louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00598936: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients
Official title: A Prospective Study With a New Device for the Monitoring of Cerebral Oxygenation on Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Heart Valve Disease
Keywords: Hypoxia
Cerebral Hypoxia
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects ≥18 year-old of age admitted to the University Hospital setting scheduled for cardiac surgery or admitted for any cause to the Intensive Care Unit (ICU).

Brief summary: The purpose of this study is to determine whether a new cerebral oxygenation monitoring device is comparatively similar to the current approved devices.

Detailed description: Cerebral oxygenation monitoring is an innovative way to monitoring cardiac surgery patients intraoperatively to reduce the incidence of postoperative hypoxic side effects. There are a number of approved devices already in the market that have proved their efficacy.

Eligibility criteria: Inclusion Criteria:

1. To be 18 years old or older
2. Scheduled for cardiac surgery
3. Treatment will include 72 hours or more of hospital stay
4. Understand enough about the risks and benefits of the study to be able to make an informed decision before agreeing to be in the study

Exclusion Criteria:

1. History of cerebrovascular disease
2. History of skin problems on forehead (skin rashes, acne, allergies, etc.)
3. History of craniofacial surgeries
4. Pregnancy

Primary outcomes:
measure: To test a new device for Cerebral Oxygenation Monitoring
timeFrame: 12 hours
Secondary outcomes:
measure: Safety of human forehead skin during period of probe adhesion
timeFrame: 12 hours
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Jeffrey C Milliken, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285736: Efficacy of Oral Ivabradine in Patients Presenting With NSTEMI
Official title: The Efficacy of Oral Ivabradine in Patients Presenting With Acute Non ST-segment Elevation Myocardial Infarction (NSTEMI): Interventional Randomized Parallel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: NSTEMI
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: National Heart Institute, Egypt
First posted: 2020-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the beneficial effect of heart rate reduction of oral ivabradine in patients presenting with non ST-segment elevation myocardial infarction (NSTEMI) during acute stage post percutaneous coronary intervention versus conventional treatment.

Materials and methods: A total of 100 patients admitted to the emergency department, National Heart Institute, Cairo, Egypt were randomized into two groups as follows: Group A: 50 patients with NSTEMI treated with ivabradine (5mg twice daily) in addition to the conventional treatment; Group B: 50 patients with NSTEMI treated with the conventional treatment only. Demographic data, detailed history, clinical examination, chest pain onset, blood pressure, heart rate (HR), temperature and respiratory rate, electrocardiogram (ECG) as well as echocardiography and laboratory investigations were recorded. Patients were monitored for a period of 3-5 days (acute stage).


Eligibility criteria: Inclusion Criteria:

* Patients with NSTEMI with normal sinus rhythm and heart rate (HR) more than 70 beats per minute (bpm) and systolic blood pressure (SBP) \>90 mm Hg undergoing PCI

Exclusion Criteria:

* Patients needing urgent cardiac surgery, IV inotropic agents or had a HR less than 60 bpm without any medication.

Primary outcomes:
measure: Heart Rate
timeFrame: acute stage post percutaneous coronary intervention (3-5 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04238936: GDM Patients and Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist
Official title: Levels of New Inflammatory Markers in GDM Patients; Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: Gestational Diabetes
Serum amyloid A
Interleukin-1 (IL-1) receptor antagonist
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Serum amyloid A (SAA) and Interleukin-1 (IL-1) receptor antagonist level will be examined in the study group consisting of pregnant women with GDM diagnosis and in the control group consisting of healthy pregnant women.

Brief summary: Serum amyloid A and Interleukin-1 (IL-1) receptor antagonist (A-SAA and IL-1Ra) values;

* Comparison of pregnant women with and without GDM diagnosis
* Comparison of insulin therapy and diet-regulated GDM patients
* Comparison of pregnant women with and without LGA (large gestational age)
* Comparison of pregnant women with and without polyhydroamnios
* Investigation of its effect on pregnancy prognosis
* In the prediction of GDM diagnosis, it is aimed to study the sensitivity and specificity of both parameters and cut off values.

(In GDM patients, liver and kidney function parameters will also be evaluated with A-SAA and IL-1Ra levels).


Eligibility criteria: Inclusion Criteria:

* Patients with 50 gr OGTT + 100 gr OGTT + at 24-28 weeks of gestation
* Patients with 75 gr OGTT + at 24-28 weeks of gestation
* 18-42 years pregnant women

Exclusion Criteria:

* any infection
* Any known fetal chromosomal or structural anomaly
* Preterm membrane rupture
* Preterm delivery
* Preeclampsia or eclampsia
* Placenta previa

Primary outcomes:
measure: Serum amyloid A
timeFrame: 1 week
measure: Interleukin-1 (IL-1) receptor antagonist
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00001336: In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients
Official title: In Vitro Studies of Immunological and Stem Cell Function in Peripheral Blood Mononuclear Cells in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunologic Deficiency Syndrome
Leukemia
Lymphoma
Neoplasm
Keywords: Transplantation
Cancer
Cellular Immunity
Stem Cell Function
Immunodeficiency
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Peripheral blood mononuclear cells (PBMC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. Peripheral blood stem cells (PBSC) from untreated donors and from cytokine treated donors will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations.

Detailed description: Peripheral blood mononuclear cells (PBMC) and mobilized peripheral blood stem cells (PBSC) will be collected from patients who have leukemia or lymphoma or other medical conditions involving altered lymphohematopoietic stem cell or immunological function. These PBMC will be assessed for cellular markers by flow cytometry and will be studied for in vitro T helper, effector and suppressor cell functions, to determine whether cell mediated immunity is involved in the condition, or indicative of therapeutic efficacy or is predictive for outcome. PBSC will be assessed for cellular markers and in vitro growth characteristics that might be useful for identifying normal stem cell populations. Furthermore the capacity of stem cells to reconstitute the T lymphocyte lineage will be assessed using ex vivo explant cultures established with thymic or secondary lymphoid tissues.

Eligibility criteria: Patients obtained from collaborators within and outside the NCI.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI)
state: Maryland
Study officials:
References:
Clinical trial NCT03451136: Cervical Length in Cases of Placenta Previa
Official title: Value of Third Trimester Cervical Length Measurement in Predicting Risk and Severity if Antepartum Haemorrhage in Cases of Placenta Previa
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Placenta Previa
Keywords: Placenta previa
Cervical length
Antepartum haemorrhage
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy pregnant females aged between 25-40 years

Brief summary: This study establishes the relationship between cervical length and whether it can be used to predict haemorrhage and preterm delivery in cases of placenta previa.

Detailed description: Some studies have reported an association between ultrasonographic decreased cervical length and the likelihood of complications as antepartum or post-partum haemorrhage requiring an emergency caesarean section (CS) .

The safety of trans-vaginal scanning is not in doubt, and the technique now has widespread acceptance. As a consequence, the clinical presentation of placenta previa has changed and most low lying placentas are diagnosed during the second trimester anomaly scan.

The objective of this study was to establish if there is a relation between transvaginal ultrasonographic measurement of cervical length in cases of placenta previa and whether it can be used as a predictor for antepartum haemorrhage or not.

Eligibility criteria: Inclusion Criteria:

1. Age: 20-45 years old
2. Single Pregnancy
3. Fetal gestational age 28 to \< 36 weeks
4. Normal amniotic fluid index (AFI)
5. Diagnosis of placenta previa by pelvic ultrasound that was confirmed when the lower placental edge overlies the internal cervical os on transvaginal ultrasound (TVS).

Exclusion Criteria:

1. Threatened preterm labor and maternal use of vaginal progesterone.
2. Preterm premature rupture of membranes;
3. Polyhydramnios;
4. Presence of cercelage and history of cervical cone biopsy which both affect cervical length.
5. Diagnosis of multiple fetal anomalies;
6. Women with other risk factors for intra-partum hemorrhage

Primary outcomes:
measure: Cervical length measured in mm in relation to antepartum haemorrhage
timeFrame: 4 months
Secondary outcomes:
measure: Need for blood transfusion
timeFrame: 4 months
measure: Need for caesarean hysterectomy
timeFrame: 4 months
measure: Type of cesarean delivery
timeFrame: 4 months
measure: Need for neonatal ICU
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04627636: MTPr With Shockwave on Pain & Function of SHS in Stroke
Official title: Myofascial Trigger Points Release With Shockwave Therapy on Pain and Function of Shoulder Hand Syndrome in Stroke Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Diabetic Neuropathy
Shoulder hand syndrome
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program
Primary purpose: TREATMENT

Brief summary: Background: shoulder-hand syndrome is considered a significant reason for the reduction of upper limb functions after stroke. Purpose: To investigate the influence of Myofascial Trigger Points (MTrPs) release and shockwave therapy on pain and functions of the upper extremity in stroke patients with diabetic neuropathy.

Detailed description: Methods: two equal groups of thirty stroke patients, divided into, study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program.

Eligibility criteria: Inclusion Criteria:

* stroke from 4:8 months
* age ranging from 45:60 years
* All the patients were identified with SHS as diagnosed by the Diagnostic criteria for SHS post-stroke 18 and were in stage I of syndrome evolution

Exclusion Criteria:

* any other causes of shoulder pain in the hemiplegic side of the body
* a cognitive impairment
* structured joint deformity in the painful shoulder or hand
* other musculoskeletal disorders of UE.

Primary outcomes:
measure: - Complex Regional Pain Syndrome (CRPS) severity score
timeFrame: 4 weeks
measure: - Figure-of-Eight Method of Measuring Hand Size for hand swelling
timeFrame: 4 weeks
measure: - Visual analogue scale for pain (VAS-P) for pain assessment
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama S Mahmoud
state: Select State
Study officials:
References:
Clinical trial NCT03963336: Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension
Official title: D-dimer and the Use of Anticoagulation in IIH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Idiopathic Intracranial Hypertension
Keywords: IIH
D-dimer
microthrombi
anticoagulation
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology.

The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients.

Detailed description: 24 patients with IIH according to the modified Dandy criteria were enrolled. Headache impact test (HIT6), ophthalmological assessment including Frisen classification for papilledema, visual acuity, visual field by perimetry, and visual evoked potentials were performed to the patients.

Serum quantitative D-dimer level was measured using the enzyme-linked immunosorbent assay (ELISA) technique for the patients and for 24 healthy matched controls.

Patients were divided into two groups: group (A) received acetazolamide and low molecular weight heparin (LMWH) in a prophylactic dose for 2 weeks while group (B) received acetazolamide only. Both groups continued the acetazolamide 1-2g/day for 6 months.

The investigators followed-up the patients after one and six months later through the HIT6 test and the ophthalmological assessment.

Eligibility criteria: Inclusion Criteria:

* IIH patients of both sexes fulfilling the modified Dandy criteria

Exclusion Criteria:

* disturbed conscious level, focal neurological signs, seizures, cerebral venous sinus thrombosis or stenosis, deep venous thrombosis or pulmonary embolism, malignancy, and acute nephritic syndrome.
* Patients with signs of disseminated intravascular coagulopathy and septic sinus thrombosis
* patients with a history of cerebral granuloma or infection, cerebrovascular stroke, head trauma or surgery.
* pregnant females or those who terminated their pregnancy in the last four weeks were also excluded.

Primary outcomes:
measure: serum quantitative D-dimer
timeFrame: Baseline assessment
Secondary outcomes:
measure: HIT6 score
timeFrame: 1 and 6 months
measure: Frisen classification for papilledema
timeFrame: 6 months
measure: Visual acuity (Log Mar)
timeFrame: 6 months
measure: Visual field (Perimetry)
timeFrame: 6 months
measure: Visual Evoked Potentials (VEP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University Hospital
Study officials:
References:
Clinical trial NCT03542136: Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime
Official title: Peripheral Neuropathy in Colorectal Cancer Patients Under Adjuvant Chemotherapy With FOLFOX, FLOX or XELOX Regime
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Polyneuropathy
Oxaliplatin
Colorectal cancer
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Oxaliplatin is a cytotoxic platinum compound and is one of the chemotherapeutic agent used in advanced colorectal cancer. It is used combined with Fluorouracil (5 FU) and Leucovorin. The main and most suffering side effect of oxaliplatin is polyneuropathy. Oxaliplatin-induced polyneuropathy (OIPN) can be acute and/or chronic neurotoxicity.

The early detection of the neurotoxicity and changing the medication dose and/or schedule can prevent its development. It has been used different neurotoxicity scales in grading OIPN. In this study the investigators try to investigate whether the evaluation of the vibrotactile perception VTP, by using a multi frequency tactilometry in a patients hand and foot is a good indicator and superior to the standard of care to detect the underlying OIPN in patients undergoing adjuvant chemotherapy treatment with FOLFOX, FLOX or XELOX regime.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Signed written informed consent.
* Fulfils the indication of the treatment with 3-6 months oxaliplatin combined adjuvant chemotherapy.
* Polyneuropathy grade according to CTCAE before treatment start ≤ 2.
* Performance status according to WHO ≤ 1.

Exclusion Criteria:

* Age \< 18 years.
* The patient does not consent to the examination
* Polyneuropathy grade according to CTCAE before treatment start \>2.
* Performance status according to WHO \>1.

Primary outcomes:
measure: To evaluate the efficacy of evaluating the vibrotactile sense using a multi frequency tactilometry, in patients hand and foot. This is by assessing the changes in the measurements of a multi frequency tactilometry device in between each two time points.
timeFrame: Investigation before cycle 1, 4, 6, 7, 8, 10, 12 and 6 months after last cycle (cycle 12), if cycle length is 2 weeks. If cycle length is 3 weeks, evaluation before cycle 1, 3, 4, 5, 6,7, 8, and 6 months after last cycle.
Secondary outcomes:
measure: To evaluate if Oxaliplatin induced polyneuropathy can be earlier detected by using a multi frequency tactilometry compared with Common Terminology Criteria for Adverse Events scale (CTCAE).
timeFrame: Investigation before cycle 1, 4, 6, 7, 8, 10, 12 and after 6 months after last cycle (cycle 12), if cycle length is 2 weeks. If cycle length is 3 weeks, evaluation before cycle 1, 3, 4, 5, 6,7, 8, and 6 months after last cycle
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
References:
Clinical trial NCT02658136: Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Official title: Computed Tomography Estimated Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on outcome has been extensively studied, the effects of late RV failure on exercise capacity and quality of life (QOL) has been sparsely described. Thus the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Detailed description: When pharmacological therapy becomes insufficient in advanced end-stage heart failure (HF) transplantation remains the gold standard of therapies. However, due to a severe lack of donor organs, mechanical circulatory support is an alternative option for some eligible patients. Mechanical circulatory support in the form of a CF-LVAD is a pump supporting the left ventricle by pumping blood from the apex to the ascending aortae. Implantation with a CF-LVAD increases survival and improves quality of life, but peak oxygen uptake (peak VO2) remains severely reduced post-implant. Complex central and peripheral hallmarks of heart failure attribute to the continued work intolerance. Furthermore a fixed CF-LVAD pump speed prevents adequate circulatory support during strenuous exercise. The effects of late right ventricular (RV) failure on exercise capacity and quality of life (QOL) is, however, unknown and the purpose of this study is to examine RV function and the association to exercise capacity in CF-LVAD patients.

Eligibility criteria: Inclusion Criteria:

* Outpatients from Department of Cardiology, Rigshospitalet, Denmark.
* Age ≥ 18 years.
* Ischemic or non-ischemic cardiomyopathy.
* Signed informed consent.

Exclusion Criteria:

* Unstable patients with the need for intravenous inotropic therapy.
* CF-LVAD implantation less than one month ago.
* eGFR \< 45 ml/min.
* Contrast allergy.

Primary outcomes:
measure: Peak Oxygen Uptake
timeFrame: Day 1
Secondary outcomes:
measure: Right Ventricular Function (RVEF) During Exercise
timeFrame: Day 1
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital Rigshospitalet.
Study officials:
References: