louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00276237: Outcomes Following Pulmonary Valve Replacement in Adults
Official title: Review of Outcomes Following Pulmonary Valve Replacement for Congenital Heart Disease in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease, Congenital
Pulmonary Valve Replacement
Keywords: Congenital Heart Disease
Pulmonary Valve Replacement
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: One of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation.

Multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. However, the optimal prosthetic valve for use in the pulmonary position has not been defined. There are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic "tube" grafts used to replace the entire right ventricular outflow tract and mechanical valves.

All three of these valve options have been used in adults with congenital heart disease at Emory Healthcare and at Children's Healthcare of Atlanta at Egleston.

The goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.


Eligibility criteria: Inclusion Criteria: Adult patients who have received a pulmonary valve replacement for congenital heart disease at Children's Healthcare of Atlanta at Egleston or are in the Emory Healthcare System between 1976 and 2004.

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Exclusion Criteria:

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Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare System
state: Georgia
Study officials:
affiliation: Emory University Medical Center
name: Paul M Kirshbom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01585337: Trunk Forward Ability in Patients With Lumbar Fusion
Official title: Joint Coordination Changes During Functional Activities After Lumbar Fusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fusion of Spine, Lumbar Region
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects will be recruited from Far Eastern Memorial Hospital. The study is approved by the Institutional Medical Research Ethics Committees in both National Taiwan University Hospital and Far Eastern Memorial Hospital. The consent form is as . We will recruit patients aged between 30 to 60 years old.

Brief summary: The hypotheses of this study are as follows:

1. There is no significant muscle activity difference of each muscle in patients between pre and post operation.
2. There is no significant forward reach distance/average velocity difference in patients between pre and post operation.
3. There is no significant standard deviation of center of pressure (COP) along x axis, speed of COP along y axis during the task and COP path during the 3-sec holding phase difference in patients between pre and post operation.
4. There is no significant muscle activity difference between muscles on both sides at post operation.

Detailed description: 30 healthy adults and 30 patients is going to undergo lumbar fusion surgery will be recruited in this study. The assessment will be held before surgery, two months, three months and six months after surgery. Visual pain scale and passive range of motion over lumbar, hip, knee, ankle joint of each subjects will be recorded. Then the maximum voluntary contraction at lower extremity will be measured by electromyography. Finally, the subjects will be asked to do forward reach by dominant upper limb/bilateral upper limbs/arm crossed in the front of chest for three times in standing and sitting position after five practices. The motion data will be collected by 3-dimension video and the muscle activity by electromyography.

Eligibility criteria: Inclusion Criteria:

1. specific low back pain with MRI finding by the radiologist and the surgeon;
2. patient who is scheduled for MISS in one week.

Exclusion Criteria:

1. scoliosis;
2. neurological disorder;
3. Self-reported impairment in daily activities;
4. leg length deficiency over 2 cm;
5. body mass index over 30.

Primary outcomes:
measure: EMG
timeFrame: one months post operation
Secondary outcomes:
measure: forward reach distance
timeFrame: one month post operation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University, College of Medicine
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Li Hsu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01030237: An Evaluation of the Safety and Efficacy of FID 114657
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 153
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: The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye
* NaFl Corneal Staining sum score ≥ 3 in either eye

Exclusion Criteria:

* Must not have worn contact lenses for 1 week preceding enrollment

Primary outcomes:
measure: Tear Break-Up Time (TBUT)
timeFrame: measured at Days 0, 7, 14, 28 and 42
measure: Corneal Staining
timeFrame: measured at Days 0, 7, 14, 28 and 42
measure: Conjunctival Staining
timeFrame: measured at Days 0, 7, 14, 28 and 42
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05361837: Efficacy of Serratus Anterior Plane Block With Dexmedetomidine During Breast Surgery
Official title: Efficacy of Single Level Versus Bilevel Serratus Anterior Plane Block With Dexmedetomidine During Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 172
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for modified radical mastectomy,
* Age 18-65 years,
* ASA I-II

Exclusion Criteria:

* patient refusal,
* coagulation defects,
* abnormal kidney or liver functions,
* local infection at site of injection.

Primary outcomes:
measure: First time to receive analgesia
timeFrame: First 24 hours postoperatively
measure: Total analgesic requisite
timeFrame: First 24 hours postoperatively
Secondary outcomes:
measure: Pain scores
timeFrame: First 24 hours postoperatively
measure: Side effects
timeFrame: First 24 hours postoperatively
measure: Perioperative heart rate values
timeFrame: First 24 hours
measure: Mean arterial blood pressure
timeFrame: First 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant Professor of Anesthesia and Pain management
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03684837: D Vitamine and Whole Body Vibration in Functional Outcomes
Official title: D Vitamine Supplementation and Whole Body Vibration Altering Functional Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Aging
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 59
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Older with Chronic obstructive Pulmonary Disease (COPD) were submitted to chronic whole body vibration training during 03 months, receiving a vitamine D dose for each week or placebo vitamine. This group was compared with healthy older which were submitted to the same intervention.


Eligibility criteria: Inclusion Criteria:

* Older patients with COPD
* Both genders
* Sedentary according to International Physical Activity Questionnaire (IPAQ) short form
* BMI in between 22.9 and 28 kg/m2.
* Older patients with COPD should have a clinical-functional diagnosis of the disease according to GOLD (GOLD, 2018), have been ex-smokers and have not used corticosteroids or have used this drug in a stable way for at least one year (without dosage or medication modifications).
* Older volunteers should be self-referenced healthy or, if they had systemic arterial hypertension or diabetes mellitus, these comorbidities should be controlled by diet or regular medication use.

Exclusion Criteria:

* Older patients with COPD who had episodes of exacerbation in the last three months, those with pulmonary rehabilitation programs in the last year, those who used home oxygen therapy, and patients with COPD-associated comorbidities were excluded.
* Volunteers of both groups who were taking vitamin D were excluded, as well as the current smokers, although occasional, volunteers with a history of labyrinthitis or thromboembolism, who had undergone surgical procedures of any size in the last year, such as plaques, pins or cardiac pacemakers, those with unconsolidated fractures that used medications that affected bone metabolism or lean mass, or those who had difficulties adapting to the assessment or the training protocol.

Primary outcomes:
measure: Functional capacity
timeFrame: before and immediately up to 12 weeks in WBV training.
Secondary outcomes:
measure: Balance static and dynamic
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Gait speed
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Body composition
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Quality of life measure by WHOQOL
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Peripheral strength
timeFrame: before and immediately up to 12 weeks in WBV training.
measure: Respiratory strength
timeFrame: before and immediately up to 12 weeks in WBV training.
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Federal University of Pernambuco
state: Pernambuco
Study officials:
References:
Clinical trial NCT01225237: A Study to Evaluate Efficacy of Ramosetron on Diarrhea-predominant Irritable Bowel Syndrome (IBS) in Male Patients
Official title: Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - Double-blind, Parallel-group Comparative Study in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: diarrhea
IBS
Colonic disease
YM060
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 296
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to verify the superiority of ramosetron hydrochloride (Irribow Tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Eligibility criteria: Inclusion Criteria:

* Patients meeting the Rome III Diagnostic Criteria
* Loose (mushy) or watery stools within the last 3 months

Exclusion Criteria:

* Patients with a history of surgical resection of the stomach, small intestine or large intestine
* Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* Patients with a history or current diagnosis of colitis ischemic
* Patients with a current diagnosis of enteritis infectious
* Patients with a current diagnosis of hyperthyroidism or hypothyroidism
* Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
* Patients with a history or current diagnosis of malignant tumor
* Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Primary outcomes:
measure: Responder rate of stool form normalization
timeFrame: For 4 weeks
Secondary outcomes:
measure: Responder rate of patients reported global assessment of relief of IBS symptoms
timeFrame: For 4 weeks
measure: Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
timeFrame: For 4 weeks
measure: Responder rate of patients reported assessment of improvement of abnormal bowel habits
timeFrame: For 4 weeks
measure: Safety assessed by the incidence of adverse events and abnormal values in labo-tests
timeFrame: For 4 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Fukudo S, Ida M, Akiho H, Nakashima Y, Matsueda K. Effect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea. Clin Gastroenterol Hepatol. 2014 Jun;12(6):953-9.e4. doi: 10.1016/j.cgh.2013.11.024. Epub 2013 Dec 4.
Clinical trial NCT03914937: Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
Official title: Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Anxiety
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for minor elective plastic surgery procedure

Brief summary: The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures

Detailed description: Patients who are undergoing minor plastic surgery procedures will be assigned to either wear a virtual reality device or to listen to music of their choice. Patients will still get the standard lidocaine/novocaine numbing agent. Patients will be asked questions about their anxiety level and pain level. Heart rate and blood pressure will be monitored as measures of anxiety and pain.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for minor elective plastic surgery procedure
* Patients without cognitive, visual or hearing impairments

Exclusion Criteria:

* Patients with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
* Lesions that involve portions of the head or face that will prohibit the use of VR goggles
* Severe vertigo
* Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure and epilepsy and those placed in isolation (MRSA, VRE) were excluded.
* Patients who are pregnant
* Hearing or visually impaired
* Patients \<18 years old

Primary outcomes:
measure: Subjective Pain
timeFrame: 1 hour
measure: Blood pressure
timeFrame: 1 hour
measure: Heart rate
timeFrame: 1 hour
Secondary outcomes:
measure: Anxiety
timeFrame: 1 hour
measure: Patient Satisfaction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Karim W Sadik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Guthrie Clinic
name: Crystal D Sadik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Guthrie Clinic
name: Nicholas Evertson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sadik, K. , Miller, M. , Evertsen, N. , Sadik, C. and Bonatti, H. (2023) Virtual Reality in Surgery: Double Blind, Randomized Clinical Trial of Pain Control and Augmented Satisfaction. Surgical Science, 14, 456-467. doi: 10.4236/ss.2023.146050.
Clinical trial NCT03073837: Rudolph: Nasal Microbiota With Red and Sore Nose
Official title: RUDOLPH Study Nasal Microbiota and Concurrent Nose Soreness Associated With Common Cold Infection - a Pilot Using the HRV-16 Challenge Model in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
Collaborators: name: NIZO Food Research
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2017-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.


Eligibility criteria: Inclusion Criteria:

* self reported proneness to developing symptoms of nose redness and/or soreness
* sero-negative to HRV-16 at screening

Exclusion Criteria:

* confirmed or self-reported allergic rhinitis
* history of nasal or otologic surgery
* use of anti-inflammatory medication, recent antibiotics or anti-histamines

Primary outcomes:
measure: nasal microbiota composition and occurrence of nose redness and soreness during rhinovirus infection
timeFrame: change from baseline compared to day 22
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: AIDS Malignancy Consortium
name: Lutter Rene, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04043637: Early Urinary Continence After Radical Prostatectomy: Surgical Procedure and Anatomic Landmarks
Official title: Complete Puborectalis, Puboperinealis Muscle and Urethral Rhabdomyosphincter Preservation in Laparoscopic Radical Prostatectomy: Anatomic Landmarks to Achieving Early Urinary Continence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Cancer
Surgical Procedure, Unspecified
Urinary Incontinence
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A series of 120 consecutive prostate cancer patients who underwent Laparoscopic Radical Prostatectomy from 2012 to 2018, always performed by the same surgeon

Brief summary: This study describes how to perform a correct prostatic apex and membranous urethra in order to preserve all anatomical elements that are necessary to achieve a very fast urinary continence after open/laparoscopic/robotic radical prostatectomy, avoiding positive surgical margins at this level.

Detailed description: This study describes a simple technical variation, aimed at the sparing of the muscle systems and neurovascular bundles in order to achieve high rates of urinary continence in the early postoperative period ( the first two months after surgery) in prostate cancer patients undergoing radical prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Age between 40 and 75 years
* A Body Mass Index lower than 35 Hg/m2
* Patients with organ-confined prostate cancer
* Signed informed consent

Exclusion Criteria:

* Contraindications for Laparoscopy

Primary outcomes:
measure: change in the proportion of patients with of urinary incontinence
timeFrame: The follow-up was at 2 weeks, 4 weeks and 8 weeks after removal of the urethral catheter (one week after surgery), and, thereafter, once a month over the first year after surgery
Secondary outcomes:
measure: change in the proportion of patients with recovery of the erectile function
timeFrame: every month during the first year after surgery
measure: number of patients with overall positive surgical margins
timeFrame: immediate postoperative period
measure: biochemical recurrence rate
timeFrame: until the completion of the study, with a mean follow-up of 72 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01893437: A Study of RO6799477 in Healthy Volunteers
Official title: A Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6799477 Following Oral Administration of Single Ascending Doses in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This single-center, randomized, double-blind, placebo-controlled, single dose study will investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Male healthy volunteers, aged 18-45 years, inclusive
* Male volunteers with female partner of childbearing potential must agree to use an effective form of birth control during the study and for 3 months after discontinuation of treatment.
* Body Mass index (BMI) of 18-30 kg/m2, inclusive

Exclusion Criteria:

* Infection with human immunodeficiency virus antibody (HIV 1 and 2), Hepatitis B, hepatitis C
* Positive testing for drugs of abuse
* Any history of alcohol and/or drug of abuse addiction

Primary outcomes:
measure: Part 1: Safety: Incidence of adverse events
timeFrame: 18 weeks
Secondary outcomes:
measure: Part 1 and 2: Pharmacokinetics: plasma concentration of RO6799477
timeFrame: Pre-dose, Day 1, 2, 3, 4
Other outcomes:
Locations:
city: Leiden
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: