cyrilzakka/clinical-trials huggingface dataset:
Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine

The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.


Eligibility Criteria:
Key inclusion criteria include:

* Age greater than or equal to 18 years upon entry into initial screening.
* Documented history of migraine with or without aura according to the International Headache Society (IHS) International Classification of Headache Disorders, Third Edition (ICHD-III) for greater than or equal to 12 months.
* Have high-frequency episodic migraine (HFEM): Defined as history of ≥ 7 to \< 15 migraine days and \< 15 headache days per month on average during the 3 months prior to screening.
* History of ≥ 4 migraine attacks of at least moderate severity per month on average during the 3 months prior to screening.
* History of treatment failure with at least 1 preventive treatment for migraine. Failure of preventive treatment for migraine is defined as treatment discontinuation due to lack of efficacy, adverse event, or general poor tolerability.
* Regular use of an oral triptan (using only eletriptan, rizatriptan, sumatriptan, or zolmitriptan) for acute migraine treatment, and typically initiating acute treatment with an oral triptan on \> 50% of attacks of at least moderate pain intensity. Regular use is defined as ≥ 4 days of oral triptan use per month during the 3 months prior to screening.

Key exclusion criteria include:

* History of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia.
* Has any medical contraindication to the use of an oral triptan.
* Previously treated with erenumab.
* Previously treated with a gepant (small molecule calcitonin gene related peptide receptor \[CGRP-R\] antagonist) in a preventive fashion in a manner consistent with migraine prevention that either:

  1. In the opinion of the investigator, did not offer any evidence of a therapeutic response or
  2. Was discontinued for less than 12 weeks from the date of initial screening or
  3. Was previously discontinued due to a known adverse drug reaction
* Currently being treated with lasmiditan and/or a gepant in the acute setting.
* No therapeutic response with greater than 4 of the defined medication categories after an adequate therapeutic trial.
* Currently has a history of consistent excellent response to oral triptans, defined as achievement of pain-freedom in ≤ 1 hour for ≥ 50% of treated attacks of at least moderate pain intensity during the 3 months prior to screening.
* Use of triptans administered via a non-oral (e.g. subcutaneous \[SC\] or intranasal delivery systems) or sublingual route at the time of screening, during the run-in and baseline periods, and throughout the study duration.
Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism

The purpose of this trial is to compare the performance of two contact lenses for contact lens wearers with astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Currently wearing soft contact lenses with astigmatism correction
* Other protocol inclusion criteria may apply

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment
* Currently enrolled in an ophthalmic clinical trial
* Strabismus
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator
* Other protocol exclusion criteria may apply
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction

This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).

Eligibility Criteria:
Inclusion Criteria:

1. age between 18-85 years
2. males or females
3. plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion Criteria:

1. those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
2. those with anatomic contra-indications to performing a TAP block
3. those unwilling to participate in follow-up assessments
4. vulnerable populations
5. chronic pain or associated diagnosis
Phase III Controlled Clinical Study of NPO-11 in Patients Undergoing Gastric Endoscopy

Patients who require gastric endoscopy will receive an intragastric single dose of NPO-11 20 mL. The superiority of NPO-11 to placebo as a premedication for endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on the percentage of patients having no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy (primary outcome measure).

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration in comparison with the placebo group.


Eligibility Criteria:
Inclusion Criteria:

Inpatients or outpatients of either sex who visit medical institutions for treatment or follow-up of confirmed or suspected upper gastrointestinal disease (symptoms) and meet the criteria (1) and (2) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.

1. Patients who need gastric endoscopy (except for endoscopy with a scope of \<9 mm in diameter, emergency endoscopy and endoscopy for comprehensive medical examination)
2. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study. The criteria (2) to (5) will be confirmed during endoscopy. Patients who meet any of these criteria will be withdrawn from the study at the time of confirmation.

1. Patients with a history of surgery to the upper gastrointestinal tract
2. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
3. Patients with upper gastrointestinal bleeding which requires hemostasis
4. Patients with reflux esophagitis (Los Angeles classification: B, C or D)
5. Patients with gastric or duodenal ulcers in active stage
6. Patients on cancer treatment (chemotherapy or radiotherapy)
7. Patients with impaired cardiac function (NYHA functional classification: III or IV)
8. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
9. Patients with a history of shock or hypersensitivity to lidocaine hydrochloride
10. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
11. Patients who have been exposed to NPO-11
12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
13. Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Sport, Rehabilitation and Nutrition in Multiple Sclerosis: The LINUS Project

Only a limited percentage of persons with MS (pwMS) participate to multidisciplinary rehabilitation because of poor support, knowledge and motivation. The investigators reasoned that pwMS should be more effectively prepared to increase their adherence. This study propose the implementation of an innovative collaborative approach, called "brief high-impact preparatory experience" (b-HIPE), inspired by an overarching model based on the interplay between competence, motivation and opportunity to increase in a short time awareness and motivation of pwMS.

The aim of the study is the evaluation of its feasibility. For this pilot study the investigator chose a single-group design with repeated measurements at baseline and post intervention.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 to 70 years
* EDSS ranging from 1 to 7.5.
* pwMS with who are on a western diet
* stabilized medical therapy and clinical conditions
* pwMS with a motor control of upper limbs sufficient to maneuver a tiller

Exclusion Criteria:

* Heavy smoking, alcohol and drugs abuse
* severe cognitive impairment
* dysphagia and/or comorbidities requiring protected environments and specific medical assistance
* blindness and severe visual disturbances (included severe nystagmus)
Genetics and Fat Taste Sensitivity

A cross-sectional quantitative study will be carried out; recruiting female, Caucasian participants aged 18-65 years. The relevance of candidate gene studies is disputed. Research has shown associations between genotype and total fat intake. However, food preference is often described as a result of exposure to food types during upbringing. Many single nucleotide polymorphisms (SNP) have been associated with fat taste sensitivity, the majority of research shows that with a reduced sensitivity comes a higher total fat consumption.

This study aims to assess the relationship between rs1761667 genotype, body mass index, fat intake, fat taste sensitivity and fat taste preference.


Eligibility Criteria:
Inclusion Criteria:

* European Citizen.
* Caucasian
* Aged between 18-65 years.
* Female

Exclusion Criteria:

* Currently following a diet or weight loss plan or have not been for over 6 months of the previous year.
* Suffering from diabetes (type I or II).
* Have cancer, or have not had cancer in the past.
* Smoker.
* Pregnant.
* Lactose intolerant .
A Study of the Safety of Atezolizumab in Participants With Locally Advanced or Metastatic Non Small Cell Lung Cancer in Argentina

This is a study of the safety and effectiveness of atezolizumab in participants with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Participants also will have progressed on an appropriate approved targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities treated in common clinical practice settings in Argentina.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent form submitted to the Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC)
* Have received at least one dose of atezolizumab as per local label and clinical practice

Exclusion Criteria:

* Contraindicated atezolizumab therapy
The Goals of Care Initiative

A single site hybrid implement-evaluation stepped wedge cluster randomised controlled trial in which cancer cluster groups (lung, colorectal, breast, renal, ovarian, upper GI \& sarcoma) are randomised sequentially to initiate the Goals of Care Initiative into clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing, or being considered for, systemic treatment from one of the cluster teams.
* 18+ years.
* Able to give written consent.
* Able to understand verbal and written English.

Exclusion Criteria:

• Patient is not being considered for Systemic Anti-Cancer Treatment.
Influence and Mechanism of Dyadic Coping on Parenting Stress and Parenting Self-Efficacy in Parents of Preterm Infant

The goal of this observational study is to investigate the parenting stress, parenting self-efficacy and dyadic coping of preterm parents and explore the influence and pathway analysis of dyadic coping between parenting stress and parenting self-efficacy.

For now, there is a lack of investigation and research on parenting stress, parenting self-efficacy and dyadic coping of co-parenting for discharged premature infants in the literature, and the mediating effect of dyadic coping between parenting stress and parenting self-efficacy of preterm parents has not been verified yet. This study aims to provide a theoretical basis for effective intervention for preterm parents with high parenting pressure and insufficient parenting self-efficacy in clinical work.

Eligibility Criteria:
Inclusion criteria for parents

* Parents of hospitalized preterm infants with a gestational age of less than 37 weeks;
* Both parents are at least 18 years old;
* Able to read and communicate in Chinese, able to complete the questionnaire independently or with the help of the investigator;

Inclusion criteria for Infants

* Gestational age less than 37 weeks;
* admitted to the NU or NICU and discharged after treatment

Exclusion criteria for parents

* Single-parent family;
* Parents diagnosed with severe anxiety and depression;

Exclusion criteria for Infants

* for birth defects cannot be cured and affect the quality of life;
* infants who were given up treatment due to illness or family reasons;
* transferred or death;
Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study

Thoracotomy is one of the most painful operation. Continuous thoracic epidural or paravertebral analgesia are gold standard for postoperative pain. But both techniques require skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose ketamine during intraoperative may be helpful in postoperative pain relief.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3
* elective thoracotomy
* can operate patient-controlled analgesia (PCA) machine

Exclusion Criteria:

patient with history of

* allergy to morphine or ketamine
* contraindicate to ketamine
* remain intubated in the postoperative period
ClariCore System Used in Transperineal Prostate Biopsy

The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach.

The overall objective of this study is to acquire ultrasound images, spectral data and prostate tissue biopsy cores using the ClariCore System via a transperineal approach. Ultrasound images corresponding to each needle insertion and T2-weighted MR scans will be saved for the purpose of further algorithm development that will provide physicians with real time tissue classification in conjunction with location information from the ultrasound imaging.

Eligibility Criteria:
Inclusion Criteria:

1. Males per Investigator assessment appropriate for transperineal prostate biopsy
2. Patient scheduled for transperineal prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy
3. Prostate volume \> 20cc and length at least 22mm as verified by ultrasound or prostate MRI prior to the procedure
4. Patient must be able to provide legal consent and signs an IRB (Institutional Review Board)/EC (Ethics Committee) approved Informed Consent form to participate in the study prior to any study mandated determinations or procedure

Exclusion Criteria:

1. Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping biopsy
2. Acute painful perianal disorder (i.e. rectal abscess)
3. Symptomatic, acute prostatitis
4. Surgical absence of a rectum or the presence of a rectal fistula
5. Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
6. Previous prostate intervention \[TURP (bipolar, monopolar, laser)\] TUMT, HIFU, Cryo, Rezum, Urolift\], not including previous prostate biopsy
7. Current required use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) prior to a medical procedure; or history of a bleeding disorder (e.g. coagulopathy)
8. Prior pelvic irradiation
9. Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
10. Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
11. Patient has compromised immune system, in the opinion of the Investigator
12. Active inflammatory bowel disease within the last 6 months
13. Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g.

    significant cardiovascular conditions or allergies)
14. Patient is not likely to comply with the protocol or follow up evaluation
15. Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study
Adenoid Hypertrophy, Respiratory Complications and Correlation With Infant Feeding Position

500 children aged 0-5 years followed since birth by Principal Investigator (PI)since January1, 2003 till December 31, 2018 and diagnosed with adenoid hypertrophy (AH) (study group) and 500 children aged 0-5 years followed by principal investigator during the same years and diagnosed as urinary tract infection (UTI), gastroenteritis (GE), diarrhea, vomiting but without AH (control group) were compared. Morbidity and treatment will be compared and correlated with gastro-esophageal reflux (GER), allergy and infant feeding position during the first few years of life in the two groups.

The 2 groups are children aged 0-5 years and treated by PI and followed since birth during years 2003-2018. Study group consists of children diagnosed at least 2 times as AH and control group as similar children with UTI, GE, vomiting or diarrhea. Respiratory problems (pneumonia, bronchopneumonia, bronchitis), ear problems (otitis media OM, serous OM), antibiotic treatment, use of bronchodilators, inhaled corticosteroid (ICS), chest X-rays, anomalous laboratory results, emergency room visits and hospitalization rates will be compared in the two groups, together with details concerning feeding position during the first years of life. Correlation between morbidity, degree of nasopharyngeal obstruction, allergy, GER and supine feeding position, will be evaluated.

Eligibility Criteria:
Inclusion Criteria: Study group: Young children with diagnosis of adenoid hypertrophy followed by PI Control group: young children with diagnosis of UTI, GE, vomiting or diarrhea followed by PI

Exclusion Criteria: Children with cystic fibrosis, primary dyskinesia, immune deficiency, congenital anatomical malformations of nasal or airway passages.

Children older than 6 months of age when starting to be followed by PI.
Prostate Screening Study Using MRI in BRCA Carriers

Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.

Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.

This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.

To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.

* Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
* To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
* Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
* Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
* Be 50 years of age or older.

Exclusion Criteria:

* Claustrophobia
* Contraindication to MRI
* Contraindication to receiving low molecular weight MRI contrast agent
* Previously diagnosed with prostate cancer
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Stable, or unstable angina and/or objective signs of myocardial ischaemia
* Informed consent
* Optimal result (\< 35% residual stenosis and \< type C dissection) after balloon angioplasty
* Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.
* Complex lesions to be included should have at least one of the following characteristics:

  * ostial in location (\< 5 mm from ostium)
  * total occlusions with a length ≥ 15 mm
  * bifurcational (side branch \> 1.75 mm in diameter)
  * angulated (\> 45° within lesion)

Exclusion criteria:

Patients:

* Other severe disease with an expected survival \< 1 year
* Other significant cardiac disease
* Known allergy against paclitaxel, clopidogrel (or ticlopidine),
* Myocardial infarction within 3 days of the index procedure
* Linguistic difficulties needing an interpreter
* Renal insufficiency (p-creatinine \> 200 micromol/l)
* Gastrointestinal bleeding within 1 month
* Childbearing potential or pregnancy
* Participation in another study

Lesions:

* Unprotected left main disease
* Restenosis
* Lesions containing visible thrombus
* Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
* Diffuse coronary disease distal to the treated lesion
* Heavily calcification
* Lesion located in saphenous vein graft