louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04618887: A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome
Official title: A Comparative Study of GPI's DBS and Pallidotomy in the Treatment of Meige Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meige Syndrome
Meigs Syndrome
Meige Disease
Meig Syndrome
Blepharospasm
Blepharospasm of Left Eyelid
Blepharospasm of Right Eyelid
Blepharospasm of Both Eyelids
Blepharospasm Oromandibular Dystonia
Keywords: deep brain stimulation
DBS
DBNL
GPi
pallidotomy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lack of incidence of Meige sydrome，and also lack of efficient of DBS or pallidotomy of Meige Syndrome. We try to collect more data as we can. We initially established a population of 100.

Brief summary: In this study, we will compare the degree of postoperative symptom improvement, postoperative complication rate, postoperative quality of life improvement degree of patients with Meige syndrome undergoing pallidotomy (unilateral globus palliotomy) and deep brain stimulation (unilateral globus pallidus) ,in order to get the conclusion of the comparison of the clinical efficacy of the two surgical plans. In addition, possible predictive factors such as age, gender, age of onset, length of disease course, scale baseline score, preoperative brain PET-CT function analysis and other possible predictive factors are added for analysis, in order to find predictive factors that can guide the choice of surgical options.


Eligibility criteria: Inclusion Criteria:

* Patients confirmed Meige sydrome

Exclusion Criteria:

* Patients who cannot finish the neurosurgery or the postoperative evaluation

Primary outcomes:
measure: Symptom
timeFrame: 2 years
measure: complications
timeFrame: 2 years
Secondary outcomes:
measure: quality of life
timeFrame: 2 years
measure: depression scale
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References:
Clinical trial NCT00279487: Preanalgesic Effect of Gabapentin in Total Knee Repair
Official title: Preanalgesic Effect of Gabapentin in Total Knee Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Patients undergoing total knee replacement who received pain management by the following modality:
IV PCA opioid
Local femoral nerve block with 1.5% Mepivacaine & 0.5% Ropivacaine
Lead sponsor: Texas Health Resources
Sponsor class: OTHER
First posted: 2006-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether gabapentin, as a one time administration prior to a total knee replacement procedure, has opioid sparing effects and a reduction in pain scores.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee replacement who received pain management by the following modality:

  * Intravenous patient-controlled analgesia (IV-PCA) opioid
  * Local femoral nerve block with 1.5% mepivacaine 20 ml and 0.5% ropivacaine 20 ml

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
Study officials:
affiliation: Texas Health Resources
name: Rob Hutchison
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05080387: Neopterin in Acute Coronary Syndrome Patients
Official title: Neopterin in Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neopterin in Acute Coronary Syndrome Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of sample size admitted to cardiology department with ACS.

Brief summary: Measurement of neopterin in ACS patients

Detailed description: 1. Detect level of neopterin in ACS patients to detect whether there is relation or not between ACS and neopterin
2. Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS patients
3. Detect relation between neopterin level and in hospital events

Eligibility criteria: Inclusion Criteria:

* All patient of sample size admitted to cardiology departmentof Assiut university hospital with :

  1. Acute typical chest pain
  2. Positive cardiac enzymes
  3. ECG show recent ischemic changes
  4. ECHO show SWMA

Exclusion Criteria:

1. Patients not fulfill inclusion criteria.
2. Patients with other diseases which may cause increase of neopterin level as viral infections, intracellular bacteria or parasites infections, certain malignancies, allograft rejection

Primary outcomes:
measure: To detect whether there is association between neopterin and ACS or not
timeFrame: 72 hours
Secondary outcomes:
measure: Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS and detection of relation between neopterin level and in hospital events
timeFrame: 72 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: Magdy Ibrahim Aldesowky, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454687: Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes
Official title: Grafting of Epidermolysis Bullosa Wounds Using Cultured Revertant Autologous Keratinocytes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Epidermolysis Bullosa
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 0
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 term epidermolysis bullosa (EB) is used to describe a group of genetic skin diseases associated with skin weakness, blisters, and chronic wounds. "Revertant mosaicism" means that there are two genetically different populations of cells due to spontaneous mutations. Some EB patients have normal, non-fragile skin patches which may be areas of revertant mosaicism. In the revertant areas, the proteins function normally, like non-EB skin. In this study, we plan to culture cells from the revertant areas and graft them on to the wounded areas.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of EB (simplex, junctional or dystrophic)
* Areas of revertant skin that has been confirmed by biopsy
* 18 years or older subject willing and able to give consent
* Confirmation of EB diagnosis by immunofluorescence (IF), electron microscopy (EM), and genetic testing confirming mutation
* At least 100 to 200 cm2 of open erosions on the trunk and/or extremities suitable for skin grafting
* Able to undergo adequate anesthesia to allow grafting procedures to take place

Exclusion Criteria:

* Medical instability limiting ability to travel to Stanford University Medical Center
* The presence of medical illness expected to complicate participation and/or compromise the safety of this technique
* Active infection with HIV, hepatitis B, or hepatitis C
* Active infection in the area that will undergo grafting
* Evidence of a systemic infection
* Current evidence or a history of skin cancer in the area that will undergo grafting
* Active drug or alcohol addiction
* Hypersensitivity to vancomycin or amikacin
* Receipt of chemical or biological study product for the specific treatment ofEB in the past six months
* Positive pregnancy test or breast-feeding

Primary outcomes:
measure: Expression of the correct protein at the basement membrane zone
timeFrame: Week 52
measure: Engraftment and healing of wounds with genetically revertant keratinocytes
timeFrame: Week 52
Secondary outcomes:
measure: Engraftment and healing of wounds with genetically revertant keratinocytes
timeFrame: Week 8-12
measure: Engraftment and healing of wounds with genetically revertant keratinocytes
timeFrame: Week 25
measure: Expression of correct protein at the basement membrane zone
timeFrame: Week 8-12
measure: Expression of the correct protein at the basement membrane zone
timeFrame: Week 25
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Alfred Lane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05536687: VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES
Official title: VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Keywords: Healthy
6MWT
Real-world
insoles
Lead sponsor: FeetMe
Sponsor class: INDUSTRY
First posted: 2022-09-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Currently, the guidelines for performing the 6MWT established by the American Thoracic Society and the European Respiratory Society (ATS/ERS) recommend the use of an indoor or outdoor corridor with a 30 m flat surface (6MWT30) for patients with respiratory diseases, which is also a recommendation for healthy adults. However, not all hospitals, nursing homes or clinics have a corridor of sufficient length to properly perform the 6MWT. A simple way to make the test available to more health care professionals would be to reduce the length of the hallway.

In times when access to the hospital is difficult, the ability to assess functional abilities at a distance becomes essential. Today, this is becoming possible with tools such as connected watches, accelerometers, connected shoes and insoles. They give access to a quantitative analysis of walking without necessarily requiring large spaces, specialized personnel or even being in a hospital environment. The FeetMe® Evaluation device consists of connected insoles as well as a mobile application allowing the evaluation of standard clinical walking tests.

This device allows a better understanding of patients' walking and is transposable in real life.

The objective of the present study is to demonstrate the validity and reliability of the measurement of the distance walked during a 6-minute test with connected insoles in standard conditions (6MW30), degraded conditions (6MW10) in a clinic and at home in a healthy population divided into age subgroups.

In addition, this study will investigate whether there is a relationship between 6 minutes of uncontrolled walking from real-life walking data and a standard 6-minute test.


Eligibility criteria: Inclusion Criteria:

* Being between 18 and 80 years old

  * Able to use a laptop
  * Able to walk 100 meters without any aid
  * Accustomed to using a smartphone

Exclusion Criteria:

* Surgery with the possibility of impacting gait in the previous 3 months having had an impact on gait: orthopedic surgery, trauma of the lower limbs and spine, gynecological or urological surgery, brain and spinal cord surgery • Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological pathology.

Primary outcomes:
measure: Reliability of the test-retest for the distance during a 6MWT
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Ch Delafontaine
Study officials:
References:
Clinical trial NCT04981587: Effects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease
Official title: Effects of Strength Exercise on Fall Risk in Elderly With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia; Alzheimer's Type (Etiology)
Fall Risk
Elderly
Resistance Training
Keywords: alzheimer disease
elderly
exercise
fall risk
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventional study to show the effects of strength exercise on fall risk in elderly with Alzheimer's disease


Eligibility criteria: Inclusion Criteria:

* accept to participate in the study, through informed consent
* subjects aged 60 or over with medical diagnosis of Azlheimer´s disease
* minimal physical and mental state to perform the cognitive tests and strength exercise routine

Exclusion Criteria:

* Neurodegenerative disease other than Alzheimer's disease
* Suffering from serious somatic or psychiatric illnesses
* Patients who have practiced strength exercise regularly

Primary outcomes:
measure: Change from baseline Short physical performance battery (SPPB) at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
Secondary outcomes:
measure: Change from baseline Activities specific balance confidence scale (ABC scale) at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
measure: Change from baseline Lawton Instrumental Activities of Daily Living Scale (IADL) at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
measure: Change from baseline Quality of life Alzheimer Disease (QoL-AD) at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
measure: Change from baseline FRAIL test at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
measure: Change from baseline Mini Mental State Examination (MMSE) at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
measure: Change from baseline Neuropsychiatric Inventory (NPI-Q) at 3 and 6 months
timeFrame: Baseline, 3 and 6 months (3 months after intervention)
measure: Change from baseline Manual dynamometry at 1,2,3 and 6 months
timeFrame: Baseline, 1, 2, 3 and 6 months (3 months after intervention)
measure: Modified Borg scale
timeFrame: 3 times/week during strength exercises sessions
measure: Change from baseline One Maximum repetition strength test (1 MR) at 1,2,3 and 6 months
timeFrame: Baseline, 1 , 2 , 3 and 6 months (3 months after intervention)
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: A.F.A La Estrella
state: Andalucía
city: Alcalá De Henares
country: Spain
facility: Alexander achalandabaso
state: Madrid
Study officials:
affiliation: University of Jaen
name: Alexander Achalandabaso, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04076787: Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
Official title: The Effect of Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) on Clinical Outcomes Among Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received First-Line Sunitinib in the International mRCC Database Consortium (IMDC) Based on Prognostic Risk Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Vascular endothelial growth factor (VEGF)
Sunitinib
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
name: Analysis Group, Inc.
First posted: 2019-09-03
Enrollment: 1769
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 diagnosed with clear cell mRCC at age 18 or older who initiated sunitinib as first-line treatment between 2010 and 2018

Brief summary: This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment.

Detailed description: Clear cell mRCC patients who initiated sunitinib as first-line treatment between 2010 and 2018 were identified from the IMDC database. Patients were classified as favorable, intermediate, or poor prognostic risk group according to IMDC criteria. Overall survival, time to treatment discontinuation, and physician-assessed tumor response were evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with mRCC
* Initiated treatment post mRCC diagnosis and received sunitinib as first-line therapy
* Age 18 years or over at the time of mRCC diagnosis
* Actively treated at an IMDC clinical center

Exclusion Criteria:

* Initiated first line sunitinib treatment before 2010
* Had non-clear cell mRCC

Primary outcomes:
measure: Overall Survival
timeFrame: 60 months
measure: Time to First-Line Sunitinib Treatment Discontinuation
timeFrame: 60 months
measure: Number of Participants Who Discontinued First-Line Sunitinib Treatment
timeFrame: 60 months
measure: Percentage of Participants With Objective Response (OR)
timeFrame: 60 months
measure: Percentage of Participants With Progressive Disease
timeFrame: 60 months
measure: Percentage of Participants With Stable Disease
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01537887: A Study of LY2484595 on the Electrical Activity of the Heart
Official title: A Placebo- and Positive-Controlled Study of the Effect of LY2484595 on QT Interval in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females
* Body mass index (BMI) of 18.5 to 29 kilograms per square meter (kg/m²)
* Reliable and willing to be available for the duration of the study and are willing to follow study procedures
* Provided written informed consent

Exclusion Criteria:

* Known allergies to LY2484595 or moxifloxacin
* Personal or family history of long QT syndrome, heart failure, or low blood potassium (hypokalemia) a family history of sudden death, or unexplained syncope within the last year
* Positive findings on urinary drug screening
* Cigarette smokers

Primary outcomes:
measure: Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo
timeFrame: Predose of Day 1, Day 10
Secondary outcomes:
measure: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State
timeFrame: Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State
timeFrame: Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose
measure: Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins
timeFrame: Baseline, Day 11
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Florida
city: Evansville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Indiana
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00612287: Sublingual Buprenorphine for Chronic Pain
Official title: Sublingual Buprenorphine for Chronic Pain in Patients at Risk for Drug Abuse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Pain
Chronic pain
Buprenorphine
Drug addiction
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Beth Israel Medical Center
First posted: 2008-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop and pilot test clinical guidelines for the use of buprenorphine for the treatment chronic pain among patients with substance abuse histories. Buprenorphine, an opioid medication, holds promise as a treatment of chronic pain because, compared to most other opioid analgesics, it has a high safety profile, a low level of physical dependence, and mild withdrawal symptoms on cessation. Moreover there are promising reports from Europe of its use as a skin patch to treat chronic pain as well as clinical reports in the U.S. that it may be effective when used sublingually (placed under the tongue). This study will test the sublingual formulation.


Eligibility criteria: Inclusion Criteria:

Undergoing treatment for moderate-severe chronic pain for at least six months at either an ambulatory practice of the Department of Pain and Palliative Medicine Beth Israel Medical Center in New York City or the the Peter Kruger Clinic at the same institution.

Either

1. On opioid therapy (any dose) and observed to have had at least four of the aberrant drug-related behaviors described in (Passik et al. Clin J Pain; 22(2):173-81 2006) during the past six months, or
2. Considered a candidate for long-term therapy by the pain specialist and a history of a substance use disorder, as determined by DSM-IV criteria, but no longer meeting criteria for at least one year.

Age 18-70

Exclusion Criteria:

* Meets DSM-IV criteria for current opioid dependence or other substance use disorder including alcohol abuse.
* Currently being treated for opioid dependence with methadone.
* Currently maintained on naltrexone (e.g., for alcohol dependence).
* Taking benzodiazepines on a daily basis.
* A history of moderate-severe cardiopulmonary disease or symptoms or signs consistent with moderate-severe cardiopulmonary disease.
* Elevated liver function test (LFT) results (\> 2.5 above normal).

Primary outcomes:
measure: Pain severity
timeFrame: 1, 2, 3, 4, 5 & 6 months
Secondary outcomes:
measure: Pain behaviors, psychiatric distress, drug use, side effects
timeFrame: Months 1 through 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: NDRI
name: Andrew Rosenblum, PhD
role: PRINCIPAL_INVESTIGATOR
References: