cyrilzakka/clinical-trials huggingface dataset:
Reiki in Symptom Management of Hemodialysis Patients

This study aims to investigate the effect of Reiki applied to individuals receiving hemodialysis treatment on hemodialysis-related symptoms and hematological indicators.

The study has a pretest-posttest randomized controlled design and it was carried out between March and July 2022 with 64 patients over the age of 18 who received hemodialysis treatment for at least 15 days in the dialysis unit of state hospitals in two different cities. Data were collected using the Patient Information Form, the Dialysis Symptom Index (DSI), and the follow-up chart including erythrocyte (RBC), hemoglobin (HGB), hematocrit (HCT), serum urea, creatinine, sodium (Na), potassium (K), phosphorus (P), and calcium (Ca) values. While the distance Reiki intervention was applied to each of the patients in the Reiki group for 60 minutes, no intervention was made in the control group. One week after the intervention, the DSI was re-administered to the patients in the posttest, and hematology and biochemistry results were recorded.

Eligibility Criteria:
Inclusion Criteria:

* To be over 18 years of age,
* To have received hemodialysis treatment for at least 15 days,
* To volunteer to participate in the study,
* To be able to answer the given forms and questionnaires

Exclusion Criteria:

* To be a Reiki practitioner or trainer,
* To have attended any energy therapy session before,
* Using other complementary and integrative medicine practices at the time of the application.
TRAIL Study: Feasibility and Pilot

This is a pilot study to compare two ways of managing newly identified thyroid nodules that are likely to be cancerous based on ultrasound result and which under usual care would undergo immediate biopsy.

The main goals of this pilot study are 1) compare anxiety at 6 months in each treatment arm using the validated instrument Anxiety-CA, 2) measure thyroid quality of life in each treatment arm

Participants will be randomized to one of two groups:

1. immediate biopsy (usual care)
2. Active monitoring (serial ultrasound based monitoring and close clinical follow-up)


Eligibility Criteria:
Inclusion Criteria:

* Participants must be ≥18 years of age.
* Participants must be able and willing to provide informed consent or have a surrogate capable of providing same.
* Participants must be absent of symptoms referable to the nodule: dysphagia or nodule physically visible and/or bothersome to patient.
* Participants' thyroid nodule must have a TI-RADS rating of 4 or 5.
* Participants thyroid nodule must be ≤2 cm in largest diameter.
* Participants must be being considered for biopsy.
* Participants with a prior history of papillary thyroid cancer are eligible.

Exclusion Criteria:

Patients who fall into one of the following categories will NOT be eligible for this study:

* Adults who are unable to provide informed consent.
* Patients for whom biopsy is not a consideration.
* Patients with a prior history of thyroid cancer other than papillary thyroid cancer.
* Patients with a history of radiation to the neck.
* Patients who are athyroidal (thyroid gland has been removed or patient has only lingual thyroid tissue).
* Patients who have ultrasound evidence of one or more of the following:
* Airway invasion of the nodule.
* Nodule adjacency to/invading the recurrent nerve.
* Extra-thyroidal invasion by the nodule.
* Patients who have metastasis to cervical lymph nodes (confirmed by needle biopsy if ultrasound suspicious), distant metastases, if identified) testing not required, not usual care)
* Patients who have already had a biopsy of the nodule being considered for inclusion in the study.

TRAIL Pilot Integrated QRI: Inclusion/Exclusion Criteria

Inclusion Criteria for Study Patient Participants:

* Participants must meet the eligibility requirements above and will be or have been approached about enrolling in the pilot study.
* Participants must be willing to allow audio recorder presence and / or willing to be interviewed by the QRI team.

Exclusion Criteria for Study Patient Participants:

-Patients who are not willing to allow audio recorder presence and/or not willing to be interviewed by QRI team will be excluded from this study.

Inclusion Criteria for Study Staff Participants:

* Staff must be willing to audio record their communications with patients about enrolling in the study.
* Staff must be willing to participate in interviews with QRI team about their views of the study.

Exclusion Criteria for Study Staff Participants:

-Staff members who are not willing to participate in audio taping of recruitment discussions and/or interviews with QRI team about their views of the study will be excluded.
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System

This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

A prospective, international, single arm, multi-center post market clinical follow-up study.

Eligibility Criteria:
Inclusion Criteria:

* Severe native valve calcific aortic stenosis
* Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).

Exclusion Criteria:

* Known hypersensitivity to Nitinol (nickel or titanium)
* Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
* Inability to tolerate anticoagulation/antiplatelet therapy
FSU Hypertension Self-Care Training Study

The purpose of this study is to compare the effectiveness of two forms of self-care training on the overall health of adults with hypertension.

The FSU College of Social Work and the Department of Psychology are seeking adults age 25 and older with a clinical diagnosis of hypertension for a randomized trial using willpower to manage high blood pressure. Voluntary participants will complete three phases: baseline, intervention, and post-treatment. Baseline phase includes a preliminary phone screening, fasting blood draw, physiological test (measuring heart rate variability, chest compression, etc.), and a psychosocial inventory. Intervention phase includes 8 weeks of once weekly trainings (approximately one hour long) to be held on a weekday evening. Participants will be randomly assigned to one of the two willpower groups and will be asked to rehearse the willpower method at least once daily for 30 minutes during these 8 weeks. Post-treatment phase includes two follow-up booster sessions (at week 12 and week 16) for refreshing willpower techniques, a follow-up fasting blood draw, a physiological test, and a psychosocial inventory.

Participation is completely voluntary and confidential. Volunteers completing each of the phases will be compensated $100 for their time. If someone is interested in participating, they should call our office at 850-645-0247 or email fsuwillpower@gmail.com.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension
* Age 25 or older

Exclusion Criteria:

* Pregnancy
* Participation in other clinical trials or drug/behavioral treatment
* Previously participated in any other clinical trials/training on health-related behavior (tai-chi, yoga, nutritional education, yoga class)
* Kidney disease
* Cancer/chemotherapy, advanced HIV/AIDS, severe liver disease
* Severe ischemic heart disease (unstable angina, hospitalization for heart attack, coronary revascularization)
* Congestive heart failure
* Severe inflammatory/rheumatologic disorders (severe arthritis)
* Severe mental health diagnosis such as schizophrenia or bi-polar disorder
* Occurrence of any neurological disorders such as stroke or dementia
* Addicted to any legal/illegal drugs or alcohol without at least 1 year of sobriety
* Any infectious conditions such as pneumonia, traumatic wound, or surgery that may cause inflammation in the past 14 days
The Effects of Limb Elevation During Gout Flare Episodes

The goal of this open-label randomized controlled trial is to explore the benefit of limb elevation in inpatient gout flare episodes, compared with standard treatment The main questions are;

* Is limb elevation able to reduce pain during gout flare episodes to a greater degree compared with standard treatment ?
* Is Is limb elevation able to reduce joint swelling during gout flare episodes to a greater degree compared with standard treatment ?

Participants will be divided into 2 group;

1. Limb elevation group
2. control group All participants will receive standard medical therapy consisting of colchicine 0.6 mg per day plus prednisolone 30 mg per day for 2 days

Pain score and joint circumference will be recored at recruitment, 24 hour and 48 hour

Limb elevation has shown benefit in ankle sprain and venous insufficiency, but its benefit has not been studied in people with gout flare. In this open-label randomized controlled trial, 30 adults diagnosed with gout flare during their hospitalization will be randomized to receive limb elevation plus standard medication for gout flare (limb elevation group) or standard medication only (control group). Primary outcome is reduction in 10-point visual analogue scale for pain at 48 hours after enrollment and the secondary outcome is the reduction of the circumference of affected joint at 48 hours after enrollment. Comparison of pain score and joint circumference reduction will be made using Wilcoxon Rank-sum test. Our study results may provide some evidence in support of limb elevation as a supplementary non-pharmacological therapy for relief of gout flare.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years
* Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria

Exclusion Criteria:

* Receive Non-Steroidal Anti-inflammatory Drugs or Intra-articular corticosteroids or prednisolone \> 10 mg within 24 hours before enrollment
* Unstable vital sign
* Receiving joint aspiration for release joint effusion ≥ 10 ml after enrollment
* Gout flares involve axial joints e.g. hip
* Glomerular Filtration Rates \< 30 ml/min/1.73m2
* Communication problems
Patient-controlled Sedation With Propofol During Cataract Surgery Under Topical Anesthesia

Controversies exist about the use of propofol in sedation of patients for cataract surgery. This prospective randomised double-blind study evaluates the efficacy of patient-controlled sedation compared with placebo using the same device.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be operated of cataract under topical anesthesia

Exclusion Criteria:

* Contra-indication to sedation
* Complicated cataract
* Hypersensitivity to propofol, known or suspected hypersensitivity to egg phospholipid, soybean or peanut protein
* State of acute shock, severe dyslipidemia, severe liver failure, serious bleeding disorders
* Comprehension and language impairment
* Written and signed informed consent by the patient to participate in the study
Early Pelvic Floor Muscle Training Improves Pelvic Floor Muscle Strength in Patient After Low Anterior Resection

The aim of study is to investigate the difference in Maximum Squeeze Pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period

The functional outcome after low anterior resection varies greatly. Proportion of patient suffers from urgency and incontinence. Pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. Peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo low anterior resection of rectum
* Patient consented for study

Exclusion Criteria:

* Patient unable to understand pelvic floor exercise
* Patient who underwent alternative procedure
* Patient who suffers anastomotic complications after surgery
* Patient who ileostomy not closed
Epilepsy Surgery and Cognitive Outcome

This study will give important information about long term consequences of temporal lobe epilepsy surgery on cognition (memory, language, concentration etc), psychiatric function and quality of life.

All patients in Norway who have undergone temporal lobe epilepsy surgery ten years ago or more, will be invited to participate. Two groups will be compared: patients who are younger than 50 years of age vs patients who are older than 50 years of age.

The aim of the study is to improve preoperative information to future epilepsy surgery patients, to aid medical personnel (doctors, psychologists) in the selection of patients for surgery, and to improve knowledge of need for long term follow-up and rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Prior temporal lobe epilepsy surgery (10 years ago or more)

Exclusion Criteria:

* Intelligence quotient (IQ) less than 70
* Other main language than Norwegian
Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects aged between and including, 10 to 25 years at the time of the first vaccination.
* Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits etc) should be enrolled in the PMS.
* Written informed consent obtained from the subject or the subjects' parent/ guardian.
* Subjects of childbearing potential must not be pregnant. Absence of pregnancy should be verified (e.g. urine pregnancy test) as per the investigator's clinical judgement.
* Subjects with no contraindication according to the local approved prescribing information.
* No previous administration of an HPV vaccine other than Cervarix®.
* No previous administration of more than two doses of Cervarix®.
* No planned administration of an HPV vaccine other than Cervarix® during the PMS
Validation of Pharmacogenetics Plus Drug Combination Guided Initial Tacrolimus Dosage in Renal Transplant Recipients

The purpose of this study is to compare pharmacogenetics plus drug combination (Schisandra sphenanthera extract,SchE)guided and standard initial tacrolimus dosage.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (both males and females, 18-65 years) recipients underwent single primary renal transplantation in the First Affiliated Hospital of Sun Yat-sen University
2. Wish to participate in the study
3. Informed consent for the trial

Exclusion Criteria:

1. Patients with abnormal hepatic function, serious infection, malignant tumour, and diabetes mellitus
2. Patients with ABO-incompatible renal transplantation
3. Panel reactive antibody (PRA) levels greater than 30% before transplantation
4. Underwent combined organ transplantations
5. Except for SchE, other medication known to affect tacrolimus blood levels, such as diltiazem, verapamil, ketoconazole, itraconazole, erythromycin or clarithromycin was used
6. Allergic history to study medicines
7. During pregnancy or plan to get pregnant during the study period
Impact of Iron Stores on Wound Healing in Plastic Surgery

In breast reduction surgery, delayed wound healing may increase surgical site infections, cutaneous necrosis and may be related to psychological harm.Some risk factors have been identified : smoking, diabetes, overweight. A normal healing involve cellular and biochemical reactions in which iron plays an important role such as cellular respiration, redox reactions and regulation of genes involved in the cell cycle. This trial will study the relationship between iron stores and postoperative wound healing after bilateral breast reduction surgery in patients without preoperative anaemia.The primary outcome of this trial is the comparison of wound healing at post operative day 15, between patients with and without iron deficiency.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* female
* scheduled bilateral breast reduction surgery
* biological exams with ferritin and transferrin saturation coefficient taken the day before surgery
* No anemia : haemoglobin \>=12g/dL (preoperative biological assessment )
* if genetic disease of haemoglobin, haemoglobin between 10 and 12g/dL and no Anaemia by iron deficiency
* absence of clinical inflammatory syndrome (no clinical signs of infection or no fever)
* non-opposition of the patient to participate

Exclusion Criteria:

* Anaemia by iron deficiency
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy

In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .

Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .

Eligibility Criteria:
Inclusion Criteria:

Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction

Exclusion Criteria:

Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction
Whole Person Care Research Program of the Suicide Cases Consultative Services

This project aims to provide more treatment options to suicide patients to further enhance the holistic medical services in Far Eastern Memorial Hospital. It focuses on high-risk cases, especially those whose suicidal behaviors are triggered by interpersonal/or emotional problems because psychological counseling or interpersonal growth groups of services have been shown to be beneficial to this population.


Eligibility Criteria:
Inclusion Criteria:

* above 20 years old, survivors from suicide.

Exclusion Criteria:

* under 20 years old
* prisoner
* suffer from a serious illness
* foreigner/ can't speak Chinese
* the people who can't express themselves
* can not be interviewed in FEMH
* people with severe physical or psychological symptoms
Explore Association Models Between Environmental Hormones andBreast Cancer

investigated the association model between environmental hormone-related living habits and breast cancer, as well as dietary improvement programs through machine learning and clinical validation of patients with breast cancer.

Female breast cancer is the second most common cancer worldwide and the age at diagnosis is decreasing. Traditional risk factor screening for breast cancer focuses on reproductive history, family history, age at menarche, and age at menopause; however, young patients diagnosed with breast cancer who do not meet the above risk factors are becoming common.This study established an association model between environmental hormones and breast cancer through machine learning to improve dietary programs to reduce the incidence of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* (1) patients aged 20 years or above; (2) patients with breast cancer.

Exclusion Criteria:

* non-patients with breast cancer
Evaluation of Three Regimens of Chemoprophylaxis for Tuberculosis in Patients co-Infected by HIV and Mycobacterium Tuberculosis

To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.

DESINGS: We performed a randomised, comparative and open clinical assay carried out in 316 HIV-infected patients. The patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to pyrazinamide and rifampin for two months (2RZ).

RESULTS: The TB rates (cases per 100 persons/year) in the three treatment groups were 3.4 in 6H, 4.5 in 3RH and 1.9 in 2RZ. The relative risk for TB with 6H as compared with 2RZ was 1.76, and with 3RH, 2.34. Twenty-seven percent of the patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects. Seven patients were withdraw due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens.

CONCLUSION: In our study the 2RZ regimen was as safe as the 6H and 3RH regimens. We have nor observed a higher incidence of hepatotoxicity in patients who received 2RZ.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection confirmed by ELISA and Western blot
* Age between 18 and 65 years
* Life expectancy greater than two years
* Reactivity to PPD \> 5 mm

Exclusion Criteria:

* Presence of active tuberculosis
* Background of previous antituberculosis therapy or chemoprophylaxis
* Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis
* History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)
* Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml
* Pregnancy
* Undergoing treatment incompatible with any of the drugs used in the study.
Bladder Environment: Microbiome Oxygen Relationship

The purpose of this study is to characterize bladder urinary oxygen tension (BUOT) in women whose urinary microbiomes contains at least one anaerobic bacterial species versus women whose urinary microbiomes do not contain anaerobes.

Throughout the human body, microbial communities (microbiota) depend on their environment, including the level of oxygen (anaerobic vs. aerobic). Recently published evidence documents the existence of a female urinary microbiota (FUM) and provides evidence that the FUM differ based on lower urinary tract symptoms, i.e. no bladder symptoms, urgency urinary incontinence, and urinary tract infection1-4. Members of the FUM include bacteria that require oxygen (aerobes), those that abhor oxygen (anaerobes) and those that thrive in both conditions (facultative anaerobes)5. This last group of microbes is known to consume low levels of oxygen to maintain an anaerobic environment. Yet, virtually nothing is known about oxygen levels in bladder urine even though bladder urine oxygen tension may both affect and be affected by the FUM. Given the role oxygen levels play in other parts of the human body, the investigators request resources to investigate bladder urine oxygen levels. The study is designed to understand if BUOT levels differ in FUMs with and without at least one anaerobe, and if so, if there are any patient factors or urinary symptoms associated with certain BUOT

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* No indwelling urethral catheter
* At least 50 mL of urine in their bladder as determined by the clinic's bladder scanner

Exclusion Criteria:

* Non-English speaker