cyrilzakka/clinical-trials huggingface dataset:
Creative Arts Therapy (CAT) in the Center for Cancer and Blood Disorders

The purpose of the study is to evaluate the effectiveness of Creative Arts Therapy (CAT) on pediatric patients undergoing chemotherapy in the Infusion Center at Children's Hospital Colorado Center for Cancer and Blood Disorders. Findings from a previous pilot study support the hypothesis that CAT may improve quality of life (QOL), resiliency, physical posture, and emotional response to pain of pediatric oncology patients undergoing chemotherapy.

A repeated measures design will be used with each patient serving as his/her own control. The subjects and/or parents will be tested with all instruments before the intervention, and approximately every 30 days for no less than 3 months and a maximum participation of 6 months. Treatment time points will be at least 30 days apart. Because some subjects are not scheduled to come into the clinic every 30 days for SOC appointments, they are unable to complete 3 sessions of CAT in a 3 month time period. For those subjects who are scheduled to come into clinic every 1-2 months for SOC appointments, study participation may take up to 6 months. This 6 month time period would allow for the completion of 4 different time points of CAT.

The testing will take place in an exam room after vital signs have been completed upon intake to the clinic. The trained research assistant, trained RN, or PI will administer the questionnaires. The PedsQL includes a subject report (ages 5 and over) and a parent report. The Resilience Scale is a self-report and will be used for ages 12 and over. The Faces Scale will use parent report for ages less than 5 and self-report for ages 5 and over. In order to confirm consistency, the posture measure will be completed by the PI (nurse practitioner) or registered nurse on the study after training with the manual included with the inclinometer tool.

Eligibility Criteria:
Inclusion Criteria:

* Center for Cancer and Blood Disorders (CCBD) patient with Oncology or Neuro-oncology diagnosis
* No more than 2 previous sessions of CAT as an outpatient in the CCBD
* English speaking
* Receiving outpatient chemotherapy, biotherapy, or transfusions in the infusion center approximately weekly for at least 3 months.
* Ages 3 to 18 years

Exclusion Criteria:

* Hematology or other patients in the infusion center
* Patients who have previously received more than 2 sessions of CAT in the infusion center
* Non-English speaking patients
Healthy Lifestyle Behavior Intervention for Latino Women

The overall goal of this randomized controlled trial is to evaluate the effects of a community-based lifestyle behavior intervention (LSBI) that is designed to improve dietary habits and physical activity (PA), and reduce weight of Latino women who are predominantly Spanish-speaking immigrants. It is hypothesized that middle-aged overweight/obese Latinas participating in a LSBI conducted by lay health advisors will demonstrate improved dietary habits, increased physical activity and a decrease in BMI compared to those in a control condition, Women in the LSBI also are expected to demonstrate improvements in selected physiologic outcomes (waist circumference, blood pressure \[BP\], measures of cholesterol and blood sugar).

Overweight/obesity and physical inactivity are two significant predictors of illness and death from cardiovascular (heart) disease (CVD) in Latina adults. These risk factors may be reduced or eliminated through prevention efforts that focus on heart-healthy diets, weight reduction, and PA. The purpose of this study is to compare the effects of a 6-month community-based lifestyle behavior intervention (LSBI) conducted by lay health advisors and a control condition (disaster preparedness and home safety program) on lifestyle behaviors -dietary habits and physical activity(primary outcome) and selected physiologic outcomes (secondary outcomes) i.e., BMI, waist circumference, blood pressure, measures of cholesterol,and fasting blood sugar of Latinas who are overweight/obese. The LSBI includes group education (8 classes) and individual teaching and coaching (8 contacts by home visits and telephone calls) delivered over a 6-month period. Acceptability and feasibility of the intervention is evaluated through examination of women's retention rates and participation in classes and home visits.

Eligibility Criteria:
Inclusion Criteria:

* Latina
* 35 to 64 years of age
* body mass index (BMI) \>25
* fluent in either Spanish or English.

Exclusion Criteria:

* pregnant or planning to get pregnant in next year
* history of myocardial infarction or stroke
* currently under treatment for cancer
* orthopedic or joint problems that would prohibit participation in physical activity
* insulin-dependent diabetes
Study to Analyze the Risk Factors Associated With Pertussis/Whooping Cough Infection Among Infants

This study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a United States (U.S.) commercially insured population. The study will utilize a large research data base associated with a geographically diverse U.S. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of DTaP vaccinations received prior to infection will also be reported.

This study will utilize the OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans to estimate the measureable demographic, clinical and historical economic risk factors that may be associated with medically diagnosed pertussis/whooping cough infection among commercially insured infants less than one-year of age. Healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough will be stratified by the number of DTaP vaccinations received prior to infection.

Eligibility Criteria:
Inclusion Criteria:

* Date of birth between July 1, 2005 and September 30, 2010.
* Enrollment in a commercial health plan within one month of birth.
* Known sex and geographic region.
* Infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria Infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control.

Exclusion Criteria:

• Enrollment does not include medical and pharmacy coverage.
Assessment of a Skin Barrier

This evaluation is being conducted to determine user perception of a new flat one-piece skin barrier compared to their normal barrier.

Design:

This is a multi-site, unblinded, historically controlled assessment of a one-piece flat skin barrier. Study barriers are CE-marked. Approximately 30 subjects are enrolled in the UK.

Eligibility Criteria:
Inclusion Criteria:

1. is at least 18 years of age.
2. has an ileostomy.
3. is at least six weeks postoperative.
4. lives and cares for their stoma independently in the community.
5. currently uses a Dansac Nova or NovaLife 1-piece flat skin barrier.
6. currently uses a drainable pouch.
7. is able to wear a 1-piece flat cut-to-fit 10-55 mm.
8. Has a peristomal skin irritation score of 2 or less.
9. is willing to follow the protocol as demonstrated by signing the informed consent and who in the opinion of the investigator is qualified to participate.

Exclusion Criteria:

1. has a fistula on or near the stoma.
2. has been involved in a study involving stoma care with in the last 30 days.
3. is pregnant or lactating, as determined by interview only.
4. is undergoing chemotherapy, radiation or steroid therapy.
5. has an existing medical condition that would compromise their participation in the study.
Have Physical Therapists Attitudes and Beliefs Towards Vital Assessment Changed Following the COVID-19 Pandemic?

Previous studies prior to the COVID-19 pandemic show that cardiovascular and blood pressure assessment by physical therapists is inadequate or lacking despite prior training. Since the COVID-19 pandemic, assessment of cardiovascular and respiratory function may become more critical as the manifestation of long COVID has become a concern. The purpose of this study is to determine whether physical therapists' attitudes and beliefs towards vital sign assessment have changed following the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

1. Must be a licensed Physical Therapist
2. Must be actively be involved in clinical practice
3. Must have ≥ 5 years of experience practicing in a clinical setting as a Physical Therapist

Exclusion Criteria:

(1) Did not provide informed consent
Meat Derivative and Satiating Compound Effect on Satiety

The purpose of this study is to evaluate the satiating effects of a meat derivative and a satiating compound on overweight subjects (BMI ≥25 and \<30 kg / m2).

A randomized, parallel, controlled and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of a meat derivate and a satiating compound in a group of healthy overweight subjects.

The investigators included 20 participants between 18 and 65 years (BMI ≥25 and \<30 kg / m2). All volunteers will be randomized into 3 study groups, and participants will receive the 2 study products during the 3 experimental phases.

Eligibility Criteria:
Inclusion Criteria:

* Men and women from 18 to 65 years old.
* Body Mass Index (BMI) ≥25 and \<30 kg/m2.
* Adequate cultural level and understanding for the clinical trial.
* Subjects willing to consume all food present in the brunch type meal.
* Signed informed consent.

Exclusion Criteria:

* Subjects with BMI ≥30 or \<25 kg /m2. Subjects with a vegetarian diet or with a great fiber consumption (\> 30 g/day)
* Subjects diagnosed with Diabetes Mellitus.
* Subjects with dyslipidemia on pharmacological treatment.
* Subjects with hypertension on pharmacological treatment.
* Subjects with hyper/hypothyroidism.
* Subjects with established diagnosis of eating disorder.
* Smokers or those subjects with high alcohol consumption (\> 2-3 servings/day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer).
* Subjects under pharmacological treatment (except oral contraceptives).
* Subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet.
* Subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients.
* Subjects with severe chronic diseases (hepatic, kidney, ...)
* Subjects with intense physical activity.
* Subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption.
* Subjects with a diagnosis of celiac disease or a gluten intolerance.
* Subjects who consume regularly oral supplements (i.e. omega-3)
* Pregnant or breastfeeding women.
* Women with menstrual irregularities (absence of menstrual cycle at least 2 months).
Adductor Under Sartorial Canal Catheter (KTT) Versus Femoral Catheter (KTF) in a Quick Rehabilitation Process After Total Knee Replacement

The main objective of this study is to show that postoperative Total Knee Replacement (TKR), an analgesic perineural catheter in position under sartorial (KTSS) best preserves motor quadriceps femoral perineural catheter that (KTF) infused with even low doses of local anesthetics, this motor being evaluated by a semi quantitative simple clinical test locking of the knee feasible at the bedside.

Patients will be randomized in two arms:

* catheter in position under sartorial (experimental group)
* femoral catheter (control group)


Eligibility Criteria:
Inclusion Criteria:

* Major Patient (≥ 18 years)
* Before tricompartmental benefit from knee replacement (TKR) unilateral,
* TKR programmed on one of the first three days of the week (Monday to Wednesday)
* Physical status score I-III,
* Non septic programmed surgery under general anesthesia
* Able to understand the protocol
* Written informed consent
* Social Insured
* Opportunity to be followed under the Protocol

Exclusion Criteria:

* Age ≥ 85 years
* Obesity (BMI ≥ 35)
* Revision TKR,
* Patients not cooperating or not including the French,
* Difficulties in understanding and evaluating the score pain (VAS),
* Preoperative cognitive dysfunction making unreliable interrogation
* Patient unable to read and / or write (literacy, ...)
* Known bleeding disorders,
* Vascular surgery for femoral vessels on the operated side,
* Neuropathy of the lower limb,
* Localized infection at the puncture catheters,
* Known allergy to ropivacaine,
* Renal and / or severe hepatic impairment,
* Taking opioids for more than a month before surgery,
* Intolerance to morphine,
* Rheumatic inflammatory disease,
* Patients receiving immunosuppressive therapy or long-term corticosteroid
* Allergy or against-indications to standard treatments administered intraoperative and postoperative
* Flexion deformity\> 10 ° or valgus deformity with significant
* Refused to participate
* Patient trusteeship, guardianship, deprived of liberty
* Women premenopausal who become pregnant
The Short-term Efficacy of Novel NTDP-RFA in the Treatment of Small HCC With Cirrhosis.

To evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Liver cancer is the fourth leading cause of cancer-related deaths globally. Hepatocellular carcinoma (HCC) accounts for 70% to 85% of primary HCC and is the leading cause of death in patients with cirrhosis. We developed a novel no-touch combined directional perfusion radiofrequency ablation system.By inserting two or more electrodes around the tumor and activating them simultaneously.The hypertonic saline solution can be directed into the focal tissue from a lateral pore through a tube within the electrode to provide more uniform and thorough necrosis.The maximum ablation volume was increased while the loss of normal tissue in the non-injection direction was reduced, thus reducing the incidence of postoperative complications. Therefore, the purpose of this study was to evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Primary hepatocellular carcinoma with a background of cirrhosis
* Single shot with diameter ≤ 3cm
* The tumor did not invade portal vein, hepatic vein trunk and secondary branches
* Child Pugh A/B
* ICG-R15 ≤ 30%
* 18-70 years old
* The follow-up time reached 2 years

Exclusion Criteria:

* The follow-up time is less than 2 years
* multiple lesions or diameter \> 3cm
* Previous history of upper gastrointestinal bleeding or severe hypersplenism
* Patients with extrahepatic or lymph node metastasis
* Wish to receive liver transplantation and hepatectomy
* The lesion is adjacent to the gallbladder, important blood vessels and bile ducts in the hilum of the liver and important organs around
* severe bleeding tendency, platelet count \< 50 × 10\^9/L, or prothrombin time prolonged \> 3s
* Other anti-tumor therapies were accepted before surgery
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.


Eligibility Criteria:
Inclusion Criteria:

1. At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 2019.

   1. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
   2. For the main analyses, only fixed dose combination (FDC) inhalers will be included.
2. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
3. At least one diagnosis of chronic obstructive pulmonary disease (COPD) at any time prior to or on the index date;
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs;
5. At least one record in the health insurance system database

Exclusion Criteria:

1. Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) in free or fixed form for one year prior to the index date;
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date (in a sensitivity analysis we will include patients with asthma);
Multicentre Study to Explore the Correlation Between Smoking Pattern and Clinical Efficacy of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Male Patients

The objective is to investigate the correlation between smoking pattern and clinical efficacy of EGFR TKIs in male patients with locally advanced or metastasized non-small cell lung cancer of adeno histology who have failed 1st line chemotherapy. Health care resource usage, quality of life (EQ-5D) and practice of EGFR mutation test will also be evaluated. Current practice of EGFR mutation testing in Taiwan will be surveyed.


Eligibility Criteria:
Inclusion Criteria:

* Male patients age 20 years or older
* Histological or cytological confirmation of NSCLC of adeno histology. If sputum is the only available sample, a second positive test is necessary for cytological confirmation
* Locally advanced or metastatic on or after first-line chemotherapy. Imaging evidence of disease progression can be either chest X ray, CT or MRI assessment on measurable lesions. If no measurable lesion is available, evaluable lesions are acceptable
A Study of LY900014 in Participants With Type 2 Diabetes Mellitus

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 and 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
* Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
* Have a glycated hemoglobin (HbA1c) less than (\<)9.0 percent (%)
* Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria:

* Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Have a history of renal impairment
* Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
* Have proliferative retinopathy or maculopathy and/or severe neuropathy
National Pregnancy Registry for Psychiatric Medications

The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.

The overarching objectives of the National Pregnancy Registry for Psychiatric Medications are twofold: to assess risk for malformations among infants exposed to specific psychiatric medications and to assess neonatal outcomes associated with prenatal exposure to such medication. Specifically, the Registry will allow us to prospectively determine whether exposure to psychiatric medication is associated with any increased risk for major malformations above the baseline risk noted in the general population. This will be achieved by careful systematic documentation of medication exposure during pregnancy, as well as other relevant exposures often not included in small case series or published reviews of drug safety derived from large administrative databases.

Although psychiatric medications are widely used by reproductive age women, reliable data regarding the reproductive safety of many of these compounds is limited. As a result, clinicians often lack sufficient evidence to evaluate the risks and benefits of using medications to treat psychiatric disorders during pregnancy. The National Pregnancy Registry for Psychiatric Medications is one of the first, and largest, hospital-based pregnancy registries which will systematically and prospectively monitor pregnancy outcomes after exposure to psychiatric medications, including antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics.

Primary Aim:

To prospectively evaluate rates of congenital malformations among infants exposed in-utero to psychiatric medications.

Secondary Aims:

1. To evaluate neonatal outcomes of infants with prenatal exposure to specific psychiatric medications alone or in combination with other psychotropics.
2. To evaluate maternal health outcomes associated with use of psychiatric medications during pregnancy.
3. To evaluate neurobehavioral development of children (1 month and older) with prenatal exposure to psychiatric medications.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Age 18-45
* Subjects will be willing to participate over the phone
* Subjects will be able to provide informed consent

Exclusion Criteria:

* Women who have completed their pregnancy
* Women who are planning to become pregnant
* Women who are not taking any psychiatric medications and/or have no history of psychiatric illness
Molecular Signatures of Cutaneous Squamous Cell Carcinoma During Recessive Dystrophic Epidermolysis Bullosa

Recessive dystrophic epidermolysis bullosa (RDEB) is a hereditary skin disease characterized by cutaneous and mucosa fragility. Blister formations and erosions, resulting in chronic wounds and dystrophic scars, lead development of aggressive cutaneous squamous cell carcinoma (cSCC) in young subjects. cSCC in RDEB patients are often recurrent and sometimes aggressive. Although fibrotic and inflammatory microenvironment plays an important role in the tumoral process, specific mechanisms in cSCC of RDEB patients are still unknown. Actually, the only treatment is a wide surgical excision with poor prognostic (80% of death after the first occurrence of cSCC).

The objective of the study is to describe the molecular signatures in the cSCC in RDEB patients


Eligibility Criteria:
Inclusion Criteria:

* for RDEB patients with a SCC :

  1. aged older than 18 years old
  2. one or more SCC surgically treated
  3. signed genetic consent form
* for non-RDEB patients with a SCC induced by ultraviolet radiation :

  1. aged older than 18 years old
  2. one or more SCC induced by ultraviolet radiation
  3. signed genetic consent form

Exclusion Criteria:

* under protection by law (tutorship or curatorship)
* without health insurance coverage