louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01352416: Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Official title: Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
Keywords: Suppress Atrial Fibrillation
heart bypass surgery
heart valve surgery
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Beaumont Foundation of America
name: Gilead Sciences
First posted: 2011-05-11
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

Detailed description: A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (Coronary Artery Bypass Graft \[CABG\], or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.

Eligibility criteria: Inclusion Criteria:

* Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.

Exclusion Criteria:

* Documented atrial fibrillation within the previous 3 months
* Ongoing therapy with suppressive antiarrhythmic drugs
* Patient currently on digoxin
* Emergent surgery
* Patient receiving hemodialysis
* Concomitant use of ketoconazole, diltiazem, verapamil
* Known tolerance or hypersensitivity to ranolazine
* Pregnant individuals
* MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery

Primary outcomes:
measure: Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
timeFrame: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Ilana Kutinsky, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03108716: Hamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures
Official title: Hamate Hook Removal, Microscrew Internal Fixation and Plaster Fixation for the Treatment of Hamate Hook Fractures: a Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Lead sponsor: Siping Central People's Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators collected data of 28 hamate hook fractures patients, who were treated in the Siping Central People's Hospital and had complete follow-up records.
Primary purpose: TREATMENT

Brief summary: To compare the effects of hamate hook removal, microscrew internal fixation and plaster fixation on fracture healing, work, life, and exercise recovery in patients with hamate hook fractures by retrospective case analysis.

Detailed description: Hamate hook fractures are rare, and mainly occur during sports activities. Its projection is often obscured by other carpal bone in conventional X-ray plain films, so hamate hook fractures are the most easily missed injury in hand surgery. As the incidence of such fractures is too small, it brings some difficulties in the clinical choice of correct and effective treatment. Currently, treatment programs of hamate hook fractures also are not consistent.

Eligibility criteria: Inclusion Criteria:

* Hamate hook fractures finally diagnosed by X-ray and CT scan at the wrist position holding a cup and the carpal canal position (appendix 2)
* Unilateral hamate hook fractures
* Irrespective of age and sex

Exclusion Criteria:

* Incomplete follow-up data

Primary outcomes:
measure: Fracture healing
timeFrame: At 6-18 months after surgery
Secondary outcomes:
measure: Time of plaster fixation
timeFrame: At 6-18 months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Siping Central People's Hospital
name: Zhuang Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182116: Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal Cancer
Official title: A Randomized, Controlled Trial to Compare the Functional Outcome and Quality of Life in Patients With Low Rectal Cancer Who Undergo a J Pouch or a Side to End Coloanal Anastomosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: J pouch
colorectal
rectal cancer
coloplasty
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2010-08-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

Detailed description: The side to end anastomosis has become popular in recent years as it is technically simple to construct. The difference between the Baker type(side to end) of anastomosis and the J pouch, is that no formal pouch is constructed in the side to end. It has one staple line and the anastomosis.

The investigators hypothesis is that the patients who receive a side to end anastomosis have bowel outcome and quality of life that is equivalent to those who receive a J pouch.

Eligibility criteria: Inclusion Criteria:

1. Patients with distal rectal cancers who will be having an abdominal proctocolectomy with a low colorectal anastomosis within 4 cm of the dentate line or a coloanal anastomosis will be candidates for this study.
2. No evidence of distant metastatsis -

Exclusion Criteria: Stage IV rectal cancer

1. History of radiation to the pelvis ( eg. for uterine or prostatic cancer)
2. Evidence of synchronus or metachronus disease
3. H/o dementia
4. Prisoners
5. Women who are pregnant
6. History of previous Right Colectomy
7. History of inflammatory bowel disease -

Primary outcomes:
measure: Improved function and capacity of the neorectum.
timeFrame: 2 years from date of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Massarat Zutshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parc Y, Ruppert R, Fuerst A, Golcher H, Zutshi M, Hull T, Tiret E, Hemminger F, Galandiuk S, Fender S, Weber K, Zimmerman A, Aiello A, Fazio V. Better Function With a Colonic J-Pouch or a Side-to-end Anastomosis?: A Randomized Controlled Trial to Compare the Complications, Functional Outcome, and Quality of Life in Patients With Low Rectal Cancer After a J-Pouch or a Side-to-end Anastomosis. Ann Surg. 2019 May;269(5):815-826. doi: 10.1097/SLA.0000000000003249.
Clinical trial NCT02573116: Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
Official title: Impact of Treatment of Periodontis on Endothelial Function in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Disease in Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
endothelial dysfunction
periodontitis
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 49
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the add-on effect on endothelial dysfunction of treatment of periodontitis in patients with chronic periodontitis and severe obstructive sleep apnea treated by CPAP. Patients with and without chronic periodontitis will be treated by CPAP for 20 weeks. At V2 (10 weeks), endothelial dysfunction will be assessed by the Reactive Hyperemia- Peripheral Artery Tone index. The endothelial dysfunction of the patients will be also assessed at V3 (20 weeks) after periodontitis treatment for the group of patients with chronic periodontitis.

Detailed description: At V2, patients with periodontitis will have full-mouth intensive removal of denatl plaque biofilms with the use of scaling and root planing. The add-on effect of the periodontitis treatment on endothelial dysfunction will be assessed ten weeks later (V3) in comparison with V2 by taking into account with the effect of 10 weeks of CPAP in the control group with severe OSA but not periodontitis.

Eligibility criteria: Inclusion Criteria:

* severe OSA defined by an apnea hypopnea index \> or = 30 per hour
* with or without chronic parodontitis

Exclusion Criteria:

* non equilibrated diabetes
* obesity (BMI \> or = 40)
* active smoker (\> 1 pack per day (20 cigarettes))
* pregnancy
* antibiotics within the preceding three months
* prophylactic antibiotherapy required for the parodontitis treatment
* acute parodontitis or all parontal pathology requiring immediate therapy
* less than 10 teeth

Primary outcomes:
measure: Endothelial function
timeFrame: 20 weeks
Secondary outcomes:
measure: Endothelial function
timeFrame: 10 weeks
measure: blood biomarkers
timeFrame: 0, 10 and 20 weeks
measure: Epworth Sleepiness Scale
timeFrame: 0, 10 and 20 weeks
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: AP-HP, Hôpital Européen Georges Pompidou
name: Priscilla Henno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02998216: Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation
Official title: Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Organ Prolapse
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 20
Sex: FEMALE
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: All female patients who are planned to receive a bilateral sacrospinous fixation as a treatment for pelvic organ prolapse Stage IV will be eligible for inclusion in the study.

Brief summary: This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.


Eligibility criteria: Inclusion Criteria:

* age 18 and above
* pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus
* signed informed consent

Exclusion Criteria:

* gynecologic surgery in the three past months before planned surgery
* history of prolapse surgery
* participation in another study
* need to simultaneously perform other surgical procedures (i.e. rectopexy)
* ongoing chemotherapy of treatment with immunosuppressant drugs

Primary outcomes:
measure: Assessment of pelvic floor symptoms
timeFrame: Twelve months
Secondary outcomes:
measure: Anatomical outcome / Prolapse stage after surgery
timeFrame: Twelve months
measure: Changes in quality of life
timeFrame: Twelve months
measure: Changes in sexual activity
timeFrame: Twelve months
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Wuerttemberg
Study officials:
affiliation: Universitys Hospital Tuebingen
name: Christl Reisenauer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kavvadias T, Schoenfisch B, Brucker SY, Reisenauer C. Anatomical and functional outcomes after hysterectomy and bilateral sacrospinous ligament fixation for stage IV uterovaginal prolapse: a prospective case series. BMC Urol. 2020 Aug 19;20(1):126. doi: 10.1186/s12894-020-00694-3.
Clinical trial NCT02499016: Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Appendectomy: a Randomized Controlled Trial
Official title: Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complications
Keywords: Appendicitis
Appendectomy
Single-incision
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 208
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: Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* acute appendicitis or interval appendicitis
* informed consent

Exclusion Criteria:

* diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems)
* history of cirrhosis and coagulation disorders
* suspected or proven malignancy
* contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
* inability to give informed consent(severe mental disease)
* pregnancy
* BMI\>30kg/m2
* generalized peritonitis

Primary outcomes:
measure: incidence of complications
timeFrame: 30 days
Secondary outcomes:
measure: mortality rate
timeFrame: 30 days
measure: cosmetic results
timeFrame: 30 days
measure: operative time
timeFrame: intraoperative
measure: time to recover
timeFrame: 14 days
measure: Pain score
timeFrame: 14 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University, China
name: Guoxin Li, M.D.,Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu J, Wang YN, Hu YF, Cheng X, Zhen L, Li GX. Single-incision laparoscopic appendectomy performed above the pubic symphysis - a new scarless approach. Minim Invasive Ther Allied Technol. 2011 Jan;20(1):18-21. doi: 10.3109/13645706.2010.518672.
citation: Wang Y, Xiong W, Lan X, Zhang J, Chen T, Liu H, Li G. Suprapubic single incision laparoscopic appendectomy. J Surg Res. 2015 Feb;193(2):577-82. doi: 10.1016/j.jss.2014.07.064. Epub 2014 Aug 4.
Clinical trial NCT04514016: Cross Sectional CFAR HIV/COVID-19 Study
Official title: Cross Sectional Survey Of Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COV-2) Infection And Seroprevalence In A Cohort Of HIV-Infected Children, Youth, And Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV Infection
Covid19
Keywords: HIV
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Miami Center for AIDS Research (CFAR)
First posted: 2020-08-14
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-positive pediatric, adolescent or young adult being treated at Batchelor Children Research Institute (BCRI) at the University of Miami.

Brief summary: The main purpose of this research study is to learn the rate of SARS COV-2 on HIV infected children, adolescents, and youth receiving their primary HIV care at the University of Miami Miller School of Medicine.


Eligibility criteria: Inclusion Criteria:

* Being a patient to the Pediatric or Adolescent clinic located at Batchelor Children Research Institute (BCRI)
* Being diagnosed with HIV infection by the time of enrollment
* At enrollment, 3 to \< 26 years

Exclusion Criteria:

* Patient will be excluded from the study if any of the following are identified:
* Patients under legal age and in the State's custody
* Participant or legal guardian unable to sign Informed Consent forms
* Participant unable to complete study visits

Primary outcomes:
measure: Number of participants who tested positive with SARS COV-2 Infection
timeFrame: month 3
measure: Number of participants who tested positive with SARS COV-2 antibody
timeFrame: month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Batchelor's Children's Research Institute
state: Florida
Study officials:
affiliation: University of Miami
name: Charles Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01118416: Risk Reduction Intervention for Vulnerable Young Adult Males
Official title: Risk Reduction Intervention for Vulnerable Young Adult Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sex
Substance Use
HIV
Keywords: sexual risk
substance use
HIV
prevention
intervention
Motivational Enhancement Therapy
young men who have sex with men
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 317
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to test a brief 4-session risk reduction intervention, based on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and sexual risk taking behaviors among non-treatment seeking young men who have sex with men (YMSM) in NYC.

Detailed description: This study is a randomized clinical trial. A sample of 300 non-treatment seeking YMSM (ages 18-24) who report risky sex and club drug use in the past 90 days are being enrolled using active and passive community-based recruitment strategies in NYC. After baseline assessment, participants are being randomly assigned to one of two study arms: a Brief Risk Reduction Intervention Condition - a four session MET intervention piloted for feasibility and acceptability among YMSM, designed to increase readiness to change club drug use and unprotected sex; or an Education Comparison Condition - four sessions of facilitated education regarding the effects of club drugs and unprotected sex. Participants undergo follow-up assessments 3, 6, 9, and 12 months after baseline.

Eligibility criteria: Inclusion Criteria:

* At least 5 days of drug use (cocaine, ketamine, ecstasy, methamphetamine, or GHB) in the past 90 days;
* At least 1 instance of unprotected anal sex in the past 90 days;
* Biological male;
* HIV-negative;
* Residential stability;
* Ability to communicate in written English.

Exclusion Criteria:

* Unstable, serious psychiatric symptoms;
* Currently suicidal/homicidal;
* Evidence of gross cognitive impairment;
* Reports current enrollment in a drug or HIV related intervention or research study.

Primary outcomes:
measure: Sexual risk
timeFrame: every three months over the course of a year
Secondary outcomes:
measure: motivation to change club drug use and unsafe sex over 12 months
timeFrame: every three months over the course of a year
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for HIV/AIDS Educational Studies and Training of Hunter College, CUNY
state: New York
Study officials:
affiliation: Hunter College of CUNY and Center for HIV/AIDS Educational Studies and Training
name: Jeffrey T Parsons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02879916: Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery
Official title: Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Regional
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.


Eligibility criteria: Inclusion Criteria:

* ASA class 1 to 3
* Need for shoulder surgery

Exclusion Criteria:

* Mental retardation
* allergy for local anesthetics
* a medical reason as a contra-indication for NSAID use
* Diabetes mellitus
* peripheral neuropathy
* chronic analgetic use
* chronic pain patients

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Need for rescue analgesia
timeFrame: 24 hours
measure: Duration of motor block
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Consultant
name: Luc Sermeus, MD
role: PRINCIPAL_INVESTIGATOR
References: