within 1 week before the first visit, current asthma or rhinoconjunctivitis that requires treatment with glucocorticoids, endocrine diseases, major surgery within 4 weeks prior to visit 1, fever \>39.5 for \>3 days

Primary outcomes:
measure: short term growth during treatment compared to run in
Secondary outcomes:
measure: U-EPX
measure: U-nTX
measure: skin prick test
Other outcomes:
Locations:
Study officials:
affiliation: Children's Clinic Randers
name: Ole Wolthers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01452906: A Drug-Drug Interaction Study of Omeprazole and PA21
Official title: A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug-drug interaction
Pharmacokinetics
PA21
Drug Interaction Potentiation
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if Omeprazole is affected by PA21.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Written informed consent

Exclusion Criteria:

* No significant medical conditions
* Pregnancy

Primary outcomes:
measure: Area Under the Curve from time zero to 24 hours (AUC0-24)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole dose on Days 0, 11, 22
measure: Area Under the Curve from time zero to infinite (AUC0-infinity)
timeFrame: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22
measure: Maximum observed plasma concentration (Cmax)
timeFrame: pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: ACRI - Phase 1
state: California
Study officials:
affiliation: ACRI - Phase 1 (Advanced Clinical Research Institute)
name: Peter J Winkle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03302806: Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Official title: Observational Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progressive Multiple Sclerosis
Keywords: disability
EDSS
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with progressive multiple receiving a daily dose of biotine of 300 mg

Brief summary: The purpose of this observational study is to collect efficacy and safety data in real life condition within the first year of treatment in patients with progressive multiple receiving a daily dose of biotine of 300 mg.


Eligibility criteria: Inclusion Criteria:

* Progressive multiple sclerosis patients with an EDSS score ≤ 7 who have been prescribed high dose of biotin (temporary use administration) at Nantes university hospital (France)

Exclusion Criteria:

* Patient with remittent recurrent multiple sclerosis
* Pregnant women or women contemplating pregnancy

Primary outcomes:
measure: Evolution of post-treatment disability
timeFrame: 12 months
Secondary outcomes:
measure: CGI-t scale
timeFrame: after 6 months and 12 months
measure: Functional disability : Multiple sclerosis Functional composite
timeFrame: 12 months
measure: Ambulation
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: adverse effect (adverse drug reaction)
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: