louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01597765: Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Official title: Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thalassemia
Keywords: Thalassemia
Oxidative stress
antioxidant cocktail
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Chiang Mai University
First posted: 2012-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.

Detailed description: 60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at least 3 months prior study. The study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.

Eligibility criteria: Inclusion Criteria:

1. age between 18-50 years
2. hemoglobin level between 6-9 g/dL during screen visit
3. WHO performance status grade 0-2
4. signed in informed consents prior to the study entry.

Exclusion Criteria:

1. receiving iron chelator and blood transfusion.
2. pregnancy or breastfeeding
3. receiving other drugs except folic acid at least 30 days before study.

Primary outcomes:
measure: Malonyldiadehyde (MDA)
timeFrame: 1 year after treatment with antioxidant cocktail.
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of Biochemistry , Faculty of Medicine Siriraj Hospital, Mahidol university
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Ruchaneekorn Kalpravidh, Assoc. Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT04292665: Effects of Classical Massage and Benson Relaxation Exercise on Heart Failure Patients
Official title: Randomized Controlled Trial of Classical Massage and Benson Relaxation Exercise for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Symptoms and Signs
Quality of Life
Keywords: Classical massage,heart failure,nursing,relaxation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with heart failure will be entered. Participants will be randomized to one of three study arms: Arm 1: Classical massage, Arm 2: Relaxation, Arm 3: Control Hypothesis: Classical Massage and Benson Muscle Relaxation will decrease frequency, severity, discomfort of symptoms and improve quality of life.

Detailed description: Previous reports have revealed that classical massage and Benson relaxation exercise are promising for physiological parameters such as respiratory rate, pulse, blood pressure in heart failure patients. On the other hand, research examining effects of these approaches on physical symptom status that is including dyspnea, orthopnea, fatigue, chest pain, peripheral edema, sleep problems and dizziness and quality of life is limited. The present study investigates the effects of classical massage and Benson relaxation exercise in a single-site, 3-arm, randomized, controlled study of 96 patients with heart failure. Arm 1: Classical massage; Arm 2: Benson relaxation exercise; Arm 3: Control. The investigators hypothesize that Classical Massage and Benson relaxation exercise will decrease frequency, severity, discomfort of symptoms and improve quality of life.

Eligibility criteria: Inclusion Criteria:

* Being at least primary school graduates,
* Being over 18 years old
* Being diagnosed Stage III-IV with heart failure
* Not using any other complementary or integrative therapy during the study period

Exclusion Criteria:

* Having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer
* Stage I-II diagnosed with heart failure
* Having an active thrombosis
* Having a coagulation problem
* Not volunteering to participate in the research
* Patients who have been hospitalized for 5 days or less and discharged before five days after the start of the application.

Primary outcomes:
measure: Change in symptom status
timeFrame: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
measure: Change in quality of life
timeFrame: Baseline measurements, at the end of 7th day and two weeks after the completion of the interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Ibni Sina Hospital Cardiology Clinic
Study officials:
affiliation: Hacettepe University
name: Zehra Gok Metın, Assos.Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03100565: Lidocaine Spray vs Coughing for Pain Relief During Colposcopy
Official title: Comparison of Lidocaine Spray With Forced Coughing in Pain Relief During Colposcopy Guided Cervical Biopsy Procedure: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colposcopy
Keywords: colposcopy
pain
coughing
anesthetic spray
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cervical cancer is the third most common genital cancer worldwide. The diagnosis of cervical cancer is performed with the cervical biopsy which is guided by the colposcopy. The colposcopy guided cervical biopsy creates pain and several methods have been reported to overcome the pain related with this procedure. Local anesthetic agent injection into the cervix has been studied and found to be effective and also, forced coughing was compared with local anesthetic injection and it is found to be more effective. In fact local injections can create the pain by itself.However no study compared the effect of forced coughing to local anesthetic spray. The study aims to evaluate the comparison of forced coughing with local anesthetic spray with respect to perceived pain during colposcopy guided biopsy.


Eligibility criteria: Inclusion Criteria:

* Patients with age \>18,
* Presence of cervix,
* Patients who need a diagnostic work up for abnormal cervical smear results.

Exclusion Criteria:

* Pregnancy,
* Presence of already known invasive cancer,
* Allergy to anesthetic agents.

Primary outcomes:
measure: Pain during procedure evaluated by the 0-10 cm scale of Visual analog scale (VAS) scoring system
timeFrame: 0-1 min
Secondary outcomes:
measure: Pain at the 30th minutes after the procedure evaluated by the 0-10 cm scale of VAS scoring system
timeFrame: 30. Min
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
Study officials:
References:
Clinical trial NCT02403765: Diagnostic Tools for Parkinson's Disease
Official title: Realization of Diagnostic Tools for the Early Analysis of Parkinson's Disease Through the Identification of Genetic Risk Profiles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 500
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be selected from the Center for Parkinson's disease of the IRCCS Neuromed, according to specific inclusion criteria. Approximatey 500 subjects, 30 years of age or older, recruited with a family-based approach, will be included in the study.

Brief summary: The study aims to identify genetic variants associated to Parkinson's disease through the analysis of exome-sequencing data of familial cases and controls. The identified variants will be used to generate a diagnostic tool for the identification of genetic risk profiles.

Detailed description: 1. Clinical evaluation of PD patients and relatives
2. High throughput analysis of genetic variants in genome exomes
3. Genotype-phenotype association testing
4. Identification of genetic risk variants for PD

Eligibility criteria: Inclusion Criteria:

* Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa)

Exclusion Criteria:

* Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.

Primary outcomes:
measure: Identification of genetic variants associated with Parkinson's disease
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: IRCCS Neuromed
Study officials:
affiliation: IRCCS Neuromed
name: Antonio Simeone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364052: Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
Official title: Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Keywords: Valganciclovir, Oral Ganciclovir, Liver transplant
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Null Hypothesis:

There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy.

Alternate Hypothesis:

There exists a significant difference in the incidence of CMV infection when oral valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis to be tested should be defined.

Detailed description: The objective for this retrospective clinical study is to describe the incidence of CMV infection in orthoptic liver transplant recipients who receive oral valganciclovir or ganciclovir as their CMV prophylactic anti-viral therapy.

Endpoints:

Primary Endpoint

CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation.

Secondary Endpoints

1. Patient and allograft survival based on donor/recipient CMV status
2. Incidence of graft rejection and loss associated with CMV infection
3. Time to hepatitis C virus (HCV) occurrence
4. Incidence of HSV, EBV and VZV reactivations
5. Severity of HCV occurrence based on biopsy reports based on the Knodell score
6. Safety and tolerability of oral valganciclovir and ganciclovir

Eligibility criteria: Inclusion Criteria:

* All liver transplants will be performed at Oregon Health \& Science University (OHSU) and the OHSU surgical and medical staff will treat patients.

Exclusion Criteria:

* Portland Veterans Affairs Medical Center liver transplant recipients
* Patients deceased within thirty days of receiving liver allograft
* Patients with low risk of acquiring CMV infection: donor-negative and recipient-negative (D-/R-)
* Patients undergoing re-transplantation
* Lost to follow-up (minimum follow-up is 1 year)
* History of CMV infection or disease
* Anti-CMV therapy within the past 30 d
* Severe, uncontrolled diarrhea or evidence of malabsorption.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Ali J Olyaei, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04890652: Digital Interventions to Treat Hazardous Drinking
Official title: Digital Interventions to Treat Hazardous Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hazardous Drinking
Stress
Keywords: Hazardous drinking
COVID-19
Stress
Digital intervention
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-05-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants received a 4-week digital intervention, "Emotion regulation via Breathing for Alcohol reduction (EBA)," which combines alcohol intervention with stress reduction techniques based on self-regulated breathing exercises. The preliminary efficacy of this digital intervention was evaluated through assessments conducted before and immediately after the intervention, as well as during a follow-up assessment 30 days later.
Primary purpose: PREVENTION

Brief summary: There has been a significant increase in the prevalence of stress- and alcohol- related disorders during the COVID-19 pandemic. This project aims to conduct a feasibility study to evaluate the preliminary efficacy of a digital intervention designed to reduce stress and alcohol use. Additionally, this study will examine the impact of stress, including COVID-19 related stress, on the risk of alcohol misuse and the outcomes of the intervention in risky social drinkers.

Detailed description: This project proposes a feasibility study to evaluate the preliminary efficacy of a digital intervention aimed at addressing stress-related drinking in risky drinkers with emotional stress. This digital intervention combines telehealth- and smartphone app- based approaches, allowing concurrent intervention and participant-initiated daily exercise in a real-life setting. This program integrates alcohol intervention with breathing-based stress reduction and focuses on developing emotion regulation skills to manage stress, craving, and alcohol misuse. After the 4-week intervention, all participants will be prospectively followed for 30 days to monitor stress, alcohol use, and other health-related behaviors.

Eligibility criteria: Inclusion Criteria:

* Heavy or binge drinkers
* Either high or low COVID-19 related stress

Exclusion Criteria:

* Current or past substance use disorder other than mild alcohol, tobacco, marijuana use disorder
* Psychiatric disorders except for mood and anxiety disorders
* Any significant current medical conditions

Primary outcomes:
measure: Change in Alcohol Use (Quantity)
timeFrame: baseline, immediately post-intervention, and follow-up (30 days)
measure: Change in Alcohol Use (Frequency)
timeFrame: baseline, immediately post-intervention, follow-up (30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Dongju Seo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00816452: Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer
Official title: Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Prostate Cancer
Keywords: Osteoporosis
Prostate Cancer
Osteoporosis in male with Prostate Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-01-01
Enrollment: 180
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male with Prostate Cancer suffering from Osteoporosis

Brief summary: Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.

Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

Secondary objectives:

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.


Eligibility criteria: Inclusion Criteria:

* Man with Prostate Cancer
* Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
* Osteopenia/osteoporosis proven by bone density test.

Exclusion Criteria:

* Creatinine clearance \< 30ml/min
* Hypercalcemia
* Actual treatment by Bisphosphonate or steroids
* Hypersensibility to Bisphosphonate or any contraindication to its use.
* Metastatic prostate Cancer
* Patients not suitable for compliance.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
timeFrame: 6 months
measure: To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics
timeFrame: 6 months
measure: To evaluate incidence of osteopenia/osteoporosis in this study population.
timeFrame: 6 months
Other outcomes:
Locations:
city: Natanya
country: Israel
facility: Sanofi-aventis administrative office
Study officials:
affiliation: Sanofi-aventis administrative office Israel
name: Nurit Tweezer
role: STUDY_DIRECTOR
References:
Clinical trial NCT02978352: A Comparison of Learning Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration
Official title: A Comparison of Learning Effectiveness of Confusion Assessment Method (CAM-ICU) Between E-learning and Conventional Face-to-face Lecture and Demonstration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Delirium is an acute and fluctuating disturbance of consciousness characterized by reduced attention, impaired cognition and perception, usually resulting from general physical conditions. Delirium contributes to longer hospital length of stay, increased mortality, increased healthcare costs, and long-term cognitive and functional impairment. However, it is often underdiagnosed and undertreated. E-learning (electronic learning) proves to be a time-efficient, flexible and convenient training method, making it suitable for a large organization like Siriraj hospital where there is a large employee turnover rate. So the investigators want to compare the passing rate between the e-learning group and the traditional learning group.

Detailed description: Primary objective: Compare the passing rate between the e-learning group and the traditional learning group

Secondary objectives: Assess the trainees' satisfaction and problems associated with e-learning implementation, Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions

Eligibility criteria: Inclusion Criteria:

* ICU nurse
* general ward nurse
* private ward nurses
* nurse anesthetists

Exclusion Criteria:

* Previous exposure to CAM-ICU
* Inability to complete the training courses
* Inability to complete the required 3 simulated patient scenarios

Primary outcomes:
measure: The passing rate between the e-learning group and the traditional learning group
timeFrame: 2 weeks
Secondary outcomes:
measure: Assess the trainees' satisfaction
timeFrame: 2 weeks
measure: Investigate the causes of inaccurate CAM-ICU assessment for improvement in future training sessions
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02445352: Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DP-R207 (Rosuvastatin /Ezetimibe Combination) and Rosuvastatin Monotherapy in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2015-05-15
Enrollment: 379
Sex: ALL
Minimum age (years): 19
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 evaluate efficacy and safety of DP-R207 in patients with primary hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Aged over 19 years
* Signed informed consent form
* At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyderide ≤ 350mg/dL

Exclusion Criteria:

* Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component of ezeimibe
* Liver transaminases \> 2 x upper limit of normal

Primary outcomes:
measure: Percent change from baseline to 8 weeks in LDL-Cholesterol
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Percent change from baseline to 4 weeks in LDL-Cholesterol
timeFrame: baseline and 4 weeks
measure: Percent change from baseline to 4 weeks in lipid related blood test results
timeFrame: baseline and 4 weeks
measure: Percent change from baseline to 8 weeks in lipid related blood test results
timeFrame: baseline and 8 weeks
measure: Percentage of patients reaching treatment goals according to NCEP ATP III Guideline
timeFrame: week 4 and week 8
Other outcomes:
Locations:
city: Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital
state: Seoul
Study officials:
affiliation: Severance Hospital
name: Yangsoo Jang, Ph.D.
role: STUDY_CHAIR
References: