cyrilzakka/clinical-trials huggingface dataset:
Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib

The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluated.

Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. Randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib; a cytogenic response (CgR) less than a partial CgR (PCgR) after at least 6 months of monotherapy with 400-mg; a PCgR after at least 12 months of monotherapy with 400-mg imatinib; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with 400-mg imatinib.

Participants received either dasatinib or imatinib for 12 months or until disease progression, unacceptable toxicity, consent withdrawal, or study discontinuation. After 12 months, who had a confirmed major molecular response and were still receiving dasatinib, 100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months. Participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study.

Eligibility Criteria:
Inclusion Criteria:

* Chronic phase Ph\^+ chronic myeloid leukemia (CML) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (CgR) that is less than a partial CgR (PCgR) after at least 6 months of monotherapy with imatinib, 400 mg; a PCgR after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with imatinib, 400 mg.
* Either gender
* Age of 18 years or older

Exclusion Criteria:

* Previous diagnosis of accelerated phase or blast crisis CML
* Uncontrolled or significant cardiovascular disease
* History of significant bleeding disorder unrelated to CML
* Concurrent malignancies
* Intolerance of imatinib, 400 mg
* Prior treatment with imatinib at a dose higher than 400 mg
* Prior stem cell transplantation and/or high-dose chemotherapy for CML
ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence

The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.

Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day

Prospective multicenter randomized controlled trial comparing two parallel arms: the implantation of an adjustable balloon (experimental arm) versus implantation of an artificial urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).

This research will focus on the assessment of improved continence, quality of life, and Cost-Effectiveness Analysis.

The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal urethra increasing the urethral coaptation and supporting to the bladder neck to prevent urine leakage at stress.

The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related to ISD. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by closing the urethra and allowing the patient to void according to the patient's will and opening of the device (sub-cutaneous pump).

An inclusion visit will take place between 3 months and 1 month before the date of the surgery to explain the purpose of the study, the benefits and risks for patients, and describe the comparative medical devices.

Patients will be randomized before surgery (at D0).

The follow-up will be conducted up to one year, with scheduled visits at M1, M3, M6 and M12.

Secondary endpoints will be assessed during scheduled visits.

The medico-economic assessment will be made during the same follow-up period. This period will take into account improvement of urinary continence and results reported from the 3rd month as well as the morbidity and mortality related to the implementation of the medical device up to 1 year.

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Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from stress urinary incontinence due to ISD.
* Patients with maximum urethral closure pressure(PCUM) \< 50 cm H2O or bladder leakage pressure \< 100 cm H2O
* Patient who accepted surgery
* Patient with normal urethra-cystoscopy (no foreign body nor calculus)
* Patient with effort leaks on clinical examination
* Patient who never had SUA or ACT ™ balloon
* Affiliation to health insurance
* Written informed consent

Exclusion Criteria:

* Patient pregnant or breastfeeding
* Patient with a life expectancy of less than 2 years
* Patient with overactive bladder uncontrolled and considered an against-indication for surgery
* Patient with reduced bladder compliance
* Patient with significant post-void residual volume according to the judgment of the Investigator
* Patient with a history of pelvic radiotherapy
Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm

Patients with advanced ovarian cancer (FIGO stage III C) and highly disseminated tumor will be randomized into two arms: primary debulking surgery followed by adjuvant chemotherapy vs. neoadjuvant chemotherapy followed by interval debulking surgery (IDS). The primary end point is the evaluation and comparison of the surgical complications of primary surgery and IDS and the evaluation of the progression free survival (PFS)


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected advanced ovarian cancer (FIGO stage IIIC)
* PIV ≥ 8, PIV ≤ 12
* Estimated life expectancy of at least 4 weeks.
* PS ≤ 2
* Appropriate respiratory, hepatic, cardiological, bone marrow and renal functions (Creatinine Clearance \> 60 mL/min according to Cockcroft formula)
* Patient capable of consent.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Non-appropriate respiratory, hepatic, cardiological, bone marrow and renal functions
* Large size mass reaching the xiphoid, occupying all the abdominal cavity and/or infiltrating the abdominal wall.
* Mesenteric retraction
Impact of the Presurgical Visit of Nursing on the Well-being of the Surgical Patient.

.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowledge of the surgical process from admission to hospital discharge. Researchers (nursing) began to make prior visits to the surgical procedure to reduce anxiety and provide information about the surgical process. The importance of the presurgical nursing visit (PNV) is sought, how to achieve a better health education throughout the surgical process, improve communication between professionals through standardized records, contributing to an optimal approach to the participant, increasing well-being, health and the satisfaction of the participant

In our Center, PNVs are carried out in the Ambulatory Area (External Consultations) in a specific and personalized nursing consultation, within an established and multidisciplinary program. One week before surgery, the patient and a family / primary caregiver are cited.

The PNV conducts a semi-structured interview; the content may vary according to the type of surgery, but in general it can be understood as all those nursing interventions; how to provide information, support, advice and training to the patient and his family (primary caregiver).

It is an innovative experience since it has been carried out for a short time. The PNV have been gradually restructured and continue to grow, since their establishment has been positively valued in the different services thanks to the experience gained and the numerous bibliographic references that demonstrate the beneficial results for the patient and the health system.

A total of 356 participants have been calculated (surveys answered in more than 3 months), taking into account an approximate population of 1,172 programmed interventions carried out in 1 year, with a confidence interval of 95%, accuracy of 3% a proportion of 5% and with an expected loss of 15%.

Sample:

Arthralplasia of knee / hip N 480 n 92 Cystectomies N 24 n 19 Esophagogastric with coloplasty N 24 n 19 Hysterectomy N 24 n 19 Colon / rectum N 192 n 65 Lumpectomy with sentinel lymph nodes N 222 n 74 Caesarean section N 206 n 68

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone the pre-surgical nursing visit (personalized).
* Patients over 18 years of age
* Live accompanied and / or with own resources of help.
* Having signed the informed consent.

Exclusion Criteria:

* Not having signed the informed consent.
* Not having done the questionnaires after pre-surgical nursing visit (STAI, EQ-5D-5L)
* For surgical complications that do not allow the telephone survey, or focal groups.
Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome

In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.

Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed MDS by bone marrow examination
* Receiving azacitidine and decitabine as a first line chemotherapy
* Adequate hepatic, cardiac, and renal function

Exclusion Criteria:

* Previously treated with another anti-cancer therapy due to MDS
* Not available for clinical information
Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia

The primary objective of the study is the evaluation of sustained response rate after discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or chronic pITP patients who failed one or more therapy lines, splenectomy included.

Increasing evidence exists in the literature on the persistent response after TPO-RAs discontinuation. However, the available data consist of description of case reports from different patients' series. At this time, systematic data collections on this topic do not exist and the real incidence of such persistent response is unknown. Therefore, because of the increasing interest in this new and challenging therapeutic field, also for the therapeutic implications, we would like to investigate the impact of TPO- RAs on the achievement of sustained and persistent responses after their discontinuation in the Italian adult patients affected by pITP who have been referred to the GIMEMA Centers.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent according to ICH/EU/GCP and national local laws;
* Persistent or chronic pITP adult patients who have been treated with TPO-RAs therapy after failure of one or more therapy lines, splenectomy included;
* Age \> 18 years.

Exclusion Criteria:

* Active malignancy;
* Active malignancy;
* HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
* Chronic liver disease;
* Treatment with Rituximab less than 8 weeks before TPO-RAs start;
* Recent splenectomy (less than 8 weeks) before TPO-RAs start. Active malignancy;
* HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
* Chronic liver disease;
* Treatment with Rituximab less than 8 weeks before TPO-RAs start;
* Recent splenectomy (less than 8 weeks) before TPO-RAs start. HCVAb, HIVAb, HBsAg, HBcAb seropositive status;
* Chronic liver disease;
* Treatment with Rituximab less than 8 weeks before TPO-RAs start;
* Recent splenectomy (less than 8 weeks) before TPO-RAs start.
Online Re-Intervention On Eating Behaviour and BMI On Obese Hypertensive Patients

This research will constitute a 3-year follow-up that includes a re-evaluation and re-intervention of overweight or obese adults suffering from hypertension, who already participated in a similar programme with the same objectives 3 years ago.

Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and physical activity levels.

Hypertension incidence and overweight or obesity related, constitute a worrying public health problem nowadays. Evidence indicates that, despite the existence of several factors involved in their etiology, diet and physical activity play a particularly important role in the treatment and prevention of obesity and associated disorders.

However, interventions for the treatment of obesity encounter some environmental and personal barriers, specifically problems or deficits in motivation. These barriers sometimes make it difficult to implement intervention strategies. In this sense, there is an important agreement about the need to generate alternatives and strategies which promote intrinsic motivation, self-regulation and self-efficacy as fundamental variables which have a direct relationship with the adherence and success of obesity treatments.

To achieve this, Information and Communication Technologies (ICTs) are a very promising alternative, as they can provide personalised feedback and can be flexibly adapted to each user. In addition, ICTs also present other important advantages, especially their excellent cost-benefit ratio, and the possibility of increasing the efficiency of the interventions, since they allow to reach a greater number of users at a lower cost.

This research will constitute a 3-year follow-up that includes a re-evaluation and re-intervention of overweight or obese adults suffering from hypertension, who already participated in a similar programme with the same objectives 3 years ago.

Patients will be recruited in the Hypertension Unit of a public hospital and assigned to a experimental group. The evaluation will include: eating behaviour, body mass index (BMI) and physical activity levels.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension.
* Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2).
* Aged between 18-65 years.
* Being a participant of the program 3 years ago.

Exclusion Criteria:

* Not having access to the Internet or lack of information about it.
* Treatment with more than 3 antihypertensive drugs.
* Meet the criteria of the DSM-IV-TR of a Food Disorder.
* Presenting some type of severe psychiatric disorder.
* Disability that prevents or hinders physical exercise.
* Receiving some treatment for weight loss.
Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
* Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.

Exclusion Criteria:

* Given the characteristics of the study there are no exclusion criteria.
Assessment Of Anterior Chamber Configuration Changes After Phacoemulsification

To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation with Swept-Source Optical Coherence Tomography (SS-OCT).

To investigate changes in anterior chamber angle configuration after phacoemulsification and intraocular lens (IOL) implantation in eyes with a shallow anterior chamber and narrow angle, compared with the eyes with normal anterior chamber and open angle using Swept-Source Optical Coherence Tomography (SS-OCT).

Eligibility Criteria:
Inclusion Criteria:

ACD was less than 2.68mm. the anterior chamber angle width on gonioscopy≤Shaffer 2 .

Exclusion Criteria:

primary or secondary glaucoma, peripheral anterior synechiae, history of ocular surgeries
Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake

Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. This problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. Recent evidence has showed that these cells increase in number in active CD and secrete more hormones that negatively affect appetite. The increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are hypotheses that require further proof. Current technological advances in magnetic resonance imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain that control food intake. The involvement of the brain in control of food intake is still not fully understood. This work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Age 16-75 years
2. Ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for Crohn's disease (SES-CD) of 4-19, in the absence of stricturing disease or,
3. Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or,
4. Faecal calprotectin of \>250µg/g
5. C-Reactive protein \>5mg/dl
6. Harvey-Bradshaw index score of 5-16
7. Body mass index (BMI) 18-35
8. As for HV participants, inclusion criteria 1 and 7 will apply.

Exclusion Criteria:

1. Malignant disease
2. BMI \<18 and \>35
3. Significant cardiovascular or respiratory disease
4. Diabetes mellitus
5. Current Infection
6. Neurological or cognitive impairment; significant physical disability
7. Significant hepatic disease or renal failure
8. Abnormal blood results other than those explained by CD including bleeding diatheses (apart from in the case of HV where all unexplained blood results are an exclusion criteria)
9. Subjects currently participating in (or in the last three months) any other research project
10. pregnancy or breastfeeding or
11. if MRI is contraindicated (e.g. pacemaker).
12. Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable.
13. As for healthy volunteer participants all exclusion criteria apart from no.12.
Cardiovascular Diseases in Elderly Asthma

This study is a cross-sectional study to evaluate the relationship between coronary calcium score and clinical parameters of asthma such as onset of disease, lung function parameter and airway inflammation parameter (sputum eosinophil or FeNO) in Korean elderly asthma (regardless of whether they have concomittent COPD or not) patients

Subjects who visited Allergy Clinic in SMG-SNU Boramae Medical Center for asthma or ACO will be recruited consecutively. Subjects who meets the inclusion criteria and agree to participate in the study will take coronary artery calcium scoring CT and asthma CT (inspiration and expiration images). The correlation between the degree of coronary calcification and airway diameter, airway wall thickness, air-trapping and emphysema will be evaluated as well as clinical parameters of asthma. We will also compare those correlations from the images of healthy control subjects who performed the coronary calcium scoring CT for health checkup purpose.

Eligibility Criteria:
Inclusion Criteria:

* If the doctor has been diagnosed with asthma and one or more of the following criteria is met;

  1. FEV1 increased more than 12% \& 200 mL after 10-20 minutes of inhalation of short-acting bronchodilator (200-400 mg salbutamol)
  2. Positive bronchial provocation tests (methacholine, mannitol, exercise, aspirin, etc.)
  3. FEV1 Increased more than 12% \& 200 mL from baseline FEV1 after anti-inflammatory treatment for 4 weeks or longer.

Exclusion Criteria:

* Those who were already diagnosed and treated for coronary artery diseases.
* Those with other structural lung diseases such as Tuberculosis destroyed lung and interstitial lung diseases
* Those who are unable to conduct a test or questionnaire due to severe systemic illness, or cognitive dysfunction.
* Those who are participating in other clinical trial using IND(investigational new drug) or finished other clinical trial within 30 days.
* Those who refuse to participate in the study or withdraw the consent.
Dermabond PRINEO for Total Shoulder Arthroplasty

This is a research study to find out whether wound closure (the process of closing the surgical wound after the procedure is complete) with Dermabond PRINEO Skin Closure System (PRINEO) will be faster and improve wound healing compared to standard closing methods after total shoulder replacement. The PRINEO system involves using running stitches to close the wound, and then taping over the sutures with a sticky film that holds the wound closed.


Eligibility Criteria:
Subjects will be included if:

* They are 18 years or older;
* They are undergoing primary total shoulder arthroplasty by the principal and co-investigator.
* They are willing and have the capacity to provide informed consent;
* They expect to continue their post-operative follow up care with their operating surgeons at Medical University of South Carolina (MUSC).

Subjects will be excluded if:

* They have a unique, identifying tattoo or skin marking within 2 inches of intended site of surgical incision
* They self-report a known hypersensitivity to cyanoacrylate, formaldehyde, benzalkonium chloride, or pressure sensitive adhesive;
* They self-report or have a documented prior ipsilateral shoulder arthroplasty or other open ipsilateral shoulder surgery utilizing the delto-pectoral approach;
* Their medical record shows that they are HIV positive or otherwise immunocompromised;
* Their medical record shows a skin abnormality or dermatological condition which affects skin healing;
* They report a personal or family history of significant keloid or significant hypertrophic scar formations, or other problems with wound healing.