louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02461082: EMST and TMS for Treatment of Dysphagia in Parkinson's Disease
Official title: Expiratory Muscle Strength Training (EMST) and Transcranial Magnetic Stimulation (TMS) for Treatment of Swallowing Disorders in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Deutsche Parkinson Vereinigung
First posted: 2015-06-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to examine the effectiveness of different methods for the treatment of dysphagia in Parkinson's disease (PD). More than 80% of patients suffering from PD develop dysphagia during the course of their disease leading to malnutrition, loss of life quality, weight loss and pneumonia, which is the leading cause of death in these patients. So far, only a few specific treatment approaches have been investigated in PD patients with swallowing disorders. The investigator want to compare a 4-week expiratory muscle strength training (EMST), transcranial magnetic stimulation (TMS), and combination of both with a sham therapy. Dysphagia severity before and after intervention is measured by flexible endoscopic evaluation of swallowing (FEES). For the evaluation of changes in cortical swallowing processing the investigators apply magnetoencephalography (MEG).


Eligibility criteria: Inclusion Criteria:

* Hoehn \& Yahr stages II-IV
* Parkinson-related dysphagia
* Oral nutrition
* Ambulant setting
* No change of medication for at least 4 weeks before study inclusion

Exclusion Criteria:

* Other causes for dysphagia
* Other neurological disease potentially causing dysphagia
* Dementia (MMSE\<25; Montreal cognitive assessment (MoCA)\<26)
* Severe depression (BDI\>19)
* Percutaneous endoscopic gastrostomy (PEG)

Primary outcomes:
measure: Dysphagia severity as measured by FEES
timeFrame: Four weeks
Secondary outcomes:
measure: Cortical reorganization of swallowing process as detected by MEG
timeFrame: Four weeks and three month
measure: Changes in quality of life as measured by the swallowing quality of life questionnaire (Swal-Qol)
timeFrame: Four weeks and three months
measure: Dysphagia severity as measured by FEES
timeFrame: Three month
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of neurology, University Hospital of Muenster
state: Nordrhein-Westfalen
Study officials:
affiliation: Universität Münster
name: Tobias Warnecke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02058082: Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage
Official title: Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
DNA Damage
Keywords: Failure to Conceive Due to Infertility of Male Partner
DNA Damage
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 25
Sex: MALE
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 determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* be considered infertile (\>1 year of unsuccessful attempts of conception
* Any race
* Male partner with persistent sperm DNA damage, DFI\>=30%
* candidates for intracytoplasmic sperm injection (ICSI)

Exclusion Criteria:

* significant female factor infertility contributing to the couple's infertility
* female partner older than 38 years
* male or female patients with genetic abnormalities
* patients unable or unwilling to give consent after properly informed
* couples unsuitable for IVF/ICSI
* male patients in whom testicular procedures were contraindicated

Primary outcomes:
measure: Live birth rates
timeFrame: Up to 1 year
Secondary outcomes:
measure: sperm DNA damage
timeFrame: Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure
measure: oocyte fertilization rates
timeFrame: at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI)
measure: embryo cleavage rate
timeFrame: Day 3 post oocytes retrieval
measure: blastocyst rate
timeFrame: Day 5 post oocytes retrieval
measure: pregnancy rate
timeFrame: 6 to 8 week ultrasound
measure: rate of spontaneous abortion
timeFrame: after a clinical pregnancy has been established, up to 10 months after procedure
measure: birth defects
timeFrame: 1-year following delivery
Other outcomes:
Locations:
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Kirk C. Lo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05343182: Vestibulectomy Surgical Techniques Comparison Study
Official title: Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the Treatment of Provoked Localized Vulvodynia (PVD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vulvar Pain
Vulvodynia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vestibulectomy Surgical Techniques Comparison Study

Detailed description: Vestibulectomy: A Prospective Comparison of Two Surgical Techniques for the treatment of Provoked Localized Vulvodynia (PVD)

Eligibility criteria: Inclusion Criteria:

1. Reported provoked tenderness to the vestibule for at least 3 months in non-pregnant, estrogen-replete healthy subjects aged 18 years or over meeting Friedrich's criteria for PVD44-45 and supported by the ISSVD Terminology Consensus Definition45 for vulvar pain. Subjects who are \>45years of age must have either have a maturation index52 of \< 10% parabasal cells or willingness to participate in local estrogen replacement until achieving this same clinical result.
2. Cotton swab Test30-31 mean verbal rating score of ≥4/10 in 4 of 6 defined points of the vestibule (2, 4, 6, 8, 10, 12 o'clock) and cotton swab test verbal score ≤ 2/10 for the labia majora and minora, intra labial sulcus, and perineum
3. Ability to insert a regular Tampax® tampon
4. Baseline Tampon Test verbal pain score ≥430

f. Phone and internet access e. Willingness to engage in pelvic floor physical therapy (PT)

Exclusion Criteria:

1. Pregnancy
2. Any other clinical reason for dyspareunia (endometriosis pain, chronic pelvic pain, vulvar dermatoses such as psoriasis, lichen sclerosus)
3. Unable or unwilling to complete baseline assessments
4. Prior vestibulectomy or hymen surgery
5. Prior or current use of testosterone dosed for gender affirmation

Primary outcomes:
measure: Change in Tampon Test pain scores from baseline to 3 months
timeFrame: Baseline visit to 3 months after surgery
measure: Change in pain scores from baseline to 6 months
timeFrame: Baseline visit to 6 months after surgery
measure: Change in pain scores from baseline to 12 months
timeFrame: Baseline visit to 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Catherine Leclair, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04611282: Surgical Treatment of Gingival Recessions
Official title: Micro and Macrosurgical Treatment of Gingival Recessions: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Trial
Connective Tissue
Gingival Recession
Microsurgery
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
Collaborators: name: Kocaeli University
First posted: 2020-11-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the effectiveness of microsurgical and macrosurgical approaches on CPFs plus SCTGs for the treatment of localized gingival recession defects (Miller class I or II) over the course of 6 months based on clinical periodontal parameters, periodontal phenotypes, and the postoperative complaints and satisfaction levels of the patients. We hypothesized that root coverage achieved through microsurgery in Miller I or II gingival recessions would improve clinical periodontal outcomes and the periodontal phenotype, with greater postoperative comfort and aesthetic satisfaction in comparison with conventional macrosurgical techniques. Miller Class I and II gingival recession defects, at least 3.0 mm deep, were selected and randomly assigned to receive micro or macrosurgical techniques. Both techniques were performed using a coronally positioned flap with a subepithelial connective tissue graft. Plaque and gingival indices, gingival recession depth and width, probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, aesthetic score and percentage of root coverage, postoperative complaints, and satisfaction of the participants completing the study were evaluated at follow-up 1st, 3rd and 6th months.


Eligibility criteria: Inclusion Criteria:

-

All participants were:

* adults aged 18 years or over
* systemically and periodontally healthy
* met the eligibility criteria for localized gingival recession of the canine or premolar teeth according to the Miller classification scheme

Exclusion Criteria:

-

Exclusion criteria included the following:

* medical disorders such as diabetes mellitus, immunologic disorders, and hepatitis;
* a history of chemotherapy or radiotherapy;
* a history of alcoholism or drug abuse;
* a history of previous mucogingival surgery at the gingival recession site;
* medications known to affect gingival tissues;
* antibiotic treatment in the past 6 months;
* smoking \>10 cigarettes per day for \>5 years, and;
* current pregnancy or lactation.

Primary outcomes:
measure: Percentage of root coverage
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Gingival recession depth
timeFrame: 6 months
measure: Changes in Gingival recession width
timeFrame: 6 months
measure: Changes in Keratinized gingival width
timeFrame: 6 months
measure: visual analog scale
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05903482: Gastric Volume in Patients on GLP-1 Medications
Official title: Gastric Volume in Patients on GLP-1 Medications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 70
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Fasting children on GLP-1 RA

Brief summary: Evaluating gastric volume in patients on GLP-1 RA medications

Detailed description: Glucagon like peptide 1 (GLP-1) receptor agonist (RA) medications have in recent years been approved for use in children with type 2 diabetes mellitis (DM) and obesity. The side effects of these medications include nausea and vomiting, and in the adult literature, delayed gastric emptying has been described. Due to the likelihood of delayed enteric motility, standard nil per os (NPO) guidelines may not be sufficient to minimize the chance of aspiration of gastric contents before anesthesia and surgery in patients receiving GLP-1 RA medications.

Investigators seek to measure the gastric volume of children on GLP-1 RA medications who are appropriately NPO (greater than/equal to 8 hours for solids and greater than/equal to 1 hour for clear liquids) using standard institutional NPO guidelines. The secondary objective is to measure the gastric volume of children not on GLP-1 RA medications, but with type 2 diabetes mellitis or obesity and/or type 1 DM.

The only study intervention is the addition of a gastric ultrasound. The gastric ultrasound is a non-invasive mode of imaging using sound waves with no known safety risks. The ultrasound will be performed while the subject is awake and will take less than 5 minutes.

Eligibility criteria: Inclusion Criteria:

Fasting Diabetic On GLP-1 RA

Exclusion Criteria:

Prior surgery that affects gastric anatomy

Primary outcomes:
measure: Gastric volume in pediatric patients on GLP-1 RA
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elaina Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02692482: Polyurethane Foam on the Sacrum for Prevention
Official title: Effectiveness of the Use of a New Polyurethane Foam Multilayer Dressing in the Sacral Area to Prevent the Onset of Pressure Sores in the Elderly With Hip Fractures. Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Pressure Ulcer
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 359
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to assess whether the application of a new hydrocellular polyurethane foam multilayer dressing shaped for the sacral area (MSP) in addition to standard care reduces the rate of pressure sores (PU) and their severity especially in the elderly population admitted for fragility Hip Fractures.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 65 years with Hip fragility fracture without National Pressure Ulcers Advisory Panel scale (NPUAP) scale grade ≥ II PU
* Patients or legal guardians who give their consent to take part in the study

Exclusion Criteria

* Patients with known allergy to the product being tested or dermatological diseases that prevent the use of topical products
* Patients with peri-prosthetic or pathological fractures
* Patients with diaphyseal or distal femoral fractures

Primary outcomes:
measure: Number of Participants With Pressure Sores
timeFrame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Secondary outcomes:
measure: Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)
timeFrame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
measure: Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification
timeFrame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
measure: Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing
timeFrame: On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT00989482: Improving Antibiotic Prescribing Practices in Mexican Primary Care Clinics
Official title: Improving Antibiotic Prescribing Practices in Mexican Primary Care Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Tract Infections
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-10-05
Enrollment: 847
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to improve antibiotic prescribing practices of Mexican primary care physicians for patients seeking care for acute respiratory tract infections (ARIs). The investigators will employ a combination of qualitative and quantitative methods to develop and evaluate a patient education and physician decision-support intervention.

Hypothesis 1: The investigators will identify barriers and facilitators of appropriate antibiotic use for ARIs that can be addressed through patient education and physician decision-support.

Hypothesis 2: The proportion of patients who report desire for antibiotics as a "very important" reason for seeking care will decrease from 50% to 30% following exposure to the educational intervention; and 90% (95% confidence interval: 80% to 100%) of patients will report that they trust the information provided by the computer.

Hypothesis 3: Antibiotic prescribing for adults with uncomplicated acute bronchitis will decrease from 80 percent to 40 percent following the introduction of a real-time clinical decision support tool.


Eligibility criteria: Inclusion Criteria:

* adults age 18 years or greater

Exclusion Criteria:

* mental disability; severe illness

Primary outcomes:
measure: antibiotic prescription rate
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cuernavaca
country: Mexico
facility: IMSS Family Practice Clinic #1
state: Morelos
Study officials:
References:
Clinical trial NCT02637882: The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients
Official title: The Effect of Applying Multidisciplinary Bundle Intervention on the Delirium Incidence in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Delirium
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The patients will exposed to different intervention through three nights (ear plug, eye mask). 50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

Detailed description: The multicomponent bundle of interventions is designed to be multidisciplinary, and included measures taken to reduce noise, light and iatrogenic sleep disturbance, as well as attempts to modify risk factors for delirium. The patients will exposed to different intervention through three nights (ear plug, eye mask) grouping of nursing activity to be delivered before the 23:00 or delay their completion until after 08:00 where possible. Orientate patients regarding time, place and date every eight hours.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old.
* No hearing problems.
* No eye disease.

Exclusion Criteria:

* Head injury.
* Psychiatric disease.
* Shocked patients

Primary outcomes:
measure: decrease delirium incidence
timeFrame: 8 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit university hospital
Study officials:
affiliation: faculty of nursing ,Assuit university
name: Ghada Sh Khalaf, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hellstrom A, Willman A. Promoting sleep by nursing interventions in health care settings: a systematic review. Worldviews Evid Based Nurs. 2011 Sep;8(3):128-42. doi: 10.1111/j.1741-6787.2010.00203.x. Epub 2010 Oct 12.
citation: Dave K, Ashia Qureshi, L.Gopichandran, Usha Kiran. Effects of Earplugs and Eye Masks on Perceived Quality of Sleep during Night among Patients in Intensive Care Units. International Journal of Science and Research (IJSR) ISSN (Online): 2319-7064 Index Copernicus Value (2013): 6.14 | Impact Factor (2013): 4.438.
citation: Rivosecchi RM, Smithburger PL, Svec S, Campbell S, Kane-Gill SL. Nonpharmacological interventions to prevent delirium: an evidence-based systematic review. Crit Care Nurse. 2015 Feb;35(1):39-50; quiz 51. doi: 10.4037/ccn2015423.
Clinical trial NCT03173482: Prevalence of Cesarean Section on Demand in Assiut University Hospital & Abnob Central Hospital
Official title: Prevalence of Cesarean Section on Demand in Assiut University Hospital & Abnob Central Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 144
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending the hospital for cesarean section

Brief summary: Cesarean section on demand: defined as a primary cesarean section performed at the mother's request to avoid a vaginal birth, without any recognized medical or obstetric indication. The medical field now acknowledges a patient's right to actively participate in her choice of medical treatments, including method of delivery.

There are many reasons for a cesarean section on demand: fear of delivery, fear of pain, family pressure, a previous bad experience, more control over events, improved care, and maintaining the integrity of the pelvic floor. of the pelvic floor.


Eligibility criteria: Inclusion Criteria:

* Accepting to participate in the study.
* pregnant Women undergoing Cesarean section

Exclusion Criteria:

* pregnant Women undergoing Cesarean section due to medical or obstetric indication
* Caesarean hysterectomy .

Primary outcomes:
measure: the percentage of cesarean section on request in patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References: