louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00695019: Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
Official title: A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Low-Dose Human Interferon-alpha During the 6-Month Follow-up Period of Standard Combination Therapy for Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Prevention of Relapse
HCV genotype 1b
Recurrence
Lead sponsor: Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: CytoPharm, Inc.
First posted: 2008-06-11
Enrollment: 169
Sex: ALL
Minimum age (years): 21
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 determine whether lozenges of interferon-alpha that are dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who had a complete virologic response after receiving a combination of injected interferon-alpha and oral ribavirin.


Eligibility criteria: Inclusion Criteria:

* HCV genotype 1b
* Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks
* Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

* Child-Pugh score of B or C
* Decompensated liver function
* History of malignancy within past 5 years
* Other causes of liver disease besides HCV infection
* Uncontrolled diabetes or hypertension
* Unwilling to use two forms of birth control during study treatment

Primary outcomes:
measure: Relapse Rate
timeFrame: 48 weeks
Secondary outcomes:
measure: Sustained Virologic Response Rate
timeFrame: 48 weeks
measure: Normalization of ALT
timeFrame: 48 weeks
measure: Change in Serum HCV RNA Concentration
timeFrame: 48 weeks
measure: Change in Serum ALT
timeFrame: 48 weeks
measure: Change in Social Functioning
timeFrame: 48 weeks
measure: Change in Fibrotest Score
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Dalin
country: Taiwan
facility: Dalin Buddhist Tzu Chi General Hospital
state: Chiayi County
city: Niaosong
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Kaosiung County
city: Changhua
country: Taiwan
facility: Show-Chwan Memorial Hospital
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Chiayi City
country: Taiwan
facility: Chiayi Christian Hospital
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
citation: Lee CM, Chen CY, Chien RN, Tseng KC, Peng CY, Tung SY, Fang YJ, Huang YH, Lu SN, Hung CH, Tsai TJ, Fang CC, Hsu CW, Yeh CT. A double-blind randomized controlled study to evaluate the efficacy of low-dose oral interferon-alpha in preventing hepatitis C relapse. J Interferon Cytokine Res. 2014 Mar;34(3):187-94. doi: 10.1089/jir.2013.0074. Epub 2013 Nov 15.
Clinical trial NCT02973919: EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
Official title: EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spider Phobia
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to increase the efficiency of exposure in virtual reality (VR).

Based on the EMDR research the investigators would like to show that the implementation of eye movements during the VR exposure results in a faster physiological relaxation response among probands with spider phobia, which has a positive effect on the subjective and behavioral efficacy of the VR exposure.

Detailed description: The VR paradigm consists of one room with a spider in it. The proband is supposed to look at it for a few minutes. This exposure is repeated several times.

In the experimental group a ball appears during the exposure, that moves horizontally across the room. The probands are supposed to follow this movement with their eyes.

EDA, EKG and respiration are being recorded. Furthermore the subjective and behavioral spider phobia is measured before, during and after the exposure to determine occurring changes.

Eligibility criteria: Inclusion Criteria:

* the Structured Clinical Interview for DSM-IV (SCID, First et al., 2002; applied German translation: Strukturiertes Klinisches Interview für DSM-IV, Achse I, SKID I, Wittchen et al., 1997), in order to get a reliable diagnosis of spider phobia

Exclusion Criteria:

* pregnancy
* current psychopharmacological medication
* current involvement in psychiatric- or psychotherapeutic treatment
* cardiovascular or neurological diseases
* color blindness
* hearing disorders

Primary outcomes:
measure: Change in Behavioral Assessment Test (BAT) in vivo
timeFrame: 5 minutes before, 5 minutes after intervention and during folow up (2 weeks post Intervention)
Secondary outcomes:
measure: Skin Conductance Reactivity (SCR)
timeFrame: during the VR-session
measure: Electrocardiogram (ECG)
timeFrame: during the VR-session
measure: manipulation check electrode below the right eye (M. orbicularis oculi)
timeFrame: during the VR- exposure sessions (5 min x 4 sessions)
measure: Change in Subjective Fear Ratings
timeFrame: 1 min before and during ( each minute) exposure in Virtual Reality
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03503019: Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
Official title: Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 3000
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: all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision).

Brief summary: A prospective multicenter study including all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision). Patients will be screened for glycemic control using HbA1c levels, fructosamine levels, and blood glucose levels. Blood samples will be obtained at the preadmission testing (PAT) within 30 days of surgery. On postoperative day 1 (POD-1), morning glucose levels will be obtained for all patients as well. Patients will be followed up for 90 days postop.

Study aims

1. To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes.
2. To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.
3. To determine the "best" threshold of fructosamine to determine adverse outcomes.


Eligibility criteria: Inclusion Criteria:

all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision)

Exclusion Criteria:

None

Primary outcomes:
measure: Prosthetic Joint Infection
timeFrame: within 90 days of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04258319: Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema
Official title: Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lymphedema
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The unaffected arm will be used to serve as control for the affected extremity.
Primary purpose: OTHER

Brief summary: Researchers are trying to validate the use of ultrasound sub-hertz analysis of viscoelastisty (SAVE) method to monitor tissue-fluid dynamics and stage disease severity in patients diagnosed with lymphedema.


Eligibility criteria: Inclusion Criteria:

* Adult (18+ years of age)
* Ability to provide written consent
* Has been diagnosed with Lymphedema

Exclusion Criteria:

* Under the age of 18 years old
* Inability to provide written consent
* Previous lymphovenous bypass or lymph node transfer surgery

Primary outcomes:
measure: Viscoelasticity parameters with lymphedema as obtained using the SAVE method
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Antonio Forte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02544919: Lipids and Neurological Complications in Liver Transplantation
Official title: Impact of Pretreatment With Omega 3 Enriched Lipid Emulsion on Early Neurological Complications After Living Donor Liver Transplantation. A Randomized Controlled Trial>
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Neurological Complications
Keywords: SMOF
neurological complications
neurotoxicity
liver transplantation
Lipid emulsions
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To study the impact of pretreatment of living donor liver transplantation recipients with SMOF lipid on the incidence and severity of post-transplantation neurological complications in patients receiving tacrolimus based immunosuppression protocol

Detailed description: All patients included in the study will receive the same immuno-suppression protocol based on tacrolimus and mycophenolate mofetil after the induction immuno-suppression during the intra-operative period.

Patients will have a full history taking and full neurological examination 48 hours prior to the designated operative date as a basal record.

the control group will not receive any lipid infusions at all the treatment group will receive the study emulsion (SMOF lipid 20% - Fresenius Kabi) starting 48 hours before the planned surgery day and will continue to receive it for 5 post-operative days by intravenous infusion.

During the post-operative period. patients will be assessed daily by full neurological examination as will as patient complaints (symptoms) related to neurological status for diagnosis of any neurological conditions (complications) that might arise during the study period.

Data will be analysed compared to the basal value in each group and between both control and intervention groups using the appropriate statistical tests.

Eligibility criteria: Inclusion Criteria:

* Adult living donor liver transplant recipients of either sex

Exclusion Criteria:

* MELD score \> 30
* Retransplantation
* Budd Chiari syndrome
* Diabetes more than 10 years

Primary outcomes:
measure: post-transplant neurological complications
timeFrame: 5 post-operative days
Secondary outcomes:
measure: Graft functions
timeFrame: 5 post-operative days
measure: survival
timeFrame: 30 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Liver transplantation project - Gastroenterology surgical center - Mansoura university
state: Dakahlia
Study officials:
affiliation: MAnsoura Faculty of Medicine
name: Amr M Yassen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06792019: Study of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Official title: A Phase IB/II Clinical Study to Assess the Safety and Preliminary Efficacy of CM313(SC) Injection in Subjects With Platelet Transfusion Refractoriness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Platelet Transfusion Refractoriness
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 125
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: This is a randomized, open-label, phase IB/II clinical study to evaluate the safety and preliminary efficacy of CM313(SC) injection in patients with Platelet Transfusion Refractoriness.


Eligibility criteria: Inclusion Criteria:

1. Thrombocytopenia dependent on platelet transfusions and diagnosed with platelet transfusion refractoriness.
2. Presence of one or more kinds of antiplatelet antibodies.
3. Male or female, age≥18 years.
4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
5. Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

1. Diagnosed with Idiopathic thrombocytopenic purpura.
2. Platelet transfusion refractoriness caused by non-immune factors.
3. Previously treated with the anti-CD38 monoclonal antibody.
4. Have an allergy to humanized monoclonal antibody or any part of CM313.
5. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
6. Any condition considered to be ineligible for the study by the investigator.

Primary outcomes:
measure: Adverse events (AE)
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Jun Shi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00401219: Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
Official title: An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioavailability Study Among 3 New Formulations of Premarin 0.625 mg/Medroxyprogesterone Acetate (Mpa) 2.5 mg Compared With a Reference Formulation of Premarin/Mpa (Prempro) 0.625 mg/2.5 mg in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Estrogen Replacement Therapy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-11-20
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Healthy, postmenopausal women ages 35 to 70 years, inclusive.
* Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation. Naturally postmenopausal women must not have had a menstrual period since the age of 54. Surgically menopausal women must have undergone bilateral oophorectomy (removal of both ovaries) at least 6 months prior to the start of the study, and the surgical report may be requested to confirm the surgery date and that the surgery was not due to a cancerous condition.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Primary outcomes:
measure: Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
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 NCT02052518: Early Childhood Obesity Prevention Program
Official title: Early Childhood Obesity Prevention Program: Building Better Families and Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Keywords: Childhood obesity
Breastfeeding
Introduction of solids
Introduction of juice
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Connecticut
name: UConn Health
First posted: 2014-02-03
Enrollment: 57
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is proposed on behalf of the Hartford Childhood Wellness Alliance, a 107 member, 35 group organization whose goal is to improve the health of children in Hartford, CT. In a randomized control trial, the primary aim of this study is to test the initial efficacy of a program of enhanced home visitation with neighborhood and community support to change maternal behaviors related to infant nutrition (sweetened beverage/juice consumption, breastfeeding and introduction of solids), parenting skills (establishing routines around sleep, reading cues for hunger, satiety, television time) and family wellness (improving the home food environment, enhancing physical activity). The investigators hypothesize that at 12 months of age, infants in the intervention arm will drink less sugar sweetened beverages/juices, will have ingested solids at an older age, will have been breastfed longer and more exclusively than infants in the control arm and will have less TV viewing, more established sleep routines and greater soothability (primary outcomes).

Detailed description: See Manuscript: 125. Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): An ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health, 15:584 PMID 26073106, 2015.

Eligibility criteria: Inclusion Criteria:

* Enrolled in the Nurturing Families Network Program
* Singleton birth \>34 weeks gestation
* Any race or ethnicity
* ECHO neighborhood
* Mothers and their newborns

Exclusion Criteria:

* Mothers or newborns with special health care needs
* Infant with major malformation
* Small for Gestational Age/low birth weight

Primary outcomes:
measure: Number of months of breast feeding
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Centr
name: Michelle M Cloutier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cloutier MM, Wiley J, Wang Z, Grant A, Gorin AA. The Early Childhood Obesity Prevention Program (ECHO): an ecologically-based intervention delivered by home visitors for newborns and their mothers. BMC Public Health. 2015 Jun 24;15:584. doi: 10.1186/s12889-015-1897-9.
Clinical trial NCT03018418: Proton Therapy in Reducing Toxicity in Anal Cancer
Official title: A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Anus Neoplasms
Keywords: Anal Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 14
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 purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.


Eligibility criteria: Inclusion Criteria:

* Karnofsky Performance Status \>70%
* Histologically documented squamous or basaloid carcinoma of the anal canal
* Stage T2-4 disease with any N category

Exclusion Criteria:

• Patients with a life expectancy of \< 3 months.

Primary outcomes:
measure: Rates of Acute Toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Rates of Late Toxicity
timeFrame: every 6 months up to 60 months
measure: Complete Response Rate
timeFrame: at 6 months from the completion of chemoradiation
measure: Local Progression Free Survival
timeFrame: every 6 months up to 60 months
measure: Overall Survival
timeFrame: every 6 months up to 24 months
measure: Distant Metastases Free Survival
timeFrame: every 6 months up to 60 months
measure: Quality of Life Changes
timeFrame: before treatment and 12 months after start of treatment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jordan Kharofa, MD
role: PRINCIPAL_INVESTIGATOR
References: