cyrilzakka/clinical-trials huggingface dataset:
Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (QST), endogenous biomarkers (cytokines), and neuro-imaging to investigate APA's efficacy and underlying mechanism(s).

Chemotherapy-induced neuropathy (CIN)-pain, numbness, or tingling distributed in the hands and feet-produces persistent symptoms affecting sensation and balance in cancer survivors. Up to 50% of cancer survivors still suffer CIN 6 years after treatment. Duloxetine, the only recommended drug by the American Society of Clinical Oncology, was found to be superior to placebo but improved CIN by only 0.73 points (0-10 scale). No effective treatment for CIN has been established except exercise, with an effect size of \<0.508. Opioids relieve CIN pain, but long-term use is strongly discouraged due to opioid overuse.

The investigators propose to test auricular point acupressure (APA), an innovative and scalable solution developed from auricular acupuncture. APA is a non-invasive (needleless) and active treatment for patients with pain, whereas acupuncture is an invasive (using needles) and passive treatment (administered by a licensed practitioner). In APA, small seeds are taped on specific ear points by a skilled provider and patients press on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and sustains pain relief for one month after a 4-week APA intervention. APA is popular in Taiwan, China, and Europe. Though its use is sparse in the U.S., a limited number of clinical trials have supported APA in pain management.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients ages ≥18 years
* have received a medication in one of the following categories: platinum-based, vinca alkaloids, bortezomib, eribulin, and/or taxanes
* have CIN due to receiving neurotoxic chemotherapy for cancer or have pre-existing peripheral neuropathy of another etiology that worsened after chemotherapy
* have one of the average intensity of pain, or numbness, or tingling on their extremities the previous week due to CIN ≥ 4 on a 11-point numerical scale.

Exclusion Criteria:

* use of an investigational agent for pain control concurrently or within the past 30 days
* use of an implantable drug delivery system, e.g. Medtronic SynchroMed®
* prior celiac plexus block or other neurolytic pain control treatment
* other identified causes of painful paresthesia existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy,)
* allergy to latex (the tapes for the APA include latex) and/or having a history of allergic reactions to the adhesive tape
* pregnant women (based on the self-reported data)
* individuals diagnosed with diabetic neuropathy
Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing with an oral once daily dose of 1200 mg of BIA 2-093

Single centre, two-way crossover, randomised, open-label study in 20 healthy female volunteers.The volunteers received an oral single-dose of a combined contraceptive containing 30 μg ethinyloestradiol and 150 μg levonorgestrel on two occasions - once as such and once after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 for 15 days separated by a washout period of at least 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal female;
* Able and willing to give written informed consent;
* Aged 18 to 40 years, inclusive;
* Not pregnant or breast-feeding;
* Body mass index (BMI) between 19 and 30 kg/m2, inclusive;
* Healthy as determined by medical history, physical examination, complete neurological examination, vital signs, and 12-lead ECG;
* Clinical laboratory tests with clinically acceptable results at screening and admission to the first period;
* Negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening;
* Negative test for drugs of abuse at screening;
* Non-smoker or smokes less than 10 cigarettes or equivalent per day;
* Agreed to either practice abstinence or use a double-barrier or intra-uterine device from screening until the follow-up visit;
* Negative pregnancy test at screening and admission to the first period.

Exclusion Criteria:

* Had any contra-indication to the use of oral contraceptives;
* Had experienced notable adverse events while on any oral contraceptive;
* Had a history of alcoholism or drug abuse;
* Had a relevant history or presence of respiratory, gastrointestinal, renal, hepatic,haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;
* Had acute gastrointestinal symptoms at the time of screening or admission to the first period;
* Had a significant infection or inflammatory process at the time of screening or admission to the first period;
* Had a relevant surgical history;
* Had a relevant family history;
* Had a history of relevant drug hypersensitivity (e.g., carbamazepine or oxcarbazepine);
* Had used relevant prescription or over-the-counter medication within 2 weeks ofadmission to the first period;
* Consumed more than 14 units of alcohol a week;
* Had participated in any clinical trial within 3 months prior to screening;
* Had previously received BIA 2-093;
* Had donated or received any blood or blood products within 2 months prior to screening;
* Was unlikely to co-operate with the requirements of the study.
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication

1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection.
2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.

For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.

Exclusion Criteria:

1. Those who have ever received Helicobacter pylori sterilization treatment.
2. Those who are allergic to the drugs used in this research.
3. Those who have had stomach surgery.
4. Those with severe liver cirrhosis or uremia or malignant tumors.
5. Women who are pregnant or breastfeeding.
Pain Due to Peripheral Intravenous Catheter Insertion

This study aimed to evaluate the effectiveness of rose oil aromatherapy and hand-holding in reducing pain associated with peripheral intravenous catheters (PIVCs) insertion.

Study Hypothesis:

H0-1. The application of rose oil aromatherapy during the PIVC insertion procedure does not reduce the pain associated with the procedure.

H0-2. During the PIVC insertion procedure, the patient's family holding the patient's hand does not reduce the pain associated with the procedure.


Eligibility Criteria:
Inclusion Criteria:

* patients voluntarily accepted to participate in the study,
* aged between 18-65,
* Turkish literate,
* PIVC placement planned,
* no hematoma, ecchymosis, scar and sensory change in the antecubital region,
* suitable for PIVC insertion with a 20 gauge (pink) catheter in the antecubital region,
* who did not take analgesic drugs for 24 hours and were accompanied by a member of the patient's family (spouse or child).
* patients with an Enhanced Adult DIVA (EA-DIVA) score below 8 for PIVC placement in a single intervention,
* the STAI score below 40

Exclusion Criteria:

* sensitive to smell and had problems in smelling,
* patients with epilepsy, asthma diagnosis,
* patients with a history of allergy
Treatment Study Comparing Medium or High Dose Uva-1 Treatment 3x/Week Versus Fluocinonide 0.05% Cream in the Treatment of Morphea.

Compare UVA-1 phototherapy treatment to topical steroid treatment in subjects with morphea.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects 18 years of age or older.
* Symmetric limited morphea.

Exclusion Criteria:

* Known sensitivity to fluocinonide 0.05% cream.
* Clinical evidence of superinfected skin.
* Immunocompromised state (including previously documented HIV).
* Generalized Scleroderma.
* Previous history of skin cancer.
* Non-English speaking subjects.
Carbohydrate Content in the Diet in Type 1 Diabetes

The aim of this study is to analyse the effect of a diet with a moderate amount of carbohydrates and compare it with a traditional diabetic diet with a higher content of carbohydrates on mean glucose level, high and low glucose levels, and the risk of ketoacidosis in patients with type 1 diabetes. The glucose levels will be measured by blinded continuous glucose monitoring (CGM).

The trial has a cross-over design and 12 weeks in duration, where patients will be randomized to; 1) a diet with moderate carbohydrate content for 4 weeks and 2) a traditional diabetes diet for 4 weeks and with a wash-out period between for 4 weeks. The two diets will both be healthy and planned by a dietitian. There will be 50 subjects included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Adults 18 years or older
* Written Informed Consent
* HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)

Exclusion Criteria:

* Pregnancy or planned pregnancy for the study duration
* Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
* Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
* Diabetes duration \< 1 year
* Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
* Other investigator-determined criteria unsuitable for patient participation
Comparison Between Infliximab and Adalimumab on Patients With Ulcerative Colitis

Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.

The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-100 years.
* Diagnosis of ulcerative colitis confirmed by endoscopy and histology.
* Mild, moderate and severe disease activity.
* Initiation of IFX or ADA-treatment at one of the centers of the study.

Exclusion Criteria:

* Clinical remission.
* Previous colonic surgery (resection of colonic segment or colectomy).
* Primary indication for anti-TNF therapy by other disease than UC.
* Prior use of any anti-TNF or other biologic or small molecule therapy.
* Rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenous corticosteroids).
Study to Evaluate the Safety, Tolerability, and Efficacy of SRP-9004 Administered by Systemic Infusion in Limb Girdle Muscular Dystrophy Type 2D/R3 Participants in the United States

The primary objective of this study is to evaluate the safety of SRP-9004.


Eligibility Criteria:
Key Inclusion Criteria:

* Ambulatory participants, defined as able to walk without assistive aid, 10MWR \<30 seconds, and NSAD total score ≥25; non-ambulatory participant, defined as 10MWR ≥30 seconds or unable to perform, and PUL 2.0 entry scale score ≥3.
* Ambulatory participants must be 4 to 20 years of age and the non-ambulatory participant must be ≥4 years of age.
* All participants must be ≤70 kilograms
* Possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic α-SG deoxyribonucleic acid (DNA) gene mutations as documented prior to screening.
* Able to cooperate with muscle testing.
* Participants must have adeno-associated virus (AAV) serotype Rh74 (rh74) antibody titers \<1:400 (that is, not elevated) as determined by an enzyme-linked immunosorbent assay (ELISA).

Key Exclusion Criteria:

* Left ventricular ejection fraction \<40% or clinical signs and/or symptoms of cardiomyopathy
* FVC ≤40% of predicted value and/or requirement for nocturnal ventilation
* Any other clinically significant illness, including neuromuscular (other than limb girdle muscular dystrophy type 2D/R3 \[LGMD2D/R3\]), that in the opinion of the Investigator might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability.

Other inclusion/exclusion criteria apply.
Implementation of Ultrasound Guided Central Venous Catheter Confirmation Protocol

The bedside use of ultrasound after central venous catheter (CVCs) insertion has lagged behind other applications in medicine, thus presenting an opportunity for innovative, evidence-based research that will influence clinician behavior. This research focuses on bedside ultrasound applications as an example, to evaluate clinical practice change. Chest radiographs are associated with delays in initiating time-critical interventions and present an unexamined opportunity for improving patient care by evaluating the use of ultrasound in lieu of chest radiographs after CVC insertion. Strategic interventions for implementation are needed to hasten the adoption of this clinical innovation (ultrasound guided CVC confirmation protocol) allowing them to de-implement chest xrays when no longer indicated.

The placement of central venous catheters (CVCs) is a common procedure performed in critically ill patients, with millions placed annually. The routine use of chest radiographs for CVC confirmation is outdated. Chest radiographs are associated with delays in initiating time-critical interventions and present an unexamined opportunity for improving resource utilization and associated costs. Radiography has been used for over 50 years for this purpose in the absence of other options. Emerging evidence suggests that a post-procedure chest radiographs are unnecessary when ultrasound is used to confirm catheter position and exclude pneumothorax (PCEP). Yet few in the medical community are likely aware of these data and even among those who are aware, chest radiographs continues to be the routine modality used for CVC PCEP.

The average 17 years it takes to translate clinical research into practice is too long and presents an opportunity to expedite implementation of innovations in critical care medicine. For the proposed project, "De-Implementation Of Routine Chest Radiographs After Adoption of Ultrasound Guided Insertion and Confirmation of Central Venous Catheter Protocol (DRAUP)", the hypothesis is that identifying determinants of behavior for intervention development (Aim 1) will increase the likelihood of developing successful strategies that will yield faster clinical adoption. Understanding the behavioral adaptations that have to occur is key to developing strategies that increase the uptake of evidence into healthcare practice and improving health outcomes. These strategies (targeting adoption and substitution) will then be implemented in a local Emergency Department (Aim 2) to determine if these selected implementation strategies will increase provider adoption, fidelity, and organizational penetrance (Aim 3) of ultrasound-guided CVC PCEP. A good clinical outcome would be a decrease in provider dependence on chest radiographs after ultrasound-guided CVC PCEP.

Eligibility Criteria:
Inclusion Criteria:

* have a clinical role in the placement and maintenance of central venous catheters

Exclusion Criteria:

-
My Body is Fit and Fabulous at School

In order to address and curb the high prevalence of childhood obesity in Malaysia, a school-based intervention program, MyBFF@school is developed for implementation in all schools in the country. The program is specific for overweight and obese students and it is hypothesized that by participating in this program, students will be able to control their body mass index.

A nationwide Nutrition Survey of Malaysian Children carried out between 2008-2009 among 3542 children aged from 6 months to 12 years showed a prevalence of 9.8% overweight and 11.8% obesity while in a more recent 2011 Global School-based Student Heath Survey showed that the percentage of overweight and obese Malaysian school children age 13-15 years old was 25.4% and 10.9% respectively . If left unchecked, these children will grow up to be obese adults, developed various obesity-related complications such as cardiovascular diseases, diabetes etc. Realising the urgent needs to address the problems, the Ministry of Health Malaysia with the cooperation of the Ministry of Education, proposed to implement MyBFF@school in all schools in Malaysia. Students participating in MyBFF@school will take part in a structured physical activity in the form of small sided football game (SSG), and are to attend intensified and interactive nutrition and psychology classes aimed at improving their knowledge, self-esteem and self-empowerment.

Eligibility Criteria:
Inclusion Criteria:

Classified as overweight and obese based on BMI of 85th percentile and above, according to WHO growth chart.

No medical conditions that could endanger their health when participating in MyBFF@school.

Obtained parental and assent consents.

Exclusion Criteria:

With either physical or mental disability. With medical condition that prevents him/her to participate in moderate-to-vigorous intensity physical activity.

With comorbidities that may interfere with the study such as diagnosed type 2 diabetes mellitus, hypertension, nephritic syndrome, epilepsy, congenital heart disease and skeletal anomalies.

On steroids, on anti-epileptics and on methylphenidate.
The Acute Burn Resuscitation Multicenter Prospective Observational Trial

This is a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Primarily, data collection will be continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. All aspects of the resuscitation and all investigations performed will be according to the participating center's regular protocol, as this is purely an observational and non-interventional study. Further data collection on outcomes (organ function, ventilation duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital discharge.

This is a prospective observational study with no intervention. Study sites have been selected to include wide cross-representation of resuscitation practices using crystalloids alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the timing of albumin initiation.

Detailed data will be continuously collected in "real time" during fluid resuscitation over the 1st 48 hours following a burn injury. Data collection during this phase will be done prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data collection will involve recording of resuscitation fluid volumes, urinary output, vital signs (heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ function, need for mechanical ventilation, hospital length of stay, and survival) will be collected at various time points during the subjects' acute care stay.

At completion of the study we intend to make the following comparisons:

1. Subjects that received crystalloids only compared to subjects that received crystalloids plus albumin.
2. Subjects that had albumin started "early" (\< 8 hours post burn), compared to subjects that had albumin started "intermediate" (8-12 hours post burn), compared to subjects that had albumin started "late" (\>12 hours post burn).
3. Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared to characteristics of resuscitation following initiation of albumin ("post albumin").

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* ≥ 20% TBSA burns
* Admitted to the burn center ≤ 12 post injury

Exclusion Criteria:

* Significant associated trauma
* High voltage (≥ 1000 volts) electrical burns
* Surgery anticipated within 48 hours from injury
* Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury
* Hypertonic saline (HTS) anticipated to be given at any time ≤ 48 hours from injury
* Hydroxyethyl starch (HES) anticipated to be given at any time ≤ 48 hours from injury
* High dose Vitamin C infusion is anticipated to be given at any time ≤ 48 hours from injury
* Death occurs or comfort measures are instituted within ≤ 48 hours from injury