louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05006170: Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
Official title: Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pediatric HIV Infection
Keywords: dolutegravir dispersible tablet
pharmacokinetics
weight below 20 kg
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)

Detailed description: After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC.

Eligibility criteria: Inclusion Criteria:

* Children living with HIV weighing 6 to below 20 kg
* Naïve to integrase inhibitors

Exclusion criteria:

* Currently active opportunistic infection
* Liver dysfunction (SGPT below 100 IU/mL)
* Renal dysfunction (GFR below 60 mL/min)
* Currently using medication that interacts with DTG

Primary outcomes:
measure: Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection
timeFrame: At 7-14 day after started on DTG
Secondary outcomes:
measure: Serious adverse event incidence
timeFrame: 24 week after medication switched
measure: Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies
timeFrame: 24 week after medication switched
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Study officials:
affiliation: Chulalongkorn University
name: Athiporn Premgamone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Thanyawee Puthanakit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06059170: Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
Official title: Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Low Anterior Resection Syndrome
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cross sectional study
Primary purpose: SUPPORTIVE_CARE

Brief summary: Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS

Detailed description: Quality of life and risk factors for developing major LARS are explored using the EORTC QLQ C30. Therapeutic options were explored in the cohort experiencing major LARS

Eligibility criteria: Inclusion Criteria:

* low anterior resection for rectal cancer between 2006-2016
* Adults

Exclusion Criteria:

* abdomino perineal resection
* patients who do not understand Dutch

Primary outcomes:
measure: Assessment QoL
timeFrame: up to 10 years after rectal resection
measure: frequencies of therapeutic options to manage LARS
timeFrame: up to 10 years after rectal resection
measure: Frequency of LARS
timeFrame: up to 10 years after rectal resection
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University hospital Ghent
state: Oost-Vlaanderen
Study officials:
affiliation: University Hospital, Ghent
name: Piet pattyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04174170: Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Official title: A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-22
Enrollment: 591
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
* Participants who have post-traumatic stress disorder (PTSD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
* Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.

Exclusion Criteria:

* The index traumatic event that led to the development of PTSD took place \> 9 years before screening.
* The index traumatic event occurred before age 16.
* Participants who have experienced a traumatic event within 3 months of screening.
* Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

Primary outcomes:
measure: Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
timeFrame: Baseline (Week 1), Week 10
Secondary outcomes:
measure: Change in Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Baseline (Week 1), Week 10
measure: Change in Brief Inventory of Psychosocial Functions (B-IPF) Score
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: New York
Study officials:
References:
Clinical trial NCT02590770: Gaze Contingent Feedback in Social Anxiety Disorder
Official title: Gaze Contingent Feedback in Treatment of SAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phobia, Social
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 40
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 purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)

Detailed description: The study examines giving social anxious participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.

Eligibility criteria: Inclusion Criteria:

* A signed consent form
* Men and women between the ages of 18 and 60.
* Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
* A minimum of a 1-year duration of SP
* SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
* Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.

Exclusion Criteria:

* Psychotic episode in the past or the present time.
* Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
* Another psychotherapeutic treatment during the study.
* Usage of neuroleptic medication.
* Change in medication status during the study.
* Substantial usage of drugs or alcohol in the present time.
* Poor judgment capacity (i.e., children under 18 and special populations).

Primary outcomes:
measure: Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
timeFrame: post treatment (1 week after treatment completion) and 3-month follow up
Secondary outcomes:
measure: Change from baseline - the Social Phobia Inventory scores
timeFrame: post treatment (1 week after treatment completion) and 3-month follow up
Other outcomes:
measure: changes in the Mini-International Neuropsychiatric Interview (M.I.N.I) diagnosis
timeFrame: post treatment (1 week after treatment completion)
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazarov A, Pine DS, Bar-Haim Y. Gaze-Contingent Music Reward Therapy for Social Anxiety Disorder: A Randomized Controlled Trial. Am J Psychiatry. 2017 Jul 1;174(7):649-656. doi: 10.1176/appi.ajp.2016.16080894. Epub 2017 Jan 20.
Clinical trial NCT01762670: GoldenCareTM for the Treatment of Bacterial Vaginosis
Official title: An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Bacterial Vaginosis
Keywords: Bacterial Vaginosis
BV
Lead sponsor: CDA Research Group, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-08
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.

Detailed description: GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis(BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Female aged 18 years or older
* Subject has clinical bacterial Vaginosis with 4 of 4 positive Amsel's criteria
* Negative pregnancy test
* For 7 day treatment period, subject agrees to refrain from using douches and intravaginal products (i.e. feminine deodorant sprays, spermicides, Nonoxynol-9 products, tampons, and condoms). Subject also agrees to refrain from taking oral or intravaginal antibiotics (unless enrolled in comparator arm),or antifungal agents during the entire study period.

Exclusion Criteria:

* Subject has another infectious or noninfectious cause of vulvovaginitis such asymptomatic candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, human papilloma virus, atrophic vaginitis, lichen sclerosus, or genital warts.

Primary outcomes:
measure: Safety and efficacy of treating BV with GoldenCare for 7 days
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Harper University Hospital Department of Infectious Diseases
state: Michigan
city: Philadelphia
country: United States
facility: Temple University Hospital Department of OB/GYN
state: Pennsylvania
Study officials:
affiliation: Temple University Hospital Department of OB/GYN
name: Ashwin Chatwani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558570: Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin
Official title: Intracellular Tight Junction Permeability in Schizophrenia: Focus on Zonulin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Celiac Disease
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Maryland, College Park
First posted: 2012-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with schizophrenia will be recruited by MPRC through their patient recruiting network including the Treatment Research Program and the Outpatient Research Program and affiliated sites. Patient with schizophrenia may also be recruited through the NIDA screening protocol process. (UMB approved IRB protocol HP-00043664)

Brief summary: The purpose of this protocol is to collect serum zonulin levels in people with schizophrenia. This one time visit will collect zonulin levels, antibodies to gliadin (tissue transglutaminase and antigliadin antibodies) and other information that may relate to increased intracellular tight junction permeability as it related to the immune and stress system and the immune association with kynurenic acid pathway 50. Data will be collected for use in future grant applications and published reports.


Eligibility criteria: Inclusion Criteria:

* DSM-IV Diagnosis of Schizophrenia or Schizoaffective Disorder
* Male or females between ages of 18 to 75 years

Exclusion Criteria:

* Score below 10/12 on the Evaluation to Sign Consent (ESC)

Primary outcomes:
measure: Zonulin concentration in serum (ng/mg)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Deanna L. Kelly, Pharm.D., BCPP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06202170: Validity and Reliability of 30SFPW Test Patients With TKA
Official title: The Validity and Reliability of the 30-Second Fast-Paced Walk Test in Patients With Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Total knee arthroplasty, knee, 30-Second Fast-Paced Walk Test, validity, reliability.
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who had primary TKA surgery at least six months ago

Brief summary: Walking speed after total knee arthroplasty (TKA) can be used as a simple tool to monitor postoperative recovery. There are different protocols for gait assessment in patients with TKA. The 30 Second Fast Walk Test (30SFW) is a simple, low-cost and easy-to-apply assessment method that requires very little equipment in clinical settings. 30SFW is a reliable, valid test of walking ability in patients with knee osteoarthritis (OA).

Objective: To investigate the reliability and validity of the 30SFW test in the evaluation of gait in patients with TKA.


Eligibility criteria: Inclusion Criteria:patients who had primary TKA surgery at least six months ago, being diagnosed with preoperative knee OA, and volunteering to participate in the research -

Exclusion Criteria:had a previous orthopedic, neurological, or systemic disease that effects walking or standing, body mass index of 40 kg / m2 and over, having any other surgery on the same limb that effect walking, and revision TKA.

-

Primary outcomes:
measure: 30SFPWT
timeFrame: 1 Hour-30 Seconds
Secondary outcomes:
measure: Hss Knee Socre
timeFrame: 15 minutes
measure: SF-12 Quality Life Score
timeFrame: 15 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT00799370: Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)
Official title: Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Osteotomy
Weight bearing
Opening wedge
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category.

The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.


Eligibility criteria: Inclusion Criteria:

* age: 40 to 65 years old
* patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication
* one sided indication
* well understanding of information note by patient, non-opposition to perform the research
* Affiliation to a national health insurance program

Exclusion Criteria:

* age \< 40 or \> 65 years old
* medial osteoarthritis of knee of level superior to 2
* bilatéral indication
* patient opposition
* non affiliation to a national health insurance program
* law protected patients
* pregnancy and breast feeding

Primary outcomes:
measure: IKS score
timeFrame: one year follow-up
Secondary outcomes:
measure: IKS score
timeFrame: 6 months follow-up
measure: VAS score of pain
timeFrame: at D1, D5, D15, M1, M2, M3, M6 and one year follow-up
measure: IKDC (International Knee Documentation Committee) score
timeFrame: at M2, M, M6 and one year follow-up
measure: Safety follow-up
timeFrame: during the one year follow-up
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Elvire SERVIEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lansdaal JR, Mouton T, Wascher DC, Demey G, Lustig S, Neyret P, Servien E. Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12):3670-3678. doi: 10.1007/s00167-016-4225-8. Epub 2016 Jul 1.
Clinical trial NCT04548570: Closure vs Non Closure of Rectus Muscle at Cesarean Section 5 Year Study
Official title: Closure vs Non Closure of Rectus Muscle at Cesarean Section Reducing Post Cesarean Adhesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraperitoneal Adhesions After Rectus Muscles Approximation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who will subjected to cesarean section with history of previous cesarean section in the same hospital with operative notes and techniques

Brief summary: approximation of both recti during lower segment cesarean section may be an important step to lower incidence of intraabdominal adhesions . peritoneal adhesions are of major medical importance and are associated with clinical problems such as chronic pain and infertility.

Detailed description: all patients included in the study should be had the operative history of the previous cesarean section and were done in the cairo university and divid them into 2 groups. 1st group were both recti approximated while the second group were closed without approximating both recti. all patients will be subjected to lower segment cesarean segment to assess the intraperitoneal adhesions, mean operative time, mean hospital stay, postoperative distension, bowel sounds, postoperative infections and morbidity

Eligibility criteria: Inclusion Criteria:

* all patients of first lower segment cs at kasr al ainy with previous recorded data including operative data, postoperative data including complications. all patients included in the study are elective cesarean section at 38 weeks of gestation

Exclusion Criteria:

* no history of infection or medical disease
* no history of previous laparotomies
* no history of pregnancy complications
* patients noted to have intraperitoneal adhesions in first cesarean section

Primary outcomes:
measure: assessment of the intraperitoneal adhesions post rectus muscle closure
timeFrame: intraoperative
Secondary outcomes:
measure: mean operative time
timeFrame: intraopertive time
measure: mean hospital stay
timeFrame: posoperative within first 48 hrs
measure: mean postoperative bowel sounds
timeFrame: posoperative within 24 hrs
measure: postoperative distension
timeFrame: posoperative within 24 hrs
measure: postoperative morbidity and infections
timeFrame: posoperative within 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: