louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02023060: Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
Official title: Functional and Quality of Life Improvement Following Transcatheter Heart Valve Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trans Catheter Aortic Valve
Aortic Stenosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with severe aortic or mitral valve dysfunction (stenosis or regurgitation) selected for transcatheter aortic or mitral valve replacement

Brief summary: The objective is to observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Detailed description: To observe trends in patient characteristics and outcomes after aortic or mitral transcatheter heart valve replacement over time.

Eligibility criteria: Inclusion Criteria:

1. Subject selected for transcatheter heart valve replacement
2. Signed informed consent to participate in the study

Exclusion Criteria:

1. Inability to sign written informed consent.
2. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).

Primary outcomes:
measure: Clinical outcome of patients undergoing transcatheter valve replacement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Shaarei Zedek amedical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
affiliation: Sheba Medical Center, Tel Hashomer
name: Israel Barbash, MD
role: STUDY_CHAIR
References:
citation: Zusman O, Barbash MI, Guetta V, Finkelstein A, Assali A, Segev A, Orvin K, Barsheshet A, Younis A, Witberg G, Kornowski R, Danenberg H, Landes U. Predicting the risk of late futile outcome after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2020 Dec;96(7):E695-E702. doi: 10.1002/ccd.28761. Epub 2020 Feb 5.
citation: Brodov Y, Konen E, Di Segni M, Samoocha D, Chernomordik F, Barbash I, Regev E, Raanani E, Guetta V, Segev A, Fefer P, Glikson M, Goitein O. Mitral Annulus Calcium Score. Circ Cardiovasc Imaging. 2019 Dec;12(1):e007508. doi: 10.1161/CIRCIMAGING.117.007508.
Clinical trial NCT00739960: Safety Study of Abatacept to Treat Refractory Sarcoidosis
Official title: Sarcoidosis, Trial of Abatacept in Refractory Disease (STAR). A Prospective Open-Label Trial of Abatacept in Progressive Sarcoidosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sarcoidosis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-08-22
Enrollment: 1
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 study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.


Eligibility criteria: Primary Inclusion Criteria:

* Diagnosis of sarcoidosis for at least 1 year with lung disease
* Active disease despite current treatment
* On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days

Primary Exclusion Criteria:

* Previous treatment with Abatacept
* Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab)
* Currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide
* Previous treatment of IVIg within the last 6 months
* History of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks
* History of congestive heart failure
* HIV

Primary outcomes:
measure: Safety of Abatacept in Progressive Pulmonary Sarcoidosis.
timeFrame: 24 weeks and 52 weeks
Secondary outcomes:
measure: Change From Baseline in 6-minute Walk Distance.
timeFrame: 24 weeks and 52 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Nadera J Sweiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05648760: Simulation-based Training Improves Competency in Communicating Bad News
Official title: Simulation-based Training Improves Medical Student Competency in Communicating Bad News to Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simulation of Physical Illness
Keywords: simulation
competency
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families.

Detailed description: Delivering bad news is a task that doctors encounter daily in most medical practices, especially in Intensive Care Unit, where morbidity and mortality are high. The term "bad news" refers to any information transmitted to patients or their families that directly or indirectly involves a negative change in their lives or view of their future. Existing reports show that practicing doctors and residents lack confidence and skill in performing this task, and most have never received any formal training. Breaking bad news is a complex task requiring many skills including communication, responding to emotional reactions, and involving the family members.

The objective of this project was to demonstrate effectiveness of an educational program using simulation-based training intervention to teach medical students to deliver bad news and communicate more effectively with families. We hypothesize that simulation-based training intervention will improve medical student competency in communicating bad news to patients.

Eligibility criteria: Inclusion Criteria:

* Residents working at the Intensive Care Unit.

Exclusion Criteria:

* Residents who are are available for the intervention or who don't have the appropriate number of meetings captured for data analysis

Primary outcomes:
measure: Number of Participants with competency in communicating bad news behavioral measure
timeFrame: One month after training
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02779660: Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
Official title: Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Lead sponsor: Heart Center Leipzig - University Hospital
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 146
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 study is to examine the effect of RIPC on physiological parameters in non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results.

The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce AF burden and minimize thromboembolic risk.

Interim Analysis will be done after 73 patients.


Eligibility criteria: Inclusion Criteria:

* planned invasive Atrial Fibrillation ablation

Exclusion Criteria:

* AF in ECG at Admission
* history of AF ablation
* age \<18
* pregnancy
* neoplastic disorders
* acute or systemic inflammation, autoimmune diseases
* documented atrial flutter

Primary outcomes:
measure: inducibility of Atrial Fibrillation by high-rate pacing of 20 s
timeFrame: during the Atrial Fibrillation Ablation procedure
measure: sustainability of Atrial Fibrillation measured in seconds
timeFrame: during the Atrial Fibrillation Ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
Study officials:
References:
citation: Kosiuk J, Langenhan K, Stegmann C, Uhe T, Dagres N, Dinov B, Kircher S, Richter S, Sommer P, Bertagnolli L, Bollmann A, Hindricks G. Effect of remote ischemic preconditioning on electrophysiological parameters in nonvalvular paroxysmal atrial fibrillation: The RIPPAF Randomized Clinical Trial. Heart Rhythm. 2020 Jan;17(1):3-9. doi: 10.1016/j.hrthm.2019.07.026. Epub 2019 Jul 26.
Clinical trial NCT00378560: V501 Efficacy Study in Women Aged 18 to 26 (V501-027)
Official title: V501 Phase II Efficacy Study in Women Aged 18 to 26
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HPV Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-20
Enrollment: 1021
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women


Eligibility criteria: Inclusion Criteria:

* Female Subject Aged 18 To 26 Years
* With 1-4 Lifetime Sexual Partners

Exclusion Criteria:

* Male Subject

Primary outcomes:
measure: Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype
timeFrame: Over 30 months
Secondary outcomes:
measure: Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6)
timeFrame: At one month after completed vaccination series (Month 7)
measure: Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11)
timeFrame: At one month after completed vaccination series (Month 7)
measure: Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16)
timeFrame: At one month after completed vaccination series (Month 7)
measure: Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18)
timeFrame: At one month after completed vaccination series (Month 7)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Yoshikawa H, Ebihara K, Tanaka Y, Noda K. Efficacy of quadrivalent human papillomavirus (types 6, 11, 16 and 18) vaccine (GARDASIL) in Japanese women aged 18-26 years. Cancer Sci. 2013 Apr;104(4):465-72. doi: 10.1111/cas.12106. Epub 2013 Mar 7.
citation: Murata S, Shirakawa M, Sugawara Y, Shuto M, Sawata M, Tanaka Y. Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants. Papillomavirus Res. 2020 Dec;10:100205. doi: 10.1016/j.pvr.2020.100205. Epub 2020 Aug 19.
Clinical trial NCT02064660: The Efficacy and Safety of Periocular Acupoint Stimulation on Myopia Progression in Children
Official title: An Integrative Medical Approach of Acupoint Stimulation for Children With Myopia : A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Keywords: Myopia
Children
Acupressure
Refractive error
Axial length
Korean medicine
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2014-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Myopia is widely one of the three commonly detected refractive errors. Myopia is usually managed by correction through glasses or contact lenses. Other alternative available include surgery, drugs and acupuncture. There are various therapeutic approaches and different points can be used in acupuncture treatment for myopia, such as auricular acupuncture, acupressure body acupuncture. However, the mechanism of acupuncture therapy for myopia is largely unknown. Furthermore, little information exists regarding the effects and safety of acupuncture for degenerative myopia in children.

The investigators aimed to assess the overall effectiveness, safety of periocular acupressure for children with myopia

The hypotheses of this study are as follows:

Periocular acupressure is effective for myopia progression delay.

The study aims to include 56 participants.


Eligibility criteria: Inclusion Criteria:

* Aged 7-12 years
* Spherical equivalent greater than -5D
* Individuals without strabismus, anistopia
* Willingness to participate in the study

Exclusion Criteria:

* The presence of a related disease such as cataract, glaucoma, or other eye disease.
* Individuals who were received ocular or scalp trauma.
* Individuals who were received ocular surgery and had ocular wound.
* Individuals who were adapted bifocal lense.
* Individuals suffering fever or bad conditions.
* Individuals suffering systemic or neurologic disease.
* Indibiduals who were receiving other therapy during the period of study
* Individuals who did not comply with the treatment which affected myopia progression.

Primary outcomes:
measure: Refractive error
timeFrame: 6 months
Secondary outcomes:
measure: Axial length
timeFrame: 6 months
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Korean Medicine Hospital
state: Gyeongsangnamdo
Study officials:
affiliation: Pusan National University Korean Medicine Hospital
name: Ki-bong Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04252560: The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.
Official title: The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion criteria and have none of the exclusion criteria are going to be asked to participate in the study

Brief summary: The role of gut microbiota in anastomosis insufficiency in patients operated for colorectal cancer and for peritoneal carcinomatosis is going to be investigated. This is a pilot study.


Eligibility criteria: Inclusion Criteria Colorectal group

* adenocarcinom in colon or rektum
* curative operation planed
* direct anastomose plan
* elective surgery

Inclusion Criteria HIPEC group :

* All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC

Exclusion Criteria:

* Ongoing antibiotics treatment
* antibiotics treatment in the last 6 months
* acute surgery
* palliative surgery
* Ulcerös colitis or Crohns disease
* Prior colectomy
* Small intestine stoma before the operation
* neoadjuvant treatment
* Colon preparation

Primary outcomes:
measure: Microbiome
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
References:
Clinical trial NCT02807376: An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Official title: A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Excision of Kidney
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for renal artery and renal vein transection) and powered vascular stapler


Eligibility criteria: Inclusion Criteria:

* Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC);
* Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable;
* American Society of Anesthesiologists (ASA) score \< 3;
* No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed);
* Willing to give consent and comply with study-related evaluation and treatment schedule; and
* At least 18 years of age

Exclusion Criteria:

* Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
* Pregnancy;
* Physical or psychological condition which would impair study participation; or
* The subject is judged unsuitable for study participation by the Investigator for any other reason.

Primary outcomes:
measure: Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
timeFrame: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours
Secondary outcomes:
measure: Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding
timeFrame: Post-Op through 4 Week Follow-up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
Clinical trial NCT04171076: Transcutaneous Spinal Cord Stimulation for Parkinson Disease
Official title: Transcutaneous Spinal Cord Stimulation for Freezing of Gait in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Gait, Rigid
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn.

Detailed description: Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn. In this pilot trial, the investigators recruit participants with Parkinson' disease and freezing of gait. The aim of the study is to explore the safety along the non-invasive magnetic thoracic spinal cord stimulation as well the effect on gait problems, especially freezing of gait, prospectively, in an open-label fashion.

Eligibility criteria: Inclusion Criteria:

* diagnosis of advanced idiopathic Parkinson's disease
* significant freezing of gait despite optimized treatment with medications and rehabilitation program

Exclusion Criteria:

* psychiatric symptoms
* dementia
* cardiac pacemaker

Primary outcomes:
measure: Freezing of gait score
timeFrame: One week
Secondary outcomes:
measure: Gait speed
timeFrame: baseline, 1 week, 4 week
measure: Freezing of gait questionnaire
timeFrame: baseline, 1 week, 4 week
measure: Safety of the intervention - urinary incontinence
timeFrame: 1 week, 4 week
measure: Safety of the intervention - lower limb strength.
timeFrame: 1 week, 4 week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
state: Sao Paulo
Study officials:
References: