louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03931187: Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing IVF-ET
Official title: Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing In Vitro Fertilization-Embryo Transfer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: cognitive psychotherapy
progressive muscular relaxation
in vitro fertilization and embryo transfer(IVF-ET)
Couples Therapy
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2019-04-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.


Eligibility criteria: Inclusion Criteria:

* The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment;
* Junior high school and above;
* voluntarily accepted for investigation and signed informed consent.

Exclusion Criteria:

* Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
* Experiencing major traumatic events in the past 2 years.

Primary outcomes:
measure: Change of depression score
timeFrame: The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).
measure: Change of anxiety score
timeFrame: The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Secondary outcomes:
measure: Change of Blood Cortisol
timeFrame: The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).
measure: Change of sleeping quality
timeFrame: The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).
measure: Successful conception rate (%)
timeFrame: The doctor will test whether it is successfully conceived 4 weeks after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 4 weeks after completion of intervention.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Infertility Reproductive Center, Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT02947087: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis
Official title: Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pancreatitis
Keywords: Islet autotransplantation
Alpha1 anti trypsin
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-10-27
Enrollment: 48
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: Primary objective: To describe and compare the safety and efficacy of treatment with AAT in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT).

Detailed description: The goal of this study is to assess whether infusion of Prolastin-C during peri-transplant period can enhance islet autograft survival and function in chronic pancreatitis patients who have total pancreatectomy and islet autotransplantation. This is a prospective, controlled, double-blind study. The primary endpoint will be area under the curve for the serum C-peptide level during the first 4 hours of an mixed meal tolerance test (MMTT), normalized by the number of islet equivalents (IEQ)/kg at day 365±14 after the transplant.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total pancreatectomy and islet auto-transplantation
* Age \> 18 years
* Diabetes free before surgery

Exclusion Criteria:

* Patients who are under immunosuppression
* Patients who have had Puestow or Frey pancreatic surgery
* Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)

Primary outcomes:
measure: Islet Graft Function
timeFrame: 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Hongjun Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06754787: Renal Recovery After PEEP Weaning in ARDS (RE2SDRA)
Official title: Renal Recovery After PEEP Weaning in ARDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS (Acute Respiratory Distress Syndrome)
AKI - Acute Kidney Injury
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were included if they were intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20 followed by a successful PEEP weaning defined as ≤6 cmH20 for more than 72 hours.

Patients were excluded if they had chronic end-stage renal disease on admission, refusal to participate, whose non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity or if they were under legal protection.

Patients with impaired hourly urine output (HUO) (≤ 1 ml/kg/h) before PEEP weaning were selected.

Therefore, 120 patients of a cohort of 338 who required invasive mechanical ventilation for ARDS in the ICU of the Brest University Hospital were included.

The ethics committee of Brest university hospital approved the investigation RE2SDRA on 03/14/2024.

No additional diagnostic, treatment or monitoring procedures were conducted.

Brief summary: The purpose of the study is to investigate renal recovery in ARDS after PEEP weaning. The primary outcome was the variation of the hourly urine output (HUO), 48 h after PEEP weaning. Secondary outcomes were the need for RRT and mortality. Two groups were defined depending wether hourly urine output was greater or lower than 0.35 mL/kg/h.


Eligibility criteria: Inclusion Criteria:

* intubated for more than 48 hours, exposed to a PEEP≥ 8 cmH20

Exclusion Criteria:

* chronic end-stage renal disease on admission
* refusal to participate
* non-opposition could not be obtained from themselves or their trusted support person in the event of incapacity
* under legal protection.

Primary outcomes:
measure: Variation of the hourly urine output on day 2 after PEEP weaning
timeFrame: From enrollement to day 2 after PEEP weaning
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT06847087: Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After a Fracture
Official title: Study of the Adequacy Between Calcium Supplementation and Dietary Intake in Treatment-naive Patients After Fracture with a Fracture Suspected of Being Due to Bone Insufficiency, Consulting a Rheumatologist for the First Time in At Least 5 Years.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Osteoporosis, Post-Traumatic
Calcium Supplementation
Osteoporosis, Management Care, Fracture
Lead sponsor: Centre Hospitalier de Colmar
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting in a rheumatology department for a hospital

Brief summary: Osteoporosis is a disease that causes many fractures. However, treatments exist such as anti-osteoporotic treatments, vitamin D supplementation and an adaptation of calcium intake. 80% of patients with an indication for anti-osteoporotic treatment are never treated with these anti-osteoporotic treatments after a first fracture. On the other hand, more than 84% of them are supplemented with calcium and vitamin D. It often appears in the practice of rheumatologists that some patients are supplemented while their dietary intake is sufficient, and vice versa. The objective of the study is therefore to take stock of the (in)adequacy between the dietary intake of patients and the supplementation prescribed to them following an osteoporotic-like fracture.


Eligibility criteria: Inclusion Criteria:

* Patient meeting a first rheumatologist after a fracture suspected of being due to bone insufficiency, whether or not he is already treated for osteoporosis
* Age ≥ 18 years
* Patient followed in one of the three investigation centers within the framework of the bone sector.
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient refusing to participate in the study
* Patient already followed by a rheumatologist
* Legal incapacity or any physical, psychological, social or geographical condition likely to hinder the patient's ability to participate in the study

Primary outcomes:
measure: Number of patients deficient, within the norm and above the norm with or without supplementation
timeFrame: Day 1
Secondary outcomes:
measure: Previously performed bone densitometry
timeFrame: Day 1
measure: Prevalence of a history of fracture
timeFrame: Day 1
measure: First indication for the initiation of anti-osteoporotic treatment.
timeFrame: Day 1
measure: Duration without treatment before a fracture occurs
timeFrame: Day 1
measure: Number of participants who need for readjustment by the rheumatologist after inclusion
timeFrame: Day 1
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
Study officials:
References:
Clinical trial NCT01480687: Fish Oil Supplementation and Vascular Function in Hypertensive Patients With Hypertriglyceridemia
Official title: Effects of Fish Oil Supplementation on Vascular Structure and Function in Hypertensive Patients With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Hypertriglyceridemia
Keywords: Hypertension
Endothelial dysfunction
Vascular stiffness
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2011-11-29
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the effects of ciprofibrate versus omega-3 fatty acid supplementation on the vascular structure and function in hypertensive patients with hypertriglyceridemia.

Detailed description: Hypertensive patients aged 40-65 years, both genders, presenting serum triglycerides levels higher than 150 mg/dl will be randomized into two groups. The first group will be receiving ciprofibrate 100mg/day and the second group will be receiving fish oil 1800mg/day. All patients will be evaluated with brachial flow-mediated dilation and with EndoPAT to assess endothelial function before and after supplementation. SPHYGMOCOR and pulse wave velocity (PWV) measurements will also be obtained.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of hypertension
* Patients with serum triglycerides levels ≥ 150 mg/dl and \<500 mg/dl
* Patients on stable antihypertensive medication for at least 4 weeks
* Patients with food consumption maintained for at least 4 weeks

Exclusion Criteria:

* Smoking
* Secondary hypertension
* Hormone replacement therapy
* Diabetes mellitus
* Chronic kidney disease
* Known coronary artery disease
* Previous stroke
* Dyslipidemia severe, with LDL cholesterol\> 160 mg/dL or triglycerides ≥ 500 mg/dl
* Use of statins or beta blockers

Primary outcomes:
measure: Endothelial function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro, RJ
country: Brazil
facility: Hospital Universitario Pedro Ernesto
state: Rio de Janeiro
Study officials:
affiliation: State University of Rio de Janeiro
name: Marcela A Casanova, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Rio de Janeiro
name: Mario F Neves, MD, PhD
role: STUDY_CHAIR
affiliation: State University of Rio de Janeiro
name: Wille Oigman, MD, PhD
role: STUDY_CHAIR
affiliation: Federal University of the State of Rio de Janeiro
name: Fernanda J Medeiros, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01649687: Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Official title: Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebellar Ataxia
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
* Subject's SARA score at 10\~20 points.
* Ages between 20\~70 years.
* Signed informed consent from the patient and/or guardian.

Exclusion Criteria:

* Subjects enrolled in any other cell therapy studies within the past 30 days.
* Pregnancy test positive.
* Subjects deemed to be not suitable for the study by the investigator.

Primary outcomes:
measure: Safety evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Alterations in SARA score
timeFrame: 12 months
measure: Positron emission tomography
timeFrame: 9 months
measure: Magnetic resonance spectroscopy
timeFrame: 12 months
measure: Assessment of language and swallowing functions
timeFrame: 12 months
measure: Evaluation of syncope
timeFrame: 12 months
measure: Balance test
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References:
Clinical trial NCT02628587: Patent Versus Generic Clopidogrel in Acute Coronary Syndrome
Official title: Comparison of Platelet Reactivity in Patients With Acute Coronary Syndrome Given Patent Clopidogrel Versus Generic Clopidogrel: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Clopidogrel
Platelet reactivity
Lead sponsor: Hospital Central San Luis Potosi, Mexico
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 60
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: Ischemic heart disease is the leading cause of death and disability in developed countries and is responsible for a third of deaths in persons over 35 years . The most severe form of ischemic heart disease is sudden death and acute coronary syndrome (ACS).

There is evidence that early and optimal treatment of ACS decreases mortality. Within the optimal treatment, these patients must receive a reperfusion therapy as mechanical or pharmacologic treatment. In addition to reperfusion treatment, antiplatelet therapy is a central part of the management. Aspirin plus a P2Y12 inhibitor have been shown to decrease mortality. In our country, clopidogrel is the more accessible and used P2Y12 inhibitor; however, it has been shown to have a wide variability in response and this variability could be influenced by different pharmacological, genetic and environmental factors.

Platelet reactivity measured by aggregometry predicts major cardiovascular events in ACS patients treated with clopidogrel. Due to their frequent prescription, generic clopidogrel efficacy must be evaluated. The purpose of this study is to compare the platelet reactivity in patients with ACS receiving clopidogrel generic versus patent.


Eligibility criteria: Inclusion Criteria:

* 18 and over
* Diagnosis of acute coronary syndrome
* Patients receiving 300 mg of Clopidogrel load and a single dose of 75 mg daily
* Signature of informed consent

Exclusion Criteria:

* Active bleeding or absolute contraindication for antiplatelet use
* Chronic kidney disease with creatinine clearance \<30 ml / min
* Liver damage documented as elevated aspartate aminotransferase/alanine aspartate 2 times upper normal limit (UNL) and/or total bilirubin \> 2 times UNL
* Prescribed antiplatelet therapy, other than aspirin

Primary outcomes:
measure: Platelet reactivity change
timeFrame: Day 0 and Day 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00973687: Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
Official title: Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: pediatric
dexamethasone
management
corticosteroids
asthma
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: IWK Foundation
First posted: 2009-09-09
Enrollment: 430
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.


Eligibility criteria: Inclusion Criteria:

* acute asthma exacerbation
* requiring oral systemic corticosteroids for management

Exclusion Criteria:

* preference for pills over liquid formulation
* history of Nissen fundoplication surgery
* needed immediate airway intervention
* require oral medications to be given via a G or J tube
* if patient care would be compromised
* enrolled in the study on a previous visit.

Primary outcomes:
measure: The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma.
timeFrame: During Emergency Department visit
Secondary outcomes:
measure: To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.
timeFrame: 7-14 days following emergency dept visit
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Lyn K Sonnenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04767087: Honey and Nigella Sativa in COVID-19 Prophylaxis
Official title: Honey and Nigella Sativa in the Prophylaxis of COVID-19: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Covid19
Keywords: Honey
Nigella sativa
Prophylaxis
COVID-19
Prophetic Medicine
Lead sponsor: Sheikh Zayed Federal Postgraduate Medical Institute
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Honey and Nigella sativa has established antiviral, antibacterial, anti-inflammatory, and immunomodulatory roles. So it is planned to test for its prophylaxis


Eligibility criteria: Inclusion Criteria:

* Health care professionals Post-exposure COVID-19

Exclusion Criteria:

* Multi-organ failure active COVID-19

Primary outcomes:
measure: SARS-CoV-2 infection rate
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Shaikh Zayed Post-Graduate Medical Institute
state: MA
Study officials:
affiliation: Massachusetts General Hospital
name: Sohaib Ashraf, MBBS
role: STUDY_DIRECTOR
affiliation: University of Veterinary and Animal Sciences
name: Muhammad Ashraf, PhD
role: STUDY_CHAIR
affiliation: Shaikh Zayed Post-Graduate Medical Institute
name: Ahmad Imran, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: King Edward Medical University
name: Moneeb Ashraf, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashraf S, Ashraf S, Akmal R, Ashraf M, Kalsoom L, Maqsood A, Imran MA, Farooq I, Ashraf S, Siddiqui UN, Ghufran M, Akram MK, Majeed N, Rafique S, Habib Z, Shahab MS, Akmal A, Shaukat Z, Abdin ZU, Khaqan A, Arshad S, Rehman Virk MA, Gul M, Awais AB, Hassan M, Khalid N, Iqbal QUA, Ahmad T, Akram M, Muhammad A, Khalil M, Aslam A, Umer M, Sherazi SSH, Safdar Z, Ahmad S, Bilal M, Zahid MN, Koshak AE, Hilal A, Malik AA, Iqbal U, Baig AA, Alahmadi YM, Humayun A, Malik A, Ahmad A, Ashraf M, Saboor QA, Izhar M; DOCTORS LOUNGE consortium. Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 15;22(1):618. doi: 10.1186/s13063-021-05510-3.