louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03026218: Group and Mobile Care for Gestational Diabetes
Official title: Group and Mobile Care for Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A critical variation in the provision of prenatal care to women with GDM is the need to keep patients engaged with their care between visits by tracking glucose levels using finger sticks and making dietary and other lifestyle modifications to keep these levels at or close to normal. Multiple studies have demonstrated that the use of mobile devices can improve medical outcomes. In order to keep patients engaged between appointments and improve self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give the user positive feedback and rewards for using the system. This model of group care with mobile phone monitoring and reminders for women with GDM has not been previously studied. A randomized control trial is purposed to determine if this approach improves patient care. The investigators hypothesize that group prenatal care along with inter-session mobile therapy will increase dietary compliance and therefore reduce the number of individuals requiring pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care (GPC) will provide a community foundation to improve learning and increase the motivation of patients to learn and change. This motivation will be further strengthened by the use of the GlucoseMama monitoring system which will provide each patient with glucose tracking and individualized nutritional support.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Gestational Diabetes
* Planning on delivering at home institution

Exclusion Criteria:

* Unwilling to participate.

Primary outcomes:
measure: Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes
timeFrame: 2 years
Secondary outcomes:
measure: Reduction in the number of neonates born large for gestational age.
timeFrame: 2 years
measure: Increased number of individuals who are screened in the postpartum period for type 2 diabetes.
timeFrame: 2 years
measure: Reduction in the number of infants with neonatal hypoglycemia.
timeFrame: 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
References:
Clinical trial NCT04110418: Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Official title: Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neonatal Sepsis
Refractory Shock
Keywords: methylene blue
terlipressin
septic shock
preterm neonate
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate

Detailed description: The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing methylene blue versus terlipressin in treatment of preterm neonate with catecholamines resistant septic shock the outcome as regard elevation of mean arterial blood pressure will be measured within 72 hours

Eligibility criteria: Neonate with Gestational age at birth ≤ 36weeks

Inclusion Criteria:

* diagnosis of Septic shock according to clinical sepsis score of Tollner and Hematologic Scoring System of Rodwell
* Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \>0.5 mcg/kg/min)
* consent form

Exclusion Criteria:

* known case of G6pd deficiency
* Hx of drug allergy MB, NE, terlipressin
* Patients with severely impaired renal function.
* History of maternal drug intake of selective serotonin reuptake inhibitors,and Serotonin-Norepinephrine Reuptake Inhibitors

Primary outcomes:
measure: to assess the efficancy of each intervention in improving hemodymaic status: time taken to reach adequate mean blood pressure
timeFrame: 24hours
Secondary outcomes:
measure: to assess the effect of intervention on survival
timeFrame: 4 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Neonatal Intensive Care Units (NICUs), Ain Shams University
state: Abbasia
Study officials:
affiliation: ain shams university faculty of medicine
name: rabab allam, physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03957018: Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia
Official title: Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Stress
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy.

Brief summary: Carotid endarterectomy (CEA) is a high risk surgical and anesthesiological procedure. It is an essential part of stroke-prevention strategies, however the incidence of CEA related peri-operative stroke is between 5% and 10%. These procedures can be performed either in general or regional anaesthesia. We hypothesized that an appropriate awake sedation is able to decrease patient's distress and an improved satisfaction can be reached.

Detailed description: We aim to explore the stress response of patients randomized according to different sedation protocols: (i) per os premedication only with alprazolam (BDZ group) or (ii) premedication with alprazolam combined with target control infusion (TCI) of propofol (BDZ+TCI) for awake carotid endarterectomy. A total of 50 consecutive patients with significant carotid artery stenosis will be enrolled into this prospective randomised study. All surgeries will be performed in regional anaesthesia. As premedication, all patients took 0.25 mg alprazolam 30 minutes before the procedure. After randomization 25 patients will be grouped to both arms of the study: either to "sedation with target controlled propofol infusion", or to "only premedication". Stress markers, such as cortisol plasma levels will be serially analysed: prior to surgery (T1), before (T2) and after release of carotid clamp (T3), at 2 (T4) and 24 post-operative hours (T5). Alprazolam levels were also measured before and after the surgery.

Eligibility criteria: Inclusion Criteria: patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy, written informed consent -

Exclusion Criteria: patient declines to participate in the study

-

Primary outcomes:
measure: major vascular events
timeFrame: at 30th postoperative day
Secondary outcomes:
measure: mortality and vascular events
timeFrame: 5-year follow-up
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: University of Pecs
state: Baranya
Study officials:
References:
Clinical trial NCT06771518: Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
Official title: Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pharmacological interventional
Primary purpose: TREATMENT

Brief summary: Investigate the role of consolidative radiotherapy treatment at the thoraco-mediastinal level in the patient suffering from lung microcytoma - extensive disease and treated with chemo-immunotherapy with atezolizumab, in association with maintenance therapy with atezolizumab.

Detailed description: Prospective phase II study on patients affected by extensive-stage small cell lung cancer. The traditional treatment of lung microcytoma-extensive disease consists in platinum and etoposide-based chemotherapy. Radiotherapy of consolidation at the thoracic mediastinal level after chemotherapy may have an impact on survival and can be offered to patients in response to chemotherapy. Studies have recently shown that the addition of immunotherapy with atezolizumab to traditional chemotherapy improves survival compared to placebo. However, the use of consolidation radiotherapy was not permitted in the study thoracic level. Therefore the objective is to evaluate the efficacy and tolerance of the thoracic radiotherapy-immunotherapy association in the maintenance phase with atezolizumab of the treatment of lung microcytoma - extensive disease treated with chemo-immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of lung microcytoma;
* Age ≥18 years;
* Performance status according to ECOG 0-2;
* Extended disease at the time of first line oncological treatment;
* Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG and brain MRI;
* In at least partial response (defined according to the Recist criteria \[18\]) after treatment chemoimmunotherapy according to the Impower 133 scheme;
* Haematological, respiratory toxicity ≤ G1, other toxicities ≤ G2 at the time of treatment radiotherapy;
* Pulmonary function tests at the time of radiotherapy treatment compatible with irradiation: FEV≥1.2 l or \>40%, DLCO≥50%;
* Written informed consent.

Exclusion Criteria:

* Previous radiotherapy treatment at the thoraco-mediastinal level;
* In disease progression after chemo-immunotherapy treatment.

Primary outcomes:
measure: Evaluate the efficacy of the association between radiotherapy and immunotherapy
timeFrame: 60 months
Secondary outcomes:
measure: Measuring the tolerability
timeFrame: 60 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT05700318: Study Using the ShiraTronics Migraine Therapy System
Official title: A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Migraine, Headache
Lead sponsor: ShiraTronics
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to assess the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System in prophylactic treatment of patients with refractory chronic migraine.


Eligibility criteria: Inclusion Criteria:

1. Participants who are 22 years of age or older.
2. History of migraine ≥ 12 months.
3. Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.
4. Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.
5. Stable use of migraine medication.

Exclusion Criteria:

1. Post-traumatic headache.
2. Medication overuse headache.
3. New daily persistent headache.
4. Report experiencing unremitting, continuous headaches with no relief.
5. Previously implanted neurostimulator to treat headache.
6. History of cervical radiofrequency ablation or had any other intervention/device for migraine.

Primary outcomes:
measure: Monthly Headache Days
timeFrame: 12-weeks
Secondary outcomes:
measure: 50% reduction in mean Headache days
timeFrame: 12-weeks
measure: Monthly Migraine Days
timeFrame: 12-weeks
measure: Migraine Disability Assessment Test
timeFrame: 12-weeks
measure: Patient-identified Most Bothersome Symptom
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Hurstville
country: Australia
facility: Australian Medical Research
state: New South Wales
city: Wayville
country: Australia
facility: CerCare
state: South Australia
city: Perth
country: Australia
facility: Paincare Perth
state: Western Australia
Study officials:
affiliation: ShiraTronics
name: Scientific Advisory Board
role: STUDY_DIRECTOR
References:
Clinical trial NCT00938418: Hypofractionated Intensity Modulated Chemoradiotherapy to Treat Locally Advanced Non-Small Cell Lung Cancer
Official title: Phase II Study on Dose Escalated, Accelerated Hypofractionated Intensity Modulated Radiotherapy for Stage III Non-Small Cell Lung Cancer With Concurrent Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage III Non-Small Cell Lung Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: Tan Tock Seng Hospital
First posted: 2009-07-13
Enrollment: 43
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Locally advanced non-small cell lung cancer can be treated successfully with chemotherapy and radiation. However, the cure rate is low.

This study is carried out to find out whether giving radiotherapy at a higher dose over fewer treatment sessions with intensity modulated radiotherapy (IMRT) can improve the treatment outcome.

This study aims to recruit 43 patients from National University Hospital and Tan Tock Seng Hospital over a period of about 2 years.


Eligibility criteria: Inclusion Criteria:

* Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer; excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, or significant pleural / pericardial effusion.

Exclusion Criteria:

* Patients for whom treatment is planned with a maximum dose of ≥ 66 Gy to the ipsilateral brachial plexus
* Greater than minimal, exudative, or cytologically positive pleural effusions
* ≥ 10% weight loss within the past month
* Prior invasive malignancy (with exceptions)
* Prior radiotherapy to the region of the study cancer
* Significant co-morbidities
* Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
* Known allergic reactions to components of planned chemotherapy regimen

Primary outcomes:
measure: Overall survival
timeFrame: 2 years
Secondary outcomes:
measure: Response rate, locoregional control, disease free survival, toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
References:
Clinical trial NCT03411018: Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia
Official title: The Impact of Modifications on Respiratory Management of Preterm Infants on the Death or Bronchopulmonary Dysplasia Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Keywords: lung protective strategies
Less invasive respiratory support
preterm infant
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 600
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All preterm infant born with less than 32wGA since January 2012 to December 2017 admitted in our NICU.

Brief summary: This observational study evaluates the impact of respiratory management modifications implemented in our institution on the intubation rates and the death or Bronchopulmonary Dysplasia (BPD) outcome.

Detailed description: Less invasive respiratory management has been implemented in most neonatal units as well as lung protective ventilatory strategies when intubation is required in order to minimize ventilator induced lung injury.

In our institution a new ventilatory protocol including less invasive surfactant administration, Synchronized nasal positive pressure ventilation and early rescue High frequency ventilation has been implemented during 2013-14.

Hypothesis: New less invasive and lung protective strategies to prevent lung injury had been effective in reducing intubation rates.

Eligibility criteria: Inclusion Criteria:

All preterm Infants born with less than 32wGA admitted in our NICU.

Exclusion Criteria:

Congenital malformations and Known Chromosomal disorders,

Primary outcomes:
measure: BRONCHOPULMONARY DySPLASIA
timeFrame: 36 weeks of postmenstrual age.
measure: mortality
timeFrame: before discharge
Secondary outcomes:
measure: Mechanical ventilation
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Cristina Ramos-Navarro
Study officials:
affiliation: Gregorio Marañon, Hospital
name: Cristina Ramos-Navarro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03327818: Comparison Between Hysterectomy and Conservative Management in Treatment of Placenta Accreta Regarding Maternal Complication
Official title: Obstetric Hysterectomy Versus Conservative Surgery for Management of Patients With Morbidly Adherent Placenta as Regard Maternal Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 491
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 55
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all cases of placenta accreta present in Ain shams university maternity hospital from 2011 to 2015 and from July 2016 to January 2017

Brief summary: AIM OF THE WORK The aim of the study is to compare the maternal morbidity and mortality between obstetric hysterectomy and conservative surgery for pregnant ladies \> 28 weeks with placenta accreta during caesarean section at Ain Shams University Maternity Hospital in the last five years and prospective study in the next six months.

Hypothesis In women with placenta accrete undergoing hysterectomy may be similar to conservative surgery as regard maternal morbidity and mortality.

Detailed description: The study included all cases of placenta accreta that were diagnosed preoperative or intra-operative and treated by conservative surgery or by hysterectomy during caesarean section between January 2011 to December 2015 at Ain Shams University Maternity Hospital and from July 2016 to January 2017.

The collected data will be categorized according to the way of management and will be analyzed regarding:

Mortality rates.

Intraoperative morbidities:

Blood loss and it's amount and need for transfusion. Amount of blood and blood products transferred. Injury to adjacent organs eg: bladder or bowel injury.

Early postoperative morbidities:

Blood and blood product transfusion Length of maternal Hospital admission post operative Acquiring intensive care unit admission and identifying the cause and duration Wound sepsis Septic shock Peritonitis DVT Acute pulmonary embolism Hysterectomy after conservative management and its indication Wound dehiscence Burst abdomen

Late postoperative morbidities:

Anemia Recurrence of placenta accretes in next pregnancy. Hysterectomy after conservative management and its indication Uterine necrosis Fistula eg. urinary fistula

Eligibility criteria: Inclusion Criteria:

* Women admitted for elective caesarean section. Pregnant women more than 28weeks of gestation. Women with no associated medical diseases eg. DM, PET. Pre-operatively Hemodynamically stable women. Women diagnosed with placenta accrete either preoperative or accidentally discovered intraoperative.

Exclusion Criteria:

* Pregnant women less than 28weeks of gestation. Women with associated medical co-morbidity eg bleeding tendency eg: DM, PET.

Primary outcomes:
measure: maternal morbidity
timeFrame: 24 hours post operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: