cyrilzakka/clinical-trials huggingface dataset:
The Effect of Hydrogen Water in Oral Mucositis in Head and Neck Cancer Patients After Therapy

Inpatients or outpatients diagnosed with head and neck cancer who met the inclusion and exclusion criteria were referred to the co-investigator(Dr. Chih-Jen Huang and Dr. Hui-Ching Wang), who then personally explained to each participant, the purpose and conduct of the study, so that they all understood their rights and interests before giving a written consent.

The study design was a randomized controlled trial and a longitudinal study with structured questionnaires (17-question basic information questionnaire、 The World Health Organization scale, WHO、NCI-CTCAE V5.0、Brief Pain Inventory-Taiwan、oral frailty checklist、European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head \& neck). The participants were randomly assigned to the experimental group (gargling with hydrogen water) and the control group (gargling with boiled water) by block randomization through a questionnaire administered by the investigator. At the end of cancer treatment (chemotherapy, radiotherapy, or Chemoradiotherapy), a hydrogen water gargle (dissolved for 12 hours or longer) or boiled water gargle was administered by the investigator or a researcher every Monday through Friday. The changes in six scales described above were tracked in the experimental and control groups on days 1 (T1), 3 (T2), 7 (T3), and 14 (T4) after the end of treatment. The data from these scales were entered into a computer and analyzed using statistical software, and the overall data are presented to demonstrate the efficacy of hydrogen water.

Eligibility Criteria:
Inclusion Criteria:

1. pathological diagnosed with head and neck cancer
2. adults over the age of 20
3. have normal cognition
4. can use Mandarin or Taiwanese to communicate
5. received radiation therapy or combined chemotherapy

Exclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status 2, 3 and 4
2. received oral cancer surgery within two months
Carbon Dioxide Insufflation on Cerebral Microemboli

The purpose of this study is to determine if blowing carbon dioxide into the surgical field during open-heart surgery to displace retained chest cavity air from the atmosphere will decrease the number of microembolic being introduced into the heart chambers and brain.

Although open-heart surgery is widely used throughout the world, from 1 to 4% of patients experience neurological impairment such as impairment of memory, language and motor skills after surgery. The cause for such cognitive impairment is thought to be air microemboli (very small bubbles of air) being introduced into the blood circulation of the brain from the heart. These air microemboli are introduced from the surgical field and/or from the heart-lung machine. During open-heart surgery, a patient's blood circulation is supported by a heart-lung machine (cardiopulmonary bypass) while the surgeon is replacing or repairing a valve or performing coronary artery bypass surgery. During valve surgery, chambers of the heart are open to room air, causing an introduction of air into the heart. Despite careful de-airing (removal of air) procedures during open-heart surgery, studies revealed that air microemboli are still formed. Past research studies have shown that carbon dioxide (CO2) filling the chest cavity by means of gravity and replacing the room air may help to decrease the amount of microemboli reaching the brain.

CO2 is 50% heavier than room air. Unlike room air, CO2 dissolves more quickly in blood and tissue (\> 25 times more soluble in blood and tissue than air) whereas air contains nitrogen, which does not dissolve easily in the blood. In either case, the emboli made of air or CO2 can block the arteries of the brain causing cognitive impairment. Due to the properties of air and CO2, CO2 emboli may be tolerated much better than air emboli.

This is a single-centre, double-blind, placebo-controlled study, randomizing 100 patients undergoing elective mitral valve repair +/- coronary artery bypass grafting. Patients will be divided into 2 groups: (n=100), 50 patients will be receiving carbon dioxide insufflated and 50 patients will not. The number of microemboli will be ascertained by an intraoperative transesophageal echocardiography and transcranial doppler. Three to seven days after surgery, a magnetic resonance imaging of the brain will be done to assess for any cerebral ischemic lesions. Plus, a battery of neuropsychologic tests will be done preoperatively and 2 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* provide informed consent
* male or female who are 18 years of age or older
* elective patients to undergo mitral valve repair +/- coronary artery bypass surgery
* ability to read and write

Exclusion Criteria:

* patients with a history of stroke, TIA, carotid vascular disease
* patients with a contraindication to TEE or MRI
* patients with an active history of drug/alcohol dependence or abuse history
Acupuncture in the Complementary Treatment of Diabetes Mellitus Type II

This is a randomized clinical research, with triple blinded multicenter involving the Federal University of Rio de Janeiro, through the School of Nursing Anna Nery, as a proponent and research coordinator; and as a collaborative educational institutions, the Federal University of Espirito Santo, represented by the Department of Nursing; and the Higher School of Sciences of the Santa Casa de Misericordia de Vitoria, through the Master's Programme in Public Policy and Local Development.

As Research, the study covers health units of the Municipal Family Health Maricá / Rio de Janeiro, the Municipal Victoria Health / Holy Spirit, beyond the scope of Integrated Project Research-Service (PIPA), linked to Nursing Anna Nery / Federal University of Rio de Janeiro.

The object of investigation is the effectiveness of acupuncture in nursing care in complementary treatment of adult patients Diabetes Mellitus type II.

This study has the general objective to evaluate the effectiveness of acupuncture as a complementary treatment to medication used in patients with diabetes mellitus type II, based on the nursing diagnoses.

Eligibility Criteria:
Inclusion Criteria:

* Be in possession of Diabetes Mellitus Type II only
* It is undergoing treatment for at least 1 year properly prescribed (to be confirmed with the medication of revenue)
* Report difficulties in glycemic control, regular saving measures higher than recommended by the Brazilian Society of Diabetes (postprandial up to 180mg / dl)

Exclusion Criteria:

* Have a lower limb amputated or part of them (because of the location of the selected acupoints for the treatment protocol)
* Be insulin
* Being a smoker
* Be alcoholic
* Be in drug treatment for other diseases including obesity
* Be making specific diet for weight loss
* Practicing regular physical activity
* Be in possession of cancer
* Being pregnant
Pilot Research on Opioid Use Disorder

This study evaluates the effects of peripheral nerve stimulation on opioid withdrawal, craving, and use in participants with opioid use disorder (OUD) who are initiating treatment with buprenorphine/naloxone. This is a pilot investigation in which participants will randomized (1:1) to the active or sham treatment.

Opioid use disorder (OUD) has become a public health emergency. Approximately 2.6 million Americans suffered from OUD in 2016. Evidence-based approaches for treating OUD include several medication-assisted treatments (MATs). While MATs are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are key contributors to treatment dropout, relapse, and overdose. Peripheral nerve stimulation via acupuncture has been shown to directly decrease drug withdrawal, craving, and self-administration. The investigators have developed the Empower Neuromodulation System, a non-invasive, portable transcutaneous electrical nerve stimulation (TENS) device intended to stimulate peripheral nerves for the treatment of OUD. In this study, a randomized, controlled study will be conducted in participants with OUD who are initiating treatment with buprenorphine/naloxone. Participants will self-administer daily treatment with the Empower device. Endpoints will be evaluated for safety, effectiveness, and acceptability.

Eligibility Criteria:
Inclusion Criteria:

* VA-eligible Veterans
* Ages ≥ 18
* Current diagnosis of opioid use disorder per DSM-5 by clinician assessment
* Scheduled to initiate, or has initiated within the past five days, treatment for OUD with buprenorphine/naloxone

Exclusion Criteria:

* Injury or nerve damage at the arm or palm and/or neuropathy in the upper extremities
* Pregnant or planning to become pregnant
* Currently implanted with an electrical and/or neurostimulator device (e.g. pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, sacral stimulator, bone growth stimulator, or cochlear implant)
* Use of an investigational drug/device therapy within the past 4 weeks
* History of epilepsy or a seizure disorder
* Has an electrically conductive metal object (e.g. jewelry) that cannot be removed and will directly contact the gel electrodes of the Empower Neuromodulation System when applied to the skin at the stimulation location
* Unable to provide informed written consent
* Has taken a medication-assisted treatment (MAT) for OUD in the past two weeks or plans to take any prescription opioid or MAT for OUD other than buprenorphine/naloxone while enrolled in the study
* Is deemed unsuitable for enrollment in the study by the PI (e.g. current medical or psychiatric instability)
An Evaluation Of Healthy Ankle Motion And Morphology

Determine motion and morphology of the healthy ankle during simulated gait.

Healthy volunteers will undergo weight-bearing, cone beam CT scans of their foot/ankle during 3 phases of simulated gait. Motion and morphology of the foot and ankle will be quantified and analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. The subject self-reports having a right healthy ankle.
2. The subject agrees to comply with the requirements of the study and complete the study measures.
3. The subject is between the ages of 18 and 65.
4. The subject is willing to provided written informed consent.

Exclusion Criteria:

1. The subject is pregnant.
2. The subject reports having been diagnosed with any form of diabetes.
3. The subject reports having surgery on the right foot, right ankle and/or right knee.
4. The subject reports a history of repeated ankle sprains or injuries to the right ankle.
5. The subject reports a history of instability of the right ankle.
6. The subject reports chronic or recurring pain of the right ankle.
7. The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, and/or known abuser of alcohol and/or drugs.
Phase I Study in RAD 001 Patients With Relapse AML

A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse

The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.

Eligibility Criteria:
Inclusion Criteria:

* patients from 18 to 65 years old
* AML in relapse more than 1 year after CR
* inform consent signed

Exclusion Criteria:

* age more than 65
* cardiac insufficiency
* renal insufficiency
* hepatic disease
* other type of AML
* blastic MCL
* HIV positive serology
* other malignancy
* pulmonary infection
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract

RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, precancerous cells and cancer cells are killed.

PURPOSE: This phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.

OBJECTIVES:

* Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract.
* Determine the safety of this regimen in these patients.

OUTLINE: Patients are stratified according to disease condition (benign vs malignant).

Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4.

After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Any of the following benign lesions:

    * Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant
    * Carcinoma in situ
  * Superficial (\< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx

    * T1-T3 disease
    * Meets one of the following criteria:

      * Failed radiation therapy and refused standard salvage surgery
      * Refused radiation therapy and/or surgery as primary therapy
      * No good surgical alternative with acceptable morbidity
  * Condemned mucosa syndrome

    * At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas

PATIENT CHARACTERISTICS:

* Creatinine ≤ 2 mg/dL
* AST and ALT ≤ 30% elevated
* Alkaline phosphatase ≤ 30% elevated
* Bilirubin ≤ 1.0 mg/dL
* No contraindication to anesthesia or analgesia
* No porphyria
* No hypersensitivity to porphyrins
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
A Study Of PF-03084014 In Japanese Patients With Advanced Solid Tumors

The purpose of this study is to determine the recommended Phase 2 dose for PF-03084014 single-agent administration in Japanese patients with advanced solid tumors. Pharmacokinetics and the overall safety profile of PF-03084014 will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of advanced solid tumors that is resistant to standard therapy or for which no standard therapy is available.
* Age ≥18 years.
* ECOG Performance Status (PS) must be 0 or 1.
* Adequate Bone Marrow Function
* Adequate Renal Function
* Adequate Liver Function
* Resolved acute effects of any prior therapy to baseline severity or Grade ≤1

Exclusion Criteria:

* Patients with known brain metastases
* Major surgery within 4 weeks of starting study treatment
* Radiation therapy within 2 weeks of starting study treatment
* Systemic anti cancer therapy within 2 weeks (4 weeks for antibody) of starting study treatment
* Previous high dose chemotherapy requiring stem cell rescue
* Prior irradiation to \>25% of the bone marrow
* Prior treatment with a Notch signal inhibitor
* Known malabsorption syndrome or other condition that may impair absorption of study medication
* Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
* Current use or anticipated need for known strong and/or moderate CYP3A4 inhibitors
* Current use or anticipated need for known strong CYP3A4 inducers
Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway

This trial compares capnographic signals using a modified CO2/O2 Guedel airway with a CO2/O2 nasal cannula without and with oxygen supply in sedated children aged 4 - 24 months.

Sedation of pediatric patients is frequently jeopardized by respiratory adverse events such as central and/or obstructive apnea resulting in hypoxemia. Various factors such as patient comorbidities, medication and inconsistent physiologic monitoring are known to contribute to or facilitate adverse events during sedation. Therefore, monitoring of breathing by capnography is recommended and has become common standard e.g. by the use of a CO2/O2 nasal cannula.

However, capnography derived from CO2/O2 nasal cannulas may be impaired and these impairments are exaggerated in infants based on their physiologic characteristics (small tidal volumes, high respiratory rates).

To overcome these impairments, the investigators developed a modified CO2/O2 Guedel airway including a CO2 sampling port at the tip of the airway. In a previous study, significantly more accurate capnographic signals resulted compared with measurements derived from a nasal cannula when using a modified CO2/O2 Guedel airway in a model of a breathing 6-month-old manikin.

The aim of the study is to examine the accuracy of capnographic measurements of the modified CO2/O2 Guedel airway in comparison with measurements from a CO2/O2 nasal cannula in sedated children aged 4 - 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Term born infants aged 4 to 24 months
* Physical status according classification I or II (American Society of Anaesthesiologists (ASA))
* Scheduled for elective diagnostic/therapeutic procedures or surgery under sedation/anaesthesia
* Informed Consent as documented by signature of the parents or legal caregiver

Exclusion Criteria:

* syndrome that affects the airway anatomy
* Physical status according classification III or IV (American Society of Anaesthesiologists (ASA))
* Upper respiratory tract infection at present or within the last two weeks before the study
* Previous enrolment into the current study
* Known hypersensitivity or allergic reactions to midazolam, nitrous oxide (N2O), Propofol or Sevoflurane.
* Positive Family History for malignant hyperthermia, Morbus Pompe or ophthalmic operations with gas injection or Sinus- or inner ear surgery.
Vibration and During Heel Lance Procedures in Newborns

This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns.

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Methods: This randomized, controlled, experimental study. The study sample consisted of 56 newborns determined using power analysis (vibration: 28, control:28). Newborns who underwent a heel lance procedure at the specified center, whose parents agreed to participate in the study and who had reached gestational age 38 and older were enrolled in the study. In the vibration group, a vibrating device was used for approximately 30 seconds before the heel lance procedure and continued throughout the procedure. No interventions were made on the newborns in the control group. Two nurses were employed for the heel lance procedure both for the experimental and control groups. One nurse performed the heel lance procedure for all newborns and the other nurse recorded the procedure. Pain in newborns was evaluated by the nurse who performed the heel lance procedure before the procedure, and 15-20 seconds and five minutes after the procedure, as well as by two specialists through observation of the video footage of the procedures using the NIPS. The heel lance procedure was performed by the same nurse both in the vibration and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 38 and older

Exclusion Criteria:

* Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
* Genetic and congenital anomalies
* Congenital metabolic disorders,
* those who had undergone cardiopulmonary resuscitation,
* Stayed in the neonatal intensive care unit for any reason,
* Heel blood could not be collected at the first attempt,
* Osteogenesis imperfecta
* Had been given an analgesic within the preceding 6 hours
Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis

Topical steroids are standard of care for Chronic Hand Dermatitis, but long-term use is associated with adverse effects. This study will assess the efficacy and safety of pimecrolimus cream 1% in patients with mild-to-moderate chronic hand dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* - Patients who are outpatients at baseline (Day 1)
* Patients must be 18 years of age or above
* Patients must have chronic hand dermatitis based upon clinical diagnosis with mild to moderate dermatitis of the target hand at baseline, as defined by an Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
* Patients must have been informed of the study procedures and medication and have given their written informed consent

Exclusion Criteria:

* - Women who are pregnant or who are breast-feeding.
* Patients who have received systemic corticosteroids (i.e., oral, intravenous, intra-articular, rectal, intramuscular) within one month prior to first application of study medication.
* Patients who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on hand dermatitis within at least one month prior to first application of study medication.
* Patients who have received pimecrolimus cream 1% or tacrolimus ointment 0.1% or 0.03% within 14 days prior to first application of study medication.
* Patients who were treated with topical therapy (e.g., tar, topical corticosteroids, Burrows solution soaks) known or suspected to have an effect on hand dermatitis within 7 days prior to first application of trial medication.

Other protocol-defined inclusion/exclusion criteria may apply.
The Ideal Deep Venous Thrombosis (DVT) Study

In the Netherlands, 25.000 patients each year are diagnosed with Deep Venous Thrombosis (DVT). Elastic compression stocking (ECS) therapy reduces the incidence of post thrombotic syndrome (PTS) following DVT from 50% without ECS to 20-30% after ECS therapy for two years. It is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ECS therapy for individual patients should be. ECS therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. Substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve.

This study aims to assess the costs and effects of tailoring the duration of ECS therapy after DVT to individual patients needs.

ECS therapy with a standard duration of 24 months will be compared with tailored ECS therapy, following an initial therapeutic period of 6 months, in patients with acute proximal DVT. The primary outcome is the percentage of patients with PTS at two year follow-up.

This is a multi-center, randomized, allocation concealed, single-blinded clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Legal age (18 yrs)
* Informed consent
* Acute objectively documented DVT of the leg
* Adequate anticoagulation

Exclusion Criteria:

* Previous DVT in the affected leg
* Recurrent DVT in the first 6 months following inclusion
* Preexistent venous insufficiency (skin signs C4-C6 on CEAP score or requiring ECS therapy)
* Contraindication for elastic compression therapy (arterial insufficiency)
* Active thrombolysis
* Life expectancy \< 6 months