louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00408304: Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
Official title: Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: interferon alpha
depression
omega 3
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-12-06
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3 fatty acids.

Detailed description: Omega-3 fatty acids are known as an alternative treatment for different conditions, including mental conditions, such as depression. We assume that combining omega-3 with the treatment by interferon alpha may prevent the development of depression, which is quite a common side effect of the interferon alpha.

Eligibility criteria: Inclusion Criteria:

* Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.

Exclusion Criteria:

* Disagreement to participation in trial.
* Diagnosed and active mental illness.
* Encephalopathic patients.
* Patients with limited ability to understand the questionnaires or the informed consent process.

Primary outcomes:
measure: The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
measure: with the BDI questionnaire which estimates the level of depression of the patient and
measure: the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status.
Secondary outcomes:
measure: Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
measure: albumin
measure: bilirubin
measure: ALT
measure: CRP
measure: hemoglobin
measure: WBC
measure: platelets
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: affiliated with Bnai Zion MC
name: Elad Schiff, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05633004: Avicena LVDP Validation Study
Official title: Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) as an Aid in the Diagnosis of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Avicena LLC
Sponsor class: INDUSTRY
First posted: 2022-12-01
Enrollment: 406
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during left heart catheterization.

Detailed description: Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.

Eligibility criteria: Inclusion Criteria:

1. Adult subjects \>21 years of age.
2. Referred for non-emergent left heart catheterization inclusive of direct measurement of LVDP as part of routine clinical management, to be performed from a femoral or radial access site.
3. Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records.
4. Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.

Exclusion Criteria:

1. Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support.
2. Carotid pulse is not palpable by a trained study researcher.
3. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck).
4. History of significant or symptomatic carotid artery disease, including TIA, ultrasound evidence of \>60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery.
5. Open skin lesions at the site of Vivio application / examination.
6. Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.).
7. Inability to obtain brachial artery blood pressure.

Primary outcomes:
measure: The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum
state: Michigan
Study officials:
References:
Clinical trial NCT03273504: Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
Official title: Efficacy Evaluation of the Activity of a Cosmetic Product (Topical Use) on Hair Regrowth vs Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrichosis
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate clinically and by non-invasive instrumental evaluations the activity on hair regrowth of a topical cosmetic product versus placebo (comparison within subjects)


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* female sex
* with hypertrichosis
* agreeing not to perform epilation or scrub/peeling treatment on the test area (legs) during the week preceding the inclusion
* good general state of health

Exclusion Criteria:

* pregnancy
* lactation
* subjects whose insufficient adhesion to the study protocol is foreseeable
* sensitive skin
* oral contraceptive therapy started less than 1 year
* presence of varicose or capillary veins of surface
* hormonal therapies able to influence hair growth.
* presence of cutaneous disease on the tested area, as lesions, scars, malformations.
* diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* cancer.
* farmacological topical treatment and surgery and/or medical treatment on the treated side performed in the last 3 months
* systemic corticosteroids
* aspirin or non-steroid anti-inflammatory drugs (FANS)
* diuretic.

Primary outcomes:
measure: Change from baseline of the hair density
timeFrame: Baseline (T0), 1 month (T1), 3 months (T3)
measure: Change from baseline of the percentage of terminal hair
timeFrame: Baseline (T0), 1 month (T1), 3 months (T3)
measure: Change from baseline of the percentage of vellus hair
timeFrame: Baseline (T0), 1 month (T1), 3 months (T3)
measure: Change from baseline of hair regrowth speed
timeFrame: Baseline (T0), 1 month (T1), 3 months (T3)
Secondary outcomes:
measure: Change from baseline of superficial skin hydration
timeFrame: Baseline (T0), 1 month (T1), 3 months (T3)
Other outcomes:
Locations:
city: Milano
country: Italy
facility: DERMING
state: MI
Study officials:
References:
Clinical trial NCT00774904: Adiponectin and Insulin Resistance in Diabetic Nephropathy
Official title: Adiponectin is Positively Associated With Insulin Resistance in Subjects With Type 2 Diabetic Nephropathy and Effects by Angiotensin Type 1 Receptor Blocker Losartan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Nephropathy
Keywords: Type 2 Diabetes
Diabetic Nephropathy
Glucose Metabolism
Angiotensin II Type 1 Receptor Blockers
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: Shanghai Jiao Tong University School of Medicine
First posted: 2008-10-17
Enrollment: 80
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: Plasma adiponectin concentration is inversely associated with renal function. There is little literature on adiponectin levels and regulation by antihypertensive medication with an angiotensin II-receptor blocker (ARB), especially in subjects with type 2 diabetes in different stage of chronic kidney disease (CKD).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic nephropathy
* CKD at stage 1\~4

Exclusion Criteria:

* Type 1 diabetes or nondiabetic renal disease
* An elevated plasma K level.

Primary outcomes:
measure: GFR, HbA1c and the adiponectin concentration
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai No.3 people's hospital
Study officials:
References:
citation: Pan Y, Qiao QY, Pan LH, Zhou DC, Hu C, Gu HF, Fu SK, Liu XL, Jin HM. Losartan reduces insulin resistance by inhibiting oxidative stress and enhancing insulin signaling transduction. Exp Clin Endocrinol Diabetes. 2015 Mar;123(3):170-7. doi: 10.1055/s-0034-1395658. Epub 2014 Dec 11.
Clinical trial NCT00214604: Type III Dysbetalipoproteinemia
Official title: An 18-week, Randomized, Multicenter, Phase 3b, Double-blind, Crossover Study, Followed by an 18-week Open-Label Period to Evaluate the Efficacy & Safety of the Lipid-Regulating Agents, Rosuvastatin & Pravastatin in the Treatment of Subjects With Dysbetalipoproteinemia (Frederickson Type III Hyperlipoproteinemia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipoproteinemia Type III
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy of rosuvastatin 10mg, rosuvastatin 20mg and pravastatin 40mg in subjects with dysbetalipoproteinemia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of dysbetalipoproteinemia defined as VLDL-C/VLDL-TG mass ratio \>0.35 at Visit 2 or the concurrence of mixed hyperlipidemia (fasting TC ≥ 200mg/dL, fasting TG ≥ 200mg/dL at Visits 2 and 3) and a genotype of ApoE published to be associated with dysbetalipoproteinemia

Exclusion Criteria:

* Use of cholesterol-lowering drugs, lipid lowering dietary supplements or food additives after Visit 1 except in accordance with the protocol as co-administered therapy (i.e., a fenofibrate) with rosuvastatin 40mg at Weeks 30 to 36; current active liver disease or hepatic dysfunction, serum CK ≥ 3 times ULN (unless explained by exercise) anytime during dietary period, serum creatinine \> 2.0 mg/dL or a history of renal transplantation before the treatment phase, fasting triglyceride \> 1000 mg/dL at any time during the dietary lead-in or a history of pancreatitis while on treatment for dysbetalipoproteinemia.

Primary outcomes:
measure: Percent change from baseline in non-HDL-C after 6 weeks of treatment at a given dose during the 18-week randomized crossover period.
Secondary outcomes:
measure: Efficacy of once daily treatment with rosuvastatin 10mg, rosuvastatin 20mg and provastatin 40mg in subjects with dysbetalipoproteinemia after 6 weeks of treatment at any given dose during the 18-week randomized crossover period.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Crestor Medical Sciences Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05781204: Stigma, Social Support and Quality of Life
Official title: "Perceived Stigma and Social Support: Relationship and Influence on Mental Health and Quality of Life in HIV+ Patients"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We expect the majority of the HIV patient population to be male, between the ages of 40 and 65 and with a high school diploma. We expect a virologically suppressed HIV population with good adherence to antiretroviral therapy. We expect a high level of perceived stigma and low quality of life and high symptoms of depression, anxiety and stress.

Brief summary: The primary goal of this observational study is to investigate the relationship between perceived stigma and social support in HIV+ patients. The secondary objective is to measure mental health indicators (depression, anxiety, and stress) and quality of life to assess whether they are affected by the relationship between perceived stigma and social support.

The main questions it aims to answer are:

* Measuring perceived stigma and social support to understand the health status and behaviour of people living with HIV.
* Monitor the mental state of people living with HIV in order to be able to implement, there where necessary, a psychological support strategy in order to promote proper adherence to treatment and care services.

Participants will fill out an online cross-sectional survey. The online questionnairesurvey will collect:

* sociodemographic and clinical data related to HIV infection,
* perceived stigma,
* social support,
* mental health,
* quality of life.


Eligibility criteria: Inclusion Criteria:

* HIV diagnosis.
* Being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Ongoing antiretroviral therapy.
* Age \> 18 years.
* Native Italian speaker.
* Informed consent to participate in the study.

Exclusion Criteria:

* Absence of an HIV diagnosis.
* Not being treated at the Infectious Diseases Outpatient Clinic of Policlinico Gemelli in Rome.
* Absence of ongoing antiretroviral therapy.
* Age \> 18 years.
* Not being a native Italian speaker.
* Refusal to sign informed consent

Primary outcomes:
measure: Perceived stigma in HIV+ patients
timeFrame: 1 year
Secondary outcomes:
measure: Influence of social support on perceived stigma
timeFrame: 1 year
measure: Influence of mental health on perceived stigma
timeFrame: 1 year
measure: Influence of quality of life on perceived stigma
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT01012804: Study of Biomarkers in Tissue Samples From Patients With Metastatic Colon Cancer
Official title: Assessment of Variation of PKA and Other Molecular Markers in Patients Undergoing Resection of Colon Cancer Metastases
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Colorectal Cancer
Keywords: stage IV colon cancer
recurrent colon cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-11-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with colorectal cancer

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in tissue samples from patients with metastatic colon cancer.

Detailed description: OBJECTIVES:

* Determine the effect of surgical resection, in terms of physiological stress, on levels of tumor markers such as protein kinase A (PKA) expression in patients with metastatic colon cancer.
* Estimate variation among patients of baseline tumor markers in tumor tissue and sera.
* Correlate markers in tumor tissues with that in sera in these patients.
* Establish a tissue bank of these specimens for future studies.

OUTLINE: Biopsy and surgical specimens are obtained before and during standard surgery (patients may have had tumor tissue obtained before study entry and stored). Serum samples and tumor tissue are analyzed by immunohistochemistry and western blot. Tumor markers (such as PKA expression) are determined and marker levels are measured in serum samples and tissues.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer

  * Metastatic disease for which surgical resection is indicated
  * Metastatic disease accessible for tissue biopsy OR previously biopsied tissue is available

PATIENT CHARACTERISTICS:

* Platelet count ≥ 80,000/mm\^3
* INR ≤ 1.3
* PTT ≤ upper limit of normal
* No history of bleeding disorders or abnormal clotting factors
* No extrahepatic biliary obstruction

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
state: District of Columbia
Study officials:
affiliation: Lombardi Comprehensive Cancer Center
name: John L. Marshall, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06091904: Effects of Sufentanil on the Intraoperative Hemodynamics
Official title: Effects of Sufentanil on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Hypotension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 92
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized, controlled trial. A total of 92 patients will be randomized to receive sufentanil or remifentanil during extracranial-intracranial bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo elective extracranial-intracranial bypass surgery
* American Society of Anesthesiologists grade 1,2,3
* Age \> 18 years old

Exclusion Criteria:

* Refuse to participate to the study
* American Society of Anesthesiologists grade 4
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* Allergic history of opioid
* pregnant
* MAO Inhibitor user
* Severe respiratory insufficiency

Primary outcomes:
measure: Intraoperative hypotension
timeFrame: During surgery
Secondary outcomes:
measure: Inotropic requirements
timeFrame: During surgery
measure: Incidence of bradycardia
timeFrame: During surgery
measure: Incidence of tachycardia
timeFrame: During surgery
measure: Maximum systolic blood pressure
timeFrame: During surgery
measure: Minimum systolic blood pressure
timeFrame: During surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02670304: Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS
Official title: The Randomized Controlled Trial Study of Letrozole in the Prevention of Medium and Severe Ovarian Hyperstimulation Syndrome in Invitro Fertilization Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: letrozole
ovarian hyperstimulating syndrome
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one candidate for the treatment or prevention of ovarian hyperstimulation syndrome.

Detailed description: Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after ovum picked up. In this randomized controlled study, investigators try to observe the effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation syndrome and vascular epithelium growth factor level of women with high ovarian hyperstimulation syndrome risks.

Eligibility criteria: Inclusion Criteria:

* infertile women undergoing IVF treatment with more than 25 oocytes collected.

Exclusion Criteria:

* letrozole contraindications,e.g. severe hepatic and renal dysfunction

Primary outcomes:
measure: incidence of early OHSS
timeFrame: up to 1 months
Secondary outcomes:
measure: vascular endothelial growth factor level
timeFrame: up to 1 months
measure: incidence of hydrothorax
timeFrame: up to 1 months
measure: incidence of liver dysfunction
timeFrame: up to 1 months
measure: incidence of renal dysfunction
timeFrame: up to 1 months
measure: incidence of electrolytic imbalance
timeFrame: up to 1 months
measure: incidence of hemoconcentration
timeFrame: up to 1 months
measure: incidence of elevated WBC
timeFrame: up to 1 months
Other outcomes:
Locations:
Study officials:
References: