louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01846585: Treatment for Insomnia During Pregnancy
Official title: The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-05-03
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.


Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
* Pregnant with gestational age between 18-32 weeks.
* Adequately fluent in English or Spanish.

Exclusion Criteria:

* Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
* Co-morbid psychiatric disorder
* Use of medications, herbs or other drugs with known effects on sleep
* Unstable medical conditions
* Currently engaged in psychotherapy or other treatments for insomnia

Primary outcomes:
measure: Rate of insomnia remission
timeFrame: Baseline to 30 weeks postpartum
Secondary outcomes:
measure: Insomnia severity
timeFrame: Baseline to 30 weeks postpartum
measure: Depression severity
timeFrame: Baseline to 30 weeks postpartum
measure: Sleep Characteristics
timeFrame: Baseline to 30 weeks postpartum
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Rachel Manber, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: King LS, Rangel E, Simpson N, Tikotzky L, Manber R. Mothers' postpartum sleep disturbance is associated with the ability to sustain sensitivity toward infants. Sleep Med. 2020 Jan;65:74-83. doi: 10.1016/j.sleep.2019.07.017. Epub 2019 Jul 27.
citation: Manber R, Bei B, Simpson N, Asarnow L, Rangel E, Sit A, Lyell D. Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):911-919. doi: 10.1097/AOG.0000000000003216.
Clinical trial NCT00082485: Baclofen for the Treatment of Cocaine Dependence - 1
Official title: Multi-Center Trial of Baclofen for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-05-12
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of baclofen for the treatment of cocaine dependence.

Detailed description: Double-blind, placebo-controlled, parallel design trial of baclofen for the treatment of cocaine dependence

Eligibility criteria: Inclusion Criteria:

* Subject must have DSM-IV diagnosis of cocaine dependence.
* Subject must be seeking treatment for cocaine dependence.
* Be be able to verbalize understanding of consent form, provide written consent and verbalize willingness to complete study procedures.

Exclusion Criteria:

* Please contact site for more information.

Primary outcomes:
measure: Effects of medication on cocaine craving
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hosptial
state: California
city: Torrance
country: United States
facility: Torrance Site
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Baltimore
country: United States
facility: VA Maryland Healthcare System
state: Maryland
city: Philadelphia
country: United States
facility: U of Penn School of Medicine
state: Pennsylvania
city: San Antonio
country: United States
facility: South TX VA Health Care System
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake City VA Medical Center
state: Utah
city: Falls Church
country: United States
facility: Institute of Resch & Educ Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: VA Maryland Health Care System
name: Liza Gorgon, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahn R, Biswas K, Childress AR, Shoptaw S, Fudala PJ, Gorgon L, Montoya I, Collins J, McSherry F, Li SH, Chiang N, Alathari H, Watson D, Liberto J, Beresford T, Stock C, Wallace C, Gruber V, Elkashef A. Multi-center trial of baclofen for abstinence initiation in severe cocaine-dependent individuals. Drug Alcohol Depend. 2009 Jul 1;103(1-2):59-64. doi: 10.1016/j.drugalcdep.2009.03.011. Epub 2009 May 2.
Clinical trial NCT06270485: Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
Official title: Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventilation Therapy; Complications
Congenital Heart Disease
Children, Only
Hemodynamic Instability
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2024-02-21
Enrollment: 58
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children \< 5 years of age with congenital heart disease.

Detailed description: Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used

Eligibility criteria: Inclusion Criteria:

* invasive mechanical ventilation
* congenital heart disease (biventricular anatomy)

Exclusion Criteria:

* univentricular hearts
* ECMO/VAD

Primary outcomes:
measure: Cardiac Output
timeFrame: 1 year
Secondary outcomes:
measure: TAPSE (cm)
timeFrame: 1 year
measure: respiratory mechanics
timeFrame: 1 year
measure: TAPSV (cm/s)
timeFrame: 1year
measure: Global Strain RV (%/sec)
timeFrame: 1year
measure: Lung Compliance (ml/Min/kg)
timeFrame: 1year
measure: Esophageal Pressure (mbar)
timeFrame: 1year
measure: EIT
timeFrame: 1year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: Charité
name: Jan Clausen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644085: Does Low-Dose Aspirin Improve Outcome in In Vitro Fertilisation/Intra Cytoplasmatic Sperm Injection (IVF/ICSI)?
Official title: Does Low-Dose Aspirin Improve Outcome in IVF/ICSI? A Prospective, Randomized, Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Keywords: IVF and ICSI
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-03-26
Enrollment: 201
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effect of daily administration of low-dose aspirin, compared to placebo, on IVF and ICSI outcome.


Eligibility criteria: Inclusion Criteria:

* Dutch-speaking women
* Starting a first or second IVF/ICSI cycle

Exclusion Criteria:

* Women suffering from

  * platelet dysfunction
  * thrombopenia
  * gastro-intestinal ulcers
  * recurrent gastritis
  * aspirin hypersensitivity
* Women on treatment with anticoagulants or aspirin

Primary outcomes:
measure: Number of oocytes retrieved
measure: Clinical pregnancy rate per embryo transfer
Secondary outcomes:
measure: Live birth rate per cycle
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Marc Dhont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dirckx K, Cabri P, Merien A, Galajdova L, Gerris J, Dhont M, De Sutter P. Does low-dose aspirin improve pregnancy rate in IVF/ICSI? A randomized double-blind placebo controlled trial. Hum Reprod. 2009 Apr;24(4):856-60. doi: 10.1093/humrep/den476. Epub 2009 Jan 8.
Clinical trial NCT01122056: Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Official title: Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
b1b-interferon
Fatigue
Exercise
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2010-05-12
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the effects and tolerability of exercise on side effects of injectable disease modifying treatments in multiple sclerosis. The investigators main hypothesis is that controlled exercise is safe and can be well tolerated in patients with multiple sclerosis and it can improve disease modifying treatment related side effects such as fatigue.

Detailed description: Patient compliance with disease modifying treatment largely depends on relatively common side effects of such treatments such as fatigue. Regular exercise can potentially improve these side effects. However, Safety and effects of exercise has not been studied in patients with multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.

Eligibility criteria: Inclusion Criteria:

* Recent diagnosis of relapsing remitting multiple sclerosis on treatment with b1b-interferon disease modifying treatment

Primary outcomes:
measure: Multiple Sclerosis Fatigue
measure: Quality of Life
measure: Injection site visual analog scale (0-10)
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health: University of British Columbia Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Laura Boyd
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Kristen Campbell
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Saul Isserow
role: STUDY_DIRECTOR
References:
Clinical trial NCT01983137: A Non-interventional, Observational Study for Targinact® Treatment in Patients With Severe Pain.
Official title: The Efficacy, With Regard to Pain Relief, of Targinact® Treatment for Patients With Severe Pain Compared to Previous Analgesic Treatment; a Non-interventional Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Pain
Keywords: Chronic pain
Severe pain
oxycodon
naloxon
opioid-induced constipation
opioid
quality of life
laxative
analgesic rescue medication
Lead sponsor: Mundipharma CVA
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 1338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GPs and specialists

Brief summary: This non-interventional, observational study evaluates the efficacy of Targinact with regard to pain relief in daily clinical practice in Belgium compared to the previous analgesic treatment.

Detailed description: Patients are treated with Targinact® according to daily clinical practice and are monitored during 3 study visits. Parameters assessed are efficacy regarding pain relief, efficacy regarding bowel function, pain relief, use of analgesic rescue medication, bowel function, use of laxatives, safety of Targinact treatment, use of concomitant medication, patient satisfaction and quality of life.

Eligibility criteria: Inclusion criteria:

Patients who are to be included in the study, are those who meet all of the following criteria based on the SPC.

1. Male or female patients at least 18 years, or older, with severe pain.
2. Patients with documented history of severe pain treated with WHO step 1, step 2 and/or 3 analgesics with insufficient pain relief and/or unacceptable side effects that require around-the-clock opioid therapy and are likely to benefit from WHO step 3 opioid therapy for the duration of the study.

Exclusion criteria are based on the SPC of Targinact®.

Primary outcomes:
measure: To evaluate the efficacy of Targinact® treatment, with regard to pain relief, in patients with severe pain
timeFrame: Up to 140 days
Secondary outcomes:
measure: Pain NAS score (0-10) will be measured at each visit
timeFrame: Up to 140 days
measure: Bowel Function Index (BFI) will be recorded at each visit
timeFrame: Up to 140 days
measure: The use of laxative medication (yes/no) per 24 hours will be recorded in the e-CRF
timeFrame: Up to 140 days
measure: The use of analgesic rescue medication (yes/no) used per day (24 hours) will be recorded
timeFrame: Up to 140 days
measure: Efficacy of Targinact® treatment, with regard to bowel function, will be evaluated by the physician (7 categories)
timeFrame: Up to 140 days
measure: The patient satisfaction will be evaluated by patient in 7 categories
timeFrame: Up to 140 days
measure: The patient's quality of life will be evaluated via the EQ-5D questionnaire
timeFrame: Up to 140 days
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp (UZA):
Study officials:
References:
Clinical trial NCT03992937: Vaginal Micronized Progesterone Versus Levonorgestrel for Treatment of Non-atypical Endometrial Hyperplasia
Official title: Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Hyperplasia Without Atypia
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.

Detailed description: Vaginal use of micronized progesterone in the treatment of endometrial hyperplasia can result in better than oral administration, as it will remain away from the first pass effect, and depending on the local application. In this study, we aimed to compare this local treatment with Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia.

Eligibility criteria: Inclusion Criteria:

* Premenopausal Patients
* Patients with histologically confirmed endometrial hyperplasia without atypia

Exclusion Criteria:

* Endometrial hyperplasia with atypia
* Endometrial Carcinoma
* Suspected pathology on Physical/Ultrasonographic Examination e.g. fibroids, adnexal abnormality

Primary outcomes:
measure: Regression and remission rate of endometrial hyperplasia
timeFrame: 3 month
Secondary outcomes:
measure: Mean Reduction From Baseline in Menstrual Blood Loss
timeFrame: 6 month
measure: Number of Participants with adverse events associated with medication and device
timeFrame: 6 month
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Şener Gezer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tasci Y, Polat OG, Ozdogan S, Karcaaltincaba D, Seckin L, Erkaya S. Comparison of the efficacy of micronized progesterone and lynestrenol in treatment of simple endometrial hyperplasia without atypia. Arch Gynecol Obstet. 2014 Jul;290(1):83-6. doi: 10.1007/s00404-014-3161-4. Epub 2014 Feb 1.
citation: Mittermeier T, Farrant C, Wise MR. Levonorgestrel-releasing intrauterine system for endometrial hyperplasia. Cochrane Database Syst Rev. 2020 Sep 6;9(9):CD012658. doi: 10.1002/14651858.CD012658.pub2.
Clinical trial NCT01857037: Post-radiation Prostate Cancer Local Recurrences: Detection With Histoscanning™ and MRI
Official title: Detection and Localization of Prostate Cancer Local Recurrences After Radiation Therapy Using Histoscanning™ and Multiparametric MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Recurrent
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Inclusion criteria:

* Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR
* Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)

Study Design:

* Included patients will undergo an endorectal US examination with a Histoscanning™ acquisition and a multiparametric (T2-weighted, diffusion-weighted and dynamic contrast-enhanced) MRI.
* Two independent operators will separately define suspicious focal lesion on Histoscanning™ images and on MR images.
* Random biopsies (at least 2 cores) will be performed in sextants negative at Histoscanning™ and at MRI ; In sextants positive at Histoscanning™ and/or at MRI, targeted biopsies will be performed in the suspicious part of the sextant (at least two cores per suspicious lesion).
* Histoscanning™ and MRI results will be compared to biopsy results.

A total of 30 patients will be included


Eligibility criteria: Inclusion Criteria:

* Patients with biochemical recurrence (Phoenix criteria: PSA nadir + 2 ng/ml) after radiation therapy for prostate cancer addressed for prostate biopsy OR Patients referred to our institution for biopsy-proven local recurrence after radiation therapy for prostate cancer but needing a re-assessment with biopsy (insufficient number of biopsy and/or imprecise location of positive biopsy and/or questionable diagnostic of recurrence)
* IRB-approved informed consent signed

Exclusion Criteria:

* Contraindication to MRI
* Contraindication to endorectal examination
* Contraindication to prostate biopsy
* History of allergy to gadolinium chelates

Primary outcomes:
measure: Evaluation of Histoscanning™ after radiation therapy in comparison to random and targeted biopsy.
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of multiparametric MRI after radiation therapy in comparison to random and targeted biopsy.
timeFrame: 1 day
Other outcomes:
Locations:
city: Lyon
country: France
facility: Prof O. ROUVIERE
state: Rhône
Study officials:
affiliation: Hospices Civiles de Lyon
name: Olivier Rouvière, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031937: Sensory and Psychomotor Profile in Depression
Official title: Sensory and Psychomotor Profile in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
psychomotor assessment
sensory profile
perception
motricity
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Despite a possible psychomotor retardation during a depressive episode, standardized psychomotor assessment is rare. So, other possible psychomotor disorders or neurological "soft signs" are not known in depression.

The investigator propose in this study to explore the psychomotor characteristics of patients with a major depressive disorder from the realization of a psychomotor assessment in comparison with adult without depressive disorder (control). It will be specifically assess muscle tone, gross motor skills, praxis, body schema and the body image and the perceptions.


Eligibility criteria: Inclusion Criteria:

* major depressive disorder according to the DSM-5
* aged to 18 from 65 years old

Exclusion Criteria:

* psychiatric comorbidity (bipolar, addiction, eating disorder, personality disorder, obsessional compulsive disorder)
* antipsychotic drug
* taken care in psychomotor therapy previously
* electroconvulsive therapy
* medical history of neurologic disease, neurodevelopmental disorder, sensory disability
* Constraint Hospitalization
* under legal protection
* pregnant
* lack of consent

Primary outcomes:
measure: % of patients with a distinctive feature at the sensory profile questionnaire from the AASP
timeFrame: At inclusion
measure: % of patients with a failure at the muscle tone test from the NP-MOT battery
timeFrame: At inclusion
measure: % of patients with a failure at the gross motor test from the NP-MOT battery
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
Study officials:
References:
citation: Paquet A, Lacroix A, Calvet B, Girard M. Psychomotor semiology in depression: a standardized clinical psychomotor approach. BMC Psychiatry. 2022 Jul 15;22(1):474. doi: 10.1186/s12888-022-04086-9.