cyrilzakka/clinical-trials huggingface dataset:
Advance Care Planning GuideTailored for Primary Care Patients

this project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers


Eligibility Criteria:
Inclusion Criteria:

* must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up English speaking

Exclusion Criteria:

* under 50
* inactive patient portal account
Conduction System Pacing Optimized Therapy

The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV), conduction system pacing (CSP)-only, and conduction system pacing optimized therapy (CSPOT) also known as a combination of conduction system pacing (CSP) and left ventricular (LV) pacing. Additionally, safety of the system will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patient is willing and able to provide written informed consent
* Subject is at least 18 years of age
* Patient is willing and able to comply with the protocol, including follow-up visits
* The patient's medical records must be accessible by the enrolling site over the follow-up period
* Standard CRT-D or CRT-P indications, with a preference for IVCD and non-LBBB patients, where LBBB is defined according to Strauss criteria.
* De-novo CRT implant, including upgrade from pacemaker or ICD

Exclusion Criteria:

* Subject has persistent or permanent AF (Atrial Fibrillation)/AFL (Atrial Flutter)
* Subject has 2nd or 3rd degree AV (Atrioventricular) Block
* Subject has RBBB with no additional conduction block
* Subject has intrinsic (non-paced) QRS width less than or equal to 120 ms
* Subject experienced MI within 40 days prior to enrollment
* Subject underwent valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation or is actively listed on the transplantation list
* Subject is implanted with a LV assist device
* Subject has severe renal disease
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm or significant valve disease expected to be operated within study period)
* Subject has severe aortic calcification or severe peripheral arterial disease
* Subject has complex and uncorrected congenital heart disease
* Subject has mechanical heart valve
* Pregnant or breastfeeding woman (pregnancy test required for woman of child-bearing potential and who are not on a reliable form of birth regulation method or abstinence)
* Subject is enrolled in another study that could confound the results of this study without documented pre-approval from Medtronic study manager
Early Postoperative Cognitive Dysfunction After Closed Loop Anesthesia vs Inhalational Anesthesia or TIVA

This study is designed to test the hypothesis that closed loop system reduces post operative cognitive dysfunction incidence 15 min after anesthesia more than desflurane, sevorane, total intravenous anesthesia manually guided by bispectral index in urologic surgical patients.

The secondary aim is to evaluate the postoperative cognitive impairment in in elderly vs younger surgical patients.

Postoperative cognitive dysfunction (POCD) is a transient cognitive impairment manifested by compromised memory and concentration with altered performance on intellectual tasks that can affect patients of any age but it is more frequent in advanced age people after anesthesia.

Recently clinical research has demonstrated the efficacy of computer- controlled endovenous drug delivery system guided by bispectral index score (BIS) of the electroencephalogram as the control variable. The BIS closed loop (CL) titration of propofol and remifentanyl target control infusion provides clinically adequate anesthesia with stability of cardiovascular parameters and favorable patients outcomes, including decreasing drug consumption and shortened postoperative recovery times when compared with manual control infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged above 18 years
* Patients undergoing elective urologic surgery under general anesthesia expected 2 hours
* American Society of Anesthesiology physical status II- III

Exclusion Criteria:

* Patients with body mass index greater than 30,
* Patients with clinically significant cardiopulmonary, hepatic, renal disorders, neurological, psychiatric or metabolic disease
* Patients unable to read and write and with impaired hearing
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).

Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Eligibility Criteria:
Inclusion criteria:

* Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant)
* Had completed the FE200486 CS12 study

Exclusion criterion:

* Had been withdrawn from the FE200486 CS12 study
Regenerative Endodontics for Non-vital Primary Molars

Non-vital primary molars will be treated with regenerative endodontic idea using different capping materials aiming to replace the necrotic pulp tissue with biological one and to provide perfect seal over the scaffold

Non-vital primary molars that fulfill the eligibility criteria will be randomly assigned into one of the 3 study groups:

Group 1: conventional root canal treatment Group 2: Regenerative endodontic treatment using MTA Group3: Regenerative endodontic treatment using Biodentine Each group will be followed up for 12 months

Eligibility Criteria:
Inclusion Criteria:

* Non-vital mandibular primary second molar.
* Restorable tooth

Exclusion Criteria:

* Patients allergic to medicaments or antibiotics necessary to complete the procedure.
* Special Health Care Needs
* Excessive mobility
* Presence of internal or external root resorption.
ANG1005 in Leptomeningeal Disease From Breast Cancer

This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. HER2-negative breast cancer
3. At least 2 months of expected survival
4. Newly diagnosed leptomeningeal carcinomatosis
5. Documented history of brain metastasis that has been previously treated with radiation therapy
6. Neurologically stable
7. Eastern Cooperative Oncology Group performance status grade ≤2
8. Adequate laboratory test results prior to first dose
9. Patients who are fertile must agree to remain abstinent or use reliable method of birth control

Exclusion Criteria:

1. Any prior treatment for leptomeningeal carcinomatosis, except emergency radiotherapy or shunt
2. Prior treatment with ANG1005
3. Patients who have not had radiotherapy for their brain metastases
4. Evidence of symptomatic intracranial hemorrhage or increased intracranial pressure
5. Patients for whom intrathecal therapy is the most appropriate therapy for leptomeningeal disease
6. Pregnancy or lactation and patients planning to be pregnant during the study
7. Peripheral neuropathy \> Grade 2
8. Evidence of severe or uncontrolled diseases
9. Presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
10. History of interstitial lung disease
11. Severe conduction disturbance
12. Central nervous system disease requiring immediate neurosurgical intervention
13. Known allergy to paclitaxel or any of its components
14. Contra-indication for contrast-enhanced MRI
Thiamin Against Robust IBD Fatigue

Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive oral Thiamine treatment for 4 weeks in a RCT, cross-over study.

Patients with Inflammatory Bowel Disease (IBD), disease in remission and chronic fatigue will receive high dose oral Thiamine treatment for 4 weeks in a RCT, cross-over study.

After the high dose treatment period, participants will be randomized to 3 months treatment with Thiamine 300mg/day or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory Bowel Disease
* Disease in remission
* Chronic fatigue

Exclusion Criteria:

* Co-morbidity that can explain fatigue
* Pregnancy
* Non-compliance to the study procedures
* Possible surgery in the study period
Face to Face vs. Group Training Methods on Pulse Rate Taking in Patients With Cardiovascular Diseases.

The aim of this study is to compare the efficacy of group training using a tutorial film and one-to-one face-to-face training in calculating the pulse rate and detecting irregularity in the pulse rhythm in patients with cardiovascular diseases.

Pulse rate self-examination can provide a fairly good assessment of the patient's condition and helps the physician with drug dosage adjustment in patients with cardiac problems.

This study will be conducted in the Cardiology wards of Modarres and Loghman hospitals in Tehran. These are two educational general referral hospitals of Shahid Beheshti University of medical sciences covering northern and southern part of Tehran, the capital of Iran respectively.

After obtaining a written consent the patients will randomly assign into two groups using random number table. One group will receive a 20-minute face-to-face training session by a nurse on how to calculate the pulse rate in a minute and detect irregularities in the pulse rhythm whereas a 10-minute tutorial film with the same content will be shown to the other group.

Three practical test sessions are arranged for each patient, before the training session, right after the training session and at least 48 hours after the training session. The tests contain two parts and evaluate the patients' ability in calculating the exact pulse rate in a minute and detecting irregularities in the pulse rhythm.

A special data-collecting questionnaire is designed for this study. This questionnaire contains background information such as sex, age, and literacy level as well as the practical test results. Data gathering process will be performed by nurses in these hospitals. Nurses, who participate in this study, will attend in briefing sessions on how to fill the data-collecting questionnaires.

The sample size consists of 300 patients who admitted in Cardiology ward (200 in Modarres hospital and 100 in Loghman hospital). The data will be inserted to the computer and the variables will be compared within and between groups using SPSS software version 16.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in cardiology ward
* Literacy (ability to read and write)

Exclusion Criteria:

-
The Molecular Mechanism of CMV-driven NKG2C+NK Cell Expansion in Human

This is an observation study to investigate the molecular mechanism of NKG2C+NK cell expansion after HCMV infection

According to the changes of molecular and gene expression in NK cells at different time points after infection, we want to find out the mechanism by which HCMV promotes the expansion of NKG2C + NK cells.

Eligibility Criteria:
Inclusion Criteria:

1. AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
2. No severe organ dysfunction or failure
3. Subjects must be capable of, and willing to provide written informed consent to participate in the study. Subjects unable to provide written informed consent by themselves may be consented through their legal representative.

Exclusion Criteria:

1. Participation in another industry-sponsored clinical study where treatment for CMV is already specified by the study protocol.
2. Patients received other adoptive immunotherapy such as donor lymphocyte infusion (DLI), Epstein-Barr virus (EBV)-specific T cells and so on.
Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults

Ireland is predicted to have the highest older adult population growth of any European Union country. A substantial economic and social challenge of this projected growth is the increased incidence of cognitive impairment and the likelihood of progression to dementia. Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain changes identifiable from the earliest stages of neuropathology, providing an opportunity for intervention. Switching to a strategy of earlier identification and prevention would significantly reduce prevalence and the associated cost.

The purpose of this pilot study is to evaluate the use of vitamin D supplements in community dwelling older adults as a lifestyle approach that may support cognitive and physical functioning. The research will incorporate several stages including an initial in-depth screening process, a novel and sensitive cognitive battery, 6 month double blind placebo controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback interview.

These results will be used to assess the feasibility of recruiting and assessing community dwelling older adults for extensive nutrition related cognitive studies.


Eligibility Criteria:
Inclusion Criteria:

* Community Dwelling healthy volunteers
* Ability to provide written consent.

Exclusion Criteria:

* Measures low or high serum vitamin D, defined as \< 15nmol/L or \>125nmol/L
* Current use of supplemental vitamin D ≥800 international units/d
* Screen positive for cognitive impairment using the Telephone Cognitive Screen (TCogS)
* Measured hypercalcaemia, defined as corrected serum calcium \> 2.7nmol/l
* Hyperparathyroidism
* Epilepsy
* Stroke
* Renal disease
* Schizophrenia
* Bipolar affective disorder
* Recurrent psychotic depression
* Alcohol and drug abuse within the past 5 years
* Anti-convulsants
* Anti-psychotic medications
* Significant hearing difficulties even when wearing hearing aid
* Illness that caused permanent decrease in memory or other mental function
Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China

The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.

Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single intravenous of ABCD in Chinese healthy subjects.

Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in Chinese healthy subjects.

Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury indicators (KIM-1 and cystatin C) in Chinese healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 19 to 26 kg/m2, inclusive 19 and 26. BMI = weight (kg)/\[height(m)\]2.
* Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion Criteria:

* History of allergy or hypersensitivity.
* Presence of any acute or chronic medical condition within 3 months prior to investigational products administration, including but not limited to: hepatic, gastrointestinal, renal, hematologic (including coagulation), pulmonary, neurologic, respiratory, endocrine, or cardiovascular system abnormalities; psychiatrical disease including major psychiatric disorders (e.g., schizophrenia, bipolar disorder); acute infection; or other conditions that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
* During the screening period, abnormal and clinically significant of physical examination, vital signs, laboratory examination, etc.
* A positive result in hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test.
* Lost blood or donated more than 400 mL of blood within 3 months prior to the screening.
* Participation in a clinical drug study 30 days prior to present study.
* Use of any other drugs within 2 weeks prior to the screening.
* Subjects planning to give birth or donate sperm during the study or within 3 months after the study.
* The partner of the subject is unwilling to take effective contraceptive measures.
* Other unfavorable factors diagnosed by investigators.
Acute Effect of Passive Joint Mobilization in Non-Specific Neck Pain

Aim of present study is investigating the acute effects of passive joint mobilization on pain perception and range of motion. Study protocol includes passive joint mobilization application to study group with neck pain and blood sample collection of study and healthy control group.

Our purpose of planning this study is to examine the acute effect of passive joint mobilization application on pain perception and range of motion in women with non-specific neck pain.

The hypotheses we will test for this purpose;

H1- Passive joint mobilization application increases the range of motion of the cervical joint in women with non-specific neck pain.

H2- Passive joint mobilization application increases the pressure pain threshold in women with non-specific neck pain.

H3- Passive joint mobilization increases serum Orexin A and Neurotensin levels in women with non-specific neck pain.

Eligibility Criteria:
Inclusion Criteria:

For Intervention Group;

* Having neck pain lasting more than 30 days and being diagnosed with non-specific neck pain
* Having obtained 14/50 points and above in Neck Disability Index
* Expressing neck pain at least 34/100 points and above on a Visual Analog Scale
* Being 20-45 years old and female

For Healthy Control Group;

- Healthy volunteers without a chronic illness and musculoskeletal pain

Exclusion Criteria:

* Congenital anomalies
* Previously diagnosed orthopedic diseases related to the spine
* Pregnancy and having just given birth
* Within the last 3 months; use of corticosteroids, cytotoxic drugs, or immunosuppressants
* Liver or kidney failure
* Acute or chronic infections (including HIV)
* Serious pathologies (such as cancer, spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis)
* Symptoms of cervical spinal stenosis (such as incoordination of hands, arms and legs, bowel and bladder incontinence)
* Radix compression (such as sensory changes, muscle weakness or decreased reflexes)
* Whiplash or a history of cervical surgery
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for study.


Eligibility Criteria:
Inclusion Criteria:

1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
2. Age: 18 - 75 years old, postmenopausal women.prepostmenopausal women, but should receive Ovary castration.

   Inclusion Criteria
3. Cohort 1 and Cohort 2 :No prior systemic anti-cancer therapy for advanced HR+ disease.

Cohort 3 and Cohort 4 : Patients must satisfy the following criteria for prior therapy:

1. a) Progressed after 2 years during treatment of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.

   b)Progressed within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.

   c) Progressed while 6 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or perimenopausal.
2. One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.

4. Eastern Cooperative Oncology Group \[ECOG\] 0-1 Measurable disease as per Response Evaluation Criterion in Solid Tumors\[RECIST\] 1.1

5. Adequate organ and marrow function

Exclusion Criteria

1. Confirmed diagnosis of HER2 positive disease
2. Patients who received any endocrine therapy as neo/adjuvant therapy for breast cancer are eligible. If the neo/adjuvant therapy of any endocrine therapy , the disease-free interval must be greater than 12 months from the completion of treatment until study entry.
3. Patients who received prior treatment with any CDK4/6 inhibitor, everolimus,fulvestant.
4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention.
5. Has known active central nervous system metastases.