cyrilzakka/clinical-trials huggingface dataset:
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be between 18 and 65 years of age.
* Patient's ASA (American Society of Anesthesiologist) class must be between 1 and 3.
* If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.
* Patient must have 1 FACTOR to qualify

  * Female Sex
  * History of PONV
  * Motion Sickness
  * Non-Smoker
  * Intended Use of Post Operative Opioids

Exclusion Criteria:

* Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.
* The surgical procedure is less than 1 hour.
* The patient is pregnant or breast feeding.
* The patient has taken antiemetic medication in previous 24 hours.
* Patients with narrow-angle glaucoma.
* Allergy to belladonna alkaloids.
* Hypersensitivity to barbiturates.
* Patient taking any of the following medications:

  * Orap
  * Seldane
  * Hismanal
  * Propulsid
  * Phenytoin
  * Phenothiazines
  * Tricyclic Antidepressants
  * Meperidine
  * Tolbutamide
  * Aluminum and Magnesium Trisilicate-containing Antacids
  * Anti-Cholinergics
  * Coumadin
* Male patients with prostate hypertrophy.
* Patients with severe hepatic disease.
* Patients on Chemotherapy and taking Aprepitant.
* Patients with fever.
* Patients with sepsis.
Erector Spinae Block Versus Thoracic Paravertebral Block for Acute Thoracic Herpes Zoster

The aim of this research is to study and compare the efficacy and safety of single injection erector spinae plane block and thoracic paravertebral block in prevention of post herpetic neuralgia in patients with acute thoracic herpes zoster.


Eligibility Criteria:
Inclusion Criteria:

* Over 50 years of age
* Chest wall herpetic eruption of less than one week
* Moderate or severe pain

Exclusion Criteria:

* Patient refusal
* Eruption more than one week duration
* Patients who will not receive appropriate anti-viral therapy
* Patients with mild pain
* Infection at the site of injection
* Patients with a history of renal, hepatic diseases, coagulopathy, steroid therapy, malignancies.
* Patient taking chemotherapy and/or radiotherapy.
A Safety Study of ARRY-300 in Healthy Subjects

This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive.
* Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight \> 50 kg (110 lbs) and \< 113 kg (280 lbs).
* Additional criteria exist.

Key Exclusion Criteria:

* Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* A condition possibly affecting drug absorption (e.g., gastrectomy).
* Women who are pregnant or breastfeeding.
* A positive test for drugs or alcohol.
* Use of tobacco- or nicotine-containing products in excess of 5 cigarettes per day, or daily use of pipe, cigar, chewing tobacco or nicotine gum or patches.
* Treatment with an investigational drug within 30 days prior to first dose of study drug.
* Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to the first dose of study drug. As exceptions, acetaminophen may be used at doses of ≤ 1 g/day or ibuprofen may be used at doses of ≤ 800 mg/day until 24 hours prior to first dose of study drug.
* Blood donation of ≥ 1 pint within 30 days prior to first dose of study drug.
* Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
* Additional criteria exist.
A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)

This study will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-childbearing potential
* body mass index between 17.5-30.5 kg/m2 with a total body weight greater than 50kg

Exclusion Criteria:

* Evidence or history of any clinically significant physiologic, psychological, or medical conditions
* a positive drug screen or alcohol breath test
* a baseline ECG demonstrating a QTc\>450msecs or a QRS interval \>120msecs
Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma

Multicentric and prospective epidemiological study (NON INTERVETIONAL) to identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in metstatic renal cell carcinoma.

Molecular determinations will be developed ay CIMA and CNIO.

In coming years new TKIs for the treatment of mRCC are expected to be available. Identificaction of novel biomarkers is required to select those patients who would most benefit from a particular therapeutic strategy:

C-Met is a tyrosine kinase receptor involved in cellular growth and vascular develoment, also identify as a proto-oncogene.

Chemiokines: an increase in pro-angiogenic chemokines such as IL-6 \& IL-8 has been also suggested as a tumor dependent possible mechanism influencing invasion and metastasis after anti-VEGF therapy.

PBRM1 (BAF 180) mutation: Second major involved gene in clear cell RCC with truncating mutations in 41% (92/227) of cases. Mutations appear to inactive a protein that plays role in remodeling the structure of genetic material.PBRM1 mutations could be (partially) involved in about 40% of clear cell RCC. PBRM1 may affect the processes of cell divsion in renal cells and could consequently be another target for new drugs.

Eligibility Criteria:
Inclusion Criteria:

* Locally avanced or metastatic renal cell carcinoma with clear-cell component histology candidates to recieve sunitinib or pazopanib in fisrt line under standard clinical practice.
* Measurable disease by CT or MRI
* Life expectancy \>3 months
* Written informed consent.
* Performance Status 0-2

Exclusion Criteria:

* Any patients who does not fulfill the inclusion criteria.
Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash

Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.


Eligibility Criteria:
Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* Currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating
Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.

This is a randomized, double-blind, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of GR1501 injection in Radiographic Axial Spondyloarthritis, as well as a confirmatory clinical trial of immunogenicity.

This clinical trial was divided into four stages, namely screening period (W-4\~W0), core treatment period (W0\~W16), maintenance treatment period (W16\~W32), and follow-up period (W32\~W48).

target population： radiographic axial spondyloarthritis who had a inadequate response to NSAIDs or have a history of intolerance to NSAIDs.

primary outcome measure:percentage of participants achieving an ASAS20 response in week 16.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
* inadequate response, contraindications or intolerance to NSAIDs

Exclusion Criteria:

* Total ankylosis of the spine
* Ongoing or serious infection
* Either a current diagnosis or a recent history of malignant disease
* Are pregnant or breastfeeding
Evaluation of Point-of-Care (EPOC) for COVID-19

EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
* SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
* Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
* Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.

Exclusion Criteria:

* Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
* Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:

  1. stroke
  2. meningitis
  3. encephalitis
  4. myelitis
  5. myocardial infarction
  6. myocarditis
  7. pericarditis
  8. symptomatic congestive heart failure (CHF; New York Heart Association \[NYHA\] class III-IV)
  9. arterial or deep venous thrombosis or pulmonary embolism
* Current requirement for any of the following:

  1. high-flow supplemental oxygen
  2. non-invasive ventilation
  3. invasive mechanical ventilation
  4. extracorporeal membrane oxygenation
  5. mechanical circulatory support
  6. vasopressor therapy
  7. commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
* In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults with Depression

This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression


Eligibility Criteria:
Inclusion Criteria:

1. Self-identifying Latinx, Spanish-speaking
2. Adults 18-64 years
3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician
4. Participants must have an MGB psychiatrist and primary care provider.

Exclusion Criteria:

1. History of primary psychotic disorder, by history
2. History Bipolar I disorder, by history
3. Unstable complex PTSD, as assessed by study clinician
4. History of dissociative identity disorder
5. History of neurocognitive disorder
6. History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview
7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be \<140/90 mmHg.
8. History of aortic dissection
9. History of myocardial infarction
10. History of aneurysm
11. History of hepatic impairment.
12. History of epilepsy
13. History of prior hypersensitivity to ketamine
14. Body Mass Index greater than 35
15. Body Mass Index less than 18.5
16. Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion
17. Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis
18. Inability to provide consent.
Water Consumption, Hydration and Resting Energy Expenditure

A randomized, cross over study will assess the effects of ingestion of high and low volumes of water on REE over 90 minutes. The high volume of water 500ml and the low volume of water 250ml. Participants will be computer randomized to determine which volume of water to receive first. Participants will arrive at the Nutrition Assessment Laboratory between 7:00 and 7:30am following a 9 hour overnight fast. Participants will be instructed not to consume any food or drink after 10pm the night before the assessment. Participants will also be asked to abstain from alcohol and caffeine for 3 days before the assessment. After verification of eligibility, baseline REE will be measured for 30 minutes followed by administration of first assigned dose of water. REE will be monitored for the next 90 minutes. Blood pressure and heart rate will also be monitored, simultaneously to REE. After a 7-10 day washout period, participants will return for their second test day where the second dose of water will be administered. A 7-10 day washout period was selected to allow participants time to resume normal diet and hydration between visits.


Eligibility Criteria:
Inclusion Criteria:

* 18-39 years of age
* Generally Healthy men and women
* BMI 18.5-28
* Willing to abstain from caffeine for 3 days prior to testing
* Able to provide written consent in English
* Ability to communicate in English (oral and written

Exclusion Criteria:

* \<18 or \>39 years
* BMI \< 18.5 or \>28
* Pregnant or Nursing
* Taking prescribed or over the counter medication affecting fluid balance or metabolism
* Suffers from hepatic, renal, pulmonary, endocrine or hematological disease
* Performs more than 3 hours a week of strenuous exercise
* Consumes, on average, more than 2 alcoholic beverages per day
* More than 5kg of weight change over the past 6 months
* Claustrophobic
ALTO-100 in MDD and/or PTSD

The goal of this study is to collect biologically based data for defining predictors and correlates of the effects of ALTO-100.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of moderate to severe major depressive disorder (MDD) and/or post-traumatic stress disorder (PTSD)
* At baseline, either not taking an antidepressant medication, or currently taking a SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
* Willing to comply with all study assessments and procedures
* Must not be pregnant or breastfeeding at time of enrollment or throughout study

Exclusion Criteria:

* Evidence of unstable cardiovascular, respiratory, liver, or renal impairment or disease
* Active suicidal ideation
* Diagnosed bipolar disorder, psychotic disorder, or dementia
* Current moderate or severe substance use disorder
* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms

At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated.

Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.


Eligibility Criteria:
Inclusion Criteria:

* adult male subjects planned to undergo simple prostatectomy (TURP, Transurethral resection of the prostate, or open prostatectomy) for benign prostatic hyperplasia;
* treatment with alpha-blockers (Tamsulosin 0.4 mg/die)
* being capable of giving informed consent.

Exclusion Criteria:

* participation in another clinical study;
* known or suspected presence of prostatic cancer or PSA (prostate specific antigen) value \>10 ng/mL;
* suspected lack of the participant's compliance;
* known severe allergies or hypersensitivity to the study drug (active substance or excipients of the formulation);
* nown neurogenic bladder (i.e. Parkinson's disease);
* suspected or proven urinary infections;
* presence of bladder stone.
Treatment of Anemia With Epoetin Beta in Low Risk Myelodysplastic Syndrome (MDS)

Chronic anemia is the symptom most frequently found at diagnosis in low risk myelodysplastic syndrome. It generates an increased rate of morbidity and mortality in this population of patients whose median age is high and the rate of co-mobidities important. The historical treatment is limited to transfusion support with a significant impact on quality of life and the incidence of secondary haemosiderosis, which contributes to the emergence of co-morbidities, especially cardiovascular. Treatment with rHuEPO allows for overall erythroid response in 40-60% of patients treated.

In this trial, the investigators intend to study the interest of a treatment with epoetin beta in patients with anemia \<10 g / dL in the context of a myelodysplastic syndrome with IPSS score \<1.

In addition to studying the erythroid response, the investigators will measure the impact on quality of life and functional performance.

Patients will receive epoetin beta (60 000UI/week). Response will be assessed after 12 and 24 weeks of treatment.

Objective of the trial Assess the level of haematological response according to IWG 2000 and IWG 2006 criteria with a pattern of administration of high doses epoetin beta (NeoRecormon ®) for 12 and 24 weeks of treatment;

To evaluate the predictive value of the rate of reticulocytes at Day 8 on the erythroid response;

* Assess time to response
* Assess tolerance
* Assess the impact on quality of life using the FACT-An and EQ-5D measurement scales;
* Assess functional capacity:

Cardiovascular performance on effort by the 6-minute walk test Performing the " Short Physical Performance Battery " tests

Evaluation The evaluation of response according to the IWG 2000 and IWG 2006 criteria will be held at 12 and 24 weeks of treatment

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Must be 18 years of age or older at the time of screening
* Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score \< 1 ) and with anemia defined by Hb \< 10 g/dl (with RBC transfusion requirement or not)
* For women of childbearing potential, need for effective contraception throughout the study period.

Exclusion Criteria:

* Intensive Chemotherapy within 3 months before inclusion
* Myelodysplastic Syndrome with IPSS score \>1
* Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
* EGOG \> 3 ;
* Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
* Uncontrolled arterial hypertension
* Life expectancy less than 6 months
* CMML
* Pregnant or breast feeding female subjects
* Patients with creatinine clearance less than 30ml/min.
REal-worLd vAlidaTION of PhotoPlehtysmoGraphy (for Atrial Fibrillation Detection)

Mobile health solutions for rhythm monitoring (e.g. atrial fibrillation detection) using photoplethysmography (PPG) technology on a smartphone have been developed. This study validates the performance of a digital health application (FibriCheck®) using PPG technology on a smartphone against a single-lead ECG device (Kardia Mobile®).


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion.
* Subject provides informed consent.
* Subject understands and agrees to comply with planned study procedures.
* Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home.

Exclusion Criteria:

* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
* No access to a smartphone or unable to perform FibriCheck measurements at home.
* Pacemaker.
Does Longitudinal Nursing Follow-up Improve Smoking Cessation in Patients Referred for COPD Screening

a monocentric study to evaluate the efficacy of a longitudinal nursing follow up in smoking cessation in patients screened for Chronic obstructive pulmonary disease (COPD).

The challenges to limit the occurrence of COPD are early detection, the fight against smoking and smoking and addictions (e.g. Cannabis), as well as the fight against environmental exposures.

we proposed to evaluate if a longitudinal nursing follow-up at 3 months, 6 months and one year, in patients coming to screening for COPD.

Cessation of respiratory toxics is the most effective intervention in stopping the progression of COPD.

Eligibility Criteria:
Inclusion Criteria:

* Smoking patients screened for COPD between 35 years old 65 years old
* Read, write and understand the French language
* Patient affiliated to a social security system
* Written and signed informed consent

Exclusion Criteria:

* Patients with a diagnosis of respiratory diseases
* Patients receiving inhaled respiratory therapy
* Persons unable to perform spirometry
* Pregnant women
* Refusal to participate in research
* Patient under guardianship, deprived of liberty, safeguard of justice