cyrilzakka/clinical-trials huggingface dataset:
Neuroplasticity in Parkinson´s Disease After Training

This project aims to determine the effects of the HiBalance program on neuroplastic changes in people with mild to moderate Parkinson´s disease. The main hypothesis is that highly challenging exercise will lead to greater gait and balance ability, increased levels of physical activity and an improved health related quality of life. The investigators further hypothesize that neuroplasticity changes will be seen in corresponding areas of the brain, neuropsychological changes on cognitive test measures, and that exercise will inhibit the degeneration of dopaminergic neurons in the brain through the mediation of neurotrophic factors.

Parkinson's disease (PD) is a neurodegenerative disease affecting many physiological systems essential for balance control. New findings suggest that intensive, challenging and cognitively demanding exercises could induce neuroplasticity in PD. A new balance training (the HiBalance program) have therefore been developed; emphasizing critical aspects of balance control through highly challenging and progressive exercises incorporating dual/multi-tasking (Conradsson et al, 2012). In an RCT, the HiBalance-program was shown to improve balance, gait and physical activity level in favor for the training group (Conradsson et al, 2015). In this proposal the investigators will combine physiotherapy, neurology and neuroimaging to characterise and determine the effects on physical and cognitive symptoms as well as structural and functional changes and wet biomarkers in the brain after the training.

Participants will be recruited through Karolinska University Hospital and via announcements in relevant forums like for instance the Swedish Parkinson Association. According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention, the investigators anticipate 40 to 50 participants in each group to detect significant changes.

The investigators will perform both per protocol analysis and intention to treat analysis using mixed model or repeated measurement ANOVAs if the data is normally distributed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson´s disease
* Hoehn \& Yahr 2-3
* ≥ 60 years of age
* Be able to ambulate indoors without mobility aid
* Balance impairment

Exclusion Criteria:

* =\< 21 points on MoCA
* Other medical conditions that could substantially influence balance performance, voice or speech performance or participation in the interventions
* Participating in an intensive exercise program for balance or speech during the last six months.

Additional exclusion criteria for the brain imaging will include the presence of; pacemakers, deep brain stimulators or other MRI incompatible implants, claustrophobia, inability to hear instructions without hearing aid, unilateral or bilateral blindness, severe diplopia, tremor, dyskinesia or dystonia.
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET

The objective of the present study is to use positron emission tomography brain imaging to investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that clinically relevant doses of buspirone will occupy the D3 receptor.

Buspirone is used for anxiety disorder treatment, a therapeutic effect that has been thought to be mediated through its partial agonist properties at the serotonin receptor. However, since one PET study in humans has shown low occupancy of the serotonin by buspirone in clinical doses and since the DRD3 has been recently implicated in anxiety, some therapeutic effects of buspirone may be mediated through the DRD3. In human clinical studies, promising effects of buspirone have been reported for treatment of substance dependence, including tobacco, marijuana, and opiates, and clinical studies in cocaine dependent subjects are underway. However, it is unclear if buspirone is producing those effects through the DRD3 and no human study has incorporated a PET imaging component to investigate this question; it remains unclear whether buspirone significantly occupies the DRD3 at therapeutic doses in humans.

Eligibility Criteria:
Inclusion Criteria:

- 19 years or older

Exclusion Criteria:

* Medical condition including cardiovascular, renal, hepatic or cerebrovascular diseases
* History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor, - Present or past psychiatric condition including mood, anxiety, psychotic disorders and substance abuse and/or dependence.
* Condition that precludes use of buspirone or that will interfere with participation in the present study (such as hypersensitive to buspirone hydrochloride).
* Pregnancy or breastfeeding.
* Presence of metal objects in the body or implanted electronic devices, that preclude safe MR scanning.
* Claustrophobia.
* Current use or use during the previous month of medication that may affect the CNS, including monoamine oxidase inhibitor (MAOI) or positive during drug screening for drugs of abuse or any medication that could increase the risk of buspirone administration.
* Exposure to radiation in the last 12 month exceeding permissible limit for subjects participating in research.
Levosimendan Efficacy for Veno-arterial ECMO Weaning: a Retrospective Study

Failure of Weaning from ECMO is a serious complication, reaching an incidence between 29 and 58%. Inotrops are frequently used to help separating patient from ECMO. Levosimendan is an ino-dilatatory medication and was used in different clinical settings. The aim of this study was to evaluate the benefit with levosimendan when used in weaning process.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patient requiring the need for short-term assistance
* Patient who has agreed to use his medical data for research purposes

Exclusion Criteria:

* Refusal to participate in the study
* Non-weaning attempts due to a death under assistance or a relay by a long-term assistance or heart transplant
* Non-cardiac indications of assistance (indication of pulmonary replacement)
* Subject under guardianship or curatorship
A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis

FRTX-02 is an orally-available, potent and selective DYRK1A inhibitor.

This is a randomized, placebo controlled, double blind study in healthy subjects and subjects with atopic dermatitis that is designed to assess the safety and tolerability of FRTX-02 capsules at single and multiple ascending doses.

Safety will be assessed through vital signs, ECG, adverse events and safety laboratory tests.

Pharmacokinetic and pharmacodynamic information will also be collected.

Eligibility Criteria:
Selected Inclusion Criteria

Part 1 (SAD/MAD)

* Healthy male or female
* 18-55 years of age, inclusive
* At least 50 kg in weight (males) and 45 kg in weight (females)
* BMI 18.5-30.0 kg/m2, inclusive

Part 2 (Subjects with AD)

* Male or female with atopic dermatitis
* 18-65 years of age, inclusive
* BMI 18-40.0 kg/m2, inclusive
* Validated Investigator's Global Assessment (vIGA-AD) score of ≥ 3 (moderate)
* Body surface area (BSA) with AD involvement ≥ 10%
* History of inadequate response to treatment with topical medications (e.g., corticosteroids, calcineurin inhibitors, etc.) or subjects for whom topical treatments are otherwise medically inadvisable.

Selected Exclusion Criteria

Part 1 (SAD/MAD)

* Use of tobacco products within 3 months prior to drug administration
* History of alcohol abuse or drug abuse
* Positive urine drug screen, alcohol breath test, or urine cotinine test
* Participation in a clinical research study involving the administration of an investigational or marketed drug within 30 days prior to drug administration
* Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.

Part 2 (Subjects with AD)

* History of alcohol abuse or drug abuse
* Positive urine drug screen, alcohol breath test, or urine cotinine test
* Participation in a clinical research study involving the administration of an investigational or marketed drug within 12 weeks prior to drug administration
Special Drug Use Surveillance of Irribow in Female Patients

The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with diarrhea-predominant irritable bowel syndrome

Exclusion Criteria:

-
Study of the Safety of QRH-882260 Heptapeptide

The purpose of this study is to evaluate the safety of orally administered QRH-882260, a topically administered Cy5-labeled heptapeptide specific for epithelial growth factor receptor (EGFR).

This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to be eligible based on a screening questionnaire will be scheduled for a study visit at MCRU. At the study visit, the subjects will review and sign the informed consent and eligibility will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a urine sample for urinalysis. A baseline EKG will be recorded. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes. Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260 heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess toxicity after post-ingestion labs (within 7 days).

Eligibility Criteria:
Inclusion Criteria

* Adults age 25 to 100 years
* Not pregnant (willing to have pregnancy test if applicable)
* No recent illness (infection, URI, virus or flu) within 2 weeks,
* Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI)
* Willing and able to sign informed consent
* Willing and able to drink the peptide and a tap water chaser
* Willing and able to get baseline and 24-48 hours post ingestion labs Exclusion Criteria
* Known allergy to Cy5 or derivatives, such as indocyanine green (ICG)
* Subjects on active chemotherapy or radiation therapy
* Diabetics on insulin/hypoglycemic (due to fasting requirements)
Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation).

Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest - this is known as lung hyperinflation. We believe that breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing; this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.

Each subject will attend 4 visits to the laboratory. Visit 1 (screening visit) will involve a record of medical history, medications used, anthropometrics measurements, questionnaires, breathing tests, an incremental cycle exercise test and a constant-workload cycle exercise test. Visit 2 will involve breathing tests and a constant-workload cycle exercise test. Visits 3 and 4 will involve breathing tests and a constant-workload cycle exercise test after subjects have been randomized to either placebo or Atrovent. These visits will be done on separate days and subjects will receive the two above treatments in random order.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild COPD OR healthy control subjects
* 40-80 years old
* able to perform all study procedures
* Smoking history \> 10 pack years (for mild COPD) or smoking history \< 10 pack years (for healthy control subjects)

Exclusion Criteria:

* allergy to atrovent
* history of asthma, atopy or nasal polyps
* Oxygen desaturation \< 80 % during exercise
* recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation
CGM Utilization With IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU

The goal of this study (CGM utilization with IV Insulin EndoTool and Subcutaneous Insulin in the Neuro ICU) is to understand how CGM technology utilized in conjunction with EndoTool IV insulin could improve glycemic management in the NeuroICU, specifically in predicting and preventing hypoglycemic and hyperglycemic episodes with resultant improvement in patient morbidity and mortality. The second arm of the study will focus on how CGM technology utilized in patients on basal bolus subcutaneous insulin while on high dose glucocorticoids could impact glycemic management. The main questions it aims to answer are:

1. Is CGM technology data accurate compared to the current standard point of care among NeuroICU patients?
2. How CGM technology could improve glycemic management in the critical care setting, specifically in predicting and preventing hypoglycemic episodes with IV or subcutaneous insulin?
3. How CGM technology could help treating hyperglycemia in the NeuroICU with resultant improvement in patient morbidity, mortality, and length of stay?

The study is comparing current standard of care blood glucose fingersticks or serum blood glucose collection to CGM data utilizing the Freestyle Libre 2.0 CGM. A recently conducted study of 8 critically ill patients with diabetes that wore Freestyle Libre 2.0 CGM's during their ICU stay demonstrated high test-retest reliability and acceptable accuracy when compared with arterial blood glucose measurements. The study aims to evaluate utilization of CGM technology and EndoTool in the critical care setting by recruiting a cohort of 10 participants with hyperglycemia and/or diabetes mellitus who are anticipated to require blood glucose monitoring and IV insulin to achieve adequate glycemic control while in the Neuro ICU. The study also aims to evaluate utilization of CGM technology and subcutaneous insulin by recruiting a cohort of 10 patients with a history of diabetes mellitus on high dose steroids who are anticipated to require blood glucose monitoring and treatment with basal bolus insulin.

Participants will be enrolled on admission to the Neuro ICU and have the CGM device placed. The study aims to evaluate CGM technology by comparison of glucose values obtained from the CGM to the serum or fingerstick blood glucose levels while the patient is either receiving IV insulin via EndoTool or subcutaneous insulin while on high dose glucocorticoids. Current standard of care with monitoring glycemic data utilizing point of care blood glucose fingersticks and serum glucose will be utilized for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Participants that are 18 years of age or older with hyperglycemia and/or diabetes mellitus with need of IV insulin management or subcutaneous insulin with concomitant high dose glucocorticoids who are admitted to the Neuro ICU at Atrium Health Wake Forest Baptist Hospital.

Exclusion Criteria:

* Pregnant women will be excluded from this study.
InvesT1D: Promoting Adolescent Investment in Diabetes Care

The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.

Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.

Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management.

The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual.

Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 1 diabetes ≥12 months
* Utilize a continuous glucose monitor (CGM) to support diabetes management
* Average daily CGM use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day
* Are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
* Cognitively able to participate in incentive program and complete surveys
* Have access to a mobile phone to receive information about goal attainment and incentive updates
* Have the ability to upload glucose and insulin administration data remotely per processes used by participant's diabetes care team
* Caregivers are willing to participate in study and complete surveys

Exclusion Criteria:

* At time of screening, average CGM wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day
* Adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
* Cognitively or physically unable to participate
* Adolescent is a ward of the state
* Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
* Caregivers are not willing to participate in study and complete surveys
High Dose Chemo With Autologous BMT for Treatment of Metastatic Breast Cancer

To evaluate the response rate and the response duration of high dose chemotherapy with autologous bone marrow transplantation as intensification following induction chemotherapy in metastatic breast cancer and to evaluate prospectively the subdivision of patients with metastatic breast cancer according to prognostic groups.

There are 2 phases to this study: 1) Induction- which consists of the administration of chemotherapeutic drugs- at the end of this phase if the cancer has responded, bone marrow will be collected and frozen untol ready for re-infusion; 2) 2nd phase- involves high-doses of chemotherapy followed by infusion of bone marrow cells

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of breast cancer
* Age 18-70
* Breast cancer at first clinical evidence of metastatic disease
* Must have objectively measurable or evaluable disease or be in complete remission

Exclusion Criteria:

* Previous diagnosis of another invasive carcinaom within 10 years (except skin cancer)
* CNS involvement
A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.


Eligibility Criteria:
Inclusion Criteria:

* Plaque psoriasis involving up to 2 to 20% Body Surface Area

Exclusion Criteria:

* Lesions solely involving intertriginous areas, the scalp or the face
* Systemic therapy for their psoriasis
* Pustular psoriasis or erythroderma
* Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the first dose of study medication
* Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis
* Receiving systemic triazole antifungals except fluconazole
Predictors of Treatment Failure Pain Among Patients Gunshot Wounds

In patients with gunshot wounds during hostilities in Ukraine, 76.9% have negative results of pain treatment, which leads to its chronicity. Identifying predictors of negative pain outcomes in these patients may improve their treatment outcomes.

One of the strongest factors that has a psychological impact on a person is war and conditions in which injury occurs, conditions in which pain occurs. A gunshot wound received during the war in the conditions of hostilities becomes the reason for the indisputable association of pain sensations with the events in which the patient was injured. It is pain and memories, memories and pain that cause the development of states with self-destructive behavior. According to statistics, gunshot wounds account for 54-70%. Gunshot wounds to the chest during anti-terrorist operations/OOS make up 7.4-11.7%, shrapnel wounds prevail here - 72.2%, explosive wounds - 17.5%, bullet wounds - 10.3%, and lethality - 12.2 -25%. According to the data of the Command of the Medical Forces of the Armed Forces of Ukraine, in the structure of gunshot injuries, 64% are injuries to the limbs: of them, 74.8% are soft tissues, 25.2% are gunshot fractures, bone defects are noted in 11.6% of patients, and wounded.

The study of predictors of negative results of pain treatment in patients with gunshot wounds requires in-depth study, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions have their own characteristics. Since in 76.9% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility Criteria:
Inclusion Criteria:

* presence of gunshot wounds during hostilities, male gender

Exclusion Criteria:

* absence of gunshot wounds during hostilities, other sex