louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01821937: Pharmacokinetics of Faldaprevir of Soft Capsule
Official title: Pharmacokinetics of Single and Multiple Oral Doses of 120 mg and 240 mg BI 201335 in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-04-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single oral dose and multiple oral doses in Chinese subjects


Eligibility criteria: Inclusion criteria:

Healthy male and female subjects

Exclusion criteria:

Any relevant deviation from healthy conditionsAny relevant deviation from healthy conditions

Primary outcomes:
measure: Cmax,ss (After Multiple Dosing)
timeFrame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir
measure: AUC(Tau,ss) (After Multiple Dosing)
timeFrame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir
Secondary outcomes:
measure: Cmax (After Single Dosing)
timeFrame: Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir
measure: AUC(0-tz) (After Single Dosing)
timeFrame: Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir
measure: t(1/2,ss) (After Multiple Dosing)
timeFrame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir
measure: Tmax,ss (After Multiple Dosing)
timeFrame: Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir
Other outcomes:
Locations:
city: Beijing
country: China
facility: 1220.52.86001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02733237: Oxytocin Effects on the Tolerance of Infidelity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: oxytocin
infidelity
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 160
Sex: ALL
Minimum age (years): 19
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate whether intranasal oxytocin (40 IU) treatment can influence the tolerance of infidelity in males and females.

Detailed description: In a double-blind, between-subject, placebo controlled design, investigators plan to investigate the effect of oxytocin treatment on the tolerance of infidelity. Male and female subjects would firstly see a neutral face of the opposite sex presented with a sentence descried their fidelity or infidelity behavior (sexual or emotional) in a relationship. Next the participant will rate the attractiveness, likability and trustworthiness of each individual, and whether they would like to have a short/long relationship with him/her. After that there will be some implicit attitude tasks to test their implicit attitude towards potential partners exhibiting previous fidelity or and infidelity.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant,menstruating,taking oral contraceptives
* medical or psychiatric illness.

Primary outcomes:
measure: attitude towards fidelity and infidelity of potential mate.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: China, Sichuan
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506337: Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
Official title: Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pancreatitis, Acute Necrotizing
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan University
First posted: 2007-07-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With multicenter randomized control clinical evaluation investigations, the scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline for integrated medicine of diagnosis and treatment of SAP would be formed, to be popularized all over China.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18yr-70yr, complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria), conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5.

Exclusion Criteria:

* Pregnancy, nursing mother, critical cases of advanced tumor, on the verge of death (estimated to be moral in 12h), severe visceral function disturbance, patients undergoing other therapeutic research that might interfere with the present study.

Primary outcomes:
measure: 1,Mortality 2,Morbidity 3,Crossing stage cure rates 4,Number of operation procedures 5,Incidences of secondary infections 6,Hospitalization days 7,Total expenses 8,Traditional Chinese medicine diagnostic parameters
timeFrame: To observe the relationship between the parameters of the first and second stages and the endpoints
Secondary outcomes:
measure: 1.Routine laboratory tests, blood and urine amylase, blood lipase. 2.Important visceral function criteria 3.microorganism culture, endotoxin determination, CRP 4.B-ultrasound, CT, chest films, plain abdomen film
timeFrame: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge.
Other outcomes:
Locations:
city: Dalian
country: China
facility: The 1st Affiliated Hospital, Dalian Medical Unversity
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital, Sichuan Unversity
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
Study officials:
affiliation: Tianjin Nankai Hospital
name: Naiqiang Cui, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Qing Xia, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: The 1st Affiliated Hospital, Dalian Medical Unversity
name: Qinghui Qi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03469037: Effects on Experimental Dyspnea of High Flow Nasal Cannula
Official title: Effects on an Experimental Dyspnea by Thoraco-abdominal Elastic Strapping of the High Flow Nasal Cannula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspnea
Healthy Volunteers
Keywords: Dyspnea, High flow nasal cannula
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To develop an experimental model of dyspnea by external thoraco-abdominal elastic strapping at rest in order to study the mechanisms involved in the relief of dyspnea by the administration of high flow by nasal cannula (HFNC).

Detailed description: This study will measure the effect of HFNC on an experimental model of dyspnea induced by thoraco-abdominal elastic strapping on healthy subjects at rest.

The study will also compare the effects on dyspnea of the administration of high flow nasal cannula with and without oxygen added.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* chronic pathology
* active smokers
* anxiety disorder
* allergy to latex
* protected adult
* woman declared herself pregnant

Primary outcomes:
measure: Effects of high flow nasal cannula on strapping induced type of dyspnea
timeFrame: One hour
Secondary outcomes:
measure: Compare the effect of the high flow by nasal cannula with and without oxygen on an experimental dyspnea, evaluated by the differences of changes in the visual analogic scale
timeFrame: One hour
Other outcomes:
Locations:
city: Paris
country: France
facility: Laboratoire de Physiopathologie Respiratoire du Service de Pneumologie et de Réanimation
city: Paris
country: France
facility: Service de Pneumologie et Réanimation Médicale
Study officials:
affiliation: Service de Pneumologie de la Pitié-Salpétrière
name: Capucine Morelot-Panzini, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Pneumologie de la Pitié-Salpétrière
name: Thomas Similowski, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01478737: Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Official title: A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Proliferative Diabetic Retinopathy
Keywords: PDRP
vitreous hemorrhage
vitrectomy
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).

Detailed description: To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

Eligibility criteria: Inclusion Criteria:

* Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

* Previous PPV
* Vitreous hemorrhage of non-PDRP origin

Primary outcomes:
measure: Reoperation
timeFrame: 12 months
Secondary outcomes:
measure: Rebleeding
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St. Erik Eye Hospital
state: NonUS
Study officials:
affiliation: St. Erik Eye Hospital
name: Anders Kvanta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00654537: STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges
Official title: A 6 Week Open Label, Dose Comparison Study to Evaluate the Safety and Efficacy of Rosuvastatin Versus Atorvastatin, Pravastatin, and Simvastatin in Subjects With Hypercholesterolemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Keywords: Cholesterol
hypercholesterolemia
low density lipoproteins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-08
Enrollment: 5625
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: To compare the efficacy of various doses of rosuvastatin with atorvastatin, pravastatin \& simvastatin in reducing levels of low density lipoprotein cholesterol in subjects with hypercholesterolaemia.


Eligibility criteria: Inclusion Criteria:

* Discontinuation of all previous lipid lowering therapy.
* Fasting LDL-c levels of between 160mg/dl - 250 mg/dl at Visits 2 \& 3 for subjects not on lipid lowering therapy at Visit 1.
* Other lipid parameters as specified in the protocol.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Abnormal laboratory parameters as defined in the protocol.

Primary outcomes:
measure: Percentage change in low density lipoprotein cholesterol.
timeFrame: 4 & 6 weeks
Secondary outcomes:
measure: Percentage change in other lipid parameters as defined by the protocol
timeFrame: 6 weeks
measure: Safety evaluation
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Eleanor Miller, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_CHAIR
References:
Clinical trial NCT02696252: G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator
Official title: Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-02
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and pediatrics with diabetes mellitus

Brief summary: Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator

Detailed description: The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.

Eligibility criteria: Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

* Use of acetaminophen
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification of the study-assigned blood glucose meter

Primary outcomes:
measure: proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
References:
Clinical trial NCT06688552: Comparison of Acute Effects of Traditional and Drop Set Training on Fatigue and Proprioception in Bodybuilding Athletes
Official title: Comparison of Acute Effects of Traditional Set and Drop Set Training Methods on Fatigue Levels and Proprioceptive Sensory Mechanism in Bodybuilding Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Intensity
Proprioception
Keywords: drop set
traditional set
fatigue
proprioception
Lead sponsor: Giresun University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomised controlled (parallel group) experimental study.
Primary purpose: BASIC_SCIENCE

Brief summary: To compare the acute effects of traditional and drop set training methods on fatigue levels and proprioceptive sensory mechanisms in bodybuilding athletes.

Detailed description: A total of 28 male bodybuilding athletes with an average age of 25.53 years from Giresun and Ordu provinces participated in the study voluntarily. The participants were randomly divided into two groups as traditional training group (GS) (n=14) and drop set training group (DS) (n=14). Borg CR10 Scale and myotonometric measurements (Myoton Pro muscle palpation device) were used to assess fatigue. Myotonometric measurements were performed on the pectoralis major, triceps brachii and deltoideus muscles. Proprioception characteristics were evaluated in four parameters: shoulder flexion, shoulder abduction, elbow flexion and wrist flexion using laser cursor-assisted angle repetition test.

After the application, fatigue levels in pectoralis major, triceps brachii, Borg CR10 parameters and proprioception errors in shoulder flexion, elbow flexion, wrist flexion parameters were significantly higher in the traditional set group compared to the drop set group.

Eligibility criteria: Inclusion Criteria:

* -Being male.
* Being between the ages of 20-30.
* To have been doing bodybuilding for at least the last five years.

Exclusion Criteria:

* -Having undergone a serious surgical operation within the last year,
* Having used a performance enhancing product that affects the neuromuscular mechanism within the last year,
* In addition, individuals who did not meet the inclusion criteria were excluded from the study.

Primary outcomes:
measure: Assessment of Demographic and Physical Characteristics
timeFrame: 1 day
measure: Assessment of Proprioception
timeFrame: 1 day
measure: Assessment of Fatigue
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Gi̇resun
country: Turkey
facility: Giresun University
state: Centre
Study officials:
References:
Clinical trial NCT00798252: Ascending Multiple-Dose Study of Brivanib Alaninate in Combination With Chemotherapeutic Agents in Subjects With Advanced Cancers
Official title: A Phase I, Multi-arm, Dose Escalation Study of Brivanib Alaninate Combined With Several Chemotherapy Regimens in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: metastatic, chemotherapy combination
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine safety and maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Histologic/cytologic diagnosis of advanced or metastatic solid tumors
* Life expectancy \>= 3 months
* Able to swallow tablets/capsules

Exclusion Criteria:

* Pregnant or breastfeeding women
* No more than 4 previous chemotherapy regimens in the advanced or metastatic setting (excluding prior adjuvant or hormonal / immuno / biologic antibody therapies

Primary outcomes:
measure: To determine safety and the maximum tolerated dose of brivanib alaninate when administered in combination with capecitabine, doxorubicin, ixabepilone, docetaxel and paclitaxel chemotherapy to subjects with advanced or metastatic solid tumors
timeFrame: Every 21 days until the maximum tolerated dose (MTD) for each combination of brivanib is reached
Secondary outcomes:
measure: To describe the anti-tumor activity of brivanib alaninate combination with the different chemotherapeutic regimens: capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel
timeFrame: Every 21 days
measure: To assess the effect each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel on the pharmacokinetics of BMS-540215 (active moiety of brivanib pro-drug) at the MTD
timeFrame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
measure: To assess the effect of brivanib alaninate on the pharmacokinetics each of capecitabine, doxorubicin, ixabepilone, docetaxel, and paclitaxel chemotherapy regimens at the MTD
timeFrame: Cycle 1D21, Days 1, 2, 3, 8 of Cycles 1 & 2
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: