louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00296569: A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)
Official title: A 4-Week, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of MK0686 in Patients With Osteoarthritis of the Knee or Hip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-02-27
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior NSAID or Acetaminophen users within the ARA functional class I,II or III and with no clinically significant diseases
* Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment
* Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA
* females must be either post-menopausal or surgically sterilized

Exclusion Criteria:

* No history of concurrent arthritic disease
* No history of neoplastic disease within a specified duration
* No history of disease that causes malabsorption
* Chronic use of certain medications excluded

Primary outcomes:
measure: Pain relief at the knee and hip over 4 weeks of treatment as assessed by the WOMAC Pain Subscale.
timeFrame: over 4 weeks of treatment
Secondary outcomes:
measure: Safety and tolerability over a 4-week treatment period
timeFrame: over a 4-week treatment period
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00186069: Magnesium Sulfate vs Placebo for Placental Abruption
Official title: Randomized, Double Blind Trial of Magnesium Sulfate Tocolysis Versus Intravenous Saline for Suspected Placental Abruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abruptio Placentae
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Santa Clara Valley Medical Center
First posted: 2005-09-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of magnesium sulfate for preterm suspected abruption.

Detailed description: We hope to learn if there is a difference in the efficacy of intravenous magnesium sulfate versus intravenous saline infusion in the resolution of vaginal bleeding and contractions in patients with a suspected placental abruption.

Eligibility criteria: Inclusion Criteria:

- vaginal bleeding and contractions consistent with suspected placental abruption between 24 and 34 weeks gestation.

Exclusion Criteria:

- preterm labor, severe bleeding necessitating immediate delivery, maternal coagulopathy, fetal distress

Primary outcomes:
measure: Undelivered With Resolution of Vaginal Bleeding and Contractions in First 48 Hours
timeFrame: 48 hours after the randomization
Secondary outcomes:
measure: Gestational Age at Delivery (Weeks)
timeFrame: Time of delivery
measure: Neonatal Apgar Score at 5 Minutes
timeFrame: At 5 minutes after birth
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Y El-Sayed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colon I, Berletti M, Garabedian MJ, Wilcox N, Williams K, El-Sayed YY, Chueh J. Randomized, Double-Blinded Trial of Magnesium Sulfate Tocolysis versus Intravenous Normal Saline for Preterm Nonsevere Placental Abruption. Am J Perinatol. 2016 Jun;33(7):696-702. doi: 10.1055/s-0036-1571324. Epub 2016 Feb 12.
Clinical trial NCT00763269: The Efficacy of a Toothpaste to Reduce Sensitivity
Official title: The Efficacy of a Toothpaste to Reduce Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dentin Hypersensitivity
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 626
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypersensitivity


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, ages: 12 years or older.
* Availability for the eight-week duration of the study.
* Two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession.
* Qualifying response to Tactile stimuli (Yeaple Probe) as defined by a score between 10-50 grams of force.
* Qualifying response to the Air Blast stimuli as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale.
* Subjects need to satisfy the qualifying response to stimuli for both parameters assessed (Tactile or Air Blast) on at least two teeth to be entered into the study.
* Good general health with no known allergies to products being tested.
* Use of a non-desensitizing dentifrice for one month prior to entry into the study.
* Signed Informed Consent Form.

Exclusion Criteria:

* Gross oral pathology, chronic disease, or history of allergy to test products.
* Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
* Sensitive teeth with a mobility greater than one.
* Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.
* Regular use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory drugs, or analgesics.
* Participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past one month.
* Current participation in any other clinical study.
* Allergies to triclosan, or oral care products, personal care consumer products, or their ingredients.
* Medical condition which prohibits not eating/drinking for 4 hours.

Primary outcomes:
measure: Hypersensitivity Tactile(Yeaple Probe)
timeFrame: 4 weeks
measure: Hypersensitivity Tactile (Yeaple Probe)
timeFrame: 8 weeks
Secondary outcomes:
measure: Air Blast Hypersensitivity (4 Week)
timeFrame: 4 weeks
measure: Air Blast Hypersensitivity (8 Week)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cedar Knolls
country: United States
facility: Concordia Clinical Research
state: New Jersey
Study officials:
affiliation: Univ of Puerto Rico
name: Augusto Elias, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00738569: Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen
Official title: A Pilot Study to Assess the Downregulation of HIV-1 Associated Chronic Inflammation in Patients With Limited Immunologic Responses When Raltegravir is Added to a Virologically Suppressed HAART Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Chronic inflammation
memory cells
activated t-lymphocytes
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether or not adding Raltegravir to a fully suppressive antiretroviral regimen will assist in reducing HIV-1 associated chronic inflammation and increase the t-lymphocyte memory cell pool.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. HIV-positive by Western blot or viral load
3. Viral load \< 400 copies/ml
4. CD4+ T-lymphocyte count less than 350 cells/mm3 or change in CD4+ T-lymphocyte count \< 100 cells/mm3 for at least one year on stable HAART with viral load \< 400 copies/ml for the same period of time

Exclusion Criteria:

1. CD4+ T-lymphocyte count greater than or equal to 350 cells/mm3 or rise in CD4+ T-lymphocyte count greater than or equal to 100 cells/mm3 within one year of study entry
2. Viral load \> 400 copies/ml
3. Allergy or resistance to raltegravir

Primary outcomes:
measure: Quantitative changes in activated CD4+/CD8+ T-lymphocytes, pro-inflammatory cytokines and the central memory cell pool
timeFrame: 12 months
Secondary outcomes:
measure: Measure the change in circulating CD4+ and CD8+ T-lymphocytes
timeFrame: 12 months
measure: Determine whether the circulating CD8+ T-lymphocyte count or the CD4+/CD8+ ratio can serve as a surrogate marker for suppression of chronic inflammation
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Kenneth A Lichtenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05058469: Tracheotomy With and Without Dual Antiplatelet Therapy
Official title: Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy Hemorrhage
Lead sponsor: Asklepios Neurological Clinic Bad Salzhausen
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.

Brief summary: Platelet-inhibiting drugs are often used after vascular interventions. Patients who require such therapies are often critically ill, are treated in intensive care units and often require long-term ventilation. For long-term ventilation a tracheotomy is necessary, which is usually performed as a percutaneous dilatative tracheotomy (PDT). As part of this intervention, there is (theoretically) an increased risk of bleeding/an increased rate of complications in patients with a antiplatelet therapy. In addition, there are various techniques for performing a PDT.

The current study aims to investigate the frequency of bleeding/complications taking into account the technique used in PDT.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent Percutaneous Dilational Tracheostomy

Exclusion Criteria:

* none

Primary outcomes:
measure: Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP).
timeFrame: 3 days
Secondary outcomes:
measure: - Does the technique of PDT affect the bleeding rate? - How often are recognizable cartilage pin fractures in the context of a PDT? - Influence of AP and PDT technology on the frequency of need for a blood transfusion?
timeFrame: 14 days
Other outcomes:
Locations:
city: Nidda
country: Germany
facility: Neurologische Klinik Bad Salzhausen
Study officials:
References:
Clinical trial NCT00915369: A Clinical Trial to Study the Effects of Nanoparticle Based Paclitaxel Drug, Which Does Not Contain the Solvent Cremophor, in Advanced Breast Cancer
Official title: A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Breast Cancer
Lead sponsor: Fresenius Kabi Oncology Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-08
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a multicentre, open label, non-randomized phase I study. The main objectives of the study are to determine the pharmacokinetic profile of the drug at different dose levels in the patients with Advanced Breast Cancer. Maximum Tolerated Dose (MTD) and safety of Paclitaxel Nanoparticle will also be simultaneously assessed.


Eligibility criteria: Inclusion Criteria:

* Female patients with histopathologically /cytologically confirmed advanced breast cancer, refractory / recurrent\* to previous anthracycline treatment as adjuvant or first line therapy for metastasis.
* Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no histopathological evidence for confirmation of ER/PR status)
* Patients must be of 18-65 years of age (inclusive of both)
* Patients with ECOG performance status between 0 - 2
* Patients with at least one measurable lesion as per RECIST

Exclusion Criteria:

* Patients with ER/PR positive status. Patients who demonstrate HER2 over expression will be excluded. Alternatively, the patients enrolled should have previously received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+ or with FISH/CIS.
* Patients with known history of hypersensitivity to paclitaxel or any other taxane or compounds chemically / biologically related to paclitaxel or excipients.
* Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy, therapy with biologicals or radiotherapy for the disease. (Patients requiring local radiotherapy for non- target bone lesion will be included).
* Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).

Primary outcomes:
measure: The primary outcomes of the study would be the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2); Ability to identify a dose higher than 220 mg/m2 that demonstrate better efficacy and manageable toxicity
timeFrame: Throughout the study
Secondary outcomes:
measure: evaluation of the effect of Paclitaxel Nanoparticle formulation on QTc.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Hyderabaad
country: India
facility: Nizam'S Institute of Medical Sciences
state: Andhra Pradesh
city: Bangalore
country: India
facility: Kidwai Memorial Institute of Oncology
state: Karnataka
city: Jaipur
country: India
facility: SEAROC Cancer Center, S K Soni Hospital
state: Rajasthan
Study officials:
References:
Clinical trial NCT05256069: Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
Official title: Sex-related Differences in Sympathetic Vascular Transduction in the Setting of Hypoxemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Vasodilation
Hypoxia
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2022-02-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to identify sex-related differences in the effect of hypoxia on sympathetic vascular transduction.


Eligibility criteria: Inclusion Criteria:

* healthy adult men and women;
* 18-45 years of age;
* BMI 18-30 kg/m2;
* non-pregnant/non-breastfeeding;
* non-nicotine users;

Exclusion Criteria:

* Pregnancy, breastfeeding, hormonal contraceptives
* Diagnosed sleep apnea
* Current smoking/Nicotine use/drug use
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications
* Recent COVID-19 diagnosis with symptoms

Primary outcomes:
measure: Forearm Blood Flow
timeFrame: Change from baseline to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline K Limberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956769: Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty
Official title: Comparison of TEG-guided and Preemptive Tranexamic Acid Administration Strategies in Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis of Hip
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment randomized prospective double-blind placebo-controlled multicenter non-inferior
Primary purpose: DIAGNOSTIC

Brief summary: The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria patients undergoing following surgery

- total hip arthroplasty

Exclusion Criteria:

* pregnancy
* refusal of allogenic blood transfusion
* taking thrombin
* history of thromboembolic and familial hypercoagulability disease
* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
* hypersensitive to TXA
* histroy of convulsion or epilepsy
* taking hemodialysis
* history of Heparin-induced thrombocytopenia

Primary outcomes:
measure: CRT maximal amplitude
timeFrame: 24 hours
Secondary outcomes:
measure: CK reaction time
timeFrame: 24 hours
measure: CK alpha angle
timeFrame: 24 hours
measure: CRT maximal lysis
timeFrame: 24 hours
measure: CFF maximal amplitude
timeFrame: 24 hours
measure: Hemoglobin
timeFrame: 6 hours
measure: packed RBC
timeFrame: 6 hours
measure: fresh frozen plasma
timeFrame: 6 hours
measure: cryoprecipitate
timeFrame: 6 hours
measure: platelet
timeFrame: 6 hours
measure: seizure
timeFrame: 48 hours
measure: thromboembolism
timeFrame: 48 hours
measure: postoperative bleeding
timeFrame: 48 hours
measure: re-operation
timeFrame: 48 hours
measure: intraoperative bleeding
timeFrame: 4 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Soi Lee
Study officials:
References:
Clinical trial NCT06065969: Photobiomodulation Dosimetry s in Patients With Orofacial Pain
Official title: Photobiomodulation Dosimetry Based on Anthropometric and Hemodynamic Variables in Patients With Orofacial Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orofacial Pain
Tension-Type Headache
Keywords: orofacial pain
Tension-Type Headache
photobiomodulation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 240
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to validate a dosimetry model for photobiomodulation treatment in patients with orofacial pain and tension-type headache symptoms. The study will involve 240 participants divided into four age groups. Different treatment approaches will be applied, including local photobiomodulation and systemic laser therapy. Various physiological measurements will be taken before, during, and after the treatments, including skin type, weight, height, blood pressure, and heart rate. Additionally, data from questionnaires on pain and headache symptoms will be analyzed. Monte Carlo simulation will be employed to validate the model based on these measurements and light transmission. The research addresses the need for effective pain management strategies in cases where medication-based treatments may have unwanted side effects.


Eligibility criteria: Inclusion Criteria Individuals of both sexes, between 7 and 65 years of age Exclusion Criteria

Participants with the following characteristics will be excluded:

Pregnant individuals Individuals with arrhythmia Individuals with Thrombocytopenia Individuals with Sickle Cell Anemia Individuals with a pacemaker Individuals with alterations in coagulation factors

Primary outcomes:
measure: Headache and orofacial pain
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03898869: Measurement of Revascularization Effect Using NIRS in BTK Arteries
Official title: Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Percutaneous Transluminal Angioplasty
Wound Heal
Ischemic Feet
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.

Brief summary: Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.

During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).

Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.

Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.


Eligibility criteria: Inclusion Criteria:

* Critical limb ischemia Rutherford V-VI
* At least one artery below the knee is planned to revascularize

Exclusion Criteria:

* Blood oxygen saturation below 85% because of any comorbidities
* Life expectancy less than 12 months
* Unavoidable amputation above ankle
* Skin diseases preventing the use of NIRS

Primary outcomes:
measure: Increase in oxygen amount sufficient for wound healing
timeFrame: 12 months
Secondary outcomes:
measure: Detection of early recoil after BTK revascularization
timeFrame: 1 hour
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilniaus Miesto Klinikinė hospital
Study officials:
affiliation: Vilnius University
name: Tomas Baltrūnas
role: PRINCIPAL_INVESTIGATOR
References: