louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01520415: Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients
Official title: A Prospective, Randomized, Double-blind, Clinical Trial of Trigger Point Injection Therapy for the Treatment of Myofascial Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Low Back Pain
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 40
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: The objective of this study is to examine the short and long-term effect of myofascial trigger point injections with either a local anesthetic or saline in patients with chronic low back pain presenting with myofasical pain syndrome.


Eligibility criteria: Inclusion Criteria:

* CLBP of non-malignant origin, with or without accompanying leg pain, including patients with history of previous back surgery or trauma
* MPS as evident by at least one active MTP, located medial or lateral to the posterior iliac crest involving the gluteus maximus or medius, quadratus lumborum and erector spinae muscles
* While not precluding the participation in the study, MTP in other areas will not make patients eligible
* Pain lasting for at least six months

Exclusion Criteria:

* Any current motor weakness, but not sensory loss or abnormal reflexes in the lower limbs
* Any injection or nerve block in the low back in the last 6 months
* Local or systemic infection
* Bleeding disorder or the use of anticoagulation medications
* Known allergy to local anesthetics
* Poor understanding of written and spoken English or French

Primary outcomes:
measure: Pressure pain threshold of the myofascial trigger points
timeFrame: 12 weeks
Secondary outcomes:
measure: Pressure pain threshold of MTPs
timeFrame: baseline, 4 weeks, 8 weeks
measure: VAS Low Back Pain
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Roland-Morris Disability Questionnaire (RDQ-20)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Short-Form Health Status Survey 12 (SF-12)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Consumption of analgesic medications
timeFrame: 12 weeks
measure: Number of participants with Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Alan Edwards Pain Management Unit - Montreal General Hospital
state: Quebec
Study officials:
affiliation: MUHC-RI
name: Yoram Shir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05092815: The Efficacy and Safety of HLX208 in Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
Official title: A Single-arm, Open Label, Multicenter Phase II Clinical Study in Rare Diseases to Evaluate Safety, Efficacy and PK of HLX208 for Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Langerhans Cell Histiocytosis
Erdheim-Chester Disease
LCH
ECD
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).


Eligibility criteria: Inclusion Criteria:

1. Volunteer to participate in the clinical study;
2. Aged ≥ 18 years;
3. Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;
4. At least one measurable lesion as per PERCIST v1.0;
5. Expected survival time ≥ 3 months;
6. ECOG score 0-2;

Exclusion Criteria:

1. Previous treatment with BRAF inhibitors or MEK inhibitors;
2. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery;
3. Severe active infections requiring systemic anti-infective therapy;
4. Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Primary outcomes:
measure: ORR
timeFrame: up to 1 year
Secondary outcomes:
measure: AEs
timeFrame: up to 1 year
measure: ORR
timeFrame: up to 1 year
measure: ORR
timeFrame: up to 1 year
measure: DCR
timeFrame: up to 1 year
measure: TTR
timeFrame: up to 1 year
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 1 year
measure: OS
timeFrame: from the date of first dose until the date of death from any cause，assessed up to 1 year
measure: Cmax
timeFrame: from the date of first dose to 85 days
measure: Tmax
timeFrame: from the date of first dose to 85 days
measure: AUC
timeFrame: from the date of first dose to 85 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT00840515: PraevoSkin Emulsion in the Prevention of Radiation Induced Dermatitis
Official title: A Phase 2,Double Blind Randomized Study of PraevoSkin,a Melatonin Containing Emulsion, in the Prevention of Radiation Induced Dermatitis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prevention of Radiation Induced Dermatitis.
Lead sponsor: Pharm Olam Pharmaceuticals Ltd.
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patientsplanned to receive whole breast radiation.

Brief summary: A phase 2 double blind randomised study of PraevoSkin,a melatonin containing emulsion, in the prevention of radiation induced dermatitis.


Eligibility criteria: Inclusion Criteria:

1. Female patients at least 18 years with unilateral breast cancer following lumpectomy +/- chemotherapy.
2. Planned to receive 50 Gy whole breast irradiation +/- boost to tumor bed.
3. ECOG PERFORMANCE STATUS 0-1.
4. Capable of giving written informed consent and following instructions for applying study emulsion or placebo as per control.
5. No co-morbidities known to affect radiotherapy reactions.
6. No co-existing acute or chronic skin disease.
7. No evidence of infection or inflammation of breast to be treated.
8. Not receiving chemotherapy during radiotherapy course.Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.

Exclusion Criteria:

1. Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
2. Prior radiotherapy to any site.
3. Collagen vascular disease.
4. Diabetes mellitus requiring medication.
5. Uncontrolled hypertension.
6. Participation in other clinical study.
7. Any contra-indicating to treatment with Melatonin.
8. History of allergy to peanuts or fragrances.
9. History of severe allergic reactions (e.g. asthma).

Primary outcomes:
measure: Digital Camera
timeFrame: Weekly
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00047515: Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-01-69
Official title: Phase III Safety and Efficacy Study to Evaluate Combination IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertensive Patients C-01-69.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: open-angle
glaucoma
ocular
hypertension
POAG
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2002-10-18
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: To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility criteria: Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations Throughout the United States
country: United States
facility: Clinical Trial Sites
state: Texas
Study officials:
References:
Clinical trial NCT00150215: A First In Human Study Of PF-00184562 In Healthy Volunteers
Official title: An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2005-09-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purposes of this study are:

* To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and
* To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects of non-childbearing potential

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).

Primary outcomes:
measure: Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
measure: Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
measure: Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
measure: Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
measure: All measurements to be assessed over single doses.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04072315: Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF/
Official title: A Phase 2a Evaluation of PLN-74809 on αvβ6 Receptor Occupancy Using PET Imaging in Participants With IPF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Pliant Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2019-08-28
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Open label, incomplete crossover, up to 2 single doses administered at two different times
Primary purpose: TREATMENT

Brief summary: A study in mild/moderate IPF patients using an αVβ6 PET ligand to evaluate target engagement.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPF, within 5 years prior to Screening,
* FVC %predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening.
* DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of screening.
* Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed,if on a stable dose for at least 3 months

Exclusion Criteria:

* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
* Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \<0.7
* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
* Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
* Smoking of any kind within 3 months of Screening

Primary outcomes:
measure: Number of Participants With a Predicted Effect on αVβ6 PET ( Positron Emission Tomography) in Lungs After Administration of Drug.
timeFrame: Following 1 day of dosing
Secondary outcomes:
measure: Safety and Tolerability of PLN-74809 as Measured by the Number / Percentage of Adverse Events
timeFrame: From screening to 1 week following the administration of PLN-74809
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
Study officials:
affiliation: Pliant Therapeutics, Inc.
name: Pliant Therapeutics Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06689215: Comparison of Noninvasive Vs. Invasive Hemodynamic Measurements
Official title: Comparison Study of EzCVP and CVP
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Heart Failure, Congestive
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
First posted: 2024-11-14
Enrollment: 30
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 admitted to the Stanford University Hospital ICU with central venous catheter.

Brief summary: Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

Detailed description: The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.

Eligibility criteria: Inclusion Criteria:

1. Adult age over 18 years.
2. Arm circumference is 18 cm to 55 cm
3. Subject will have an existing indwelling central venous catheter during their ICU stay
4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
5. Subject or LAR is willing and able to comply with protocol procedures

Exclusion Criteria:

1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
2. Pregnant (self-reported)
3. Upper extremity deep venous thrombosis currently being treated
4. Severe skin disease involving the upper arm(s)
5. Study investigator may exclude patients based on clinical judgement

Primary outcomes:
measure: Non-invasive pressure indicator
timeFrame: 1-7 days
Secondary outcomes:
measure: Direction of change
timeFrame: 1-7 days
measure: Correlation with invasive CVP
timeFrame: 1-7 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
Study officials:
affiliation: Stanford University
name: Masataka Kawana, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00680615: An Internet-Based Smokeless Tobacco Cessation Program for Teens
Official title: QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smokeless Tobacco Use
Keywords: Smokeless tobacco
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 1716
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search.


Eligibility criteria: Inclusion Criteria:

* 14-25 years of age
* Have access to the Internet
* Currently using smokeless tobacco products
* Currently contemplating quitting all tobacco products
* Able to read and write English; and
* Willing to share phone number, e-mail, and mailing address with the research project

Primary outcomes:
measure: Abstinence from all tobacco
timeFrame: 3 months and 6 months
measure: Abstinence from smokeless tobacco
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Evaluate the relative effectiveness of the two programs on secondary outcomes, including reduction in smokeless tobacco use, number of quit attempts, and confidence in quitting.
timeFrame: 3 months and 6 months
measure: Identify participant characteristics, including demographic characteristics, initial smokeless tobacco use and dependence, and patterns of program use that predict treatment outcomes.
timeFrame: 3 months and 6 months
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Herbert H. Severson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Research Institute
name: Brian G Danaher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06788015: Hydrogen-Infused Water for Endurance Performance, Body Hydration Biomarkers, and Health-Related Quality of Life
Official title: The Effects of Hydrogen-Infused Water on Endurance Performance, Body Hydration Biomarkers, and Health-Related Quality of Life in Healthy Young Men and Women (HYDRO2EAU): A Randomized-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Overtraining
Keywords: endurance
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the impact of 4-week hydrogen-infused water consumption on various health and performance outcomes. Conducted with healthy young adults, the trial assesses endurance performance, hydration biomarkers, and health-related quality of life. Participants are randomized into intervention and control groups, with outcomes measured over a specified period. The findings aim to elucidate whether hydrogen-infused water water provides significant benefits for physical performance, hydration status, and overall well-being compared to standard hydration methods.


Eligibility criteria: Inclusion Criteria:

* Age 18.0 - 29.9 years
* Body mass index 18.5 - 24.9 kg/m2
* Collegiate athletes with training experience \>3 years
* Weekly exercise \> 5 hours
* Given written informed consent

Exclusion Criteria:

* Major chronic diseases or acute disorders
* History of dietary supplement usage in the 4 weeks preceding the study initiation
* Unwillingness to return for a follow-up
* Participation in other clinical trials

Primary outcomes:
measure: Time to exhaustion
timeFrame: Change from baseline time to exhaustion at 4 weeks
Secondary outcomes:
measure: Total body water
timeFrame: Change from baseline total body water at 4 weeks
Other outcomes:
measure: 36-Item Short Form Health Survey
timeFrame: Change from baseline 36-Item Short Form Health Survey total score at 4 weeks
Locations:
city: Novi Sad
country: Serbia
facility: FSPE Applied BIoenergetics Lab
state: Vojvodina
Study officials:
References:
citation: Ostojic SM. Hydrogen Gas as an Exotic Performance-Enhancing Agent: Challenges and Opportunities. Curr Pharm Des. 2021;27(5):723-730. doi: 10.2174/1381612826666200922155242.
Clinical trial NCT00908115: Post Market Surveillance for Infanrix™
Official title: Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Acellular Pertussis
Tetanus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 1258
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children receiving Infanrix™ were eligible for this survey.

Brief summary: The purpose of this study was to investigate the following questions through post-marketing surveillance:

* Unknown/Unexpected adverse events and the serious adverse events.
* The circumstances in which the adverse events occurred under the practical application.
* Factors considered to have influence on safety.
* Factors considered to have influence on efficacy.
* Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.


Eligibility criteria: Inclusion Criteria:

All children receiving Infanrix™ were eligible for this survey.

Exclusion Criteria:

Primary outcomes:
measure: Number of Subjects Reporting Serious Adverse Events
timeFrame: Since the beginning of the study and during the entire study period (up to 6 years)
measure: Number of Subjects Reporting Solicited Symptoms
timeFrame: During the 4-week follow-up period after each dose
measure: Number of Subjects Reporting Unsolicited Adverse Events
timeFrame: Within the 31-day (Day 0-30) following vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: