cyrilzakka/clinical-trials huggingface dataset:
Hypofractionated Radiation Therapy With Concomitant Boost in Treating Women After Breast Conserving Surgery

This phase II study is to evaluate the safety of hypofractionated whole breast radiation (HFRT) with simultaneous tumor bed boost(SIB) in women with early breast cancer after breast-conserving surgery.

OBJECTIVES:

Primary:

To determine the toxicity with adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost (SIB) in women with early breast cancer after breast conserving surgery.

Secondary:

To determine the short term cosmetic and quality of life of the participants treated with this regimen.

To determine the local control of the participants treated with this regimen.

OUTLINE: Patients undergo adjuvant hypofractionated whole breast radiation with simultaneous tumor bed boost once daily a week for 3 weeks. Toxicity, quality of life and cosmetic result is assessed before radiation, at the end of the radiation, within 2, 4, 6 weeks after completion of radiotherapy, and then every 3 months for 1 ear.

PROJECTED ACCRUAL: A total of 90 participants will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* female, aged between 18-70
* pathological confirmed breast invasive carcinoma
* patients after breast lumpectomy(including quadrantectomy) with axillary lymph nodes dissection or sentinel node biopsy
* stage p T 1-2 N 0
* metastasis omitted by routine examinations in 1 months before enrollment
* complete blood count obtained in 2 weeks prior to study entry should meet the following criteria: absolute neutrophil count \> 1.8 \*10\^9/L, hemoglobin \> 8.0g/dl, platelet \> 75 \* 10\^9/L
* hepatic and renal function in 2 weeks prior to study entry should be normal
* study entry within 60 days from whichever comes later: surgery or last chemotherapy
* women of childbearing potential must have a negative urine or serum pregnancy test with 2 weeks of study entry
* signs study specific informed consent prior to study entry

Exclusion Criteria:

* breast cancer with stage III/III (AJCC 7th)
* occult breast cancer
* in-situ breast carcinoma
* bilateral breast cancer
* male breast cancer
* breast lymphoma or breast sarcoma
* combined with Paget's disease
* received preoperative treatment(including neoadjuvant chemotherapy, endocrine therapy and target therapy
* positive surgical margin
* axillary lymph nodes dissection or sentinel lymph node biopsy omitted
* regional lymph nodes radiation needed
* boost volume larger than 1/4 of the whole breast
* tumor bed unable to recognize on CT
* prior invasive malignant tumor history
* prior radiation to thoracic
* connective tissue disease, such as active systemic lupus erythematosus and scleroderma, etc.
* severe, active co-morbidity, defined as follows:

  * unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
  * severe, acute bacterial or fungal infection within the last 2 weeks
  * chronic obstructive pulmonary disease exacerbation or other respiratory illness within 30 days
* pregnant women
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation

This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old and ≤75 years old
2. Symptomatic AF with at least one AF episode electrocardiographically documented within one (1) year prior to enrolment. Documentation may include diagnosis in the patient medical files, electrocardiogram (ECG), Trans-telephonic monitoring (TTM), Holter monitor or telemetry strip.
3. Selected for catheter ablation for the treatment of atrial fibrillation

Exclusion Criteria:

1. History of previous left atrial ablation or surgical treatment for AF/AFL/AT
2. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, and prior thoracotomy)
3. Presence of LA thrombus by TEE, CT scan, MRI, or angiography
4. Known conditions or anatomical abnormality that may interfere with the device delivery or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or tortuosity)
5. Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others)
6. Uncontrolled heart failure or NYHA Class III or IV heart failure
7. Valve repair or replacement or presence of a prosthetic valve
8. Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months
9. MI or PCI procedure within 3 months before screening
10. Left Ventricular Ejection Fraction (LVEF) \< 40%
11. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD)
12. Severe pulmonary hypertension or prior pulmonary stenting
13. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
14. Contraindication to anticoagulation (e.g., heparin)
15. History of blood clotting or bleeding disease
Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study

The number of adolescents engaging in a transidentity journey has been increasing rapidly over the last decade. However, the knowledge of the medical world concerning the specificities of these adolescents is still too little in France. The objective of this study is to refine the knowledge of the different health care providers who are brought to meet these adolescents. This research proposes to study more specifically the register of psychological vulnerabilities: to cite only a few examplesThese include disorders such as depression, anxiety disorders and eating disorders, all of which cause suffering and difficulties in everyday life. A better understanding of the presence or absence and the distribution of these different types of vulnerabilities among transgender adolescents would allow, among other things, to promote their their screening by health care providers. This better screening would allow doctors to physicians to offer targeted treatment for these disorders in parallel with the transition process. transition process.


Eligibility Criteria:
Inclusion Criteria:

* Be between 12 and 18 years old
* Be followed up at the gender consultation of the Toulouse University Hospital

Exclusion Criteria:

* Have not yet completed the first consultation on gender issues at the time of selection.
* Have only one last appointment with the gender consultation at the time of selection
Diagnostic Value of AFP-L3 and PIVKA-II in HCC

The incidence of Hepatocellular carcinoma (HCC) is increasing worldwide. However, most of HCC cases were at advanced stage when the diagnosis established.Early diagnosis improves the prognosis.The study is intended to evaluate the diagnostic efficiency of alpha-fetoprotein-L3 (AFP-L3) and Protein Induced by Vitamin K Absence or antagonist-II (PIVKA-II). This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.

Hepatocellular carcinoma (HCC) is the third leading cause of cancer deaths worldwide.Early diagnosis improves the prognosis. Protein induced by vitamin K antagonist-II (PIVKA-II), also known as des-γ-carboxyprothrombin (DCP) or acarboxy prothrombin, is an abnormal form of prothrombin induced by vitamin K absence or antagonist-II. The study is intended to evaluate the diagnostic efficiency of AFP-L3 and PIVKA-II. AFP-L3 and PIVKA-II as an effective tumor marker for hepatocellular carcinoma(HCC). Despite the extensive application of PIVKA-II in some hospitals from Vietnam, the diagnostic efficiency including sensitivity, specificity, positive predictive value and negative predictive value still needs more clinical data to evaluate. The research purposes list as follows：1. Determination of changes in AFP-L3 and PIVKA II for HCC.2. Investigating the diagnostic value of AFP-L3 and PIVKA II for HCC. This study is performed at Hanoi Medical University Hospital. Participants including patients with HCC and hepatic hemangioma. All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, AFP, AFP-L3 and biochemical indexes including alanine aminotransferase(ALT),aspartate aminotransferase (AST), gamma-glutamyl transferase, HbsAg, Anti HCV, etc.The diagnosis of HCC was based on HCC criteria of Ministry of Public Health of Vietnam. All HCC diagnoses were confirmed at the time of analysis. Stages of tumor is evaluated by Barcelana classification. The Student's t-test (or Mann-Whitney test) was used to compare continuous variables, and the chi-square test (or Fisher's exact test) was used for categorical variables. A receiver operator characteristic (ROC) curve was used to assess the performance characteristic of PIVKA-II,AFP,AFP-L3 measurement.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85
* Receiving no treatment before diagnosis
* Establishing Diagnosis according to thecriteria of Ministry of Public Health of Vietnam 2012.

Exclusion Criteria:

* Clinical data missing
* Laboratory tests information missing
* Serum samples doesn't qualified
* Obstructive jaundice patients
* Medical history of taking warfarin
Study of Acceptability of a New Distance-learning Tool "MyFIT"

The investigators developed an on-line learning tool "MyFIT" enabling to patients with T1D to acquire the knowledge and skills for practicing functional insulin therapy from their home.

The aim of the present study is to evaluate the acceptability of this new learning modality via the tool "MyFIT" by the patients and by the health professionnals.


Eligibility Criteria:
Inclusion Criteria:

* type one diabetes on intensified insulin therapy

Exclusion Criteria:

* Hearing loss
* Visual problems
Influence of Physical Training on Mitochondrial Function in Type 2 Diabetic Patients

Physical activity as treatment for patients with type 2 diabetes (T2D). Treatment of T2D is often done by medication, changing the diet and increased physical activity. It is well established that physical training has a positive effect on the pathology of T2D such as increased insulin sensitivity and reduced fasting plasma glucose (7) and blood lipids (15). It is also well known that in healthy subjects endurance training increases mitochondrial density, lipid oxidation during submaximal exercise, and results in a number of qualitative changes in the control of OXPHOS (24). However, the effect of physical training on the mitochondrial function in skeletal muscle of patients with T2D has not been investigated.

The purpose of this project is to investigate the effect of physical training on the mitochondrial respiratory function in muscles of patients with T2D. Skeletal muscle biopsies will be taken before and after 10 weeks of physical training in patients with T2D and matched control subjects. Mitochondria will be isolated from the muscle biopsies, and respiratory function, free radical production and UCP3 will be determined. Furthermore, measures of maximal oxygen consumption (VO2max), heart rate and capillary lactate concentrations and carbohydrate and lipid oxidation will be determined partly to verify an increased aerobic capacity and partly to investigate the changes in these factors in T2D patients.


Eligibility Criteria:
Inclusion Criteria:

* Male,
* BMI above 26,
* Age between 40 and 65,
* Living a sedentary lifestyle

Exclusion Criteria:

* Women
* BMI under 26
* Age under 40 and over 65
* Trained subjects Control subjects: relatives to type 2 diabetic patients, T2D trial subjects
A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis

This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.

Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study.


Eligibility Criteria:
Inclusion Criteria:

* Give written informed consent and any authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
* Are ≥18 years of age;
* Have a positive history of ocular allergies during ragweed pollen season;
* Have signs and symptoms of allergic conjunctivitis in both eyes;
* If female and of child-bearing potential, she must not be pregnant or lactating

Exclusion Criteria:

* Have signs of ocular infection;
* Have a known history of alcohol or drug abuse;
* Have been exposed to an investigational drug or device within 30 days of the study;
* Have planned surgery (ocular or systemic) during the trial period or within 30 days after
Efficacy and Safety of Dapagliflozin in Children With Proteinuric Chronic Kidney Disease

We aim to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria.

Blockers of renin angiotensin aldosterone system (RAAS) such as angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) are considered the standard of care in treatment of Proteinuric Chronic Kidney Disease. However, these agents lead to incomplete renal protection. The purpose of the study is to investigate the antiproteinuric effect of adding Dapagliflozin to the standard of care in children with proteinuria. In this study, participants were randomly assigned (1:1) to receive ACEI+Dapagliflozin (5mg or 10mg, based on body weight) or ACEI only once daily for 24 weeks. Prespecified outcomes includes changes in 24-hr proteinuria, albumin, eGFR (estimated glomerular filtration rate), blood pressure, body weight and so on.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 years to 18 years；
* Urinary protein excretion \> 200 mg in a 24-hr urine collection；
* Without any immunosuppressant medications such as corticosteroids, CNIs and so on；
* Estimated GFR ≥ 60 ml/min/1.73m2（estimated with Schwartz formula）；
* No history of diabetes；
* On stable doses of ACE inhibitors or angiotensin receptor blockers (ARBs) for \> 1 month；
* Willing to sign informed consent.

Exclusion Criteria:

* Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis;
* Blood pressure less than 5th percentile of the same gender, age, and height;
* Uncontrolled urinary tract infection at screening;
* At risk for dehydration or volume depletion;
* Evidence of hepatic disease: an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
* History of organ transplantation, cancer, liver disease;
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:

  1. History of active inflammatory bowel disease within the last six months;
  2. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
  3. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
  4. Pancreatic injury or pancreatitis within the last six months;
* Participation in another therapeutic trial with an investigational drug within 30 days prior to informed consent;
* History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.

A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
2. ECOG performance status of ≤ 2.
3. Life expectancy of ≥ 3 months.
4. The results of the laboratory tests must meet all criteria.

Exclusion Criteria:

1. Patients have received antitumor therapy during the first 4 weeks before study drug use.
2. Received a live attenuated vaccine within 4 weeks prior to C1D1.
3. Known cerebral parenchymal metastasis or meningeal metastasis.
4. History of serious cardiovascular or cerebrovascular diseases.
5. Active or recurrent autoimmune diseases.
6. History of ascites or pleural effusion requiring drainage.
7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.
Different β -Blockers in STEMI and Primary PCI

Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily

The investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in STEMI patients undergoing primary PCI.

Eligibility Criteria:
Inclusion Criteria:

* Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
* Age ≥18 years;
* Informed consent from patient or next of kin.

Exclusion Criteria:

* Nonischaemic Cardiomyopathy;
* Cardiac surgery planed in the 6 months;
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
* Renal or hepatic failure;
* Malignancy, HIV, or central nervous system disorder;
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness;
* Cardiogenic shock;
* Current participation in any research study involving investigational drugs or devices;
* No written consensus;
* Previous myocardial infarction.
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking male or female subjects
2. Aged between 18 and 45 years inclusive
3. Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively.

Exclusion Criteria:

1. Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications
2. Female subjects who are pregnant
3. Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders
Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients

We are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. The walking group does the same training, only without robotic assistance. The control group will receive physiotherapy treatments financed by the state. Control examination after 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

post stroke 6MWT : 120\> minimum after stroke 3 days be a stroke patient first stroke hemiplegia

Exclusion Criteria:

multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug
Effectiveness of Extracorporeal Shockwave Therapy Combined With Platelet-rich Plasma in the Treatment of Chronic Insertional Achilles Tendinopathy

The goal of this clinical trial is to learn about the effectiveness of extracorporeal shockwave(ESWT) combined with platelet-rich plasma(PRP) to treat chronic insertional tendinopathy. The main questions it aims to answer are:

Does ESWT combined with PRP treatment reduce the symptom and improve functional score after treatment? What medical complication do participants have when receive the treatment?

Researchers will compare ESWT combined with PRP to ESWT treatment alone to see if ESWT combined with PRP works to treat chronic insertional tendinopathy.

Participants will:

* Receive ESWT once a week for 4 weeks then receive PRP injection at a week later or ESWT once a week for 4 weeks
* Visit the clinic at 6 weeks, 3 months, 6 months and 1 year after treatment for checkups and record functional score


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with insertional Achilles tendinopathy
* Had symptom more than 6 months
* Failed other standard conservative treatment (rest, medication, activity modification, stretching exercise, and heel lift orthosis)

Exclusion Criteria:

* Receive corticosteroid injection at the Achilles insertion
* History of infection around ankle and heel
* Has neurological deficit
* Has a contraindication for ESWT(hemophilia, coagulopathy or foot and ankle malignancy)
The Influence of Running to ACL Deficiency

The aim of this study is to investigate the influence of running to kinematic parameters of patients with anterior cruciate ligament.


Eligibility Criteria:
Inclusion Criteria:

1. 20\< age \< 30.
2. Body mass index \< 30.
3. For controls, no history of major injury or surgery in lower limbs; no symptoms of lower limbs; physical examination to test the lower limbs to be healthy.
4. For ACLD group, history of knee injury for at least 2 weeks and able to walk and run; confirmed to be unilateral ACL injury by MRI; knee pain in the knee (ACL injury).
5. The habit of moderate exercise (e.g. Jogging) at least once a week for at least 30 minutes.

Exclusion Criteria:

1. Body mass index \>30.
2. For controls, injury or surgery in hip/knee/ankle.
3. For ACLD group, injury or surgery in hip/ankle; confirmed to be no ACL injury by arthroscopy.
4. Neuropathic disease.
5. Muscular disease.
6. Lack ability to finish the procedure physically or mentally.
7. Easy to fall.
8. Any other conditions that can influence gait parameters of the lower limbs.