louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05226533: Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
Official title: A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and efficacy of DWRX2003 combination with Remdesivir in moderate to severe COVID-19 patients will be confirmed.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at time of signing the Informed Consent Form (ICF).
* SARS-CoV-2 infection documented by RT-PCR within 7 days prior to randomization.
* Hospitalized patients who meet the criteria of moderate or severe COVID-19.
* Patients who are not pregnant, based on urine pregnancy test during screening, and randomization.
* Female patients of childbearing potential practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment.
* Male patient and/or Female patient's partner agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment.
* Patients who are anticipated to available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff.
* Patients who agree to give written informed consent and are willing to participate in the study.

Exclusion Criteria:

* Patients with BMI ≥30 and/or body weight \< 40kg
* Patients receiving or who have received antiviral therapy and antiretroviral therapy within 28 days prior to the screening visit.
* Patients who cannot be administered intramuscularly to bilateral ventro-gluteal area.
* Patients with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. COPD, asthma, cystic fibrosis, etc.)
* Patients who have active malignancy, history of active malignancy or chemotherapy within 1 year from the screening.

Primary outcomes:
measure: The proportion of subjects requiring mechanical ventilation and invasive mechanical ventilation or extra-corporeal membrane oxygenation (ECMO) till day 14.
timeFrame: day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: RSUP Fatmawati
state: DKI Jakarta
city: Jakarta
country: Indonesia
facility: RSUPN Cipto Mangunkusumo
state: DKI Jakarta
city: Bandung
country: Indonesia
facility: RS. Hasan Sadikin
state: Jawa Barat
Study officials:
References:
Clinical trial NCT02107833: Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers
Official title: A Phase 1, Randomized, Parallel-Design, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Human Volunteer
Lead sponsor: Protalix
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: : This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106 doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein. Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days. Subjects will remain at the clinical center for 24 hours after the first administration (Day 1) of OPRX-106 including PK sampling and then return to the site daily for additional administrations and study procedures.


Eligibility criteria: Inclusion Criteria:

* Healthy male age 18-45
* Body mass index (BMI) 18-30 kg/m2
* Male subjects or their partners must use an adequate method of contraception at all times during the study.
* Negative laboratory tests for HIV, HBcAb and HCV at the screening visit
* Naïve to any previous recombinant protein therapy
* Provide written informed consent
* Have the ability to understand the requirements of the study and to comply with the study protocol and dosing regimen

Exclusion Criteria:

* Clinical evidence of any active significant disease that could potentially compromise the ability of the Investigator to evaluate or interpret the effects of the study treatment on safety assessment, thus increasing the risk to the subject to unacceptable levels
* Presence of any acute or chronic diseases
* History of any allergies or protein-drug hypersensitivity
* Exposure to long-term steroid treatment within the last 12 months prior to the study
* Subject had a major operation in last 6 months
* Subject has received immunosuppressive treatment prior to the study
* Chronic use of any medication including vitamins
* Participation in another clinical trial during the previous 3 months (subject report)
* Reported history of alcohol or drug abuse
* Subjects with short bowel (more than 1 m removed of small bowel).

Primary outcomes:
measure: Adverse Events
timeFrame: 5 days
Secondary outcomes:
measure: Area under the curve
timeFrame: 24 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Protalix Ltd.
name: Einat Almon, PdH
role: STUDY_DIRECTOR
References:
Clinical trial NCT02521233: Efficacy and Safety of Candesartan Associated With Chlorthalidone in Essential Arterial Hypertension Control
Official title: Efficacy and Safety Evaluation of the New Association on Fixed Dose of Candesartan + Chlorthalidone, Produced by EMS S.A,in Arterial Hypertension Control
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Essential Arterial Hypertension
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2015-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who have never been treated and have indication for drug combination treatment.

Obs: The diagnosis may be established by previous evaluation of two blood pressure measures ≥ 140/90 mmHg, with two months difference between measurements

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL /min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria in urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactating patients;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Efficacy of essential hypertension control based on proportion of participants who achieve the therapeutic goal
timeFrame: 60 days
Secondary outcomes:
measure: Safety will be evaluated by the occurrences of adverse events.
timeFrame: 9 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06215833: Recovery of TIVA vs Inhalation in Pediatric Anesthesia
Official title: Comparison of Emergence and Recovery Profile After Total Intravenous Anesthesia ( TIVA ) Vs Inhalational Anesthesia in Opioid Free Pediatric Tonsillectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Best Technique for Pediatric Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children planned for ambulatory tonsillectomy from primary care clinic

Brief summary: Compare recovery profile from TIVA and that of total inhalational anesthesia in ambulatory pediatric tonsillectomy and which strategy is more safe and less cost and more smooth in pediatric anesthesia.

Detailed description: Complications in pediatric anesthesia can happen even in our modern hospitals with the most advanced equipment and skilled anesthesiologists.

Typical complications in pediatric anesthesia are respiratory problems , medication errors , difficulties with intravenous puncture , and pulmonal aspiration. In postoperative setting , nausea and vomiting , pain , emergence delirium can be mentioned as typical complications.

The choice of anesthetic agent and techniques can influence the occurrence of these complications and thus delay in discharge.

Eligibility criteria: Inclusion Criteria:

* child between 4 to 10 years
* without co morbidity
* ASA score 1
* mallampati score 1 and 2

Exclusion Criteria:

* child below 4 years and above 10 years
* child with co morbidity
* ASA score above 1
* mallampati score 3 and 4

Primary outcomes:
measure: level of consciousness score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
measure: physical activity score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
measure: hemodynamic stability score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
measure: respiratory stability score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
measure: Oxygen saturation score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
measure: post operative pain score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
measure: post operative emetic score
timeFrame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00443833: Genetic Analysis of Thyrotoxic Periodic Paralysis
Official title: Genetic Analysis of Thai Patients With Thyrotoxic Periodic Paralysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyrotoxic Periodic Paralysis
Keywords: Thyrotoxicosis
genetic association study
periodic paralysis
whole genome scan
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2007-03-06
Enrollment: 80
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Thyrotoxic periodic paralysis (TPP) is characterized by episodes of reversible hypokalemia and weakness in thyrotoxic patients. It is commonly found in males of Asian descent and is also seen in individuals having Native American or Hispanic ancestry. Therefore genetic etiology has been hypothesized. This study, we aim to find the susceptibility genes that associate with TPP. Both candidate genes approach and genome wide association study have been conducted.

Detailed description: This study is a genetic association study. It included 50 cases of TPP patients and 80 cases of male, hyperthyroid patients who didn't have hypokalemia as a well characterized controls. After informed consent were obtained, genomic DNA from leukocyte were extracted. Pooled DNA were constructed and whole genome scan using 10K GeneChip microarray were genotyped on pooled genomic DNA.

Eligibility criteria: Inclusion Criteria:

TPP

* Hyperthyroid patients from any causes
* Evidence of hypokalemia (k\<3.5 mg/dl)from intracellular shift (Urine K\<15 mg/dl, TTKG\<2)
* Episodic paralysis

Exclusion Criteria:

* Hypokalemia from GI or renal loss

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Endocrinology Unit, Ramathibodi Hospital, Mahidol University
name: Wallaya Jongjaroenprasert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625933: The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
Official title: The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Change, Body
Stroke
Keywords: Body Mass Index
Stroke Rehabilitation
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient admitted to Tan Tock Seng Tertiary Rehabilitation Centre and fulfilled the inclusion criteria within the study period will be consented to the study.

Brief summary: Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes. Some data demonstrating that gains are often more rapid at BMI above "normal". The aim of this study is to investigate the association between BMI and the functional progress of all patients admitted to Tan Tock Seng Tertiary Rehabilitation Center.


Eligibility criteria: Inclusion Criteria:

* clinical strokes (ischaemic or haemorrhagic) diagnosed by acute neurologists or neurosurgeons and confirmed on computerized tomography (CT) or Magnetic resonance imaging (MRI) brain imaging
* aged 18 years and above
* admitted directly from acute stroke units
* able to provide informed consent by self or by next of kin in incompetence patient
* must receive physical therapy (either physiotherapy, occupational therapy or speech therapy) at least 5 times a week with each session at least 30 minutes

Exclusion Criteria:

* rehabilitation was not the primary reason for the inpatient admission
* failure to complete the rehabilitation program due to either an acute transfer off rehabilitation or a discharge against medical advice
* incomplete or missing Body Mass Index (BMI) or Functional Independence Measure (FIM) data
* patients who were not of Asian ethnicity

Primary outcomes:
measure: Functional Independence Measure (FIM) on Admission
timeFrame: Functional Independence Measure (FIM) was measured within 72 hours of admission
measure: Functional Independence Measure (FIM) on Discharge
timeFrame: Functional Independence Measure (FIM) was measured within 72 hours of discharge.
Secondary outcomes:
measure: Mean Functional Independence Measure (FIM) Gain
timeFrame: Within 72 hours
measure: Mean Functional Independence Measure (FIM) efficiency
timeFrame: Through study completion, an average of 1 year
measure: Mean Functional Independence Measure (FIM) effectiveness
timeFrame: Within 72 hours
measure: Body Mass Index (BMI)
timeFrame: Within 72 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: SZE CHIN JONG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05554133: Precision Optical Guidance for Oral Biopsy
Official title: Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Lesions
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2022-09-26
Enrollment: 90
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: To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.

Detailed description: Primary objective:

-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.

Secondary objective:

-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).

Eligibility criteria: Inclusion Criteria:

1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.
2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).

Exclusion Criteria:

1. Known allergy to proflavine or acriflavine.
2. Age less than 18 years.
3. Pregnant or nursing females.
4. Adults unable to consent
5. Prisoners and other vulnerable populations

Primary outcomes:
measure: To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology
timeFrame: Through study completion an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson Caner Center
name: Ann Gillenwater, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06812533: Alleviant ALLAY-HFrEF Study
Official title: Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Lead sponsor: Alleviant Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.


Eligibility criteria: Inclusion Criteria:

* LVEF ≤ 40%
* NYHA class II, III or ambulatory IV HF
* Receiving optimal, maximally tolerated, stable GDMT

Exclusion Criteria:

* Advanced heart failure
* Life-expectancy \< 12 months
* Evidence of right heart dysfunction

Primary outcomes:
measure: Composite Primary Endpoint
timeFrame: 12-Month
Secondary outcomes:
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Ascension Sacred Heart
state: Florida
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Abilene
country: United States
facility: Hendrick Health
state: Texas
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Gregg Stone
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: James Udelson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06223633: PK Papyrus Covered Coronary Stent System
Official title: PK Papyrus Covered Coronary Stent System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Disease
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.

Detailed description: The FDA has approved the PK Papyrus Covered Coronary Stent System for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a Humanitarian Device Exemption (HDE #H170004). Methodist Dallas Medical Center will use this device for treating the above-described patient population.

Eligibility criteria: Inclusion Criteria:

* Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter

Exclusion Criteria:

* Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
* Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
* Lesions that cannot be reached or treated with the system.
* Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
* Risk of treatment-related occlusion of vital coronary artery side branches.
* Uncorrected bleeding disorders.
* Allergy to contrast media.

Primary outcomes:
measure: Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
timeFrame: Up to 10 years
measure: Number of patients with the device
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Luis Bowen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: