louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04113252: Impact of Coaching Patients on Pain Control With and Without Financial Incentivization
Official title: The Economy of Pain: A Pilot Study of the Impact of an Opioid Buyback Program
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Use
Keywords: opioid buyback
opioid misuse prevention
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Opioids are commonly prescribed pain medications, but they can lead to addiction. The study team is trying to determine if providing someone with an incentive (money in the form of a Visa gift card) to use less pain medications will result in study participants actually using fewer pain tablets than allowed by their health care provider. The study team also wants to know if providing the incentive (the Visa gift card alone) works the same as the incentive (the Visa gift card) plus providing additional information about addiction and alternative pain management.

Detailed description: Study participants will receive the standard of care for pain management at discharge. If study participants were not hospitalized at discharge, the study team will begin that standard of pain management at the participant's first outpatient clinic visit. Study participants will be randomized to 1 of 3 groups. All groups will receive a gift card if participants return the completed medication diary to the study team.

* Group 1 will complete a medication diary. Also, group 1 will be encouraged to return any unused tablets to the study clinic.
* Group 2 will be asked to complete a medication diary. Group 2 will also have a 50/50 chance of receiving money for each unused opioid tablet returned to the study clinic.
* Group 3 will be the same as group 2 except in addition, they will be given a coaching session about the use of pain medication and a simple way that may help participants use less opioid pain medication.

Eligibility criteria: Inclusion Criteria:

* Patients suffering from a burn injury of one or both hands/upper extremities
* Patients staying less than 2 midnights after date of injury or presenting for first visit to the clinic 4 or less days after injury
* Patients able to self-administer their oxycodone.
* Aged 18-89 years old

Exclusion Criteria:

* No burns on either hand or upper extremity
* Patients suffering chemical or electrical burns
* Patients with other traumatic injuries for which they might require opioids/pain treatment
* Patients taking opioids prior to injury
* Patients who are discharged with prescriptions other than oxycodone with a dosage of 5 milligrams by mouth every six hours as needed

Primary outcomes:
measure: Mean number of opioid tablets used daily
timeFrame: up through two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: John K Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06552052: A Retrospective and Prospective Natural History of Genetic Vasculopathies
Official title: A Retrospective and Prospective Natural History of Genetic Vasculopathies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multisystemic Smooth Muscle Dysfunction Syndrome
ACTA2
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 29
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who have been diagnosed with a genetic vasculopathy, ACTA2 R179 for example.

Brief summary: This study will combine retrospective review of medical records from patients with ACTA2 and ongoing collection of clinical data using standardized instruments and intervals on an observational basis from patients with ACTA2.

Patients in cohorts 1-3 will be asked to attend clinic visits in person per the schedule of events. At minimum, the medical records of patients with ACTA2 will be reviewed to record data on aspects of the disease, including disease characteristics and developmental milestones. The study is planned to enroll a total of 100 patients: 7 in cohort 1, 7 in cohort 2, and the remaining in cohorts 3 and 4.

This study is planned to study patients for at least 3 years with the option to continue as long as possible for assessment of disease progression. During their continued study participation, as patients age, they may move into the next cohort. Beyond 3 years the duration of the study with be determined by availability of funding from sponsors.


Eligibility criteria: Inclusion Criteria:

* Confirmed ACTA2 pathogenic variant
* Available medical records since birth that permit documentation of disease characteristics and developmental milestone
* Have two parents and/or legal guardians who are English speaking and are able to read, understand, and sign the informed consent
* Able to tolerate travel to study site

Exclusion Criteria:

* Patient does not meet the inclusion criteria
* Patient is currently pregnant

Primary outcomes:
measure: Retrospectively define sequence and timing of vascular and non-vascular symptoms and disease progression
timeFrame: 3 Years
measure: Prospectively assess the rate of change of vascular and non-vascular disease in MSMDS using quantitative measures, patient/caregivers reported outcomes (PROs).
timeFrame: 3 Years
measure: Determine whether remote assessments with wearable technology systems are comparable with quantitative performance measures obtained in Aim 2
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06624852: Clinical Validation of PROPECG-TMT
Official title: Clinical Validation of PROPECG-TMT: Evaluation of Ability of the Artificial Intelligence Model, PROPECG-TMT, to Improve Physician's in Screening Patients Who Needs Coronary Artery Revascularization Based on TMT-ECG.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * At least 100 TMT ECG exams adjudicated as equivocal cases
* 7% of exams are positive (one or more percutaneous coronary interventions or coronary artery bypass surgeries have been performed) and 93% of exams are negative (no percutaneous coronary interventions or coronary artery bypass surgery have been performed)

Brief summary: This clinical validation evaluates the performances of physicians with and without learning with PROPECG-TMT assistance for screening coronary artery revascularization on TMT-ECG.

There are two endpoints used to evaluate performances: Accuracy (primary endpoints with pair specificity/sensitivity, and PPV/NPV), and time needed for screening (secondary endpoints with time measurements in all cases).


Eligibility criteria: Inclusion Criteria:

* TMT ECG exams adjudicated as equivocal cases

Exclusion Criteria:

* Exams not converting to median beat ECG
* Exams not containing interpretable exercise

Primary outcomes:
measure: measurement of screening performances
timeFrame: 1 month
Secondary outcomes:
measure: Time needed for screening all cases
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Biomedicine Systems Informatics, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00444652: Thromboprophylaxis and Bariatric Surgery
Official title: Thromboprophylaxis During Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thromboembolism
Keywords: Thromboprophylaxis
Bariatric surgery
prevention of venous thromboembolism in bariatric surgery
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: French State
name: Sanofi
First posted: 2007-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is an assessment of the efficacy of three thromboprophylaxis regimens in two types of bariatric surgery.

- gastric banding and gastric bypass on anti-Xa activity levels

The study includes two groups of 150 patients scheduled for gastric banding or gastric bypass.

Assessment of anti-Xa levels before and 4 hours after the injections from day 0 to 2 in order to determine the best prophylactic regimen allowing expected values ranged between 0.3 and 0.5 IU / ml.


Eligibility criteria: Inclusion Criteria:

* BMI over 40
* Gastric banding or gastric bypass

Exclusion Criteria:

* Renal insufficiency
* Thrombopenia
* Long term anticoagulant treatment
* Pregnancy
* Allergy to heparin

Primary outcomes:
measure: Anti-Xa activity level measured 4 hours before and after enoxaparin injection at different doses
timeFrame: 48 heures
Secondary outcomes:
measure: Microparticles
timeFrame: day 0, 1, 9,30
measure: Thrombotic events until D30
timeFrame: day 30
measure: Bleeding events
timeFrame: day 30
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinique de l'Orangerie
state: Alsace
city: Strasbourg
country: France
facility: Département d'Anesthésiologie Hôpital Civil
state: Alsace
city: Strasbourg
country: France
facility: Laboratoire d'hémostase Hôpital de Hautepierre
state: Alsace
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive Hopital de Hautepierre
state: Alsace
city: Strasbourg
country: France
facility: Service de Chirurgie Générale et Endocrinienne Hôpital Civil
state: Alsace
city: Nancy
country: France
facility: Département d'Anesthésiologie Hôpital de Brabois
state: Lorraine
city: Nancy
country: France
facility: Laboratoire d'Hémostase Hôpital de Brabois
state: Lorraine
city: Nancy
country: France
facility: Service de Chirurgie Digestive Hôpital de Brabois
state: Lorraine
city: Nantes
country: France
facility: Service de chirurgie générale et digestive,Hôpital Hôtel Dieu
city: Strasbourg
country: France
facility: Centre investigation Clinique Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaire de Strasbourg
name: Annick Steib, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04657952: Sphenopalatine Ganglion Block for Post-Dural Puncture Headache in Orthopedic Patients
Official title: Sphenopalatine Ganglion Block With Adrenaline Additive for Post-Dural Puncture Headache in Orthopedic Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sphenopalatine Ganglion Block
Adrenaline
Post-Dural Puncture Headache
Orthopedic
Randomized Controlled Study
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 60
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 aim of this study is to assess the efficacy, onset and duration of analgesia of sphenopalatine ganglion bock (SPGB) using lidocaine 4% with adrenaline as a treatment of postoperative Post dural puncture headache (PDPH) of orthopedic patients after lower limbs surgeries.


Eligibility criteria: Inclusion Criteria:

* Admitted to the orthopedic department
* Complaining of criteria of severe post-dural puncture headache within 7 days following subarachnoid block used for lower limbs surgeries.
* American Society of Anesthesiologists (ASA) physical status I and II.

Exclusion Criteria:

* Patient refusal or uncooperative.
* Patients with uncontrollable hypertension.
* Patient with known coagulopathy.
* Patient with nasal septal deviation, polyp, history of nasal bleeding.
* Patient with allergy to local anesthetics
* American Society of Anesthesiologists physical status\>2.

Primary outcomes:
measure: Efficacy of analgesia demonstrated by visual analogue scale (VAS) less than 4 (effective) in the first 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Onset of analgesia
timeFrame: 48 hours
measure: Duration of analgesia
timeFrame: 48 hours
measure: Adverse events
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05258552: Efficacy of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis
Official title: Efficacy and Safety of Preoperative Enema in the Prevention of Catheter Dysfunction in Peritoneal Dialysis: A RCT Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peritoneal Dialysis Access Failure
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction.

Detailed description: A prospective, randomized, controlled study was conducted to identify patients with end-stage renal disease who required open peritoneal dialysis catheterization, preoperative enema or no enema was used to evaluate the efficacy and safety of reducing catheter dysfunction. All the patients were divided into two groups: preoperative enema group and no intervention group. The peritoneal dialysis malfuction were observed.

Eligibility criteria: Inclusion Criteria:

* Age ≥18;
* Maintenance peritoneal dialysis treatment is required for end-stage Renal Disease;
* First-time open surgeon peritoneal dialysis catheterization patient;
* Only straight double-cuff Tenckhoff dialysis catheters were used.
* Willing to participate in this study and sign informed consent form.

Exclusion Criteria:

* peritoneal dialysis contraindication;
* Enema contraindication;
* Patients refuse enema;
* Expected survival time \< 3 months;
* Catharsis such as Senna Leaf and lactulose used before operation or colonic dialysis and enema used 3 days before operation.

Primary outcomes:
measure: Incidence of Catheter dysfunction requiring intervention within 3 months of peritoneal dialysis catheterization
timeFrame: 3 months
measure: Time of first peritoneal dialysis catheter dysfunction
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Catheter dysfunction requiring intervention within 6 months of peritoneal dialysis catheterization
timeFrame: 6 months
measure: Catheter survival time
timeFrame: 6 months
measure: Incidence of peritoneal dialysis-associated Peritonitis
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02187952: Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
Official title: Impact of Behavioral Feeding Intervention on Parent-Child Attachment in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric Feeding Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2014-07-11
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the proposed study is to determine whether behavioral feeding intervention impacts mother-child attachment in infants and toddlers with feeding problems. The investigators propose the following hypotheses:

* Behavioral feeding intervention will not significantly impact parent-child attachment.
* Behavioral feeding intervention will not significantly impact parent-child unstructured play interactions.
* Severity of feeding problems will decrease after behavioral feeding intervention is implemented.
* Behavioral feeding intervention will have either no significant effect or a significant positive effect on general child behavior.


Eligibility criteria: Inclusion Criteria:

Caregiver Based

* Mothers
* Conducts feeding intervention ≥75% of the time at home
* Understands and speaks English

Child Based

* 12-14 or 30-48 months old at initial assessment
* Clinically significant feeding problem
* Self-initiates movement
* Can be left alone in a room for 3 minutes
* Capable of initiating eye contact

Primary outcomes:
measure: Change in attachment status
timeFrame: Enrollment, 6 months, 1 year
Secondary outcomes:
measure: Change in infant social and emotional behavior
timeFrame: Enrollment, 6 months, 1 year
measure: Change in child externalizing and internalizing behavior.
timeFrame: Enrollment, 6 months, 1 year
measure: Change in maternal behavior when interacting with her child
timeFrame: Enrollment, 6 months, 1 year
measure: Change in child feeding behavior.
timeFrame: Enrollment, 6 months, 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy K Drayton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03615352: Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation in Ovarian Endometrioma
Official title: Impact of Laparoscopic Ovarian Cystectomy Versus Aspiration and Coagulation on Ovarian Reserve and Pelvic Pain in Cases of Ovarian Endometrioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Endometrioma
Keywords: Endometrioma
laparoscopy
ovarian reserve
pelvic pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 92
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on ovarian reserve and pelvic pain in cases of ovarian endometrioma.

Detailed description: All patients are presenting with ovarian endometrioma. They are all subjected to informed written consent, full history, general examination, local examination and transvaginal ultrasound. Follicular stimulating hormone (FSH), Lutenizing hormone (LH), Anti Mullerian hormone (AMH), Antral follicular count (AFC) and chronic pelvic pain which is assessed by Visual Analogue Scale (VAS) of pain scoring system ,all are to be determined before and after laparoscopic surgery (postoperative three months); for two groups (Group A) cystectomy and (Group B) aspiration and coagulation. Histopathological examination was done to the cystectomy group to confirm endometriosis and detect the presence of healthy ovarian tissue in the excised cyst wall.

Eligibility criteria: Inclusion Criteria:

* Female with age group 20-40 years.
* Female diagnosed by ultrasound with unilateral ovarian endometrioma ≥3cm.

Exclusion Criteria:

* Previous ovarian surgery.
* Endocrinological diseases affecting ovarian reserve e.g. Diabetes mellitus, hypothyroidism.
* Polycystic ovary syndrome (PCO).
* Suspicion of ovarian malignancy by ultrasound.
* Other pelvic pathology e.g. uterine fibroid, pelvic inflammatory disease (PID).
* High basal FSH \>10mIU/mL (milli-international unit per milliliter).

Primary outcomes:
measure: Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Anti Mullerian hormone (AMH) as a measurement of ovarian reserve .
timeFrame: 3 months after laparoscopy
Secondary outcomes:
measure: Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on Antral Follicular Count (AFC) as a measurement of ovarian reserve.
timeFrame: 3 months after laparoscopy
measure: Exploration of the impact of laparoscopic ovarian cystectomy versus aspiration and coagulation on chronic pelvic pain.
timeFrame: 3 months after laparoscopy
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Mohammed Zayed Abd Elaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573452: Galectin-3 and Placenta Accreta
Official title: The Role of Galectin-3 in the Pathogenesis and Prediction of Placenta Accreta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 62
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: Galectins are a family of carbohydrate-binding proteins that have a high affinity to galactosides, its protein portion is located in the nucleus and the cytoplasm with its carbohydrate recognition domain which has high ability to be glycosylated inside or outside the cell.

They are expressed by vascular endothelium, immune cells (macrophages, neutrophils, and mast cells), uterus, placenta, cardiac muscle, liver, epithelium of the gastrointestinal tract, and many other tissues.

Although some galectins have intracellular functions, the majority of them have extracellular activities, which facilitate their contribution to cell adhesion, cell activation, and inflammation. Galectin-3 (Gal-3) is a unique pentamer of the galectins family and it is involved in both physiological functions; cell growth and differentiation, and pathological conditions; inflammation, fibrosis, and metastasis.

Regarding pregnancy, Gal-3 is proved to participate in angiogenesis, embryo developmental processes, and modulation of maternal immunity.


Eligibility criteria: Inclusion Criteria:

1. Pregnant women between 28-32 weeks.
2. Age between 20-40 years.
3. Singleton pregnancy.
4. Women with suspicion of placenta accreta
5. Cases with mild vaginal bleeding or not having any vaginal bleeding.

Exclusion Criteria:

1. Women are known to have any medical disorders.
2. Patients with known bleeding disorders or on anticoagulant therapy.
3. Patients refuse to participate.

Primary outcomes:
measure: Galactin 3 level in the blood
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women Health Hospital - Assiut university
Study officials:
References: