cyrilzakka/clinical-trials huggingface dataset:
Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer

Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph system is a network of lymph vessels, tissues, and organs that carry extra fluid from your cells/tissues throughout the body. If this lymph fluid is not able to flow in the body how it should, there will be swelling which can lead to lymphedema. It can be classified into stages 0 to 3 depending on the severity of the condition. Stages 0 and 1 are reversible, and through early diagnosis and treatment, the recovery to the normal volume and normal skin status of arms can be possible. On the other hand, stage 2 or higher is irreversible, and tissue fibrosis progresses and cannot return to normal skin; therefore, it is important to detect early and start treatment.

This is an observational longitudinal study. Potential participants will be recruited for follow-up after breast cancer surgery. Only patients who fit the inclusion criteria will be considered for participation in the study and contacted by the healthcare provider. Standard of care will be used to guide any treatment needed by participants while they are part of the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 and over who are diagnosed with unilateral breast cancer.
* Unilateral lumpectomy, unilateral mastectomy, or simultaneous contralateral prophylatic mastectomy within 12 months of enrollment
* Axillary lymph node dissection or sentinel node biopsy within 12 months of enrollment
* Adjuvant or neoadjuvant chemotherapy and/or radiation therapy are allowed
* Breast cancer reconstruction completed or planned is allowed
* Study participants must own or have access to a smartphone, iPhone (IOS version 9.0 or above) or Android phone (Android 8.1 or above).

Exclusion Criteria:

* Bilateral breast cancer
* Previous history of breast cancer prior to current diagnosis.
* Existing diagnosis of lymphedema at the time of enrollment
* Cellulitis or other active infection at the time of enrollment
* Adults who are unable to consent.
* Pregnant women
* Prisoners
* Individuals under the age of 18 years old
* Individuals who are illiterate
* Individuals who lack the capacity to consent
* Non-English speakers
* Individuals with medical implant devices such as pacemakers, or essential support devices such as patient monitoring systems.
Genetic Evaluation of AAAS Gene in Early-Onset Achalasia and Alacrima Patients

The AAAS gene has been known to cause achalasia, alacrima, adrenal abnormalities and a progressive neurological syndrome. A considerable proportion of achalasia patients have been known to show alacrima (decreased secretion of tears). However, the genetic mechanism between achalasia and alacrima has not been defined yet. The investigators postulated that some proportions of early-onset achalasia could be correlated with AAAS gene; thus, the investigators aimed to investigate the relationship between the AAAS gene and early-onset achalasia.


Eligibility Criteria:
Inclusion Criteria:

* early age onset
* primary achalasia patient
* less than 35 years old

Exclusion Criteria:

* secondary achalasia patients
Evaluation of SOST, TWEAK, RANKL, OPG Levels in Smokers and Non-Smokers With Periodontitis

Periodontitis is a chronic inflammatory disease with multifactorial etiology. Although periodontal disease is initiated by pathogens within the biofilm layer, disease development and tissue destruction occur as a result of the interaction of periodontal pathogens and the host immune response. It has been determined in the literature that smoking has a significant negative effect on periodontal tissues and increases the risk of periodontitis by 2-5 times. It has been shown that there is a relationship between smoking and the incidence and progression of periodontitis. However, the mechanisms by which this occurs have not been explained. In this study, the effect of smoking on the levels of sclerostin (SOST), tumor necrosis factor-like weak inducer of apoptosis (TWEAK), receptor activator of nuclear factor-kB ligand (RANKL), and osteoprotegerin (OPG), which are effective in bone metabolism, in gingival crevicular fluid (GCF) and saliva will be evaluated. Participants in the study were in accordance with the 2017 World Workshop on Classification of Periodontal and Peri-implant Diseases and Conditions criteria as a result of clinical evaluations systemically healthy, non-smokers diagnosed with stage 2, 3 and/or 4 periodontitis (Group 1) (n=26); systemically healthy, diagnosed with stage 2, 3 and/or 4 periodontitis and smokers (Group 2) (n=26); systemically and periodontally healthy, non-smokers (Group 3-Control Group) (n=26). Clinical periodontal indixes will be obtained from participants meeting the inclusion criteria; GCF and saliva samples will be collected. The samples will be examined by ELISA test at Gazi University Faculty of Medicine, Department of Immunology.


Eligibility Criteria:
Inclusion Criteria:

* Study participants have no history of periodontal therapy or drug therapy for at least 6 months.

Exclusion Criteria:

* Pregnancy, lactation, during orthodontic treatment and systemic conditions related to bone metabolism, diabetes were excluded.
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.


Eligibility Criteria:
Inclusion Criteria

* Patient has measurable disease by RECIST v1.1
* Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines
* Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.
* Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
* Provision of archival tumor tissue or fresh tumor biopsy.
* Capable of giving informed consent
* Male or female subjects aged ≥ 18 years.
* Subjects must be willing to receive blood transfusions if medically indicated.
* ECOG 0-1
* Adequate hematologic and organ function
* Life expectancy of at least 3 months as assessed by the investigator
* Compliance with contraceptive requirement

Exclusion Criteria:

* Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.
* Unstable CNS metastasis requiring treatment in the last 28 days.
* Acute infection requiring IV treatment in the last 14 days.
* Grade ≥2 peripheral neuropathy.
* Pregnant or breastfeeding women.
* Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk
* Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.
* Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy.
* Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome.
* Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled.
* Have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
* Have significant, uncontrolled or active cardiovascular disease
* Have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. Patients with radiation pneumonitis that does not require treatment is allowed.
* Have uncontrolled diabetes.
* Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
* Subjects known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.
* History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
* Have received a live vaccine within 30 days of planned start of study therapy.
Effectiveness of Musicotherapy in Reducing Pain Induced by Leg Ulcer Care

Venous leg ulcer is the final stage of chronic venous disease and only develops due to advanced chronic venous insufficiency. The problems caused by venous disease are initially minor and often neglected, but can impact the quality of life of patients.

The prevalence of leg ulcers is estimated at 1% of the general population and 3% to 5% of subjects over 65 years old. Its prevalence increases with age in both men and women.

Managing chronic ulcers requires a certain number of care procedures, including debridement.

The act of treatment by mechanical debridement is little relieved by the analgesics given beforehand, and can be painful, with risks of bleeding.

Musicotherapy, particularly the U-shaped method, has shown its effectiveness in the treatment of pain and anxiety in several areas (geriatrics, intensive care, rheumatology, oncology, etc.).

The standardized musicotherapy method of the U-shaped sequence was developed and initially evaluated by clinical studies coordinated by the INSERM unit U1061 (Pr. Jacques Touchon; Dr. Stéphane Guétin).

Following the publication of numerous controlled, randomized studies presenting results on the effectiveness in the treatment of pain and anxiety, a digital application was developed in order to standardize the method. The Music Care health application is now a Class 1 Medical Device, with CE marking obtained.

This "U-shaped sequence" is standardized and has been clinically validated, which makes Music Care a unique tool available for pain relief.

No studies have been found in the literature regarding the use of music therapy during debridement care.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient,
* Patient followed at the M@diCICAT healing center requiring wound debridement :

  * For a venous or arterial ulcer or necrotizing angiodermatitis of the lower limbs,
  * Having the ability to verbalize about their pain (communicating),
  * With a planned debridement time of less than 40 minutes.
* Patient affiliated to or beneficiary of a social security scheme,
* Patient having given free, informed and express consent.

Exclusion Criteria:

* Patient with a diabetic foot (loss of sensitivity-neuropathy),
* Patient not requiring a debridement session,
* Patient with an infected ulcer (abscess, etc.),
* Patient with critical ischemia,
* Patient with hearing problems,
* Patient with cognitive disorders,
* Patient placed under legal protection, guardianship or curatorship,
* Pregnant or breastfeeding woman.
Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects

This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 to 65 years of age.
* Subjects must weigh at least 50 kg (110 pounds \[lbs.\]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).
* Physical examination and vital signs are within normal range or slightly abnormal.

Exclusion Criteria:

* Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
* Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.
* History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.
* History of viral hepatitis or HIV
* History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).
Carboplatin, Paclitaxel and TLK286 (Telcyta) as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

The purpose of this trial is to study the efficacy and safety of the triplet combination of TLK286, carboplatin and paclitaxel as first-line therapy for patients with advanced non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed non-small cell lung cancer (NSCLC)
* Stage IV or IIIB (disease that is not eligible for combined modality chemotherapy and radiation)
* Measurable disease by RECIST
* ECOG status of 0-1
* Adequate liver and renal function
* Adequate bone marrow reserves

Exclusion Criteria:

* Prior chemotherapy, immunotherapy or biologic therapy for metastatic NSCLC
* Up to one prior adjuvant or neoadjuvant chemotherapy is allowed
* History of bone marrow transplantation or stem cell support
* Pregnant or lactating women
Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients

To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.

This cross sectional study will evaluate a sample of 360 subjects with luminal Crohn's disease who are receiving infliximab in 15-20 Canadian infusion centres. The sample will be stratified by disease activity \[mild = CDAI \<150, moderate/severe = CDAI ≥150\] and whether or not subjects are on concomitant immunosuppressive therapy. Thus 4 strata will be created consisting of 90 subjects each. Consent will be obtained prior to or at Visit 1, subjects will retrospectively complete a CDAI diary card for the preceding 7 days and blood work will be drawn prior to infliximab infusion. Four weeks thereafter at Visit 2, subjects will provide an additional blood sample to measure serum infliximab concentrations and CRP levels. Between Visits 1 and 3, subjects will complete daily CDAI diary entries. Visit 3 will take place at the next scheduled infusion, 8 weeks after Visit 1 (+/- 7 days ).

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18 years of age or older at time of consent)
* Confirmed diagnosis of inflammatory luminal Crohn's Disease
* Receive infliximab therapy and have received a minimum of 5 consecutive infusions at prescribed intervals (minimum of 24 weeks and maximum of 156 weeks on infliximab therapy)
* Plan to receive the next 2 infliximab infusions at 8-weekly intervals (+/- 7 days)
* Able to provide written consent

Exclusion Criteria:

* Active draining fistulizing Crohn's Disease
* Presence of an ostomy
* Diagnosis of ulcerative colitis
* Infliximab dose of \>5mg/kg
Comparison of Safety And Efficacy of Neuraxial Anesthesia, Palpation Versus Ultrasound

The purpose of this study is to determine whether use of the ultrasound to locate the epidural space and assist with performing neuraxial anesthesia will decrease numbers of the attempts required for successful placement of epidural catheter.

It is known that ultrasound can be useful to assist placement of epidural analgesia among pregnant women.extenseve research on the usefulness of ultrasound imaging to facilitate the placement of neuraxial anesthesia in pregnant have been done.The potential advantages of successful placement among non-pregnant patients include increases the safety and comfort.

In our study all patients schedueld to receive an nueraxial anesthesia for non-obstetric surgery will be included.The investigator will request permission from the Helsinki committee of hadassah university hospital.Patients will be requesting for surgery and will be randomized to one of two study groups.One group will be passed neuraxial anesthesia on the standart technique and the secound group will be passed neuraxial anesthesia with the help of ultrasound.

Eligibility Criteria:
Inclusion Criteria:

* all patients scheduled for neuraxial anesthesia

Exclusion Criteria:

* previous spine surgery
* contraindication for neuraxial anesthesia
* refusing to sign the consent form
Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury

Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury (TBI) with pattern of oligemia (diastolic velocity \< 30cm/second and/or mean velocity \< 45cm/second measured with transcranial doppler or oxygen tissue pressure \< 15mmHg)
* Closed traumatic brain injury
* Isolated TBI or polytraumatism
* Age between 18 and 65 years old
* Affiliated to a social security system

Exclusion Criteria:

* Instable episodes of high cerebral pressure
* Craniectomy
* High cerebral pressure without TBI
* No autoregulation
* Current hemorrhagic shock
* Chronic cardiac failure
* Chronic renal failure
* Hyperemia measured with transcranial doppler
* Short life expectancy
* Refused consent from the family
* Protected patients by the law
* Hypersensibility to one of the treatment or sulfites
Evaluation of an Asynchronous Remote Communities Approach to Behavioral Activation for Depressed Adolescents

The goal of this clinical trial is to learn if a digital health intervention, called "ActivaTeen," improves depression treatment for teenagers with depression. The investigators also want to know if ActivaTeen is easy to use for both teenagers and mental health clinicians who help deliver treatment through ActivaTeen. All teenagers in the study will receive an individual depression therapy called Behavioral Activation or "BA" and about half will also use ActivaTeen.

The main questions this trial aims to answer are:

* Does ActivaTeen improve depression treatment for teenagers?
* Do teenagers and clinicians find ActivaTeen to be acceptable?

Researchers will compare teenagers using ActivaTeen along with BA to teenagers who are only doing BA to see the effects of ActivaTeen.

Participants in the study will:

* Fill out surveys online several times during the study, which lasts about 6 months
* Receive individual BA therapy


Eligibility Criteria:
Inclusion Criteria:

* Age 13 - 19
* Referred for MDD treatment
* Clinically assessed diagnosis of current MDD based on caregiver or patient report or a PHQ-8 total of 8 or greater (moderate MDD)
* MDD clinically determined to be the primary diagnosis
* English-speaking
* Access to a smartphone device

Exclusion Criteria:

* Developmental disability (e.g., intellectual disability, autism spectrum disorder)
* Severe psychiatric comorbidity (e.g., active suicidality requiring higher level of care; psychosis or substance use, bipolar, or conduct disorder)
* Previously completed a full course of evidence based psychosocial intervention for depression
Protocol of Assistance to Patients With Covid-19 Submitted to Treatment With HD-tDCS

COVID-19 has a variety of symptoms from asymptomatic respiratory dysfunction to death. Considering the pathophysiology of SARS-CoV-2 and its relationship with the neuroimmune system, response, autonomic balance, musculoskeletal and respiratory and neuropsychiatric symptoms presented by patients, the investigators highlight the potential use of non-invasive neuromodulation methods to assess the effectiveness of treating patients with COVID-19, as these techniques can be useful in the management of important clinical aspects in the functional recovery of individuals affected by the disease.

The investigators intend to evaluate the effects of HD- tDCS to promote ventilatory weaning in patients admitted to the Intensive Care Unit (ICU) and to improve the respiratory performance of those hospitalized in nursing beds for treatment of COVID - 19.


Eligibility Criteria:
Intensive Care Unit's Inclusion Criteria:

Patients of at least 18 years-old with a PCR-confirmed SARS-CoV-2 diagnosis and receiving mechanical ventilation at least 48 hours of meeting criteria for moderate to severe acute respiratory distress syndrome (ARDS), under weaning, were enrolled in this study. An ARDS diagnosis was made according to the Berlin Definition criteria.

Intensive Care Unit's Exclusion Criteria:

Patients were excluded if they had a condition that could prevent adequate performance of inspiratory muscle training (e.g., neuropathy or myopathy), pregnancy or active lactation, Richmond Agitation and Sedation Scale (RASS) scores between -2 and + 1, Glasgow Coma Scale (GCS) ≤ 8, consent refusal, and contraindications to brain stimulation (e.g., aneurysm clips).
Drug Facts Page or a Short Drug Summary in Helping Patients and Doctors Understand Medical Information

RATIONALE: The way in which information about a drug is provided may affect the ability of patients and doctors to understand how a drug works and the side effects of the drug.

PURPOSE: This randomized trial is studying how well a drug facts page works compared with a standard brief summary in helping patients and doctors understand medical information.

OBJECTIVES:

Primary

* Compare the effect of a prescription drug summary (one-page summary of drug information that includes a table with data on drug benefit and side effects) vs standard brief summary in direct-to-consumer advertisements on the comparisons of two drugs for the same indication, knowledge of drug efficacy and side effects of each drug.

Secondary

* Comprehension of information contained in the drug facts box and rating of the usability of the drug information.

OUTLINE: This is a randomized study. Participants are contacted by phone via random-digit dialing for initial interview using the computer-assisted telephone interviewing (CATI) system. Eligible participants are then randomized to 1 of 4 intervention arms.

* Arm I: Participants receive 2 advertisements for a drug to treat heartburn with a drug facts second page.
* Arm II: Participants receive 2 advertisements as in arm I for drugs to treat heatburn with the standard second page (i.e., brief summary).

Participants in both arms complete the self-reported questionnaire mailed with the advertisement intervention.

PROJECTED ACCRUAL: A total of 200 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* English-speaking adults
* Must be able to be chosen by Random Digit Dialing

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified