louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04632420: Evaluation of Headache and Childbirth in a Chronic Pain Population
Official title: Evaluation of Headache and Childbirth in a Chronic Pain Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 1112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who went to the pain clinic and fulfill the inclusion and exclusion criteria.

Brief summary: Headache and backache are common symptoms following childbirth. The incidence of these symptoms have been shown to increase during the postpartum period between 5 to 12 months following delivery. By 12 months postpartum up to 45% and 65% of women experience headache and backache, respectively. While studies have reported headache and backache as frequently persistent symptoms beyond the first year postpartum, few studies have specifically interrogated women seeking specialist pain physician input or identified predisposing risk factors. Finally there is little known about typically described pain characteristics of women who suffer with chronic postpartum headache and backache. We aim to compare the prevalence of chronic headache in women that have versus have not experienced childbirth.


Eligibility criteria: Inclusion Criteria:

* Women greater than 18 years old
* Agreeing to be contacted for research purposes.
* Able to read and understand English who have had agreed to be contacted with a valid email address

Exclusion Criteria:

* Self identified as non-female
* Age \<18 years old.
* Women without computer or electronic device access or valid email address and women who did not respond

Primary outcomes:
measure: Prevalence of chronic headache
timeFrame: 10 minute questionnaire
Secondary outcomes:
measure: Severity of headache
timeFrame: 10 minute questionnaire
measure: Frequency of worst headache
timeFrame: 10 minute questionnaire
measure: Age of onset of headache
timeFrame: 10 minute questionnaire
measure: Postpartum headache
timeFrame: 10 minute questionnaire
measure: Predictors for postpartum headache
timeFrame: 10 minute questionnaire
measure: Risk factors for developing acute or acutely worsened headache within 5 days of delivery
timeFrame: 10 minute questionnaire
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT01225120: Amputee Gait Training Using Virtual Reality and Real-Time Feedback
Official title: Amputee Gait Training Using Virtual Reality and Real-Time Feedback
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Gait Kinematics
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2010-10-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this repeated measures design gait training study is to develop and quantitatively assess the effectiveness of a virtual reality training environment using real-time feedback for modification of pelvic motion during gait.


Eligibility criteria: Inclusion Criteria:

* Unilateral traumatic trans-tibial or transfemoral amputation
* Independent ambulation without an assistive device for a minimum of three months
* Ability to ambulate continuously for a minimum of 15 minutes
* Trans-femoral participants must use an ischial containment socket
* VAS Pain scores on the involved side of less than 4/10
* Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.

Exclusion Criteria:

* Blindness
* TBI-Glascow Coma Scale score of 12 or lower at the time of injury
* Cardiac or pulmonary problems limiting physical activity
* PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.

Primary outcomes:
measure: Gait Biomechanics
timeFrame: 3 weeks
measure: Gait Biomechanics
timeFrame: immediately prior to start of 3 week training
measure: Gait Biomechanics
timeFrame: Immediately post training
measure: Gait Biomechanics
timeFrame: 3 weeks from initial post training
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Center for the Intrepid
state: Texas
Study officials:
affiliation: Director, Military Performance Lab-Center for the Intrepid
name: Jason M Wilken, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01014520: Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
Official title: Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Herniated Disc
Intervertebral Disc Displacement
Keywords: Lumbar
Diskectomy
Laminectomy
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2009-11-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.

Detailed description: Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.

Controversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Age:18 to 60
* Weight: 60 to 80 Kg
* ASA Class: I,II
* Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation
* Single level lumbar disk herniation unresponsive to medical treatment

Exclusion Criteria:

* Previous consumption of Gabapentin or Amitriptyline
* Known allergy to investigated drugs
* Reluctant to sign informed consent
* Previous history of intolerance to narcotics
* Simultaneous lumbar diskectomy and a fusion technique
* Known renal failure
* Pregnancy
* Contraindications to Amitriptyline or Gabapentin prescription
* Unable to use PCA
* Habitual use of alcohol or opium
* History of analgesic consumption during the last 24hours

Primary outcomes:
measure: 30% reduction in opium consumption in either study arms compared to the placebo group
timeFrame: Within the first 24 hours after surgery
Secondary outcomes:
measure: 30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group
timeFrame: Within the first 24 hours after surgery
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Tabriz University of Medical Sciences
state: East Azerbayjan
Study officials:
affiliation: Tabriz University
name: Dawood Aghamohammadi, MD
role: STUDY_CHAIR
affiliation: Tabriz University
name: Payman Vahedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06456320: Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery
Official title: Mayo Clinic Tapestry 2.0: Applying Multi-Omics for Scientific Discovery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Genetic Predisposition
Exposure, Environmental
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 50000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic patients

Brief summary: The purpose of this study is to use multi-omics testing on samples collected from Mayo Clinic patients to build and expand on what has been learned about genomic data.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Registered Mayo Clinic patient
* Able to provide informed written consent
* Able to receive mail and packages within a United States (US) state
* Able to collect and ship samples within a US state

Exclusion Criteria:

* Active hematological cancer or history of a hematological cancer
* Allogeneic Bone Marrow Transplant (e.g., samples from autologous bone marrow transplant recipients are acceptable if collected at least one month after transplant)
* Other co-morbidity that, in physician's opinion, would interfere with patient's ability to participate in the study (e.g., reduced ability to comprehend, i.e., dementia, intellectual disability, etc.)

Primary outcomes:
measure: Creation of a unique integrated asset of multi-omics data
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Konstantinos N. Lazaridis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05958420: Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors
Official title: Evaluation of HDL Subfraction Changes and HDL-Associated Enzymes in Liver Failure Patients and Healthy Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Failure
Keywords: Liver Failure
HDL Subfractions
ApoA1
CETP
LCAT
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients who underwent living donor LT procedure between 2018 and 2019.

Brief summary: This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Detailed description: Objectives: This study aimed to determine high-density lipoprotein (HDL) subfraction profile and HDL-associated enzyme changes in liver failure patients and healthy donors.

Materials and Methods: Twenty liver failure patients and twenty healthy donors are selected. Blood samples obtained from all patients prior to transplant will analyzed. HDL subfraction analysis will done by continuous disc polyacrylamide gel electrophoresis. Plasma levels of apolipoprotein A-1 (ApoA-I), cholesteryl ester transfer protein (CETP), and lecithin-cholesterol acyltransferase (LCAT) will determined by enzyme-linked immunosorbent assay.

Eligibility criteria: Inclusion Criteria:

* Liver failure patients

Exclusion Criteria:

* patients not giving consent
* Participants who had oncological and hematological diseases, coronary failure, kidney failure, malnutrition, diabetes, traumatic brain injury, or cadaveric LT and who were using psychoactive medicines or having a respiratory system or CNS diseases were excluded from the study

Primary outcomes:
measure: HDL Subfractions
timeFrame: Blood will collected from all patients before surgery
Secondary outcomes:
measure: HDL-associated enzymes
timeFrame: Blood will collected from all patients before surgery
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: AkdenizU
Study officials:
affiliation: Akdeniz University
name: İlker O Aycan
role: STUDY_CHAIR
References:
Clinical trial NCT05668182: A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects
Official title: Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: a Case Series
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tibia Fracture
Humerus Fracture
Femoral Fracture
Long Bone Segmental Defect
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years or older presenting to UCSD Medical Center with a humerus, femur, or tibia segmental defects requiring surgery

Brief summary: This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.


Eligibility criteria: Inclusion Criteria:

* Humerus, femur, or tibia segmental defects requiring surgery
* Evaluation and treatment at UCSD
* Ages 18 year and older
* Abiltiy to understand the content of the patient information/informed consent form

Exclusion Criteria:

* Any not medically managed severe systemic disease
* Their doctor has decided that it is in the patient's best interest to receive a different method of repair
* Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
* Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it
* Prisoner
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.

Primary outcomes:
measure: Use of the TRUMATCH Graft Cage- Long Bone
timeFrame: 2 years
Secondary outcomes:
measure: Healing Rates
timeFrame: 2 years
measure: Reoperation Rates
timeFrame: 2 years
measure: Complications
timeFrame: 2 years
measure: Pain Scores
timeFrame: 2 years
measure: Time to Return to Normal Activity
timeFrame: 2 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT02182882: Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy People
Official title: Efficacy of Ginsana in Improving Half -Time Hemoglobin Re-oxygenation in Recreational Sportspeople: a Double Blind, Placebo Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the efficacy of ginsana in improving half-time hemoglobin re-oxygenation in healthy, recreational sportspeople and to assess the safety of the product


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers between 18 and 40 years old
* Females must test negative for pregnancy
* Recreational athletes according to the american college of sports medicine (ACSM) definition
* Familiar with the cycle ergometer exercise methodology
* Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria:

* Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that any drug that could have influence the trail methodology
* Alcohol and drug abuse (as defined in Diagnostic and Statistic Manual IV( DSM-IV)) per subject verbal report
* Smokers
* Known hypertension
* Known hypercholesterolemia (moderate/severe)
* Female volunteers taking oral or injectable contraceptives
* Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills \[intrauterine devices (IUDs)\]
* Pregnancy and/or lactation
* Liver and/or renal disease and/or vascular disease
* Relevant allergy or known hypersensitivity to the investigational drug or its excipients
* Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial

Primary outcomes:
measure: Change from baseline in half-time hemoglobin re-oxygenation by Near InfraRed Spectroscopy (NIRS) methodology
timeFrame: Baseline, day 84 post first drug dispense
Secondary outcomes:
measure: Change from baseline in half-time hemoglobin re-oxygenation by NIRS methodology
timeFrame: Baseline, day 21, 42 and 63 post first drug dispense
measure: Maximum endurance time
timeFrame: up to day 84 post first drug dispense
measure: Change from baseline in respiratory threshold
timeFrame: Baseline, up to day 84 post first drug dispense
measure: Change from baseline in thiobarbituric acid (TBARS)
timeFrame: Baseline, up to day 84 post first drug dispense
measure: Change from baseline in glutathion superdismutase / glutathion superdismutase oxidised (GSA/GSSG)
timeFrame: Baseline, up to day 84 post first drug dispense
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04590482: Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion
Official title: Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Missed Abortion
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Detailed description: Intervention type: drug

Intervention name: letrozole then misoprostol

Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion

Arm group label:study group

Intervention type :drug

Intervention name:placebo then misoprostol

Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion

Arm group label: control group

Eligibility criteria: Inclusion Criteria:

1. Maternal age more than 18 years old.
2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
3. Hemoglobin \>10 g/dl
4. Missed abortion

Exclusion Criteria:

1. Mullerian Uterine anomalies as septate, bicornuate uterus.
2. Fibroid uterus.
3. Coagulopathy.
4. Medical disorder that contraindicate induction of abortion.
5. Allergy to misoprostol or letrozole.

   -

Primary outcomes:
measure: Complete abortion
timeFrame: 6 hours
Secondary outcomes:
measure: surgical evacuation
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: AinShams University
name: shereen khedr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05399082: Feasibility of Performing Peripheral Pulmonary Lesion Biopsy Using Robotic Bronchoscopy-Guided Cryoprobe
Official title: A Study to Evaluate the Feasibility of Robotic Bronchoscopy-guided Miniature Cryoprobe Biopsy of Peripheral Pulmonary Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchi--Diseases
Lung Diseases, Obstructive
Lesions Mass
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Erbe USA Incorporated
First posted: 2022-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This research is being done to evaluate the feasibility, and biopsy quality, of using a 1.1mm disposable cryoprobe that is passed through the working channel of the Ion Robotic bronchoscope to collect biopsy tissue.


Eligibility criteria: Inclusion Criteria:

- Patient clinically meets indication for peripheral lung nodule biopsy and has been scheduled for robotic bronchoscopy.

Lesion Criteria:

- Pulmonary nodules of 8-50mm in largest dimension.

Exclusion Criteria:

* Patients with known bleeding diathesis; Platelet count \< 50,000.
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable).
* Inability or unwillingness to give informed consent.
* Pregnant or nursing females, or females of child-bearing potential who decline a pregnancy test prior to enrollment.
* Pulmonary hypertension, defined as a right ventricular systolic pressure \> 50 mmHg.
* Individuals with current or recent systematic conditions, such as, acute kidney injury, or conditions that would mandate anticoagulation, such as a recent coronary stent.
* International Normalized Ratio (INR) \< 1.5.
* Do Not Resuscitate (DNR) status; Do Not Intubate (DNI) status.

Primary outcomes:
measure: Ability to Successfully Obtain Sample
timeFrame: Baseline
Secondary outcomes:
measure: Duration of Biopsy Procedure
timeFrame: Biopsy procedure, approximately 3 hours
measure: Freezing Time for Cryoprobe Biopsies
timeFrame: Biopsy procedure, approximately 60 seconds
measure: Number of Successful Biopsy Attempts
timeFrame: Biopsy procedure, approximately 3 hours
measure: Histological Accessibility Grade
timeFrame: Pathology review, approximately 1 day
measure: Histological Diagnostic Yield
timeFrame: Pathology review, approximately 1 day
measure: Total Histological Area
timeFrame: Pathology review, approximately 1 day
measure: Crush Artifacts
timeFrame: Pathology review, approximately 1 day
measure: Other Pathologic Artifacts
timeFrame: Pathology review, approximately 1 day
measure: Different Tissue Types in the Tissue Specimen
timeFrame: Pathology review, approximately 1 day
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ryan Kern, MD
role: PRINCIPAL_INVESTIGATOR
References: