louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04506229: Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function
Official title: Genetic Mechanisms Underlying SARS-CoV-2 Infection and the Impact of COVID-19 on Cognitive Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Known exposure to COVID-19 or confirmed cases of COVID-19

Brief summary: There is a considerable variation in the disease behavior in terms of contracting the infection, manifesting none to a range of symptoms and severity of the infection among individuals exposed to or infected with SARS-CoV-2 virus, the causative organism of COVID-19. Although the respiratory system appears to be the primary target of this virus infection, emerging evidences suggests involvement of extra-pulmonary organs including central nervous system. We aim to compare the genetic profile of individuals with vs without COVID-19 after being exposed to infected cases. Additionally, we will assess the cognitive function in covid-19 positive cases with vs. without neurological symptoms at the time of infection and 1-month follow-up using the Montreal Cognitive Assessment (MoCA) questionnaire.


Eligibility criteria: Inclusion Criteria:

1. Male or female over 18 years of age at the time of enrollment
2. Have symptoms of COVID-19 (with or without hospitalization) or contact history
3. Willing to undergo nasopharyngeal swab test for viral-RNA at baseline (in non-hospitalized cases) and the MoCA survey at baseline and 1-month follow-up

Exclusion Criteria:

1. Unwilling to provide informed consent
2. MoCA score ≤17 at baseline
3. Patients with clinical diagnosis of dementia
4. Impaired consciousness

Primary outcomes:
measure: Genetic variants with vs without COVID-19
timeFrame: 1 day
measure: Cognitive function at baseline
timeFrame: 1 day
Secondary outcomes:
measure: Change in cognitive function at 1 month
timeFrame: 1 month
measure: Genetic analysis
timeFrame: 1 day
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Institute, St.
name: Andrea Natale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06166329: Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
Official title: Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-severe Pulmonary Embolism
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current pulmonary embolism risk stratification score using the sPESI score refined by the use of cardiac biomarkers and right ventricular dysfunction


Eligibility criteria: Inclusion Criteria:

* Diagnosis of pulmonary embolism according to clinical algorithm, confirmed by thoracic angioscan or ventilation perfusion (V/P) scan,
* Non-serious pulmonary embolism, not requiring intensive care (thrombectomy or fibrinolysis not considered).
* sPESI score ≥ 1 \[or = 0 with elevated troponin or presence of markers of VD dysfunction, or = 0 with need for hospitalization due to comorbidities unrelated to PE (social isolation, comprehension disorders, intercurrent infection, chronic renal failure, advanced cancer...)
* Patients with no contraindications to chair lift testing (no O2 at the time of testing).
* Effective anticoagulation for at least 1 hour.

Exclusion Criteria:

* sPESI score = 0 with outpatient referral.
* Diagnostic confirmation of Pulmonia Embolism by thoracic angioscan or scintigraphy more than 24h after suspicion of diagnosis.
* Hospitalization \> 24h after introduction of anticoagulation, with subsequent confirmation by scintigraphy.
* Any sign of serious Pulmonia Embolism, requiring hospitalization in an intensive care unit.
* Asymptomatic Pulmonia Embolism discovered by chance

Primary outcomes:
measure: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the one-minute chair rise test in comparison with the gold standard refined by the use of cardiac biomarkers and right ventricular dysfunction
timeFrame: 1 day
Secondary outcomes:
measure: Troponin measurement
timeFrame: 1 day
measure: Presence or absence of post-pulmonary embolism dyspnea
timeFrame: 6 months
measure: Overall survival
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: Delphine SIMON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758329: Retrospective Data Review of ReCap Total Hip Resurfacing
Official title: Retrospective Data Review of ReCap Total Hip Resurfacing
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis of the Hip
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet U.K. Ltd.
First posted: 2008-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received ReCap Total Hip Resurfacing

Brief summary: Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip Resurfacing


Eligibility criteria: Inclusion:

* Patients received ReCap total hip resurfacing

Primary outcomes:
measure: Survival rate
timeFrame: 2 yr
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 2yr
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02567929: Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
Official title: Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 218
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

Detailed description: The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

1. immediate before anesthesia induction
2. postoperative 1 hours
3. postoperative 24 hours

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Eligibility criteria: Inclusion Criteria:

* patient who was planned to undergo colon cancer surgery.

Exclusion Criteria:

* age \< 20 years old
* history of hypersensitivity reaction in propofol or sevoflurane
* history of previous cancer
* patient with ongoing inflammation

Primary outcomes:
measure: CD39 and CD73 on circulating regualtory T cells
timeFrame: preoperative time. postoperative 1 hours and 24 hours
Secondary outcomes:
measure: Circulating natural killer cells
timeFrame: preoperative time. postoperative 1 hours and 24 hours
Other outcomes:
measure: Circulating type 1 and type 17 helper T cells
timeFrame: preoperative time. postoperative 1 hours and 24 hours
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Seong-Hyop Kim, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03076229: Relationship Education:Project Harmony
Official title: A Randomized Control Trial of Relationship Education: Project Harmony
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Marriage
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-03-10
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness of relationship education (RE) for individuals and couples participating in Project Harmony.

Detailed description: Although considerable research supports the positive effects of relationship education (RE) on relationship satisfaction and communication skills, the majority of existing research designs have favored pre/post or quasi-experimental designs. Furthermore, gaps in the empirical bases for RE remain regarding programmatic moderators that influence change. Consequently, there has been less emphasis on understanding which program elements contribute to positive change within couple relationships. To this end, Project Harmony seeks to conduct an impact local evaluation design utilizing a randomized control trial (RCT) to assess the effectiveness of relationship education between low income, ethnically diverse individuals and couples in the treatment group compared to the wait-list control group. Secondary research questions are focused on investigating mechanisms and moderators of change for the target population. Participants (individuals and couples) in Project Harmony will be randomly assigned to either the treatment or wait-list control group.

Eligibility criteria: Inclusion Criteria:

* Individuals and couples who are at least 18 years of age.

Exclusion Criteria:

* Does not meet the inclusion criteria

Primary outcomes:
measure: 1200 participants with relational and interpersonal stressors
timeFrame: 6 months
Secondary outcomes:
measure: 1200 participants with relational and interpersonal stressors
timeFrame: 6 months
Other outcomes:
measure: 1200 participants with relational and interpersonal stressors
timeFrame: 6 months
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Sejal M Barden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Central Florida
name: Bridgette Toussaint, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05409729: Subclinical Hypothyrodism and Ovarian Reserve
Official title: Evaluation of Ovarian Reserve in Women With Subclinical Hypothyrodism in Reproductive Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertility Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 300
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with thyroid dysfunction who seeking fertility

Brief summary: This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve

Primary outcome:

Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)

Detailed description: Thyroid dysfunction is one of the commonest disorders in women of reproductive age .there is association between subclinical hypothyrodism and infertility and ovarian reserve .It's known that subclinical hypothyrodism can be associated with reduced ovarian reserve in women more than 35 years old .Aclear association between subclinical hypothyrodism and ovarian reserve not established in reproductive age in women less than 35 .This retrospective study investigate serum thyroid hormone /Antithyroid hormone ,ovarian reserve markers (basal FSH,AMH,Antral follicle count on day 2-4/prolactin level .

Eligibility criteria: Inclusion Criteria:

* All reproductive age groups included women less than 35 and women more than 35

Exclusion Criteria:

* Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby

Primary outcomes:
measure: Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut Medical School
Study officials:
References:
citation: Rao M, Wang H, Zhao S, Liu J, Wen Y, Wu Z, Yang Z, Su C, Su Z, Wang K, Tang L. Subclinical Hypothyroidism Is Associated with Lower Ovarian Reserve in Women Aged 35 Years or Older. Thyroid. 2020 Jan;30(1):95-105. doi: 10.1089/thy.2019.0031. Epub 2019 Dec 20.
citation: Korevaar TIM, Minguez-Alarcon L, Messerlian C, de Poortere RA, Williams PL, Broeren MA, Hauser R, Souter IC. Association of Thyroid Function and Autoimmunity with Ovarian Reserve in Women Seeking Infertility Care. Thyroid. 2018 Oct;28(10):1349-1358. doi: 10.1089/thy.2017.0582. Epub 2018 Aug 14.
Clinical trial NCT05356429: Small Molecule LCDM and GV Oocyte
Official title: Study on the Effectiveness of Small Molecule LCDM Combined With Oocyte Activation in Improving GV Oocyte in Vitro Maturation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assisted Reproduction
Keywords: Small molecule LCDM
Oocyte activation
In vitro maturation
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: GV oocytes were collected for IVM patients undergoing in vitro fertilization embryo transfer (IVF-ET) in our center. IVM combined with artificial oocyte activity was used to observe and accurately estimate the state of oocyte, then select MII oocyte for the further experiment. All patients in this study were ICSI cycle that the number of oocytes more than two GV oocytes.

Brief summary: Immature eggs obtained during the oocyte retrieval cycle are discarded as medical waste because they cannot complete fertilization, but each egg is important for people with poor clinical outcome. In vitro maturation (IVM) technique allows immature GV and MI eggs to mature in vitro, offering hope for this population to increase the clinical pregnancy rate in a single oocyte retrieval cycle. However, the clinical effectiveness of IVM clinical application is still very low, especially the utilization rate of GV eggs is extremely low. The cocktail of small molecules includes four chemical components of LCDM, which are related to cell proliferation, in vitro maturation of eggs, and protection of cells from oxidative stress. Our preliminary experiments confirmed that the addition of a certain concentration of LCDM in the culture medium can significantly improve the in vitro maturation rate and embryo utilization rate of immature GV eggs. In this study, LCDM immature oocyte culture system was used to carry out in vitro maturation culture of GV oocytes, and combined with oocyte activation technology to verify the clinical safety of LCDM in vitro culture system by observing the in vitro maturation rate, fertilization rate and embryo development results of GV oocytes, so as to provide laboratory data for clinical application of GV oocytes in special patients.


Eligibility criteria: Inclusion Criteria:

* ICSI cycle with more than 2 GV oocytes

Exclusion Criteria:

* The etiological diagnosis is that the man has extremely severe oligoasthenospermia and primary azoospermia. These patients can lead to low fertilization rate due to sperm, so they are excluded from the group.

Primary outcomes:
measure: Number of GV oocyte maturation rate at 48 hours
timeFrame: 48 hours
measure: Change from the quality of MII oocytes between the two groups at 48 hours
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00002129: A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
Official title: A Phase I Study of Three Doses of OPC-8212 (Vesnarinone) in HIV-Infected Persons With CD4+ Cell Number > 300 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: vesnarinone
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count \> 300 cells/mm3.

Detailed description: Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and herpes simplex.

Patients must have:

* Asymptomatic HIV infection.
* CD4 count \> 300 cells/mm3.
* No prior AIDS-defining illness or current constitutional symptoms of HIV disease.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening.
* Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix.

Concurrent Medication:

Excluded:

* Antiretroviral agents, including ddI, ddC, and AZT.
* Immunosuppressive agents.
* Investigational HIV drugs/therapies including vaccines.
* Interferon.
* Steroids (other than topical).
* Hematopoietins.
* Megestrol acetate.
* Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly.
* Cytotoxic chemotherapy.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Patients with the following prior conditions are excluded:

* Prior history of cardiac disease.
* History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function.

Prior Medication:

Excluded:

* AZT, ddI, and ddC within 14 days prior to study entry.
* Prior cytotoxic chemotherapy.

Prior Treatment:

Excluded:

* Radiation therapy (including electron beam irradiation) within 30 days prior to study entry.

Active illicit drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
Study officials:
References:
citation: Mitsuyasu R, Bort L, Miles SA, Hardy WD, Petit RG. Preliminary results of a phase I study of vesnarinone (OPC-8212) in HIV-infected persons with CD4 > 300 cells/MM3. Int Conf AIDS. 1994 Aug 7-12;10(1):8 (abstract no 005B)
Clinical trial NCT01152229: Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine
Official title: Platelet Reactivity In Patients With Nuisance Bleeding On A Thienopyridine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation
Bleeding
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone PCI and have reported no bleeding, nuisance bleeding or alarming bleeding.

Brief summary: The objective is to describe and quantify levels of platelet reactivity in three different cohorts of patients taking thienopyridine: patients who report nuisance bleeding, patients who report alarming bleeding, and patients who report no nuisance or alarming bleeding. The investigators hypothesize that patients with nuisance or alarming bleeding events on maintenance thienopyridine therapy will have lower levels of platelet reactivity than patients without nuisance or alarming bleeding on thienopyridine therapy.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older from both genders
* Underwent PCI within the last year
* Taking maintenance dose of clopidogrel 75 mg once a day or prasugrel 10 mg once a day for at least five days

Exclusion Criteria:

* Known allergies to aspirin, clopidogrel, or prasugrel.
* Use of a glycoprotein (GP)IIb/IIIa inhibitor within 8 hours of the blood draw.
* Patient known to be pregnant or lactating
* Patient with known history of anemia, thrombocytopenia, bleeding disorder, or currently active bleeding
* On warfarin therapy at the time of blood draw
* Known blood transfusion within the preceding 10 days of the blood draw
* Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS, not to include aspirin) within the previous 5 days
* Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Primary outcomes:
measure: platelet reactivity
timeFrame: post percutaneous coronary intervention (PCI) while still on clopidogrel
Secondary outcomes:
measure: Platelet reactivity
timeFrame: post PCI while still on clopidogrel
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Cardiovascular Research Institute
name: Michael Gaglia, MD
role: PRINCIPAL_INVESTIGATOR
References: