louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06281288: Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms
Official title: Effect of Cognitive-Behavioral Therapy Combined With Exercise Training in Adolescent Females With Elevated Depression Symptoms
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Lead sponsor: Suez University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms

BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"

RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls.

Detailed description: The interventions start after assessment of depression to know the level of depression by using the Center for Epidemiological Studies Depression Scale for Children (CES-DC), and the exercise intervention consist of physical activity combined with Cognitive behavioral therapy. Group - A perform regular physical activity in addition to cognitive therapy, Group - B perform irregular physical activity in addition to cognitive therapy, Group - C cognitive therapy only

Eligibility criteria: Inclusion Criteria:

* 1. Depression adolescent girls 2. All patients should be in school

Exclusion Criteria:

1. obesity
2. malignant diseases
3. psychotic disorders or psychosis.
4. Permanent long-term psychiatric medication

Primary outcomes:
measure: Center for Epidemiological Studies Depression Scale for Children (CES-DC),
timeFrame: First at baseline and then after 12 weeks of the exercise program
Secondary outcomes:
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: doaa Tammam Atia
Study officials:
affiliation: Misr University for Science and Technology, Giza, Egypt.
name: Sally MS Mahmoud, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04558788: Cellular Stress Reactions During Graft-versus-host Disease
Official title: Analysis of Cellular Stress Markers in the Intestine of Patients With Graft-versus-host Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft Vs Host Disease
Graft Versus Host Disease
Keywords: GVHD
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will recruit adults at least 18 years of age, who underwent intestinal biopsy and either had (i) non-inflamed intestinal tissue, (ii) colitis, (iii) graft-versus-host disease.

Brief summary: This study has the aim to analyze intestinal expression of cellular stress molecules in patients with intestinal GVHD. Patients with colitis and patients without intestinal inflammation will serve as controls.

Detailed description: Acute graft-versus-host disease (GVHD) is a major cause of morbidity and mortality in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT). Acute GVHD results from a complex multi-step crosstalk between extensive epithelial tissue damage in the patient and activation of the allo-reactive immune system transferred with the donor graft. The conditioning treatment prior to allo-HCT creates an inflamed microenvironment with high concentrations of pathogen-associated and danger-associated molecular patterns (PAMPs and DAMPs) as well as pro-inflammatory cytokines. This inflammation is perpetuated by activation of myeloid immune cells and recruitment of allo-reactive T cells to the intestine. Enterocytes are subjected to cellular stress and undergo apoptosis. As a result, patients can develop high-voluminous diarrhea, dehydration, intestinal bleeding, hypalbuminemia, and generalized infections.

In this study, the investigators aim to analyze the expression of molecules related to different types of cellular stress in the intestine of patients with acute GVHD. The hypothesis is that some stress-related markers would be upregulated during GVHD. The results will be valuable to study the role of cellular stress reactions during acute GVHD pathogenesis or as potential biomarkers for disease activity.

Eligibility criteria: Inclusion Criteria:

Age \>18 years intestinal biopsy depending on cohort: healthy intestinal tissue, colitis or GVHD

Primary outcomes:
measure: Immunohistochemical staining
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Medical Center University of Freiburg
state: Baden-Württemberg
Study officials:
References:
Clinical trial NCT03916588: Dementia Management With Interactive Technology
Official title: Dementia Management With Interactive Technology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dementia
Memory Disorders in Old Age
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents living on the memory care unit will have pre diagnosed advanced dementia or Alzheimer's disease. Subjects will have diminished or no capacity and will require a legally authorized representative.

Brief summary: To investigate the efficacy of an individualized treatment plan delivered through remote technology along with enhanced staff training within a supervised memory unit on patient outcome, care quality, health care utilization/cost, and staff burden. Remote monitoring of activity data will also be explored.


Eligibility criteria: Inclusion Criteria:

* Residents living in a specific locked memory care unit in Southeastern Louisiana or
* Family or staff identified as part of the care team of the resident

Primary outcomes:
measure: Mortality/Survival Rate
timeFrame: through study completion, an average of 1 year
measure: Quality of Life Scale (QoL)
timeFrame: through study completion, an average of 1 year
measure: Fall Incidence
timeFrame: through study completion, an average of 1 year
measure: Zarit Caregiver Burden
timeFrame: through study completion, an average of 1 year
measure: Patient Care Team Burden Scale (PCTB)
timeFrame: through study completion, an average of 1 year
measure: Healthcare Utilization
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Fitbit Charge HR activity and sleep data
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: R. John Sawyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01525888: Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiographic Contrast Agent Nephropathy
Keywords: Contrast induced nephropathy
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence the change in estimated glomerular filtration rate or GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

Detailed description: Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years,
* chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and
* planned coronary angiography

Exclusion Criteria:

* chronic utilization of NSAIDS and Cox-2 selective inhibitors,
* chronic treatment with mineralocorticosteroid receptor blocker, and
* administration of contrast within 14 days prior to the enrollment.

Primary outcomes:
measure: change in eGFR from baseline to 48-72 hours following the exposure to the contrast.
timeFrame: 48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06265688: First In Human Study of CX-2051 in Advanced Solid Tumors
Official title: An Investigational Study of CX-2051 in Participants With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: CytomX Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors.

Detailed description: The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051. Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 in indication-specific expansion cohorts.

Eligibility criteria: Inclusion Criteria:

* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Additional inclusion criteria may apply

Exclusion Criteria:

* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
* Known active central nervous system (CNS) involvement by malignancy
* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
* Elevated baseline laboratory values
* Serious concurrent illness
* Pregnant or breast feeding
* Additional exclusion criteria may apply

Primary outcomes:
measure: Safety and tolerability of CX-2051
timeFrame: 44 months
measure: Determine the recommended Phase 2 dose (RP2D)
timeFrame: 44 months
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: 60 months
measure: Duration of response (DOR)
timeFrame: 60 months
measure: Progression-free survival (PFS)
timeFrame: 60 months
measure: Disease control rate (DCR)
timeFrame: 60 months
measure: Duration of disease control (DODC)
timeFrame: 60 months
measure: Overall survival (OS)
timeFrame: 60 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Huntersville
country: United States
facility: Carolina BioOncology Institute, PLLC
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute, LLC
state: Tennessee
Study officials:
affiliation: CytomX Therapeutics
name: Monika Vainorius, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04080388: How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)
Official title: How to Prevent Heart Failure Readmission by Using Lung Impedance Device (HOPE-HF Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Heart Failure Acute
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The readmission of Heart Failure (HF) patients for exacerbation HF within 30-day is unmet goal. The mail reason for readmission is excessive accumulation of fluid in patient's lung. According our data (1,2) around 40% of HF patient have excessive lung fluid at discharge from HF hospitalization ("unacceptable" residual congestion on discharge). In other words, around 40% patients are discharged from HF hospitalization prematurely when they are not ready to be discharged. Only 60% of HF patients are discharged from HF admission with "acceptable" level of residual pulmonary congestion (2). There are some techniques to assess "readiness" of HF patients for discharge. Pulmonary congestion (lung fluid accumulation) may be assessed non-invasively by measurement Brain Natriuretic Peptide (BNP), (3,4), by lung ultrasound (LUS), (5-7) and by Lung Impedance (LI) method (1,2). LUS is operator depended technique. LI and BNP techniques are most reliable methods (2) and easy to use.


Eligibility criteria: Inclusion Criteria:

* Acute Heart Failure Patients Prior to Hospital Discharge

Exclusion Criteria:

* No Cardiac Resynchronization Device Implanted During Current Hospitalization
* Estimated glomerular filtrating rate (GFR) less than 30 ml/min

Primary outcomes:
measure: Prevention of heart failure re-admission
timeFrame: 30 days
measure: Prevention of heart failure re-admission
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Karina Zilber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00865488: Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery
Official title: A Prospective, Controlled, Randomized, Multi-Center, Pivotal Study Evaluating the Safety and Efficacy of AdhexilTM in Prevention And/Or Reduction of Adhesions in Gynecology Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Ovarian Cysts
Endometriosis
Adhesions
Lead sponsor: OMRIX Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and efficacy of ADHEXIL™ in preventing and/or reducing post-operative adhesions in patients undergoing surgery involving the ovaries.

Detailed description: Patients will be divided into two arms: 1) patients who will be treated in accordance with standard of care; 2) patients for which ADHEXIL™ will be applied on one ovary and fallopian tube.

Eligibility criteria: Inclusion Criteria:

* Female patients aged 18-45 years at screening.
* Patients undergoing elective laparoscopic surgery involving at least one adnexa.

Exclusion Criteria:

* Pregnant (including ectopic pregnancy) or breastfeeding patient.
* Patients with a documented diagnosis of cancer.
* Patients with a lymphatic, hematologic or coagulation disorder.
* Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of Adhexil™.
* Patients who are immunocompromised, possess autoimmune disorders, or who are routinely taking anticoagulants.
* Patients who have participated in another clinical study within 30 days of enrolment.
* Investigator's opinion that the patient is medically unfit or would be at major risk if enrolled into the study.

Primary outcomes:
measure: Adhesions will be assessed according to incidence, extent and severity.
timeFrame: 8 weeks post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
state: Virginia
city: Duisburg
country: Germany
city: Mexico City
country: Mexico
city: Moscow
country: Russian Federation
city: Valencia
country: Spain
Study officials:
affiliation: OMRIX Biopharmaceuticals
name: Eran Kurman, B.med.Sc, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT02326688: Quantification of Arm Non-Use After a Stroke
Official title: Reliability of Kinematic Analysis in Assessment and Rehabilitation of the Upper Arm of Stroke Patients Following a Cerebral Vascular Accident, Hemiparetic Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-12-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Reproducibility assessment of a quantitative measure of the amount of trunk compensation by kinematic analysis in a grasping task in stroke patients.This "maladaptive trunk compensation" is suspected to be underlined by "arm non-use" in some patients, since this abnormal movement impairs the ability of patients to correctly flex their shoulder and extend their elbow during grasping.


Eligibility criteria: Inclusion Criteria:

* · Patient hemiparetic

  * Hemiplegic Patient
  * Patient can perform a global task with the gripping limb

Exclusion Criteria:

* Patient can not actively tender elbow of the affected limb,

  * Patient who can not actively flex the shoulder of the affected limb,
  * Patient with a passive extension deficit elbow\> 30 °,
  * Patient with a shoulder flexion passive deficit\> 60 °,
  * Patient with severe neglect
  * Patient bearer severe cognitive impairment
  * A patient with aphasia understanding disorders

Primary outcomes:
measure: Kinematic measurement of trunk displacement by the maladaptive index trunk compensation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
References:
citation: Bakhti KKA, Laffont I, Muthalib M, Froger J, Mottet D. Kinect-based assessment of proximal arm non-use after a stroke. J Neuroeng Rehabil. 2018 Nov 14;15(1):104. doi: 10.1186/s12984-018-0451-2.
Clinical trial NCT01271088: Protective Effect of N-acetylcysteine Against From Ototoxicity
Official title: Phase 3 Study of Protective Effect of N-acetylcysteine Against From Ototoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hearing Loss, Extreme
Keywords: ototoxicity
aminoglycoside
vancomycine
peritoneal dialysis
peritonitis
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 60
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: PREVENTION

Brief summary: Peritonitis is currently one of the leading complications of continuous ambulatory peritoneal dialysis (CAPD). Aminoglycosides and vancomycin are used in the treatment of CAPD peritonitis despite their potential risk for ototoxicity. NAC is a molecule used in the treatment and prophylaxis of many diseases related to oxidative stress. The aim of this study was to examine whether ototoxicity due to antibiotics used in the treatment of CAPD peritonitis can be prevented by N-acetylcysteine

Detailed description: NAC, a thiol-containing antioxidant because of this,we want to investigate antioxidant status.

Eligibility criteria: Inclusion Criteria:

* End-stage renal disease
* Undergoing continuous ambulatory peritoneal dialysis as a renal replacement therapy
* Developing the first continuous ambulatory peritoneal dialysis related peritonitis episode

Exclusion Criteria:

* Being treated with aminoglycoside antibiotics and vancomycine within the previous 3 months
* Detection of mechanical occlusion of external ear
* Having signs of disturbed integrity of tympanic membrane on otoscopy or tympanometry
* History of a continuous ambulatory peritoneal dialysis related peritonitis

Primary outcomes:
measure: Threshold hearing levels
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
affiliation: TC Erciyes University
name: Ismail Kocyigit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kocyigit I, Vural A, Unal A, Sipahioglu MH, Yucel HE, Aydemir S, Yazici C, Ilhan Sahin M, Oymak O, Tokgoz B. Preventing amikacin related ototoxicity with N-acetylcysteine in patients undergoing peritoneal dialysis. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2611-20. doi: 10.1007/s00405-014-3207-z. Epub 2014 Jul 30.