louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04218552: Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension
Official title: A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-209 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension,Essential
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-06
Enrollment: 176
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
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 determine the optimal dose of AD-209 in patients with Essential Hypertension.

Detailed description: Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* orthostatic hypotension with symptom
* Other exclusions applied

Primary outcomes:
measure: 1. Change rate of MSSBP
timeFrame: [ Time Frame: baseline, 8 weeks ]
Secondary outcomes:
measure: 1. Change rate of MSSBP
timeFrame: [ Time Frame: baseline, 4 weeks ]
measure: 2. Change rate of MSDBP
timeFrame: [ Time Frame: baseline, 4 weeks, 8 weeks ]
measure: 3. Proportion of BP normalization MSSBP/MSDBP < 140/90 mmHg MSSBP/MSDBP < 130/80 mmHg (Diabetes or Chronic renal disease)
timeFrame: [ Time Frame: 4 weeks, 8 weeks ]
measure: 4.Reaction rate of BP
timeFrame: [ Time Frame: baseline, 4 weeks, 8 weeks ]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: ChangGu Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung KC, Sung JH, Cho EJ, Ahn JC, Han SH, Kim W, Kim KH, Sohn IS, Shin J, Kim SY, Kim KI, Kang SM, Park SJ, Kim YJ, Shin JH, Park SM, Park CG. Efficacy and safety of low-dose antihypertensive combination of amlodipine, telmisartan, and chlorthalidone: A randomized, double-blind, parallel, phase II trial. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1298-1309. doi: 10.1111/jch.14570. Epub 2022 Sep 12.
Clinical trial NCT06337500: Validation of a Making Decision Hybrid (ecologic and Virtual) Task
Official title: Validation of a Making Decision Hybrid (ecologic and Virtual) Task
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Behavior and Behavior Mechanisms
Keywords: decision-making
ecological task
brain activity
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 65 inclusive
* Subjects with no neurological or psychiatric disorders
* Subjects with no addictive disorder except tobacco
* Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study
* Affiliation with a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Men and women under 18 or over 65 years of age
* Subjects suffering from a neurological or psychiatric disorder
* Subjects suffering from an addictive disorder, with the exception of tobacco
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* Subject without health insurance
* Pregnant
* Subject within the exclusion period of another study or on the "national volunteer list".

Primary outcomes:
measure: Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
state: Not in US/Canada
Study officials:
affiliation: CHU Besançon
name: Julie GIUSTINIANI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03753100: Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients; a 5-year Follow up Study
Official title: Periprosthetic Bone Remodeling in Femoral Neck Fracture Patients: a 5-year Follow up Study Addressing the Influence of Surgical Approach on Periprosthetic Bone Mineral Density.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Mineral Density
Femoral Neck Fractures
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2018-11-26
Enrollment: 51
Sex: ALL
Minimum age (years): 70
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Periprosthetic bone remodeling in femoral neck fracture patients: a 5-year follow up study addressing the influence of surgical approach on periprosthetic bone mineral density.

Detailed description: Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468).Patients between 70 and 90 years of age with displaced femoral neck fractures, intact cognitive function and the ability to walk with or without a walking aid prior to falling were asked for their agreement to be enrolled and partition occurred after informed consent.A subgroup analysis looking at periprosthetic bone mineral density around the femoral component was part of this level 1 single-center randomized trial. 51 patients were enrolled in this DEXA study, and future examination of bone remodeling in these patients is now planned.

Eligibility criteria: Inclusion Criteria:

* Patients between 70 and 90 years of age with displaced femoral neck fractures
* Intact cognitive function
* Ability to walk with or without a walking aid prior to falling.

Exclusion Criteria:

* Dementia
* Fractures in pathologic bone
* Patients not belonging to the hospital community
* Patients with sepsis or local infection
* Fracture not eligible to be treated with a hemiarthroplasty

Primary outcomes:
measure: Periprosthetic bone mineral density measured by dual-energy X-ray absorbtiometry
timeFrame: 5-year follow- up study
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Departement of Orthopaedics, Sorlandet Hospital
Study officials:
affiliation: Department of Rheumatology, Sorlandet hospital, Kristiansand, Norway
name: Glen Haugeberg, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01483300: Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
gemcitabine
lobaplatin
cisplatin
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* Disease progression during or after previous 1st line chemotherapy
* Scheduled to receive 2nd line chemotherapy.
* Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
* 18 years of age or older
* ECOG performance status of 0-2
* Life expectancy of greater than 6 months

Exclusion Criteria:

* Previous treatment with one of the study drugs
* Application of other cytotoxic chemotherapy or radiotherapy
* Insufficent renal function (creatinine clearance \< 60ml/min)
* Clinically unstable brain metastasis
* Pregancy or lactation
* History of other malignancy within last 5 years.

Primary outcomes:
measure: Overall response rate
timeFrame: 4 weeks after chemotherapy
Secondary outcomes:
measure: Time to progression
timeFrame: one year after last patient in
measure: Overall Survival
timeFrame: one year after last patient in
measure: Treatment related toxicity
timeFrame: 4 weeks after chemotherapy
Other outcomes:
Locations:
city: Harbin
country: China
facility: Cancer Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: Cancer Hospital of Harbin Medical University
name: Qingyuan Zhang, MD
role: STUDY_DIRECTOR
affiliation: Cancer Hospital of Harbin Medical University
name: Xinmei Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01011400: Ultrasonic Measurements of the Clitoris in Fetuses
Official title: Measurements of the Fetal Clitoris by 2D Ultrasound
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ambiguous Genitalia
Keywords: clitoris
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women with a female fetus in the second or 3 ed trimester

Brief summary: Abnormal enlargement of the clitoris in fetal life may be a sign for different pathologies. To the investigators knowledge there is no published nomogram of the clitoris size through gestation and it's assessment is usually subjective. The purpose of this study is to create a nomogram of clitorial size through gestation by measuring its size in fetuses of different age in the second and third trimester.


Eligibility criteria: Inclusion Criteria:

* well dated pregnancy
* singleton pregnancy
* female fetus
* appropriate for gestational age

Exclusion Criteria:

* small for gestational age
* other fetal anomalies
* maternal conditions that can cause exposure of the fetus to high androgen environment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT05991700: Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Official title: Anthocyanin-Rich Table Grape Powder for Prophylaxis of Post-Operative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Post-operative Atrial Fibrillation (POAF)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: California Table Grape Commission
First posted: 2023-08-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of POAF, however many typical anti-inflammatory medications, such as ibuprofen, are contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a drug was identified with anti-inflammatory properties with minimal deleterious side effects, this could be broadly applied to cardiac surgery patients for the prevention of POAF. Interestingly, several small trials have shown that medications that alter transcription of inflammatory markers lead to decreased POAF. Furthermore, we have shown that phytochemicals, such as those found in grapes, have excellent bioavailability and can affect cardiac gene transcription related to inflammation. In this study, we propose to evaluate the efficacy of preoperative administration of concentrated grape powder in the prevention of POAF.


Eligibility criteria: Inclusion Criteria:

* Males and female patients (age 50-79) at the Mitral Valve Clinic/CVC undergoing elective cardiac surgery for mitral valve repair without the Cox MAZE procedure (MVR patients also undergoing CABG and/or tricuspid valve repair are also eligible)
* In sinus rhythm (no pre-operative atrial fibrillation)

Exclusion Criteria:

* Age ≥ 80 years
* Diagnosed pre-operative chronic or paroxysmal AF
* Prior ablation procedure for AF
* Previous cardiac surgery
* Implanted pacemaker
* Active smoker
* Comorbidities such as congenital or cardiac re-operation
* Use of antiarrhythmic agents
* Active inflammatory or infectious disease or malignancy
* Diagnosed autoimmune disease
* Corticosteroid or other immunomodulatory or immunosuppressive medication
* Risk factors for POAF including low ejection fraction (EF) (EF\<50%), left atrial (LA) dilation (LA\>5.0 cm), and high degree of mitral regurgitation (grade 3-4).

Primary outcomes:
measure: POAF-related events during initial hospital stay and within 30 days after surgery
timeFrame: 30 days
measure: Atrial transcripts related to NFκB activation; Impact on NIDDM, Angiotensin II
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Michigan Medicine
state: Michigan
Study officials:
References:
Clinical trial NCT05812300: Local Injection of Periodontal Pocket Method for the Treatment of Gingivitis
Official title: The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: Dove Medical Press Ltd
Sponsor class: NETWORK
First posted: 2023-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can reduce symptoms and signs of gingivitis or periodontitis. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.

Detailed description: The previous studies showed that toothpastes containing the cosmetic grade raw material of the 35 kDa low molecular hyaluronan fragment HA35 significantly reduced symptoms and signs of gingivitis or periodontitis. In this study, patients with mild to moderate periodontitis suffering from symptoms and signs, including discomfort and swelling and bleeding of periodontal tissue, were treated by intrapocket injection of freshly manufactured hyaluronan fragment HA35. This study is an repeat clinical study comparing pre- and posttreatment effects similar to others.

Eligibility criteria: Inclusion Criteria:

* Healthy condition and with a clinical diagnosis of mild to moderate gingivitis.
* Male or female volunteers aged 18-60 years.
* Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing)

Exclusion Criteria:

* Healthy condition and with a clinical diagnosis of severe gingivitis.
* Pregnant or lactating females.
* Be concomitantly participating in another clinical study.
* History of any allergic reaction to HA.
* To treat the gingivitis with any other medication/mouthwashes in the period of the study.

Primary outcomes:
measure: Measurement of gum discomfort
timeFrame: 7 days
measure: Measurement of gum redness and swelling
timeFrame: 7 days
measure: Measurement of probe gingival bleeding
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Huinuode Biotechnology Co., Ltd.
Study officials:
References:
Clinical trial NCT00604500: A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1)
Official title: An Open-Label, Multi-Center, Patient Handling Study of Mometasone Furoate/Formoterol Fumarate MDI With an Integrated Dose Counter in Adolescent and Adult Subjects and Adult With Asthma or COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
COPD
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2008-01-30
Enrollment: 272
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.


Eligibility criteria: Diagnosis and Criteria for Inclusion:

* A participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or COPD of at least 12 months.
* A participant must have been able to demonstrate correct use of an MDI without a counter at the Screening Visit.
* A participant must have demonstrated at least 90% compliance with completion of the e-diary, use of the counterstrip, and use of the study medication over the 2-week Screening Period.

Exclusion Criteria:

* Participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study.
* Participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (RSI) that may have impacted their ability to effectively participate in the full duration of the study.

Primary outcomes:
measure: Overall Discrepancy Rate
timeFrame: 4-week Treatment Period
measure: Overall Quartile Discrepancy Rate
timeFrame: 4-week Treatment Period
measure: Overall Discrepancy Size
timeFrame: 4-week Treatment Period
measure: End of Use Agreement: Number of Inhalers With an End of Use Agreement of 0 (Completer Population)
timeFrame: 4-week Treatment Period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Weinstein C, Staudinger H, Scott I, Amar NJ, LaForce C. Dose counter performance of mometasone furoate/formoterol inhalers in subjects with asthma or COPD. Respir Med. 2011 Jul;105(7):979-88. doi: 10.1016/j.rmed.2011.01.013. Epub 2011 Mar 12.
Clinical trial NCT03279900: Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy
Official title: Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014

Brief summary: This study use an observational study design from patient medical records to obtain data on patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child patients.

Detailed description: All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age, gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels, hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.

Eligibility criteria: Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in period of 2012 - 2014, with Inclusion Criteria:

* LLA Patients, male and female, age 1 - \<18 years
* Received chemotherapy maintenance phase based on Indonesian protocol of ALL - 2013

Exclusion Criteria:

* Incomplete medical record data.

Primary outcomes:
measure: The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy.
timeFrame: october 2017
Secondary outcomes:
measure: The relationship of the incidence of hematotoxicity with influencing factors
timeFrame: November 2017
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusomo hospital
state: Jakarta
Study officials:
affiliation: Departemen of Pharmacology and therapeutics, FMUI
name: Rianto Setiabudy, Professor
role: STUDY_DIRECTOR
References: