cyrilzakka/clinical-trials huggingface dataset:
Ursodiol in Huntington's Disease

The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is processed by the body.

Huntington's disease is an inherited neurodegenerative disease that causes a movement disorder, dementia, and psychiatric and behavioral disturbance in affected individuals.

Tauroursodeoxycholic acid (TUDCA) is a bile acid synthesized in the liver by the conjugation of taurine to ursodeoxycholic acid (UDCA). It is thought to function as an anti-apoptotic agent in HD, evidenced by studies in toxic cell models and both toxic and transgenic rodent models of the disease.

Ursodiol is a commercially-available exogenous form of UDCA, the precursor of TUDCA. Although the compound has an established dosing, safety, tolerability and efficacy profile in patients with hepatobiliary disorders, gaps exist in the understanding of the pharmacokinetics / pharmacodynamics of the compound, particularly in patients with normal gastrointestinal function, and no human data exist for its therapeutic use in neurodegenerative disorders. The specific aims of this study are:

1. To establish whether treatment with the drug ursodiol will result in measurable levels of its bile acid metabolites in serum and CSF at standard oral doses; and whether a dose-response can be detected using these measures.
2. To establish a preliminary safety and tolerability profile of the drug in subjects with HD.

Eligibility Criteria:
Inclusion Criteria:

* All subjects will be age 18 or older
* All subjects will have manifest Huntington disease determined by clinical exam plus either documented prior DNA testing for the HD gene or a documented family history of the disease

Exclusion Criteria:

* Subjects taking oral contraceptives, cholestyramine, colestipol, or aluminum-based antacids will be excluded
* Subjects with known allergy or other contraindication to the study drug will be excluded
* Subjects with bleeding diathesis, or on coumadin or mandatory aspirin will be excluded
* Subjects with unstable medical or psychiatric illness will be excluded
* Subjects with clinically significant lab / EKG abnormalities at screening will be excluded
* Subjects who are currently pregnant or breastfeeding will be excluded
An Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan

This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention). Participants will complete a questionnaire at baseline and 4 months.


Eligibility Criteria:
Inclusion Criteria:

* Aged 16-24
* Own a personal Android mobile phone
* Live in Tajikistan

Exclusion Criteria:

* Cannot read Tajik or Russian
The Impact of a Heart Failure Review on Self-Care Knowledge, Adherence and Clinical Outcomes

This study is assessing the effects of a new heart failure self-care education program in the Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of an initial intensive self-care education session with the Principal Investigator or her nurse practitioner. Topics to be discussed include medications, sodium and fluid consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as studies have shown that the impact of HF education is not always durable and must be a continual process. This study will assess the impact of this review on their medication knowledge, disease state knowledge, quality of life, disease state progression and clinical outcomes such as ejection fraction and number of hospitalizations.

This is an observational study as all patients in the heart failure clinic, regardless of whether or not they will choose to be in the study, will receive heart failure self-care education from now on.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ages 19 and older
* Able to speak, read and understand English and able to understand and provide informed consent
* Diagnosis of cardiomyopathy and/or HF, preserved or reduced ejection fraction

Exclusion Criteria:

* Patients not-responsible for self-care.
* Inability to provide written informed consent.
* Co-morbid condition with an expected survival of less than six months.
Effect of Beta-Alanine on Heart Rate Response

Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. The physical working capacity test has been used to show significant increases in physical working capacities following supplementation. The physical working capacity tests were originally developed by Moritani et al. 1981 and Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized that beta-alanine will increase physical working capacity at heart rate threshold, thereby signifying a delay in fatigue.

An equal number of men and women will be recruited \[Men, n=20 (10 placebo \[PL\]; 10 beta-alanine (Active)\]; \[Women,n=20 (10 PL; 10 Active)\]. Men and women will be randomly assigned to respective groups to allow for equal numbers in supplement and placebo groups.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-35 years old
* Be recreationally active (defined as accumulating 1-5 hours of moderate intensity

Exclusion Criteria

* Any health risks or indicators that would prevent them from participating in physical activity, as determined by a health history questionnaire
* Must not have taken performance enhancing supplements containing beta-alanine or creatine during the last 3 months
Schizophrenia TreAtment With electRic Transcranial Stimulation

The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct current stimulation) for treatment of negative symptoms in patients with schizophrenia. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study. Participants will receive ten sessions of active or sham stimulation in five consecutive days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests. Another goal is to see improvement in biological markers related to schizophrenia, plasma and DNA will be stored.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID
* Minimum score of 20 points in the sum of negative PANSS
* Stable antipsychotic medications

Exclusion Criteria:

* Unstable medical illness
* Uncontrolled pretreatment with rTMS or tDCS
* At least six months without being in ECT
* Benzodiazepines in doses of 10mg of diazepam
* Electronic or metal implants in the cephalic segment.
* Other mental disorders and dependence of substances
Clinical Trials of Five Different Food Supplements With Restriction Diet in Adults

In recent years, dietary supplement are of great interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical and anthropometric parameters.

The incidence of obesity has been rapidly increasing, and this condition has become a major public health threat, since it is strongly linked with increased risk for several diseases including type 2 diabetes, cardiovascular disease, cancer and brain aging. Obesity and overweight are chronic disorders of multifactorial origin that are characterized by high oxidative status and by low chronic inflammation. Thus far, molecular mechanisms underlying obesity and obesity-related metabolic disorders have not been fully clarified, and effective therapeutic approaches to lower inflammation and oxidative stress are currently of general interest.

In recent years, dietary supplement and are of interest for the improvement of human health. This study is designed as a parallel, randomized, double blind study exploring the efficacy of two months daily oral dosing of five different food supplements together with diet restriction in 120 otherwise healthy overweight or obese adults on different biochemical (lipid profile, glucose, C-reactive protein, bilirubin, alanine aminotransferase, etc), and anthropometric parameters (body mass, the percentage of body fat, visceral fat index, etc,...). Food supplements are mainly composed of different fiber and other bioactive compounds.

Eligibility Criteria:
Inclusion Criteria: BMI \> 25 kg/m2

* BMI \> 25 kg/m2
* personally signed and dated informed consent form
* ability to understand and willingness to comply with all protocols required visits assessments and interventions

Exclusion Criteria:

* use of dietary supplements
* use of medication for any component of metabolic syndrome
* presence of inflammatory and/or autoimmune disorders
* pregnancy or lactating
Evaluation of the Clinical Effectiveness and Safety of Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction

This is the multi-centered, open, prospective and retrospective study of up to total 120 subjects in breast reconstruction surgery with applying acellular dermal matrix(ADM). The aim of the study is to ascertain any difference in the rate of complications between the test group of undergoing breast reconstruction with SC Derm and the control group of taking breast reconstruction with other ADM products.

In South Korea, breast reconstruction surgery using implants or autologous abdominal tissue is commonly performed as the standard treatment to address the aesthetic and psychological needs of breast cancer patients who have undergone total mastectomies. In this procedure, acellular dermal matrix (ADM) is used to compensate for the skin deficit resulting from the removal of cancerous tissue. This clinical study is designed to ascertain whether there are differences in clinical efficacy, aesthetic outcomes, and safety in breast reconstruction surgery using ADM processed with supercritical carbon dioxide technology compared to other ADMs. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology). The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 20 to 69 scheduled for total mastectomy
* Patients who are willing to undergo immediate breast reconstruction using implants.

Exclusion Criteria:

* Patients who have undergone organ transplantation and are currently taking immunosuppressive medication.
* Patients with mental conditions that could impact the conduct of the clinical study, such as alcohol or drug abuse.
* Patients who have participated in another clinical trial within 120 days prior to screening.
* Any other cases where the investigator deems the patient unsuitable for this clinical study.
Study Evaluating the Pharmacokinetics of a Single Microdose of ACD856

This is a Phase 0, open-label, non-controlled, single-centre study designed to evaluate the pharmacokinetics (PK) and safety and tolerability of a single, bolus intravenous (iv) injection of a microdose of ACD856 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged \>18 and \<65 years.
* Signed and dated informed consent prior to any study-mandated procedure
* Willing and able to comply with study requirements.
* BMI \>18.0 and \<30.0 kg/m\^2
* Male subjects must be willing to use condom or be vasectomised or practice sexual abstinence to prevent pregnancy and drug exposure of a partner and refrain from donating sperm from the date of dosing until 3 months after dosing with the IMP.
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.

Exclusion Criteria:

* History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
* Any planned major surgery within the duration of the study.
* Clinically relevant findings in laboratory parameters, ECG or vital signs at screening
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
* Regular use of any prescribed or non-prescribed medication
* Planned treatment or treatment with another investigational drug within 3 months
* Current smokers or users of nicotine products.
* Positive screen for drugs of abuse or alcohol at screening
* History of alcohol abuse or excessive intake of alcohol
* Presence or history of drug abuse
* History of, or current use of, anabolic steroids.
* Excessive caffeine consumption
* Plasma donation within one month of screening or blood donation during the 3 months prior to screening.
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)

This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.

Research Question: This is the pilot phase of a two-phase study. Phase 1 - What is the feasibility of conducting a randomised controlled trial of therapy for adults with post-stroke communication impairment? to be followed in 2006 by Phase 2 - What are the effectiveness, costs and service user preferences, for the provision of speech and language therapy for communication difficulties experienced by people in hospital with a stroke? Methodology: Phase 1 - Qualitative (focus groups \& individual interviews) and quantitative (pilot RCT). Phase 2 - Qualitative (focus groups \& individual interviews) and quantitative (a pragmatic, multicentred, randomised controlled trial, stratified by diagnosis and therapist/centre, using an 'intention to treat' approach). Discrete choice experiments will be used to determine cost effectiveness.

Outcome Measures: The primary outcome will be functional communicative ability. The economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. The qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment.

Sample Group: Adults with dysarthria or aphasia, seen early after admission to hospital with a stroke. Exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.

Eligibility Criteria:
Inclusion Criteria:

* Adults with communication impairment following a new stroke

Exclusion Criteria:

* Not fluent in the English language
* Subarachnoid haemorrhage
* Pre-existing, progressive dementia or learning disability
* Palliative care only or deceased since admission
* Resident outside the treatment area
Family-Implemented Treatment on the Behavioral Inflexibility of Children With Autism

The overall goal of this project is to determine whether a new form of family-based treatment for repetitive and inflexible behaviors, delivered using videoconferencing technology, can counter any negative effects of those behaviors, but also improve positive outcomes for young children with ASD.

The overall goal of this project is to conduct a parallel group randomized controlled trial comparing remote delivery of FITBI (13-week intervention + 3 booster sessions over 6 months) to remote delivery of a parent education only (PE) control condition in a final sample size of 100 (3 years, 0 months to 9 years, 6 months) children with ASD and high rates of ritualistic repetitive behaviors. We will use TORSH, a comprehensive secure online platform that enhances therapist-parent coaching via telehealth. Further, an important objective of this proposal is to examine child and parent factors associated with treatment response and uptake in order to advance translational research and knowledge on personalized intervention approaches. Thus, the aims of this project are to:

Aim 1: Examine the acute and distal effects of the FITBI intervention on child and parent outcomes.

H1: In comparison to a PE only condition, FITBI will result in reductions in children's repetitive behaviors and increases in appropriate play skills immediately post-treatment.

H2: Effects of the FITBI intervention will be maintained at a 6-month follow-up and increases in child adaptive functioning and decreases in parent stress will be found.

Aim 2: Determine if the FITBI intervention shows differential treatment effects for lower versus higher order repetitive behaviors.

H1: FITBI will be effective at treating both lower and higher order RRBIs.

Aim 3: Examine if child variables (i.e., IQ and anxiety) moderate treatment response.

H1: Based on prior behavioral intervention research, it is hypothesized that children with higher IQs and fewer symptoms of anxiety at pretreatment, will show a better treatment response.

Aim 4: Explore if parent variables (i.e., SES, race/ethnicity, marital status, and stress) predict intervention fidelity and telehealth acceptance.

H1: As this is an exploratory aim, we do not have specific hypotheses.

Eligibility Criteria:
Inclusion Criteria:

* ASD criteria on Social Communication Questionnaire-Lifetime and Autism Diagnostic Interview-Revised.
* Between ages of 3 years, 0 months and 9 years, 6 months
* exhibiting clinically significant levels of repetitive behavior (Score \>26 on Repetitive Behavior Scales-Revised
* prior clinical or medical diagnosis of autism spectrum disorder

Exclusion Criteria:

* diagnosed comorbid genetic disorder known to associated with increased symptom severity
* child engages in serious self-injurious behavior with intensity or frequency that warrants hospitalization
* change in psychotropic medications within last 6 weeks
* child already receives \>20hours per week of home-based ABA services
Antigen Presentation and Lymphocyte Response in Parkinson's Disease

The way the immune system responds to certain PD-related proteins in PD donors compared to the way it responds in persons without or fewer PD related proteins is not well studied and this study aims to analyze the autoimmune response in each group. The study involves a one time visit involving brief questionnaires and a blood draw of 30 mL (approximately 2 tablespoons) to be collected.

The role of the immune response in Parkinson's disease (PD) is controversial. Recent studies show that neurons can present MHC-I (major histocompatibility complex - class 1) molecules and therefore may be susceptible to an attack by immune cells. The investigators anticipate that the results of this study will improve our understanding of the mechanisms of immune mediated neuronal degeneration in PD. Initial results suggest that antigens are presented by neuronal MHC-I in PD, and that this could lead to T-cell mediated neuronal death. The most obvious antigen that could be differentially expressed in PD patients and controls would be alpha-synuclein (-syn): -syn oligomers appear in all Lewy bodies and Lewy neurites and are the hallmark of PD changes in the brain. This study will offer the opportunity to further characterize the immune mediated component of PD, and to continue elucidating the biology that underlies antigen presentation and T-cell cytolytic activity.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to advanced PD with classic motor features, and must demonstrate two of the following three: rest tremor, rigidity, or bradykinesia
* Dopaminergic medication benefit (self-reported improvement)
* Age at recruitment: 50 - 90 years
* Age at diagnosis \> 47
* PD duration \> 3 years
* Willingness to have genotyping and genetic studies as part of laboratory research

Exclusion Criteria:

* Atypical parkinsonism or other neurological disorders
* Recent history of cancer (past 3 years)
* Autoimmune disease (except thyroid disease)
* On chronic immune-modulatory therapy (e.g. SIT (specific immunotherapy), anti-IgE)
* Inability to provide informed consent
The Impact of Involving Informal Health Providers for Tuberculosis Control in Sudan

Training and engaging of unpaid informal providers (such as tea-sellers, women's groups, youth clubs, small traders and religious groups) from poorer localities in TB disease recognition, referral and community awareness raising will increase the access of TB patients to formal health facilities and decrease their delay in initiating TB treatment.

Barriers to accessing health services faced by poor and vulnerable populations are numerous in developing countries. These include; geography, income poverty, lack of trust in the quality of public health services, and lack of empowerment of women and adolescent girls (as patients and carers) to mobilize adequate and timely resources to access these services.

The project aims to test if TB case detection can be increased by engaging informal health care providers in active case finding. In one urban district of Khartoum, these providers will be trained to work as first point of entry to the health system using a comprehensive package that includes disease recognition, health communication, and patient referral. In a comparator urban district of Khartoum, no attempts will be made to engage informal providers.

By comparing data of TB patients and Lab registers between the intervention and comparator districts in Khartoum, this project aims to test if, and to what extent, these expected effects can be realized.

Overall this is a trial of a health policy so individual patients will not be recruited or randomized to one intervention or the other. Rather the policy is being applied in one district while the other district is being used as a comparator.

Eligibility Criteria:
Inclusion Criteria:

* Access point for health seeking by the poor and vulnerable
* Active and well known in community
* Intervention activities can be confined to intervention area
* Based in community/locality
* Longevity; long standing
* Present in control and intervention areas
* Able and willing to complete the training to be Triage-Plus providers (ie giving formal consent)

Exclusion Criteria:

* Formal health providers, e.g. clinics, labs, hospitals (MOH, NGO or private)
* Internationally funded organizations, e.g. international NGOs
* Civil servants e.g. teachers