cyrilzakka/clinical-trials huggingface dataset:
Bicuspid Valve Aortopathy Feasibility Study

In order to determine the effectiveness of medical therapy options to prevent enlargement of the aorta in patients with a bicuspid aortic valve, a randomized study will be planned. This feasibility study will gather accurate data on number needed to screen, changes in medication use over time, and variance of the intended study endpoint.

The study will consider all patients with a bicuspid aortic valve and 1) determine the number of patients needed to be screened for a clinical trial, based on patient eligibility percentages applying specific inclusion and exclusion criteria, 2) for those meeting these criteria, follow changes in and compliance with medical therapy over two years, and 3) in a limited subset of eligible patients, perform MRI at baseline and after 2 years to measure the change in aortic area over time.

Eligibility Criteria:
Inclusion Criteria:

* Bicuspid aortic valve
* Aortic measurement of 35 - 49 mm on prior imaging study

Exclusion Criteria:

* Prior aortic valve or thoracic aortic surgery
* Prior aortic dissection
* Other condition associated with enlarged aorta including Coarctation, Marfans, Turner syndrome, Loeys-Dietz, etc.
* Severe aortic stenosis or regurgitation
* Contraindication to MRI such as claustrophobia or implanted pacer/defibrillator
* Anticipated pregnancy, surgery, or move outside the area within 2 years
Music and Adherence Home Programs Post Stroke

The purpose of this study is to explore whether adherence to upper extremity home programs changes when persons post stroke practice with preferred music.


Eligibility Criteria:
Inclusion Criteria:

* Ages 40-85
* Mild to Moderate hemiparesis as determined by a score of 21 to 50 on the FM- UE
* At least 6 months post stroke
* American English as primary language

Exclusion Criteria:

* Significant visual impairment as determined by "aphasia-friendly" and age appropriate screening
* Significant hearing impairment as determined by self-report
* Actively receiving occupational or physical therapy services for upper extremity motor recovery
* Severe auditory comprehension impairment such that they cannot understand one-step directions as indicated by a WAB-R score below 8/10 on Sequential Commands Subtest
* Sitting or standing blood pressure of 180/110 or HE \> 100 bpm
Sweet Scents to Sweet Dreams

The purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. The goal of this study is to improve sleep and quality of life using herbal and Ayurveda/holistic-based botanical pillows.


Eligibility Criteria:
Inclusion Criteria:

* You must be at least 18 years of age.
* You must be willing to adhere to a sleep hygiene protocol (e.g., 10pm-midnight-6-8am) for 2 weeks without interruption in the comfort of your home.
* You must be willing to wear a watch that monitors your sleep and light as well as a sleep mask for two consecutive weeks.
* During the testing period, you must be willing to refrain from alcohol and anything that can affect mood and sleep.
* You must allow for the placement of an herbal pillow next to your head while sleeping for one week during testing.
* You must be willing to fill out short sleep logs during the 2 weeks of testing.
* You must also be willing to come to the study location on 3 occasions over a 2 week period.

Exclusion Criteria:

* Males or females with any condition that prevents adequate inhalation of botanical pillows \[e.g., Chronic Obstructive Pulmonary Disease (COPD), use of a Continuous Positive Airway Pressure (CPAP), deviated septum, etc\].
* Males or females on mood altering substances prescription (e.g., anti-depressants, anxiolytics, Ritalin, Adderall, anti-convulsants; opioids, etc), non-prescription/over-the-counter (OTC) drugs/herbal/natural products \[(e.g., tetrahydrocannabinol (THC)-containing compounds, melatonin, St. John's Wort, lavender capsules, essential oils, perfume-containing products, etc\].
* Any environmental, physical condition or pathology that can significantly impact on sleep and prevent an approximate 10pm-midnight-6-8am sleep rhythm (e.g., shift work, studying/exams, rotations, insomnia, new parents, nocturia, restless leg syndrome, chronic pain, etc).
* Any medications that can influence sleep \[(e.g., use of beta blockers; anti-histamines; dexamethasone; angiotensin converting enzyme inhibitor (ACEI); nicotine products, alpha blockers\]
* Chemical sensitivities
* Allergies
* Pregnancy.
Effectiveness of Ketamine for Depression and Suicidal Ideation in the Emergency Department

The purpose of this study is to examine the effect of a low-dose ketamine infusion on depression symptoms within the Emergency Department (ED) visit, and healthcare utilization after leaving the ED, when administered in the ED for depression or suicidal ideation.

Patients will be identified based on either a chief complaint of suicidal ideation, suicide attempt, or severe depression, or if the patient indicates during intake assessment that they have thoughts of harming or killing their self. Identified patients will be assessed by the ED provider for inclusion and exclusion criteria. If the patient is a candidate for the trial and gives their informed consent for enrollment, they will be randomized to receive either ketamine or placebo by a computer program that maintains blinding. The patient will be assessed by psychiatry for disposition and treatment plan prior to receiving the study drug, and will be reassessed four hours after the infusion. Thirty days after the patient leaves the hospital (either leaves from the ED or is discharged from inpatient admission), they will be contacted to follow up on their healthcare utilization after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older
* Presenting to the ED with a chief complaint of severe depression or suicidality, or presenting to the ED with any other chief complaint but answering "yes" to "Thoughts of harming/killing yourself?" during intake/triage

Exclusion Criteria:

* Acute mania or psychosis
* Enrollment in trial during a prior emergency department visit
* History of ketamine abuse or dependence
* Known hypersensitivity to ketamine
* Acute intoxication with any drug of abuse (including alcohol)
* Pregnancy or lactation
* Any condition that would place the patient at serious risk of harm from an increase in blood pressure (e.g. history of intracerebral hemorrhage, aneurysmal vascular disease, or arteriovenous malformation)
* Assessing provider does not want to enroll patient for any other reason, based on their clinical judgement
Effective Treatment of Hepatitis C in Substance Users

We hypothesize that integrating Hepatitis C into methadone and buprenorphine treatment will improve Hepatitis C outcomes as well as drug treatment outcomes in patients who are addicted to opiates. We will test this hypothesis by randomly assigning patients to receive integrated or separated care. The first group will receive Hepatitis C treatment and substance abuse treatment contemporaneously at the South Central Rehabilitation Center (SCRC). They will take both methadone or buprenorphine and Hepatitis C medications under the daily (methadone) or weekly (buprenorphine) observation of a health care provider. The second group will receive substance abuse treatment at SCRC, and go to another facility to receive Hepatitis C treatment services. These participants will take their medications on their own (without observation).

We will look at outcomes such as Hepatitis C viral loads, adherence to medications, and drug treatment outcomes such as receipt of buprenorphine and methadone and urine toxicology testing.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a DSM IV diagnosis of opioid dependence who are currently enrolled in methadone or buprenorphine maintenance at South Central Rehabilitation Center in good standing (opiate free urine with positive methadone or buprenorphine, respectively) for at least 30 days.
* Hepatitis C infection as evidenced by a positive HCV antibody and a detectable HCV RNA.

Exclusion Criteria:

* Suicidal or homicidal ideation
* Psychiatric condition that is not stable
* Pregnancy (RBV is a Class C drug during pregnancy)
* Pending court case or warrant which would interrupt treatment
* Decompensated cirrhosis (Child's Class B or C) or presence of hepatocellular carcinoma
* HIV+ with CD4\<200 or CD4\>200 and VL\>5,000 copies/mL
* Platelet count \< 75,000 /mL
* Hemoglobin \< 10 mg/dL
* Absolute neutrophil count \<1500 cells/mL
Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism

Female patients with thyroid disorders, referred to the Department of Head and Neck Surgery, at Metaxa Anti-Cancer Hospital of Piraeus, for total thyroidectomy.

Based on the development of biochemical hypocalcemia (cCa \< 8.4 mg/dl), subjects were divided into 2 groups: Group A: without postsurgical hypoparathyroidism that served as controls and group B: subjects, with acute postsurgical hypoparathyroidism.

Blood collections were performed in the morning after an overnight fast, in at least 3 different time points; preoperatively, 1st postoperative day and 7th postoperative day for the detrmination of sclerostin levels

Eligibility Criteria:
Inclusion Criteria:

* Indication for total thyroidectomy

Exclusion Criteria:

* parathyroid disorders, chronic kidney disease (eGFR\< 60 ml/min), treatment with antiosteoporosis drugs, rheumatic disease and history of long term (\>1 month) or current corticosteroid use
Gardasil Versus Cervarix in the Treatment of Warts

Warts are common, benign, epidermal proliferations caused by HPV infecting skin and mucous membranes. Treatment of warts poses a true challenge despite existing variable therapeutic modalities, whether destructive or immunotherapeutic. Human papilloma virus (HPV) vaccines are FDA approved for the prevention of genital warts and wart related precancerous and cancerous lesions but they are not indicated for treatment of preexisting warts yet

Approximately 35% of viral warts tend to be recalcitrant either showing no response to treatment or having prompt recurrences after treatment, causing frustration for both patients and physicians. Success rates vary significantly across patients and across different therapeutic interventions ranging from 7% to 90%.

Immunotherapy is proposed to enhance virus recognition by the cell mediated immunity, which allows the clearance of both treated and untreated warts and helps to prevent recurrences through induction of a long-term acquired immunity to HPV.

Few reports suggest the possibility of using quadrivalent or bivalent HPV vaccines as therapeutic modality rather than only preventive modality. This is a randomized controlled study to assess the efficacy and safety of quadrivalent and bivalent HPV vaccines in the treatment of warts

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients with recalcitrant multiple warts of any type. Warts were considered recalcitrant if they persisted for at least 6 months without any response to 2 different therapeutic modalities or more.
* Immunocompetent patients.
* Patients who do not receive any treatment of warts for at least 1 month before the start of study.

  * Patients who are able to understand and follow the study protocol and approve to sign the informed consent

Exclusion Criteria:

* Patients with acute febrile illness.
* Past history of asthma.
* Allergic skin disorders, such as generalized eczema, or severe urticaria.
* Pregnancy or lactation

  * History of hypersensitivity to the treatment vaccines.
  * Children
  * Immunocompromised patients
  * Patients unable to follow the study protocol
Lurasidone HCL - A 6-week Phase 3 Study of Patients With Acute Schizophrenia.

Lurasidone HCl is a compound being developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe as compared with quetiapine XR short term among acutely psychotic patients with chronic schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent and aged between 18 and 75 years of age.
* Meets DSM-IV™ criteria for a primary diagnosis of schizophrenia.
* Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
* Able and agrees to remain off prior antipsychotic medication for the duration of study.
* Good physical health on the basis of medical history, physical examination, and laboratory screening.
* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

* Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
* Any chronic organic disease of the CNS (other than schizophrenia).
* Used investigational compound within 30 days.
* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.
In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis

Subjects will receive the "Basel phenotyping cocktail" capsule orally with 120-200ml tap water in fasted state. After intake peripheral venous blood samples will be drawn.

12 patients (male and female) with liver cirrhosis for each Child Pugh Category A, B, and C, and 12 age- and gender-matched healthy control subjects will be included (in total 48 participants).


Eligibility Criteria:
Inclusion Criteria:

* Full mental and legal capacity.
* Signed informed consent prior to any study related procedure.
* Ability to communicate in German, sufficient to comprehend and adhere to study protocol.
* Normal physical examination, vital signs, laboratory workup, and CombiCaps LC Study Protocol Version 1.2 09.08.2017 Page 9 of 50 electrocardiogram (ECG) (in the opinion of investigator).
* Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening (in the opinion of investigator).
* No other conditions or circumstances that might interfere with compliance with study protocol (in the opinion of investigator).

Exclusion Criteria:

* Known hypersensitivity to probe substances or any excipient of the drug formulation.
* Ongoing or past treatment with another investigational drug within 30 days prior to screening.
* Concomitant treatment with drugs that inhibit or induce CYP3A4, CYP2D6, CYP2C9, CYP2C19, CYP2B6 and CYP1A2 function (in the opinion of investigator).
* Actual infection
* Severe heart failure (NYHA IV).
* Actual alcohol or drug abuse
* Positive results from urine drug screen at screening.
* Excessive caffeine consumption, defined as \>800 mg per day at screening\*.
* Subjects unwilling to stop consumption of alcoholic- and caffeine-containing beverages on study days until after the last sampling time-point of the study period.
* Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450 (e.g. grapefruit juice)
* Loss of 250 ml or more of blood within 3 months prior to screening.
* Pregnant or lactating women
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Legal incapacity or limited legal capacity at screening. \*100 mg caffeine is approximately 1'000 ml Coca Cola®, 2½ espresso cups or 1 cup of strong coffee.
Comparison of Respiratory Support for Acute Pulmonary Edema

This study is a retrospective study. The demographic and vital signs of patients with acute pulmonary edema are retrospectively collected to compare the prognosis of patients after receiving different respiratory support.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute pulmonary edema

Exclusion Criteria:

* Under 18 years old
The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization.

The study is a Prospective, Multi-center, Single Armed Registry to Evaluate The Safety and Efficacy of 'AVI' Stent for Treating Coronary Revascularization, 1200 primary coronary artery disease patients will be enrolled, at approximately 40 sites. Subject follow-up will occur via telephone contact or clinical visit at 30 days, 6 months, 9 months, 12 months, 2-5 years after procedure.

Eligibility Criteria:
Inclusion Criteria:

Patient must be at least 18 years of age;

Ischemic heart symptom and/or myocardial ischemia, include chronic stable/unstable coronary artery disease or acute coronary syndrome(ST elevated MI and Non-ST elevated MI);

At least one lesion with a diameter stenosis \>70% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5mm to 3.5mm;

If the subject has multiple vessel lesions, the implanted stents must be the same brand. The staged procedure only be allowed within 3 months after procedure, the implanted stent must be the same brand stent as the index procedure;

Subject has no CABG contraindication;

Subject or legal representative is informed the property of the study, understand the stipulations in the protocol, ensure the compliance and sign the ICF;

Exclusion Criteria:

Pregnant or nursing patients and those who plan to become pregnant up to 1 year post index procedure;

Subject has a tendency to bleeding or coagulation disorders, or has contraindication of antiplatelet and/or anticoagulant therapy, or can't accept the continue DAPT within 6 months;

Poor compliance or expectation of life less than 1 year;

Implanted any brand stent in the same target vessel within 1 year;

Left Ventricular Ejection Fraction (LVEF) of \<30%;

Cardiogenic shock or haemodynamics abnormal, needs inotropic agents or mechanical support;

The subject is allergic to asprin, heparin, clopidogrel/ticlopidine, stainless steel alloy, arsenic trioxide, sirolimus, styrene-butene-styrene or polylactic acid(PLA) polymer and contrast agent;

Severe tortuous and/or heavy calcification lesion;

Two or more proximal chronic total occlusion lesion;

Bifurcation lesions with double stents;

The subject has multi-vessel lesions but can not be implanted the same brand stents;

The subject that the investigator considers he/she was unfit to implant the AVI stents and Firebird 2 stents;

The subject attended other drug/device study or in the follow-up period.
Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

- No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to cevimeline or any comparable or similar product.
International CDKL5 Registry

Owing to the recent classification of CDKL5 Deficiency Disorder (CDD) as a unique disorder, there is a limited understanding of overall disease natural history and meaningful outcome measures. An international patient registry aimed at collecting both patient/caregiver and clinician-entered demographic, patient-reported outcome (PRO) and treatment data would benefit both the scientific and patient communities. This CDD registry will follow up to 500 patients diagnosed with CDD over several years through both the patients/caregivers and their clinicians. Initial data will be collected upon enrollment in the registry, followed by the collection of additional CDD-specific data on a bi-annual/ annual basis. No procedures will be performed as part of this registry. Clinician-entered data will be collected following standard of care visits conducted as part of patients' ongoing clinical care. Ultimately, the goal is to create a contact registry to allow patients/families to be alerted about relevant clinical trials and to collect valuable information that is accessible to the patient and scientific communities, thereby aiding and encouraging research in CDD.


Eligibility Criteria:
Inclusion Criteria:

* Person of any age, living or deceased;
* Be a patient or the legal guardian (parent or caregiver) of a patient with a diagnosis of CDD (Diagnoses must be confirmed by a clinician or genetic test);
* Have the ability to understand and complete an informed consent process where applicable per local regulations or have a legal guardian to provide consent on the patient's behalf if the patient is under the legal age, per local regulations, or otherwise unable to provide consent.

Exclusion Criteria:

* Patient with a diagnosis of CDD who is under the legal age, per local regulations, enrolling without a legal guardian;
* Legal guardian of a patient who is 1) over the legal age, per local regulations, and 2) is able to read and provide consent and enter data. (We require that patients over the legal age who are capable of reading and understanding and informed consent provide data directly.)
L-5-HTP-Related EMS

In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the patients who became ill died. It is suspected that impurities in the supplements caused the disease. More recently, similar impurities have been detected in batches of a similar dietary supplement called L-5-hydroxytryptophan.

This study is designed to learn more about EMS that develops in patients taking L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview, take a memory test, and fill out questionnaires relating to sadness and depression.

Patients may also undergo special tests to study conduction of nerve impulses and muscle function.

Samples of patients' supplements will be taken for chemical analysis.

The L-tryptophan-related eosinophilia myalgia syndrome (EMS), characterized by eosinophilia, myalgias, myositis, scleroderma-like skin fibrosis and fasciitis, occurred in 1989 in over 1500 patients who had ingested L-tryptophan for sleep disturbances and depression. The identical clinical syndrome has also occurred in subjects ingesting L-5-hydroxytryptophan (L-5-HTP).

Recently, a letter to Nature Medicine reported the presence of an impurity in 6 out of 6 samples of L-5-HTP obtained randomly at health food stores. This impurity appears to be the same as the one identified in material ingested by a family (mother and 2 babies) who had developed an EMS-like syndrome after ingesting L-5-HTP.

Although there have been no definite new cases of L-5-HTP-related EMS, the FDA is currently investigating unconfirmed reports of possible new cases.

Eligibility Criteria:
Patients must be at least 18 years of age.

Patients newly diagnosed with eosinophilia and myalgia, and who ingested L-5-HTP.

Subjects will be defined as having 5-L-HTP related EMS according to the diagnostic criteria originally established by the CDC for diagnosis of L-tyrptophan-related EMS.