louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01527370: Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
Official title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Herpes Zoster
Shingles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.


Eligibility criteria: Inclusion Criteria:

* No fever on day of vaccination
* Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
* Underlying chronic illnesses must be stable

Exclusion Criteria:

* History of hypersensitivity reaction to any vaccine component
* Prior receipt of a varicella or zoster vaccine
* Prior history of herpes zoster
* Have recently had another vaccination
* Have recently received blood products other than autologous blood transfusion
* Pregnant or breast feeding
* Use of immunosuppressive therapy
* Known or suspected immune dysfunction
* Use of nontopical antiviral therapy with activity against herpesvirus

Primary outcomes:
measure: The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
timeFrame: Prevaccination up to 6 weeks postvaccination
measure: Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
timeFrame: Prevaccination up to 6 weeks postvaccination
measure: Number of Participants With Serious Adverse Events
timeFrame: Up to 42 days postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX) in Healthy Adults in India. J Assoc Physicians India. 2018 Jul;66(7):50-54.
Clinical trial NCT03374670: ZIMURA in Combination With Eylea in Patients With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)
Official title: A Phase 2A Open-Label Trial to Assess the Safety of ZIMURA™ (Anti-C5) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Idiopathic Polypoidal Choroidal Vasculopathy
Keywords: Zimura
ARC1905
Eylea
aflibercept
IPCV
avacincaptad pegol
complement factor C5 inhibitor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPCV
* Patients must have had 3 sequential Eylea injections within the previous 4 months

Exclusion Criteria:

* Intravitreal treatment in the study eye prior to screening, regardless of indication, except 3 prior injections of Eylea
* History or evidence of severe cardiac disease
* Any major surgical procedure within one month of trial entry
* Subjects with a clinically significant laboratory value
* Any treatment with an investigational agent in the past 60 days for any condition
* Women who are pregnant or nursing
* Known serious allergies to the fluorescein dye, ICG dye, iodine, povidone iodine, or to the components or formulation of either Zimura or Eylea

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
Study officials:
References:
Clinical trial NCT04951570: Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial Intelligence
Official title: Clinical Diagnosis and Treatment of Intracerebral Hemorrhage Based on Artificial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
Hematoma Expansion
Artificial Intelligence
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 1374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with sICH that arrived at hospital within 24 hours.

Brief summary: The purpose of this study is to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.

Detailed description: This is a investigator-initiated, multi-center, prospective, registered cohort study. The study is intended to enroll 4000 patients with intracerebral hemorrhage from 50 hospital in China. Clinical and imaging data, as well as the results of laboratory examination will be collected to test the reliability and validity of an artificial intelligence system and a related 5-score scale to predict hematoma expansion, and conduct a study cohort of intracerebral hemorrhage to screen out imaging and biological markers that could predict hematoma expansion in real-world.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)
2. Age ≥18;
3. Admission within 24 hours of symptom onset
4. CT available at 24 hours
5. Informed consent obtained

Exclusion Criteria:

1. Intracerebral hemorrhage caused by tumor, vascular malformation, aneurysm, etc.
2. Deep coma at admission (GCS≤8)
3. Intended to have a surgery within 24 hours
4. Congenital coagulation dysfunction
5. Previous intracerebral hematoma have not been absorbed

Primary outcomes:
measure: hematoma expansion
timeFrame: 24-48 hours from symptom onset
measure: Recurrence of intracerebral hemorrhage
timeFrame: 90 days from symptom onset
measure: Functional dependence
timeFrame: 3 months
measure: Cerebrovascular death
timeFrame: 3 months
measure: Cardiovascular death
timeFrame: 3 months
Secondary outcomes:
measure: New ischemic stroke
timeFrame: 3 months
measure: New subarachnoid hemorrhage
timeFrame: 3 months
measure: Other cardiovascular events
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References:
Clinical trial NCT06024070: Effect of Rigid Tapping on Chronic Functional Ankle Instability in Basketball Players
Official title: Effect of Rigid Tapping on Chronic Functional Ankle Instability in Basketball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Inversion Sprain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre post study design
Primary purpose: TREATMENT

Brief summary: This study aims rigid tapping on chronic functional ankle instability in professional basketball players.

Detailed description: Lateral ankle sprains (LASs) are common injuries in sports and physical activities, with up to 40% of individuals experiencing a first-time LAS developing chronic ankle instability (CAI). LASs predominantly affect the anterior talofibular ligament, and residual symptoms can persist in a significant percentage of patients. However, many individuals with ankle sprains do not seek professional treatment, leading to potential underestimation of the injury severity. CAI is characterized by recurrent episodes of ankle giving way, ongoing symptoms, reduced ankle range of motion, diminished self-reported function, and persistent ankle sprains beyond one year. It is attributed to both mechanical and functional instability, with factors such as proprioceptive deficits and mechanical insufficiencies contributing to the condition. Taping, particularly rigid taping, is commonly used by athletes to enhance joint stability and improve dynamic balance and functional performance. Rigid taping limits joint movement, improves joint position, and provides external support without compromising functional performance. Taping is especially prevalent in multidirectional sports like basketball, where ankle sprains are frequent. The use of tapes aims to restrict ankle movement, increase joint stability, and enhance proprioception without hindering athletic performance.

Eligibility criteria: Inclusion Criteria:

* Basketball players with age range from 18-40 years old.
* Body mass index (BMI) range from 18-25 H/m2.
* Participants had episodes of subjective sensation of instability in the last six months.
* Participants have at least moderate ankle instability, defined as a score of \<25 on the Cumberland Ankle Instability Tool (CAIT).

Exclusion Criteria:

* Participants had a history of surgery or fractures in the ankle joints.
* Participants had a neurological or vestibular disorder.
* Participants were unable to understand the nature of the protocol and test instructions.

Primary outcomes:
measure: Ankle Stability
timeFrame: 3 days
measure: functional performance
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
affiliation: Cairo University
name: Salwa Fa Abdel-Majeed, phd
role: STUDY_CHAIR
References:
Clinical trial NCT05117970: Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms
Official title: Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Systolic Dysfunction (Disorder)
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 13631
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* Patients with EF\>50% or without Transesophageal Echocardiography (TEE)

Exclusion Criteria:

* Patients with a history of heart failure or an EF\<= 35%.

Primary outcomes:
measure: New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)
timeFrame: Within 30 days
Secondary outcomes:
measure: All cause mortality(death)
timeFrame: Within 30 days
measure: Completion of an echocardiogram
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Defense Medical Center
Study officials:
References:
Clinical trial NCT05468970: Study on Clinical Features, Treatment Mode and Survival of Bone and Soft Tissue Tumors
Official title: Single-center Real World Prospective Observational Study of Clinical Features, Treatment Patterns, and Survival of Bone and Soft Tissue Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone and Soft Tissue Tumors
Clinical Features
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-21
Enrollment: 6000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bone and soft tissue tumors receiving inpatient treatment in Henan Tumor Hospital.

Brief summary: It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor.

Detailed description: It is planned to prospectively collect, collate and report real-world clinical data of BSTS patients treated in our hospital in the next ten years to evaluate the changes in clinical characteristics, treatment patterns and survival information of these patients, in order to provide reference for clinical treatment and research of this type of tumor. This study is a single-center, prospective, real-world observational study that plans to enroll all eligible patients. Basic information, treatment methods, and prognostic information of these patients were collected.

Eligibility criteria: Inclusion Criteria:

All ages, male and female.

The pathological diagnosis of BSTS in our hospital was a subtype.

Has received at least one hospitalization in this hospital.

The target lesions could be evaluated according to the efficacy evaluation criteria of solid tumor (RECIST; Version 1.1) Measure diameter changes.

Exclusion Criteria:

No definite pathology.

Primary outcomes:
measure: Overall survival
timeFrame: Up to approximately 120months
measure: 6/5000 Progression-free survival
timeFrame: Up to approximately 48months
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Bone and Soft Tissue ,Henan Cancer Hospital
state: Henan
Study officials:
References:
Clinical trial NCT04347070: Implementation of Physiotherapy on COVID-19 Patients in ICU
Official title: Implementation of Physiotherapy on COVID-19 Patients in Intensive Care Units : a Retrospective, Multicentric, International Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sars-CoV2
COVID-19
Keywords: COVID-19
Physiotherapy
implementation
critical care
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Société espagnole de pneumologie (SEPAR)
name: Societe française de kinésithérapie en réanimation (SKR)
First posted: 2020-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted in ICU with COVID-19 will be eligible

Brief summary: Despite new charachersitics of COVID-19 patients, critical care implementation seems to be similar to those with Acute Respiratory Distress Syndrome (ARDS) in intensive care units (ICU).

Regarding the initial gravity of these patients, sedation and neuromuscular blockers are usually administrated, increasing the risk to develope an ICU-acquired weakness which is directly correlated to morbi-mortality and a burden during recovery.

Respiratory symptoms are mostly related to dyspnoea and non-productive cough, with only 33% of COVID-19 patient having a bronchial hypersecretion ; consequently, chest physiotherapy is only implemented in after case-by-case evaluation.

This unprecedented situation requires to identify how physiotherapy is being implemented in COVID-19 patients in ICU.

This retrospective, multicentric study aims to identify the charactheristics of physiotherapy (type and time spent) implemented in Argentina, Belgium, Chili, France, Italy and Spain

Detailed description: * Demographics data : hospitalisation date, ICU date, COVID+ date, extubation date, discharge date, mortality
* ICU data : ventilatory mode, type of physiotherapy implemented (early rehabilitation, chest physiotherapy, time spent (minutes), number of interventions per day.

Eligibility criteria: Inclusion criteria:

* Age \> 18 years
* Patient admitted in ICU
* Patient with COVID-19 diagnosis

Exclusion criteria:

- Explicite denie to participate in the study

Primary outcomes:
measure: Time of physiotherapy
timeFrame: 1 day
measure: Time of physiotherapy
timeFrame: 3 day
measure: Time of physiotherapy
timeFrame: 7 day
Secondary outcomes:
measure: Type of physiotherapy implemented
timeFrame: 1 day
measure: Type of physiotherapy implemented
timeFrame: 3 day
measure: Type of physiotherapy implemented
timeFrame: 7 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Roberto Martinez-Alejos, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05409170: The Change of Clinical Features and Surgical Outcomes in Patients With Pressure Injury During the COVID-19 Pandemic: A Retrospective Study
Official title: Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Injury
COVID-19
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 213
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the January 2016-December 2019 and January 2020-December 2021 intervals were defined as pre-COVID and COVID periods, respectively.

Brief summary: The COVID-19 pandemic has considerably and negatively affected numerous lives and economies worldwide; specifically, it has led to delays in seeking medical treatment among many people \[1-3\]. Delaying or avoiding seeking medical advice can result in worsened symptoms, delayed evaluation, and treatment complications \[4-7\]. Moreover, the pandemic has significantly impacted health-care systems, leading to numerous issues including shortages of medical staff, beds, equipment, medicines, and isolation facilities. The concern of cross-contamination-where COVID-19 may spread within wards unknowingly-has also increased the emotional burden among health-care workers \[8-10\].

Pressure injury (PI) is a common health issue particularly among older people who have physical limitations or are bedridden. PI management often requires a long-term individualized plan. Failure to implement this strategy may influence the quality of life and may cause wound-related psychosocial issues (e.g., low self-esteem), increase health-care expenditures, and shorten survival among the patients \[11\]. Moreover, long-term PIs are prone to infection and bleeding, which may lead to sepsis or anemia \[12-14\].

The current study explored whether COVID-19 pandemic-related changes affected the characteristics and treatment outcomes of patients with PIs.


Eligibility criteria: Inclusion Criteria:

* all patients who received debridement or flap-reconstruction surgery for Pressure injury at Wan Fang Hospital from January 2016 to December 2021.

Exclusion Criteria:

* Patients who underwent debridement or flap-reconstruction surgery across the pre-COVID and COVID periods were excluded from the study.

Primary outcomes:
measure: flap surgery outcomes
timeFrame: from January 2016 to December 2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04509999: Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Official title: Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for study participation:

* Men ≥ 36 years old diagnosed with at least one temperature elevation ≥ 100.4 F., OR new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay
* Men ≥ 18 years but \< 36 years old must exhibit EITHER new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay.
* Access to working telephone or other form of communication such as email.
* Randomization within 7 days of COVID-positive study result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a positive test is required to stay on study
* Written informed consent obtained from the subject and the subject agrees to comply with all study-related procedures

Exclusion Criteria:

Subjects with any of the following will not be eligible for study participation:

* Randomization greater than 7 days from a positive COVID test result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a negative test will result in a screen-fail and removal from study
* Admission to hospital at time of screening
* Inclusion in another randomized trial for COVID therapy
* Diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months
* Current treatment with any androgen replacement products
* Prior allergic reaction or intolerance to Bicalutamide or other Androgen receptor Inhibitors
* Requirement for coumarin product or warfarin products due to potential displacement by bicalutamide
* Subject unable to take oral bicalutamide
* Known Hepatitis B or C
* Liver Cirrhosis
* AST/ALT greater than or equal to 3 X institutional ULN

Primary outcomes:
measure: Proportion x 100 = percent of patients with improved COVID-19 symptoms
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Frederic Kaye, MD
role: PRINCIPAL_INVESTIGATOR
References: