cyrilzakka/clinical-trials huggingface dataset:
A Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospital costs.

This is a Phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age.
* Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
* Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
* Patients who abuse alcohol or other drug substance.
* Patients with severe hepatic impairment.
* Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
* Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
* Participation in an EXPAREL study within the last 30 days.
* Patients who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, a patient was ineligible if he or she met the following criteria during surgery:

* Patients who had any concurrent surgical procedure.
* Patients with unplanned multiple segmental resections of large intestine.
* Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
* Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
* Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
* Patients who received Entereg.
Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation Among Patients Undergoing Magnetic Resonance Imaging in Radiology Department at ILBS, New Delhi.

A study to assess the Effectiveness of Video Based Education Versus Music Therapy on Anxiety, Experience, and Co-operation among Patients undergoing Magnetic Resonance Imaging. This is a Experimental Multiple Interventions Pre test - Post test Design. Three groups namely, Video Based Education group, Music Therapy Group and control groups are there in study.There will be significant difference in the Mean Anxiety Scores, Experience level, and Co-operation level of patients undergoing MRI in Video Based Education , Music Therapy group and Control Group


Eligibility Criteria:
Inclusion Criteria:

* undergoing MRI with or without contrast
* having age between 18- 60 years.
* alert, oriented
* able to comprehend, speak and listen English or Hindi.
* patients without hearing and visual impairment.
* available during period of data collection

Exclusion Criteria:

* unconscious
* critically ill and sedated.
* visiting Radiology Department for other procedures such as Computed Tomography scan, and MRI brain
* having pain score of 3-10 on universal pain assessment scale..
Exploring Massage Benefits for Arthritis of the Knee

The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with OA of the knee.


Eligibility Criteria:
Inclusion Criteria:

* 35 years of age or greater.
* Written confirmation of OA of the knee as provided by the participant's physician.
* Radiographically-established OA of the knee.
* Pre-randomization rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale).
* Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
* Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
* American College of Rheumatology defined OA of the knee; specifically:

  a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness \< 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth

Exclusion Criteria:

* Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
* Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
* Signs or history of kidney or liver failure.
* Presence of asthma requiring the use of corticosteroid treatment.
* Use of oral corticosteroids within the past four weeks.
* Use of intra-articular knee depo-corticosteroids with the past three months.
* Use of intra-articular hyaluronate with the past six months.
* Arthroscopic surgery of the knee within the past year.
* Significant injury to the knee within the past six months.
* Presence of a rash or open wound over the knee.
* Unable to satisfy the treatment and follow-up requirements.
* Unable to provide written informed consent.
* Currently receiving massage therapy on a regular basis (at least twice a month).
* Knee replacement of study knee (ok if the knee not being studied has been replaced).
* History of participating in the EMBARK Phase I or II studies.
A Study to Evaluate the Effect of Mechanical Ventilation on the Inferior Vena Cava Collapsibility Index

Previous research has shown that the Inferior Vena Cava Collapsibility Index (IVCCI) can be used to assess volume status. One limitation of the previous work is that changes in intra-thoracic pressure can influence this measurement, and the magnitude of this effect has never been described. The investigators aim is to correlate the degree of change in IVCCI with the set degree of change in intra-thoracic pressure in a heterogeneous population of critically ill patients.

Initially eligible patients will be those admitted to the OSU MICU and 8ICU within the prior 48 hours. These patients will be screened for predetermined exclusion criteria. Eligible patients will have their IVCCI measured and baseline peak and plateau pressures noted. For those patients meeting a second set of criteria, a common ventilator maneuver will be preformed. The positive end-expiratory pressure will be increased by 5-10 cm/H20 pressure. This procedure will be aborted if ANY safety criteria are exceeded. During the interval, the IVCCI will be re-measured, the ventilator settings will be recorded, and the ventilator will be return to the initial settings. Since changes of these same magnitude are made daily in clinical practice, the risks to the patients in this study will be minimal and no more than that experienced in the course of usual care.

Eligibility Criteria:
Inclusion Criteria:

1. Age\>17 years
2. Current use of mechanical ventilation through an endotracheal tube.
3. Admitted to ICU within last 48 hours

Exclusion Criteria:

1. Severe COPD by history (documented FEV1\<50% predicted or CT evidence of emphysema)
2. Current suspected Asthma Exacerbation
3. Profound Hypoxia defined as a FiO2 requirement \>90% or a PEEP \>10 mmHg
4. Patient-ventilator desynchrony or active agitation
5. Unstable O2 requirement as determined by the primary clinical team.
6. Prisoners
7. Bedside clinician refusal (physician or treating nurse).

Exclusion Criteria for ventilator changes:

1. Cardiovascular instability (any increase in rate of vasopressors or i.v. fluid bolus for hypotension within the last four hours)
2. Current PEEP requirements of \>15cmH2O
3. Current SpO2 of \<88%.
Clinical Signs and Activity Limitations Associated With Dural Ectasia in Patients With Marfan Disease

Primary outcome is to compare the frequency and clinical features of spinal symptoms between Marfan patients with dural ectasia (cases) and those without (controls).

1. / Frequency of orthostatic headaches
2. / Frequency of low back pain due to orthostasis
3. / Frequency of low back pain during Vasalva maneuvers
4. / Frequency of lumbar claudication
5. / Frequency of root claudication

Secondary outcomes are to compare activity limitations, quality of life and intensity of low back and radicular pain between Marfan patients with dural sac ectasia (cases) and those without (controls).

1. / Average intensity of back pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain)
2. / Average intensity of radicular pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain)
3. / Activity limitations specific to the lumbar spine measured using the self-administered Oswestry Disability Index questionnaire (ODI, 0 = no limitations and 100 = maximum limitations)
4. / Physical component of quality of life measured using the physical component of the self-administered questionnaire 12-Item Short Form Health Survey (SF-12, 9.95 = worst quality of life imaginable, 70.02 = worst quality of life imaginable )
5. / Mental component of the quality of life measured using the mental component of the SF-12 self-administered questionnaire (5.89 = worst quality of life imaginable, 71.97 = worst quality of life imaginable)

Marfan's disease is a rare condition. Clinical phenotypes are heterogeneous. Among the abnormalities of the spine, dural ectasia is common with a prevalence of 66%. This is a major sign of Ghent's diagnostic criteria. To our knowledge, the clinical and functional signs associated with dural sac ectasia have never been described with precision. Only a few uncontrolled case series have been published. This is the case of the study by Foran and colleagues published in the American Journal of Genetics in 2005 which included 22 patients with Marfan disease with dural ectasia questioned about their symptoms and quality of life. We hypothesize the existence of a clinical and functional spinal phenotype specific to dural ectasia in patients with Marfan disease.

Eligibility Criteria:
Inclusion Criteria:

* Marfan disease according to the Ghent criteria revised in 2010
* Patients followed at the CNMR in Bichat
* Adults ≥18 years old and ≤ 55 years old (to limit the incidence of degenerative lumbar pathologies)
* Patient not opposing the research
* Mastery of the French language

Exclusion Criteria:

* History of lumbar surgery \<1 year
* Specific pathologies of the spine (tumor, infection, trauma, fracture, inflammatory rheumatism)
* Inability to write, read or speak French
* Cognitive or behavioral problems making assessment impossible
* Patients receiving AME
* Patients under tutorship or curatorship
Effective Management of Calcific Aortic Stenosis in the Elderly

Although aortic valve replacement is recommended for any symptomatic severe calcific aortic stenosis, the therapeutic decision may be difficult. because of patient age and comorbidities.

Transcatheter Aortic Valve Implantation (TAVI) has recently extended the therapeutic indications in patients at high risk of surgery. However, the proportion of different treatments is not known in a contemporary population that can be treated according to the different resources currently available.

The scientific goal of this observational research is to evaluate intra-hospital therapeutic decision in elderly patients referred because of symptomatic severe aortic stenosis.

The one-year survival will be analyzed according to the therapeutic decision and the characteristics of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized due to symptomatic tight aortic stenosis (NYHA \>= II, dyspnea, angina or syncope);
* Having given his consent to participate in the study.

Exclusion Criteria:

* Non-severe aortic stenosis;
* Asymptomatic aortic stenosis;
* Patient under the age of 75;
* Patient refusing to participate in the study.
Rhythm and Depression

The study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.

Patients are included at the time of their hospitalization in the psychiatry unit. They perform rhythmic parameters recording within 48hours after the initiation of the antidepressant treatment. An evaluation of the evaluation of the severity of depression symptoms is performed at 2, 4 and 6 weeks after the initiation of the antidepressant treatment.

A correlation analysis will be performed with rhythmic parameters and the response to the antidepressant treatment.

Eligibility Criteria:
Inclusion Criteria:

* current unipolar major depressive disorder according to the Diagnostic ans Statistics Manual (DSM)V
* MADRS score \> 25

Exclusion Criteria:

* other psychiatric disorder
* current treatment with thymoregulating agent
* clozapine treatment
* heart disease that could alter heart rate characteristics
* disease associated with fever
* shift work within 3 months before inclusion
* transmeridian travel in the preceding month
* guardianship
A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers before and after the administration of multiple-doses of rifampin.

This is an open-label (volunteer and study staff will know the identity of study drugs assigned) study of canagliflozin and rifampin taken in a sequential order by healthy volunteers for up to 12 days. Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet and/or two 300 mg rifampin capsules daily in sequential order as follows: on Day 1 volunteers will take one 300-mg canagliflozin tablet, on Days 4 to 9 volunteers will take two 300-mg rifampin capsules once daily, on Day 10 volunteers will take one 300-mg canagliflozin tablet + two 300-mg rifampin capsules, and on Days 11 and 12 volunteers will take two 300-mg rifamplin capsules once daily.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index between 18 and 30 kg/m2 (inclusive)

Exclusion Criteria:

* History of or current medical illness deemed clinically significant by the Investigator
Post-COVID-19 Epidemic Depression Assessment in Adults in South Punjab Pakistan

To assess the depression in adults especially in post COVID-19 duration in the rural and urban settings.

This study is designed to assess the prevalence of depression after the general and smart lockdown in various areas. This study includes both genders of any age.

Eligibility Criteria:
Inclusion Criteria:Any individual who can respond to the given questionnaire, with or without any ailment will be included in this study -

Exclusion Criteria:

Unconcious and non-cooperative individuals

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Glycan Analysis in Diagnosing Cancer in Women With Ovarian Epithelial Cancer and in Healthy Female Participants

RATIONALE: New diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer.

PURPOSE: This clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.

OBJECTIVES:

Primary

* Evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer.

Secondary

* Compare the new assay to the standard CA 125 for diagnostic accuracy.

OUTLINE:

* Ovarian cancer patients: Blood samples are obtained periodically for up to 2 years. Patients undergoing surgery have blood samples drawn before and after surgery. Medical charts are reviewed periodically for up to 3 years.
* Healthy volunteers: One blood sample is obtained. Volunteers also complete a 1-page questionnaire.

PROJECTED ACCRUAL: A total of 300 healthy female participants and 400 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand consent document for participation in the study
* Not pregnant
* Negative pregnancy test

Participants must meet 1 of the following criteria:

* Patients scheduled for ovarian surgery for an ovarian mass
* Healthy female volunteers with no active cancer or history of cancer
A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject

This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women of non-child bearing potential,
* Between the ages of 18 and 55 inclusive,
* Body mass index from 18 to 33 kg/m2,
* Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct.

Exclusion Criteria:

* Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia,
* Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system,
* History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.
Trimetazidine Therapy in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a common inherited heart condition that causes breathlessness, chest pain and fatigue. There are few treatments available. The investigators have recently shown that a drug called perhexiline reduced symptoms and improved exercise capacity in patients with HCM. This change appears to be driven by alterations in myocardial energy metabolism. The aim of this trial is to test a similar drug, trimetazidine, in a group of symptomatic patients with non-obstructive HCM.

HYPOTHESIS: trimetazidine will improve symptoms, peak oxygen consumption, cardiac function and arrhythmia burden in medically refractory symptomatic patients with non-obstructive HCM.

BACKGROUND:

Hypertrophic cardiomyopathy (HCM) is a common inherited disorder of heart muscle affecting 1 in 500 individuals worldwide. It is associated with arrhythmias, heart failure and sudden death in young people. In the majority of patients, HCM is caused by mutations in genes encoding cardiac contractile proteins. It has been hypothesised that excessive sarcomeric energy consumption is an important and early factor in the pathophysiology of HCM. Therefore modulation of myocardial metabolism presents a novel target for improving myocardial performance and symptoms in patients with HCM. Trimetazidine is an anti-anginal agent which like perhexiline reduces fatty acid oxidation and increases glucose oxidation, thus increasing the efficiency of energy production. Trimetazidine has been shown to significantly improve exercise performance in patients with stable angina, ischaemic and non ischaemic cardiomyopathy, either as monotherapy or in combination with beta-blockers or calcium channel blockers,

DESIGN: A single centre prospective randomised, double blind, placebo-controlled, trial of trimetazidine therapy.

DOSING: 20 mg Trimetazidine or Placebo three times daily for three months

METHODS: The following assessments will be made at baseline and after 3 months treatment: history and physical examination, Minnesota heart failure questionnaire, fasting blood tests, electrocardiogram, echocardiogram, cardiopulmonary exercise test, six minute walk test, 24 hour ECG Holter monitor.

Eligibility Criteria:
Inclusion Criteria:

* Non-obstructive hypertrophic cardiomyopathy (gradient \<30 mmHg at rest)
* NYHA (New York Heart Association) Class ≥ 2
* Peak VO2 (maximal oxygen consumption) ≤80% predicted for age and gender
* Heart rate \< 90/minute at rest

Exclusion Criteria:

* Diabetes Mellitus
* Abnormal renal function (GFR\<60ml/min) or hepatic impairment
* Female who is pregnant, lactating or planning pregnancy during the course of the study
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis

The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.

Prospective, single center, open-label study to

1. compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI
2. correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI
3. correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
* Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
* CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).
* Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)
* Eligible for coronary CT-angiography and functional assessment (CT-FFR)

Exclusion Criteria:

* Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
* Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
* Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
* Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
* Contraindication to adenosine (e.g. bronchial asthma)
* Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR \<30 ml/min)
* Presence of cardiogenic shock
* Participation in another interventional study involving the left heart or coronary arteries