louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01884818: Thoracic Spine Manipulation for Patients With Thoracic Spine Pain
Official title: The Effect of Manipulation for Thoracic Spine Pain and Mobility, and Reliability of Used Mobility Measurements.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Thoracic spine, pain, manipulation
Lead sponsor: University of Jyvaskyla
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study includes two phases. In phase one the reliability of thoracic spine mobility measurements are studied in subjects with thoracic spine pain. In phase two the reliable measurements are used to measure the effects of thoracic spine manipulation in subjects with thoracic spine pain. The changes in pain is measured as well.

In second phase the control group receives TNS treatment six times at home as a placebo so that the power of TNS is limited to very low level. The number of treatments are controlled as well as the time of treatment. The treatment group receives six manipulation treatments within 3 week period. The effects are measured immediately after the treatment weeks, and 3 and 8 week follow-up. Moreover the one year follow-up will be performed by mail questionnaire.

Detailed description: Outcome measures are intensity of pain (VAS, Roland-Morris questionnaire) thoracic mobility (measured with computer, tape measurements, inclinometer and manually).

Eligibility criteria: Inclusion Criteria:

* Thoracic spine pain,
* 18-55 years old

Exclusion Criteria:

* Inflammatory spine disease,
* previous surgery on thoracic spine area,
* osteoporosis

Primary outcomes:
measure: Thoracic spine pain (Visual analogue scale)
timeFrame: up to 49 week follow-up
Secondary outcomes:
measure: Thoracic spine mobility (computer controllod spine PA measurement, tape measurements, inclinometer)
timeFrame: Baseline, after treatment, 3, 8, and 49 week follow-up
Other outcomes:
measure: Work absent
timeFrame: Baseline, after treatment, 3, 8 and 49 week follow-up
Locations:
city: Oulu
country: Finland
facility: Fysioteekki
Study officials:
affiliation: University of Jyvaskyla
name: Jani Takatalo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takatalo J, Ylinen J, Pienimaki T, Hakkinen A. Intra- and inter-rater reliability of thoracic spine mobility and posture assessments in subjects with thoracic spine pain. BMC Musculoskelet Disord. 2020 Aug 10;21(1):529. doi: 10.1186/s12891-020-03551-4.
Clinical trial NCT00005218: Epidemiological Tool To Detect Angina Pectoris in Blacks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Angina Pectoris
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To develop a prototype questionnaire for the detection of angina pectoris in Blacks.

Detailed description: BACKGROUND:

Angina pectoris is often considered a manifestation of coronary artery atherosclerosis that is associated with an increased mortality risk. Overall, coronary heart disease is the leading cause of morbidity and mortality in United States Blacks. In an attempt to standardize the diagnosis of angina pectoris in epidemiologic studies, Rose developed a questionnaire for cardiovascular field surveys which has primarily been used in United States and other white populations. However, in 1988, there were no valid epidemiological tools for the assessment of angina pectoris in Blacks. The development of a cardiovascular survey instrument capable of assessing angina pectoris in Black populations was identified by the Association of Black Cardiologists as an urgent epidemiologic need. Also, such a survey instrument could ultimately enhance knowledge and treatment of cardiovascular disease among Blacks.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Clark LT, Adams-Campbell LL, Maw M, Bridges D, Kline G. Atypical myocardial infarction and hypertension: an inner city experience. J Hum Hypertens. 1990 Apr;4(2):105-7.
Clinical trial NCT03678818: Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
Official title: Latrunculin A Supplementation to ICSI Handling Medium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Latrunculin A serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Latrunculin A during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,


Eligibility criteria: Inclusion Criteria:

* ICSI participants

Exclusion Criteria:

-

Primary outcomes:
measure: oocyte survival rate
timeFrame: 6 days of culture
Secondary outcomes:
measure: fertilization rate
timeFrame: 6 days of culture
measure: Blastocyst formation rate
timeFrame: 6 days of culture
measure: Blastocyst quality rate
timeFrame: 6 days of culture
measure: Clinical pregnancy rate
timeFrame: three months
measure: Implantation rate
timeFrame: 7 weeks
measure: Ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT04843618: Prevalence and Risk Factors of Pressure Ulcers in Beni Suef Governorate of Egypt
Official title: Prevalence and Risk Factors of Pressure Ulcers in Hospitalized Patients in Beni Suef Governorate of Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pressure Ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cross-sectional study

Brief summary: the study aims at examining the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt

Detailed description: pressure ulcers are defined as localized damage to the skin as well as underlying soft tissue, usually occuring over a bony prominence or to medical devices.

immobility and friction are important risk factors for pressure ulcers, Malnutrition and body mass index are associated with pressure injury prevalence, the days in hospital, skin moisture and other neurological factors are significant risk factors for pressure ulcer development.

Beni-Suef is one of the upper Egypt governorates located about 120 Km south of cairo, according to population estimates from 2019, the majority of residents in the governorate live in rural areas, with an urbanization rate of only 23.2%, Due to greater reliance on federal and state payers, low volume and complxity of services provided, rural residents often encounter barriers to healthcare that limit their ability to obtain the care they need

Eligibility criteria: Inclusion Criteria:

* hospitalized patients will be selected from ICU and CCU
* both sexes males and females
* their age ranges between 25-65 years old
* patients who have peripheral arterial disease
* their body mass index (class II and class III obesity)
* diabetic patients more than 5 years old

Exclusion Criteria:

* medically unstable patients
* un cooperative patients
* semi- conscious or unconscious patients according to glascow coma scale

Primary outcomes:
measure: examine the relation between the prevalence and risk factors of pressure ulcers among hospitalized patients in Beni Suef governorate of Egypt
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bergstrom N, Horn SD, Rapp M, Stern A, Barrett R, Watkiss M, Krahn M. Preventing Pressure Ulcers: A Multisite Randomized Controlled Trial in Nursing Homes. Ont Health Technol Assess Ser. 2014 Oct 1;14(11):1-32. eCollection 2014.
Clinical trial NCT01779518: Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
Official title: An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Post-transplant Hepatitis C
Keywords: HCV
Sustained Virologic Response
Direct Acting Antiviral
GS-7977
Pegylated interferon
Ribavirin
Open Label
Sofosbuvir
Liver transplant
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-01-30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years
* Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
* Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
* Life expectancy of \< 12 months if the HCV is left untreated

Exclusion Criteria:

* History of clinically significant drug allergy to nucleoside/nucleotide analogs
* Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
* Unable or unwilling to follow the contraception requirements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01319318: Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitrectomy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 25
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 who plan on undergoing a pars plana vitrectomy

Brief summary: This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.


Eligibility criteria: Inclusion Criteria:

* Require pars plana vitrectomy in at least 1 eye
* Best corrected visual acuity in the study eye between 20/400 and 20/40

Exclusion Criteria:

* Use of any NSAIDs (topical or systemic) within 14 days
* Use of topical or systemic steroids within 30 days
* Active eye infection in either eye
* Any eye surgery within 6 months
* Prior pars plana vitrectomy, YAG capsulotomy or uveitis

Primary outcomes:
measure: Percentage of Participants With Vitreous Cell Count of 0
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01217918: Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects
Official title: APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PH-797804
Japanese
Phase 1
multiple dose study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* Japanese

Exclusion Criteria:

* Subjects with clinically significant skin lesions
* Subjects with known tuberculosis infection

Primary outcomes:
measure: Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.
timeFrame: Day 1 to Follow-up
measure: Mean change from baseline in vital signs (blood pressure and heart rate) measurements
timeFrame: Baseline to Follow-up
measure: Mean change from baseline in 12-lead ECG parameters
timeFrame: Baseline to Follow-up
measure: Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax
timeFrame: Days 1 and 10
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01678118: Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care
Official title: Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Minority Smokers
Keywords: Patient Navigation
Tobacco dependent
smoking
Cessation
11-028
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Sophie Davis School of Biomedical Education at The City College of New York
name: NYU Langone Health
name: Ralph Lauren Center for Cancer Care and Prevention
name: Heritage Health Center, New York
First posted: 2012-09-03
Enrollment: 16
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: Participants will also be recruited from Heritage Health Center, located at 1727 Amsterdam Ave, which serves a large proportion to low income, minority patients in Harlem, New York. Also, from the Ralph Lauren Center for Cancer Care and Cancer Prevention (RLCCCP), a community based Center for the prevention, diagnosis, and treatment of cancer located at 1919 Madison Avenue.

Brief summary: Patient navigators have been shown to assist people seeking cancer screening and other medical services. The purpose of this study is to see whether a patient navigator can link smokers to available community resources shown to help smokers quit smoking.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Self-reported current daily smoker, as verified with a portable alveolar carbon monoxide (CO) analyzer (24 hour point prevalence); CO levels ≥ 8 ppm.
* English and/or Spanish-speaking
* Referred to the navigation program by their primary care clinician
* At baseline, participants report at least thinking about quitting (i.e., Contemplation or Preparation stages of readiness to quit).

Exclusion Criteria:

* Serious, untreated psychiatric illness (e.g., schizophrenia,) or active substance abuse likely to preclude adherence to the protocol

Primary outcomes:
measure: patient navigation (TPN) feasibility
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Heritage Health Center
state: New York
city: New York
country: United States
facility: Ralph Lauren Center for Cancer Care and Prevention
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00379418: Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients
Official title: Anti Ischemic Effects of Abciximab in Angioplasty and Stenting Patients (AIR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-09-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease undergoing left heart catheterization

Brief summary: AIR STUDY

TITLE: Anti-Ischemic effects of Abciximab(Reopro)

PATIENT POPULATION: Patients undergoing PCI(an interventional procedure placing a small stent/metallic tube to keep a narrowed artery in your heart open) and either on a stable statin dose or not on a statin. Statin= cholesterol lowering drug(ie, lipitor, zocor).

INTERVENTION: Heparin vs. heparin + abciximab during PCI

PURPOSE: Measure the effects of abciximab on special healing blood stem cells (EPC's-Endothelial Progenitor Cells), on inflammation, on oxidative stress and on microvascular blood flow.

PATIENT ASSESSMENT:

1. 50ccs blood draw on day 1(from sheath), day 2 ,day 7 and day 28.
2. Measurement of blood flow in selected suitable patients
3. 10 minute questionnaire before discharge and on visit on day 28.


Eligibility criteria: Inclusion Criteria:

1. Have either:

   * clinical history of anginal symptoms or positive stress test or
   * in stent restenosis
2. Have an angiographic \>70% coronary artery stenosis that will be treated with coronary angioplasty or stenting procedure
3. For at least four weeks prior to the procedure have been on, no Hmgcoa- reductase inhibitor or a stable statin dose
4. negative pregnancy test
5. are able to give informed consent

Exclusion Criteria:

1. Coronary intervention within four weeks prior to enrollment.
2. Treatment with abciximab antagonist within four weeks.
3. treatment with thrombolytic therapy within 48 hours
4. MI within 2 months.
5. recent infections
6. general anesthesia within 3 months.
7. renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: EUH
name: Arshed A Quyyumi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01900418: Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Official title: Physical Activity to Reduce Joint Pain During Aromatase Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Breast Cancer
Keywords: breast cancer
aromatase inhibitors
physical activity
joint pain
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-07-16
Enrollment: 78
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: For post-menopausal women diagnosed with hormone-receptor positive breast cancer tumors, aromatase inhibitors (AIs) are the standard adjuvant hormone treatment to prolong disease-free survival and time-to-recurrence. Unfortunately, joint pain/stiffness/achiness (arthralgia) is a common side-effect of AIs. This "proof-of-concept" study explores how an evidence-based physical activity (PA) program- the Arthritis Foundation's Walk with Ease (WWE) program- can be adapted for breast cancer survivors on AI therapy to: 1) Help them maintain or achieve recommended levels of PA, 2) reduce their joint pain/stiffness/achiness, and 3) thereby enable them to remain on AI therapy as prescribed.


Eligibility criteria: Inclusion Criteria:

* Taking an aromatase inhibitor as adjuvant treatment for State I, II, or II breast cancer for at least 4 weeks
* Experiencing more than mild joint pain/symptoms
* 21 or older
* have permission from physician to engage in moderate intensity physical activity

Exclusion Criteria:

* Undergoing chemotherapy and/or radiation therapy at any time during the study period
* Scheduled for major surgery during the study period
* Presently engaged in high levels of physical activity on a daily basis
* Less than 21 years of age
* Unable to walk or engage in moderate intensity physical activity

Primary outcomes:
measure: Self-reported joint pain
timeFrame: 6 weeks
Secondary outcomes:
measure: Self-reported walking
timeFrame: 6 weeks
Other outcomes:
measure: Self-reported fatigue
timeFrame: 6 weeks
measure: Self-reported joint stiffness
timeFrame: 6 week
measure: Pain
timeFrame: 6 weeks
measure: Lower extremity pain and function
timeFrame: 6 weeks
measure: Quality of life
timeFrame: 6 weeks
measure: Beliefs about engaging in exercise
timeFrame: 6 weeks
measure: Self-efficacy to manage joint pain
timeFrame: 6 weeks
measure: Engagement in Physical Activity
timeFrame: 6 weeks
measure: Helplessness
timeFrame: 6 weeks
measure: Adverse event
timeFrame: 6 weeks
measure: Feasibility
timeFrame: 6 weeks
measure: Tolerability
timeFrame: 6 weeks
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Leigh F Callahan, PhD
role: PRINCIPAL_INVESTIGATOR
References: