cyrilzakka/clinical-trials huggingface dataset:
ASHBY: Accelerated Super-Hypofractionated Breast Brachytherapy

The purpose of this study is to compare any good and bad effects of giving radiation treatment for breast cancer in 3 treatments over about 2 days.

This phase 2, single-arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a short course over 1.5 days

Eligibility Criteria:
Inclusion Criteria:

* Female
* New diagnosis of ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma per histologic evaluation
* Age 45-79 at diagnosis
* Previous lumpectomy with surgical margins histologically free of invasive tumor and DCIS as determined by the pathologist.
* T stage of Tis, T1, or T2.
* T2 tumors must be ≤3 cm in maximum diameter
* If the tumor is human epidermal growth factor receptor 2 (HER2)-positive, the patient must receive HER2-directed therapy.
* For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy alone or axillary dissection \[with a minimum of 6 axillary nodes removed\]) and the axillary node\[s\] must be pathologically negative.
* Note: N0(i+) is not an exclusion criterion.
* Note: Patients meeting all of the following criteria are not required to undergo the axillary staging procedure:

  * ≥70 years of age
  * estrogen receptor, Her2 = human epidermal growth factor receptor 2, PR = progesterone receptor negative (ER+PR+HER2-)
  * G1-2
  * Tumor ≤2 cm in size
  * Agrees to comply with aromatase inhibitor recommendation
* Ability to understand and the willingness to sign a written informed consent document in English

Exclusion Criteria:

* Pregnant or breastfeeding
* Active collagen-vascular disease
* Paget's disease of the breast
* History of DCIS or invasive breast cancer prior to the current diagnosis
* Prior breast or thoracic radiation therapy (RT) for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive
* Excision cavity that cannot be clearly delineated per the treating investigator
* Any of the dosimetric treatment criteria defined in Section 6.1 have not been met. Patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as - defined in this protocol and will come off the study. Any subsequent adjuvant radiation will be delivered at the discretion of the treating physician
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Diurnal Variation in Rectal Diameter

The purpose of the study is to determine the diurnal variation of rectal diameter in healthy and constipated children using transabdominal ultrasound.


Eligibility Criteria:
Constipated Inclusion Criteria:

* Children from 4 to 12 years with previously diagnosed simple constipation defined by ROME III criteria, which at inclusion is in maintenance therapy with PEG + E and has been in treatment for at least 1 month.

Exclusion Criteria:

* Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
* Children receiving drugs known to affect bowel function during a 2 month period before initiation besides laxatives.

Healthy inclusion Criteria:

* Children between 4 and 12 years of age.

Healthy exclusion Criteria:

* Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases.
* Children receiving drugs known to affect bowel function during a 2 month period before initiation.
* Children with a previous history of constipation, fecal incontinence and / or urinary tract infections.
RCT of CESIP for Children With Emotional and Stress Problems

To explore the effect of Child-Adolescent Emotion and Stress Intervention Program for children with emotional and stress problems, providing early social psychological intervention for aiming the core impairments of emotional and stress problems.

80 children with emotional and stress problems will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes emotional regulation and stress intervention training for children by two therapists, which were carried out in one meeting rooms in Xinhua Hospital. Therapists are psychotherapists with a background in child psychotherapy training. After 12 weeks, the improvement of emotional symptoms was compared.

Eligibility Criteria:
Inclusion Criteria:

* The results were positive on the SCARED scale; Age 6 years 0 to 12 years 11 months; Total IQ is above 80 assessed by WPPSI.

Exclusion Criteria:

* Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school; Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).
Aza-Ven Followed by Reduced Toxicity Conditioning Regimen (MBF) as Salvage Therapy for Refractory AML.

In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML .

In refractory AML, allogeneic hematopoietic stem cell transplantation (allo-HCST) is considered as the only curative regimen. In this phase II clinical trial, we plan to evaluate the efficacy and feasibility of new sequential transplantation protocol. All patients receive azacytidine and venetoclax as leukemia debulking treatment which is followed by reduced intensity conditioning regimen consisting of Fludarabine (150mg/m2) + Busulfan (6.4mg/kg) + Melphalan (70mg/m2). The graft-versus host disease (GVHD) prophylaxis regimen is based on reduced dose of post-transplantation cyclophosphamide (PT-CY) 40mg/kg day+3\~+4, tacrolimus and low-dose anti-thymoglobulin (ATG, 2.5mg/kg) in case of HLA-matched unrelated donor or halo-donor transplantation.

Eligibility Criteria:
Inclusion Criteria:

* refractory AML (no remission after 2 induction therapy, relapsed AML within 6 months of first complete remission (CR), relapse AML no CR after reinduction therapy), multiple relapse and refractory relapse AML
* patients with HLA matched related or unrelated donor (9\~10/10) or haplo-identical related donor

Exclusion Criteria:

* Patients with poor liver function (enzyme \>2N or bilirubin \>2N)
* poor renal function (Scr \>1.5N)
* poor cardiac function （EF\<45%）
* inform consent not provided
A Prospective Observational Study About Adjuvant or Neoadjuvant Chemotherapy Related Adverse Effects in Postmenopausal Breast Cancer Patients

Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. It is a multicenter prospective observational study. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after adjuvant or neoadjuvant chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures. In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Breast cancer is one of the most common malignant tumor in women. About 69.75% of breast cancer women patients in China are over 45 years old. Chemotherapy is one of the important treatments for breast cancer, but it brings a series of adverse effects, especially increasing the risk of hyperlipidemia, cardiovascular disease and osteoporosis in postmenopausal women. It is a multicenter prospective observational study. The postmenopausal breast cancer women patients who are planning adjuvant or neoadjuvant chemotherapy are enrolled in the study after signing the informed consent form and passing the screening. We collect the basic information, medical history, chemotherapy-related adverse reactions, and the results of blood lipid and bone density test before, during and after chemotherapy. The purpose of the study is to investigate the risk factors for hyperlipidemia, cardiovascular disease, and osteoporosis in postmenopausal breast cancer patients before and after chemotherapy, and to assess the risk of future arteriosclerotic cardiovascular disease and osteoporotic fractures in this population.In addition, the collected information of the subjects are analyzed to provide suggestions for the relevant prevention strategy.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form has been signed.
2. Breast cancer patients whose age is ≥ 18 years old and have been diagnosed by histological examination.
3. Postmenopausal women who are defined by any of the following:

   * Previous bilateral oophorectomy;
   * Age ≥ 60 years old;
   * Age \<60 years old, menopause at least 12 months, and follicle stimulating hormone \[FSH\] and estradiol levels in the postmenopausal range.
4. Plan for adjuvant or neoadjuvant chemotherapy.

Exclusion Criteria:

1. Those who have already received adjuvant or neoadjuvant chemotherapy.
2. Those who have chemotherapy contraindications.
3. Those who have any mental condition that prevents the understanding of the contents of this study and can't provide the complete information required.
A Randomized, Two-arm, Open Label Study to evalUate the Effect of a Smart Phone-based Patient Support Tool On Patient AdheRence of Treatment in Stable Angina Patients Prescribed Beta-blockers in China (SUPPORT)

The present study aims to enhance the adherence of beta-blockers by Patient Support Tool through a smart phone application and a wristband, subsequently reduce the risk of angina attacks in patients with stable angina pectoris.

To control heart rate in terms of guidelines in patients with stable angina pectoris reduces risk of cardiovascular events, rehospitalization, and death effectively. Using beta blockers is an efficient therapy to management the HR in SAP patients. However, the recent epidemiological studies have provided evidences that the rate of beta blocker prescribed and used was inadequate, as the first-line therapy to CAD patients with the usage rate less than 30%. Several studies showed that with a reminder supported by smart phones and wearable devices, the adherence of management of patients with chronic disease could be improved significantly.Thus,the present study aims to enhance the adherence of beta-blockers by Patient Support Tool through a smart phone application and a wristband, subsequently reduce the risk of angina attacks.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 years;
2. Stable angina pectoris;
3. Indicated for beta blockers;
4. HR ≥ 60bpm;
5. Patient must have a smart phone that is compatible with the Patient support tool at their disposal and are comfortable with using of interactive smart phone applications. The required specification for the phone will be determined after completed testing;
6. Ability to read, understand and write Chinese;
7. Beta-blockers naïve or with no Beta-blocker use during the last 1 month.

Exclusion Criteria:

1. Previous myocardial infarction during the recent 1 year;
2. Cardiac shock or unstable heart failure (NYHA III);
3. SBP\<100 mmHg;
4. Sick sinus syndrome;
5. II-III degree atrioventricular block;
6. Existing contraindication for Beta-blockers or allergic to beta-blockers;
7. Participation in another clinical study with a beta blocker during the last 3 months;
8. Inability to sign the informed consent form;
9. Females during pregnancy and lactation and women of child bearing potential planning to be pregnant within 24 weeks.;
10. Patients who withdraw from this study for any reason cannot re-enter the study;
11. Life expectancy \< 1 year;
12. Severe asthma or COPD;
13. Severe peripheral vascular disease;
Safety and Feasibility of Hyperkalemic Cardioplegia With Diazoxide in Cardiac Surgery (CPG-DZX) Trial

This study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. The investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. Thirty patients will receive treatment. Safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. Efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and Vasoactive Inotrope Score (VIS) between the two groups. The information gained could pave the way for the use of Katp (Potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

This is a Phase I clinical trial. Thirty patients total will receive treatment (IV Diazoxide added to cardioplegia). Diazoxide will be added to the first dose of cardioplegia only. Subsequent doses of cardioplegia will not contain additives.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest
* Patient scheduled for elective cardiac surgery
* If female participant of childbearing potential, she must agree to and be able to use a highly effective method of birth control (eg, barrier contraceptives, hormonal contraceptives, intrauterine devices, or sexual abstinence) continuously for six days post- diazoxide dose

Exclusion Criteria:

* Patient with Diabetes Mellitus on sulfonylurea medications
* Scheduled for left ventricular assist device (LVAD) or heart transplant
* Left ventricular ejection fraction \< 30%
* Pre-operative placement or planned use of mechanical circulatory support during surgery
* Allergy to Thiazide and its derivatives
* History of gout
* Patient is pregnant or breastfeeding
* Patients with seizure disorders controlled by diphenylhydantoin
* Patients with a history of cold agglutinins
Notation Optimization Through Template Engineering

This is a randomized non-blinded controlled trial of a standard note template versus a redesigned note template using a simulated patient encounter and the electronic medical record.

Residents documented the simulated patient encounter using one of two templates. The standard template was based on the usual outpatient progress note. The new template placed the assessment and plan section in the beginning, grouped subjective data into the assessment section, and deemphasized elements not related to the current presentation.

Eligibility Criteria:
Inclusion Criteria:

* Residents who had open visit slots during their outpatient clinic time

Exclusion Criteria:

* None
Effects of Transcutaneous Spinal Cord Stimulation on Residual Voluntary Motor Control in Individuals With Incomplete Spinal Cord Injury

Recently, a transcutaneous protocol of electrical spinal cord stimulation (tSCS) has been developed. It was suggested, that this method could be used to improve the therapy process after a spinal cord injury (SCI). The aim of this study is to investigate the immediate effects of tSCS with different stimulation modalities on voluntary motor control in patients with incomplete SCI.


Eligibility Criteria:
Inclusion Criteria:

* Patients with incomplete SCI
* Chronic (≥ 12 months post-injury) or subacute (≥ 3 months post-injury) stage of recovery
* Age: ≥18 years
* Able to complete the 10mWT with walking aids as required but no physical assistance
* Neurological level of SCI: above T12
* Preserved segmental and cutaneo-muscular reflexes in the lower limbs
* Bodyweight \> 20 kg and \< 120 kg
* Mini-Mental state examination score 6 (test only performed if cognitive deficits are suspected)

Exclusion Criteria:

* Any other neurological diseases
* Current orthopedic problems
* Premorbid major depression or psychosis
* History of significant autonomic dysreflexia with treatment
* Dermatological issues (e.g. decubitus) at the stimulation or harness attachment site (back, abdomen, upper legs)
* Active implants (e.g. cardiac pacemaker, implanted drug pump)
* Passive implants at vertebral level T9 or more caudal vertebrae (metal screws and plates for surgical stabilization of spinal fractures)
* Malignant diseases
* Heart insufficiency NYHA III-IV
* Potential pregnancy (pregnancy test must be conducted before each session)
* Unlikely to complete the intervention or return for follow-up
* Participation in another training study
* Contraindications for BWS training using the FLOAT (according the manual):
* No responsiveness
* Severe muscle contractures
* Acute fractures
* Osteoporosis or osteogenesis imperfecta
* Body size shorter than 1 meter or taller than 2 meters
To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

An open label study to evaluate drug-drug interactions between HEC585 and Pirfenidone or Nintedanib in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

- Subjects who are willing and are able to provide a written informed consent to participate in the study.

Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial.

Subjects aged between 18 and 45 (both inclusive) years old. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female in the first part of the trial) and body mass index ≥19 and ≤28 kg/m2 at screening.

Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram.

Exclusion Criteria:

* Subjects with a positive serology for HIV antibodies, HBsAg, HCV antibodies and/or TP antibodies at screening.

Subjects suffering from gastrointestinal diseases that can interfere with absorption or metabolism of drugs within 6 months before screening; and/or with history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, reproductive system; and/or thyroid disease or previous thyroid surgery, malignant tumor, metabolic disorder or others medical conditions that are not suitable for clinical trial participation.

Patients with photosensitivity and/or other skin diseases. Bleeding or thrombosis risk. Allergic. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.

Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.

Positive results from urine drug screen test. History of alcoholism or drink regularly within 3 months prior to the study. Positive for urine cotinine or smoked within 1 month before administration of study drug in the first part，regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug in the second part.

Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.

Subjects who plan to receive or have had organ transplants. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential.

Subjects who participated in another clinical trial and have taken other study drugs within 3 months prior to initial dosing.

Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication

To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.

Exclusion Criteria:

* Subject of seven years or more who have been prescribed fluconazole.
Central Hypothyroidism, a Novel Laboratory Measurement

Medical management of central hypothyroidism is controversial due to lack of reference for evaluation of pituitary negative feedback. Therefore, titration of medical treatment is based on T4 levels, measured with variable laboratory methods. Patients who have central hypothyroidism usually have concomitant deficiencies in other pituitary hormones for which they need replacement therapy such as steroids, testosterone and growth hormone. This combined hormone deficiency makes clinical and laboratory evaluation challenging among these patients. Symptomatically, central hypothyroidism is relatively mild and lack non-specific and it might be overlooked due to other hormonal deficiencies. Replacement therapy for central hypothyroidism is titrated by arbitrary target free T4 levels of above 50th percentile of normal. The goal of our study is to compare the standard results from well known measure methods to a new method for measuring Ft4 using Liquid chromatography - tandem mass spectrometry.


Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of central hypothyroidism: status post pituitary surgery and/or radiotherapy plus laboratory documentation of central hypothyroidism, with or without concurrent hormonal deficiencies in other axes, such as ACTH, LH, FSH

Exclusion Criteria:

* Primary hypothyroidism