louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04728100: LQT and Smartphone/Smartwatch
Official title: Smartphone and Smartwatch Based ECG for Patients With Congenital Long QT Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Long QT Syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: LQT patients

Brief summary: Congenital long QT syndrome (LQTS) is a rare genetic disorder characterized by prolongation of the corrected QT interval (QTc) on the electrocardiogram. LQTS is associated with a risk of syncope or sudden death from ventricular arrhythmia.

The increase in the duration of the corrected QT interval and / or changes in the morphology of the T wave on the electrocardiogram are markers of an increased risk of sudden death and syncope.

Recently, a personal portable 6-lead device (DI, DII, DIII, aVF, aVL and aVR) connected to the patient's smartphone has entered the market (KARDIA MOBILE 6L, AliveCor, Mountain View, CALIFORNIA, USA). The APPLE WATCH Series 6 (Apple, Cupertino, CA, USA) can also record an ECG. If the device is designed to record a single lead (DI), several works have shown that it is possible to record 9 leads (DI, DII, DIII, V1, V2, V3, V4, V5 and V6) by moving simply the device (Spaccarotella CAS et al. JAMA Cardiology 2020).

These devices were originally designed to screen for atrial fibrillation, but they produce accurate 6- and 9-lead ECGs and could potentially allow ambulatory ECG monitoring of patients with LQTS.


Eligibility criteria: Inclusion Criteria:

Patient with diagnosis of LQTS based on the following criteria:

* Corrected QT (Qtc) interval according to Bazett method ≥ 480 ms, at several times in the absence of a secondary cause
* and / or class 4 or 5 mutation in a gene involved in long QT syndrome
* and / or syncope (s) and QTc\> 460ms in the absence of other cause

  * All ages
  * No opposition from the patient

Exclusion Criteria:

None

-

Primary outcomes:
measure: the duration of the QTc (ms)
timeFrame: at the inclusion visit
measure: the morphology of the T waves (bpm).
timeFrame: at the inclusion visit
measure: the heart rate (bpm).
timeFrame: at the inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Chevalier
Study officials:
References:
Clinical trial NCT05669300: Uterine Closure for Cesarean Section: a Novel Technique
Official title: All Layer Continuous Paralel Uterine Closure for Cesarean Section: a Novel Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Cesarean Section; Dehiscence
Keywords: cesarean section
uterine closure
novel technique
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-12-30
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this retrospective study pregnant women who had a cesarean delivery in our hospital between 1 January 2021 and 31 April 2022 were included. Decrease of postoperative hemoglobine levels between Yilmaz Tecnique and single layer continue locked suturation compared

Brief summary: In here we want to describe a new technique to uterin closure at caesarean section which has been performed about 20 years by Bülent Yılmaz. The technique (we suggest the name of the technique as Yılmaz technique) provide less resuturing need when closing the uterus in cesarean section, bringing together better wound edges, providing more effective suture in thin uteruses, stopping active bleeding areas with the same suture, thus enabling to complete the surgery at low cost by using a single suture material in almost all cases.

The aim of this study is to describe the technique and compare the blood loss of patients in caserean section between Yılmaz technique and single layer continue locked suturation .

Detailed description: The participants of the study were divided into two groups as uterine closure with Yilmaz technique (study group) and single layer continue locked suturation (control group). Maternal age, gestationale age, fetal weight, preoperative and postoperative hemoglobin levels are recorded. Hemoglobin decrease was calculated by subtracting the postoperative hemoglobin value from the preoperative hemoglobin values of the pregnant women.The postoperative hemoglobine decrease of the groups are compared.

Eligibility criteria: Inclusion Criteria:

* patients underwent to ceseren section and

  1. singleton
  2. alive fetus

Exclusion Criteria:

The patients with

1. uterine atonia,
2. coagulaopathy,
3. plasenta previa
4. blood transfusion -

Primary outcomes:
measure: Decrease of hemoglobine levels
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Mehmet Kagitci
Study officials:
References:
Clinical trial NCT04396600: The Professional Peer Resilience Initiative
Official title: The Professional Peer Resilience Initiative: Leveraging a Data-Driven Model to Maximize the Resilience of Healthcare Workers During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Stress Disorder
Stress, Psychological
Trauma, Psychological
Anxiety
Anxiety State
Post Traumatic Stress Disorder
Secondary Traumatic Stress
Professional Quality of Life
Stress Related Disorder
Stress Reaction
Stress Risk
Mental Resilience
Emotional Resilience
Keywords: Resilience
COVID-19
Coronavirus Disease 2019
Coronavirus
Healthcare Workers
Frontline
Traumatic Stress
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of healthcare workers and mental health consultants in the University of Minnesota healthcare workforce.

Brief summary: The Professional Peer Resilience Initiative (PPRI) study is an observational study aimed at understanding how symptoms of traumatic stress and resilience evolve over time in the University of Minnesota (UMN) healthcare workforce during the coronavirus disease 2019 (COVID-19) pandemic. The study is being conducted concurrently with a UMN peer support program called the MinnRAP program and will remotely administer quality of life and mental health surveys to healthcare workers before they start the MinnRAP program and throughout their participation in the program.


Eligibility criteria: Inclusion Criteria:

* Healthcare workers (HCWs) and mental health consultants (MHCs) in UMN medical school departments

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in professional quality of life
timeFrame: Before peer support program, through study completion (an average of 7 months)
Secondary outcomes:
measure: Change in mental health symptoms and resilience markers
timeFrame: Before peer support program, through study completion (an average of 7 months)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Cristina S Albott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00256100: Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Kidney Failure.
Official title: Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Failure
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 20
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: The purpose of this project is to assess the safety and effectiveness of fondaparinux, a new drug to prevent blood clotting in the continuous dialysis machine used in intensive care patients who have kidney failure.

Detailed description: The study hypothesis is that when used as an anticoagulant in haemofiltration, fondaparinux prolongs the filter life when compared to enoxaparin.

Fondaparinux is the first compound of a new class of synthetic oligosaccharides with antithrombotic effects. It represents the active portion of the natural heparin molecule.

The null hypothesis is that there is no difference in filter life when using fondaparinux or enoxaparin as anticoagulation for haemofiltration.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (18 years or over) admitted to the ICU and expected to stay for more than 48 hours.
2. Patients who require continuous renal replacement therapy.
3. Patients who consent or if the patient is not competent, the next of kin who consent to inclusion in the study. .

   -

Exclusion Criteria:

1. Patients aged less than 18 years of age.
2. Patients who are pregnant
3. Patients with a contraindication to anticoagulation for pre existing bleeding diathesis
4. Patients or next of kin who do not consent to study inclusion. -

Primary outcomes:
measure: The study will evaluate the duration of filter patency using fondaparinux as an anticoagulant in haemofiltration and compare this to the current standard haemofilter anticoagulant, enoxaparin.
timeFrame: Duration of the haemofilter life
Secondary outcomes:
measure: To assess the incidence of complications, primary bleeding with fondaparinux compared to enoxaparin in this setting.
timeFrame: Until hospital discharge
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital Intensive Care Unit Grattan Street
state: Victoria
Study officials:
affiliation: Melbourne Health
name: John F Cade
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02174900: Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM)
Official title: Evaluation of the Safety of Primaquine in Combination With Artemether-lumefantrine in Glucose-6-phosphate Dehydrogynase Deficient Males With an Asymptomatic Malaria Infection in Burkina Faso (SAFEPRIM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Malaria
Keywords: G6PD deficiency
safety
transmission
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Centre national de recherche et de formation sur le paludisme
name: University Medical Center Nijmegen
First posted: 2014-06-26
Enrollment: 70
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: The purpose of this study is to evaluate the tolerability and safety of increasing doses of primaquine in combination with artemether-lumefantrine in G6PD deficient males with an asymptomatic P. falciparum malaria infection.


Eligibility criteria: Inclusion Criteria:

1. Male gender
2. Age ≥18 years and ≤45 years
3. BMI ≥16
4. P. falciparum parasitaemia at any density
5. G6PD deficiency by Beutler Fluorescent Spot test for intervention groups and control group receiving AL only (N=50)
6. G6PD normal activity by Beutler Fluorescent Spot test for control groups (N=20)
7. Informed consent by participant

Exclusion Criteria:

1. Enrolled in another clinical trial
2. Fever \>37.5°C (tympanic) or history of fever in the last 24 hours
3. Evidence of severe illness / danger signs or active infection other than malaria
4. Known allergy to study medications
5. Hb \<11 g/dL
6. Antimalarials taken within the last 2 weeks
7. PQ taken within the last 4 weeks and blood transfusion within the last 90 days
8. Non-falciparum malaria co-infection
9. Current use of tuberculosis or anti-retroviral medication, sulphonamides, dapsone, nitrofurantoin, , nalidixic acid, ciprofloxacin, , methylene blue, toluidine blue phenazopyridine and co-trimoxazole.
10. History of severe chronic illness

Primary outcomes:
measure: Haemoglobin concentration relative to baseline value
timeFrame: 28 days
Secondary outcomes:
measure: Gametocyte clearance time
timeFrame: 14 days
Other outcomes:
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Centre National de Recherche et de Formation sur le Paludisme
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Teun Bousema, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bastiaens GJH, Tiono AB, Okebe J, Pett HE, Coulibaly SA, Goncalves BP, Affara M, Ouedraogo A, Bougouma EC, Sanou GS, Nebie I, Bradley J, Lanke KHW, Niemi M, Sirima SB, d'Alessandro U, Bousema T, Drakeley C. Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials. PLoS One. 2018 Jan 11;13(1):e0190272. doi: 10.1371/journal.pone.0190272. eCollection 2018.
Clinical trial NCT03811600: Exosomes Implication in PD1-PD-L1 Activation in OSAS
Official title: Exosomes Implication in PD1-PD-L1 Pathway Activation in Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes, Obstructive
Cancer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients investigated by sleep recording for suspected OSAS will be included in the study.

Brief summary: An increased occurrence of cancer associated mortality has been described in patients with Obstructive Sleep Apnea Syndrome (OSAS). This association might be partially explained by an impaired cellular immune response that has been described in OSAS. Is has been suggested that OSAS impact immune cells by upregulation of the PD-1/PD-L1 pathway. Exosomes are small membrane vesicles released by numerous cells in the bloodstream. Exosomes have been shown to be implicated in cancer cells proliferation via a PD-1/PD-L1 pathway activation.

This study will evaluate exosomal PD-1/PD-L1 expression in patients with OSAS as compared to controls and will further investigate their impact on immune cells function and proliferation capacities.


Eligibility criteria: Inclusion Criteria:

* Patients requiring a sleep recording for suspected OSAS

Exclusion Criteria:

* Préviously treated OSAS
* Cancer past history
* Pregnant women
* Cognitif impairment

Primary outcomes:
measure: exosomal PD1 expression
timeFrame: at baseline
measure: exosomal PD-L1 expression
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Laboratoire du Sommeil, Département de Pneumologie, CHU d'Angers
Study officials:
References:
Clinical trial NCT00348400: Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost
Official title: Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-07-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy


Eligibility criteria: Inclusion Criteria:

* · Male or female \> 18 years of age

  * Diagnosis of open-angle glaucoma or ocular hypertension
  * IOP \> 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
  * Presently on latanoprost monotherapy for at least 6 weeks
  * Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

* · Known contraindication or allergy to brimonidine or any of its components

  * Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
  * Uncontrolled systemic disease
  * Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
  * Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
  * Corneal abnormalities
  * History of intraocular surgery within the last 3 months
  * Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
  * Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Dr. Noecker
state: Pennsylvania
Study officials:
affiliation: UPMC Eye Center
name: Robert Noecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05252000: Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease
Official title: Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical and Surgical Treatment of Teeth With Periodontal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Keywords: plaque
laser therapy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 20
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: The purpose of this study is to compare clinical outcomes after mechanical debridement of at sites exhibiting plaque induced inflammation with or without adjunctive Antimicrobial photodynamic therapy (aPDT) and to assess the the microbiologic profile before and after treatment with or without aPDT


Eligibility criteria: Inclusion Criteria:

* One pocket on each side of the mouth (split design)
* Single rooted tooth
* Pocket depths measured greater than 4mm with bleeding on probing
* Horizontal bone loss
* No furcation involvement

Exclusion Criteria:

* current heavy smokers (\>10 cigarettes/day)
* have uncontrolled diabetes (HbA1c ≥ 6.5%)
* other uncontrolled systemic diseases that may comprise healing, such as Vitamin C deficiency, any neutrophil deficiencies, immunodeficiency syndromes, or leukemia
* taking antibiotics within 3 months before the procedure
* vertical bone defects that requires surgical regenerative treatment.
* Pregnancy

Primary outcomes:
measure: Change in number of bleeding sites (Bleeding On Probing)
timeFrame: baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
measure: Change in probing depth (Periodontal pocket depth )
timeFrame: baseline, at the re-evaluation appointment (4 to 6 weeks after baseline), and 3 months after the osseous surgery
Secondary outcomes:
measure: change in microbiologic profile of plaque
timeFrame: baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
measure: change in microbiologic profile of gingival crevicular fluid(GCF)
timeFrame: baseline, at the re-evaluation appointment(4 to 6 weeks after baseline), and 3 months after the osseous surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreena P Bhakta, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154700: Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer
Official title: A Phase II Study of Twice Weekly Paclitaxel, Cisplatin and Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil and Folinic Acid in the Treatment of Recurrent or Metastatic Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: Combination,Chemotherapy,Esophageal Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy.

Detailed description: The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy. The secondary objectives include overall survival, progression-free survival, and toxicity.

Eligibility criteria: Inclusion Criteria:

* Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or metastasis Measurable disease (\> 1 X 1 cm) by CXR, CT scan or MRI,Age \> 18, KPS \> 60% , Cre \< 1.5mg/dl, AST/ALT \< 3.5 X N, Bil \< 2.0mg/dl WBC \> 4,000/mm3, ANC \> 2,000/ mm3, Plt \> 100,000/mm3

Exclusion Criteria:

* Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except \> 2 months)

Primary outcomes:
measure: Response rate
Secondary outcomes:
measure: Overall survival
measure: Progression-free survival
measure: Toxicity
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology, National Taiwan University hospital
name: Ann-Lii Cheng, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D.,Ph.D
role: STUDY_CHAIR
References: