louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03342690: Drug Use Investigation of Selara Tablets (an Investigation for Chronic Heart Failure)
Official title: DRUG USE INVESTIGATION OF SELARA(REGISTERED). TABLETS(AN INVESTIGATION FOR CHRONIC HEART FAILURE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure
Keywords: Selara
Chronic Heart Failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-11-17
Enrollment: 1165
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study

Brief summary: Secondary Data Collection Study; Safety And Effectiveness Of Selara Under Japanese Medical Practice

Detailed description: This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. The patients will be observed up until Week 52.

Eligibility criteria: Inclusion Criteria:

* Patients in whom treatment with this drug is for CHF. The indications at approval for this drug are as follows. When using this drug, refer to the latest package insert of this drug.

Exclusion Criteria:

* Patients who were previously registered for this study. Patients who received eplerenone within the past three months regardless of the reason for use.

Primary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants With Moderate Renal Impairment
timeFrame: 52 weeks from the start date
Secondary outcomes:
measure: Percentage of Participants With Adverse Drug Reactions in Chronic Heart Failure Participants
timeFrame: 52 weeks from the start date
measure: The Number of Deaths (Overall Deaths)
timeFrame: 52 weeks from the start date
measure: The Number of Deaths (Cardiovascular Deaths)
timeFrame: 52 weeks from the start date
measure: The Overall Mortality Rate
timeFrame: 52 weeks from the start date
measure: The Cardiovascular-related Mortality Rate
timeFrame: 52 weeks from the start date
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03420690: Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families
Official title: Study of the Impact of Art Therapy in Palliative Care on the Relationship Between Patients and Their Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Close to a patient who died more than 1 month old and who benefited from more than one art therapy session in the palliative care unit.

Brief summary: Negative symptoms in cancer in palliative care, such as pain, can lead to a withdrawal that can lead to a form of social exclusion. Maintaining pre-illness relationships is often difficult for the patient, especially since he is often not available to relationships.

Art therapy defined as the exploitation of artistic potential in a therapeutic and humanitarian aim can contribute to the reduction of symptoms, to adaptation and to well-being. A recent review shows that positive affective states and meaningful social connections are important factors contributing to more effective adaptation to pain. Study hypothesis is that art therapy could play on these two factors.

The objective of the qualitative study is to measure, using a questionnaire, the indirect impact of art therapy sessions on parents, during support and after death, from a relational and emotional point of view.


Eligibility criteria: Inclusion Criteria:

Any major person who has accompanied a patient to the palliative care unit of the Lyon-Sud hospital

* Man or woman ;
* 18 years old or older;
* Death of the accompanied patient\> 1 month;
* Number of art therapy session of the accompanied patient \> 1;
* Having agreed to participate in the study;
* Not subject to a legal protection measure.

Exclusion Criteria:

* Nobody without the physical or mental abilities to respond to the questionnaire ;
* No one reading or speaking French.

Primary outcomes:
measure: Overall satisfaction with art therapy
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Marilène FILBET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00565890: Supplemental Thyroxine Treatment for Preterm Infants With Hypothyroxinemia
Official title: Randomized Controlled Clinical Trial of Thyroxine Supplementation for Very-low-birth-weight Infants With Hypothyroxinemia During the First Month of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothyroxinemia
Keywords: very low birth weight infant
hypothyroxinemia
outcomes
Lead sponsor: Tokyo Women's Medical University
Sponsor class: OTHER
Collaborators: name: Tokyo Metropolitan Bokuto Hospital
First posted: 2007-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.

Detailed description: A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.

Eligibility criteria: Inclusion Criteria:

* Birth weight: less than 1500g
* Gestation: 22 weeks 0 day ≤
* Serum free thyroxine level lower than 0.8 ng/dl
* Serum thyrotropin lower than 10 μU/ml
* Age of between 2 and 4 weeks after birth
* Informed consent

Exclusion Criteria:

* any known thyroid disease in mother

Primary outcomes:
measure: Psychomotor development at 1.5 years of age
timeFrame: 18 months
Secondary outcomes:
measure: Psychomotor development at 3 years of age
timeFrame: 6 years
measure: Somatic growth at 3 years of age
timeFrame: 6 years
measure: Duration of hospital stay
timeFrame: 6 years
measure: Frequency of morbidities during the stay in NICu
timeFrame: 6 years
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Maternal and Perinatal Center, Tokyo Women's Medical University
Study officials:
affiliation: Tokyo Women's Medical Unversity
name: Satoshi Kusuda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04351490: Impact of Zinc and Vitamin D3 Supplementation on the Survival of Aged Patients Infected With COVID-19
Official title: Impact of Zinc and Vitamin D3 Supplementation on the Survival of Institutionalized Aged Patients Infected With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: SARS-CoV 2
Keywords: Survival
Covid-19
Aged subjects
Zinc
25-OH cholecalciferol
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mortality from Covid-19 increases with age, reaching 14.8% from the age of 80. The severity of the infection is linked to the acute respiratory distress syndrome (ARDS) which requires intensive care. ARDS is the consequence of the reactional inflammatory storm that damages the lungs.

Aged subjects are particularly prone to zinc and vitamin D deficiency. These two micronutrients are able to modulate the immune response by reducing the inflammatory storm.

The hypothesis is that supplementation with zinc and vitamin D would reduce the inflammatory reaction which worsens ARDS and leads to the death of subjects infected with Covid-19.


Eligibility criteria: Inclusion Criteria:

* Institutionalized

Exclusion Criteria:

* Life expectancy \< 1 month independently of Covid-19 infection (overall subjects)
* Known hypercalcemia
* History of renal lithiasis

Primary outcomes:
measure: Survival rate in asymptomatic subjects at inclusion
timeFrame: Two months after inclusion
Secondary outcomes:
measure: Survival rate in symptomatic subjects at inclusion
timeFrame: Two months after inclusion
measure: Survival rate in overall subjects
timeFrame: Two months after inclusion
measure: Cumulative incidence of Covid-19 infection in asymptomatic subjects at inclusion
timeFrame: Within two months after inclusion
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: David SEGUY, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shakoor H, Feehan J, Al Dhaheri AS, Cheikh Ismail L, Ali HI, Alhebshi SH, Apostolopoulos V, Stojanovska L. Role of vitamin D supplementation in aging patients with COVID-19. Maturitas. 2021 Oct;152:63-65. doi: 10.1016/j.maturitas.2021.03.006. Epub 2021 Mar 16. No abstract available.
Clinical trial NCT01800890: Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
Official title: Investigating the Safety and Performance of New 2-piece Ostomy Product Concept Compared With SenSura Click in Subjects With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects With an Ileostomy
Keywords: stoma ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.

Detailed description: The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.

Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent and signed letter of authority form.
2. Be at least 18 years of age and have full legal capacity.
3. Be able to handle the appliances themselves
4. Have an ileostomy with a diameter between 15 and 40 mm.
5. Have had their ostomy for at least three months.
6. Use minimum 1 baseplate every third day.
7. Currently use 2-piece flat mechanical coupling product with open bag and a coupling size in the inter val of 43-55mm (both extremes included)
8. Must be able to use custom cut product
9. Accept to test three 2-piece products within the study.
10. Negative result of a pregnancy test for women of childbearing age.

Exclusion Criteria:

1. Use irrigation during the study (flush the stoma with water).
2. Currently receiving or have within the past 2 months received radio- and/or chemotherapy.
3. Currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area.
4. Are pregnant or breastfeeding.
5. Participating in other interventional clinical investigations or have previously participated in this investigation.
6. More than three days wear time as usual change pattern.
7. Currently using ostomy belt
8. Currently using extended wear product (Sensura Xpro, Assura TERA, Dansac NovaLife X3, Hollister Flextend, Convatec Durahesive)
9. Have a loop ileostomy
10. Known hypersensitivity towards any of the test products
11. Suffer from peristomal skin problems that preclude participation in the investigation (assessed by the investigation nurse)

Primary outcomes:
measure: Degree of Leakage
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
affiliation: Coloplast A/S
name: Daniel Carter, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT03546790: Laboratory Smoking of Marijuana "Blunts"
Official title: Laboratory Smoking of Marijuana "Blunts"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cannabis
Keywords: Cannabis
Lead sponsor: Battelle Memorial Institute
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a double-blind within-subjects clinical laboratory study comparing the product appeal and abuse liability-related subjective effects of different flavored cigar wrappers for marijuana blunts.


Eligibility criteria: Inclusion Criteria:

* Currently living in Baltimore City or Baltimore County, MD;
* Able to read, understand, and sign informed consent;
* 18-55 years old;
* Currently smokes marijuana blunts;
* Designation of Medically Healthy for Research by the Study Physician; and
* Willing to abstain from illicit drug use other than marijuana for the duration of the study.

Exclusion Criteria:

* BAC \> 0.020% as measured by alcohol breathalyzer;
* Meets DSM-5 criteria for severe current or lifetime Cannabis Use Disorder;
* Meets DSM-5 criteria for any current Axis I disorder, other than current mild or moderate Cannabis Use Disorder;
* Self-reported current desire to stop marijuana use;
* Self-reported current asthma, chronic obstructive pulmonary disease, hypertension, cardiovascular disease or any other medical illness that precludes participation;
* Has difficulties with blood draws or poor venous access;
* History of blood donation in the past 30 days or receiving blood products within the past 2 months prior to any experimental visit;
* Among females, current pregnancy or lactation or attempting to get pregnant, or at risk of becoming pregnant;
* Acute illness which will require participant to be rescheduled

Primary outcomes:
measure: Puff topography
timeFrame: During marijuana blunt smoking
Secondary outcomes:
measure: Carbon monoxide
timeFrame: Immediately after marijuana blunt smoking
measure: Subjective drug effects
timeFrame: Immediately after marijuana blunt smoking
measure: Measures of demand
timeFrame: Immediately after marijuana blunt smoking
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Battelle Memorial Institute
state: Maryland
Study officials:
affiliation: Battelle Memorial Institute
name: Wallace B Pickworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06612190: Evaluation on Visual Outcome of TMS
Official title: Evaluation on Visual Outcome of Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Impairment
Lead sponsor: Evidence Based Cataract Study Group
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients with visual impairment. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients who suffer from visual impairment? Researchers will compare TMS to the control group who will not receive effective TMS treatment) to see if TMS works to improve the visual outcomes of the patients.

Participants will

* Undergo TMS treatment or no effective TMS for consecutive 5 days.
* Visit the clinic once every 2 weeks for checkups and tests.


Eligibility criteria: Inclusion Criteria:

* Post cataract surgery or clear lens
* Best-corrected visual acuity less than 0.1logMAR

Exclusion Criteria:

* Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
* Diagnosed with ocular diseases that affect observation of visual function;
* History of epileptic seizures;
* Long term use of psychotropic drugs；
* Metal implants in the body.

Primary outcomes:
measure: Visual acuity
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Visual field
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
measure: Visual quality
timeFrame: From enrollment to the end of treatment at 6 months
Locations:
city: Shanghai
country: China
facility: Eye and Ear, Nose Throat Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Xiangjia Zhu
role: STUDY_CHAIR
affiliation: Eye and ENT Hospital of Fudan University
name: Yating Tang
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Yinglei Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Jiaqi Meng
role: PRINCIPAL_INVESTIGATOR
affiliation: Eye and ENT Hospital of Fudan University
name: Xin Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02506790: Neoadjuvant Toremifene With Melatonin or Metformin in Locally Advanced Breast Cancer
Official title: Phase II Multicenter Randomized Study to Compare Neoadjuvant Toremifene With Melatonin or Metformin Versus Toremifene in the Therapy of Locally Advanced Breast
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Melatonin, metformin, toremifene
Lead sponsor: N.N. Petrov National Medical Research Center of Oncology
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 96
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: This study evaluates the addition melatonin and metformin to toremifene in the treatment of locally advanced breast cancer. Third of patients will receive toremifene, other third will receive combination of melatonin and toremifene and other patients will receive combination of metformin and toremifene.

Detailed description: The management of locally advanced breast cancer is complicated issue. Neoadjuvant treatment is often needed to downstage locally advanced ER positive BC tumors prior to surgery. However, many patients do not achieved objective response on treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover, several studies confirm, that this drugs in combination with conventional anti - estrogen treatment may increase objective response. But, this data is still controversial. We hypothesizes that the combinations of melatonin and metformin with conventional anti - estrogen such as toremifene could be more effective than toremifene alone in terms of response rate.

Eligibility criteria: Inclusion Criteria:

* Age \> 18.
* Obtained Inform Concent.
* Morphologically confirmed breast cancer stage IIB, IIIA, IIIB, IIIC ER positive.
* Eastern Collaborative Oncology Group Performance Status Scale 0-2.
* Expected survival \> 6 month.
* Adequate liver and bone marrow function.

Exclusion Criteria:

* Systemic treatment for breast cancer.
* Stage IV disease.
* Evidence of liver and bone marrow clinically meaningful disfunction.
* Severe uncontrolled concomitant conditions and diseases.
* Pregnancy or lactation.
* Second malignancy.
* Diabetes mellitus requiring drug therapy.
* Any condition preventing study participation by investigators opinion.

Primary outcomes:
measure: Response rate
timeFrame: 4 months after FPFV
measure: Pathomorphological response
timeFrame: 4 months after FPFV
Secondary outcomes:
measure: Adverse events incidence
timeFrame: Until 30 days after last patient treatment visit
Other outcomes:
Locations:
city: Saint - Petersburg
country: Russian Federation
facility: N.N. Petrov Research Institute of Oncology Clinical Diagnostic Department
Study officials:
affiliation: N.N. Petrov Research Institute Of Oncology
name: Vladimir F Semiglazov, MD,PhD, DSc, Professor
role: STUDY_DIRECTOR
affiliation: N.N. Petrov Research Institute Of Oncology
name: Tatiana Y Semiglazova, MD, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912690: The Influence of Different Training Regimens on Electrical Stability Following Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Congestive Heart Failure
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 60
Sex: ALL
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: The hypothesis of the study is that aerobic conditioning following acute heart attack will improve autonomic function and electrical stability of the heart.


Eligibility criteria: Inclusion Criteria:

* s/p acute myocardial infarction 14-30 days
* ability to perform exercise

Exclusion Criteria:

* unstable angina
* chronic atrial fibrillation
* severely reduced LV function
* NYHA 4
* severe valvular disease

Primary outcomes:
measure: Left ventrcular dyssynchrony
timeFrame: 3 months
Secondary outcomes:
measure: Autonomic function
timeFrame: 3 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Medical Center
Study officials:
References:
Clinical trial NCT03564990: The Impact of Interactive, Multifaceted Approach Education on Congenital Cataract
Official title: The Impact of Interactive, Multifaceted Approach Education on Parental Anxiety, Knowledge and Satisfaction for Congenital Cataract: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Cataract
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the impact of a health education program on parental anxiety, the comprehension-memorization of the information and their satisfaction.

Detailed description: Prospective study including parents of congenital cataract, randomized in two groups: health education program with an interactive, multifaceted approach versus conventional follow-up. A health education module consisting of a lecture and workshop was incorporated into a health-care course. A non-validated survey assessed knowledge. Parental stress was assessed using self-questionnaires before and after training .At each moment we evaluated the level of anxiety, satisfaction of information quality and the comprehension-memorization of the data.

Eligibility criteria: Inclusion Criteria:

* children with regulated cataract surgery

Exclusion Criteria:

* difficulty in understanding the language
* uncompleted questionnaires or badly filled in by two different people

Primary outcomes:
measure: Parenting stress
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Professor
name: Haotian Lin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: