cyrilzakka/clinical-trials huggingface dataset:
Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology

This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality.

PRIMARY OBJECTIVE:

I. To evaluate the patient-perceived quality of care by group (telemedicine versus in-person visits) in patients with central nervous system (CNS) cancer.

SECONDARY OBJECTIVES:

I. To characterize the visits provided by telemedicine compared to those in-person.

II. To contrast the average time spent on telemedicine visits compared to in-person visits, and the delay between visit order placement and visit occurring.

III. To evaluate the domains of patient care addressed on a telemedicine visit versus in-person visit per documentation, including (1) treatment planning, (2) symptom burden, (3) goals of care.

IV. To evaluate frequency of acute care sought (through emergency room or urgent care clinic) within 30 days of encounter in telemedicine visit versus (vs) in-person visit.

V. The impact of patient and clinical characteristics on perceived quality of care in the context of covariate-adjusted modeling.

OUTLINE:

Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a CNS tumors: this includes patients with primary brain tumors, brain metastases, and leptomeningeal disease
* Established patients with a follow up encounter with Neuro-Oncology at the Brain and Spine Center at the University of Texas MD Anderson Cancer Center; this encounter can be

  * An in-person visit
  * A telemedicine appointment

Exclusion Criteria:

* Encounter occurred with the assistance of official language translation support
* Patients with telephone encounters (without interactive video)
* New patient or consult visits
* Neither patient nor caregiver present during the visit are available or able to answer survey questions
Diagnostic Relevance of Laser Confocal Microscopy for the Screening of Upper Urinary Tract Tumors

Upper Urinary Tract Tumors have an incidence of 1 to 2 cases for 100 000 persons per year. The standard treatment for these tumors is the ablation of the kidney, ureter and a part of the bladder surrounding the ureteral orifice. The development of new diagnosis and treatment techniques through natural routes opens the possibility to use conservative treatments. The investigators hypothesis is that during a reno-ureteroscopy, laser confocal microscopy will allow the discrimination between normal and pathologic urothelium by microscopic analysis. This will prevent the systematic use of biopsies which are often difficult and iatrogenic.

The objective of the present study is to assess contribution of laser confocal microscopy in diagnosing of upper urinary tract tumors during a reno-uteroscopy compared to analysing of architectural elements (vascular characteristics, organization) and cellular (morphology, cohesion, border).

Eligibility Criteria:
Inclusion Criteria:

* Any legally adult fully informed patient who consent to participate to the study
* Patient followed by the Urology Department
* Indication for a diagnosis or treatment reno-ureteroscopy
* Coverage of the social insurance

Exclusion Criteria:

* Minor Patient
* Pregnancy or breast feeding
* Concomitant treatment (for example beta-blocker)
* Contra-indication to general anaesthesia
* Hypersensitivity to sodium fluorescein
* Medical history of cardio-pulmonary disease (myocardial infarction, cardiovascular event, bronchospasm ...) due to fluorescein instillation
* Medical history of asthma or allergy due to fluorescein instillation
A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

The purpose of this study is to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in participants with moderately to severely active ulcerative colitis (UC).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed clinical diagnosis of ulcerative colitis (UC) at least 3 months before screening
* Moderately to severely active UC as defined by Mayo score
* History of inadequate response to or failure to tolerate conventional therapy
* Has screening laboratory test results within the study protocol defined parameters
* A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin) pregnancy test result at screening and a negative urine pregnancy test result at Week 0

Exclusion Criteria:

* Has severe extensive colitis as defined in the study protocol
* Has UC limited to the rectum only or to less than (\<) 20 centimeter (cm) of the colon
* Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
* Has any known malignancy or has a history of malignancy (with the exception of basal cell carcinoma; squamous cell carcinoma in situ of the skin; or cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years before screening)
* Has known allergies, hypersensitivity, or intolerance to guselkumab or golimumab or their excipients
Distribution of Nutrient Derived Amino Acids

The project examines over several days how the distribution pattern of dietary protein stimulate and affect the protein turnover of important proteins in the aging perspective, such as skeletal muscle proteins.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Between 65-80 years of age

Exclusion Criteria:

* BMI above 30
* Smokers
* Vegetarians
* Diabetes or other metabolic diseases
* Medical treatment which affects protein turnover
* Gastro-intestinal diseases, reduced kidney or liver function, or chronic inflammation diseases
* Elevated blood-pressure or signs of atherosclerosis
* More than 5 hours of regular exercise each week
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.

The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis. The study will also examine how the drug acts on the body

Study details include:

The study duration will be up to 63 days (9 weeks).

* 1 or 2 screening visits (up to 28 days before treatment)
* 28 days of treatment including 5 clinic visits
* Week 1: 24-hour in-clinic stay (Day 1)
* Week 2: Outpatient clinic visit (Day 7)
* Week 3: Outpatient clinic visit (Day 14)
* Week 4: Telephone visit (Day 21)
* Week 5: 24 to 48-hour in-clinic stay (Day 28)
* Week 6: Follow-up visit (Day 35) Disclosure Statement: The study consists of two cohorts, each with a parallel-group design and two arms, with participants blinded to treatment allocation.

Number of Participants:

The study will randomise approximately 36 participants in total. Cohort A: Approximately 75 participants with presumed MASH/NASH with fibrosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo. Cohort B: Approximately 75 participants with SLD with advanced fibrosis including compensated cirrhosis will be screened such that approximately 18 participants will be randomised. Twelve participants will be randomised to receive AZD2389 and 6 participants will receive placebo.

Eligibility Criteria:
Key inclusions:

* Males/females aged ≥ 18 years
* Indications: Presumed MASH (cohort A) or other steatotic liver disease (cohort B) with fibrosis
* No significant change in weight over the last 6 months
* Barrier contraceptives use by males
* Capable of informed consent
* Judged to be suitable for study by investigator

Key exclusions:

* A condition that could put the participant at risk, influence the participant's ability to participate in the trial, interfere with evaluation of the study intervention or affect the interpretation of the results
* Other causes of liver disease which are not the principal inclusion criteria for each cohort
* Significant elevations in liver blood tests or platelets \<140 x10\^9/L
* Decompensated liver disease, hepatobiliary cancer or listing for liver transplantation
* Bleeding disorders or major bleeding risk
* HIV infection or hepatitis B infection
* Clinically significant cardiovascular (e.g. severe ischaemic heart disease, severe heart failure or cardiac dysrhythmia) or cerebrovascular disease within the past 3 months
* Stage 2 hypertension
* eGFR \<60ml/min/1.73m2
* Clinically significant gastrointestinal disease which can affect the interpretation of pharmacokinetic, safety, and tolerability data
* Skin disorders or ongoing wound healing
* Psychiatric disorders which may negatively affect participation in the trial.
* Females of childbearing potential
IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease

To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric \[urinary albumin excretion (UAE): 30-500 mg/day\], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.

Group Β: Placebo. Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).

Eligibility Criteria:
Inclusion Criteria:

* 1. Type 2 diabetes and coronary heart disease;
* 2. Urinary albumin excretion: 30-500mg/24h;
* 3. Sinus rhythm, and resting heart rate ≥ 70bpm;

Exclusion Criteria:

* 1. Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2;
* 2. Atrial flutter, and atrial fibrillation;
* 3. Resting heart rate \< 70bpm;
* 4. Combined with non-dihydropyridine CCB;
* 5. UAE\<30mg/24h, or \> 500mg/24h;
* 6. Acute heart failure;
* 7. Low blood pressure (BP\<90/50mmHg);
* 8. Acute myocardial infarction (\<14 days);
Italian Platelet Technology Assessment Study

Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately.

Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets.

Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments

Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization

Patients will be evaluated for 4 weeks after randomization.

When patient's platelet count, done in early morning every day, falls below 10000/microliter, physician in charge issues a platelet transfusion request to transfusion service. Transfusion service (which knows patient treatment arm) issues a PRT product or a standard product as indicated, typically within hours of request receipt; patient's physician identifies unit code and intended recipient's code and determines vital signs (pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each enrolled patient and transfers filled forms to data coordinating center in Milan.

Eligibility Criteria:
Inclusion Criteria:

1. adults (\> 18 years)
2. a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed)
3. expected to require 2 or more PLT transfusions in 4 weeks
4. hospital admission (patients admitted to out-patient clinics will not be enrolled)
5. chemotherapy, related and matched unrelated donor (MUD)transplant recipients
6. recurrent auto-transplanted patients, requiring chemotherapy
7. negative pregnancy test in female patients less than 60 years old

Exclusion Criteria:

1. presence of HLA class I abs on admission with PRA \>20%
2. historical documented record of 2 or more 1 hour post-TX PLT corrected count increments \<5,000 per microliter
3. previously included in IPTAS
4. diagnosis of a solid tumor
Prevention of PONV With Traditional Chinese Medicine

Postoperative nausea and vomiting (PONV) is particularly one of the most common complications after laparoscopic sleeve gastrectomy (LSG). It can lead to serious adverse events and delayed activity, and prolong the time of rehabilitation and discharge. Numbers of studies have been focused on identifying risk factors and therapies of PONV. Unfortunately, there' no consistent comments for PONV prevention in women after LSG. Notably, Zusanli (ST36) acupoint and anisodamine have been evidenced to treat various gastrointestinal conditions. The primary outcome of this study was to evaluate the impact of anisodamine injection in ST36 on PONV in women following bariatric surgery.

At the onset of this investigation, we have already identified several methodologic issues, such as the timing of the acupuncture intervention, sample size, perioperative anesthetic techniques, and appropriate control groups. All subjects were randomly assigned to the following two groups: ST36 acupoint injection group (bilateral ST36 acupoint injection with scopolamine); pharmacoprophylaxis group (bilateral ST36 injection with normal saline). The primary outcome of this study was the total incidence of PONV during the hospital and after the discharge. Participants were randomly assigned into different groups according to the computer-generated randomization sequence (http://www.randomization.com). Patients, surgeons, care givers, anesthesiologists, nursing staff, and outcomes assessor, were all blinded to the group assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with an American Society of Anesthesia (ASA) physical status I-IV
2. Scheduled for elective bariatric surgery
3. Written informed consent was obtained

Exclusion Criteria:

1. Patients with contraindications for acupoint injection
2. Difficulty in communicating with patients
3. Allergic diathesis for drugs used in the study or serious illness (heart, lung, kidney, or liver, et. al)
4. Coagulation dysfunction
5. Pre-existing psychological or neurological disorder
6. Pre-use medicine before surgery that would interferenced objective assessment (including the use of opioids, antiemetics or glucocorticoids)
7. Gastroesophageal reflux disease
Dementia Pain Management Educational Program

This study aims to develop and test a scale for exploring hospital nurses' knowledge about dementia pain and dementia pain management.

The researcher recruited 285 nurses from three hospitals, and divided them into the experimental group and the comparison group. The experimental group took two-hour online course about dementia pain care in two weeks. The comparison group took two-hour online course about dementia care in two weeks. The nurses performed a post-test after the two-week course immediately; two weeks later, the second post-test was performed again.

Eligibility Criteria:
Inclusion Criteria:

* Nurses working in district hospitals, regional hospitals, or medical centers.

Exclusion Criteria:

* Nurses working with obstetrics, pediatrics, or outpatient.
The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams

In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthiness
* Good capacity of remembering dreams
* No opiate consumption

Exclusion Criteria:

* Simultaneous participation in other studies
* Addictive disorder
* Abnormal liver function
* Abnormal kidney function
* Hypersensitivity to active ingredient or pharmaceutical additives
* Hereditary galactose intolerance
* Lactase deficiency
* Glucose-galactose malabsorption
* Intake of opioid medication
Mouth Breathing Habits Improvement Intervention

This study intends to investigate the improvement in patients with OSA through objective measurement, including oxygen desaturation index (ODI) and the percentage reduction in intermittent mouth puffing (IMP) before and after the intervention. The oral appliances are placed between the tongue and the soft palate to reduce the oral ventilation space. A total of 24 participants aged between 36 and 57 years were identified with ODI above 5 events/hour by measuring their blood oxygen and with an originally designed mouth puffing detector to find out those who were still mouth-puffed when their mouths were taped. A suitable appliance was chosen for the participants between the two originally designed oral appliances, tongue pressed device (TPD) and tongue elevated device (TED), and the intervention lasted for six weeks.


Eligibility Criteria:
Inclusion Criteria:

* (1) aged 20-60 years old,
* (2) having symptoms of OSA including snoring, daytime sleepiness, etc.
* (3) AHI \& ODI \>=5 events/hour,

Exclusion Criteria:

* (1) taken sleep medication within the last two months or were on long-term use,
* (2) reported tobacco, alcohol, caffeine or drug addiction,
* (3) cancer, cardiovascular disease, psychiatric illness, kidney disease, diabetes mellitus, or other sleep disorders.
Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C


Eligibility Criteria:
Inclusion Criteria:

* Subject is a man or a woman aged 18 to 55 years of age.
* Subject has chronic Hepatitis C
* Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period

Exclusion Criteria:

* Patient has evidence of advanced liver disease.
* Patient has human immunodeficiency virus (HIV)
* Patient has Hepatitis B
Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692)

Participants who have completed the 3-week trial P05691 (NCT00764478) can be screened for eligibility for this 26-week extension study in which they will continue treatment. The primary purpose of this trial is to evaluate the long-term safety of asenapine.


Eligibility Criteria:
Inclusion criteria:

* Each participant must have completed the short-term trial P05691, and be judged by the investigator to likely benefit from continued treatment
* Each participant must have demonstrated an acceptable degree of compliance with trial medication, visits, and other requirements in the short-term trial P05691

Exclusion criteria:

* A participant must not have had any adverse event or other clinically significant finding(s) in the short-term trial P05691 that would prohibit the subject's continuation into this long-term extension trial
* A participant must not have any newly diagnosed or discovered psychiatric condition that would have excluded the subject from participation in the short-term trial P05691
* A participant must not be at imminent risk of self-harm or harm to others
Peer Mentoring in Promoting Follow-up Care Self-Management in Younger Childhood Cancer Survivors

This pilot trial studies a peer mentoring and online self-management program to see how well it works in promoting follow-up care self-management in younger childhood cancer survivors. Childhood cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors. A peer mentoring program + self-management may improve disease knowledge, health motivation, problem-solving skills, stress management, and communication with caregivers and providers in adolescent and young adult cancer survivors.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.

II. Assess preliminary outcomes of the peer mentoring program.

OUTLINE:

All Participants will be asked to complete online self-management educational modules and 6 weekly peer mentor calls to facilitate engagement with the online modules and offer specialized support. We will also recruit and train peer Mentors.

Eligibility Criteria:
Inclusion Criteria:

PEER MENTOR ELIGIBILITY:

* Age 21-29
* At least 1.5 years from treatment
* Self-reported primary responsibility for care and "complete readiness" using the Readiness for Transition Questionnaire

PATIENT ELIGIBILITY:

* Age 18-25
* At least 1.5 years from treatment
* Currently does not independently self-manage follow-up care according to self-report to assume total responsibility for care (i.e., reports low readiness \[score of 1 or 2 out of 4\] OR scores \<3 on any of the 10-item responsibility scale from the Readiness for Transition Questionnaire)

Exclusion Criteria:

PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare
The Effects of TAP Block on Postsurgical Pain After Minimally Invasive Partial Nephrectomy:

Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* asa score I,II,II
* patients scheduled for robot assisted partial nephrectomy

Exclusion Criteria:

* previous abdominal surgery
* inability to provide informed consent
* allergy to the anesthetic drugs