cyrilzakka/clinical-trials huggingface dataset:
A Study of the Use of Text Message Reminders to Take Palbociclib

The purpose of this study is to find out whether it is feasible (acceptable to participants) to use a smartphone app to send text message reminders to take palbociclib, and whether these reminders are effective at helping people remember to take palbociclib according to the treatment schedule.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a breast cancer diagnosis who are initiating therapy on palbociclib (Ibrance)
* \>/= 18 years of age
* Able to speak, read and write English
* Willingness and ability to send and receive text messages with intervention app
* Own a mobile telephone "smartphone" with text messaging capabilities. Only iPhone or Android operating systems support OhMD Application
* Criteria applicable for both Control and Intervention groups
* Flip-phones do not support OhMD Application and thus ineligible to participate
* Initiation palbociclib (Ibrance) for the first time, either as monotherapy or in conjunction with other medication such as Lstrozole (Femara) or Fulvestrant (Faslodex)

Exclusion Criteria:

* History of taking palbociclib (Ibrance)
* Patients whose caregivers coordinate their health care
Cadonilimab Combined With Chemotherapy as First or Second Line Treatment in Recurrent or Metastatic Triple Negative Breast Cancer

The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or metastatic TNBC patients;
* TNBC defined by immunohistochemistry as ER\<1%, PR\<1%, Her2=0\~1+, or 2+ while HER2 Fish test shows no amplification；
* Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC；When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment；
* ages 18 to 75 years at the time of signing the informed consent form (ICF);
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
* expected survival of ≥3 months; at least one measurable lesion per RECIST (version1.1);
* acceptable renal and liver function;

Exclusion Criteria:

* They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)；
* Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases；
* Patients with an active autoimmune disease that requires systemic treatment in the past two years；
* A known history of primary immunodeficiency；
* Pregnant or lactating women；
* Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study
Testosterone and Cortisol Levels in Infants

Very low birth weight (VLBW) infants have more health and developmental problems than normal birth weight full-term infants. These problems are more common in males than female VLBW preterm infants. Male VLBW infants also experience less positive mother-infant interactions than females, especially when mothers are emotionally distressed. This is a significant problem because positive mother-infant interactions function as an important protective factor against the negative health and developmental outcomes associated with prematurity. The source of the vulnerability of male VLBW infants to health problems, suboptimal mother-infant interactions, and poor development goes beyond gender socialization differences and includes biological factors. Identification of infant and maternal biological markers/predictors of infant health and developmental outcomes could ultimately lead to interventions for VLBW preterm infants.

The purpose of this study is to confirm that testosterone rather than cortisol is a more reliable marker/predictor of complications affecting infants' health outcomes, mother-infant interactions, and infant cognitive/motor/language developmental outcomes; and that male infants exhibit a higher sensitivity to testosterone levels than female infants.

This longitudinal study will examine the associations of the steroid hormones, testosterone and cortisol, levels with infant health, mother-infant interactions, and infant cognitive/motor/language development ('infant development') in very low birthweight (VLBW, BW \< 1,500 g) preterm (gestational age \< 32 weeks gestation) infants after adjusting for maternal physical and mental health state, infant socioemotional and behavioral development, and characteristics of infants and mothers. Concurrent and repeated measurement of testosterone and cortisol levels both in infants and mothers will be conducted through infancy and early childhood (at birth, 40 weeks postmenstrual age, 12 and 24 months corrected age).


Eligibility Criteria:
Inclusion Criteria:

* Neonates will be included if they are less than or equal to 32/0 weeks gestational age at birth and have a birth weight \< 1500 grams.
* Mothers will be included if they are (1) older than 15 years, (2) able to communicate in English or Spanish, (3) primary caregivers of the newborn.

Exclusion Criteria:

* Neonates will be excluded if they (1) are born \> 32/0 weeks GA, (2) weigh more than 1,500 grams at birth, (3) have congenital abnormalities, (2) will be discharged before day 7 of life, (3) have a positive urine drug screen, or (4) are being placed for adoption after discharge from the hospital.
* Mothers will be excluded if they have (1) narcotic or injection drug dependence or (2) a documented serious health (e.g., cancer or HIV positive) or psychological (e.g., schizophrenia) problem.
The Impact of Clinical Pharmacists Role in Transition of Care From Other Departments to Critical Care Units in Alexandria Main University Hospital.

Transition of care between hospital departments is an important step in patient care. Every patient may need to be transmitted either for case deterioration, improvement or interventions purposes. It includes patient transition from home to hospital, transition from one hospital to another, transition from one department to another in the same hospital, transition from hospital to home. This step has many patient safety risks due to health care teams' miscommunications, shifts handoffs and use of hard copies patients' profiles crowded with papers. So many pharmaceutical and health care organizations mentioned transition of care as one of patient and organizational related quality standards . All health care team members, including clinical pharmacists, have important roles to be played. Clinical pharmacists' services differ according to the setting at which patients are presented in.

They include medication reconciliation, resolution of medications discrepancies and medication related problems, interprofessional collaboration and communication, recommendations to patients and care givers and their engagement in the therapeutic plan and post discharge follow up .

ACCP structured task force recommendations for quality measures and associated metrics according to Avedis Donabedian's model of health care quality. Process metrics involve measuring the proportion of patients receiving transition of care services and calculating the total number of medication discrepancies and medication therapy problems and their distribution, overall and by type. Outcome measures include rates of unplanned 30 days, all cause hospital readmissions, total hospital length of stay, completion rates of first planned follow-up contact within prespecified time intervals as completion of post discharge telephone interview within 72 hours and completion rates of pharmacist-referred visits for preventive medicine or other medication-related concerns.

In this study ,the investigators will focus on clinical pharmacist services within transition in the same hospital from other department to critical care units. the investigatorswill select to measure the most important and applicable outcomes regarding this step of transition.


Eligibility Criteria:
Inclusion Criteria:All patients transmitted from any department in the hospital to critical care units.

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Exclusion Criteria:Patients transmitted from other hospitals.

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Mechanisms, Predictors, and Social Determinants of Cardiotoxicity in Prostate Cancer

This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.

The investigators propose a prospective longitudinal cohort of prostate cancer patients treated with Androgen Deprivation Therapy (ADT) to determine the associations between social determinants of health (SDOH) and cardiotoxicity risk and to determine wither associations between SDOH and cardiotoxicity risk differs according to race. Patients will be followed with serial echo, blood draw, and surveys prior to start of ADT and then 6 months, 1 year, 2 years, 3 years, and 5 years after start of ADT.

Eligibility Criteria:
Inclusion Criteria:

Men older than 18 years of age Prostate cancer diagnosis planned for treatment with ≥6 months of ADT (with or without RT) for clinically localized, biochemically recurrent, or oligometastatic disease. Planned ADT regimens may include: GnRH agonists (goserelin, histrelin, leuprolide, triptorelin) with or without first-generation anti-androgens and GnRH antagonists (degarelix). Additional systemic agents, including second-generation androgen receptor signaling inhibitors, may be used in combination with GnRH agonist/antagonist therapies per provider clinical discretion.

Ability to provide informed consent

Exclusion Criteria:

Prior ADT injection within 6 months prior to enrollment Inability or unwillingness to provide consent
A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects

The primary objective in this study is to assess if single doses of BMS-986104 that are safe, tolerable, and result in sufficient lymphopenia (50% to 70% reduction in absolute lymphocyte count) can be achieved without bradycardia or other adverse events in healthy male subjects.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Healthy male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study
* Men ages 18 to 49 years, inclusive

Exclusion Criteria:

* Any acute or chronic medical illness judged to be clinically-significant by the Investigator and/or Sponsor medical monitor
* Presence of fecal occult blood at screening
* History of prolonged occupational exposure to organic solvents or pesticides
* History of vitamin B12 deficiency and/or achlorhydria; or a vitamin B12 level at screening \<lower limit of normal (LLN), confirmed by repeat test
* History of Guillain-Barré Syndrome
* Past or current history of central or peripheral neuropathies, or past or current symptoms of sustained or recurrent paresthesias (tingling), numbness, or neuropathic pain (burning, aching or stabbing) in any extremities. Note: Experiencing an extremity "falling asleep" occasionally is not be exclusionary
* Clinically significant abnormality in the neurological exam at baseline (predose)
* Clinically significant nerve electrophysiology abnormalities at baseline (predose)
* Any history of testicular or epididymal disease/disorder
* Clinically significant abnormality on ophthalmologic exam or any findings suggesting an increased risk of macular edema at baseline (predose)
* History of hypothyroidism or carpal tunnel syndrome
* Subjects with history of diabetes mellitus
* Subjects with history of any type of heart disease, including ischemia, infarction, arrhythmias, hypertension, atrioventricular block of any degree, bradycardia, syncope, clinically significant ECG abnormalities, or any congenital heart disease
* Subjects with any acute or chronic bacterial, fungal or viral infection within the last 3 months prior to screening, as well as any febrile illness of unknown origin within 14 days of screening
* Subjects who have received any live vaccines within 1 month of study drug administration or who plan to have a live vaccine at any time during the study
* Positive test for tuberculosis at screening (QuantiFERON® GOLD)
English as a Second Language Health Literacy Program

This research is using a Community-Based Participatory Action Research (CBPAR) approach to design, implement, and evaluate English as a Second Language health literacy classes for Hispanic adults to reduce lead exposure.

This Community-Based Participatory Action Research (CBPAR) aims to:

1. Develop a community-based participatory English as a Second Language (ESL) health literacy curriculum for lead exposure that can be used in other locations or programs.
2. Determine the outcomes of the curriculum, including changes in knowledge about lead, access to health resources, and health behavioral changes to reduce lead exposure.
3. To evaluate the implementation of the ESL health literacy curriculum.

This research focuses on ESL health literacy classes provided to Hispanic adults to reduce lead exposure. This research will use a pilot test with a pre-post test design. The program will last for 8 weeks; with weeks 1 and 8 as the assessment weeks. The curriculum uses pedagogies that move participants from health literacy as functional skill to health literacy as social practice where knowledge is used for empowerment and meaningful change. The goals of this research are to demonstrate increased health literacy knowledge, improved health behaviors, increased access to health services, and improved English language proficiency for Hispanic residents of Flint in relation to lead exposure prevention.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic immigrants living in or around Flint.
* Native speakers of Spanish, with varying degrees of English fluency and literacy.
* 18 years old and older.

Exclusion Criteria:

* Immigrants from other linguistic backgrounds will be excluded at this time because all program materials will be bilingually available in English and Spanish.
* Children will be excluded at this time because we are focusing on ESL health literacy for adults.
Comparison of Tele-rehabilitation or Video-Based Core Exercises in Individuals With Axial Spondyloarthritis

Exercise is a core treatment method in the management of Axial Spondyloarthritis. Clinical guidelines recommend a combination of pharmacologic and non-pharmacologic approaches to reduce disease activity and symptoms and improve physical function. The COVID-19 pandemic has accelerated the provision of healthcare services remotely and the digitalization of rehabilitation services. Telerehabilitation methods provide advantages in terms of transportation, prevention of infections that may occur due to suppression of immunity with drugs, and continuity of treatment in patients with axial spondyloarthritis. In this context, it is important to evaluate the effects of remote physiotherapy and rehabilitation delivery in chronic inflammatory rheumatic diseases. This study, which will examine the effects of telerehabilitation in the disease management processes of individuals with axial spondyloarthritis, is thought to shed light on future studies.

The aim of this study was to compare the effectiveness of telerehabilitation or pre-recorded video-based core exercise program on core endurance, disease activity and physical function in subjects with axial spondyloarthritis.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 55 years old,
* Axial Spondyloarthritis diagnosed by a rheumatologist,
* Not having any orthopedic, neurological, or mental illness that would affect exercise,
* Not using any assistive device for ambulation
* People who volunteer to participate

Exclusion Criteria:

* Pregnancy, malignancy, and recent surgery
* Presence of cardiopulmonary disease
* Patients with endoprosthesis and prosthesis
* Attending a regular exercise program (Pilates, core, or yoga etc.)
Transurethral Ventral Wall of Urethra-preserving Enucleation of Prostate

In this study, the investigators designed a randomized and double-blind prospective trial to evaluate the efficiency and safety of the investigators new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.

Although in recent dozen of years, laser operation and other safer minimally invasive surgeries have been well-developed, transurethral resection of the prostate (TURP) is still the gold standard for the surgical treatment of benign prostatic hyperplasia, despite of its various complications, and not suitable for the hyperplasia over 80 g which should be resected under open surgery. In this study, we design a randomized and double-blind prospective trial to evaluate the efficiency and safety of our new approach-transurethral ventral wall of urethra-preserving enucleation of prostate in comparison with TURP for the hyperplasia weighing more than 45 g.Urodynamic examination \[maximum flow rate (QMax), detrusor pressure, and so on\], transrectal color Doppler ultrasonography for the prostate, blood routine, blood electrolyte, prostate specific antigen (PSA), International Prostate Symptom Score (IPSS), the quality of life (Qol), blood loss during operation, and the weight of resected prostate were studied before and after the operation.

Eligibility Criteria:
Inclusion Criteria:

* BPH was diagnosed by DRE, Ultrasonography, CT or MR
* IPSS:\>15
* Qmax:≤10ml/s and volume of bladder \>200ml
* The weight of prostate \>45g

Exclusion Criteria:

* Patient with other aggravating malignant tumor
* Total-PSA\>20ng/ml, or 4\<total-PSA\<20ng/ml but the value of Free-PSA/total-PSA\<0.16
* The maximum press of detrusor muscle \<15cmH2O
* Patient with urethral stricture
* Patient with urinary infection
* Patient with Nervous System Disease
* Patient with surgical contraindication, such as severe cardiac or lung disease, diaphragmatic hernias, and so on
Observational Registry of the Treatment of Glanzmann's Thrombasthenia

This observational registry is conducted in Europe, Asia, Africa and the United States of America (USA).

The purpose of the registry is to evaluate the efficacy and safety of activated recombinant human factor VII (rFVIIa) during bleeding episodes and for the prevention of bleeding during invasive procedures/surgery in patients with Glanzmann's thrombasthenia (GT) with past or present refractoriness to platelet transfusions. Attention will be directed towards complications related to thrombo-embolic events and concomitant medications especially antifibrinolytics.


Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital GT defined as patients with lifelong bleeding tendency characterised by impaired or absent platelet aggregation, impaired clot retraction and prolonged bleeding time or prolonged platelet function analyser closure time. The patient has normal platelet counts and platelet morphology. Optional diagnosis criteria are quantitative or qualitative evaluation of GP (Glycoprotein) IIb/IIIa receptor including flow cytometry and identification of gene defects
* Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode or surgical event as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent must be obtained before entry of data into the registry

Exclusion Criteria:

* Patients with acquired thrombasthenic states caused by autoimmune disorders (acute or chronic) or drugs
Clinical Effectiveness of Polymethoxy Flavones Solid Dispersion as a Dressing Material for Palatal Grafts Donor Sites

Free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complication .

After the preparation and characterization of the solid dispersion of hydroxylated methoxy flavones, free gingival grafting surgeries require palatal grafts harvesting from the patient own palates . The donor sites pain , infection and retarded healing by secondary intension are the complications ; the aim of the study is to assess the analgesic , anti inflammatory effects of hydroxylated methoxy flavones.

Eligibility Criteria:
Inclusion Criteria:

* insufficient zone of keratinized gingiva recession of the gingiva non smokers free from systemic disorders

Exclusion Criteria:

* smokers insufficient palatal donor sits un realistic expectations