cyrilzakka/clinical-trials huggingface dataset:
The Effect of Education and Telephone Follow-up Given to Cancer Patients Receiving Immunotherapy on Symptom Management and Self-care Power

This study, it was aimed to evaluate the effects of education and telephone follow-up given to cancer patients receiving immunotherapy on symptom management and self-care power. It is expected that the education given to the patients who will receive immunotherapy for the first time and the monitoring by phone, prevention of immunotherapy-related side effects, early recognition, and follow-up will reduce unnecessary hospital admissions and increase the self-care power of the patient.

The research consists of two parts. For the qualitative part of the research; A semi-structured interview form was created. In this form, face-to-face interviews were conducted with the patients receiving immunotherapy about the symptoms they experienced, how they coped, and the subjects they wanted to learn.

Quantitative part for sample selection; G Power 3.1 statistical program was used to calculate the sample size of the study. After calculating the effect size as 0.73 by using the standard deviation and group averages of the Self-Care Scale of the study closest to the research, the sample calculation was made (Çetin,2020). According to this; The sample size was calculated with a total of 56 patients, 28 people in both groups, with a power of 85% in the 95% confidence interval. However, due to the possible losses in the number of patients, 33 people were planned for both groups, with a total of 66 patients (Çetin A.A.2020).

A randomization list created with a computer-based random number sequence was used to ensure the random distribution of the patients scheduled for immunotherapy to the groups (www.random.org). The patients were numbered according to the order of arrival, and the patients were assigned to the groups (intervention group with training and followed up by phone, and control group with routine follow-up) according to the numbers in the randomization list. Due to the nature of the study, the principal investigator and patients could not be blinded during grouping. However, single-blind randomization was achieved by blinding the evaluator groups.

Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write in Turkish,
* Absence of any psychiatric disorder that will reduce the ability to comprehend and understand,
* Not having any physical discomfort in the area of hearing or speaking that would prevent telephone conversations,
* Will receive immunotherapy for the first time and only,
* Willingness to participate in the research,
* Willingness to participate in the research,
* Patients who agreed to participate in the study verbally and in writing were included in the study.

Exclusion Criteria:

* Not being voluntarily or willing to participate in the research,
* Will receive radiotherapy or chemotherapy together with immunotherapy,
* Not knowing that he will receive immunotherapy,
* Patients who did not accept to participate in the study were not included in the study.
The Relationship Between Obesity and Chronic Headache

The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.

Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18 who suffered a head injury

Exclusion Criteria:

* People with severe head trauma
* Those who do not speak Turkish
* Those with a history of chronic opioid user
* Those with alcohol and drug addiction
SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)

This is a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* 1. Has fully understood and voluntarily signed an informed consent form for this study , willing and able to comply with study procedures.

  2. Age ≥ 18 years. 3. Histologically confirmed EGFR positive (immunohistochemistry ≥ \[+\]) advanced NSCLC ,including: (1) Cohort A: Treatment-naïve subjects; (2) Cohort B: Subjects resistant to first-line treatment contain immune checkpoint inhibitors (stability period \> 3 months).

  4. At least one measurable lesion via RECIST v1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 6. Expected survival ≥ 3 months. 7. Adequate organ function .

Exclusion Criteria:

* 1. Driver gene-positive (EGFR, ALK, ROS1) . 2. history of dual primary malignancies within the past 5 years. 3. active autoimmune diseases or a history of autoimmune disorders requiring systemic corticosteroid therapy.

  4. systemic infections requiring systemic treatment. 5. known central nervous system metastases or other central nervous system diseases or abnormalities deemed unsuitable for inclusion in this study by the investigator.

  6. Fertile individuals unable to maintain effective contraception during the trial.

  7. Subjects in Cohort B who have received prior docetaxel treatment. 8. Subjects in Cohort B who experienced Grade 3 or higher immune-related adverse events during first-line treatment with immune checkpoint inhibitors.

  9. Individuals deemed unsuitable for participation in this clinical trial by the investigator for various reasons .
Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC

Adding chemotherapy or anti-VEGF to immunotherapy is an emerging strategy to enhance the efficacy of immunotherapy in many cancers. This phase 2 study aims to explore the preliminary efficacy of combination pembrolizumab with lenvatinib and chemotherapy in NSCLC patients with sensitizing EGFR, ALK, or ROS1 genetic aberration refractory to standard targeted therapy.


Eligibility Criteria:
Main Inclusion Criteria:

* Histologically proven NSCLC
* Unresectable or metastatic NSCLC, including squamous cell carcinoma, harboring sensitizing EGFR, ALK, or ROS1 genetic aberrations who have received standard of care targeted therapy and have progressed on treatment. Patients with known T790M mutation should have received osimertinib and failed.
* Measurable disease per RECIST 1.1
* ECOG performance status ≤ 1
* Adequate organ function
* Adequately controlled blood pressure

Main Exclusion Criteria:

* Prior exposure to immunotherapy or chemotherapy
* Active untreated brain metastasis and/or carcinomatous meningitis
* Active, known or suspected autoimmune disease
* History of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
* Condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications
* Baseline proteinuria ≥ 1 g/24 hrs
* Electrolyte abnormalities that have not been corrected
* Significant cardiovascular impairment
* Gastrointestinal pathology that might affect the absorption of lenvatinib
* Preexisting grade ≥ 3 gastrointestinal or non gastrointestinal fistula
* Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage
* Radiographic evidence of intratumoral caviations, encasement, or invasion of a major blood vessel
* Known history of tuberculosis
* Active, acute, or chronic clinically significant infections requiring therapy, including hepatitis B, hepatitis C, and HIV
* ECG with long QTc interval ≥ 470 ms
Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* all risk groups of peripheral T cell lymphoma
* performance status ECOG 0-2
* written consent
* measurable disease

Exclusion Criteria:

* stage I N without bulky disease
* already initiated treatment
* serious accompanying disorder or impaired organ function
* bone marrow involvement \>25%
* HIV positivity
* leukemic manifestation of lymphoma
* simultaneous participation in another trial
* platelets \< 100 000/ mm, leukocytes \< 2500 /mm
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
* Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight \>40 kg (88 lbs).
* Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

Exclusion Criteria:

* Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
* History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
Nutritious Eating With Soul at Rare Variety Cafe

To date, few dissemination and implementation (D\&I) studies exist of successful healthy eating interventions delivered through restaurant settings. Therefore, the proposed study will investigate the following aims:

Aim 1: Examine reach and adoption of a modified, 12-week NEW Soul vegan intervention delivered through a train-the-trainer approach in a soul food vegan restaurant.

Aim 2: Assess resource use and cost associated with a train-the-trainer D\&I approach in a restaurant setting.

Aim 3: Examine effectiveness through changes in participants' diet, self-efficacy, weight loss, and quality of life from baseline to follow-up (3-months) and at maintenance (9-months).

Aim 4: Assess implementation fidelity and participant satisfaction of modified NEW Soul.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American
* between 18-65 years old
* be free on meeting night (Tuesday at 6PM)
* be free of eating disorder
* be free of major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
* willing to travel weekly to Rare Variety Café

Exclusion Criteria:

* currently following a plant-based/vegan diet
* have a body mass index of under 25 or over 49.9 kg/m2
* currently on medication for diabetes
* women who are currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* currently participating in a weight loss program or taking weight loss medications
* recent weight loss (\>10lbs in the last 6 months)
* living in the same household as somebody already participating in the larger NEW Soul Study at the University of South Carolina
* currently in the NEW Soul study
EFFORT Asthma: Effects of Diet and Exercise in Asthma

This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.

After screening and enrollment, a total of 200 Danish sedentary, non-obese asthma patients will be randomized to one of four groups: 1) control group (no intervention), 2) physical exercise intervention, 3) diet intervention (a diet with an overall high content of protein and a low glycemic index) or 4) exercise plus diet intervention.

Asthma is defined as respiratory symptoms and at least one positive asthma test. Patients will continue their regular doses of anti-asthma treatment unchanged throughout the study period. Type of anti-inflammatory medicine will be recorded and the adherence to the therapy will be assessed before the intervention period and at follow-up using questionnaires

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Uncontrolled or partly uncontrolled asthma
* Capable of exercising on bike
* Sedentary (currently do less than 60 min of structured/planned physical activity per week)

Exclusion Criteria:

BMI ≥ 30.0 or \<20.5

* Chronic obstructive pulmonary disease (COPD), pregnancy, other inflammatory or metabolic diseases
* The use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.
Histopathology Images Based Survival Prediction of Glioma Patients Using Artificial Intelligence

This registry aims to collect clinical, molecular and histopathology imaging including detailed survival data, clinical parameters, molecular pathology (1p/19q codeletion, MGMT methylation, IDH and TERTp mutations, etc) and images of HE slices in primary gliomas. By leveraging artificial intelligence, this registry will seek to construct and refine hstopathology imaging based algorithms that able to predict patients' survivals in the frame of molecular pathology or subgroups of gliomas.

Non-invasive and precise prediction for survivals of glioma patients is challenging. With the development of artificial intelligence, much more potential lies in the histopathology images of HE slices in primary gliomas could be excavated to aid prediction of patients' prognosis in the frame of molecular pathology of gliomas. The creation of a registry for primary glioma with detailed survival data, molecular pathology, histopathology image data and with sufficient sample size for deep learning (\>1000) provides opportunities for personalized prediction of survival of glioma patients with non-invasiveness and precision.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have radiologically and histologically confirmed diagnosis of primary glioma
* Life expectancy of greater than 3 months
* Must receive tumor resection
* Signed informed consent

Exclusion Criteria:

* No gliomas
* No sufficient amount of tumor tissues for detection of molecular pathology
* Patients who are pregnant or breast feeding
* Patients who are suffered from severe systematic malfuctions
Brain Imaging in Early Psychosis

This study assesses brain connectivity and function of individuals ages 13-25 at a prodromal or early stage of a psychotic disorder. Participation involves approximately 3 hours of MRI scanning and up to 6 hours of behavioral testing at Washington University School of Medicine's campus.

Schizophrenia is a devastating illness inflicting about 1% of the population worldwide. Symptoms of schizophrenia include paranoia, hallucinations, and disorganized behaviors, and is associated with lifelong occupational and social disability. It typically develops in adolescence or early adulthood, which are particularly formative periods in life when major educational, vocational, and social life changes occur, and then the brain undergoes a rearrangement of critical neural circuits. The "prodrome" is the period before the onset of a psychotic disorder, like schizophrenia. Prodromal youth often have significant emotional distress and social withdrawal, and family members may observe a concerning change in behavior or school or work performance. Identifying those at clinical high risk for a psychotic disorder is important, as early intervention can improve symptoms and functioning, and could prevent the eventual development of a psychotic disorder. This study will focus on individuals aged 13-25 years who have met criteria for a psychosis-risk syndrome (or attenuated psychosis syndrome) or are at a very early stage (first 3 years after diagnosis) of a psychotic disorder, such as schizophrenia or schizoaffective disorder. Involvement will be either 2 or 3 partial days at Washington University and will involve approximately 3 hours of MRI scanning and up to 6 hours of behavioral testing. Additionally, the investigators will study the effect of genetics on the patterns of brain connectivity in various psychiatric populations. DNA will be collected non-invasively from saliva and stored and processed in Washington University facilities.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of 13 and 25
* Meet diagnostic criteria for a prodromal syndrome or early psychosis by either meeting: 1) criteria for psychosis-risk on the structured assessment of psychosis-risk syndrome, or 2) meeting criteria for a psychotic disorder on the SCID diagnostic interview only within the last 3 years.
* Understand and sign an informed consent (or assent form for minors) document in English

Exclusion Criteria:

* IQ of 70 or under
* Past or current history of clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment
* Pregnancy
* The diagnostic symptoms are clearly caused by an Axis I disorder, including substance use disorders, as judged by the evaluating clinician.
Cognitive Behavioral Therapy (CBT) for Late Life Anxiety

The purpose of this research study is to assess the acceptability and feasibility of the implementation strategy and fidelity of cognitive-behavioral therapy (CBT) for older adults with Generalized Anxiety Disorder.

All participants will receive CBT. Each subject will be given a workbook and each chapter in the workbook provides information about a different coping strategy for managing worry and anxiety. There will be a daily assignment in the workbook to complete before a call with the personal study coach. For 10 weeks, participants will have a 45-50 minute session (telephone or video) each week with their study coach. These calls will be confidential. The participant and the personal study coach will review the assigned chapter and completed homework during the weekly telephone sessions. Participants will also fill out questionnaires before starting sessions, when completing all 10 sessions, and 6 months after completing sessions.

Eligibility Criteria:
Inclusion Criteria:

* participants who have had an outpatient visit to an Atrium provider
* at least one of the following: any diagnosis of an anxiety or depressive disorder; anxiety, depression, or sleep disturbance as a symptom in the problem list or in the note; and use of anxiolytic, anti-depressant, and sleep aide medications.

Exclusion Criteria:

* diagnosis of dementia or cognitive impairment in the problem list
An Observational Study on the Prevalence of Human Papillomavirus Types in Women in the Kingdom of Bahrain

The purpose of this study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women ≥ 20 years of age attending routine cervical screening and among women ≥ 16 years of age presenting for post-natal check up in the Kingdom of Bahrain.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 20 years of age attending a clinic for routine cervical screening OR
* Women ≥ 16 years of age presenting for post-natal check-ups
* Women providing a cervical sample
* Written informed consent or oral-witnessed thumb printed informed consent obtained from the subject

Exclusion Criteria:

* Referral for abnormal cervical sample at the current visit
* Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed (Note: Enrolment can be delayed until this condition is resolved)
* Pregnant women
* History of hysterectomy
* Known diagnosis of immunosuppression, or patient on immunosuppressives
* Having received one or more doses of human papillomavirus vaccine prior to participating in the study
A Trial of HRS-9813 in Healthy Volunteers

The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
2. Male or female aged 18-55 (adult healthy volunteers);
3. Body mass index (BMI) between 19 and 26 kg/m2;
4. Normal Electrocardiogram (ECG);
5. Men and women of childbearing potential must agree to take effective contraceptive methods.

Exclusion Criteria:

1. Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome;
2. History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion;
3. Seated systolic blood pressure (SBP) of \<90 mmHg or seated diastolic blood pressure (DBP) of \<60 mmHg;
4. Patients with orthostatic hypotension;
5. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.