louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05675033: Serplulimab Combined With Anti-VEGF Antibody in Advanced Lung Adenocarcinoma
Official title: Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Adenocarcinoma
Stage IV Non-small Cell Lung Cancer
PD-1 Inhibitor
VEGF
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.


Eligibility criteria: Inclusion Criteria:

* Fully understood this study and voluntarily signed the informed consent form (ICF);

  -≥ 18 years and ≤ 75 years old;
* ECOG score 0-1;
* Non-squamous NSCLC;
* stage IV;
* EGFR and ALK negative;
* Treatment-naive;
* According to RECIST1.1 criteria, there are measurable or evaluable lesions.

Exclusion Criteria:

* Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
* Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
* The estimated survival time is less than 3 months.

Primary outcomes:
measure: PFS
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
measure: ORR
timeFrame: up to 12 months
measure: DCR
timeFrame: up to 12 months
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01885533: Post-Radioiodine Graves' Management: The PRAGMA-Study
Official title: POST-RADIOIODINE GRAVES' MANAGEMENT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves' Disease
Keywords: Graves' disease
radioiodine
thyroid
hypothyroidism
Graves' orbitopathy
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Cardiff and Vale University Health Board
name: Royal Devon and Exeter NHS Foundation Trust
First posted: 2013-06-25
Enrollment: 803
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: Adult patients with a history of Graves' disease treated with radioiodine

Brief summary: Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Out-patients 18 years of age or over, who have given written informed consent to participate in the study
* Diagnosed with Graves' disease
* Received radioiodine for treatment of Graves' disease
* Had a minimum of 12 months follow-up after RI
* Most recent RI dose 5 years ago or less at the time of enrollment

Exclusion Criteria:

* Patients unable to give informed consent
* Age 17 years or younger
* Cause of thyrotoxicosis other than Graves' disease
* Patients who have had more than one dose of radioiodine can only be included in the study once, using data pertaining to their most recent treatment episode.
* Patients who might not adequately understand verbal explanations or written information given in English, or who have special communication needs

Primary outcomes:
measure: Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK
timeFrame: 12 months post radio-iodine
Secondary outcomes:
measure: Graves orbitopathy
timeFrame: 12 months post-radiodiodine
measure: weight gain
timeFrame: 12 months
measure: progression of Graves' orbitopathy
timeFrame: 12 months
measure: patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
state: England
city: Newcastle upon Tyne
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT01125033: Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
Official title: Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Restless Legs Syndrome
Kidney Failure, Chronic
Keywords: Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.

Detailed description: RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
* Patients who are stable on HD without any internment illness or admission

Exclusion Criteria:

* Patients who have renal stone
* Patients who receive medications with RLS aggravating or alleviating properties

Primary outcomes:
measure: Absolute Change in IRLS Sum Score
timeFrame: 8 Weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Hamideh Akbari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Mohammad Mahdi Sagheb, MD
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Sahar Sohrabi Nazari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Mohammad Kazem Fallahzadeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05587933: Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?
Official title: Ejection Fraction of Normal Gall Bladder on Ultrasonography in Patients With Biliary Colic: Is it a Predictor of Cholecystectomy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gall Bladder Pain
Hepatobiliary Iminodiacetic Acid
Acalculous Cholecystitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study investigators aim to evaluate gallbladder ejection fraction as a predictor for cholecystectomy.

Detailed description: The flow of bile through the biliary system is a complex process that depends on the hormonal environment, digestive phase, and functional response of the gallbladder and sphincter of Oddi to all of these factors. Biliary dyskinesia is a disorder of some component of biliary part of the digestive system in which bile cannot physically flow in the proper direction through the tubular biliary tract which causes biliary colic as defined by Rome IV criteria.

Functional causes of biliary pain, also referred to as biliary dyskinesia, are biliary hypokinesia , biliary hyperkinesia and sphincter of Oddi dysfunction (SOD). The exact pathology of functional biliary colic is still unknown. Reviewing Literature status, There is still some debate about the best method to establish the diagnosis gallbladder dyskinesia and hyperkinesia and whether or not ejection fraction is an accurate predictor of outcome. Which led to difficult.

Biliary dyskinesia is identified through gallbladder ejection fraction (GBEF), which is calculated as the flow of radioactive tracer that is ejected from the gallbladder. A GBEF of \<35% is considered dyskinesia and a GBEF of \<35% is considered hyperkinesia. Patients considered for CCK-HIDA (cholecystokinin hepatobiliary iminodiacetic acid) are those presenting with functional biliary pain based on the Rome IV criteria. Those who present with atypical pain may not need as HIDA (hepatobiliary iminodiacetic acid) as the presentation may be from other pathology.

Eligibility criteria: Inclusion Criteria:

* Patients older than 14 years of age
* food-related abdominal pain
* normal gallbladder ultrasound (US)
* GB EF 80% and greater or 35% and less on HIDA scan with CCK injection

Exclusion Criteria:

* Patients younger than 14 years old
* Patients with the positive US defined as the presence of gallstones, gallbladder wall thickening (\> 4 mm), pericholecystic fluid, sludge, or polyps
* Normal GB EF

Primary outcomes:
measure: Rate of quality of life improvment after cholecystectomy according to ROME IV criteria
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01651533: Mental Practice in Chronic, Stroke Induced Hemiparesis
Official title: Mental Practice in Chronic, Stroke-Induced Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis
Keywords: Mental practice group
Active control group
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the leading cause of disability in the United States, producing motor impairments that compromise performance of valued activities. Hemiparesis (or weakness in one arm) is particularly disabling, is the primary impairment underlying stroke-related disability, and the most frequent impairment treated by therapists in the United States. This study will test efficacy of a promising technique in reducing arm disability and increasing function, thereby improving outcomes and health, reducing care costs, for community dwelling patients with stroke-induced hemiparesis.


Eligibility criteria: Inclusion Criteria:

* a Fugl-Meyer score \> 27, which is indicative of minimal to moderate arm impairment;
* stroke experienced \> 6 months prior to study enrollment;
* minimal cognitive impairment, a score \> 25 on the Folstein Mini Mental Status Examination (MMSE);
* age \> 21 years old and \< 80 years old;
* have experienced one clinical stroke as verified by a physician;
* discharged from all forms of physical rehabilitation targeting the affected arm.

Exclusion Criteria:

* \< 21 years old;
* excessive pain in the affected hand, arm or shoulder, as measured by a score \> 5 on a 10-point visual analog scale;
* excessive spasticity in the affected biceps, triceps, wrist, or fingers, as defined as a score of greater than or equal to 2 on the Modified Ashworth Spasticity Scale;
* currently participating in any experimental rehabilitation or drug studies targeting UE;
* mirrors movements(i.e., involuntary movements by the unaffected hand during attempts at unilateral movement by the stroke-affected hand during attempts at unilateral movement by the stroke-affected hand);
* history of parietal stroke (because some data suggest that ability to estimate manual motor performance through mental imagery is disturbed after parietal lobe damage);
* affected arm joint restriction that in the opinion of the investigator would hinder study participation

Primary outcomes:
measure: Change in movement in the affected fingers and wrist as measured by the Action Research Arm Test
timeFrame: 2-3 weeks before intervention; 1 week after intervention; 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Metrohealth
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Stephen Page, PhD,M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05013333: AED 3 Post-Approval Study
Official title: Post-Approval Study for AED 3 With Uni-padz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest, Out-Of-Hospital
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-19
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.


Eligibility criteria: Inclusion Criteria:

* Suspected out-of-hospital cardiac arrest
* Use of ZOLL AED 3 public-access defibrillator (running software v.1.03.602 or newer (US) or v. 6.03.006 or newer(OUS)) with Uni-padz III
* Unconsciousness
* Absence of breathing
* Absence of pulse and other signs of circulation

Exclusion Criteria:

* Pre-existing Do Not Attempt Resuscitation (DNAR) orders
* No evidence of cardiac arrest

Primary outcomes:
measure: CPR sensor placement
timeFrame: Procedure (At time of device placement)
measure: Selection of adult or pediatric mode
timeFrame: Procedure (At time of device placement)
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Latham
country: United States
facility: Colonie EMS
state: New York
Study officials:
References:
Clinical trial NCT05607433: Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation
Official title: Air Q Intubating Laryngeal Airway (Air QILA) Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation Assisted by Tube Exchanger, a Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Difficult Intubation
Keywords: assisted intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized comparative study
Primary purpose: OTHER

Brief summary: The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.

Detailed description: Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA .

the hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.

Eligibility criteria: Inclusion Criteria:

* Age : 18 to 60
* ASA physical status 1 and 2
* body weight less than 90 kilos
* Ganzouri airway score less than or equal to 3.

Exclusion Criteria:

* Active respiratory or cardiac disease
* Any expected airway difficulties
* Craniofacial abnormalities or fractures
* patients with abnormal coagulation profile

Primary outcomes:
measure: Total endotracheal intubation time
timeFrame: time of tube exchanger insertion and endotracheal tube insertion
Secondary outcomes:
measure: success rate of endotracheal intubation
timeFrame: 1 second after insertion tube exchanger until successful endotracheal intubation
measure: Tube exchanger insertion time
timeFrame: from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea
Other outcomes:
measure: postoperative hoarseness of voice
timeFrame: 2 hours postoperative
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Hospital
state: Elmanial
Study officials:
References:
citation: Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
citation: Bakker EJ, Valkenburg M, Galvin EM. Pilot study of the air-Q intubating laryngeal airway in clinical use. Anaesth Intensive Care. 2010 Mar;38(2):346-8. doi: 10.1177/0310057X1003800217.
Clinical trial NCT03111433: Efficacy of Coenzyme q10 in Pediatrics With Type 1 Diabetes Mellitus
Official title: Effect of Coenzyme Q10 on Markers of Endothelial Dysfunction in Pediatric Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes mellitus
Coenzyme Q10
endothelial dysfunction
pediatric patients
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 49
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine wether coenzyme Q10 is effective in reducing markers of endothelial dysfunction in pediatric patients with type 1 diabetes mellitus and aslo to investigate its effect on glycemic control and lipid profile of those patients and its effect on patient's quality of life.


Eligibility criteria: Inclusion Criteria:

1. Age: patients from 8 to 18 years old.
2. Outpatient with at least 1 year history of type 1 diabetes mellitus.
3. Insulin requirement of more than or equal 0.5 U/Kg/day.
4. Approval to participate and give informed consent.

Exclusion Criteria:

1. Presence of systemic disorders such as celiac disease, hypothyroidism or hyperthyroidism.
2. Preexisting cardiovascular disease or hypertension.
3. Chronic kidney disease or chronic liver disease.
4. Significant mental illness.
5. Intake of other antioxidants such as ascorbic acid and α-tocopherol and omega3 supplement within the last 3 months.
6. Intake of coenzyme Q10 within the last 3 months.

Primary outcomes:
measure: change in soluble interacellular adhesion molecule level
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams university pediatric's hospital
Study officials:
References:
Clinical trial NCT02067533: Flexion Versus Extension Soft Tissue Repair in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty(TKA)
Total Knee Replacement
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of the present study is to determine the influence of position of soft tissue repair (flexion versus extension) in post operative range of motion(ROM) and functional outcome in patients who underwent primary total knee arthroplasty (TKA).


Eligibility criteria: Inclusion Criteria:

* were individuals with osteoarthritis indicated for primary Total Knee Arthroplasty

Exclusion Criteria:

* previous fracture in thigh
* previous fracture in leg
* previous high tibial osteotomy

Primary outcomes:
measure: Knee Range of Motion (ROM)
timeFrame: 1 year after total knee arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Study officials:
References: