louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00937534: Study to Compare and Assess the Safety and Pharmacokinetic Characteristics After Oral Administration of Fimasartan (BR-A-657∙K) in Healthy Elderly and Young Male Volunteers
Official title: An Open Label, Single-dosing, and Parallel Study in Healthy Elderly and Young Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: Fimasartan
healthy elderly and young male volunteer
pharmacokinetic
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kyungpook National University Hospital
name: Seoul National University Hospital
First posted: 2009-07-13
Enrollment: 22
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare and assess the safety and pharmacokinetic characteristics after oral administration of fimasartan (BR-A-657∙K) in healthy elderly and young male volunteers.

Detailed description: Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models.

Phase I study, Fimasartan (BR-A-657-K) 20 mg \~ 480 mg single dosing with healthy subjects, demonstrated that the Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A open-labeled, single-dosing, parallel Clinical Study to Evaluate pharmacokinetic characteristics after oral administration of fimasartan in healthy elderly and young male volunteers.

22 male healthy volunteers were enrolled during 2 months.

In part A, 240 mg of fimasartan per day was taken once by younger male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

In part B, 240 mg of hydrochlorothiazide per day was taken once by elderly male healthy volunteers in day 1. Then blood and urine samples were collected 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours after administration.

Eligibility criteria: Inclusion Criteria:

* age

  * young: 19-45 years
  * elderly: more than 65 years
* sex: male
* body weight: greater than 55 kg

Exclusion Criteria:

* patients with contraindication to angiotensin II receptor antagonist.
* patients with a history of liver, renal, gastrointestinal, hematological or cardiac diseases
* patients with history or diseases which might affect absorption of the drug
* patients with HIV, type B or C hepatitis
* smokers of 20 or more cigarettes per day

Primary outcomes:
measure: Cmax, AUClast, tmax, t1/2
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48 h
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04392934: Conservative Physiotherapy and Acromion Morphology
Official title: The Short-term Effects of a Conservative Physiotherapy Method in Subacromial Impingement Syndrome and Its Relation to Acromion Morphology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Morphologic Change
Keywords: physiotherapy
acromion morphology
subacromial impingement syndrome
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants are grouped according to their acromion type. First group is flat shape acromion group, second is hook shape group and the third one is curved shape acromion group. All groups are treated with the same physiotherapy protocol.
Primary purpose: TREATMENT

Brief summary: In this study, we aimed to evaluate the short-term effects of conservative physiotherapy in the subacromial impingement syndrome (SIS) and its relation to the acromion morphology.

Detailed description: The aim of this study is to investigate the short term effects of physiotherapy in SIS patients on pain, range of motion, muscle strength, joint position sense and functionality and its relation to the acromion shape. Fifty patients (26 female, 24 male) with SIS were evaluated in this study. Patiens were divided into 3 groups according to the their acromion morphology. A conservative physiotherapy method was applied to the patients. All patients were evaluated before and 4 weeks after the treatment.

Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed (clinically and by MRI) with SIS by the physician, at a stage of II-III levels according to Neer's criteria, who were undergoing physiotherapy for the first time and who had not received any treatment from the shoulder region before were included in this study.

Exclusion Criteria:

* Patients who had a history of fracture in the upper extremity and, surgical operation from any part of the upper extremity, who had acute cervical disc herniation or a neuromuscular disease, receiving a medical therapy for pain relief, less than 80 % participation to sessions were excluded.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 weeks
measure: Muscle strength
timeFrame: 4 weeks
measure: Range of motion
timeFrame: 4 weeks
measure: Joint position sense
timeFrame: 4 weeks
measure: Painful arc sign
timeFrame: 4 weeks
measure: Functionality
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Begumhan Turhan
role: STUDY_DIRECTOR
References:
Clinical trial NCT00245934: Study Evaluating Enbrel in Patients With Rheumatoid Arthritis
Official title: Observational Study With Enbrel in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated.


Eligibility criteria: Inclusion Criteria:

* Proven diagnosis of rheumatoid arthritis

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the following points will prevent or restrict participation:

  * Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®
  * Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localized infections
  * Patients with sepsis or risk of sepsis should not be treated

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257034: The Effect of Tai Chi in Treating Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effect of Tai chi on Fibromyalgia


Eligibility criteria: Inclusion Criteria:

* 40 years of age or older
* meeting the classification of FM per the 1990 ACR criteria
* approval by a healthcare provider for participation

Exclusion Criteria:

* had practiced Tai chi within the past 6 months
* had exercised \>30 min three times weekly for past 3 months
* could not independently ambulate without assistive devices
* had BPI pain severity or interference scores less than 5
* had planned elective surgery during study period
* were actively involved in health-related litigation
* were unwilling to keep all treatments/medications steady throughout the study period

Primary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: up to 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Area Command PLA
state: Sichuan
Study officials:
References:
Clinical trial NCT01608334: Comparison of Intrathecal Fentanyl or Sufentanil in 1 mg Bupivacaine Spinal Anesthesia for TURP in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adequate Anesthesia With Unimpaired Motor Strength
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 56
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Adequate sensory block for surgical procedure without side effects and immediate mobilization after surgery are desirable anesthetic technique in various surgeries. Considering the sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP. Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of sufficient sensory block could be troublesome. In this randomized study, the investigators evaluated the spinal anesthetic characteristics following intrathecal administration of bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.


Eligibility criteria: Inclusion Criteria:

* age over 65 \~ under 85yrears old
* male
* elderly patients undergoing TURP
* only spinal anesthesia
* patients consent about this study

Exclusion Criteria:

* spine surgery History
* coagulopathy
* impaired communication
* impaired orientation
* DM complication neuropathy
* BMI \> 30 -\> overweight patients.

Primary outcomes:
measure: time to achieve peak sensory block without unimpaired motor strength
timeFrame: 2 minites after injection intrathecally start
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT01310634: Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Official title: Epidemiology and Prevention of Anxiety and Depression in Parents of Hospitalized Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Neonates
Parenting
Anxiety
Depression
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 600
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 overall goal of this project is to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in this setting.

Detailed description: Parents of hospitalized neonates experience high stress levels and feelings of helplessness in the neonatal ward and often concern for the health and well being of their fragile infant. Parental stress associated with admission to the neonatal ward of infants has been extensively studied in developed countries for many years, but rarely have epidemiological and intervention studies been reported in Chinese parents of hospitalized neonates. The aim of the present study was to elucidate the epidemiology of anxiety and depression in parents of hospitalized neonates and test a comprehensive intervention program to prevent anxiety and depression in parents in a Chinese hospital.

Eligibility criteria: Inclusion Criteria:

* Speaks and reads Chinese
* No severe handicapping conditions or mental diseases
* Informed consent, no medical dispute
* Infants born within 28 days to be cared in the neonatal ward for at least 24 hours

Exclusion Criteria:

* Significant mental health history
* Newborns died within a week after hospitalization

Primary outcomes:
measure: Parental anxiety symptoms
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Shuping Han, PhD
role: STUDY_DIRECTOR
References:
citation: Kong LP, Cui Y, Qiu YF, Han SP, Yu ZB, Guo XR. Anxiety and depression in parents of sick neonates: a hospital-based study. J Clin Nurs. 2013 Apr;22(7-8):1163-72. doi: 10.1111/jocn.12090.
Clinical trial NCT01249534: Diagnostic Value of C-reactive Protein for Detection of Postoperative Inflammatory Complications After Gastroesophageal Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Given Indication for Gastroesophageal Cancer Surgery
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2010-11-30
Enrollment: 200
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: Given indication for gastroesophageal cancer surgery

Brief summary: Although widely used, there is a lack of evidence concerning diagnostic value of C-reactive protein (CRP) in the postoperative course. The aim of this study was to evaluate the diagnostic accuracy of CRP for postoperative inflammatory complications after gastroesophageal cancer.


Eligibility criteria: Inclusion Criteria:

* all patients with gastroesophageal cancer surgery

Exclusion Criteria:

* lack of measurement of C-reactive protein

Primary outcomes:
measure: postoperative Inflammatory complications
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Department of surgery
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Rene Warschkow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03126734: Effects of Infant Massage on Acceptance, Commitment and Conscience of Influence of Parents With Down Syndrome Babies
Official title: Effects on Acceptance, Commitment and Awareness of Influence of Parents of Babies With Down Syndrome, After Participation in a Course of Infant Massage. Study on the Spanish Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Keywords: Down Syndrome
Acceptance
Commitment
Concience of influence
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analyze whether the course of infant massage serves as a tool to improve acceptance, commitment and awareness of influence of parents of babies with Down syndrome. These variables will be measure before and after the course of infant massage in the experimental group, investigators will make measurements with the same rate in the control group, but they will receive the course after the measurements.

Detailed description: In the present study, investigators propose to study the effects of infant massage in the levels of acceptance, commitment and awareness of influence of parents of babies with Down syndrome. The measuring instrument of acceptance, commitment and awareness of parental influence will be the "This is my baby Interview". Two groups of intervention will be analysed, the experimental, in which parents have participated and applied the knowledge learned in the course of infant massage, and control, which does not receive the infant massage course during the study. Parents and babies of both groups have been evaluated twice, at the beginning of the intervention (pretest) and at the end after five weeks (postest). The study population consists of father or mother of 32 infants with Down syndrome between 4 and 8 months old.

Eligibility criteria: Inclusion Criteria:

* Parents with babies with Down Syndrome between 4 and 8 months old.

Exclusion Criteria:

* Parents with babies without Down Syndrome.

Primary outcomes:
measure: Change from Acceptance
timeFrame: At the start and the end of the study (5 weeks)
Secondary outcomes:
measure: Change fron Commitment
timeFrame: At the start and the end of the study (5 weeks)
Other outcomes:
measure: Change from Conscience of Influence
timeFrame: At the start and the end of the study (5 weeks)
Locations:
city: Sevilla
country: Spain
facility: Elena Piñero Pinto
Study officials:
affiliation: University of Seville
name: PIÑERO PINTO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914134: Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease
Official title: Effect of Duodenal Levodopa Infusion on Quality of Life and Autonomic Dysfunction in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Autonomic nervous system
Levodopa infusion
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Solvay Pharmaceuticals
First posted: 2009-06-04
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effect of continuous levodopa infusion on autonomic nervous system in patients with Parkinson's Disease (PD), blood pressure regulation and sweating. The investigators' hypothesis is that levodopa infusion may alleviate hyperhidrosis and orthostatic hypotension.

Detailed description: Parkinson's disease (PD) is one of the most common neurodegenerative disorders with increasing prevalence because of aging population. The main symptoms include rigidity, hypokinesia, tremor and impaired balance, but the disease also causes autonomic dysfunction. Motor fluctuations are common treatment related problems in PD, around 50-70% of patients treated with levodopa finally develop motor fluctuations. Continuous duodenal levodopa infusion has been effective in the treatment of motor dysfunction in advanced PD. However, little is known of its effects on autonomic nervous system.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease: diagnosis made at least five years earlier
* Positive response to levodopa
* Motor fluctuations that cannot be adequately controlled with oral medication
* No signs or symptoms of cerebellar dysfunction or vascular parkinsonism

Exclusion Criteria:

* Severe cognitive symptoms
* Glaucoma
* Severe arrythmias
* Severe asthma or COPD
* Heart, liver or kidney failure
* No significant vascular lesions in brain MRI imaging.

Primary outcomes:
measure: Orthostatic blood pressure change
timeFrame: Before levodopa infusion, after 3-5 days of levodopa infusion and 2 months after levodopa infusion was started
Secondary outcomes:
measure: Sweating measured by evaporimeter
timeFrame: Before levodopa infusion, after 3-5 days of levodopa infusion, 2 months after levodopa infusion was started
measure: Autonomic nervous system symptoms questionnaire (NMSS)
timeFrame: Before levodopa infusion and 2 months after levodopa infusion was started
measure: Quality of life questionnaire (PDQ-39)
timeFrame: Before levodopa infusion and 2 months after levodopa infusion was started
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Neurology
Study officials:
affiliation: Helsinki University Central Hospital, Department of Neurology
name: Eero Pekkonen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05343234: Drug Name Identification an Ignored Patient's Problem That Needs a Solution
Official title: Drug Name Identification an Ignored Patient's Problem That Needs a Solution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Remember the Name of a Given Drug
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Each of the recruited patient was given 3 different placebo drugs with 3 different mad up names to be taken for one month with different regiments.

The drug name resembled a real drug but with enough difference to prevent the patient from trying to buy it as a safety precaution. The name was printed on the box in English and Arabic letters. The coloured shape was printed to 2x2 cm dimension.

After one month the participants were intervened by a doctor blinded to the study. The doctor asked about the drug history of the patient. If the participant could remember the drug name and its correct regiment the doctor documented that. if the patent failed to remember the correct name and its regiment then the doctor asked the patient to try and remember anything about the drug.

Then the patient would be asked about the symbol on the drug and was it helpful for him in any way.

Detailed description: A scoring system was used to evaluate pateints memory of the drugs used 0- 3 0 is the minimal score and will be given if no recall of any drug name and 3 is the maximum score and will be given if the patient could remember the name of the tree drugs correctly.

The same scoring system was used for the symbols

Eligibility criteria: Inclusion Criteria:

* ASA I and II patients

Exclusion Criteria:

* severe or life-threatening condition
* severe visual impairment
* mental or cognitive dysfunction

Primary outcomes:
measure: score for remembering the drug name
timeFrame: memory will be tested after one month from prescribing the drugs
measure: score for remembering the drug symbol
timeFrame: memory will be tested after one month from prescribing the drugs
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
Study officials:
affiliation: Alexandria University
name: yasser M osman
role: PRINCIPAL_INVESTIGATOR
References: