louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00799331: Exploratory Study to Assess the Pharmacokinetics of AZD5985
Official title: An Exploratory Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacokinetics of Increasing Oral Doses of AZD5985 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures.
* Healthy male subjects aged 18 to 45 years (inclusive).
* Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder in the opinion of the investigator.
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
* Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Primary outcomes:
measure: It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985.
timeFrame: Frequent sampling occasions during study days
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Lund, Sweden
name: Eva Pettersson
role: STUDY_DIRECTOR
affiliation: Parexel, Berlin, Germany
name: Maura Fallon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097473: Long Term Physical Training in Asthma
Official title: Effects of Long Term Physical Training Once a Week on Fitness and Quality of Life in Elderly Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2010-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This controlled study is undertaken to investigate the effects of a long term outpatient training program on physical fitness and quality of life in elderly asthmatics.

Detailed description: Physical training is well known to support a healthy lifestyle. Patients with asthma are often unnecessarily restricted of physical activities or avoid exercise due to the unpleasant experience of exercise-induced dyspnea. As a consequence both children and adults with asthma are less fit than their peers. Like in healthy individuals, regular training supports health in asthmatics. In short-term training programs improvements of physical capabilities have been achieved in children and young adults with asthma. Programs of longer durations than 3 months have not been published in controlled trials. Effects of exercise training on quality of life in adult asthmatics are lacking.

Eligibility criteria: Inclusion Criteria:

* physician diagnosed asthma
* non-smoker
* stable condition
* informed consent

Exclusion Criteria:

* participation in pulmonary rehabilitation in the past 12 months prior to study inclusion
* unability to attend training sessions on a regular basis for one year
* symptomatic coronary heart disease
* uncontrolled heart failure
* hemodynamically relevant cardiac rhythm disorders
* hemodynamically relevant cardiac valvular disorders
* uncontrolled arterial hypertension
* hypercapnic respiratory failure
* severe hypoxemia (i.e. PaO2 \<50 mm Hg resp. SaO2 \<80% at rest)
* history of decompensated right heart failure
* pulmonary arterial hypertension (PA mean pressure at rest \>20 mm Hg)
* severe osteoporosis
* severe airway obstruction (FEV1 \<50% predicted, FEV1 \<60% predicted following bronchodilatation)
* maximum work rate of less than 50 watt during ergometer testing
* uncontrolled asthma
* COPD exacerbation
* severe adipositas (BMI \>35 kg/m2)

Primary outcomes:
measure: Maximum oxygen uptake
timeFrame: One year
Secondary outcomes:
measure: General quality of life
timeFrame: One year
measure: Disease-specific quality of life
timeFrame: One year
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Kliniken Mariahilf GmbH, Mönchengladbach, Germany
name: Andreas Meyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer A, Gunther S, Volmer T, Taube K, Baumann HJ. A 12-month, moderate-intensity exercise training program improves fitness and quality of life in adults with asthma: a controlled trial. BMC Pulm Med. 2015 May 7;15:56. doi: 10.1186/s12890-015-0053-8.
Clinical trial NCT02994173: Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients
Official title: Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
name: University of Helsinki
First posted: 2016-12-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation


Eligibility criteria: Inclusion Criteria:

* 20 - 75 years of age
* Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
* Written informed consent from the participating patient

Exclusion Criteria:

* A previous history of intolerance to the study drug or related compounds and additives
* Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
* Patients younger than 20 years and older than 75 years.
* BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
* Existing significant liver or kidney disease
* History of ischemic heart disease or conduction disturbance
* History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
* Donation of blood for 4 weeks prior and during the study.

Primary outcomes:
measure: Change in opioid consumption (mg) postoperatively
timeFrame: 24 and 72 hours
Secondary outcomes:
measure: Change in numerical rating scale (NRS 0-10)
timeFrame: 24 and 72 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Study officials:
affiliation: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
name: Marko Peltoniemi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01335373: Observational Program Neo-Penotran® Forte
Official title: Observational Program Neo-Penotran® Forte
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Candidiasis
Bacterial Vaginosis
Trichomonal Vaginitis
Keywords: Vaginal candidiasis
Bacterial vaginosis (also known as non-specific, or Gardnerellosis, or anaerobic vaginosis)
Trichomonal vaginitis
Vaginitis due to mixed infection
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 13024
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in primary care setting.

Brief summary: Vaginitis is the most common gynecologic diagnosis in the primary care setting. In approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.

Neo-Penotran Forte is registered for treatment of these most common vaginal infections. Efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of Neo-Penotran® Forte in real life setting.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.

Exclusion Criteria:

* Presence of contraindications according to package insert.

Primary outcomes:
measure: Percent rate of different vaginal infections
timeFrame: Approximately within 6 months after the last patient last visit.
Secondary outcomes:
measure: Clinical characteristics of vaginitis after treatment.
timeFrame: Depending on treatment time chosen by the physician, after 7 or 14 days.
measure: Change of microbiological characteristics after treatment
timeFrame: Depending on treatment time chosen by the physician, after 7 or 14 days.
measure: Patient rating of tolerability and treatment results
timeFrame: Depending on treatment time chosen by the physician, after 7 or 14 days.
measure: Physician's rating of tolerability and treatment results
timeFrame: Depending on treatment time chosen by the physician, after 7 or 14 days.
Other outcomes:
Locations:
city: Many Locations
country: Kazakhstan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04793373: Superiority of Epidural Placement Technique Using EpiFaith Syringe
Official title: Superiority of Epidural Placement Technique Using EpiFaith® Syringe Versus Conventional Glass Syringe in Laboring Paturients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Detailed description: We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

Eligibility criteria: Inclusion Criteria:

* Females 18 years of age and older at screening
* Request labor epidural analgesia
* Able to give informed consent to participate in the study
* American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
* BMI ≤ 40 kg/m2

Exclusion Criteria:

* BMI \> 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
* Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
* Any allergy to bupivacaine or fentanyl

Primary outcomes:
measure: Success of epidural localization
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT05208073: Effectiveness of Cosmetic Therapy on Self-esteem and Depression for Elderly Residents in Long-Term Care Institutions
Official title: Effectiveness of Cosmetic Therapy on Self-esteem and Depression for Elderly Residents in Long-Term Care Institutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long-Term Care
Aged
Keywords: Elderly Residents
Long-Term Care Institution
Depression
Self-esteem
Cosmetic Therapy
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cosmetic therapy provides a psychological effect on the elderly, improving their self-confidence and social participation. This study was conducted to investigate the effectiveness of cosmetic therapy to enhance the self-esteem and reduce depression of elderly residents in long-term care institutions. We expect that a 6-week cosmetic therapy will improve the elderly's mental health, including depression and self-esteem.


Eligibility criteria: Inclusion Criteria:

* Aged over 65 years old.
* Having been admitted to a long-term care institution (conservation type) for three months.
* Be able to communicate in Mandarin, Taiwanese and written languages.
* The total score of Mini-mental state examination (MMSE) is higher than 24 points.
* The muscle strength of the left or right hand is 4 points (inclusive) or above, and the maintenance and makeup procedures can be operated with one or both hands.
* After the researcher's explanation, the participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Under the age of 65.
* The applicant has been admitted to a long-term care institution (conservation type) for less than three months.
* Unable to communicate in Mandarin, Taiwanese and written language.
* Participated in cosmetic therapy.
* Diagnosed with mental illness (except depression), dementia and delirium.
* Currently taking antidepressant drugs.
* Currently receiving depression-related treatment.
* The maintenance and makeup steps cannot be operated with assistance.
* Failure to sign the research consent form.

Primary outcomes:
measure: Geriatric Depression Scale short-form (GDS-SF)
timeFrame: Pre-test before cosmetic therapy intervention and post-test at the end of six-week cosmetic therapy
measure: Rosenberg Self-Esteem Scale (Chinese version)
timeFrame: Pre-test before cosmetic therapy intervention and post-test at the end of six-week cosmetic therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yi-xing Elderly long-term care center
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsui-Wei Chien, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02925273: Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia
Official title: The Effect of Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia or Suspected Frontal Lobe Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
Lead sponsor: Rowan University
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, the investigators will determine the difference between the two techniques used to elicit the grasp response in patients with frontal lobe dysfunction, primarily in dementia patients versus control patients.

Detailed description: The goal of this project is to determine the optimal technique to elicit the grasping response in patients with dementia or suspected frontal lobe dysfunction. The proposed study is to perform two techniques to elicit grasp response in patients with dementia or suspected frontal lobe dysfunction and observe the presence or absence of the response and prominence of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians in refining their clinical techniques to be more sensitive for diagnosing frontal lobe dysfunctions.

Eligibility criteria: Inclusion Criteria:

1. Ability to sign informed consent or have a surrogate present to sign the consent
2. Age 18 or above
3. Patients are diagnosed with dementia, Alzheimer's disease, or frontal lobe dysfunction
4. Medications are to remain stable during the course of the study except for emergency modifications.

Exclusion Criteria:

1. Inability to obtain informed consent from patient or surrogate
2. Unable to follow commands.
3. Physical restrictions (i.e. spasticity of hands/arms, upper extremity amputation)
4. Other comorbidities such as muscular diseases, hepatic encephalopathy, renal failure, down syndrome, NPH, depression, and cerebral palsy.

Primary outcomes:
measure: Grasp response
timeFrame: six months
Secondary outcomes:
measure: Frontal Lobe release- Glabellar Response
timeFrame: six months
measure: Frontal lobe release- Palmomental Response
timeFrame: six months
measure: Frontal lobe release- Snout Response
timeFrame: six months
Other outcomes:
Locations:
city: Stratford
country: United States
facility: Rowan University School of Osteopathic Medicine
state: New Jersey
Study officials:
affiliation: Rowan University School of Osteopathic Medicine
name: Donald Barone, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452673: Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Women With Advanced Breast Cancer
Official title: Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-03-27
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline


Eligibility criteria: For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Female with advanced breast cancer previously treated with a taxane and an anthracycline
* No pleural or pericardial effusion
* Not receiving anticoagulants

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicities Per Dose Level - Safety Population
timeFrame: Day 1 to 30 days post last dose
Secondary outcomes:
measure: Number of Participants With Deaths, Serious Adverse Events, Adverse Events, Adverse Events Leading to Discontinuation and Treatment-related Adverse Events - Safety Population
timeFrame: Day 1 up to 30 days post last dose
measure: Number of Participants With Overall Response to Tumor - Efficacy Evaluable Population
timeFrame: Day 1 to 30 days post last dose
measure: Objective Response Rate (ORR) and Disease Control Rate - Efficacy Evaluable Population
timeFrame: Day 1 up to 30 days post last dose
measure: Number of Participants On-Study With Grade 3 - 4 Hematology Laboratory Test Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population
timeFrame: Day 1 up to 30 days post last dose
measure: Number of Participants On-study With Grade 3 - 4 Chemistry Laboratory Values in Those Participants With a Baseline Laboratory Value of Grade 0 - Safety Population
timeFrame: Day 1 to 30 days post last dose
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope National Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School Of Medicine
state: Illinois
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Rozzano
country: Italy
facility: Local Institution
state: Milano
city: Barcelona
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: