louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01391312: Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines
Official title: A Pilot Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Glabellar Lines - Establishing Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Frown Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 40
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: TREATMENT

Brief summary: This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe glabellar wrinkles (frown lines)

Exclusion Criteria:

* Previous treatment with botulinum toxin therapy of any serotype
* Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
* Mid-facial or periorbital treatment with non-permanent soft tissue fillers
* Subjects planning a facial cosmetic procedure or visible scars
* Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
* History of facial nerve palsy
* A planned extended absence during the study

Primary outcomes:
measure: Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30
timeFrame: Day 30
measure: Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60
timeFrame: Day 60
Other outcomes:
Locations:
city: East Chicago
country: United States
state: Illinois
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02963012: The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy
Official title: The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ectopic Pregnancy
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
Collaborators: name: Ziv Medical Center
First posted: 2016-11-15
Enrollment: 242
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with ectopic pregnancy, in the first trimester.

Brief summary: A prospective trail. Pregnant women in the first trimester with positive BHCG and no visualization of gestational sac will be recruited.

The correlation between endometrial pattern and ectopic pregnancy will be assessed.


Eligibility criteria: Inclusion Criteria:

* First trimester of pregnancy
* No visualization of gestational sac

Exclusion Criteria:

* Hemodynamic instability

Primary outcomes:
measure: the corellation between presence and width of trilaminar endometrium as evaluated by transvaginal ultrasound and the diagnosis of ectopic pregnancy
timeFrame: first trimester of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03397212: Treatment of Withdrawal Symptoms With NADA Acupuncture in Chronic Pain Patients
Official title: Assessment of NADA Acupuncture for Treatment of Withdrawal Symptoms During Gradual Opioid Withdrawal in Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Pain
Opiate Withdrawal Syndrome
Keywords: NADA
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This project aims at examining the following hypotheses:

* Treatment with NADA and clonidine reduces intensity of withdrawal symptoms to a greater extent than treatment with clonidine.
* Opioid withdrawal improves pain, physical and mental functioning and reduces opioid consumption 3 months and 1 year after withdrawal.


Eligibility criteria: Inclusion Criteria:

* Chronic pain patients treated with opioids over 3 months
* The patient's doctor or nurse assesses that there is an indication to opioid withdrawal and / or the patient wishes to withdraw.
* The patient is motivated for opioid withdrawal
* The patient has experienced withdrawal symptoms
* The patient must be able to understand, speak and write Danish
* The patient must be able to transport himself to the pain center

Exclusion Criteria:

* Children under 18 years old
* External ear infection
* Treatment with benzodiazepines.
* Active substance abuse and alcohol abuse.
* Contraindications for treatment with clonidine:
* Allergy
* Bradyarrhythmias caused by diseased sinus cube or AV block of 2nd or 3rd grade.
* lactose intolerance
* Heart failure
* High medullary damage
* Cardiac conduction disturbances
* Pregnancy and breastfeeding

Primary outcomes:
measure: Change in intensity of withdrawal symptoms
timeFrame: 3 months and 1 year
Secondary outcomes:
measure: Change in quality of life assessed with SF36
timeFrame: 3 months and 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT03726112: Spoton Trial Evaluating the Efficacy on BAlance Disorder sYmptoms (STEADY)
Official title: A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn Specs for the Treatment of Chronic Dizziness & Imbalance
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Balance Disorders
Lead sponsor: SpotOn Therapeutics Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double Blind, Placebo-Controlled Study followed by an open label phase
Primary purpose: TREATMENT

Brief summary: A Randomized, Double Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of SpotOn specs for the Treatment of Chronic Dizziness \& Imbalance.


Eligibility criteria: Inclusion Criteria:

* Age: 18≤ years ≤70
* DHI score of at least 36 (moderate to severe handicap)
* One or more symptoms of unsteadiness, dizziness or vertigo are present on most days. Symptoms could vary in intensity however lasts for 3 months or more
* Ability to perform all tests (including computerized test) and interviews
* At least three months after the last Vestibular Balanced Rehabilitation Therapy - (if applicable)
* Gave informed consent for participation in the study

Exclusion Criteria:

* Dizziness disease with fluctuating symptoms
* Any active or non-controlled disease that might cause dizziness and imbalance, unless well controlled for at least 3 months
* Moderate-Severe Depression or Anxiety
* Known related eye disease
* Pregnant women
* Currently taken part in a clinical trial or within 30 days prior to screening
* Concomitant use of any medications that might affect the balance system

Primary outcomes:
measure: Change from Baseline in the Dizziness Handicap Inventory (DHI)
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Clinical Global Impression of Improvement
timeFrame: 8 weeks
measure: Change from baseline in the Clinical Global Impression of Severity
timeFrame: baseline, 8 weeks
measure: Change from baseline in Postural sway
timeFrame: baseline, 8 weeks
measure: Change from baseline in the Visual Vertigo Analog Scale (VVAS)
timeFrame: baseline, 8 weeks
measure: Change from baseline in the Beck Anxiety Inventory
timeFrame: baseline, 8 weeks
measure: Change from baseline in the Vertigo Symptom Scale-Short Form (VSS-SF)
timeFrame: baseline, 8 weeks
measure: Incident rate of falls
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rishon LeZion
country: Israel
facility: Assaf Harofeh Medical Center, Rishon LeZion, ENT Department
Study officials:
affiliation: Assaf Harofeh Medical Center, Rishon LeZion, ENT Department
name: Nathan Shlamkovitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00013312: Effects of Acute SCI on Colonic Motility & Tone
Official title: Effects of Acute SCI on Colonic Motility & Tone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal cord injury, gastrointestinal motility, gastrointestinal transit
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare individuals with acute SCI to control patients in order to: 1. Determine if there are changes in colonic tone and sensation after SCI by comparing the fasting responses to the postprandial responses; 2. Determine if there are changes in colonic phasic motility after SCI by comparing the fasting responses to the postprandial responses; 3. Determine if colonic motor and sensory function after SCI change over time by repeating these studies six month later in SCI and control patients.


Eligibility criteria: Acute SCI with impaired colonic tone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: VAMC, Hines
state: Illinois
Study officials:
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: John Fryer, Ph.D. Asst. Director
affiliation: Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
name: Nancy Rocheleau, Program Analyst
References:
Clinical trial NCT06305312: Community Services Navigation to Advance Health Equity in Breast Cancer Screening
Official title: Community Services Navigation to Advance Health Equity in Breast Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2024-03-12
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to evaluate if adding community services navigation to the standard referral process for social needs is an effective and scalable strategy for addressing disparities in follow-up to abnormal breast cancer screening results. The investigators will determine the effectiveness of social needs referrals combined with a community services navigation intervention in the screening mammography setting to improving breast screening outcomes in underserved women.


Eligibility criteria: Inclusion Criteria:

* English and Spanish speakers
* Received an abnormal result of a screening mammogram
* Self-reports at least one social need on the B-SINCERE Screener

Exclusion Criteria:

-Prior diagnosis of breast cancer

Primary outcomes:
measure: Change in participants' level of social needs as measured by the B-SINCERE (Breast-Screener for Intensifying Community Referrals for Health) screener
timeFrame: 18 months
measure: Episode Completion (EC). EC is the name of a dichotomous scale, reported on a 2-point scale that is calculated from patient electronic health record (EHR), with 0=No Breast Cancer Screening completed, 1=Breast Cancer Screening completed.
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Elissa Ozanne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696812: Web-based International Multi-Center Clinical Study for Parkinson's Disease
Official title: Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: electrodeposition
Subthalamic Nucleus
Deep Brain Stimulation
Parkinson Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objectives of this study are (1) to compare the clinical outcome in correlation with the electrode positions estimated by web-based image fusion of the preoperative MRI and the postoperative brain CT taken at a stable period after surgery using mutual information technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and (2) to examine whether the documentation of the electrode position by using mutual information technique at a stable period after unilateral or bilateral STN stimulation provides useful information for the postoperative programming.


Eligibility criteria: Inclusion Criteria:

* Advanced Parkinson Disease patients

Exclusion Criteria:

* The patients who have experienced any perioperative or postoperative complications
* The patients with severe cognitive impairment, ongoing psychiatric problems, an unsatisfactory general condition for evaluation, or an inability

Primary outcomes:
measure: To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
timeFrame: at 1 month after surgery
Secondary outcomes:
measure: UPDRS, H&Y, ADL scores, LEDD
timeFrame: at 6 and 12 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurosurgery, Seoul National University Hospital
Study officials:
affiliation: Department of Neurosurgery, Seoul National University Hospital
name: Sun Ha Paek, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00977912: Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
Official title: Prevention of NEC in Preterm Infants With B. Lactis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Necrotizing Enterocolitis
Keywords: B. lactis
Preterm
Necrotizing Enterocolitis (NEC)
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-09-16
Enrollment: 318
Sex: ALL
Minimum age (years): 12
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.


Eligibility criteria: Inclusion Criteria:

* Weight between 800 - 1500g
* Tolerating enteral feeding within 48 hours
* Having obtained his/her parents or legal representative informed consent

Exclusion Criteria:

* Chromosomal abnormality
* Hydrops featalis
* Congenital malformation of the gastrointestinal tract
* Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
* Currently participating in another clinical trial

Primary outcomes:
measure: NEC onset
timeFrame: 6 weeks
Secondary outcomes:
measure: Antibiotic administration and stool microbiology
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bertsham
country: South Africa
facility: University of Witwatersrand & Chris Hani Baragwanath Hospital
city: Johannesburg
country: South Africa
facility: University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
city: Johannesburg
country: South Africa
facility: University of Witwatersrand & Rahima Moosa Mother & Child Hospital
Study officials:
affiliation: University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
name: Peter A. Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Clinical trial NCT00548912: Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease
Official title: Cardiac Magnetic Resonance Imaging in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Keywords: Kidney Failure, Chronic
Hemodialysis
Spironolactone
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2007-10-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass

Detailed description: Dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. Aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. Animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. This study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.

Eligibility criteria: Inclusion Criteria:

* hemodialysis patients

Exclusion Criteria:

* non compliance
* hyperkalemia
* pregnancy
* expected survival less than 9 months

Primary outcomes:
measure: Left ventricular mass
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: West Penn Allegheny Health System
name: Richard Marcus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05252481: Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
Official title: Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Post-COVID-19 syndrome
Post-COVID-19 condition
Persistent COVID-19
Long-Haul COVID-19
Fatigue
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 47
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: Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. This is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. Secondary aims include changes in cognition, depression, and quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COVID-19 with PCR-confirmation.
* Fatigue linked to COVID-19
* No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.

Exclusion Criteria:

* Stroke before COVID-19
* History of traumatic brain lesion or central nervous system infection previous to COVID-19
* Radiotherapy or chemotherapy for cancer
* Severe sensorial deficits
* Drugs or uncontrolled medical disorder with potential impact on fatigue.
* History of abuse of alcohol or other toxics.
* Any contraindication for tDCS (metallic implants, brain devices, pacemakers, head injuries).

Primary outcomes:
measure: Change in Fatigue
timeFrame: 2 weeks
Secondary outcomes:
measure: Change in cognition
timeFrame: 2 weeks
measure: Change in depressive symptoms
timeFrame: 2 weeks
measure: Change in quality of life
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos.
Study officials:
References:
Clinical trial NCT05195281: Pancreatic Cancer Evolution Upon Treatment
Official title: Pancreatic Cancer Evolution Upon Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims at evaluating the different subtypes of pancreatic cancer on EUS-tissue acquisition of pancreatic cancer patients, and their possible modifications throughout time. The study takes advantage of a systematic evaluation of pancreatic cancers through diagnostic EUS-guided fine needle biopsy (FNB) sampling of the mass performed during a restaging EUS. FNB samples represent a valuable source of cancer cells, both for the histological diagnosis and as the source of tumor macromolecules, including DNA and RNA.

Study design This is a prospective study enrolling patients with non-metastatic pancreatic cancer who already underwent diagnostic EUS with tissue acquisition and rapid on-site evaluation (ROSE) by cytologist positive for pancreatic cancer, with a first sample acquired for diagnostic purposes and a second sample stored for RNA extraction acquired with the already approved protocol BIOGASTRO.

As recommended by guidelines, patients will follow the standard pathway of treatment, being sent to chemotherapy and will then undergo restaging of the lesion and re-evaluation of vascular invasion by CT and EUS. During this second session of EUS a new specimen of the tumor will be sampled for diagnostic purposes, with a second pass undergoing for RNA extraction.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Willing to sign informed consent
* Patient with CT scan or MRI or EUS defining the lesion as locally advanced
* Patient who already underwent EUS-TA for solid lesion of the pancreas positive for pancreatic ductal adenocarcinoma (PDAC)
* Patient undergoing neoadjuvant chemotherapy
* Patient primarily followed at San Raffaele Hospital

Exclusion Criteria:

* Patients not willing to sign informed consent
* Pregnancy and breastfeeding
* Cytology positive for malignancies other than PDAC
* Patient undergoing progression at re-staging CT scan

Primary outcomes:
measure: Evaluation of molecular subtype modification
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References: