louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01957319: Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability
Official title: Silybin Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin Reduces Depression and Increases Work Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Work Ability
Depression
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Hepatitis C virus infection and interferon treatment have shown to be risk factors for depression, distressing, psychosocial burden and poor health-related quality of life.

Aim: To determine the effect of a Sylibin-vitamin E-phoshpolipids complex on work ability and whether health related factors (anxiety and depression) were associated with work ability in subjects with chronic hepatitis C treated with Peg-IFN-α and RBV.

Patients and Methods: In this prospective, randomized, placebo controlled, double blind clinical trial, 31 subjects (Group A) with chronic hepatitis, received Pegylated-Interferon-α2b (1.5 mg/kg per week) plus Ribavirin and placebo, while 31 subjects (Group B) received the same dosage of Pegylated-Interferon-α2b plus Ribavirin plus association of Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill for 12 months. All subjects underwent laboratory exams and questionnaires to evaluate depression (Beck Depression Inventory - BDI), anxiety (State-trait anxiety inventory - STAI) and work ability (Work ability Index - WAI).


Eligibility criteria: Inclusion Criteria:

* HCV infection

Exclusion Criteria:

* cancer severe jaundice pulmonary and renal chronic diseases prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy hemoglobinopathies hemocromatosis

Primary outcomes:
measure: Work ability index
timeFrame: 12 months
Secondary outcomes:
measure: depression
timeFrame: 12 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania, Cannizzaro Hospital
Study officials:
References:
citation: Malaguarnera G, Bertino G, Chisari G, Motta M, Vecchio M, Vacante M, Caraci F, Greco C, Drago F, Nunnari G, Malaguarnera M. Silybin supplementation during HCV therapy with pegylated interferon-alpha plus ribavirin reduces depression and anxiety and increases work ability. BMC Psychiatry. 2016 Nov 15;16(1):398. doi: 10.1186/s12888-016-1115-z.
Clinical trial NCT02893319: Maternal and Infant Growth Study
Official title: Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Behavior
Body Weight
Infant Behavior
Keywords: Infant Feeding
Infant Growth
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. This research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. The hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. Growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.

Detailed description: Mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. Infant growth and body composition are measured via PEA POD, and maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8, and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.

Eligibility criteria: Inclusion Criteria:

* pregnant or newborn aged 28 days or younger

Exclusion Criteria:

* gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight

Primary outcomes:
measure: Change in Infant Weight-for-Age Z-score over time by group
timeFrame: 2, 8 and 16 weeks of age
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Georgia
name: Leann L Birch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03269019: Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
Official title: Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heparin-Induced Thrombocytopenia
Thrombosis
Biomarkers
Keywords: Heparin-induced thrombocytopenia
Thrombosis
thrombin-antithrombin
d-dimer
Thrombelastograghy
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 200
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: Patients are those who receiving cardiac surgery, including valve replacementheart,Coronary Artery Bypass Grafting,aorta replacement etc.

Brief summary: Heparin induced thrombocytopenia (HIT) is a kind of catastrophic thrombotic complications after the application of heparin. If HIT without treatment, death rate is as high as 30% to 50%. Early diagnosis of HIT and prevention of thrombosis is very important.

This study is planned to assess the use of thrombotic biomarkers in patients with HIT, including thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy monitoring . These biomarkers are monitored in 5-14 days post-operation to assess the risk of thrombosis in HIT patients. All patients were followed up for 30 days, and clinical outcomes, including new thrombus and death, were recorded during follow-up.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients undergoing cardiac surgery.
* Receiving unfractionated heparin anticoagulation.

Exclusion Criteria:

* history of heparin-induced thrombocytopenia
* pregnant woman

Primary outcomes:
measure: Thrombotic event
timeFrame: 30 days
measure: Deaths
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Zhenlu Zhang, MD,Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02927119: Serum Thyroglobulin as a Marker of Iodine Status During Pregnancy
Official title: Serum Thyroglobulin as a Marker of Iodine Nutrition Status During Pregnancy in Hungarian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Iodine Deficiency
Thyroid; Functional Disturbance
Keywords: thyroglobulin
iodine
pregnancy
Lead sponsor: University of Debrecen
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 189
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at week 16 of gestation living in Debrecen and its sorroundings

Brief summary: The purpose of the investigation is to assess iodine status of pregnant women at week 16 of gestation targeting serum thyroglobulin as a biomarker of iodine deficiency. The investigators aim to assess whether pre-gestational initiation of iodine supplementation is more advantageous in comparison to supplementation start at the time of pregnancy detection.

Detailed description: Mild iodine deficiency is still a public health issue in many industrialized countries, especially during pregnancy. During the last decade there was no monitoring of the iodine status in pregnancy in Hungary.

Since urinary iodine concentration (UIC) only reflects recent iodine intake and carries limited information on individual existing iodine stores, another biomarker e.g. measurement of serum thyroglobulin concentration, would be useful to gain comprehensive information. In the present study, the purpose of the investigation is to compare UIC, UIC normalized to creatinine concentration and serum thyroglobulin as biomarkers of iodine supply in pregnant women in a geographical region where previously iodine deficiency had been found.

UIC, serum thyroglobulin level and thyroid function are measured, and information about iodine supplementation and smoking before and during pregnancy are recorded.

Eligibility criteria: Inclusion Criteria:

* healthy pregnant women at week 16 of gestation

Exclusion Criteria:

* thyroid disease

Primary outcomes:
measure: Urinary iodine concentration
timeFrame: At subject enrollment
measure: Serum thyroglobulin concentration
timeFrame: At subject enrollment
Secondary outcomes:
measure: Serum thyroid stimulating hormone concentration
timeFrame: At subject enrollment
measure: Serum free thyroxine concentration
timeFrame: At subject enrollment
measure: Serum free triiodothyronine concentration
timeFrame: At subject enrollment
measure: Serum anti-thyroglobulin autoantibody concentration
timeFrame: At subject enrollment
Other outcomes:
Locations:
Study officials:
affiliation: University of Debrecen
name: Endre V Nagy, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02466919: Study of Levofloxacin-based Concomitant Therapy for H. Pylori Eradication in Diabetic Patients
Official title: Strategy on the Increment of H. Pylori Eradication Rate and Investigating the Gastric Pathology and Antimicrobial Resistance in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2015-06-09
Enrollment: 114
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: The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with Helicobacter pylori infection

Exclusion Criteria:

* Pregnancy or physically poor performance status
* Patients with contraindication for upper endoscopy
* Severe coagulopathy for endoscopic biopsy
* Chronic kidney disease (eGFR \< 50) or end stage renal disease
* Known allergy to interventional drugs
* Previous eradication failure

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: 1-4 months after eradication therapy
Secondary outcomes:
measure: Acute inflammatory score
timeFrame: 1-4 weeks after gastric tissue obtained by upper endoscopy
measure: Chronic inflammatory score
timeFrame: 1-4 weeks after gastric tissue obtained by upper endoscopy
measure: H. pylori density score
timeFrame: 1-4 weeks after gastric tissue obtained by upper endoscopy
measure: Intestinal metaplasia
timeFrame: 1-4 weeks after gastric tissue obtained by upper endoscopy
measure: Spasmolytic polypeptide expressing metaplasia
timeFrame: 1-4 weeks after gastric tissue obtained by upper endoscopy
measure: H. pylori resistance panel
timeFrame: 1-4 weeks after H. pylori culture obtained by upper endoscopy
Other outcomes:
Locations:
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Yao-Jong Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Male non-insulin users with type 2 diabetes mellitus are predisposed to gastric corpus-predominant inflammation after H. pylori infection. J Biomed Sci. 2017 Oct 30;24(1):82. doi: 10.1186/s12929-017-0389-x.
citation: Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Ten days of levofloxacin-containing concomitant therapy can achieve effective Helicobacter pylori eradication in patients with type 2 diabetes. Ann Med. 2017 Sep;49(6):479-486. doi: 10.1080/07853890.2017.1294761. Epub 2017 Mar 7.
Clinical trial NCT00228319: Treatment of Newly Diagnosed Ovarian Cancer With Antioxidants
Official title: Antioxidant Effects on the Outcome of Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ovarian Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Cancer Treatment Research Foundation
name: University of Kansas Medical Center
First posted: 2005-09-28
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
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 try and understand if there is added benefit or increased harm when antioxidant nutritional supplements are added to traditional chemotherapy in the treatment of ovarian cancer.

Detailed description: The subjects are randomized to 2 study groups. Group 1 receives standard chemotherapy prescribed by the cancer doctor (carboplatin and paclitaxel)with a possible choice to extend chemotherapy for up to an additional 12 months.

Group 2 receives standard chemotherapy in the same manner as group 1. In addition, they receive 12 months of oral or IV nutritional supplements.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed carcinoma of the ovary stage III or IV
* measurable or assessable disease
* drug refractory ovarian cancer
* must be 18 years of age or must have parental consent to enroll in the study
* must be ambulatory

Exclusion Criteria:

* evidence of significant psychiatric disorder by history or exam
* consumption of excess alcohol (more than 4 of any of the following per day: 30 ml distilled spirits, 340 ml beer, or 120 ml wine) or recreational drugs
* tobacco use
* prior treatment with an investigational drug, chemo, radiation therapy, or hormonal therapy within the preceeding month
* pregnancy

Primary outcomes:
measure: Adverse events by NCI CTC version 3.0
timeFrame: At each oncology clinic visit
Secondary outcomes:
measure: Quality of Life Questionnaire
timeFrame: once a month for 6 months and the end of the study
measure: Blood chemistry
timeFrame: At each oncology clinic visit
measure: CA-125 analysis
timeFrame: At each oncology clinic visit
measure: complete CBC with differential
timeFrame: At each oncology clinic visit
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeanne A. Drisko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154.
Clinical trial NCT01598441: Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)
Official title: Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension, pulmonary hypertensive crisis
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
First posted: 2012-05-15
Enrollment: 8
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

Detailed description: Primary objectives:

1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
2. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.

Secondary objectives:

1. To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.
2. To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.

Eligibility criteria: Inclusion Criteria:

* CHD children who have associated PH risk factors and have accepted biventricular repair
* Pp/Ps \>= 0.75 (before surgery) or Pp/Ps \>= 0.5 (after surgery)

Exclusion Criteria:

* severe mitral stenosis
* obstructive drainage of pulmonary veins
* platelet count \< 50,000,000,000/L \& obvious bleeding

Primary outcomes:
measure: The total incidence of RPH, PHC or death
timeFrame: within 48 hours after surgery
Secondary outcomes:
measure: Change from base line of pulmonary hemodynamic measurements
timeFrame: within 48 hours after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Children's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Wuhan Asia Hear Hospital
state: Hubei
city: Shanghai
country: China
facility: Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Zhuomin Xu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01881841: Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Official title: Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Abuse
Tobacco Use Disorder
Substance Use
Keywords: Alcohol abuse
Substance use
Tobacco use disorder
Motivational Enhancement Therapy
Adolescents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 150
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care.

Detailed description: The study aims are to:

1. Assess cMET feasibility and acceptability and estimate its effect size on underage drinking. Hypothesis: Among 14- to 20-yr-old primary care patients, those receiving cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual.
2. Estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems.
3. Identify potential moderators and mediators of cMET's effect.

Eligibility criteria: Inclusion Criteria:

* 14- to 20- yr-olds
* arriving for routine care to one of our participating pediatric practices (Lexington Pediatrics, Lexington, MA; East Boston Community Health Center, Longwood Pediatrics, Tufts Medical Center Adolescent Clinic, Boston, MA; Cambridge Health Alliance Dept. of Pediatrics, Cambridge, MA)
* any alcohol use days in the past 90 days,
* have an email address and internet access at home, school, or library
* provide informed assent/consent.

Exclusion Criteria:

* unable to read or understand English,
* living away at college at the time of the recruitment visit,
* not available for computer/telephone follow-ups,
* judged by the provider to be medically or emotionally unstable at the time of the visit.

Primary outcomes:
measure: Alcohol use
timeFrame: up to 9-months follow-up
Secondary outcomes:
measure: Drinks per drinking day
timeFrame: up to 9-months follow-up
Other outcomes:
measure: Heavy episodic drinking
timeFrame: up to 9-months follow-up
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John R Knight, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Sion K Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00271141: Multifunctional Substrate for Early Detection of Oxidative Stress Susceptibility and Application to Parkinson's Disease
Official title: Multifunctional Substrate for Early Detection of Oxidative Stress Susceptibility and Application to Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Oxidative Stress
Keywords: Parkinson's disease
Oxidative stress
Marker
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2005-12-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The proposed work is based on the detection of a novel molecule for sensitivity to oxidative stress in humans in venous blood

Detailed description: Since alterations in mitochondrial functions in platelets and lymphocytes have been detected in Parkinson's disease we plan to monitor the metabolism a a new molecule (LTG) in the blood samples of Parkinson's disease patients and compare them to controls. We shall use 10 cc of venous blood and analyze serum, white blood cells and platelets. We shall not extract nor use DNA.The main purpose is to develop a marker for Parkinson's disease in venous blood.

Eligibility criteria: Inclusion Criteria:

Parkinson's disease Healthy control -

Exclusion Criteria:

None -

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rivka Inzelberg, MD
role: PRINCIPAL_INVESTIGATOR
References: