louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05047640: COVID-19 3rd Dose Vaccine in Transplant Patients
Official title: A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Covid19
Keywords: transplant patients
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age and older
* Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors.
* Patients with active graft with at least one immunosuppressive medication
* Completed two doses of BNT162b2 vaccination at least 28 days ago

Exclusion Criteria:

* Patient with non-active graft
* Any significant side effect with previous COVID-19 vaccination
* Within 28 days of BNT162b2 vaccine completion
* Already received more than and equal to three doses of COVID-19 vaccination
* Previously received COVID-19 vaccine other than BNT162b2 vaccine
* Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination.
* Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)
* History of Capillary Leak Syndrome
* Adults unable to consent
* Individuals who are not yet adults (younger than 18 year old)
* Vulnerable patients (prisoners)
* Pregnant women

Primary outcomes:
measure: Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
timeFrame: Up to 1 month (post booster vaccination)
Secondary outcomes:
measure: Proportion of Participants With a Positive COVID-19 Test
timeFrame: Up to 1 month (post third dose)
measure: Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
timeFrame: Up to 1 month (post third dose)
measure: Number of Participants With Vaccine-related Adverse Events
timeFrame: Up to 7 days (post third dose)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Giselle Guerra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05511740: Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer
Official title: Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Radiotherapy Side Effect
Keywords: Radiosensitivity
Circadian rhythm
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 71
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was a Randomized Clinical Trial (RCT) or clinical trial comparing the results of radiation treatment of 2 treatment groups, i.e. subject groups irradiated in the morning and in the afternoon, to check melatonin levels in cervical cancer patients. Since it is known that the function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.


Eligibility criteria: Inclusion Criteria:

* cervical cancer patients stage IIB-IIIB (FIGO)
* no previous treatment
* histopathologic examination results of squamous cell carcinoma (SCC)
* KPS \> 70 with levels of Hb \> 10 g%,

Exclusion Criteria:

* Distant metastasis and locally spread to the adjacent healthy tissue (urinary bladder or rectum).

Primary outcomes:
measure: Radiation response
timeFrame: Four weeks after the completion of radiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Radiation Oncology Cipto Mangunkusumo Hospital
name: Irwan Ramli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung B, Ahmad N. Melatonin in cancer management: progress and promise. Cancer Res. 2006 Oct 15;66(20):9789-93. doi: 10.1158/0008-5472.CAN-06-1776.
citation: Karbownik M, Reiter RJ. Melatonin protects against oxidative stress caused by delta-aminolevulinic acid: implications for cancer reduction. Cancer Invest. 2002;20(2):276-86. doi: 10.1081/cnv-120001154.
citation: Vijayalaxmi, Thomas CR Jr, Reiter RJ, Herman TS. Melatonin: from basic research to cancer treatment clinics. J Clin Oncol. 2002 May 15;20(10):2575-601. doi: 10.1200/JCO.2002.11.004.
citation: Ramli I, Susworo S, Nuranna L, Mansyur M, Harahap AR, Soetopo S, Siregar NC, Wanandi SI. Circadian as a prognostic factor for radiation responses in patients with cervical cancer: A nested case-control study. Oncol Rep. 2022 Nov;48(5):199. doi: 10.3892/or.2022.8414. Epub 2022 Sep 23.
Clinical trial NCT01782040: Auriculotherapy in the Cares to the Premenstrual Syndrome
Official title: Auriculotherapy in the Cares to the Premenstrual Syndrome: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome
Physical distress
Behavioral changes
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Sociedade Hospital Samaritano
First posted: 2013-02-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Premenstrual syndrome (PMS) is a collection of physical and emotional symptoms related to a woman's menstrual cycle. These symptoms occurring only during the luteal phase of the menstrual cycle that are of sufficient severity to interfere with some aspects of life of these women, reflecting also in interpersonal relationships, workplace and in their productivity. For these reasons, this research was conducted with the nursing staff of the Samaritan Hospital in order to verify the effectiveness of auricular acupuncture to alleviate some of the symptoms of PMS.

Detailed description: The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semipermanent needles in specific points of the auricular pavilion.

Eligibility criteria: Inclusion Criteria:

1. Belong to the nursing staff
2. Present at least one behavioral or physical symptom that is self-perceived as related to the symptoms that precede menstruation (irritability, depression, fatigue, headache, breast tenderness, swelling, anxiety, insomnia, crying spells, changes in appetite)
3. Voluntary participation in the study
4. Availability of time for submission to the sessions

Exclusion Criteria:

1. Medical license or vacation during the period of the research.
2. Pregnancy

Primary outcomes:
measure: Premenstrual syndrome symptoms
timeFrame: after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Samaritan Hospital
Study officials:
affiliation: São Paulo University
name: Leonice FS Kurebayashi, Ms
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Rafael FB Homo
role: STUDY_CHAIR
affiliation: Samaritan Hospital
name: Ana LL Giaponesi
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Maria JP Silva, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03633240: Emergency Room Visits and Older Patients (ER2)
Official title: Emergency Room Visits and Older Patients: Assessment of Jewish General Hospital Program Screening Frail Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Length of Stay
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 356
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They will be separated in four main groups:

1. Those without any PRISMA-7 and ER2.
2. Those with PRISMA-7 and without ER2.
3. Those with ER2 and without PRISMA-7.
4. Those with PRISMA-7 and ER2. Each group of participants with PRISMA-7 and ER2 will be divided in two subgroups: those with all items completed and a score, and those with incomplete tools.

Brief summary: Today's population is living longer than prior generations. Senior patients, defined as 65 years or older, are therefore increasing in number, and representing a larger number of hospitalized patients. Thus, assessing and addressing the needs of the growing number of older ER users is essential. The overall objective of the study is to examine the feasibility and the epidemiology of two screening tools ("Programme de Recherche sur l'Intégration des Services pour le Maintien de l'Autonomie" (PRISMA-7) and Emergency Room Evaluation and recommendations (ER2)) used in the Emergency Room of Jewish General Hospital to screen older patients (i.e.; ≥65 years) at risk of adverse health events. A prospective observational cohort design will be used for the study's two phases; phase 1- assessment and phase 2- assessment as well as recommendations.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years.
* Unplanned ER visits.

Exclusion Criteria:

* Death within the 24 hours of first visiting ER.
* Palliative care due to ER visit.

Primary outcomes:
measure: Feasibility of using both tools in the ER
timeFrame: 1 day
measure: Prevalence of tools filed
timeFrame: 1 day
Secondary outcomes:
measure: Feasibility of tools
timeFrame: 1 day
measure: Length of stay
timeFrame: 1 day
measure: Acute medical events
timeFrame: 1 day
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital - Lady Davis Institute
name: Olivier Beauchet
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beauchet O, Afilalo M, Allali G, Lubov J, Galery K, Launay CP. "Emergency Room Evaluation and Recommendations" and Incident Hospital Admissions in Older People with Major Neurocognitive Disorders Visiting Emergency Department: Results of an Experimental Study. Dement Geriatr Cogn Disord. 2022;51(3):291-296. doi: 10.1159/000524533. Epub 2022 May 12.
Clinical trial NCT04406740: Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
Official title: Clinical Evaluation of a Novel Neuromuscular Blockade Monitoring System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anesthesia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients \>18 years of age, who are scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated.

Brief summary: This study is designed to formally evaluate the performance of the QTOF, as compared with the newest commercially available NMB monitoring equipment, EMG (the TwitchView).

Detailed description: The disposable stimulus/recording electrode array for the TwitchView will be placed on one of the patient's wrist/hand and connected to the device. Next, the stimulating electrodes and vibration sensor of the QTOF device will be placed over the contralateral ulnar nerve and thenar eminence. The devices will be placed prior to the induction of anesthesia - but no electrical stimuli will be delivered until AFTER the patient is asleep (as per routine). After induction, both devices will be started. The TwitchView automatically selects the appropriate stimulus current (takes about 10 seconds) - and when that is complete, the QTOF stimulus current will be set to the same value. The stimulus interval for both devices will be 20 seconds. Paired measurements of twitch count and TOF ratios will be gathered for the entirety of the surgical procedure, and cross checked with Epic regarding the administration of neuromuscular blocking drugs (time, dose) and reversal agents (time, dose). RAs will be present to verify the correct function of both devices. Note that information from the TwitchView monitor will be continuous available to the providers (it is a standard device available for use in our ORs). Information from the QTOF will NOT be made available to providers.

Eligibility criteria: Inclusion Criteria:

- patients scheduled to undergo any elective procedure under general anesthesia in the MHealth East Bank operating rooms in which the administration of a nondepolarizing neuromuscular blocking drug (rocuronium or cisatracurium) is anticipated

Exclusion Criteria:

* Emergent procedures will be excluded
* Procedures performed outside of regular Monday to Friday working hours will be excluded
* Inability to provide their own consent

Primary outcomes:
measure: Train-of-Four (TOF) Ratio
timeFrame: 420 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: MHealth Farview University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael Todd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01791140: BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer
Official title: Program for Assessment of Activity and Safety of 1st-line Bevacizumab (Avastin) Therapy in Elderly Patients With Metastatic Colorectal Cancer (BEVERLY-C Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients (\</= 65 years of age) with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy

Brief summary: This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (\>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 65 years of age
* Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics
* Patients suitable for Avastin treatment as assessed by the treating physician

Exclusion Criteria:

* Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics

Primary outcomes:
measure: Median progression-free survival
timeFrame: approximately 3.5 years
Secondary outcomes:
measure: Overall response rate (complete response + partial response)
timeFrame: approximately 3.5 years
measure: Clinical benefit rate (complete response + partial response + stable disease)
timeFrame: approximately 3.5 years
measure: Metastasectomy rate
timeFrame: approximately 3.5 years
measure: Mean duration of Avastin treatment
timeFrame: approximately 3.5 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 3.5 years
measure: Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy
timeFrame: approximately 3.5 years
measure: Median progression-free survival according to age group (65-74 years; >/= 75 years)
timeFrame: approximately 3.5 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05399940: The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters
Official title: The Relationship Between Serum PSA Levels and WBC, Delta Neutrophil Index (DNI) and Other Hematological Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Infection
Prostate Disease
Prostate Cancer
Keywords: prostatit
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 250
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male patients with acute prostatitis were included in the study.

Brief summary: Purpose:

To find the correlation between hemogram parameters and Delta Neutrophil Index(DNI) and Serum PSA in patients presenting with the diagnosis of acute prostatitis.

Material-Metod: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.

Detailed description: Serum PSA levels and hemogram parameters of patients who came to the urology outpatient clinic in January 2018 and May 2022 and were diagnosed with prostatitis were collected retrospectively.

WBC, neutrophil, lymphocyte, neutrophil-lymphocyte ratio, delta neutrophil index (DNI), PLT, RDW, and MPV values were determined in the Hemogram Parameters. Serum Total PSA and Free PSA values of the patients were also checked. Urine culture, urinary ultrasound, and antibiotic therapy

Eligibility criteria: Inclusion Criteria:

Acute prostatitis Male

-

Exclusion Criteria:

Prostate cancer Chronic prostatitis Other Urinary infections,

-

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Basri Cakiroglu
Study officials:
References:
Clinical trial NCT00582504: Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
Official title: A Phase 2 Open-Label, Safety and Immunogenicity Study of a Single Dose of Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried, TC-83, NDBR-102, as Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Venezuelan Equine Encephalomyelitis
Keywords: Encephalitis,VEE
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2007-12-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* VEE PRNT80 \< 1:10 before immunization.
* (females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
* Actively enrolled in the SIP
* At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
* Up-to-date (within 1 year) physical examination/tests.
* Sign and date the approved informed consent.
* Willing to return for all follow-up visits.
* Agree to report adverse event (AE) up to 28 days after vaccination.

Exclusion Criteria:

* Over age of 65 years.
* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
* History of immunodeficiency or current treatment with immunosuppressive medication.
* (females) Currently breastfeeding.
* Confirmed human immunodeficiency virus (HIV) titer.
* Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (\> 125 mg/dL).
* Serious allergic reaction to guinea pigs/guinea pig products.
* Any known allergies to components of the vaccine.
* A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
* Administration of any vaccine within 28 days of TC-83.
* Any unresolved AEs resulting from a previous immunization.

Primary outcomes:
measure: Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
timeFrame: 21-35 days, 42-56 days, 12-15 months
measure: Number of adverse events.
timeFrame: 7 years
Secondary outcomes:
measure: Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20.
timeFrame: 7 years
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: U.S. Army Medical Research Institute of Infectious Diseases
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Ronald Reisler, MD
role: PRINCIPAL_INVESTIGATOR
References: