cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Efficacy and Safety of Nilotinib 300mg Twice Daily in Patients With Philadelphia Positive Chronic Myeloid Leukaemia (CML) in Chronic Phase Who Are Intolerant to Prior Tyrosine Kinase Inhibitors.

The purpose of this Australian study was to assess the efficacy and safety of nilotinib 300mg twice daily in patients with chronic myeloid leukemia chronic phase who were intolerant but responsive to 1st line treatment with imatinib or dasatinib. Eligible patients have been previously treated with imatinib or dasatinib for at least 3 months and are experiencing non-hematologic toxicity whilst having documented responses that meet PBS authority for 1st line treatment of CML without current MR4.5.

The study was planned to enroll 130 patients to achieve the sample size requirement for a meaning full conclusion. Study got terminated with 20 patients because of slow recruitment. Therefore, due to small sample size, the results cannot be considered clinical significant.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent prior to screening procedures
2. Eastern Cooperative Oncology Grou (ECOG) Performance Status of 0, 1, or 2.
3. Patient with diagnosis of Ph+ CML-CP associated with BCR-ABL quantifiable by RQ-PCR (IS).
4. Patient has received a minimum of 3 months of imatinib or dasatinib treatment (any dose) since initial diagnosis with a documented response.
5. Patient is eligible for Pharmaceutical Benefits Scheme (PBS) reimbursed 1st line TKI treatment.
6. Patient has experienced non-hematological Adverse Events (AE(s)) of any grade, which persisted for at least 1 month despite supportive care or recurred at any grade at least once. Patients who, at the Investigator's discretion, require immediate discontinuation due to the severity of the adverse event are also eligible.
7. No other current or planned anti-leukemia therapies.
8. Adequate organ function.
9. Potassium, Magnesium and Total Calcium above Lower limit of normal.
10. life expectancy of more than 12 months in the absence of any intervention

Key Exclusion Criteria:

1. Prior treatment with nilotinib.
2. Prior Accelerated Phase (AP), Blast Crisis (BC) or allogeneic-transplant (unless the patient received an autologous transplant and was in Chrionic Phase (CP) prior to transplant and never in AP or BC).
3. Patient has documented Molecular Response (MR) 4.5 at the time of study entry
4. Patients with atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
5. Known impaired cardiac function.
6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
7. Pregnant or breast feeding (lactating) women.
8. Women of child-bearing potential unwilling or unable to use highly effective contraception.
A Study of Atezolizumab in Combination With Carboplatin + Paclitaxel or Carboplatin + Nab-Paclitaxel Compared With Carboplatin + Nab-Paclitaxel in Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower131]

This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically or cytologically confirmed, treatment-naïve Stage IV squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from biopsy at screening
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastasis
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for Human Immunodeficiency Virus (HIV)
* Active hepatitis B or hepatitis C
* Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
* Severe infection within 4 weeks prior to randomization
* Significant history of cardiovascular disease
Impact of an Educational Video on Satisfaction After Glaucoma Surgery

Overall Objective: This study will assess whether an educational video is effective in increasing patient satisfaction with glaucoma surgery.

1. Investigate the impact of educational interventions on glaucoma patients' surgical satisfaction.
2. Investigate the post-operative satisfaction of rural glaucoma patients in county hospitals
3. Investigate the difference in postoperative satisfaction between urban and rural glaucoma patients in urban hospitals
4. Investigate other factors that influence postoperative glaucoma satisfaction.

Glaucoma is the leading cause of irreversible blindness in China, as elsewhere in the world. In Chinese rural settings, where topical glaucoma medication is unlikely to be a practical and sustainable option, surgery is the primary treatment modality for glaucoma.

However, it is known that vision is quite likely to decline in the short to medium term after glaucoma surgery, and there are concerns that dis-satisfaction resulting from such vision changes might lead to negative social marketing, affecting uptake not only of glaucoma surgical care but other eye operations (principally cataract) as well. We propose to test the impact on post-operative satisfaction of a multi-media educational intervention designed to give patients a realistic expectation of their post operative course: glaucoma surgery is being performed NOT to improve vision, but do protect it from future harm, and vision may in fact decline for several weeks post operatively.

A randomized controlled design will be used, and subjects undergoing glaucoma surgery will be enrolled at 4 rural county hospitals in rural Guangdong province, and randomized to receive the intervention or usual care. The principal outcome will be subjective satisfaction on a previously-tested questionnaire instrument, administered pre-operatively and post-operatively on two occasions in the first month following surgery. Patients not returning post-operatively to the surgical facility will be contacted by telephone for administration of the questionnaire. Other facility- and patient-related clinical and personal factors expected to influence satisfaction will also be recorded, and adjusted for in all analyses.

Eligibility Criteria:
Inclusion Criteria:

* age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy

Exclusion Criteria:

* patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Personalized Transcranial Magnetic Stimulation Treatment for Depression

This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression.

Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot.

All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations.

Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach).

Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days.

All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up.

The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 21 years.
2. DSM-5 diagnosis of current Major Depressive Episode.
3. Montgomery-Asberg Depression Rating Scale score of 20 or more.
4. Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
5. Able to give informed consent.

Exclusion Criteria:

1. DSM-5 psychotic disorder
2. Drug or alcohol abuse or dependence (preceding 3 months).
3. Rapid clinical response required, e.g., high suicide risk.
4. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
5. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
6. Pregnancy.
7. Unsuitable for MRI.
Reduction of Blood Recirculation in Veno-Venous ECMO

Blood which recirculates through the circuit of a veno-venous Extracorporeal Membrane Oxygenation (V-V ECMO) does not contribute to the systemic oxygenation of a patient on V-V ECMO and is called the recirculation fraction (Rf). Theoretically, the optimization of ECMO blood flow is possible using Rf measurements.

A prospective, observational study will be performed measuring the Rf of total ECMO blood flow in patients with acute respiratory distress syndrome (ARDS) on V-V ECMO with an ultrasound dilution technique.

ECMO blood flow will be optimized by reducing ECMO blood flow in accordance with the measured Rf as long as systemic oxygenation is not compromised.

Based on data from the 'Blood Recirculation and vvECMO' trial (ClinicalTrials.gov ID: NCT03200314) (i.e. an expected frequency of successful blood flow reduction of 66.7%), using a one-sample Chi square test, a two-sided type-1 error of 5%, a power of 80%, a total of 68 patients is needed to show that the proportion of patients with a secure ECMO blood flow reduction is greater than 50%. Presumably, 136 Patients have to be included into the trial to study 68 patients with a relevant Rf since not all patients on V-V ECMO suffer from a high Rf.

Eligibility Criteria:
Patients aged 18 years or older requiring veno-venous ECMO for treatment of refractory hypoxemia in ARDS.
Permacol Paste in Perianal Crohn's Disease

The purpose of this study is to collect data about the efficacy of Permacol Paste treatment in perianal Crohn's Disease.

This is an observational prospective cohort study aimed to assess the efficacy of Permacol Paste treatment in perianal Crohn's Disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to Permacol Paste treatment during one year.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18, any sex
* Diagnosis of CD at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria
* Presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and MRI
* Non-active or mildly active luminal CD defined by a CDAI \< 220

Exclusion Criteria:

* CDAI \> 220
* Dominant luminal active CD requiring immediate surgical or medical therapy
* Fistula with \> 3 external openings and \> 2 internal openings
* Severe active proctitis and/or rectal stenosis
* Abscess or pelvic collection \> 2 cm diameter
* Concomitant rectovaginal fistulas
* Concomitant steroid treatment or treated with steroids in the last 4 weeks
Measurement of the Electromechanical Window to Improve the Diagnosis of Congenital Long QT Syndrome

The goal of this research is to prospectively evaluate the performance of the electromechanical window according to a phonographic method, as a mean of diagnosis of long QT syndrome, and to compare its performance with routine tests used.

Familial long QT syndrome (LQTS) is a hereditary cardiac disorder in which most affected family members have delayed ventricular repolarization manifest on the electrocardiogram (ECG) as QT prolongation. This disease is associated with an increased propensity to palpitations, syncope, polymorphous ventricular tachycardia and sudden arrhythmic death. The diagnosis relies mostly on resting ECG findings and on genetic testing. In clinical practice however, this diagnosis is complicated by 2 main reasons: 1) a significant overlap in ECG findings between healthy and diseased individuals and 2) a frequent identification of genetic variants of unknown significance. Recent studies have suggested that echocardiographic measurement of the electromechanical window (EMW - the delay between the end of mechanical contraction and electrical activation of the heart) has better performance in the diagnosis of LQTS. The echocardiographic technique is however too complicated for routine clinical use. Preliminary work conducted at the University Hospital of Bordeaux and at the University Hospital of Reunion Island has demonstrated that a phonocardiographic approach leads to similar results with an improved feasibility and a good reproducibility.

Eligibility Criteria:
Inclusion Criteria:

* Propositus patients with genetically proven LQTS and their relatives,
* Patients of both sexes aged 12 and over,
* Free, informed and written consent of the patient and the two holders of parental authority for minors.

Exclusion Criteria:

* Inability to consent,
* Person deprived of liberty by judicial or administrative decision,
* Majors subject to a legal protection measure,
* Person participating in another research including an exclusion period still in progress,
* Severely impaired physical and / or psychological health, which, according to the investigator, may affect the participant's compliance with the study.
The Added Value of a Third Supervised Training Session to a Standard 12-week Rehabilitation Program After Breast Cancer: Pilot Study

Breast cancer is the most common type of cancer diagnosed in women. A good rehabilitation program is essential for a good recovery after breast cancer, both physically and mentally. The aim of this study is to determine if there is an added value of a third supervised training session within a standard 12-week rehabilitation program to improve physical and mental functioning after breast cancer. The investigators also want to determine the added value of hydrotherapy as a third training session within a 12-week rehabilitation program compared to a third training session with ground exercises to improve physical and mental functioning after breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* men and women after surgery for breast cancer (mastectomy/breast-conserving and/or axillary gland resection/sentinel biopsy)
* possible (neo)adjuvant chemotherapy and radiotherapy have been completed
* hormone and/or immunotherapy may still be ongoing

Exclusion Criteria:

* comorbidities that make hydrotherapy impossible, i.e. open wounds or allergy to chlorine
* oncological unstable disease
* terminal patients
* severe physical disabilities
* severe mental disabilities
* pregnancy
Evolutionary Systems Therapy for Schizotypy

This study aims at replicating existing preliminary evidence about the effectiveness of Evolutionary Systems Therapy for Schizotypy (ESTS). The present randomized controlled trial (RCT) will compare ESTS with Cognitive Behavioral Therapy (CBT) in treating Schizotypal Personality Disorder (SPD). The main questions our RCT aims to answer are:

1. Is ESTS more effective than CBT in treating SPD?
2. Is ESTS more feasible than CBT in treating SPD?

38 patients diagnosed with SPD will be recruited and randomly allocated to either the experimental group (i.e. ESTS) or the control group (CBT). Primary outcome will be reduction in general symptomatology, whereas secondary outcomes will be changes in target mechanisms (self-criticism and metacognition) and remission from diagnosis.

A previous study suggested how ESTS (experimental group; EG) may be not inferior in respect to a combine treatment comprising of CBT and psychopharmacological treatment (control group; CG). Despite the encouraging results, it has been suggested that the presence in the CG of a mandatory pharmacological treatment would have represented a bias. Indeed, a few partecipants refused pharmacological treatment.

Thus, the investigators outlined an RCT aimed at comparing the two interventions (ESTS and CBT) without any mandatory pharmacological treatment. Moreover, the investigators consider the need for a pharmacological treatment during the study as an exclusion criterion.

The investigators expect to extend our knowledge about the feasbility and effectiveness of ESTS for those diagnosed with SPD:

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizotypal Personality Disorder at SCID-5-AMPD Module III
* Age 18 or older
* Being capable of reading and signing the inform consent form in Italian
* Being capable of attending a talk therapy in Italian

Exclusion Criteria:

* Being diagnosed with schizophrenia spectrum disorders or other psychosis disorder
* Being diagnosed with neurodevelopmental or neurological disorders
* Being diagnosed with bipolar disorder
* Being under any psychological or pharmacological treatment
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer

RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment.

PURPOSE: This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer.

OBJECTIVES:

Primary

* Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I, II, or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry.

Secondary

* Compare multicolor fluorescence immunocytochemistry vs bright field immunocytochemistry in the detection of bone marrow micrometastases in these patients.

OUTLINE: This is a multicenter study.

Patients undergo bone marrow aspiration during surgical resection of the primary tumor. Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry.

Patients are followed every 12 months for up to 10 years.

PROJECTED ACCRUAL: A total of 1,634 patients will be accrued for this study within 3 years.

Eligibility Criteria:
Inclusion criteria

* Histologic diagnosis of invasive adenocarcinoma of the breast diagnosed by core, incisional, or excisional biopsy.
* All of the following staging criteria must be met: Primary tumor must be operable and staged as cT1-3 by clinical evaluation. Ipsilateral nodes must be cN0-1 by clinical evaluation. No evidence of metastatic disease (M0).

Exclusion criteria:

* Patients with any history of breast malignancy including DCIS (patients with a history of Lobular Carcinoma in Situ (LCIS) are eligible).
* Treatment including radiation therapy, chemotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to study entry. The only exception is hormonal therapy, which may have been given for up to a total of 28 days after diagnosis and before study entry.
* Patients who will be receiving preoperative chemotherapy.
* Bilateral malignancy (including DCIS).
* Other non-breast malignancies unless the patient is considered disease-free for 5 years before study entry and is deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, colon carcinoma in situ, and basal cell and squamous cell carcinoma of the skin.
Online Education and Counseling Regarding Gynecological Examination

This research was carried out to determine the effect of online education and counseling on women's attitudes and anxiety levels regarding gynecological examination.

The research is a pre-test-post-test, randomized controlled experimental study.

The research is a pre-test-post-test, randomized controlled experimental study. Simple randomization method was used to assign the participants to the groups. The sample consisted of a total of 100 women (experimental group: 50 women and control group: 50 women). The study was carried out with women who applied to Aydın Adnan Menderes University Application and Research Hospital, Gynecology Clinic, Gynecology Outpatient Clinic and met the study criteria.

Eligibility Criteria:
Inclusion Criteria:

* Applying to Aydın Adnan Menderes University Application and Research Hospital, Gynecology Clinic, Gynecology Clinic,
* Coming to the examination within the first 3 months after the examination,
* Internet access,
* Having a Whatsapp or e-mail address,
* Able to read and write,
* Able to speak and understand Turkish,
* Women in the 18-50 age group are included.

Exclusion Criteria:

* Having a communication (speech, hearing, etc.) disability,
* Having any psychological illness,
* Pregnant and postpartum,
* Diagnosed with cancer,
* Women who received infertility diagnosis and treatment were excluded.
Active Choice Clinical Decision Support (CDS): Hepatocellular Carcinoma (HCC) Screening in Patients With Cirrhosis

The research team will evaluate the effectiveness of an auto-pended bot liver ultrasound order that will prompt providers at the time of encounter to place appropriate imaging orders for hepatocellular carcinoma (HCC) screening in patients with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* cirrhosis diagnosis,
* 6 months or more after since most recent imaging.

Exclusion Criteria:

* previous liver transplant,
* HCC diagnosis,
* receiving hospice care,
* completed external imaging in the past 6 months.