cyrilzakka/clinical-trials huggingface dataset:
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.


Eligibility Criteria:
Inclusion Criteria:

* PDS defined as DSM-IV-TR criteria, symptoms starting before age 8, and a total overall score of 18-36 on the SSI-3
* English-speaking, with 8th grade education, able to understand and cooperate with study requirements without assistance
* Not pregnant or breastfeeding
* Able to consent

Exclusion Criteria:

* No diagnoses of other CNS/Mental health disorders in the last 6 months
* No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening
* No use of non-medicinal stuttering treatments for 5 months prior to the study
* No use of illicit drugs or opiates of any kind
Survivorship Post-HCT Optimization Program

The purpose of this project is to investigate the effects of 12 weeks of high-intensity interval training (HIIT) and resistance training on several domains of health including physical function, cognitive function, mental health, and quality of life in patients who have undergone hematopoietic stem cell transplant (HCT). In addition, the project will determine the effects of 12 weeks of HIIT and resistance training on physical function, caregiver strain, mental health, and caregiver confidence in individuals who are providing care for patients undergoing HCT.


Eligibility Criteria:
Patient Inclusion Criteria:

1. ≥18 years old
2. English speaking
3. Within 90 ± 30 days post allogenic HCT

Caregiver Inclusion Criteria:

1. ≥18 years old
2. English speaking
3. Providing post-discharge care for the patient who has undergone HCT

Patient and Caregiver Exclusion Criteria:

1. Have an absolute contraindication to exercise including a recent acute cardiac event (\<6 months), unstable angina, uncontrolled dysthymias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspects or known dissecting aneurism, or coronary artery disease.
2. In addition to these absolute contraindications, the patient and caregiver will complete cardiopulmonary exercise testing (CPET) where the heart rate and heart rhythm will be monitored via a 12-lead ECG before, during, and after the test. The results from the CPET will be reviewed by a physician before the subject is cleared to participate in the HIIT and resistance training program. If the participant is not cleared by the physician following the CPET, then the patient and his or her caregiver will not be eligible to participate in the study.
Health Benefits of Writing Therapy Among Asian American Cancer Survivors

To learn more about participant experience as a Asian American immigrant breast cancer survivor and how writing about participant experiences may affect participant's health.

Primary Objective:

To determine the effects of writing therapy on QOL and perceived stress at the 6- and 12-month follow-ups.

Secondary Objective:

To discover the effects of writing therapy on stress biomarkers and perceived stress at the 3-month follow-up.

To explore the psychosocial and cultural mechanisms responsible for the benefits of writing therapy by using mixed methods.

Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 and older) diagnosed with stage 0-III cancer (or acute leukemia in remission/ chronic myeloid leukemia in chronic phase).
* Self-identified as Asian, Asian Americans, any Asian or Asian American subgroup (Chinese, Vietnamese, Indian, Korean, etc.) ethnic/cultural background
* Completed primary treatment, including surgery, chemotherapy, and/or radiation therapy, immunotherapy, or targeted therapy within the preceding 5 years.
* Comfortable reading in English or in Chinese.

Exclusion Criteria:

- Inability to provide informed consent.
EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders)

The EMERALD intervention involves 1) ordering an Emergency Department (ED) lipid panel, 2) calculating 10-year Atherosclerotic cardiovascular disease (ASCVD) risk using the Pooled Cohort Equations, 3) prescribing a moderate- or high-intensity statin if applicable, and 4) referring patients to outpatient care (primary care, preventive cardiology, or general cardiology, depending on risk level).

EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) is a pilot study seeking to determine the feasibility of initiating medical therapy for hyperlipidemia (HLD) in the Emergency Department (ED) and will collect data essential to inform a future randomized controlled trial comparing ED HLD treatment to usual care. HLD is a key cardiovascular disease (CVD) risk factor that is causally associated with atherosclerotic cardiovascular disease (ASCVD), the leading cause of US mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Emergency Department (ED) patients with chest pain
* 40-75 years old
* a low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL on an ED lipid panel or have known diabetes or Atherosclerotic Cardiovascular Disease (ASCVD)

Exclusion Criteria:

* Subject unwilling to take study medication
* Pregnancy or breastfeeding
* Inability to take study medication or, in the opinion of the Investigators/subject's doctors unsuitable for study participation
* ST-Segment Elevation Myocardial Infarction (STEMI) Activation
* ST-Segment Depression \>1 mm
* On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran)
* Unstable Vitals (Blood Pressure (BP) \<90, Heart Rate (HR) \>120 or \<50, O2 sat \<90%)
* Statin Intolerance
* High-sensitivity Troponin I ≥100 ng/L
* End-Stage Renal Disease (ESRD) and/or glomerular filtration rate (GFR) \<30 mL/min/1.73 m2
* Liver Cirrhosis
* Hospitalization
* Life Expectancy \<1 Year
* Transfer from Another Hospital
* Prisoner
* Non-English Speaking
Mobile Application Support for Women With Breast Cancer Undergoing Chemotherapy

Mobile phones have become an essential tool for everyday life. The convenience and easy accessibility of the data and information received through mobile phones have made mobile applications as the latest trend to provide education for patients in medical centers. In Taiwan, breast cancer incidence has been the highest among all cancers and the fourth leading cause of cancer deaths in women. Women with breast cancer who are undergoing chemotherapy suffer from a number of symptoms throughout the chemotherapy treatment that detrimentally affects their quality of life. Thus, providing social support and nursing care aids for these vulnerable women is imperative to help them face their breast cancer challenges. This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers. This study will use a mixed-methods design to develop a Mobile device application based on breast cancer literature and the clinical experiences of breast cancer patients to fulfill the needs women may experience during the chemotherapy treatment. Women with breast cancer will be invited to help refine the Mobile device application's content based on their experiences and feedback about the mobile application. Upon completing the mobile application development, women with breast cancer patients will be recruited to participate in a randomized controlled trial to examine the effectiveness of the mobile application. The results of this study will provide a foundation to deliver a remote, personalized, and continuous health care model to improve the self-efficacy, social support, and quality of life of women with breast cancer, and ultimately enhancing the overall quality of care and patient satisfaction with the medical care participants receive.

This application has four modules: 1) a Learning forum; 2) a Ask-the-Expert forum; 3) a Website link forum; 4) a Encouragement forum. The intervention group will receive routine care plus access to the "B with you" program during their six cycles of chemotherapy. Self-efficacy, social support, and quality of life will be measured at baseline, then the 3rd and 6th cycles of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* at least 20 years of age.
* diagnosed with breast cancer for the first time.
* treated with chemotherapy at the study sites.
* able to access the internet with a mobile phone.
* Fluent in spoken and written Chinese .

Exclusion Criteria:

* patients with cognitive dysfunction.
* diagnosed mental health problems.
* having with other cancers.
Incidence and Risk Factors of Low Anterior Resection Syndrome

Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.

With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 18

  * Diagnosed patients with rectal adenocarcinoma and who received low anterior resection with anastomosis creation or after a minimum 6 months interval after stoma reversal.
  * Tumors of the rectum (2-15 cm) from anal verge

Exclusion Criteria:

* • cognitive dysfunction

  * Having a history of inflammatory bowel disease or any disease with bowel function impairment namely, Crohn's disease, irritable bowel syndrome, ulcerative colitis or others.
  * Age less than 18
  * Metastatic cancer or tumor recurrence
  * Rectal tumors within 2 cm from anal verge( abdominoperineal)
Role of Vitamin C to Augment Iron Chelation With DFP or DFX

role of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

assess safety and efficacy of Vit C to Augment iron chelation with DFP or DFX in thalassemic patients.

Eligibility Criteria:
Inclusion Criteria:

* • Subjects with overload secondary to thalassemia major

Exclusion Criteria:

* • with HIV positive or have active HCV.

  * A history of serious immunologic hypersensitivity to any medication such as anaphylaxis or angioedema.
  * Participation in a previous investigational drug study within the 30 days preceding screening.
  * A woman of childbearing potential must have a negative serum pregnancy test at screening. She must use a medically acceptable form of birth control during the study and for a month afterwards who are pregnant or breast-feeding.
  * An inability to adhere to the designated procedures and restrictions of this protocol.
Herombopag Added to Cyclosporine in Non Severe Aplastic Anemia

This is a prospective, multicenter, single-arm, phase 2 trial. The aim of this study is to evaluate the efficacy and safety of herombopag combined with cyclosporine for patients with non severe aplastic anemia (NSAA).

This study aims to improve the 24 weeks response rate. The sample size is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 15 patients. If after 24 weeks at least 9 patients achieved a response, then enrollment was expanded to a total of 43 patients. The null hypothesis was unaccepted if more than 26 of 43 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 54 patients.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to comply with the requirements for this study and written informed consent.
* Male or female age ≥ 18 years
* Diagnosis of untreated non severe aplastic anemia.
* Platelet counts \< 50 x 10\^9/L at least 2 times consecutively (time interval ≥ 1 week)

Exclusion Criteria:

* Receive immunosuppressive therapy more than 4 weeks before enrollment
* Treatment with TPO-RA within 1 week before enrollment
* Inherited bone marrow failure syndromes
* Bone marrow fibrosis grade ≥ 2
* The presence of hemolytic PNH clone
* The presence of clonal karyotypic abnormalities (del(20q), +8 and -Y are not included in this category)
* Previously treated with TPO-RA ≥ 4 weeks
* Previously received immunosuppressive therapy ≥ 12 weeks
* Ferritin \> 1000 ng/ml (The increased level of Ferritin led by infection is not included in this category)
* Have an allergy to eltrombopag or any other part of this medicine.
* History of radiotherapy and chemotherapy for malignant solid tumors
* Cytopenia caused by other non-hematologic diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etc
* Abnormal liver function: ALT or AST \> 3 ULN, or TBil \> 1.5 ULN after treatment.
* Abnormal kidney function: Creatinine clearance \< 30 ml/min, or serum creatinine (sCr) \>1.5 ULN
* Patients with diabetic nephropathy, neuropathy, or eye disease
* Patients with poorly controlled hypertension or cardiac arrhythmia
* Patients with congestive heart failure and the NYHA grade ≥ 3 historically or currently, and LVEF \< 45% within 4 weeks before enrollment
* History of arteriovenous thrombosis within 1 year before enrollment
* Participation in another clinical trial within 4 months before the start of this trial
* Pregnant or breast-feeding patients
* Patients considered to be ineligible for the study by the investigator for reasons other than the above
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).
* Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.
* Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
* Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.

Exclusion Criteria:

* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.
* History of central nervous system (CNS) metastases or active CNS involvement.
* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Has an active infection requiring systemic treatment.
* History of hemophagocytic lymphohisticytosis.
* Has an active seizure disorder that is not well controlled.
* Has clinically significant (ie, active) cardiovascular disease.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.
* Has not adequately recovered from major surgical procedure.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* History of human immunodeficiency virus (HIV).
* Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.
Outcome Comparisons of Vibratory Airway Clearance Devices

This pilot study aims to compare the ability of a higher oscillatory index device versus a lower oscillatory index device on airway secretion clearance and other clinically significant outcomes.

This pilot study is a randomized control trial of adult patients admitted to an academic medical center. Subjects included in this study must be adults 18 years or older and will receive a respiratory assessment and allocation of therapy (RAAT) score of at least 10 and a secretion score of at least 5. Exclusion criteria include those younger than 18 years of age, those who are pregnant, with an SVC of \<10mL/kg, and who cannot follow instructions or currently receiving cough assist, vest or intrapulmonary percussive ventilation. Patients receiving more than one therapy session using the oscillatory index device before enrollment will be excluded. Patients with multiple ICU admissions will be enrolled once. After randomization, the study team will give the device to the patient and administer instructions on the device use. Each eligible patient will receive clinical evaluation using RAAT scores per the department policy. The frequency of using oscillatory index devices will be based on the department protocol. Each subject will be followed up until discharge from the hospital. The primary outcome will be the RAAT score. The RAAT score range from 0-50 and includes five components: respiratory rate, oxygen therapy, chest x-ray, secretion clearance, and vital capacity. The higher score denotes respiratory compromise, and therapy is assigned for score 10 or greater per departmental protocol. The secondary outcomes include respiratory interventions used or other bronchial hygiene (vest therapy, intrapulmonary percussive ventilation) performed, ICU re-admission, need for continuous positive pressure, and length of stay (hospital and ICU).

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* Respiratory assess and treat (RAAT) score of at least 10 and a secretion score of at least 5

Exclusion Criteria:

* Younger than 18 years of age
* Pregnant
* Slow vital capacity (SVC) of \<10 mL/kg
* Unable to follow instructions
* Currently receiving cough assist, vest therapy or intrapulmonary percussive ventilation
* Received more than 1 therapy session using oscillatory index device
* Multiple ICU admission with previous study enrollment
Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients

The aim of this study is to compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus.

Patients with diabetes type 1 and type 2 older than 21 years of age, in the specialized clinic of Kowsar Hospital (Semnan University of Medical Sciences) are examined. Eligible individuals enter the study and are randomly assigned to group 1 or group 2. In each group, visual acuity measurement, slit lamp biomicroscopy and fundus examination are performed. Intraocular pressure is measured with Goldmann applanation tonometer. pupil size, refraction and keratometry are measured with two different autorefractokeratometers. keratometry, pupil size and other anterior chamber parameters are also evaluated by Oculus Pentacam imaging. Then, the patients receive tropicamide 0.5% drops in group 1 and tropicamide 1% drops in group 2. 30 minutes later, all previous measurements are repeated. Patients and the ophthalmologist and the data analyzer are unaware of the drug type.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetes Mellitus type 1 and 2

Exclusion Criteria:

* Proliferative diabetic retinopathy
* History of cataract surgery
* severe nuclear and cortical cataract
* Glaucoma
* Intraocular pressure (IOP) greater than 21 mmHg
* Familial history of glaucoma
* Narrow angle (Van Herick 1, 2)
* Cup to disc ratio greater than 0.5
* Pregnancy
* Pterygium
* Corneal ectasia
* History of keratorefractive surgery
* Corneal dystrophy
* Iris disorders
* Anisocoria
* Iris neovascularization
* Use of miotics or mydriatics
The Association of Transgelin-2, Metallothionein-2 and Ezrin With Asthma

Asthma is one of the most common chronic respiratory diseases. Previous study found a series of differentially expressed genes and proteins (transgelin-2, metallothionein-2, ezrin) in asthmatic rat. The aim of the study is to investigate the changes and associations of these gene with asthma in human.

This study will investigate the changes and associations in asthma. In this project, the investigators will explore the changes of gene expression of transgelin-2, metallothionein-2 and ezrin in asthma and investigate their correlation with current diagnosis markers of asthma, including pulmonary function, fractional exhaled nitric oxide,eosinophil counts,immunoglobulin E, interleukin-5, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, aged 14-75 years;
2. Patients with a definite diagnosis of bronchial asthma;
3. The diagnosis of asthma according to the Global Initiative for Asthma (GINA), with positive bronchodilator responsiveness (reversibility) test;
4. Healthy volunteers without respiratory symptoms such as cough, wheezing, chest tightness or dyspnea;
5. Agree with all procedures in this trial by signing a written informed consent form.

Exclusion Criteria:

1. Patients with chronic obstructive pulmonary disease or other airway disease;
2. Complicated with other severe primary diseases (including hypertension, cancer, hyperthyroidism, bronchiectasia, cardiac insufficiency) and conditions that would prevent participation in the trial or put the participant at risk;
3. Women who are known to be pregnant or breastfeeding;
4. Not willing to participate;
5. Psychiatric history and neurological disorders can not work normally;
6. Other conditions that the researcher considers inappropriate to participate in this study.
Effects of Ventavis in Patients With Pulmonary Hypertension (PH) Secondary to Chronic Obstructive Pulmonary Disease (COPD)

This is a phase 2, Multi-center, double-blind, randomized, placebo-controlled study to evaluate the effects of inhaled Iloprost in patients with pulmonary hypertension secondary to COPD. The main objective is to investigate the effect of iloprost on exercise endurance time during constant work rate cardiopulmonary exercise testing. Other efficacy and safety endpoints will additionally be analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to initiation of any study mandated procedure
2. Male or female ≥ 40 and ≤ 75 years of age
3. Women of childbearing potential1 must use a reliable method of contraception
4. Clinical diagnosis of moderate to severe COPD, with an obstructive pattern on pulmonary function tests
5. Current or past smokers of ≥ 10 pack years
6. Ability to perform exercise testing without supplemental oxygen (in the best opinion of the investigator)
7. Confirmed pulmonary hypertension by right heart catheterization (RHC)

Exclusion Criteria:

1. Other causes of pulmonary hypertension than COPD
2. BMI \> 35 kg/m2
3. Conditions considered as contraindications for cardiopulmonary exercise testing (CPET) and/or inability to pedal on a cycle ergometer
4. Pregnant or nursing
5. Currently (within 30 days prior to RHC) taking specific pulmonary arterial hypertension (PAH) therapy (e.g., bosentan, ambrisentan, tadalafil, sildenafil, epoprostenol, treprostinil, iloprost, beraprost)
6. Participation in any other clinical trial, except observational, or receipt of an investigational product within 30 days prior to RHC visit
7. Known concomitant life-threatening disease with a life expectancy \< 12 months
8. Known hypersensitivity to iloprost or any of the excipients of the drug formulations