louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01164488: A Study of RO5190591 (Danoprevir) in Healthy Volunteers
Official title: A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, aged 18-64 years, inclusively
* Weight \>/=50.0 kg
* Body Mass Index (BMI) 18.0-32.0 kg/m2
* Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the clinical study center until discharge
* Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
* Medical history without major recent or ongoing pathology

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Sustained supine systolic blood pressure \>140 or \<90 mmHG and supine diastolic blood pressure \>90 or \<50 mmHG at Screening or Day -1
* Resting heart rate \>100 or \<45 beats per minute at Screening or Day -1
* Any history of clinically significant cardiovascular or cerebrovascular disease
* Positive drug test result at screening or each admission
* Donation or loss of blood over 450 ml (1 pint) within 60 days prior to screening

Primary outcomes:
measure: To investigate the interaction between RO5190591/ritonavir and ketoconazole
timeFrame: Day 40
Secondary outcomes:
measure: To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole
timeFrame: Day 40
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01004588: The Effects of Resistance Training and Protein Supplementation in Healthy Elderly Men and Women.
Official title: The Effects of Resistance Type Exercise Training and Protein Supplementation on Skeletal Muscle Mass, Strength, and Muscle Characteristics in Healthy Elderly Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss in Elderly
Keywords: elderly
sarcopenia
protein drink
resistance training
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2009-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to examine the effects of resistance type exercise training combined with nutritional support on body composition and muscle characteristics in healthy elderly men and women. For a comprehensive insight into the potential underlying mechanisms of the intervention effects on whole body-, muscle- and myocellular level, a broad range of tests will be performed before, during, and after the intervention period.


Eligibility criteria: Inclusion Criteria:

* over 65 years
* healthy men and women

Exclusion Criteria:

* cardiovascular disease
* COPD
* Parkinson
* rheumatoid arthritis
* musculoskeletal/orthopaedic disorders
* cognitive impairment
* subjects with metal implants

Primary outcomes:
measure: Change in muscle mass measured by DXA-scan and CT-scan
timeFrame: 0, 12 and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University Medical Center
name: Marika Leenders, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01001988: Long-term Follow-up of Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Toddlers
Official title: Long-term Follow-up of Immunogenicity of a Single Dose of JE-CV in Toddlers in Thailand and the Philippines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis
Japanese Encephalitis
Keywords: Encephalitis
Japanese Encephalitis
Japanese Encephalitis Chimeric Virus Vaccine
Toddlers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 596
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a long-term follow-up of the persistence of immune response in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644) . No vaccination was administered during the present long-term follow-up study.

Primary Objective:

* To describe the yearly persistence of humoral immune response to Japanese encephalitis after a single dose of JE-CV

Detailed description: Persistence of immune response will be determined in participants who previously received a single dose of JE-CV at age 12 to 18 months in Study JEC02 (NCT00735644). No vaccination will be given in this study.

Eligibility criteria: Inclusion Criteria :

* Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
* Participant who was vaccinated with JE-CV in JEC02 trial and had a pre-vaccination blood sample at baseline in JEC02 trial.
* Participant and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria :

* Receipt of any JE vaccine other than JE-CV during JEC02 trial and during the period up to inclusion in JEC05 trial.
* Planned participation in another clinical trial up to the first year of the follow-up in the present trial.

Primary outcomes:
measure: Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Dose of JE-CV
timeFrame: Day 0 (pre-vaccination) from study JEC02, Day 28 post-vaccination from study JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination
measure: Summary of Geometric Mean Titers of Japanese Encephalitis Virus Antibodies Following a Single Dose of a JE-CV
timeFrame: Day 0 (pre-vaccination) from JEC02, Day 28 post-vaccination from JEC02, and at Years 1, 2, 3, 4, and 5 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01648088: Detection of Staph Colonization in Pre-op Arthroplasty Patients
Official title: Enhanced Detection of Staphylococcus Aureus Colonization in Patients Undergoing Prosthetic Joint Implantation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Keywords: staphylococcus aureus
prosthetic joint implantation
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 234
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing prosthetic joint implantation.

Brief summary: This study will evaluate which body site(s) provide the best source of possible staph presence in participants undergoing total joint arthroplasty. If the pre-operative cultures indicate staph presence, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. Participants will be followed for 2 years post-implantation of prosthetic joint to monitor development of prosthetic joint infection.

Detailed description: The presence of Staph in/on a patient who will undergo total joint replacement is a risk in that the patient could go on to develop infection at the surgery site after surgery. The purpose of this study is to evaluate if it is beneficial to to administer a questionnaire and obtain cultures from various body sites from patients prior to surgery and also to determine which body site(s) provide the best source of possible staph presence. If the pre operative cultures indicate staph is present, an Infectious Disease specialist will be consulted for standard of medical care consultation and treatment management. All patients scheduled to have total joint arthroplasty are eligible to participate. The research team will follow the study patients for 2 years after they undergo prosthetic joint implantation to monitor for development of prosthetic joint infection.

Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing prosthetic joint implantation

Exclusion Criteria:

* None

Primary outcomes:
measure: Development of surgical site infection.
timeFrame: Change in surgical site from baseline at 6 months, 1 year, 18 months and 2 years.
Secondary outcomes:
measure: Anatomical site(s) which are best utilized for swab cultures to detect S aureus.
timeFrame: Up to 24 months post operatively.
measure: Post operative infection (s.aureus) development.
timeFrame: Up to 24 months post operation.
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Angela Hewlett, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432588: Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Preeclampsia
Fetal Death
Fetal Membranes, Premature Rupture
Keywords: IUFD
POSTTERM
ROM
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-02-08
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).


Eligibility criteria: Inclusion Criteria:

* Term pregnancy
* Singleton
* Vertex
* Bishop score below 6

Exclusion Criteria:

* History of drug reaction
* Medical disease
* IUGR
* Oligohydramnios
* Vaginal bleeding
* Fetal anomaly
* Uterine scar

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariaty Maternity Hospital
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Mitra Ahmad Soltani
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obs and Gyn - HUMS
name: Minoo Rajaee Lari, Perinatologist - Obs and Gyn
role: STUDY_CHAIR
References:
Clinical trial NCT06733688: A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)
Official title: A Study to Evaluate the Pharmacokinetics and Definitive Bioequivalence of Tedizolid Phosphate Single Unit Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Multiple Dose Bottle Powder for Oral Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the absorption and elimination of different oral formulations from the healthy person's body.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18.5 and ≤34 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of clinically significant cancer (malignancy)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Maximum Plasma Concentration (Cmax) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
Secondary outcomes:
measure: Time to Maximum Plasma Concentration (Tmax) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Apparent Terminal Half-Life (t1/2) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Apparent Volume of Distribution of Tedizolid After Nonintravenous Administration (Vd/F)
timeFrame: At designated time points (up to 3 days postdose)
measure: Oral Clearance (CL/F) of Tedizolid
timeFrame: At designated time points (up to 3 days postdose)
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 2 weeks
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to approximately 2 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04120688: 3D Autotransplantation of Teeth
Official title: 3D Autotransplantation of Teeth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Loss
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2019-10-09
Enrollment: 120
Sex: ALL
Minimum age (years): 9
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to clarify the usefulness of 3D-printed replicas in association with autotransplantation of teeth in children and young adults.


Eligibility criteria: Inclusion Criteria:

* Need for tooth transplantation
* Open apex tooth available for transplantation

Exclusion Criteria:

* Facial syndrome
* Chronic facial pain
* Allergy to replica material

Primary outcomes:
measure: Number of patients with healthy transplanted teeth as assessed by clinical examination at one year.
timeFrame: One year postoperatively
measure: Number of patients with healthy transplanted teeth as assessed by radiological examination at one year.
timeFrame: One year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: University of Turku
name: Hanna Thorén, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877188: Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors
Official title: Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors: Upper Extremity Function, Quality of Life and Fitness Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Exercise
Physical Function
Keywords: breast cancer
exercise
upper extremity function
quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of a combined aerobic and resistance exercise program in breast cancer survivors.

Detailed description: Cancer and cancer treatment side effects are associated with fatigue, pain, decreased cardiovascular fitness and muscle strength, and overall quality of life. Furthermore, cancer survivors are at increased risk for cancer recurrence and for secondary effect such as cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. Increase physical activity or exercise is proposed to overcome the negative psychological and physiological effects. Preliminary research evidence shows that exercise in cancer survivors improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of fatigue. However, the best exercise mode and intensity has not been well established. Little is known regarding the long term effect. No study investigated impact of exercise for breast cancer survivors on upper extremity function, and correlation between fitness, upper extremity function and quality of life.

Eligibility criteria: Inclusion Criteria:

* stage 0 to II breast cancer diagnosed within 5 years
* complete adjuvant therapy \> 2 months, except hormone therapy
* \> 18 years

Exclusion Criteria:

* disease in progress, recurrent, or metastasis
* medical or musculoskeletal condition which resistance exercise is contraindicated
* medication which may alter exercise response

Primary outcomes:
measure: muscle fitness, quality of life, upper extremity function
timeFrame: baseline, 12 weeks post exercise training and follow up 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Graduate School of Physical Therapy, College of Medicine, NTU
Study officials:
affiliation: Graduate School of Physical Therapy, College of Medicine, Nationall Taiwan University, Taipei, Taiwan
name: Jau-Yih Tsauo, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT00067288: Meaning-Centered Psychotherapy in Advanced Cancer
Official title: Meaning-Centered Psychotherapy in Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Non-Hodgkin
Neoplasms
Keywords: Stage 3 cancer;
Stage 4 cancer;
solid tumor cancer;
Non-Hodgkin's Lymphoma;
solid tumors;
end-stage cancer;
group psychotherapy;
psychotherapy;
emotional support;
support groups
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-08-15
Enrollment: 118
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: We have developed an 8-week Meaning-Centered Group Psychotherapy designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose despite the limitations of their cancer illness. This project's overall aim is to explore the feasibility and efficacy of this new and unique psychotherapy intervention for advanced cancer patients in enhancing psychological and spiritual well-being and quality of life by comparing it with a standard supportive group psychotherapy.

Detailed description: As per Brief Summary

Eligibility criteria: Inclusion Criteria:

* 21 years of age or older;
* English speaking;
* Stage III or IV solid-tumor or Non-Hodgkin's Lymphoma;
* Receiving ambulatory care at Memorial Sloan-Kettering Cancer Center in New York City;

Exclusion Criteria:

* Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude participation in a group-format intervention;
* Presence of cognitive impairment disorder, such as delirium or dementia that is sufficient, in the investigator's opinion, to preclude meaningful participation and/or informed consent;
* Karnofsky Performance Rating Scale below 50 or physical limitations or illness severity sufficient to preclude participation in outpatient group psychotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Institute for Cancer Research
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Breitbart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Project Coordinator Memorial Sloan-Kettering Cancer Center
name: Christopher Gibson, PhD
References:
Clinical trial NCT00614588: Temperature Measurement in Post-Anesthesia Care Units
Official title: Accuracy of Temperature Measurement in Post-Anesthesia Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Postoperative
Laparoscopic Surgery
General Anesthesia
Keywords: temperature
monitor
surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing laparoscopic surgery requiring general anesthesia and a bladder catheter.

Brief summary: This study will evaluate the accuracy of several thermometers and temperature changes during surgery and immediately after surgery.

Detailed description: Several measurements of temperature will be taken at 30 minute intervals during surgery under general anesthesia and in the post operative care unit. Measurements will be taken as follows:

* esophagus using an internal stethoscope
* urinary bladder using a catheter
* ear canal
* skin of the forehead using adhesive devices(4 thermometers)
* axilla ("armpit") using adhesive devices(2 thermometers)
* mouth
* skin of the upper chest

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* American Society of Anesthesiologists (ASA) physical status of 1-3
* laparoscopic surgery of the abdomen or pelvis that is expected to require general endotracheal anesthesia and insertion of a Foley catheter expected to be in place for at least one hour after surgery

Exclusion Criteria:

* under 18 or over 80 years of age
* pre-existing nasogastric tube
* require bispectral index monitoring
* upper esophageal disease
* forehead rash or infection, oral infection or trauma, or ear infection or drainage

Primary outcomes:
measure: To determine the accuracy of various temperature-monitoring methods and sites suitable for Post Anesthesia Care Unit use.
timeFrame: Discharge from Post Anesthesia Care Unit
Secondary outcomes:
measure: To quantify the core temperature changes that occur during transport from the Operating Room to the PostAnesthesia Care Unit.
timeFrame: PostAnesthesia Care Unit
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References: