louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05542472: The Effect on Caregivers of a Family Support Program
Official title: The Effect on Caregivers of a Family Support Program Based on a Nurse-Led Case Management Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burnout
Keywords: caregiver
case management
nurse-led
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the effect of a family support program based on the nurse-led case management model on individuals providing care for patients who are confined to bed at home.

Detailed description: It is of paramount importance to enable the patients receiving home care and their relatives to adapt social life, to fulfil their social integration, to relieve the burden of family members of the individual in need of care, especially the individual providing care, by supporting them in the environment where they live. In this study, it is aimed to investigate the effect of the family support program based on the nurse-led case management model for family members who care for bedridden patients.The family support program based on a five-stage nurse-led case management model is administered for the caregivers in the intervention group, the caregivers in the control group is monitored by home health services through routine follow-ups. The research will conducted as a randomized controlled study with an experimental design.

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the study,
* To have been taking care of the caregiver for at least 6 months,
* Being literate
* Not to have sensory loss such as vision and hearing,
* Being open to communication and cooperation,
* Internet access and being able to use it,
* Having a phone where he can be reached,
* Not receiving any remuneration for the provision of care,
* Having a family bond with the person being cared for.

Exclusion Criteria:

* Caregivers who do not meet the inclusion criteria,
* Caregivers who did not give consent at any stage of the study and left.

Primary outcomes:
measure: Change in caregiver burden in 6 months
timeFrame: 6 months
Secondary outcomes:
measure: assessment of caregivers' quality of life
timeFrame: 6 months
Other outcomes:
measure: determination of family functional status
timeFrame: 6 months
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University of Applied Sciences
Study officials:
affiliation: Sakarya University of Applied Sciences
name: Yurdanur Dikmen, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00459472: Operating Room Outcomes After Resident Training on a Virtual Reality Simulator
Official title: Operating Room Outcomes After Resident Training on a Virtual Reality Simulator
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gall Bladder Disease
Keywords: resident training
laparoscopy
virtual reality
surgical education
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2007-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare outcomes of patients undergoing laparoscopic cholecystectomy before and after a laparoscopic training curriculum was implemented.

Detailed description: All general surgery interns and PGY-2's AND PGY 3's will be enrolled in a laparoscopic surgery training curriculum that includes practicing surgical skills on a laparoscopic simulator. The PI has constructed an examination on the simulator that will document a significant level of laparoscopic skill. Each general surgery intern, second, AND THIRD year general surgery resident will be required to pass this examination on the simulator prior to being given more responsibility during cases of laparoscopic cholecystectomy. Specifically, interns, second, AND THIRD year residents must pass the examination on the simulator before they are allowed to function as primary surgeon in a supervised setting during laparoscopic cholecystectomy. These interns, PGY-2's, AND PGY 3'S would then be allowed to function as primary surgeon under the supervision of an attending surgery for laparoscopic cholecystectomy cases. The outcomes of these cases would be compared to a matched group of laparoscopic cholecystectomy cases performed by second year general surgery residents in the same supervised environment (but without having trained on the simulator) one year prior.

Eligibility criteria: Inclusion Criteria:

* General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.

Exclusion Criteria:

* persons who are not General Surgery residents at NewYork Hospital/Columbia in PGY 1, 2, or 3.

Primary outcomes:
measure: Operative time
timeFrame: 1 year
measure: Prevalence of complications (such as bile duct injuries, bilomas, infections, bleeding)
timeFrame: 1 year
measure: Mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Average days of hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Physicians and Surgeons
state: New York
Study officials:
affiliation: Columbia University
name: Dennis L Fowler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351572: Frequency of Circulating Tumour Cells in Stage II and Stage III Colon Cancer Patients
Official title: Frequency of Circulating Tumour Cells in Stage II and Stage III Colon Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: colon cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic and any other interested parties

Brief summary: This study will determine whether a new diagnostic test called the Cell Search Assay can detect circulating colon cancer cells in patients who have had surgery for colon cancer and had visible cancer removed. Other parts of the study will look at whether the presence of the circulating tumor cells in blood predicts whether a patient will have their colon cancer return.


Eligibility criteria: Inclusion Criteria:

* stage II or III colon cancer

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Michael Sawyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201772: Prasugrel Re-load Strategies
Official title: Impact of Prasugrel Re-load on Platelet Aggregation in Patients on Chronic Prasugrel Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
percutaneous coronary revascularization
prasugrel therapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-09-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.


Eligibility criteria: Inclusion Criteria:

1. Patients with angiographically documented coronary artery disease.
2. Age between 18 to 74 years
3. On treatment with prasugrel 10mg/daily for at least 14 days.

Exclusion Criteria:

1. Blood dyscrasias or bleeding diathesis
2. Antiplatelet treatment with clopidogrel or ticlopidine
3. Recent antiplatelet treatment (\< 14 days) with a glycoprotein IIb/IIIa antagonist
4. Platelet count \<100x106/µL
5. Active bleeding or hemodynamic instability.
6. Unstable angina, acute or recent (\<14 days) myocardial infarction.
7. Serum creatinine \>2 mg/dL
8. Baseline ALT \>2.5 times the upper limit of normal
9. Oral anticoagulation with a coumarin derivative
10. History of stroke, TIA or intracranial bleeding
11. Weight \<60kg
12. Pregnant females

Primary outcomes:
measure: PRI Levels at 4 Hours
timeFrame: 4 hours after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Dominick Angiolillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tello-Montoliu A, Tomasello SD, Ferreiro JL, Ueno M, Seecheran N, Desai B, Kodali M, Charlton RK, Box LC, Zenni MM, Guzman LA, Bass TA, Angiolillo DJ. Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study. J Am Coll Cardiol. 2012 May 8;59(19):1681-7. doi: 10.1016/j.jacc.2011.12.039.
Clinical trial NCT01719172: A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Official title: A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-emergent, Soft Tissue Procedures, Performed Via an Open Approach
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2012-11-01
Enrollment: 30
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 objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.


Eligibility criteria: Inclusion Criteria:

* Subject or authorized representative has provided informed consent.
* Subject is ≥ 18 years old.
* Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
* Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
* Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
* TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).

Exclusion Criteria:

* Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
* Subject has an estimated life expectancy of less than 6 months.
* Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
* Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
* Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
* Subject has an active local infection at the TBS.
* The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.

Primary outcomes:
measure: Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
timeFrame: Intra-operative (Day 0)
Secondary outcomes:
measure: Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
timeFrame: Intra-operative (Day 0)
measure: Median Time to Achieve Hemostasis
timeFrame: Intra-operative (Day 0)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Hannover
country: Germany
city: München
country: Germany
Study officials:
References:
Clinical trial NCT04641572: Different Positions During Childbirth
Official title: Application the Recommended Positions of the World Health Organization During Normal Childbirth and Its Effect on Maternal and Labor Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childbirth Process
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random selection based on the woman's preference for certain positions during her first stage of labor.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To encourage the application the recommended positions of the World Health Organization during normal childbirth and its effect on maternal and labor outcomes

Detailed description: To assess the effects of adopting upright positions (walking, sitting, standing) during first stage of labor.

To measure the effect of different individual positions on maternal-fetal outcomes.

To determine which position was more comfortable for women.

Eligibility criteria: Inclusion Criteria:

* aged \> 18 years old with normal pregnancy, primiparas and multi-paras labor cases.

Exclusion Criteria:

* All high-risk associated factors (Hypertension- DM, Heart disease- renal disease) will be excluded.

Primary outcomes:
measure: The maternal outcome.
timeFrame: Within labor process
measure: Newborn outcome
timeFrame: At 1 minute and 5 minutes after delivery.
Secondary outcomes:
measure: -Increase self-direction of participants through choosing the preferable position
timeFrame: Within labor process
measure: Improve women's satisfaction of childbirth experience
timeFrame: After childbirth process.
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Woman Health Hospital
Study officials:
affiliation: Woman's Health Hospital
name: Howieda Fouly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06637072: A Study to Assess Adults with CIDP Transitioning from IVIg to Efgartigimod PH20 SC
Official title: A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy Who Transition from Treatment with Intravenous Immunoglobulin to Efgartigimod PH20 SC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 25
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: This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.


Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age and the local legal age of consent
* Is diagnosed with CIDP (confirmed or possible CIDP) according to the criteria of the European Academy of Neurology/Peripheral Nerve Society
* Is being treated with IVIg every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses
* If receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month.
* If receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months

Exclusion Criteria:

* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk
* Types of other polyneuropathy other than CIDP

Primary outcomes:
measure: Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Changes from baseline in EQ-5D-5L scores over time
timeFrame: Up to 12 weeks
measure: Changes from baseline in TSQM-9 scores over time
timeFrame: Up to 12 weeks
measure: Changes from baseline in PGI-C scores over time
timeFrame: Up to 12 weeks
measure: Changes from baseline in PGI-S scores over time
timeFrame: Up to 12 weeks
measure: Incidence of (S)AEs
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Neurology Associates PA
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Austin
country: United States
facility: National Neuromuscular Research Institute
state: Texas
Study officials:
References:
Clinical trial NCT05496972: Survey Assessment of Patient and Provider Impressions of Telemedicine in Radiation Oncology
Official title: Survey Assessment of Patient and Provider Impressions of Telemedicine in Radiation Oncology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: To understand more about the opinions of patients and health providers on the use of telemedicine in radiation oncology.

Detailed description: Primary Objective:

To characterize patient and provider satisfaction with telemedicine in RO

Secondary Objective:

* To provide evidence for or against the use of telemedicine in radiation oncology (RO)
* To assess the feasibility of and value added by telemedicine in RO
* To describe barriers and facilitators to telemedicine in RO
* To identify preferred use cases for telemedicine in RO

Eligibility criteria: Inclusion Criteria:

* Patients will be eligible if they are aged 18 or older and have undergone at least 1 telemedicine encounter (video visit) with the radiation oncology department at MD Anderson or its affiliates within 2 months from the initiation of the study (and prospectively as the study enrolls). This would include weekly see visits, follow-up visits, or consultations
* English speaking
* Access to email and internet to complete the survey
* Attending physicians in the radiation oncology department who have utilized telemedicine will be contacted to fill out surveys reflecting their experience

Exclusion Criteria:

• Protected populations such as adults unable to consent, pregnant women, prisoners, and individuals who are not yet adults will be excluded

Primary outcomes:
measure: Patient satisfaction survey with telemedicine in radiation oncology (RO)
timeFrame: through study completion and average of one year.
measure: Provider satisfaction survey with telemedicine in radiation oncology (RO)
timeFrame: through study completion and average of one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Chenyang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194972: Clinical Effects of Soluble Dietary Fiber Supplementation
Official title: Study of Soluble Dietary Fiber on Colonic Transit Time and Clinical Symptoms in Adults With Slow-transit Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypomotility
Constipation
Keywords: constipation
colon transit time
gut microbiota
soluble dietary fiber
disturbance of gut microbiota in constipation
Lead sponsor: Nanjing PLA General Hospital
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.

Detailed description: Patients were randomized to receive either pectin or placebo. Treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. We evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.

Eligibility criteria: Inclusion Criteria:

* All patients(age≧18y)
* Admitted for slow-transit constipation were considered eligible

Exclusion Criteria:

* Mental disorders
* Cancer
* Inflammatory bowel disease

Primary outcomes:
measure: efficacy: intestinal transit time
timeFrame: four weeks after inclusion
Secondary outcomes:
measure: efficacy: clinical symptoms
timeFrame: four weeks after inclusion
measure: efficacy: gut microbiota
timeFrame: four weeks after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Nanjing PLA General Hospital
name: Tao Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: