louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01863810: Efficacy and Safety of KW21052 Compared to Lyrica in the Diabetic Patients With Neuropathic Pain
Official title: Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Neuropathy
Keywords: Diabetic Neuropathy
Neuropathic Pain
Pregabalin
Lead sponsor: KunWha Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 394
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.

Detailed description: Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.

Eligibility criteria: Inclusion Criteria:

* Type 1 and 2 diabetic patients
* Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
* 40mm and more on VAS
* 4 and more on NRS
* Informed consented patients

Exclusion Criteria:

* Participating in another clinical trial
* Pregnancy or lactating
* Sensitivity to pregabalin
* Significant underlying disease or disorders
* Prohibited concomitant medications
* Significant laboratory abnormalities

Primary outcomes:
measure: Numerical pain rating scale (NRS)
timeFrame: After 8 weeks of intervention
Secondary outcomes:
measure: Change on on the numerical pain rating scale (NRS)
timeFrame: From baseline to 8th week of intervention
measure: Response rate
timeFrame: From baseline to 4th and 8th week of intervention
measure: Clinical Global Impression of Change (CGIC)
timeFrame: After 8 weeks of intervention
measure: Improved quality of life (QoL)
timeFrame: After 4 and 8 weeks of intervention
measure: Drug compliance
timeFrame: During 8 weeks of intervention
measure: Adverse events
timeFrame: Every clinic visit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kwang-Kuk Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06901310: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
Official title: Effectiveness of Recruitment, Retention Strategies, and Data Collection Quality: A Feasibility Study in Combat Athletes With Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury (mTBI)
Brain Injury
Concussion
Keywords: brain injury
concussion
Mild traumatic brain injury (mTBI)
Lead sponsor: Marshfield Clinic Research Foundation
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of Hyberbaric Oxygen Therapy (HBOT) would be a new treatment plan rather than conventional rest. If effective, this new use technology would add to the clinical treatment among mild traumatic brain injury (mTBI) patients. The use of a point of care Glial Fibrillary Acidic Protein (GFAP) biomarker would aid in clinical decision making to create a new care plan of return to sport among unarmed combat athletes who suffer from mTBI. The innovation would be a new treatment and diagnosis strategy that will protect these athletes from serious long-term sequelae. There are no published randomized controlled studies using HBOT to treat concussed athletes within one week of injury. There are no published studies using GFAP levels to predict post concussive symptoms (PCS).


Eligibility criteria: Inclusion Criteria:

* 18 Years or older
* Male Unarmed Combat Athlete
* 30-day suspension (head injury without technical knockout or incapacitation)
* 60-day suspension (head injury with technical knockout or incapacitation)
* 90-day suspension (head injury with loss of consciousness)

Exclusion Criteria:

* Prisoner status
* Female
* Suspension group injury severity would not include moderate to severe GCS \<13

These suspension groups are not based on GCS; therefore, GCS is not part of the inclusion criteria. This group will be divided into randomized groups, patients who will be treated with HBOT and patients who will receive the standard of care, which is rest.

Primary outcomes:
measure: Impact Neurological Scores
timeFrame: 13 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
References:
Clinical trial NCT01423110: Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Official title: A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sporadic Inclusion Body Myositis
Keywords: sporadic Inclusion Body Myositis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis


Eligibility criteria: Inclusion Criteria:

- Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis

Exclusion Criteria:

* Unable to walk at least 3 meters without assistance from another person
* Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months
* patients with a history or presence of renal impairment and/or liver disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Effect of BYM338 on Thigh Muscle Volume by MRI
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect of BYM338 on muscle function by 'Timed Get Up and Go' test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Amato AA, Sivakumar K, Goyal N, David WS, Salajegheh M, Praestgaard J, Lach-Trifilieff E, Trendelenburg AU, Laurent D, Glass DJ, Roubenoff R, Tseng BS, Greenberg SA. Treatment of sporadic inclusion body myositis with bimagrumab. Neurology. 2014 Dec 9;83(24):2239-46. doi: 10.1212/WNL.0000000000001070. Epub 2014 Nov 7.
Clinical trial NCT04421781: Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results
Official title: Salvage HIFU for Local Recurrence in the Prostatic Bed After Prostatectomy and External Beam Radiation Therapy : Preliminary Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 22
Sex: MALE
Minimum age (years): 60
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.

Brief summary: Retrospective monocentric analysis performed on patients treated with salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence will be evaluated.


Eligibility criteria: Inclusion Criteria:

* patient treated by S-HIFU for a single recurrence within the prostatic bed after an initial RP with curative intent with or without lymphadenectomy followed by salvage or adjuvant EBRT (with or without pelvic lymph node irradiation) combined or not with ADT;

  * life expectancy of ≥10 years;
  * histological local recurrence (positive biopsy),
  * negative metastatic evaluation (All patients underwent multiparametric MRI (mpMRI) to confirm the relapse in the prostatic bed and Choline PET/CT to exclude metastasis (lymph node, visceral or bone metastasis).
  * the use of ADT at BF after S-EBRT was not an exclusion criterion (ADT was introduced by the centre referring the patient).
  * no limits were placed on prostate cancer characteristics, PSA (value, doubling time (PSA-DT)), Gleason score and location of suspected recurrence in relation to the sphincter.

Exclusion Criteria:

* patients who do not meet the inclusion criteria

Primary outcomes:
measure: Oncological outcomes in the prostatic bed after S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT.
timeFrame: December 31, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Urology and Transplantation Surgery, Edouard Herriot Hospital,
Study officials:
References:
Clinical trial NCT02883881: Correlation Between Eye Rubbing and Keratoconus Severity in a Treatment-naive Keratoconic Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients presenting with treatment-naive keratoconus.

Brief summary: determination if, within a keratoconic population, strong eye rubbing was correlated with visual acuity, spherical equivalent value, biomicroscopic signs, corneal pachymetry, keratometry, and tomography classification determinating keratoconus stage.

Detailed description: A retrospective study was performed between november 2014 and october 2015 in the Metz Hospital Center. Were included 33 patients presenting with treatment-naive keratoconus. Patients responded to a questionnaire that assessed eye rubbing habits, family history of keratoconus, history of atopy. 2 groups were separated: group 1 constituted by 15 eyes with no eye rubbing, and group 2 constituted by 18 eyes with moderate or severe eye rubbing. The following informations were collected: best visual corrected acuity (BCVA), spherical equivalent value (SEV), corneal opacities or Vogt striae. For each eye were performed an anterior segment OCT (AS-OCT) to determine the OCT stage for keratoconus (Fourrier domain OCT classification, 2013), and a Scheimpflug camera imaging to determine the maximal keratometry (Kmax) and the minimal corneal thickness (MCT).

Eligibility criteria: Inclusion Criteria:

* patients presenting with treatment-naive keratoconus.

Exclusion Criteria:

-

Primary outcomes:
measure: visual acuity
timeFrame: month 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03438981: Optimization of PK/PD Target Attainment for Ceftriaxone in Critically Ill Patients With Community-acquired Pneumonia.
Official title: Impact op Capillary Leak and Hypoalbuminemia on PK/PD of Ceftriaxone in Critically Ill Patients With Overwhelming Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacokinetics
Critical Illness
Keywords: Pharmacokinetics
Ceftriaxone
critical illness
capillary leak
hypoalbuminemia
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: KU Leuven
First posted: 2018-02-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients receiving ceftriaxone treatment for pneumonia.

Brief summary: WP2.1. PK/PD target attainment Plasma exposure ELF exposure WP2.2. Predictive dosing algorithm WP2.3. ECMO subset

Detailed description: First, the investigators will document exposure to ceftriaxone in plasma and epithelial lining fluid.

Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.

Finally in a small subset of ECMO patients PK exposure will be explored.

Eligibility criteria: Inclusion Criteria:

* Pneumonia
* Admitted to an ICU ward
* Treated with ceftriaxone

Exclusion Criteria:

* Pregnancy
* DNR code 2-3
* Renal replacement therapy

Primary outcomes:
measure: Risk factors for target non attainment
timeFrame: on day of sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZLeuven
Study officials:
affiliation: isabel.spriet@uzleuven.be
name: Isabel Spriet, PhD PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02751281: Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
Official title: Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Stone
Keywords: pneumatic
ultra-sonic
percutaneous nephrolithotomy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2016-04-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones

Detailed description: While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.

Eligibility criteria: Inclusion Criteria:

- patients with \>2cm kidney stone

Exclusion Criteria:

* Pregnant women
* patients with coagulopathies
* patients with scattered stones who needed several accesses

Primary outcomes:
measure: stone free rate
timeFrame: 3 months after surgery
Secondary outcomes:
measure: hemoglobin loss
timeFrame: 2 days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Shahid Beheshty University of Medical Sciences
name: Nasser Simforoosh, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03103581: BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Official title: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 17
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 objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.


Eligibility criteria: Primary Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. At least 18 years of age
3. If female, and of child-bearing potential, is using an acceptable form of birth control.
4. Negative urine pregnancy test at screening, if applicable
5. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Primary Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Primary outcomes:
measure: Proportion of Subjects With Successful Bowel Preparation
timeFrame: Day of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Braintree Research Site 1
state: California
city: Bastrop
country: United States
facility: Braintree Research Site 2
state: Louisiana
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT06990581: Effect of Core Exercises on Trunk Stability and Balance
Official title: Effect of Core Exercises on Trunk Stability and Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Core Stability
Lead sponsor: Batterjee Medical College
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study is to investigate the effect of core exercises on trunk stability and balance

Detailed description: participants will be divided into two groups

Eligibility criteria: Inclusion Criteria:

* active well-trained female (more than 2 years of training)

Exclusion Criteria:

* any injuries or surgeries in back, lower limbs or upper limbs

Primary outcomes:
measure: McGill test
timeFrame: pre and after 6 weeks
measure: upper quarter Y-balance test
timeFrame: pre and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Batterjee Medical College
Study officials:
affiliation: Batterjee Medical College
name: Osama R Abdelraouf, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05057481: Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
Official title: Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Autoimmune Hemolytic Anemia
Systemic Lupus Erythematosus
Keywords: autoimmune hemolytic anemia
systemic lupus erythematosus
mycophenolate mofetil
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 30
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: There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Detailed description: There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, the investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.

Eligibility criteria: Inclusion Criteria:

* diagnosis of erythematosus (SLE) according to The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) guidelines.
* secondary autoimmune hemolytic anemia (AIHA) that does not respond properly to corticosteroid or when the patients are intolerant to treatment, or refuse standard treatment.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* any contraindication of the used drugs.
* any known hypersensitivity of the used drugs.
* congenital hemolytic anemia.
* chronic renal failure.

Primary outcomes:
measure: complete response (CR) proportion
timeFrame: 12 weeks
measure: partial response (PR) proportion
timeFrame: 12 weeks
measure: rate of Adverse events
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional Assessment of Chronic Illness
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: faculty of medicine, Assiut university
Study officials:
References: