cyrilzakka/clinical-trials huggingface dataset:
Treatment of CML Patients With Imatinib and Hydroxyurea (CML2004)

The study will test the tolerability and efficacy of the combination therapy Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic phase (CP1) newly diagnosted or failing interferon-based therapy.

The protocol consists of a part 1, a phase I study that will enrol 20 patients, with the goal to determine the safety of the combination as well as the maximal tolerated dose. If the toxicity of the combination is acceptable, up to 200 more patients may be recruited and randomized to receive either Imatinib/HU or Imatinib alone (part 2).

Patients who meet the inclusion criteria will be started on 400 mg Imatinib daily. In part 1 of the protocol, the dose of HU will be increased by 500 mg at 3-weekly intervals until the maximal tolerated dose has been reached. In part 2 of the study, patients will be randomized to receive either the combination or Imatinib monotherapy.

Hematological and cytogenetic response will be evaluated at 3-months intervals during the first year, and at 6 months' intervals thereafter. Primary endpoints for part 1 are dose-limiting toxicity and maximal tolerated dose. Primary endpoints for part 2 are the rates of major and complete molecular response at 6, 12 and 18 months, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Ph-positive CML in CP1, newly diagnosed or resistant (hematologic or cytogenetic) or intolerant to interferon-based therapy
2. Age ≥ 18 years
3. Negative pregnancy test
4. Low- and intermediate risk patients younger than 45 with an HLA (Human Leukocyte Antigen) -matched sibling donor and medically fit to undergo allografting should be included only after they have been adequately counselled about the potential risk (of disease progression) associated with delaying the allograft
5. Informed consent

Exclusion Criteria:

1. Objective signs of disease progression beyond CP1 defined as

   * bone marrow or peripheral blood blasts \> 15% and/or
   * blasts + promyelocytes ≥ 30% and/or
   * peripheral blood basophils ≥ 20% and/or
   * platelets \< 100/nl and/or
   * chromosomal abnormalities in addition to the Ph chromosome
2. Findings suggestive of extramedullary involvement
3. Any severe and uncontrolled medical condition
4. Previous treatment with Imatinib (only part 2 of the study)
5. History of non-compliance
6. Simultaneous inclusion in other studies

Important note: previous treatment with Imatinib only is not an exclusion criterion for part 1 of the study.
Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

To compare conventional treatment of congestive heart failure (CHF) with two experimental interventions: amiodarone and an implantable cardioverter-defibrillator (ICD).

BACKGROUND:

Congestive heart failure is a major cause of mortality and morbidity, and sudden arrhythmic death is the cause of death in from 30 to 50 percent of those who die. The study addresses the problem and tests two interventions that have promise of benefit. To date, many of the therapies that have been tested for congestive heart failure have either been ineffective or actually decreased survival. Conventional therapy is still relatively ineffective in that recent studies such as the Congestive Heart Failure - Survival Trial of Antiarrhythmic Therapy (CHF-STAT) have demonstrated a mortality of 40 percent during two-and-half years of follow-up. The implantable cardioverter-defibrillator appears to be effective in patients who are resuscitated from cardiac arrest, but until recently, the devices required a thoracotomy and had to be reserved for patients with the highest risk for sudden death. The newer transvenous devices with pectoral patches can now be considered for broader applications. Although there have been mixed results with amiodarone in patients with congestive heart failure, there is a general consensus that it could be effective in the proper subset of patients with congestive heart failure. A comparison of the optimal device and drug is appropriate for such a high risk population.

DESIGN NARRATIVE:

Three-armed, randomized, multicenter trial conducted at over 125 North American, Australian and New Zealand sites. Patients were enrolled over 2.5 years after being randomly assigned to amiodarone, matched placebo or an implantable cardiac defibrillator (ICD). Median follow-up was 45.5 months. All three arms used conventional therapy for heart failure and coronary artery disease (ACE inhibitors, lipid lowering and beta-blockers). The central hypothesis was that amiodarone or the ICD would improve survival compared to placebo. The primary outcome was the prevention of all-cause mortality. Secondary outcome measures included cardiac mortality and arrhythmic mortality, morbidity, quality of life, and incremental cost-effectiveness of the interventions.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Patients with New York Heart Association class II or class III heart failure and ejection fraction less than or equal to 35%.
Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema

Lymphedema is the result of accumulation of fluid and other elements in tissue spaces because of an imbalance between the production of fluid interstitial and transport. Lymphedema can cause significant physical and psychological morbidity. Prevalence of lymphedema in patients after breast cancer surgery is 12-60% and the incidence is 12-26%.Psychological and social consequences of secondary lymphedema related breast cancer have been little recognized and documented. Although, it have performed many studies related secondary lymphedema it not found sufficient evidence in the literature to suggest the most effective treatment. There is some evidence suggesting that compression therapy and manual lymphatic drainage can improve lymphedema but more studies are needed. The aim of this research is to to evaluate the clinical effect of multimodal treatment (compression bandaging and manual lymph drainage) versus applying manual lymphatic drainage in women with arm lymphedema after breast cancer surgery.

This study has two sub research: a quantitative approach and a qualitative approach. The research will be carried out by a multicenter way

Quantitative approach consist in carried out a single-blind randomized controlled trial of 44 women with arm lymphedema. Patients will be distributed in two intervention groups by a randomized way. Participants will be given his assignment by closed envelope. Both treatments will be administered five days a week for six weeks. The experimental group (n=22) will receive multimodal treatment: combination of manual lymphatic drainage and compression bandaging. The control group (n=22) only will receive manual lymphatic drainage. We want to determinate the effect on volume arm decrease, quality of life, level of hand strength, degree of pain, fatigue level, and state of anxiety and depression. The influence on the lymphedema will be analyzed with lower limbs strength, physical activity, lung function, respiratory muscle strength by maximal inspiratory and expiratory pressure measurements (MIP and MEP) and cardiorespiratory functional capacity. Patients adherence will be analyzed by a smartphone.

Qualitative apprach: to know the perceptions and experiences of the participants in both interventions groups through a qualitative descriptive study. Data will be obtained with semi-structured depth interview.

Eligibility Criteria:
Inclusion Criteria:

* Women between 45 and 65 years with secondary lymphedema in upper limb after breast cancer surgery.
* Cancer stages I-III according to TNM classification of the American Joint Committee on Cancer.

Exclusion Criteria:

* To have received lymphedema treatment previously.
* To be treated by radiation therapy or chemotherapy.
* Distant metastases or local recurrence of cancer.
* Infectious signs in the upper limb with lymphedema.
* Uncontrolled hypertension.
* Heart disease.
Digital Perineal Massage and Pelvic Floor Muscle Exercise During Pregnancy for Prevention of Perineal Laceration

Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual education program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Pregnant participants will be recruited at the obstetrics outpatient clinic during their visits 4 weeks before the due date. They are randomized into two groups. The first group will be educated to do digital perineal massage. They will be also educated to do pelvic floor muscle exercises and will receive the usual educational pelvic floor dysfunction prevention program for strengthening the pelvic floor. The second group will receive the usual education program for strengthening the pelvic floor. Occurrence of perineal laceration will be reported at time of delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥ 35 years old
* Primigravida or multi gravida

Exclusion Criteria:

* History of chronic constipation
* History of chronic cough
* Current or past urinary or anal incontinence
* History of genital prolapse before pregnancy
* History of neuromuscular disorders or connective tissue disorders
* History of medical disorders
* History of preterm or precipitate labour
* History of premature preterm rupture of membranes.
* Genital infections
Evaluating Safety of Andiabet on Diabetes Mellitus Type II Patients, Phase I CT.

This phase I clinical trial is used to evaluate the safety of Andiabet, a herbal-derived medicinal product that assists in the treatment of type 2 Diabetes (T2D). Thereby, determine efficacy of the drug on stabilizing blood glucose in T2D patients.

This is a 28-day phase I, open-label clinical trial to evaluate safety of Andiabet on . The general purpose is the evaluate safety via adverse events and tolerability of Andiabet on T2D patients, and evaluate effect of Andiabet on clinical and laboratory parameters.

The study conducted on volunteering T2D patients, whose HbA1c level is =\< 7.5% and are not pregnant, had no records of addiction, allergy, hypersensitivity, and chronic diseases. The main evaluation criteria are fasting glucose, used for evaluating efficacy and safety, which evaluated based on adverse events.

Ensuring quality of the data:

Sponsor and CRO are supervisors. Supervision will be conducted periodically, ensuring the compliance with the research proposal, following GCP.

Hanoi Medical University-Clinical center of Pharmacology is responsible for managing the data. Completed CFR are sent to the Center of Clinical Pharmacology, entered by Microsoft Excel and analysed using SPSS 16.0 Before analysing, these data will be checked randomly, avoiding errors in data entry.

Eligibility Criteria:
Inclusion Criteria: Participants must meet ALL the following criteria:

* Type 2 Diabetes (T2D) patients with HbA1c lower than or equal to 7.5%
* BMI range: 18-40 kg/m2
* Diagnosed with T2D or currently treating T2D (prescribed by physicians) with one or more of the following drugs: Metformin, Sulfonyl urea, dipeptidyl peptidase-4 inhibitors, or a-glucosidase inhibitors
* Be able to stop using T2D drugs in 4 weeks, while maintaining diets and exercising routine.
* Willing to take part in the study.

Exclusion Criteria: Participants that have ONE of the following:

* Diagnosed with Type 1 Diabetes.
* History of complications due to Diabetes Mellitus.
* History of cardiovascular diseases: hypertension, heart failure, Unstable agina, stroke or transient ischemic attack, myocardial infarction, arrhythmias, coronary artery interventions.
* History of drugs, alcohol addiction.
* Uncontrolled high blood pressure
* Pre-study screening blood test with abnormal results in total blood compositions, urea, AST, ALT, creatinine, albumin, total bilirubin, total urine analysis.
* Test positive for HIV or HbsAg
* Abnormal ECG results that are clinically significant.
* History of hypersensitivity to any of the ingredients in the testing product.
* Female participants that are pregnant or having pregnancy intention
Sngception and Pain in Spine Enhanced Recovery After Surgery (ERAS) Pathways

Enhanced recovery after surgery (ERAS) is a recognized, evidence-based and patient-centered clinical pathway that has an array of benefits. Minimally invasive techniques, a cyclopedic pain management plan and precise administration of anesthetics, which will render patients a rapid and comfortable recovery if executed correctly, followed by early mobilization and discharge.

Pain management practice is traveling through a paradigm shift as opioid crises arise in the western countries. Opioid-based pain control is being disarmed and replaced by multimodal analgesia (MMA) and becoming the mainstay strategy. Opioids are increasingly being reserved as rescue medications. MMA target different parts of the nociceptive pathway, preventing its wind-up during surgery. Decreased firing of the nociceptive neurons may be linked to lower postoperative pain scores or even the suppressing chronic pain incidence. In our ERAS pathway, we implement erector spinae plane block (ESPB) as the main analgesic firepower.

As postoperative pain decreases, an observed rising complaint is "sng", or soreness, in native Taiwanese in our ERAS spine patients. It is very different from the nociceptive "pain" we are familiar with. Patients avoid movements if it causes pain, but they tend to stretch or adjust postures if sngception dominates. The term "sngception" has been proposed in 2018 by Taiwanese scholars. It is believed to be a sense of acidosis, possibly within the muscles. Acidosis and associated pain are well documented, such as in muscle aches from exercise, cancer or diabetic ketoacidosis. The underlying mechanism is yet to be established but does not entirely overlap with nociception. There are numerous similarities of sngception in our patients and sngception:

1. a sensation different from nociception,
2. usual painkillers are ineffective, suggesting an alternative route of transmission,
3. relieved by movement,
4. inflammation and acidosis in the vicinity of surgical wound. In this study, we intended to characterize sngception by observing various perioperative factors, as well as the short- and long- term outcomes they bring. This will be done through a detailed sngception and pain trajectory analysis. Only when we know the main causative factor(s), we can design treatment plans toward guarding against sngception. This further improves the quality of postoperative recovery and safety as less opioids may be required as rescue medications.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing routine ERAS protocol for spine surgeries
2. American Society of Anesthesiologists Physical Status (ASA-PS) I\~III

Exclusion Criteria:

1. Communication issues that preclude proper preoperative counselling for ERAS and study design.
2. Active alcohol or drug addiction.
3. Pregnancy
4. Allergy to main anesthetics that preclude the use of routine ERAS anesthesia management.
5. Patient refusal to participate in study.
6. Emergent operations.
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL

The aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.

In china, previous studies showed patients with non-Hodgkin lymphoma (NHL) are likely to have hepatitis B virus (HBV) infection. The risk of HBV reactivation is high when patients were treated with CHOP, especially in combination with rituximab. The aim of this study is to compare entecavir with lamivudine, 2 commonly used anti-virus agents, for preventing the risk of HBV reactivation in patients with NHL on CHOP/R-CHOP.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated NHL suitable for CHOP/R-CHOP treatment
* Age range 18-80 years old
* HBsAg positive with high level of HBV DNA
* Eastern Cooperative Oncology Group performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Primary or secondary central nervous system involvement
* With hepatitis C virus infection
* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
Aspirin on CTCs of Advanced Breast and Colorectal Cancer

The purpose of this study is to determine whether Aspirin could affect the number and subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.

BACKGROUND:

* Invasion and metastasis are the main reason of death in metastatic cancer, and abundant evidence find circulating tumor cells(CTCs) take the core position in breast and colorectal cancer metastasis.
* Platelets play multiple role to facilitate the epithelial to mesenchymal transition of tumor cells and protect CTCs to survival in the circulation, which enrolled in the whole process of metastasis.
* Several clinical trials and observational study have validate the primary and secondary prevention effect of aspirin to both breast and colorectal cancer.

OBJECTIVES:

* Determine the effect of aspirin on CTC number of metastatic breast and colorectal cancer;
* Determine the effect of aspirin on CTC subtype (epithelial/mesenchymal/mixed type) of metastatic breast and colorectal cancer.

ELIGIBILITY:

* Adults age from 18-75 years old.
* Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
* Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted. Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
* No disease of hemorrhagic tendency or history of non-steroid drug allergy.
* CTCs≥5 / 7.5ml blood

STUDY DESIGN:

* Aspirin will be administered orally once a day in 28-day cycles.
* The CTC was evaluated every 28 days for 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults age from 18-75 years old.
* Patients were diagnosed for metastatic breast or colorectal cancer by pathology.
* Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted.
* Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted.
* PS score ≤ 3
* Anticipated survival time ≥ 3 months
* CTCs≥5 / 7.5ml blood

Exclusion Criteria:

* Allergic to aspirin or other types of non-steroid
* History of hemorrhage of digestive tract or other hemorrhagic disease
* Plan to receive surgery within the time frame of the trial
* Medication history of aspirin or other types of anti-platelets drug within one months before the trial
* Women in pregnant or lactation period
* Any psychological or objective problem may influence the compliance of the patients
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent,
* Male or female patients, 18 to 75 years of age,
* Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
* Active symptomatic and histological EoE
* Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria:

* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
* Achalasia, scleroderma esophagus, or systemic sclerosis,
* Other clinically evident causes than EoE for esophageal eosinophilia,
* Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection \[candida esophagitis\]),
* Any relevant systemic disease (e.g., AIDS, active tuberculosis, hepatitis B or C),
* If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
* Liver cirrhosis or portal hypertension,
* History of cancer in the last five years,
* History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
* Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
* Existing or intended pregnancy or breast-feeding.
Epidemiology and Outcome of Ventilator-associated Pneumonia Among Critically Ill COVID-19 Patients

The aim of this study is to determine the risk factors for development of ventilator-associated pneumonia (VAP) and to identify the prognostic factors of VAP among Coronavirus Disease 2019 (CoViD-19) patients. We hypothesized that CoViD-19 serves as a high risk factor for the development of VAP and it affects clinical outcome measures negatively.

Coronavirus Disease 2019 (CoViD-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) became a pandemic affecting thousands of individuals worldwide. A considerable proportion of CoViD-19 patients require admission to the intensive care unit (ICU), although limited data are available on their clinical characteristics and course. The results of retrospective studies indicate older age, presence of comorbidies and secondary infections as predictors of mortality among this population. Further evaluation regarding ICU clinical course and predictors of mortality is needed.

The aim of this study is to determine the risk factors for development of VAP and to identify the prognostic factors of VAP among CoViD-19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill individuals diagnosed with PCR confirmed CoViD-19 disease
* Started mechanical ventilation for \> 48 hours
* Informed consent signed by the patient or authorised representative

Exclusion Criteria:

* Participation in an interventional trial aiming nosocomial infections
* refused informed consent