louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00379860: Study Evaluation LXR-623 in Healthy Adults
Official title: A Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of LXR-623 Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Generally healthy adults.
* Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening.

Exclusion Criteria:

* A history or active presence of clinically important medical disease.
* Any metal implants or devices.
* Claustrophobia.

Primary outcomes:
measure: Safety is the primary outcome.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00503360: Tolerability, Safety and Efficacy of SAD448 in Subjects With Ocular Hypertension
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Masked, 4-Arm Parallel Group Study to Assess the Tolerability, Safety and Efficacy of Two Doses of SAD448 in Subjects With Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension
Keywords: Ocular Hypertension
SAD448
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the tolerability and safety of SAD448 and explore the compound's effect on intraocular pressure in subjects with ocular hypertension.


Eligibility criteria: Key inclusion criteria:

* Males and females, 18 - 65 years of age, with ocular hypertension
* Females must be post-menopausal or surgically sterile

Key exclusion criteria:

* Diagnosis of glaucoma in either eye
* A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug

Primary outcomes:
measure: Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs from baseline up to 24 hours post-dosing.
Secondary outcomes:
measure: Change in ocular hypertension from baseline up to 24 hours post-dosing. Systemic exposure to SAD448 following the administration of two doses.
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Novartis Investigative site, Sydney, Australia
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT01589276: Risk Factors and Results of Emergency Ventral Hernia Repair
Official title: Risk Factors and Results of Emergency Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 10976
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: Hernia repairs registered in the Danish Ventral Hernia Database during the study period

Brief summary: The aim of present study was to evaluate the clinical course after emergency ventral hernia repair in terms of 30-day-readmission, -reoperation and -mortality and to identify risk factors for emergency repair.

Detailed description: All incisional, umbilical and epigastric hernias registered in the Danish Ventral Hernia Database

Eligibility criteria: Inclusion Criteria:

* All incisional, umblilical and epigastric hernia repiars

Primary outcomes:
measure: risk factors for emergency ventral hernia repair
timeFrame: 4 years
Secondary outcomes:
measure: 30-day readmission
timeFrame: 30 days
measure: 30-day reoperation
timeFrame: 30 day
measure: 30-day mortality
timeFrame: 30 day
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Dept. of Surgery, Køge Hospital
Study officials:
affiliation: dept. surgery, Køge sygehus, Denmark
name: Frederik Helgstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Outcomes after emergency versus elective ventral hernia repair: a prospective nationwide study. World J Surg. 2013 Oct;37(10):2273-9. doi: 10.1007/s00268-013-2123-5.
Clinical trial NCT01516476: Study of RO6807952 in Patients With Diabetes Mellitus Type 2
Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of RO6807952 in Type 2 Diabetic Patients Inadequately Controlled With Metformin Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind, placebo-controlled, multi-center study will evaluate the efficacy and safety of RO6807952 in patients with diabetes mellitus type 2 inadequately controlled with metformin alone. Patients will be randomized to receive doses of RO6807952, placebo, or liraglutide. The anticipated time on study treatment is 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/= 18 and \</=70 years of age
* Diagnosis of diabetes mellitus, type 2 for at least 3 months
* Treated with a stable dose of metformin
* Hemoglobin A1c \>/=7.0% and \</=10.5% at screening
* Fasting plasma glucose \</=240 mg/dL at screening
* Body mass index \>/=27 kg/m2 and \</=42 kg/m2 at screening
* Willing and able to maintain existing diet and exercise habits throughout the study
* C-peptide \>1.5 ng/mL at screening

Exclusion Criteria:

* History of significant liver or kidney disease
* History of uncontrolled hypertension
* History of significant cardiovascular disease
* History of significant diabetic complications
* History of significant gastrointestinal conditions
* History of weight loss surgery or procedures involving the gastrointestinal tract
* History of chronic or acute pancreatitis

Primary outcomes:
measure: Change in hemoglobin A1c (HA1c)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in fasting plasma glucose
timeFrame: Baseline and 12 weeks
measure: Safety (incidence of adverse events)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
state: Ohio
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00518076: Staphylococcus Aureus Carriers Students Nursing Oxacillin Resistant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcal Infections
Keywords: Staphylococcus aureus carriers students nursing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2007-08-20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The Staphylococcus aureus is an important pathogen bacteria actuating as an agent of a wide variety of infections, such as the superficials to the disseminates ones, its commonly find into hospitals ambient, assailing mainly immunosupress patients. Around 30% to 50% of people carries this agent in their nasal bone as part of their normal flora, occuring larger in hospitals workers. The S. aureus is also known for its high capacity of developing resistance to various antibiotic. Facing these considerations, the importance of nursing precaution and the infections control inside hospitals ambient, the purpose of this present study aimed to verify the rates of carriers of S. aureus in nursing students and the connection with the hospitals time involvement during graduation in the Faculty de Medicine de Botucatu - UNESP, embracing the 4 years of graduation college.


Eligibility criteria: Inclusion Criteria:

* Students nursing

Exclusion Criteria:

* Students nursing with infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: São Paulo State University
state: São Paulo
Study officials:
affiliation: São Paulo State University
name: Eliane Patrícia Pereira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06609876: Donafenib as Adjuvant Therapy Following Ablation for Recurrent HCC
Official title: Thermal Ablation Combined With Low-dose Donafinib for Early Recurrent Hepatocellular Carcinoma: a Multicenter Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Microwave Ablation
Donafenib
Recurrent Tumor
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2024-09-24
Enrollment: 108
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 study intends to evaluate the efficacy and safety of low-dose adjuvant donafenib after thermal ablation for early recurrent HCC within Milan criteria.

Detailed description: Thermal ablation is available as the major curative treatments for early-stage recurrent HCC. Donafenib was inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. No study has evaluated low-dose donafenib as adjuvant therapy after thermal ablation. There needs further investigation to explore the efficacy and safety of the combination treatment. Thus, the investigators carried out this prospective, randomized, open-label, phase II trial study to find out it.

Eligibility criteria: Inclusion Criteria:

1. were aged 18-75 years;
2. had recurrent HCC (RHCC) diagnosed by imaging studies, the first or the second RHCC;
3. RHCC met the Milan criteria, namely single RHCC lesion less than 5 cm in diameter or no more than 3 tumors (each ≤3 cm in diameter);
4. the early RHCC (recurrent time \<1 year)
5. patients were unwilling to undergo repeat hepatectomy or liver transplantation;
6. had well-preserved liver function, i.e., Child-Pugh class A or B, and prolonged prothrombin time≤5 s;
7. patients had an Eastern Cooperative Oncology Group performance status score ≤1.
8. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. were under 18 years or over 75 years of age;
2. primary HCC;
3. recurrent HCC beyond Milan criteria;
4. RHCC with metastasis or macrovascular tumor thrombus

Primary outcomes:
measure: Tumor-free survival rate
timeFrame: 24 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 36 months
measure: Adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
state: None Selected
Study officials:
affiliation: Chinese PLA General Hospital
name: Feng Duan, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05738876: Non Obstructive Versus Obstructive Coronary Artery Disease
Official title: Non Obstructive Versus Obstructive Coronary Artery Disease Documented by Coronary Angiography; Prevalence & Diagnostic Features in a Single Center Experience : A Prospective Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Obstructive Coronary Artery Disease
Lead sponsor: Arab Board of Health Specializations, Iraq
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with clinical features of IHD underwent coronary angiography in CCU of imam hussain hospital from January to May of 2021

Brief summary: The goal of this observational study is to study the non obstructive type of ischemic heart disease by identifying unique clinical features , frequency and age group .in patient admitted in coronary care unit , suffered from angina or heart attack. . The main question\[s\] it aims to answer are:

* how it different from classical type of ischemic heart disease ( obstructive coronary artery disease)
* what is frequency and age prevalence of these patient Participants evaluated by history , clinical examination, serum troponin and coronary angiography.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with IHD ( MI, unstable angina ,chronic stable angina)
* \>18 years of age
* patients undergoing CAG for emergency or elective situations.

Exclusion Criteria:

* Patients who were hemodynamically unstable.
* patients with incomplete data
* patients with clinical features of pericarditis or others of non cardiac origin chest pain .

Primary outcomes:
measure: Non obstructive versus obstructive coronary artery disease documented by coronary angiography; prevalence & diagnostic features in a single center experience : A prospective cross sectional study
timeFrame: BASELINE
Secondary outcomes:
Other outcomes:
Locations:
city: Karbala
country: Iraq
facility: Arab board of health specializations-Iraq, Karbala , Iraq
Study officials:
References:
Clinical trial NCT01525576: Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)
Official title: Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive-compulsive Disorder
Keywords: booster program
internet
cbt
Study the specific effects of adding a booster program
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 98
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: In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).

Detailed description: Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.

Eligibility criteria: Inclusion Criteria:

* Signed consent
* Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099

Exclusion Criteria:

* Suicidal ideation that could jeopardize participation

Primary outcomes:
measure: Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.
timeFrame: 3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended
Secondary outcomes:
measure: Change from Baseline of obsessions and compulsions after 8 and 20 months.
timeFrame: 3 months before treatment, 6 and 18 months after treatment has ended
measure: Change from Baseline of obsessions and compulsions after 8 and 20 months.
timeFrame: 3 months before treatment, 6 and 18 months after treatment has ended
measure: Change from Baseline of obsessions and compulsions after 8 and 20 months.
timeFrame: 3 months before treatment, 6 and 18 months after treatment has ended
measure: Change from Baseline of obsessions and compulsions after 8 and 20 months.
timeFrame: 3 months before treatment, 6 and 18 months after treatment has ended
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Psykiatri sydväst
Study officials:
References:
Clinical trial NCT00824876: Orthostatic Tolerance in Mamma Cancer Patients After Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Mammae cancer patients
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-01-19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mammasurgery patients

Brief summary: The investigators want to investigate the effect of anaesthesia, on the ability to maintain upright posture immediately after surgery in mamma cancer patients.

The investigators hypothesis is, that a standard anaesthesia does not effect the ability to maintain upright posture right after surgery.

Detailed description: It is known, that patients undergoing major surgery have problems maintaining upright posture after major surgery. This can be due to fall in bloodpressure, with symptoms like dizziness, nausea/vomiting and fainting.

With this investigation, we want to prove that anaesthesia is not the decisive factor, in patients ability to maintain upright posture after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients having performed elective breast surgery
* Age between 18 and 70 years
* Patients who have given written consent to participate in the project after haven completely understood the contents and limitations of the protocol

Exclusion Criteria:

* Patients who do not understand or speak Danish
* Patients who have not signed the informed consent or the written authority pre-medication, except 1g paracetamol
* ASA \> II
* Pregnant or breastfeeding
* Known to have Renal disease
* Known to have Psychiatric disorder (not considering the use of SSRI antidepressive)
* Need for crash induction or prone position
* Oesophageal varicoses
* Necrosis or cancer in: Mouth, Pharynx, Larynx or Oesophagus
* Coarctation or aneurism in the proximal Aorta
* Severe bleeding disease

Primary outcomes:
measure: To investigate orthostatic function, measured by Finapress
Secondary outcomes:
measure: To investigate the occurrence of postsurgery nausea/vomiting
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
Study officials:
affiliation: dept of surgical patophysiology
name: Henrik Kehlet, MD, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03846076: Internet Delivered CBT for Olfactory Reference Syndrome
Official title: Investigating Treatment and Information Processing in Olfactory Reference Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olfactory Reference Syndrome
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2019-02-19
Enrollment: 15
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: The primary aim of the study is to test the feasibility and efficacy of, a manual based, Internet-delivered, cognitive behaviour therapy (CBT) for patients with Olfactory Reference Syndrome (ORS) who live in Sweden. The secondary aim is to investigate smell sensitivity and body odor in these ORS-patients.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of ORS
* Outpatients
* Male or female
* Signed informed consent
* Have regular access to a computer with Internet access and skills to use the web

Exclusion Criteria:

* Not able to read or understand the basics of the ICBT self-help material
* Psychotropic medication changes within two months prior to treatment
* Completed CBT for ORS within last 12 months
* Ongoing substance dependence or misuse
* Lifetime bipolar disorder or psychosis
* Suicidal ideation
* Axis II diagnosis that could jeopardize treatment participation
* Serious physical illness that will be an obstacle in ICBT
* Other ongoing psychological treatments that could affect ORS symptoms
* Epilepsia

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome (ORS-YBOCS)
timeFrame: Change from baseline (week 0) to post-treatment (week 10).
Secondary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale Modified for olfactory reference syndrome - Self Report (ORS-YBOCS-SR)
timeFrame: Change from baseline (week 0) to post-treatment (week 10).
measure: The Montgomery Åsberg Depression Rating Scale - self report (MADRS-S)
timeFrame: Change from baseline (week 0) to post-treatment (week 10).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: M46: Karolinska Universitetssjukhuset, Psykiatri Sydväst Stockholm, Huddinge, Sweden, 141 86
Study officials:
References:
Clinical trial NCT01168076: Noninvasive Transcutaneous Glucometer Development
Official title: Noninvasive Transcutaneous Glucometer Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Prediabetic State (IGT)
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Lead sponsor: InLight Solutions
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Those with Type 1 and 2 diabetes

Brief summary: The objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.

Detailed description: The feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (NIR) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 UNM HRRC protocol. Now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. We must develop a device that is portable, affordable, and rugged - all while improving accuracy. We must also improve our understanding of the nature of glucose in whole, intact skin. Since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. The noninvasive measurement can be no more accurate than the reference measurement on which it was based. Finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. This effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. To account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Healthy
* Type I diabetics
* Type II diabetics
* Impaired glucose tolerance

Exclusion Criteria:

* Minor status (\<18 years of age)
* Pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: InLight Solutions
state: New Mexico
Study officials:
affiliation: UNMHSC
name: Mark Rohrscheib, M.D.
role: PRINCIPAL_INVESTIGATOR
References: