cyrilzakka/clinical-trials huggingface dataset:
Acute Intense Paraphilic Desire (DSM-V) Down-Regulation Via taVNS Neuro-Modulation [Transcutaneous Afferent Vagus Nerve] With Future Operative Implant Consideration

Transcutaneous Afferent Vagus Nerve Stimulation \[taVNS\] is used to modulate persistent \& intense desire control amongst a specific participant group.

Testing Center Order of Deliver Number

taVNS Diagnostic Spectrum Testing Center Order of Delivery

1. - Addiction - Opioid
2. - Chronic Pain - Central
3. - Anxiety + Panic Disorder
4. - MDD - Major Depression Disorder
5. - Addiction - Nicotine
6. - ADHD
7. - Addiction - Stimulant
8. - Addiction - Sexual + Love
9. - Addiction - Paraphilia
10. - Parkinsons
11. - Immune Enhancing
12. - Addiction - Overeating

RE-ORDERED CLINICAL TRIAL - NINE

Physiologic effects of taVNS stimulation have been extensively researched for over 150 years. Drug-resistant depression (MDD), migraine headaches, pelvic pain modulation, facilitation of motor learning in neonates, post stroke rehabilitation and seizures are some of the conditions investigated with favorable results using taVNS intervention. taVNS physiologic \& mental effects have been noted to have advantageous therapeutic results on a vast diagnostic spectrum.

A clinical testing program for pre- and post-test was devised as a means to identify \& measure treatment effects in specific T3, 4 and early 5 (Tanner) sub-group visual stimulation. The programmatic (software) of the stimulation medium created for this study is aimed to abate the use of a phallometric device purposed to measure sexual stimulation effects on participants.

Great effort has been assigned for the preservation of visual data to be shared in the investigators' research centre with other researchers internationally. The participant testing platform created for this study allows for a full-proof research ethics anonymous \& confidential registry \& testing process (triple blind).

Aggressive optimum (supra-threshold and below-pain threshold) taVNS is the therapeutic modality of choice in order to examine desire down-regulation effects using taVNS. DSM-V stock participants must be sub-grouped in the paraphilic categorical structure of the DSM-V.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 60 years old - heterosexual identifying as he/him

Exclusion Criteria:

* 35 to 40 age group - heterosexual identifying as he/him
Protons Vs. Photons for High-risk Prostate Cancer

The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.

Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients.

Most PC patients treated with PT receive PT to the prostate gland alone. With PT, we aim to examine PC patients in high risk with both lymph node and prostate treatment will experience less late side effects with PT compared to photon treatment.

The investigators propose a national open-labelled phase III randomized controlled trial (RCT) of proton therapy versus photon therapy of the prostate including the regional elective LN for localized/locally advanced prostate cancer patients combined with androgen deprivation therapy (ADT) aimed at 3 years. The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinical significant, measured by mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel scores at 24 months and improve HRQOL. Secondary endpoints include morbidity, quality of life and survival data up to 10 years after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified localized/locally advanced prostate cancer T1-3bN0-1M0 (TNM 8th edition). A clinical T4 is allowed if it is because of invasion into the bladder neck.
* Adenocarcinoma (mixed histology allowed as long as the adenocarcinoma component comprise more than 50%)
* Indication for elective lymph node irradiation
* PSA \< 100 ng/mL
* Age ≥18 years
* Performance status 0-1
* Life expectancy ≥ 10 years
* Able to understand and comply with the treatment protocol
* No evidence of inflammatory bowel disease Ability to adhere to procedures for study and follow-up
* Signed informed consent to participate in the study

Exclusion Criteria:

* No previous treatment for prostate cancer
* Hip-prostheses
* Other metal devices in the pelvic region (except fiducials)
* Previous major abdominal/rectal surgery
* Any other malignancy the last five years except for basal or squamous cell skin cancer
* Unable to understand patient information or comply with treatment and safety instructions
* Unable to read and understand patient information due to cognitive disabilities or language (Danish).
Effect of Exercise on Vessel Diameter in Hemodialysis Patients

In this study, 100 hemodialysis patients aged between 18-65 were examined. Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercises for 30 minutes three times a week during hemodialysis sessions. Additionally, they engaged in walking exercises for 30 minutes three times a week outside of hemodialysis sessions, maintaining their heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels 2-3 days a week outside of hemodialysis sessions. The vessel diameters of the patients were measured by ultrasound at the beginning and after 12 weeks.

Background: As it is known, many negative situations occur in CKD patients on hemodialysis. One of these is the problems seen in the vascular access. The prevention and management of vascular access complications may benefit from exercise The purpose of this study is to investigate the effect of exercise on the vessel diameter in HD patients.

Methods: Present study we were included 100 hemodialysis patients between the ages of 18-65.Participants were randomly divided into two groups: the exercise group and the control group. The exercise group performed moderate-intensity aerobic exercise on a stationary bicycle ergometer for 30 minutes during hemodialysis sessions, three days a week over 12 weeks. Additionally, the exercise group engaged in walking exercise for 30 minutes, three days a week outside of hemodialysis sessions, maintaining the heart rate between 50-60%. The exercise group also performed isolated exercises to expand wrist vessels, including wrist and elbow flexion, extension, and rotation, repeated 10 times, 2-3 days a week outside of hemodialysis sessions. And the vessel diameters of patients were measured by ultrasound at the beginning and after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being between 18-65 years of age
* Undergoing hemodialysis treatment for at least 6 months
* Using arteriovenous fistula, arteriovenous graft, or permanent catheter as the vascular access type.
* Having no orthopedic, neurological, cardiac, or respiratory diseases that could hinder exercise
* Willingness to participate in exercise.

Exclusion Criteria:

* Access complications such as acute or chronic infections, inflammation, bleeding, aneurysms, stenosis, thrombosis, or any condition that hindered exercise,
* Acute or chronic cardiovascular complications such as cardiac arrhythmias, ischemia, heart failure.
* Hypertension, or hypotension that hindered exercise.
* Acute or chronic musculoskeletal injuries, pain, inflammation, or deformities that hindered exercise.
* Refusal to participate in exercise. were excluded from the study.
Vitality Health Incentives for Physical Activity

The aim of the study is to prospectively compare the effectiveness of diverse incentives on physical activity behaviour, in a cohort of newly-enrolled, adult members of the Vitality health promotion programme based in South Africa.

Newly enrolled adult members of the Discovery Health medical plan who have, themselves, prospectively registered for the Vitality health promotion programme will be eligible for the study, and will be invited to participate by Discovery Vitality. A final sample of 9000 adult members, who are recruited and have agreed to participate, will be randomly allocated by Discovery Vitality (with replacement) to one of six study (incentive) groups (n=1500 per group) and followed for six months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* enrolled in Vitality

Exclusion Criteria:

* under 18 years of age
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to \<5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to \<5 years on the day of inclusion
* History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
* In good general health at the time of inclusion
* Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria:

* Receipt of blood or blood products in the past 3 months
* Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
* Previous receipt of 2 doses of any vaccine against JE virus
* Known hypersensitivity to any of the vaccine components
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease

The study treatment period is 15 days in length and includes patients with pituitary Cushing's disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing's post operatively.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pituitary Cushing's disease within the two months prior to study entry
* Patients for whom written informed consent to participate in the study has been obtained
* Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended

Exclusion Criteria:

* Female patients who are pregnant or lactating
* Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
* Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C \> 10
* Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater)
* Patients with chronic liver disease
* Patients with clotting disorders or abnormal blood counts
* History of immuno-compromise, including a positive HIV test result
* Patients with active gall bladder disease
* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
* Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 30 years or older.
2. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
3. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
4. Subject must have a VAS pain scale greater than 30.

Exclusion Criteria:

1. Subject has active infection at the injection site.
2. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
3. BMI greater than 45 kg/m2
4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
6. Subject has had major surgery or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
12. Subject has had prior radiation at the site
13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
14. New diagnosis of gout in the past 6 month
15. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
16. Subject has a diagnosis of Osteonecrosis of the knee.
17. Subject has had a total knee replacement.
Long-term Safety and Tolerability of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria

This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets until the end of treatment in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have previously received and completed HRS-5965 study treatment, and are judged by the investigator to have treatment benefit and may benefit from continued treatment of HRS-5965;

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;
2. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
Effect of Myofascial Release by Foam Rolling on Back Muscles Endurance

This study evaluate the effect of the a low back self-application of myofascial release using a foam rolling on back muscles endurance measured by the Biering-Sorensen test.

Self-myofascial release performed with a foam roller is an incoming technique what is very popular in sport. Scientific literature currently suggests that the effects of self-myofascial release are mediated by the stimulation over neural and connective tissue. There is evidence that this stimulation could improve the maximum range of motion and decrease muscle soreness. Nonetheless, there is few evidence about the effects of self-myofascial release on muscle endurance.

Given the increased use of autonomously (self-treatment) in the athlete population, this study aims to assess the effect of a low back short application (60 seconds) on the back extensor muscles endurance measured by the Biering-Sorensen test.

With the obtained results we want to elaborate an evideced based recommendation about its use prior to physical activity or sports competition.

Eligibility Criteria:
Inclusion Criteria:

* Basketball players, between 18-25 years who participate on a official league and do regular physical training (4 training sessions 1.5 hours each and a competitive session a week)
* Be able to read and understand the premises of the informed consent of the study.

Exclusion Criteria:

* to present some osteo-articular and / or muscle-tendon pathology that could be exacerbated by the implementation of the Biering-Sorensen test or by the intervention with foam compression.
Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

A standard clinical gait analysis consists of observing walking with video (2D) or advanced equipment (VICON 3D). This 3D method provides detailed information about the gait pattern, but is time-consuming in implementation and data analysis. There are commercial 3D systems on the market that are used in healthy individuals and in sports. These so-called Inertial Measurement Units (IMUs) may also be suitable for use in the clinic. In this research protocol, the aim is to test the usability of commercial sensors and technically compare them with standard clinical 3D gait analysis in adult patients with a neurological disorder.

Measurements will include subjects that perform routine clinical 3D gait analysis because of a clinical question related to stiff knee gait or surgical intervention of the foot. During routine clinical gait analysis, Vicon markers and EMG-measurements of specified muscles is included. IMU-sensors will be included to this routine measurements to measure accelorometer, gyroscope and magnetometer data of both feet, both upper and lower legs, the sternum and the sacrum.

Eligibility Criteria:
Subjects referred for clinical gait analysis at Roessingh Centre for Rehabilition in Enschede, the Netherlands:

Inclusion Criteria:

* Disorders affecting walking, including amongst others stroke, traumatic brain injury, MS, incomplete spinal cord injury, CP, Spina Bifida, neuromuscular diseases
* age minimum 18 years
* Viosca score minimum 2; meaning minimal independent walking ability indoors
* increased fall risk or increased effort of walking because of: 1) decreased stability during stance; and/or 2) decreased foot clearance during swing; and/or 3) not able to walk on bare feet because of equinovarus; and/or 4) fatigue during walking because of compansatory strategies.

Exclusion Criteria:

* subjects referred for clinical gait analysis because of problems other than stiff knee gait or foot surgery
* severe deficits in communication, memory and understanding at such a level that it would affect instructions during the measurements
The Satiety Effect After Okara Compared to Porridge Eating

To examine the satiety effect after eating of Okara.

This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after.

Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 20-65 years old
* Written Informed Consent

Exclusion Criteria:

* History of gastro-intestinal surgery
* On medication that may influence gastric emptying, or medication for weight loss
* Patient on PPI treatment, H2 Blockers or medication for weight loss
* Known allergies to soy
* Pregnancy or breast-feeding
* Smoking
* Athletes
* Metabolic syndrome or diabetes mellitus
* Family history of metabolic syndrome or diabetes mellitus
* Weight loss \> 2 kg during two months before the study
The Effect of Hybrid Simulation-Based Lactation Consultancy Training on the Skills of Midwifery Students

This research was planned to examine the effects of hybrid simulation-based breastfeeding consultancy training on midwifery students' psychosocial care competence and communication skills. The research population will consist of second-year students studying at Health Sciences University (SBU), Hamidiye Faculty of Health Sciences (HSBF), Department of Midwifery in the spring semester of the 2023-2024 academic year (N: 80). Students participating in the study will be divided into intervention (n: 40) and control (n: 40) groups according to the computer-assisted simple random sampling technique. Control group students will practice on a simple breast model within the scope of classical education. "Descriptive Information Form", "Psychosocial Care Competency Self-Assessment Scale" and "Communication Skills Scale-Adult Form" will be applied to the students participating in the research.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in research.
* Being an active student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.

Exclusion Criteria:

-Being a passive student in the second year of the University of Health Sciences, Hamidiye Faculty of Health Sciences, Department of Midwifery.
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Cerebral Autoregulation in Lowlanders

Prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on cerebral autoregulation

Baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 8 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants will return to the Santiago area (520 m) for a 6 day recovery period.

A second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility Criteria:
Inclusion Criteria:

* Born, raised and currently living \<800m
* No overnight stay at altitudes \>1500 m 4 weeks before the study

Exclusion Criteria:

* Previous altitude intolerance to altitude \<3000 m
* Pregnancy
* Health impairment, which requires regular treatment