louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03743857: Effects of Improvement of the Ankle Joint Range on Balance in the Elderly.
Official title: Effects of Improvement of the Ankle Joint Range on Balance in the Elderly: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Problems
Keywords: Ankle
Balance
Manual Therapy
Older Adult
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effects of aging on the ankle joint will contribute negatively to balance in the elderly. Manual therapy is a technique that is usually used to treat ankle arthrokinematics, although there is little literature on this population. This study seeks to investigate the effects that a mobilization on the ankle will produce in order to improve its joint range and if the balance of the older adult improves after the intervention.


Eligibility criteria: Inclusion Criteria:

* 60 years or more

Exclusion Criteria:

* Do not sign the consent
* No acute pathology (3 months)
* Vestibular pathology
* CNS disease

Primary outcomes:
measure: Test Up and Go
timeFrame: Change from baseline to day 21
measure: One Leg Balance Test
timeFrame: Change from baseline to day 21
measure: Functional Reach Test
timeFrame: Change from baseline to day 21
measure: Analysis of Center of Pressure
timeFrame: Change from baseline to day 21
Secondary outcomes:
measure: Active ankle range of movement
timeFrame: Change from baseline to day 21
measure: Weight Bearing Dorsiflexion Lunge Test
timeFrame: Change from baseline to day 21
measure: Falls Efficacy Scale
timeFrame: Change from baseline to day 21
measure: Assessment of ankle plantar flexion muscle strength
timeFrame: Change from baseline to day 21
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universidad de Valencia
Study officials:
affiliation: Study Principal Investigator
name: David Hernández-Guillén, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924157: Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease
Official title: Effect of a Protein Hydrolysate Rich in Lacto-tripeptide (IPP) on Hyperemic Blood Flow and Flow-mediated Dilation in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the function of the endothelium in patients with coronary artery disease. The study has a crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12 weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The investigators will use ultrasound to test the function of the endothelium in the brachial artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected before and after each treatment. The investigators hypothesize that IPP will improve endothelial function.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Treatment with an ACE inhibitor or ARB
* Pregnancy
* Other major illness
* Treatment with an investigational drug within 4 weeks

Primary outcomes:
measure: Brachial Artery Flow-Mediated Dilation and Reactive Hyperemia
timeFrame: 12 weeks
Secondary outcomes:
measure: Carotid-Femoral Pulse Wave Velocity
timeFrame: 12 weeks
measure: Leg Reactive Hyperemia
timeFrame: 12 weeks
measure: Digital Pulse Amplitude Tonometry
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Joseph A Vita, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03043157: Rocuronium Effective Dose for Laparoscopic Cholecystectomy
Official title: Rocuronium ED50 for Excellent Laparoscopic Conditions for Cholecistectomy: Dose-finding Adaptative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Muscle Relaxation
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Dose-finding using Dixon's up-and-down adaptative clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an adaptative study where each participant's rocuronium dose will depend on the previous patient's response, being higher if it was not enough and lower if it was more than enough.

Detailed description: Rocuronium is one of the most used neuromuscular blockers to help intubation and to relax abdominal wall for laparoscopic surgery.

Rocuronium intubation dose can be enough for intubation but not last enough for excellent laparoscopic conditions. There is little variation in time from anesthesia induction to the end of the laparoscopy for cholecystectomy and avoiding excess rocuronium dose can help providing excellent conditions and fast track extubation.

Dixon's up-and-down method will guide this dose-finding study for the ED50.

Eligibility criteria: Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* deny participation

Primary outcomes:
measure: Excellent laparoscopic conditions
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital das Forças armadas
state: Distrito Federal
Study officials:
affiliation: Universidade de Brasilia
name: Gabriel MN Guimaraes, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02239757: Left vs Right Radial Approach in the Setting of Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transradial Approach, Primary PCI, ST-segment Elevation Myocardial Infarction
Keywords: Transradial Approach, Primary PCI, ST-segment elevation myocardial infarction
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Outcomes of patients with acute ST-elevation myocardial infarction (STEMI) are directly related to reperfusion time. Effect of transradial approach (left vs right) on reperfusion time has not been fully studied for SETMI patients undergoing primary percutaneous coronary intervention (PCI). The aim of this study was to randomly investigate the efficacy and safety of left radial approach for primary PCI in STEMI patients compared with right radial approach.

Detailed description: The investigators will enroll consecutively for 3 years all STEMI patients undergoing primary PCI.

Patients will be included within 12 hours of symptom onset for primary PCI. Patients will be excluded if they are in cardiogenic shock.

Eligibility criteria: Inclusion Criteria:

All consecutive patients with ST-segment elevation myocardial infarction within 12 hours of symptom onset for primary PCI.

Exclusion Criteria:

Patients are excluded if they were in cardiogenic shock.

Primary outcomes:
measure: Needle to balloon time
timeFrame: 1 day
Secondary outcomes:
measure: Radiation dose
timeFrame: 7 days
measure: Fluoroscopy time
timeFrame: 7 days
measure: Contrast volume
timeFrame: 7 days
Other outcomes:
measure: Vascular complications
timeFrame: 7 days
Locations:
city: Beijing,
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Buxing Chen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu H, Fu Q, Chen W, Wang D, Hua X, Chen B. A prospective randomized comparison of left and right radial approach for percutaneous coronary angiography in Asian populations. Clin Interv Aging. 2014 Jun 20;9:963-8. doi: 10.2147/CIA.S64235. eCollection 2014.
Clinical trial NCT02827357: Responses to Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation
Official title: Review of Responses to Systemic Chemotherapy of Patients With Non-small Cell Lung Cancer Harboring a Known Somatic Activating HER2 Mutation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with advanced nonsmall-cell lung cancer (NSCLC), a known HER2 exon-20 insertion, treated with chemotherapy and/or HER2-targeted drugs

Brief summary: This chart review describe the response to systemic chemotherapy of patients with non-small cell lung cancer (NSCLC) harbouring a known somatic activating human epidermal growth factor receptor 2 (HER2) mutation. The analysis of this data will provide an initial description of the response to systemic chemotherapy in patients with NSCLC harboring an activating HER2 mutation in order to inform the design and powering of future randomized controlled clinical trials of HER2-directed therapy.


Eligibility criteria: Inclusion Criteria:

* patients with advanced nonsmall-cell lung cancer
* known HER2 exon-20 insertion
* treated with chemotherapy and/or HER2-targeted drugs

Exclusion Criteria:

* none

Primary outcomes:
measure: Overall response rate
timeFrame: 24 months
Secondary outcomes:
measure: Median progression-free survival (PFS) with conventional chemotherapy
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Toulouse
name: MAZIERES Julien, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165757: The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers
Official title: The Effects of Non Harmonic and White Noise on Human Pain Sensitivity: a Study of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Noise
Pain
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Study the effects of 60dB and 80dB white noise, 50-70dB and 70-90dB non harmonic tones on the basic pain threshold of subjects, including the threshold and tolerance of electrical stimulation pain,the threshold and tolerance of cold pain stimulation, and the threshold and tolerance of tenderness stimulation.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 35, regardless of gender
* No serious chronic diseases
* There is no self-reported history of chronic opioid drug use or neuropathy

Exclusion Criteria:

* A history of alcohol or drug abuse
* Pregnant or lactating
* Severe cardiovascular, kidney, or liver diseases

Primary outcomes:
measure: mechanical pain sensitivity
timeFrame: from the study beginning to 30 min after the procedure
measure: cold pain sensitivity
timeFrame: from the study beginning to 30 min after the procedure
measure: electrical pain sensitivity
timeFrame: from the study beginning to 30 min after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital, Chongqing Medical University
name: He Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01448057: Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Official title: A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Upper Respiratory Tract Infection
Nasal Congestion
Rhinorrhea
Sneezing
Keywords: Paracetamol
dimethindene maleate
phenylephrine hydrochloride
cold and flu symptoms
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).


Eligibility criteria: * Inclusion criteria:

  • acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea.
* Exclusion criteria:

  * Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.
  * History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Physician Global Evaluation of Effectiveness on Nasal Symptoms
timeFrame: Day 2
Secondary outcomes:
measure: Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms
timeFrame: Day 3
Other outcomes:
Locations:
city: Belo Horizonte/MG
country: Brazil
facility: Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia
city: Campinas/SP
country: Brazil
facility: Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades
city: Fortaleza/CE
country: Brazil
facility: Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -
city: Jau/SP
country: Brazil
facility: Polonio Clinica De Servicios Medicos EM Gastroenterologia E Cirurgia Toracica S/S LTDA - ME, Rua Major Alfredo Servulo de Oliveira Romao, 103, Chacara Braz Miraglia
city: Sao Paulo
country: Brazil
facility: Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino
city: São Paulo
country: Brazil
facility: : Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos
Study officials:
References:
Clinical trial NCT00075257: Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of DVS-233 SR For Prevention Of Depressive Relapse In Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2004-01-09
Enrollment: 603
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: Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis.

Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] \< 7).


Eligibility criteria: Inclusion criteria in the open-label phase:

* Outpatients
* Men and women 18 to 75 years of age, inclusive. Sexually active women participating in the study must use a medically acceptable form of contraception (Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception)
* Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features (If other allowable psychiatric diagnoses are present, MDD must be the predominant psychiatric disorder present.)

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or ER) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 26;17(1):10.4088/PCC.14m01681. doi: 10.4088/PCC.14m01681. eCollection 2015.
citation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
Clinical trial NCT02647957: A Study of the Efficacy of the Code Stroke in Spain
Official title: Indicators for Quality Assessment of Hospitalized Ischemic Stroke Patients. A Study of the Efficacy of the Code Stroke in Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: acute ischemic stroke
quality
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Ramon y Cajal
name: Hospital Serranía de Ronda
name: Hospital of Navarra
name: Hospital Virgen de la Concha
name: Hospital of Jaen
name: Hospital General San Jorge
First posted: 2016-01-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Code Stroke is a system for the rapid identification, pre-notification and transport of acute ischemic stroke patients. The objective of this study was to define quality indicators and to compare treatment outcomes in hospitals where Code Stroke has been implemented and hospitals without the use of Code Stroke (control patients).

Detailed description: In a first step qualitative technique has been conducted to define treatment quality indicators of acute ischemic stroke patients. In a second step a prospective study is conducted to collect data of 240 inpatients from two groups of hospitals. Two hospitals applying Code Stroke (N= 120) and four hospitals non-applying Code Stroke procedure (N=120). A consecutive sampling method will be conducted. Inclusion criteria: acute ischemic stroke patients treated in the hospitals during the field study. The referral to the hospital could be from primary care, Emergency Unit of other hospital. Patients will enroll after inform consent.

A Singer-blind- research method will applied. Quality indicators defined in the first phase will be applied and comparisons will be realized using ANOVA.

Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke in-patients

Exclusion Criteria:

* Patients who refuse participate

Primary outcomes:
measure: Recovery rate of the Intravenous trombolysis treatment
timeFrame: 1 month
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 1 month
measure: Patient engage
timeFrame: 1 month
measure: response capacity
timeFrame: 1 day
measure: Treatment adequacy: Intravenous trombolysis treatment
timeFrame: 1 month
measure: Patient safety. Complications in the recombinant tissue plasminogen activator treatment after tromobysis
timeFrame: 1 month
measure: Mortality rates of the Intravenous trombolysis treatment
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Alvarez Sabin J, Molina C, Abilleira S, Montaner J, Garcia F, Alijotas J. ["Stroke code". Shortening the delay in reperfusion treatment of acute ischemic stroke]. Med Clin (Barc). 1999 Oct 23;113(13):481-3. Spanish.