cyrilzakka/clinical-trials huggingface dataset:
Mindfulness Training in Nurses and Its Effect on Work Stress

The aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. The sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in Çanakkale. The mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total.

One of the most important problems of nurses in Turkey is the stress they experience at work. This stress experienced in the workplace is accompanied by consequences such as depression, anxiety, and decreased job satisfaction. Therefore, it is clear that addressing the stress associated with the nursing profession is an urgent problem. The aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. The sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in Çanakkale. The mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total. The Personal Information Form, the Job Stress Scale, the Mindful Attention Awareness Scale, and the Rosenbaum's Learned Resourcefulness Scale were used for data collection. A total of three follow-ups were conducted to the nurses before the training, at the end of the training, and 3 months after the training. Descriptive analysis, Chi-square test, Independent Samples T-test, Dependent Samples T-test, and one-way analysis of variance were used in the analysis of the research data.

Eligibility Criteria:
Inclusion Criteria:

* Working as a nurse in the relevant health practice and research hospital
* Not having participated in any mindfulness-based training program before

Exclusion Criteria:

* Working as an executive nurse
* Not attending any session of the 8-week training
A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma

This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).


Eligibility Criteria:
Phase 1

Inclusion Criteria:

* Histologically confirmed diagnosis of Malignant Pleural Mesothelioma (MPM) or Non-Small Cell Lung Cancer (NSCLC).
* Measurable disease as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) for MPM or the RECIST 1.1 for NSCLC.
* ≥ 20 years of age.
* Provision of written informed consent.
* For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Hemoglobin (Hb) ≥ 9.0 g/dL.
* Neutrophils ≥ 1500/μL.
* Platelets ≥ 100,000/μL.
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5-fold the upper limit of normal range (ULN) \[≤ 5-fold ULN with any liver metastasis\].
* Total bilirubin ≤ 1.5-fold ULN.
* Creatinine clearance (estimated value) ≥ 60 mL/min.
* Life expectancy ≥ 3 months.
* Females of childbearing potential have a negative urine pregnancy test.

Phase 2

Inclusion Criteria:

* Histologically confirmed diagnosis of MPM.
* Treatment naïve and not indicated for resection.
* Measurable disease as defined by the modified RECIST.
* ≥ 20 years of age.
* Provision of written informed consent.
* For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.
* ECOG Performance Status of 0 or 1.
* Hb ≥ 9.0 g/dL.
* Neutrophils ≥ 1500/μL.
* Platelets ≥ 100,000/μL.
* AST and ALT ≤ 2.5-fold ULN \[≤ 5-fold ULN for patients with any liver metastasis\].
* Total bilirubin ≤ 1.5-fold ULN.
* Creatinine clearance (estimated value) \> 60 mL/min.
* Life expectancy ≥ 3 months.
* Females of childbearing potential have a negative urine pregnancy test.

Both Phase 1 and 2

Exclusion Criteria:

* Prior anti-cancer chemotherapy and radiotherapy.
* Prior hormonal therapy, immunotherapy, thermotherapy, operation.
* Any brain metastasis requiring treatment or symptomatic.
* Active multiple primary cancers.
* Crohn's disease, ulcerative colitis, small intestine resection.
* Abnormal ECGs.
* Prior myocardial infarction.
* Current use of antiarrhythmic medication.
* Uncontrolled concurrent diseases.
* Known severe hypersensitivity to pemetrexed, cisplatin or other drugs containing platinum.
* Women who are pregnant or breastfeeding.
* Received other investigational drugs.
* Unable or unwilling to swallow BBI608 capsules daily.
* Prior treatment with BBI608.
* Ineligible for participation in the study in the opinion of the Investigators.
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis

The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment with moderate to severe psoriasis. Any adverse events related to AD-MSCs infusion will be monitored.The primary outcome is the reduction rate of PASI(Psoriasis Area and Severity Index) and treatment response will be computed from PASI before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

1. moderate to severe psoriasis vulgaris ( PASI \> 10 or BSA \>10%)
2. 18 to 65 years old
3. written/signed informed consent

Exclusion Criteria:

1. guttate psoriasis, inverse psoriasis or exclusively associated with the face
2. Acute progressive psoriasis, and erythroderma tendency
3. current (or within 1 year) pregnancy or lactation
4. current significant anxiety or depression with the Self-rating Anxiety Scale (SAS) \> 50 or the Self-rating Depression Scale (SDS) \> 53, or with other psychiatric disorders
5. With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: abnormal serum calcium level ( Ca2+ \> 2.9 mmol/L or \< 2 mmol/L);AST or ALT 2 times more than normal upper limit; Creatinine and cystatin C more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit,or hemoglobin reduction to anemia; Platelet count less than 75.0\*10\^9/L; White blood cell less than 3.0\*10\^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study
6. Patients with malignant tumors, or when they were enrolled with abnormal tumor markers or with other organ dysfunction
7. allergy to anything else ever before;
8. current registration in other clinical trials or participation within a month;
9. topical treatments (i.e. corticosteroids or retinoic acid or Vitamin D analogs ) within 2 weeks; systemic therapy or phototherapy (ultraviolet radiation B,UVB) and psoralen combined with ultraviolet A (PUVA) within 4 weeks; biological therapy within 12 weeks;
10. medical conditions assessed by investigators, that are not suitable for this clinical study.
Prevent Return of Stroke Study

The purpose of this study is to evaluate if a peer-led stroke recurrence prevention intervention, versus usual care, will help reduce risk factors for recurrent strokes among adults in Harlem.

Twenty nine percent of the 700,000 strokes that occur yearly nationwide are among stroke survivors. Blacks, both nationally and among Harlem residents, have a twofold increase in recurrent strokes. Harlem Latinos have a threefold increase in risk relative to Whites.

Primary risk factors for recurrent stroke include hypertension, hyperlipidemia, and under use of anti-thrombotic agents. Controlling risk factors can be particularly challenging for low-income, minority populations who lack the resources needed to adhere to necessary therapies. In Harlem, 72% of adults studied six months post stroke did not have these three risk factors treated adequately.

We propose to determine if participation in a recurrent stroke prevention educational intervention, versus usual care, can activated stroke survivors to at reduce primary risk factors for recurrent strokes while providing an effective, low-cost, sustainable recurrent stroke prevention program in neighborhoods like Harlem, whose residents bear a disproportionate burden of suffering from strokes. Specifically, we propose:

1. Recruit 600 adults who sustained a stroke or transient ischemic attack (TIA) within the past five years by working with Harlem community leaders, local clinical sites including the Mount Sinai Medical Center and the Institute for Family Health, and the Visiting Nurse Service of New York;
2. To conduct a randomized, controlled trial to determine if participation in a peer-led stroke prevention program activates stroke and TIA survivors to improve their knowledge and self-management strategies and treatments related to stroke prevention; and
3. To rigorously compare the impact of the intervention with usual care (delayed intervention), on increasing the proportion of individuals with strokes and TIAs who are appropriately treated to reduce the risk of recurrent events, specifically through control of hypertension (blood pressure ≤ 140/90mmHg), hyperlipidemia (LDL cholesterol≤100 mg/dl) and use of anti-thrombotic medicines.

Eligibility Criteria:
Inclusion Criteria:

* Had a stroke or TIA diagnosed within 5 years
* 40 years of age or older
* Able to participate in group education classes
* English or Spanish speaking
* Community dwelling

Exclusion Criteria:

* No incidence of stroke or TIA
* Stroke or TIA occurred more than 5 years ago
* less than 40 years of age
* Cognitive or physical impairment that would preclude comprehension of a conversation and communicating as part of a group (i.e., dementia, deafness, inability to speak, aphasia)
* Self-reported terminal illness with life expectancy of less than 1 year
* Plans to relocate from New York City within one year of enrollment
* Pregnant
* Nursing home resident
* Prisoner
COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life

COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs but also various other organs of the body already in early stages of the disease. Due to the multiple organ involvements in the acute phase, it is conceivable that - in a significant proportion of patients - longterm sequels in various organ systems might occur, thereby impacting the individual's health status and quality of life; and posing a relevant burden to the resources of the health care system

Assessment of SARS-CoV-2-longterm morbidity and sequels on the population level:

In order to identify and treat these sequels in a timely fashion and to get a sense of the prevalence of such SARS-CoV-2 sequels on the population level, it is important to collect follow-up data and to comprehensively re-examine a population-representative sample of SARS-CoV-2 infected individuals.

Within the COVIDOM study we will conduct deep clinical and biochemical phenotyping in population-representative samples in Germany. This will allow novel insights into disease pathogenesis and chronicity of virus infections.

Background:

COVID-19 is a novel disease caused by SARS-CoV-2. Severity of infection in the acute phase ranges from asymptomatic to critically ill and fatal courses of the disease. Besides the acute respiratory distress syndrome (ARDS), also thromboembolic events and acute damages of other organs are contributing to severe and critical courses of the disease in the acute phase of the infection.

It is, however, largely unknown whether and to what extent different organs are affected in individuals with milder courses of the disease.

Hypotheses:

1. Across all severity stages in the acute phase, SARS-CoV-2 infection causes longterm damages in various organ systems in a significant proportion of patients.
2. Beyond the damages directly caused by the infection, also the behavioral changes implemented to reduce the spread of the virus might impact an individual's health status and quality of life.
3. The infection itself and the pandemic in general results in increased use of health care resources.

Methods:

SARS-CoV-2 infected individuals in defined geographic regions will be contacted through the responsible health authorities and will be informed about the study and invited to participate. These individuals will presumably represent all severity grades in the initial phase of the infection (asymptomatic, uncomplicated, complicated, critical course of disease) and each of them will be offered a detailed clinical examination program that Includes structural and functional assessment of various organ systems (lungs, cardiovascular, CNS including smell/tase, liver), a comprehensive medical history, as well as psychological and psychiatric assessments.

Eligibility Criteria:
Inclusion Criteria:

* PCR-confirmed SARS-CoV-2 infection
* living in one of the target areas
* age at least 18 years
* written informed consent

Exclusion Criteria:

* Acute SARS-CoV-2 infection or reinfection
Bioequivalence Study of Esomeprazole in Healthy Adult Subjects Under Fasting Condition

The current study is conducted to evaluate and compare the relative bioavailability for Esomeprazole in two different products containing 40 mg Esomeprazole after a single oral dose administration under fasting conditions.

A randomized, single-dose, two-treatment, partial replicate, three-phase, three-sequence, bioequivalence study of the two study products. Blood samples were collected at different time intervals and stored at -70⁰C freezer. Esomeprazole plasma concentrations were analyzed using a validated LC-MS-MS method then pharmacokinetics and statistical analysis were performed on the concentrations obtained using Phoenix WinNonlin® software.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for study.
* Age 18 - 55 years,
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug, or multiple allergies.
* Clinically significant illness 28 days before study period I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of period I of the study.
Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate

Recent sutdies indicate that the existence of corpus lutein in the ovary is a key point to prevent preeclampsia, and patients undergoing FET with hormone replaced cycle have no corpus lutein and the absence of corpus lutein significantly increases the risk of preeclampsia in these patients. We aim to conduct a single center randomized trial study to compare the preeclampsia rate between the natural cycle and the hormone replaced cycle in patients undergoing FET.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 42 years old women;
2. normal ovulation;
3. Scheduled to undergo frozen-thawed embryo transfer.
4. Agreeing with the informed consent.

Exclusion Criteria:

1. Those who experienced embryo transfer cycle failure for at least three times;
2. One or both of the ovaries removed;
3. Hypertention disease before embryo transfer;
4. No available embryo for transfer
5. Oocyte or sperm donated cycles
Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation

Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.

A recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established.

Design: prospective, cross-over, physiological trial.

PURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patients
* scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery)
* Expected duration of surgery \>= 150 minutes

Exclusion Criteria:

* Pregnancy
* BMI\>30 kg/m\^2
* hepatic surgery
* Cardiac failure NYHA\>2
* History of chronic respiratory failure
A Study of Adavosertib (MK-1775) in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)

This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with the P53 mutation. In Part 1, a small group of participants will receive adavosertib along with paclitaxel plus carboplatin to establish the tolerability of adavosertib with this combination. In Part 2, participants will be randomly assigned to receive either adavosertib plus paclitaxel and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy of adavosertib compared to placebo. The primary hypothesis of the study (Part 2) is that administration of adavosertib in combination with paclitaxel plus carboplatin in participants with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression free survival (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1 (enhanced RECIST 1.1) compared to participants treated with paclitaxel plus carboplatin alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, or primary peritoneal cancer which has progressed after paclitaxel / platinum-based therapy.
* Platinum-sensitive disease. Radiological progression must have occurred 6 months or more after the completion of the most recent platinum-based treatment.
* Measurable disease.
* Available tumor sample(s).
* Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Adequate organ function.

Exclusion Criteria:

* Pregnancy or the intention to become pregnant during the course of the study.
* Participation in a study with an investigational compound or device within 28 days of receiving first dose of study medication.
* Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Primary CNS tumor.
* Known hypersensitivity or contraindications to the components of potential study therapy (paclitaxel, carboplatin, adavosertib) or its analogs (i.e., cremophor, mannitol, etc.).
* Participant requires the use of medications or products that are metabolized by, or inhibit, or induce Cytochrome P450 3A (CYP3A4).
* Ongoing peripheral neuropathies ≥Grade 2 and related to previous treatment.
* Known psychiatric or substance abuse disorders.
* Regular use (including "recreational use") of any illicit drugs or recent history (within the last year) of drug or alcohol abuse.
* HIV positive.
* Active Hepatitis B or C.
* Symptomatic ascites or pleural effusion.
* Clinical history suggestive of Li Fraumeni Syndrome.
Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
* Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis