louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01133288: Yulex Glove Prospective Study in Spina Bifida
Official title: Yulex Glove Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spina Bifida
Latex Allergy
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2010-05-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves for use in the general population and has recognized and labeled these gloves as Hevea Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for development of allergy because Yulex does contain a small amount of Guayule protein. Yulex Corporation has proposed doing further studies to demonstrate safety and lack of allergenicity in a population that is prone to latex allergy. In the proposed pilot study, the investigators goal is to complete the protocol on 10 adults with spina bifida who are allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder and bowel care for approximately 30 minutes daily over a 3 month period. The investigators anticipate that the investigators will need to recruit and enroll up to 50 study participants to achieve a final sample of 10 adults with complete study data. Individuals with a history of anaphylaxis will be excluded from the study. The study participants will be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the study. The FDA Devices group has reviewed the study design and agreed that this is a suitable first pilot study.


Eligibility criteria: Inclusion Criteria:

* Individuals with spina bifida between the ages of 18 and 60 who exhibit positive serology to latex (Hevea Brasiliensis).

Exclusion Criteria:

* Possible exclusion criteria include age under 18, does not have spina bifida, or does not exhibit positive serology to latex (Hevea Brasiliensis).

Primary outcomes:
measure: Sensitization to Yulex
timeFrame: Approximately 3 months
Secondary outcomes:
measure: Immune Response to Yulex
timeFrame: 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Hugo W. Moser Research Institute at Kennedy Krieger Inc.
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Eric B Levey, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07018388: Intrapatient Comparison of STN and GPi tTIS in PD
Official title: Intrapatient Comparison of Subthalamic and Globus Pallidus Internus Temporal Interference Stimulation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson Disease
Keywords: subthalamic nucleus
Globus Pallidus Internus
transcranial temporal interference stimulation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus Internus-transcranial Temporal Interference Stimulation (GPi-tTIS) on motor symptoms in patients with early to mid-stage Parkinson's Disease (PD) during "on" medication states.

The main questions this study aims to answer are:

1. Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?
2. What is the degree of improvement in motor symptoms of Parkinson's Disease patients after receiving STN-tTIS or GPi-tTIS during the "on" medication phase?

Researchers will compare the MDS-UPDRS-III improvement scores of tTIS therapy at different targets. Participants are required to:

1. Visit the clinic twice within two weeks for therapy and testing.
2. Record their symptoms and scores.

Detailed description: This clinical trial aims to explore which targets are better for improving PD motor symptoms. Patients were randomly assigned to either Group A or Group B. Group A first received STN-tTIS therapy, followed by GPi-tTIS therapy; Group B received the treatments in the reverse order. Each session lasted 20 minutes, and patients were in the on-medication state for both treatments. The order of sessions was randomized, with at least 7 days of washout between sessions to avoid carryover effects. MDS-UPDRS-III evaluations were assessed before and after each treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary Parkinson's disease (MDS);
* Hoehn \& Yahr stage \< 3;
* Antiparkinsonian drugs must have remained unchanged in the past four weeks, and the dosage must have remained stable throughout the study.

Exclusion Criteria:

* Presence of neurological disorders that may affect the study (e.g., traumatic brain injury);
* History of antipsychotics, antidepressants, or dopamine modulators outside of PD drugs;
* Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers);
* Unstable vital signs.

Primary outcomes:
measure: MDS-UPDRS-Ⅲ scores
timeFrame: pre-intervention, immediately after the intervention
Secondary outcomes:
measure: MDS-UPDRS-Ⅲ sub-scores
timeFrame: pre-intervention, immediately after the intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04570488: Predicting Favorable Outcomes in Hospitalized Covid-19 Patients
Official title: Predicting Favorable Outcomes in Hospitalized Covid-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Corona Virus Infection
Adverse Event
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 1415
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a threshold at 90% PPV, with at least one low risk during their admission who are discharged alive and have not been in the ICU

Brief summary: Testing use of predictive analytics to predict which COVID-19+ patients are at low risk for an adverse event (ICU transfer, intubation, mortality, hospice discharge, re-presentation to the ED, oxygen requirements exceeding nasal cannula at 6L/Min) in the next 96 hours

Detailed description: To assess if display of low risk of adverse event in EPIC can safely reduce length of stay and plan for discharge.

Eligibility criteria: Inclusion Criteria: Adult hospitalized COVID19+ patients predicted to have no adverse event at 96 events with a threshold at 90% PPV, with at least one low risk during their admission who are discharged alive and have not been in the ICU

Exclusion Criteria: Age \< 18 years not hospitalized for COVID19+.

Primary outcomes:
measure: Reduction in days from first low-risk score to discharge
timeFrame: 96 Hours
Secondary outcomes:
measure: Reduction in length of stay (LOS)
timeFrame: 96 hours
measure: Reduction in GTD vs. LOS
timeFrame: 96 hours
measure: No change in 30 day re-ED presentation or hospital admission rate for cohort
timeFrame: 96 hours
Other outcomes:
measure: Re-presentation to ED
timeFrame: 96 hours
measure: Readmission to hospital
timeFrame: 96 hours
measure: Mortality
timeFrame: 96 hours
measure: Postdischarge mortality
timeFrame: 96 hours
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jonathan Austrian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Major VJ, Jones SA, Razavian N, Bagheri A, Mendoza F, Stadelman J, Horwitz LI, Austrian J, Aphinyanaphongs Y. Evaluating the Effect of a COVID-19 Predictive Model to Facilitate Discharge: A Randomized Controlled Trial. Appl Clin Inform. 2022 May;13(3):632-640. doi: 10.1055/s-0042-1750416. Epub 2022 Jul 27.
Clinical trial NCT05772078: Compliance and Cumulative Interceptive Rate After Therapy of Peri-implantitis
Official title: Compliance Rate After Therapy of Peri-implantitis: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peri-Implantitis
Lead sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that underwent therapy of peri-implantitis and were recommended to SPT

Brief summary: Peri-implantitis is a plaque-mediated inflammatory condition featured by progressive bone loss. This entity jeopardizes the longevity of dental implants, thus impacting negatively on the quality of life of patients. Moreover, peri-implantitis is suggested to lead to an increased systemic status of inflammation. This may rise the susceptibility to experience life-threating conditions. Therefore, peri-implant infections must be promptly diagnosed and eliminated.

Aiming at resolving the inflammation, several options are advised to remove the infection. Accordingly, implant removal or therapeutic manoeuvres to stablish a healthy ecosystem in the peri-implant environment have been suggested. While the former proved being more predictable, the later demonstrated being more conservative. Indeed, implant removal is commonly associated with regenerative procedures of the alveolar bone deformity that often demand time and is more costly. Anyways, disease severity, implant expendability for biomechanical reasons or esthetic demand seem to be few of the leading aspects in the decision-making process on maintaining or extracting implant showing peri-implant lesions.

Supportive maintenance care (SPT) was shown to be key in preventing disease recurrence. Nonetheless, the compliance of these patients is often erratic. In fact, it is yet unknown the rate of compliance after therapy. Therefore, the goal of this study is to assess the rate and confounders for compliance.


Eligibility criteria: Inclusion Criteria:

* Patients that underwent treatment of peri-implantitis
* \>12 months of follow-up after therapy
* Patients managed in our center

Exclusion Criteria:

* Patients that were managed in other centers
* Patients that have incomplete records

Primary outcomes:
measure: Compliance rate
timeFrame: 1 to 6 years of follow-up
Secondary outcomes:
measure: Demographics
timeFrame: 1 to 6 years of follow-up
Other outcomes:
measure: Cumulative Interceptive Rate
timeFrame: 1 to 6 years of follow-upo
Locations:
city: Badajoz
country: Spain
facility: Centro de Implantologia Cirugia Oral y Maxilofacial
Study officials:
affiliation: Assistant
name: Mamen Tomé, DH
role: STUDY_CHAIR
References:
Clinical trial NCT00237978: Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Official title: Control of Therapy of Acne Papulopustulosa by Visible Light With Waterfiltered Infrared and / or Adapalen (Differin Gel)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acne Papulopustulosa
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effectivity of visible light in combination with waterfiltered infrared in treating acne papulopustulosa. The reduction of inflammatory and non-inflammatory lesions within 8 weeks will be measured and compared with the standard treatment with Adapalene.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate acne papulopustulosa according to Burton Scale Stage 3 to 4
* At least 5 inflammatory and 5 non-inflammatory lesions in the face
* Age \>= 14 years

Exclusion Criteria:

* pregnant and nursing women
* Antiandrogen therapy
* therapy with antibiotics within the last 4 weeks
* therapy with retinoids within the last 6 months
* natural or artificial UV-therapy within the last 4 weeks
* severe acne papulopustulosa according to Burton Scale 5 or 6
* Severe systemic condition
* Secondary acne

Primary outcomes:
measure: reduction of inflammatory and non-inflammatory lesions within 8 weeks after start of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
state: Sachsen
Study officials:
affiliation: Technische Universität Dresden, Fetscher Str. 74, 01307 Dresden, Germany
name: Roland Aschoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105178: Verbal Stimulation of Orientation on Emergence Agitation
Official title: Effect of a Repeated Verbal Stimulation of Orientation on Emergence Agitation After General Anesthesia: a Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergence Delirium
Keywords: Emergence delirium, Emergence agitation, Orientation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 126
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: PREVENTION

Brief summary: The purpose of this study is to investigate whether information of the orientation such as time, place, and patient's own name can reduce emergence delirium after general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective laparoscopic or robot-assisted abdominal surgery

Exclusion Criteria:

* Patients' refusal
* Change in operation schedule
* American Society of Anaesthesiologists (ASA) physical status Ⅳ
* Day surgery
* BMI ≥35
* Neurocognitive impairment, hearing disorder
* Psychological drug intake
* Experience of general anesthesia or sedation within 1 month

Drop out Criteria

* Changes in operation schedule (e.g. unexpected collaborative surgery, conversion to laparotomy, delay of the schedule to night-duty hours)
* Significant protocol violation

Primary outcomes:
measure: Incidence of emergence agitation at operating room (OR)
timeFrame: 20 minutes after anesthesia emergence
Secondary outcomes:
measure: Incidence of dangerous emergence agitation
timeFrame: 20 minutes after anesthesia emergence
measure: maximal Riker sedation agitated scale during emergence
timeFrame: 20 minutes after anesthesia emergence
measure: Time to emergence
timeFrame: 20 minutes after anesthesia emergence
measure: Bispectral index (BIS)
timeFrame: 20 minutes after anesthesia emergence
measure: Incidence of emergence agitation at PACU
timeFrame: 30 minutes after PACU adminstration
measure: Incidence of postoperative delirium
timeFrame: 30 minutes after PACU adminstration / Postoperative 24 hours
measure: Postoperative Pain
timeFrame: 10/20/30 minutes after PACU administation / Postoperative 24 hours
measure: PACU stay
timeFrame: up to 3 hours after PACU administration
measure: Postoperative opioid consumption
timeFrame: 30 minutes after PACU adminstration / Postoperative 24 hours
measure: Analgesics requirement
timeFrame: Postoperative 24 hours
measure: Postoperative quality of recovery
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bo Rim Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03433378: To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris
Official title: A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 700
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Bioequivalence
Primary purpose: TREATMENT

Brief summary: Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Detailed description: A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below).

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.

Primary outcomes:
measure: Demonstration of Bioequivalence
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Taro Pharmaceuticals Inc
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01907178: Postoperative Pain Management in Hospital and Following Discharge From Hospital.
Official title: Assessment of Postoperative Pain Management in Patients Undergoing Total Knee Arthroplasty Immediately After Surgery and Following Discharge From Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Knee Joint
Keywords: total knee arthroplasty
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2013-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at Saint Francis Hospital undergoing total knee replacement

Brief summary: To investigate postoperative pain management in patients undergoing knee or hip replacement while they are in the hospital and following discharge to their home. Additionally, sample questions will be asked prior to surgery to predict patient's postoperative pain experience.

Detailed description: We hypothesize that patients experience more postoperative pain at home than they do in hospital and factors such as preoperative anxiety, depression, and preoperative pain affect the level of postoperative pain experienced by patients. A total of 200 patients undergoing total knee surgery will be enrolled in this observational study. They will be asked to fill a baseline questionnaire including demographic information, medical problems, anxiety, depression, preoperative pain level, etc. Following routine standard anesthesia and surgery, patient's pain will be assessed every 4 hours when they are in the hospital after surgery, then daily assessment for 1 week after they are discharged home followed at 2 months, and 6 months after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee arthroplasty

Exclusion Criteria:

* Patients attending rehabilitation facilities after discharge
* unwilling or unable to provide consent

Primary outcomes:
measure: Pain scores
timeFrame: during hospital stay (average 3 days)
Secondary outcomes:
measure: preoperative anxiety scores
timeFrame: preoperative
measure: Preoperative depression scores
timeFrame: preoperative
Other outcomes:
measure: Pain medication consumption
timeFrame: during hospital stay (average 3 days)
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital
name: Sanjay Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06078878: Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
Official title: Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomy
Lead sponsor: Gentuity, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.

Detailed description: Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.

Eligibility criteria: Inclusion Criteria:

* Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
* Patients that present with a Modified Rankin Score (mRS) ≤3
* Patients 18 years of age or older
* Patients willing and able to provide written informed consent to participate in evaluation

Exclusion Criteria:

* Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
* Pregnant
* Patient has a known hypersensitivity to contrast media
* Patients undergoing an urgent or emergent neurointerventional procedure
* Patients that present with a Modified Rankin Score (mRS) ≥4
* Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage
* Participation in another clinical trial of an investigational drug or device
* Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System

Primary outcomes:
measure: Device Safety
timeFrame: 7 days
Secondary outcomes:
measure: Clinical performance
timeFrame: 1 day
measure: Technical performance
timeFrame: 1 day
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clínica La Sagrada Familia
Study officials:
affiliation: Clínica La Sagrada Familia
name: Pedro Lylyk, MD
role: PRINCIPAL_INVESTIGATOR
References: