louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06483243: Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State.
Official title: A Randomized, Open-label, Single Oral Dosing, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Administration of CKD-383 and the Co-administration of CKD-501, D745, and D150 for Healthy Subjects in Fed State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of CKD-383 and the co-administration of CKD-501, D745, and D150 for healthy subjects in fed state

Detailed description: Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 or 4 tablets in single dose: actual medication)

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19 to 65 years
* Based on screening, no congenital or chronic disease, who have no athological symptoms or findings(If necessary, EEG, ECG, chest and gastroscopy or gastrointestinal radiation, Examination)
* within 5 years prior to the start of the trial(Period 1 administration) of any clinically significant mental medical history
* Other inclusion criteria, as defined in the protocol

Exclusion Criteria:

* who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period 1 administration)
* Other exclusive criteria, as defined in the protocol

Primary outcomes:
measure: AUCt of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Cmax of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Secondary outcomes:
measure: AUC∞ of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Tmax of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: T1/2 of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: CL/F of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
measure: Vd/F of Lobeglitazone, Empagliflozin, Metformin
timeFrame: 0 hour ~ 48 hour after drug administration
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
Study officials:
affiliation: Chung-Ang University Gwangmyeong Hospital
name: Yun Hwan Oh, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756143: Exercise During Pregnancy and Perinatal Outcome
Official title: Exercise During Pregnancy and Perinatal Outcome. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Healthy
Keywords: fetal heart
cesarean section
exercise
pregnancy
Lead sponsor: University Hospital of Torrejon
Sponsor class: OTHER
Collaborators: name: Universidad Politecnica de Madrid
First posted: 2016-04-29
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effect of Physical Exercise Program on fetoplacental circulation and perinatal outcome.

Detailed description: The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental circulation, fetal heart echocardiogram parameters and perinatal outcome.

Eligibility criteria: Inclusion Criteria:

* Healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
* Able to communicate in spanish
* Giving birth at Torrejon Universitary Hospital

Exclusion Criteria:

* Medical or obstetric complication excluding exercise ( ACOG guideline)
* Interested in the study after 18 weeks or pregnancy
* Not availability to attend to the physical exercise program

Primary outcomes:
measure: Maternal weight gain during pregnancy
timeFrame: From the beginning of the pregnancy to 1 month postdelivery
Secondary outcomes:
measure: Cesarean Section Rate
timeFrame: Birth
measure: Gestational Diabetes
timeFrame: Birth
measure: Preeclampsia
timeFrame: birth
measure: Fetal TAPSE
timeFrame: up to 36 weeks of pregnancy
measure: Fetal Tei Index
timeFrame: up to 36 weeks of pregnancy
measure: Ductus Arteriosus PI
timeFrame: up to 36 weeks
measure: Aortic Isthmus PI
timeFrame: up to 36 weeks
measure: Fetal Heart Rate Variability
timeFrame: birth
measure: Newborn weight
timeFrame: birth
measure: Placental weight
timeFrame: birth
Other outcomes:
Locations:
city: Torrejon de Ardoz
country: Spain
facility: University Hospital de Torrejon
state: Madrid
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Ruben Barakat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00656643: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
Official title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injections of Sirolimus in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: MacuSight, Inc.
First posted: 2008-04-11
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.


Eligibility criteria: Inclusion Criteria include but are not limited to:

* Diagnosed with diabetes mellitus
* Macular edema secondary to diabetic retinopathy
* Visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria include but are not limited to:

* Any other ocular disease that could compromise vision in the study eye
* Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
* Capsulotomy of the study eye within 30 days prior to study start

Primary outcomes:
measure: Best-corrected visual acuity by ETDRS
timeFrame: 180 days
Secondary outcomes:
measure: Foveal central subfield thickness as determined by OCT
timeFrame: 180 days
measure: Safety across dose groups versus placebo
timeFrame: 180 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
Study officials:
affiliation: MacuSight, Inc.
name: Joel Naor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02230943: Rheumatology Informatics System for Effectiveness
Official title: American College of Rheumatology's Rheumatology Informatics System for Effectiveness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Osteoarthritis
Gout
Keywords: rheumatoid
arthritis
osteoarthritis
gout
Lead sponsor: American College of Rheumatology
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The RISE Registry is an enhanced version of the ACR's Rheumatology Clinical Registry (RCR) and allows for a simplified entry process, while establishing a best-in-class resource to manage your patient population and improve patient care.

RISE provides participants with an infrastructure for robust quality improvement activities leading to improved patient outcomes, patient population management and quality reporting related to rheumatic diseases and drug safety. RISE gives physicians and researchers the information they need to optimize patient outcomes, meet reporting requirements, and make discoveries that advance rheumatology.

Detailed description: RISE helps providers benchmark performances on key rheumatology clinical quality measures and align with best practice standards. The RISE benchmarking tool allows providers to view the details of their patient population against established rheumatology quality metrics. RISE allows access to aggregate data from other participating sites so providers can view their patient population in comparison to other RISE participants.

RISE is integrated into an electronic health records (EHR) system, bringing a single point of entry into one solution for filing for quality-based incentive payments, avoiding penalties, complying with reporting requirements and tracking caseloads for quality monitoring and improvement initiatives. RISE collects the data needed to meet current federal reporting requirements.

Participating in RISE helps push the field of rheumatology practice forward. RISE provides a source of information on patient outcomes and quality care for rheumatology leading to new discoveries, better understanding and a source of comparative effectiveness research.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age and older with one of the following diagnoses: rheumatoid arthritis, osteoarthritis, gout

Exclusion Criteria:

-

Primary outcomes:
measure: Controlling High Blood Pressure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: American College of Rheumatology
state: Georgia
Study officials:
References:
Clinical trial NCT05162443: Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation
Official title: Expanded Access Use of Adagrasib (MRTX849) for the Treatment of Patients With Advanced Solid Tumors With a KRAS G12C Mutation
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Advanced Cancer
Metastatic Cancer
Malignant Neoplasm
Keywords: adagrasib
expanded access
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The objective of this EAP is to provide expanded access of adagrasib (MRTX849) to patients with previously treated advanced solid tumors harboring a KRAS G12C mutation.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor
* Confirmed presence of a KRASG12C mutation
* Ineligible for an ongoing clinical trial of MRTX849
* No available or not eligible for standard of care treatment
* Adequate organ function
* CNS Metastases (within set parameters) are allowed
* ECOG performance status of ≤ 2

Exclusion Criteria:

* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of MRTX849 treatment or result in inability to swallow
* Prior therapy targeting a KRAS G12C mutation
* Other active cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Santa Rosa
country: United States
facility: Providence Medical Group Santa Rosa - Cancer Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Piedmont Cancer Institute
state: Georgia
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Reno
country: United States
facility: Renown Health
state: Nevada
city: Allentown
country: United States
facility: Lehigh Valley Cancer Institute
state: Pennsylvania
city: Kingwood
country: United States
facility: Lumi Research
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Renton
country: United States
facility: Seattle Integrative Cancer Center
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
Study officials:
References:
Clinical trial NCT00196443: The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Disease
Official title: Prospective, Randomized and Explorative Controlled Study About Influences of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Venous Insufficiency
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Bauerfeind AG, Zeulenroda, Germany
First posted: 2005-09-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. Conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. Secondary aim was to find out if urea containing stockings increase the compliance to wear the compression stockings regulary by patients with diagnosed chronic venous insufficiency.


Eligibility criteria: Inclusion Criteria:

* Clincial diagnosis of chronic venous insufficiency
* Age: 18-80 years
* Patient's information and willingness to participate

Exclusion Criteria:

* Age under 18 years
* Lower limp edema not caused by venous insufficiency
* Acute deep venous thrombosis
* Arterial occlusive disease
* Diabetes mellitus with neuropathy or peripheral arterial disturbance of perfusion
* immobile Patients
* Pregnancy

Primary outcomes:
measure: skin moisture at day 0 and day 7
measure: loss of water throughout epidermis at day 0 and day 7
measure: throatiness of epidermis at day 0 and day 7
Secondary outcomes:
measure: compliance of patients at every day of intervention
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
state: Fleischmannstr. 42-44
Study officials:
affiliation: Clinic and Polyclinic of Dermatology, University of Greifswald
name: Michael Jünger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic and Polyclinic of Dermatology, University of Greifswald
name: Andrea Ladwig
role: STUDY_CHAIR
References:
Clinical trial NCT05024643: Endoscopic Repair of Frontal Sinus CSF Leak
Official title: Outcome of the Endoscopic Repair of Frontal Sinus Cerebrospinal Fluid Leak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CSF Leakage
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 27
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with frontal sinus leaks attended Al-Azhar University Hospital, New Damietta, Egypt

Brief summary: This retrospective study was conducted on patients with frontal sinus leaks came to ENT departments of Al-Azhar University Hospital, New Damietta, Egypt, for a period of five years.

Detailed description: All patients in this study were evaluated during the follow-up period. Patients' age, sex, occupation, residence, and telephone number were recorded for each participant for demographic purposes. General and local examinations were also performed preoperatively as usual.

Medical history, surgical approach, leakage site, complications, reconstruction technique, and follow-up were recorded.

All cases were treated by endonasal endoscopy

* Complete sphenoethmoidectomy.
* Draf type IIa, IIb, and III according to defect location.
* Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa.
* Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata.

Eligibility criteria: Inclusion Criteria:

* patients who underwent endoscopic frontal sinus repair. Traumatic or spontaneous patients with a CSF leak at a minimum of six months not responding to conservative measures were included.

Exclusion Criteria:

* Known malignancy or patients with frontal leak due to extensive tumor resection or intracranial injury

Primary outcomes:
measure: Successful treatment
timeFrame: 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01042743: Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Keywords: colon cancer
robot
laparoscopy
primary, right-side colon cancer
robot-assisted surgery
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2010-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.


Eligibility criteria: Inclusion Criteria:

* primary cancer
* right-side located tumor (from cecum to proximal transverse colon)

Exclusion Criteria:

* tumor with obstruction
* tumor with perforation
* clinically advanced tumor (T4 stage)
* tumor with distant metastases
* synchronous tumor

Primary outcomes:
measure: surgical quality based on pathological examination
timeFrame: during perioperative period (1-30 days after operation)
Secondary outcomes:
measure: complication
timeFrame: during perioperative period ( 1-30 days after primary operation)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
citation: Park JS, Choi GS, Park SY, Kim HJ, Ryuk JP. Randomized clinical trial of robot-assisted versus standard laparoscopic right colectomy. Br J Surg. 2012 Sep;99(9):1219-26. doi: 10.1002/bjs.8841.
Clinical trial NCT03273543: Perioral Rejuvenation and Upper Lip Enhancement
Official title: Premaxillary Injection for Perioral Rejuvenation and Upper Lip Enhancement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioral Rejuvenation
Upper Lip Projection
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if subjects who receive premaxillary injection demonstrate an increase in nasal tip projection and an associated increase in upper lip projection, and vermillion height.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects Age 21 to 70. 2. Subjects who demonstrate signs of perioral aging or poor upper lip projection.

Exclusion Criteria:

* 1. Subjects who plan to undergo peri oral neurotoxin treatments or ablative skin treatments, or have had either of these treatments in the previous 6 months, other injectable filler treatments during the course of the study.

  2. Subjects who are pregnant or nursing. 3. Subjects with a known allergy or sensitivity to any component of the study ingredients.

  4. Any history of rhinoplasty or nasal filler injections. 5. Recent history of upper lip augmentation (surgical and non-surgical) within the last 12 months.

  6. Any history of lip lift or other surgical procedures involving the upper lip.

  7. Any history of chin augmentation (surgical and non-surgical). 8. Any history of orthognathic surgery. 9. Any history of bleeding disorders (iatrogenic or otherwise). 10. Current history of chronic drug or alcohol abuse. 11. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product (i.e. immunosuppressive therapy).

  12. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.

Primary outcomes:
measure: Nasal Tip Projection
timeFrame: Baseline and 2 months
measure: Upper Lip Projection
timeFrame: Baseline and 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
affiliation: DeNova Research
name: Steven H Dayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03759743: Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
Official title: a Randomised, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 97
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of LMT1-48(Probiotics) compared to a placebo in reducing the body fat in overweight subjects


Eligibility criteria: Inclusion Criteria:

* Age between 19 and 70 years
* Overweight (25 kg/m2 ≤ body mass index (BMI) \< 30 kg/m2)

Exclusion Criteria:

* Pregnancy or breast-feeding
* Unstable body weight (body weight change \> 10% within 3 months before screening)

Primary outcomes:
measure: change from baseline fat percentage at 12 week
timeFrame: at baseline and 12-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
citation: Sohn M, Jung H, Lee WS, Kim TH, Lim S. Effect of Lactobacillus plantarum LMT1-48 on Body Fat in Overweight Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial. Diabetes Metab J. 2023 Jan;47(1):92-103. doi: 10.4093/dmj.2021.0370. Epub 2022 Apr 29.