cyrilzakka/clinical-trials huggingface dataset:
Renal Replacement Therapies Decision Aids

Different renal replacement therapy methods will cause significant impacts on the physical, mental, and social for patients with end-stage renal disease. Application shared decision-making should be able to effectively assist patients in choosing suitable renal replacement therapy. Currently, most of the patient decision aid of renal replacement therapy are written health education leaflets, which have problems such as too many words, more difficult content, and inconvenience. In shared decision-making, even though different treatment options are communicated to patients, there is still a gap between "understanding" and "real experience", it will be creating uncertainty of decision, and emphasizing true situational learning strategies should be a viable auxiliary method. Therefore, this study aims to develop a web-based patient decision aid of renal replacement therapy and integrates situational learning strategies into it. First, investigators have conducted a qualitative study to explore the related experience of patients with end-stage renal disease the decision-making needs in renal replacement therapy choice, and the experience and barrier of reading paper patient decision aid. Next, based on the results of the pilot study, the modified Delphi method will be used to collect the opinions of experts, and the situational learning theory will be integrated into the patient decision aid to develop the web-based situation renal replacement therapies patient decision aid. After completion, investigators will apply quasi-experimental, a repeated measurement that will be adopted to analyze the effectiveness of web-based patient decision aid of renal replacement therapy in shared decision-making in patients with end-stage renal disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed by nephrologists as patients with chronic kidney disease, and GFR \<30 ml/min/1.73m2.
* As a patient admitted to the "Pre-ESRD care plan".
* Clear awareness, ability to communicate in Mandarin and Taiwanese, and agree to participate in the research.
* Those who are unable to answer the questions without other serious diseases or diseases affecting the mind.

Exclusion Criteria:

* Those who cannot freely choose hemodialysis or peritoneal dialysis due to absolute contraindications.
Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B

The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Children from 2 years old to under 16 years old are diagnosed with hepatitis B chronic disease AND
* HBsAg or HBV DNA: positive for at least six months AND
* Liver enzyme ALT: continuously increased by\> 70 for male and \> 50 for female (\> 2 x ULN) AND
* The virus is proliferating: HBV DNA above 20,000 IU/mL (if HBeAg positive) OR HBV DNA above 2,000 IU/mL (if HBeAg negative) AND
* A parent or legal guardian of the pediatric patient obtains consent for them to participate in research.

Exclusion Criteria:

* HIV and hepatitis C co-infection
* Patients have other chronic liver disease (Wilson, autoimmune hepatitis)
* Patients are being treated with immunosuppressive drugs
* Psychomotor retardation, cerebral palsy, brain sequelae
Circulating Micro RNAs Expression in Egyptian Bronchial Asthma and COPD Patients

This cross sectional study will be carried out on 30 subjects who will be recruited from the outpatient clinic of Chest Department, Tanta University Hospital.

They will be classified into 3 groups:

Group I: It will include 10 healthy volunteer subjects. Group II: It will include 10 asthmatic patients. Group III: It will include 10 COPD patients. miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 will be measured in serum samples from all subjects

The following will be done for all subjects:

1. Thorough history taking with stress on age, age at onset, duration of the disease, smoking history, therapeutic history with stress on their drugs, course of the disease, history of any previous attacks of acute severe asthma or exacerbation of COPD.
2. Complete physical examination.
3. Chest x-ray P.A view.
4. Complete blood picture.
5. Ventilatory function tests including FVC, FEVI and FEVI/FVC, PEFR and FEF25-75% using computerized spirometry apparatus.

Quantitative assessment of miRNA levels: will be used to assay miR-7, miR-20a, miR-21, miR-22, miR-145 and miR-155 in serum samples from all subjects. These miRNAs were selected based on prediction algorithms that suggested that these miRNAs were involved in the regulation of cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Group 1: healthy volunteers with no history of chest troubles.
* Group 2: 10 asthmatic patients with history of paroxysmal wheezing, dyspnea, chest distress, and/or coughing; with Reversible airflow limitation as will be measured by an increase in forced expiratory volume in one second (FEV1) of at least 12% and of more than 200 ml after inhalation of 200 μg salbutamol.
* Group 3: 10 COPD patients who have chronic airﬂow limitation on spirometry (FEV1/FVC is less than 0.7), and the patients have irreversible airflow limitation as will be measured by an increase in (FEV1) by less than12% or less than 200 ml after inhalation of 200 μg salbutamol.

Exclusion Criteria:

* Upper or lower respiratory tract infection during the month preceding the study.
* Other chronic respiratory or systemic illness.
* Usage of systemic steroids within 2 months prior to the study.
* Inability to provide informed consent or who refused to draw off blood.
Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers.

The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-80 years old
* Chronic Diabetes Mellitus type 1 and type 2 diagnosed at least 3 years before the screening
* Have a single non-infected diabetic hard-to-heal wound (ulcers/foot ulcers) ≤ 0.8-40 cm2 wound area at start of treatment, for period of at least for 3 months.
* Wagner classification stage 1 or 2 or post-debridement stage 3.
* At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) ≥0.65
* Stable diabetic drugs 4 weeks before Screening
* Be available for the entire study period, and be able and willing to adhere to protocol requirements
* Provide written informed consent prior to admission into the study

Exclusion Criteria:

* Have a glycosylated hemoglobin (HbA1c) \> 10.5%
* Have more than one wound
* Have a body mass index (BMI) \> 40 kg/m2
* Have visible bone exposure at wound site
* Anemia (Hemoglobin \< 9 g/dL) or White Blood Cells count \> 11,000/μL or Platelets count \< 100,000/μL or liver function tests \> 3 times upper normal lab values or Creatinine \> 3 mg/dL; any indication of malnourishment (Albumin \< 3 g/dL); INR\>2 or any other clinically significant blood and urinalysis tests per the physician's discretion
* Patients with unstable hypertension
* Have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except diabetes type 1 or 2 or during screening period
* Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test
* Participation in a clinical study or use of an investigational drug within 30 days prior to admission to this study
* Patients with active Gangrenous foot ulcers
* Active osteomyelitis (Have any signs of infection in the wound (which could be linked to raised body temperature), abscess, cellulitis, necrosis, erythema, mild drainage or known osteomyelitis)
* Patients with uncontrolled hyperthyroidism
* Patients with history of collagen diseases
* Patients with known allergy to ozone
* Anxiety, Depression, history of Mental illness or patient under Guardian
* Any medical condition for which the investigator deems the subject unable to participate in the study
Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients

This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Eligibility Criteria:
Inclusion Criteria:

* Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

Exclusion Criteria:

* Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg
* History of angioedema, drug-related or otherwise, as reported by the patient
* Patients unwilling or not able to discontinue safely the use of current antihypertensive medications during the study, as required by the protocol.
* Patients have significant cardiovascular co-morbidities
* Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol defined inclusion/exclusion criteria may apply.
Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care

Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.

In order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.

As part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.

In recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.

However, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 to 80 years
* Patients with biliary pathology requiring cholecystectomy
* Patients with signed consent
* Patient eligible to outpatient care
* No allergy to Naropin
* Support by laparoscopy
* Patients affiliated to a social security s

Exclusion Criteria:

* Contraindications for laparoscopy
* Contraindications to outpatient surgery
* Patients with an allergy to paracetamol or tramadol
* Patient with an addiction to painkillers and / or alcohol
* Patient with a disease causing chronic pain
* Patient using analgesics bearing 1 , 2 or 3 chronically
* Pregnant or breastfeeding women , of reproductive age without effective contraception
* Minor Patient,
* Contraindication to surgery,
* Physical or psychological state does not allow the patient's participation in the study ,
Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families

This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows.

1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers?
2. What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme?
3. What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?


Eligibility Criteria:
Inclusion Criteria:

Service users

* diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians
* aged 18 to 64
* able to communicate in Cantonese

Family caregivers

* aged 18 or above
* able to communicate in Cantonese
* live with service users

Exclusion Criteria:

Service users

* have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
* live in hostel

Family caregivers

-have active psychiatric conditions
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)

The purpose of this investigational study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus (a specific type of diabetes).

The duration of treatment is 104 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES: I. Evaluate the efficacy of carmustine, cisplatin, and etoposide administered prior to and during radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme. II. Assess the toxicities of this treatment regimen in this patient population. III. Assess fatigue, depression, and excessive daytime somnolence in terms of incidence, duration, and relation to age, tumor type, tumor site, cancer therapy, and symptoms in this patient population. IV. Evaluate the quality of life of these patients.

OUTLINE: Patients receive pre-irradiation chemotherapy consisting of carmustine IV over 1 hour on days 1-3 and oral etoposide on days 1-21 and 29-49 immediately followed by cisplatin IV over 1-2 hours on days 1-3 and 29-31. Treatment repeats every 8 weeks for 2 courses. Patients receive concurrent cranial radiotherapy daily over 8 weeks during course 2. Patients then receive carmustine IV over 1-2 hours every 8 weeks for 4 courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before the study, prior to each treatment course, every 4 months for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients are followed every 4 months for 1 year, every 6 months for 4 years, annually for 5 years, and then for survival.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed glioblastoma multiforme No oligodendrogliomas or oligoastrocytomas

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 130,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Renal: Creatinine no greater than 0.5 mg/dL above ULN Other: No uncontrolled infection No other major medical conditions No other concurrent malignancy except superficial skin cancers Must be able to read English (quality of life assessment only) No other problem that may preclude quality of life assessment Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Concurrent steroids allowed Radiotherapy: No prior radiotherapy Surgery: Not specified
TMS Stimulation and Cognitive Training in Alzheimer Patients

The aim of this study is to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of mild to moderate Alzheimer's disease (AD) patients.

The current available pharmaceutical treatment for Alzheimer Disease (AD) is only partially and temporary effective. Therefore, new approaches are needed. rTMS is a non-invasive technique which generates a small electric current that induces a modulation in cortical excitability. In addition, cognitive training was suggested to improve cognitive functions in Alzheimer patients.

In this study we intend to treat mild to moderate AD patients with rTMS interlaced with cognitive training (rTMS- COG).

Patients with probable AD will be treated with rTMS-COG daily for 6 weeks followed by maintenance sessions for additional 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 55-85 years
* Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.
* MMSE score 18 to 24
* Global Dementia rating 1 or 2
* Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG
* Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication)
* Written informed consent by both patient and legally responsible caregiver.
* Able to undergo MRI scan and EEG recordings prior to the onset of the study.
* Agreement to participate in up to 9 months the study.
* Right handed
* Hebrew or Russian as mother tongue and/or ability to read and understand the inform consent form (ICF), and the Patient Information document in Hebrew or Russian.

Exclusion Criteria:

* Severe agitation;
* Mental retardation;
* Unstable medical condition;
* Use of benzodiazepines or other hypnotics during the study and preceding two weeks;
* Pharmacological immunosuppression;
* Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;
* Alcoholism;
* History of Epileptic Seizures or Epilepsy;
* Contraindication for performing MRI scanning;
* Contraindication for receiving TMS treatment according to a TMS questionnaire;
* Clinically significant abnormal laboratory findings which have not been approved by the Principle Investigator;
* Patients treated with cholinesterase inhibitors, or memantine or ginko-biloba will be allowed to participate, if the treatment has started at least 2 months previous to recruited.
Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States

This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
* Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
* Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)

Exclusion Criteria:

* Physicians unwilling or unable to follow study instructions
* Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and more
* Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
* Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
* 70 % stenosis or more in coronary CTA
* Willing to provide informed, written consent

Exclusion Criteria:

* Requirement for surgical procedure
* Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
* Recent STEMI (\<5 days)
* Non STEMI, if the cardiac troponin is not stable or starting to decline
* Left ventricular ejection fraction \<30%
* Life expectancy \<2 years
* Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
* Undergoing evaluation for organ transplantation
* Participation or planned participation in another cardiovascular clinical trial
* Pregnancy
* Inability to take dual antiplatelet therapy for six months
* Previous CABG
* Left main disease requiring revascularization
* Any target lesion with in-stent restenosis
* NYHA class 3 or 4a
* Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)