louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01379495: Education Program for Burn Patients
Official title: Randomized Controlled Clinical Trial on Telephone Follow-up in Rehabilitation of Burn Patients: Impact on Health Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: burns
rehabilitation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-06-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effect of an educative program including telephone follow-up for burn patients regarding the impact of this intervention on the health status and return to work at six months after hospital discharge.


Eligibility criteria: Inclusion Criteria:

* adult burned patients (18 years or older), male and female
* patients burned for the first time who needed hospitalization at the Burns Unit
* in cognitive conditions to participate (being able to tell one's address, day of the week and age or birth date)
* in physical conditions to accomplish self-care.

Exclusion Criteria:

* participants burned due to suicide or with previous psychiatric diagnoses or cognitive and psychological difficulties that do not allow them to answer the instrument questions and take care of themselves.

Primary outcomes:
measure: change from baseline in perceived health status at six months
timeFrame: six months
Secondary outcomes:
measure: comparison the return to work of burn victims between groups
timeFrame: baseline and six months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Burns Unit of the University of São Paulo at Ribeirão Preto Hospital das Clínicas
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Natália Gonçalves, PhDcandidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Lidia Ap Rossi, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04106895: Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
Official title: Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 200
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: Patients having received Fibryga® ("on-demand" or for regular prophylaxis) in the centres participating in the study during the recollection period (limited to 7 patients by centre and by period). A total of 4 recollection periods is planned by centre.

Data from all consecutive patients having received Fibryga® whatever the indication (congenital or acquired fibrinogen deficiency; "on-demand" or regular prophylaxis) will be collected. The data collection will be limited to 7 patients by centre and by period, meaning that only data from the 7 first patients treated during the recollection period willbe collected.

Brief summary: To describe the characteristics of patients treated with Fibryga®, the indications and conditions of use of Fibryga® and, for patients treated " on-demand", the short-term outcomes.


Eligibility criteria: Inclusion Criteria:

* Patient with fibrinogen deficiency (congenital or acquired)
* Having received an treatment with Fibryga® during the recollection period
* Having been informed of the potential retrospective collection of their data by a Clinical Research Associate mandated by Octapharma® when Fibryga® has been delivered and who did not refuse.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: proportion of treatments given for an ongoing bleeding episodes
timeFrame: 6 months
Secondary outcomes:
measure: On-demand Treatment Success
timeFrame: 6 months
measure: Surgical Prophylaxis Success
timeFrame: 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux Study Site
city: Le Plessis-Robinson
country: France
facility: Le Plessis Robinsin Study Site
city: Marseille
country: France
facility: Marseille Study Site
city: Nantes
country: France
facility: Nantes Study Site
city: Valence
country: France
facility: Valence Study Site
Study officials:
References:
Clinical trial NCT02020395: Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
Official title: Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endocrine System Diseases
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2013-12-24
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide (GLP)-1 responses to a test meal in lean and obese individuals.

Detailed description: The primary hypothesis is that obese adolescents have a disturbed balance of hormones associated with appetite regulation with less suppression of ghrelin and attenuated stimulation of GLP-1 secretion in response to meal intake compared to lean normal weight controls. A second aim of the study was to test which gastrointestinal peptides are most associated with insulin resistance.

Eligibility criteria: Inclusion Criteria:

* caucasian youth
* pubertal Tanner stage x, y, or z

Exclusion Criteria:

* fasting plasma glucose \> 7.0 mmol/L
* significant illness
* taking medications

Primary outcomes:
measure: Comparison of gastrointestinal peptide secretion in normal weight and obese adolescents
timeFrame: 2 hours blood sampling
Secondary outcomes:
measure: Association between gastrointestinal peptides and insulin release
timeFrame: 2 hours blood sampling
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Division of Gastroenterology and Hepatology
Study officials:
affiliation: Division of Gastroenterology and Hepatology, University Hospital Basel
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03784495: Melatonin Plus Aminoacids for Sarcopenic Elderly
Official title: Is a Combination of Melatonin and Aminoacids Useful to Sarcopenic Elderly Patients? A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 159
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of melatonin and essential aminoacid supplementation on body composition, protein metabolism, strength and inflammation. The investigators performed a Randomized controlled parallel groups preliminary trial in 159 elderly sarcopenic people (42/117 men/women) assigned to 4 groups: isocaloric placebo (P, n=44), melatonin (M, 1 mg/daily, n=42,), essential aminoacids (eAA 4 g/daily, n=40) or eAA plus melatonin (eAAM, 4 g eAA and 1 mg melatonin/daily, n= 30). The period of intervention was 4 weeks. Data from body composition (DXA), strength (handgrip test) and biochemical parameters for the assessment of protein metabolism (albumin) and inflammation (PRC) were collected at baseline and after the 4-week intervention


Eligibility criteria: Inclusion Criteria:

* Aged \> or equal 65 years
* Sarcopenic patients, following the Rosetta Study criteria: Skeletal Muscle Index \[SMI\] was \<7.23 kg/m2 in men and \<5.45 kg/m2 in women) and loss of strength, evaluated by dynamometer and defined as \<30 kg for men and \<20 kg for women, using the average value of the two handgrip measurements of the dominant hand.

Exclusion Criteria:

* acute illnesses
* severe liver dysfunction
* severe heart dysfunction
* severe kidney dysfunction
* severe dementia
* uncontrolled diabetes
* dysthyroidism
* any endocrinopathies
* neoplasia
* patients treated with steroids
* patients entirely unable to walk

Primary outcomes:
measure: Change in Total Fat Mass and Total Free Fat Mass (DXA)
timeFrame: 0, 30 days
measure: Change in Handgrip Strenght
timeFrame: 0, 30 days
Secondary outcomes:
measure: Height
timeFrame: At baseline (0)
measure: Change in Body Weight
timeFrame: 0, 30 days
measure: Change in serum proteins
timeFrame: 0, 30 days
measure: Change in blood lipids (total cholesterol and triglycerides)
timeFrame: 0, 30 days
measure: Change in High-sensitivity C-reactive protein (CRP)
timeFrame: 0, 30 days
measure: Change in erythrocyte sedimentation rate (ESR)
timeFrame: 0, 30 days
measure: Change in glycaemia
timeFrame: 0, 30 days
measure: Change in Mini Nutritional Assessment (MNA)
timeFrame: 0, 30 days
measure: Change in dietary intake
timeFrame: Measures taken at day 1,2,3 and at day 28,29,30
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Geriatric physical medicine and rehabilitation division at the Istituto Santa Margherita - Azienda di Servizi alla Persona di Pavia
Study officials:
affiliation: IRCCS Mondino Foundation, Pavia
name: Mariangela Rondanelli, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00187395: CHIPS (Control of Hypertension in Pregnancy Study): A Pilot Trial
Official title: Control of Hypertension in Pregnancy Study: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Hypertension, Pregnancy
Keywords: hypertension
blood pressure
pregnancy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-09-16
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prior to undertaking CHIPS which will be a large and difficult trial, we believe we need to first determine whether clinicians will comply with the interventions of 'less tight' and 'tight' control of dBP, and whether the interventions will result in differences in mean dBP between groups. A pilot will also allow us to confirm the ability of centres to identify eligible women and the willingness of women to join CHIPS.

Detailed description: To determine whether 'less tight' control of mild-moderate non-proteinuric maternal hypertension, aiming for a diastolic blood pressure (dBP) of 100mmHg, can decrease the risks of adverse perinatal outcome without increasing maternal risk compared with 'tight' control, aiming for a dBP of 85mmHg.

Eligibility criteria: Inclusion Criteria:

* dBP 90-109mmHg due to pre-existing or gestational hypertension; live fetus(es); and 20-33+6 weeks.

Exclusion Criteria:

* dBP consistently \< 85mmHg by home BP monitoring; severe systolic hypertension; proteinuria; contraindication to either arm of the trial or to prolongation of pregnancy; or known lethal/major fetal anomaly.

Primary outcomes:
measure: Mean dBP at 28, 32 and 36 weeks gestation
Secondary outcomes:
measure: Clinician compliance with treatment protocols; women's satisfaction with care.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Maternal Infant and Reproducting Health Research Unit - CHIPS Data Coordinating Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Laura Magee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05848414: Short Term Outcomes in Hospitalized Patients With Liver Cirrhosis
Official title: Short Term Outcomes in Hospitalized Patients With Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-08
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: All liver cirrhosis patients admitted to hospital

Brief summary: This study will be conducted to assess the baseline characteristics and evaluate the 90-day mortality of patients admitted with liver cirrhosis. Also, the study will be done to identify the risk factors of 90-day mortality.

Detailed description: Liver cirrhosis is the end spectrum of all chronic liver diseases characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to hepatic architectural distortion.

Liver cirrhosis is a major cause of health burden worldwide. According to the Global Burden of Disease study, liver cirrhosis caused 1.2% of global disability-adjusted life years and 2% of all deaths worldwide in 2010, the 14th leading cause of mortality.

The progress rate of compensated cirrhosis to decompensated cirrhosis is approximately 58% and once it progresses to decompensated cirrhosis, its mortality rate within 5 years becomes 85% without liver transplantation. Since the progression of cirrhosis is accelerated each time a complication recurs, the management and treatment of the complication are critical in enhancing the quality of life and the life expectancy of patients .

Post-discharge outcomes are an integral component of healthcare, as they may aid in determining the success and longevity of treatment and how clinicians approach future cases .

This study will focus on the short-term outcomes of patients hospitalized with liver cirrhosis to provide insight into methods for future healthcare interventions.

Eligibility criteria: Inclusion Criteria:

- diagnosis of liver cirrhosis, adult (age ≥ 18 years old) and patients willing to give consent during the selected period.

Exclusion Criteria:

- Patients with ages \< 18 years or patients that will be lost on follow-up will be excluded from the study.

Primary outcomes:
measure: evaluate the 90-day mortality of patients admitted with liver cirrhosis
timeFrame: 90 days
Secondary outcomes:
measure: identify the risk factors of 90-day mortalit
timeFrame: 90 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Esraa Hassan Mohamed Kotbey
Study officials:
affiliation: AhlamGastro2000@yahoo.com
name: Ahlam M Farghaly
role: STUDY_DIRECTOR
References:
citation: Tsochatzis EA, Bosch J, Burroughs AK. Liver cirrhosis. Lancet. 2014 May 17;383(9930):1749-61. doi: 10.1016/S0140-6736(14)60121-5. Epub 2014 Jan 28.
Clinical trial NCT03683914: Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients
Official title: Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Office Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 102
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Detailed description: hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body.Cervical ripening is made possible by the use of medication through different routes.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Eligibility criteria: Inclusion Criteria:

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion Criteria:

* • Nulliparous patients

  * patients with cervical pathology
  * retroverted uterus (detected by transvaginal ultrasound)
  * previous cervical surgery
  * patients with severe vaginal bleeding
  * allergy or contraindications to dinoprostone therapy (asthma, liver, kidney, or heart disease).

Primary outcomes:
measure: Intensity of pain
timeFrame: an expected average of 10 minutes
Secondary outcomes:
measure: Intensity of pain
timeFrame: 30 minutes after the procedure
measure: Operative time
timeFrame: an expected average 10 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Cairo University
Study officials:
affiliation: Cairo University
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05282914: A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics Between "UI058" and "UIC202004" in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-16
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in healthy subjects


Eligibility criteria: Inclusion Criteria:

* Subjects able to read and understand a written informed consent, and willing to decide to participate in the study
* Healthy subjects between the ages of 19 and 55 years at screening
* Body weight more than 50.0kg(male)/45.0kg(female)
* Body Mass Index more than 18.0kg/m2 and under 30.0kg/m2

Exclusion Criteria:

* Have clinically significant disease that hepatobiliary system, kidney, respiratory system, nervous system, hemato-oncology disease, cardiovascular system
* Have a gastrointestinal disease history that can effect drug absorption or surgery
* Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product

Primary outcomes:
measure: AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state
timeFrame: Day 7, 0~24hours
measure: percent change from baseline in integrated gastric acidity for 24-hour interval after 7th dose
timeFrame: baseline versus multiple dose during 7days
Secondary outcomes:
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk national university hospital
state: Chungcheongbuk-do
Study officials:
affiliation: Chungbuk National University Hospital
name: Min Kyu Park, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01731314: The Learning and Memory of the Experience of Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study investigates the learning and memory of pain.


Eligibility criteria: Inclusion Criteria:

1. Male and female healthy volunteers.
2. 18-65 years of age.
3. Right-handed.
4. Fluency in English. Ability to read and understand English; English can be a second language provided that the participant feels that he/she is able to understand all the questions used in the assessment measures.

Exclusion Criteria:

1. Any previous experience with conditioned analgesia/hyperalgesia paradigms.
2. Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids.
3. Unwillingness to receive brief pain stimulation administered by a heat probe on the hand.
4. Instability of responses to experimental heat pain
5. Any contraindications to fMRI scanning for subjects in Experiment 2 (including metal implants, claustrophobia, history of head trauma, and pregnancy).
6. Peripheral neuropathy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: MGH East Campus, 149 13th St.
state: Massachusetts
Study officials:
References:
Clinical trial NCT00374114: A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia
Official title: A Pilot Study to Evaluate Ultrasonic Surgical Aspiration as a Treatment Modality for Cervical Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dysplasia
Keywords: cervical
dysplasia
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Integra LifeSciences Corporation
First posted: 2006-09-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ultrasonic surgical aspiration of the cervix may be an effective method of treating cervical dysplasia without compromising the integrity of the cervix in reproductive age women.

Detailed description: Women age 18 to 55 years of age with Cervical Intraepithelial Neoplasia 2 or 3 on colposcopy with a negative EndoCervical Curettage are enrolled in a pilot study comparing ultrasonic surgical aspiration and traditional cervical excision procedure for the treatment of cervical dysplasia. In this pilot study, the patients serve as their own control group. Prior to receiving the traditional treatment for cervical dysplasia consisting of Cold Knife Conization with EndoCervical Curettage, each patient's cervix is treated with ultrasonic surgical aspiration. The aspirate is sent to pathology and the results compared with the findings from the cervical cone biopsy. The patients then are followed with Liquid-based Cytology pap smears every 4 to 6 months until completion of the study enrollment/treatment period.

Eligibility criteria: Inclusion Criteria:

* cervical intraepithelial neoplasia II or III
* negative endocervical curettage
* not pregnant
* cervical conization is part of treatment plan

Exclusion Criteria:

* positive endocervical curettage
* pregnant
* medically unable to undergo surgery

Primary outcomes:
measure: Adequate treatment of cervical dysplasia
Secondary outcomes:
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: University of Tennessee College of Medicine
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Sciences Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Stephen DePasquale, DO
role: PRINCIPAL_INVESTIGATOR
References: