louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03343028: Biomarker Establishment for Superior Treatment of PTSD
Official title: Biomarker Establishment for Superior Treatment of PTSD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Keywords: veterans
post traumatic stress disorder
depression
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: New Mexico VA Healthcare System
First posted: 2017-11-17
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will assess and acquire data on these Veterans across the course of the project prior to and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment at VA Palo Alto (VAPAHCS) and the Albuquerque VA.

Brief summary: The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate research on the discovery of biological, neurological and neuroimaging markers for Post- Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether there are pretreatment biological factors that can predict response to therapy. They want to do this by understanding the brain network function, relating EEG to functional magnetic resonance imaging, and application of network analysis tool.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of PTSD by VA clinicians and acceptance into PE or CPT treatment as part of the PCT
* Veterans of any era

Exclusion Criteria:

* MRI safety contraindications
* Active, uncontrolled medical illness
* Acute suicidality
* Current substance dependence
* Current use of thyroid medication or active hyper/hypothyroidism
* Neurological disorder affecting the CNS Seg stroke, epilepsy, tumorW or penetrating head injury
* Use of PRN within 48 hours of the MRI/EEG

Primary outcomes:
measure: Understanding the brain network function-neuroimaging and behavioral with Clinician-Administered PTSD Scale for DSM-5
timeFrame: Approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System (VAPAHCS)
state: California
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System
state: New Mexico
Study officials:
affiliation: Stanford University
name: Alan Schatzberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04059328: Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Official title: Use of Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti: Utility in Bending the Learning Curve for Global Programs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecology
Surgery
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OBGYN attendings and residents practicing at University Hospital of Mirebalais

Brief summary: The researchers traveled to University Hospital Mirebalais in Haiti and provided a one week long laparoscopic training and simulation course to the 7 OBGYN faculty there. The researchers used novel checklists to help the faculty to set up for laparoscopic cases and care for the equipment needed. The researchers then asked the physicians their opinion of the checklists.


Eligibility criteria: Inclusion Criteria:

* OBGYN physician in Haiti

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of physicians that reported favoring the checklist greater than 3 on a likert scale of 1-5.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Mirebalais
country: Haiti
facility: University Hospital at Mirebalais
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lara Harvey, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04620928: Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography
Official title: Defining the Neural Dynamics of Concept Retrieval Using Electrocorticography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Present a behavioral intervention to a single group of participants and measure subsequent electrical activity in the brain.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will look at the way activity within the brain changes over time while a person is trying to think about certain everyday concepts. To measure brain activity accurately, we will be using electrodes placed on people's brains during awake brain surgery.

Detailed description: This study will measure the dynamics of cortical activity among early modal cortex and multimodal cortical regions during conceptual retrieval using electrocorticography. Participants will be patients undergoing awake temporal lobe craniotomies. During the surgery patients will have multiple high-density grids placed to simultaneously record activity in multiple areas while the patient is performing language tasks. Activity in each of these regions will be tested for timing differences and informational directionality to determine the temporal dynamics.

Eligibility criteria: Inclusion Criteria:

* Clinically determined to require an awake left temporal resection of a brain lesion with concurrent language testing.
* English as a first language.

Exclusion Criteria:

* Significant preoperative neuropsychological deficits in memory or naming.
* Patients with inability to make decisions regarding their participation in this research project.
* Surgeon does not plan to expose the area of interest or determines that recording during the resection will interfere with his surgical plan.

Primary outcomes:
measure: Brain activity
timeFrame: Recorded immediately during experiment
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Assistant Professor
name: William Gross, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02479828: Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
Official title: The Effect of Fascia Iliaca Compartment Block in Acute and Chronic Pain Management in Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hip Pain
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
First posted: 2015-06-24
Enrollment: 198
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: PREVENTION

Brief summary: This study evaluates the effect of fascia iliaca compartment block (FICB) in the management of acute post -surgical pain in hip fracture patients and in the appearance of chronic post -surgical hip pain, by means of von Korff Graded Chronic Pain Scale -modified for hip pain in Greek.

Half of the patients will not receive fascia iliaca compartment block.


Eligibility criteria: Inclusion Criteria:

* ASA I-III (American Society of Anesthesiologists classification)
* intertrochanteric fractures
* fractures of femoral neck

Exclusion Criteria:

* existing pain in hip Joint to be operated
* cognitive or mental disorder
* administration of analgesic drugs prior surgery
* contraindications of spinal anesthesia
* refusal to participate in the study

Primary outcomes:
measure: Acute postsurgical pain after hip fracture surgery
timeFrame: 48 hours
measure: Chronic postsurgical pain after hip fracture surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion General Hospital
state: Voula
Study officials:
affiliation: Asklepieion General Hospital
name: MARIA DIAKOMI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Clinical trial NCT01936428: Prospective Study of the Perception of Palliative Care by Relatives of Patients Treated in Oncology
Official title: Prospective Study of the Perception of Palliative Care by Relatives of Patients Treated in Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care Perception
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate (thanks to analysed interview) the perception of palliative care by relatives of patients treated in oncology.


Eligibility criteria: Inclusion Criteria:

* man or woman of age who is a relative of a patient treated in oncology
* subject who signed the informed consent
* subject without any legal protection measure and having health coverage

Exclusion Criteria:

* Relatives of patients already followed in the palliative care departement
* Subjects with cognitive impairment or expression;
* Not french spoken subjects
* Pregnant or breastfeeding women

Primary outcomes:
measure: Perception of palliative care evaluated by an interview with the investigator
timeFrame: 1 day
Secondary outcomes:
measure: analysis of main elements to be used in the early information to patients and their families about palliative care.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03359928: Acute Physiological and Perceptual Responses to Novel Forms of High-intensity Interval Exercise
Official title: Acute Physiological and Perceptual Responses to Novel Forms of High-intensity Interval Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-intensity Interval Exercise
Heart Rate
Rating of Perceived Exertion
Blood Pressure
Acute Mood
Physical Activity Enjoyment
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Using a randomised crossover trial design participants will be randomised computer assisted random sequence generation to sequences in which they are exposed to each experimental condition (exercise modality: stair stepping, stair climbing and non-contact boxing).
Primary purpose: OTHER

Brief summary: Randomised cross-over study seeking to explore the acute physiological and perceptual responses to three novel forms of high-intensity interval training (HIT).

Detailed description: Randomised cross-over study seeking to explore the acute physiological (heart rate and blood pressure) and perceptual responses (rating of perceived exertion, mood and enjoyment) to three novel forms (non-contact boxing, stair stepping and stair climbing) of high-intensity interval training (HIT).

Eligibility criteria: Inclusion Criteria:

* adult (≥18 years) employees
* no health conditions that preclude them from exercise and on no medication, information obtained via their self-report.
* able to understand written and spoken English.
* participants reporting that they are asthmatic will allowed to participate with medical clearance and instructed to bring their bronchodilator medication and use it when required.

Exclusion Criteria:

* symptoms of or known presence of heart disease
* condition or injury or co-morbidity affecting the ability to undertake exercise
* diabetes mellitus
* early family history of sudden cardiac death
* pregnancy or likelihood of pregnancy.

Primary outcomes:
measure: Heart rate
timeFrame: 6 months
Secondary outcomes:
measure: Mood
timeFrame: 6 months
measure: Enjoyment
timeFrame: 6 months
measure: RPE
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: Teesside University
Study officials:
affiliation: Teesside University
name: Kathryn Weston, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03306628: Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Official title: Early Carbon Dioxide Laser Therapy for Alleviation of Incisional Scar Burden
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Scarring
Keywords: Skin Scarring
keloids
hypertrophic scars
CO2 laser therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized pilot study of patients who will undergo either early or late incisional laser therapy after breast reduction surgery to alleviate scar burden at NYU Langone Medical Center. The purpose of this study is to see how well carbon dioxide (CO2) laser therapy works at preventing scar formation after surgery.CO2 laser therapy is currently being used by dermatologists and plastic surgeons to help with scarring after acne and to rejuvenate the face; its benefits are now being explored by medical professionals in dermatology and cosmetic surgery to prevent scarring after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients of all ethnic origins will be considered, although certain ethnic groups will be preferentially excluded more than others such as black and South Asian patients due to our exclusion criteria related to darker skin individuals (see below).
* Patients undergoing bilateral breast reduction surgery

Exclusion Criteria:

* Males will be excluded from this study as male patients rarely undergo breast reduction surgery. When males do undergo breast reduction surgery for gynecomastia, it is often unilateral, and is performed with several techniques and incision types that are not typical employed during female breast reduction. Thus, for this study, only female patients will be considered (see below).
* Any patient enrolled in this study who shows evidence of delayed wound healing, dehiscence, or post operative infection at the first post operative visit will be excluded
* Patients with darker skin (Fitzpatrick IV and above), which is a well-known contraindication to laser therapy
* Pregnant patients
* Patients who have had prior breast surgery
* Patients who have had prior chest/breast irradiation
* Patients with the following diseases which interferes with wound healing: prior hypertrophic scarring/keloids, type I or type II Diabetes Mellitus, autoimmune diseases/collagen vascular diseases
* Patients who are active smokers
* Patients using blood thinners that cannot be stopped
* Patients who have used aspirin within a week of the procedure date

Primary outcomes:
measure: Change in Vancouver Scar Scale Score
timeFrame: 1 Week to Post Laser 1-Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alexes Hazen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02100293: Effects of Magnesium Sulfate on Onset and Duration of Low Dose Rocuronium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Observation of Neuromuscular Block
Intubation Condition
Surgical Condition
Keywords: magnesium sulfate, rocuronium
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-03-31
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate effects of magnesium sulfate on onset and duration of low dose rocuronium, intubation condition and surgical condition.


Eligibility criteria: Inclusion Criteria:

* 18-75 yr American Society of Anesthesiologists physical status 1 or 2, BMI of 20-24.9 kg/m2 scheduled for elective laryngeal microsurgery

Exclusion Criteria:

* severe respiratory or cardiac disease hepatic or renal function impairment neuromuscular disease on medications affecting neuromuscular function with known allergy to the drugs

Primary outcomes:
measure: onset time of rocuronium
timeFrame: from injection of rocuronium to T1 suppression more than 95% up to 10 minutes
Secondary outcomes:
measure: maximal suppression time and duration of rocuronium
timeFrame: time from the injection of rocuronium to T1 maximal suppression time and reversal of T1 25% up to 1 hours
Other outcomes:
measure: intubation condition
timeFrame: intubation condition during induction of anesthesia up to 10 minutes
measure: surgical condition
timeFrame: intraoperative surgical condition
measure: postoperative sore throat
timeFrame: postoperative sore throat up to 4 hours
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hospita
state: Gyeonggi-do
Study officials:
affiliation: Seoul National Univ. Bundang Hospital
name: Sang Hwan Do
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00463593: Schistosomiasis in Formal and Non-Formal Schools in Uganda: Implications for Control Programmes
Official title: Schistosomiasis in Formal and Non-Formal Schools in Uganda: Implications for Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schistosomiasis
Helminthiasis
Anaemia
Keywords: schistosomiasis
helminthes
anaemia
Lead sponsor: DBL -Institute for Health Research and Development
Sponsor class: OTHER
First posted: 2007-04-20
Enrollment: 1293
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children enrolled in formal schools and children not enrolled in formal school identified by household survey

Brief summary: Current efforts to control schistosomiasis and soil-transmitted helminthes infections focus on the school-age population, and school-based treatment delivery programs offer a major cost advantages because of the use of the existing school infrastructure and the fact that schoolchildren are accessible through schools. However, in many developing countries, large numbers of school-age children are not in school and this has raised questions about the effectiveness of school-based programs in reaching non-enrolled children. Increasingly, the non-formal education sector is providing a growing solution to the problem of poor enrolment in basic education, especially in sub-Saharan Africa, and has recently been used to deliver praziquantel as part of a national schistosomiasis control program in Uganda. However, it is unclear how effective this program has been in reaching children who attend non-formal schools and whether the program has been reaching children from the poorest households.

Detailed description: This study will compare infection and nutritional status of children enrolled in formal schools and non-formal schools, and non-enrolled children in Nakasongola District in Uganda, and investigate the process and impact of treatment delivered by the national control program. The study will consist of household surveys and cross-sectional parasitological and hematological surveys, with follow-up six months later. The evaluation will take place over the course of a year and will:

* Compare the infection and nutritional status of children enrolled in formal schools and non-formal schools, and non-enrolled children in Nakasongola District, Uganda
* Compare programmatic process indicators, including enrolment rates, attendance rates, access to water and sanitation, treatment coverage in formal and non-formal schools
* Investigate the impact of treatment on intensity of infection and reinfection rates in formal and non-formal schools.

Eligibility criteria: Inclusion Criteria:

* School children in grad 1 and 2

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Vector Control Division
Study officials:
affiliation: Vector Control Division, Ministry of Health Uganda
name: Narcis Kabatereine, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412993: Evaluation of ABO Isoagglutinins Level in Blood Group O Donors
Official title: Evaluation of ABO Isoagglutinins Level in Blood Group O Donors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Isoagglutinins Level
Keywords: urgent blood transfusion , group O
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group O donors

Brief summary: Our study is aiming for evaluation f the titre of anti-A and anti-B in plasma of blood grop O donors, study the effect of pooling of blood product on the level of A and B isoagglutinins in blood group O donors and screening for the safest group o donors(who have the lowest anti-A antd anti-B titre) for transfusion in urgent need of blood.

Detailed description: the use of O blood group transfusion to patients of all groups has continued since the second world war, nevertheless the transfusion of group O plasma/ platelet concentrate to group A, B and AB recipient sometimes causes severe red cell destruction , Acute haemolysis has been reported following transfusion of non-iso group single donor platelet (PLT) concentrates and may be more common than is appreciated.

This red blood cells destruction happens based on the fact that the sera from group O people contain two separable antibodies, anti-A and anti-B .

When it comes to PLT transfusion therapy we are dealing with issues arising from the fact that PLTs contain both significant amounts of ABO antigen on their surface, as well as anti ABO isogglutinins in the donor's plasma which caused reduction the volume of incompatible plasma administrated.

From another point of view the risk of high titer units is considered low with group O, post storage, pooled PLT concentrate. However its necessary to establish a (golden standard) method for the determination of antibody titer in order to be able to differentiate accurately the high titer donors.

So, for improving the safety of group O plts we need to define a safe level of antibody titer or reduce the volume of incompatible plasma administrated.

Eligibility criteria: Inclusion Criteria:

* Healthy adults blood group O donors

Exclusion Criteria:

* Other blood groups donors.
* Donors with history of chronic or autoimmune diseases

Primary outcomes:
measure: Decrease the risk of red cell destruction resulting from transfusion of RBCs/ platelet concentrate group O transfusion in urgent cases.
timeFrame: 2 years
Secondary outcomes:
measure: screening for the best group O donors to use for other groups urgent cases as a reserve for transfusion.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: