louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03260699: Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)
Official title: To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthropathy of Knee
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.


Eligibility criteria: Inclusion Criteria:

Age: 50 years or older

Exclusion Criteria:

* BMI \> 40
* Radiographic deformity of greater than 10 degrees

Primary outcomes:
measure: Number of Physical Therapy Visits
timeFrame: Total number of visits from date of surgery to 12 weeks after surgery
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Pain (0-10 Scale)
timeFrame: Change from baseline to 12 weeks after surgery
measure: Timed up and go Test (Timed Measurement)
timeFrame: Change from baseline to 12 weeks after surgery
measure: Timed Stair Climb (Timed Measurement Over Fixed Distance)
timeFrame: Change from baseline to 12 weeks after surgery
measure: One-leg Stance Time (Timed Measurement)
timeFrame: Change from baseline to 12 weeks after surgery
measure: 6 Minute Walk Test (Distance Measurement)
timeFrame: Change from baseline to 12 weeks after surgery
measure: Knee Society Score Questionnaire
timeFrame: Change from baseline to 12 weeks after surgery
measure: Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
timeFrame: Change from baseline to 12 weeks after surgery
measure: Hospital for Special Surgery (HSS) Score (0-100 Scale)
timeFrame: Change from baseline to 12 weeks after surgery
measure: Type of Pain Medication Used
timeFrame: Change from baseline to 12 weeks after surgery
measure: Amount of Pain Medication Used
timeFrame: Change from baseline to 12 weeks after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Department Chair
name: Spindler Kurt, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01205399: A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
Official title: A Single Arm, Multi-Center, Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

Brief summary: This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past.

All subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past will be contacted and asked to take part in this clinical study. The consented subjects' medical records will be reviewed for evidence of any risk factors of hernia recurrence, procedure time, complications and any documented recurrences. The subjects will be asked to undergo a physical exam to rule out any recurrences that were not documented in the medical records.

Detailed description: Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.

Eligibility criteria: Inclusion Criteria:

* Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
* Have signed an informed consent form (ICF).

Exclusion Criteria:

* Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
* June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.

Primary outcomes:
measure: Number of Subjects With Hernia Recurrence Post Repair With an AlloMax Surgical Graft
timeFrame: 9 + Months
Secondary outcomes:
measure: Complications in Subjects With Hernias Repaired With an AlloMax Surgical Graft.
timeFrame: 9+ Months
measure: Procedural Time for AlloMax Surgical Graft Placement.
timeFrame: 0 Days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Saint Peters
country: United States
facility: Benrus Surgical Associates, Inc
state: Missouri
city: Mineola
country: United States
facility: Winthrop Surgical Associates, Inc.
state: New York
city: Tulsa
country: United States
facility: Surgical Associates, Inc.
state: Oklahoma
city: Pittsburg
country: United States
facility: Golla Center for Plastic Surgery
state: Pennsylvania
Study officials:
affiliation: University of Kentucky
name: John S Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03053999: Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
Official title: Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Endocrine Neoplasia
Pancreatic Neuroendocrine Tumors
Hyperparathyroidism
Keywords: Multiple Endocrine Neoplasia
Pancreatic Neuroendocrine Tumors
Hyperparathyroidism
HPTH
PNET
Biomarkers
Parathyroidectomy
Genome sequencing
Data review
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 53
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants identified as follows: Patients of the Surgical team at MD Anderson Cancer Center who have undergone parathyroidectomy.

Brief summary: The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.

Detailed description: Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.

Eligibility criteria: Inclusion Criteria:

1. MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
2. MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Genome Sequencing
timeFrame: 10 years
Secondary outcomes:
measure: Identification of Somatic Mutations and Inherited Genetic Variants to Help Predict the Development of Pancreatic Neuroendocrine Tumors (PNET) in Participants with Hyperparathyroidism by Data Review
timeFrame: 10 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Nancy D. Perrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02405299: Assessment of Neurocognitive Rehabilitations of Inhibition of Disorders in ADHD in Children (ERNTITDAH)
Official title: Evaluation Des rééducations Neuropsychologiques Des Troubles de l'Inhibition Chez l'Enfant Avec un TDAH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: child
disorders inhibition
neuropsychology
rehabilitation
ADHD
assessment of neurocognitive rehabilitations in ADHD in children
Lead sponsor: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to assess the cognitives rehabilitations in attention deficit disorder (ADHD) in children. the objective is to demonstrate what are the most relevant cognitive factors for rehabilitative to improve the inhibition of disorders in ADHD.

Detailed description: This study examines the effect of neuropsychological rehabilitation on the disorder inhibtion in the child with ADHD.

Sample includes 60 subjects aged 9-13 years with disorder of inhibition evalued with neuropsychological test. Neuropsychological rehabilitation protocol was developed and evaluated.

This study use baseline and includes a control group and an experimental group. The type of cognitive procedure (up / down, or rehabilitative / metacognitive) is examined.

Eligibility criteria: Inclusion Criteria:

* presence of a disorder of inhibition (assessed by neuropsychological subtests) as part of an ADHD with normal intellectual potential (ICV WISC4) in children born at term or preterm (-33SA)

Exclusion Criteria:

* patient refusal and family to participate in the study
* subjects with sensory disorders, psychological or unsupported, subjects carrying other cognitive disorders prevalent disorder of inhibition
* subjects with psychostimulant treatment at inclusion in the study

Primary outcomes:
measure: scores to neuropsychological testing inhibition before and after rehabilitation in experimental groupe
timeFrame: 5 months
Secondary outcomes:
measure: scores to neuropsychological testing inhibition before and after rehabilitation in control group
timeFrame: 5 months
Other outcomes:
Locations:
city: Villefranche Sur Saone
country: France
facility: Seguin
state: Rhone
Study officials:
References:
Clinical trial NCT06506799: Effect of Training on the Use of Physical Restraints
Official title: "Determining the Effect of the Training Given to Intensive Care Nurses on Their Knowledge Level, Attitudes and Practices Regarding the Use of Physical Restraints"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fixation Device; Complications
Nursing Caries
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Patients in the intensive care unit may harm themselves by pulling medical equipment such as endotracheal tube, monitoring, arterial and peripheral catheters. Physical detection is also one of the common practices used in this case. Physical restraint is a practice performed by using patient aids to protect the individual or other patients around him, to ensure his safety and to control his behavior. Although physical detection seems to be a useful and simple method, it brings with it various physical, psychological, ethical, legal and moral problems. Nurses should use alternative strategies to prevent and reduce the use of restraint, and to avoid the negative consequences that may be caused by restraint by performing restraint appropriately and effectively, and thus ensure the safety of the patient. Evaluating nurses' knowledge on this subject, identifying deficiencies and providing training is important in terms of improving the quality of care and ensuring patient safety.


Eligibility criteria: Inclusion Criteria:

* Working as a nurse in an adult intensive care unit
* Fill out the form completely
* Volunteering to participate in the study
* No vision or language problems to fill out the form

Exclusion Criteria:

* Filling the form incompletely
* Coming to the intensive care unit on rotation
* Not attending training
* No vision or language problems to fill out the form
* Having previously received training on physical detection

Primary outcomes:
measure: outcome 1
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02021799: The Effect of Under-nutrition on the Human Microbiota
Official title: The Effect of Nutrition on the Microbiome in Pregnant Women and the Use of Micronutrient Supplemented Probiotic Yogurt to Improve Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Gut microbiome
Vaginal microbiome
Oral microbiome
Human milk microbiome
Nutritional Status
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: National Institute for Medical Research, Tanzania
First posted: 2013-12-27
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether a difference exists in the gut, oral, vaginal and human milk microbiome of under-nourished pregnant women as compared to healthy and obese pregnant women. In addition, the investigators are setting out to determine if a micronutrient enriched probiotic yogurt can improve the microbiome and pregnancy outcomes of under-nourished pregnant women.


Eligibility criteria: Inclusion Criteria:

* Greater than 12 weeks pregnant
* between the ages of 18 and 40 years

Exclusion Criteria:

* Less than 12 weeks pregnant

Primary outcomes:
measure: Characterization of gut, oral, vaginal and human milk microbiomes
timeFrame: Monthly for an average of four months
Secondary outcomes:
measure: Assessment of 48-hour Dietary Recalls
timeFrame: Monthly on average for four months
measure: Changes in body toxin levels
timeFrame: Before and after intervention (approximately 100 days)
measure: Changes in blood nutrient levels
timeFrame: before, half-way through and after intervention (approximately 100 days)
measure: Analysis of anthropometric measurements
timeFrame: Monthly on average for four months
Other outcomes:
measure: Analysis of Anthropometric Measurements
timeFrame: Monthly on Average for 4 months
Locations:
city: Buswelu
country: Tanzania
facility: Nyerere Dispensary
Study officials:
affiliation: Western University, Canada; Lawson Health Research Institute
name: Gregor Reid, BSc Hons PhD MBA ARM CCM Dr HS
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Jeremy P Burton, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bisanz JE, Enos MK, Mwanga JR, Changalucha J, Burton JP, Gloor GB, Reid G. Randomized open-label pilot study of the influence of probiotics and the gut microbiome on toxic metal levels in Tanzanian pregnant women and school children. mBio. 2014 Oct 7;5(5):e01580-14. doi: 10.1128/mBio.01580-14.
Clinical trial NCT05219799: Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Official title: Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Obesity
Vasodilation
Healthy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2022-02-02
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to examine key mechanisms contributing to sex-differences in hypoxic vasodilation and the impact of obesity, with particular emphasis on the sympathetic nervous system.

Detailed description: Patients with sleep apnea are at increased risk of developing cardiovascular disease - with women at potentially greater risk than men. Contributing mechanisms are not well understood, but may be related to how women respond to low oxygen and, given over 70% of patients with sleep apnea are obese, the impact of obesity. This project seeks to increase our understanding of mechanisms that may contribute to sex differences in the cardiovascular response to low oxygen with the hope that this knowledge will improve the efficacy of current therapies and support the discovery of novel therapeutics.

Eligibility criteria: Inclusion Criteria:

* BMI \>18 kg/m2

Exclusion Criteria:

* Pregnancy, breastfeeding
* Diagnosed sleep apnea or AHI \>10 events/hr
* Current smoking/Nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications, Sensitivity to lidocaine

Primary outcomes:
measure: Change in forearm vascular conductance with intra-arterial drug infusion
timeFrame: Change from baseline to last 1-minute of drug infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jacqueline Limberg, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04312399: Hormone Replacement Trial Against ALzheimers' Disease
Official title: Hormone Replacement Trial Against ALzheimers' Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postmenopausal Symptoms
Alzheimer Disease
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-03-18
Enrollment: 600
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 study groups: 9 groups who start with hormonal treatment and 1 control group who doesn't start with hormonal treatment
Primary purpose: DIAGNOSTIC

Brief summary: The influence of postmenopausal hormone treatment on dementia is not clear. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid.

The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy.

Postmenopausal women with and without history of breast cancer will be recruited for the trial.


Eligibility criteria: Inclusion Criteria:

* postmenopausal women
* 40 - 65 years

Exclusion Criteria:

* Longer than 10 years in menopause
* thyroid dysfunction
* hypertension
* medical history of psychiatric comorbidity
* Alcohol and/or drug abuse
* medical history of neurologic symptoms with cognitive symptoms

Primary outcomes:
measure: Degradation products of the Amyloid metabolism in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: Degradation products of the Amyloid metabolism in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: Degradation products of the Amyloid metabolism in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: Degradation products of the Amyloid metabolism in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: Degradation products of the Amyloid metabolism in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: Degradation products of the Amyloid metabolism in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: APOE-genotyping in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
measure: identify BACE1 in blood
timeFrame: 2 years after the first patient was included, the first batch of samples will be analysed.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent university hospital
Study officials:
affiliation: University Hospital, Ghent
name: Herman Depypere, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02010099: A Prospective, Randomized, Three Arms, Open Label Study Comparing the Safety and Efficacy of Two Formulations of PP110 to the Active Comparator Preparation-H® Cream in the Treatment of Bleeding Hemorrhoids Grades 2-3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bleeding Hemorrhoids
Lead sponsor: Peritech Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-12
Enrollment: 101
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: Eligible patients with bleeding hemorrhoids of grade 2-3 are randomized to test-1 product (PP110 Gel), test-2 product (PP-110 medicated wipes) or control (Preparation-H cream).

Test product usage: once daily, about 1-5 minutes prior to first bowel movement. Control product usage: according to label, 3-4 times daily application to rectal region.

At the end of each day, subject fills a questionnaire regarding bleeding, pain, discharge, swelling, itching, discomfort and painkiller usage.

Treatment is for two weeks, after which subjects fill a feedback questionnaire addressing treatment efficacy and subject satisfaction. Also, at the end of two weeks, subjects are examined by study physician who assesses hemorrhoid severity.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70
2. Bleeding hemorrhoids with / without pain
3. Diagnosis of internal hemorrhoids of grade 2-3, or external bleeding hemorrhoids
4. Signed Informed Consent

Exclusion Criteria:

1. Known rectal sensitivity
2. Rectal infection
3. Grade IV hemorrhoids
4. Use of anti-coagulants (except Aspirin or Plavix) within 30 days prior to enrollment
5. Known inflammatory bowel disease
6. Anal fissure
7. Military personnel
8. Female patients that are pregnant, or are not using a reliable method of birth control, or are nursing
9. Patients who have been involved in another experimental trial within the past 30 days
10. Patients presently diagnosed with cancer

Primary outcomes:
measure: Bleeding / Spotting
timeFrame: 14 days
Secondary outcomes:
measure: Pain
timeFrame: 14 days
measure: Discharge
timeFrame: 14 days
measure: Itching
timeFrame: 14 days
measure: Swelling
timeFrame: 14 days
measure: Discomfort
timeFrame: 14 days
measure: Painkillers usage
timeFrame: 14 days
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
city: Kiryat Ono
country: Israel
city: Modiin
country: Israel
city: Ramat-Gan
country: Israel
city: Tel-Aviv
country: Israel
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Ehud Klein, Prof.
role: PRINCIPAL_INVESTIGATOR
References: