cyrilzakka/clinical-trials huggingface dataset:
PTC Guiding Neoadjuvant Treatment in Breast Cancer

Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.

1. Before neoadjuvant therapy, all samples will be obtained by core needle biopsy for PTC drug sensitivity test.
2. After obtaining drug sensitivity results and confirming ER/PR and HER2 expression state, all recruited patients will be randomized into the PTC group or the routine treatment group, according to the method of random number table.
3. Beijing Cornerstone Life Science and Technology Co., Ltd. is responsible for gene sequencing and PTC drug sensitivity test for biological samples. All samples for the study are clinical residuals and will be used in the study, store or destruction is unapplicable.
4. Neoadjuvant therapy regimen in the PTC group is guided by PTC drug sensitivity results, and regimen in the routine treatment group is based on clinical guideline, such as (dd)EC-T for HER2 negative breast cancer, and TCH(P) or EC-TH(P) for HER2 positive breast cancer. All neoadjuvant therapy will be completed before operation if without PD.
5. According to postoperative pathological remission, pCR patients in two groups continued to complete adjuvant targeted therapy based on original treatment. For non-pCR patients in the PTC group, PTC drug sensitivity test will be done again to guide adjuvant therapy, for non-pCR patients in the routine treatment group, Capecitabine for HER2 negative breast cancer, and T-DM1 or H(P) will be selected.
6. All patients will be received radiotherapy or endocrine therapy if necessary.

Eligibility Criteria:
Inclusion Criteria:

1. Female between 18 to 70 years old.
2. Patients diagnosed with invasive breast cancer by pathology.
3. Clinical stage considered as T2-4N0-2M0 .
4. HER2 overexpression by IHC or FISH positive.
5. Patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery.

Exclusion Criteria:

1. Patients have already accepted any other anti-tumor treatment not included in our project.
2. Patients with metastasis are not considered surgery therapy.
3. Patients cannot accept chemotherapy or anti-HER2 targeted therapy, because of severe cardiovascular diseases or other reasons
Advanced Carbohydrate Counting and Automated Bolus Calculation

The investigators hypothesize, that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates, and that the metabolic control can be further improved with concurrent use of Accu-Chek Aviva Expert. Additionally, the investigators propose that carbohydrate counting will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose. Finally the investigators hypothesize that the use of Accu-Chek Aviva Expert will lead to fewer hypoglycemic episodes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes
* Age \>18 years
* Diabetes duration more than 12 months
* Multiple Daily Injections therapy (fast acting analog for meals; long acting analog as basal)
* HbA1c between 8.0% and 11.3%

Exclusion Criteria:

* Present or former practice of carbohydrate counting
* Gastroparesis
* Pregnancy or nursing
Adherence in Pediatric Multiple Sclerosis

Disease modifying therapies (DMT) are widely used for children and adolescents with MS. Nonetheless, many pediatric patients continue to relapse and therefore require changes in therapy. We designed this research study to learn more about medication use in children and adolescents with MS. We are also interested in learning what a behavioral feedback intervention can tell us about adherence to medicine. Finally, we hope this research project will inform the way we provide clinical care for children and adolescents with MS.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent boys/girls who are 10 to 17 years 11 months old;
* Have a diagnosis of MS, as per revised McDonald diagnostic criteria and International Pediatric MS Study Group criteria;
* Prescribed with an oral or injectable disease-modifying therapy for MS for at least six months.

Exclusion Criteria:

* Have non-specific white matter abnormalities and metabolic or infectious etiologies for white matter abnormalities. This is indicative of not having a true diagnosis of MS.
* Patients on IV DMT will not be included in the study.
* Non-English speaking patients
Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder

The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.


Eligibility Criteria:
Inclusion Criteria:

* Men and Woman equal or \> 20 years old
* Patients with urgency, urinary frequency and urgency incontinence

Exclusion Criteria:

* Patients with genuine stress incontinence
* Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
* Patients suffering from complications contraindicating the use of antimuscarinic medication
* Patients with polyuria
Pharmacokinetics of Micafungin in Critically Ill Patients

A study of micafungin in ICU versus non-ICU patients showed a significantly lower treatment success in ICU patients compared with non-ICU patients. It is known that in critically ill patients, alterations in function of various organs and body systems can influence the pharmacokinetics and hence the plasma concentration of a drug. The pharmacokinetic parameters of micafungin in critically ill patients are most likely different, but this has not been specifically studied.

The pharmacokinetic parameters of micafungin in critically ill patients will be established and plasma concentrations of micafungin will be correlated with disease severity.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with micafungin.
* Admission to an ICU.
* Age ≥ 18 years.
* Invasive candidiasis.

Exclusion Criteria:

* Blood sampling not possible.
Investigation of Relation With Preoperative Fragility and ASA Score in Elderly Patients

Frailty is a term specific to the geriatric period. It is used to describe weak, unstable, frail patients and partially expresses the frailty of the elderly patient. Once the frailty process begins, the risk of loss of mobility, dependency and mortality increases.

Frailty is an important predictor of adverse outcomes after surgery. According to studies conducted in various surgical situations, fragility is a major risk factor for morbidity, mortality and longer hospital stay. According to the available data, frailty has a sufficient basis for determining the risks of patients before surgery, developing preventive methods and making personal treatment decisions. As the frailty index increased, it was observed that the duration of postoperative hospital stay was associated with the need for intensive care, postoperative complications, and the rate of re-admissions within 30 days.

ASA (American Society of Anesthesiologists) classification is widely used in order to evaluate the physical condition preoperatively in geriatric individuals with multiple comorbidities. Considering the fragility variable while creating the ASA score in the preoperative period may be useful in determining the follow-up strategy during the operation and postoperative period. For example, a patient who is evaluated as ASA 2 because he has no problems other than simple 1-2 comorbid conditions, involuntary weakening of 5% in the last 1 year (not easily noticed), weakness (can only be detected with a dynamometer) and cessation of going out of the house (can only be understood when asked privately). ) can be categorized as at risk at ASA level 3-4, as it is understood to be fragile.

The aim of this project is to examine the frequency of frailty in elderly individuals who will be operated on, and to examine the relationship between frailty and ASA score using the anthropometry and comorbidity differences between frail preoperative patients and those who do not.


Eligibility Criteria:
Inclusion Criteria:

- Patients over the age of 65 who were admitted to the general surgery service for surgery and then operated.

Exclusion Criteria:

-Patients with advanced stage dementia
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Seladelpar in Subjects With Hepatic Impairment and Healthy Subjects

This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent (signed and dated) and any authorizations required by local law.
* Willing to be confined to CRU for the entire duration required by the protocol.
* Male or female, between 18 and 80 years of age.
* Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
* Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.

Exclusion Criteria:

* Pregnant or lactating women.
* Treatment with another investigational drug or device within 30 days prior to study drug administration.
* Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
* Inability to swallow medication.
* Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -1.
* Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
The Impact of the COVID-19 Pandemic on Testicular Cancer

In this study, investigators aim to reveal how the COVID-19 pandemic process affects testicular cancer presentations, tumor stages, the time elapsed between diagnosis and intervention, tumor recurrence and progression, which are oncological outcomes.

The rapid spread of the 2019 coronavirus disease (COVID-19) caused by a novel betacoronavirus known as the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has had dramatic effects on individuals and health systems around the world. Beyond those infected with SARS-CoV-2,the intense demand for limited health system resources has led to reduced capacity, rapid depletion of healthcare systems and hospitals becoming a source of virus transmission.

Urology associations and reference centers have issued recommendations to inform urology care during the COVID-19 outbreak. It is essential that urologists give priority to patient safety. Potential delays in the diagnosis and treatment of urological conditions and the additional burden on healthcare resources must be balanced against the risks of exposure to COVID-19. While this situation aims to conserve healthcare resources, it has created the risk of delaying cancer treatment. As a result, the transformation of health services and the increasing interest of the public in avoiding exposure to the disease has led to a decrease in the number of hospital admissions.

The effects of the pandemic on patients with testicular cancer due to a decrease in emergency room and urology clinic admissions are not clear. During theCOVID-19 outbreak, the EAU (European Association of Urology) panel of testicular cancer published an evidence-based guideline. According to this guideline, four priority groups were formed and a certain period of delaying treatment was defined for patients in each group according to their priorities.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with testicular cancer in the urology clinic.

Exclusion Criteria:

* Previous history of genitourinary system tumor
* Previous history of radiotherapy or chemotherapy
Colorectal Cancer Screening in Xinxiang City

The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).

The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 45-74 years at time of consent
2. Have not had gastrointestinal resection

Exclusion Criteria:

1. Previous history of colorectal cancer
2. Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
3. Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
4. Those with severe mental disorders and language communication disorders
5. History of contraindications to colonoscopy
6. Pregnant women
Implementing a Family Caregiver Checklist in Primary Care: A Pilot Study

The goal of this project is to pilot test CHEC (Collaborative Healthcare Encounters with Caregivers) in primary care. CHEC is brief intervention with two components: 1) a checklist to identify the needs and concerns of unpaid/family caregivers who accompany older patients (aged 65+) to their primary care visits and 2) accompanying Tip Sheet for clinicians.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Age 65-89
* English speaking
* Women and men
* Of varying race/ethnicity
* Accompanied to primary care visits at the Center on Aging by a family caregiver (family caregiver also consents to participating in this study)
* Sufficient cognitive capacity to consent themselves or through a legal representative

Caregivers

* Age 21+
* English speaking
* Women and men
* Of varying race/ethnicity
* Accompany an older adult to his or her primary care visits at the Center on Aging (Older adult also consents to participating in this study)
* Cognitively intact (on basis of a 6-item cognitive screen)

Clinicians

* Age 21+
* Women and men
* Of varying race/ethnicity
* Treat patients at the Center on Aging

Exclusion Criteria:

* Patients, caregivers, and clinicians that do not meet the inclusion criteria.
* Patients and caregivers who are deaf or have hearing impairments that limit their ability to answer telephone queries.
* Caregivers who are visually impaired and cannot see well enough to read large print and complete paper-based surveys.
* Patients and/or caregivers whose dyad counterpart does not consent to take part in the study (i.e., Patients gives consent and their caregiver does not).
Respiration Rate V2.0 in Healthy Volunteers

The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).

Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors.

The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects.
* 18 years or older.
* Subject is willing and able to provide written consent.

Exclusion Criteria:

* Subject is younger than 18.
* Subject is pregnant or lactating
* Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
* Subject has an abnormality that may prevent proper application of the device.
* Subject is in atrial fibrillation.
* Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
* Subject has an implanted pacemaker.
* Subject is unwilling or unable to sign informed consent.
Na-Phenylbutyrate VAscular Trial

This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age and less than 60.
* Healthy subjects will have no history of diabetes or prediabetes.
* Diabetes subjects can be either insulin dependent or not.
* Able to provide written consent and to comply with the procedures of the study protocol.

Exclusion Criteria:

* Age \<18 or \>60
* Pregnant or lactating women.
* Subjects with hypertension or taking any vasodilatory medications, any steroidal drugs, haloperidol, or valproic acid.
* Patients with congestive heart failure, severe renal insufficiency, hepatic failure, or known sodium retention with oedema.
* Active alcohol or substance abuse.
* Use of tobacco within the previous six months.
* Unble to provide written consent and to comply with the procedures of the study protocol.
A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant either must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s).
* Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
* Participant had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing).
* Participant was ≤ six months postpartum.
* Participant was amenable to intravenous therapy.

Key Exclusion Criteria:

* Active psychosis.
* Attempted suicide associated with index case of postpartum depression.
* Medical history of bipolar disorder.

Note: Other protocol-defined inclusion/exclusion criteria applied.
Rewards Sensitivity After Brain Injury

A study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.

Individuals in acute rehabilitation following acquired brain injury journal (ABI) and aged-matched, non-injured controls will be recruited for this study.

Testing sessions will take place in a private treatment room at the Shirley Ryan AbilityLab and required 45 minutes to complete. Upon entering the room, participants will be greeted, electrodes placed on the participant's fingers to record their electrodermal activity, and participants will provide demographic information. Participants will then be instructed about how to respond on the Cued Reinforcement Response Time task (CRRT, see description below), and complete the task on a laptop computer while their electrodermal activity is being recorded. In this task, they are instructed to respond as quickly and accurately as possible, and will be informed that they will receive a monetary reward based on their accuracy at the completion of the task. Finally, participants will complete 3 self-report measures: (1) explicit level of motivation was measured in a post-study survey which included two items from the Sensitivity to Punishment and Sensitivity to Reward Questionnaire, (SPSRQ); (2) Reward sensitivity was evaluated using the Reward Responsiveness Scale , and (3) depression was evaluated using the Patient Health Questionnaire (PHQ-8) survey. At the end of the session, the electrodes will be removed, and participants will be debriefed and provided their monetary reward

Eligibility Criteria:
Inclusion Criteria:

* Individuals with ABI

  * Diagnosis of Traumatic Brain Injury or Stroke, based on their medical records
  * Age between 18-100
  * Able to follow directions in English (measured informally during screening)
  * Able to use at least one upper extremity (demonstrated by holding a pen)
  * Mild-moderate or lesser diagnosis in cognitive-communication area
  * Score of 25 or higher on the Orientation Log assessment
  * Able to consent for participation in study (identifies through chart review)
  * Capable of understanding and cooperating with the experimental procedures.

Healthy participants

* Age of 18 to 100 years old
* Ability to follow directions in English
* Ability to use at least one upper extremity.

Exclusion Criteria:

* Individuals with ABI

  * Additional diagnosis of a neurological disorder other than ABI
  * Additional diagnosis of aphasia.
  * Having cognitive or behavioral impairments that preclude participation in the experimental procedures

Healthy Participants

• history of significant cerebrovascular or neurological disease including (but not limited to) meningitis, epilepsy and/or seizures, stroke, tumor, multiple sclerosis, meningitis, mental retardation, dementia.