louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03953859: Embryo DNA Repair Capacity Project
Official title: Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 42
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteer subjects will be recruiting from amongst the gamete donor population and patients undergoing in vitro fertilization (IVF) for treatment of their infertility

Brief summary: The mail aim of the present study is to use molecular methods to analyze the ability of human preimplantation embryos to repair their DNA

Detailed description: The main aim of the present study is to investigate the DNA repair pathways of preimplantation embryos, examining the events that take place following induction of a DSB at a unique targeted site. The investigators aim to address questions concerning the functionality of the DNA repair mechanism(s) in developing embryos, before and after genome activation.

Eligibility criteria: Inclusion Criteria:

* gamete donors: be at least 21 years of age, in good health and eligible to donate their games through the standard gamete donation programs
* IVF couples: any couples proceeding with a routine IVF cycle

Exclusion Criteria:

* less than 21 years of age
* inability to provide informed consent

Primary outcomes:
measure: repair of double strand break in DNA
timeFrame: up to 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Assoicates of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT03830359: Efficacy, Safety of T2769 in Dry Eye Disease
Official title: Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Efficacy of T2769 in Dry Eye Desease

Detailed description: Multicenter and open study

Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from ≥ 18 years old
* Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening

Exclusion Criteria:

* Best far corrected visual acuity ≤ 2/10
* Severe blepharitis Severe dry eye

Primary outcomes:
measure: Ocular Symptomatology
timeFrame: Baseline and Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Hôpital Universitaire Tahar Sfar
city: Monastir
country: Tunisia
facility: "Hôpital Universitaire Fattouma Bourguiba
city: Tunis
country: Tunisia
facility: "Hôpital de Forces de Sécurité Intérieure La Marsa
Study officials:
affiliation: fekihlamia63@gmail.com
name: Lamia El Fekih, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03361059: Falling Risks in Elderly Adults : a Prospective Cohort Study
Official title: Falling Risks in Elderly Adults: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fall
Keywords: risk factors
elderly patients
risk of falling
Lead sponsor: Hospital Donación Francisco Santojanni
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient elderly patients of 65 years or more living in the community

Brief summary: Introduction: the prevalence of falls in adults aged 65 years or older living in the community is 30%, being the second cause of accidental fatal injury and the fifth cause of death. About 20 to 30% of falls result in injuries: 10% constitute serious injuries, from which 5% are fractures. As a result, older adults decrease their mobility, are afraid of falling depressed and socially isolated, increasing the risk of later falls, death and health costs. Falls and their consequences can be prevented, so knowing and assessing the demographic, medical, self-perceived and functional characteristics constitutes an important information for health professionals. Given the high rate (29.59%) of older adults treated at the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni" and the relevance of falls in this population, it is convenient to take a behavior and start by knowing their risk characteristics.

Objectives: to determine the incidence of falls of adults aged 65 years and older, seen in the Physical Therapy outpatient consult of the "Hospital Francisco Santojanni"; to describe the characteristics of these population and to identify the potential risk-of-falling factors.

Subjects and Methods: observational, prospective, longitudinal cohort study. Demographic (age and sex), medical (history of falls, visual alterations, medication and walking aids), self-perceived (fear of falling and instability perception) and functional characteristics (Test of Timed up and Go, Dynamic Index of gait and balance tests) will be evaluated in those patients of 65 years or more who initiate physical treatment in the outpatient consult of the of the "Hospital Francisco Santojanni" "Autonomous City of Buenos Aires, from March 2017 to February 2018, with a follow-up of 6 months until August 2018, to verify the development of the fall event


Eligibility criteria: Inclusion Criteria:

* Patients of 65 years or more treated at the Physical Therapy outpatient consult of the " Hospital Francisco Santojanni" that they walk at least inside their home and have signed informed consent

Exclusion Criteria:

* patients who walk with partial body weight load
* patients using a lower limb immobilization device

Primary outcomes:
measure: Fall
timeFrame: From May 2017 to August 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Donación Francisco Santojanni
state: Buenos Aires
Study officials:
References:
Clinical trial NCT00918359: Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes
Official title: Following Study: Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heat Intolerance
Genotypic Variations
Gene Expression
Genomic Markers for Predisposition of Heat Intolerance
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2009-06-11
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Blood samples of HT and HI subjects will be collected from volunteers who experienced heat exhaustion or heat stroke in their past and participating in heat tolerance test (HTT). The test, using conservative criteria discriminates between HI and HT groups. The distinction between HI and HT groups occurs only following analyses of the HTT.

Brief summary: Heat Intolerance (HI) is a life threatening deficiency that can lead to heat exhaustion, heat stroke (and possibly death) in a large number of military and civilian occupational groups. We have demonstrated malfunction of transcriptional pathways in the heat stressed HI phenotype and an altered gene expression profile compared to Heat Tolerant (HT) individuals. Such differences are evident even under normothermic basal/comfort conditions. Heat and exercise challenges during the heat tolerance test (HTT) further emphasize the differences between the groups, particularly during recovery at comfort temperatures. Our results indicate that it may be possible to identify markers of heat intolerance. To achieve this goal, we plan to design a cellular (lymphocyte) HTT experimental model and detect gene expression profiles using customized DNA microarrays and bioinformatic tools (the genes selected will be based on our previous DNA microarray studies). Lymphocyte samples collected from HT and HI individuals under resting/comfort conditions will be examined. Treatments and analyses are designed to reveal HI-associated gene-expression profiles (constitutive or inducible), and thereby find lymphocyte markers to identify individuals predisposed to heat injury. The identification of such subjects could prevent unnecessary loss of life. Notably, the rapidly changing climate in our era increases the number of occupation/age groups in which manifestations of HI will appear.


Eligibility criteria: Inclusion Criteria:

* Experienced heat exhaustion or heat stroke in their past
* Participating in heat tolerance tests (HTT)

Exclusion Criteria:

* Unambiguous result of the HTT
* HTT stop by the subject decision

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Heller Institute of Medical Research
Study officials:
References:
Clinical trial NCT01542359: Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
Official title: Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Yoga, Hypertension
Blood Pressure
Autonomic Nervous system
Lead sponsor: Long Island University
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and Stage I hypertension. The information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.


Eligibility criteria: Inclusion Criteria:

* Age: 21-64; Pre- or Stage I hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmHg or Diastolic between less than or equal to 80 and 99 \[1\]
* Medically stable on any current medications; BMI (kg/m2) between 18.5 - 40
* English speaking

Exclusion Criteria:

* Taking anti-hypertensive medication; Current use of insulin or oral hypoglycemic agents
* Previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris)
* Current or previous cancer diagnosis
* Congestive heart failure
* History of kidney disease
* Signs or symptoms of significant peripheral vascular disease
* Significant co-morbidities that preclude successful completion of the study
* Yoga practitioner (participated in more than 3 yoga sessions within the last year)

Primary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Assessed within one week post a 12 week intervention
Secondary outcomes:
measure: Psychosocial Stress
timeFrame: Assessed within one week after 12 week intervention
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Long Island University
state: New York
Study officials:
affiliation: Long Island University
name: Marshall A Hagins, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04311359: A Pharmacovigilance Study of Brain Oedema
Official title: A Pharmacovigilance Study of Brain Oedema in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Edema
Brain Edema Caused by Drugs
Lead sponsor: University of Peshawar
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 9524
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented with brain oedema treated for any disease

Brief summary: Literature reports the development of brain oedema following the use of certain drugs. Therefore, this study aims to present a comprehensive disproportionality analysis of brain oedema cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS).

Detailed description: Brain oedema is a serious neurological condition, as it possesses a significant impact on the functional abilities of an individual by causing irreversible brain damage and potentiates the risk of mortality. Apart from a number of medical conditions causing brain oedema, evidence suggests the association of various drugs with brain oedema. Therefore, this study aims to provide a comprehensive disproportionality analysis of the drug-induced brain oedema reports in the FAERS database.

Eligibility criteria: Inclusion Criteria:

* Brain Oedema cases reported in the FAERS database till 31/03/2019
* Adverse event reported was included using the MedDRA term: Brain Oedema

Exclusion Criteria:

* Drugs with less than 19 brain oedema reports

Primary outcomes:
measure: Identification of drugs associated with Brain Oedema
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
measure: Detection of signals of Brain Oedema
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
Secondary outcomes:
measure: Stratification of new signals with respect to age
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
measure: Stratification of new signals with respect to gender
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
measure: Trends of Brain Oedema reports in FAERS database
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
measure: Trends of Brain Oedema reports in Google searches
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
measure: Description of the population of patients having Brain Oedema
timeFrame: Cases reported to the FAERS database since inception till 31/03/2019
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: University of Peshawar
state: KPK
Study officials:
References:
Clinical trial NCT01573559: ClearView Predicate Comparison Testing
Official title: ClearView Predicate Comparison Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Ambulatory adults with no apparent health conditions
Lead sponsor: Epic Research & Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women ages 18-85.

Brief summary: This study serves as a comparison study between the EPIC ClearView and a predicate device.

Detailed description: The EPIC ClearView is a galvanic skin response (GSR) measurement system that is intended to be used to determine autonomic response as psychological indicators by measuring the electrical resistance of the skin. The EPIC ClearView is a non-invasive digital bioelectrography instrument that is used to assess the electrophysiology of humans. The measurements are digital photographs taken in a brief exposure to an electric field. These measurements are quantified to produce a standardized Response Scale.

Eligibility criteria: Inclusion Criteria:

* Sex: Male or Female.
* Age range: 18 to 85.
* The subject is able to understand and provide signed consent for the procedure.
* Every effort will be given to balance subjects by gender, age, and race.

Exclusion Criteria:

* Subjects \< 18 years in age or \> 85 years in age.
* Inability or unwillingness to provide informed consent.
* Subjects with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body.
* Subjects missing all or part of any of their fingers.
* Subjects with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.

Primary outcomes:
measure: Correlation Between ClearView and Predicate
timeFrame: At time of study scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit.)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: EPIC Research & Diagnostics, Inc.
state: Arizona
Study officials:
affiliation: Epic Research & Diagnostics, Inc.
name: Nancy R Rizzo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03978559: Trimethoprim/Sulfamethoxazole Combined With Caspofungin as First-line Therapy in PCP
Official title: A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumocystis Pneumonia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 122
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: TREATMENT

Brief summary: This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.

The aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Non-HIV immunosuppressed patients admitted to the ICU
3. confirmed or suspect PCP

3) Not receiving anti-PCP treatment or anti-PCP treatment \< 48 hours

Exclusion Criteria:

1. Age less than 18 years old
2. Known pregnancy
3. allergy to TMP/SMZ or caspofungin
4. Decision to withhold life-sustaining treatment
5. Patients with advanced pulmonary fibrosis
6. severe liver dysfunction(Child-Pugh C )

Primary outcomes:
measure: mortality to day 28
timeFrame: 28 days after randomization
Secondary outcomes:
measure: ICU Free Days to day 28
timeFrame: 28 days after randomization
measure: Mean Ventilator Free Days to day 28
timeFrame: 28 days after randomization
measure: ICU mortality
timeFrame: through ICU discharge, an average of 14 days
measure: hospital mortality
timeFrame: through hospital discharge, an average of 28 days
measure: PO2/FiO2 on day 7, 21
timeFrame: day 7, 21 after randomization
measure: serum (1,3)-β-D gluca level on day 3, 7, 21
timeFrame: day3, 7, 21 after randomization
measure: PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization
timeFrame: day 7 after randomization
measure: SOFA
timeFrame: day3, 7, 21 after randomization
measure: BALF cytokines level on day3, 7, 21
timeFrame: day3, 7, 21 after randomization
measure: adverse events
timeFrame: till 21 days after randomization
measure: serious adverse events
timeFrame: till 21 days after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: MICU of Peking Union Medical College
Study officials:
References:
Clinical trial NCT01621659: Multidisciplinary Team IntervenTion in CArdio-ONcology (TITAN Study)
Official title: Multidisciplinary Team IntervenTion in CArdio-ONcology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: multidisciplinary team
exercise
nutrition
cardiology
physiotherapy
imaging
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Supportive care intervention
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with breast cancer often experience many short and long-term side effects as a result of both the cancer and the necessary treatments.

Receiving extra assessments and care from teams of multiple health professionals has been shown to be helpful for people with other health problems, such as heart disease. These 'multidisciplinary' teams may include nurses, doctors, pharmacists, dietitians, exercise therapists, counselors, and other specialists. Currently, the investigators do not know if receiving extra assessments from a multidisciplinary team is helpful for people receiving cancer treatment.

In this study, the investigators hope to learn the effect of extra assessments and early interventions from teams of health care professionals in people diagnosed with cancer, during and after the treatment period.

After initial assessments, participants will be randomized to multidisciplinary team intervention or usual care.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed malignancy (breast or lymphoma);
* scheduled to receive anthracycline and/or trastuzumab-based chemotherapy;
* age ≥ 18 years;
* willing to attend follow-up visits.

Exclusion Criteria:

* physical disability preventing exercise testing or DEXA scan;
* psychiatric disease or disorder precluding informed consent;
* participation in other cardiotoxicity or exercise intervention study;
* contraindication to anti-cancer therapy, including known heart failure, cardiomyopathy, or baseline LVEF \< 50%;
* previous anthracycline or trastuzumab-based therapy;
* previous radiotherapy to thorax.

Primary outcomes:
measure: cardiac MRI
timeFrame: change from baseline to 12 months
Secondary outcomes:
measure: serum biomarkers
timeFrame: change from baseline to 12 months
Other outcomes:
measure: multidisciplinary team interventions
timeFrame: change from baseline to 12 months
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
References:
citation: Pituskin E, Haykowsky M, McNeely M, Mackey J, Chua N, Paterson I. Rationale and design of the multidisciplinary team IntervenTion in cArdio-oNcology study (TITAN). BMC Cancer. 2016 Sep 15;16(1):733. doi: 10.1186/s12885-016-2761-8.