cyrilzakka/clinical-trials huggingface dataset:
Movement Tracking Devices to Monitor Physical Activity in Patients Undergoing Chemotherapy

This clinical trial studies movement tracking devices in optimizing and monitoring physical activity in patients with solid tumors undergoing chemotherapy in a health care facility during the day without spending the night. Movement tracking devices, such as Microsoft Kinect 2 and Microsoft Band 2, may help doctors learn about the health of cancer patients.

PRIMARY OBJECTIVES:

I. To determine the feasibility of monitoring cancer patients using wrist-worn activity monitors and movement trackers.

SECONDARY OBJECTIVES:

I. To evaluate the association between activity and patient reported fatigue. II. To evaluate the association between movement and incidents of health care interventions (hospitalizations, physical visits, intravenous hydration, etc.)

TERTIARY OBJECTIVES:

I. To compare physician and patient assessed Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status scores with the data obtained from movement trackers.

OUTLINE:

Patients perform 2 physical activities in an exam room that are recorded using a Microsoft Kinect 2 stationary movement tracking device on days 1 and 21. The first activity is rising from a chair, walking 10 feet, and returning to the chair. The second activity is moving from the chair to the step-up examination table. Patients also wear a movement tracking wristband, Microsoft Band 2, around their wrist, complete a smartphone application based patient reported outcome (PRO) questionnaire, and weigh themselves daily for 60 days.

After completion of study, patients are followed up at 90 days.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of a solid tumor, undergoing palliative or adjuvant therapy
* Undergoing at least 2 planned cycles of highly emetogenic chemotherapy defined according to the Hekseth scale; the cycles may range in duration from 14 days to 28 days, according to standard of care practices
* Ability to understand and the willingness to sign a written informed consent
* Willingness to wear sensors to track physical activity, Global Positioning System (GPS) location, and provide symptom ratings each night for up to 60 days
* Able to read English, Spanish, or Traditional Mandarin to complete patient reported outcomes
* Able to ambulate without an assistive device
* Able to operate a smartphone and wearable wristband

Exclusion Criteria:

* Patients may not be missing limbs
* Patient does not have a diagnosis of a hematologic malignancy
* Patients with symptomatic brain metastases are excluded from this clinical trial; those with asymptomatic brain metastasis are permitted; it is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis
* Patient with a known movement disorder such as Parkinson's disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy
Sweden Cancerome Analysis Network - Breast (SCAN-B) Coupled to Psychological Resilience

This study aims to define the association between psychological resilience and biomolecular signatures in cancer patients and to relate psychological resilience to prognosis, as this could potentially open up a novel avenue of therapeutic interventions, medical as well as psychosocial.

Individual patients differ in psychological response when receiving a cancer diagnosis. Given the same disease burden some patients master the situation well and others do experience a great deal of stress, depression and lowered quality of life. A patient's mental resistance after acquiring a threat, like a cancer diagnosis, called psychological resilience, is known to impact the outcome of the disease. Patients with high psychological resilience are likely to experience less stress reactions, and a better adaptation and management of the life threat and the demanding therapeutic interventions. How this phenomenon of mastering difficult situations is reflected also in bio-molecular processes is not much studied and how these have an impact on the cancer prognosis and the effectiveness of treatment is today not fully understood. However, there is evidence that expressing the emotions evoked is an important part of fighting cancer.

Our hypothesis is that patients displaying a high psychological resilience, according to a standardized method "The Connor-Davidson resilience scale" i.e. low stress reactions, low hopelessness and low fatigue, also present a specific pattern of biomolecular signatures in blood, represented by its epigenome, microRNA and proteomic patterns.

This project specifically aims to investigate if breast cancer patient´s psychological resilience can be coupled to bio-molecular parameters, using advanced "omics" and as a secondary aim, if it relates to prognosis and quality of life one year after diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with primary breast cancer
* Patients consented to be included in the SCAN-B study at (Blekinge County Hospital, Central Hospital Växjö and Hallands Hospital Halmstad HBG??
* Oral and written consent for the SCAN-B Resilience study
* Age ≥ 18 years
* Patients that do understand the Swedish language (written and spoken)

Exclusion Criteria:

* No diagnosis of breast cancer
* Not consented to be included in the SCAN-B study
* Do not understand the Swedish language
Gluing Lacerations Utilizing Epinephrine

Minor lacerations are a commonly treated injury in the paediatric emergency department . Over the past decade, standard closure of these lacerations has evolved from suture repair to closure with tissue adhesive (also referred to as "skin glue"). Local anaesthetic is not routinely used during application of skin glue as it was with sutures. There are, however, several potential advantages to pre-treating wounds with topical LET (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive properties. Some believe LET can improve patient comfort, increase the ease of glue application, and lead to better healing when used on lacerations being repaired with tissue adhesive. This study aims to address the question of whether or not pre-treatment with LET improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual Analog Scale) during repair with tissue adhesive.


Eligibility Criteria:
Inclusion Criteria:

* aged 0 to 17 years inclusive;
* with a laceration that is less than 3 cm in length (the upper limit recommended for tissue adhesive repair by the manufacturer).
* with said laceration on the face, torso, trunk or extremities;
* with said laceration deemed by the treating physician to be appropriate for repair via tissue adhesive

Exclusion Criteria:

* the wound for study needs debridement or suturing prior to first glue attempt
* said wound is an animal or human bite or scratch wound, puncture wound, stellate crush wound, wound crossing mucocutaneous junctions, a scalp laceration, an ear laceration, a wound crossing a joint line, a wound on the fingers or toes, or a wound in an area of concentrated hair such as the eyebrow
* the patient has a history of keloid formation or
* a known allergy to cyanoacrylates or
* is presently taking oral steroids, immunostimulants, anticoagulants or other medications known to impair wound healing or haemostasis; or
* has a known diagnosis of Diabetes Mellitus or Vascular Insufficiency
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)

A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).

This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.

Eligibility Criteria:
Inclusion Criteria:

* A man or woman over 20 years old less than 70 years old.
* A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A\~D) measured through the endoscopy which is carried out within (-2W±D2)

  \* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
  1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
  2. Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
* A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.

Exclusion Criteria:

* Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
* Who has NERD
* Who get a diagnosis as a IBS within the last 3 months.
* Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
* Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (\* refer to the Concomitant medication in text.)
* Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
* Who has clinically significant abnormal result of ECG.
* Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
* Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.
Retrospective Review of CT and MR in Pediatric Patients With Cholestasis

The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and the measurement of transverse diameters of paraesophageal and gastroesophageal veins.

We intend to review retrospectively 80 pediatric patients on an average of 2 years, who underwent 64-slice CT or MR examinations between January 2005 and Oct 2010 and had EVs on esophagogastroduodenoscopy. Splenic diameters (mm) and hepatic diameters of all patients were measured. Splenic and hepatic volume indices also calculated. The transverse diameters of paraesophageal varices (PVs) and perigastric varices (PGVs) were measured adjacent to the lower thoracic esophagus and within the lesser sac, respectively.

We will try to find out the possible splenic, hepatic or vascular predicting factors useful to evaluate the risk of clinically evident esophageal varices.

Eligibility Criteria:
Inclusion Criteria:

* all cholestatic children with CT, MR and complete medical record

Exclusion Criteria:

* all cholestatic children without either CT, MR or complete medical record
COVID-19 Antigen Rapid Test Kit

The SG Diagnostics COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is intended for use with self-collected nasal swab samples in individuals who are suspected of COVID-19. This test utilizes a lateral flow immunoassay technology for the qualitative detection of spike and nucleocapsid protein antigens of SARS-CoV-2 in individuals with known or suspected COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged ≥ 18 years) volunteers

Exclusion Criteria:

* Children (aged \< 18years)
A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

* To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency
* To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.


Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years on the day of inclusion
* Informed consent form signed
* Able to attend all scheduled visits and to comply with all trial procedures
* For a woman, inability to bear a child or negative urine pregnancy test at Visit 1
* For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.

Exclusion Criteria:

* Febrile illness (oral temperature \>=37.5°C) on the day of vaccination
* Breast-feeding
* Participation in another clinical trial in the four weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy
* Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
* Blood or blood-derived products received in the past three months
* Any vaccination in the four weeks preceding the trial vaccination
* Vaccination planned in the three weeks following the trial vaccination
* Vaccination against influenza in the previous six months
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
Pharmacokinetics of Intramuscular Adrenaline in Food--Allergic Teenagers

Food allergy affects up to 2% of adults and 8% of children in the United Kingdom (UK), and is a major public health issue. It is the commonest cause of life-threatening allergic reactions (anaphylaxis), which can be fatal. Adrenaline (epinephrine) auto-injector (AAI) devices are the first-line treatment for anaphylaxis, yet in a UK survey, over 80% of 245 teenagers experiencing anaphylaxis did not use their AAI. Delays in, or lack of adrenaline (epinephrine) administration during anaphylaxis are risk factors for fatal anaphylaxis.

In 2010, a coroner's investigation into the death of a food-allergic teenager in the UK raised several questions around AAI safety and efficacy, since the teenager died despite administering her auto-injector device. This prompted a review by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2014 into the clinical and quality considerations of AAIs. Two recommendations which came from the review was that companies 'should be encouraged to develop a 0.5mg \[dose\] AAI.' In the UK currently only Emerade, one of the three companies selling AAIs, manufactures a 0.5mg (500mcg) version. Emerade also has a longer needle length (23mm) compared to other AAIs (typically 15mm).

The investigators plan to formally assess the pharmacokinetics (PK) and pharmacodynamics (PD) of self-injection with intramuscular adrenaline (epinephrine) in teenagers at risk of anaphylaxis due to food allergy, and have been prescribed AAI.

1. The investigators will compare self-injection with 300mcg vs 500mcg in teenagers of body weight \>40kg. In a 40kg person, an adrenaline dose of 300mcg results in an effective UNDER-dosing of 30% by body weight.
2. The investigators will also assess the impact of needle length on injection, by comparing two different devices, both of which deliver 300mcg, but one via a 15mm needle and the other with a 23mm needle.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 - 18 years inclusive
* Body mass \>40kg
* Prescription of AAI due to physician diagnosis of Immunoglobulin E-mediated food allergy.
* Written informed consent from parent/guardian together with patient assent, for participants under 16 years of age. For young people age 16+ years, consent will be obtained from the participant themselves.

Exclusion Criteria:

* Known cardiac comorbidity (including hypertension, structural or electrophysiological diagnoses) or prescribed a medicine to control cardiovascular disease/hypertension.
* Known endocrine or renal disease
* Poorly controlled asthma requiring daily rescue treatment with a bronchodilator.
* Pregnancy
* Unwilling or unable to comply with study requirements
Can Lower-body Occlusion Influence Sports Recovery?

This study ai ms to compare the recovery kinetics of different interventions: i) active recovery; ii) continuous vascular occlusion during active recovery; iii) intermittent vascular occlusion during active recovery; iv) control group.


Eligibility Criteria:
Inclusion Criteria:

* soccer players
* elite athletes
* present in the pitch training sessions

Exclusion Criteria:

* injured athletes
* female athletes
Articaine vs Dexmedetomidine Supplemented Articaine

The aim of this study to test efficacy of adding dexmedetomidine to articaine on sensory, motor and duration of analgesia during hemodialysis fistula creation under ultrasound guided supraclavicular block

Adult fifty patient with chronic renal failure on hemodialysis, scheduled for arteriovenous fistula creation under ultrasound guided supraclavicular block. Patients were randomly allocated in two group. The articaine group (group A) received 40 ml articaine hydrochloride 2% and articaine-dexmedetomidine group (group AD) received 40 ml. Of articaine 2% mixed with dexmedetomidine (1micogram/kg)

Eligibility Criteria:
Inclusion Criteria:

* adult patient with chronic renal failure on hemodialysis scheduled for radiocephalic fistula creation

Exclusion Criteria:

* Allergy to local anesthetics.
* Infection at the site of needle insertion.
* Those having international normalized ratio more than 1.5.
* Coagulopathy.
* Neuromuscular, or severe hepatic or severe pulmonary disease.
* Those having epilepsy.
* Patients who refused to participate.
Safety and Efficacy of EVT 101 in Treatment-Resistant Depression

This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.


Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder
* Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
* Has as score of \>/= 18 on the Ham-D-17

Exclusion Criteria:

* Pregnant or breast-feeding women
* Evidence of age-related cognitive decline or mild dementia
* At imminent risk of committing suicide
* Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease
* Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
* Has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening
Safety and Efficacy on Deoxyspergualin (NKT-01) in Patients With Lupus Nephritis

The aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

The purpose of this phase I/II study ia to establish that dose of NKT-01 which leads to complete response during a minimum of 6 cycles of treatment without causing WHO grade 3 leukopenia (WBC \< 2x10\^9/L). The patients suffered from uncontrolled lupus nephritis (LN) and took OCS (\<= 1.0 mf/kf/day, a maximum dose of 80 mg/day) in addition to NKT-01. Therefore the aim of the open multi-center study is to determine an efficient and safe dose and dosing schedule of NKT-01 in induction of response in treatment of lupus nephritis.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-70 years.
* A diagnosis of SLE according to the ACR criteria (at least 4/11 criteria).
* Sufficient signs to diagnose active SLE nephritis.
* Serum creatinine concentration of \<= 5.0 mg/dL.
* Leucocyte counts \>= 4000/uL.
* Receiving OCS (\<= 1.0 mg/kg/day; a maximum dose of 80 mg/day).
* Prior treatment with cyclophosphamide, azathioprine, cyclosporin A, or any other immunosuppressive drugs.

Exclusion Criteria:

* Chronic infection of HIV, Hepatitis B, Hepatitis C.
* Acute infection including fungal, viral, bacterial or protozoal diseases.
* Liver toxicity (WHO CTC class 2 and higher). No adequate liver function (total bilirubin \> 25 umol/L = 1.4 mg/dL unless explained otherwise (e.g. inherited, hemolysis), SGOT \> 2.5 x N, SGPT \> 2.5 x N).
* Pregnant or lactating women
* Female patients of child bearing age without safe method of contraception.
* Anemia (hemoglobin \< 8.0 g/dL), leucopenia (leucocytes \< 4000/uL unless attributable to SLE: leucocytes \< 2000/uL), thrombocytopenia (platelets \< 50000/uL).
* Neutrophils below 1000/uL.
* Hypogammaglobulinemia below 400 mg/dL of serum IgG.
* Any other condition that in the eyes of the investigator might have rendered the patient unsuitable for participation in the study. This especially includes major and active SLE organ involvement other than the kidney. Patients with SLE involvement of the central nervous system are not allowed to be included into the study.
* History of malignancy.
* Current participation in another trial or lass than 6 months since participation in a similar trial.