louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01179295: Japanese BAY86-9766 Monotherapy Phase I Study
Official title: Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: MEK inhibitor
BAY86-9766
RDEA 119
Solid tumor
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

* Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.
* Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)
* At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1
* Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
* Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
* Inadequate bone marrow, liver and renal function
* Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs
* Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers

Primary outcomes:
measure: Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.
timeFrame: At the end of 30-day follow up after discontinuation of study drug administration
measure: Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).
timeFrame: Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.
Secondary outcomes:
measure: Response rate
timeFrame: On average 3 months
measure: Disease control rate
timeFrame: On average 3 months
Other outcomes:
Locations:
city: Kashiwa
country: Japan
state: Chiba
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00516581: Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the HAART
Official title: Occurrence of Pneumocystis Pneumonia in HIV-Infected Patients and the Interference of the Highly Active Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: Pneumocystis Pneumonia
Acquired Immune Deficiency Syndrome
Highly Active Antiretroviral Therapy
Treatment Experienced
Treatment Naive
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2007-08-15
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002

Brief summary: From the beginning of the AIDS epidemic, pulmonary pneumocystosis (PCP) has been distinguished as one of the most frequent opportunistic diseases with high morbid-mortality. As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the characteristics of such epidemic by reducing its related diseases and, as a result, AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference, 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002.

Detailed description: From the beginning of the AIDS epidemic, pneumocystis pneumonia (PCP) has been distinguished as one of the most frequent opportunistic diseases with high morbid-mortality. As from 1996, the advent of the highly active antiretroviral therapy (HAART) has changed the characteristics of such epidemic by reducing its related diseases and, as a result, AIDS-related mortality. With the purpose to estimate PCP occurrence and HAART interference, 376 HIV-infected or AIDS patients were studied from January 1992 to December 2002. Among them, 58 (15.5%) PCP cases were found. There was a higher occurrence of PCP in the group of patients in which HAART was not used, with 40 (69.0%) of the episodes. As regards the studied period, a tendency to a linear reduction in annual PCP incidence was observed. The mean of T CD4+ lymphocytes in the patients with PCP (117 cells/mm3) was significantly lower when compared to that of the other individuals (325 cells/mm3). Therefore, this study suggests a temporal reduction in PCP occurrence related to HAART use with higher T CD4+ lymphocyte counts. Nevertheless, this opportunistic infection still shows significant incidence in AIDS patients.

Eligibility criteria: Inclusion Criteria:

* HIV infection

Exclusion Criteria:

* No HIV infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - Unesp
state: Sao Paulo
Study officials:
affiliation: UPECLIN HC FM Botucatu Unesp
name: Alexandre N Barbosa, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720681: Plating of Humeral Shaft Fractures in Multiple Trauma Patients.
Official title: Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Humeral Fractures
Multiple Trauma
Lead sponsor: OhioHealth
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma and Reconstructive Surgery
First posted: 2008-07-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by our practice for diaphyseal fracture of the humerus after multiple trauma.

Brief summary: The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)
* patients for whom the above fracture has healed
* patients willing and able to provide informed consent and able to participate in study procedures

Exclusion Criteria:

* patients with known pathological fractures
* patients with metabolic bone disease
* patients with humeral head or inter-articular surface fractures, or other upper extremity fractures
* patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)
* patients with neurologic injury to upper extremities

Primary outcomes:
measure: DASH (Disabilities of the Arm, Shoulder and Hand) Score
timeFrame: At Enrollment
measure: Strength of injured arm compared to uninjured arm
timeFrame: At enrollment
measure: Range of motion in injured arm compared to uninjured arm
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Grant Medical Center
name: Bruce French, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Idoine JD 3rd, French BG, Opalek JM, DeMott L. Plating of acute humeral diaphyseal fractures through an anterior approach in multiple trauma patients. J Orthop Trauma. 2012 Jan;26(1):9-18. doi: 10.1097/BOT.0b013e318214ebd5.
Clinical trial NCT00287781: A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
Official title: A Double Blind Randomized Controlled of Placebo and Nebulized Lidocaine for Migraine Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Headache
Keywords: Migraine
Lidocaine
Headache
Lead sponsor: Kern Medical Center
Sponsor class: OTHER
First posted: 2006-02-07
Enrollment: 150
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: Migraine headaches have previously been shown to be responsive to intranasal lidocaine in a small study. Using a nebulizer to administer the drug would improve the feasibility of using the treatment. It would also spare the patient narcotics with their attendant side effects. Because of the potential for placebo effect a placebo control is necessary in this study.


Eligibility criteria: Inclusion Criteria:

* Meets IHS criteria for migraine

Exclusion Criteria:

* Pregnant
* Breast feeding
* Allergic to Lidocaine
* Worst or first Headache
* Abnormal neurological exam
* Substance abuse within 6 months
* Cardiac, liver or pulmonary disease
* Participation n another study within 30 days

Primary outcomes:
measure: Resolution of symptoms
Secondary outcomes:
measure: Improvement in 10 point pain score
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Medical Center
state: California
Study officials:
affiliation: Kern Medical Center UCLA
name: Rick McPheeters, DO FAAEM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03523481: NHF in Acute Hypercapnic Acute Exacerbation of COPD
Official title: NHF in Acute Hypercapnic Acute Exacerbation of COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety of NHF in Acute Hypercapnic AECOPD
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AECOPD and failure of NIV therapy

Brief summary: Patients with AECOPD and NIV failure and in absence will be treated with NHF device. Inclusion criteria are pH \< 7,38 and pCO2 \> 45 mm Hg. Patients were treated if pH \>7,38 or refusal of therapy.


Eligibility criteria: Inclusion Criteria:

* pH \< 7,38
* hypercapnic AECOPD

Exclusion Criteria:

* Need of intubation

Primary outcomes:
measure: pH
timeFrame: up to 24 hours
Secondary outcomes:
measure: pCO2
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
Study officials:
References:
Clinical trial NCT02501681: Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients
Official title: Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microcirculation
Keywords: sublingual microcirculation
cardiovascular surgery
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 40
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: Single-centre prospective randomized study will be included the patients who undergo elective cardiovascular surgery. Preoperative fluid deficit will be calculated by the formula as starvation period X 4 X weight. Patients will be divided into two groups: Group A (n=20); crystalloid as priming solution used in patients, Group B (n=20); colloids as priming solution used in patients. In addition to priming solutions, extracorporeal pump will be filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin. Standard anesthesia protocol will be administered to all patients. Ringer's Lactate will be given at first 30 minute after induction. Ringer's Lactate as fluid maintenance will be administered at a rate of 100 mL/h except in extracorporeal circulation. Goal-directed fluid management will be performed by PVI (Pleth Variability Index). Cut off level of PVI will be accepted %15.

Detailed description: For integrative investigation of the effects of priming solution and postoperative fluid management on the complex interrelation between microcirculation and reactive oxygen species; sublingual microcirculation using microcirculation imaging system (IDF, Cytocam, NL) will be displayed and measure ekstra vascular lung water (EVLW) using PiCCO and plasma levels of oxidative stress markers will be measured. Sublingual tissue microcirculation will be evaluated in all patients at different time points as before induction (T0), after induction (T1), before cross clamping-hypothermic period (T2), after cross clamping (T3), before end of pump (normothermic period, heating) (T4), acceptance to intensive care unit (T5), third hour after surgery (T6) and twenty forth hour after surgery (T7).

Eligibility criteria: Inclusion Criteria:

* cardiovascular surgery needed

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: change in microvascular flow index (MFI)
timeFrame: 1 day
Secondary outcomes:
measure: difference in MFI
timeFrame: 1 day
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
References:
Clinical trial NCT02071381: Phase 1 Study of DDI Between DW330SR and DW1030 in Healthy Male Subjects
Official title: A Randomized, Open Label, Single-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between DW330SR and DW1030 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT

Brief summary: The purpose of this study is to evaluate drugs interactions to compare pharmacokinetics in groups of monotherapy DW330SR, monotherapy DW1030, and coadministration DW330SR and DW1030


Eligibility criteria: Inclusion Criteria:

* Healthy Adult males aged 20\~40 years at screening visit
* Subjects with range of 19 kg/m2 \~ 27 kg/m2 as BMI measurements at screening visit
* Subjects with BP range of below:

  90 mmHg ≤ Systolic BP ≤ 140 mmHg 50 mmHg ≤ Diastolic BP ≤ 90mmHg
* Subjects who voluntarily agreed with written consent that be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the reguirement of the study

Exclusion Criteria:

* Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.)
* Subjects with history of gastrointestinal disease (ex, Chrones dz, peptic ulcer, etc) affect the absorption of Investigational drugs or history of surgery (except for a simple appendectomy or hernia surgery)
* Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID and antibiotics) including ingredient of DW330SR and DW1030 and Food

Primary outcomes:
measure: Trans-OH as Main Metabolites of DW330SR, DW330SR, Cmax, AUClast of DW1030
timeFrame: -28 ~ -2day(screening), -1day, 1day, 2day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center IRB
Study officials:
References:
Clinical trial NCT00998881: Monotherapy Study of MP-513 in Patients With Type 2 Diabetes
Official title: A Phase III, Double-blind, Placebo Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus - Confirmative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 203
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
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 efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.


Eligibility criteria: Inclusion Criteria:

* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 6.5% - 10.0%
* Patients who were not administered diabetes therapeutic drugs within 12 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
* Patients with serious diabetic complications.
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Primary outcomes:
measure: Change From Baseline in HbA1c at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12
timeFrame: 12 weeks
measure: Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sapporo-shi
country: Japan
state: Hokkaidou
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03721081: Local Anesthesia for Pediatric Cochlear Implant
Official title: Preemptive Local Anesthetic Infiltration Reduces Opioid Requirements Without Attenuation of the Intraoperative Evoked Stapedial Reflex Thresholds in Pediatric Cochlear Implant Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Local
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Bahteem Specialized Hospital
First posted: 2018-10-26
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).

Detailed description: Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.

Eligibility criteria: Inclusion Criteria:

* ASA I-II physical status,
* age between 1 and 6 year,

Exclusion Criteria:

* known allergy to local anesthetics,
* predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.

Primary outcomes:
measure: number of patients requiring rescue opioid analgesia (Tramal)
timeFrame: During the length of hospital stay post surgery (on average 24 hours)
Secondary outcomes:
measure: The operative time
timeFrame: Intraoperative
measure: The anesthesia time.
timeFrame: Intraoperative
measure: Heart rate
timeFrame: Intraoperative
measure: mean arterial blood pressure
timeFrame: Intraoperative
measure: ESRT responses
timeFrame: Intraoperative
measure: Anesthetic consumption
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
affiliation: Ain Shams University
name: wahba Z Bakhet, MD
role: PRINCIPAL_INVESTIGATOR
References: