louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04175548: Cut-out of the Cervical Screw on Pertrochanteric Fractures
Official title: Cut-out of the Cervical Screw on Pertrochanteric Fractures: Retrospective Analysis of 12 Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pertrochanteric Fracture
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 12
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: All patients admitted for a pertrochanteric and subtrochanteric fracture of the femur treated by cerebrospinal nailing with all the methods of fixation of the head (blade or screw) and who evolved to a cut-out of the cervical screw.

Brief summary: Pertrochanteric fractures are a highly relevant topic not only because of the high frequency or age of the population concerned, but also because of comorbidity (osteoporosis, malnutrition, decreased physical activity, decreased visual acuity, neurological deficits, asthenia, disorders of the equilibrium and impaired reflexes) and the mortality associated with this type of fractures.

The cut-out of the cervical screw is a mechanical complication common to different means of osteosynthesis of pertrochanteric fractures, this complication significantly increases the morbidity.

From January 2013 to May 2019, out of a total of 340 patients having had surgery for pertrochanteric fracture, 12 cases of cervical screw cut-out were recorded within the Brugmann University Hospital. The average follow-up after surgery was 18 months.

This study analyses different parameters and their link with cervical screw cut-outs, and compares the results with the ones published in the scientific literature.


Eligibility criteria: Inclusion Criteria:

All patients admitted for a pertrochanteric and subtrochanteric fracture of the femur treated by cerebrospinal nailing with all the methods of fixation of the head (blade or screw) and who evolved to a cut-out of the cervical screw.

Exclusion Criteria:

* Fractures treated by open osteosynthesis
* Fractures operated with good radiological outcome
* Incomplete or non useable medical files

Primary outcomes:
measure: Ender Classification
timeFrame: 5 minutes
measure: Bone quality
timeFrame: 5 minutes
measure: Type of osteosynthesis
timeFrame: 5 minutes
measure: Correct positioning of the screw
timeFrame: 5 minutes
measure: Delay between fracture and screw cut-off
timeFrame: up to 18 months
measure: Tip Apex Distance (TAD)
timeFrame: 5 minutes
measure: Parker ratio
timeFrame: 5 minutes
measure: Age
timeFrame: 5 minutes
measure: Sex
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Mohammed Lahsika, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002148: Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Official title: Parallel Group, Placebo-Controlled, Tolerability, Safety, and Efficacy Study of OPC-14117 in HIV Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cognitive Disorders
HIV Infections
Keywords: Cognition Disorders
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Free Radical Scavengers
Antioxidants
OPC 14117
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To assess the tolerability and safety of OPC-14117. To evaluate effects of OPC-14117 on cognitive function, quality of life, and activities of daily living.

Detailed description: Patients receive OPC-14117 or placebo bid for 12 weeks, followed by 12 weeks of open label therapy.

Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV seropositivity.
* Cognitive impairment.

Prior Medication:

Allowed:

* Prior OPC-14117 other than on the current study.
* Antiretroviral therapy if stable for 6 weeks prior to study entry (12 weeks for stavudine).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).
* Severe pre-morbid psychiatric illness including schizophrenia and major depression that would interfere with protocol compliance.
* CNS neoplasms.
* Any other clinically significant condition or laboratory abnormality that would interfere with ability to participate on study.
* Current participation in other drug studies.

Patients with the following prior conditions are excluded:

* Past history of opportunistic CNS infection (i.e., toxoplasmosis or cryptococcal meningitis).
* History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.
* History of adverse reaction / allergy to OPC-14117.
* Prior participation on this study.

Prior Medication:

Excluded:

* Other investigational drugs within the past 30 days. Alcoholism within past 6 months (more than 2 drinks daily).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: New York
country: United States
facility: Columbia Univ
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
Study officials:
References:
citation: Safety and tolerability of the antioxidant OPC-14117 in HIV-associated cognitive impairment. The Dana Consortium on the Therapy of HIV Dementia and Related Cognitive Disorders. Neurology. 1997 Jul;49(1):142-6. doi: 10.1212/wnl.49.1.142.
Clinical trial NCT04124848: Obstructive Sleep Apnea Among Somali-Americans
Official title: Evaluating the Prevalence and Implications of Obstructive Sleep Apnea Among Somali-Americans: A Translational Research Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: Somali-Americans
Sleep Disordered Breathing
Cardiovascular Diseases
Sex and Racial Differences
Respiratory Disorders
Hypertension
Diabetes
Health Disparities
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Sleep Number Corporation
First posted: 2019-10-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population are individuals who are of Somali descent compared to those of different racial/ethnic origins.

Brief summary: The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

Detailed description: Participants can be healthy volunteers or volunteers diagnosed with obstructive sleep apnea. All patients may undergo a sleep study (i.e. hospital or home-based), physical examination, questionnaires, blood and urine samples, ultrasound scan of the heart and brachial artery in the arm, CT scan, DEXA scan, paced breathing test, cardiopulmonary test and chemo-sensitivity test.

Eligibility criteria: Inclusion Criteria:

* Self-identify as Somali, African, Asian, and European descent.
* Adult males and females who are older than 18 years of age.

Exclusion Criteria:

* Minors under 18 years or adults over 100 years
* Positive pregnancy

Primary outcomes:
measure: To assess the prevalence of obstructive sleep apnea
timeFrame: 10 years
measure: To determine the severity of obstructive sleep apnea
timeFrame: 10 years
Secondary outcomes:
measure: 24 hour mean arterial pressure
timeFrame: 10 years
measure: Vascular endothelial function
timeFrame: 10 years
measure: Insulin sensitivity
timeFrame: 10 years
measure: Body composition
timeFrame: 10 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987048: Cirrhotic Patients With Septic Shock
Official title: Cirrhotic Patients Admitted to the ICU With Septic Shock: Factors Predicting Short and Long-term Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Cirrhosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 149
Sex: ALL
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 with cirrhosis who require ICU admission for septic shock

Brief summary: Cirrhotic patients have a poor outcome in intensive care unit (ICU). Septic shock is a leading cause of ICU admission and death in this specific population. We performed a monocentric retrospective study; all cirrhotic patients admitted in the ICU with septic shock from 2002 to 2013 were included. The aim of the study was to identify prognostic factors for both short- and long-term mortality in these patients. Demographic, clinical and biological data, organ supports, and outcomes were collected. Univariate and multivariate analysis were carried out regarding both ICU and one-year mortality.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* diagnosis of cirrhosis
* diagnosis of septic shock at ICU admission

Exclusion Criteria:

* prior liver transplantation

Primary outcomes:
measure: Short-term outcome: analysis of independent predictors of ICU mortality rate.
timeFrame: Between ICU admission (from January 2002 to December 2013) and ICU discharge
measure: Long-term outcome: analysis of independent predictors of one-year mortality rate.
timeFrame: At one year after ICU admission (from January 2002 to December 2013)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot (HCL)
Study officials:
References:
Clinical trial NCT05510648: Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
Official title: The Effect of High-intensity Laser Therapy in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Laser Therapy
Muscle Strength
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
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 evaluate the effects of high intensity laser therapy (HILT) on range of motion, pain, quality of life, muscle strength and femoral cartilage thickness in patients with knee osteoarthritis.

Detailed description: Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study.

Eligibility criteria: Inclusion Criteria:

1-40-70 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more

Exclusion Criteria:

1. History of surgery or traumatic injury
2. Inflammatory arthritis
3. History of cancer, bleeding diathesis and psychiatric disease
4. Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events)
5. Hip and ankle problems
6. Participating in another physical therapy program in the last 3 months
7. History of intra-articular injections in the last 6 months

Primary outcomes:
measure: Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
timeFrame: Baseline and month 3
Secondary outcomes:
measure: Knee joint range of motion Change from baseline in knee joint on the measuring the range of motion at knee joint at month 3
timeFrame: Baseline and month 3
measure: Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3
timeFrame: Baseline and month 3
measure: SF-36 quality of life scale Change from baseline in physical and mental functions on SF-36 quality of life scale at month 3
timeFrame: Baseline and month 3
measure: Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month 3
timeFrame: Baseline and month 3
measure: Isokinetic muscle strength measurement Change from baseline in knee joint on the measuring the isokinetic muscle strength at month 3
timeFrame: Baseline and month 3
Other outcomes:
Locations:
Study officials:
affiliation: Meram Medical School, Necmettin Erbakan University, Konya, Turkey
name: BANU ORDAHAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02323048: Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans
Official title: Acquisition of Responses to a Methamphetamine-associated Cue in Healthy Humans: Self-report, Behavioral, and Psychophysiological Measures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to extend our investigations of drug-associated conditioning with healthy volunteers. The investigators have recently completed a pilot study demonstrating that subjects show an increase in self-reported preference for a visual stimulus paired with stimulant drug administration. Furthermore, our pilot data suggest that methamphetamine acts synergistically with rewards in the environment, such that this conditioning effect is facilitated by experiencing the drug in the presence of rewarding, or positive events, such as earning money. The investigators now aim to extend these findings by assessing not only self-reported preference, but also attentional and psychophysiological (electromyogram; EMG) responses to the drug-associated stimuli.

Detailed description: The study will consist of an orientation session following by 6 experimental study sessions. The first experimental session will consist of a "Pre-test", where baseline data regarding attentional, psychophysiological, and self-reported responses tovarious stimuli will be collected. The following 4 sessions will consist of a drug (sedative or stimulant) or placebo. During these sessions, subjects will play simple computer games, as well as complete questionnaires regarding mood and potential subjective drug effects. The subjects will then complete a "Test" session, where attentional, psychophysiological, and self-reported responses to the stimuli will be assessed, as in the first experimental session.

Eligibility criteria: Inclusion Criteria:

* BMI of 19-26kg/m, high school education,
* fluency in English,
* resting blood pressure less than140/90mmHg and consumption of less than 4 standard alcohol or caffeinated drinks per day.

Exclusion Criteria:

* current substance abuse or lifetime substance dependence,
* regular medication,
* history of cardiovascular illness,
* current major Axis I DSM-IV disorder (APA, 2004),
* mood disorder or psychotic symptoms within the past year.
* Shift workers and pregnant or nursing mothers will also be excluded.

Primary outcomes:
measure: Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire
timeFrame: End of study (time 0 and approximately 4 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Graduate Student
name: Leah Mayo
role: STUDY_DIRECTOR
References:
Clinical trial NCT00954148: Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
Official title: Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer Recurrence
Solid Tumors
Keywords: cancer
colorectal
head/neck
lung
PET/CT
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2009-08-07
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with PET/CT only, over a five year period. The purpose is to show through utilization of the single most sensitive and specific test currently available-PET/CT-that survival for patients in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence and compliance with follow-up appointments).

Detailed description: Routine visits would include COLON:14 visits with cea and 6 CTs over a 5 year period plus PET/CT at last visit RECTAL: 14 visits with cea and 6 CTs and 4 procto exams over 5 year period plus PET/CT at last visit HEAD/NECK: 14 visits with 4 CTs and PET/CT at last visit LUNG:12 visits plus 4 CTs and PET/CT at last visit

Limited follow-up ALL GROUPS: a history and physical plus PET/CT at 3 month, 9 month, 18 month, 36 month and 60 month only

Eligibility criteria: Inclusion Criteria:

* Completed primary therapy such that no disease is evident at the time of enrollment in the study

Exclusion Criteria:

* Patients unable to consent
* Without diagnosis of colorectal cancer
* Non-small cell lung cancer or squamous cell cancer of the head and neck
* Unwilling or unable to participate in the assigned follow-up program
* Having a serum glucose at time of PET/CT greater than 180mg/dl
* Stage IV disease or with evidence of disease recurrence post treatment
* Who are not a candidate for further treatment should a recurrence of disease be identified

Primary outcomes:
measure: ThatPET/CT will be superior (15% improvement) to conventional methods of follow-up in terms of 5 year survival, cost and time to identification of new disease
timeFrame: 5 years
Secondary outcomes:
measure: Improvement in patient/caregiver compliance in keeping their appointments and completing their tests
timeFrame: 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: ACOS for Research VA North TX Health Care System
name: James LePage, PH.D
role: STUDY_CHAIR
References:
Clinical trial NCT05779748: The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain
Official title: The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: Taif University
Sponsor class: OTHER
Collaborators: name: King Abdullah Hospital
First posted: 2023-03-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to investigate the efficacy of an acute bout of exercises on pain sensitivity (primary aim) and clinical pain intensity (secondary aim) among adults with Chronic Low Back Pain. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adults with Chronic Low Back Pain?

Participants who agree to participate and sign the informed consent will be randomized to one of three groups:

Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30).

Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30-sec rest between rep, ;(n=30).

Group 3 (Control group): true control (do nothing);(n=30).


Eligibility criteria: Inclusion Criteria:

1. aged 18 years or older; and
2. diagnosed with chronic non-specific LBP (lasting for more than 12 weeks).
3. Able to perform physical therapy exercises.

Exclusion Criteria:

1. pregnancy.
2. patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise).
3. Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis)
4. Uncontrolled diabetic.
5. who has any history of heart disease (e.g., myocardial infarction, embolism)
6. Orthopaedic impairment (e.g., balance problems)

Primary outcomes:
measure: Pain pressure threshold
timeFrame: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
Secondary outcomes:
measure: Pain intensity
timeFrame: [ Time Frame: Change from pre-intervention (baseline) compared to post-intervention (immediately after session) ]
Other outcomes:
Locations:
city: Bisha
country: Saudi Arabia
facility: King Abdullah Hospital
Study officials:
affiliation: Taif University
name: Hossam Alzahrani, PhD
role: PRINCIPAL_INVESTIGATOR
References: