louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04603053: Determining Effectiveness of an mHealth Intervention to Provide Adolescent CBT
Official title: Acceptability and Effectiveness of an mHealth Intervention to Provide Cognitive Behavioral Therapy (CBT) for Adolescents With Depression/Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Depression
Anxiety Disorders
Keywords: Cognitive Behavioral Therapy
mHealth
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Washington University Institute of Clinical and Translational Sciences
First posted: 2020-10-26
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Washington University will evaluate the acceptability and effectiveness of a mobile health (mHealth) intervention to provide cognitive behavioral therapy for adolescents with depression.

Detailed description: In this pilot project, Washington University will start to evaluate CBot-A, a promising mHealth therapeutic intervention designed to deliver cognitive behavioral therapy (CBT) through an app on a phone or other mobile device. The evaluation will include a randomized trial among 40 adolescents diagnosed with depression and/or anxiety and will assess if CBot-A is usable by teens and likely to provide benefit, and acceptable to adolescents.

The primary outcome of depression and anxiety symptoms in adolescents will be assessed at 1 month and 3 months to check for any changes.

Eligibility criteria: Inclusion Criteria:

Adolescents 12-17 years of age and diagnosed with a major depressive disorder (MDD) and/or generalized anxiety disorder by their primary care provider within the past 3 months.

Exclusion Criteria:

Adolescents with the following conditions (identified by parental report) will be excluded:

* Participated in formal CBT within the past 12-months
* Diagnosed with severe depression
* Diagnosed with the following anxiety disorders - obsessive-compulsive disorders, post-traumatic stress disorder, panic disorder, or specific phobias
* A psychiatric hospitalization in the previous month
* With significant comorbidities such that the PCP would refer to a mental health professional for treatment, including those with a substance use disorder or a psychotic illness.
* Are not accompanied by a guardian to the diagnostic visit
* Without access to a mobile device (cell phone or tablet) for regular use
* Unable to read and write English
* Participants may also be excluded at the discretion of the PI.

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 1 month
Secondary outcomes:
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: 1 month
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jane Garbutt, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03270553: A Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin
Official title: A Phase 1, Open Label, Randomized, 2-Period, 2-Treatment, Crossover Study to Assess the Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-center, Phase 1, open label, randomized, two-sequence, two-period, crossover study to evaluate the drug-drug interaction potential between plazomicin and metformin in healthy subjects.


Eligibility criteria: Key Inclusion Criteria:

* Medically healthy, with no clinically significant medical history, physical examination findings, vital signs, or ECG findings

Key Exclusion Criteria:

* Estimated creatinine clearance \<90 mL/min
* Use of tobacco- or nicotine-containing products
* History in the past 90 days of prior trauma to the outer or internal structures of the ear or tinnitus
* History or family history of vestibular disorder, chronic vertigo (sensation of spinning), chronic dizziness
* History of hearing loss or a family history of hearing loss, or a prior diagnosis of sensorineural hearing loss or Ménière's disease

Primary outcomes:
measure: Pharmacokinetics of metformin in plasma
timeFrame: 9 days
Secondary outcomes:
measure: Incidence and severity of adverse events
timeFrame: 15 days
measure: Change from baseline in vital signs post dose (temperature, pulse, respiration, blood pressure)
timeFrame: 8 days
measure: Absolute values of and change from baseline in clinical laboratory values (hematology, serum chemistry, urine analysis)
timeFrame: 9 days
measure: Pharmacokinetics of metformin in urine
timeFrame: 9 days
measure: Pharmacokinetics of plazomicin in plasma
timeFrame: 9 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Site
state: Nebraska
Study officials:
affiliation: Achaogen, Inc.
name: Shyeilla Dhuria
role: STUDY_DIRECTOR
References:
citation: Choi T, Komirenko AS, Riddle V, Kim A, Dhuria SV. No Effect of Plazomicin on the Pharmacokinetics of Metformin in Healthy Subjects. Clin Pharmacol Drug Dev. 2019 Aug;8(6):818-826. doi: 10.1002/cpdd.648. Epub 2019 Jan 3.
Clinical trial NCT05104177: Effectivness of Conservative Techniques in Management of PAS
Official title: Effectivness of Conservative Techniques in Management of PAS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: females in reproductive age

Brief summary: To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity

Detailed description: Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium . Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS . PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality .

Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches .

The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture . Recently, Women's health hospital has adopted a new approach for conservative management of most cases of PAS, including wedge resection of the myometrium over the adherent part of the placenta, or a staged-approach following delivery of the fetus starting with meticulous dissection of the urinary bladder form the lower uterine segment, then bilateral uterine artery ligation at a level below the apparent placenta-myometrial bulge, followed by removal of the placenta, after which a catheter is inserted in the cervix and the placental pouch is closed .

Eligibility criteria: Inclusion Criteria:

1. - Gestational age starting from 28 weeks onwards.
2. - Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)
3. - Elective or emergent Caesarean deliveries

Exclusion Criteria:

* A pre-existing decision of performing intrapartum hysterectomy

Primary outcomes:
measure: number of patients who undergo hysterectomy after failure of conservative techniques
timeFrame: baseline
Secondary outcomes:
measure: recurrence of PAS
timeFrame: baseine
Other outcomes:
Locations:
Study officials:
References:
citation: Jauniaux E, Collins S, Burton GJ. Placenta accreta spectrum: pathophysiology and evidence-based anatomy for prenatal ultrasound imaging. Am J Obstet Gynecol. 2018 Jan;218(1):75-87. doi: 10.1016/j.ajog.2017.05.067. Epub 2017 Jun 24.
Clinical trial NCT01551277: Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity
Official title: Use of Breath Stacking Technique on Regional Ventilation in Box Chest in Women With Morbid Obesity: Clinical Trial Controlled and Randominzado
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbidly Obese
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 32
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To evaluate the effects of the technique of Breath Stacking (BS) in the distribution of ventilation in the chest in women with morbid obesity. Methods: Randomized clinical trial, blinded, and controlled with 32 women (BMI ≥ 40kg/m2), separated into two groups: control (GC) with n = 16 and 41.94 ± 9.38 years and group Breath Stacking (GBS) , n = 16 and 40.38 ± 10.16 years. Optoelectronic plethysmography (POE) was used to assess lung ventilation. For the BS technique was used to mask the expiratory branch occluded and Wright spirometer. GBS held three techniques with an interval of three minutes. The GC used the same circuit without the occlusion of the expiratory branch. Results: GBS was found to be higher in the contribution of tidal volume (VT) into the chest circumference (p = 0.04) and decrease in abdominal compartment (p = 0.03), whereas the CG showed no difference in distribution. Spirometric variables: FEV1 (%), FVC (%), FEV1/FVC (%), VC and CI showed no difference before and after the technical BS and GBS in the GC. Conclusions: The technique BS altered the distribution pattern of regional ventilation, resulting in greater contribution in lung volume in the lower rib cage, corresponding to activity of the diaphragm, with redistribution of volume between compartments.


Eligibility criteria: Inclusion Criteria:

* Women aged 19-60 years
* BMI ≥ 40 kg/m2

Exclusion Criteria:

* Women with chronic lung disease
* Smokers
* Neuromuscular disease
* Disability in performing the procedures

Primary outcomes:
measure: Chest wall regional volume
timeFrame: ten months
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
References:
citation: Cala SJ, Kenyon CM, Ferrigno G, Carnevali P, Aliverti A, Pedotti A, Macklem PT, Rochester DF. Chest wall and lung volume estimation by optical reflectance motion analysis. J Appl Physiol (1985). 1996 Dec;81(6):2680-9. doi: 10.1152/jappl.1996.81.6.2680.
citation: Chlif M, Keochkerian D, Choquet D, Vaidie A, Ahmaidi S. Effects of obesity on breathing pattern, ventilatory neural drive and mechanics. Respir Physiol Neurobiol. 2009 Sep 30;168(3):198-202. doi: 10.1016/j.resp.2009.06.012. Epub 2009 Jun 24.
Clinical trial NCT02422277: Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
Official title: Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Cystoprostatectomy
Sexual function
Phosphodiestrase 5 inhibitors
Low intensity extracorporeal shock wave therapy
Erectile dysfunction
Penile rehabilitation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.

Detailed description: 60 patients for whom nerve sparing radical cystoprostatectomy will be carrried out, penile rehabilitation by using low intensity extracorporeal shock wave therapy will be applied in 20 patients, another 20 patients will receive oral phosphodiestrase type 5 inhibitorrs and 20 patients will not receive any interventions in the control group.

Eligibility criteria: Inclusion Criteria:

- Patients will be eligible if he is sexually motivated and potent men with stable relationship of more than 6 months duration who will undergo nerve sparing radical cysto-prostatectomy for organ-confined bladder cancer.

Exclusion Criteria:

- 1. Men with Peyronie's disease. 2. Inflammation in the shock wave area. 3. Evidence of disease failure after surgery. 4. Patients developing postoperative complications requiring hospital readmission after surgery which interferes with the process of SWL.

5. Unstable medical or psychiatric disorder.

Primary outcomes:
measure: Improvement of sexual function by increase satisfaction and good vaginal penetration
timeFrame: 6 MOTHES
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and Nephrology Center
state: DK
Study officials:
affiliation: a_assmy@yahoo.com
name: Ahmed M. Asmy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04467177: Analgesic Effect of Oral Glucose in Neonates
Official title: Efficacy of Oral Glucose in Pain Alleviation Among Healthy Term Neonates Undergoing Circumcision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 60
Sex: MALE
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Male circumcision is one of the oldest and most common operations performed all over the world. It can be performed at different ages, using different surgical techniques, for different religious, cultural and medical reasons. It was thought that the newborn baby does not experience pain because of incompletely developed nervous system. However, it has been shown that neurological system known to be associated with pain transmission and modulation, is intact and functional.

OBJECTIVE: Our objective is to determine if a 30% glucose solution would reduce pain after circumcision compared with normal saline.

STUDY DESIGN: This is a randomized placebo-controlled double-blinded clinical trial.

POPULATION: We will include full term neonates, who will be recruited from the inpatient nursery at Makassed General Hospital over a 1-year period.

OUTCOME MEASURE: The primary outcome is to assess efficacy of 30% glucose on pain measured using the Neonatal Infant Pain Score.

Secondary outcome is to assess effect of 30% glucose oh physiologic parameters


Eligibility criteria: Inclusion Criteria:

* Estimated gestational age: 37 weeks-42 weeks
* Birth weight: 2500 grams-4000 grams
* Apgar scores a minimum of 7 at 1 and 5 minutes respectively
* Heart rate between 100 and 160 per minutes
* Blood O2 saturation of at least 95%
* No recognized congenital abnormalities

Exclusion Criteria:

* They were transferred to the neonatal intensive care unit (NICU)
* They required respiratory support

Primary outcomes:
measure: Pain score
timeFrame: Pain will be assessed 1 minute before the procedure and during the procedure
Secondary outcomes:
measure: Heart rate
timeFrame: 2 minutes before the procedure, during the procedure and one minute after the procedure
measure: Respiratory rate
timeFrame: 2 minutes before the procedure, during the procedure and one minute after the procedure
measure: Oxygen saturation
timeFrame: 2 minutes before the procedure, during the procedure and one minute after the procedure
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Amal Naous, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03440177: Bariatric Surgery and Pharmacokinetics of Ramipril
Official title: Bariatric Surgery and Pharmacokinetics of Ramipril: BAR-MEDS Ramipril
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Ramipril
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on ramipril.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Ramipril concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090777: Health Coaching for Glaucoma Patients
Official title: Health Coaching for Glaucoma Patients, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will be conducted to examine the feasibility of using a Health Coach for improving the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a coaching intervention and adherence to glaucoma drops will be monitored using a dose-recording device. The dosing data will be analyzed to examine the effect on adherence and qualitative interviews at the conclusion of the study will be used to examine which elements of the coaching experience were most helpful in the glaucoma patient population.

Detailed description: Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.

Eligibility criteria: Inclusion Criteria:

* Adult whose age is \>18 years
* Diagnosed with glaucoma
* Patient of Duke Glaucoma Service
* Prescribed or using topical glaucoma eye medication for at least 6 months
* Primarily self-administering his or her eye drops
* English speaking
* Patient should be able to use the telephone for the coaching intervention,
* Patient should be available by phone to complete the coaching intervention
* Patient should be willing and able to use the MEMS (Medication Event Monitoring System) device for recording medication use
* Patient must be willing and able to come to the Eye Center for an exit interview and to return the MEMS device
* Patient must be able to give consent

Exclusion Criteria:

* Patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period

Primary outcomes:
measure: Glaucoma Medication Adherence
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jullia Rosdahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04031053: Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults
Official title: Assessment of Itraconazole Pharmacokinetic With and Without Efavirenz Using the Capsule Formulation as Part of Talaromycosis Treatment in HIV-infected Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pharmacokinetics
Efavirenz
Penicilliosis
Keywords: Pharmacokinetics
Efavirenz
Penicilliosis
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2019-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected participant who has an evidence of T. marneffei invasive infection will be enrolled to the study.

Brief summary: Talaromycosis continues to be a common opportunistic fungal infection among people living with HIV/AIDS (PLWHA) in Southeast Asia and remains a leading cause of death among this population. Itraconazole (ITZ) is an important component of talaromycosis treatment. In Thailand, the capsule formulation of ITZ is primarily used to treat talaromycosis but it is known to have lower bioavailability than the more expensive solution formulation. Limited data on the drug exposure of ITZ with the capsule formulation are available in adults PLWHA in Thailand. Moreover, the effect of efavirenz (EFV), which has been recommended as the first line antiretroviral therapy in Thailand, to ITZ level is not well understood. Thus, our aim is to assess ITZ pharmacokinetics with and without EFV in adult PLWHA receiving talaromycosis treatment with the capsule formulation. An understanding of the relationship between ITZ drug exposure and its active metabolite (hydroxyl-itraconazole) and treatment response is also planned to help optimize therapy.


Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Available documentation of HIV infection
3. ITZ capsule therapy is indicated for talaromycosis infection with the anticipation to start on EFV-based ART
4. Willing to consent and compliance to the study protocol

Exclusion Criteria:

1. History of ITZ allergy
2. Pregnancy or lactation
3. Use concurrent medication that could interfere with ITZ level
4. Creatinine clearance less than 30 mL/min
5. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) value is more than 5 times of upper normal limit and total bilirubin is more than 3 times above upper normal limit
6. Hemoglobin less than 7 mg/dL
7. History of ITZ exposure within 35 days (only applicable to intense PK group)

Primary outcomes:
measure: Itraconazole and its metabolites level
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Hospital
Study officials:
affiliation: Chiang Mai University
name: Quanhathai Kaewpoowat, MD
role: PRINCIPAL_INVESTIGATOR
References: