louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04222712: A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Official title: A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-infectious Anterior Uveitis
Lead sponsor: Tarsier Pharma
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 16
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: The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis

.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study.
* Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.

An eligible subject must have:

* Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
* Must have vision ≥ 20/40 in the non-study eye.
* Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.

Exclusion Criteria:

* Any form of infectious uveitis
* Active retinitis
* Cancer or melanoma that is actively treated with immunotherapy
* Pregnancy / lactation
* Receiving specific medication/interventions as specified per protocol

Primary outcomes:
measure: Assessment of Both Systemic and Ocular Adverse Events
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palisades Park
country: United States
facility: Palisades Park
state: New Jersey
city: San Antonio
country: United States
facility: San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT05338112: Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity
Official title: Evaluation of the Relationship of Tzanck Smear Findings And Disease Activity In Patients With Pemphigus Vulgaris
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pemphigus Vulgaris
Keywords: pemphigus vulgaris, Tzanck smear, disease activity, prognostic factor
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with pemphigus vulgaris by clinical, histopathological and immunological methods.

Brief summary: Aim: Pemphigus vulgaris (PV) is a rare, life-threatening autoimmune bullous disease that can involve the skin and mucous membranes, characterized by intraepidermal bullae and eroded lesions caused by rupture of the bullae. The aim of this study is to research the relationship of the findings obtained with Tzanck smear, which is an inexpensive and easy method, with disease activity and its prognostic importance in the clinical course in PV patients.

Material and Methods: Pemphigus patients who visited to Goztepe Prof. Dr. Suleyman Yalcın City Hospital, Dermatology Clinic will be included in our study. Pemphigus disease area index (PDAI), Tzanck smear findings from the lesions and desmoglein levels during routine follow-up of patients with pemphigus vesicle/bulla/erosion will be evaluated. In the evaluation of Tzanck smear preparations, the entire slide will be scanned, acantholytic cell count performed and scored 1 to 4 accordingly (1 point: 1-3 cells, 2 points: 4-10 cells, 3 points:11-20, 4 points: \>21 cells or cell clusters). Anti-desmoglein antibody levels will be analyzed by using enzyme-linked immunosorbent assay (ELISA) method.


Eligibility criteria: Inclusion Criteria:

* Clinical, histopathological and immunological diagnosis of pemphigus vulgaris
* Must be active bullae or erosion at any stage of the disease

Exclusion Criteria:

* Patients with uncertain diagnosis of pemphigus vulgaris
* Eroded lesions due to causes other than pemphigus vulgaris (such as herpes in the oral mucosa, candida infection)

Primary outcomes:
measure: The number of acantholytic cells
timeFrame: 1or 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
Clinical trial NCT06138912: Thoracolumbar Junction
Official title: Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction: A Cross-Sectional Study of Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Curvatures
Keywords: Thoracolumbar spine
Alignment
Range of motion
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints

Brief summary: Several studies have investigated the mechanical behavior of the thoracolumbar spine. However, an accurate reference for normal functional local alignment and segmental motion at the thoracolumbar junction is still illusive. Therefore, we conducted a cross-sectional cohort study with a balanced distribution of age and sex of healthy subjects to examine the normal alignment and segmental motion at the thoracolumbar junction using dynamic plain radiography. This study aimed to provide data that can be used when planning surgery or performing rehabilitation in pathological situations.


Eligibility criteria: Inclusion Criteria:

* A total of 120 asymptomatic healthy volunteer subjects aged 20 to 79 without back pain complaints were included if they successfully met the study's exclusion criteria

Exclusion Criteria:

* (1) coronal deformity (Cobb angle \> 10°); (2) a history of prior spine surgery; (3) a history of hip or knee arthroplasty or any other realignment surgery of the lower extremities (osteotomy, trauma, etc.); (4) complaints of back or neck pain that resulted in missed work, affected daily living activities, participation in recreational activities or required narcotic pain medication; (5) degenerative or pathologic conditions of the spine that necessitated physician intervention (i.e., physician appointment or epidural steroid injections); (6) non-ambulatory patients; (7) a history of neuromuscular disorders, inflammatory arthritis, or congenital anomalies; and (8) pregnancy

Primary outcomes:
measure: Normal Functional Local Alignment and Segmental Motion at the Thoracolumbar Junction
timeFrame: 2year
Secondary outcomes:
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Dong-gu
Study officials:
References:
Clinical trial NCT01620112: The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
Official title: The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fascicular Block
Motor Activity
Pain, Postoperative
Latency Period
Keywords: brachial plexus
lidocaine
alfa 2 adrenergic receptor clonidine
orthopedic procedure
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 60
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 purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity

Detailed description: Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics.

Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use.

There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.

Eligibility criteria: Inclusion Criteria:

* both genders,
* over 18 years old,
* American Society of Anesthesiologists (ASA) 1 to 3

Exclusion Criteria:

* patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
* pregnant,
* with infection at the puncture site,
* coagulopathies or intolerance to drugs used in the study

Primary outcomes:
measure: sensorial and motor block duration
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
timeFrame: 24 hours after surgery
measure: postoperative analgesia duration
timeFrame: 24 hours
measure: sensorial and motor block onset time
timeFrame: 24 hours
measure: postoperative pain intensity
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05396612: Role of the Immune Environment in Response to Therapy in Breast Cancer
Official title: Role of the Immune Environment in Response to Therapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
ER Positive Breast Cancer
HER2-negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
Keywords: Immune microenvironment
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 18 years of age or older undergoing surgery for breast cancer.

Brief summary: This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.


Eligibility criteria: Inclusion criteria:

Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.

Exclusion criteria:

Males Children Pregnant individuals

Primary outcomes:
measure: Collecting, processing and archiving breast cancer tumor tissues
timeFrame: Through study completion, average of 2 years
Secondary outcomes:
measure: Associating breast cancer dendritic cell infiltrate with outcome
timeFrame: 5 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center
name: Jennifer Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01490112: Surveillance Study of NovoRapid® for New Drug Re-examination
Official title: Regulatory Post Marketing Surveillance Study of NovoRapid for New Drug Re-examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 1239
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

Brief summary: This study is conducted in Asia. The aim of this study is to observe the safety and efficacy of insulin aspart (NovoRapid®) administered via vial and three different devices.


Eligibility criteria: Inclusion Criteria:

* Subjects with diabetes mellitus (type 1, type 2, or gestational) prescribed with insulin aspart (NovoRapid®)

Primary outcomes:
measure: Change in weight
Secondary outcomes:
measure: Fasting blood glucose (FBG)
measure: HbA1c (glycosylated haemoglobin)
measure: Adverse events: Serious and non-serious
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06475612: Using the GTOS to Stratify the Mortality Risk of Adult Trauma Patients
Official title: Using the Geriatric Trauma Outcome Score (GTOS) to Stratify the Mortality Risk of Adult Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma Injury
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 40068
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study cohort included 46,808 trauma patients from the Trauma Registry System, covering the period from 2009 to 2021 Of these, 41,131 were adult patients aged 20 years and older. After excluding patients with burns (n = 1,040), hanging injuries (n = 19), drowning (n = 3), and unavailable laboratory data (n = 1), a final study population of 40,068 patients was analyzed. Within this cohort, there were 818 deaths, and 39,250 patients survived.

Brief summary: Trauma significantly impacts both short- and long-term health outcomes, resulting in substantial mortality. Early identification and risk stratification in trauma patients are crucial for timely medical interventions. The Geriatric Trauma Outcome Score (GTOS), designed by incorporating age, the Injury Severity Score (ISS), and the need for packed red blood cell transfusion, has emerged as a valuable prognostic tool for elderly trauma patients, but its applicability to general trauma patients remains underexplored.


Eligibility criteria: Inclusion Criteria:

* The study includes all patients aged equal to or over twenty who had trauma.

Exclusion Criteria:

* Patients with burns.
* Patients with hangings.
* Patients with drowning.
* Patients with with unavailable laboratory data.

Primary outcomes:
measure: Mortality outcome
timeFrame: Through hospital stay of patients, an average of 14 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT02401412: The Advocate Study
Official title: A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ostomy
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers.


Eligibility criteria: Inclusion Criteria:

Ostomy patients who:

* Have healthy peristomal skin
* Are within 12 weeks post op

Exclusion Criteria:

Ostomy patients who:

* Have a fistula, wound, lesion or suspected infection in the peristomal area
* Are in-patient in healthcare facility

Primary outcomes:
measure: Stoma Related Cost of Care
timeFrame: 12 weeks
Secondary outcomes:
measure: Peristomal Skin Complication Rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Stoia Consultants
state: California
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
city: Muncie
country: United States
facility: Indiana Health Ball Memorial University
state: Indiana
city: Kansas City
country: United States
facility: Restored Images
state: Missouri
city: Cuyahoga Falls
country: United States
facility: Klein's Orthopedic & Medical Supply
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Hospital
state: Ohio
city: Kelowna
country: Canada
facility: Lakeside Medicine Center
state: British Columbia
city: Nanaimo
country: Canada
facility: Pharmasave
state: British Columbia
city: New Westminster
country: Canada
facility: Ostomy Care Centre
state: British Columbia
city: Toronto
country: Canada
facility: Rouge Valley Health System
state: Ontario
Study officials:
affiliation: Hollister Incorporated
name: Mark Kalifa
role: STUDY_DIRECTOR
References:
Clinical trial NCT02500212: Pharmacokinetic Study of ENVARSUS in Adult De-novo Kidney Transplant Patients
Official title: OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Organ or Tissue Transplant; Complications
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 75
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: Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.


Eligibility criteria: Inclusion Criteria:

* Recipients of a kidney transplant from a deceased donor or a living donor

Exclusion Criteria:

* Recipient of any transplanted organ other than a kidney;
* Recipients of a bone marrow or stem cell transplant;
* Recipients of a kidney from a cardiac death donor;
* Recipients of a kidney from an ABO incompatible donor;

Primary outcomes:
measure: Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL
timeFrame: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose
Secondary outcomes:
measure: Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL
timeFrame: 24.0 hr post-dose
measure: Serum creatinine (mg/dL)
timeFrame: before dosing
measure: estimated glomerular filtration rate (eGFR) mL/min;
timeFrame: before dosing
measure: Heart Rate, (beats per minute)
timeFrame: before dosing
measure: Qt (milliseconds)
timeFrame: before dosing
Other outcomes:
Locations:
city: Brest
country: France
facility: Nephrology Department Hopital La Cavale Blanche
city: Grenoble
country: France
facility: Clinique de Nephrologie CHU Grenoble
city: Limoges
country: France
facility: CHU Limoges
city: Montpellier
country: France
facility: Service de Nephrologie
city: Nice
country: France
facility: Unité de transplantation rénale -Hopital Pasteur
city: Saint Etienne
country: France
facility: Nephrology department CHU de Saint-Etienne Hospital Nord
city: Toulouse
country: France
facility: CHU Rangueil, 1 avenue J Poulhes TSA 50032.
Study officials:
References:
citation: Kamar N, Cassuto E, Piotti G, Govoni M, Ciurlia G, Geraci S, Poli G, Nicolini G, Mariat C, Essig M, Malvezzi P, Le Meur Y, Garrigue V, Del Bello A, Rostaing L. Pharmacokinetics of Prolonged-Release Once-Daily Formulations of Tacrolimus in De Novo Kidney Transplant Recipients: A Randomized, Parallel-Group, Open-Label, Multicenter Study. Adv Ther. 2019 Feb;36(2):462-477. doi: 10.1007/s12325-018-0855-1. Epub 2018 Dec 14.
Clinical trial NCT00447512: Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Official title: Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Major Depression
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2007-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach but has been also identified in a variety of other organs. Alike, a wide range of central and peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study are:

A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30, 35-45, 60-70 years).

B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with major depression (age range: 20-65 years).


Eligibility criteria: Inclusion Criteria:

* Healthy females and males
* Male and female patients with major depression

Exclusion Criteria:

* Life time or family history of psychiatric or neurological disorders
* Sleep disturbances
* Shift work
* Any current disease
* Any medication
* Long distance flight within 3 months prior to study entry
* Smoking
* Any medication during the week prior to study entry
* Any current disease other than major depression

Primary outcomes:
measure: sleep, conventionally and quantitatively analyzed
timeFrame: study duration
Secondary outcomes:
measure: hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis
timeFrame: study duration
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Professor Axel Steiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluge M, Schussler P, Schmidt D, Uhr M, Steiger A. Ghrelin suppresses secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) in women. J Clin Endocrinol Metab. 2012 Mar;97(3):E448-51. doi: 10.1210/jc.2011-2607. Epub 2012 Jan 18.