cyrilzakka/clinical-trials huggingface dataset:
Quality of Life Among Children and Adolescents With Cancer

This descriptive study aims to allow children and adolescents who have cancer to self-evaluate their quality of life. It is hypothesized that treatment affects quality of life in the areas of physical and social functioning. It is further hypothesized that these effects dissipate within 6 months after treatment is completed.

Study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the Hematology/Oncology Clinic at the CMHC, which will serve as the study site. These individuals will be identified by the health care professionals working in the clinic. Specific study criteria will include only those individuals who (1) can read or write in the English language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the Clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. The weekly list of appointments will be reviewed by the researchers who already work in the Clinic for appropriateness (JH, JB and KS). To prevent participation coercion, solicitation for participation will be provided through the Child Life Specialist (CLS). The CLS is known to each participant and will function as a data collector for this study.

Eligibility Criteria:
Inclusion Criteria:Study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the Hematology/Oncology Clinic at the CMHC, which will serve as the study site. These individuals will be identified by the health care professionals working in the clinic. Specific study criteria will include only those individuals who (1) can read or write in the English language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the Clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. -

Exclusion Criteria: (1) Those electing not to participate; (2) those with no guardian available to consent or (3) those not yet diagnosed with a cancer condition.

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Transcutaneous pO2, Transcutaneous pCO2 and Central Venous SO2 Variations to Define Fluid Responsiveness

Fluid challenge is often carried out in critical ill patients. Its responsiveness usually requires invasive monitoring. To use non-invasive methods is very tempting. Investigators hypothesize that transcutaneous pO2,transcutaneous pCO2 and Central Venous SO2 variations provide feasible estimation on fluid responsiveness in critical ill patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older ICU patients;
* Septic shock;
* Monitored with PICCO or Swan-Ganz catheter;
* The decision of fluid challenge made by the treating physician;

Exclusion Criteria:

* Evidence of fluid overload;
* Pregnancy
Efficacy and Safety of Olmesartan Associated With Chlorthalidone Versus Benicar HCT® in Essential Hypertension Control

The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the essential hypertension control.


Eligibility Criteria:
Inclusion Criteria:

* Signed Consent of the patient;
* Participants with decompensated essential hypertension, classified into stage 1 (with high or very high cardiovascular risk), stage 2 or stage 3 according to the Brazilian Society of Cardiology (2010), who are being treated with monotherapy.

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator opinion can not participate in the study;
* Secondary hypertension diagnosis or blood pressure above 190x100 mmHg in the screening/randomization visit;
* Morbid obesity or immunocompromised patients;
* Participants with greater than 10 mmHg difference in the measurements of systolic or diastolic blood pressure between the two arms;
* Participants who do not have the two upper limbs;
* Participants with important electrocardiographic changes;
* Creatinine clearance - less than 60 mL / min;
* History of hypertensive emergencies and cardiovascular and / or moderate to severe cerebrovascular events in the past 6 months;
* Microalbuminuria urine sample greater than 30 mg/g;
* Patients with history of hypersensitivity to any of the formula compounds;
* Pregnancy or risk of pregnancy and lactation patients;
* Participation in clinical trial in the year prior to this study;
Marijuana for HIV-Related Peripheral Neuropathy

To evaluate whether smoked marijuana reduces pain in people with HIV-related peripheral neuropathy.

The study will include subjects with peripheral neuropathy caused either by HIV-disease or antiretroviral medication for the treatment of HIV. A neurologist will conduct a neurological and pain evaluation to determine eligibility for the study. Subjects who meet all eligibility criteria will be admitted to the General Clinical Research Center at San Francisco General Hospital for seven days. Subjects will be randomized (like a toss of a coin) to smoke marijuana or a placebo (cigarettes with no THC).

Eligibility Criteria:
INCLUSION CRITERIA:

* HIV positive.
* Be 18 years or older.
* Diagnosis of HIV-related painful neuropathy.
* Stable antiretroviral therapy or no antiretroviral therapy for at least 8 weeks.
* Prior use of marijuana, at least 6 occasions in their lifetime prior to enrollment.

EXCLUSION CRITERIA: (Not allowed)

* Current use of smoked tobacco products.
* Current methadone treatment.
* Use of smoked marijuana within 30 days of enrollment.
* Diagnosis of diabetes mellitus.
* Currently receiving treatment with corticosteroids.
* Use of INH, dapsone or metronidazole within 8 weeks prior to enrollment.
* Severe heart disease, uncontrolled high blood pressure or lung disease.
* Women who are pregnant or breastfeeding.
Safety and PK Study of BIBF 1120 in Japanese Patients With IPF

To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment.

To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone background treatment.

To assess pharmacokinetics of pirfenidone in Japanese patients, alone and in combination with BIBF 1120 treatment.


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of idiopathic pulmonary fibrosis (IPF) according to American Thoracic Society (ATS) /European Respiratory Society (ERS) guideline
2. Forced vital capacity (FVC) 50-90%
3. Diffusing capacity for carbon monoxide (DLCO) 30-79%
4. For patients on pirfenidone, have been on a steady dose for at least 3 months

Exclusion criteria:

1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 1.5 x upper limit of normal range (ULN) at screening.
2. Bilirubin \> 1.5 x ULN at screening.
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC \<0.7) at screening.
4. Continuous oxygen supplementation.
5. Active infection at screening or randomisation.
6. Being treated with any of the following concomitant medications.

   * Oral corticosteroid medication at unstable dose
   * ketoconazole or atazanavir
7. Patients who are expected to go on to lung transplantation, have rapidly deteriorating disease, or have a life expectancy less than 3 months from screening
a Clinical Risk Score to Predict Bloody Stool in Neonates

Bloody stool is a main focus in non-neonatal intensive care unit ward, and it is one of the risk factors in neonates with subsequent necrotizing enterocolitis(NEC) and usually lead to longed duration of hospitalization.

NEC is one of the most serious disease in the newborn infants, and two and more grades of NEC might lead to surgery, even death. But, it is difficult to predict when the bloody stool comes and develop to two and more grades of NEC.

NEC is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.

Bloody stool in newborn infant is a urgent condition, and neonatologist usually need to predict whether or not two and more grades of NEC it is.

Here, the investigators will develop a score system in one retrospective cohort to predict bloody stool, and the score system is validated in another prospective cohort.

Eligibility Criteria:
Inclusion Criteria:

* more than or equal to 35 weeks' gestational age(GA)
* less than or equal to 28 days
* non-neonatal intensive care unit ward

Exclusion Criteria:

* parents' rejection
* main congenital malformation
Palliative Care Yields Cancer Wellbeing Support

The goal of this study is to evaluate the effectiveness of a programme for transitional palliative cancer care (Pal-Cycles) in seven countries (the Netherlands, Germany, United Kingdom, Hungary, Poland, Romania and Portugal) and its consequent effects on the number of readmissions into hospital.

The main hypothesis for the study is: that fewer people in the intervention arm of the study will require hospital re admission than those having usual care.

Participants will be asked to fill in questionnaires regarding their quality of care and quality of life.

The study described in this protocol, a stepped wedge clinical trial, is part of a larger research project named: The Palliative Care Yields Cancer Wellbeing Support Programme (Pal-Cycles). The aim is to test and evaluate the implementation of the Pal-Cycles intervention, by implementing it in 14 care setting across seven European countries (the Netherlands, Germany, United Kingdom, Poland, Hungary, Romania and Portugal.) The primary focus of the evaluation will be on measuring the effect of the Pal Cycles intervention using the number of patients being readmitted into hospital after they had transferred to community care in comparison with patients receiving usual care. Additional relevant outcomes will also be gathered and analysed such as: the patient's quality of life, the experience from the family carer and the experience from the healthcare professional. Finally, an economic analysis will be embedded in the stepped wedge design.

The goals of the overarching research project are as follows:

1. To develop, implement and evaluate a transitional palliative cancer care intervention, with an intervention (the Pal-Cycles intervention) that aims for a smooth transition from the hospital to community-based care in the final months of life.
2. Adaptation of the transitional palliative cancer care intervention for patients with advanced cancer for its implementation in seven European countries within the project.
3. Training of oncologists in identifying patients with palliative care needs, establishing collaboratively comprehensive treatment and care plans, delivering patient-centred communication around discharge planning, advance care planning, and end-of-life care.
4. A clinical trial using a stepped wedge design will be implemented in fourteen care settingsacross seven European countries.
5. An implementation support intervention will guide the implementation of the clinical trial in all settings and will investigate barriers and opportunities for implementation and provide tailormade solutions where needed.
6. Dissemination of project results.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or above
* Patients diagnosed with advanced cancer
* Patients that are expected to develop or already may have palliative care needs
* Patients who are in transition from curative (hospital) to palliative care (community care)

Exclusion Criteria:

* People with cancer unable or unwilling to provide consent to participate in the study
A Safety and Efficacy Study of Estradiol Vaginal Capsule in Postmenopausal Women With Vulvovaginal Atrophy

This study will access the safety and efficacy of three doses of estradiol vaginal capsules in postmenopausal women with vulvovaginal atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of vulvovaginal atrophy due to post menopause
* Age ≥ 40 years or if bilateral oophorectomy ≥ 35 years
* Moderate to severe vaginal dryness
* Normal breast exam; if \> 40 years
* Vaginal pH \> 5.0
* \< 5% superficial cells on vaginal wall cytology smear

Exclusion Criteria:

* Known hypersensitivity to estrogen and/or progestin therapy
* Known or suspected premalignant or malignant disease
* Undiagnosed abnormal genital bleeding
* A history of or treatment for significant cardiovascular disease, congestive heart failure, or stroke
* Active or known protein C, protein S, or antithrombin deficient, or other known thrombophilic disorders or thromboembolic events
* Increased frequency/severity headaches with estrogen therapy
* Smokes ≥ 15 cigarettes/day
Topical Agents Containing Magnesium Sulfate & Wound Healing in the Rat Model

An experimental study examining wound healing in 5 different groups on 30 rats.

Magnesium topically increases collagen synthesis and angiogenesis, providing faster and higher quality wound healing. In addition, with its analgesic effect, it will also eliminate the pain sensation caused by the wound and increase the quality of life of the patient whose skin integrity is impaired.

Eligibility Criteria:
Inclusion Criteria:

* healthy rats between ages of 8- 12 weeks

Exclusion Criteria:

* weight loss of more than 15% of body weight
Evaluation of Long-Acting Injectable (LAI) and Teen Clubs in Adolescents (ATTUNE).

This is a 2-stage study assessing the effect of peer navigation (support from peers) and long-acting injectable antiretroviral therapy (ART) on viral suppression and retention in care among adolescents living with HIV and receiving care in South Africa.

This study aims to deploy peer-navigated support (psychosocial support, HIV education, appointment reminders, adherence support, sexual and reproductive health, and healthcare navigation) to facilitate viral suppression and retention in care as adolescents living with HIV transition into adult care. The study population includes adolescents from South Africa aged 12 to less than 19 years, living with HIV, aware of their HIV status and receiving ART for at least six months.

In Stage 1, the peer navigation intervention in a stepped-wedge, cluster-randomised trial implemented over 18 months in three 6-month steps across 12 clinics will be evaluated. In addition, during Stage 1, user and key stakeholder preferences will be evaluated for the uptake and use of long-acting injectable ART, perform a costing and economic analysis and a program evaluation of the public health impact of the intervention. In Stage 2, an individually-randomised trial will be nested in a subset of clinics to evaluate long-acting injectable ART in adolescents with HIV.

The study procedures include a peer navigation intervention in Stage 1, alongside a user and key stakeholder preferences evaluation for the uptake and use of long-acting injectable ART and a cost and economic evaluation.

The study duration is three years (about 7 visits). The stepped-wedge trial will be implemented in the first 18 months, after which participants will be followed for an additional 18 months to assess the sustainability of the intervention. The nested individually-randomised trial of long-acting ART will be conducted during the second 18-month period.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 12 - 19, at enrolment
* Living with HIV
* Aware of their HIV status
* Receiving ART for at least six months
* Able to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
* Willing and able to consent to study activities
* Willing and able to get parental consent for study activities
* (Stage 1, objective 2 only) Age ≥ 18 years and Caregiver of an adolescent with HIV
* (Stage 1, objective 2 only) Age ≥ 18 years and provides clinical services or is a policy maker involved in adolescents with HIV

Exclusion Criteria:

* Inability to read and/or speak English, isiZulu, Sepedi, Afrikaans, Xhosa, or Sesotho
* Severe mental or physical illness preventing participation in informed consent activities.
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer

This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced head and neck squamous cell carcinoma
* oral cavity, oropharynx, hypopharynx, larynx
* measurable lesion
* unresectable
* age 18 or more
* ECOG 0 or 1

Exclusion Criteria:

* distant metastasis
* pregnancy
* prior chemotherapy or radiation therapy
* 2ndary malignancy
* other unfit medical condition
Safety of Allogeneic Hematopoietic Cell Transplantation (HCT) For Patients With Classical Hodgkin Lymphoma (CHL) Treated With Nivolumab

An observational database analysis, using existing data of patients diagnosed with Classical Hodgkin Lymphoma.

This study will include a retrospective and prospective observational database analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to18 years;
* First allogeneic HCT for cHL;
* Patients with prior autologous HCT for cHL;
* Any conditioning regimen, graft source or donor type.
* For the primary analysis additional criterion includes prior exposure to nivolumab for treatment of cHL immediately prior to the allogeneic HCT, as defined as nivolumab used alone or in combination with other agents and used as the last line of therapy prior to an allogeneic HCT with the interval between the last dose of nivolumab and start of the conditioning regimen no longer than 12 months.

Exclusion Criteria:

* Patients with nodular lymphocyte-predominant HL
* Previous chimeric antigen receptor T-cell therapy or other genetically modified cellular product
Effect of Micronized Creatine Monohydrate on Muscle Mass, Strength and Performance in Older Adults Submitted to Total Knee Arthroplasty

Double-blind randomized placebo-controlled clinical trial with two parallel arms. The main objective is to evaluate the efficacy and safety of creatine supplementation in older adults who have been operated on for total knee arthroplasty and undergoing a usual rehabilitation program. The intervention will consist of daily creatine monohydrate supplementation for 12 weeks. The intervention will start after surgery with a loading dose of 20g/day for 1 week and then continue with a maintenance dose of 5g/day for 11 weeks.

Main outcome mesures included muscle mass, muscle strenght, sarcopenia, frailty, functional capacity and physical performance and will be assessed at baseline, 3 and 6 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Persons 65 years of age or older who have been operated on for the first time for total knee arthroplasty,
* who are undergoing an outpatient rehabilitation program according to standard clinical practice,
* who sign the informed consent form.

Exclusion Criteria:

* Chronic renal disease at stage G3b or higher or glomerular filtration rate \<30 ml/min/1.73m2.
* Hepatic insufficiency, cirrhosis.
* Neuromuscular and neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, Parkinson's disease, etc.).
* Severe or very severe chronic obstructive pulmonary disease (COPD) (GOLD III-IV).
* Moderate or severe chronic heart failure (NYHA 3-4).
* Central sensitivity syndrome (fibromyalgia and chronic fatigue syndrome).
* Moderate or severe cognitive impairment (GDS≥4).
* Moderate-severe dependence for basic activities of daily living (preintervention Barthel index \<60 points).
* Hemiparesis, amputation or malformation of any limb.
* Consumption of creatine monohydrate supplements in the last 6 months.
Chronic Ankle Instability and Proprioception

The purpose of this investigation is to determine the effects of chronic ankle instability on cervical spine and knee proprioception as measured using joint position sense to investigate whether correlation can be drawn between the two.


Eligibility Criteria:
Inclusion Criteria:

* History of ankle instability
* Ages 20-65 yoa Exclusion Criteria: - Recent surgery, have any unstable or fused joints of the cervical spine.
* Medications, prescription or herbal muscle stimulants, relaxants.
* Any previ
Project ABLE:Advancing Better Living for Elders

The specific aims of the study are to: 1) test the effectiveness of a home-bases intervention to improve home safety, fall efficacy and functional performance; 2) determine if the use of environmental strategies results in occurrence of less negative health events (falls and depression); 3) compare types of environmental strategies accepted and used under different treatment conditions; and 4) evaluate the cost-effectiveness of the intervention program.


Eligibility Criteria:
Inclusion Criteria:

* 70 years or older
* community dwelling
* functional vulnerability/HRCA vulnerability index= \>1 problem area

Exclusion Criteria:

* Mini-Mental Status Examination (MMSE) score of less than or equal to 23
* legal blindness
* bed bound
* nursing home placement or relocation expected within 12 months of study eligibility
The Effect of Simulation Method on Nursing Students' Burn Patient Care Planning

Aim: This research was conducted as a single-blind randomized control group intervention trial to determine the effectiveness of simulation method performed using high-fidelity human patient simulator in nursing students' burn patient care planning.

Materials and Methods: The research was carried out with randomly-selected 61 students including 31 in intervention and 30 in control groups who took the Surgical Diseases Nursing Course in the spring term of the 2017-2018 academic year. The research data were collected using "Personal Information Form", "Cognitive Level Assessment Test for Burn Patient Care", "The Student Satisfaction and Self-Confidence in Learning Scale", "Simulation Design Scale", "Educational Practices Questionnaire", and "Evaluation Form for Burn Patient Care Plan". In the application process of the research, knowledge tests were administered as a pretest, second test, and posttest, and first and second applications of burn patient care plans were performed with all students. In the research, the application of burn patient scenario was performed only with the intervention group. Descriptive statistics, Chi-Square, Mann-Whitney U Test, and Wilcoxon Sign Test were used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the course
* Had not taken this course and any training on burn patient care before
* Accepted to participate in the research

Exclusion Criteria:

* Have any records of absence
* Taken this course and training on burn patient care before
* Graduate of health vocational high school