louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02195622: Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
Official title: Randomized Controlled Trial Comparing Two Different Morcellators for HoLEP Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hypertrophy Requiring Surgical Intervention
Lead sponsor: Indiana Kidney Stone Institute
Sponsor class: OTHER
Collaborators: name: Richard Wolf Medical Instruments Corporation (RWMIC)
First posted: 2014-07-21
Enrollment: 74
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: To compare efficiency, in terms of tissue morcellation and removal time, of two commercially available FDA-approved morcellators: the VersaCut and the Piranha in subjects undergoing HoLEP procedure for benign prostatic hyperplasia (BPH).

Detailed description: Holmium laser enucleation of the prostate (HoLEP) with mechanical morcellation is a surgical technique used for treatment of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH). HoLEP represents a state of the art alternative to transurethral resection of the prostate (TURP). HoLEP has been shown to be safe and effective for treating prostates of all sizes and has low perioperative morbidity.

A holmium laser fiber is passed through a continuous-flow resectoscope and is used to resect the obstructing prostate tissue (enucleation). After enucleation is performed, the resected tissue is advanced into the bladder. The morcellator is then used to cut the tissue into small pieces which are then removed from the bladder via suction through the morcellator blades (morcellation). We currently use the first commercially available morcellator (VersaCut, Lumenis Incorporated, Santa Clara, CA). The Storz continuous-flow resectoscope (Karl Storz,Tuttlingen, Germany) is currently used to perform the enucleation portion of the procedure.

Recently, a new morcellator has been developed (Piranha, Richard Wolf, Knittlingen, Germany). The Wolf morcellator has been reported to remove tissue at a faster rate than the Lumenis device

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo HoLEP for bladder outlet obstruction due to the prostate.
* Able to give informed consent.
* Age 18 years or older

Exclusion Criteria:

* • Inability to give informed consent.

  * Age less than 18 years

Primary outcomes:
measure: Morcellation Rate
timeFrame: Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Physicians Urology
state: Indiana
Study officials:
References:
Clinical trial NCT05979922: Mindfulness-based Cognitive Coping for ADRD Caregivers
Official title: Mindfulness-based Cognitive Coping Mobile App Intervention for Caregivers of Individuals with Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Caregiver Stress
Lead sponsor: Photozig, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project will evaluate the effectiveness of the Mindfulness-based Cognitive Coping (MCC) intervention to alleviate stress and depressive symptoms of caregivers of Individuals with Alzheimer's Disease and Related Dementia.


Eligibility criteria: Inclusion Criteria:

* Care for an individual with Alzheimer's Disease or Related Dementia (ADRD).
* Own a smartphone or tablet and have Internet access.
* Minimum age of 18 years old.
* Able to read and speak English.
* Spend at least 8 hours/week caring for a person with dementia.
* Plan to stay in the area for six months.

Exclusion Criteria:

* Severe psychological or physical illness.
* Cognitive impairment or any serious medical problem that interferes with caregiving role.
* Caring for ADRD patient with a life expectancy less than six months.
* Unwillingness to participate in all aspects of the study.

Primary outcomes:
measure: Center for Epidemiological Studies Depression Scale
timeFrame: 3 months
measure: Perceived Stress Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Photozig, Inc.
state: California
Study officials:
References:
Clinical trial NCT01687322: Long Term Follow-Up After Patients Underwent Total Hip Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Hip Replacement
Pain
Keywords: quality of life
functioning
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-09-18
Enrollment: 150
Sex: ALL
Minimum age (years): 28
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: men and women than underwent total hup replacment

Brief summary: The investigators want to contact patients that underwent total hip replacement for the past ten years. The investigators will ask them about their daily living, functioning and quality of life.


Eligibility criteria: Inclusion Criteria:

1. total hip replacement from 01.01.2002

Exclusion Criteria:

1. no

Primary outcomes:
measure: quality of life
timeFrame: up to ten years
Secondary outcomes:
measure: functioning
timeFrame: up to ten years
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT04614922: Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms
Official title: Acceptance and Commitment Therapy-based Rehabilitation of Post-concussion Symptoms: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Concussion Syndrome
Post-Traumatic Headache
Keywords: Acceptance and Commitment Therapy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2020-11-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to evaluate effects of an outpatient rehabilitation program based on Acceptance and Commitment Therapy compared to usual care on function in patients with post-concussion syndrome (PCS) and post-traumatic headache (PTH). This study builds on the investigators' previous observational studies and treatment studies in this patient group.

Detailed description: The study is run in an outpatient setting at the Department of Physical Medicine and Rehabilitation, St. Olavs Hospital, Trondheim University Hospital, Norway. All patients are also participants in the observational study: "Minimal and mild head injury: an exercise and outpatient follow-up study at St. Olavs Hospital" (REK number 2018/2159).

Eligibility criteria: Inclusion Criteria:

* Having sustained a minimal HI or MTBI
* PCS/ PTH had evolved within 1 week after the head trauma.
* At least one post-concussion symptoms of at least moderate degree, that affects daily life.
* \> 6 months post-injury.
* First line treatment has been tried, e.g. psychoeducation, increase of physical activity and pharmacological treatments for headache

Exclusion Criteria:

* More than 5 years since last injury.
* Symptoms are better explained by other conditions.
* Severe communication problems, typically due to poor knowledge of Norwegian.
* Severe psychiatric, neurological, somatic or substance abuse disorders that will make it problematic to function in a group and/or will complicate follow-up and outcome assessment.

Primary outcomes:
measure: Postcincussion symptom burden
timeFrame: 3, 6 and 12 months after the intervention
Secondary outcomes:
measure: Headache
timeFrame: 3, 6 and 12 months after the intervention
measure: Work participation
timeFrame: 3, 6 and 12 months after the intervention
Other outcomes:
measure: Change of level of cytokines in peripheral blood
timeFrame: at baseline and at 3 months after the intervention
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital Clinic of Physical Medicine and Rehabilitation
Study officials:
affiliation: Norwegian University of Science and Technology, INB
name: Toril Skandsen, phd
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Olavs hospital, Clinic of Rehabilitation
name: Brit-Elin Lurud, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT05292222: Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease
Official title: A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Early-Stage Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: transmagnetic stimulation
functional MRI guided Theta Burst Stimulation
Early Stage
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a pilot trial using rs-fMRI to target dysfunctional LSBNs in early stage AD.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of Mild Cognitive Impairment (MCI)/mild AD
* Evidence for Central Nervous System (CNS) amyloidosis (e.g., Amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) biomarkers consistent with AD)
* Prior brain imaging performed
* Mini-Mental State Examination (MMSE) \>24
* Clinical Dementia Rating (CDR) Scale 0.5-1
* Stable dose of cholinesterase inhibitors and memantine for at least one month
* Subjects are between 40-90 years of age

Exclusion Criteria:

* Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
* Inability to tolerate rs-fMRI
* Contraindication of rs-fMRI due to implants or metal
* Seizure disorder

Primary outcomes:
measure: Change in Connectivity Measure of the TGd Parcellations.
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Bhavani Kashyap, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03097822: Response Prediction After GKS in Patients With Vestibular Schwannoma Using DCE MR Imaging
Official title: Response Prediction After Gamma Knife Surgery (GKS) in Patients With Vestibular Schwannoma Using Dynamic Contrast-Enhanced (DCE) MR Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vestibular Schwannoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with vestibular schwannoma, who underwent gamma knife surgery

Brief summary: Response Prediction after Gamma Knife Surgery (GKS) in Patients with Vestibular Schwannoma using Dynamic Contrast-Enhanced (DCE) MR Imaging

Detailed description: The purpose of this study was to evaluate the response of Gamma Knife Surgery to Ktrans, Ve, and Vp, which are indicators of permeability map obtained from dynamic contrast enhanced (DCE) MRI in patients with vestibular schwannoma .

Eligibility criteria: Inclusion Criteria:

* Patients with vestibular schwannoma, who underwent gamma knife surgery and pre-op dynamic contrast enhanced (DCE) MRI
* Patients with vestibular schwannoma, who received consent

Exclusion Criteria:

* In addition to the vestibular schwannoma, if the brain has other underlying or systemic disease
* During the observation period, other treatments were performed other than gamma knife surgery
* If patients have a contraindication to MRI (eg, pacemaker, cochlear implants, hemodynamically unstable)
* Concomitant use of gadolinium MRI contrast agents (eg, renal insufficiency \[glomerular filtration rate \<30 ML / min\]), or if there was a side effect when using a contrast medium.
* Adults with impaired ability to cope
* If the images and medical records required for this study are not available or are not appropriate

Primary outcomes:
measure: Tumor size change before and after surgery
timeFrame: pre-op, Immediately after surgery
Secondary outcomes:
measure: In patients who underwent gamma knife surgery, the magnitude of tumor size change before and after surgery
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital(Radiology)
name: SeungHong Choi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01801722: Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease
Official title: Using NT-proBNP to Detect Chronic Heart Failure in Patients With Chronic Obstructive Pulmonary Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Heart Failure
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years and older with a registered diagnosis of COPD.

Brief summary: The aim of the present study was to evaluate if the analysis of NT-proBNP might be used as an initial step for the diagnosis of chronic heart failure in patients with COPD in primary health care, and to select patients for a further examination by echocardiography.

Detailed description: Patients with a confirmed diagnosis of COPD were examined regarding chronic heart failure.

1. An interview regarding symptoms: breathlessness, orthopnoea, night cough, nocturia, walking distance.
2. Physical examination: weight and height, heart and lung auscultation, blood pressure measurement after 5 minutes' rest in the sitting position and the presence of peripheral oedema.
3. Electrocardiography.
4. Natriuretic peptide- NT-proBNP (Immulite 2500, Siemens Healthcare Diagnostics AB Sweden).
5. Patients with the NT-proBNP level of \> 1200 pg/ml were referred for echocardiography to assess left ventricular function.

Eligibility criteria: Inclusion Criteria:

* Patients aged 65 years and older with the following diagnosis codes according to International Statistical Classification of Diseases and Related Health Problems - Tenth Revision:J44 (COPD) and J41, J42 (chronic bronchitis) registered during the period 1 January 2008-16 April 2008 according to the electronic patient record.

Exclusion Criteria:

* Impaired cognitive function and/or anticipated difficulties in carrying out spirometry due to immobility,
* psychiatric disorders or terminal illness.

Primary outcomes:
measure: Percentage of patients with elevated NT-proBNP.
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of patients with abnormal left ventricular function assessed by echocardiography. Association between elevated NT-proBNP and symptoms, signs and electrocardiography.
timeFrame: 3 months
Other outcomes:
Locations:
city: Olofström
country: Sweden
facility: Primary health care center.
state: Blekinge
Study officials:
affiliation: Lund University
name: Elzbieta Kaszuba, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04126122: Maternal and Neonatal Outcome in Severe Preeclampsia
Official title: Maternal and Neonatal Outcome in Severe Preeclamptic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-10-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant ladies with preeclampsia

Brief summary: In normal pregnancy the spiral arteries in the placental bed are invaded by trophoblast, which becomes incorporated into the vessel wall and replaces the endothelium, muscular layer and neural tissue

Detailed description: Preeclampsia is considered severe if one or more of the following:

1. Blood pressure of 160mmHg systolic or high or 110mmHg diastolic or high on two occasions at least 6 hours a part while the patient on bed rest.
2. Proteinuria of 0.3gm. or high in 24 hours urine specimen or +1 or great on two random urine samples collected at least 4 hours apart.
3. Oliguria of less than 500ml in 24 hours.
4. Cerebral or visual disturbance.
5. Pulmonary edema or cyanosis.

Eligibility criteria: Inclusion Criteria:

* • All women with severe preeclampsia

Exclusion Criteria:

* • History of epilepsy.

  * Patients with chronic hypertension.
  * Patients with renal disease.

Primary outcomes:
measure: The number of women who will develop adverse outcome
timeFrame: within 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Aljazeera( Al Gazeera) hospital
Study officials:
References:
Clinical trial NCT05134922: Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Official title: Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in a Celcuity-Sponsored Clinical Study (B2151009)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Breast Neoplasm Malignant Female
Lead sponsor: Celcuity Inc
Sponsor class: INDUSTRY
First posted: 2021-11-26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Continued access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Detailed description: The primary purpose of this study is to provide continuing access to treatment for subjects who continue benefit from therapy with gedatolisib in combination with palbociclib, and fulvestrant or letrozole.

Eligibility criteria: Inclusion Criteria:

1. Currently enrolled in the B2151009 clinical study and benefiting from treatment with gedatolisib in combination with other therapies as determined by the Investigator
2. Previously demonstrated compliance and are willing and able to comply with scheduled visits, treatment plans, and other study procedures
3. No evidence of progressive disease, as determined by the Investigator
4. Provide written informed consent prior to enrolling and receiving treatment

Exclusion Criteria:

1. Permanently discontinued from treatment in Study B2151009, or discontinued from Study B2151009 for any reason
2. Women who are pregnant, intend to become pregnant, or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
References:
Clinical trial NCT01279525: Intervention to Reduce Falls Incidence
Official title: EFFECTIVENESS OF A MULTIFACTORIAL INTERVENTION PROGRAM TO REDUCE FALLS INCIDENCE AMONG COMMUNITY-LIVING ELDERLY PEOPLE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Fall
Keywords: Falls
Prevention
Elderly
Lead sponsor: Andalusian Regional Ministry of Health
Sponsor class: OTHER_GOV
Collaborators: name: Andalusian Society of Family Medicine
name: Spanish Society of Family and Community Medicine
First posted: 2011-01-19
Enrollment: 404
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effectiveness of a multifactorial intervention program to prevent falls among the elderly as compared to a brief intervention.

Detailed description: The objective of this research is to verify if a simple multifactorial intervention program that is applicable in PC settings is more effective to decrease fall incidence than a brief advice for community-living people aged 70 or older.

Eligibility criteria: Inclusion Criteria:

* Patients residing in the community

Exclusion Criteria:

* to be institutionalized
* Immobilized or bedridden
* Present a terminal disease or severe psychiatric illness
* Have contraindications to physical exercise

Primary outcomes:
measure: fall incidence rate
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Unidad Docente de Medicina Familiar y Comunitaria
Study officials:
affiliation: Andalusian Health Service
name: Luis A Pérula, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perula LA, Varas-Fabra F, Rodriguez V, Ruiz-Moral R, Fernandez JA, Gonzalez J, Perula CJ, Roldan AM, de Dios C; EPICA Study Collaborative Group. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living older adults: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Oct;93(10):1677-84. doi: 10.1016/j.apmr.2012.03.035. Epub 2012 May 15.