louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03672656: Pattern Laser Versus Conventional Laser in Diabetic Retinopathy
Official title: Single Session of Pattern Scanning Laser Versus Multiple Sessions of Conventional Laser for Panretinal Photocoagulation in Diabetic Retinopathy: Efficacy, Safety and Painfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: diabetic retinopathy
patterns
low time of impulse
Pascal
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy.

Methods: The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (SSP) (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method (MSM).


Eligibility criteria: Inclusion Criteria:

* Diabetic retinopathy

Exclusion Criteria:

* No

Primary outcomes:
measure: Clinical efficiency - progression of diabetic retinopathy, scored by calculating of microaneurisms and intraretinal hemorrhages
timeFrame: 1 year
measure: Pain assessed by NRS
timeFrame: 1 day
Secondary outcomes:
measure: Satisfaction assessed by the VAS
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
citation: Nemcansky J, Stepanov A, Nemcanska S, Masek P, Langrova H, Studnicka J. Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness. PLoS One. 2019 Jul 16;14(7):e0219282. doi: 10.1371/journal.pone.0219282. eCollection 2019.
Clinical trial NCT04412356: Timing of Tracheotomy in Covid-19 Patients
Official title: Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
ARDS
Tracheostomy Complication
Respiratory Insufficiency
Corona Virus Infection
Keywords: Covid-19
Tracheotomy
Tracheostomy
RCT
ARDS
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single blinded, controlled trial
Primary purpose: TREATMENT

Brief summary: Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.


Eligibility criteria: Inclusion Criteria:

* Verified Covid-19 infection
* Intubated due to respiratory insufficiency and need for mechanical ventilation
* Informed consent from patient or relative

Exclusion Criteria:

* Age below 18 years
* Need for mechanical ventilation less than 14 days
* Tracheotomy not possible within 7 days
* Tracheotomy not possible due to anatomical or other medical reasons

Primary outcomes:
measure: Mechanical ventilation
timeFrame: Through the individual ICU stay assessed up to 60 days
Secondary outcomes:
measure: ICU stay
timeFrame: Through the individual ICU stay assessed up to 60 days
measure: Oxygen support
timeFrame: Through the individual ICU stay assessed up to 60 days
measure: Sedation
timeFrame: Through the individual ICU stay assessed up to 60 days
measure: Adverse events
timeFrame: Through the individual ICU stay assessed up to 60 days
measure: Mortality
timeFrame: Through the individual ICU stay assessed up to 90 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Henrik Bergquist, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eeg-Olofsson M, Pauli N, Hafsten L, Jacobsson J, Lundborg C, Brink M, Larsson H, Lindell E, Lowhagen K, Gisslen M, Bergquist H. TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial. Crit Care. 2022 May 18;26(1):142. doi: 10.1186/s13054-022-04005-0.
Clinical trial NCT05539456: Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old
Official title: Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old: a Quality-of-life Measure for Patients With Spinal Muscular Atrophy in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Muscular Atrophy
Quality of Life
Neuromuscular Diseases
Pediatric Disorder
Keywords: Spinal Muscular Atrophy
Quality of Life
Neuromuscular Diseases
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 55
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with spinal muscular atrophy between 2 to 4 years age.

Brief summary: The aim of the investigator's study was to investigate translating the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old and using it in clinics reliably and validity with a Turkish version of the PedsQL Generic Core (Pediatric Quality of Life Questionnare) in children with Spinal Muscular Atrophy in Turkey

Detailed description: The PedsQL 3.0 Neuromuscular Module for 2-to 4- year-old will be translated into Turkish by following the language translation steps. First of all, the English form will be translated into Turkish by two people who are fluent in English. Then, the forms translated by another expert in the field will be reviewed. The revised text will be translated from Turkish into English by another person with a good command of English and will be compared with the original scale by the lecturer. If a significant change in meaning is not detected, the scale will be applied to 10 parents. In case of incomprehensible questions, which are reported to be lacking in expression, the scale will be finalized after revision and corrections are made by the research team.

Eligibility criteria: Inclusion Criteria:

* Having a child with spinal muscular atrophy
* Having a child between the ages of 2-4
* Accept to participate in the study

Exclusion Criteria:

* Lack of cooperation during work
* Presence of disease other than SMA, which will prevent participation in the study

Primary outcomes:
measure: PedsQLTM 3.0 neuromuscular module for 2-to 4- Year-old
timeFrame: 5-10 minutes
Secondary outcomes:
measure: PedsQLTM 4.0 generic core scales
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Seval Kutlutürk Yıkılmaz
state: Kavacık
Study officials:
affiliation: Medipol University
name: Seval Kutlutürk Yıkılmaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02305056: Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: High-grade Glioma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2014-12-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).

Detailed description: The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.

Eligibility criteria: Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* informed consent form signed
* High-grade Glioma tumor suspicion
* Resective surgery indication
* Hematological assessment :

  * neutrophils \> 1500/mm3
  * Platelet \> 150 000
  * blood Creatinin normal
  * alkaline Phosphatases and transaminases no more than two times normal
  * Bilirubin \< 1.5 times normal

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Precedent complete macroscopic tumor resective surgery
* No valid inclusion criteria
* Intratumoral hemorrhage MRI detected
* Treatment anticoagulant or antisludge treatments
* Active Infections and non controled or medical affection or psychiatric intercurrent non treated
* Evolutive cerebral oedema without corticoid response
* Non controled Epilepsy without antiepileptics response
* Karnofsky score \< 40%
* Weight \> 100 kg
* No possibility of resective surgery

Primary outcomes:
measure: Mass spectrometry measurement of C13 labelled proteins
timeFrame: during 30 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
affiliation: University Grenoble Hospital
name: François BERGER, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474356: Hyperthermia Combined Brachytherapy in CCU
Official title: HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Cancer
Keywords: brachytherapy
interstitial hyperthermia
cervical cancer
side effects
Locally advanced cervical cancer patients
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.


Eligibility criteria: Inclusion Criteria:

* patients with locally advanced cervical cancer FIGO stage II - III
* signed informed consent for participation in the study

Exclusion Criteria:

* patients with FIGO stage I and IV
* patients with poor performance status with contraindications for radical treatments

Primary outcomes:
measure: LC
timeFrame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
Secondary outcomes:
measure: Late side effects
timeFrame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
measure: Early complications of BT procedure
timeFrame: 24 hours after BT procedure
measure: DFS
timeFrame: Follow up was scheduled every 3 months. Preliminary results after 3 years.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Skłodowska-Curie Memorial Cancer Center and Institute
Study officials:
affiliation: M. Sklodowska-Curie Memorial Cancer Centre and Institute, Roentgena 5, 02-781 Warsaw, Poland
name: Agnieszka Żółciak-Siwińska, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02245256: Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients
Official title: Perioperative Low-dose Dexmedetomidine Decreases Incidence of Delirium in Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: delirium
incidence
dexmedetomidine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2014-09-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative delirium in liver transplant patients in the ICU.

Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia for liver transplantation and continued until 48 hours after surgery.

Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18years old or older) undergoing living-donor or deceased-donor liver transplantation

Exclusion Criteria:

* Pediatric patients (under 18 years) Pregnancy Patients who are unresponsive at baseline, who have neurologic deficits at baseline, or who are allergic to dexmedetomidine

Primary outcomes:
measure: analysis of the incidence of postoperative delirium in liver transplant patients in the ICU.
timeFrame: 1 week or transfer to ward, whichever comes first.
Secondary outcomes:
measure: analysis of the duration of postoperative delirium, ICU length of stay in liver transplant patients in the ICU.
timeFrame: 1 week or transfer to ward, whichever comes first.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Agree
Study officials:
affiliation: Seoul National University Hospital
name: Hogeol Ryu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125956: Improving Diabetes Control Through Peer Counseling and Incentives
Official title: Improving Diabetes Control Through Peer Counseling and Incentives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes
Diabetes mellitus
HbA1c
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The specific aims of this study are to test whether in a cohort of low-income minority veterans with poor diabetes mellitus (DM) control:

1. Peer counseling is an effective means of reducing HbA1c (a measure of glucose control).
2. Financial incentives are an effective means of reducing HbA1c. This is a randomized controlled pilot study. There will be 3 arms: 1) a control group of poorly controlled diabetics getting usual care; 2) peer counseling with no incentives; and 3) financial incentives without peers. Ultimately, contingent on the success of this intervention, the researchers plan to apply for funding for a large scale intervention employing both peer counseling and incentives to improve DM control in low income and minority patients who are at high risk for premature morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* African American veteran
* 50-70 years old
* ICD-9CM diagnosis code consistent with DM (any ICD-9CM code starting with 250)
* For patients: last two HbA1c greater than 8% with at least one measure being within 3 months of enrollment
* For peer counselors: HbA1c of greater than 8% in the past 3 years and an HbA1c less than or equal to 7.5% within 3 months of enrollment

Exclusion Criteria:

* Unstable medical condition that would likely prevent the subject from completing the study
* Patients enrolled in Telehealth will be excluded as such enrollment does not constitute usual care

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Counts of the number of hypoglycemic events
timeFrame: 6 months
measure: Number of peer encounters
timeFrame: 6 months
measure: Experience of peer counseling
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Veterans Affairs Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Judith Long, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Long JA, Jahnle EC, Richardson DM, Loewenstein G, Volpp KG. Peer mentoring and financial incentives to improve glucose control in African American veterans: a randomized trial. Ann Intern Med. 2012 Mar 20;156(6):416-24. doi: 10.7326/0003-4819-156-6-201203200-00004.
Clinical trial NCT05076656: Epigenetic and Microbiota Modifications
Official title: Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes type2
Obesity
Keywords: Diabetes type2
FMT
Probiotics
Microbiota
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.


Eligibility criteria: Inclusion Criteria:

* Type2 diabetes in treatment with metformin
* 30 kg/m2≤IMC≤40 kg/m2
* 30-70 years old
* HOMA-IR \>6
* Informed consent

Exclusion Criteria:

* psychopathologic alterations that do not permit the adherence to the trial.
* Diabetes medication different from metformin.
* History of cholecystectomy.
* Use of Probiotics, and/or antibiotics in the last 3 months

Primary outcomes:
measure: Changes in HOMA-IR
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Changes in gut microbiota
timeFrame: Baseline, 12 weeks
measure: Changes in glucose metabolism
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: Instituto de Investigacion Biomedica de Malaga
name: Francisco J Tinahones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03715556: Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response
Official title: Prospective, Randomized and Blind Comparative Analysis Between Attraction of Restrict Control Versus Liberal Cardiac Frequency in Patients in Sepse With Atrial Fibrillation of High Ventricular Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Sepsis
Septic Shock
Atrial Fibrillation
Ventricular Fibrillation
Atrial Fibrillation Rapid
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 126
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: Amiodarone is considered the medicine of choice in heart rate control in critically ill patients with atrial fibrillation with high ventricular response. However, a recent retrospective study showed a greater number of events in critical patients in whom there was an attempt to control versus in which there was no. Therefore, the prospective and randomized comparative use of amiodarone in this group of patients has not yet been described. The aim of this study was to evaluate the safety of the use of amiodarone (restricted group) versus placebo (liberal group) in heart rate control in atrial fibrillation with high ventricular response in patients with sepsis and vasopressor cardiovascular dysfunction. For this, a unicentric, randomized, blind and prospective study will be performed, in which the restrictive versus liberal strategy is performed in a comparative way. Hospital data (test results, medical evolutions complications) of patients will be analyzed to calculate safety and effectiveness. Expected results: The liberal strategy is superior to the restrictive strategy and causes fewer adverse events.


Eligibility criteria: Inclusion Criteria:

* Permanent FA presence with FC\> 110 bpm
* Presence of infection (any infectious outbreak)
* Cardiovascular dysfunction - need for vasopressor drugs (noradrenaline, adrenaline or vasopressin) to maintain SBP\> 90 mmHg
* Signed consent form

Exclusion Criteria:

* Pregnancy
* Body mass index greater than 40 kg / m2
* Contraindication to the use of oral or parenteral anticoagulants
* Acute coronary syndrome
* Left ventricular ejection fraction \<35%
* Valvular Heart Disease
* Contraindication to the use of amiodarone
* Child C cirrhosis
* Dialytic chronic renal insufficiency
* Chronic obstructive pulmonary disease
* Acute myocarditis
* Pulmonary thromboembolism
* Terminal neoplasia

Primary outcomes:
measure: Complications of safety outcomes
timeFrame: 48 hours
Secondary outcomes:
measure: Effectiveness in the control of the heart rate
timeFrame: 48 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto do Coração - HMFMUSP
Study officials:
affiliation: Unidade Clínica de Emergência
name: Mucio Tavares, MD
role: PRINCIPAL_INVESTIGATOR
References: