louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00847834: Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population
Official title: Multi-center Open Label, Non-comparative Observational Study of Irbesartan-Hydrochlorothiazide in the Treatment of Hypertension in Chinese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the treatment of patients with mild to moderate primary hypertension.


Eligibility criteria: Inclusion criteria:

* Systolic blood pressure \< 180 mmHg
* 90 mmHg ≤ Diastolic blood pressure \< 110 mmHg

Exclusion criteria:

* Pregnancy or lactation. Women of child bearing potential (not post-menopausal) should be using a reliable contraceptive method
* Known or suspected secondary hypertension (e.g., coarctation of aorta, renovascular stenosis, etc.)
* Presence of clinically significant ventricular or supraventricular arrhythmias, or second or third degree atrioventricular block, or sick sinus syndrome
* ALAT\[SGPT\]\>2 times of upper limit，
* ASAT\[SGOT\]\>2 times of upper limit
* Patients with known renal disease
* Serum potassium \> normal upper limit
* Uncontroled BD（FBG\>10mmol/L or PBG\>12.22mmol/L)
* Patients treated with tricyclic antidepressants
* Clinical hematological disease.
* Patients with a history of irbesartan, or hydrochlorothiazide sensitivity defined as irbesartan, or hydrochlorothiazide discontinuation due to medically significant adverse effects.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Proportion of patients who reach a diastolic blood pressure <85 mmHg
timeFrame: At 2, 4 and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanofi aventis administrative office
Study officials:
affiliation: Sanofi
name: Ji Jing
role: STUDY_DIRECTOR
References:
Clinical trial NCT03209934: Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center
Official title: Daptomycin > 6 mg/kg/Day as Salvage Therapy in Patients With Complex Bone and Joint Infection: Cohort Study in a Regionalreference Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Treated by Daptomycin
Keywords: Bone and Joint Infection
Daptomycin
Eosinophilic pneumonia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received daptomycin \>6 mg/kg/d as an alternative therapy for complex BJI from January 2011 to July 2013 in a French regional reference center.

Brief summary: The choice of antimicrobial therapy to treat complex bone and joint infections (BJI) is challenging, requiring consideration of: (i) the problem of bone diffusion; (ii) the necessity of using antimicrobials active against bacterial biofilms; (iii) the growing incidence of antibiotic resistance; and (iv) the high risk of severe adverse events (SAE) in response to first-line antimicrobials in these patients.

Consequently, off-label use of recently developed antimicrobials, such as daptomycin, is frequently required as salvage therapy in complex BJI. Even if daptomycin does not have approval for the treatment of BJI, the Infectious Diseases Society of America guidelines propose this antibiotic as alternative therapy for prosthetic joint infection. The recommended dose is 6 mg/kg/d, whereas recent data support the use of higher doses in these patients as bone penetration of daptomycin is limited.

The present cohort study aimed to assess the safety and efficacy of prolonged high-dose (\>6 mg/kg/d) daptomycin salvage therapy in patients with complex BJI.


Eligibility criteria: Inclusion Criteria:

* patients having BJI treated by daptomycin at \>6 mg/kg/d

Exclusion Criteria:

-

Primary outcomes:
measure: Measure of daptomycin through plasma concentration (Cmin)
timeFrame: 300 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03940534: Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
Official title: Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Satisfaction, Personal
Lead sponsor: Intent Solutions, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a randomized crossover design.
Primary purpose: OTHER

Brief summary: A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be patient, nursing, and provider satisfaction.

Detailed description: This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.

Eligibility criteria: Inclusion Criteria:

* any patient taking morphine ER or Oxycontin on one of three hospice home teams

Exclusion Criteria:

* pregnancy
* inability to demonstrate competent use of the device
* age less than 18

Primary outcomes:
measure: Difference from Scheduled Dosing Time
timeFrame: through study completion, up to 1 year
measure: Missed Doses
timeFrame: through study completion, up to 1 year
Secondary outcomes:
measure: Patient Satisfaction: scale of 1 to 5
timeFrame: through study completion, up to 1 year
measure: Nurse Satisfaction: scale of 1 to 5
timeFrame: through study completion, up to 1 year
measure: Physician Satisfaction: scale of 1 to 5
timeFrame: through study completion, up to 1 year
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Haven: Advanced Illness Care
state: Florida
city: Lake City
country: United States
facility: Haven: Advanced Illness Care
state: Florida
city: Palatka
country: United States
facility: Haven: Advanced Illness Care
state: Florida
Study officials:
affiliation: Clinical Pharmacist
name: Christopher E Richter, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Director
name: Ellen Talos, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06431334: Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique
Official title: Protein Requirements Amongst Male Masters-Level Athletes Following a Cycling Exercise Bout as Determined by the Indicator Amino Acid Oxidation Technique
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Increased Metabolic Requirements
Dietary Reference Intakes
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 8
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Masters level cyclists are a population above the age of 35 years who frequently participate in prolonged as well as heavy-volume training. Like most endurance-trained athletes, a greater recommended dietary allowance (RDA) for protein of 1.2-1.4 g/kg/bw is suggested.

Dietary protein intake is vital for maximizing the benefits of training and ensuring optimal recovery. Dietary recommendations traditionally have been determined through nitrogen balance techniques, however, recent research indicates how this method is potentially underestimating protein requirements. Therefore, there is a need to reassess current dietary recommendations in order to meet the demands of physical activity for highly active populations.

Recent efforts to understand protein requirements during rest and following exercise have been completed using the indicator amino acid technique (IAAO). This non-invasive method is reported to provide a robust measure of protein requirements. However, there is limited work in older (≥60 years) active populations.

The purpose of this study is to measure the protein requirements in master cyclists, following an endurance training session, using the non-invasive IAAO technique.


Eligibility criteria: Inclusion Criteria:

* 18.5\< BMI \<35 kg/m\^2
* Overtly healthy masters level cyclists ≥65 years
* Masters level cyclist training (\>4 days per week; \~100 km per week)
* Body mass stable over previous 6-months
* Availability for multiple metabolic trials (\~7 trials)
* Ability to travel to and from laboratory facility

Exclusion Criteria:

* Recent history of weight loss or weight gain (\>5% body weight)
* Uncontrolled hypertension
* ≥2 chronic diseases (e.g. diabetes, osteoporosis, dyslipidemia)
* Acute illness that could affect protein metabolism (HIV, renal dysfunction, influenza)
* Currently using anti-inflammatory medications
* Inability to adhere to study protocol (i.e., alcohol, caffeine, dietary restrictions)
* Regular tobacco user
* Illicit drug use
* Habitually ingesting ≥3 g/kg/bw

Primary outcomes:
measure: 13CO2 Excretion
timeFrame: 7-weeks
Secondary outcomes:
measure: L[13C]phenylalanine Oxidation
timeFrame: 7-weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
References:
Clinical trial NCT00403234: Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: Postoperative pain
opioid
transdermal
TKA (total knee arthroplasty)
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-11-23
Enrollment: 10
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 objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug.

Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria: Inclusion Criteria:

* Males and females of 18 to 80 years of age with American Society of Anesthesiologists (ASA) physical status classification of 1, 2 or 3
* Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the osteoarthritis.

Exclusion Criteria:

* Subjects who have pain or disability in a site other than the operative joint.
* Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery or are scheduled to undergo bilateral knee arthroplasty.
* Subjects whose body mass index (BMI) is 40 or more.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety
timeFrame: From signed informed consent to 7 days after end of study (approx. 35 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: San Clemente
country: United States
facility: Accurate Clinical Trials, Inc
state: California
city: Orlando
country: United States
facility: Southeastern Clinical Research Consultants
state: Florida
city: Baltimore
country: United States
facility: Greater Chesapeake Orthopaedic Associates
state: Maryland
city: Sewickley
country: United States
facility: Sewickley Valley Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04307134: Besponsa Post Marketing Surveillance Study
Official title: Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Maligmancy
Keywords: Refractory and relapsed B-cell ALL
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-03-13
Enrollment: 108
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).

Brief summary: Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.

Detailed description: Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.

Eligibility criteria: Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
2. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
2. Patients to whom BESPONSA® is contraindicated as per the local labeling.

   -

Primary outcomes:
measure: Incidence of adverse events categorized according to physical organ and disease/symptom
timeFrame: 28 days following the last administration of BESPONSA®.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05287334: Blood Loss Measurement Using Electrical Impedance Tomography
Official title: Measurement of Blood Loss Using Electrical Impedance Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss
Keywords: Blood donation, EIT
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
Collaborators: name: Military University Hospital, Prague
First posted: 2022-03-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment. Approx 10-15 voluntary blood donors.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project focuses on the possibility of detecting blood loss using electrical impedance tomography. Based on previous animal experiments, it was found that the bolus of saline significantly affects the signal of chest bioimpedance. It is assumed that blood loss of a similar volume will cause a similar signal change with the opposite trend. The aim of this project is to determine whether there is a significant change in the thoracic electrical impedance tomography signal when blood loss is caused by voluntary blood donation.

Detailed description: Electrical impedance tomography is a bedside method of ventilation monitoring. The bioimpedance of the tissue depends, among other things, on its blood content. The area of the chest and especially the lungs is a heavily perfused tissue, which also serves as one of the reservoirs of blood in case of blood loss. It is therefore possible that blood loss will be visible on chest bioimpedance relatively soon.

The study will be performed on voluntary blood donors. Blood loss of 450 mL will be caused by the collection of donated blood. During blood collection at the transfusion department, thoracic bioimpedance will be measured using electrical impedance tomography. The resulting signal change will then be analyzed to determine the possibility of detecting and measuring blood loss using electrical impedance tomography.

Eligibility criteria: Inclusion Criteria:

* voluntary blood donation

Exclusion Criteria:

* standard exclusion criteria for voluntary blood donation based on the transfusion station protocol
* standard exclusion criteria for electrical impedance tomography according to the manufacturer

Primary outcomes:
measure: Change in chest electrical impedance due to blood loss.
timeFrame: Time frame of one voluntary blood donation process (15 min)
Secondary outcomes:
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University, Faculty of Biomedical Engineering
city: Kladno
country: Czechia
facility: Czech technical university in Prague, Facutly of biomedical engineering
Study officials:
affiliation: Czech Technical University in Prague, Fac. of Biomedical Engineering
name: Vaclav Ort, M.Eng.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05969834: HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome
Official title: Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Ovulation triggering
uHCG
rHCG
GnRH
Dual trigger
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)

Brief summary: This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose

Detailed description: The aims of this study are:

1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including: oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and pregnancy rate
2. To determine if there is an association between type and dose of the trigger and ICSI outcome.

Eligibility criteria: Inclusion Criteria:

* Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol

Exclusion Criteria:

* BMI \> 30 kg/m2
* Irregular menstruation
* Severe male factor abnormality
* Poor ovarian reserve
* Endometriosis
* Uterine abnormality

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
measure: Oocyte maturation rate
timeFrame: On 1 day of oocyte retrieval
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Royal Center
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Engy Abdallah, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, MD
role: STUDY_DIRECTOR
affiliation: Royal Center
name: Mohamed Elzayat, MD
role: STUDY_CHAIR
affiliation: Mansoura University
name: Amoura Abou-ElNaga, MD
role: STUDY_CHAIR
References: