louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02815709: Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active-controlled Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.


Eligibility criteria: Inclusion Criteria:

* Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
* Experiences a pain intensity rating of moderate to severe acute pain.
* Able to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse.
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.

Primary outcomes:
measure: Number of Patients Who Respond to Study Medication at the 48-hr Numeric Pain Rating Scale (NRS) Assessment Compared to Placebo.
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Respiratory Safety Events Compared to Morphine.
timeFrame: 48 hours
measure: Duration of Respiratory Safety Events Compared to Morphine.
timeFrame: 48 hours
measure: Odds Ratio of Patients Who Respond to Study Medication at the 48-hr NRS Assessment Compared to Morphine.
timeFrame: 48 hours
measure: Number of Patients With Treatment-related Adverse Events.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Anaheim
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: Maryland
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Resarch Site
state: Utah
Study officials:
affiliation: Trevena Inc.
name: Franck Skobieranda, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01306409: Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)
Official title: Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Anemia
Keywords: anemia
kidney disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2011-03-01
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* age \> 18 years, dialysis dependent chronic renal failure
* hemodialysis three times a week
* Kt/V \> 1,2 od URR \> 65%
* hemoglobin between 11 and 13 g/dl within the last 2 months
* hemoglobin change +/- 1g/dl within the last 4 weeks
* ESA for at least 8 weeks
* Ferritin \> 300 ng/ml and Tsat \> 25%

Exclusion Criteria:

* Significant bleeding in the last 8 weeks
* blood transfusion within the last 8 weeks
* hemoglobin disorder
* hemolysis
* Malignant disease
* Significant inflammation
* Acute infection
* CRP \> 30 mg/l
* Temporary vascular dialysis access
* Vitamin B12 deficiency
* Folic acid deficiency
* Not controlled hyperparathyroidism
* Not controlled hypertension
* Epilepsia within thze last 6 months
* Thrombocyte count \> 500 x 10\^9 /l

Primary outcomes:
measure: Reticulocyte count on day 7
timeFrame: day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Nephrology and Transplantaton Immunology
state: BS
Study officials:
affiliation: Transplantation immunology and nephrology, unversity hospital Basel, Switzerland
name: Michael Dickenmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06850909: Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial
Official title: Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Embryo Culture
Keywords: 3D culture dish
embryo culture
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial

Detailed description: The configuration of culture dishes plays a crucial role in preimplantation embryo development by influencing key culture conditions such as media distribution, oxygen exchange, and embryo spacing, all of which directly impact embryonic growth, fertilization, blastocyst formation, and overall blastocyst quality. Traditional 2D culture dishes provide a flat surface for embryo development, whereas 3D culture dishes create a microenvironment that better mimics in vivo conditions by optimizing nutrient availability and reducing stress from environmental fluctuations. In this study, we compare the effects of two different 3D culture dishes-Dish 1 (Microdrop GPS Dish) and Dish 2 (16-Well BIRR Dish)-on preimplantation genetic outcomes. Using a sibling oocyte split design, oocytes were randomly divided after intracytoplasmic sperm injection (ICSI) and cultured in either dish, ensuring that each patient serves as their own internal control. Embryo development was closely monitored from fertilization to blastocyst formation, to determine whether dish design has a significant impact on preimplantation embryo development.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 35 years or younger
* A minimum of 15 mature oocytes available for ICSI
* Classified as a good prognosis patient

Exclusion Criteria:

* Cases with severe DNA fragmentation
* Patients undergoing FNA or TESE procedures
* Severe male factor infertility
* History of low or failed fertilization in previous cycles
* Any contraindications to gonadotropin stimulation
* Presence of leukocytospermia

Primary outcomes:
measure: Blastocyst Development rate
timeFrame: 5 - 6 days
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 day
measure: Cleavage rate
timeFrame: 3 days
measure: Blastocyst Quality rate
timeFrame: 5 - 6 days
measure: High Quality Day 3 rate
timeFrame: 3 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
References:
Clinical trial NCT02130609: Skintel Integration Study
Official title: Skintel Integration Study for Use With the Elite+ Laser System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Type From I-VI on Non-hair Bearing Skin
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial. The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI).
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Able to read, understand, and sign the Informed Consent Form
* Willing and able to comply with all study requirements

Exclusion Criteria:

* Hypersensitivity to light in the near infrared wavelength region
* Sun-damaged skin (treatment contraindicated with Alex laser only)
* Unprotected sun exposure (for Alex laser within four weeks of treatment; for
* Nd:YAG laser within one week of treatment), including the use of tanning beds or
* tanning products, such as creams, lotions and sprays
* Take medication which is known to increase sensitivity to sunlight
* Seizure disorders triggered by light
* Take anticoagulants
* Take or have taken oral isotretinoin, such as Accutane®, within the last six months
* Take medication that alters the wound-healing response
* History of healing problems or history of keloid formation
* Active localized or systemic infection, or an open wound in area being treated
* Significant systemic illness or an illness localized in area being treated
* History of skin cancer or suspicious lesions
* Lupus
* Have received or are receiving or gold therapy
* Pregnancy, planning on becoming pregnant or have been pregnant recently

Primary outcomes:
measure: improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Sean Doherty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327609: SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Official title: SAVE Trial - Use of the Selution Sirolimus Eluting Balloon for Dysfunctional AV accEss Treatment Indications
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: AV Fistula
Lead sponsor: M.A. Med Alliance S.A.
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective multi-center single-blinded randomized controlled trial (RCT) investigating the safety and feasibility of the SELUTION SLR™ (Sustained Limus Release) 018 drug eluting balloon (DEB) for the treatment of failed AV fistula in renal dialysis patients. Patients will be randomised to either SELUTION SLR or POBA.


Eligibility criteria: Inclusion Criteria:

* Age 18-90 years
* Patient is able and willing to provide written informed consent
* A Dialysis Access that has performed at least 1 successful dialysis session
* Stenosis \>50% at the outflow vein (by visual estimation) with clinical circuit dysfunction
* Lesion of ≤7mm in diameter
* Lesion of up to the 70mm in length

Exclusion Criteria:

* Life expectancy \<1year
* Lower extremity AVG
* Infected AVG
* Uncontrolled systemic infection
* Aneurysm or pseudoaneurysm in proposed target lesion
* Presence of previous CS or BMS
* ≥2 lesions present within the circuit
* Unable to perform protocol prescribed pre-dilation of the lesion
* Patient is female and is pregnant, or planning to become pregnant during the course of the study.

Primary outcomes:
measure: Primary Patency
timeFrame: 6 months
measure: Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Freedom from any serious adverse event(s) involving the AV access circuit or the patient at 6 months.
timeFrame: 6 months
measure: Late lumen loss
timeFrame: 6 months
measure: Device Success
timeFrame: During Procedure
measure: Anatomic success
timeFrame: Immediately after angioplasty
measure: Clinical Success
timeFrame: 6 months
measure: Binary Vessel Restenosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University of Athens
city: Patras
country: Greece
facility: University of Patras
city: Singapore
country: Singapore
facility: Singapore General Hospital LTD
Study officials:
References:
Clinical trial NCT00548509: The Effect of Vitamin K2 on Bone Turnover
Official title: Short-Term Menatetrenone Therapy Increases Gamma-Carboxylation Of Osteocalcin With A Moderate Increase Of Bone Turnover In Postmenopausal Osteoporosis: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-24
Enrollment: 131
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of menatetrenone on bone turnover in postmenopausal patients with osteoporosis. One month of menatetrenone therapy enhanced the secretion and gamma-carboxylation of osteocalcin. Moderate increases of bone resorption and formation markers were observed after 6 months. These changes may contribute to fracture prevention in patients with osteoporosis.


Eligibility criteria: Inclusion criteria:

* A diagnosis of osteoporosis was made according to the Year 2000 version of the Diagnostic Criteria for Osteoporosis proposed by the Japanese Society for Bone and Mineral Research.
* These criteria state that patients with a lumbar bone mineral density (BMD)\<70% of the young adult mean or patients with pre-existing osteoporotic fractures and a lumbar BMD\<80% of the young adult mean can be diagnosed as having osteoporosis.

Exclusion criteria:

* Patients with secondary osteoporosis (e.g., due to major gastrointestinal surgery, steroid therapy, rheumatoid arthritis, premenopausal bilateral oophorectomy, renal dysfunction, and thyroid dysfunction ).
* Patients taking medications that could affect bone turnover (such as bisphosphonates, estrogen, calcitonin, SERM, active vitamin D3, or Warfarin) were excluded.

Primary outcomes:
measure: Gamma-carboxylation
Secondary outcomes:
measure: Bone turnover marker
Other outcomes:
Locations:
city: Kumagaya-shi
country: Japan
state: Saitama Prefecture
city: Hachioji-shi
country: Japan
state: Tokyo
city: Setagaya-Ku
country: Japan
state: Tokyo
city: Nishiyatsushiro-Gun
country: Japan
state: Yamanashi Prefecture
Study officials:
affiliation: Post -marketing Clinical Research Department, Clinical Research Center - Eisai Company Limited
name: Norio Iinuma
role: STUDY_DIRECTOR
References:
Clinical trial NCT02377609: To Validate an Analytical Method to Measure Concentration of Tacrolimus in Blood Taken From Finger Pricks
Official title: Cross-validation of the Finger Prick Dried Blood Spot Assay Method With the Established Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Validation
Dried Blood Spot
Transplant Patients
Keywords: Dry Blood Spot (DBS)
Validation
Tacrolimus
Bioanalytical assay method cross-validation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable kidney or liver transplant recipient receiving Advagraf® (tacrolimus) therapy

Brief summary: The principal aim of this study is to define the relationship between tacrolimus concentrations determined from the finger prick DBS (Dry Blood Spot) method and those determined from blood samples collected by venepuncture in transplant recipients.

Detailed description: This will be a bioanalytical assay method cross-validation study using blood samples donated by up to 100 liver and 100 kidney transplant patients. Subjects who will be attending a routine outpatient follow-up visit will be asked to provide 3 whole blood venepuncture samples (each sample = 3 mL blood) and 3 finger prick DBS blood samples at predose and at 1 and 3 hours postdose. All subjects will be discharged from the study and clinical site at 3 hours postdose. Subjects will derive no benefit from the blood collection procedures and will be paid a predetermined stipend for participating in the study.

Eligibility criteria: Inclusion Criteria:

* Stable adult transplant recipients aged ≥ 18 years maintained on a once daily Advagraf® based immunosuppressive regimen for the prophylaxis of kidney or liver allograft rejection.

Exclusion Criteria:

* Subjects who are still participating in another clinical study (e.g. attending follow up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.

Primary outcomes:
measure: Cross-validate the dried blood spot (DBS) method by defining the relationship between tacrolimus concentrations determined via DBS method, with those determined using the established and validated whole blood method
timeFrame: 1 day
Secondary outcomes:
measure: Compare estimated area under the curve (AUC) values of the DBS and whole blood assay methods using a Bayesian model
timeFrame: 1 day
Other outcomes:
Locations:
city: Clichy
country: France
facility: Site: 7
city: Paris
country: France
facility: Site: 3
city: Toulouse
country: France
facility: Site: 1
city: Villejuif
country: France
facility: Site: 5
city: Cambridge
country: United Kingdom
facility: Site: 2
city: London
country: United Kingdom
facility: Site: 6
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03143309: Physical Activity Intervention to Promote Walking Among Female University Students
Official title: WhatsApp Physical Activity Intervention to Promote Walking Among Female University Students in Al-Qassim, Saudi Arabia: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 207
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a parallel group randomized controlled trial among female university students designed to test the effect of a physical activity intervention on daily walking. Both groups will receive messages 2-3 times per week via WhatsApp. Intervention group will receive orientation and wear a pedometer for the study period. The follow-up duration is 3 months.

Detailed description: Background: Sedentary lifestyle is a major risk factor for chronic diseases. The majority of Saudi females do not meet a recommended level of physical activity.

Study Objective: To test the effect of a physical activity intervention on daily walking.

Study Design: Parallel group randomized controlled design among female university students.

Methods: Students will be randomly assigned to either the intervention or the control arm. WhatsApp groups (2 per arm) will be formed within each study arm for communications. The intervention participants will receive a brief (15-minute) orientation on diet, exercise, and benefits of keeping a healthy weight; each will be instructed to wear a pedometer every day for 12-weeks with a daily step goal of 8,000. They will receive 2-3 health-promotional (walking and diet) messages per week via WhatsApp; group interaction is optional. The control group participants will receive 2-3 non-health related messages per week. Average daily steps will be assessed in all participants at baseline and 3-month follow-up using a 7-day pedometer measurement.

Eligibility criteria: Inclusion Criteria:

* female
* student enrolled at Qassim University during 2016-2017 academic year
* owns smartphone with internet access
* willing to complete all study requirements

Exclusion Criteria:

* Physical disability that precludes physical activity
* Morbidly obese (Body Mass Index \>45 kg/m2)
* Physician recommendation not to exercise

Primary outcomes:
measure: Walking
timeFrame: Baseline to 3-month follow-up
Secondary outcomes:
measure: Self-reported walking
timeFrame: Baseline to 3-month follow-up
measure: Body Mass Index
timeFrame: Baseline to 3-month follow-up
measure: Barriers to weight management
timeFrame: Baseline to 3-month follow-up
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Qassim University
state: Al-Qassim
Study officials:
affiliation: College of Medicine, Qassim University
name: Juliann Saquib, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05617807: Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy
Official title: Outcomes of the Nanoscopic Partial Meniscectomy Versus Standard Arthroscopic Partial Meniscectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Tear
Keywords: Arthroscopy
Meniscus
Meniscectomy
Nanoscopic
Lead sponsor: Marshall University
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
name: Medstar Health Research Institute
First posted: 2022-11-16
Enrollment: 100
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Standard arthroscopy has been the gold standard for treatment of meniscus tears since the 1980's. The purpose of this study is to analyze the clinical outcomes of using the smaller diameter Nanoscope for partial menisectomy. The authors hypothesize that the Nanoscopic partial menisectomy patients will have less pain and return function faster than standard arthroscopy.


Eligibility criteria: Inclusion Criteria:

* MRI positive for meniscus tear
* More than 3mm of joint space on PA flexion weightbearing x rays
* Primary arthroscopy

Exclusion Criteria:

* Workers compensation
* Older than 60 years of age
* Revision surgeries

Primary outcomes:
measure: Functional Outcomes following partial meniscectomy: Knee Injury and Osteoarthritis Score
timeFrame: 6 weeks
measure: Functional Outcomes Following Partial Meniscectomy: International Knee Documentation Committee Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain: Visual Analog Pain Score
timeFrame: 6 weeks
measure: Narcotic Medication Use
timeFrame: 24 hours
measure: Return to work
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Scott Depot
country: United States
facility: Marshall Orthopaedics - Teays Valley
state: West Virginia
Study officials:
References: