cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.

i) Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.

ii) Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.

- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.

i) Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.

ii) Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.

- Inclusion Criteria for a Matched Healthy Participant (Group 3):.

i) Participant must be free of any clinically significant disease that would interfere with the study evaluations.

ii) Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.

iii) Participant must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator.

Exclusion Criteria:

- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.

i) Any major surgery within 4 weeks of the study intervention administration.

ii) History of drug abuse within 1 year of study intervention administration.

iii) History of alcohol abuse within 1 year of study intervention administration.

iv) Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

- Other protocol-defined Inclusion/Exclusion criteria apply.
Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
5. Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria:

1. Is participating in any concurrent clinical study;
2. Has any known active\* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Has undergone refractive error surgery;

   * \*For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Retrospective Observational Cohort Study of SYMBOL CUP DM 2

This is a single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty (THA) with a SYMBOL CUP DMR HA or a SYMBOL CUP DM CEM hemispherical dual mobility acetabular implant. The purpose of this study is to estimate the safety and efficacy of those two implants at two-year follow-up.

Description according to PICOS (Patient, Intervention, Comparator, Outcomes, Study design) framework:

Patients:

- Adult men and women requiring a total hip arthroplasty

Intervention:

- THA with SYMBOL CUP DMR HA or SYMBOL CUP DM CEM hemispherical dual mobility acetabular implants.

Comparator: None

Outcomes:

* Safety 1: Implant survival over 2-year follow-up.
* Safety 2: All adverse events, with focus on implant dislocation, infections, revision surgery
* Efficacy 1: Harris Hip Score (HHS) at baseline and 1-year follow-up.
* Efficacy 2: Modified HHS (mHHS) consisting of pain + functional subscores at baseline, 1-year and 2-year follow-ups.
* Efficacy 2: Devane score at baseline, 1-year and 2-year follow-ups.
* Efficacy 3: Charnley classification at baseline, 1-year and 2-year followups.

Study design:

* single-center retrospective observational cohort study of consecutively operated patients who underwent total hip arthroplasty 2 years prior to study start.
* Prospective 2-year follow-up letter and phone questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* All patients with total hip implant using hemispheric dual-mobility SYMBOL CUP DMR HA or SYMBOL CUP DM CEM
* Operation performed by the primary investigator
* Delay between index operation and March 1 2018 has reached 2 years

Exclusion Criteria:

* patient refusal to participate in the study
* minors (age \< 18 years)
* patients under guardianship
A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone

The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females
* Age 18 to 65 years of age at the time of signing informed consent
* Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
* Must be willing and able to communicate and participate in the whole study
* Must provide written informed consent
* Must agree to use an adequate method of contraception

Exclusion Criteria:

* Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose.
* Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
* Subjects who have previously been enrolled in this study.
* History of any drug or alcohol abuse in the past 2 years.
* Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* Females of childbearing potential who are pregnant or lactating
* Subjects who do not have suitable veins for multiple venepunctures / cannulation as assessed by the investigator at screening
* Clinically significant abnormal biochemistry, hematology or urinalysis as judged by the investigator
* Hemoglobin below the lower limit of normal
* ALT or AST outside the normal reference range at screening or admission.
* Confirmed positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
* History of clinically significant cardiovascular, neurological, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorder, as judged by the investigator
* Subjects with a history of cholecystectomy or gall stones
* Serious adverse reaction or serious hypersensitivity to any drug, the formulation excipients, or lactose intolerance
* Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration.
* Contraindication for Tasmar®
* Failure to satisfy the investigator of fitness to participate for any other reason

NOTE: Other inclusion/exclusion criteria may apply, per protocol
CoQ10 in Statin-associated Asthenia

This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effects of supplementation with CoQ10 phytosome on physical performance in older adults with self-reported statin-associated asthenia.


Eligibility Criteria:
Inclusion criteria:

* 65-80 years of age
* treatment for \>6 months with statin monotherapy (i.e. enrolled individuals were asked to be on the same statin at the same dosage for \>6 months)
* statin-associated asthenia for \>3 months

Exclusion criteria:

* serious or disabling diseases (e.g. severe organ failure, malignancy or dementia)
* orthopedic disorders, myopathies and any other acute or chronic disease that could significantly affect the individual's perception of asthenia
* obesity (body mass index (BMI)\> 30 Kg/m2)
* known gastrointestinal disorders potentially affecting the absorption of CoQ10
A Study of Survival and Outcome After Stroke

The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score \>10 who are eligible for mechanical thrombectomy but without receiving the treatment. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event.

The objective of this observational study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. The target population is a stroke cohort with a known infarct volume who presents within 8 hours from symptom onset with a NIH Stroke Scale (NIHSS) score \>10. Functional outcome as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event. This is a prospective, single arm, multi-center trial. Up to 200 patients at up to 30 centers will be enrolled in the study. It is anticipated that up to 150 evaluable patients will be needed for analysis. The sample size estimate is based on the primary study functional outcome at 90 days as defined by a mRS of 0-2. Assuming that this observational study will have as outcome of 25% (37/150) mRS 0-2 at day 90, the expected two-sided exact binomial confidence interval is (18%, 32%). This sample size is adequate to estimate the mRS outcome of 0-2 at day 90 for the natural history of acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* From 18 to 85 years of age
* Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1/TICI 0-1)from CT Angiography. Target vessel occlusion may include the supra-clinoid segment of the ICA through the M1 segment of the MCA.
* Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy.
* At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score \> 10
* Known core infarct volume assessed by CTP, CTA or DWI scans

Exclusion Criteria:

* History of stroke in the past 3 months.
* Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score \>1
* Known severe allergy to contrast media
* Uncontrolled hypertension (defined as systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
* CT evidence of the following conditions before enrollment:

  * Significant mass effect with midline shift
  * Evidence of intracranial hemorrhage
* Treated with endovascular therapy for acute stroke
* Life expectancy was thought to be less than 90 days prior to stroke due to non-stroke illness
* Participation in another clinical investigation that could confound the evaluation of the study
Immunity Against COVID-19 Vaccine in Healthcare Workers in Argentine

Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine.

Vaccination against coronavirus disease 19 (COVID-19) is an essential primary prevention tool to limit the health and economic effects of the pandemic. The Ministry of Health of the Nation, designed the "Strategic Plan for vaccination", which the first line being the health workers " The National Administration of Medicines, Food and Medical Technology authorized two emergency vaccines for administration, Sputnik V and Sinopharm vaccine. It is important to evaluate immunogenicity and its correlation with the long-term efficacy and safety profile of this vaccines.

Objectives: To determine the variation in the levels of Immunoglobulin G (IgG) antibodies in health workers who received a COVID-19 vaccine between the time before the first dose, and after 1 month, 6 months and 12 months after the completion of the immunization, depending on whether they have received the Sputnik V vaccine or the Sinopharm vaccine, and correlate the Immunoglobulin G levels with the presence of adverse events and infection with COVID-19 Methodology: Design: observational and analytical study of a prospective cohort of healthcare workers immunized with some COVID-19 vaccine. The presence of IgG will be determined qualitatively and quantitatively. The immunoglobulin G titer in each period will be compared globally and according to the type of vaccine administered.

Eligibility Criteria:
Inclusion Criteria:

* Subjects receiving any COVID-19 vaccine.

Exclusion Criteria:

* Subjects who do not agree to participate
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years

Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.

Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint

Eligibility Criteria:
Inclusion Criteria:

* Aged 3-8 years old
* Healthy subjects judged from medical history and clinical examination
* Subjects themselves or their guardians able to understand and sign theinformed consent
* Subjects themselves or their guardians can and will comply with therequirements of the protocol
* Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
* Subjects with temperature \<=37.0°C on axillary setting

Exclusion Criteria:

* Any prior administration of other research medicine/vaccine in last 30 days
* Any prior administration of influenza vaccine in last 6 month
* Any prior administration of immunodepressant or corticosteroids in last 3 months
* Any prior administration of blood products in last 3 months
* Any prior administration of any attenuated live vaccine in last 14 days
* Any prior administration of subunit or inactivated vaccines in last 7 days
* Subject who developed guillain-Barre syndrome post influenza vaccination
* Subject who is allergic to any ingredient of the vaccine
* Subject with acute febrile illness or infectious disease
* Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
* Subject with damaged or low immune function which has already beenknown
* Subject with congenital heart disease or other birth defects unsuitable for vaccination.
* Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
* Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's Disease

To determine the effects of the NMDA antagonist, CP-101,606, in subjects with Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

* 30- 80-year-old PD patients (UK Parkinson's Disease Brain Bank criteria) with a Hoehn \& Yahr stage score of 2-5 in the "off" state.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Improving Pulmonary Function Following Radiation Therapy

The purpose of this study is to develop radiation plans that will help preserve lung function in healthy tissue surrounding the tumor. We believe that 4DCT scans can be useful in designing radiation treatment plans that help us avoid healthy normal functioning lung tissue close to lung tumors. Currently 4DCT scans are used to help us determine exactly where the tumor is and how it moves when you breathe. In this study we will also use the 4DCT scans to try to identify high functioning normal lung tissue.


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of non-small cell lung cancer or lung metastasis from a solid tumor. One biopsy site is adequate for multiple sites of thoracic disease.
* Treatment includes localized radiation therapy with or without chemotherapy
* Karnofsky ≥ 60%
* Not pregnant per radiation oncology standard procedures
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior (within last 6 months) or future planned therapeutic surgery for the treatment of the existing lung cancer
* Prior thoracic radiotherapy
* Severe COPD defined as disease requiring an inpatient stay for respiratory deterioration within the past 3 months
* Oxygen dependence of \> 2 L/min continuously throughout the day at baseline
* Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
The Perioperative Pain Self-Management Program Trial

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

Surgery can precipitate the development of both chronic pain and long-term opioid use. There is a need for strategies to augment perioperative pharmacotherapeutic management of pain with non-pharmacologic strategies to prevent long-term sequelae. Psychological interventions such as cognitive behavioral therapy (CBT) can effectively reduce distress and improve functioning among patients with chronic pain. While CBT has been used extensively in patients with established chronic pain, it has not been used as a preventive intervention targeting the transition from acute to chronic postsurgical pain. The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among Veterans. This study will: Examine the efficacy of PePS compared to standard care on 6-month pain (primary outcome), mood and functioning outcomes as well as time to post-surgical opioid and other analgesic use cessation.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers

Exclusion Criteria:

* inability to complete study forms/procedures because of a language/literacy barrier
* active bipolar or psychotic disorder
* history of brain injury
* dementia
* CBT therapy within the past year
* lack of access to a telephone for PePS sessions
Elimination of Albumin-Bound Substances by MARS and Prometheus

This trial compares the efficacy of two artificial liver support systems, MARS (Molecular Adsorbents Recirculating System) and Prometheus (FPSA, Fractionated Plasma Separation and Adsorption), in removing albumin-bound substances such as bilirubin, bile acids, and cytokines.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients with acute-on-chronic liver failure (severe deterioration of chronic liver disease) unresponsive to standard medical treatment for \>=48 hours

Exclusion Criteria:

* arterial hypotension
* extrahepatic malignancy