louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02133482: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-05-08
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects
2. age of 18 to 50 years
3. body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion criteria:

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mmHg, or pulse rate outside the range of 50 to 90 mmHg at screening
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Primary outcomes:
measure: Number of subjects with drug-related adverse events
timeFrame: up to 19 days postdose
Secondary outcomes:
measure: AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
timeFrame: up to 120 hours postdose
measure: Cmax (maximum measured concentration of the analyte in plasma)
timeFrame: up to 120 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01475682: Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea
Official title: Long Term Cardiovascular Complications in Men With Obstructive Sleep Apnea - Prospective 9 Years Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Cardiovascular Diseases
Metabolic Diseases
Keywords: Obstructive sleep apnea
cardiometabolic complications
Effects of CPAP treatment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 167
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 167 subjects recruited from our previous "OSA and metabolic syndrome" (OSAMS) cohort from October 2002 to June 2007 will be invited to be reassessed at this time point.

Brief summary: Subjects with Obstructive Sleep Apnea (OSA) are at increased risk of developing cardiometabolic complications, and effective long-term nCPAP treatment significantly reduces the risk of cardiovascular morbidity and mortality.

Detailed description: 1. Primary outcome:

   Incidence of cardiometabolic diseases in subjects with OSA over 9 years.
2. Secondary outcomes:

Effects of CPAP treatment on cardiometabolic conditions

Eligibility criteria: Inclusion Criteria:

* From previous cohort for reassessment.

Exclusion Criteria:

* Unstable medical conditions

Primary outcomes:
measure: Incidence of cardiometabolic complications
timeFrame: 9 years
Secondary outcomes:
measure: Effects of CPAP treatment on cardiometabolic conditions
timeFrame: 9 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Jamie C Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004482: Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocarditis
Giant Cell Myocarditis
Keywords: cardiovascular and respiratory diseases
giant cell myocarditis
rare disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 1999-10-19
Enrollment: 40
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: OBJECTIVES:

I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis.

II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms.

III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.

Detailed description: PROTOCOL OUTLINE:

This is a randomized, open label, multicenter study.

Patients are randomized to receive standard care with immunosuppression (arm I) or standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine)(arm II).

Arm I: Patients receive methylprednisolone IV once daily for 3 days and muromonab-CD3 IV once daily for 10 days. Oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year.

Arm II: Patients receive standard care with or without immunosuppression (no muromonab-CD3 or cyclosporine).

Patients are followed for one year.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Idiopathic giant cell myocarditis confirmed by endomyocardial biopsy

Heart failure and/or arrhythmia of less than 3 months duration

--Patient Characteristics--

Hepatic: AST/ALT no greater than 3 times upper limit of normal

Renal: Creatinine no greater than 2.5 mg/dL

Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); No contraindication to immunosuppression; No allergy to cyclosporine or muromonab-CD3; No other severe concurrent diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Leslie T. Cooper, Jr.
role: STUDY_CHAIR
References:
Clinical trial NCT03679182: Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
Official title: A Pilot Study on Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nausea
Vomiting
End Stage Cancer
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Oral olanzapine showed superior antiemetic efficacy to metoclopramide as rescue treatment to control breakthrough emesis induced by chemotherapy. This study aims to evaluate safety and efficacy of olanzapine for nausea and vomiting in advanced cancer patients.

Detailed description: This will be a pilot study; open-label prospective clinical trial. Oral olanzapine 5 mg tablet will be given to patients who fail two standard treatment medications for nausea and vomiting within 30 minutes after the first vomiting episode. Other doses of olanzapine will be given at 12, 24, and 36 hours following the first dose concurrently with standard regimen.

Patients with emesis will be followed up after receiving olanzapine every 12 hour for 48 hours. We will record the frequency of vomiting, nausea, and retching.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years.
2. Diagnosis of advanced malignancy.
3. Failed two standard medications for nausea/vomiting (after 6 hours from last dose).
4. Adequate organ function, including the following:

   1. Hepatic: bilirubin ≤1.5 times the upper limit of normal (x ULN); aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement), alkaline phosphatase (AP) ≤5.0 x ULN.
   2. Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.
5. Expected life expectancy \> 1 month.
6. Patients must be able to read Thai.
7. Patients must sign an informed consent document.

Exclusion Criteria:

1. Patients with history of abdominal radiotherapy.
2. Patients who receive chemotherapy within 1 week.
3. Patients who take fluoxetine.
4. Patients with heart failure or myocardial infarction in the past 6 months.
5. Patients with QTc prolongation from baseline ECG.
6. Known hypersensitivity to olanzapine.
7. Patients who are unwilling to participate in the study.

Primary outcomes:
measure: Emesis control
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Jarin Chindaprasirt
Study officials:
affiliation: Khon Kaen University
name: Attakorn Raksasataya, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02060682: Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice
Official title: Post-Market Registry of the ACIST Cardiovascular Pressure Measurement (CPM) System and Navvus Catheter in Clinical Practice-ADVANCE-EU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Fractional Flow Reserve
Rapid Exchange
Catheter
Lead sponsor: Acist Medical Systems
Sponsor class: INDUSTRY
First posted: 2014-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age or older, in whom FFR measurement is indicated to guide PCI strategy and use of the ACIST CPM System and Navvus Catheter is attempted.

Brief summary: This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS Catheter. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

Detailed description: There are no protocol-specific procedural requirements for this registry. Enrolled subjects will undergo a diagnostic angiography procedure including an FFR measurement with the CPM System and NAVVUS Catheter according to the center standard of care and the Instructions for Use of the CPM System and Navvus Catheter. Participants will be followed for the duration of hospital stay, an expected average of 1 day.

Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older in whom FFR measurement is indicated to guide percutaneous coronary intervention (PCI) strategy and use of the ACIST CPM System and Navvus Catheter is attempted.

Exclusion Criteria:

-

Primary outcomes:
measure: Procedural Success
timeFrame: From enrollment through hospital discharge, an expected average of 1 day.
Secondary outcomes:
Other outcomes:
Locations:
city: Massy
country: France
facility: Hospital Privé Jacques Cartier
city: St. Denis
country: France
facility: Centre Cardiologique du Nord
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe Universität
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
Study officials:
affiliation: Hospital Privé Jacques Cartier
name: Thierry Lefèvre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06325982: Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury
Official title: Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Injuries
Rectal Diseases
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-22
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.

Detailed description: The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.

Eligibility criteria: Inclusion Criteria:

* There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
* ECOG score 0-1;
* normal mind, clear consciousness;
* High compliance;
* Able to cooperate with the interviewer

Exclusion Criteria:

* Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
* Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;
* serious heart, brain, liver, kidney disease;
* Long-term immune dysfunction;
* Pregnant or lactating women;
* Patients who terminate treatment for various reasons.

Primary outcomes:
measure: Occurrence time of acute and chronic radiation rectal injury
timeFrame: Up to approximately 4 months
measure: Evaluation of acute and chronic radiation rectal injury
timeFrame: Up to approximately 4 months
Secondary outcomes:
measure: Clinical symptom assessment
timeFrame: Up to approximately 4 months
measure: Quality of life assessment assessed by IBDQ
timeFrame: Up to approximately 4 months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: lingdong Shao, Bachelor
role: STUDY_CHAIR
References:
Clinical trial NCT04635982: Kinesiotape on Quadriceps and Gluteus in Counter Movement Jump and Sprint in Soccer Players
Official title: Kinesiotape on Quadriceps and Gluteus in Counter Movement Jump and Sprint in Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Athletics
Performance
Keywords: Kinesiotape
Soccer
Sprint
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2020-11-19
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty-seven subjects were randomly allocated to the different study groups using the software AleatorMetod.xls. Subjects were divided into three groups: 13 subjects were assigned to the experimental group with KT activation (KTact); 12 subjects, to the placebo group with a sham tape KT (KTst); and 12 subjects, to the control group (CG).
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to analyse the effect of KT on countermovement jump (CMJ) and sprint immediately and 24 hours after its application on the quadriceps and gluteus maximus.

Detailed description: Kinesiotape (KT) is a technique commonly used in sports practice. It may be beneficial in enhancing muscle function by additional cutaneous afferent stimulation. The objective of this study was to analyze the effect of KT on countermovement jump (CMJ) and 20-m sprints immediately and 24 hours after its application on the quadriceps and gluteus maximus. A total of 37 male soccer players (19.7 ± 0.9 years old) were randomly assigned to one of 3 groups: experimental group: KT activation (KTact), placebo group: sham tape (KTst), and control group (CG). Participants performed a 30-minute preliminary warm-up, after which they conducted CMJ and 20-m sprint tests. These tests were repeated later (with KT application or not) and after 24 hours.

Eligibility criteria: Inclusion Criteria:

* soccer players;
* age of 18-25 years;
* a regular attendance at training sessions

Exclusion Criteria:

* history of L1-L5 radiculopathy or lumbo-sacral pathology ;
* any treatment with KT on quadriceps or gluteus in the month prior to the study;
* history of systemic diseases that may affect the nervous system, musculoskeletal injuries or surgeries in the lower limb during the year prior to the study;
* use of analgesics or nonsteroidal anti-inflammatory drugs.

Primary outcomes:
measure: Countermovement vertical jump
timeFrame: 24 hours
measure: 20 m sprints test
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Maria Cinta Gomez
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Javier Reina Abellan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01067482: The Performances of Spectral Domain Optical Coherence Tomography (OCT) for Distinguishing Glaucomatous Eyes
Official title: The Performances of Spectral Domain Optical Coherence Tomography for Distinguishing Between Normal Eyes, Glaucoma Suspect and Glaucomatous Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma Patient
Glaucoma Suspect Patient
Normal Population
RNFL Thickness by Location
Macular Thickness by Location
Keywords: OCT
spectral domain cirrus
glaucoma
glaucoma suspect
normal population
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: glaucoma patient from glaucoma clinic that is POAG Glaucoma suspect cases normal population case

Brief summary: The purpose of this study is to evaluate performances of each parameters of spectral domain (Cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma suspect and glaucomatous eyes

Detailed description: Aim to determine which parameter of cirrus OCT is best sensitivity and specificity for glaucoma detection

Eligibility criteria: Inclusion Criteria:

* BCVA at least 20/60
* refractive error +/- 5 D Or astig +/- 3 D
* enrolled in 3 population group (glaucoma, glaucoma suspect or normal)

Exclusion Criteria:

* VA less than 20/60
* marked RF error
* previous ocular trauma or surgery
* unreliable visual field
* poor signal cirrus OCT (less than 7)
* other causes of optic nerve or macular disease other than glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hat-yai,
country: Thailand
facility: Glaucoma unit , Department of Ophthalmology Faculty of Medicine Prince of Songkla University
state: Songkhla, Thailand.
Study officials:
affiliation: Prince of Songkla University
name: Weerawat Kiddee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235482: Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Official title: Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Melanoma
Lead sponsor: Viralytics
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CAVATAK
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Detailed description: Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Eligibility criteria: Inclusion Criteria:

* stage IV melanoma (AJCC classification)
* minimum of 2 sc metastases
* failure or refusal of standard chemotherapy
* ECOG score of 0 or 1
* other

Exclusion Criteria:

* metastatic CNS disease
* ocular or mucosal melanoma
* immunodeficiency
* splenectomy
* other

Primary outcomes:
measure: Safety profile of treatment, characterisation of adverse events
Secondary outcomes:
measure: Efficacy - clinical response of injected and non-injected tumours
Other outcomes:
Locations:
city: Newcastle
country: Australia
facility: Melanoma Unit, Mater Misericordiae Hospital
state: New South Wales
Study officials:
References: