louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04206748: iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes
Official title: iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Type2 Diabetes
Pregnancy in Diabetic
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Smart Meter Corporation
First posted: 2019-12-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT


Eligibility criteria: Inclusion Criteria

* All patients \>/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks.
* Non-anomalous singletons
* Ability to provide informed consent

Exclusion Criteria

* Patients with Type 1 diabetes
* Patients with fetal major congenital abnormalities
* Patients identified/referred after 30.6 weeks

Primary outcomes:
measure: Neonatal morbidity
timeFrame: at the time of discharge (about 2-7 days after birth)
measure: Neonatal gestational age at delivery
timeFrame: at delivery
measure: # of neonates who where Small for gestational age (SGA)
timeFrame: at delivery
measure: Neonatal intensive care unit (NICU) length of stay
timeFrame: delivery to discharge (2-7 days)
measure: # of Neonates with hyperbilirubinemia-requiring therapy.
timeFrame: delivery to discharge (2-7 days)
Secondary outcomes:
measure: Average Neonatal Weight
timeFrame: at the time of discharge (about 2-7 days after birth)
measure: Maternal Mean fasting glucose
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal Mean post prandial glucose
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal # of Hypoglycemia events (<60 mg/dl)
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal weight gain during pregnancy
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal Gestational hypertension
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal Preeclampsia
timeFrame: perinatal to postpartum (32 weeks)
measure: Maternal Cesarean delivery
timeFrame: at delivery
measure: Maternal Operative vaginal delivery
timeFrame: at delivery
measure: Effect of SMBG checks on pregnancy
timeFrame: perinatal to postpartum (32 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
Clinical trial NCT02428348: EEG@HOME (Phase 3b of the Project, Interviews)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Pilipili NV
name: Imec
First posted: 2015-04-28
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this project is the development of an EEG-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that hospital admission in the EMU can be avoided for some patients and an increasing number of patients can be examined.

Phase 3 of this Project will be divided into Phase 3a and Phase 3b.

In Phase 3b of the project epilepsy patients and their family will be interviewed about different EEG-cap models in development. This interview is anticipated to take approximately 1 hour.

Minimum 4 - maximum 20 epilepsy patients and their family will be interviewed.

The results of the interviews will be analysed by the design company pilipili nv.


Eligibility criteria: Inclusion Criteria:

* Epilepsy patient

Exclusion Criteria:

* No experience with EEG

Primary outcomes:
measure: User opinion (questionnaire)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
Clinical trial NCT02433548: Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Official title: Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Neck Fracture
Keywords: Analgesia
Emergency medicine
Anesthesia, Regional
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain.

Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.

Detailed description: The objective of this trial is to compare the fascia iliaca block with a sham injection on patients arriving in the emergency department with a femoral neck fracture.

The fascia iliaca block will be performed with an anatomical landmark technique and a volume of 30 mLs of bupivacaine 0.5% with epinephrine 5 mcg/mL will be injected.

Eligibility criteria: Inclusion Criteria:

- patients with femoral neck fracture in the emergency department

Exclusion Criteria:

* presence of demencia
* body weight less than 40kg
* presence of a cancer or patients receiving chemotherapy
* allergy to local anaesthetics

Primary outcomes:
measure: Pain scores at rest
timeFrame: 45 minutes after the injection
Secondary outcomes:
measure: Pain scores at rest
timeFrame: 60 min, 4h, 8h, 12h, 24h after the injection
measure: Pain scores on movement
timeFrame: 60 min, 4h, 8h, 12h, 24h after the injection
measure: Morphine consumption
timeFrame: 60 min, 4h, 8h, 12h, 24h after the injection
measure: Length of stay
timeFrame: up to 3 weeks
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUVaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
citation: Pasquier M, Taffe P, Hugli O, Borens O, Kirkham KR, Albrecht E. Fascia iliaca block in the emergency department for hip fracture: a randomized, controlled, double-blind trial. BMC Geriatr. 2019 Jul 1;19(1):180. doi: 10.1186/s12877-019-1193-0.
Clinical trial NCT03108248: ISP-TACE Versus TACE for HCC With PVTT
Official title: Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Survival Benefit of Transarterial Chemoembolization in Combination With Irradiation Stent Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Portal Vein Tumor Thrombosis
Keywords: transarterial chemoembolization
stent
irradiation
survival
decompensation
tumor response
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between January 2011 and December 2016, patients with HCC and PVTT underwent TACE combined with irradiation stent placement or TACE monotherapy as an initial treatment at the authors' center were retrospectively reviewed.

Brief summary: For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.


Eligibility criteria: Inclusion Criteria:

* (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.

Exclusion Criteria:

* (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.

Primary outcomes:
measure: survival
timeFrame: 0-6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital,Southeast University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01745848: Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Official title: Effect of Roflumilast on Systemic Markers of Bone Metabolism and Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Roflumilast
COPD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2012-12-10
Enrollment: 26
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.

Detailed description: Study participants will be given Roflumilast 500 micrograms daily for 30 days. At baseline, prior to drug administration, blood samples will be collected for analysis of markers of bone metabolism (C-terminal telopeptide of Type I Collagen (CTx), Amino-terminal Propeptide of Type-1 Procollagen (P1NP) and participants will undergo measurement of endothelial function with measurement of brachial flow mediated dilation. After completion of one month of Roflumilast therapy, participants will have a repeat blood collection for measurement of CTx and P1NP and repeat measurement of brachial flow mediated dilation testing.

Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco exposure, airflow obstruction (FEV1/FVC \< 0.70) with an FEV1 \< 70%
* baseline sputum production at least some of the time as reported on the Saint George's Respiratory Questionnaire, and at least one exacerbation within the past year

Exclusion Criteria:

* Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates, calcitonin, parathyroid hormone)
* Subjects with a body mass index less than 18 or greater than 34

Primary outcomes:
measure: Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP))
timeFrame: 30 days - measurements at baseline and 30 days
Secondary outcomes:
measure: Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation
timeFrame: 30 days - measured at baseline and 30 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Emphysema COPD Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jessica Bon Field, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01558648: Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer
Official title: Quality of Life Outcomes Following Minimally Invasive and Open Esophagectomy for Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: Minimally Invasive Esophagectomy
Open Esophagectomy
Quality of Life
12-003
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the Thoracic Surgery clinics.

Brief summary: The goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. The investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. This study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Diagnosis of esophageal cancer, stages I-IIIC, with no prior esophageal resection. Neoadjuvant therapy given prior to presentation at MSKCC will be accepted.
* Anticipated to undergo surgical resection (Ivor Lewis, Trans Hiatal, thoracoabdominal, or McKeown procedure) of esophageal cancer either by open or minimally invasive methods
* Chest and abdomen CT scan
* Ability to speak read and write English.

Exclusion Criteria:

* Inability to give informed consent
* Patients requiring a laryngectomy or colon interposition as part of their surgical resection.
* Patients with scleroderma.

Primary outcomes:
measure: short-term pain
timeFrame: 4 months
measure: short -term quality of life (QOL)
timeFrame: 4 months
Secondary outcomes:
measure: long-term pain
timeFrame: 2 years
measure: long time quality of life (QOL)
timeFrame: 2 years
measure: differences in surgical outcomes
timeFrame: 90 days
measure: Complications
timeFrame: 90 days
Other outcomes:
measure: predict EUS T3/T4/stricture disease
timeFrame: 2 years
measure: predict EUS T3/T4/stricture or earlier EUS disease
timeFrame: 2 years
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Matthew Bott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02168348: Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
Official title: Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Type 1 or 2 Diabetes
Lesion Situated on a Toe or on the Plantar or Dorsal Side of the Foot
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 1 or 2 diabetes who have a lesion situated on a toe or on the plantar or dorsal side of the foot

Brief summary: The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided oral consent
* Patients older than 18
* Patients with type 1 or 2 diabetes
* Patients who can be followed-up in the context of consultations for diabetic foot at the endocrinology, diabetology and metabolic diseases unit of Dijon CHU.
* Lesion situated on a toe or on the plantar or dorsal side of the foot
* Lesion that has evolved for 1 to 24 months

Exclusion Criteria:

* Adult under guardianship
* Patient without national health insurance
* Pregnant or breast-feeding women
* Patients with progressive cancer
* Patients with terminal renal insufficiency on dialysis
* Patient with severe respiratory insufficiency
* Patients with terminal heart failure
* Patients with severe liver failure
* Patients with immunodepriession (treatement with immunosuppressants, long-term corticotherapy, diseases leading to immunodepression)
* Patients with nephrotic syndrome (hypoalbuminemia)
* Patientswith a chronic inflammatory syndrome
* Alcohol consumption greater than 4 glasses per day
* Systemic infection uncontrolled by antibiotics
* Infected lesion with systemic repercussions
* Charcot foot
* Patients taking part or who have planned to take part in another clinical trial
* Severe disease affecting survival in the short term
* Lesion on an amputation
* Lesion of the ankle or leg

Primary outcomes:
measure: Percentage of healed lesions
timeFrame: After 24 weeks of follow-up
Secondary outcomes:
measure: Number of malnourished patients according to HAS 2003 and 2007 criteria
timeFrame: At inclusion
Other outcomes:
measure: Percentage of healed lesions during the follow-up
timeFrame: At 2, 4, 8, 12, 16 and 20 weeks
measure: Number of malnourished patients at 12 and 24 weeks
timeFrame: At 12 and 24 weeks
Locations:
city: Dijon
country: France
facility: CHU de DIJON
Study officials:
References:
Clinical trial NCT00847548: Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting
Official title: Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Domestic Violence
Substance Abuse
Keywords: intimate partner violence
domestic violence
substance abuse
alcohol abuse
drug abuse
addiction
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Intimate partner violence is a significant societal problem. However, treatment of IPV perpetrators is far from effective, which may be partly due to the fact that the role of substance abuse is not taken into account. There is considerable evidence that a strong relationship between the use of alcohol and other drugs and intimate partner violence exists. Besides, a few studies indicate that reducing substance use may have a positive impact on IPV. Therefore, in this study, perpetrators of intimate partner violence with substance use disorders enrolled in domestic violence treatment will be randomly assigned to either standard treatment for offenders of domestic violence or a combination of the latter treatment with cognitive-behavioral therapy addressing substance abuse (combined treatment).


Eligibility criteria: Inclusion Criteria:

* A history of perpetration of intimate partner violence
* Current alcohol, cannabis and/or cocaine abuse or dependence
* Still in an intimate relationship with the victim

Exclusion Criteria:

* Not sufficient fluency in Dutch to complete treatment and measures
* (ab)use of crack cocaine and/or heroin
* In need of clinical detoxification
* Severe mental disorders, such as psychosis
* Severe cognitive disorders, such as Korsakoff's syndrome
* In treatment for other mental health problems
* Abuse of children

Primary outcomes:
measure: Quick Drinking Screen (QDS)
timeFrame: pretest, posttest, 6 & 12 months follow-up
measure: Conflict Tactics Scale (CTS)
timeFrame: pretest, halfway treatment, posttest, 6 & 12 months follow-up
measure: Timeline Followback interview
timeFrame: pretest, posttest
Secondary outcomes:
measure: Brief Symptom Inventory (BSI)
timeFrame: pretest, posttest, 6 and 12 moths follow-up
measure: Maudsly Marital Questionnaire (MMQ)
timeFrame: pretest, posttest, 6 and 12 months follow up
Other outcomes:
Locations:
city: Amsterdam / Rotterdam
country: Netherlands
facility: De Waag Amsterdam & Rijnmond
Study officials:
affiliation: University of Amsterdam
name: Paul M.G. Emmelkamp, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292148: Measurement of Core Temperatures During Therapeutic Hypothermia
Official title: Core Temperature Measurement in Therapeutic Hypothermia: Tympanic Membrane, Bladder and Rectal Versus Pulmonary Artery Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: resuscitation, hypothermia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2011-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post cardiac arrest care with therapeutic hypothermia

Brief summary: The purpose of this study is to determine that the measurements of rectal and bladder temperature are correctly consistent with core temperature by using the pulmonary artery catheter during therapeutic hypothermia; rapid cooling, maintenance, and slow rewarming phase.

Detailed description: The guidelines of therapeutic hypothermia(TH)are rapid cooling, from normothermia to mild hypothermia(32\~34 degree), maintenance, and slow rewarming phase. If core temperature maintained below 32 degree during TH, som complications will be developed, such as arrythmia, hypotension, cold diuresis, coagulopathy, and so on. Therefore correct measurement of core temperature during TH is very important process for successful post cardiac arrest care. we will know that rectal or bladder temperature are really reflect the core temperature during TH for post cardiac arrest care, especially rapid cooling phase, maintenance phase, and slow rewarming phase, respectively.

Eligibility criteria: Inclusion Criteria:

* Out of cardiac arrest patient who is 18 years old.
* Mean arterial pressure must be over 65 mmHg after return of spontaneous circulation.
* Family consent to this study.

Exclusion Criteria:

* In hospital arrest.
* Arrest due to trauma
* Arrest due to intracranial hemorrhage.
* Below 30 degree at initial core temperature.
* Pregnancy.
* Family do not agree with our study.
* Active bleeding patient.

Primary outcomes:
measure: Difference of core temperature between rectum, bladder, esophagus and pulmonary artery
timeFrame: During 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Hospital
Study officials:
affiliation: Seoul National University Boramae Hospital
name: Shin JongHwan
role: PRINCIPAL_INVESTIGATOR
References: