louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01059032: Enhancement and Restoring of Low Dose Abdominal CT Images
Official title: Enhancement and Restoring of Low Dose Abdominal CT Images by a Novel Adaptive Nonlinear 3D Post Processing Filter - a Prospective Blinded Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Radiation Protection
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Sykehuset Buskerud HF
First posted: 2010-01-29
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.


Eligibility criteria: Inclusion Criteria:

* Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast.

Exclusion Criteria:

* Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast

Primary outcomes:
measure: Rating of image quality
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Buskerud Hospital
Study officials:
References:
Clinical trial NCT06292832: Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Pain Control After Cesarean Section in Obese and Morbidly Obese Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.

Detailed description: The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).

Eligibility criteria: Inclusion Criteria:

* ASA I-II women scheduled for elective CS under intrathecal anesthesia.

Exclusion Criteria:

* had local infection, bleeding disorder or known allergy to any of the study medications

Primary outcomes:
measure: postoperative time to rescue analgesia requirement
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar University
Study officials:
affiliation: Al-Azhar University, Assiut, Egypt
name: Warda Ali
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02544932: Pleotropic Effect of New Oral Anticoagulants
Official title: Prospective Randomized Study for Evaluating Vascular Protective Effects of New Oral Anticoagulants in High Risk Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: anticoagulant
atherosclerosis
endothelium
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atrial fibrillation (AF) has been known to have several pathophysiologic mechanisms including endothelial dysfunction of heart and vessel. This study was designed to determine the efficacy of NOAC therapy in the prevention of endothelial dysfunction and progression of atherosclerosis of AF subjects.

Detailed description: The properties of oral, direct inhibitors of factor Xa (e.g. rivaroxaban) and thrombin (e.g. dabigatran) have been examined the haemostasis and thromboembolism management. Preclinical studies have provided evidences for the effects of direct factor Xa or thrombin inhibition beyond anticoagulation, including anti-inflammatory and protective activities in atherosclerotic plaque development . Therefore, this study evaluates the protective effects of NAOC with the reactive hyperemia peripheral arterial tonometry (RH-PAT) measurements reflecting endothelial function by Endo-PAT2000 and intima-media thickness (IMT) of the carotid artery, which is used as a surrogate endpoint of atherosclerosis.

Eligibility criteria: Inclusion Criteria:

* CHA2DS2-VASc score above 2

Exclusion Criteria:

* severe peripheral arterial disease (greater than a Fontaine IIb category)
* grade 4 or higher cerebral infarction on the Modified Rankin Scale
* proven coronary artery disease by coronary angiogram
* severe hepatic or renal dysfunction
* uncontrolled congestive heart failure
* uncontrolled hypertension or diabetes mellitus
* hematologic disorders
* allergy or hypersensitivity to the investigational drugs
* pregnant or lactating women or women wishing to become pregnant

Primary outcomes:
measure: The changes in reactive hyperemia index (RHI)
timeFrame: 12months
Secondary outcomes:
measure: right and left maximum IMT of the common carotid artery (CCA)
timeFrame: 24months
measure: right and left mean IMT of the common carotid artery (CCA)
timeFrame: 24months
measure: adverse events
timeFrame: 24months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University
Study officials:
affiliation: Kyunghee University Medical Center
name: Weon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JB, Joung HJ, Lee JM, Woo JS, Kim WS, Kim KS, Lee KH, Kim W. Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial. Trials. 2016 Aug 24;17(1):422. doi: 10.1186/s13063-016-1541-8.
Clinical trial NCT00509132: A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers
Official title: A Phase I, Double-Blind, Randomized, Placebo-Controlled Ascending IV Single-Dose Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Genaera Corporation
Sponsor class: INDUSTRY
First posted: 2007-07-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerance of single intravenous (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to each volunteer group throughout the study. Another purpose is to evaluate the pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues over time) of trodusquemine. Finally, this study will also determine whether trodusquemine has any effect on appetite, mood or behavior, and selective biomarkers (substances in your blood that may change in response to the study drug).


Eligibility criteria: Inclusion Criteria:

* male or female subjects, between 18 and 55 years old (inclusive);
* body mass index (BMI) of 27-40 kg/m2;

Exclusion Criteria:

* likely allergy or sensitivity to any components of Trodusquemine for Injection based on known allergies to drugs of the same class, or which, in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity to trodusquemine HCl;
* any subject with a history of allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications;
* any subject with a history of severe allergy or bronchial asthma;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Quintiles, Inc.
state: Kansas
Study officials:
affiliation: Quintiles, Inc.
name: Phil Leese, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06188832: Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
Official title: Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
supplements
body mass index
overweight
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
name: Triangel Scientific
First posted: 2024-01-03
Enrollment: 108
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: This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.


Eligibility criteria: Inclusion Criteria:

* Confirmed presence of one or more specified gene polymorphisms (FTO, MC4R, LEP, LEPR).
* Overweight or obese status (BMI ≥ 25).

Exclusion Criteria:

- BMI \< 25

Primary outcomes:
measure: Body-weight change in %
timeFrame: 180 days
Secondary outcomes:
measure: body-weight reduction ≥5%
timeFrame: 180 days
measure: body-weight reduc-tion ≥10%
timeFrame: 180 days
measure: Body weight in kg
timeFrame: 180 days
measure: Body mass index change in %
timeFrame: 180 days
measure: Fat mass change in %
timeFrame: 180 days
measure: Systolic blood pressure in mmHg
timeFrame: 180 days
measure: Fat-free mass change in kg
timeFrame: 180 days
measure: Visceral fat rating change from baseline
timeFrame: 180 days
measure: Diastolic blood pressure in mmHg
timeFrame: 180 days
measure: Total cholesterol ratio
timeFrame: 180 days
measure: LDL-C ratio
timeFrame: 180 days
measure: HDL-C ratio
timeFrame: 180 days
measure: Triglycerides ratio
timeFrame: 180 days
measure: hsCRP ratio
timeFrame: 180 days
measure: Fasting plasma glucose mmol/l
timeFrame: 180 days
measure: Side effects %
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References:
citation: Pokushalov E, Ponomarenko A, Garcia C, Pak I, Shrainer E, Seryakova M, Johnson M, Miller R. The Impact of Glucomannan, Inulin, and Psyllium Supplementation (SolowaysTM) on Weight Loss in Adults with FTO, LEP, LEPR, and MC4R Polymorphisms: A Randomized, Double-Blind, Placebo-Controlled Trial. Nutrients. 2024 Feb 17;16(4):557. doi: 10.3390/nu16040557.
Clinical trial NCT03971032: An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure
Official title: A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Cervical Neoplasm
Uterine Neoplasms
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-06-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing hysteroscopy

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Comparison of infrared spectroscopy with routine histopathology
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00489437: Heparin-Induced Thrombocytopenia Score Card Study
Official title: Improving the Diagnosis of Heparin-Induced Thrombocytopenia: Utility of the 4T's Score and Evaluation of New Rapid Assays
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heparin-Induced Thrombocytopenia
Keywords: diagnosis
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Ontario
First posted: 2007-06-21
Enrollment: 536
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: Main Research Question:

Can two new types of test, one called the 4T's score and the other called a rapid assay, help doctors correctly identify which patients are unlikely to have heparin-induced thrombocytopenia (HIT)?

HIT is a severe allergic reaction to the blood thinner heparin. This allergic reaction can lead to heart attacks, strokes, limb amputations, and death. Because heparin is one of the most commonly used drugs in the hospital setting, it is very important that the investigators are able to correctly identify who can safely continue to take heparin and who cannot.

It can be very difficult to diagnose HIT because it can look like many other medical conditions and the best laboratory tests for HIT are difficult to run and only available at specialized centres.

It would be very helpful if doctors had tests they could use that would tell them quickly and accurately which patients with symptoms that look like HIT really do have HIT (and require urgent treatment with another type of blood thinner) and which patients are very unlikely to have HIT (and could continue to take heparin safely). In this study, the investigators will compare the 4T's score (a scoring system that assigns "points" to the presence or absence of specific clinical features) and a rapid laboratory test with the old laboratory test to find out if one or both of these types of tests are useful for telling doctors which patients have HIT and which patients don't have HIT.


Eligibility criteria: Inclusion Criteria:

* Suspected heparin-induced thrombocytopenia

Exclusion Criteria:

* Unable to give consent
* Unable to provide a blood sample
* Previous entered in study

Primary outcomes:
measure: Proportion of patients with a low or intermediate 4T's Score and a negative ID-PaGIA assay result who have a positive SRA.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Lori-Ann Linkins, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linkins LA, Bates SM, Lee AY, Heddle NM, Wang G, Warkentin TE. Combination of 4Ts score and PF4/H-PaGIA for diagnosis and management of heparin-induced thrombocytopenia: prospective cohort study. Blood. 2015 Jul 30;126(5):597-603. doi: 10.1182/blood-2014-12-618165. Epub 2015 Apr 29.
Clinical trial NCT00213837: Reconstruction Implant Bone After Removal Using Porous Titanium Prosthesis
Official title: Reconstruction Implant Bone (Anterior Mandibular Arch) After Removing Using Porous Titanium Prosthesis in ENT Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Otorhinolaryngologic Diseases
Keywords: porous titanium implants
thyroplasty
vocal cord paralysis
male or female more than 18 years old
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This trial will study the reconstruction of the anterior part of the mandible and the adjacent soft tissue parts by a mandibular prosthesis made in porous titanium, associated or not, to a latissimus dorsi or pectoral flap, to avoid reconstruction with free microanastomosed bone flaps that are often associated with important morbidity.

The implant is consolidated by two prolonged parallel plates of titanium, allowing their fixation to the bone, easy to fix in a short time.


Eligibility criteria: Inclusion Criteria:

* Male or female more than 18 years old

Exclusion Criteria:

* Age less than 18 years old
* Pregnant women
* Local carcinoma excluding radiotherapic or surgical control
* Poor general condition
* Contraindication to general anesthesia
* Uncontrolled diabetes

Primary outcomes:
measure: TEP scan + MRI + CT scan
timeFrame: 3 months after surgery
measure: Blood analysis (interleukin)
timeFrame: 8, 15, 30 days and 3 months after surgery
measure: All types of complication
timeFrame: 8, 15, 30 days, 3, 6 months after surgery and then every 6 months during the whole trial
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Oto-Rhino-Laryngologie et de Chirurgie Cervico-Faciale, Hôpital de Hautepierre
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Christian Debry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00042237: Treatment of Depressed Women Who Have Been Sexually Abused
Official title: Treatment of Women With Depression and Sexual Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Child Abuse, Sexual
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-07-26
Enrollment: 24
Sex: FEMALE
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 compare Schema-Focused Therapy plus antidepressant medication and antidepressant medication alone for the treatment of major depression in women with a history of childhood sexual abuse.

Detailed description: Schema-Focused (SF) Therapy is an extension of cognitive therapy that was developed to address the treatment needs of patients with long-standing mental disorders. SF therapy focuses on early maladaptive schemas (EMS): broad, pervasive themes regarding oneself and one's relationship with others, developed during childhood and elaborated throughout one's lifetime, which are dysfunctional to a significant degree. SF Therapy involves the identification of the particular EMS that is most relevant for each patient and attempts to modify the relevant schemas by altering the distorted views of self and others.

Participants are assessed pretreatment, after 12 weeks, posttreatment, and 3 and 6 months posttreatment. The severity of depressive symptomatology is measured and a self-report Beck Depression Inventory is administered. At the end of the study and at the follow-up intervals, participants are given the Longitudinal Interval Follow-up Evaluation, an instrument that assesses the severity of depression and dysthymia symptoms.

Eligibility criteria: Inclusion criteria:

* Major depression
* History of childhood sexual abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: