louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04474795: Clinic to Community Connections - Broader Distribution
Official title: Clinic to Community Connections: Enhancing Prenatal to Postpartum Care Transitions to Prevent Type 2 Diabetes in Low Income Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Gestational Diabetes Mellitus in Pregnancy
Keywords: diabetes in pregnancy
type 2 diabetes prevention
diabetes
Care coordination
care delivery
care fragmentation
community health worker
community partnership
community health aides
federally qualified health center
underserved population
patient education
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Longer Life Foundation
First posted: 2020-07-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Staff participants will complete surveys on diabetes knowledge, attitudes, and self-efficacy before and after completing online training modules on gestational diabetes.
Primary purpose: PREVENTION

Brief summary: This study addresses education needs in gestational diabetes care and followup at the staff and patient levels.

In the initial phase, nurses and community health workers will complete specific training modules on gestational diabetes developed for this study. The effectiveness of the education modules will be evaluated through pre/post surveys of participants assessing diabetes knowledge, attitudes, and self-efficacy.


Eligibility criteria: Inclusion Criteria:

Clinic staff: nurses (RN, LPN, BSN), community health workers, and others involved in maternal child health care

Exclusion Criteria:

Clinic staff: individuals not involved in maternal child health care or who do not consent to participate in study

Primary outcomes:
measure: Staff - Self-efficacy to Provide Diabetes Education Questionnaire (Newly Developed)
timeFrame: Baseline and upon module completion (approximately 3 months)
Secondary outcomes:
measure: Staff - Diabetes Knowledge Test
timeFrame: Baseline and upon module completion (approximately 3 months)
measure: Staff - Diabetes Attitudes (Diabetes Attitudes Scale-3 (DAS-3))
timeFrame: Baseline and upon module completion (approximately 3 months)
measure: Staff - Intention to Recommend Diabetes Prevention Activities Questionnaire (Newly Developed)
timeFrame: Baseline and upon module completion (approximately 3 months)
Other outcomes:
measure: Staff-General Self Efficacy Scale (Schwarzer)
timeFrame: Baseline
measure: Staff-Provider Teaching Motivation Questionnaire Intrinsic Motivation Subscale
timeFrame: Baseline
Locations:
city: Saint Louis
country: United States
facility: Affinia Healthcare
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Cynthia J Herrick, MD, MPHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00799695: Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population
Official title: Diabetic Retina Exam Rate Does Not Increase With Phone Reminders in Non-HMO Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
screening
annual
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2008-12-01
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Diabetic retinopathy is the major cause of blindness in working age Americans, and screening for it is cost-effective. There are a quarter of a million people in Southeast Michigan with diabetes and pre-diabetes.

Only half of patients with diabetes are screened regularly for diabetic retinopathy, and this proportion has been difficult to increase despite various interventions. Previous research focused on HMO patient groups because preventative care was thought to decrease plan costs. In addition, it was administratively feasible to track patient-doctor interactions.

This project builds on published research and institutional experience to determine an effective method for increasing the screening rate, in a mobile, non-HMO population. It uses administrative methods and information technology infrastructures, such as large scale electronic medical records and patient demographic databases, to identify existing patients requiring examinations.

Patients were telephoned by a trained service representative who offered and scheduled firm examination appointment times.

Hypothesis: Annual screening rates for diabetic retinopathy can be substantially improved in non-HMO patient groups by directly contacting patients and scheduling firm appointment times.


Eligibility criteria: Inclusion Criteria:

* were Henry Ford Health System patients,
* diabetic
* using the BCBSM payer plan

Exclusion Criteria:

* retina examination in prior year

Primary outcomes:
measure: a change in the proportion of diabetic patients who acted as a result of the phone contact, and obtained a retina eye exam.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Robert M Levine,, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242995: Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope
Official title: Prospective Evaluation of the Clinical Utility of the Thin Scope/Anchoring Balloon Cholangiopancreatoscopy System for Disorders fo the Pancreatobiliary System
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorders of the Pancreatobiliary System
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a medical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for this study.

Brief summary: The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy system for the medical care of pancreatic and/or biliary disorders.


Eligibility criteria: Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has clinical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangioscopy and/or pancreatoscopy
3. Subject must be able to give informed consent.

Exclusion Criteria:

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
2. The subject is unable to give informed consent.

Primary outcomes:
measure: use of a thin endoscope system for the evaluation and/or treatment of pancreatobiliary disorders.
timeFrame: approxiamtely 2-4 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Peter Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235595: Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea
Official title: Comparison of the Effects of High-frequency TENS and Connective Tissue Manipulation on the Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Primary dysmenorrhea
Connective tissue manipulation (CTM)
Transcutaneous electrical nerve stimulation (TENS)
Pain
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study was to compare the early and short-term effects of high-frequency transcutaneous electrical nerve stimulation (TENS) versus connective tissue manipulation (CTM) in participants with primary dysmenorrhea. Half of the participants received CTM, while the other half received TENS.

Detailed description: CTM and TENS each relieve dysmenorrhea pain, but they do so by different. The electrotherapy modality that is most commonly used in the treatment of dysmenorrhea is TENS. It has been reported in studies that high-frequency TENS is more effective in reducing pain than either low-frequency TENS or placebo TENS.

A scan of the literature reveals that although there are differing opinions and applications related to the number and duration of CTM, it has been shown that women with primary dysmenorrhea experience reduced pain after CTM,

Eligibility criteria: Inclusion Criteria:

* being between the ages of 18-30
* having a diagnosis of primary dysmenorrhea

Exclusion Criteria:

* having used an oral contraceptive in the last 3 months,
* having an active sexual life,
* pregnancy,
* having gone through childbirth,
* having a neurological deficit,
* any kind of systemic condition,
* a diagnosed gynecological condition (pelvic inflammatory diseases, endometriosis, uterus cancers, ovarian cysts, etc.),
* taking psychotherapeutic drugs.

Primary outcomes:
measure: Assessment of Pain Severity
timeFrame: Change from Pain severity at 3 months
Secondary outcomes:
measure: Assessment of Sleep Disorders and Fatigue
timeFrame: Change from Sleep Disorders and Fatigue severity at 3 months
measure: Assessment of Depressive Symptoms
timeFrame: Change from Beck Depression Inventory score at 3 months
measure: Assessment of Anxiety
timeFrame: Change from Beck Anxiety Inventory score at 3 months
measure: Assessment of General Health Status
timeFrame: Change from General Health Questionnaire score at 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: Nesrin Yağcı
role: STUDY_DIRECTOR
References:
Clinical trial NCT05588895: Picture of Incidental Calcium To Understand Risk Estimate (PICTURE) Trial
Official title: NOTIFY 2: Picture of Incidental Calcium To Understand Risk Estimate
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Calcification
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective randomized controlled trial assessing the impact of notifying patients and their clinicians of an incidental finding of coronary artery calcification (CAC) indicating increased cardiovascular risk. Patients will be identified through completed radiology orders for non-gated, non-contrast chest CT in the appropriate clinical context and then will have an EHR screen for inclusion criteria. The presence of CAC will be confirmed by a board-certified physician. Eligible patients will be randomized to CAC notification or usual care using a 1:1 stratified block randomization method based on baseline statin use.


Eligibility criteria: Inclusion Criteria:

* Age 18 and above and \<85
* Non-gated chest CT with CAC
* An encounter after July 1, 2021 with a Stanford-affiliated clinician from one of the following clinics:

  * Stanford Internal Medicine (includes University affiliated clinics)
  * Stanford Family Medicine (includes University affiliated clinics)
  * Non-EP cardiologist

Exclusion Criteria:

* Advanced or poor-prognostic cancer
* No active primary care or cardiology care at Stanford Health Care
* Primary language other than English, Spanish, Vietnamese, Cantonese, or Mandarin
* Baseline statin or non-statin lipid lowering therapy
* Allergy to statin medication or identification of statin-associated muscle symptom

Primary outcomes:
measure: Number of new statin prescriptions or increased dose prescriptions
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Number of participants using statin medication
timeFrame: Month 6
measure: Change in Low-density lipoprotein (LDL) cholesterol
timeFrame: Baseline and Month 6
measure: Change in 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Pooled Cohort Equation
timeFrame: Baseline and Month 6
measure: Number of events requiring primary care intervention, cardiology referrals, or cardiac testing
timeFrame: Baseline through Month 6
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT00433095: Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma Breast Stage IV
Keywords: Navelbine
Herceptin
oral
breast cancer
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Laboratories
First posted: 2007-02-09
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1st-line treatment of HER2/neu overexpressing breast cancer

Detailed description: The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.

Eligibility criteria: Inclusion Criteria:

* Histologically proven, metastatic breats cancer.
* HER2-neu overexpression (IHC3+ or IHC2+/FISH+)
* Written informed consent
* no previous therapy with vinorelbine or trastuzumab
* Age \* 18 and \* 75 years
* Karnofsky-Performance status \> 70%
* Life expectance 16 weeks and more
* Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions
* Exclusion of pregnancy and adequte contraception during childbearing age.

  * Adequate hematological, renal, and hepatic function
* Normal cardiac function. LVEF should not be \>10% below normal.
* Adequate compliance to perform treatment and subsequent follow-up visits

Exclusion Criteria:

* Locoregional recurrence of breast cancer only or development of contralateral breast cancer
* Pregnancy or lactation
* Symptomatic brain- or meningeal metastasis
* Concurrent endocrine antitumor therapy
* Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix
* Peripheral neuropathy \>= NCI CTC Grade 2.
* other severel disease which preclude adequate treatment
* Participation in a clinical trial within the last 30 days.
* Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Time to tumor progression
measure: Overall survival
measure: Safety
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University of Munich - Klinikum Grosshdern
Study officials:
affiliation: University of Munich - Klinikum Grosshadern
name: Volker Heinemann, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Munich - Klinikum Grosshadern
name: Hans-Joachim Stemmler, PhD, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04365595: SARS-CoV-2 Associated Respiratory Failure Recovery (COVID-19 CAir)
Official title: Recovery in Patients With SARS-CoV-2 Associated Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV 2
COVID
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with SARS-CoV-2 associated respiratory failure

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.

Detailed description: Study aims:

* To evaluate subjective and objective recovery after discharge from hospital in patients with respiratory failure due to COVID-19.
* To identify risk factors for COVID-19 associated respiratory failure and prolonged recovery

Eligibility criteria: Inclusion Criteria:

* hospitalization at University Hospital Zurich due to COVID-19 infection
* hospital discharge max. 4 weeks ago
* requiring supplemental oxygen

Exclusion Criteria:

* \<18 years
* non-German speaking
* no smartphone access

Primary outcomes:
measure: Health-related quality-of-life
timeFrame: 3 months
Secondary outcomes:
measure: Anxiety and depression
timeFrame: 3 months
measure: Symptom burden
timeFrame: 3 months
measure: Spirometry
timeFrame: 1 month
measure: Spirometry
timeFrame: 1 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Christian F Clarenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohlbrenner D, Kuhn M, Stussi-Helbling M, Nordmann Y, Spielmanns M, Clarenbach CF. Longitudinal Smartphone-Based Post-hospitalisation Symptom Monitoring in SARS-CoV-2 Associated Respiratory Failure: A Multi-Centre Observational Study. Front Rehabil Sci. 2021 Nov 24;2:777396. doi: 10.3389/fresc.2021.777396. eCollection 2021.
Clinical trial NCT05995795: Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy
Official title: Arthroscopic Release Of Shoulder Internal Rotation Contracture In Brachial Plexus Palsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Arthroscopy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with brachial plexus injury operated or not with internal rotation contracture

Brief summary: The purpose of this study is to evaluate the efficacy periarticular capsuloligamentous arthroscopic release of shoulder internal rotation contracture in brachial plexus palsy without any further intervention as tendon transfer.

Detailed description: Obstetrical brachial plexus paralysis (OBPP) refers to complete or partial injury of the brachial plexus produced at the time of birth. OBPP involves most commonly the upper cervical roots (C5, C6) resulting in muscle imbalance between internal and external rotators of the shoulder . Although the majority of the patients (80-90%) recover spontaneously, some have a remaining imbalance causing severe functional impairment . In addition to diminished function, prolonged muscle contractures result in bony deformities in both the glenoid and proximal humerus. Internal rotation contractures due to external rotational weakness are the most common deformity in OBPP. Contracture release, tendon transfers, and rotational osteotomies are surgical methods used, depending on the level of deformity and the patient's age. To achieve functional external rotation of the arm, contracted structures should be released first. Currently, there is a lack of consensus on which procedures over the best outcome for mobility and function, and what are the precise indications for each type of surgery. There is also a large variation of practice between centers

Eligibility criteria: Inclusion Criteria:

* children from 1 year to 15years of age.
* all genders
* patients with brachial plexus injury operated or not with internal rotation contracture
* patient with traumatic brachial plexus injury have residual internal rotation contracture

Exclusion Criteria:

* History of septic shoulder
* Flail anaethetic limb
* glenohumeral posterior sublaxation or dislocation in CT

Primary outcomes:
measure: Number of participants with failure of initial intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Koteb, phD
role: STUDY_CHAIR
References:
citation: Hale HB, Bae DS, Waters PM. Current concepts in the management of brachial plexus birth palsy. J Hand Surg Am. 2010 Feb;35(2):322-31. doi: 10.1016/j.jhsa.2009.11.026.
Clinical trial NCT00311038: Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT
Official title: Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice Computed Tomography (CT) Due to Suspected Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: ONO-1101
Landiolol Hydrochloride
Multi-slice CT
Coronary Artery Disease
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.


Eligibility criteria: Inclusion Criteria:

1. 20-74 years old
2. Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

Exclusion Criteria:

1. Previous allergic reactions to contrast agent
2. Renal failure
3. Asthma
4. Other exclusion criteria as specified in the protocol

Primary outcomes:
measure: heart rate
measure: image quality
measure: safety
Secondary outcomes:
Other outcomes:
Locations:
city: Hokuriku
country: Japan
facility: Hokuriku Region Facility
city: Kanto
country: Japan
facility: Kanto Region Facility
city: Kyusyu
country: Japan
facility: Kyusyu Region Facility
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leaders Development Planning
role: STUDY_DIRECTOR
References: