cyrilzakka/clinical-trials huggingface dataset:
Early-Phase Safety of Proton Therapy Equipment

The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries' proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on tumors, as well as to assess the operating functionality of the proton therapy system.

The main purpose of this study is to collect the safety data of Sumitomo Heavy Industries' proton therapy equipment for the treatment of solid cancer patients in Linkou Chang Gung Memorial Hospital, including the patients' early-stage adverse reactions and the efficacy on tumors, as well as to assess the operating functionality of the proton therapy system.

In this study, solid cancer subjects will be treated with Sumitomo's proton therapy system. Safety and operating functionality data will be collected during the treatment and following-up.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are pathologically confirmed to be suffering from solid cancer or brain tumor
2. Subjects who are measurable or with disease that is evaluable
3. Subjects who are expected to survive for at least 90 days
4. Subjects who did not receive any treatment that may affect this treatment (such as PEI, TAE) 4 weeks before they are chosen to receive this treatment
5. ECOG Performance Status (ECOG PS): 0, 1 or 2
6. Patients who can cooperate with the treatment requirements and maintain the gestures required during the irradiation process
7. Patients with well functioning main organs
8. The subject retained main organ functions.
9. The subject age is between 20-75 years old

Exclusion Criteria:

1. Subjects who once received radiotherapy on the area planned to be irradiated
2. Subjects whose irradiated area has active or persistent infectious disease
3. Pregnant or possibly pregnant subjects
4. Subjects with other serious complications
5. Subjects who are judged by the Principle Investigator (or co-principle investigator) as unsuitable or because of other reasons described above
6. The subject has the radiotherapy contraindication
7. Breast feeding
8. All the subjects have no plan to conception during the treatment and within one year after treatment
9. Subject who has any electronic devices in the body which could be affected by radiotherapy and has chance to cause accident. For example: pacemaker, artificial heart, brain and spinal cord stimulation, semi-implantable and implantable electrical stimulation、artificial inner ear ...etc
68Ga-Pentikra PET/CT Imaging Study in Healthy Subjects

This is a prospective, interventional clinical pilot study that recruited 10 normal volunteers who underwent 68Ga-Pentikra PET/CT imaging to evaluate the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra in normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 1) Age: 18 \~ 60 years old (including boundary values); 2) Gender: male or female; 3) Body weight: males weighing ≥50kg, females weighing ≥45kg, and body mass index \[BMI = weight (kg)/height 2 (m2)\] within the range of 19.0 \~ 26.0kg/m2 (including boundary values); (4) Subjects can fully understand and voluntarily participate in this experiment, and sign the informed consent form.

Exclusion Criteria:

- 1) Minors, pregnant women, lactating women, and those with severe hepatic or renal insufficiency (alanine aminotransferase exceeding the upper limit of normal values by 8-10 times and serum creatinine of 186-442 umol/L).

2) Previous history of tumour and surgery; 3) Other conditions judged by the investigator to be unsuitable as study subjects .
Sexual Function During COVID 19 Pandemic

The outbreak of a new Coronavirus disease (COVID-19), caused by the 2019-nCoV infection in December 2019 is one of the most severe global epidemic health problems.The rapid contagion of this Novel virus has provoked the World Health Organization (WHO) to classifying the outbreak as a "Public Health Emergency of International Concern" on January 30 2020 to a "Pandemic" on March 11th 2020


Eligibility Criteria:
Inclusion Criteria:

* health care staff
* working during the outbreak

Exclusion Criteria:

* refuse to participate
Comparison of Two Schemes of Cryosurgery and Imiquimod Combination Treatment for Basal Cell Carcinoma

To compare the effectiveness of two application schemes of cryosurgery during a 5 week course of topical imiquimod i.e. cryosurgery at the end of the second week of imiquimod followed by 3 more weeks of imiquimod (immunocryosurgery) versus cryosurgery at day 0 followed by 5 weeks of topical imiquimod (cryoimmunotherapy)

Comparison of efficacy

* Number of patients: N=40
* Arms: Two equal arms (20 patients each)
* Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy
* Exclusion criteria: (1) Size of the tumors \>5cm; (2) Distance from the eyelid \<0,5cm; (3)Number of tumors \>5
* Interim analysis: When at least 10 patients are included in each arm or at the end of the first year of the study

The patients will be randomized in 2 groups Group 1 (Immunocryosurgery) and Group 2 (Cryoimmunotherapy)

Treatment protocols:

Group 1 (Immunocryosurgery): Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again.

Group 2 (Cryoimmunotherapy): Patients will be submitted into cryosurgery (2 cycles of 15 seconds, with open spray liquid nitrogen) and subsequently will apply imiquimod on the tumor and a rim of 2mm around the tumor for 5 weeks in total. They will be evaluated in week 2 and 5.

Patients from both groups will be evaluated at 1, 3, 6, 12 months after termination of imiquimod treatment. In case of clinical relapse, it will be confirmed by biopsy and all the patients will treated with immunocrysurgery.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven basal cell carcinoma of the skin
* Size \<5cm
* Number of tumors \<5 cm
* Distance from eyelids, mouth 0,5cm

Exclusion Criteria:

* Size \>5cm
* Number of tumors \> or =5
* Distance from eyelids or mouth \< or =0.5cm
Development of IVR and WEB Alcohol Interventions

The primary aim of the present study is to study the effect of a brief automated alcohol intervention in University students, and if there is a difference in effect between automated brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to study if there is difference in effect between single and repeated interventions.


Eligibility Criteria:
Inclusion Criteria:

* Females scoring 6 and above and males scoring 8 and above on AUDIT.

Exclusion Criteria:

* Females scoring 5 and below and males scoring 7 and below on AUDIT
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for RA

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). Patients with RA will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Long-Term Safety Follow-Up Of Subjects Previously Enrolled In Rheumatoid Arthritis Studies Of CP-690,550

The purpose of this study is to follow the health of subjects who have previously been enrolled in studies of CP-690,550 for treatment of their rheumatoid arthritis. Subjects are only eligible for this study after they have completed all participation in other studies of CP-690,550.

At their last visit of a qualifying study, eligible subjects will be given the opportunity to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed all participation in any other Phase 2B or Phase 3 studies of CP-690,550 for rheumatoid arthritis.

Exclusion Criteria:

* Any subject who refuses consent.
Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy

Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the OAA/S group.

In the BIS group, the anesthesiologist set the target controlled infusion（TCI）parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5 ug/ml, and the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group, the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the OAA/S value at 1 point.

Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the OAA/S group.

In the BIS group, the anesthesiologist set the target controlled infusion (TCI) parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5 ug/ml, and the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group, the target concentration would be increased or decreased 0.5 ug/ml every two minutes to maintain the OAA/S value at 1 point.

Body movement, the time of gastroscopy, endoscopist satisfaction scores to sedation, the propofol consumption during gastroscopy and the time to awake were be recorded. In addition, the event of the respiration and circulation suppression during the gastroscopy were recorded. Atropine 0.3 mg was injected intravenously if bradycardia occurred (heart rate \<50 beats/min), M-hydroxyamine 0.3 mg was injected intravenously if hypotension (mean arterial pressure\<65 mmHg), Ephedrine 3 mg was injected if bradycardia and hypotension occured. Patients would receive face mask-assisted ventilation if the Spo2 dropped below 90% or respiratory frequency was lower than 8 breaths/min during the gastroscopy.

Eligibility Criteria:
Inclusion Criteria:

1. 18≤Age≤65 years old
2. American Society of Anaesthesiologists (ASA) Physical Status of I - II
3. 18≤BMI≤30 kg/m²
4. Outpatient patients who planned to undergo painless gastroscopy under propofol anesthesia

Exclusion Criteria:

1. Patients with communication disorders
2. Patients with alcohol and drug abuse or allergic or contraindicated drugs related to this trail
3. Patients who take anti-anxiety, depression or sedative drugs
4. Patients who participated in or were participating in other clinical trials within 3 months
Wrinkle Injection With Autologous Platelet Rich Plasma Study

Wrinkles result from imperfect repair of the dermal layer resulting in loss of collagen commonly due to ageing, smoking and sun exposure. Platelet rich plasma (PRP) contains a host of growth factors, which have been used in other clinical trials for various medical conditions such as tendonitis, and also in surgery such as the surgical repair of facial defects. Results from these clinical trials suggest that PRP helps in collagen formation and organisation to promote healing of tissues. This study attempts to document the clinical effects of intradermal injection of PRP on wrinkles.

10 selected participants will have 10 ml of blood removed for platelet extraction with MyCells®. The resulting Platelet rich plasma will be injected intradermally into the facial wrinkles.

Eligibility Criteria:
Inclusion Criteria:

* Adults more than 21 years of age
* Dis-satisfied or anxious about facial wrinkles (total wrinkle length more than 1cm)

Exclusion Criteria:

* Pregnant women.
* Psychiatric patients.
* Known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia
* Anticoagulants(eg.aspirin, warfarin)
* Had other wrinkle therapy for less than a month.(laser, peels, injections)
* Had facelift surgery for less than a year.
* Diseased states such as organ failure, severe anaemia, cancer, acute/chronic infections.
* Involved in personal litigation against an aesthetic service provider
Outcomes of Group Dance and Movement Training in Ambulatory MS Patients

GroundWorks DanceTheater and Cleveland Clinic are partnering to create and offer an initial study of a dance movement-based community program for people with Multiple Sclerosis (MS). The program will address major needs in the MS community including social-emotional well-being, body awareness, and motor function. GroundWorks artists will use a variety of widely accepted movement-based practices with the goal of improving upper and lower body function and overall well-being. By partnering, GroundWorks and Cleveland Clinic hope to encourage more study of the benefits of dance movement-based programming in individuals affected by MS.

GroundWorks DanceTheater and Cleveland Clinic are partnering to design and implement a pilot study of a dance movement-based community program for people with Multiple Sclerosis (MS). The program is aimed at addressing major needs in the MS community including social-emotional well-being, body awareness, and motor function. GroundWorks artists will use a variety of movement-based practices including personalized tasks and imagery, mirroring, and inscription, with the goal of improving upper and lower extremity function, and well-being. Cleveland Clinic will assist GroundWorks in the selection, monitoring, and testing of the participants. Cleveland Clinic will also take the lead with data management and analysis. By partnering, GroundWorks and Cleveland Clinic hope to create a promising program that will lead to further exploring the impact of dance movement-based programming in individuals affected by MS.

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 inclusive
* diagnosis of MS (relapsing or progressive form) based on the revised MacDonald Criteria established by a neurologist
* self-reported upper and lower extremity dysfunction
* ability to walk safely without an assistive device (e.g. cane, walker) indoors and outdoors

Exclusion Criteria:

* comorbidity (e.g. cardiac, respiratory, musculoskeletal) representing a contra-indication to the dance movement program
* exacerbation of MS within the past 60 days
* severe cognitive impairment
* clinically significant concern regarding the participant's ability to safely perform study procedures
Playful Sensorimotor Training in Pediatric Brain Tumor Patients

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically relevant side-effect of cancer treatment. The severe symptoms such as loss of sensation, numbness, pain, absent reflexes or loss of balance control not only diminish children's quality of life but also affect the medical therapy. To date, there are no effective treatment options to reduce the symptoms of CIPN. Promising results have so far been achieved with specific exercise interventions.

The investigators would therefore like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients (N=20) will be recruited from the Hospital for Children and Adolescents, Kantonsspital Aarau. Prior to randomization, all primarily eligible patients that have received a platin derivate or vinca-alkaloid, will be screened for symptoms of CIPN. Eligible patients with a neurologically confirmed CIPN will then be randomized either into an intervention group or a control group (CG). Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for 12 weeks in addition to usual care, while the control group receives treatment as usual. The CG will be given the opportunity to participate in the intervention after study completion. Data change will be assessed at 3 time points: At baseline (T0), after 12 weeks (post intervention testing, T1), and after 12 weeks of follow-up (T2). Primary endpoint is the Ped-mTNS score in order to subjectively as well as objectively assess the severity of CIPN symptoms. It contains a short questionnaire as well as more objective parameters such as light touch sensation, pin sensibility, vibration sensibility, deep tendon reflexes and muscular strength. Additionally, the CIPN symptom pattern will be assessed via nerve conduction studies, CIPN related pain, dorsiflexion and knee extension as well as postural control. Furthermore, investigators will be evaluating patients' level of physical activity, walk to run transition time, lower limb power as well as patients integration in physical education (PE) in school and sport club activities. The investigators hypothesize that patients in the intervention group will be able to reduce relevant symptoms of CIPN, improving related physical functions and enhancing children's social reintegration.


Eligibility Criteria:
Inclusion Criteria:

* patients with a central nervous system (CNS) tumor
* age: ≥ 6 and ≤ 18 years
* neurotoxic chemotherapy treatment is completed 3 months to 2 years ago
* neurotoxic chemotherapy comprised a platinum-derivate or vinca-alkaloid (low grade gliomas: vincristine/carboplatin or vinblastin mono and embryonal tumors as well as ependymomas: cisplatin/ lomustine and vincristine or cyclophosphamide/ carboplatin/ vincristine/ etoposide)

Exclusion Criteria:

* neuropathies of other cause (e.g. diabetes)
* disabilities
* lack of German language that prevent the understanding of the informed consent as well as the instructions for training
School Intervention Study of Nutrition, Wellbeing and Dental Health

The purpose of this study is to evaluate the effects of an intervention programme on dietary intake and dental health of 8th grade students.


Eligibility Criteria:
Inclusion Criteria:

* 7th grade students from the participating schools, written informed consent both from the student and the parent
Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo

This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.

Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in the severity of tinnitus after 4 weeks of treatment with the study medicine or the placebo (dummy drug which does not contain the medication). Subjects will undergo a safety follow-up after the treatment period.

Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.) and in case of any serious medical event during the study. The amount of drug in the blood will also be measured.

It is expected that up to 152 people with tinnitus may take part in the study. The study participants will be recruited at around 16 Hospital sites in the UK.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking, who are UK residents registered with a UK General Practitioner;
* Experiencing stable tinnitus (consistent from day to day)
* Tinnitus has existed for not less than 6 months, and not more than 18 months - Contraceptive methods must be used before and for at least 30 days after the stop of the study treatment.

Exclusion Criteria:

* Severe hearing impairment such that verbal communication is unreliable;
* History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant at the time of the study by the Investigator and which might be jeopardised by entering the study;
* Moderate or severe depression or generalised anxiety
* Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of starting the investigational treatment
* Participation in hearing study, involving an intervention, within 3 months from last study visit;
* Central nervous system pathologies e.g. Multiple Sclerosis, Parkinson's disease;
* Tinnitus as a concomitant symptom of a known otological condition (including but not limited to otitis externa, otitis media, otosclerosis, cholesteatoma, Ménière's disease or other vestibular problems, acoustic neuroma, or temporo-mandibular joint disorder);
* Pulsatile tinnitus (rhythmical sounds that often beat in time with the heartbeat);
* Intermittent tinnitus (comes and goes from one day to the next);
* Surgery or medical condition that might would be expected to significantly affect absorption of medicines;
Enhancing Resilience in Senior Living Community Residents

This single-arm pilot study tests the feasibility of integrating the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP), a mind-body intervention, into senior living residential communities. The investigators hypothesize that the SMART-3RP intervention will be feasible for senior living community residents to attend.


Eligibility Criteria:
Inclusion Criteria:

* Resident of an Erickson Living senior living community
* Currently residing in an Erickson Living apartment home
* Sufficient English language skills to participate in study procedures

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable or unwilling to participate in group sessions