louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05814783: Clinician Training Program to Integrate Digital CBTI Into Routine Psychotherapy
Official title: A Clinician Training Program to Integrate Digital Cognitive Behavior Therapy for Insomnia Into Routine Psychotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Sleep Research Society Foundation
First posted: 2023-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to pilot test and refine a training program for licensed therapists to promote the integration of digital cognitive behavior therapy for insomnia (dCBTi) into their routine mental health care services.


Eligibility criteria: Therapist Criteria:

Inclusion Criteria:

* Licensed mental health clinicians
* Have a clinical care model that includes seeing patients weekly or biweekly
* Provide therapy in English
* Treat patients with depression and/or anxiety
* Can identify 1-2 patients who are willing to consent to be training cases.

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Patient Criteria:

Inclusion Criteria:

* Aged 18+ years old
* Receive weekly or biweekly therapy from participating study therapist
* Identify improving sleep as a goal for treatment and experience insomnia (Insomnia Severity Index score greater than or equal to 10)
* Have daily access to a smartphone, tablet, or computer
* Can read, write, and speak in English

Exclusion Criteria:

* Conditions known to make study treatment less effective (e.g., current chronic medication use known to interfere with sleep, alcohol or substance use disorder, thought disorder)
* Conditions for which dCBTi is a safety risk (e.g., bipolar disorder, excessive daytime sleepiness)
* Current psychotherapy for insomnia

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Pre-treatment and immediately post-treatment (treatment phase is 12 weeks)
measure: Change in Knowledge of Supporting Integrated dCBTi
timeFrame: Pre-training (at the start of the one day training) and immediately post-training (at the end of the one day training)
Secondary outcomes:
measure: Time spent supporting dCBTi
timeFrame: Through study duration, usually 3 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Nicole Gumport, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374283: Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients
Official title: Monitoring of Biopsy-Proven Interstitial Polyomavirus Nephritis in Kidney and Kidney Pancreas Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polyomavirus
Keywords: Monitoring
Polyomavirus
Kidney
Pancreas
Transplant
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Detailed description: Evaluate techniques for monitoring the course of interstitial therapy for polyomavirus nephritis in kidney and kidney pancreas transplant recipients by monitoring blood, urine, and renal transplant biopsies of patients affected by polyomavirus.

Eligibility criteria: Inclusion Criteria:

* Recipients of a kidney or kidney pancreas transplant diagnosed with biopsy proven interstitial nephritis due to polyomavirus.
* Age 18 to 70 years.
* Capable of providing written informed consent.

Exclusion Criteria:

* Age less than 18 years or greater than 70 years.
* Patient is on chronic warfarin or heparin therapy or has a disease that puts them at risk of bleeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Prabir Roy-Chaudhury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07027683: Cardiac Magnetic Resonance for Diagnosing and Guiding Treatment in Concealed Myocardial Rupture
Official title: CMR UNCONCEALED Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Early Infarct-associated Pericarditis
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI patients with a clinical diagnosis of Early infarct-associated pericarditis

Brief summary: looking for the incidence of concealed myocardial rupture in patients with post infarct pericarditis


Eligibility criteria: Inclusion Criteria:

* STEMI
* Clinical diagnosis of Early infarct-associated pericarditis

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Myocardial rupture
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Università di Pisa
Study officials:
References:
Clinical trial NCT05281783: RFA for Treatment of Intermediate Stage HCC
Official title: Efficacy and Response Predictors of Percutaneous Radiofrequency Ablation for Treatment of Intermediate Stage Hepatocellular Carcinoma: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: Percutaneous Radiofrequency Ablation
Intermediate Stage
Hepatocellular Carcinoma
Clinical Trial
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2022-03-16
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-center, prospective non-randomized, controlled clinical trial
Primary purpose: TREATMENT

Brief summary: In Egypt, chronic hepatitis C virus (HCV) is the most prevalent cause of hepatoma. The study aims to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC). The present study was a single-center, prospective non-randomized, controlled clinical trial in the Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals, between October 2018 and August 2021. Abdominal ultrasonography and triphasic computerized tomography (CT) abdomen were used to diagnose HCC. The abdominal ultrasonography and a dynamic CT scan were performed six weeks following the ablation to assess treatment efficacy.


Eligibility criteria: Inclusion Criteria:

* Patients were early and intermediate-stage HCC (BCLC stage A and B).
* Patients accepted to be treated by percutaneous radiofrequency ablation in the Interventional Ultrasonography Unit.
* Patients with early-stage-HCC should have up to 3 tumors, all smaller than 3 cm with a Child-Pugh A score.
* Patients with intermediate-stages-HCC should have multinodular HCC (\>3 nodules \<3 cm) or single focal lesion more than 3 cm, with Child-Pugh Score A or B liver cirrhosis, international normalized ratio (INR) less than 1.7, and platelet count more than 50,000/cm.

Exclusion Criteria:

* Patients with HCC with and vascular spread (portal vein thrombosis), lymph node metastasis or distant metastasis, subcapsular lesions, or lesions with close vicinity to the gall bladder, bowel, or portal vein.
* Patients with clinically decompensated liver disease (Child-Pugh Score C liver cirrhosis).

Primary outcomes:
measure: The efficacy
timeFrame: six weeks after the date of the last ablation
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: six weeks after the date of the last ablation
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals
Study officials:
affiliation: ragaeyahmad@med.bsu.edu.eg
name: Ragaey A Eid
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01064583: Cocoa Flavanols and Painfree Walking Distance
Official title: Long-term Effect of Dietary Intervention With Flavanol-containing Cocoa on Vascular Function of Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Artery Disease
Diabetes Mellitus
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 62
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: To characterize potential vascular long-term effects of flavanols in patients with peripheral artery occlusive disease (PAOD), a placebo-controlled double-blinded randomized control study will be performed in 62 patients randomized in two groups. Patients will twice daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of 60 days months.

Detailed description: 62 Type 2 diabetics according to the criteria of the American Diabetes Association suffering from PAOD with a pain free walking distance less than 250m will be enrolled.

Patients will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 60 days.

The general condition, the pain free walking distance and the vascular function measured by Doppler Ultrasound will be determined before and two month after cocoa ingestion

Eligibility criteria: Inclusion Criteria:

* peripheral artery disease (Fontaine IIb)
* diabetes mellitus
* \> 18 years

Exclusion Criteria:

* acute and terminal renal failure
* acute infection
* heart failure (NYHA III-IV)
* arrhythmias

Primary outcomes:
measure: painfree walking distance
timeFrame: 60 days
Secondary outcomes:
measure: endothelial function
timeFrame: 60 days
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich Heine University
state: NRW
Study officials:
affiliation: Heinrich Heine University
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heinrich Heine University
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04666883: Splenic Hilar Nodes in Splenic Flexure Cancer
Official title: Aberrant Lympahtic Drainage of Splenic Flexure Cancer: Are Splenic Hilar Nodes Metastases an Underecognized Phenomenon?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Metastases, Lymphatic
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer of the splenic flexure of the colon

Brief summary: Report the incidence of metastases to the splenic hilar lymphnodes from splenic flexure primaries. This mode of spread has not been previously characterized for these tumours.


Eligibility criteria: Inclusion Criteria:

* All splenic flexure cancer patients

Exclusion Criteria:

* No consent to data utilization

Primary outcomes:
measure: Splenic hilum nodal metastases
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Tor Vergata
state: RM
Study officials:
References:
Clinical trial NCT01861483: Vessel Resection and Reconstruction of Biliary Tract Cancers
Official title: Resection and Reconstruction of Major Vessels in Biliary Tract Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Tract Cancer
Lead sponsor: Kansai Hepatobiliary Oncology Group
Sponsor class: NETWORK
First posted: 2013-05-23
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent vessel resection and reconstruction in biliary tract cancer after 1990 will be included for analysis.

Brief summary: To investigate the vessel resection and reconstruction in biliary tract cancer.

Detailed description: The vessel resection and reconstruction of hepatic artery and portal vein in biliary tract cancer surgery is still controversial. In this study, we retrospectively evaluate the diagnostic image, pathology, peri-operative events, recurrence, and prognosis in these patients, as a multi-center surveillance.

Eligibility criteria: Inclusion Criteria:

* Cases of vessel resection and reconstruction in biliary tract cancer.

Exclusion Criteria:

Primary outcomes:
measure: Comparison of vascular invasion in diagnostic image and in pathology.
timeFrame: 20 years
measure: R0 resection rate
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Osaka University, Graduate School of Medicine
Study officials:
affiliation: Osaka University Graduate School of Medicine
name: Hiroaki Nagano, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06051383: Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Official title: Building Patient Capability for Managing Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 60
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (LUTS) for patients with benign prostatic hyperplasia (BPH).

Research hypothesis:

To fulfill the aim of this study, the following research hypothesis was formulated:

Patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (LUTS) after conducting self-management intervention than before conducting.

Detailed description: Research design: Quasi-experimental (pre-posttest) research design was utilized to conduct this study.

This study was conducted at Assiut Urology and Nephrology Hospital. A purposive sample of 60 adult male patients diagnosed with benign prostatic hyperplasia were older than 40 years old, had no other factors influencing their urination, such as prostate cancer.

Patients had been assessed at base line using the following tools:

Tool (I): A structured interview questionnaire. Tool (II): International Prostate Symptom Score (IPSS).

Each patient will be assessed before conducting self-management intervention for socio-demographic data, clinical data, and patients' knowledge regarding self-management using the tool I.

Each patient will be assessed for lower urinary tract symptoms before conducting self-management intervention using tool tool II(IPSS).

IPSS is a scoring system used to screen for and diagnose BPH as well as to monitor symptoms and guide decisions about how to manage the disease monitor lower urinary tract symptoms, It includes seven questions, about symptom of BPH.Each question had a range from 0 to 5 for its answer. Maximum score of 35 points. On the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35).

After 3 months from conducting self-management intervention each patient was reassessed for clinical progression "severity" of lower urinary tract symptoms(LUTS)using (tools II).

Eligibility criteria: Inclusion:

* Adult patients.
* Men.
* Clinical diagnosis of benign prostatic hyperplasia.

Exclusion:

* Prostate cancer.
* Severe symptoms necessitating surgical treatment.
* Uncontrolled diabetes.
* End-stage cardiac disease or respiratory failure.

Primary outcomes:
measure: Severity of lower urinary tract symptoms of benign prostate hyperplasia.
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
Clinical trial NCT05346783: Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
Official title: A Phase 1/2. Multicenter, Randomized, Double-blinded, Placebo and Active-controlled, Parallel Study for Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Dry Eye Syndromes
Lead sponsor: Taejoon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized study compared with active control and placebo arms.


Eligibility criteria: Inclusion Criteria:

* Male or female, age 20 or over
* Patient who have been diagnosed with dry eye syndrome at least 6 months ago
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 21 mmHg

Primary outcomes:
measure: Evaluate the safety and tolerability of TJO-083 to use questionnaire [Part1]
timeFrame: Baseline and Day 2, 8
measure: Change From Baseline in Corneal Staining in 9 point Score at Week 4 [Part 2]
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Change From Baseline in Non-anesthetic Schirmer Test at Week 2, 4, 8, 12 [Part 2]
timeFrame: Baseline and Week 2, 4, 8 and 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hyung Keun, Lee
Study officials:
affiliation: Gangnam Severance Hospital
name: Hyung Keun Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04478383: Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique
Official title: Repair of Achilles Sleeve Avulsion: a New Transosseous Suture Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achilles Tendon Rupture
Fracture, Avulsion
Keywords: Sleeve Avulsion
Achilles Tendinopathy
Suture, transosseous
Achilles Tendon
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One patient was lost to follow-up because she could not be contacted, having moved out of the country. The remaining 11 patients (10 men and one woman, average age: 46 years) were reviewed with an average follow-up time of 40 months (30-57 months).

Brief summary: This retrospective study identified 12 patients with Achilles sleeve avulsion from November 2013 to March 2016, aiming to explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.

Detailed description: Purpose: To explore a new transosseous suture technique for the repair of Achilles sleeve avulsion and observe the short-term curative effect.

Methods:In total, 11 patients diagnosed with Achilles sleeve avulsion underwent this new surgical technique and were followed for a mean time of 40 months. Clinical outcomes were measured using the visual analog scale (VAS), American Orthopaedic Foot \& Ankle Society (AOFAS) score, Victorian Institute of Sports Assessment-Achilles (VISA-A) score, Tegner score, and time taken to return to activities. Preoperative and postoperative MRI, the ability to perform heel rise, and complications were also evaluated.

Eligibility criteria: Inclusion Criteria:

* clinical presentations and physical examination, routine ankle X ray and MRI

Exclusion Criteria:

* calcaneal tuberosity avulsion fractures
* Achilles tendon rerupture
* previous surgical procedure on the affected Achilles tendon

Primary outcomes:
measure: change of Victorian Institute of Sports Assessment-Achilles score
timeFrame: from pre-surgery to two years after surgery
measure: change of visual analog scale
timeFrame: from pre-surgery to two years after surgery
measure: change of American Orthopaedic Foot & Ankle Society score
timeFrame: from pre-surgery to two years after surgery
measure: change of Tegner score
timeFrame: from pre-surgery to two years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Haidian District
Study officials:
References:
Clinical trial NCT00671983: The Effect of Obstructive Sleep Apnea on Medical Outcomes After Gastric Bypass Surgery
Official title: The Effect of Obstructive Sleep Apnea on Medical and Neurobehavioral Outcomes After Gastric Bypass Surgery - An Exploratory Investigation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Obesity
Sleep Apnea, Obstructive
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Obstructive sleep apnea (OSA) is a syndrome characterized by repetitive episodes of airway obstruction during sleep, which result in low oxygen level in the blood and bad sleep quality. Both of these effects are implicated in medical, neurological and cognitive disorders in subjects with OSA. The purpose of this study is to examine how OSA affects medical and neurobehavioral outcomes after gastric bypass surgery for weight loss in morbidly obese patients.


Eligibility criteria: Inclusion Criteria:

Scheduled for Laparoscopic roux-en-Y gastric bypass (RYGB) surgery Presence or absence of OSA confirmed by polysomnography Comprehension of spoken and written English

Exclusion Criteria:

Major psychiatric, neurological, or neuromuscular disorder History of untreated thyroid disease Known diabetes mellitus History of stroke with or without apparent neurological deficits Alcohol consumption which exceeds 2 drinks per day or drug abuse. Undergone a sleep study in the past

Primary outcomes:
measure: The effect of preoperative OSA on the long term neurocognitive function after Roux-en-Y gastric bypass (RYGB) surgery for weight loss in morbidly obese patients
timeFrame: 1 year after surgery
Secondary outcomes:
measure: The effect of preoperative neurocognitive impairment on the long term neurocognitive function after RYGB
timeFrame: 1 year after surgery
measure: The effect of preoperative neurocognitive impairment on the weight loss function after RYGB and how this relates to the presence of OSA
timeFrame: 1 year after surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Anthony Doufas
role: PRINCIPAL_INVESTIGATOR
References: