louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05786339: Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects
Official title: Bioequivalence Study of Two Irbesartan in Healthy Chinese Subjects: an Open, Randomized, Single-Dose and Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female aged over 18years
2. Subjects willing to provide written informed consent and to adhere to protocol requirements
3. Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)), males with minimum of 50 kg weight, females with minimum of 45kg weight.
4. Subjects have not clinically significant abnormalities, including vital signs, physical examinations, laboratory tests, and ECG as determined by clinical examination

Exclusion Criteria:

1. History or presence of significant cardiovascular, Urogenital, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder
2. Allergic constitution(Allergic to two or more substances) or hypersensitivity to investigational product
3. History or presence of significant gastrointestinal inflammation /ulcer. or other medical history affecting drug absorption
4. Use of any drugs or herbal medicine within 14 days prior to the first dose
5. Can not follow approved birth control methods (a double barrier method) from the screening（Female subjects from two weeks prior to the screening） till 3 months after the last dose -

Primary outcomes:
measure: Cmax
timeFrame: 48hours
measure: AUC0-t
timeFrame: 484hours
measure: AUC0-∞
timeFrame: 48hours
Secondary outcomes:
measure: safety
timeFrame: 30days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University Phase I Clinical Research Center
state: Shandong
Study officials:
affiliation: The Affiliated Hosptial of Qingdao University
name: Yu Cao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770639: A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
Official title: A Retrospective Study to Assess the Outcome After Surgical Reconstruction of the Midfoot With the Midfoot Fusion Bolt in Patients With Neuroarthropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Charcot Neuroarthropathy
Diabetic Foot
Keywords: charcot foot
charcot neuroarthropathy
midfoot arthrodesis
midfoot fusion
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuro-osteoarthropathy of the foot or with other neurological impairment in combination with foot deformity who have previously undergone surgical reconstruction of the midfoot with the Midfoot Fusion Bolt.

Brief summary: The aim of this study is to investigate the clinical outcomes of surgical correction of foot deformity with the MFB in a larger group of patients with neurological impairment of the foot.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 at date of inclusion
* Previous surgical reconstruction of the midfoot with Midfoot Fusion Bolt(s) for one of the following indications:

Neuroarthropathy Deformity of the foot with neurological impairment - Signed informed consent according to local regulation

Exclusion Criteria:

- Prisoner at date of inclusion

Primary outcomes:
measure: Treatment failure within the first year after surgery
timeFrame: Date of surgery to 1 year posto-op
Secondary outcomes:
measure: Treatment failure within the first two years after surgery
timeFrame: Date of surgery to 2 years post-op
measure: Adverse events related to the treatment or device under investigation
timeFrame: Date of surgery to 2 years post-op
measure: Immobilization and non-weightbearing
timeFrame: Date of surgery to time of full weightbearing
measure: Surgery details
timeFrame: Date of surgery
measure: Foot angles
timeFrame: Pre-op, post-op, 6w, 12w, 6m, 12m
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Rostock
country: Germany
facility: Universität Rostock
city: Rummelsberg
country: Germany
facility: Klinik für Fuss und Sprunggelenkchirurgie Rummelsberg
Study officials:
References:
citation: Richter M, Mittlmeier T, Rammelt S, Agren PH, Hahn S, Eschler A. Intramedullary fixation in severe Charcot osteo-neuroarthropathy with foot deformity results in adequate correction without loss of correction - Results from a multi-centre study. Foot Ankle Surg. 2015 Dec;21(4):269-76. doi: 10.1016/j.fas.2015.02.003. Epub 2015 Mar 9.
Clinical trial NCT02549339: Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest including12-month Follow-up
Official title: Efficacy and Safety of LEO 43204 in the Field Treatment of Actinic Keratosis on Face or Chest Including 12-month Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 383
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 objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on face or chest when applied topically once daily for 3 consecutive days as field treatment


Eligibility criteria: Inclusion Criteria:

* Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on either the full face or a contiguous area of approximately 250 cm2 (40 in2) on the chest
* Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 in2). The tracking area must be within the treatment area

Exclusion Criteria:

* Location of the treatment area (full face or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
* Treatment with ingenol mebutate gel in the treatment area within the last 12 months
* Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
* History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)

Primary outcomes:
measure: Complete Clearance of Actinic Keratosis (AK)
timeFrame: At Week 8
Secondary outcomes:
measure: Percentage of Participants With Partial Clearance (Multiple Imputation)
timeFrame: At Week 8
measure: Percentage of Participants With Partial Clearance (Multiple Imputation)
timeFrame: At Week 4
measure: Percent Reduction in AK Count in the Treatment Area Compared to Baseline
timeFrame: At Week 8
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
Study officials:
affiliation: Laser & Skin Surgery Center of Indiana
name: C. William Hanke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01856439: Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease
Official title: A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Parkinson's Disease
Keywords: ProSavin
Gene therapy
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
Collaborators: name: Oxford BioMedica
First posted: 2013-05-17
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .


Eligibility criteria: Inclusion Criteria:

* must have met all inclusion criteria for study PS1/001/07
* willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication.
* affiliated with the French social security health care system (Patients enrolled in France only)
* signed and dated written informed consent obtained from the patient and/or the patient's legally acceptable representative, if applicable, in accordance with the local regulations
* must have been treated with ProSavin/Sham

Exclusion Criteria:

-

Primary outcomes:
measure: To assess the long term safety and tolerability of ProSavin
timeFrame: 10 years
Secondary outcomes:
measure: Patients' responses to ProSavin administration
timeFrame: 10 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Henri Mondor Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
Study officials:
affiliation: Henri Mondor University Hospital
name: Stephane Palfi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Roger Barker, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palfi S, Gurruchaga JM, Ralph GS, Lepetit H, Lavisse S, Buttery PC, Watts C, Miskin J, Kelleher M, Deeley S, Iwamuro H, Lefaucheur JP, Thiriez C, Fenelon G, Lucas C, Brugieres P, Gabriel I, Abhay K, Drouot X, Tani N, Kas A, Ghaleh B, Le Corvoisier P, Dolphin P, Breen DP, Mason S, Guzman NV, Mazarakis ND, Radcliffe PA, Harrop R, Kingsman SM, Rascol O, Naylor S, Barker RA, Hantraye P, Remy P, Cesaro P, Mitrophanous KA. Long-term safety and tolerability of ProSavin, a lentiviral vector-based gene therapy for Parkinson's disease: a dose escalation, open-label, phase 1/2 trial. Lancet. 2014 Mar 29;383(9923):1138-46. doi: 10.1016/S0140-6736(13)61939-X. Epub 2014 Jan 10.
Clinical trial NCT02657239: Mobility & Vitality Lifestyle Program
Official title: Health Promotion and Disease Prevention Research Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Physical Function
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-01-15
Enrollment: 303
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: MOVE UP is a weight management program for adults 60-75 in community settings led by trained community health workers.

Detailed description: MOVE UP is a weight management program designed for adults who desire to lose weight and improve their overall health.

Topics include: Overall Health, Weight management, Healthy eating, Behavior change, Physical activity

Eligibility criteria: Inclusion Criteria:

1. Age 60-75 at time of program start
2. Self-reporting \< 60 minutes per week of moderate structured physical activity
3. BMI \>= 30 but \< 40 for screen. In person measurement on site will allow for 27-45 as inclusion criteria.
4. Able to consent for participation and data collection
5. Medical release before start of Weight Management
6. Ability to walk with or without an assistive device
7. Can regularly attend sessions
8. Has not had bariatric surgery over the past year, or current use of weight loss prescription drug.

Exclusion Criteria:

1. Uncontrolled diabetes mellitus (FBS \> 300 \& A1C \> 11%) \[to be assessed by physician on medical release\]
2. Uncontrolled hypertension (SBP \> 180/110) %) \[to be assessed by physician on medical release\]
3. Recent hospitalization (past 6 months)
4. Active treatment for cancer (other than non-melanoma skin cancer)
5. Significant visual or hearing impairment
6. Dementia/psychiatric disorder
7. Inability to communicate in English/lack of translator

Primary outcomes:
measure: Short Physical Performance Battery
timeFrame: 1 year
Secondary outcomes:
measure: Self-reported Physical Function
timeFrame: 1 year
measure: Weight
timeFrame: 1 year
measure: Height
timeFrame: 1 year
measure: BMI
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Community sites
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Anne B. Newman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu X, King J, Boak B, Danielson ME, Boudreau RM, Newman AB, Venditti EM, Albert SM. Effectiveness of a behavioral lifestyle intervention on weight management and mobility improvement in older informal caregivers: a secondary data analysis. BMC Geriatr. 2022 Jul 28;22(1):626. doi: 10.1186/s12877-022-03315-w.
Clinical trial NCT01251939: Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious
Official title: Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ductus Arteriosus, Patent
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants who born in Zekai Tahir Burak Maternity and Teaching Hospital between january 2011 and january 2012 and met the entry criteria first underwent echocardiography and cranial ultrasonography.

Brief summary: Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.

Detailed description: Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.

Eligibility criteria: Inclusion Criteria:

* Gestational age \<32 weeks and \<1500 g
* Echocardiographic evidence of hemodynamically significant patent ductus arterious

Exclusion Criteria:

* Major congenital anomalies
* Intraventricular hemorrhage of grade 3 within the previous 24 hours
* Serum creatinine level 1.5 mg%,serum urea nitrogen concentration \>50 mg%,
* Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites)
* Hyperbilirubinemia necessitating exchange transfusion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Zekai Tahir Burak Maternity and Teaching Hospital
Study officials:
affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
name: Nilufer Guzoglu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896739: A Phase III Study to Assess the Immunogenicity and Safety of Eutravac (DTap-HB Combined Vaccine) With DTaP and Hepatitis B Vaccines in Healthy Infants
Official title: A Multicentre, Comparative, Open-label, Randomized, Phase III Study to Assess the Immunogenicity and Safety of EutravacTMinj (DTaP-HB Combined Vaccine) Administered at 2,4, 6 Months of Age Compared With DTaP Vaccine at 2, 4, 6 Months of Age Combined Administered Monovalent Hepatitis B Vaccine Administered at Birth, 1, 6 Months of Age in Healthy Infants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Infants
Keywords: Healthy infants with over than 37 weeks gestation periods.
over than 2.5Kg at at birth weight.
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 289
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate and compare the immunogenicity of Eutravac (Diphtheria-Tetanus-acellular Pertussis \[DTaP\] Hepatitis B \[HB\] combined) vaccine with separate but simultaneous administrations of DTaP and HB vaccine each administered to healthy infants, as measured by seroprotection/vaccine response rates 4-8 weeks post-final immunisation.


Eligibility criteria: Inclusion Criteria:

* Were healthy, male or female infants born at full term pregnancy (≥37 weeks) with a birth weight ≥2.5 kg to mothers with a negative HBsAg serology, documented prior to giving birth as per routine, site-specific ante-natal care procedures.
* Signed parental or legally acceptable representative's informed consent was obtained

Exclusion Criteria:

* Evidence of an acute febrile illness with axillary temperature ≥37.5℃ on the day of the vaccination. Infants with symptoms of minor illness eg, mild gastroenteritis, mild upper respiratory tract infection and who did not have a temperature ≥37.5℃ on the day of the vaccination could be included at the Investigator's discretion
* History of diphtheria, tetanus, pertussis or hepatitis B disease
* History of any vaccine-related hypersensitivity or anaphylactic reaction after previous administration of Euvax B

Primary outcomes:
measure: Seroprotection rate
timeFrame: After final immunisation at 4-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea ST. Vincent's Hospital
state: Gyeonggi-do
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Cha Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
Study officials:
References:
Clinical trial NCT06137339: AvoCog - the Effect of Daily Avocado Intake on Cognitive Function in Older Adults
Official title: AvoCog - The Effect of Daily Avocado Intake on Cognitive Function in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Aging
Keywords: Older Adults
Brain Health
Avocado
Brain Imaging
Cognition
Dietary Intervention
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Avocado Nutrition Center
First posted: 2023-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomly assigned equally to either the intervention or the control group.
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to determine if adding avocados to the diet of impacts cognition in 70 older adults, age 65-85, without dementia. We will test for change in functional MRI, cognitive performance, and brain blood flow. Intervention group participants will be asked to consume 1 avocado per day for 12 weeks. Participants in the control group will be asked to continue their normal intake for 12 weeks. Throughout the study, participants will be asked to perform cognitive tests, MRI, blood tests, and questionnaires.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 65-85 years
* Good general health with no concomitant disease
* BMI 18.5 - 35 kg/m2
* Mini Mental State Exam ≥26
* Reports consuming ≤2 medium avocados per month
* Reports consuming ≤3 servings of carotenoid-rich foods per week and ≤3 servings of fruits and vegetables per day
* Skin carotenoid content \<400

Exclusion Criteria:

* Unwilling or unable to consume avocado
* Latex allergy
* Consistently taking lutein + zeaxanthin supplements
* Skin carotenoid content ≥400
* Central neurological disease such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, stroke, brain tumor, etc.
* Serious medical risk: cancer requiring chemotherapy or radiation within the past 5 years, recent cardiac event (i.e. heart attack, etc.)
* Diabetes mellitus or uncontrolled hypertension
* Use of psychoactive or investigational medications
* Consumption of ≥3 alcoholic drinks per day or substance abuse
* Unable to undergo MRI

Primary outcomes:
measure: Change in brain activity
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Changes in cerebral blood flow
timeFrame: Baseline and 12 weeks
measure: Changes in memory and executive function
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References: