cyrilzakka/clinical-trials huggingface dataset:
Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation

The study results will be used to check the hypothesis that CareLink Express remote monitoring system increases the detection rate of asymptomatic AF and allows to change timely the treatment strategy in patients at high risk of thromboembolic events, e.g. anticoagulation therapy onset, electrical cardioversion or/and PVI.

It is expected to enroll 200 consecutive patients without previously diagnosed AF, who have indications for implantation of dual chamber cardiac pacemakers according to the current guidelines. All the patients will be randomly assigned into 2 groups. Patients in the RM group will undergo the implantation of Ensura DR MRI SureScan pacing system, whereas patients in the control group will receive ADAPTA DR pacing system without RM using. The impact of the Care Link Express service on prevention of thromboembolism will be evaluated. The rate of in-hospital visits for 1 patient per year and compliance with scheduled CareLink transmissions (ratio of the number of the performed transmissions to the planned ones) will be assessed in all patients in the remote monitoring group. Moreover, we are going to estimate the interaction between the follow-up center and other healthcare facilities equipped with the CareLink Express service, which will facilitate faster treatment decision.

Eligibility Criteria:
Inclusion Criteria:

* patients with indications for implantation of dual chamber cardiac pacemaker
* patients with no AF history;
* written informed consent.

Exclusion Criteria:

* patients with contraindications for CIED implantation;
* patients with previously implanted CIEDs;
* infection;
* patients with previously diagnosed AF
Study on Chinese and Western Medicine in MNE Children

Monosymptomatic nocturnal enuresis (MNE) is a common pediatric developmental disorder. MNE refers to urinary incontinence in the sleep state in children aged ≥5 years, without other LUT symptoms, and without bladder dysfunction. Its pathogenesis mainly include overnight polyuria, overactive bladder, sleep-arousal dysfunction, genetics, and abnormal secretion of anti-diuretic hormone (ADH). Desmopressin is a synthetic analog of ADH arginine-vasopressin (AVP), which is used to treat central diabetes insipidus and primary nocturnal enuresis (PNE). Desmopressin decreases urine production at night when taken at bedtime. Insufﬁcient ADH secretion at night will contribute to nocturnal polyuria, which is an important cause of NE. Therefore, desmopressin, a synthetic analog of ADH, is frequently used for NE and is an evidence-based therapy (grade ⅠA evidence). Some children, however, have desmopressin resistance and do not achieve the desired treatment goals. What's more,there's a high relapse rate of desmopressin after withdrawing. Suoquan mixture is a Chinese medicine commonly used to treat NE in children. It is composed of Cuscuta, Codonopsis, Psoralea corylifolia Linn ,Astragalus,mantis egg-case and ephedra. It has not only a certain cure rate but also has a lower relapse rate . However there's few evidence could prove that. In this study,the investigators compared the 3 month treatment response and relapse rate (RR) in the following 6 months of desmopressin and desmopressin plus suoquan, and observe if there will be a lower relapse rare in desmopressin plus Suoquan. Moreover, the investigators will try to explore the mechanism of Suoquan mixture in MNE.


Eligibility Criteria:
Inclusion Criteria:

* bedwetting occured ≥2nights/week,last for at least 3 months
* without other LUT symptoms
* without bladder dysfunction.
* no treatment in last 3 months
* signed the consent

Exclusion Criteria:

* had other LUT symptoms
* with bladder dysfunction
* had treatment in last 3 months
* without the consent
Mobile Health to Improve Oral Chemotherapy Adherence Among Women With Breast Cancer

This clinical trial evaluates the feasibility and acceptability of a mobile health device in improving oral chemotherapy adherence in women with triple negative breast cancer that has not spread to other places in the body (non-metastatic). A mobile health device, called SMRxT smart pill bottle may help doctors to remind patients to take medicine on time and monitor their symptoms.

PRIMARY OBJECTIVES:

I. Feasibility. II. Acceptability. III. Capecitabine/Xeloda adherence.

EXPLORATORY OBJECTIVES:

I. Symptom burden. II. Patent physician communication. III. Quality of life. IV. Self-efficacy for managing symptoms.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive a SMRxT smart pill bottle, report symptoms weekly, and receive reminders for missing or incorrect dose for standard of care 3-week capecitabine/Xeloda treatment cycles.

GROUP II: Patients receive standard of care.

After completion of study, patients are followed up for 90 days after the initiation of capecitabine/Xeloda.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Breast cancer
* English speaking
* New or existing prescription for capecitabine/Xeloda
* Willingness and ability of the subject to comply with study procedures
* Have a mobile phone with text message
* Evidence of an online informed consent indicating that the subject is aware of the risk and benefits of study participation

Exclusion Criteria:

* Those who do not receive their capecitabine/Xeloda prescription until a month after enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
Mediterranean Diet, Circuit Resistance Training, Empagliflozin in Elderly With Type 2 Diabetes: a Study Protocol

Primary objective: To assess the effects of a modified plant-based Mediterranean diet (vegeterranean diet), circuit resistance training (CRT) and empagliflozin alone or in combination on body composition and physical function in elderly subjects with type 2 diabetes. The rationale for this study is to assess three interventions associated with a negative energy/caloric balance (increased caloric use in exercise, caloric restriction in the vegeterranean diet and caloric wasting by glycosuria with empagliflozin), their interaction and effect on body composition and physical function.

Methods and analysis: One hundred and twenty men and women ≥ 65 years of age with type 2 diabetes, and low levels of physical activity will be randomized (1:1:1 manner, gender-stratified) for 10 weeks to one of 3 parallel arms: CRT consisting of 3 home sessions/week; ad-libitum plant-based Mediterranean diet (limited consumption of eggs, dairy and fish, avoidance of red meat and poultry) or empagliflozin 10mg/day. After 10 weeks CRT will be added to the empagliflozin or diet arms for an additional 10 weeks. Allocation concealment and blinding of primary outcome assessors will be implemented. Efficacy will be determined by assessment of lean body mass, body weight, frailty status, sarcopenia, HbA1c and quality of life questionnaires. Safety will be evaluated by routine monitoring of adverse events. This study was approved by the Tel-Aviv Sourasky Medical Center Institutional Review Board


Eligibility Criteria:
Inclusion Criteria:

Subjects who have type 2 diabetes mellitus in accordance with American Diabetes Association guidelines and:

1. Are ≥65 years of age (inclusive) on the day of signing the informed consent form.
2. Perform \<2 days a week of any leisure aerobic physical activity (PA), who are able to walk independently either with or without an assistance device (cane or walker).
3. HbA1C ≥6.5% to ≤8%.

Exclusion Criteria:

1. Recent use of steroid agents (\<6 months, replacement therapy is allowed)
2. Uncorrected hypothyroidism \[thyroid stimulating hormone (TSH) \> 6 mlU/L\]
3. Diagnosis of malignancy within the past 5 years except for non-melanoma skin cancer.
4. Severe kidney disease (eGFR\<45cc/ml)
5. Active depression
6. Recent (≤6 months) or unstable cardiovascular condition; New York Heart Association (NYHA) Class 3 or higher congestive heart failure;
7. Subjects with PA limiting pain due to neuropathy
8. Subjects who are in an active nutritional therapy changed their diet recently (\<1 month) and/or in a weight-loss program (actively losing weight).
9. Has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.
Risk Factors for Benign Breast Disease

Benign diseases of the breast are common clinical conditions that affect young women. Complaints related to the breast often cause significant discomfort and mental stress. The following study will try to identify the risk factors that may be associated with symptomatic benign breast diseases. Identification of such factors may help preventing and / or treating these conditions.

Benign breast disease (BBD) is a common cause of hospital visit. In young adults, benign breast conditions surpass cancer as a cause of symptoms related to the breast. However, breast symptoms may be associated with significant distress and may impose diagnostic difficulties. Moreover, certain pathological entities of benign breast conditions are well known to increase the risk of breast cancer.

Identification of modifiable risk factors associated with symptomatic breast disorders has several potential benefits. Modification of such factors may help decrease patients' distress, hospital visits and indirectly decrease the risk of cancer.

the available data point to the possible association of several environmental factors with symptomatic BBD. Most of the available information points to an association of BBD with anthropometric features, growth pattern, family history of breast conditions and dietary consumption. Substantial evidence are however lacking and further studies are strongly required to better characterize the risk factors of the condition.

In this study, the investigators will systematically collect epidemiological, developmental and clinical data in young patients presenting with breast complaints. The association with disease incidence, pattern and histology will be examined.

Eligibility Criteria:
Inclusion Criteria:

* adult females with current symptoms related to the breast.

Exclusion Criteria:

* Current or past malignancy of the breast.
* Discrete breast mass that necessitate work-up to exclude cancer.
* Current psychiatric morbidity.
* Persons unwilling to participate.
Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain

The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.


Eligibility Criteria:
Inclusion Criteria:

* thermal or mechanical hyperalgesia
* chronic neuropathic pain (NRS =\> 6)

Exclusion Criteria:

* non-specific
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
* HER2-positive breast cancer
* Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* LVEF of at least 50 percent (%)

Exclusion Criteria:

* Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (\</=) 6 months
* Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
* Central nervous system (CNS) metastases
* Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
* History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
* Inadequate bone marrow, liver or renal function
* Uncontrolled hypertension
* Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes

The purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians over 18 years with type 1 diabetes (WHO criteria)
* Arginine test without rise in plasma C-peptide
* Normal blood Hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease
* Diabetic nephropathy
* Treatment with medications unpausable for 12 hours
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.


Eligibility Criteria:
Inclusion Criteria:

* Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
* Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.
* Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective.
* Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.
* Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.

Exclusion Criteria:

* Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.
* Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.
* Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).
Weaning Outcome From Invasive Mechanical Ventilation

The main purpose of the present study was to explore the weaning failure rate from invasive mechanical ventilation and to identify risk factors of weaning failure.


Eligibility Criteria:
Inclusion Criteria:

* Requiring endotracheal intubation and invasive mechanical ventilation

Exclusion Criteria:

* Duration of invasive mechanical ventilation \< 48 hours；
* Presence of tracheostomy；
* Presence of upper airway obstruction.
Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. In a phase Ib part, investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy. After completing the phase Ib part, investigators will review the data and decide whether this patient is included in before the start of a phase II part. In the phase II part, investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed HER2 positive advanced breast cancer
2. Age\>18 years. brain metastases confirmed by enhanced brain MRI
3. KPS≥70
4. Life expectancy of more than 12 weeks
5. Prior therapy of oral dexamethasone not exceeding 16mg/d
6. Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
7. Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
8. Prior endocrine therapy were allowed
9. Anti-Her2 targeted treatment were allowed
10. Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

    1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
    2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
    3. Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
    4. LVEF ≥ 50%
    5. QTcF \< 480 ms
    6. INR≤1.5×ULN，APTT≤1.5×ULN
11. Signed the informed consent form prior to patient entry

Exclusion Criteria:

1. Leptomeningeal or hemorrhagic metastases
2. uncontrolled epilepsy
3. Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
4. Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
5. Inability to complete enhanced MRI
6. Patients who are difficult or unable to be followed-up
7. Not suitable for inclusion for specific reasons judged by sponsor
8. Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption
9. History of allergy to pyrotinib or capetabine
10. History of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history
11. Previous use of pyrotinib combined with capetabine
Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)

This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the study is to examine the safety and determine the recommended Phase 2 dose of lenzilumab when administered to subjects with previously treated CMML who meet the entry criteria. Study will begin enrollment in July 2016.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CMML
* CMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatment
* Eastern Cooperative Oncology Group (ECOG) score ≤ 2
* Able to provide bone marrow biopsy samples
* Acceptable laboratory results

Exclusion Criteria:

* Leukemia other than CMML
* Recent chemotherapy or radiation therapy (within 14 days before first dose of lenzilumab)
* Concurrent use of human granulocyte-macrophage colony-stimulating factor
* Pregnant or breastfeeding
* Know HIV virus infection
* History of another malignancy within the past 2 years (some skin cancer and prostate cancers permitted)
* Significant intercurrent illness
* History or current diagnosis of Pulmonary Alveolar Proteinosis or Hypoxemia
Sun Protection Factor Assay (344/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
A Brief Cognitive Intervention After Intrusive Memories of Trauma With Young Refugees: An Extension

This research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "Tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. The design is a single case experimental AB design with optional replication (ABAB). Participants will aim to complete a no-intervention phase ('A': baseline phase) of one week followed by a one-week intervention phase ('B'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. Follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. It is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.

This research study follows from ClinicalTrials.gov ID: NCT03525158, with a focus on the ABAB design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Refugee or asylum seeker
* Experiencing intrusive memories of trauma
* Have access to a smartphone
* Able to speak or read the study material in Swedish, English, Arabic or Farsi
* Able to attend five to six meetings with a researcher

Exclusion Criteria:

* Exhibit psychotic symptoms or other symptoms of severe mental illness