cyrilzakka/clinical-trials huggingface dataset:
Expectations of People With Type 1 Diabetes About Voice-based Interventions to Support Diabetes Distress Management

This study explores the perspectives and needs of people dealing with type 1 diabetes or their carers to co-design a voice-based digital health intervention for supporting diabetes distress management.

New technologies restore people with type 1 diabetes to a certain degree of independence and control over their lives while allowing medical providers to keep an overview of their patient's general health conditions and the evolution of their treatments. Notably, solutions integrating voice-processing technology appeared to be encouraging alternatives for remote monitoring.

Diabetes distress is a common condition in people living with type 1 diabetes. Diabetes distress is associated with poor metabolic control and low quality of life. Because voice analysis involves highly complex methods for processing audio features, this kind of development might also be capable of detecting subtle changes associated with psychological factors, like diabetes distress.

Nevertheless, digital health incorporation into the everyday lives of potential users might also imply a big challenge for many of them.

For this reason, studying the needs of the end-users of technological tools before defining any aspect of their design has become a critical step in developing this kind of technology.

The main objective of Psyvoice is to identify the preferences of people living with type 1 diabetes for voice-based digital health solutions for diabetes distress detection and control.

Secondary objectives are:

1. Delineating the properties that an instrument for diabetes distress management must incorporate to be considered adequate by its intended users (e.g. single voice-analysis function exclusively for diabetes distress management vs multiple functions or multiple uses).
2. Determining the attributes (e.g. frequency of use) that could make a digital health solution prone to be integrated by its end-users into their everyday lives.
3. Defining the characteristics likely to make a digital health solution acceptable. These are privacy and security concerns, barriers of use (difficulties with technology, disability) and facilitators of use (technical support, use of plain language).

To achieve all of these objectives, the investigators will conduct in-depth interviews.

The study will combine qualitative and quantitative methods. The investigators will invite twenty people with a T1D diagnosis or caregivers of children diagnosed with this condition to participate in semi-structured in-depth interviews and questionnaires. The questionnaires will be composed of a Socio-demographic, an e-Health Literacy (eHLQ) questionnaire, and a Diabetes Distress (PAID) scale.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women with a Type 1 diabetes diagnosis /caregivers of children diagnosed with T1D
2. Able to speak and read in English, German, or French.

Exclusion Criteria:

Unwilling or unable to participate in online interviews.
Efficacy and Safety of Volenrelaxin in Adults With Chronic Kidney Disease

The main purpose of this study is to investigate the efficacy and safety of Volenrelaxin in adults with Chronic Kidney Disease. The study will last about 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of Chronic Kidney Disease (CKD) based on eGFR category and albuminuria category per the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
* Have been on a maximally tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for 90 days preceding screening and is expected to remain on a stable regimen through the study
* If on additional treatment for CKD, must be on stable dose for at least 90 days before screening.
* If diagnosed with Type 2 Diabetes, should be on stable antihyperglycemic treatment for at least 90 days before screening.

Exclusion Criteria:

* Have any one of the following cardiovascular conditions 90 days prior to screening:

  * myocardial infarction
  * stroke
  * hospitalization or urgent visit for heart failure, and
  * coronary, carotid, or peripheral artery revascularization.
* Have a documented New York Heart Association (NYHA) Class IV heart failure at the time of screening.
* Have chronic or intermittent hemodialysis or peritoneal dialysis 90 days prior to screening.
* Have acute dialysis or acute kidney injury 90 days prior to screening.
* Have a history of a congenital or hereditary kidney disease, polycystic kidney disease, lupus nephritis, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and nephrotic syndrome
* Requires chronic immunosuppression.
* Have HbA1c \>8.5% at screening
* Have had a transplanted organ or are awaiting an organ transplant
* Have a diagnosis or history of malignant disease within 5 years prior to baseline.
* Have symptomatic hypotension.
* Have acute or chronic hepatitis.
Bariatric Surgery vs. Lifestyle Modification for NASH

Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.

Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution

Eligibility Criteria:
Inclusion Criteria:

* BMI between 30 and 45
* with biopsy-proven NASH
* with or without type 2 diabetes
* that fit for bariatric surgery.

Exclusion Criteria:

* borderline NASH ou cirrhosis;
* alcohol consumption (\> 20 g/day for men and \> 10 g/day for women, for the last 2 years);
* other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
* HIV infection;
* unable to provide informed consent;
* previous foregut or bariatric surgery;
* malignancy;
* patients that unfit for bariatric surgery.
Fecal Microbiota Transplantation for the Prevention of Infectious Complications After Liver Transplantation

The increasing emergence and spread of MDRB represents a major public health problem, with higher mortality in patients experiencing infections. Cirrhotic patients listed for OLT and after OLT are at high risk of MDRB colonization or infection due to the large use of broad-spectrum antibiotics in the post-transplant setting. Therefore, effective decolonization strategies in this particular setting are urgently needed. The investigators hypothesize that heterologous FMT can reduce infections rates in the pre-and post- OLT setting by MDRB decolonization and restoration of a more physiological microbiome.

The study is a double-blind, single-center, randomized controlled trial and will be offered consecutively to every adult patient on the liver transplant list.

Enrolled patients will be randomized (1:1) and assigned to either the heterologous or autologous fecal microbiota transplantation.

The intervention of the trial is heterologous fecal microbiota transplantation, which involves the administration of fecal material from a healthy donor into the intestine of the enrolled patient. Fecal samples will be collected every three months and before each microbiota transplant for evaluation of fecal microbiota composition. Gut permeability tests will be evaluated at enrollment and after the first fecal transplantation. Moreover, clinical and microbiota assessments will be performed after liver transplantation. All other planned assessments are part of the normal course of care.

Eligibility Criteria:
Inclusion Criteria:

* Adult (age≥18 years) patients listed for OLT for various etiologies.
* Patient's consent to participate in the study

Exclusion Criteria:

* Previous total colectomy
* Pregnancy or breastfeeding
* Patients on oral or intravenous antimicrobial agents
* HIV positive and not well controlled on antiretroviral therapy, or CD4+ \<200/ mm3
* Active SARS-CoV-2 infection
* Neutropenia \<0.5X10\^9/L
* Toxic megacolon
* Contraindications to colonoscopy
* Any conditions for which, according to the physician, FMT endangers the patient's health
* History of hypersensitivity to macrogol contained in bowel preparations.
A Study to Evaluate the Pharmacokinetic Drug-drug Interactions Between VX-548, Midazolam, and Digoxin

The purpose of this study is to evaluate the pharmacokinetics of midazolam and digoxin in the absence and presence of VX-548.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m\^2)
* A total body weight greater than (\>) 50 kilogram (kg)
* Females of non-childbearing potential

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 5 days before the first dose of study drug
* Any condition possibly affecting drug absorption
* History of cardiovascular disease, cardiac dysrhythmias or central nervous system disease
* Hypersensitivity to midazolam, other benzodiazepines, or digoxin

Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Preoperative Oral Carbohydrate on Hypotension After Anesthesia Induction in Elderly Patients With Joint Replacement

The goal of this Randomized controlled trial is to investigate the effect of shortening the duration of preoperative oral carbohydrate drinks on blood pressure after anesthesia induction in elderly patients undergoing joint replacement surgery. The main question it aims to answer is Whether preoperative oral carbohydrate drinks can reduce the incidence of hypotension after anesthesia-induced hypotension in elderly patients undergoing joint replacement surgery.According to the numerical table method, the patients in the experimental group will drink carbohydrate drinks the night before the operation and 3 hours before the operation, and the control group patients will routinely fast


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective unilateral joint replacement (total hip or knee)
2. ASAⅠ-Ⅲ

Exclusion Criteria:

1. Diagnosed patients at high risk of reflux aspiration (diabetes mellitus, obesity (BMI\>30), gastrointestinal obstruction, elevated intracranial pressure, and esophageal disease)
2. Eating disorders
3. History of gastrointestinal or epigastric surgery
4. Recent use of drugs that affect gastrointestinal motility
5. Heart disease (severe arrhythmias, severe heart valve disease, heart failure, unstable angina on the day of surgery)
6. Severe poorly controlled hypertension (MAP≥135 mmHg) or hypotension (MAP≤55 mmHg) before induction
7. Difficult airway
8. Severe hepatic and renal insufficiency
Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease

Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that it has a effect of decreasing the degree of leaky gut syndrome.

So the investigators are planning to find out whether Colostrum has a effect of decreasing the degree of leaky gut syndrome.

We randomly sort the participant as placebo group and colostrum group. Each group consists of 17 people. and the duration of our study for one participant is 3 weeks. (Participant takes colostrum for 3 weeks.)

When a person gets leaky gut syndrome, his or her endotoxin and lactulose/mannitol ratio (L/M ratio, in urine) can elevate.

So We will compare the value of those two parameters and LFT. etc. after the administration of colostrum or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Men aged over 20 who's alcohol consumption per day is 20.0gram average

  * He must agree to participate this trial voluntarily.
* Liver function test within 3 months :

AST more than 30 or ALT more than 33 or Gamma-GT more than 46

* Men who have result of Ultra-sono result of abdomen without Liver cirrhosis

Exclusion Criteria:

* Hepatitis B or C , liver cirrhosis patient
* Men who have undergo bowel operation
* Men who are taking NSAIDs
* Periodontitis or GERD or other G-I tract infection within 2 weeks before enrollment
* Men who have been given anticancer drug within one year
* Men who have been given antibiotics within 2 weeks
* Creatinine level \>= 1.4mg/dl
* Men who are taking G-I motility drugs or anti-ulcer drug
* Milk allergy
Mediastinal Temperature and Post-operative Bleeding

This study will investigate how chest temperature relates to blood loss and blood clotting. Researchers will use infra-red thermometers to measure the temperature of the chest at the end of surgery see if this relates to the amount of blood collected from the surgical drains. In addition, researchers will test if warm irrigation of the chest increases the temperature of the chest and if this impacts blood loss.

Low body temperature during surgery, defined as a temperature below 34 °C, occurs commonly in patients undergoing cardiac surgery due to the bypass machine and an open chest. Low body temperature has been associated with blood loss, but the relevant published data are inconclusive. Nevertheless, evidence suggests that blood loss during and after surgery are higher in low body temperature patients than in the normal body temperature patients. In addition, low body temperature can impair blood clotting. The clinical significance of this is high as it is well established that blood transfusion increases mortality after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open cardiac surgery at VCU
* Age18 to 80 years
* American Society of Anesthesiologists Physical Status 1-3

Exclusion Criteria:

* history of excessive bleeding
* partial thromboplastin time \> 35 s
* prothrombin time \> 35 s
* fibrinogen \< 200 mg/dL
* platelet count \< 100,000/L
* history of infection and fever within 4 weeks before surgery
* use of steroid or immunosuppressant within 4 weeks before surgery
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment

This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).

The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.

The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.


Eligibility Criteria:
Inclusion Criteria:

* Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
* Vision 20/40 to 20/800 Snellen equivalent
* Age \> 50 years
* Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria:

* Intraocular surgery or injection within 30 days prior to enrollment in the study eye
* Intravitreal triamcinolone within the past 6 months in the study eye
* History of prior PDT treatment in the study eye
* History of argon laser treatment of subfoveal CNV in the study eye
* Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
* Clinically significant intraocular inflammation in the study eye
* No light perception in the fellow eye
* Anterior segment opacity preventing adequate visualization of fundus for FA or OCT
* Are currently participating in another clinical trial
* Women of childbearing potential not using adequate contraception, as well as women who are breastfeeding
* Known sensitivity to study drug(s) or class of study drug(s)
* Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days
Theophylline for Treatment of Pseudohypoparathyroidism

Pseudohypoparathyroidism is a genetic disorder with limited treatment options, characterized by early-onset obesity, short stature, hormone resistance and cognitive impairment. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. We hypothesize that theophylline will cause weight loss, improve glucose tolerance and decrease hormone resistance in children and young adults.

Trial Objectives

1. The primary objective of this study is to evaluate the long-term safety of theophylline in patients with PHP.
2. The secondary objectives of this study are to evaluate changes in BMI, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with PHP.

Study Design The proposed study is a single center, 24-month open label extension clinical trial for patients with PHP who complete the randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* 1. Successful completion of the randomized clinical trial "Phase 2 Study of Theophylline Treatment of Pseudohypoparathyroidism IND 133103 (11/1/2016)".

Exclusion Criteria:

1. History of a seizure disorder unrelated to hypocalcemia
2. History of a cardiac arrhythmia (not including bradycardia)
3. Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \>3x upper limit of normal)
4. Congestive heart failure
5. Current cigarette use or alcohol abuse
6. Pregnancy or intention to become pregnant during the next year
7. Active peptic ulcer disease
8. Current use of medications known to effect theophylline levels
9. History of hypersensitivity to theophylline or other medication components
10. Unable to comply with study procedures in the opinion of the investigator
Iron Treatment for Young Children With Non-anemic Iron Deficiency

The pre-school years are critical years for children to acquire early learning skills such as language, fine motor and social skills; this is termed early child development. Primary care doctors (family doctors and pediatricians) are in a unique position to identify children with health or developmental problems. Screening is the process of testing healthy people for the earliest signs of health problems, followed by treatment, with the expectation that screening will improve the health of those screened. The focus of this research is screening young children for the earliest signs of iron deficiency (low blood iron levels) followed by treatment with oral iron.

Previous research has shown that children with later stages of iron deficiency have serious delays in their development. Some research has shown that these delays may persist into young adulthood often with a significant reduction in intelligence. Early stages of iron deficiency may be difficult for parents or doctors to detect, and a blood test is usually needed. However, Canadian guidelines do not recommend screening all children for iron deficiency, because there is not enough good quality research to prove that screening is effective.

In this study, the investigators will ask parents to allow their child between the ages of 1 to 3 years to have a blood test for iron levels. If the blood level is low, the child will be randomly assigned to receive either oral iron liquid for 4 months plus diet counseling, or a placebo liquid plus diet counseling. A psychologist will measure each child's early learning ability before and after the treatment. If this approach to screening children's blood iron levels followed by treatment improves children's development, parents and doctors may consider that routine blood screening tests are justified. Overall, this research is an important step to improving the ways in which primary care doctors can ensure that children have the best start to life-long health and achievement.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 36 months attending any well child visit
* Informed parental consent

Exclusion Criteria:

* Previously diagnosed: developmental disorder, genetic, chromosomal or syndromic condition, chronic medical condition, (with the exception of asthma and allergies), including chronic anemia, iron deficiency or recent oral iron supplementation or treatment
* Prematurity with a gestational age less than 35 weeks; low birth weight less than 2500 grams
* Attending the office for an acute illness, such as a viral illness, or other health concern other than well-child assessment
* Any contraindications to receiving elemental iron (i.e. NHP \[natural health product\], comparator or placebo)
* The use of any Natural Health Product containing the same medicinal ingredient(s) as the investigational product
* English not spoken to the child in the home or in a child care setting
Home Balance Pilot for Fall Reduction in COPD

There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary effects of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

Chronic obstructive pulmonary disease (COPD) is highly prevalent among older adults and is a leading cause of death, disability and hospitalization in Canada. There is a growing body of evidence demonstrating that older adults with COPD have important problems with their balance and a high incidence of falls compared to those of a similar age. This research will explore the feasibility and preliminary efficacy of a tailored 6-month home balance exercise program for reducing falls in older adults with COPD.

The primary objective of this pilot study is to determine the feasibility of a tailored home balance intervention for older adults with COPD in terms of recruitment, retention and adherence. The secondary objective is to examine the within-subject effects of the home-balance intervention on intermediate outcomes linked to falls including balance, functional strength and self-reported disability.

Thirty-five older adults with COPD will be recruited from respirology clinics at West Park Healthcare Centre (Toronto) and the Firestone Institute for Respiratory Health (Hamilton) to participate in a single-group, non-randomized clinical trial. Eligible participants will be enrolled in a 6-month balance home exercise intervention. The home program will be supervised by a physiotherapist and outcome measures will be collected at home at baseline, 3- and 6-months by a research assistant not involved in the intervention.

Eligibility Criteria:
Inclusion Criteria:

* a clinical diagnosis of COPD;
* age ≥ 60 yrs;
* a history of 1 or more falls in the previous year;
* ability to provide written informed consent.

Exclusion Criteria:

* inability to communicate in English;
* history of significant cardiovascular disease;
* marked decrease in arterial oxygen saturation at rest or during previous assessments of exercise capacity;
* severe cognitive impairment;
* evidence of a condition that severely limits mobility and may jeopardize safety;
* completion of a course of rehabilitation in the last 6 months or on a wait list for admission to rehabilitation.