cyrilzakka/clinical-trials huggingface dataset:
Does a Peer Navigator Improve Quality of Life at Diagnosis for Women With Breast Cancer?

Women indicate the greatest needs for counseling at the time of initial diagnosis for primary breast cancer. The time of initial diagnosis is also often the time of greatest need for information for women and their families. However, this is the time when a woman, overwhelmed by shock and trauma, is least likely to absorb information provided or seek new sources of information. An informed peer navigator with carefully trained communication skills can judge the level of information to disclose and pace that information in a way that can be easily absorbed and understood. She will also provide support. WomenCARE, a well-established Santa Cruz agency providing free support services for women with cancer, and the Psychosocial Treatment Lab at Stanford therefore ask whether women newly diagnosed with breast cancer will improve their quality of life by participating in a peer navigator program. WomenCARE's peer navigators provide emotional support, good listening skills, and information on resources for women just diagnosed with breast cancer. Having a peer counselor while a woman goes through treatment may reduce the magnitude of distress or shorten its time course. It may also reduce distress in family members, and improve relationships with medical personnel.

This study is designed to evaluate the effectiveness of a peer navigator program where a woman newly diagnosed with breast cancer is carefully matched for 3 to 6 months after diagnosis with a trained volunteer who is herself a breast cancer survivor. Navigators and Sojourners (newly diagnosed women) are matched on things that are important to them. Women often want to be matched on the type of surgery or treatment they have received. We assign half of the women (by a process similar to a coin toss) to our peer navigator program and half to a group that receives standard medical care but no peer navigator. In this way we can compare the groups to see whether those matched with a peer navigator have better quality of life over the 3 to 6 month period. All women who join our study, regardless of the group to which they are assigned, get an extra consultation with a nurse specialist at a local hospital. In this consultation, the nurse reviews the cancer resources available to the woman in Santa Cruz County. This meeting is tailored to the woman's individual diagnosis and situation.


Eligibility Criteria:
Inclusion Criteria:

women within 2 months of diagnosis of breast cancer can read English within the catchment area of Watsonville and Santa Cruz California -

Exclusion Criteria:

women who have previously had a peer navigator intervention women who have a chronic history of hospitalization for psychiatric reason

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The Immediate Effect of Manual Therapy Application on Respiratory Functions in Healthy Young Individuals

Manual therapy techniques targeting the thoracic region are commonly used in clinical practice. It has been suggested that manual therapy interventions directed at the spine can increase mobility of the spine and chest wall, which may have a positive impact on lung functions. The potential positive effects of thoracic manipulation on respiratory system diseases such as chronic obstructive pulmonary disease (COPD) and asthma have been investigated and continue to be studied. Specifically, the results of studies investigating the physiological outcomes of this therapeutic approach in healthy adults are conflicting. The aim of this study is to investigate the short-term effects of thoracic manipulation and mobilization, as well as diaphragm mobilization, through a single session of manual therapy interventions on respiratory functions.

In this planned study, designed as a randomized controlled intervention trial, two groups will be formed: an experimental group and a control group. After completing these procedures, the intervention group will receive the method of "thoracic mobilization and manipulation with diaphragm mobilization," while the control group will receive a placebo thoracic mobilization method. All techniques will be applied by a physiotherapist.

Within 5 minutes after the completion of the intervention, a respiratory function test will be repeated, resulting in a total of two respiratory function tests: one before the intervention and one after the intervention. The changes in respiratory function criteria before and after the intervention will be compared in both groups

Eligibility Criteria:
Inclusion Criteria:

* be between the ages of 18-25,
* to be a studen

Exclusion Criteria:

* those who have any health problems
* those with orthopedic disorders
* those with systemic and cardiopulmonary diseases that would interfere with the evaluation
Trial of Monthly Versus Bi-weekly Endoscopic Variceal Ligation for the Prevention of Esophageal Variceal Rebleeding

Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.

Endoscopic variceal ligation (EVL) is a safe and simple procedure now being used on a widening scale. A lot of patients who undergo endoscopic treatment for esophageal varices eventually require additional treatment for recurrent varices. Many physicians suggest repeating EVL every 1-2 weeks until esophageal varices are obliterated to prevent variceal rebleeding， however, the evidences supporting the efficacy of EVL intervals of 1-2 weeks are insufficient.This randomized controlled study was conducted in order to compare the long-term results of EVL when performed at two different results from monthly and bi-weekly treatments.

Eligibility Criteria:
Inclusion Criteria:

1. acute or recent bleeding from esophageal varices;
2. portal hypertension caused by cirrhosis;
3. age between 18 and 80 yr.

Exclusion Criteria:

1. history of endoscopic, pharmacological, interventional or surgical treatment of esophageal varices;
2. presence of liver failure with a serum total bilirubin concentration greater than 3 mg/dL;
3. presence of hepatocellular carcinoma or other malignancy;
4. an association with a cerebral vascular accident, uremia, acute coronary syndrome, or other severe illness;
5. history of gastric variceal bleeding;
6. encephalopathy of stage II or worse;
7. failure to control initial variceal bleeding;
8. death within 48 h of admission;
9. refusal to participate in the trial.
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke

This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 years old;
2. Patients with anterior circulation cerebral infarction;
3. NIHSS: 6-25, and the limb movement score is at least 2 points;
4. Hemoglobin \> 115g / L, platelet \> 100 × 109 / L, leukocyte \> 3 × 109 / L;
5. the time from onset to treatment: group A（6-24 hours）、group B（1-3 days）、gourp C（4-7 days）、group D（1-4 weeks）、group E（1-6 months）;
6. The patient or the legal representative of the patient can and is willing to sign the informed consent.

Exclusion Criteria:

1. Patients who need or expect decompressive craniectomy;
2. Patients who need or are expected to receive endovascular treatment ;
3. Patients receiving intravenous thrombolysis;
4. Disturbance of consciousness；
5. Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
6. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
7. Posterior circulation cerebral infarction;
8. Tumor patients;
9. Epilepsy patients;
10. Severe neurological deficit caused by stroke (MRS = 5);
11. Previous diseases with obvious functional impairment, such as Parkinson's disease, motor neuron disease, moderate Alzheimer's disease, osteoarthritis, etc;
12. Patients with history of coagulation disorders, systemic bleeding tendency and thrombocytopenia (\< 100000 / mm3);
13. Chronic liver disease, liver and kidney dysfunction, elevated ALT or ast (2 times higher than the upper limit of normal value), elevated serum creatinine (1.5 times higher than the upper limit of normal value) or dependent on renal dialysis;
14. Patients with moderate to severe mental illness obviously interfere with treatment compliance;
15. Patients with high blood pressure (systolic blood pressure \> 180mmhg) or low blood pressure (systolic blood pressure \< 90mmHg);
16. The expected survival time is less than one year;
17. Those who have conducted other trials within 3 months;
18. Other circumstances considered unsuitable by the researcher.
Systolic Time Intervals in the Diagnosis of Heart Failure in Emergency Departement

the gold standard for the diagnostic of acute heart failure is based on clinical, biological (BNP levels) and echocardiographic findings, but still in some cases, the diagnosis is difficult and requires further investigations.

BNP dosages and echocardiography are not always available in many medical centers, especially in emergency departements, and are expensive.

we investigated the use of alternative methods, such as the systolic time intervals (STI), in the diagnosis of acute heart failure (AHF) in emergency departement patients consulting for dyspnea.

AHF is a common cause for dyspnea, but still hard to diagnose. in emergency departements, physicians dispose of a variety of techniques helping them to identify patients with acute onset dyspnea due to cardiac causes and allowing them to initiate the appropriate therapeutics.

techniques such as the N type brain natriuretic peptid (NT BNP) dosages and echocardiography, in addition to the clinical exam, are efficient in these cases but they encounter many problems:

* the BNP dosages are non-conclusive in some cases (grey zone) and must be repeated wich takes time.
* echocardiography is operator - dependent technique and could be misleading in some conditions.
* both BNP and echocardiography are expensive and not found in many emergency structures, especially in poor countries.

all the arguments pushed us to investigate other simpler and cheaper techniques to apply in these conditions.

STI is an old technique based on the recording of two parameters: electrocardiogram and phonocardiogram, and from them measuring the different systolic intervals:

* pre-ejection period (PEP): defined as the interval between the beginning of the QRS wave and the first heart sound (B1).
* electro-mechanic activation time (EMAT): defined as the interval between the two heart sounds B1 and B2
* the PEP / EMAT time in acute onset heart failure, the conduction times are increased, due to tissular lesions, which prolong the PEP, also the myocardial contractility is deficient and the heart puts less time to eject the blood volume which decrease the EMAT and in summary the PEP/EMAT is increased significatively.

in this study protocol, we aimed to investigate the diagnostic performance of STI compared to conventional methods in the diagnosis of acute heart failure in emergency department settings.

Eligibility Criteria:
Inclusion Criteria:

* non traumatic dyspnea
* age more than 18 years old.

Exclusion Criteria:

* ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours
* history of a heart transplant
* pericardial effusion
* chest wall deformity suspected of causing dyspnea
* coma, shock,Mechanical Ventilation, vasopressor drugs
* arrhythmia serious and sustained, pace maker severe mitral valve disease, severe pulmonary arterial hypertension
* renal failure with creatinine \>350micromol/l
Data Collection of Normal Tissue Toxicity for Proton Therapy for Pediatrics

The goal of this research study is to collect information on the side effects of proton therapy and the details of proton treatment plans so that researchers can develop a method to predict the risk of side effects and to improve the planning and delivery of proton treatment for patients in the future.

If you agree to take part in this study, researchers will gather information about your treatment and treatment outcomes and store it electronically in a database. By carefully evaluating the data about your treatment, researchers may improve proton treatment for patients in the future. There will be no change to your recommended standard of care and follow-up studies. The treatment information and follow-up information will be stored in a database. The information will then be available at a later date for researchers to study. The database will be stored on a secure information network, and only those people who are involved with this research and who have prior approval from the study doctor will have access to it.

Researchers will request information from the follow-up visits that you have as part of your standard of care yearly or more often and test results for at least 10-15 years. The tests may be performed at other clinics, but MD Anderson researchers will request that the results be sent to them at MD Anderson.

This is an investigational study. Proton radiotherapy is FDA approved. Researchers hope to enroll all children who will be treated with proton radiotherapy at MD Anderson on this study so that as much information as possible will be gathered. Up to 1000 patients will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria

1. All patients under the age of 18 who are treated with PBT will be eligible to participate in this trial.
2. Signed informed consent must be obtained from the patient or patient's representative prior to study enrollment.

Exclusion Criteria:

1. Pregnant females are not eligible.
2. Patient or patient's parent or legal guardian representative is unable or unwilling to give informed consent.
ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients

The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.


Eligibility Criteria:
Inclusion Criteria:

* patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures
* mono- or combination therapy
* male and female from the age of 6

Exclusion Criteria:

* hypersensitivity to oxcarbazepine MR or one of its excipients
Effects of Dry Needling, Static Stretching and IASTM in People With Hamstring Muscle Shortness

The aim of this study was to investigate the effects of dry needling, static stretching and instrument assisted soft tissue mobilization on joint range of motion, performance and muscle structure in individuals with Hamstring muscle shortness and to examine the changes in soft tissue before and after application with the help of ultrasound elastography.

The study was randomly divided into 3 groups. Group 1: Hamstring muscle group of patients for 5 minutes Instrument Assisted Soft Tissue Mobilization made of stainless steel instruments used by soft tissue mobilization by the therapist. In order to reduce friction and increase lubricity before application; If there is an unexpected erythema, edema or other unexpected side effects, the application will be stopped immediately.

2.Group: In the Hamstring muscle group of the patients, the acupuncture needles, which are made of stainless steel, sterile and disposable, will be applied under the supervision of an expert doctor for 30-45 seconds. In case of unexpected side effects, the application will be terminated.

Group 3: Patients' Hamstring muscle group under the supervision of the physiotherapist for a total of 5 minutes; A total of 10 repetitions of static tension will be applied for 30 seconds.

Before starting the study, anthropometric measurements, vertical and horizontal jump amounts of all participants will be measured before the application. Digital inclinometer will be used to determine the range of motion of the joint. Measurements will be made before and after the first application and the last measurement will be made 3 days after the end of 12 sessions. In addition, soft tissue changes in the hamstring muscle of the participants will be evaluated by US elastography before and at the end of the 12th session.

Eligibility Criteria:
Inclusion Criteria:

1. 18-35 age range
2. Volunteer to participate in the study
3. Not having a diagnosed condition

Exclusion Criteria:

1. Having any diagnosed discomfort
2. Being pregnant
3. Previously undergo surgery on the lower extremity
4. Physical therapy and rehabilitation of lower extremity in the last 6 months
Telerehabilitation in Patients With Idiopathic Pulmonary Fibrosis

It is to determine the effectiveness of different telerehabilitation exercise programs received to 2 groups randomly formed in idiopathic pulmonary fibrosis (IPF) patients. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TGr) and Video Group (VGr).

Patients diagnosed with idiopathic pulmonary fibrosis by a chest diseases specialist and referred to pulmonary rehabilitation will be included in the study. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as Telerehabilitation Exercise Group (TGr) and Video Group (VGr). TGr will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the group smartphone. As for the VGr group, after 1 session of online simultaneous exercise training in the company of a physiotherapist via videoconference on the smart phone, an exercise video including the exercises will be sent to them and the patients will be asked to do their exercises 3 days a week. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling them once a week. The exercise period will be 8 weeks for both groups.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-75
* Having a diagnosis of IPF disease diagnosed according to the following clinical diagnostic criteria according to the American Thoracic and European Respiratory Societies (ATS-ERS)
* Presence of dyspnea on exertion
* Stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\min).
* A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
* Participation in a pulmonary rehabilitation program within the past 12 months.
Use of a Fabric Mattress Cover for Patient Comfort

The main objective of this research project is to measure the impact on patient satisfaction of the use of a fabric mattress cover fabric on a bedsheet protecting a plastic mattress.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has a planned hospitalization \> 4 days
* The patient is "movable" within 48 hours

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
Immunogenicity of a Single Dose of GSK Biologicals' Boostrix™ in Infants Prior to Primary Pertussis Vaccination, When Administered to Pregnant Women as Per Routine Practice in Bogota, Colombia

The purpose of the study is to support the recommendation of vaccination of all pregnant women in Colombia with Diptheria, tetanus and pertussis (dTpa) by studying the transfer of pertussis specific IgG antibodies from mother to the child.

This study will assess the immunogenicity in infants (at birth and just prior to primary pertussis vaccination \[i.e. diphtheria, tetanus and pertussis \[DTP\] vaccination\] administered at 8 weeks of age), of a single Boostrix booster dose administered to their mothers during the second or third trimester as per routine practice in Bogota, Colombia.

Eligibility Criteria:
Inclusion Criteria:

Criteria applicable at screening (before the birth of the infant):

* Male or female infants whose mothers have received Boostrix during their current pregnancy, as per routine practice.
* Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from both parents of the infant.

Criteria applicable at enrolment (after the birth of the infant):

* Confirmation of written informed consent obtained from both parents of the infant at the time of screening.
* Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.

Exclusion Criteria:

Criteria applicable at screening (before the birth of the infant):

* Infants whose parents are below the legal consenting age of the country.
* Infant's whose mother has multiple pregnancies.
* Infant's whose mother has any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus \[HIV\]), based on medical history, physical examination or positive test result.
* Infant's whose mother is concurrently participating in another clinical study, at any time during the study period, in which the infant's mother has been or will be exposed to an investigational or a non-investigational vaccine/product.

Criteria applicable at enrolment (after the birth of the infant):

* Child in care.
* In case of multiple births.
* Infants with any confirmed or suspected immunosuppressive or immunodeficient condition , based on medical history, physical examination or positive test result.
* Infants who are concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.