louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04139031: Corrected Flow Time in the Carotid Artery as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume in the Intensive Care Unit
Official title: Corrected Flow Time in the Carotid Artery as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients With Low Tidal Volume in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemic
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing postoperative mechanical ventilation with low tidal volume

Brief summary: The purpose of this study is to evaluate predictability of carotid corrected flow time for fluid responsiveness in mechanically ventilated patients with low tidal volume in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

1. Adult patients with age more than 19
2. Undergoing postoperative mechanical ventilation with low tidal volume
3. Clinically diagnosed with hypovolemic status
4. If one of follow criteria is satisfied 1) Systolic blood pressure \<90mmHg 2) Mean arterial pressure(MBP)\<70mmHg or fall more than 20% from baseline 3) Heart rate \>100bpm 4) Urine output \<0.5mg/kg/hr more than 1 hour 5) Arterial lactate \>2mmol/L 6) Capillary refilling time \>3secs

Exclusion Criteria:

1. Body mass index \<40 or \>15 kg/m2
2. Medical history of carotid artery stenosis \>50% or diagnosed while examination
3. Cardiac arrhythmia other than normal sinus rhythm
4. Moderate or severe valvular heart disease, intracardiac shunt, heart failure, pulmonary hypertension
5. Moderate or severe chronic obstructive pulmonary disease
6. Increased intracranial pressure
7. Using vasopressor
8. Pregnancy

Primary outcomes:
measure: Corrected carotid artery flow time during low tidal volume ventilation
timeFrame: Procedure (During low tidal volume ventilation before fluid resuscitation)
Secondary outcomes:
measure: Pulse pressure variation during low tidal volume ventilation
timeFrame: Procedure (During low tidal volume ventilation before fluid resuscitation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00964431: Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Indomethacin Test Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Pain
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female between 18 and 50 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Patient requires extraction of 2 or more third molars
* Patient must be willing to stay at the study site for at least 8 hours after dosing of the study drug

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to Screening

Primary outcomes:
measure: Total Patient Pain Relief Over 0 to 8 Hours.
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Premier Research Group Limited
state: Texas
Study officials:
References:
Clinical trial NCT01514227: Nobori Dual Antiplatelet Therapy as Appropriate Duration
Official title: Nobori Dual Antiplatelet Therapy as Appropriate Duration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Associations for Establishment of Evidence in Interventions
Sponsor class: OTHER
First posted: 2012-01-23
Enrollment: 3773
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.


Eligibility criteria: Inclusion Criteria:

* Subjects \> 20 years old
* Undergoing percutaneous intervention with Nobori deployment
* No contraindication to prolonged DAPT

Exclusion Criteria:

* Subjects absolutely necessitating continuous DAPT
* Planned surgery necessitating discontinuation of antiplatelet therapy after enrollment.
* Active pathological bleeding
* Status of cardiogenic shock at enrollment
* Pregnant women
* Life expectancy of \< 1.5 years
* Subjects unable to give informed consent
* Episode of stroke \< 6 months
* Subjects with allergies or hypersensitivity to material of coating, Biolimus A9, and antiplatelet drugs.
* Subjects treated with other kind of DES or BMS during the index procedure
* Previous intervention with DES \< 6 months.
* Study participation impractical per investigator judgment

Primary outcomes:
measure: Net adverse clinical and cerebral event (NACCE)
timeFrame: 18 months
Secondary outcomes:
measure: All-cause death
timeFrame: 18 months
measure: Non-fatal myocardial infarction
timeFrame: 18 months
measure: Cerebrovascular events
timeFrame: 18 months
measure: Major bleeding
timeFrame: 18 months
measure: Rate of target lesion revascularization
timeFrame: 18 months
measure: Minor bleeding
timeFrame: 18 months
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Non-profit organization Associations for Establishment of Evidence in Interventions
state: Tokyo
Study officials:
References:
citation: Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H; NIPPON Investigators. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2017 Jun 26;10(12):1189-1198. doi: 10.1016/j.jcin.2017.04.019.
Clinical trial NCT02681627: Sim (Scratch in Miscarriage) Study
Official title: Pilot Randomised Controlled Trial of the Effect of Endometrial Scratch in Recurrent Miscarriage on Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Miscarriage
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Warwick
First posted: 2016-02-12
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: There is increasing amount of evidence which suggests that miscarriage is related to a primary endometrial problem. Recent cochrane meta-analysis (March 2015) has proven that endometrial scratch improves live birth in women who underwent IVF.

The aim of the study is to find out if scratch of the endometrium prevents recurrent miscarriage.

Detailed description: The Warwick BRU-RH (Biomedical Research Unit- Reproductive Health) hypothesis is that failed pregnancies are the result of failed decidualisation of the endometrium.

Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent
2. Actively trying for a pregnancy

Exclusion Criteria:

1. No active treatment in pregnancy
2. Inherited or acquired thrombophilia
3. Medical conditions- diabetes,hypertension,thyroid disorders
4. inability to tolerate internal examinations
5. uterine anomalies
6. Previous entry or randomisation in the present trial

Primary outcomes:
measure: Live Birth Rate after 24 weeks of gestation
timeFrame: from the recruitment of the first patient up to 12 months after the recruitment of last patient. the live birth rate of all the pregnant patients in the study who delivered after 24 weeks will be included in the outcome.
Secondary outcomes:
measure: Miscarriage until 23+6 weeks of gestation
timeFrame: from the recruitment of the first patient and up to 12 months after the recruitment of last patient. the outcomes of all the pregnant patients in the study who delivered up to 23+6 weeks will be included in the outcome.
measure: Pregnancy complications
timeFrame: from the recruitment of the first patient and up to 12 months after the recruitment of last patient. The patients who delivered after 24 weeks with a live birth will be included in the outcome and the described outcomes will be measured
measure: Acceptability of the intervention
timeFrame: Patient questionnaire will be issued at the time of randomisation. the returned forms up to 4 weeks after randomisation will be analysed and reported. this will be helpful for assessing the patients tolerability of the procedure
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals of Coventry and Warwickshire NHS Trust
state: West Midlands
Study officials:
affiliation: UHCW NHS Trust
name: Siobhan Quenby, MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02090127: Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Official title: Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Mullerian Mixed Tumor of Ovary
Lead sponsor: AVEO Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient

Detailed description: This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.

Eligibility criteria: Inclusion Criteria:

* Per original P05538 protocol

Exclusion Criteria:

* Per original P05538 protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: START
state: Texas
Study officials:
References:
Clinical trial NCT01472627: Effects of Bortezomib-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Official title: Effect of Bortezomib (Velcade)-Based Therapy on Cellular Immunity and Response to DC/Myeloma Fusion Vaccines in Vitro
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: MM
Bortezomib
Velcade
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2011-11-16
Enrollment: 11
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: Receiving standard of care treatment with a regimen containing bortezomib at Beth Israel Medical Center or Dana-Farber Cancer Institute

Brief summary: The purpose of this study is to better understand what effects Bortezomib, a drug used for multiple myeloma therapy, has on the immune system.

Detailed description: Subjects on this study will be receiving treatment for multiple myeloma according to the standard of care with a regimen containing Bortezomib.

If a bone marrow sample is clinically indicated to guide treatment, an additional 1 tablespoon of the specimen will be obtained for further laboratory studies.

Approximately 3 tablespoons of blood will be taken for research purposes before therapy with Bortezomib starts. When subjects return for follow-up after cycle 1, 2, and 3 and additional 3 tablespoons of blood will be taken for research purposes.

Optional samples of blood may be taken at follow-up visits after cycles 4, 5 and 6 and 1, 3 and 6 months after completing therapy.

This study also includes a medical record review.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed multiple myeloma
* Therapy with bortezomib alone or bortezomib/dexamethasone being initiated as the standard of care therapy for myeloma by their treating physician

Exclusion Criteria:

* Hypersensitivity to bortezomib, boron or mannitol
* Treatment with other investigational drugs within 28 days before enrollment
* Diagnosed or treated for another malignancy within 6 months of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
* Use of other myeloma directed therapy (except for dexamethasone) in combination with bortezomib

Primary outcomes:
measure: Effect of bortezomib on circulating dendritic cell and T cell populations
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jacalyn Rosenblatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02428127: Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
Official title: Efficacy of a Carbohydrate Drink on Speed, Agility and Power in School Going Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Development
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the impact of a beverage containing carbohydrate powder fortified with micronutrients on agility, speed, and power in school going children


Eligibility criteria: Inclusion Criteria:

* Informed consent by participant's parents or legally accepted representative
* Good general health
* Non anemic children (Hb≥12 g/dl)
* Academy/development level athlete (at least 3 activity sessions per week, for a minimum of 2 hours of activity in each session e.g. hockey, football, team sports)

Exclusion Criteria:

* Child in care
* Allergy/Intolerance to study materials
* History of cardiovascular disorder, respiratory diseases, diabetes mellitus, serious infection/injuries/surgeries (within past 3 months)
* Participation in any nutritional study in past 1 year
* Substance abuse
* Children on any kind of medication in past 1 month of screening

Primary outcomes:
measure: Change from baseline in Agility fatigue index
timeFrame: Baseline and 4h post-baseline
Secondary outcomes:
measure: Change from baseline in Speed fatigue index
timeFrame: Baseline and 4h post-baseline
measure: Change from baseline in Mean power output
timeFrame: Baseline and 4h post-baseline
Other outcomes:
Locations:
city: Pune
country: India
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: http://www.i-scholar.in/index.php/Ijnd/article/view/130266
Clinical trial NCT03899727: Sleep Disturbance in Pregnant Women in Upper Egypt
Official title: Sleep Disturbance in Pregnant Women in Upper Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disturbance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients visiting out patient clinic at Women Health Hospital will be counseled to participate in our study careful history taking and examination to exclude patients who not eligible to participate in the study.

Brief summary: Pregnant women are associated with hormonal, anatomic and mechanical changes that Change sleep patterns and quality of sleep. Several Investigators have reported Associations between sleep disturbances and hypertension, Coronary artery disease, Diabetes, and depression. Most of these associations have been established in the association with sleep disturbances


Eligibility criteria: Inclusion Criteria:

* All viable third trimester pregnancy

Exclusion Criteria:

* Intrauterine fetal death
* Any History of neurological, mental disorder.
* Any previous diagnosed sleep disturbances breathing disorder before pregnancy.
* Any patient with respiratory infection in the pregnancy.

Primary outcomes:
measure: The percentage of women with sleep disturbances among overall included women
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT03006627: Gender and Opioid Consumption
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative; Parotitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Opioids are widely used for pain relief after major abdominal surgeries\[1\]. Sex differences in the opioid analgesia have been reported and investigated in human subjects and animal models In this study, effects of sex difference on response to opioid analgesics after abdominal surgeries will be assessed regarding; analgesic duration (primary variable), frequency of analgesic requirement, total opioid consumption, Opioid related complications (respiratory depression, Nausea \& vomiting, itching, over-sedation, delayed intestinal motility).


Eligibility criteria: Inclusion Criteria:

* ASA I and II Cases scheduled for elective intraabdominal surgeries

Exclusion Criteria:

* diabetes,
* postmenopausal females,
* laparoscopic surgery,
* regional anesthesia emergency procedures,
* sepsis,
* hepatectomy,
* Renal impairment, and
* hepatic impairment,
* mental and psychiatric disorders.

Primary outcomes:
measure: postoperative morphine consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01794273: Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery
Official title: Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endovascular Carotid Surgery
Preoperative Hypotension
Keywords: Ephedrine
Phenylephrine
Vasopressor
Carotid surgery
Hypotension
Haemodynamics
Brain ischemia
Tissue perfusion
Stroke
anaesthesia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The effects on brain perfusion of the two currently vasopressors used to treat accidental hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and according to published reports

Detailed description: This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).

Eligibility criteria: Inclusion Criteria:

* Age over 18 ASA score I-III Planned carotid endarteriectomy under general anaesthesia Hypotension defined as SAP \< 90 mm Hg during general anaesthesia Informed consent to the trial Protected by the French health welfare

Exclusion Criteria:

* Emergency surgery Cardiac arrythmia Pregnancy or breastfeeding Allergy to the tested treatment Allergy to hydroxyethylstarch Allergy to the glue of the NIRS's electrodes Current medication: MAOI, intranasal vasopressors

Primary outcomes:
measure: Cerebral oxygen saturation (SctO2)
timeFrame: at day 1
Secondary outcomes:
measure: Incidence of post-treatment hypotension
timeFrame: At day 1
measure: Incidence of post-treatment bradycardia
timeFrame: at day 1
measure: Postoperative morbidity: cardiovascular, cerebral, renal, surgical
timeFrame: at day 1
measure: Postoperative recovery
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Charlotte BAUD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aliane J, Duale C, Guesmi N, Baud C, Rosset E, Pereira B, Bouvier D, Schoeffler P. Compared effects on cerebral oxygenation of ephedrine vs phenylephrine to treat hypotension during carotid endarterectomy. Clin Exp Pharmacol Physiol. 2017 Jul;44(7):739-748. doi: 10.1111/1440-1681.12759.