louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00694083: Study of Ridaforolimus (MK-8669) in Participants With Solid Tumors (MK-8669-003)(COMPLETED)
Official title: A Phase I Study of MK-8669 in Patients With Metastatic or Locally Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus (MK-8669) in participants with locally advanced or metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically - Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid Tumors That Have Failed To Respond To Standard Therapy, Or For Which Adequate Standard Therapy Does Not Exist
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Adequate Organ Function

Exclusion Criteria:

* Participant Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks (6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration
* Any central nervous system Metastasis Which Has Symptoms Or Requires Treatment
* Any Primary Central Nervous System Tumor
* Any Symptomatic Ascites Or Plural Effusion Which Requires Treatment
* A History Or Current Evidence Of Any Clinically Significant Disease That Might Confound The Results Of The Study, Complicate The Interpretation Of The Study Results, Interfere With The Participant's Participation, Or Pose An Additional Risk To The Participant

Primary outcomes:
measure: Number of Participants With Ridaforolimus Dose Limiting Toxicities
timeFrame: Cycle 1 (28 days)
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg)
timeFrame: Day 1
measure: Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg)
timeFrame: Day 26
measure: Maximum Plasma Concentration (Cmax) for Day 1 (Single Dose of Ridaforolimus, 20 mg or 40 mg)
timeFrame: Day 1
measure: Maximum Plasma Concentration (Cmax) for Day 26 (Multiple Doses of Ridaforolimus, 20 mg and 40 mg)
timeFrame: Day 26
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Seki Y, Yamamoto N, Tamura Y, Goto Y, Shibata T, Tanioka M, Asahina H, Nokihara H, Yamada Y, Shimamoto T, Noguchi K, Tamura T. Phase I study for ridaforolimus, an oral mTOR inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Apr;69(4):1099-105. doi: 10.1007/s00280-011-1788-4. Epub 2011 Dec 6.
Clinical trial NCT03626961: The Role of NEWS on Intensive Care Discharges
Official title: The Role of NEWS on Tertiary Intensive Care Discharges
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care
Keywords: NEWS
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical and medical patients who met the criteria of the tertiary stage intensive care unit

Brief summary: To determine the ability of the NEWS at tertiary intensive care unit discharges to predict the development of clinical deterioration.

To determine a cut-off value for NEWS score for early readmission

Detailed description: The Nationaly Early Warning Score (NEWS) is a single score based on the measurement of vital signs and inspired gases by the patient. A higher NEWS indicates severity of illness and risk of adverse outcomes. The use of NEWS values to select the appropriate patients for tertiary ICU discharges has not been tested. Our aim is to test the value of NEWS on discharges tertiary ICU.

Eligibility criteria: Inclusion Criteria:

* Older than 18 years old
* Stay higher than 48 hours

Exclusion Criteria:

* Under 18 years old
* Stay lower than 48 hours
* Intoxication
* Exitus

Primary outcomes:
measure: Readmission rate
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit university
state: Corum
Study officials:
affiliation: Hitit universtiy
name: Ozgur Yagan, Assoc.Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01783561: Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Official title: Early Versus Routine Caffeine Administration in Extremely Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caffeine
Keywords: caffeine
intubation
hemodynamic
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

Detailed description: This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants \<29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Eligibility criteria: Inclusion Criteria:

* Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion Criteria:

* Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
* Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
* Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.

Primary outcomes:
measure: Intubation
timeFrame: First 12 hours of life
Secondary outcomes:
measure: Subjects Requiring Inotropes in the First 24 Hours
timeFrame: first 24 hours of life
measure: Systemic Blood Flow
timeFrame: first 24 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968861: Outcome After 24 Months of Participants in the TOBY Xenon Study
Official title: Neurological Outcome After 24 Months of Age Following Treatment With Xenon Combined With Moderate Hypothermia After Perinatal Asphyxia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perinatal Asphyxia
Encephalopathy
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 69
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population were the surviving participants in the TOBY Xenon study. There were 69 survivors from 92 participants at 2 years after birth and 62 of the 69 participants entered the TOBY Xenon Follow-up Study

Brief summary: The objective of this study is to document the outcome at 2-3 years of age of participants of the TOBY Xe trial, to provide preliminary information about the later clinical effects of treatment with Xenon gas combined with moderate hypothermia following perinatal asphyxia. The TOBY Xe trial was a randomised controlled trial of inhaled xenon gas combined with hypothermia for the treatment of perinatal asphyxia. The trial primary outcome was changes on magnetic resonance parameters examined prior to discharge from hospital.

Continuing clinical follow-up of trial participants is important following any therapeutic trial and is essential in early phase trials where information on the clinical effects of the intervention are lacking. Therefore, we have set up this study to determine the major clinical and neurological outcomes of participants of the TOBY Xe trial and to determine whether the magnetic resonance parameters in that trial are qualified to predict outcome following neural rescue therapy. This information is necessary for planning further studies of this intervention.


Eligibility criteria: Inclusion Criteria:

Surviving participants in the TOBY Xenon study

Exclusion Criteria:

Lack of consent to participate

Primary outcomes:
measure: Scores on Bayley scales of infant and toddler development
timeFrame: at 2-3 years of age
measure: Relation between magnetic resonance markers and neurodevelopmental outcome
timeFrame: at 2-3 years of age
Secondary outcomes:
measure: Grade of disability
timeFrame: At 2-3 years of age
Other outcomes:
measure: Optimality Scores on Hammersmith neurological examination
timeFrame: At 2-3 years of age
measure: Gross Motor Function Classification System
timeFrame: At 2-3 years of age
measure: Manual Ability Classification System
timeFrame: At 2-3 years of age
measure: Clinical signs of cerebral palsy
timeFrame: At 2-3 years of age
Locations:
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Trust
city: London
country: United Kingdom
facility: Imperial College London NHS Healthcare Trust
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
Study officials:
affiliation: King's College London
name: David A Edwards, FMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593861: Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China
Official title: Assessment of Enhanced Recovery After Surgery Implementation at Pediatric Surgery Practices in Mainland China: Based on a Survey of Performing Congenital Biliary Dilatation Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ERAS
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chief pediatric surgeons at each center

Brief summary: Enhanced recovery after surgery (ERAS) is a new mode to optimize perioperative management, the core of which is to reduce perioperative physiological and psychological trauma and stress damage, and accelerate postoperative rehabilitation. ERAS has been gradually introduced in pediatric surgery in recent years, however, there are limited reports on its overall implementation. We aimed to determine the popularity of ERAS among pediatric populations in mainland China.

Detailed description: The application of ERAS in children with congenital biliary dilatation (CBD) was investigated. A total of 31 province-level administrative regions in mainland China were involved and each of them had at least one participating center. A questionnaire was designed to assess the baseline adherence of 17 recovery elements and chief pediatric surgeons at each center were invited to complete.

Eligibility criteria: Inclusion Criteria:

* chief pediatric surgeons at each center

Exclusion Criteria:

* Incomplete questionnaire

Primary outcomes:
measure: Element adherence
timeFrame: immediately after all the questionnaires are collected
Secondary outcomes:
measure: Factors associated with baseline ERAS utilization
timeFrame: immediately after all the questionnaires are collected
Other outcomes:
measure: Barriers to implementation
timeFrame: immediately after all the questionnaires are collected
measure: Outcomes of concern
timeFrame: immediately after all the questionnaires are collected
Locations:
city: Nanjing
country: China
facility: NJMU
state: Jiangsu
Study officials:
affiliation: Department of pediatric Surgery, Children's Hospital of Nanjing Medical University, Nanjing, China.
name: Hua Xie, M.M.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vacek J, Davis T, Many BT, Close S, Blake S, Hu YY, Holl JL, Johnson J, Strople J, Raval MV. A baseline assessment of enhanced recovery protocol implementation at pediatric surgery practices performing inflammatory bowel disease operations. J Pediatr Surg. 2020 Oct;55(10):1996-2006. doi: 10.1016/j.jpedsurg.2020.06.021. Epub 2020 Jun 27.
Clinical trial NCT05808283: Preoperative Anemia Frequency
Official title: Preoperative Anemia Frequency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Evaluation
Keywords: preoperative evaluation
preoperative anemia
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 853
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age, without massive bleeding, of both sexes

Brief summary: In our retrospective study, it was aimed to determine the frequency of anemia in non-emergency patients over the age of 18 who applied to the Anesthesiology and Reanimation Department of our hospital.


Eligibility criteria: Inclusion Criteria:

* -patient over 18 years old,
* Patients applying to the Department of Anesthesiology and Reanimation AD

Exclusion Criteria:

* Pregnant,
* under 18 years old,
* will undergo cardiac and emergency surgery
* Patients with Massive Bleeding
* Patients who underwent multiple surgeries during the study period

Primary outcomes:
measure: PREOPERATIVE ANEMIA FREQUENCY AND TREATMENT APPROACH
timeFrame: Patients who applied to the outpatient clinic within a 3-month period after ethical approval
Secondary outcomes:
measure: PREOPERATIVE ANEMIA FREQUENCY AND TREATMENT APPROACH
timeFrame: Patients who applied to the outpatient clinic within a 3-month period after ethical approval
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Gamze Küçükosman
Study officials:
References:
Clinical trial NCT06225583: Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
Official title: Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bertolotti's Syndrome
Lower Back Pain
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 Bertolotti's Syndrome patients and 20 lower back pain patients

Brief summary: The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients.


Eligibility criteria: Inclusion Criteria:

Lower Back Pain Cohort

* Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain
* Age ≥ 18 years

Bertolotti's Syndrome Cohort

* Positive diagnosis of Bertolotti's Syndrome
* Age ≥ 18 years
* Positive imaging for Bertolotti's Syndrome
* Previous analgesic injection results

Exclusion Criteria:

Lower Back Pain Cohort

* History of spinal deformity, previous spinal surgeries, spinal infections
* Pregnant women

Bertolotti's Syndrome Cohort

* History of spinal deformity, previous spinal surgeries, spinal infections
* Pregnant women

Primary outcomes:
measure: To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.
timeFrame: 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael Steinmetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710983: Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth
Official title: Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Newborn
Healthy
Keywords: Mortality
Morbidity
Growth
Immunology
Lead sponsor: Bandim Health Project
Sponsor class: OTHER
First posted: 2008-07-08
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.


Eligibility criteria: Inclusion Criteria:Normal birth weight, no overt illness or gross malformations -

Exclusion Criteria:

-

Primary outcomes:
measure: Mortality by sex
Secondary outcomes:
measure: Morbidity, growth, immunology
Other outcomes:
Locations:
city: Bissau
country: Guinea-Bissau
facility: Bandim Health Project
Study officials:
affiliation: Bandim Health Project
name: Peter Aaby, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lund N, Andersen A, Hansen AS, Jepsen FS, Barbosa A, Biering-Sorensen S, Rodrigues A, Ravn H, Aaby P, Benn CS. The Effect of Oral Polio Vaccine at Birth on Infant Mortality: A Randomized Trial. Clin Infect Dis. 2015 Nov 15;61(10):1504-11. doi: 10.1093/cid/civ617. Epub 2015 Jul 28.
citation: Eriksen HB, Biering-Sorensen S, Lund N, Correia C, Rodrigues A, Andersen A, Ravn H, Aaby P, Jeppesen DL, Benn CS. Factors associated with thymic size at birth among low and normal birth-weight infants. J Pediatr. 2014 Oct;165(4):713-21. doi: 10.1016/j.jpeds.2014.06.051. Epub 2014 Jul 30.
Clinical trial NCT03097783: Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Official title: A Randomized, Multi-center, Evaluator-blinded, No-treatment Controlled Study to Evaluate the Efficacy and Safety of Restylane Perlane Lidocaine for Correction of Midface Volume Deficit and/or Midface Contour Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Midface Volume Deficit
Keywords: hyaluronic acid, midface
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-03-31
Enrollment: 169
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: This is a randomized, multi-center, evaluator-blinded, no-treatment controlled study to evaluate the efficacy and safety of Restylane Perlane Lidocaine for correction of Midface Volume Deficit and/or Midface Contour Deficiency.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Men or women aged 18 years of age or older of Chinese origin
3. Subjects willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study
4. Subjects seeking augmentation therapy for the midface
5. MMVS score of 2, 3 or 4 on each side of the face as assessed by the blinded evaluator

Exclusion Criteria:

1. Known/previous allergy or hypersensitivity to any injectable HA gel/local anaesthetics, e.g.lidocaine or other amide-type anaesthetics.
2. Previous surgery or tattoo in the area to be treated
3. Previous tissue augmentation therapy or contouring with any permanent (non-biodegradable) or semi-permanent filler, autologous fat, lifting threads or permanent implant below the level of the lower orbital rim.
4. Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim or neurotoxin within 12 months before treatment.
5. Scars or deformities, active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne psoriasis and herpes zoster near or in the area to be treated.
6. Other condition preventing the subject from entering the study in the Investigator's opinion.

Primary outcomes:
measure: Percent Responders With 1 Point Improvement on the Medicis Midface Volume Scale
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Q-Med AB
Study officials:
References:
citation: Wang X, Wu Y, Li B, Mu X, Li L. Lifting the midface using a hyaluronic acid filler with lidocaine: A randomized multi-center study in a Chinese population. J Cosmet Dermatol. 2022 Dec;21(12):6710-6716. doi: 10.1111/jocd.15286. Epub 2022 Oct 25.