louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04732793: To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Official title: A Prospective, Active Controlled, Randomised, Parallel Group, Double Blind, Multicentre Study to Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 284
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe


Eligibility criteria: Inclusion Criteria:

1. Subject is ≥40 years old.
2. Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.
3. Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.

Exclusion Criteria:

1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
2. Subject has a documented history of hypersensitivity to HA.
3. Subject has a documented infection or severe inflammation of the target knee joint.
4. Subject has a skin disease in the area of the injection site.
5. Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.

Primary outcomes:
measure: The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
timeFrame: from Baseline to 13 weeks post injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Świdnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
Study officials:
References:
Clinical trial NCT00958893: An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext
Official title: An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed description: This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Eligibility criteria: Inclusion Criteria:

* Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion Criteria:

* All other subjects

Primary outcomes:
measure: To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.
timeFrame: three 4 month cycles separated by off-drug intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Houston,
country: United States
facility: Advances in Health, Inc.
state: Texas
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03395093: BIS of Sedation Depth During Flexible Bronchoscopy.
Official title: Bispectral Index Monitoring of Sedation Depth During Flexible Bronchoscopy: With or Without Fentanyl .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease
Keywords: bronchoscopy
conscious sedation
fentanyl
Bispectral Index
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 500
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: Fentanyl is analgesia medication. There has not pain nerve in the lung. Flexible bronchoscopy(FB) is used in the respiratory medicine. So people will not feel pain in the process of FB. The purpose of the study is to know if Fentanyl is useful in the conscious sedation of FB.

Detailed description: Fentanyl is opioid receptor agonists. It is a fast-acting, short duration and potent analgesics.

Flexible bronchoscopy (FB) is mostly used in the diagnosis and therapy in the respiratory disease. As we know, there has not pain nerve in the lung. People will not feel pain when they are in FB.

If fentanyl will be effective in FB? Our study will observe the effect of conscious sedation in FB with fentanyl or without fentanyl.

Eligibility criteria: Inclusion Criteria:

Cough reflex is good agree to do bronchoscopy agree to take part in the study no the contraindication of bronchoscopy

Exclusion Criteria:

Forced expiratory volume in one second\<1 L severe hemoptysis severe heart, liver,kidney failure psychiatric and nervous disorders allergic to the anesthetic ( fentanyl, midazolam, or propofol)

Primary outcomes:
measure: perioperative changes of blood pressure
timeFrame: every 5 minutes from the operation beginning to end
Secondary outcomes:
measure: perioperative time
timeFrame: from the operation beginning to end
measure: Adverse events
timeFrame: in the process of the operation
measure: Patient satisfaction rate
timeFrame: One day after the operation
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: wei gu, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark G, Licker M, Younossian AB, Soccal PM, Frey JG, Rochat T, Diaper J, Bridevaux PO, Tschopp JM. Titrated sedation with propofol or midazolam for flexible bronchoscopy: a randomised trial. Eur Respir J. 2009 Dec;34(6):1277-83. doi: 10.1183/09031936.00142108. Epub 2009 May 14.
citation: Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.
Clinical trial NCT04769193: A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity
Official title: A Clinical Trial Evaluating the Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy, Hemifacial
Elastosis
Photoaging
Keywords: Sagging
Depletion
Atrophy
Photoaging
Lead sponsor: Adipeau Inc.
Sponsor class: INDUSTRY
Collaborators: name: Romo Plastic Surgery
First posted: 2021-02-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.

Detailed description: This is a single-arm study with subjects serving as their own controls. The study evaluates a face cream comprised of natural agents with adipogenic and lipolytic activities. The combination of adipogenic and lipolytic impulses is theorized to be more effective in promoting regeneration and healthy cell size in the dermal white adipose tissue than other approaches (e.g., adipogenic + lipogenic or anti-adipogenic + lipolytic). The health of the dermal white adipose tissue is reflected by the strength and elasticity of the skin and the distribution of volume in the face.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period
* Plans to undergo injectable filler treatment.

Primary outcomes:
measure: Change in Skin Elasticity
timeFrame: Six months and 12 months..
measure: Change in Skin Volume
timeFrame: Six months and 12 Months.
Secondary outcomes:
measure: FaceQ skin satisfaction surveys
timeFrame: Two, Six and 12 Months.
Other outcomes:
Locations:
city: New York
country: United States
facility: Thomas Romo Plastic Surgery
state: New York
Study officials:
affiliation: Romo Plastic Surgery
name: Jacob Tower, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galanin I, Nicu C, Tower JI. Facial Fat Fitness: A New Paradigm to Understand Facial Aging and Aesthetics. Aesthetic Plast Surg. 2021 Feb;45(1):151-163. doi: 10.1007/s00266-020-01933-6. Epub 2020 Sep 10.
Clinical trial NCT05558293: Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy
Official title: Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 88
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients undergo non-surgical quadrant scaling and root planing
Primary purpose: TREATMENT

Brief summary: In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth periodontal debridement.

Detailed description: This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. Patients were enrolled from January 2020 to December 2022. The local ethical committee of approved the study protocol (125/PO) and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival plaque will acquired from 4 separate proximal periodontal sites.

Eligibility criteria: Inclusion Criteria:

1. good condition of general health,
2. a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
3. no involvement of the furcation,
4. a minimum of a six teeth per quadrant, respectively.

Exclusion Criteria:

1. periodontal therapy during the last 12 months,
2. assumption of antibiotics during the last 6 months,
3. pregnancy,
4. any systemic condition which might affect the effects of the study treatment,
5. previous or current radiation or immunosuppressive therapies,
6. use of mouthwash containing antimicrobials during the previous 3 months,
7. no use of hormonal contraceptives,
8. medication by anti-inflammatory and immunosuppressive drugs,
9. previous history of hard-drinking,
10. smoking,
11. class II and III tooth mobility.

Primary outcomes:
measure: Probing depth changes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania
state: CT
Study officials:
affiliation: University of Catania
name: Gaetano Isola
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004493: Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lactic Acidosis
Keywords: inborn errors of metabolism
lactic acidosis
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 1999-10-19
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia.

II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developmental function, or slowing neurological or developmental deterioration in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, cross over study. Patients are randomized to start with one of two different doses of sodium dichloroacetate (DCA).

Patients receive one of two doses of oral DCA for 6 months, then switch to the alternate dose for 6 months. This course is repeated once.

Patients are followed for up to 2 years.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of stable, persistent lactic acidemia Venous lactate at least 3 mM under basal conditions defined as: At least 4 hours postprandial No concurrent illness

OR

* Diagnosis of cerebral lactic acidemia with elevated lactic acid in CSF but not in the blood
* No organic acidemias or defective gluconeogenesis

--Patient Characteristics--

* Hematopoietic: Hemoglobin at least 7 mg/dL
* Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST, ALT, or GGT no greater than 10 times ULN
* Renal: Creatinine no greater than 2 mg/dL
* Cardiovascular: Ejection fraction at least 25%
* Other: No hypoglycemia (blood sugar less than 50 mg/dL at no greater than 12 hours fasting) No severe peripheral neuropathy interfering with normal activities of living

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego School of Medicine
state: California
Study officials:
affiliation: University of California, San Diego
name: Bruce Barshop
role: STUDY_CHAIR
References:
Clinical trial NCT06412393: Evaluation of Eye Health Benefits of Black Tomato Extract
Official title: Evaluation of Eye Health Benefits of Black Tomato Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye
High Myopia
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Verification of the efficacy of black tomato extract for eye health.


Eligibility criteria: Inclusion Criteria:

* Age greater than 20 and capable of providing informed consent.
* Daily usage of 3C (computer, communication, and consumer electronics) for more than 6 hours (OSDI screening - those experiencing dryness and fatigue in the eyes).
* BMI between 22 and 35.
* High myopia population (-5.00 to -9.00D)

Exclusion Criteria:

* History of any eye surgery (e.g., strabismus surgery, refractive surgery).
* Presence of systemic diseases affecting the anterior surface of the eye.
* Long-term use of medications affecting the anterior surface of the eye.

Primary outcomes:
measure: Intraocular Pressure Measurement (IOP)
timeFrame: Change from Baseline at 8 weeks
measure: Grading of Retinal Vascular Diameter
timeFrame: Change from Baseline at 8 weeks
measure: Visual Contrast Sensitivity Function
timeFrame: Change from Baseline at 8 weeks
measure: Negative Fusional Vergence (NFV)
timeFrame: Change from Baseline at 8 weeks
measure: Positive Fusional Vergence (PFV)
timeFrame: Change from Baseline at 8 weeks
measure: Negative Relative Accommodation (NRA)
timeFrame: Change from Baseline at 8 weeks
measure: Positive Relative Accommodation (PRA)
timeFrame: Change from Baseline at 8 weeks
measure: Accommodative Facility
timeFrame: Change from Baseline at 8 weeks
Secondary outcomes:
measure: Questionnaire Survey - Ocular Surface Disease Index (OSDI)
timeFrame: Change from Baseline at 8 weeks
measure: The change of Endothelin-1 (ET-1)
timeFrame: Change from Baseline at 8 weeks
measure: The change of Tumor necrosis factor-α (TNF-α)
timeFrame: Change from Baseline at 8 weeks
measure: Best-corrected visual acuity
timeFrame: Change from Baseline at 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Chung Shan Medical University
name: Bo-Yie Chen boychen@csmu.edu.tw
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06981793: Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery
Official title: Predictors of Anesthesia Complications in Patients Undergoing Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Anesthesia, General
Postoperative Complications
Obesity
Risk Factors
Lead sponsor: Centre Hospitalier de Gonesse
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be selected from adult patients who underwent sleeve gastrectomy as part of bariatric surgery at the Gonesse Hospital (CHG) between January 1, 2020, and June 30, 2021.

Brief summary: This study aims to identify factors that can predict complications related to anesthesia in patients undergoing weight-loss surgery. By looking at patient data from past surgeries, we hope to better understand which factors increase the risk of anesthesia problems, helping doctors improve patient safety during these procedures.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥ 18 years)
* Patients who underwent a longitudinal gastrectomy (sleeve) between January 1, 2020, and June 30, 2021, at CHG, as part of bariatric surgery treatment.

Exclusion Criteria:

* Minor patients
* Patients who underwent a bariatric surgery other than sleeve gastrectomy
* Patients who objected to the use of their data for research purposes

Primary outcomes:
measure: Occurrence of Anesthesia-Related Complications in Bariatric Surgery Patients
timeFrame: October 2023 - January 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Gonesse
country: France
facility: France
Study officials:
References:
Clinical trial NCT02020993: Urine NT-ProBNP in Neonatal Respiratory Distress
Official title: The Prognostic Value of Urine NT-ProBNP in Neonatal Respiratory Distress
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Respiratory Distress
Keywords: Nt-proBNP, newborn, preterm
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborns with first postnatal 2 days with or without respiratory distress

Brief summary: There is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease.

Urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn.

The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory diseases in newborns by a controlled trial.

Detailed description: Neonatal diseases such as respiratory distress and transient tachypnea of newborn may require high level of intensive care. On the other hand, some minor difficulties in respiration can resolve within hours. Therefore, there is a need for a biochemical marker in addition to clinical condition which will help the physician to understand the clinical progress of the disease.

Serum NT-ProBNP level has been evaluated in transient tachypnea of newborn and found compatible with the clinical progress. Urine NT-proBNP has recently been evaluated in patent ductus arterioses and found compatible with the cardiac progress. However, urine Nt-proBNP, which does not need any blood sampling and can be collected easily, has not been evaluated for respiratory distress in newborn.

The investigators aim to evaluate the prognostic value of urine NT-proBNP in respiratory diseases in newborns by a controlled trial.

Eligibility criteria: Inclusion Criteria:

* study group; newborns who are admitted to the neonatal intensive care unit within first 2 days of life and have transient tachypnea of newborn or respiratory distress syndrome signed informed consent form
* Control Group: Newborns without any respiratory distress

Exclusion Criteria:

* any cardiac anomaly sepsis acute renal insufficiency syndromic cases low APGAR score at 5th minute (\<7) lung malformations no informed consent inability in collection of urine

Primary outcomes:
measure: severity of respiratory distress
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Begüm Atasay, Professor
role: PRINCIPAL_INVESTIGATOR
References: