louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01066338: Genome-wide Pharmacogenetic Candidate Gene Single Nucleotide Polymorphism (SNP) Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype
Official title: Genome-wide Pharmacogenetic Candidate Gene SNP Array-based Approach to Predict Chemoresponse and Survival in Patients With Acute Myeloid Leukemia With Normal Karyotype
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myeloid Leukemia
Keywords: SNP array
prognosis
acute myeloid leukemia
normal karyotype
acute myeloid leukemia with normal karyotype
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who were diagnosed as acute myeloid leukemia with normal karyotype will be enrolled.

Brief summary: The most reliable prognostic marker of acute myeloid leukemia(AML) is cytogenetics by karyotyping. According to cytogenetic results, the patients with AML are classified as better, intermediate and poor prognosis groups. The normal karyotype AML was reported in about 50% of all AML and classified as intermediate risk group. However, the patients with normal karyotype AML showed various prognosis. Therefore, the further studies about subgroup analysis of normal karyotype AML are needed. Recently, the understandings of human genome polypmorphism using SNP array have been accumulated. However, the advanced researches for clinical application are not enough.

The study design is a retrospective and single-center study. The patients with normal karyotyping AML who were diagnosed from 1994 to 2008 at Samsung Medical Center (South Korea) will be enrolled. The stored bone marrow samples of enrolled patients are used for genome wide scanning by SNP array.

The purpose of present study is to develop predictive pharmacogenemic biomarkers model associated wit clinical outcomes including efficacy and toxicity in patients with AML with normal karyotype treated with chemotherapy using pharmacogenetic SNP array. And secondly, to develop enrichment clinical trial based on predictive pharmacogenomic model.


Eligibility criteria: Inclusion Criteria:

* patients with normal karyotype acute myeloid leukemia
* 18 years or older
* patients were treated with standard chemotherapy
* patients with available medical record and stored bone marrow specimen at time of diagnosis

Exclusion Criteria:

* no definitive criteria

Primary outcomes:
measure: overall response rate
timeFrame: within 1 month after enrollment
Secondary outcomes:
measure: overall survival time
timeFrame: within 1 month after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Division of Hematology and Oncology/Samsung Medical Center
name: Dong Hwan Kim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06686238: Acute Effects of Intermittent Hypoxia-Hyperoxia in Older Adults
Official title: Acute Effects of a Hypoxia-hyperoxia Exposure Session on Sedentary Older Adults on Heart Rate Variability, Blood Pressure, and Oxygen Saturation, a Randomized Double-blind Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Older Adults
Cardiovascular Health
Blood Pressure
Sedentary
Keywords: hypoxic exposure
older adults
heart rate variability
Lead sponsor: Sierra Varona SL
Sponsor class: OTHER
Collaborators: name: Universidad Europea de Madrid
First posted: 2024-11-13
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The supply of oxygen is essential for energy production, recovery from efforts, and human life. Intermittent Hypoxia-Hyperoxia Exposure (IHHE) is a novel technique in which the subject is exposed to a respiratory environment with reduced oxygen fraction, controlled through a specific software, using a facial mask and a hypoxic generation device. The objective of this study is to determine if there is a relationship between intermittent hypoxia-hyperoxia exposure and cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

According to our hypothesis, acute IHHE in elderly adults may influence cardiorespiratory condition, blood pressure, and arterial oxygen saturation.

The study will be conducted as a randomized clinical trial. The subjects will be divided into two groups: the experimental group will undergo an IHHE session, breathing air with an oxygen concentration (FiO2) ranging from 10-14% for 1-5 minutes, with 1-3 minutes of rest in hyperoxia (FiO2 30-40%) for a total of 4-8 cycles, based on their acute response to hypoxia. The placebo group will undergo a 5-cycle protocol with an FiO2 of 21%.


Eligibility criteria: Inclusion Criteria:

* Being over 60 years old.
* Having no previous experience in hypoxic training.
* Engaging in less than 150 minutes of physical activity per week.

Exclusion Criteria:

* Having any pathology that prevents the subject from being independent in terms of walking and functionality.
* Subjects with impaired cognitive abilities.
* Subjects with pulmonary hypertension, decompensated heart or respiratory disease.
* To have or have had cancer

Primary outcomes:
measure: Heart rate variability
timeFrame: Immediately before intervention and immediately after intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: Immediately before intervention and immediately after intervention
measure: Arterial oxygen saturation
timeFrame: Immediately before intervention and immediately after intervention
Other outcomes:
Locations:
city: Manzaneque
country: Spain
facility: Residencial Montes de Toledo
state: Toledo
Study officials:
References:
Clinical trial NCT03290638: Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration
Official title: Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Deficiency
Keywords: Guided Bone Regeneration
Dehydrated Human Amnion Chorion Membrane
Type I Bovine Collagen Membrane
Ridge Preservation
Ridge Healing
Teeth Extraction
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.

Detailed description: Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.

Eligibility criteria: Inclusion Criteria: .

Patients included in the study were required:

* Not to be completely edentulous.
* To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned

Exclusion Criteria: Patients were excluded if they :

* Had received radiation therapy
* Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
* Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
* Were smokers (more than 10 cigarettes per day)
* Were pregnant or breastfeeding.

Primary outcomes:
measure: Alveolar Ridge Dimensional Changes
timeFrame: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
measure: Alveolar Ridge Bone Vitality
timeFrame: Mean= 19.5 weeks after tooth extraction and bone grafting
Secondary outcomes:
measure: Ridge Healing Evaluation
timeFrame: Two weeks form the time of the extraction
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01050738: Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
Official title: Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Orthopedic Surgery
Analgesia
Lead sponsor: Spenshult Hospital
Sponsor class: OTHER
First posted: 2010-01-15
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing arthroplastic surgery of knee or hip

Exclusion Criteria:

* Sensitivity to local anesthetics
* Other reason not to use local anesthetics

Primary outcomes:
measure: Need for other postoperative analgesia.
timeFrame: 48 hours
Secondary outcomes:
measure: Patient mobility within the first 48 hours.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Oskarström
country: Sweden
facility: Spenshult Hospital
Study officials:
affiliation: R&D-center Spenshult
name: Stefan Bergman, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03037138: Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients
Official title: Use Of Blood Flow Rate Profiling For Postdialysis Washed-Out Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis-Induced Symptom
Keywords: postdialysis washed-out
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: New Jeddah Clinic Hospital
First posted: 2017-01-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Use of blood flow profiling for prevention of postdialysis washed-out feeling through same group scale before and after profiling
Primary purpose: PREVENTION

Brief summary: Hemodialysis patients frequently complain of postdialysis fatigue and washed-out feeling. The aim of this study is to use blood flow rate (BFR) profiling to mitigate postdialysis washed-out state.

Detailed description: Hemodialysis patients who complain of the postdialysis washed-out state were recruited. blood flow rate was altered to be 350 ml/min in the first hour of the session then decreased by 50 ml/min hourly for the 4-hour dialysis session. blood flow rate profiling was continued for 9 dialysis sessions (21 Days). Patients were asked to grade their washed-out state on a scale from 1 (no washed-out state) to 5 (severe washed-out state) before and after blood flow rate profiling. Paired t=-test and Wilcoxon Signed Ranks Test were used in appropriate context to compare washed out scale before and after together with urea reduction rate and other blood chemistry tests.

Eligibility criteria: Inclusion Criteria:

* Hemodialysis Patient
* Postdialysis washed-out complain

Exclusion Criteria:

* schedule-non complaint patients
* Patients with recent blood pressure drug modification

Primary outcomes:
measure: Washed-out Scale
timeFrame: after 9 modified dialysis session (21 dyas from start of study)
Secondary outcomes:
measure: Urea reduction Rate
timeFrame: after 9 modified dialysis session (21 dyas from start of study)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01089738: A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
Official title: An Investigator And Subject-blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of Pf-03382792 In Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: mulitple dose
pharmacokinetics
safety
healthy elderly volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.

Detailed description: To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer aged 65-80 years old
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with symptoms or signs of adrenal insufficiency.
* Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.

Primary outcomes:
measure: Safety Endpoints include: AEs, vital signs, triplicate ECGs,
timeFrame: Day 0 to Day 28
measure: Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations
timeFrame: Day 0 to Day 28
measure: Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive),
timeFrame: Day 0 to Day 28
measure: Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14.
timeFrame: Day 0 to Day 28
measure: Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated.
timeFrame: Day 0 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05778838: Midodrine Effect on the Mortality Rates in Septic Shock Patients
Official title: Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Midodrine in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Septic Shock
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 100
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: Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.


Eligibility criteria: Inclusion Criteria:

* Adult aged 18 years or older diagnosed with septic shock.
* Hypotensive and require IV vasopressor for more than 24 hours.

Exclusion Criteria:

* Hypovolemic shock.
* Severe organic heart disease (ejection fraction \<30 percent).
* Bradycardia (HR\<50 b/m).
* Chronic kidney disease (serum creatinine \>2mg/dl).
* Thyrotoxicosis.
* Pheochromocytoma.
* Known allergy to midodrine.
* Unable to administer an oral medication.

Primary outcomes:
measure: Mortality rates
timeFrame: Time Frame: Starting from date of randomization till shock reversal or date of death from any cause, whichever came first,assessed up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT05231538: Neurodevelopmental Therapy for Spastic Cerebral Palsy
Official title: Effects of Neurodevelopment Therapy on Gross Motor Function and Postural Control in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Spastic
Diplegia, Spastic
Keywords: Neurodevelopmental therapy
NDT
Spastic cerebral palsy
Physical Therapy
Rehabilitation
Neurorehabilitation
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: This study was conducted to find out the Effects of Neurodevelopment therapy (a rehabilitative program designed by Bobath) on Gross Motor Function and Postural Control in Children with Spastic Cerebral Palsy. To investigate either there was a significant difference between the effects of neurodevelopment therapy and routine physical therapy on gross motor function and postural control in children with Spastic Cerebral Palsy.

Detailed description: A randomized controlled trial was conducted at Department of pediatric rehabilitation, Sher e Rabbani Hospital, Sheikhupura. Sample size was 66 and purposive sampling technique was adopted to collect data. Sample selection was completely based on inclusion and exclusion criteria. A diagnosed Spastic Cerebral Palsy patient aged 2-6 years with no other severe abnormalities such as seizure were recruited. While patients with mental retardation or undergone medical procedures likely to affect motor function such as botulinum toxin injections, orthopedic remedial surgery were excluded. Data was collected at baseline, 4th, 8th and 12th week of the treatment sessions. Gross motor function measure scale (GMFM-88) and posture and postural ability scale (PPAS) were used as data collection tools.

Eligibility criteria: Inclusion Criteria:

* • A diagnosed Spastic Cerebral Palsy (patient's diagnosis of CP confirmed by an expert pediatrician neurologist)

  * Spastic CP
  * No other severe abnormalities such as seizure
  * Aged 2-6 years
  * Both Genders

Exclusion Criteria:

* Medical procedures likely to affect motor function such as botulinum toxin injections
* Orthopedic remedial surgery
* Mental retardation, or a learning disability.

Primary outcomes:
measure: Gross Motor Function Scale (GMFS)
timeFrame: 12 weeks
measure: The Posture and Postural Ability Scale (PPAS)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Abdullah Khalid khan, MSNPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03767738: Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Official title: A Study in Patients With Chorioretinal Vascular Disease to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chorioretinal Vascular Disease
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.

The secondary objective of the study is to assess ocular safety in the study eye.


Eligibility criteria: Key Inclusion Criteria:

* Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye

Key Exclusion Criteria:

* Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
* Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
* History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
* Any intraocular surgery in the study eye at any time during the past 3 months
* Current systemic infectious disease or a therapy for active infectious disease
* Pregnant or breastfeeding women

Note: Other inclusion/ exclusion apply

Primary outcomes:
measure: Number of Aflibercept Injections Successfully Administered Utilizing the Prefilled Syringe (PFS)
timeFrame: At Day 1
Secondary outcomes:
measure: Incidence of Ocular Treatment-Emergent Adverse Events (TEAEs) of Study Eye Through Day 29
timeFrame: Baseline through Day 29
measure: Incidence of Ocular Serious TEAEs of Study Eye Through Day 29
timeFrame: Baseline through Day 29
Other outcomes:
Locations:
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: The Woodlands
country: United States
facility: Regeneron Study Site
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: