louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00001194: NMR Scanning on Patients
Official title: NMR Scanning on Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Imaging
Keywords: Helium Cryogen
Magnetic Field
Multi-Institute
Nitrogen Cryogen
Radiofrequency
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 99999
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This protocol is designed to investigate the use of novel techniques in MRI that may not yet be commercially available. Specifically, the protocol enables patients to take advantage of new pulse sequence software, coil design or post processing capabilities not otherwise available. The informed consent explains MRI in lay terms, describes the use of contrast agents and lists contraindications to MRI.

Detailed description: NMR imaging promises to provide useful and unique diagnostic information in a variety of diseases. In an attempt to evaluate its role, we plan to study a wide range of diseases during the initial year of imaging. Exposure to magnetic fields and radiofrequency energies of this magnitude have demonstrated no deleterious effects clinically or in the laboratory. The only restrictions will be those imposed by ferromagnetic objects within the patient which would increase the risk of placing them in a strong magnetic field.

Eligibility criteria: Any patient undergoing MRI for research or clinical purposes who is participating in a currently active NIH protocol.

No patients with pacemakers, cochlear implants, implanted pumps, shrapnel, metal in the globe of the eye, cerebral aneurysm clips or other contraindication to MRI.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren G. Magnuson Clinical Center (CC)
state: Maryland
Study officials:
References:
citation: Choyke PL, Walther MM, Wagner JR, Rayford W, Lyne JC, Linehan WM. Renal cancer: preoperative evaluation with dual-phase three-dimensional MR angiography. Radiology. 1997 Dec;205(3):767-71. doi: 10.1148/radiology.205.3.9393533.
citation: Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.
Clinical trial NCT00298194: The Effects of Z-338 in Subjects With and Without Functional Dyspepsia
Official title: The Effects of Z-338 on the Symptomatic Response to a Nutrient Challenge and Gastric Nutrient Distribution and Emptying in Subjects With and Without Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyspepsia
Lead sponsor: Zeria Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-03-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

1. Type and severity of symptoms a standardized nutrient challenge
2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
3. The association of the above with the manifestations of symptoms and symptom pattern


Eligibility criteria: Inclusion Criteria:

1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score
2. Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: Royal Adelaide Hospital
name: Gerald Holtmann, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367094: Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension
Official title: Efficacy and Safety of the Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Benazepril
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, benazepril, hydrochlorothiazide, fixed combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-22
Enrollment: 296
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: This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day.


Eligibility criteria: Inclusion Criteria:

* Male or female patients, age 18 or older
* Given informed consent
* Diagnosed as having mild to moderate essential hypertension

Exclusion Criteria:

* Severe hypertension
* Significant preexisting cardiovascular and cerebrovascular disease
* Diabetes mellitus type 1 or poorly controlled diabetes mellitus type II
* Advanced renal impairment

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change in diastolic blood pressure from baseline to week 8
Secondary outcomes:
measure: Change in systolic blood pressure from baseline to week 8
measure: Proportion of patients with blood pressure less than 140/90 mmHg at week 8
measure: Ambulant blood pressure monitoring profiles at baseline and week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05434494: The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients
Official title: The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Remimazolam
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study prospectively uses the biased coin technique to investigate the effect of concomitant administration of remifentanil on the 95% effective dose of intravenous remimazolam (Effective dose 95 \[ED95\]) required for loss of consciousness during anesthesia induction. .


Eligibility criteria: Inclusion Criteria:

* The adult patients who are scheduled to surgery under general anesthesia

Exclusion Criteria:

* Severe obesity (BMI \> 30 kg/m2)
* Allergy to remimazolam or remifentanil
* Under conditions which make it difficult to respond to the investigator's verbal commends like hearing impairment, etc.
* Patients with general conditions are more than ASA class III
* Patients with brain disease (dementia, cerebral infarction, etc.)

Primary outcomes:
measure: Remimazolam dose at which loss of consciousness occurs
timeFrame: 3 min after remimazolam injection
Secondary outcomes:
measure: Time to loss of consciousness
timeFrame: time after injection of remimazolam to loss of conciousness
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04270994: Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients
Official title: Misoprotol as a Treatment for Endometrial Polyps in Infertile Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Endometrial Polyps in Infertile Patients
Lead sponsor: Mateo-Sánez, Henry A.
Sponsor class: INDIV
First posted: 2020-02-17
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endometrial polyps are one of the main causes of infertility in women. In this work we propose an alternative, effective, economical and safe treatment: the use of misoprostol

Detailed description: The prevalence of uterine polyps has been estimated in the general population at 10-15%, while in infertile patients it ranges from 6-32%. Its etiology is considered as multifactorial. Polyps induce a local inflammatory response in the endometrial cavity, causing infertility. The treatment of choice considered "gold standard" is the excision by hysteroscopy, however, improvement has been shown in patients with conservative management due to the regression rate of 27%. There are no recommended drugs to provide a definitive treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing contractions of the myometrium, which cause endouterine evacuation. The present study shows a possible utility of misoprostol for the conservative treatment of uterine polyps.

Eligibility criteria: Inclusion Criteria:

* Women with uterine polyps diagnosed by endovaginal ultrasound and/or hysterosonography, female ≤ 45 years of age

Exclusion Criteria:

* Patients older than 45 years, polyps larger than 60 mm, who did not perform surveillance and/or minimum assessment 6 months after medical management

Primary outcomes:
measure: Expulsion rate of endometrial polyps
timeFrame: 7 days after misoprostol has been applied
Secondary outcomes:
measure: Pregnancy rate after expulsion
timeFrame: 14-21 days after positive β-human Chorionic Gonadotropin (β-hCG)
measure: The pregnancy rate after expulsion in patients with primary sterility
timeFrame: 14-21 days after positive β-hCG
Other outcomes:
Locations:
Study officials:
affiliation: Henry Aristoteles Mate-Sánez
name: HENRY A MATEO-SÁNEZ, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03767894: MyHand: An Active Hand Orthosis for Stroke Patients
Official title: MyHand: An Active Hand Orthosis for Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand orthosis
Stroke
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
name: U.S. National Science Foundation
First posted: 2018-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to explore the efficacy of several control mechanisms for the device and the impact of a device training program on its utility as a neuroprosthetic and training tool for upper limb recovery.

Detailed description: Hand rehabilitation through occupational therapy is critical for many stroke survivors, but it is also greatly limited by insurance coverage, shortage of therapists, and logistic constraints. To address this, stroke patients need a rehabilitation method they can use on their own, without direct clinical supervision, and for activities of daily living. MyHand is a wearable and active hand orthosis consisting of a glove and forearm splint, equipped with actuators and tendons which connect to the fingers.

Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years of age
* History of stroke resulting in significant upper limb impairment
* Full passive range of motion
* Gross control of the proximal upper extremity
* Lacks timely grasp/release
* No more than moderate flexor tone
* Intact cognition

Exclusion criteria include:

* Other Neurological/orthopedic disorders
* Excessive spasticity/contracture

Primary outcomes:
measure: Score on Action Research Arm Test (ARAT)
timeFrame: Baseline; Post-test at Week 4
measure: Score on the Upper Extremity Component of the Fugl-Meyer Scale (UEFM)
timeFrame: Baseline; Post-test at Week 4
Secondary outcomes:
measure: Score on Modified Ashworth Scale (MAS)
timeFrame: Baseline
measure: Score on Box and Blocks Test (BBT)
timeFrame: Baseline; Post-test at Week 4
measure: Number of Participants Completing Treatment Protocol
timeFrame: 4 Weeks
measure: Total Number of Adverse Events During Intervention
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Joel Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05210894: Expanded Access for Anti-IL8
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-01-27
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access designed to provide access to Anti-IL8 for eligible participants.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05394194: Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer
Official title: Dosimetric Comparison of Three Radiation Techniques for Hypofractionated Whole Breast Radiotherapy in Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Keywords: computer assisted, radiotherapy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 30 Female patients who will present to clinical Oncology department with early breast cancer, with pathological staging ≤ T2N0M0 and are operated by conservative breast surgery will be included in our current study.

Brief summary: We aim to compare three different radiation delivery techniques, namely three-dimensional conformal radiation therapy (3D-CRT), intensity modulated radiotherapy (IMRT) and volumetric modulated radiation therapy (VMAT) in left-sided early breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* left sided early breast cancer patients. Should have histopathological prove to have invasive breast cancer. Operated by breast conservative surgery. Have no associated comorbidities

Exclusion Criteria:

* locally advanced breast cancer. Patients who have total mastectomy. Patients who had previous chest irradiation or known comorbidities.

Primary outcomes:
measure: Comparison of coverage of planned target volume(PTV) among the three plans.
timeFrame: 1 year
measure: Comparison of doses to organs at risk among the three plans.
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of target homogeneity among the three plans.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Alshaymaa Abdelghaffar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00542594: Survey in Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy
Official title: A Report Upon a Cohort of Post-menopausal Women Followed up After Treatment With Anastrozole as Adjuvant Therapy for Hormone-dependant Breast Cancer. Long-term Tolerance Evaluation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: breast cancer
anastrozole
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 1840
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Woman seen by their physician in the current care setting and for whom a treatment with anastrozole is decided by the physician (adjuvant treatment of breast cancer in postmenopausal women with hormone receptor positive status)

Brief summary: The purpose of this survey is to describe long-term tolerance as seen under current conditions of use for anastrozole.


Eligibility criteria: Inclusion Criteria:

* woman treated with anastrozole as adjuvant therapy for hormone-dependant breast cancer in post-menopausal women with positive hormone-receptors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca France Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01076894: Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia
Official title: Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracotomy
Keywords: pain
thoracotomy
pulmonary function
epidural anesthesia
intercostal nerve block
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 83
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: Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the "gold standard" for postoperative pain control and restoration of pulmonary function after thoracic surgery.

Thus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection

Exclusion Criteria:

* age\<18 yr
* any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac
* lack of patient's cooperation
* any type of chronic painful condition or current opioid use

Primary outcomes:
measure: Pain at rest and on coughing after thoracic surgery
timeFrame: Pain during the first four postoperative days
Secondary outcomes:
measure: pulmonary function (peak expiratory flow rate) after thoracic surgery
timeFrame: first four postoperative days
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universtity Clinic Ulm
Study officials:
affiliation: Department for Anesthesiology University Clinic Ulm
name: Michael Georgieff, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01655394: Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
Official title: Change of Nerve Conduction Properties in IVIg Dependent Neuropathies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Guillain-Barre Syndrome
CIDP
Multifocal Motor Neuropathy
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with immune neuropathies

Brief summary: IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored.

Detailed description: IVIg exert a variety of different immunomodulatory effects and several mechanism of action have been proposed for IVIg. In this study the role of IVIg on short term nerve conduction in patients with immune-mediated neuropathies will be explored

Eligibility criteria: Inclusion Criteria:

* immune neuropathy
* age above 18 y
* IVIg treatment

exclusion:

* no IVIg treatment

Primary outcomes:
measure: Clinical Improvement
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
Study officials:
affiliation: PI
name: Helmar C. Lehmann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02270294: Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Official title: Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
Thai traditional massage
Vascular function
Cerebral blood flow
Cerebrovascular reactivity
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.


Eligibility criteria: Inclusion Criteria:

1. A single ischemic stroke with Middle cerebral artery (MCA) stenosis
2. Men or women age 50-80 years
3. Physician's approvals to participate the study
4. Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment
5. The modified rankin scale level is 2 or 3

Exclusion Criteria:

1. History of serious diseases

   * Musculoskeletal diseases (Chronic arthritis, Lower spondylosis/spondylolisthesis with radiculopathy, Spinal deformity, Cervical spondylosis, Rheumatoid arthritis)
   * Cardiovascular diseases (Poorly control hypertension, Heart disease class C and D)
   * Neurological disorders (Peripheral neuropathy, Parkinson)
   * Respiratory diseases (Chronic Obstructive Pulmonary Disease)
   * Brain disorders (Cardioembolic, Severe dementia, Alzheimer's disease)
   * Medical condition precluding taking Anticoagulant and Statin drug
2. Temporal window were not found

Primary outcomes:
measure: Change from baseline in cerebrovascular reactivity
timeFrame: baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Secondary outcomes:
measure: Change from baseline in stress indicators
timeFrame: Baseline, Post-test (immediately: 0 min after finish massage intervention)
measure: Change from baseline in stress indicators
timeFrame: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
measure: Change from baseline in Peripheral arterial stiffness
timeFrame: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
measure: Change from baseline in blood chemistry
timeFrame: baseline, Post-test (immediately: 0 min after finish massage intervention)
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Faculty of Sports Science, Chulalongkorn University
state: Bangkok
Study officials:
References: