louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05567263: Post-operative Sensitivity of a Self-adhesive Restorative Material
Official title: Post-operative Sensitivity and Clinical Performance of a Self-adhesive Restorative Material in Posterior Restorations.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restorations, Permanent
Keywords: Composite, self-adhesive, sensetivity
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2022-10-05
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The design of study will be a split-mouth randomized clinical trial with two study groups.
Primary purpose: TREATMENT

Brief summary: Adhesively restoring teeth using a resin-based composite and a modern dental adhesive is now considered a reliable, predictable, and durable procedure. However, adhering resin-based composite in conditions of suboptimal field control or complex cavity configurations remains challenging. In addition, the continuing discussions on the clinical use of dental amalgam and the feasibility of a phase out of the use of dental amalgam in the long term has become a central concern for restorative dentistry and has led to strong efforts to develop a substitute material for amalgam. With the goal of clinically shorter application times and lower technique sensitivity, the development of an advanced self-adhesive restorative tooth-colored restorative materials (ASAR) that no longer need pre-treatment with a separate adhesive have been under investigation. The aim of this study is to assess the post-operative sensitivity following restoration of teeth using a self-adhesive tooth-colored restorative material and to assess its clinical performance in comparison with conventional resin-based composite in posterior restorations


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years' old
* Teeth are vital
* Teeth are periodontal healthy
* Tooth to be restored in normal occlusion with natural antagonist and adjacent teeth
* Patient did not receive orthodontic treatment
* Good level of oral hygiene.

Exclusion Criteria:

* Non-vital or endodontically treated teeth
* (Profound, chronic) periodontitis
* Deep carious defects (close to pulp, \< 1mm distance)
* Heavy occlusal contacts or history of bruxism
* Poor oral hygiene
* Sustained dentin hypersensitivity
* Taking anti-inflammatory, analgesic, or psychotropic drugs

Primary outcomes:
measure: The post-operative sensitivity.
timeFrame: One month after the treatment.
Secondary outcomes:
measure: Clinical performance of the restorations
timeFrame: 6 months and 1 year after the treatment.
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Ghada A Maghaireh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122663: Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo
Official title: A Pilot Feasibility Trial of Emergency Department Vestibular Rehabilitation Therapy for Dizziness and Vertigo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dizziness
Vertigo
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 125
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: ED patients presenting with a chief complaint relating to dizziness or vertigo.

Brief summary: ED-VeRT will enroll up to 125 adult emergency department (ED) patients presenting with a chief complaint of dizziness or vertigo to collect longitudinal outcomes over 3 months of follow-up. This will include 50 patients who were evaluated by an ED physical therapist (ie, vestibular rehabilitation) during their ED visit and 50 patients who received usual care. The aims of this trial are to: (1) obtain initial estimates of participant recruitment and retention, intra-cluster correlation, and between-group outcome differences that will inform sample size calculation for a future randomized clinical trial, and (2) assess feasibility and fidelity of a clinical classification protocol for undifferentiated dizziness among patients receiving ED vestibular rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Chief complaint relating to dizziness or vertigo
* Ability to complete follow-up data collection electronically or by telephone
* English-speaking

Exclusion Criteria:

* Severe neurologic deficit concerning for ischemic or hemorrhagic stroke
* Known pregnancy, under police custody, unable to consent

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Three months after the index ED visit.
Secondary outcomes:
measure: Vestibular Activities Avoidance Instrument (VAAI-9)
timeFrame: Three months after the index ED visit.
measure: ED Diagnostic Imaging Utilization
timeFrame: Index ED visit (one day)
measure: ED Length of Stay
timeFrame: Index ED visit (up to one week)
measure: Patient-Reported Medication Use in Last 24 Hours
timeFrame: Three months after the index ED visit.
Other outcomes:
measure: Global Rating of Change (GROC)
timeFrame: Three months after the index ED visit.
measure: Numeric Rating Scale (NRS)
timeFrame: Three months after the index ED visit.
measure: Advanced Healthcare Utilization
timeFrame: Three months after the index ED visit.
measure: Benzodiazepine Prescription Filling
timeFrame: Three months after the index ED visit
measure: Follow-up with Outpatient Physical Therapy
timeFrame: Three months after the index ED visit
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT00191763: Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer
Official title: Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell-Lung Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.


Eligibility criteria: Inclusion Criteria:

* define histologic or cytologic diagnosis of non small cell lung cancer.
* determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer.
* define performance status of 0-1 on ECOG scale
* do not have any prior tumor therapy
* to be suitable for curative resection

Exclusion Criteria:

* to have any treatment within the last 30 days with any investigational drug.
* to get concurrent administration of any other tumor therapy
* to be pregnant
* to have poorly controlled diabetes mellitus
* to have serious concomitant disorders.

Primary outcomes:
measure: To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer
Secondary outcomes:
measure: To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin
measure: To determine the complete tumor resection rate
measure: To evaluate overall survival and time to documented disease progression
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00170963: Efficacy and Safety of Valsartan/Amlodipine Combination in Hypertensive Patients Not Controlled With Valsartan Alone
Official title: Valsartan/Amlodipine 160/5 mg or 160/10 mg Versus Valsartan 160 mg Alone for 8 Weeks in Hypertensive Patients Who Are Not Adequately Controlled on Valsartan 160 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, high blood pressure, valsartan, amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 1018
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication


Eligibility criteria: Inclusion Criteria:

* Patients with uncomplicated, essential hypertension

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney, or pancreas disease
* Insulin dependent diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in mean systolic blood pressure after 8 weeks
measure: Decrease in diastolic blood pressure of at least 10 mmHg or diastolic blood pressure was less than 90 mmHg after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg after 8 weeks
Other outcomes:
Locations:
city: Investigative Centers
country: Germany
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Sinkiewicz W, Glazer RD, Kavoliuniene A, Miglinas M, Prak H, Wernsing M, Yen J. Efficacy and tolerability of amlodipine/valsartan combination therapy in hypertensive patients not adequately controlled on valsartan monotherapy. Curr Med Res Opin. 2009 Feb;25(2):315-24. doi: 10.1185/03007990802630588.
Clinical trial NCT05442463: Hormone Therapy and Angiotensin-Dependent Arterial and Renal Vasoconstriction in Humans
Official title: Hormone Therapy and Angiotensin-Dependent Arterial and Renal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hormone Therapy
Keywords: post menopausal hormone replacement therapy
transgender men
transgender women
nonbinary
cis gender
post menopause
HRT
hormone replacement therapy
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult ages 18 - 90 years cisgender (gender identity that aligns with sex at birth) and transgender (gender identity that does not align with sex at birth) adult women and men who are on oral, non-oral or no hormone therapy.

Brief summary: 1. to investigate the association between route of administration of exogenous estrogen (transdermal vs. oral) and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) women.
2. to investigate the association between exogenous testosterone exposure and cardiorenal risk in cisgender (gender identity aligning with sex at birth) and transgender (gender identity not aligning with sex at birth) men.

Detailed description: Participants are screened for eligibility.

Study involves a 4.5 hour morning in the lab:

1. Participants come fasting
2. IV infusion and blood draws
3. Non invasive testing - Holter monitor, sphygmocor, bioelectrical impedance, blood pressure checks

Eligibility criteria: Inclusion Criteria:

* Age 18 to 90 years
* Taking hormones orally or non-orally (either estrogen, progesterone or testosterone)

Exclusion Criteria:

* Cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
* Cerebrovascular disease (transient ischemic attacks or stroke)
* History of hypertension (BP\>140/90 or use of antihypertensive medications)
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2
* Diabetes mellitus (defined by history, use of hypoglycaemic agents or a fasting glucose \>7mmol/L)
* Current smoker
* Previous history of preeclampsia
* Anabolic steroids, cortical steroids, or non-steroidal anti-inflammatory medications, or at the discretion of the investigator.

Primary outcomes:
measure: First association in transgender women and cis women
timeFrame: 2025
measure: Second association in transgender men and cis men
timeFrame: 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: Alberta Health services
name: Sofia Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02609763: Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale
Official title: Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Steatoblepharon
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible adults with varying degrees of lower eyelid steatoblepharon

Brief summary: This observational study will test the inter-rater and test-retest reliability of the LESS scale in a live context.


Eligibility criteria: Inclusion Criteria:

* Must provide informed consent

Exclusion Criteria:

* Unable or unwilling to complete study procedures

Primary outcomes:
measure: LESS score (Clinician-Reported)
timeFrame: Eyelids will be assessed on one day only (cross-sectional study)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01537263: Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage
Official title: Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: Aneurysmal Subarachnoid Hemorrhage
SAB
SAH
Ultrasound
Perfusion imaging
Lead sponsor: Asklepios Kliniken Hamburg GmbH
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 30
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: Primary care clinic

Brief summary: The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).

Detailed description: The delayed cerebral ischemia is a main complication in patient with aneurysmal subarachnoid hemorrhage which causes neurological deficit. So far there is no reliable diagnostic tool to predict the appearance of cerebral ischemia.

The causal correlation between presence of cerebral vasospasm measured daily by transcranial Doppler sonography (TCD) and occurrence of cerebral ischemia detected by cranial computed tomography scan (CCT) is not finally verified.

First studies demonstrated that ultrasound perfusion imaging (UPI) allows the detection of perfusion deficits in middle cerebral artery infarction.

The purpose of our study is to evaluate the diagnostic and prognostic value of UPI to predict delayed cerebral ischemia. In our trial we compare parameters of UPI (b= rise rate, A= plateau of acoustic intensity) in patients with aneurysmal subarachnoid hemorrhage with results of follow-up cranial computed tomography scans (CCT), TCD results and clinical outcome.

Eligibility criteria: Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage, Hunt and Hess 0-5
* Informed consent
* Sufficient transtemporal acoustic window
* First examination within 48h after subarachnoid hemorrhage
* Minimum Age 18 years

Exclusion Criteria:

* Contraindication against computed tomographic scan
* Incompatibility against SonoVue™
* Acute respiratory distress syndrome
* Uncontrollable hypertensive crisis
* Severe pulmonary disease(pulmonary hypertension \> 90 mmHg)
* acute severe cardiac insufficiency (New York Heart Association IV)
* known right-left-shunt
* pregnancy and breastfeeding
* Substance dependence

Primary outcomes:
measure: Change of perfusion
timeFrame: Baseline, Day 5
Secondary outcomes:
measure: Correlation between perfusion parameters, clinical course and flow velocities
timeFrame: Day 1 to 90
measure: Change of Perfusion
timeFrame: Baseline, Day 5
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Neurology, Asklepios Hospital North
Study officials:
affiliation: Asklepios Kliniken Hamburg GmbH
name: Günter Seidel, MD, Professor of Neurology
role: STUDY_DIRECTOR
References:
Clinical trial NCT01359163: A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study Of Commercial Femulen Tablets Versus Reformulated Femulen Tablets In Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Therapeutic Equivalency
Keywords: bioequivalence study
marketed vs reformulation tablets
Femulen
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 20
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).
* Healthy female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).

Primary outcomes:
measure: Area under the curve to last time point observed (AUCt)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
measure: Highest concentration (Cmax)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Secondary outcomes:
measure: Area under the curve to infinity (AUCinf)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
measure: Area under the curve percent to infinity (AUC%inf)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
measure: Half-life (T1/2)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
measure: Time at maximum concentration (Tmax)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00804063: Serum Citrate in Diagnosis and Follow-up for Glaucoma
Official title: Serum Citrate in Diagnosis and Follow-up for Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: glaucoma
citrate
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Kantonsspital Baselland Bruderholz
First posted: 2008-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary university center

Brief summary: Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.


Eligibility criteria: Inclusion Criteria:

* age\> 18 years
* glaucoma

Exclusion Criteria:

* Active ocular inflammation
* Ocular Hypertension
* Nephropathy
* Alcohol-, Drug abuse
* Mitochondriopathy

Primary outcomes:
measure: serum citrate level
timeFrame: 1
Secondary outcomes:
measure: urine citrate
timeFrame: 1
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: David Goldblum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Josef Flammer, MD
role: STUDY_CHAIR
affiliation: University Hospital, Basel, Switzerland
name: Selim Orguel, MD
role: STUDY_DIRECTOR
affiliation: University Hospital, Basel, Switzerland
name: Stephan Fraenkl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Basel
name: Fabrizio Branca, MD
role: PRINCIPAL_INVESTIGATOR
References: