louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05125354: A Retrospective Analysis to Evaluate Long Term Outcomes of SCC Patients Previously Treated With Alpha DaRT
Official title: A Retrospective Analysis to Evaluate Long Term Outcomes of Squamous Cell Carcinoma Patients Previously Treated With Alpha Diffusing Alpha-emitters Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma
DaRT Treated Patients
Keywords: Squamous Cell Carcinoma
Alpha Radiation
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2021-11-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The medical records of patients previously treated with Alpha DaRT as part of the completed clinical trial "CTP-SCC-00" will be accessed to follow up with their status, if available.

Brief summary: Evaluation of long-term efficacy outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response.

Detailed description: Medical records of patients that previously underwent the Alpha DaRT treatment will be reviewed by an authorized staff member.

Evaluation of long-term outcomes of patients previously treated with the Alpha DaRT seeds for management of their malignancy following initial response. These outcomes include:

* Safety - assessment of late onset of Alpha DaRT related AE in patients treated with the Alpha DaRT seeds
* Efficacy -

  * assessment of local recurrence rates in patients who achieved initial complete response (CR) following the Alpha DaRT treatment
  * assessment of duration of response in patients who achieved initial CR following the Alpha DaRT treatment
  * assessment of survival status in patients treated with the Alpha DaRT seeds

Eligibility criteria: Inclusion Criteria:

* Patients previously treated with the Alpha DaRT seeds for management of either skin or oral cavity SCC
* Available information in medical charts and records (electronic or paper)

Exclusion Criteria:

None.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 60 months following DaRT insertion
measure: Adverse Events (AE)
timeFrame: Up to 60 months following DaRT insertion
Secondary outcomes:
measure: Duration of Response
timeFrame: Up to 60 months following DaRT insertion
measure: Overall Survival (OS)
timeFrame: Up to 60 months following DaRT insertion
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Davidof Cancer Institution at the Rabin Medical Center Israel
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Study officials:
affiliation: Davidof Cancer Institution at Rabin Medical Center Israel
name: Noga Kurman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05160454: NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
Official title: NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Moyamoya
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: patients and controls
Primary purpose: OTHER

Brief summary: Near infrared spectroscpy is a validated method of evaluating cerebral blood flow. The aim in this pilot study to explore its use in children with moyamoya disease.

Detailed description: Moyamoya disease is a cerebrovascular condition in which there is chronic brain hypoperfusion. As surgery can possibly augment brain blood flow, a method for evalutaing cerebrovascualr reserve would be helpful in selecting patients for intervention.

Near infrared spectroscopy (NIRS) is a validated non-invasive method of evaluating cerebral blood flow. We aim to investigate the feasibility and tolerability of using NIRS haemodynamic reserve in children with moyamoya and controls by evaluating cerebral blood flow in the baseline state and after breath-holding.

Feasibility will be assessed by how many successful studies are carried out. Tolerability will be assessed by asking children some simple questions about their experience.

Eligibility criteria: Inclusion Criteria: Patients with moyamoya and unaffected healthy controls -

Exclusion Criteria: age \<6

-

Primary outcomes:
measure: Number of NIRS studies that can be completed in moyamoya patients
timeFrame: 2years
Secondary outcomes:
measure: Patient questionnaire to evaluate children's experience of NIRS in moyamoya
timeFrame: 2years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
Study officials:
References:
Clinical trial NCT02646254: Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique
Official title: MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Protection in TOF Repair
Keywords: tetralogy of fallot, cardioplegia
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2016-01-05
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Detailed description: Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.

Eligibility criteria: Inclusion Criteria:

* Tetralogy of fallot

Exclusion Criteria:

* TOF with absent pulmonary valve , TOF with pulmonary atresia

Primary outcomes:
measure: inotropic score
timeFrame: First 24 hours
measure: Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours
timeFrame: 72hrs
measure: resumption of spontaneous rhythm after aortic cross clamp off
timeFrame: 10 minutes
Secondary outcomes:
measure: duration of mechanical ventilation in hours
timeFrame: 48 hours
measure: ICU stay
timeFrame: 7 days
measure: hospital mortality
timeFrame: 30 days
measure: echocardiographic assessment
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02530554: Pilot Trial of Chlorhexidine Gluconate (CHG) Preoperative Skin Preparation
Official title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot study to evaluate and compare activity of CHG preoperative preparation with comparator CHG

Detailed description: Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Efficacy was assess using Tentative Final Monograph (TFM) criteria.

Eligibility criteria: Inclusion Criteria:

* Healthy
* No dermatological conditions

Exclusion Criteria:

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products

Primary outcomes:
measure: Log Change in Bacterial Flora on Abdomen and Groin
timeFrame: 10 min, 6 hr and 8 hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: S.C. Bio High Tech S.R.L
name: R Olsavszky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05728554: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
Official title: BIC4VMR: Breakthrough Improvement Collaborative for Ventral Mesh Rectopexy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Rectal Prolapse
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with rectal prolaps admitted for planned surgery

Brief summary: Different studies showed large variation between care processes in multiple diseases, this leads to large variation in outcomes. Better adherence to evidence-based guidelines for these diseases can reduce this variation and can improve the health outcomes.

Ventral mesh rectopexy has gained popularity in Europe to treat different rectal prolapse syndromes. This procedure has been shown to achieve acceptable anatomic results with low recurrence rates, few complications, and improvements of both constipation and fecal incontinence. However, there is limited data on the care process and outcomes. Moreover, there is no insight in the variation between different centers for patients undergoing ventral mesh rectopexy.

This study aims to map the variation in care for patients undergoing ventral mesh rectopexy in Flemish hospitals and to get an overview about the variation within and between these hospitals. Hereby, this will be a repeat of the studies for colorectal cancer, fragility hip fractures, stroke and breast cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years;
* Elective admission for ventral mesh rectopexy
* Total rectal prolapse
* Grade III Internal prolapse with incontinence or obstructed defaecation

Exclusion Criteria:

* Colpo posterior
* Patients diagnosed with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.

Primary outcomes:
measure: Length of stay
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
measure: In-hospital complication rate
timeFrame: through study completion, an average of 4 months
measure: in-hospital mortality
timeFrame: through study completion, an average of 4 months
measure: 30 day readmission rate
timeFrame: through study completion, an average of 4 months
measure: 30 days mortality rate
timeFrame: through study completion, an average of 4 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
Clinical trial NCT04500054: The Effects Of Music In Retrograde Intrarenal Surgery
Official title: The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retrograde Intrarenal Surgery
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the effect of music listening during the preoperative and postoperative stages in patients undergoing retrograde intrarenal surgery(RIRS) on basic life findings, anxiety, pain, and the amount of analgesic used. This is a randomized controlled experimental study.

The study was conducted with two groups: the intervention group (n=30) and control group (n=30). The control group received standard care. In contrast, the intervention group, in addition to standard care, was listened to the music by the researchers for 15 minutes one hour before their surgery.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or above,
* had elective RIRS,
* without hearing/speech impairment,
* without mental problems,
* without a diagnosis of psychiatric disorders,
* without a diagnosis of depression,
* had the surgery under general anesthesia,
* and volunteered to participate.

Exclusion Criteria:

* Patients under 18 years of age,
* with hearing/speech impairment,
* with mental problems,
* with a diagnosis of psychiatric disorders,
* with a diagnosis of depression,
* undergoing the surgery through spinal anesthesia,
* not willing to participate in the study

Primary outcomes:
measure: Visual Analog Scale for Anxiety (VAS-A)
timeFrame: 2 days
Secondary outcomes:
measure: Visual Analog Scale for Pain (VAS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar Health Science University
state: Centre
Study officials:
References:
Clinical trial NCT00143754: Effect of Chronic Oral Hydration in Patients With Recurrent Unexplained Syncope
Official title: Benefit of Controlled Rehydration in Unexplained Syncope
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hydration
Loss of Consciousness
Neurocardiogenic Syncope
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2005-09-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Beneficial effect of chronic hydration with salt supplementation in patients with recurrent unexplained syncope is not established. We sought to determine if chronic oral rehydration with salt supplementation improved the tolerance and hemodynamic responses of patients with unexplained recurrent syncope.


Eligibility criteria: Inclusion Criteria:

* Syncopal and/or near syncopal episodes at least twice within the prior 3 months

Exclusion Criteria:

* Neurological disease
* Structural heart disease
* Metabolic and psychiatric illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: HUAngers
name: Georges PN Leftheriotis, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615354: A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers
Official title: Single-Center, Randomized, Double-Blind, Placebo Controlled, Crossover Study to Assess the Effect of Aleglitazar on the Pharmacokinetics and Pharmacodynamics of Ethinyl Estradiol and Levonorgestrel as Components of the Oral Contraceptive Microgynon®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteer, 18 to 45 years of age
* Body mass index (BMI) between 18.0 and 29.9 kg/m2
* Body weight at least 55.0 kg
* Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment
* Non-smoker for at least 3 months

Exclusion Criteria:

* Currently active gynecological disorder
* History of amenorrhea within the previous 3 years
* Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors
* Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.
* History of clinically significant disease that could jeopardize the volunteer safety in the study

Primary outcomes:
measure: Pharmacokinetics of Levonorgestrel: area under the concentration time curve
timeFrame: pre-dose and up to 24 hours post-dose
measure: Pharmacokinetics of ethinyl estradiol: area under the concentration time curve
timeFrame: pre-dose and up to 24 hours post-dose
Secondary outcomes:
measure: Pharmacodynamics: luteinizing/follicular stimulation hormone concentration
timeFrame: Days 1, 7, 13, 14, 15, 21
measure: Safety: incidence of adverse events
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03532854: Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802
Official title: A Randomized, Open-label, Multiple-dose, Crossover Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between LGEV1801 and LGEV1802 in Healthy Korean Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2018-05-22
Enrollment: 42
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male
* Age between 19 and 50
* Subjects with BMI of 18\~27 kg/m2 with a weight of 55kg or more
* Subjects with SBP of 90\~150 mmHg and DBP of 60\~150 mmHg
* Signed informed consent

Exclusion Criteria:

* Presence of medical history or a concurrent disease
* Has a history of hypersensitivity to IP ingredients

Primary outcomes:
measure: AUCT,ss
timeFrame: Day 1~Day 8
measure: Cmax,ss
timeFrame: Day 1~ Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: LG chem
state: Gangseo-Gu
Study officials:
References:
Clinical trial NCT00574054: Far Infrared Radiation Treatment of Dementia and Other Mental Illness
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Dementia and Other Related Mental Illness.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Dementia
Keywords: Familial Dementia
Semantic Dementia
Senile Paranoid Dementia
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 4
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is a preliminary study to determine the use of far infrared radiation for the treatment of dementia and other mental sickness.

Detailed description: Dementia is the progressive decline in cognitive function due to damage or disease in the brain beyond what might be expected from normal aging. Particularly affected areas include memory, attention, language, and problem solving. Especially in the later stages of the condition, affected persons may be disoriented in place and in person (not knowing who they are).

The prevalence of dementia is rising as the global life expectancy is rising. Particularly in Western countries, there is increasing concern about the economic impact that dementia will have in future, older populaces.

It is a disease that is strongly associated with age; 1% of those aged 60-65, 6% of those aged 75-79, and 45% of those aged 95 or older suffer from the disease.

We are postulating that the use of far infrared radiation on the central nervous system, the endocrine system and the viscera will have a positive effect on treating dementia and other neurological illnesses.

Eligibility criteria: Inclusion Criteria:

* Persons age 2 or older, with dementia, Alzheimer's, Huntington's disease, Parkinson's disease, Down's syndrome, multiple sclerosis or stroke

Exclusion Criteria:

* Persons with severe mental illness that are confined to mental hospitals etc., as defined by the USA Diagnostic and Statistical Manual of Mental Disorders (DSM)

Primary outcomes:
measure: The primary end point is to determine the therapeutic effects of far infrared radiation on dementia.
timeFrame: 1 year
Secondary outcomes:
measure: The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related mental illness including Alzheimer's, multiple sclerosis and stroke rehabilitation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Kwasi Donyina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05334654: Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients
Official title: Bivalirudin Versus Enoxaparin for Anticoagulation in Critically Ill COVID-19 Patients: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Failure
SARS CoV 2 Infection
Anticoagulants
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 58
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: Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin.

Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.


Eligibility criteria: Inclusion Criteria:

* ratio between arterial partial pressure to inspired fraction of oxygen (PaO2/FiO2) \< 200 mmHg
* age equal or greater of 18 years/old
* detection of coronavirus 2019 at the nasal swab;
* need for endotracheal intubation and invasive mechanical ventilation

Exclusion Criteria:

* known allergies to one of the two investigated drugs
* presence of hematological diseases
* pregnancy
* recent (10 days) surgery
* presence of active bleeding

Primary outcomes:
measure: Time spent under invasive mechanical ventilation
timeFrame: from randomization till 28 days after randomization
Secondary outcomes:
measure: Incidence of vein thrombosis and embolism
timeFrame: from randomization till 28 days after randomization or ICU discharge
measure: Gas Exchange
timeFrame: Every day till 28 days after randomization or ICU discharge
measure: Intensive Care Unit length of stay
timeFrame: Up to 1 year
measure: Intensive Care Unit mortality
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: AOU Mater Domini
Study officials:
affiliation: Magna Graecia University
name: Federico Longhini, MD
role: PRINCIPAL_INVESTIGATOR
References: