cyrilzakka/clinical-trials huggingface dataset:
The Effect of Reiki on Anxiety, Stress, and Comfort

Upper gastrointestinal (GI) endoscopy is a procedure that is used in the examination, diagnosis, and treatment of the esophagus, stomach, and duodenum. With developments in present-day technology, it is safe and widely used. This study's aim is to determine the effect of Reiki when applied before upper gastrointestinal endoscopy on levels of anxiety, stress, and comfort. This single-blind, randomized, sham-controlled study was held between February and July 2021.

Anxiety and stress are problems that are often seen in patients undergoing upper GI endoscopy, and managing them is an important step in calming the patient and thereby reducing complications.The results of this study will contribute to the literature in forming a basis for other studies on the topic. The aim of this study is to evaluate the effects of the application of Reiki and sham Reiki on anxiety, stress, and comfort levels in patients undergoing upper GI endoscopy.

Eligibility Criteria:
Inclusion criteria

* patients who were having an upper GI endoscopy for the first time,
* patients who were age 18 or over,
* patients who had not previously had Reiki or sham Reiki (SR),
* patients who did not have a history of an operation in the previous six months,
* patients who were not using anxiolytic, hypnotic, or sedative drugs,
* patients who had no cognitive or effective problems or any hindrance in communication,
* patients who was literate, and who agreed to take part in the study.

Exclusion criteria

* patients who had an upper GI endoscopy with more than one elective condition,
* patients who was undergoing an emergency upper GI endoscopy,
* patients who were using anxiolytic, hypnotic, or sedative drugs,
* patients who had taken an opioid analgesic before the procedure,
* patients who completed the data collection forms incorrectly or incompletely,
* patients who had previously had Reiki or SR,
* patients who had a runny nose, fever, cough or any complaint of breathing difficulty,
* patients who were not literate and who did not wish to voluntarily participate.
Patient Considerations of Social Media Account Management After Death

This study examines how supportive care clinic patients have made decisions or had discussions about how their caregivers or family should manage their social media account(s) after death. Collecting information on the use of social media and preferences will allow for a better understanding of patient's needs in the dying process and may identify populations in need of education, identify a possible source of anxiety and stress, and allow for an informed discussion of digital legacy.

PRIMARY OBJECTIVE:

I. Identify the proportion of patients with advanced cancer in the supportive cancer clinic who have had discussions regarding their social media account (e.g. Facebook, Twitter, Instagram) management after death.

SECONDARY OBJECTIVE:

I. Identify the proportion of social media participation among advanced cancer patients seen in the supportive care clinic.

II. Evaluate the baseline awareness advanced cancer patients seen in the supportive care clinic have regarding how their Facebook account may be managed after death.

III. Evaluate affect changes and distress as a result from the conversation regarding their social media account management after death.

IV. Evaluate if discussion of social media account management among patients with advanced cancer in the supportive cancer clinic will increase their awareness of and motivation to address their social media account management options.

OUTLINE:

Patients complete questionnaires over 30 minutes about level of anxiety and social media use and management.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least 1 follow-up visit to the outpatient Supportive Care Clinic at MDACC
* Patients with any type of advanced cancer
* Patients aged 18 years or older
* Patients who have used social media
* Patients able to read and write in English

Exclusion Criteria:

* Delirium as diagnosed by treating Supportive Care Center (SCC) physician or Memorial Delirium Assessment Scale (MDAS) score \>= 7
Preventive Intervention Against Lymphedema After Breast Cancer Surgery

This study will examine whether lymphedema after breast cancer surgery can be reduced. In a randomised controlled design the aim is to investigate whether an early intervention with progressive resistance training and close monitoring of arm swelling can reduce the incidence of lymphedema after breast cancer surgery.

Lymphedema is a well known and much dreaded complication after breast cancer surgery. The aim in this study is to examine if lymphedema can be prevented with early progressive strength training focusing on the arm, and close monitoring of pre clinical lymphedema in the 1 year exercise period. The primary outcome is lymphedema, and secondary outcomes are pain, self-reported symptoms of swelling, sensory disturbance, physical and psychological functioning, fatigue, depression, anxiety and health related quality of life.

158 patients operated for breast cancer with axillary node dissection, will be invited from three hospitals in Denmark, Sealand (Rigshospitalet, Ringsted Hospital, and Herlev Hospital), while on the surgical wards. Two weeks later upon consent they are recruited, baseline tested and randomized to either exercise intervention or usual care control.

The exercise intervention consists of progressive resistance training, combined with a stretching programme, with a total duration of 60 minutes per session. The group attend supervised exercises twice a week and a once weekly home exercise programme of 45 to 60 minutes duration. After 20 weeks, exercises are converted to home exercises, and they are monitored by a weekly sms-service. At 12 months, follow-up measurements are taken for both groups. Lymphedema is defined as 3% limb volume change from the baseline measurement.

Eligibility Criteria:
Inclusion Criteria:

* invasive unilateral breast cancer
* undergone Axillary Lymph Node Dissection (ALND), planned for Radiotherapy
* Danish speaking
* consent to participate and to be randomized to either study arm.

Exclusion Criteria:

* have undergone primary breast reconstruction
* distant metastases
* physically unable to participate for any reason
* mental illness or cognitive impairment (dementia etc.)
* no past history of lymphedema diagnosis or treatment
* not previously operated with axillary lymph node dissection either side
Pre-operative Preparation Using 2% Chlorhexidine Cloth For Shoulder Surgery

We intend to determine how effective the use of a 2% Chlorhexidine Cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. We will be comparing the Chlorhexidine Cloths with a control group which will be performing an ordinary shower prior to surgery. At this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.

The use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. However, it's use in shoulder surgery has not been published up to this point. The shoulder has a unique microbial flora due to the prevalence of Propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. This study is designed to examine the efficacy of using a preoperative Sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. This study will compare the rate of post-operative infections and also the rate of positive skin cultures. The skin cultures will be obtained in the preoperative area from subjects who used the Sage 2% Chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing shoulder surgery (open or arthroscopic)

Exclusion Criteria:

* Patient unwilling to comply with instructions
* Active infection in the operative extremity
* Documented allergic reaction to chlorhexidine
Core Stabilization Versus Routine Routine Exercises in Pelvic Girdle Pain.

Pregnancy Induced Pelvic Girdle Pain (PGP) is common complaint in pregnant women all over the world and it has a major impact on health and functioning as it decreases quality of life. The onset of PGP is usually seen at 17-19 week of gestation, with a peak of incidence at 24- 36 weeks. The purpose of this study is to compare the effects of stabilization exercises on pregnancy induced pelvic girdle pain and its effects on the activity levels as compare to the physiotherapy exercises that are routinely prescribed

the study is Randomized Controlled trial which will be conducted in the Outpatient Physical therapy Department. Patient with suspected PGP will be referred by midwives, physicians or directly contact to Physiotherapist. Sample size of 30 individual was calculated by using open Epi tool with 95% confidence Interval (CI) and 80% Power. Inclusion criteria for patients is 13-28 gestational weeks determined by special test include P4 Test (Posterior Pelvic Pain Provocation) and FABER test (Flexion Abduction and External Rotation). Individuals would be randomly allocated into two groups by sealed envelope method.

Assessment will be done at base line and 4th week by using NPRS and PGP Questionnaire. Data will be analyzed by using SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* Women having Pelvic Girdle Pain in 2nd trimester or 1st month of third trimester.
* Age between 20-40 years.
* Positive FABER test (leg of patient is placed in figure of 4 and apply small amplitude oscillation are applied at end range of motion after stabilizing opposite side of Pelvis.

Positive test elicits pain and limited ROM)

* Positive P4 test (leg of patient is flexed at 90 degrees in supine position. Sacrum is stabilized by one hand and axial pressure is applied along the femur by other hand.

Positive test elicits pain in SI joint).

Exclusion Criteria:

* History of Pelvic Fractures and Surgery
* History of metabolic diseases.
* Radiculopathy
Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.


Eligibility Criteria:
Inclusion Criteria:

* Male and post-menopausal female adults aged 40-80 years inclusive.
* Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005)
* Smoking history of at least 10 pack years (either smokers or ex-smokers).
* Able to perform reproducible spirometry maneuvers.
* Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion Criteria:

* COPD exacerbations within 6 weeks prior to dosing
* Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery.
* Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry.
* Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations.

Other protocol-defined inclusion/exclusion criteria may apply
Biomarkers in Samples From Young Patients With Neuroblastoma

RATIONALE: Studying samples of tissue and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study studies biomarkers in samples from young patients with neuroblastoma.

OBJECTIVES:

Primary

* To analyze the expression of ROR1 on the surface of primary neuroblastoma cells.
* To investigate the therapeutic potential of anti-ROR1 monoclonal antibodies (mAbs), bispecific antibodies, and immunotoxins in in vitro and in vivo models of neuroblastoma.

OUTLINE: Archived bone marrow and tumor tissue samples are analyzed for ROR1 expression by flow cytometry, western blotting, qPCR, and IHC.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with neuroblastoma

  * With or without N-myc amplification
* Primary tumor samples as frozen tissue in liquid nitrogen or -80 degrees C
* Bone marrow samples from high-risk patients as peripheral blood mononuclear cells (PBMC) that have been cryopreserved with DMSO as viable cells to be used for flow cytometry or slides of bone marrow that can be used for immunohistochemistry

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Genetic Feature of Congenital Hearing Loss in Chinese Population

Congenital hearing loss, as well as hearing loss present at birth, is one of the most common chronic conditions in children, with a prevalence of permanent bilateral hearing loss of 2.83 per 1000 children of primary school age, which is mainly caused by genetic factors. The goal of this observational study is to learn about novel causative genes in infants with hearing loss in the Chinese population. The main problem it aims to deal with are:

* to present the genetic characteristics of the infant with hearing loss in the Chinese population
* to build up a prognostic model base on diverse data.

Participants will be asked to receive audiological tests and collection of the peripheral blood sample.


Eligibility Criteria:
Inclusion Criteria:

* Age up to 6 months
* Fail in the neonatal hearing screening programs, including oto-acoustic emissions and automated auditory brain stem response
* Promise to complete the tests required at baseline and follow-ups by the legal representative
* Informed consent by the legal representative

Exclusion Criteria:

* Congenital infections related to acquired or congenital hearing loss, including rubella virus, cytomegalovirus, herpes simplex virus, rubella virus, toxoplasma gondii and treponema pallidum infections
* Other explicit otologic conditions which could induce hearing loss, including cerumen, otitis media, congenital middle ear abnormalities, microtia and external ear abnormalities
* A drug with ototoxicity usage during pregnancy
* Other severe congenital anomalies
The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study

The objective of this study is to evaluate arm rejuvenation and tightening with a nanofractional radiofrequency device, Venus viva, Venus concept, Toronto Canada. We recruit 20 subjects. All 20 subjects are treated with 3 sessions, 1 month interval with a nano fractional radiofrequency device on the inner upper arm. We evaluate skin tightening using %improvement of treated surface areas and skin elasticity using Dermalab the result at 3 months after the last treatment and clinical improvements evaluated by two board certified dermatologist (using compared photos between before treatment and 3 months after the last treatment).


Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy female or male subjects, at least 30-60 years old of age 2. Subject who has BMI 18.50- 25 kg/m2 (as picture criteria above) 3. Subject has clinically evident moderate skin laxity with or without wrinkle on the upper arm 4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

- 1. Patient with weight loss \> 15% 2. Pregnancy or Lactation 3. History of pacemaker, defibrillator 4. History of laser resurfacing, prior radiofrequency, ultrasound or focused ultrasound on treatment areas within 1 year on the treatment area 5. History of Heat sensitivity, collagen vascular disorder disease including morphea, scleroderma, heat contact urticaria 6. History of medical illness that primary investigator thinks could interfere or influence the wound healing process 7. History of abnormal scars (keloid, hypertrophic scars) 8. History of skin cancer, radiation therapy or metal implants on treatment areas 9. Active local or systemic infection on treatment areas 10. Any other conditions that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

11. Subject is unable or unwilling to comply with the study requirements. 12. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans

The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.

The noble gas xenon is used for general anesthesia in clinical routine. Recent reports indicate that xenon is also used for increasing performance in high-performance sports. The purpose of this study is to establish a method for detecting xenon exposure in humans.

In patients undergoing surgery with xenon anesthesia as part of routine hospital care, small blood samples (3ml) will be taken before anesthesia, during anaesthesia and at 1,2, 4, 8, 16, 24, 32, 40 and 48 hours after anesthesia. These blood samples will be analyzed for traces of xenon.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years and older
* Xenon-based anesthesia as part of routine care

Exclusion Criteria:

* Inability to give written informed consent
* Known pregnancy
* Hemoglobin concentration of less than 12g/dl
Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA

In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.

This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.

Eligibility Criteria:
Inclusion Criteria:

1. Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:

   * bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
   * bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
2. Completion of the KeyPathTM BTA Test on the sample.
3. Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.

Exclusion Criteria:

1. Samples from blood culture positives over 24 hours from alarm
2. Samples deemed contaminated.
3. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.
First Presentation of Parkinson Disease Patients to Neurologist

In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time


Eligibility Criteria:
Inclusion Criteria:

- Parkinson Disease patients presenting to neurologist for first time

Exclusion Criteria:

- Hypersensitivity to the active substance or to any of the excipients
Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure

A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam

Primary objective:

To determine whether antibody geometric mean titer (GMT) to vaccine type HPV16 and HPV18 at 7 months (m) are non-inferior between female sex workers (FSW) aged 18-26 years who received the standard (0, 2m, 6m) and those received the extended 3-dose (at 0, 6m and 18m) 9vHPV schedule and age-matched non-FSW who received an extended 3-dose (at 0, 6m and 18m) 9vHPV schedule. This extended 3-dose schedule is in line with the recommended schedule by the vaccine manufacturer in Vietnam.

Secondary objectives:

1. To compare antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline.
2. To compare antibody GMT at 18m and 19m between FSW and non-FSW.
3. To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.
4. To measure incidence and 6m/12m/18m persistent HPV infection.

Primary hypothesis:

HPV antibody GMT to HPV16 and 18 in FSW is non-inferior to those of young women of the same age group (non-FSW) at 7m.

Secondary hypothesis:

1. HPV antibody GMT are similar at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive and HPV DNA-/seronegative at month 0.
2. HPV antibody GMT are similar at 18m and 19m between FSW and non-FSW who received the extended schedule.
3. Cellular immune responses to HPV16 and 18 are similar between FSW and non-FSW at 2m, 7m, 18m and 19m who received the extended schedule.
4. No new vaccine-type HPV infection in FSW and non-FSW in all groups at 6m, 12m, 18m.

Eligibility Criteria:
Inclusion Criteria:

* Is between the reporting ages of 18-26 years at the time of recruitment.
* Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)
* Willing and able to give written informed consent.
* Willing to complete the follow-up requirements of the study.

Exclusion criteria

Participants meeting any of the following criteria will be excluded from the trial:

* Pregnant or possibly pregnant
* Has received any HPV vaccine previously
* Has an axillary temperate greater than 38°C
* Known allergies to any vaccine component
* incapacity to provide consent
* Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
* Known HIV infection.
* Known Congenital immune deficiency syndrome.
A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)

The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).


Eligibility Criteria:
Inclusion Criteria:

* Completed participation in Part C of study ALN-AS1-001 (NCT02452372)
* Not on a scheduled regimen of hemin
* Women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception
* Willing and able to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Clinically significant abnormal laboratory results
* Received an investigational agent (other than ALN-AS1) within 90 days before the first dose of study drug or are in follow-up of another clinical study
* History of multiple drug allergies or intolerance to subcutaneous injection