louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03794648: The Effectiveness of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Adherence to HIV Medication
Official title: The Feasibility and Preliminary Efficacy of a Mobile Interactive Supervised Therapy (MIST) Intervention for Improving Medication Adherence of Patients With HIV Infection: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-infection/Aids
Keywords: mobile app
HIV-infections
medication adherence
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A total of 40 HIV infected patients will be randomly assigned into intervention or control group. Participants in the intervention group will use an smart phone application for two months. Participants will receive reminder notifications and use the app to take and send videos of themselves taking the pill(s), uploaded videos will be centrally reviewed by a study nurse . Control group participants will receive standard care. Antiretroviral Therapy adherence will be measured by self-report, pill count, and smart bottle as well as the App. Participants' perceptions of app using experience will be recorded via face to face interview.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 21
* HIV infection diagnosis confirmed by western blot
* Taking a once daily regimen of HIV medications
* Able to take pills orally
* Willing and able to give informed consent

Exclusion Criteria:

* Inability to operate a smart phone
* Active Tuberculosis infection requiring treatment during study (due to additional challenge posed to adherence that may confound the assessment of HIV adherence)
* Substance use
* Visual or hearing impairment
* Cognitive impairment

Primary outcomes:
measure: Change from one month percentage ART adherence at two months (by MEMScap)
timeFrame: one-month follow-up and two-month follow-up visits
Secondary outcomes:
measure: Percentage ART adherence (self-reported)
timeFrame: Baseline visit, one-month follow-up visit and two-month follow-up visits (end of study visit)
measure: Percentage ART adherence (by pill count)
timeFrame: One-month follow-up visit, two-month follow-up visit(end of study visit)
measure: Variability in time (minutes) between prescribed pill time and actual dose taken
timeFrame: One-month follow-up visit, two-month follow-up visit(end of study visit)
measure: Participants' perceptions on using MIST intervention
timeFrame: two-month follow-up visit (end of the study visit)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: Pang Y, Molton JS, Ooi WT, Paton NI, He HG. Preliminary Effects of a Mobile Interactive Supervised Therapy Intervention on People Living With HIV: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Mar 27;8(3):e15702. doi: 10.2196/15702.
Clinical trial NCT06420648: Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair
Official title: A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flexor Tendon Rupture
Lead sponsor: University of Hail
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand

Detailed description: a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature.

Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

Eligibility criteria: Inclusion Criteria:

* males or females
* between 25-50 years
* Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit
* the case should be recent (2-3 days post-surgical)

Exclusion Criteria:

* age below 25 or above 50
* a systemic disease affecting hand joints such as rheumatic arthritis
* thumb flexor tendon repair will be excluded
* chronic cases
* concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss

Primary outcomes:
measure: Total active motion (TAM)
timeFrame: at baseline
measure: Total active motion (TAM)
timeFrame: after the 12th week of intervention
measure: handgrip strength
timeFrame: baseline
measure: handgrip strength
timeFrame: after the 12th week of intervention
measure: Functional disability
timeFrame: at baseline
measure: Functional disability
timeFrame: after the 12th week of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Hail University Poly Clinic
city: Hail
country: Saudi Arabia
facility: Hisham Hussein
Study officials:
References:
Clinical trial NCT06399848: Peritoneal Dialysis Daily Versus Six Days Per Week
Official title: Peritoneal Dialysis Daily Versus Six Days Per Week
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peritoneal Dialysis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study will enroll patients receiving daily peritoneal dialysis who have significant residual native kidney function. The investiators will visit the patients at a routinely scheduled clinic visit and again at a non-routine visit after the patients skip a single day of dialysis. Blood samples will be obtained and a quality of life questionnaire will be administered at both visits.

The primary aim will be to determine whether the patients would prefer daily treatment or being allowed to skip one day per week.

Other aims will be to determine the effect of skipping a day on plasma levels of urea nitrogen and creatinine.

Detailed description: The patients' preference will be assessed by asking the simple question would you prefer to perform peritoneal dialysis daily of six days per week.

The quality of life questionnaire to be used will be the Dialysis Symptom Index (DSI) which has a range of 0 to 150 with a high score reflecting worse quality of life.

The chemical to be measured will be the plasma urea nitrogen in mg/dl and the plasma creatinine in mg/dl as measured by the clinical laboratory.

Eligibility criteria: Inclusion Criteria:

* Daily treament with peritoneal dialysis and residual native kidney funciton with residual urea clearance greater than 2 ml/min.

Exclusion Criteria:

* less than 3 months on peritoneal dialysis
* recent change in the dialysis prescriptoin
* recent peritonitis

Primary outcomes:
measure: Patient's preference for treatment regimen
timeFrame: Two weeks per patient
Secondary outcomes:
measure: Symptoms
timeFrame: Two weeks per patient
measure: Plasma solute levels
timeFrame: Two weeks per patient
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06126848: Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation
Official title: Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation: A Potential Role for Ambient Sensor Systems in the Patients Home
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Kantonsspital Olten
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 24
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Digital biomarkers extracted by ambient sensor signals are a promising tool for early detection of health deterioration in the setting of remote patient management of heart failure patients.The primary objective of the study is to evaluate new digital biomarkers as predictors of impending heart failure decompensation.

Secondary objectives are (1) outcome assessment (re-hospitalizations, cardiovascular death, all-cause death), (2) quality of life and (3) System User Satisfaction (SUS)


Eligibility criteria: Inclusion Criteria:

* admitted to hospital for worsening HF
* age ≥ 70 years
* LVEF \< 50% and need of diuretics
* NYHA II or III
* living alone
* willing to participate with informed consent.

Exclusion Criteria:

* Major depression (PHQ 9-score \>9)
* being on hemodialysis
* had been admitted to hospital for any reason within 7 days before HF decompensation.
* patients with a left ventricular assist device
* coronary revascularization or cardiac resynchronization therapy implantation within 28 days before the index event of HF decompensation or have been scheduled for such interventions.

Primary outcomes:
measure: Sensitivity and specificity of ambient sensor derived digital biomarkers
timeFrame: 6 months
Secondary outcomes:
measure: Outcome assessment
timeFrame: 6 months
measure: Quality of life (heart failure symptoms) - KCCQ
timeFrame: 6 months
measure: System Usability Scale (SUS)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02021448: Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
Official title: Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity-hypoventilation Syndrome
Nocturnal Alveolar Hypoventilation
Keywords: OHS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects


Eligibility criteria: Inclusion criteria:

* Obese volunteer Subject (BMI\> 30 kg/m2)
* Adults of either sex
* Social security affiliation
* Written informed consent

Exclusion criteria:

* Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2\> 45mmHg
* Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery ...
* Obstructive ventilatory defect with FEV1/ FVC \<70% post-bronchodilator
* Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure
* Any serious illness involving life-threatening within 3 years after inclusion
* Drug or alcohol abuse
* Pregnancy

Primary outcomes:
measure: Occurrence of obesity-hypoventilation syndrome
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Cannes
country: France
facility: CH Cannes
city: Grenoble
country: France
facility: CHU Grenoble
city: Reims
country: France
facility: CHU Reims
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: KESSLER Romain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02476448: Evaluation of Ureteral Jets on Cystoscopy
Official title: Evaluation of Ureteral Jets on Cystoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Ureter
Keywords: ureteral jet
pelvic surgery
cystoscopy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2015-06-19
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy.

Detailed description: This study proposes to test and compare the surgeon's impression/confidence in identifying ureteral jets using 3 other methods in contrast to standard diagnostic cystoscopy: 1) cystoscopy with Dextrose 10% solution, 2) cystoscopy with phenazopyridine and 3) IV sodium fluorescein 4) standard cystoscopy with saline.

Eligibility criteria: Inclusion Criteria:

* adult
* undergoing a cystoscopy or as part of their planned procedure

Exclusion Criteria:

* Chronic kidney disease
* known prior surgical removal of kidney or ureteral obstruction
* Current ureteral stent placed
* Allergy to any of the interventions

Primary outcomes:
measure: Ureteral Jet Visibility
timeFrame: 5 minutes
Secondary outcomes:
measure: Surgeon Satisfaction
timeFrame: 5 mins
Other outcomes:
measure: Number of Participants With Urinary Tract Infections
timeFrame: 6 weeks
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Guillermo Davila, MD
role: STUDY_CHAIR
affiliation: Cleveland Clinic Florida
name: Alexandriah Alas, MD
role: STUDY_DIRECTOR
affiliation: Cleveland Clinic Florida
name: Luis M Espaillat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Florida
name: Eric A Hurtado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA. Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1378-1383. doi: 10.1097/AOG.0000000000001750.
Clinical trial NCT04612348: Gastric Ultrasound in Tube Fed Intubated Patients
Official title: Utility of POC Gastric Ultrasound in Confirming Stomach is Empty in Intubated Patients Fed Gastrically (NG) Versus Transpylorically (NJ) to Ensure Low Risk of Aspiration.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Critical Illness
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill children at Nationwide Children's Hospital

Brief summary: This study will use point of care (POC) gastric ultrasound to confirm that nasojejunal tube (NJ) feeds result in minimal to no gastric content and therefore are low risk for aspiration and should be allowed at the very least to decrease the time that enteral feeds need to be held prior to a procedure or if they need to be held at all. This would allow critically ill children to receive the nutrition that they need to heal for longer periods of time. Using ultrasound would also potentially eliminate the need for exposure to x-rays to confirm tube placement. Most ICUs have a POC ultrasound machine so this would be any easy tool to access to improve patient care.


Eligibility criteria: Inclusion Criteria:

* all PICU patients intubated \< 7 days that are receiving NJ or NG feeds

Exclusion Criteria:

* patients that cannot be moved
* patients with significant GI conditions affecting motility
* patients intubated for more than seven days

Primary outcomes:
measure: Gastric contents
timeFrame: Baseline (Day 1)
Secondary outcomes:
measure: Gastric contents
timeFrame: Day 2 (if still intubated & being tube fed)
measure: Gastric contents
timeFrame: Day 3 (if still intubated & being tube fed)
measure: Gastric contents
timeFrame: Day 4 (if still intubated & being tube fed)
measure: Gastric contents
timeFrame: Day 5 (if still intubated & being tube fed)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph D Tobias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02490748: Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer
Official title: Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Lead sponsor: The First People's Hospital of Changzhou
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cervical cancer.

Detailed description: The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cervical cancer.

Eligibility criteria: Inclusion Criteria:

* They were systematic reviews based on randomized controlled trials (rcts). They were phase II rcts comparing chemotherapy with other systemic therapy agents or with no further treatment for recurrent, metastatic, or persistent cervical cancer.

they reported at least one of these outcomes: complete or partial response rate, overall or progression-free survival rate, adverse effects, or healthrelated quality of life (rcts reporting on heterogeneous populations-for example, women at a range of disease stages-were included if results were given separately for patients with recurrent, metastatic, or persistent cervical cancer).

Exclusion Criteria:

* studies evaluating the role of radiotherapy administered with chemotherapy, or second- or subsequent-line therapy options.

Primary outcomes:
measure: Recurrence-free survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01023048: Concurrent Single Gene and 24 Chromosome Aneuploidy Preimplantation Genetic Diagnosis (PGD)
Official title: First Use of Parental Support Technology(R) for Single Gene Analysis Plus Aneuploidy Screening in Preimplantation Genetic Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Any Single Gene Disorder (Cystic Fibrosis, Tay-Sachs)
Keywords: preimplantation diagnosis
Lead sponsor: Natera, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 56
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Gene Security Network has developed a novel technology called Parental SupportTM (PS) which is used for Preimplantation Genetic Screening/Diagnosis (PGS/D) during in vitro fertilization (IVF). This technology allows IVF physicians to identify embryos, prior to transfer to the uterus, which have the best chance of developing into healthy children. The purpose of this study is to validate clinical use of PS to detect specific genetic mutation(s) known to cause severe inheritable diseases in embryos produced by at-risk couples. This may be done while simultaneously testing these embryos for aneuploidy. This study will allow for first of its kind commercial PGS/D testing to detect disease-associated genetic mutations together with aneuploidy screening.


Eligibility criteria: Inclusion Criteria:

* couple (mother and father)at risk to have a child with a single gene disorder (e.g. cystic fibrosis, Tay-Sachs, sickle cell anemia)
* Able to provide laboratory report from commercial CLIA certified laboratory confirming presence of disease associated mutation in mother and/or father
* couple planning to go through IVF and desiring PGD for the specified mutation
* Father (male) willing and able to provide sperm sample
* Maternal (female's) age \<40 years (e.g., 39 or younger)
* CVS/Amnio planned once the pregnancy occurs; willing/able to provide amnio/cvs sample for confirmatory testing or provide test results of confirmatory testing performed by an external CLIA certified laboratory.
* FSH \<10 (FSH = Follicle Stimulating Hormone. FSH is an indicator of egg quality and rough predictor of egg stimulation success. FSH is routinely measured by the IVF center prior to beginning an IVF cycle.)

Exclusion Criteria:

* Couples without prior documentation of genetic mutation as specified above
* Adult couples where the male partner is not willing, able, or available to provide a semen sample.
* Maternal age \>=40 years
* Couple unwilling to have amnio/cvs

Primary outcomes:
measure: Confirm diagnosis through prenatal diagnosis (CVS or amniocentesis)
timeFrame: 10-20 weeks post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Gene Security Network
state: California
Study officials:
affiliation: Natera, Inc.
name: Matthew Rabinowitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: