louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00373308: Quality of Life Following Radical Prostatectomy
Official title: Quality of Life Following Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Prostate Cancer
Keywords: Quality of Life
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-09-08
Enrollment: 888
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo radical prostatectomy at Stanford

Brief summary: This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn what impact the surgery has upon the participant's sense of health, sexual and urinary quality of life.

Detailed description: To define impact on quality of life issues for patients undergoing radical prostatectomy. This study will distribute a questionnaire to patients who are being scheduled for radical prostatectomy, both before and after surgery, to assess the impact on quality of life issues. This will provide important information regarding the temporal return of issues pertaining to quality of life.

Eligibility criteria: Inclusion Criteria:

- Patients scheduled to undergo radical prostatectomy at Stanford

Exclusion Criteria:

- Patients treated with neoadjuvant or adjuvant hormonal therapy or radiation therapy

Primary outcomes:
measure: urinary and bowel habits
timeFrame: before and after surgery
measure: sexual and hormonal index as self-reported in the questionnaires
timeFrame: before and after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Benjamin I Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03560908: Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Official title: Dasatinib Combined With Multi-agents Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Relapsed AML
T(8;21)
C-KIT Mutation
Keywords: leukemia,myeloid, acute
relapse
mutation
KIT
dasatinib
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this multi-center, open-label, no control,prospective clinical trial, a total of 30 relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation patients will be enrolled. Dasatinib 70 mg twice a day will be administrated for two weeks from day 1 of re-induction chemotherapy. The purpose of current study is to determine the clinical efficacy and tolerability of combination therapy of dasatinib with multi-agent chemotherapy in relapsed acute myeloid leukemia with t(8;21) translocation and KIT D816 mutation.


Eligibility criteria: Inclusion Criteria:

1. T(8;21)acute myeloid leukemia patients with KIT D816 mutation diagnosed by bone marrow morphology, immunology, molecular genetics. The diagnosis and classification are according to WHO 2016 criteria.
2. Conform to relapsed diagnosis.Only morphological relapsed cases will be enrolled.Molecular relapsed and isolated extramedullary relapsed cases are not eligible.
3. Age is not limited. Both male and female are eligible.
4. Eastern Cooperative Oncology Group performance status (ECOG-PS):0-2 point.
5. Informed consent form must be signed by patients themselves before enrolled for patients aged 18 years or older. Informed consent form must be signed by the legal guardian for patients younger than 18 years.

Exclusion Criteria:

1. Patients with other blood diseases at the same time (such as haemophilia, primary myelofibrosis and so on) are not considered suitable.
2. Isolated extramedullary relapsed leukemia.
3. With other malignant tumors accompanied with AML and needed treatment. 4 .Patients who are unsuitable for the trial considered by investigators.

Primary outcomes:
measure: composite complete remission (CR) rate
timeFrame: 8 weeks
Secondary outcomes:
measure: mortality during induction chemotherapy
timeFrame: 30 days
measure: post relapsed overall survival
timeFrame: 2 years
measure: overall survival
timeFrame: 5 years
measure: post relapsed disease free survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: HBDH
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Jianxiang Wang, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04260308: A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia
Official title: A Survey of Psychological Status of Medical Workers and Residents in the Context of 2019 Novel Coronavirus Pneumonia in Wuhan, China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Virus; Pneumonia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: medical staff and residents of China who is volunteer to take part in the investigation

Brief summary: Due to the outbreak of 2019 Novel Coronavirus Pneumonia in Wuhan, Hubei province, medical staff and residents are facing great psychological pressure, the investigator plan to use electronic questionnaire to carry out investigation research.

Detailed description: From December 2019, 12 cases of new coronavirus pneumonia broke out in Wuhan, and then the epidemic spread rapidly. Till February 1, 2020, there were 14446 confirmed cases in China, 19544 suspected cases, and 304 deaths. There were confirmed cases reported in 34 provincial administrative regions in China; 23 foreign countries reported new coronavirus pneumonia cases, 147 confirmed cases. In the face of the rapid spread of the epidemic, people's panic and anxiety have seriously affected the prevention and control of the epidemic. In the face of the occupational exposure risk and treatment brought by the sudden outbreak of the epidemic, the change of mental state of medical staff may affect the prevention and control of the epidemic. In order to help the epidemic prevention and control, the investigator plan to carry out investigation research.

Eligibility criteria: Inclusion Criteria:

* can use mobil phone or computer
* volunteer to take part in the investigation

Exclusion Criteria:

* can not use phone or computer
* unwilling to take part in the investigation

Primary outcomes:
measure: GHQ-12(general health questionnaire-12)
timeFrame: 2 weeks
Secondary outcomes:
measure: IES-R(Impact of Event Scale-Revised)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital，Tongji Medical College Affiliated，Huazhong University of Science ＆ Technology
state: Hubei
Study officials:
References:
Clinical trial NCT00737308: Properties and Clinical Performance of Zirconia-based Dental Ceramics
Official title: Properties and Clinical Performance of Zirconia-based Dental Ceramics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration Wear
Keywords: crowns
ceramics
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2008-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to determine the clinical performance of zirconia-based dental prostheses and their related properties.

Detailed description: Zirconia has been used in dentistry since 2000 for constructing fixed partial denture. Its advantages are high fracture resistance, excellent biocompatibility, moderate opacity, etc. Because the increase in demand for more esthetic restoration, zirconia becomes more popular for use as a core material for all-ceramic systems. Its properties have been investigated extensively in many in vitro studies. However, clinical performance of zirconia-based restorations would require a period of time before the results can be assessed. Currently, there are not much results regarding clinical performance of zirconia-based prosthesis and more information are required for future research.

Eligibility criteria: Inclusion Criteria:

* Occlusion: At least 20 remaining teeth for each patient, and at least one posterior endodontically treated tooth with natural opposing teeth
* Bruxism: No evidence based on an intraoral exam
* Dental history: No evidence of either moderate or severe periodontal disease
* Medical history: Good to excellent general health

Exclusion Criteria:

* Periodontal status: Pocket depth greater than 4 mm
* Occlusion: Evidence of bruxism or excessive clenching force, Abutment tooth that opposes a removable partial denture, Abutment teeth for fixed partial dentures, Gingival recession of an abutment tooth more than 1 mm from the cementoenamel junction, Tooth with first or second degree of tooth mobility, Tooth with extensive carious lesions

Primary outcomes:
measure: ceramic crown fracture
timeFrame: 2 years
Secondary outcomes:
measure: masticatory function
timeFrame: 2 years
Other outcomes:
Locations:
city: Pyathai
country: Thailand
facility: Faculty of Dentistry, Mahidol University
state: Bangkok
city: Bangkok
country: Thailand
facility: Faculty of Dentistry, Mahidol University
Study officials:
affiliation: Mahidol University
name: Kallaya Suputtamongkol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03632408: Hangover and Residual Zopiclone Effect on Spatial Perception
Official title: The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Alcohol Drinking
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: University of Turku
First posted: 2018-08-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hangover after recreational alcohol use, residual effect of zopiclone and placebo compared in terms of spatial perception, psychomotor tests and simulated driving ability. Three recording visits plus screening included.


Eligibility criteria: Inclusion Criteria:

* weight \>45 kg
* likely to experience and predict alcohol hangover within the next five weeks
* no childbearing potential of negative pregnancy test at screening
* a valid driving license

Exclusion Criteria:

* breastfeeding
* infection with HCV, HBV or HIV
* a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
* suspected or current drug or alcohol abuse

Primary outcomes:
measure: Driving error rate
timeFrame: Day 1
measure: Number of erroneous responses to peripheral visual stimuli during driving
timeFrame: Day 1
Secondary outcomes:
measure: digit symbol substitution
timeFrame: Day 1
measure: drug concentration
timeFrame: Day 1
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Teutori clinical trial facility
Study officials:
affiliation: Turku University Hospital
name: Petri J Vainio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190408: Variation in Fluids Administered in Shock
Official title: Observation of Variation in Fluids Administered and Characterization of Vasopressor Requirements in Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shock
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 1639
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with shock

Brief summary: To conduct a multicenter observational cohort study to determine the variability in fluid resuscitation in shock in a broad range of areas in hospitals and treatment areas.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years admitted to the participating hospital.
* Patients in the emergency department, intensive care unit, PACU, or any hospital floor. For patients not in the ICU, there must be plans to transfer to an intensive care unit when an ICU bed is available for patient.
* Patients with shock as defined by:
* Need for vasopressor (dopamine, norepinephrine, or epinephrine at any dose) to keep MAP \> 65 mmHg Or
* Systolic BP \< 90 mmHg

Exclusion Criteria:

* Patients previously enrolled into this study.
* Patients who were in the operating room at time of shock and fluid bolus.
* Patients admitted to an ICU after cardiac surgery Patients with primarily cardiogenic shock as etiology for their shock
* Patients transferred from another hospital or emergency room to the study hospital.

Primary outcomes:
measure: Method used to guide volume resuscitation
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01116908: Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study
Official title: Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
HIV Infection
Keywords: Diarrhea
Water
Household Water Treatment
HIV
Infant Health
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital, Lusaka, Zambia
name: University of Zambia
name: Vestergaard Frandsen
First posted: 2010-05-05
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether children under 2 years and other members of households in which HIV-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level.

Detailed description: Contaminated drinking water is a leading cause of morbidity and mortality in low-income settings. Safe drinking water is of particular concern for HIV-positive mothers since many HIV-infected Zambian women choose replacement feeding and early cessation of breastfeeding of infants to minimize the risk of transmission of the virus. This study builds upon preliminary baseline research which determined that HIV-positive mothers would potentially benefit from an intervention that encourages HIV-positive mothers to treat their water at the household level.

Eligibility criteria: Inclusion Criteria:

* Known HIV-status based on clinical testing
* Have a child between 6-12 months at the initiation of the study
* Within the catchment area of Kasisi or Ngwerere health clinics, Chongwe district, Lusaka

Exclusion Criteria:

* Lived in the catchment area less than one year or planning to move

Primary outcomes:
measure: Use of LifeStraw Family for children under 2 and all household members
timeFrame: One year
Secondary outcomes:
measure: Microbiological performance of LifeStraw Family
timeFrame: One year
measure: Impact of LifeStraw Family on longitudinal prevalence of diarrhea
timeFrame: One year
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Ngwerere Health Clinic and Kasisi Health Clinic
state: Chongwe District, Lusaka Province
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Thomas Clasen, JD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peletz R, Simunyama M, Sarenje K, Baisley K, Filteau S, Kelly P, Clasen T. Assessing water filtration and safe storage in households with young children of HIV-positive mothers: a randomized, controlled trial in Zambia. PLoS One. 2012;7(10):e46548. doi: 10.1371/journal.pone.0046548. Epub 2012 Oct 17.
Clinical trial NCT05483608: Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain
Official title: Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
exercise
vertical climbing
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized control trial of vertical climbing ergometer exercise for individuals with chronic low back pain. Using a parallel-arm design, participants will be randomized to 8 weeks of supervised exercise using either the vertical climbing ergometer (CLMBR) or a recumbent cycling ergometer. This feasibility study will examine the safety, tolerability, and efficacy of vertical climbing exercise for individuals with chronic low back pain.


Eligibility criteria: Inclusion criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Confirmed chronic (\>12 weeks) low back pain at screening assessment (based on patient history)
* Ability to comply with the current Mount Sinai Health system COVID-19 requirements for research participants (e.g., vaccination, masks)

Exclusion criteria:

* Criteria will be evaluated during the clinical evaluation at the screening visit. All determinations will be the decision of the study physician:
* Less than 2/10 low back pain on 0-10 numeric rating scale for average pain over past 7 days at baseline assessment
* Any cardiovascular or musculoskeletal contraindication to exercise
* Impaired balance contraindicating exercise
* Known psychological illnesses or cognitive impairments contraindicating exercise or preventing the ability to complete study assessments
* Current pregnancy
* Current medications or new medications commenced that may impact the ability for change to be detected in study
* Any other contraindication in the opinion of the study physician

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 8 Weeks
measure: Number of completed exercise sessions
timeFrame: 8 Weeks
measure: Change in Numeric Pain Rating Scale
timeFrame: Baseline and 8 Weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 8 weeks
measure: Minutes of exercise completed
timeFrame: 8 weeks
measure: Change in The Oswestry Disability Index
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Union Square
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jamie Wood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00281008: Study of ISIS 301012 (Mipomersen) in Heterozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
Official title: A Phase 2, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of ISIS 301012 as Add-on Therapy in Heterozygous Familial Hypercholesterolemia Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia, Familial
Keywords: LDL-cholesterol
apoB-100
Heterozygous Familial Hypercholesterolemia
Lead sponsor: Kastle Therapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Ionis Pharmaceuticals, Inc.
First posted: 2006-01-24
Enrollment: 44
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: The aim of this study is to assess the safety and efficacy of varying doses of ISIS 301012 (mipomersen) as add-on therapy in subjects with Heterozygous Familial Hypercholesterolemia


Eligibility criteria: Inclusion Criteria:

* Weight ≥ 50 kg
* Diagnosis of Heterozygous Familial Hypercholesterolemia.
* Females must be non-pregnant and non-lactating.
* On stable lipid lowering therapy for at least 4 weeks.
* Lipid levels meet the pre-specified criteria.

Exclusion Criteria:

* Subject had heart problems in the prior 6 months.
* Subject has elevated ALT, AST, or CPK.
* History of renal disease, liver disease, or malignancy.
* Use of oral anticoagulants, unless the dose has been stable for 4 weeks
* Have any other conditions, which in the opinion of the Investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in or completing the study.

Primary outcomes:
measure: Percent reduction in LDL-cholesterol from baseline
timeFrame: Week 7 (Cohorts A-C), Week 15 (Cohort D)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Auburn
country: United States
state: Maine
city: Scarborough
country: United States
state: Maine
city: New York City
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Houston
country: United States
state: Texas
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02900508: Virtual Reality-based Training in Cerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebellar Ataxia
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of SCA 1, 2, 3 and 6 by a neurologist
* ability to walk independently with or without any walking aids
* age ≥ 20
* a score of ≥ 24 on the mini-mental state examination

Exclusion Criteria:

* histories of other neurological, cardiovascular, or orthopedic diseases affecting motor performance and balance
* uncontrolled chronic diseases

Primary outcomes:
measure: Scale for the Assessment and Rating of Ataxia
timeFrame: Change from baseline at 4 weeks
measure: Alternate nose to finger test
timeFrame: Change from baseline at 4 weeks
measure: Alternate heel on shin test
timeFrame: Change from baseline at 4 weeks
Secondary outcomes:
measure: Nine-hole peg test
timeFrame: Change from baseline at 4 weeks
measure: Walking speed
timeFrame: Change from baseline at 4 weeks
measure: Step width
timeFrame: Change from baseline at 4 weeks
Other outcomes:
Locations:
Study officials:
References: