cyrilzakka/clinical-trials huggingface dataset:
Treatment of Chemotherapy-induced Nausea and Vomiting

Delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. This study wants to compare standard prophylactic anti-emetic therapy with the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend will reduce nausea and vomiting.

A single centre randomized placebo-controlled phase II-study with a random assignment to experimental (EXP) or control (CTR) group. All patients with lymphoproliferative diseases ≥18 years of age, scheduled for myeloablative therapy before autologous stem cell transplantation at the Akademiska University Hospital in Uppsala, Sweden, will be included consecutively during one and a half year. A total of 90 patients (45 per treatment arm) will be accrued for this study. They will be invited by mail to participate in the study a couple of weeks before hospital entry. A random assignment to EXP or CTR will be performed by research nurses not participating in any other way in the study. Patients will be stratified for diagnosis which also means myeloablative therapy (lymphoma (BEAC) or myeloma (high-dose melphalan)), and the groups are expected to be similar in size. One box for each diagnosis (lymphoma and myeloma) will contain equal numbers of randomisation cards for the experimental and control groups, randomly mixed within each box. Cards will be picked consecutively by a research nurse not otherwise involved in the study. The EXP group will receive aprepitant (EMEND®) in combination with standard anti-emetic treatment and the CTR group will receive standard anti-emetic treatment. All treatment will be given in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Able to communicate in Swedish
* Diagnosis of lymphoproliferative disease
* Scheduled for myeloablative therapy and autologous stem cell transplantation
* Written informed consent
* Able to swallow oral medications

Exclusion Criteria:

* Nausea at baseline (immediately before start of chemotherapy)
* Gastrointestinal obstruction or active peptic ulcer
* Current illness requiring chronic systemic steroids or requirement for chronic use of antiemetic agent(s)
* Hypersensitivity to any component of the study regimen
* Pregnancy or nursing
* Unrelenting hiccups
* Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
* Psychiatric illness or multi-system organ failure
* Hepatic insufficiency with ASAT, ALAT three times over reference value
* Renal insufficiency with creatinin value three times over reference value.
Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children

The purpose of this study is to improve overall survival while maintaining a good quality of life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas, supratentorial PNETs, ependymomas WHO grade II and III). Response to different chemotherapy options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a multimodal therapy will be assessed. Progression-free, overall survival and toxicity will be evaluated additionally.

Parts of the study:

P-HIT-REZ-2005: a trial for the treatment of relapsed PNETs (medulloblastomas,supratentorial PNETs)

E-HIT-REZ-2005: a trial for the treatment of relapsed ependymomas (Phase II-Study with temozolomide)

Phase II-Study: intraventricular therapy with etoposide in neoplastic meningitis in relapsed PNETs and ependymomas with subarachnoid tumor manifestation (window study)

Eligibility Criteria:
Inclusion Criteria:

Disease Characteristics

* Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma
* Refractory or relapsed disease
* Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid Patients characteristics
* Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40%
* Life expectancy ≥ 8 weeks

Hematological:

* Absolute leukocyte count ≥ 2.0 x 10\^9 /l
* Hemoglobin ≥ 10g/dl
* Platelet count ≥ 70 x 10\^9/l

Renal:

* Creatinine no greater than 1.5 times UNL
* No overt renal disease

Hepatic:

* Bilirubin less than 2.5 times UNL
* AST and ALT less than 5 times UNL
* No overt hepatic disease

Pulmonary:

* No overt pulmonary disease

Cardiovascular:

* No overt cardiovascular disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection Prior concurrent therapy
* More than 2 weeks since prior systemic chemotherapy
* More than 4 weeks since prior radiotherapy
* No other concurrent anticancer or experimental drugs Examinations required
* Examination of lumbar CSF
* Cranial and spinal MRI within 14 days prior to start of treatment
Mindful Steps 2.0: Promoting Physical Activity in Patients With COPD and HF

The goal of this fully-remote randomized controlled trial is to test the efficacy of Mindful Steps in facilitating physical activity compared to usual standard of care among 136 patients with COPD and/or HF. The main question it aims to answer is can this intervention promote physical activity as measured by daily step counts in sedentary patients with COPD and/or HF. Participants will be randomized (1:1 ratio) to receive either the Mindful Steps intervention or usual care for 12 months, with both arms receiving a Walking for Health education booklet.

This is a 2-arm parallel remotely delivered RCT. A total of 136 participants with COPD and/or HF will be randomized in a 1:1 ratio to one of 2 arms in a pragmatic design: 1) Mindful Steps multi-modal intervention, or 2) usual care (including an education booklet on walking). Subjects will participate in the intervention for 12 months. Testing will occur at baseline, 3, 6, 12 (end intervention), and 15 months (post-intervention follow up) for all participants. Physical activity as measured by pedometer (i.e., daily step counts) at 12 months is the primary outcome to assess the efficacy of the Mindful Steps intervention. Secondary outcomes include cognitive-behavioral measures that may relate to behavior change in a conceptual model (self-efficacy, intrinsic motivation, mindful awareness/interoception) as well as patient-centered clinical outcomes (HRQL, dyspnea, fatigue, PA engagement, sedentary behavior).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD (defined as cigarette smoking history \> 10 pack-years, and either a ratio of FEV1 to forced vital capacity \< 0.70 or chest CT evidence of emphysema) OR clinical diagnosis of HF syndrome (with left ventricular systolic dysfunction or preserved ejection fraction and New York Heart Association Class 1-3)
* Medical clearance from provider to participate in an exercise program
* Have an active email account; access to a computer device (desktop, laptop, tablet, or smartphone that supports the Fitbit app).

Exclusion Criteria:

* COPD or HF exacerbation in the previous month
* Inability to ambulate
* Inability to collect at least 7 of 14 days of baseline step counts
* Current participation in a cardiac or pulmonary rehabilitation program
Measurement of Adherence to ART in HIV-Infected Children in Uganda (The CHARTA Study)

This study will compare methods of determining whether HIV-infected children take their medications.

HIV is a virus that weakens people's immune systems and can cause AIDS. Antiretroviral therapy (ART) is a treatment for HIV that combines different types of antiretroviral medications, but it must be taken throughout a person's life without missing doses to be effective. When people do miss doses, the HIV virus has an opportunity to develop resistance to the medications, making them less effective in the future. Reports indicate that as many as 50% of children infected with HIV who are living in resource-limited countries regularly miss doses of their ART. This study will test different methods for determining children's rates of adherence to ART medications. This will both define the exact magnitude of the problem and direct future efforts in increasing ART adherence in children.

Participation in this study will last 12 months. All children enrolled will undergo a series of assessments of medication adherence. At baseline and every month over the course of the study, researchers will make unannounced home visits to measure the amount of medicine that remains untaken by participants and to record how many times the electronic cap on participants' medication bottles have been removed. Participants with cell phones will also receive monthly phone calls during which they will be asked to measure the amount of their medicine that remains untaken. At study entry and after 6 and 12 months, researchers will also examine child participants' medical records and the results of their regularly scheduled blood tests. At these blood tests, an additional half teaspoon of blood, which may be used in future testing, will be collected and stored by the researchers. After 3, 6, 9, and 12 months, researchers will request to collect hair samples from child participants to test levels of HIV medications in the hair, but participation in this part of the study is optional.

Assessments of reasons for medication adherence will also be performed. At study entry and after 3, 6, 9, and 12 months, children and their parents will complete questionnaires about their understanding of HIV medicines and HIV infection, motivation for the child to take medications, behaviors related to taking medications, and basic personal information. One and 7 months after study entry, some parent participants will also complete interviews with study staff about giving HIV medicines to their children.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Receiving highly active antiretroviral therapy (HAART) through the Children's HIV/AIDS Care Clinic
* Resident in the Mbarara district, defined as living within 30 km or a 2-hour driving radius of the city of Mbarara
* Plans to stay within the Mbarara district for the next year

Exclusion Criteria:

* Attendance at a boarding school
A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Objective:

The overall objective is to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation and whether it promotes tolerance.

3.2 Research question

Is it possible to avoid the use of corticosteroids in pediatric liver transplantation?

3.3 Trial objectives

This will be a pilot study to

i) investigate to what degree a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation

ii) investigate the effect of a steroid free immunosuppressive regimen on lymphocyte function and donor-specific immune responsiveness following pediatric liver transplantation

iii) investigate the effect of a steroid free immunosuppressive regimen on expression of tissue markers of tolerance following pediatric liver transplantation

It is hoped that this pilot study will be used to develop a definitive multicentre study of a steroid free regimen.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing primary isolated hepatic transplantation.
* Age \<=18 years
* Ability to provide informed consent

Exclusion Criteria:

* Children undergoing retransplantation.
* Transplantation for Intestinal failure associated liver disease.
* Multi-organ transplantation.
* Transplantation for autoimmune liver disease.
* Transplantation for extra hepatic malignancy.
* Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants

The main purpose of this study is to evaluate the effect of Pirtobrutinib (LOXO-305) on multiple oral doses of digoxin (P-gp substrate) when administered as single and multiple doses by collecting the blood samples and conducting the blood tests to measure how much digoxin is in the bloodstream and how the body handles and eliminates it in healthy participants. The study will also evaluate the safety and tolerability of Pirtobrutinib. Participants will stay in this study for up to 58 days, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must have comply with all study procedures, including the 20-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening
* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening or Check-in (Day -1)
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
* Have previously completed or withdrawn from any other study investigating Pirtobrutinib (LOXO-305) and have previously received the investigational product
Antithrombotic Effects of Ticagrelor Versus Clopidogrel

The purpose of this study is to determine whether treatment with ticagrelor (plus aspirin and bivalirudin) is more effective than treatment with clopidogrel (plus aspirin and bivalirudin).

The HORIZONS-AMI Trial compared the effectiveness of heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) versus bivalirudin in acute myocardial infarction (AMI) patients undergoing stent deployment 1. Overall the data showed benefits associated with the bivalirudin treatment with lower rates of all-cause mortality, cardiac mortality, re-infarction and non-CABG related major bleeding; However, the data seems to indicate a non-significant increase in acute stent thrombosis in the bivalirudin group. This observation seems to suggest the potential benefits of adding an antiplatelet agent to bivalirudin. A study by Dangas G et al found that in the HORIZONS-AMI patients, the group receiving 600 mg loading-dose of clopidogrel had significantly lower 30-day unadjusted rates of mortality, reinfarction and stent thrombosis than the 300 mg loading-dose group, without increase in bleeding rate. Furthermore, even though the benefits of bivalirudin were independent of the clopidogrel loading dose; the 600mg LD was associated with more benefits with both anticoagulation regimens. Similar observations have been reported in the ARMYDA-6 MI study.

It is our hypothesis that using ticagrelor instead of clopidogrel, given its more potent and faster activity, would have greater antithrombotic activity and therefore may reduce the rate of acute stent thrombosis when administered in combination with bivalirudin + ASA in AMI patients. To investigate this hypothesis, we will compare the antithrombotic effects of ticagrelor with clopidogrel, when administered in combination with ASA and bivalirudin, in healthy human volunteers using a cross-over study design. The antithrombotic activity will be assessed pre-treatment and 2-hours and 24-hours post treatment, using methodologies including Badimon Perfusion chamber, VerifyNow P2Y12 assay, platelet aggregation with Multiplate Analyzer and Thromboelastography.

Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers between 18 and 65 years old.
* Body mass index (BMI) 18 - 30 kg/m2 inclusive.
* Healthy as assessed by a detailed medical history and physical examination.
* Laboratory est results within the normal range.
* Ability to provide signed informed consent.

Exclusion Criteria:

* History of clinically relevant disease, bleeding, acute infectious disease or signs of acute illness.
* Allergy or hypersensitivity to aspirin or thienopyridines, or atopy diagnosed by a physician.
* Use of medication within one month prior to study drug administration.
* History of drug abuse or alcohol consumption \>20 g/day.
* Inability to abstain from intensive muscular effort or sport competition.
* Loss of \>400 mL blood or blood donation within 3 months.
* Positive serology for hepatitis B (HBs Ag) or hepatitis C.
* Conditions associated with hemorrhagic risk.
* Positive pregnancy test.
Observational Study - ILM Peeling

This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Epimacular Gliosis
* Must be scheduled for ILM-peeling independently of study
* Must be older then 18 years of age

Exclusion Criteria:

* Visual acuity \> 0,4 logMAR (\< 20/50 EDTRS)
* Other ophthalmological disorder affecting visual acuity and/or visual field and/or retinal structure
Art Therapy and Music Reminiscence Activity in the Prevention of Cognitive Decline

The objective of this study is to determine the impact of Art Therapy and Music Reminiscence Activity on cognition in community living elderly with Mild Cognitive Impairment (DSM V: Mild Neurocognitive Disorder) using a randomized control design.

Specifically, the structural cerebral changes that occur with the two interventions and the extent to which the therapies may reverse cognitive impairment and/or prevent further cognitive decline, will be determined.

The hypothesis is that participants in both active intervention arms will perform better on neuropsychological tests of cognition and will show positive changes on functional imaging studies compared to controls who will not receive any intervention. Participants in the interventions will also have positive changes in blood biomarkers, enhanced psychological well-being and reductions in anxiety and depressive symptoms compared to the control group. No a priori hypotheses were developed as to whether Art Therapy or Music Reminiscence Activity is more effective as the comparison is exploratory.

Participants: 90 community-living elderly, with mild cognitive impairment.

Interventions: Participants will be randomized into 3 arms: Art Therapy, Music Reminiscence Activity or a Control arm. Sessions will be conducted weekly for 3 months and fortnightly for 6 months. Each intervention session will last for 40 minutes. The Control group will not receive any intervention and continue their life as usual.

Assessments: Demographic data will be collected at baseline. Neuropsychological tests of cognitive functioning will be done at baseline, 3 months and 9 months. Anxiety and depressive symptoms will be assessed at the 3 time-points. Blood sampling will occur at all time points (except control group, only at baseline and 9 months). Participants will also undergo a task-free brain fMRI scan at baseline and at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Older person between 60 and 85 years of age, living in the community and fulfills the operational criteria/definition of MCI:

  1. At least one age-education adjusted neuropsychological test Z score \<-1.5
  2. Do not meet DSM V criteria for a Major Neurocognitive Disorder
  3. Memory/Cognitive complaint preferably corroborated by a reliable informant
  4. Intact Activities of Daily Living
* Functions independently
* Does not have dementia
* Able to travel to the data collection site on their own and participate in the activity

Exclusion Criteria:

* Those who do not meet the above inclusion criteria (ie. do not have a MCI diagnosis)
* Those with Dementia/Major Neurocognitive Disorder or Normal Ageing
* Presence of a neurological condition e.g. epilepsy, Parkinson Disease, stroke
* Presence of a major psychiatric disorder e.g. Major Depression, Psychoses
* Terminal illness e.g. cancer
* Presence of significant visual and/or hearing impairment and Color Blindness
* Participants in another intervention study at the same time
2018 Intern Health Study Micro-randomized Trial

The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.

Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.

The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.

Eligibility Criteria:
Inclusion Criteria:

* Medical intern during the 2018-2019 internship year
* iPhone user
* Affiliated with one of 47 recruitment institutions
* Downloaded app, completed consent, and filled out baseline survey prior to June 25th 2018

Exclusion Criteria:

-None
Clinical Outcome of Laparoscopic or Robotic Metroplasty for Uterine Isthmocele

To evaluate the clinical outcomes of conventional or robotic - laparoscopic metroplasty for uterine isthmocele with the aid of a bending probe.


Eligibility Criteria:
Inclusion Criteria:

* \> 20 years of women
* uterine isthmocele status post laparoscopic or robotic metroplasty with a bent uterine sound

Exclusion Criteria:

* Those underwent traditional open surgery.
Oxygen Portable Concentrator During Exercises in Patients With COPD

The purpose of this study is to compare differences in oxygen delivery between portable oxygen concentrators (POCs) and liquid oxygen (LOs) portable units, pose a question if POCs are equally effective as LOs in reducing exercise-induced hypoxaemia. DESIGN: Randomized, single-blind clinical trial.

Our primary objective is to compare at rest and during exercise the evolution of oxygen saturation and dyspnea during 6 minutes walking test in patients with COPD receiving oxygen supplementation either with portable concentrators or liquid oxygen in a random order.

Eligibility Criteria:
Inclusion Criteria:

* COPD with respiratory failure and indication for oxygen supplementation at rest and/or during exercice.

Exclusion Criteria:

* Evolutive heart disease.
* Unability to understand or realize the tests.
* Acute exacerbation during the last month.