louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02816671: MicroCutter Assisted Thoracic Surgery Hemostasis Registry
Official title: MicroCutter Assisted Thoracic Surgery Hemostasis Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lobectomy
Segmentectomy
Lead sponsor: AesDex, LLC
Sponsor class: INDUSTRY
First posted: 2016-06-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for thoracic surgical procedures requiring the use of a surgical stapler.

Brief summary: The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic surgery (VATS) including robotic surgical cases. Clinicians will provide objective and subjective evaluation of the use of the stapler in their procedures.

Detailed description: The MATCH registry is a prospective, open label, multi-center observational registry with enrollment of patients requiring surgical stapling during a lobectomy or segmentectomy. Patients will be treated per the clinicians standard of care with medical history and demographic data collected pre-procedure, operative data including clinician's objective and subjective evaluation of the stapler and confirmation of any complications via query and data collection at hospital discharge and each clinician's standard post-operative contact.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lobectomy/segmentectomy in which the MicroCutter Stapler and Reloads were used.
* Patient is willing and able to sign informed consent form to participate in registry, allowing for collection of data.

Exclusion Criteria:

* Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.

Primary outcomes:
measure: Hemostasis of vessel staple line
timeFrame: through study completion, approximately 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: Mayo Clinic
name: Shanda Blackmon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: James Cook University Hospital
name: Joel Dunning, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03496688: Comparative Results of Six Biomaterials Used in Two-stage Maxillary Sinus
Official title: Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-stage Maxillary Sinus Augmentation Model After 6-month-healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophy
Jaw, Edentulous, Partially
Sinus Floor Augmentation
Bone Substitutes
Bone Regeneration
Keywords: Sinus floor augmentation
Bone regeneration
Histology
Biocompatible materials
Bone transplantation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 6
Sex: ALL
Minimum age (years): 33
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized,controlled, double-blind clinical trial
Primary purpose: TREATMENT

Brief summary: Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.

Detailed description: Materials and Methods:

A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).

Eligibility criteria: Inclusion Criteria: patients healthy, absence of systemic pathologies (ASA class I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan.

-

Exclusion Criteria:

-

Primary outcomes:
measure: to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces.
timeFrame: 6 month-healing after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Maria Paola Cristalli, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: La Monaca G, Iezzi G, Cristalli MP, Pranno N, Sfasciotti GL, Vozza I. Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-Stage Maxillary Sinus Augmentation Model after 6-Month Healing. Biomed Res Int. 2018 Jun 27;2018:9430989. doi: 10.1155/2018/9430989. eCollection 2018.
Clinical trial NCT02148588: Peripheral Sensory Input in Central Post Stroke Pain (CPSP)
Official title: How "Central" is Central Post-stroke Pain? Investigating the Role of Peripheral Sensory Input in Maintaining Central Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Post Stroke Pain
Keywords: Central Post Stroke Pain
Nerve block
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2014-05-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Prospective, open-label study in 10 patients with Central Post Stroke Pain (CPSP). The study will evaluate the effects of peripheral nerve blockade on spontaneous pain and evoked thermal and mechanical responses in CPSP, and assesses the associated local anesthetic pharmacokinetics.


Eligibility criteria: Each subject must meet all of the following criteria:

* Age ≥18;
* CPSP affecting an upper or a lower limb, in a distribution that may be completely covered by a peripheral nerve block;
* Patient fulfills all mandatory criteria for CPSP, fulfills at least one supportive criteria, and has definite CPSP by probability grading.
* Pain duration at least 3 months;
* Spontaneous pain intensity (average pain in past week) of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Exclusion Criteria

Subjects will not be enrolled if any of the following criteria exist:

* Not giving consent to participate in the study;
* Significant psychiatric or cognitive impairment;
* Moderate to severe renal or liver failure;
* Concomitant treatment with warfarin or other anticoagulants;
* Pregnancy or lactation.

Primary outcomes:
measure: Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.
timeFrame: baseline and 30 minutes
Secondary outcomes:
measure: Change in the Intensity of Cold Sensation
timeFrame: baseline and 30 min
measure: Change in the Intensity of Warm Sensation
timeFrame: baseline and 30 min
measure: Change in the Intensity of Pinprick Sensation
timeFrame: baseline and 30 min
measure: Change in the Intensity of Brush Sensation
timeFrame: baseline and 30 min
measure: Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire
timeFrame: baseline and 40 min
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington Univesity School of Medicine
name: Simon Haroutounian, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05988788: Effect of Epigallocatechin-3-Gallate Solution as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Necrotic Tooth
Official title: Effect of Epigallocatechin-3-Gallate Solution Versus Sodium Hypochlorite as a Root Canal Irrigant on Post-Operative Pain Intensity and Bacterial Load Reduction in Asymptomatic Necrotic Mandibular Premolars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotic Pulp
Keywords: Asymptomatic
Necrotic Mandibular premolar
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: clinically compare the intensity of post-operative pain and the amount of bacterial load reduction after using 20% Epigallocatechin-3-gallate solution during chemomechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.

Detailed description: The patients will be randomly divided into 2 groups. Intervention group (20% epigallocatechin-3-gallate solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant).

Post-operative pain will be measured at 6, 12, 24 and 48 hours post-operatively. The pain will be recorded using the Numerical Rating Scale (NRS).

Amount of bacterial load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFUs/mL) before and after root canal preparation.

Eligibility criteria: The inclusion criteria:

1. Systematically healthy patient (ASA I, II).
2. Age between 18 and 45 years
3. Male or female.
4. Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis.

The exclusion criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. Teeth with:

   * Immature roots
   * Association with swelling or sinus tract.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III
   * Previously accessed or endodontically treated
   * Deep periodontal pockets more than 4 mm
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
3. Patients who could not interpret the NRS.

Primary outcomes:
measure: Postoperative pain
timeFrame: Postoperative pain measured at 6, 12, 24, 48 hours after single visit treatment.
Secondary outcomes:
measure: Amount of intracanal bacterial load reduction
timeFrame: T0: preintervention, preinstrumentation after access cavity. T1: postinstrumentation up to 10 min
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Dentistry
Study officials:
affiliation: Cairo University
name: rayan adlan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04602988: Study to Assess and Monitor Brain Activity
Official title: Continuous, Non-Invasive Monitoring of Mental Status
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Delirium
Encephalopathy
Keywords: EEG
Mental Status
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited after their admission to inpatient medical units at the participating hospital.

Brief summary: A mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. Changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. Patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. Delirium remains under-recognized in the hospital, in part due to its fluctuating nature. Typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. As such, there is a clear clinical need for objective, continuous methods to monitor mental status. Such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. In this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of EEG.


Eligibility criteria: Inclusion Criteria:

* Admitted to a general medical ward
* Expected stay of at least one night

Exclusion Criteria:

* patients who have any scalp incisions or head wound(s) that would prevent EEG attachment
* Non-English speakers

Primary outcomes:
measure: Delirium Severity
timeFrame: Daily during the time of EEG recording up to 7 days
measure: EEG
timeFrame: Daily during the time of EEG recording up to 7 days
Secondary outcomes:
measure: Functional status
timeFrame: 3 months after completion of EEG recording
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Eyal Y Kimchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04596488: Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients
Official title: Pharmacodynamics of Efavirenz 400mg in Treatment-naïve Chinese HIV-infected Patients in a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Keywords: Efavirenz 400mg
Chinese HIV-infected patients
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: National Key Technologies R&D Program for the 13th Five-year Plan
name: National Key Technologies R&D Program for the 12th Five-year Plan
name: CAMS Initiative for Innovative Medicine
First posted: 2020-10-22
Enrollment: 25
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: Evaluating the efficacy, pharmacodynamics, and safety of Efavirenz 400mg in treatment-naïve Chinese HIV-infected patients.

Detailed description: Treatment-naive HIV-infected patients are designed to enroll and receive efavirenz 400mg combined with tenofovir (TDF) and lamivudine (3TC) as initial antiretroviral regimens, and monitoring for 48 weeks, to evaluate efavirenz concentration, T-cell subsets, HIV RNA load, and neuropsychiatric tests with Hamilton depression scale (HAMD) and Pittsburgh sleep quality index (PSQI) at baseline, 4, 12, 24, 48 weeks.

Eligibility criteria: Inclusion Criteria:

* (1) HIV treatment-naïve, (2) age between 18 years or older, (3) be willing to complete the HAMD and PSQI scale and follow-up regularly, (5) not participating in other studies.

Exclusion Criteria:

* (1) acute HIV-1-infected patients, (2) an AIDS-defining illness such as pneumocystis pneumonia, tuberculosis within 2 weeks of entry, (3) transaminase and alkaline phosphatase levels beyond three times the upper limit of the normal range, bilirubin level more than 2.5 times the upper limit of the normal range, and serum creatinine level excess 1.5 times the upper limit of the normal range, (4) pregnancy or breast feeding

Primary outcomes:
measure: Viral suppression
timeFrame: 48 weeks
Secondary outcomes:
measure: Drug concentration
timeFrame: 48 weeks
measure: Neuropsychiatric adverse events
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Taisheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu L, Peng W, Song X, Li Y, Han Y, Zhu T, Fu Q, Du X, Cao W, Li T. Pharmacodynamics of efavirenz 400 mg in treatment-naive Chinese HIV-infected patients in a prospective cohort study. BMC Infect Dis. 2021 Jan 23;21(1):112. doi: 10.1186/s12879-021-05802-8.
Clinical trial NCT00673088: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions
Official title: A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Restless Leg Syndrome
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Detailed description: The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to ropinirole or any other comparable product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two Period, seven day washout
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SFBC Anapharm
name: Richard Larouche, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644488: A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
Official title: A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 7
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer


Eligibility criteria: Inclusion Criteria:

* Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria

Primary outcomes:
measure: To assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer
timeFrame: throughout the study
Secondary outcomes:
measure: To evaluate the pharmacokinetics of BMS-641988 and the metabolites BMS-501949 and BMS-570511
timeFrame: at cycle 1 day 1, day 15 and day 29
measure: To identify the dose(s) of BMS-641988 for Phase II
timeFrame: at the end of study
measure: To assess any preliminary evidence of anti-tumor activity by PSA decline, tumor shrinkage, radionuclide bone scans
timeFrame: throughout the study
measure: To assess the effects of BMS-641988 on pharmacodynamic markers (LH, total and free testosterone, 5(alpha)-DHT, estradiol, prolactin, FSH, and SHBG)
timeFrame: throughout the study
Other outcomes:
Locations:
city: Hidaka
country: Japan
facility: Local Institution
state: Saitama
city: Hamamatsu-Shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Koto-Ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00738088: Variation in Sulphonylurea Response in Type 2 Diabetes
Official title: The Use of Glycaemic Response to Sulphonylureas as a Tool to Investigate Type 2 Diabetes Pathophysiology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Sulphonylurea
Pharmacogenetics
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
First posted: 2008-08-20
Enrollment: 14
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. We are using two approaches to study this. In one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. The second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the TCF7L2 gene) and then looks at how well they respond to sulphonylurea medication.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Age \>35 and \< 70
* Age of diabetes diagnosis \>35 and \<70
* White European
* Pre-SU HbA1c \<=10%
* HbA1c (on treatment) \<= 9%
* No myocardial infarction or Acute coronary syndrome in previous year
* No stroke or transient ischaemic attack in previous year
* No or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months)
* eGFR \> 60mls/min
* No Proteinuria \>30mg/dl on multistix 10SG
* No active foot ulceration or infection
* Liver ALT ≤ twice the upper limit of the reference range
* Contactable by telephone

Exclusion Criteria:

* Type 1 diabetes
* HbA1c \>10% prior to commencing SU
* HbA1c\>9% on SU treatment
* Recent MI or Stroke within last 12 months
* Pre-proliferative or proliferative retinopathy
* eGFR\<60 ml/min
* Proteinuria \>30mg/dl on multistix 10SG
* Active foot ulceration or infection
* Liver ALT \> twice the upper limit of the reference range
* Female planning to conceive within the study period
* Any other significant medical reason for exclusion as determined by the investigator

Primary outcomes:
measure: HbA1c reduction
timeFrame: 6 weeks
Secondary outcomes:
measure: insulin secretory response to glucose and tolbutamide
timeFrame: acute
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside
Study officials:
affiliation: NHS Tayside
name: Ewan R Pearson
role: PRINCIPAL_INVESTIGATOR
References: