louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01279551: Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Official title: Topical Application of GTN 0.4% in the Treatment of Anismus Following Stapled Haemorrhoidopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain After Stapled Haemorrhoidopexy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2011-01-19
Enrollment: 40
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 wants demonstrate that the use of 0.4% nitroglycerin ointment can reduce the postoperative pain related to anorectal spasm (anismus) while performing a stapled haemorrhoidopexy.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
* Adults aged ≤ 75, male or female

Exclusion Criteria:

* Concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)

Primary outcomes:
measure: Postoperative pain related to upper anal canal pressure increasing (yes or no)
timeFrame: from the intervention to 1 month
measure: Postoperative pain remission
timeFrame: from 1 to 90 days after intervention
measure: Postoperative anal resting pressure at pain remission
timeFrame: from 1 to 90 days after intervention
Secondary outcomes:
measure: Duration of therapy
timeFrame: from 1 to 90 days after intervention
measure: Use of additional analgesic
timeFrame: from 1 to 90 days to intervention
measure: Postoperative pain intensity
timeFrame: from 1 to 90 days after intervention
measure: Patients satisfaction
timeFrame: 45 days after intervention
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
Study officials:
affiliation: Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
name: Francesco Saverio Mari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oneday-Day Surgery Unit, II Faculty of Medicne and Surgery, Sapienza University of Rome
name: Luigi Masoni, MD
role: STUDY_CHAIR
References:
citation: Mari FS, Nigri G, Dall'Oglio A, Cosenza UM, Milillo A, Terrenato I, Pancaldi A, Brescia A. Topical glyceryl trinitrate ointment for pain related to anal hypertonia after stapled hemorrhoidopexy: a randomized controlled trial. Dis Colon Rectum. 2013 Jun;56(6):768-73. doi: 10.1097/DCR.0b013e31828b282c.
Clinical trial NCT01601951: Outcomes Data of Bone Marrow Stem Cells to Treat Hip and Knee Osteoarthritis
Official title: Autologous Bone Marrow Concentrate Database Outcomes Research Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip and Knee Osteoarthritis
Keywords: Osteoarthritis
Stem Cell Injections
Bone Marrow
Autologous
Lead sponsor: Regenerative Pain Center, Illinois
Sponsor class: OTHER
First posted: 2012-05-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopedic clinic, those with a diagnosis of hip or knee osteoarthritis, scheduled for an Autologous Bone Marrow injection

Brief summary: The purpose of this study is to determine if Bone Marrow Concentrate may be successful in the treatment of osteoarthritis. Bone Marrow Concentrate is known to contain a community of cells that has been shown to have "regenerative" properties. This study is designed to evaluate the short-term clinical and x-ray outcomes of injections for hip and knee osteoarthritis.

Inclusion Criteria:

* Subjects must be scheduled for an autologous bone marrow hip or knee injection
* Subjects must have a diagnosis of hip or knee osteoarthritis
* Subjects must be between the ages of 18 and 85
* Subjects must be willing and able to sign Informed Consent
* Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
* Subjects for whom baseline data is not available


Eligibility criteria: Inclusion Criteria:

* Subjects must be scheduled for an autologous bone marrow hip or knee injection
* Subjects must have a diagnosis of hip or knee osteoarthritis
* Subjects must be between the ages of 18 and 85
* Subjects must be willing and able to sign Informed Consent
* Subjects must be willing and able to return for scheduled follow-up evaluations

Exclusion Criteria:

* Subjects who have had any type of visco-supplementation in the treated joint within the last three months prior to enrollment
* Subjects for whom baseline data is not available

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Baseline, 6 weeks, 3 months, 1 year
measure: Harris Hip Score or Knee Society Score
timeFrame: Baeline, 6 weeks, 3 months, 1 year
measure: Physician Global Assessment
timeFrame: Baseline, 6 weeks, 3 months, 1 year
Secondary outcomes:
measure: Radiologic
timeFrame: Baseline, 1 year
Other outcomes:
Locations:
city: Des Plaines
country: United States
facility: Regenerative Pain Center
state: Illinois
Study officials:
affiliation: Regenerative Pain Center
name: Mitchell Sheinkop, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814151: MicroPhage S. Aureus / MSSA / MRSA Blood Culture Beta Trial
Official title: Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Staphylococcal Infection
Sepsis
Infection
Keywords: Blood culture
Staphylococcus aureus
Bacteremia
MRSA
MSSA
MicroPhage
Lead sponsor: MicroPhage, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-24
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Blood culture positive specimens from three academic medical centers.

Brief summary: In-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform.

Detailed description: This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age.
* Blood culture positive, of ANY of the following bottle types:
* BD Bactec Standard Aerobic and Anaerobic,
* BD Bactec Plus Aerobic and Anaerobic,
* bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
* bioMerieux BacT/Alert FAN Aerobic and Anaerobic.

Exclusion Criteria:

* BD Bactec Lytic, Pediatric, or other bottle types not listed above.
* bioMerieux Pediatric FAN or other bottle types listed above.
* Trek bottles.
* Specimens from patients under 18 years of age.

Primary outcomes:
measure: Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
timeFrame: Within 48 hours
Secondary outcomes:
measure: Qualitative feedback on the preliminary MicroPhage test protocol.
measure: Comparative results to market-available S. aureus / MRSA tests for Blood Culture.
timeFrame: Within 48 hours
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare Research Institute
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institute
state: Maryland
Study officials:
affiliation: MicroPhage, Inc.
name: J D Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06324851: The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation
Official title: The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endometrial Polyp
Endometrial Diseases
Keywords: hysteroscopy
Endometrial preparation
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
First posted: 2024-03-22
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Drospirenone/Estetrol or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.


Eligibility criteria: Inclusion Criteria:

* Patients with endometrial polyps.

Exclusion Criteria:

* Patients with other endometrial pathologies.

Primary outcomes:
measure: Quality of endometrial preparation
timeFrame: 14th day of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Andrea Etrusco
city: Rome
country: Italy
facility: Marco Monti
Study officials:
References:
Clinical trial NCT00395551: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.
Official title: A Single Center Study of the Safety and Efficacy of Multiple Intravitreal Injections of Ranibizumab in Subjects With CNV Secondary to Causes Other Than AMD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Choroidal Neovascularization
Keywords: choroidal neovascularization
Choroidal Neovascularization Not related to Age-Related Macular Degeneration
Lead sponsor: Ophthalmic Consultants of Boston
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.


Eligibility criteria: Inclusion Criteria:

* active choroidal neovascularization

Exclusion Criteria:

* pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies

Primary outcomes:
measure: The primary outcome measures for safety and tolerability
timeFrame: Mean change in visual acuity from baseline to 6 months & 12 months
Secondary outcomes:
measure: The secondary outcome measures for efficacy
timeFrame: Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA
Other outcomes:
Locations:
Study officials:
affiliation: Ophthalmic Consultants of Boston
name: Jeffrey S Heier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05282251: Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain
Official title: Pain Managment After VATS to Reduce Postoperative Pain and Improve Pulmonary Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracic surgery is now common and as other surgeries evolution of minimally invasive techniques is employed. Video-assisted thoracic surgery (VATS) produces little scar but may produce severe pain that may affect the pulmonary function. Many procedure was developed like intercostal nerve block which require injections at multiple levels, Insertion of local anaesthetic (LA) in the surgical drain but that was dangerous due to the large amount of LA and not sufficient to completely eliminate pain. Bupvicaine nebulization, through surgical port which won't make any other wound, thought to be sufficient because Nebulization will enable us better distribution and less amounts of LA. Bupvicaine is local anaesthetic amide group that works by blocking sodium channels thus preventing progression of action potential.


Eligibility criteria: Inclusion Criteria:

* Patients that reach American socity of anesthesiologist class 1-3
* Scheduled for VATS surgery under general anesthesia.

Exclusion Criteria:

* ● Allergy to local anesthetics

  * Patient with pleural inflammation due to recent pneumonia
  * Patients who are unable or unwilling to perform spirometer test
  * Renal dysfunction: (Elevated creatinine \> 2 mg\\dl)
  * Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)
  * History of addiction

Primary outcomes:
measure: Time to first rescue analgesia
timeFrame: The first 24 hours postoperatively
Secondary outcomes:
measure: Total opioid consumption
timeFrame: The first 24 hours postoperatively
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
state: Assuit
Study officials:
References:
Clinical trial NCT00365651: Nutrition and Soccer for Pediatric Overweight and Obesity
Official title: Multi Intervention Approach to Pediatric Overweight and Obesity: A Randomized Control Group Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Overweight
Keywords: obesity
overweight
Lead sponsor: Leach Chiropractic Clinic
Sponsor class: OTHER
Collaborators: name: Mississippi University for Women
name: MUW Southern Women's Institute
First posted: 2006-08-17
Enrollment: 22
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether two months of youth soccer, combined with a single brief behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.

Detailed description: Female overweight and obese public school students will be recruited during the summer of 2006 based on FitnessGram testing done by graduate students at MSU during their prior (4th grade) school year. After receiving informed consent from parent/child, the subjects will be checked for height/weight and other screening criteria, then exposed to 2005 My Pyramid for Kids, "Tips for Families" information, and watch a short 8 minute DVD that discusses the importance of exercise and fitness by way of interviewing two club level female soccer players of equivalent age. Subjects will then be randomly assigned to fall youth soccer in Starkville, or spring youth soccer, after first phase data collection occurs in November, 2006.

Eligibility criteria: Inclusion Criteria:

* obese or overweight 4th grade public school student in Starkville

Exclusion Criteria:

* unable to run or physical disease or disability

Primary outcomes:
measure: BMI
timeFrame: 5 months
Secondary outcomes:
measure: My Tips for Families Quiz
timeFrame: 5 months
Other outcomes:
Locations:
city: Starkville
country: United States
facility: Leach Chiropractic Clinic, Inc.
state: Mississippi
Study officials:
affiliation: Leach Chiropractic Clinic, Inc
name: Robert A Leach, DC, MS(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Mississippi University for Women
name: Joyce M Yates, Ed.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04660851: Improving Diet Protein Intake in Middle-aged Women
Official title: Improving Diet Protein Intake in Middle-aged Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Keywords: Protein intake, coaching, strength
Lead sponsor: Florida Atlantic University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 54
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study sought to examine the effectiveness of nutrition education with and without diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Detailed description: The study sought to examine the effectiveness of nutrition education alone and with 10 weeks of diet coaching on dietary protein intake and muscle mass, strength and function among a group of middle-aged women.

Eligibility criteria: Inclusion Criteria:

* able to understand and respond to questions or instructions in English
* working telephone
* willingness to consume protein-containing animal products,
* willingness to make changes to the diet

Exclusion Criteria:

* self-reported information that they have been told by a medical doctor that they have kidney (renal) disease
* current or past history of a diagnosed eating disorder
* have an internal cardiac pacemaker/defibrillator or other metal-type implant present
* vegan dietary practices
* refusal to make changes to usual dietary protein intake
* usual dietary protein intake greater than 1.2 g per kg body weight

Primary outcomes:
measure: Changes in dietary protein intake from baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in muscle mass
timeFrame: 12 weeks
measure: Changes in upper body muscle strength
timeFrame: 12 weeks
measure: Changes in lower body muscle strength and function
timeFrame: 12 weeks
measure: Changes in muscle function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Florida Atlantic University
state: Florida
Study officials:
affiliation: Professor, College of Nursing, Florida Atlantic University
name: Sareen S Gropper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00525551: Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis
Official title: Acetylcystein Vid Stapedotomi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Otosclerosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: AstraZeneca
First posted: 2007-09-06
Enrollment: 152
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: In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.

Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.


Eligibility criteria: Inclusion Criteria:

* Otosclerosis where surgery is planned
* Air / bone gap larger than 20 dB
* Normal middle ear status

Exclusion Criteria:

* Hypersensitivity to acetylcysteine
* Deafness on the other ear
* Stapedotomy previously performed on the ear
* Pregnancy
* Asthma

Primary outcomes:
measure: Hearing thresholds
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Dept. of Otorhinolaryngology
city: Uppsala
country: Sweden
facility: Academic Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Dan Bagger-Sjoback, M.D.,Ph.D.
role: STUDY_CHAIR
affiliation: Karolinska Institutet
name: Anders Fridberger, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bagger-Sjoback D, Stromback K, Hakizimana P, Plue J, Larsson C, Hultcrantz M, Papatziamos G, Smeds H, Danckwardt-Lilliestrom N, Hellstrom S, Johansson A, Tideholm B, Fridberger A. A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery. PLoS One. 2015 Mar 12;10(3):e0115657. doi: 10.1371/journal.pone.0115657. eCollection 2015.