cyrilzakka/clinical-trials huggingface dataset:
Pravastatin for Hyperlipidaemia in HIV.

This study is a randomised, placebo-controlled study of the effect of treatment with the HMG-CoA reductase inhibitor, pravastatin, in HIV-infected, protease inhibitor treated patients with high serum cholesterol. We hypothesise that pravastatin will result in greater reductions in cholesterol than placebo when used in conjunction with appropriate dietary advice.

High serum cholesterol concentrations are commonly seen in HIV-infected patients treated with some protease inhibitor medications as part of long-term antiretroviral therapy for HIV. There is concern that these elevations in cholesterol may negatively impact on long-term risk of cardiovascular disease in this patient population. Pravastatin, a HMG-CoA reductase inhibitor, is commonly used to treat hypercholesterolaemia in the general population. We aim to examine the effect of 12 weeks therapy with 40mg pravastatin daily in conjunction with dietary advice in HIV-infected patients with elevated serum cholesterol on continued protease inhibitor therapy.

After 4 weeks of dietary advice, patients will be randomised to receive either pravastatin or placebo for 12 weeks. Assessments include fasting lipid and glycaemic parameters, measures of body composition and HIV disease, and surrogate markers for cardiovascular disease.

Although previous small studies of pravastatin in this field have been performed, none has done so in a randomised placebo controlled trial taking into account all the relevant measures.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent to participate in the trial
* HIV-1 sero-positive
* Male/female \>18 years age
* Currently receiving HIV protease inhibitor therapy for \> 12 weeks and unlikely to require change in existing regimen during the 16 week study period
* Fasting cholesterol \> 6.5 mmol/L (mean of 2 samples collected \> 3 days apart)

Exclusion Criteria:

* Any condition which may interfere with ability to comply with study
* Gastrointestinal disorder which may affect drug absorption
* Hypertension or congestive cardiac failure
* Lactic acidemia (serum lactate level \>2.2 mmol/L)
* Any serious medical condition which may compromise the patient's safety, including pancreatitis or hepatitis within past 6 months
* Active AIDS defining conditions
* Concurrent therapy with any other lipid lowering agents, oral hypoglycaemics, anabolic steroids or insulin
Estimation of Preoperative Gastric Volume Using Ultrasound

Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.


Eligibility Criteria:
Inclusion Criteria:

* Infants undergoing general anesthesia with endotracheal intubation were included in this study

Exclusion Criteria:

* a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (\>5 min) between completion of US assessment and suctioning of gastric contents
Autism Genomics Sweden - Genetic Guidance and Information Trial

This observational clinical trial aims to evaluate whether providing genetic information about the origins of autism and related psychiatric disorders enhances understanding, well-being, and empowerment in adolescents and young adults with autism. The study will compare the outcomes of two groups: one receiving a 1.5-hour genetic counseling session with a clinician and the other receiving general genetic information via leaflet. Participants will be assessed using pre- and post-intervention questionnaires, including measures of understanding of their condition (mGCOS-24) and mental health (GAD-7 and PHQ-9). The study also explores whether mental health factors like anxiety and depression influence the effectiveness of the interventions.

The goal of this observational clinical study is to assess whether receiving genetic information about the origins of autism and related neuropsychiatric disorders, either at a population level or as individual information after genetic testing, can improve understanding of their condition, well-being, and empowerment in adolescents and young adults with autism spectrum condition (ASC). The main questions to answer are:

* Does a genetic counseling session improve participants' understanding of autism and its origins, well-being, and empowerment as measured by the modified Genetic Counseling Outcome Scale (mGCOS-24)?
* Is the outcome modified by mental health indicators such as anxiety and depression measures, and does the information improve these?
* We will also assess how genetic knowledge and beliefs prior the genetic information session affect the main outcome mGCOS-24 change.

The comparsion will be made between the group receiving a 1.5-hour genetic counseling session with a clinician to a group receiving general genetic information via leaflet by email to see if the genetic information session by the clinician leads to greater improvements in understanding, empowerment, and well-being.

Participants will:

* Answer basic demographic questionnaire as well as a questionnaire about genetic knowledge and beliefs
* Be randomized to receive a 1-1.5 hour genetic counseling session in person or through online, or general genetic information via leaflet.
* Complete pre-and post-intervention questionnaires, including the mGCOS-24, GAD-7 and PHQ-9.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 15 - 30 years of age.
* Living in Sweden.
* Able to consent independently or with guardian consent if necessary.
* Understanding of Swedish-language questions.
* Interest in receiving genetic counselling information on autism.

Exclusion Criteria:

* Participants unwilling to complete pre- or post-intervention surveys.
* Participants unwilling to participate in either form of genetic counseling
Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion

The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention.

Participants will:

will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program.

A weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments.

All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.


Eligibility Criteria:
Inclusion Criteria:

* aged 9-18 years
* seven days-3 months post-concussion,
* at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances).

Exclusion Criteria:

* known heart disease,
* previous neurological problems other than concussion
Fecal Microbiota Transplantation After Autologous HSCT in Patients With Multiple Sclerosis

The hypothesis of the study is that according to modern data, the pathogenesis of multiple sclerosis is inextricably linked to the patient's microbiota. Therefore, transplantation of a normal fecal microbiota (FMT) can improve the outcome of autologous hematopoietic stem cell transplantation (autoHSCT) by increasing the disease-free period and disease progression suspension for at least 5 years after transplantation, which meets the NEDA (No Evidence of Disease Activity) criteria, satisfying the current trends of clinical neurology.

AutoHSCT may be a method of choice to treat patients with refractory forms of multiple sclerosis, taking into account the insufficient efficacy of first line therapy, lack of availability (government approval) and high cost of monoclonal antibodies as a second line drugs. In this setting, according to the safety-efficiency ratio the most appropriate are reduced intensity conditioning regimens in autoHSCT. In 75% of cases for refractory forms of multiple sclerosis it is possible to achieve 5 years remission with transplant mortality less than 1%. In recent years, it is quite clear that gut microbiota abnormalities may be one of mechanisms for autoimmune diseases development. Therefore, the correction of gut dysbiosis through FMT from a healthy donor can improve the effectiveness of basic therapies. Currently, FMT is a rapidly developing method of treating intestinal infections associated with multi-resistant bacteria, based on the replacement of the recipient's microbiota by the donor's microbiota.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Multiple sclerosis (Relapsing-Remitting, Secondary-Progressive, Primary-Progressive)
* AutoHSCT
* Signed informed consent
* No second tumors
* No severe concurrent illness
* 1.0-6.5 points by EDSS
* Disease duration less than 20 years
* Disease progression on 1 and/or 2 line therapy (1 point EDSS 1.0-6.0 and 0,5 point EDSS 6.0-6.5)

Exclusion Criteria:

* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
My Skin & Hair Journey_virtual Registry

This is a longitudinal, observational, direct to participant registry to better understand biological, clinical, and environmental aspects of skin/hair health and beauty.

This is a longitudinal, observational, direct to participant registry to better understand biological, clinical, and environmental aspects of skin/hair health and beauty. By collecting, organizing, and analyzing data for a group of participants over time, researchers will use information to learn more about these topics. This study will collect long-term information about study participants, developing a lean, participant-centric approach to curating meaningful longitudinal data that incorporate participant perspectives including quality of life and personal beauty health preferences. This should allow researchers to understand how participant skin health changes over time and what factors can inﬂuence those changes with a speciﬁc focus on participant-centric learning.

Additionally, this study will look for ways to develop and/or improve data handling approaches to increase the depth, generalizability, and/or longitudinality of skin health and beauty data based on approaches that decrease burden, as appropriate, over time (eg, for study participants, investigators, clinical research stakeholders)

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Willing and able to provide applicable privacy authorization(s)
* Current resident of the United States
* 18 to 70 years of age at the time of informed consent Self identiﬁed female gender
* Able to read and understand English and/or Spanish
* Ability to access internet based study-related tools (eg, applications, software, email notiﬁcations)
* Willingness to use study web/mobile applications (eg, selﬁe assistant, air quality and weather monitoring)

Exclusion Criteria:

- Employee of the Sponsor(s), contracted research organizations, or virtual research sites
Holographic Augmented Reality Versus Screen Visualisation of 3D Rendering Models for the Pre-operative Evaluation and Planning of Liver Resections

The goal of this trial is to compare the evaluation of 3D liver models visualised as holograms with HoloLens 2 and on digital PDF files in HPB surgical trainees.

The main questions it aims to answer are:

* Do the holographic models allow a superior accuracy in terms of anatomical evaluation and surgical planning?
* Is there any difference in terms of time consumed and Task Load Index? Participants will analyse cases through both modalities and answer a questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* General Surgery Trainees with at least 6 months experience in HPB surgery

Exclusion Criteria:

* No informed consent
A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection

The purpose of this study is to determine the extent to which vaginal microflora and immune profiles of patients with urinary tract infection (UTI) differ from healthy controls.

Recurrent urinary tract infections, which occur mostly in the female population, can be potentially harmful if not treated and significantly reduce quality of life. By characterizing the vaginal microflora and immune profiles of women that suffer recurrent UTIs in contrast to a healthy age matched normal group of women (with no history of recurrent UTIs), we can better understand the differences. This in turn can lead to development of better quality probiotics that will be based on their scientific basis, clinical efficacy, and quality in terms of shelf life and delivery to target sites. The reduction in only one third of UTI cases seen each year would have a significant impact on reducing health care costs.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for UTI Group:

1. At least 2 recurrent UTIs within the last year
2. Written informed consent

Inclusion Criteria for Normal Group:

1. No UTI within the past 5 years
2. Written informed consent

Exclusion Criteria:

Exclusion Criteria for Both Groups:

1. Active UTI
2. Urinary tract anomalies
3. Evidence of a neurogenic bladder
4. Known immunodeficiencies
5. Use of antibiotics, within the last month
6. Concomitant use of oral steroids
7. Known renal calculi
8. Previous or ongoing chemotherapy
9. Pregnancy
Carbohydrate-based Strategies to Prevent Exercise-induced Hypoglycemia

To prevent hypoglycemia during prolonged exercise (\>30 minutes), additional carbohydrate intake is frequently required. Carbohydrate intake required will vary with insulin regimens, timing and type of exercise as well as starting blood glucose level. In addition to the amount of carbohydrate ingested, the timing of carbohydrate intake could also have an impact on glucose control during exercise. Therefore, the objective of this study will be to compare the efficacy of two snacking strategies to maintain glucose levels in the target range during an exercise period in adolescents and adults with type 1 diabetes: 1) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - given 5 minutes before exercise; 2) a snack containing \~0.5g of carbohydrates per kilogram of body weight - rounded to the nearest 5g - distributed this way: \~40% given 5 minutes before exercise, \~30% after 20 minutes of exercise and the last \~30% after 40 minutes of exercise.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 14 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. Last (less than 3 months) HbA1c ≤ 10%.
4. Patients using multiple daily injections with basal-bolus insulin regimen.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Abnormal blood panel and/or anemia.
4. Ongoing pregnancy.
5. Severe hypoglycemic episode within two weeks of screening.
6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
7. Treatment with CSII (Continuous Subcutaneous Insulin Infusion) "insulin pump therapy".
Use Of Capnography As Surrogate Measure Of PC02 In Medical Intensive Care Unit (ICU) Patients

The purpose of this study is to evaluate the use of Capnography (Continuous recording of the carbon dioxide content of expired air)as an alternative test to measure PC02 levels in patients with asthma, chronic obstructive pulmonary (COPD,interstitial lung disease(ILD)or coronary disease who are at risk of intubation.

This is a prospective study to evaluate the usefulness of capnography as a non-invasive, accurate method of measuring of PC02 levels in medical intensive care unit patients with asthma, COPD, ILD, or coronary disease who are at risk of intubation.

Eligibility Criteria:
Inclusion Criteria:

* Medical Intensive Care Patients
* Not intubated
* Age 18 or older
* History of any one of the following: asthma, COPD, ILD, or coronary disease

Exclusion Criteria:

* Sepsis
* Life expectancy less than 1 month
* Requiring BIPAP
Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)

Inhaled corticosteroids (ICS) are considered first-line treatment for persistent asthma, yet little is known about the genetic factors that influence response to this therapy. This study seeks to quantify response to ICS therapy in African American and white patients, as well as look for genetic markers that predict treatment response.

Inhaled corticosteroids (ICS) are considered first-line therapy for the management and control of patients with persistent asthma. Use of inhaled steroids has been associated with improved lung function, diminished symptoms, and fewer exacerbations. However studies show considerable inter-subject variability in ICS response. It has also been estimated that corticosteroid resistance accounts for half of all asthma-related health care costs. Therefore, identifying factors associated with ICS response is both clinical and economically important. African-American patients have been understudied with respect to genetic predictors of asthma controller medication response, and to date there have been no sufficiently powered genome-wide association studies of ICS treatment response among African American individuals with asthma. This issue is of particular importance, since African-American individuals are disproportionately affected by asthma-related complications. In this proposal, we seek to identify novel genetic loci associated with ICS treatment responsiveness (defined by the change in Asthma Control Test score) among African American individuals treated with beclomethasone dipropionate (BD) for 6 weeks. We will attempt to validate loci identified in the discovery set by 1) reassessing these variants for their interaction with ICS treatment on asthma exacerbations in a separate group of African American individuals with asthma, and 2) by reexamining the genetic association with change in asthma control among similarly treated (i.e., treatment with 6 weeks of BD) European Americans with asthma.

Eligibility Criteria:
Inclusion Criteria for Discovery Group:

* Age 12-56 years
* Physician diagnosis of asthma (identified by using encounter data prior to screening and by the survey administered at the clinic visit)
* Bronchodilator reversibility on pulmonary function testing (i.e., improvement in baseline FEV1 of \>12%)
* African-American/Black self-reported race-ethnicity

Exclusion Criteria for Discovery Group:

* Smoking in the preceding year or \<10 pack-year smoking history total
* Pregnant at the time of enrollment or intending to get pregnant during the 6-week treatment period
* Oral or inhaled corticosteroid use in the 4 weeks preceding enrollment
* Prior diagnosis of chronic obstructive pulmonary disease or emphysema
* Prior diagnosis of congestive heart failure
* Self-reported race not African-American/Black or Hispanic ethnicity (these groups could be included in Replication/Validation group)
Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy

The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Additionally, prolonging withdrawal time could only improve the ADR of right colon, but had limited effect on the ADR of left colon in our previous research. Our aim is to evaluate the effect of a second forward view examination of the left colon on the detection of adenoma detection during colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age are between 40-75, or aged 76-85 depending on his condition
* Patients who have indications for screening
* Patients who have signed inform consent form.

Exclusion Criteria:

* Patients who have undergone colonic resection
* Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
* Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
* Patients with inflammatory bowel diseases
* Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
* Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
* Patients with failed cecal intubation
* Patients with poor BPQ that necessitated a second bowel preparation
* Patients with therapeutic colonoscopy for existing lesions
* Patients refusing to participate or to provide informed consent