cyrilzakka/clinical-trials huggingface dataset:
Scale of Therapeutic Adherence to Respiratory Rahabilitation for Lung Cancer

The goal of this non experimental, transversal instrument study is to Construct and determine the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer in Mexican patients with a lung cancer diagnosis.

The main question it aims to answer is: What is the reliability and validity of the Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer of the patients with this diagnosis that are currently undergoing an assessment or follow up program of Respiratory Rehabilitation?

The Scale of Therapeutic Adherence for Respiratory Rehabilitation in Lung Cancer (STA-RR-LC) will be psychometrically valid and reliable for the evaluation of therapeutic adherence on patients with lung cancer that are undergoing an assessment or follow up of Respiratory Rehabilitation.Participants will be asked to fill out an Identification card and fill out the fifty-six items presented on the STA-RR-LC.

For the recruitment patients with lung cancer diagnosis that arrive at the Respiratory Rehabilitation service will be asked if they are willing to participate and fill out the STA.

It will be explained to them as clearly as possible the objective, procedure, risks and benefits of the study and a copy of the Informed Consent will be provided. Lung cancer patients attending the Pulmonary Rehabilitation service will be approached and a verbal explanation of the study will be given.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with lung cancer (SCLC and NSCLC).
* Over 18 years of age.
* Voluntary participation by understanding and accepting the informed consent letter.
* Patients undergoing Respiratory Rehabilitation treatment with one month assessment and follow-up.
* Patients in active medical treatment.
* Any clinical stage.
* Karnofsky Index ≥ 70.

Exclusion Criteria:

* Severe hearing or visual problems that prevent them from understanding the instructions and answering the instruments (this will be identified as reported in the clinical record file).
* Severe psychiatric conditions (schizophrenia or psychotic disorders) and/or addiction to any psychoactive substance (this will be identified as reported in the INCanet file).
* Attentional or memory problems that prevent them from understanding the instructions and answering the instruments (this will be identified as reported in the INCanet file).
Exploring Virtual Reality Adventure Training Exergaming

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on women veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

The current project aims to design and implement an 8-week Virtual Reality Adventure Therapy Exergaming (V-RATE) intervention focused on veterans. A randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed. The project addresses two specific aims:

Aim 1. To examine the effects of an 8-week V-RATE intervention on physical health (i.e., BMI, physical activity, sedentary behavior) among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group would exhibit more improvement in the physical health indicators after the intervention compared to individuals in the control group. We further hypothesize gains would be maintained or enhanced at 1-month follow-up measure.

Aim 2. To examine the effects of an 8-week V-RATE intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive function, health-related quality of life), among veterans. We hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the V-RATE group will exhibit more improvement in the mental health indicators after the intervention compared to individuals in the control group. We further hypothesize gains maintained or enhanced at 1-month follow-up measure.

Eligibility Criteria:
Inclusion Criteria:

1. Are between the ages of 18 and 45
2. Identify as a U.S. military veteran

4. Normal vision (no colorblindness)

Exclusion Criteria:

1. Unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter)
2. Self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury
3. Self-reported pregnancy or suspicion of pregnancy
4. Self-reported motor disorder or impaired sense of motion or balance (such as Parkinsonism)
5. Self-reported color blindness
6. Self-reported neurological or cognitive disorder (e.g., TBI, history of seizure)
7. Self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.
Pain and Stress Assessment in Children

There may be pain and / or stress with vibrocompression. There may be pain and / or stress with the aspiration of secretions.

Randomization to 10 children and 10 vibrocompression for aspiration of secretion.

Fill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during and after the technique performed).

Photographic Record (rest, during and after the technique performed). Saliva Collection (rest, 5, 20 and 40 minutes after running technics). Data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Indication of Respiratory Therapy

Fasting for one hour before the moment of collection

Term of Free and Informed Consent Form (ICF) signed by parents or legal guardians

Exclusion Criteria:

* Children in postoperative period acute

Presence of thoracic drain or mediastinal

Children using drugs to sedative or analgesic purpose of deep sedation
Combined Effects of Meal Frequency and Protein Load on Cardiometabolic Risk Factors

This study examines the effect of meal frequency and meal composition on risk factors of cardiometabolic disease.

Cardio-Metabolic Disease (CMD) is the leading cause of death globally \& in Singapore. Large scale epidemiological evidence confirmed that elevated postprandial Glucose, Insulin, Triglycerides are major risk factors for CMD. Recent evidence suggests benefits from high protein diets but the health effects of eating smaller meals remain enigmatic. The aim of this study is to examine Meal frequency (2-large vs 6-smaller isocaloric meals), under High or Low Protein loads on acute postprandial health biomarkers . The investigators hypothesized that Higher Protein \& Higher Meal Frequency would be beneficial for cardiometabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Chinese Males
* Age: 21 - 50 years.
* Body mass stable within the last 2 months by self-report.
* Body mass index (BMI): \< 30kg/m2.
* Normal fasting blood glucose level≤ 6.0 mmol/L
* Blood pressure ≤ 140/90 mmHg
* Not participating in any dietary interventions in the past 2-months.

Exclusion Criteria:

* Special dietary practice (e.g. Vegetarians, Atkins diet) or diets due to religious reasons during the study period (e.g. Fasting for Ramadan)
* Smoking.
* Excessive alcohol consumption: consuming alcohol on \>4 days per week with ≥5 alcoholic drinks (males) and ≥4 alcoholic drinks (females) per time (National Health Survey, 2010).
* Metabolic Diseases (including thyroid dysfunction)
* Using Medication affecting carbohydrate and fat metabolism
* Allergy to any components of the provided meals (gluten, nuts, milk, dairy)
Intravenous Immunoglobulin for Unverricht-Lundborg Disease.

Single patient randomized double blind trial to assess whether intravenous immunoglobulin can improve the clinical outcome of a case suffering from Unverricht-Lundborg disease.

Single patient randomized double blind trial to assess whether intravenous immunoglobulin can improve the clinical outcome of a case suffering from Unverricht-Lundborg disease (clinical and genetic diagnosis).

The patient was randomized to be treated with intravenous immunoglobulin or placebo 1:1 (crossover) once a month for at least one year.

Main objective: improvement of the action myoclonus. Secondary objectives: Improvement in the overall score and in individual sections of the Unified Myoclonus Rating Scale at one year; patient preferences based on results at the end of the trial.

The first analyst was scheduled at one year from the start of the trial. The program was to discuss the patient's analysis data and to let the patient decide in three possible ways: to continue the trial, to continue treatment with immunoglobulins, to suspend the treatment. Depending on the decision, it was planned to follow the patient throughout the year after the analysis, at least for one year.

Eligibility Criteria:
Inclusion Criteria:

* Malattia di Unverricht-Lundborg (genetic diagnosis)

Exclusion Criteria:

* Contraindications to intravenous immunoglobulin
Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens

The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must be a current wearer of Comfilcon A contact lenses
* Distance visual acuity of 20/25 or better with current contact lenses
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study, which includes attending three study visits and be willing to wear contact lenses on days between study visits.
* Either gender.
* Any racial or ethnic origin.

Exclusion Criteria:

* No current ocular inflammation or infection.
* Not currently pregnant or lactating
Effect of Interscalene and Suprascapular Nerve Block on Analgesia Consumption After Adhesive Capsulitis Surgery

In this study, a combination of different types of blocks for adhesive capsulitis surgery, the investigators will investigate the impact on patient satisfaction and analgesic consumption after surgery.

General anesthesia will be performed in all patients for arthroscopic adhesive capsulitis shoulder surgeries. In the first group of patients (Group IPSB), interscalene brachial plexus block will be applied 30 minutes before surgery, while interscalene brachial plexus block and suprascapular nerve block (SSNB) administration to the second group patients (Group SSNB) before surgery. Patients in the third group (Group C) will be considered the control group and no block will be performed. Patient-controlled analgesia (PCA) with morphine will be used in all three groups for postoperative analgesia. Preoperative hemodynamic data of patients, postoperative pain scores (VAS), morphine consumption, patient satisfaction score, requirement of additional analgesia and observed side effects were recorded. Consumption of analgesia 24 hours after surgery and patient satisfaction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* ASA I- ASA II Patients

Exclusion Criteria:

* history of allergy to the study medication
* refusal to participate
Multimodal Spectroscopy (MMS) for in Vivo Noninvasive Assessment of Skin

The goal of this research program is to develop a simple, noninvasive diagnostic device for assessing skin pathology without the need for a biopsy. The device being studied is a single system capable of collecting three spectroscopy measurements (Raman, diffuse reflectance and laser induced fluorescence spectroscopy) from skin lesion sites. In order to accomplish this objective, the investigators propose to: 1) develop biophysical model for Raman spectroscopy of skin cancers, 2) conduct a clinical pilot study to collect MMS data from a minimum of 250 patients to determine the diagnostic accuracy (sensitivity and specificity) of MMS for diagnosing skin malignancy.

To develop a biophysical model the investigators will recruit patients based on their known histopathology diagnoses, from each of 6 skin-cancer categories: basal cell carcinoma, squamous cell carcinoma, melanoma, atypical nevus, actinic keratosis, and benign skin. Patients with non-cancer diagnosis such as psoriasis, eczema / dermatitis, lichen planus or lupus will also be recruited. Recruitment will include 5 patients from each of these categories, giving a total of 20 patients. Measurements for the biophysical models are conducted on skin tissues that have been excised from the patients. Furthermore, these skin tissues are excised tissues that under standard screening procedure will be biopsied by the dermatologist. Therefore, patients are not undergoing extra \& unnecessary biopsies, and will not be exposed to any risk involved with the microspectroscopy measurements.

To determine the diagnostic accuracy of MMS, MMS data will be collected from six clinical groups, each with a preoperative diagnosis: 1) malignant melanoma (MM), 2) basal cell carcinoma (BCC), 3) squamous cell carcinoma (SCC), 4) pre-cancerous lesions (AK), 5) benign or atypical nevi, or 6) other lesions or conditions (rare skin cancers such as merkel cell carcinoma, and inflammatory conditions such as psoriasis). The aim is to collect MMS data from a minimum of 240 patients (40 patients for each of the 6 groups), which will be split to training and validation datasets. Since several biopsies are required to diagnose a single skin cancer, it is anticipated that the actual number of pre-cancerous, benign and inflammatory lesions sampled will be much higher than our target total of 240, to be around 300. We will also collect data from non-skin cancer skin conditions: 1) psoriasis, 2) eczema / dermatitis, 3) lichen planus and 4) lupus. For the non-skin-cancer part of the study, we will enroll 20 patients from each of the categories, with a total target of 80 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing examination of skin
2. Male or Female 18 years and older
3. Patients with lesion(s) including one of the following: BCC, SCC, pre-cancerous, pigmented lesion, benign lesions, OR suspected diagnosis of psoriasis, eczema, dermatitis, lichen planus and/or lupus.
4. Signed consent form

Exclusion Criteria:

1. Patients with skin lesions in difficult to measure locations
2. Patients that do not sign the consent forms
Comparison Study of EAP and Disease-Specific Chemotherapy Regimens in Hematopoietic Stem Cell Mobilization for Lymphoma

This study utilizes a prospective, multicenter, randomized two-arm design to evaluate the efficacy and safety of the etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) combination therapy (EAP regimen) in mobilizing hematopoietic stem cells in patients with non-Hodgkin's lymphoma (NHL). A total of 99 NHL patients will be enrolled as research subjects and will be randomly allocated in a 2:1 ratio to compare the EAP regimen versus disease-specific chemotherapy mobilization regimen. The primary endpoint is the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×10\^6/kg).

Based on strict inclusion and exclusion criteria, a total of 99 non-Hodgkin's lymphoma patients from 16 hospitals will be selected. Eligible subjects will be randomly assigned in a 2:1 ratio to either the experimental group or the control group. The experimental group will receive the EAP regimen, which combines etoposide, cytarabine, and pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF), while the control group will receive disease-specific chemotherapy mobilization regimens, such as the CHOP and Hyper-CVAD. Subsequently, the number of CD34+ cells will be monitored. The study will evaluate the proportion of patients achieving the ideal collection value after a single collection (CD34+ cells ≥5×106/kg); the proportion of patients achieving the target collection value cumulatively; the total amount of CD34+ cells collected and the average number of collections; hematological and non-hematological adverse reactions; and the proportion of patients receiving plerixafor.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with non-Hodgkin's lymphoma before enrollment.
* Indication for autologous stem cell transplantation (ASCT).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
* Achieved partial or better response after multiple courses of chemotherapy.
* Life expectancy ≥ 3 months.
* Subjects must be able to understand the protocol and sign the informed consent.

Exclusion Criteria:

* Cardiac function class II or higher or cardiac ejection fraction \< 40%.
* Serum direct bilirubin (DBIL) more than twice of the upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than three times the upper limit of normal (ULN).
* Serum creatinine clearance rate ≤ 50%.
* Patients with active infection.
* History of prior hematopoietic stem cell mobilization.
Tumour Necrosis Factor Release in Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Docetaxel

The purpose of this study is to assess the fine needle aspiration methodology in collecting sufficient tumour cells to measure tissue TNFa levels serially in human breast cancer sample receiving Taxane treatment

This pilot study will begin to test the clinical relevance of the TNFa pathway in docetaxel response in breast cancer patients receiving Taxane chemotherapy.

- Assess whether docetaxel can induce TNFa expression in breast cancer patients being treated with docetaxel

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven LABC, Locally advanced breast cancer. (operable or non-operable)
* Any T3/T4 or N2, N3 Clinical TNM stage breast cancer without metastases
* ECOG Performance Status of 0, 1 or 2.
* Patients should be able to comprehend the Letter of Information and be capable of giving informed consent.
* Female age 18 years old
* History and physical
* Negative serum pregnancy test for women of child bearing age

Exclusion Criteria:

* Inflammatory cancer (as defined by clinical evidence of dermal-lymphatic tumour involvement.)
* Ineligible for chemotherapy
* Patients with metastatic disease.
* Patients who have received prior chemotherapy or radiotherapy for this or any other malignancy.
* Previous breast cancer diagnosis
* Pregnant or lactating females are ineligible.
* Female patients of reproductive potential who decline to employ an adequate contraceptive method are ineligible.
* Participation in any concomitant trials.
Prevalence of Genetic Mutations in Patients With Neuropathy Associated With Anti-Myelin-associated Glycoprotein (MAG) Antibodies

Anti-MAG (Myelin Associated Glycoprotein) neuropathy is related to clonal B lymphocyte proliferation producing an monoclonal immunoglobulin (IgM) with anti-MAG activity. IgM may be a reflection of malignant lymphoproliferative syndrome (Waldenström disease) or, more often, monoclonal gammopathy of unknown significance.

The anti-MAG antibody has a direct toxicity on the myelin sheath of the peripheral nervous system responsible for a length-dependent demyelinating polyneuropathy. Clinically, this results in a sensitive, ataxic predominant polyneuropathy in the lower limbs, sometimes associated with a tremor of attitude and action tremor of the upper limbs.

Clonal B cells at the origin of IgM production may have acquired mutations affecting MYD88 (MYD88 L265P mutation) and CXCR4 (Whim-like CXCR4 mutation). The prevalence of the MYD88 L265P mutation is estimated to be 50% in monoclonal gammopathies of undetermined significance and more than 80% in Waldenström disease. CXCR4 Whim-like mutations are found in 40% of patients with Waldenström's disease.

No studies have reported the prevalence of these mutations in patients with anti-MAG neuropathies.

This is a retrospective observational study in patients with anti-MAG neuropathy. Mutational analysis will be performed for patients with a medullary or blood sample stored in a bio-bank during lymphocyte phenotyping. This phenotyping was carried out most often in search of a malignant haemopathy associated with the monoclonal peak. No new samples were taken from the patient (blood or spinal cord).

Immunoglobulin gene rearrangement of the clonal B cells are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with anti-MAG neuropathy
* Blood and/or bone marrow samples available in bio-bank
* Given informed consent

Exclusion criterion

* Participation refusal
Pilot Study on Once Daily FTC, ddI, Efavirenz Combination in Antiretroviral Naive HIV Infected Adults

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Such therapy induces side effects and the number of pills may reduce therapy adherence. The aim of this study is to evaluate the efficacy and the safety of a once daily FTC, ddI, efavirenz combination, in HIV patients with CD4 cell count over 100/mm3, antiretroviral naive.

In 1999, when initiating antiretroviral treatment in HIV infected adults, a triple combination with protease inhibitor is recommended. Side effects of this products and the number of pills may induce a lower adherence, and thus a lower efficacy. 40 patients with a CD4 count over 100/mm3, a HIV RNA over 5,000 copies/ml and antiretroviral naive, take the once daily combination of FTC, ddI, efavirenz during 24 weeks. The primary end-point is the viral success maintained from 12 weeks until 24 weeks. Secondary end-point is the adherence to the association and safety.

The trial is prolonged during a total of 72 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Antiretroviral naive
* CD4 cell count over 100/mm3
* Plasma HIV RNA load over 5,000 copies/mL
* Signed written informed consent

Exclusion Criteria:

* Hepatitis B infection
* Pregnancy
* Alcool abuse
* Acute infection, past neurological or pancreatic disease, biological abnormalities
* Chemotherapy or immunotherapy