louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02767817: Injectable Collagen Scaffold™ Combined With MSCs Transplantation for Brain Injury
Official title: The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Mesenchymal Stem Cells Transplantation in Patients With Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Brain Injury
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Affiliated Hospital of Logistics University of CAPF
First posted: 2016-05-10
Enrollment: 30
Sex: ALL
Minimum age (years): 35
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 assess the safety and efficacy of injectable collagen scaffold combined with Mesenchymal stem cells (MSCs) transplantation in patients with brain injury.


Eligibility criteria: Inclusion Criteria:

1. Male or female，35-75 years old.
2. The surgery time should be \> 6 hours after symptom onset.
3. Glasgow coma score (GCS) was 9-15.
4. CT diagnosis of intracerebral hemorrhage (25-40 ml), except for patients with signs of craniotomy to remove the hematoma.
5. Signed informed consent obtained from the patient or patient's legally authorized representative.

Exclusion Criteria:

1. Glasgow coma scale of \<8.
2. Patients suffering severe heart failure, severe lung disease, uremia, cirrhosis, end-stage cancer, coagulation disorders, stroke sequela.
3. Asphyxia, cardiac arrest or successful cardiopulmonary resuscitation before hospitalization.
4. Lactating or pregnant woman.
5. Refuse to sign informed content.

Primary outcomes:
measure: Number of adverse events and participants with those adverse events
timeFrame: 24 month
Secondary outcomes:
measure: Change in functional outcomes as measured by National Institutes of Health stroke scale (NIHSS) score
timeFrame: baseline, day 1-7, and 1, 3, 6, 12, 18 and 24 month after surgery
measure: Change in motor recovery evaluated by Brunnstrom stage
timeFrame: 1, 3, 6, 12, 18 and 24 month after surgery
measure: Change in self-care ability as measured by Barthel Index (BI)
timeFrame: 1, 3, 6, 12, 18 and 24 month after surgery
measure: Change in pain intensity as measured by Visual Analogue Scale (VAS)
timeFrame: 1, 3, 6, 12, 18 and 24 month after surgery
measure: Change in electrical brain activity as measured by Electroencephalography (EEG)
timeFrame: baseline, day 1, 4, 7, and 1, 3, 6, 12, 18, 24 month after surgery
measure: Changes in brain electrophysiology as measured by Somatosensory evoked potential (SSEP)
timeFrame: baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
measure: Change in brain pathology diagnosed by Head CT scan
timeFrame: baseline, day 1,4,7, and 1, 3, 6, 12, 18, 24 month after surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Affiliated Hospital of Logistics Universtiy of CAPF
Study officials:
affiliation: Chinese Academy of Sciences
name: Jianwu Dai, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694317: Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Short Term Treatment of Insomnia
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zaleplon or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceutical Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507517: Quality Control Project of Stroke in Liaoning Province
Official title: Quality Control Project of Secondary Prevention and Treatment of Stroke in Liaoning Province
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Keywords: prevention
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients diagnosed with ischemic stroke

Brief summary: To reduce the incidence of stroke and standard the treatment of stroke in Liaoning Province, the present study should be conducted.


Eligibility criteria: Inclusion Criteria:

* ischemic stroke

Exclusion Criteria:

* disagreed patients

Primary outcomes:
measure: Key Performance Indicator of Secondary Prevention of Stroke in Liaoning Province
timeFrame: 2 years
Secondary outcomes:
measure: The results of Stroke prevention in Liaoning Province
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01410617: The Effect of Prophylactic Hemodialysis on the Morbidity and Mortality of the Patients With Chronic Kidney Disease Stages 3-4 Undergoing Coronary Artery Graft Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Coronary Artery Disease
Lead sponsor: Imam Khomeini Hospital
Sponsor class: OTHER
Collaborators: name: Tehran University of Medical Sciences
First posted: 2011-08-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Coronary artery disease is a major cause of death in patients with renal dysfunction Among patients who undergo coronary artery bypass grafting ,renal dysfunction is known To be a major predictor of in-hospital and remote mortality As little is known about the impact of non-dialysis-dependent renal dysfunction on short and mid term Outcomes following coronary surgery we have decided to investigate the effect of prophylactic Hemodialysis on the mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these Effect with the control group


Eligibility criteria: Inclusion Criteria:

* 80\<age\>18
* ckd patients with stage 3,4
* CABG for the first time

Exclusion Criteria:

* age\<18
* previous CABG (coronary artery bypass grafting)
* AKI(acute kidney injury)
* dialysis patients

Primary outcomes:
measure: morbidity
timeFrame: the morbidity during the time of hospitalization until discharge (baseline) and six month later
Secondary outcomes:
measure: mortality
timeFrame: from the time of CABG (baseline) until six months later
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran Herat Center
Study officials:
affiliation: Imam Khomeini Hospital
name: Roghieh Borji, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology research Center
name: Mohammad R Khatami, MD
role: STUDY_DIRECTOR
affiliation: Tehran Herat Center
name: Seyyed Hossein Ahmadi, MD
role: STUDY_CHAIR
affiliation: Tehran Heart Center
name: Khosro Barkhordari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nephrology Researc Center
name: Mohammad R Abbasi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505517: Inspiratory Resistive Loading and Diaphragm Fatigue
Official title: Inspiratory Resistive Loading and Diaphragm Fatigue in Healthy Individuals and Individuals With Recurrent Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaphragm Fatigue
Healthy
Low Back Pain
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2012-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: young flemish volunteers

Brief summary: The aim of the study is to clarify whether specific loading of the inspiratory muscles induces contractile fatigue of the diaphragm muscle in healthy individuals and individuals with recurrent low back pain.


Eligibility criteria: Inclusion Criteria individuals with low back pain:

* Age: 18-35 years old
* At least 1 year of low back pain with/without referred pain in buttock/thigh
* At least 3 episodes of disabling low back pain
* At least a score of 20% on the Oswestry Disability Index
* Willingness to sign the informed consent

Inclusion Criteria healthy individuals:

* Age: 18-35 years old
* No history of low back pain
* A score of 0% on the Oswestry Disability Index
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy
* Radicular symptoms
* Not Dutch-speaking
* Strong opioids
* Neck pain
* Smoking history

Primary outcomes:
measure: transdiaphragmatic pressure
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Simon Brumagne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
citation: Hermans G, Agten A, Testelmans D, Decramer M, Gayan-Ramirez G. Increased duration of mechanical ventilation is associated with decreased diaphragmatic force: a prospective observational study. Crit Care. 2010;14(4):R127. doi: 10.1186/cc9094. Epub 2010 Jul 1.
Clinical trial NCT06137417: Role of PET/CT in Peritoneal Deposits Assessment
Official title: Role of PET/CT in Peritoneal Deposits Assessment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peritoneal Metastases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions and will do PET/CT for assessment of peritoneal deposits

Brief summary: • Suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions and will do PET/CT for assessment of peritoneal deposits

Detailed description: Suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions and will do PET/CT for assessment of peritoneal deposits. we will find its diagnostic role.

Eligibility criteria: Inclusion Criteria:

* • Suspected patients known to have a primary malignant tumour, patients with metastasis of unknown primary and had incidental peritoneal lesions.

Exclusion Criteria:

* • Patients unable to sit calm without movement during imaging.

  * Severely ill patients.
  * Patients unable to sleep in a fixed position for 20 minutes.
  * Pregnancy

Primary outcomes:
measure: role of pet/ct in peritoneal deposits assessment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dawson H, Kirsch R, Messenger D, Driman D. A Review of Current Challenges in Colorectal Cancer Reporting. Arch Pathol Lab Med. 2019 Jul;143(7):869-882. doi: 10.5858/arpa.2017-0475-RA. Epub 2019 Jan 23.
citation: Husain A, Chi DS, Prasad M, Abu-Rustum N, Barakat RR, Brown CL, Poynor EA, Hoskins WJ, Curtin JP. The role of laparoscopy in second-look evaluations for ovarian cancer. Gynecol Oncol. 2001 Jan;80(1):44-7. doi: 10.1006/gyno.2000.6036.
citation: Patel CM, Sahdev A, Reznek RH. CT, MRI and PET imaging in peritoneal malignancy. Cancer Imaging. 2011 Aug 24;11(1):123-39. doi: 10.1102/1470-7330.2011.0016.
Clinical trial NCT00384917: Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796
Official title: An Open Label, 2-Period, Sequential Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, 2-period, sequential study to determine the impact of multiple doses of ketoconazole on single-dose pharmacokinetics of HCV-796


Eligibility criteria: Inclusion Criteria:

- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Primary outcomes:
measure: To evaluate the effects of multiple oral doses of ketoconazole on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects.
Secondary outcomes:
measure: To assess the safety and tolerability of HCV-796 and ketoconazole when coadministered to healthy subjects.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03100617: Alzheimer's Family Caregiver Intervention in Vietnam
Official title: Single Arm Study of Modified REACH-VA Alzheimer's Caregiver Intervention in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia Alzheimers
Keywords: Family caregiver
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of South Carolina
First posted: 2017-04-04
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a Alzheimer's family caregiver intervention in Vietnam.

Detailed description: This is a single arm pilot study of 6-8 families to test the feasibility and acceptability of a modified version of the REACH-VA caregiver intervention in Vietnam. The REACH-VA caregiver intervention is an evidence-based intervention that has been shown to be effective in multicultural populations in the US. The model has been modified for use in Vietnam. This study will test the modified model in Vietnam. Participants in this study will be adult family caregivers of non-institutionalized persons with dementia who are living in Hanoi, Vietnam. They will receive 4-6 sessions delivered over the course of 2-3 months that will included the following components: 1) education about the nature of the disease, 2) risk assessment, 3) enhancing caregiver skills and problem-solving, and 4) caregiver stress reduction. The intervention will be delivered by a social worker or nurse using a Vietnamese language versions of the REACH-VA protocol and caregiver intervention notebook.

Eligibility criteria: Inclusion Criteria:

* Primary adult family caregiver of person with dementia

Exclusion Criteria:

* Caregivers of persons with dementia who are institutionalized

Primary outcomes:
measure: Caregiver Burden
timeFrame: Change from baseline Zarit burden scale score to 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Geriatric Hospital
Study officials:
References:
Clinical trial NCT04115917: Evaluation of Discomfort Associated With Scleral Depression During Retina Examinations
Official title: Scleral Depression Pain With Schocket Depressor and Cotton Tipped Applicator: Depression Eye Pain Relief Evaluation Study (DEPRESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retina--Diseases
Retinal Detachment
Retinal Degeneration
Keywords: Scleral Depression
Visual Analog Scale
Pain
Discomfort
Schocket Scleral Depressor
Cotton Tipped Applicator
Diabetes
Lead sponsor: New York City Health and Hospitals Corporation
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The first eye to undergo scleral depression was randomly assigned, then that eye was randomized two either of the scleral depression methods. The contralateral eye then had the alternative method of scleral depression performed.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Scleral depression is an important technique used to examine the peripheral retina but often causes patient discomfort. The goal of this study was to compare levels of discomfort during scleral depression with a Schocket scleral depressor and cotton tipped applicator.


Eligibility criteria: Inclusion Criteria:

* Adult patients who received dilated eye examinations in the retina or general eye clinic

Exclusion Criteria:

* Younger than 18
* Pregnant
* Prior scleral buckle, filtering bleb or underwent any other ocular surgery within the past month

Primary outcomes:
measure: Discomfort During Scleral Depression with Schocket Depressor and Cotton Tipped Applicator
timeFrame: Pain evaluated immediately scleral depression was completed on the eye
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 1 year
measure: Spherical Equivalent of Glasses Prescription
timeFrame: 1 day
measure: Age
timeFrame: 1 day
measure: Left Eye vs Right Eye
timeFrame: 1 day
measure: Retinal pathology
timeFrame: 1 day
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Kings County Hospital
state: New York
Study officials:
affiliation: Kings County Hospital Department of Emergency Medicine
name: Joseph J Raevis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956917: Comparison Study for Bioelectrical Impedance Device to Measure Human Body Composition
Official title: Comparison of Impedance Components and Estimated Body Composition Variables Determined by Using Bioelectrical Impedance Devices Manufactured by Akern SRL and RJL Systems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Composition Measurement
Lead sponsor: Akern USA LLC
Sponsor class: INDUSTRY
First posted: 2009-08-11
Enrollment: 109
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition.

Detailed description: The purpose of this study is to determine if the ElectroFluidGraph(tm) (EFG) impedance analyzer is comparable to a predicate device in measuring human body composition under normal patient conditions. Specifically, the goal of this study is to compare impedance measurements (R and Xc) determined by using each bioelectrical impedance device and the estimated body compositional estimates \[total body water (TBW); fat-free mass (FFM); and fat mass (FM)\] calculated by using the same prediction equation (models) as the predicate device.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* None

Primary outcomes:
measure: Resistance (R) - (ohms)
timeFrame: 5 minutes
Secondary outcomes:
measure: Fat Free Mass (FFM)
timeFrame: 5 minutes
measure: Total Body Water (TBW)
timeFrame: 5 minutes
measure: Extra Cellular Water
timeFrame: 5 minutes
measure: Fat Mass (FM)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: D'Annunzio
country: Italy
facility: Laboratorio, FIGC, Settore Tecnico Coverciano
state: Florence
Study officials:
name: Luca Gatteschi, MD
role: PRINCIPAL_INVESTIGATOR
References: