louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04912804: Perceived Health After Hospitalization for COVID-19
Official title: Perceived Health After Hospitalization for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19, Post-hospitalization, Disease Impact
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 207
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: Patient with COVID-19 discharged from a conventional short-stay hospital ward.

Brief summary: There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Patient with a diagnosis of COVID-19 confirmed by PCR and/or CT scan
* Patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a COVID-19 infection
* Patient providing oral consent to participate in the study
* Patient able to understand and answer the questionnaires used
* Patient able to answer the questions on an electronic device and to receive requests by email and/or SMS
* Patient who has electronic equipment at home and an Internet subscription allowing him/her to answer the questionnaires online

Exclusion Criteria:

* Patient under guardianship, curatorship or a measure of judicial safeguard

Primary outcomes:
measure: Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease
timeFrame: Through study completion, an average of 6 months
measure: The value of perceived health scores in patients who achieved PASS and MCII
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT05578404: High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease
Official title: The Effect of High Oral Loading Dose of Cholecalciferol in Non-Alcoholic Fatty Liver Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder with high prevalence in patients suffering from chronic liver diseases \[1\]. NAFLD is characterized by the accumulation of \> 5% of fat deposits in hepatocytes (hepatic steatosis) with no known other reasons for steatosis as excessive alcohol intake.The global prevalence of NAFLD differs depending on the population reaching 13% in Africa, 32% in the Middle East, and 30 % in the United States


Eligibility criteria: Inclusion Criteria:

* Either male or female adult patients (\>19 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US) and with type II diabetes diagnosed according to American Diabetes Association (ADA) 2019 criteria and treated with metformin

Exclusion Criteria:

* pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake of\> 30 g per day in men and \> 20 g per day in women),
* Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, patients suffering from chronic kidney disease, and hyper/hypoparathyroidism.
* Hypersensitivity to cholecalciferol, hypercalcemia, patients taking supplementation with vitamin D, and calcium.
* Medications affecting calcium/vitamin D metabolism (as anticonvulsants, glucocorticoids, and antacids).

Primary outcomes:
measure: Fasting blood glucose (FBG mg/dl)
timeFrame: 4 months
measure: Glycated hemoglobin (HbA1C%)
timeFrame: 4 months
measure: Fasting insulin (mU/L).
timeFrame: 4 months
measure: Alanine transaminase (ALT U/L)
timeFrame: 4 months
measure: Aspartate transaminase (AST U/L)
timeFrame: 4 months
measure: Albumin (g/dl)
timeFrame: 4 months
measure: Gamma-glutamyl transferase (GGT U/L)
timeFrame: 4 months
measure: Alkaline phosphatase (ALP U/L)
timeFrame: 4 months
measure: Lipid profile: Low-density lipoprotein (LDL-C mg/dl), High-density lipoprotein (HDL-C mg/dl)
timeFrame: 4 months
measure: Lipid profile: Triglycerides (TG mg/dl)
timeFrame: 4 months
measure: Lipid profile: Total cholesterol (TC mg/dl)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT04892004: Symptom Recognition Improves Self-care in Patients With Heart Failure.
Official title: Does Symptom Recognition Improve Self-care in Patients With Heart Failure. A Growth Latent Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Symptoms and Signs
Keywords: Heart failure
Self-care behaviors
Symptom recognition
Nurse-led program
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 63
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: Describe a behaviour intervention to analyse self-care engagement in heart failure patients. Allocate patients with heart failure into 2 arms study: a control group and an intervention group.

Detailed description: According to medical record at admission, a pilot study was described and included 63 patients in New York Heart Association (NYHA) functional class II-III. Patients were recruited in a hospital setting after discharge from a heart failure unit.

Patients were allocated into a control group (n=33) and an intervention group (n=30) through the computerised random allocation generator at http://random.org.

The pilot study was performed during three months per patient, with four moments of assessment (baseline, first-week follow-up, first-month follow-up, third-month follow-up).

Eligibility criteria: Inclusion Criteria:

* adults aged \>18 years old, with diagnosed HF and with no cognitive disability associated.

Exclusion Criteria:

* patients placed on the heart transplant waiting list and patients in class IV NYHA.

Primary outcomes:
measure: Symptom recognition
timeFrame: up to 3 months
measure: Self-care behaviors
timeFrame: up to 3 months
measure: Emergency and Hospital admissions
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pereira Sousa J, Neves H, Pais-Vieira M. Does Symptom Recognition Improve Self-Care in Patients with Heart Failure? A Pilot Study Randomised Controlled Trial. Nurs Rep. 2021 Jun 1;11(2):418-429. doi: 10.3390/nursrep11020040.
Clinical trial NCT01943201: Low Friction Bed Sheet
Official title: Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Pressure Ulcer
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
Collaborators: name: Swiss Federal Laboratories for Material Sciences and Technology
First posted: 2013-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Introduction:

It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI.

Method:

Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.


Eligibility criteria: Inclusion Criteria:

* SCI patients without a presser ulcer for the last 2 months
* Paraplegic and tetraplegic patients
* complete and incomplete lesion (AIS A, AIS B, AIS C, AIS D)
* caused by illness or traumatic event
* smoker and non-smoker

Exclusion Criteria:

* progressive disease
* severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)

Primary outcomes:
measure: well-being
timeFrame: 1 day in the morning after sleeping on the new bed sheet
Secondary outcomes:
measure: Skin redness
timeFrame: 1 day in the morning after sleeping on the new bed sheet
measure: Skin perfusion
timeFrame: 1 day in the morning after sleeping on the new bed sheet
measure: Skin hydration
timeFrame: 1 day in the morning after sleeping on the new bed sheet
measure: Skin elasticity
timeFrame: 1 day in the morning after sleeping on the new bed sheet
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic-Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Center
name: Anke Scheel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05006001: Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
Official title: Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Impairment
Gout
Colchicine Adverse Reaction
Nonsteroidals (NSAIDs)Toxicity
Keywords: Acute kidney injury
Renal impairment
Nonsteroidal antiinflammatory drug
Drug-drug interaction
Lead sponsor: En Chu Kong Hospital
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with gout and initiating anti-gout drug

Brief summary: Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment regimens and evaluating risks of renal impairment.

Detailed description: Background: Gout is a common prevalent disease, which causes a low quality of life and poses a significant health burden nationally and internationally. Colchicine and Nonsteroidal anti-inflammatory drug (NSAID) are the mainstay treatment of gout. Concurrent use of colchicine and NSAIDs are more than half in all prescriptions of the gout patients. Both colchicine and NSAIDs may cause renal impairment. However, the empirical evidence of renal impairment of colchicine and NSAIDs combination therapy is limited and even absent.

Objectives: This proposal will assess the association between colchicine and NSAIDs combination therapy and acute kidney injury. The investigators further evaluate the relationships of duration-response, recency-response, and dose-response.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of a gout diagnosis
* Initially receiving at least one anti-gout drug

Exclusion Criteria:

* \<1 year of continuous health insurance enrollment
* Colchicine and NSAID use before the cohort entry date
* Patients with hemodialysis or peritoneal dialysis before the cohort entry date
* Patients with acute kidney injury before the cohort entry date

Primary outcomes:
measure: Acute kidney injury
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: All cause mortality
timeFrame: Through study completion, an average of 1 year
measure: Hemodialysis or peritoneal dialysis
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02437201: Study of Liberty Program on Women's Health and Intimate Partner Violence
Official title: Study of Liberty Program on Women's Health and Intimate Partner Violence: Multinational, Open, Randomised, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Violence Against Women
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: Goldington Family Center, UK
name: Vinita Nursing Home, India
name: Sonal Foundation, India
First posted: 2015-05-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous studies indicated high frequency of abuse in families and its consequences. Considering the importance of interventions such as educational interventions, in order to increase women's abilities to prevent abusive behaviors, the current research aims to determine the impact of an Liberty program on prevention of violence against women and propose solutions for less damages and consequences.


Eligibility criteria: Inclusion Criteria:

* Be married,
* Be under the aegis of Foundation at least for a year,
* Have at least one child.

Exclusion Criteria:

* Not participating in two educational sessions,
* Not being interested in continuing the cooperation.

Primary outcomes:
measure: Quality of Life measured by SF 36 Scale
timeFrame: Change from baseline in SF 36 Scale at 6 months
Secondary outcomes:
measure: Self-Esteem measured by Rosenberg Self-Esteem Questionnaire
timeFrame: Change from Baseline in Rosenberg Self-Esteem Questionnaire at 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Liberty USA
state: Massachusetts
city: Melbourne
country: Australia
facility: Liberty Australia
city: Shanghai
country: China
facility: Liberty China
state: Shanghai
city: Athens
country: Greece
facility: Liberty Europe
city: Mahesana
country: India
facility: Sonal Foundation
state: Gujarat
city: Hindaun
country: India
facility: Vinita Nursing Home
state: Rajasthan
city: Lahore
country: Pakistan
facility: Liberty Pakistan
state: Punjaab
city: Johannesburg
country: South Africa
facility: Liberty Africa
Study officials:
affiliation: Sonal Foundation, India
name: Bharat B Chaudhari, MA
role: STUDY_DIRECTOR
affiliation: Vinita Nursing Home, India
name: Paramjeet S Makkar, MD
role: STUDY_DIRECTOR
affiliation: Goldington Family Centre, UK
name: Michael Howe, MA
role: STUDY_CHAIR
affiliation: Shanghai University, China
name: Avinash Mishra, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT03232801: A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Official title: A Mindfulness-based Intervention for Older Women With Low Sexual Desire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoactive Sexual Desire Disorder
Sexual Dysfunction
Female Sexual Dysfunction
Keywords: hypoactive sexual desire disorder
female sexual dysfunction
low libido
female sexual interest-arousal disorder
low desire
sexual dysfunction
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Institutes of Health (NIH)
First posted: 2017-07-28
Enrollment: 62
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall aim of this research is to adapt and pilot test a multi-component, mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.

Detailed description: Specifically, the investigators will conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of the intervention. Fifty women will be randomized to the mindfulness intervention or an educational control group. Both groups will be conducted in 3 sessions over 6 weeks in groups of 10 women. Feasibility, acceptability, facilitators, and barriers will be assessed by surveys after each session and after intervention completion. Preliminary efficacy will be assessed by measures of sexual desire, sexual function, and overall sexual satisfaction at 6 and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* meet criteria for a diagnosis of Female Sexual Interest/Arousal Disorder
* English-speaking
* have a current sexual partner with whom they are or would like to be sexually active

Exclusion Criteria:

* active major depression
* active substance abuse
* current intimate partner violence
* partner with active major depression
* partner with active major substance abuse
* significant relationship dissatisfaction
* current use of antidepressants
* untreated dyspareunia (sexual pain)

Primary outcomes:
measure: Feasibility - Number of Enrolled Women Participating in All Sessions
timeFrame: 6 weeks
measure: Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in FSFI Desire Score
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Change in Overall Sexual Function
timeFrame: Baseline and 12 weeks
measure: Comprehensive Sexual Desire
timeFrame: 6 weeks and 12 weeks
measure: Sexual Distress
timeFrame: 6 weeks and 12 weeks
measure: Quality of Life - SF 36
timeFrame: 6 weeks and 12 weeks
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00817401: Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy
Official title: Effect of Systemic Hypothermia on Neonatal Hypoxic-Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: asphyxia
hypothermia
hypoxic-ischemic encephalopathy
neonates
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2009-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. Although many neuroprotective strategies appeared promising in animal models, most of them were not feasible and effective in human newborns. However, hypothermia was reported not to be effective if introduced beyond and thus should be introduced within 6 hrs after birth.Applying this selection criterion naturally would deprive many patients of the opportunity of hypothermia treatment.

Detailed description: Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions. Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury. The aim of this study was to investigate whether systemic hypothermia induced up to 10 hrs after birth would improve the neurodevelopmental outcome at 18 months in infants with moderate or severe HIE.

Eligibility criteria: Inclusion Criteria:

1. Gestation age ≥37 weeks and body weight \>2500g.
2. with one of the following factors:

   1. Apgar score\<5 at 5min;
   2. Assisted respiration \>3min due to respiratory distress;
   3. pH≤7.1 of cord or arterial blood within 60min after birth;
   4. clinical manifestation of encephalopathy during the first 10 hrs of life.

Exclusion Criteria:

1. Major congenital abnormalities;
2. Head trauma or skull fracture causing major intracranial hemorrhage;
3. Mild HIE;
4. Financial problems of the parents;
5. Lack of permanent address;
6. Postnatal age \> 10 hrs

Primary outcomes:
measure: Mortality and disability rate.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: NICU, the Third Affiliated Hospital, Zhengzhou University
state: Henan
Study officials:
affiliation: Zhengzhou University
name: Changlian Zhu, MD, PhD
role: STUDY_DIRECTOR
References: