cyrilzakka/clinical-trials huggingface dataset:
Low-calorie Sweeteners and Adipose Signaling

The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS) exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese adolescents and young adults. We will examine changes in gene expression in subcutaneous fat and will correlate these molecular changes with plasma biochemistry.

The proposed study will investigate LCS-induced changes in metabolically "at-risk" young adults, under conditions that reflect typical beverage consumption. We will first identify molecular pathways potentially affected by LCS (adipose transcriptomics via global RNAseq) and then identify links between LCS-induced gene expression changes and circulating levels of key metabolic biomarkers and clinical outcomes. We will perform subcutaneous adipose biopsies before and after consumption of 12 ounces of diet soda three times daily for eight weeks. Within-subjects changes in adipose gene expression will be evaluated using RNAseq. We will then correlate transcriptomic changes with circulating levels of key inflammatory and metabolic biomarkers, to provide mechanistic insight into which pathways drive clinically-relevant LCS-induced metabolic impairments. We will measure glucose, insulin, inflammatory markers and adipose-derived hormones before and after eight weeks of LCS exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 18-25 years of age
3. Overweight and mild to moderate obesity (25 ≤ body mass index (BMI) \<35 kg/m2)
4. Consumption of \<1 food/beverage with sucralose and/or acesulfame-potassium per month
5. Able and willing to comply with all study procedures for the duration of the study

Exclusion Criteria:

1. Overt diabetes
2. Renal/gastrointestinal conditions
3. Pregnant/lactating
4. Recent significant weight change
5. Acute illness (w/fever)
6. Antibiotics in past 3 months
7. Use of illegal drugs/condition limiting ability to give consent.
Family Planning Knowledge, Attitudes, and Practices of Postpartum Malawian Women

The purpose of this study is to understand the family planning needs and practices of postpartum Malawian women, with a focus on long-acting reversible contraception (LARC).

Hypotheses:

1. Postpartum women who are older, who have a history of unintended pregnancy, who do not desire another child within 2 years, and who were counseled about LARC during their pregnancy are more likely to have interest in using LARC.
2. Postpartum women who are older are more likely to be aware of LARC methods.
3. HIV+ postpartum Malawian women will have similar knowledge about LARC as postpartum Malawian women who are HIV-.

This study is a prospective cohort study of 630 postpartum Malawian women. Since our focus is on HIV+ women, HIV+ participants will be recruited in a 1:2 ratio, with a total of 210 HIV+ women and 420 HIV- women. We will recruit in the postpartum ward of Bwaila Maternity Hospital in Lilongwe, Malawi. Participants will complete a baseline survey about demographics, reproductive health history, and family planning knowledge, attitudes, and practices. At 3, 6, and 12 months postpartum, we will complete follow-up phone calls to determine what family planning methods they are using and if they encountered any barriers to receiving LARC if they had been interested in using them.

Eligibility Criteria:
Inclusion Criteria:

1. Admission to the postpartum ward at Bwaila Maternity Hospital
2. Live birth ≥28 weeks gestational age within past 4 weeks
3. Fluent in English or Chichewa
4. Age 18-45 years
5. Access to a working phone number
6. Willingness to be contacted by phone for up to one year postpartum

Exclusion Criteria:

1. History of female sterilization via tubal ligation or hysterectomy
2. Prisoner
3. History of mental disability
4. Serious illness that would prevent participation in the opinion of the Principal Investigator
Evaluation of Minimally Invasive Microdiscectomy Versus Conventional Open Microdiscectomy For Lumbar Herniated Disc

Overall Objective: To evaluate pain and functional status of patients undergoing surgical correction for lumbar herniated disc, pre- and post-surgery, using subjective (VAS, Oswestry, PSQI, Patient Expectation), as well as, objective measures of physical activity (triaxial accelerometry).

Design and Methods: Two groups of subjects will be examined; 1) patients diagnosed with lumbar herniated disc undergoing minimally invasive microdiscectomy (MD), and 2) patients diagnosed with lumbar herniated disc undergoing open microlumbar discectomy (OD).

Subjects who agree to participate, will be assessed (assessments listed below) after the diagnosis and prior to surgery. The subject will then be assessed postop and they will continue with follow-up after surgery with a visit at 3 weeks postop. Both methods of discectomy will be discussed with the subject. Once the subject has consented to participate (and prior to surgery), subjects will be randomized with a 50/50 chance of being placed in the MD or OD groups. Subjects will be distributed into the MD group and the OD group using a block randomization method. The study will be single blinded. A longitudinal, within group, comparison will be made to assess the change in the measured parameters. Data involving the MD and OD groups will be accumulated in a cross-sectional fashion.

Subjects will be recruited from the referrals to the practices of the Orthopedic and Neurosurgeon Spine Surgeons at the Health Sciences Centre. This encompasses the majority of new and currently managed cases in the Manitoba and Northwestern Ontario.

Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited into the study. All patients will clinically demonstrate unilateral lower extremity pain in greater proportion to low back pain symptoms if present. Imaging (CT) will document single level lumbar herniated nucleus pulposis. Exclusion criteria will be cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury). Subjects participating will be required to speak and read English.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be between the ages of 18 and 90.
* Male and female subjects will be recruited into the study.
* All patients will clinically demonstrate unilateral lower extremity pain in greater proportion to low back pain symptoms if present. Imaging (CT) will document single level lumbar herniated nucleus pulposis.
* Subjects participating will be required to speak and read English.

Exclusion Criteria:

* Cauda equina syndrome, progressive neurologic deficit, bilateral lower extremity symptoms, low back pain more than leg pain, the existence of significant co-morbidity (e.g. cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury).
Investigation of the Effect of Hippotherapy Simulator in Children With Spastic Diplegia and Cerebral Palsy

The aim of the study is to examine the effect of hippotherapy simulator on trunk control, balance and gait in children with spastic diplegia cerebral palsy and its relationship with quality of life.

Patients diagnosed with spastic diplegia cerebral palsy in the study; It will be classified according to Gross Motor Function Classification System (KMFSS). The Trunk Control Measurement Scale will be used to assess trunk control. Pediatric Berg Balance Scale will be used to assess balance. The 1 Minute Walk Test and the Timed Get Up and Go test will be used to assess walking. The WEEFIM scale will be used to assess quality of life. The study sample will be divided into two groups. The first group will receive 45 minutes of conventional physical therapy. In addition to 45 minutes of physical therapy, the other group will receive 15 minutes of hippotherapy simulator. The results will be compared at the beginning and end of the study.

Then, individuals will be divided into two groups with a simple randomized method. Traditional physical therapy will be applied to the control group for 45 minutes, 2 days a week, for 8 weeks. In addition to traditional physical therapy, 15 minutes of therapy training with a hippotherapy device will be applied to the experimental group. Evaluation tests will be repeated at the beginning and end of the study. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Diplegic Cerebral Palsy between the ages of 4 and 16
* Levels 1,2 and 3 according to KMFSS
* Have not had botox or surgery in the last 6 months
* Able to perceive simple commands
* Patients who can sit in the hippotherapy simulator will be included.

Exclusion Criteria:

* With hip dislocation
* Those with hearing or visual disabilities
* Those who do not want to be involved in the study
* Adductor spasticity is stage 3 and above according to the ashworth spasticity scale.
* With upper extremity amputation
Online Intervention to Modify Interpretation Biases in Depression

Cognitive biases have been found to be possible causal and vulnerability factors for depression. There is empirical evidence on the presence of negative emotional biases in interpretation in people with depressive symptoms. A whole new area of research, called Cognitive Bias Modification (CBM), is focused on targeting negative cognitive emotional biases to investigate its impact on clinical symptoms. A recent meta-analysis has shown that this type of programs are effective in reducing cognitive biases but there is still controversy on their clinical value to reduce symptoms. The purpose of the study is to create a brief online intervention aimed to reduce negative emotional cognitive biases present in depression and to analyze its impact on clinical symptoms and well-being.

More specifically, the intervention is framed within the area of CBM but it is rooted on techniques and change procedures used in cognitive-behavioral therapies. While original CBM studies train participants to change cognitive biases in an automatic manner, by forcing individuals to find positive outcomes to ambiguous scenarios, this new intervention focuses on teaching participants the meaning of emotional cognitive biases and how to modify them by using an effortful type of processing (i.e., looking for adaptive alternative interpretations to ambiguous stories).

The study has been design to overcome some of the limitations that have been pointed out in this emerging research area. Firstly, although there are recent efforts to understand how interpretation, attention and memory cognitive biases may be related, it is still not clear how they interact with each other. For this purpose, some authors have pointed out the need to use longitudinal data to see how one process may affect each other over time. Secondly, different systematic reviews and meta-analyses have investigated the moderating role of variables that may be affecting the heterogeneity of results found in CBM interventions. Mental imagery has been found to be a useful tool to help participants in their changing process, while there is no preferred number of sessions for these interventions. This study will help shed some light into this factors by using mental imagery during four sessions online.

Eligibility Criteria:
Inclusion Criteria:

* Present (PHQ-9) or past (DID) episode of depression.
* Access to Internet
* Fluent in Spanish language

Exclusion Criteria:

* Being under any psychological treatment
* Having a psychotic condition
* Having any cognitive impairment or condition that do not allow to follow the program
* Serious auditory or visual impairments
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed chronic genotype 1 or 3 HCV infection
* HCV treatment-naive
* Individuals will have cirrhosis status assessment; liver biopsy may be required.
* Screening laboratory values within predefined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Contraindication to ribavirin therapy
* Excessive alcohol ingestion as defined by protocol
* History of solid organ transplantation
* Current or prior history of clinical hepatic decompensation
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
Effect of Pulse Width on Scar Treatment Using a 595-nm Pulsed Dye Laser

To investigate the effect of pulse width on the treatment response of keloidal and hypertrophic sternotomy scars to a 595-nm pulsed dye laser

The pulse width of the previous model of pulsed dye laser was fixed at 0.45 millisecond, whereas the pulse widths of the latest model of PDL are tunable ranging between 0.45-40 milliseconds. The long-pulsed PDL has been proven to be safe and more effective in treating certain vascular abnormalities including adult port-wine-stain and small leg vein.9-12 In the present study, we would like to investigate the effect of pulse widths on the treatment response of keloidal and hypertrophic sternotomy scars to the 595-nm PDL.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, adult subjects aged above 18.
* Subjects must be in good health as determined by the investigator.
* Presence of keloidal and hypertrophic sternotomy scars for at least 6 months
* Subjects must have no prior treatment of the scar within 1 month before the first treatment session.
* Subject or authorized representative must sign Informed Consent Form prior to study enrollment.

Exclusion Criteria:

* Female subjects known to be pregnant.
* Subjects with scleroderma, connective tissue disorders, hematologic disorders, hepatitis, infection, or uncontrolled diabetes mellitus.
* Subjects with photosensitive dermatoses such as Systemic Lupus Erythematosus (SLE)
* Subjects with a documented positive HIV test.
* Subjects who are on any types of anticoagulants.
* Subjects who are habitual smokers of cigars, pipe tobacco, or cigarettes.
* Subjects with history of radiation treatment at treatment sites.
* Subjects who use of any types of treatment of scars at the treatment site within one month before the first treatment visit.
* Subjects who are on medication that may interfere with wound healing or hemostasis.
* Subjects that have not signed the Informed Consent Form.
Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)

Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care.

Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.

The study will include adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Trained health workers will conduct home care monitoring of pulmonary performance using oximetry, Quick Walk Test and Single Breath Count.

Monitoring will be done daily until disappearance of symptoms or hospitalization which will be requested by health workers or study coordination board on the basis of the monitoring results (blood oxygen level SpO2\< 90% OR SpO2\> 90% with desaturation index of at least 5% at Quick Walk Test)

Eligibility Criteria:
Inclusion criteria:

adult patients with suspected or confirmed COVID-19 for whom home care is considered appropriate.

Exclusion criteria: physical, mental or temporary impairments that preclude the conduction of the test
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery

As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).


Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ-Ⅱ
2. Aged 3-8 years, weight \> 10 kg, sex was not limited；
3. Children were scheduled for selective ophthalmic surgery under general anesthesia,

Exclusion Criteria:

1. Respiratory infection was present within 4 weeks before surgery.
2. Potential or presence of difficult airways, airway obstruction, sleep apnea, and other contraindications to general anesthesia.
3. The blood routine or blood biochemical indexes were obviously abnormal.
4. Allergy or hypersensitive reaction to test drug, including remimazolam, sevoflurane, and remifentanil.
5. Any child who has taken benzodiazepines in the last 3 months.
6. Unable to cooperate to complete the test, and the guardian refused to attend.
7. Other reasons that researchers hold it is not appropriate to participate in this trial.
Shrinking the Size of the Tobacco Power Wall

The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.

This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that we developed to evaluate how altering aspects of tobacco promotion at POS influences tobacco use risk during simulated shopping experiences. The study will use a between-subjects design, in which adolescents are randomly assigned to shop in the RSL under one of three conditions: (1) Large power wall/ multiple product units displayed; (2) Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single product units displayed. We will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 11 and 20

Exclusion Criteria:

* any medical or psychological condition that would make participation in the procedures of the study difficult (based on self-report).
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype

This study evaluated the safety \& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
Interventions to Improve the HIV PrEP Cascade Among Methamphetamine Users

Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.

Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.

Eligibility Criteria:
Inclusion Criteria:

* Meets the clinic's eligibility criteria for PrEP
* 18 years of age or older
* HIV-negative
* Cisgender man or individual on the trans gender variant spectrum who has sex with men
* Ability to understand, read, and speak English
* Reports meth use in the past 3 months
* Has a cell phone able to send and receive text messages

Exclusion Criteria:

* PrEP use in the prior month,
* Discomfort or anxiety with regards to text messaging.
* Has any circumstances that, based on the study staff's opinion, would preclude provision of informed consent, make participation unsafe, or make it unlikely the participant would be able to participate for 6 months.