cyrilzakka/clinical-trials huggingface dataset:
Assessing Patient Care Through Routine Use of Patient-Reported Outcomes

Patient reported outcome measures (PROMs) are assessments of health status or health-related quality of life. The EuroQol-5D (EQ5D) is an example of a generic instrument to assess health-related quality of life. The investigators will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6 months and 12 months to track patient care in a cohort of 300 older adults who are at high-risk of falls.

1. Purpose: We will use the EQ5D in the Falls Prevention Clinic as part of routine clinical assessment at baseline, 6-months and 12-months to track patient care in a cohort of 300 older adults who are at high-risk of falls.
2. Objectives:

O1: Our primary objective is to use a routinely administered patient reported outcomes measure, the EuroQol-5D (EQ-5D), in older adults at high risk of falls to determine patients self-reported health status over a 12-month followup period.

O2: Our secondary objective is to develop an explanatory model and a predictive model of covariates that explain significant gains or losses in health related quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Referred to falls clinic for assessment by general practitioner or emergency department physician.
2. Index fall presentation not due to overwhelming force resulting in presentation to Emergency Department or general practitioner (including syncopal presentation, see below).
3. At least 70 years of age.
4. No progressive neurological disorder (e.g. Dementia, Parkinson's, Alzheimer's).
5. Community dwelling (within Vancouver and Burnaby only).
6. Mini Mental State Examination Score of at least 24.
7. Walk at least 3 meters.
8. Has at least one of the following 'high-risk' criteria:

   * At least one other non-syncopal fall in the past 12 months
   * PPA of at least 1.0 (using dominant score for strength test)
   * TUG of at least 15 seconds
9. Life expectancy of greater than 12 months as determined by the geriatrician.

Exclusion Criteria:

1. Any patients who do not meet the inclusion criteria specified above will be excluded from assessment at the Falls Prevention Clinic.
How to Identify Fatigue in Stroke Patients

This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale


Eligibility Criteria:
Inclusion Criteria:

Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant.

Patients that have given written informed consent

-

Exclusion Criteria:

Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -
Dapagliflozin in Allo-HCT for AGVHD

The goal of this clinical trial is to learn if Dapagliflozin could prevent acute graft-versus-host disease (aGVHD) in patients undergoing allogeneic hematopoietic cell transplantation (allo-HCT) and to assess its safety. The main questions it aims to answer are: Dose Dapagliflozin lower the cumulative incidence of aGVHD? What medical problems do participants undergoing allo-HCT have when taking Dapagliflozin? Researchers will document the occurrence of graft-versus-host disease, hematopoietic reconstitution, survival rates and adverse effects. Participants will take Dapagliflozin every day in -1 to 14 days.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years old.
* Patients with hematologic malignancies indicated for allo-HCT and having a suitable haploidentical donor.
* Willing to undergo myeloablative conditioning and graft-versus-host disease prophylaxis base on cyclosporin A and methotrexate.
* With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
* Patients with prior use of Dapagliflozin or other hypoglycemic medications may switch to Dapagliflozin, contingent upon the treating physician's assessment of contraindications, will be eligible.
* Signing an informed consent form, having the ability to comply with study and follow-up procedures.

Exclusion Criteria:

* With other malignancies.
* With a previous history of autologous hematopoietic cell transplantation, allo-HCT or chimeric antigen receptor T-cell therapy.
* With a history of allergies to Dapagliflozin.
* With type 1 diabetes or a history of ketoacidosis.
* With a history of recurrent urinary tract infections.
* With severe organ dysfunction.
* With active hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection.
* In pregnancy or lactation period.
* With any conditions not suitable for the trial (investigators' decision).
Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

As part of the global clinical development program for Dacomitinib, studies are planned in cancer patients in China. An assessment of Dacomitinib pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.

The single 45 mg oral dose pharmacokinetics of Dacomitinib will be characterized.

To evaluate the pharmacokinetics of Dacomitinib in Chinese healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese volunteers (individuals currently residing in mainland China, who were born in China, and whose parents are both of Chinese descent).
* Healthy male and/or female (of non-childbearing potential) subjects between the ages of 18 and 45 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests).
* Body Mass Index (BMI) of 19.0 to 24.0 kg/m2; and a total body weight should be 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant dermatologic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Drug dependency, a positive urine drug screen and/or alcohol dependency.
* Use of tobacco- or nicotine- containing products (or a positive urine cotinine test).
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Treatment with an investigational drug or biologic within the last 3 months (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication, whichever is longer.
Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 1

This study assess the ways in which e-cigarette product characteristics, such as marketing strategies, impact user experience to inform potential regulations.

There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile.

Eligibility Criteria:
Inclusion Criteria:

Vapers/E-cigarette Users

* Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

- Regular use of cigarettes containing nicotine

Exclusion Criteria:

* Pregnant or planning to become pregnant
Bioavailability of Bosutinib Administered as Capsule Contents Mixed With Applesauce or Yogurt Relative to Intact Capsules Under Fed Condition

This study is intended to estimate the relative bioavailability of a single 500 mg dose of bosutinib when administered as capsule contents mixed with applesauce or yogurt to intact capsules under fed condition in adult healthy participants. The comparisons will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. Statistical analyses will be performed comparing these parameters calculated after administration of a single 500 mg dose with the intact capsule formulation (100 mg x 5) as the Reference treatment and the capsule contents mixed with applesauce or yogurt (100 mg x 5) as the Test treatments.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the informed consent document (ICD).
* Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
* Any condition possibly affecting drug absorption.
* Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:

  1. estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \< 90 mL/min/1.73 m2;
  2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \> upper limit of normal (ULN);
  3. Serum (total and direct) bilirubin level \> ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= ULN;
  4. Amylase and lipase levels \> ULN.
Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine.

Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world.

Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of migraine (with or without aura) for \>= 12 months prior to screening (Visit 1).
* History of \>= 4 migraine days per month who require preventive treatment of migraine and are eligible for conventional migraine prophylaxis.

Exclusion Criteria:

* Have used topiramate or atogepant in the past.
* Have clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Pregabalin Peripheral Neuropathic Pain Study

To evaluate the efficacy of pregabalin, using a flexible, optimized dose schedule with dose adjustment based on Daily Pain Rating Scale (DPRS), compared to placebo in subjects with peripheral neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of peripheral neuropathic pain syndrome, including diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or post-traumatic neuropathic pain (including post-surgical), confirmed by a qualified pain specialist.
* Subjects must have completed at least 4 daily pain diaries during the 7 days prior to Visit 2 and have an average pain score of ≥4 over the 7 days prior to Visit 2 (randomization).

Exclusion Criteria:

* Neurologic disorders unrelated to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical), that may confuse or confound the assessment of neuropathic pain.
* Presence of any severe pain associated with conditions other than DPN, PHN, or post-traumatic neuropathic pain (including post-surgical) that may confound the assessment or self evaluation of the pain due to DPN, PHN, or post-traumatic neuropathic pain (including post-surgical).
* Creatinine clearance \< 30 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation in Appendix E). Maximum dose for subjects with creatinine clearance of 30 to 60 mL/min is 300 mg/day
CHASE Registry of Patients With Pulmonary Hypertension Receiving Targeted Therapy

CHina Registry for the chAracteristics and Management strategieS of patiEnts With Pulmonary Hypertension Using Targeted Therapy (CHASE Study)

The purpose of this study was to establish the clinical characteristics and treatment strategies of targeted pulmonary hypertension patients in China: a multicenter, prospective case registry (CHASE) study to describe the clinical characteristics, treatment used, disease progression, and outcomes (e.g., death, hospitalization) of patients taking targeted drugs in real-world clinical practice. This study will collect high-quality real-world data that can be used as a standalone dataset or combined with other data sources to address critical issues in the PH field.

This is a prospective, observational, multicenter study. The expected number of enrolled cases for the entire study: at least 5000; No experimental group and control group were divided. Patients were followed up every 6 months ±2 weeks after enrollment for 3 years. The study selected patients who signed informed consent, aged 18-25 years, clinically diagnosed with pulmonary hypertension, and were applying or planning to apply targeted drugs for pulmonary hypertension as the study objects. The primary endpoint was the incidence of clinical exacerbations at 1 year after enrollment. Secondary endpoints were all-cause mortality at 1, 2, and 3 years after enrollment, rate of lung transplantation or combined cardiopulmonary transplantation, 6-minute walking distance, NT-proBNP level, WHO cardiac function grade, ratio of right ventricular end-diastolic diameter to left ventricular end-diastolic diameter, pulmonary hypertension targeted drug regimen, and incidence of associated adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent;
* Between the ages of 18 and 85;
* Clinical diagnosis of pulmonary hypertension, using or planning to use pulmonary hypertension targeted drugs (including any one or more of the following: prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase agonists and prostacyclin receptor agonists).

Exclusion Criteria:

* Have a history of mental illness or drug or poison addiction, and can not sign informed consent or can not cooperate with the experimental study;
* Patients with malignant tumor and other diseases and life expectancy of less than half a year;
* Short-term (less than 2 weeks) patients taking targeted drugs for pulmonary hypertension
Telerehabilitation in Patients With Bronchiectasis

It is to determine the effectiveness of pulmonary rehabilitation by telerehabilitation method in bronchiectasis patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (CGr).

Patients diagnosed with bronchiectasis by HRCT by a chest diseases specialist and referred to pulmonary rehabilitation by determining the severity of bronchiectasis with the Modified Reiff Score and Bronchiectasis Severity Index Score will be included in the study.

The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TRGr) and Control Group (KGr). TRGr will be given online exercises, synchronized 3 days a week, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the KGr group, a pulmonary rehabilitation information brochure will be given to after the initial evaluation. They will be asked to do the exercises on the brochure. The exercise period will be 8 weeks for both groups. Standard medical treatments for both groups will continue.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Diagnosed with bronchiectasis by HRCT
* Stable clinical state at the time of admission without infection or exacerbation in the previous 3 weeks
* Know how to use technological devices

Exclusion Criteria:

* A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training
* Patients with systemic diseases other than bronchiectasis that also affect the lungs, such as systemic lupus erythematosus, infection, interstitial lung disease, lung cancer, heart and kidney failure, which will cause shortness of breath
* Having balance problems that prevent them from doing exercises
* Participation in a pulmonary rehabilitation program within the past 12 months
Single-site, Open-label, Randomized, Cross-over Study in Healthy Chinese Subjects to Evaluate the Bioequivalence of Single-dose Rotigotine Transdermal Patch Comparing 2 Different Formulations

The primary objective of the study is to establish Bioequivalence (BE) of 2 different formulations of the 2 mg/24 hr (10 cm\^2) Rotigotine transdermal patches in Chinese subjects.

Bioequivalence will be concluded if the 90 % Confidence Intervals (CIs) for the ratio Treatment A/Treatment B are fully included in the acceptance range from 0.8-1.25 for AUC(0-t) and AUC, and within the acceptance range from 0.7 to 1.43 for Cmax.

Eligibility Criteria:
Inclusion Criteria:

* An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
* Subject is considered reliable and capable of adhering to the protocol, visit schedule, and patch application according to the judgment of the investigator
* Subject is willing and able to comply with all study requirements
* Subject is Chinese (with all 4 grandparents being of Chinese origin, as well), male, and aged between 18 and 40 years (inclusive)
* Subject is healthy (no clinically significant findings in any of the investigations at the Eligibility Assessment (EA))
* Subject has a body mass index between 19 kg/m² and 24 kg/m² (inclusive), and a body weight greater than or equal to 50 kg
* Subject agreed to practice a medically accepted method of contraception (eg, condom, spermicide) unless sexually abstinent for the duration of the study and up to 3 months after the final patch application

Exclusion Criteria:

* Subject has previously participated in this study or subject has previously been assigned to treatment in a Rotigotine study
* Subject has participated in another study of an Investigational Medicinal Product (IMP) (or a medical device) within the previous 3 months or is currently participating in another study of an IMP (or a medical device)
* Subject has a history of diagnosis, counseling, or treatment for chronic alcohol or drug abuse within the previous 2 years
* Subject has a known clinically significant allergy or known or suspected clinically significant drug hypersensitivity to any components of the IMP or comparable drugs that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subject has lifetime history of suicide attempt
* Subject has a history of significant skin hypersensitivity to adhesives or other transdermal products or has recently unresolved contact dermatitis
* Subject has an medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subject has a history or present condition of epilepsy and/or seizures
* Subject has a history or present condition of an atopic or eczematous dermatitis, psoriasis, and/or an active skin disease
Application and Safety Evaluation of 3D Visualization System in Microsurgical Training

Based on the relative shortage of ophthalmic surgeons in China, the long micromanipulation cycle and the existing micromanipulation training methods have their own limitations, such as traditional operating in porcine eyes limited to synchronous guidance and evaluation, while surgical simulators are very different for the simulation of real tissues, and the price is expensive and easy to lose. Based on these, the development of a digital training system, that is, based on traditional micromanipulation platforms such as animal tissue, physical microscopic instruments supplemented by synchronous surgical guidance and evaluation, can combine the advantages of traditional training and simulator, so as to improve the efficiency of ophthalmic surgeon training, and also provide digital ideas for other disciplines based on traditionally surgical teaching.

The digital vision technology are required for the daily training of microsurgeons enrolled in our study. We only observed biological indicators of surgeons before and immediately after the operation using the digital technology, according with the prospective observational study design.

Eligibility Criteria:
Inclusion Criteria:

* Age:20-45 years
* Refractive diopters: spherical: - 6.00 to + 1.00 D, cylindrical: - 1.50 to - 0 D, and binocular difference less than 1.5 D
* Monocular best-corrected visual acuity (BCVA) ≥ 20/20
* Normal stereoacuity (60 s of arc or better)

Exclusion Criteria:

* history of strabismus
* history of systemic diseases
* history of eye surgery