cyrilzakka/clinical-trials huggingface dataset:
Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis

The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body reacts to the drug) compared to placebo (an inert substance) in patients with moderate-to-severe extrinsic Atopic Dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit
* Investigator's Global Assessment (IGA) score of \>/= 3 at the screening and baseline visits
* \>/= 15% body surface area (BSA) of AD involvement at the screening and baseline visits
* History of inadequate response to a stable (\>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit
* Willing and able to comply with clinic visits and study-related procedures
* Patient able to read and understand, and willing to sign the informed consent form

Exclusion Criteria:

* A positive QuantiFERON® - TB (tuberculosis) Gold Test at the screening visit
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV)
* Treatment with an investigational drug within 8 weeks before the baseline visit
* Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
* Treatment with systemic corticosteroids within 4 weeks before the baseline visit
* Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
* Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
* Chronic or acute infection requiring treatment
* History of clinical parasite infection, other than treated trichomoniasis
* History of malignancy within 5 years before the baseline visit
* Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
* Pregnant or breast-feeding women
* Unwilling to use adequate birth control, if of reproductive potential and sexually active
Mycobiome Supporting Diet to Reduce GI Toxicity Associated With ASCT

The purpose of this study is to determine if this specific Mycobiome Supporting Diet (MSD diet) can help reduce gut inflammation during post-transplant period. The MSD is an special diet which will be explained in detail by a dietician that works by supporting the body's good gut bacteria and fungi.

This is a non-randomized cohort study. Participants will be on a specific diet for 4 weeks prior to transplant and 10 days after transplant, and will then be asked to fill out several questionnaires during this period to see if this diet is easy and simple to follow. The questionnaires will be weekly while participants are outpatient and once admitted to the hospital, participants will need to fill it on the last day (10 days after stem cell infusion). Participants will also be requested to provide fecal swab samples which we will test for bacteria and fungi. A total of 3 samples will be taken at different time points during this study.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for first autologous transplant for myeloma
* Willing to adhere to the allowed and disallowed foods of the diet plan.
* Able to get and prepare their own food items for all meals during the study

Exclusion Criteria:

* Active inflammatory bowel disease, celiac disease, other chronic intestinal disorders
* Pregnant women, planning to get pregnant or breastfeeding
* Prior bowel resection
* Inability to tolerate the study diet due to allergies/ intolerance/ preference
* Inability to consent to trial
* Patients with restrictions in diet including inability to have oral nutrition with regular consistency
* Any condition that the investigator feels may limit the volunteer's ability to complete the study protocol.
* Patients with absolute neutrophil count (ANC) \< 1000 on long term antibacterial prophylaxis ongoing 3 days prior to enrollment
* Patients who received antifungal therapy in 3 days prior to enrollment
* Patients who received steroid therapy in 7 days prior to enrollment
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself against low blood sugar.

The purpose of this study is to see if the drug atomoxetine (Strattera) has effects on the body's ability to defend itself against low blood sugar. Normally, when blood sugar levels drop below normal, the body creates a series of responses, which increase the sugar inside the body to bring blood sugar levels back to normal. The hormone epinephrine is a key defense against low blood sugar in people with diabetes. Atomoxetine has been shown to increase this hormone level. Thus, any approaches to increase levels of this key defense during low blood sugar may have great value.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals aged 18-50 years
* Type 1 Diabetes individuals aged 18-50 years
* BMI \<40 kg/m2
* Females of childbearing potential with negative urine pregnancy test
* Volunteers over 40 years of age, a cardiac stress test with no clinically significant conduction or ischemic changes

Exclusion Criteria:

The following groups of subjects will be excluded from the study:

* Pregnant women
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs or with known bleeding diatheses
* Subjects with uncontrolled hypertension, heart disease, cerebrovascular incidents
* Subjects taking MAOIs
* Subjects with narrow angle glaucoma
* Subjects with diagnosed psychiatric disorders
* Subjects with allergy to atomoxetine, heparin, or lidocaine

Physical Exam Exclusion Criteria:

* Uncontrolled severe hypertension (i.e., blood pressure greater than 150/95)
* Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects \> 40 years old.
* Pneumonia
* Hepatic Failure/Jaundice
* Renal Failure
* Acute Cerebrovascular/ Neurological deficit
* Fever greater than 38.0 C

Screening Laboratory Tests Exclusion Criteria Blood values as defined in protocol
Use of Otoscope as a Non-invasive Tool for Diagnosis of Pilomatricoma

Stanford University Dermatology Clinics and Lucile Packard Children's Hospital are evaluating the use of the otoscope for the diagnosis of skin lesions. We are particularly looking for children and/or adults with nodules, cysts, tumors, or pilomatricomas. The study will take 15-30 minutes and we will use light to examine and take a picture of your skin lesion. There is no monetary compensation for participating in the study.

Pilomatricoma is a benign tumor that presents as a 3-30mm firm, solitary, deep dermal or subcutaneous tumor on the head, neck, or upper extremities. The clinical diagnosis is often made by the firm, sometimes rock hard texture of the skin. The diagnosis can be confirmed by a skin biopsy and/or excision of the lesion. We have recently noted that pilomatricomas appear as a black mass in the skin when the lesion is transilluminated by placing the light of a fiberoptic otoscope adjacent to the skin lesion. We would like to confirm our impression by a prospective study using transillumination to examine subcutaneous tumors in the skin. Pilomatricoma is also known as a benign calcifying or calcified epithelioma, pilomatrixoma, or a calcifying epithelioma of Malherbe.

Eligibility Criteria:
Inclusion Criteria:- Potential participants will be any patient that is seen at Stanford Dermatology or LPCH that has a cyst, nodule, vesicle, tumor, or possible pilomatricoma Exclusion Criteria:- Inability of subject or subject's guardian to understand informed consent form.
Reliability and Interest of Circulating Tumor DNA in Endometrial Cancers.

The recent histo-prognostic molecular discoveries of the TCGA (The Cancer Genome Atlas) have shed new light on the classification of endometrial carcinomas.

After carrying out different types of high-throughput molecular analyzes on 373 endometrial carcinomas of different histological types, 4 major tumor subtypes could be identified, each with a different survival profile (the "ultra-mutated" group with POLE mutations, the "hypermuted" group with microsatellite instability (MSI), the "low number of copies" group, and the "high number of copies" group).

This histomolecular classification is not yet directly transposable to clinical practice and tumor genetic characteristics have not had any direct therapeutic impact to date.

The main objective of the study is to determine the concordance rate between molecular analysis of tumor tissue and that of cDNA in patients with endometrial cancer during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven endometrial adenocarcinoma type I or type II.
* With recent abdomino-pelvic imaging, less than 3 months old.
* Tumor tissue sufficiently exploitable for research (\> 20% of tumor cells)
* Informed consent signed by the patient after clear and fair information about the study.
* Free patient, without tutorship, curatorship or subordination.
* Patient benefiting from a Social Security scheme or benefiting from it through a third person.
* Patient not opposed to participating in the study.

Exclusion Criteria:

* Histologies other than adenocarcinoma (sarcoma, leiomyosarcoma)
* Linguistic or mental refusal or incapacity to understand and / or sign the informed consent
* Patients benefiting from enhanced protection, namely: minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection.
* Pregnant and / or lactating women
Effects of Exercise Training at Different Timeline on Shoulder Dysfunction After Breast Cancer Modified Radical Mastectomy

Patients who underwent modified radical mastectomy were enrolled in the study. 200 subjects were randomly divided into 4 groups: 7 days postoperative shoulder isotonic training + 4 weeks postoperative progressive resistance training group, postoperative 7 Isometric training for the shoulder joint + progressive resistance training for 3 weeks after surgery group, 3 days postoperative isotope training + 4 weeks postoperative progressive resistance training group, 3 days postoperative shoulder isotonic training + postoperative 3 Weekly progressive resistance training group. The effects of interventional rehabilitation at different time points on the recovery of shoulder function after breast cancer operation were observed. The results of the study will provide evidence-based evidence for the time point of intervention in early functional exercise after modified radical mastectomy for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 25 and 75 years;
2. Diagnosed with breast cancer by pathological diagnosis, the time of diagnosis and the time of inclusion are less than 6 weeks;
3. Patients undergoing modified radical mastectomy: mastectomy includes unilateral total breast or breast-conserving surgery, as well as dissection of the affected axillary lymph nodes, but does not include sentinel lymph node biopsy;
4. Postoperative chemotherapy or radiation therapy according to the condition;
5. No other malignant tumors within 5 years;
6. No physical therapy related contraindications;
7. Signing informed consent.

Exclusion Criteria:

1. The result of SLNB is negative who did not receive ALND;
2. Received breast reconstruction surgery (prosthesis, latissimus dorsi, etc.);
3. Combined tumor metastasis with other tissues and organs (liver, kidney, lung, brain, etc.);
4. Combined severe heart disease, cerebrovascular disease, and mental illness;
5. Patients with shoulder joint dysfunction before surgery;
6. Unable to understand the rehabilitation training program provided by doctors or physiotherapists.
Music Therapy Advocacy Recording Intervention (MTAR) on Internalized Stigma

This study will use a systematic music therapy intervention on patients with mental illness trying to help them with their internalized stigma.

The primary objective of this study is to determine the effect of a systematic music therapy intervention on internalized stigma of mental illness. The secondary objective is to evaluate the potential for the treatment effect to vary across subject diagnostic categories. This study will also examine the ability of the treatment effect to persist after 3 weeks as an exploratory objective.

Data collection will be conducted in the Acute Care Unit (ACU) of Hackensack Meridian Health Carrier Clinic (HMHCC) over a period of ten months. Subjects will be drawn from the pool of patients admitted to the HMHCC ACU during that time. Adults aged 18-65 with severe mental illness with a diagnosis of bipolar or a related disorder, depressive or anxiety disorder, or schizophrenia spectrum or other psychotic disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5 : 5th ed.; American Psychiatric Association, 2013), of prolonged duration with a significant degree of disability or social dysfunction (Ruggeri et al., 2000) are eligible to participate. Eligible participants must be able to provide informed consent as determined by the doctor.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the HMHCC ACU
* Able to read and comprehend the ISMI questionnaire, provide informed consent,
* With a severe mental illness of prolonged duration with a significant degree of disability or social dysfunction

Exclusion Criteria:

* Patients on S1 status (1:1 patient observation) or isolation protocol
* Evidence of organic brain disease, severe acute symptomatology, hearing deficit, and intellectual disability.
Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination

Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination

Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA \< 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination.

The change of PSA will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Intact Rectum
* Prostate Cancer eligible for active surveillance

Exclusion Criteria:

* Pror radiation therapy
* Under Androgen Deprivation Therapy
* Prior prostate surgery
Comparison of Enhanced Recovery After Surgery (ERAS) Pathway With Conventional Pathway After Laparoscopic Sleeve Gastrectomy

The aim of this study is to compare two postoperative recovery pathways namely, enhanced recovery after surgery (ERAS) pathway and conventional recovery pathway after laparoscopic sleeve gastrectomy with respect to outcomes including hospital stay, postoperative pain and other postoperative outcomes.

The Enhanced recovery after surgery (ERAS) pathway, initially introduced for colorectal surgery, is an evidence based perioperative pathway which has resulted in earlier recovery, less pain, and lower complication rates. Bariatric surgical patients, without severe co-morbidities, are good candidates for ERAS pathway, but the application of ERAS concepts has been limited in this field, specially, in Asia.

Although the current literature shows that 2 randomized clinical trials (RCT) have been performed for application of ERAS in bariatric surgery, data is still scarce as per outcomes with respect to postoperative pain and analgesic usage. One of the RCTs has compared with historical controls and both the RCTs have not clearly defined their conventional standard pathways. In this study, the investigators have clearly defined both ERAS pathway and standard pathway leaving no ambiguity.

This study is a prospective, randomized, parallel group trial comparing ERAS pathway and standard pathway after laparoscopic sleeve gastrectomy in relation to the hospital stay, postoperative pain, complications and other perioperative parameters.

This is a single institute based trial, being conducted at GEM hospital and research centre, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

In this trial, the investigators are planning to enroll participants with morbid obesity planned to undergo laparoscopic sleeve gastrectomy. After full assessment, informed consent, these participants will be randomised using computer generated random numbers either into ERAS pathway group or into Standard pathway group.

All the intraoperative and perioperative details with respect to anaesthetic drugs usage, intravenous fluid requirement, time to ambulation, time to oral liquids, postoperative pain score, analgesic requirement and hospital stay will be recorded in the proforma.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing laparoscopic sleeve gastrectomy during this study period

Exclusion Criteria:

* 1. Redo procedures 2. ASA III and above status 3. Previous major upper abdominal surgeries 4. Not willing to participate
Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy

The goal of this study is to evaluate the impact of an innovative web-based school nutrition intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit and dairy products in high school students and to identify facilitators and/or barriers influencing its success.

Classes of first and second year secondary students (grades 9 and 10) from the Québec City region will be randomized into two groups. Participants in the intervention (Team Nutriathlon) will be asked to increase their consumption of fruits and vegetables and dairy products using an innovative web-based platform, developed for this study, over six weeks. The control group will follow the regular school curriculum. The number of servings of fruits and vegetables and dairy products consumed by students per day and facilitators and barriers influencing the success of the program will be compared between the two groups over the study.

Eligibility Criteria:
Inclusion Criteria:

* Schools were recruited on a voluntary basis via email invitation and sent across the region of Québec. The selected schools were of medium to high socioeconomic levels according to the Deprivation Index of the Ministry of Education of Québec.

Exclusion Criteria:

* None
Cachexia in NSCLC Patients: Diagnosis, Characterization, Prognosis, Functional and Skeletal Muscle Implications

LUCAX01 is a cohort study with patients with advanced NSCLC in tobacco users. in this study, patients will be submitted to baseline physical tests, blood and biopsy sample collection, and the main objective is to study the functional and prognostic implications of cachexia and to validate skeletal muscle dysfunction markers.

Non-small-cell lung cancer (NSCLC) is currently the neoplasm leading in deaths worldwide and in Brazil, it figures as the second most common cancer in terms of the number of deaths. Patients are usually diagnosed in advanced stages and, consequently, more than 45% of all patients are diagnosed with cachexia. This syndrome is characterized by a loss of muscle mass with or without fat loss and it cannot be reversed by nutritional support. In the physiopathology of cachexia, generally are present exacerbated inflammation, severe loss of muscle contractile proteins, leading to fatigue and increased mortality. Furthermore, patients with cachexia usually do present lower response rates to anticancer treatments and it is also associated with a worse overall prognosis.

Treatments directed to mitigate muscle loss in these patients are awaited. Cohort studies do suggest a significant positive impact of physical fitness and prognosis in different chronic diseases; however, its impact in advanced NSCLC patients is not clear. Here our aim is to better understand the relationship between cachexia and physical fitness variables (muscle and cardiorespiratory function, body composition, and daily physical activity level) with prognosis and mortality in a group of NSCLC patients, as well as to study the effect of chemotherapy on these variables. Besides that, will be evaluated the skeletal muscle, Treg lymphocytes, and inflammatory biomarkers and compare cachectic and non-cachectic patients.

Sixty NSCLC patients will be accrued. Will be assessed the maximum oxygen consumption, daily physical activity, muscle function, muscle morphology, anxiety, depression, performance status, and fatigue pre-treatment. Blood and muscle biopsy samples will be collected. The prognostic impact of these physical fitness variables will be defined, as well as their predictive value in terms of response to anticancer treatments in advanced NSCLC patients.

Eligibility Criteria:
Inclusion Criteria:

* Advanced stage IVa or IVb NSCLC patients histologically diagnosis.
* Eastern Cooperative Oncology Group Performance status 0 - 2
* Treatment-naive
* Current smokers or ex-smokers
* Normal renal, hepatic and hematological functions
* Able to perform the physical functional tests
* Able to read and sign the consent form

Exclusion Criteria:

* Initiate treatment before initiate
* Diagnostic of tumor mutation ( epidermal growth factor receptor, Anaplastic lymphoma kinase)

Obs: A smoker population with no known cancer will be used as controls (n=10)
Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic

The Treatment Cabin 'Elosan cabin' is a closed, electrically insulated cabin for the short-term application of a high electrostatic voltage to the body of patients with chronic pain.

Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.

Included in the study can be all persons suffering from chronic pain as it is often the case with rheumatic disease or traumata. The electric charge is created by a generator which can produce a high electrostatic field. The electrical voltage is delivered to the hands via a metal handle and is spread over the entire body surface. After the short treatment, the patient is completely discharged and earthed again.

Over 100 patients in eight pain centers are to be included into this trial in order to show a statistically significant reduction of pain.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* adults, age ≥ 18 years, male or female patients
* History of pain ≥ 3 months
* Suffering from chronic pain
* Intensity of pain rated ≥ 50 mm on VAS pain

Exclusion Criteria:

* Patients with an electrical or electronic implant.
* Women who are pregnant, breastfeeding or planning to become pregnant
* Patients who have already been treated with the cabin within the last 4 weeks.
* Patients who are currently participating in other studies or who have participated in other studies in the last 30 days
* Patients who have indicated their intention or who are suspected of intending to discontinue or discontinue therapy before the end of the study