louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00561171: Phase IIa Study to Investigate the Efficacy and Safety of SPP635 in Diabetic and Hypertensive Patients With Albuminuria
Official title: A Phase IIa, Double-Blind, Randomized, Parallel-Design, Four-Week Study to Investigate the Efficacy and Safety of Two Different Doses of the Renin-Inhibitor SPP635 Once Daily in Type II Diabetic Patients With Mild to Moderate Hypertension and Albuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Type II Diabetes Mellitus
Lead sponsor: Speedel Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II a, double-blind, randomized, parallel-design, four-week study to investigate the efficacy, safety and tolerability of two different doses of SPP635 in type II diabetic patients with mild to moderate hypertension and albuminuria.

The total study duration for patients completing the entire study will be approximately 7 weeks including a 2 weeks Screening Phase, 1 week Wash-out Phase, 4 week Treatment Phase and 1 week Follow-up Phase.

All treatments other than certain antihypertensive drugs (which are to be washed-out) with an effect on BP and all antidiabetic treatments must be kept at stable dose during the whole study.

A maximum of 50 patients in total is planned to be enrolled.


Eligibility criteria: Inclusion Criteria:

* men or women, 18 to 75 years
* hypertension
* diabetes mellitus type II
* albuminuria

Exclusion Criteria:

* donation of blood in the past month
* significant illness
* history of malignancy
* Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months
* Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months

Primary outcomes:
measure: ABPM
timeFrame: 28 days
Secondary outcomes:
measure: sitting PB
timeFrame: 28 days
Other outcomes:
Locations:
city: Ballinasloe
country: Ireland
facility: Dr. John Barton
state: Co Galway
Study officials:
affiliation: Speedel Pharma Ltd.
name: Maria Nicolaides, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02849171: Assessing 11C-Choline (11C-CH) PET to Distinguish True Tumor Progression From Pseudoprogression in High-grade Gliomas
Official title: Pilot Study of 11C-Choline (11C-CH) PET in Assessing Post-treatment True Tumor Progression From Pseudo-progression in High-grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Cancer
Keywords: 11C-Choline (11C-CH) PET
16-676
High-grade Gliomas
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-07-29
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: DIAGNOSTIC

Brief summary: This is a pilot study. The purpose of this study is to test if an imaging tracer, not approved by the FDA, called 11C-Choline (11C-CH) is useful for evaluating your type of cancer. This tracer is used to perform PET scans. The researchers want to see if the 11C-CH PET scan, using the study tracer 11C-CH, can improve upon the usual scans at diagnosing or monitoring your type of cancer.

In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It is important to distinguish true tumor growth from inflammation since inflammation indicates the tumor is responding to treatment. With standard MRI, it is difficult to determine if changes following treatment are due to tumor growth or inflammation early on. Researchers hope to learn if the investigational tracer, 11C-CH, will be able to distinguish true tumor growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patient is able to provide written informed consent prior to study registration
* Histologically-confirmed high-grade glioma
* Completion of treatment with standard radiation (with or without concurrent therapy).
* Standard gadolinium-enhanced MRI changes that are considered indeterminate for tumor progression vs. treatment-related changes by the neuroradiologist or clinician within 24 weeks of completion of radiation.

Exclusion Criteria:

* Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
* Renal insufficiency with recent (\<3 month old) creatinine \> 2.0 mg/dL
* Pregnant or nursing female

Primary outcomes:
measure: SUV Measures
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ronald Blasberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00637871: Casodex - Nolvadex Combination
Official title: Randomised, Double-blind, Placebo Controlled, Parallel-group, Multicentre Phase II Study to Assess Dose Response Relationship of Nolvadex (Oral Tablet) in Prophylactic Treatment of Gynaecomastia and Breast Pain Associated With CASODEX 150 mg (Oral Tablet), and to Assess the Tumour Control…..
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gynaecomastia
Prostate Cancer
Keywords: Casodex
bicalutamide
Tamoxifen
Gynaecomastia
Prostate Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-18
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study looks at the relationship in the dose of nolvadex and the incidence of gynaecomastia and also Prostate Specific Antigen (PSA) inhibition when co-administered with Casodex. The aim of the study is to assess the optimal dose of nolvadex which will reduce the breast tissue adverse effects without reducing the efficacy of Casodex.


Eligibility criteria: Inclusion Criteria:

* Subjects with adenocarcinoma of the prostate gland but with no evidence of distant metastasis. The stage of disease should be T1-T4, any N, M0 confirmed histologically or cytologically
* Subjects in need of immediate hormonal therapy.
* PSA equal or above 4 ng/ml

Exclusion Criteria:

* Presence of gynaecomastia and/or breast pain at screening visit
* Any previous endocrine therapy for prostate cancer other than neoadjuvant LHRH therapy prior to primary therapy of curative intent.
* Current use, or within the previous 6 months, of any medication known to have a high risk of causing gynaecomastia .
* Previous mastectomy or radiation to chest wall

Primary outcomes:
Secondary outcomes:
measure: To describe the extent of gynaecomastia and breast pain by treatment group
measure: To describe the relative change from baseline in sex hormones concentrations by treatment group
measure: To describe the pharmacokinetics of tamoxifen, N-desmethyltamoxifen and R-bicalutamide when nolvadex is co-administered at varying doses with CASODEX 150 mg once daily
measure: To assess the tolerance of nolvadex when co-administered at varying doses with CASODEX 150 mg once daily
Other outcomes:
Locations:
Study officials:
affiliation: Quebec City
name: Yves Fradet, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02690571: Pulmonary Effects of 100% Biodiesel Exhaust
Official title: Pulmonary Effects of 100% Biodiesel Exhaust
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: Air Pollution
Biodiesel exhaust
Bronchoscopy
Metabolomics
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a "green fuel", as it is sustainable and of biological origin, and therefore is often predicted to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have advantageous ecological impacts, consequences to respiratory health remained largely unexplored.

The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel exhaust would result in an acute airway inflammatory response in healthy human subjects, as shown previously following exposure to petrodiesel exhaust.


Eligibility criteria: Inclusion Criteria:

Normal ECG

Normal Lung function

Normal Blood samples

Exclusion Criteria:

Smoking

Pre-existing metabolomic, respiratory and cardiovascular disease

Exposure to high levels of pollutants in occupation

Primary outcomes:
measure: Cytokines in Bronchial wash (BW)
timeFrame: 6 hours
measure: Cell counts in Bronchial Wash
timeFrame: 6 hours
Secondary outcomes:
measure: Oxylipin Metabolomic profiling
timeFrame: Baseline, 2 hours, 6 hours, 24 hours
measure: Inflammation in bronchoalveolar lavage (BAL)
timeFrame: 6 hour
measure: Inflammation in endomucosal biopsies
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Jenny A Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06045871: Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression Osteogenesis.
Official title: Evaluation of Surgical Correction of Anterior Vertical Maxillary Excess (Gummy Smile) by Compression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compression Osteogenesis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The technique of compression osteogenesis will be studied to verify its value as applied to manage anterior vertical maxillary excess in patients wohm are suffering from gummy smile.


Eligibility criteria: Inclusion Criteria:

* patients suffering from anterior vertical maxillary excess that requires surgical intervention

Exclusion Criteria:

* total vertical maxillary excess Excessive horizontal maxillary excess Patients with systemic diseases that may affect normal bone healing

Primary outcomes:
measure: Measuring amount of vertical impaction of anterior maxilla after performing labial maxillary cotricotomy and activation of functional loading
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Elhelaly
Study officials:
References:
Clinical trial NCT05865171: A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
Official title: A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Severe Renal Impairment and Healthy Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of Inaxaplin (IXP) in participants with severe renal impairment and healthy participants with normal renal function.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m\^2)
* Stable renal function for at least 1 month prior to enrollment

Key Exclusion Criteria:

* Uncontrolled hypertension
* Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of IXP
timeFrame: Day 1 up to Day 7
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
timeFrame: Day 1 up to Day 7
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through completion of study participation (up to a maximum of 17 days)
Other outcomes:
Locations:
city: Ocala
country: United States
facility: GCP Research
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
Study officials:
References:
Clinical trial NCT06563271: Approach to Ankle Sprains in the Emergency Department
Official title: Evaluation of Analgesic Treatments for Ankle Sprains in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Sprains
Keywords: Range of motion
Numerical Rating Scale
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).

Detailed description: It is aimed to examine the effects of intravenous (IV) 50 mg dexketoprofen, IV ibuprofen 400mg and IV paracetamol 10 mg on pain and joint range of motion. To determine the effects of these agents on pain, the easily applicable Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale will be used. A standard handheld half-circle goniometer will be utilized to calculate active ankle joint ROM.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older who present to the emergency department within the first 72 hours after ankle sprain.
* Grade 1 (mild) and Grade 2 (moderate) ankle sprains.
* Exclusion of fractures and dislocations (after X-ray according to Ottawa rules).
* Absence of muscle-tendon ruptures.
* Absence of vascular and nerve injuries.
* Absence of open wounds and burns.
* Stable vital signs.
* Patients who provide written and verbal consent.

Exclusion Criteria:

* Patients who did not present to the emergency department within the first 72 hours after ankle sprain.
* Grade 3 (severe) ankle sprains.
* Multiple traumas.
* Pregnancy or suspected pregnancy.
* Ankle fractures and dislocations.
* Forensic cases.
* History of previous ankle surgery or fracture.

Primary outcomes:
measure: To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.
timeFrame: *Patient's pain level, NRS Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment
measure: To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains.
timeFrame: *Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment
measure: To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains.
timeFrame: - 0 minute ROM before treatment - 60 minute ROM after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Ahmet B. Erdem
role: STUDY_DIRECTOR
References:
Clinical trial NCT02028871: Intranasal Insulin for Weight Management During Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Abstinence Syndrome
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.


Eligibility criteria: Inclusion Criteria:

* smokers (\>10 cig/day) for the past 1 year
* normosmic olfactory function

Exclusion Criteria:

* previous/current use of insulin
* current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
* current pregnancy (or lactation)
* lifetime history of endocrine disease
* excessive alcohol use (\>25 standard units of alcohol/week)
* current use of illicit drugs
* current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent
* local infections, inflammation, structural abnormalities, or other nasal pathology
* current use of any medications administered intranasally, including intranasal steroids

Primary outcomes:
measure: Amount Eaten in Taste Test
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
measure: Nicotine Cravings Measured by Questionnaire of Smoking Urges
timeFrame: 210 minutes
Locations:
city: Albuquerque
country: United States
facility: UNM College of Pharmacy
state: New Mexico
city: Albuquerque
country: United States
facility: UNM College of Pharmacy
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Ajna Hamidovic, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03984071: The Predictive Value of eGFR for Adverse Cardiovascular Events in Patients With STEMI
Official title: The Predictive Value of Estimated Glomerular Filtration Rate (eGFR) for Adverse Cardiovascular Events in the Hospital in Patients With ST-segment Elevation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 3
Sex: ALL
Minimum age (years): 24
Maximum age (years): 93
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI Patients

Brief summary: Estimated glomerular filtration rate(eGFR) is significantly reduced in patients with ST-segment elevation myocardial infarction (STEMI). The aim of this study is to research that the incidence of adverse cardiovascular events (MACE) in patients with ST-segment elevation myocardial infarction is significantly higher when the glomerular filtration rate below a certain value.

Detailed description: The investigators retrospectively analyzed the clinical data of 1157 patients with ST-segment elevation myocardial infarction. In-hospital adverse cardiovascular events (MACE) was defined as: cardiac arrest, cardiac rupture, malignant arrhythmia, and cardiac death. All the patients were divided into 3 groups according to the patient's estimated glomerular filtration rate(eGFR) (eGFR≥90ml/min/1.73m2; 90ml/min/1.73m2\>eGFR≥60ml/min/1.73m2; eGFR\<60ml/min /1.73m2). COX regression analysis and K-M survival curves are used to calculate the correlation between eGFR and in-hospital MACE.

Eligibility criteria: Inclusion Criteria:

* 1.Patients with STEMI 2.Patients from whom informed consent has been properly obtained in writing prior to start of the trial

Exclusion Criteria:

* 1.Patients with previous myocardial infarction, congenital heart disease 2.Patients with liver disease, and renal failure 3.Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.

Primary outcomes:
measure: major adverse cardiac events
timeFrame: The median time of 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01614171: Growth Hormone for Osteoporosis Pseudoglioma Syndrome
Official title: Trial of Growth Hormone for Osteoporosis Pseudoglioma Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoporosis Pseudoglioma Syndrome
Keywords: osteoporosis pseudoglioma
OPPG
growth hormone
osteoporosis
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2012-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

Detailed description: Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

Eligibility criteria: Inclusion Criteria:

* Osteoporosis pseudoglioma syndrome
* Age 4 years and above
* not on medication for osteoporosis

Exclusion Criteria:

* pregnant
* Age under 4 yrs
* Active malignancy

Primary outcomes:
measure: Bone quality by pQCT
timeFrame: 6 months
Secondary outcomes:
measure: Body fat percent
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland School of Medicine, Division of Endocrinology
name: Elizabeth A Streeten, MD
role: PRINCIPAL_INVESTIGATOR
References: