louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00272025: Treatment Resistant Bipolar Depression
Official title: Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bipolar Depression
Keywords: Bipolar Depression
Escitalopram
Mood Stabilizer
Atypical Antipsychotic
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if adding Escitalopram to current mood stabilizer (MS) or atypical antipsychotic (AA) will improve in rates similar to or better than adding a placebo (inactive pill)in resistant bipolar patients.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosis of Bipolar Disorder and currently be in depressive state, and not responded to mood stabilizer or atypical antipsychotic alone or combined with an antidepressant medication.

Exclusion Criteria:

* Pregnant or breastfeeding
* History of seizure disorder or other unstable medical condition
* Received Electroconvulsive Therapy or Transcranial Magnetic Stimulation in the last three months
* Experienced hallucinations or delusions

Primary outcomes:
measure: To evaluate the response rates when Escitalopram vs. placeboes added to the current mood stabilizer or antipsychotic medication
timeFrame: 6 weeks
Secondary outcomes:
measure: To evaluate efficacy, safety and tolerability of added Escitalopram, to a mood stabilizer or atypical antipsychotic.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Providence Care, Mental Health Services
state: Ontario
Study officials:
affiliation: Queen's University
name: Roumen V. Milev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05498025: The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
Official title: The Effect of a Charcoal Deactivation Pouch on Opioid Disposal After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Opioid Misuse
Obstetric Pain
Cesarean Section Complications
Keywords: opioid disposal
drug deactivation
Deterra
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective single arm interventional pilot study.
Primary purpose: PREVENTION

Brief summary: Background: There is scarce literature investigating how patients dispose of unused opioid supplies after their cesarean postoperative pain has faded. The Office of the Surgeon General has identified research on the prevention of opioid use disorder area as well as research on the management of pain as a "Surgeon General Priority" that needs urgent investigation.

Hypothesis: At least 33% of postpartum women discharged home with an opioid prescription and a drug deactivation pouch will use the pouch to dispose of remaining opioids within 30 days of delivery.

Methods: This is a prospective single arm interventional pilot study.


Eligibility criteria: Inclusion criteria:

* Age 18+ at time of enrollment, per ERM
* Delivered ≥26.0 weeks, per ERM
* Status post low transverse cesarean delivery, per ERM
* Physically located on labor \& delivery and is postpartum day #1 or #2 at time of enrollment, per ERM
* Opioid prescription has been sent (per ERM) or will be sent (per obstetric team).

Exclusion criteria:

* Positive urine toxicology anytime in pregnancy for non-prescription opioids, fentanyl, amphetamines, benzodiazepines, cannabinoids, LSD, or cocaine, per ERM.
* Buprenorphine or methadone Rx, per ERM
* Patient preferred communication language not English, per ERM
* Documented history, per ERM:

  * Cannabinoid use disorder
  * Hypnotic use disorder
  * Opioid use disorder
  * Stimulant use disorder
  * Fibromyalgia
  * Sickle cell anemia
  * Lumbar disc herniation
  * Multiple sclerosis
  * Trigeminal neuralgia
  * Active cancer
  * Complex regional pain syndrome
  * Systemic lupus erythematosus
  * Rheumatoid arthritis

Primary outcomes:
measure: Actual pouch use
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Michael J Paglia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285125: High Resolution Imaging for Analysis of MVNT
Official title: High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Neuronal Desease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-02-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspicion of MVNT during a first exploratory MRI.

Brief summary: MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown.

It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR.

The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion.

The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Prospective inclusion of all patients with suspected MVNT on a first exploratory MRI: at least the 2 major criteria associated with at least 1 minor criterion will be required to fit into the definition of suspected MVNT:

  * Major criteria :

    * Multinomodular clustered appearance
    * Franc hypersignal FLAIR/T2
  * Minor criteria :

    * No mass effect
    * Hyposignal T1
* Having received informed information about the study and having given express consent to participate in the study

Exclusion Criteria:

* Contraindication to MRI
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman

Secondary exclusion criteria:

- No characterization MRI done

Primary outcomes:
measure: Comparison of the proportion of patients with a central T2 / FLAIR hyposignal visible on standard sequences and on ultra-high resolution sequences.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Paris
country: France
facility: Fondation A De Rothschild
city: Pierre Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Herblain
country: France
facility: Hôpital Laennec
city: Toulouse
country: France
facility: Hôpital Pierre Paul Riquet, CHU Purpan
Study officials:
References:
Clinical trial NCT04083625: the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy
Official title: the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Myomectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 138
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy


Eligibility criteria: Inclusion Criteria:

* • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

  * Age ≥ 25 years and ≤ 50 years
  * Pre-operative hemoglobin \>10 g/dl
  * Ability to understand and the willingness to sign a written informed consent.
  * Admissible medical/surgical history
  * Five or less symptomatic uterine myomas
  * symptomatic stage 3 to 6 fibroids, according to FIGO staging

Exclusion Criteria:

* • Post-menopausal women

  * Patients with known bleeding/clotting disorders
  * Patients with a history of gynecologic malignancy
  * Hypertension.
  * Cardiac and Pulmonary diseases.
  * History of allergic reactions attributed to carbetocin

Primary outcomes:
measure: Mean amount of intraoperative blood loss
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Giza hospital
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.
Clinical trial NCT04721925: A Social Media Intervention for Risky Drinking
Official title: A Social Media Intervention for High-intensity Drinking in a National Sample of Emerging Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drinking Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-01-25
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is being completed to pilot prevention methods to promote wellness and reduce risky behaviors, including the use of substances such as alcohol and other drugs. This study will help the study team learn about ways of delivering this information that is both appealing and helpful to young adults.


Eligibility criteria: Inclusion Criteria:

* Reside in the United States of America (USA)
* Be able to read English, view, and click on a social media advertisement.
* Self-reported past-month high-intensity drinking (HID)
* Regular Snapchat use (at least 3 days/week).

Exclusion Criteria:

* If they fail identity verification based on: 1) internet protocol address (IP), 2) survey time completion, 3) repeat attempts, and 4) survey responses.

Primary outcomes:
measure: Intervention Acceptability
timeFrame: 2 months
measure: Feasibility of the Intervention (Engagement)
timeFrame: During the 8 week intervention delivery period
measure: Feasibility of the Intervention (Completion)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Erin Bonar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04432025: Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
Official title: Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: obesity
type 2 diabetes
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated to the control arm (bariatric surgery- either RYGB or SG) or intervention (bariatric surgery- either RYGB or SG + goal directed medical therapy for t2DM)
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the continued usage of standard diabetes medications in the post operative period following bariatric surgery to determine whether this approach may improve long term diabetes control. At present, the standard of treatment in patients with type 2 diabetes is that all medication is stopped in the immediate postoperative period and only re-started if symptoms of diabetes re-emerge. Although a large proportion of patients with diabetes will initially go in to remission, 80% experience relapse within five years. This study is needed to determine whether continuing medications is not only safe but will improve long term outcomes for patients with diabetes.


Eligibility criteria: Inclusion Criteria:

* eligible for bariatric surgery according to NICE guidelines (GC 189)
* Type 2 diabetes mellitus
* BMI \>30kg/m2

Exclusion Criteria:

* Recent hospitalisation in the past 30 days
* Recurrent hypoglycaemic episodes
* Recurrent hypotensive episodes
* Contraindications to bariatric surgery
* Previous bariatric surgery
* Current pregnancy
* Breastfeeding

Primary outcomes:
measure: Proportion of patients in each group reaching the composite end point
timeFrame: 5 years
measure: Proportion of patients reaching end point for glycemic control
timeFrame: 1 year
Secondary outcomes:
measure: Change in body weight
timeFrame: 5 years
measure: Change in BMI
timeFrame: 5 years
measure: Change in waist circumference
timeFrame: 5 years
measure: Change in lipid control
timeFrame: 5 years
measure: Change in glycaemic control
timeFrame: 5 years
measure: Change in blood pressure
timeFrame: 5 years
measure: Change in liver function
timeFrame: 5 years
measure: Change in renal function
timeFrame: 5 years
measure: Change in inflammatory markers
timeFrame: 5 years
measure: Change in urine albumin: creatinine ratio
timeFrame: 5 years
measure: Change in quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
References:
citation: Sudlow A, Miras AD, Cohen RV, Kahal H, Townley J, Heneghan H, Le Roux C, Pournaras DJ. Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study. BMJ Open. 2022 Jul 25;12(7):e054313. doi: 10.1136/bmjopen-2021-054313.
Clinical trial NCT02522325: Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
Official title: Behavioral Effects of Drugs (Inpatient): 31 (Cocaine and Phendimetrazine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which the subjective, physiological and reinforcing effects of cocaine are evaluated during maintenance on placebo and phendimetrazine.


Eligibility criteria: Inclusion Criteria:

* Recent cocaine use

Exclusion Criteria:

* Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
* Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
* Females not currently using effective birth control
* Contraindications to cocaine or phendimetrazine

Primary outcomes:
measure: Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
timeFrame: After at least seven days of maintenance placebo or target phendimetrazine dose
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Department of Behavioral Science
state: Kentucky
Study officials:
References:
Clinical trial NCT05435625: Fractional Laser Versus Radiofrequency in Androgenetic Alopecia
Official title: Fractional Microneedling Radiofrequency Versus Fractional Carbon Dioxide Laser in Combination With Minoxidil for the Treatment of Androgenetic Alopecia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Androgenic Alopecia
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 30
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: Patients with Androgenetic alopecia will be randomized into 2 groups; Group FCO2 receiving Fractional CO2 or Group FRF receiving Fractional Microneedling Radiofrequency.

Detailed description: Group FCO2 will be to receiving fractional CO2 to one randomized side of the scalp, and Group FRF will be receiving Fractional Microneedling radiofrequency to one randomized side of the scalp.

All patients will receive 4 sessions with 4-week intervals.each session will be followed by immediate topical application of 6 puffs (=1 mL) of minoxidil 5% solution twice daily and also in between the sessions and during follow up period

Eligibility criteria: Inclusion Criteria:

* • both genders are included.

  * Patients above 18 years old.

Exclusion Criteria:

* • Patients with patchy hair loss.

  * Patients with Telogen Effluvium or diffuse alopecia areata.
  * Patients with cicatricial alopecias.
  * Patients with associated inflammatory scalp disorders such as psoriasis or seborrheic dermatitis.
  * Patients with collagen vascular disorders.
  * Prior use of topical steroids on scalp in the previous 2 weeks.
  * Prior use of systemic steroids in the previous 1 month.

Primary outcomes:
measure: Clinical Global improvement Assessment
timeFrame: 6months-1 year
measure: Clinical Global improvement Assessment
timeFrame: 6months-1 year
measure: Phototrichogram assessment.
timeFrame: months-1 year
measure: Phototrichogram assessment.
timeFrame: 2 months
measure: Patient satisfaction
timeFrame: 6months-1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy Hospital
state: El Manial
Study officials:
References:
Clinical trial NCT01613625: Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies
Official title: Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: RENAL FIBROSIS
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 106
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.


Eligibility criteria: Inclusion Criteria:

* Male children or feminine from 5 to 18 years old to whom is indicated a renal biopsy by the néphrologue paediatrician whatever is the initial pathology, whatever are one or several current or previous treatments and whatever is their associated comorbidity

Exclusion Criteria:

* Children of less than 5 years old or more than 18 years
* Children for whom a draining renal biopsy is not or more indicated by néphrologues
* Refusal or withdrawal of the consent lit by the holders of the exercise of the parental authority or by the child if he is capable of receiving the information
* Contraindication in the realization of a draining renal biopsy (current infection, disorder of the coagulation.)

Primary outcomes:
measure: the elastography
timeFrame: 30 months
Secondary outcomes:
measure: The dosage of the créatininémie
timeFrame: 30 months
measure: the debit of filtration glomérulaire at the child
timeFrame: 30 MONTHS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: alix RUOCCO
role: PRINCIPAL_INVESTIGATOR
References: