cyrilzakka/clinical-trials huggingface dataset:
Electroacupuncture With or Without Combined Warm Needling for Tinnitus

This randomized controlled trial aims to evaluate the efficacy and safety of either electroacupuncture alone or combined with warm needling in reducing tinnitus loudness and improving the impairment caused by tinnitus in Hong Kong.

This study is a prospective, multicenter, assessor-blind, three-arm, parallel-group, randomized waitlist-controlled trial. A total of 90 eligible subjects with tinnitus will be recruited and randomly assigned to electroacupuncture (EA), electroacupuncture combined with warm needling (EAWN) or waitlist control with n=30 subjects each group. The entire study period will last for 10 weeks, including a 5-week intervention period and a 5-week follow-up period. Outcome measures include the loudness of tinnitus and the Tinnitus Handicap Inventory. Any adverse event will be observed and recorded for safety assessment. The study findings will provide evidence to determine the efficacy and safety of electroacupuncture with or without combined warm needling for tinnitus in Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with subjective tinnitus;
* Male and female, age 50 to 70 years old;
* Unilateral or bilateral tinnitus for 0.5-24 months;
* Loudness of tinnitus rated 3 points or more on a 0-10 numeric rating scale (NRS) at the time of enrollment; and
* Agree to sign the informed consent form voluntarily.

Exclusion Criteria:

* Known disease conditions that could cause tinnitus such as Meniere's syndrome, acoustic duct diseases, and middle ear diseases;
* History of head trauma;
* Currently using cardiac pacemaker or metal implants;
* Known severe cardiac diseases, cerebrovascular diseases, renal diseases, or hematologic diseases;
* Known severe psychiatric or psychological disorder;
* Pregnant, lactation or expecting a pregnancy during the study period;
* Severe needle phobia;
* Known hypersensitive reaction after acupuncture and moxibustion treatment or an inability to cooperate with the acupuncture and moxibustion procedure;
* Incapable to understand and answer the questions of the assessors in the study; and
* Other factors deemed unsuitable for inclusion in the study by investigators.
Visual Performance of Four Types of Multifocal Intraocular Lenses

This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Preoperative BCVA (distance) more impacted than 20/40
* Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.
* By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.
* Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities

Exclusion Criteria:

* Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.
* Large pupil
* Corneal transplant surgery or previous glaucoma-filtering,
* A history of retinal detachments.
* Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,
* Endothelial disease
* Iris neovascularization, and amblyopia)
β Blocker Use and Mortality in Hospital Survivors of Acute Myocardial Infarction Without Heart Failure

The aim of the study is to investigate the association between the use of β blockers and mortality among hospital survivors of acute myocardial infarction without heart failure.


Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction patients only
* aged 18 to 100 years

Exclusion Criteria:

* other final diagnosis besides acute myocardial infarction
* died in-hospital
* patients with missing mortality data
* aged \> 100
* patients with previous acute myocardial infarction or angina
* patients who have received coronary interventions before
* patients with heart failure
* patients with β blocker prior use
* patients contraindicated for β blocker use
* patients with use of a loop diuretic
Axillary Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Patients With Initial cN1 Breast Cancer

SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies.

SLNB has been recommended by domestic and foreign guidelines for patients with initial cN1 and NAC descending to ycN0. However, the best technical path is still not very clear at present, and the long-term tumor safety data is still insufficient. Therefore, it is necessary to further explore the optimal technical pathway and long-term tumor safety for SLNB in patients with initial cN1 and NAC downgrading to ycN0 in the real world.This study will evaluate the optimized technical pathway and long-term tumor safety of SLNB in patients with initial cN1 and NAC downgrading to ycN0 in real-world studies. The main endpoint of the study was axillary recurrence free survival. The secondary study endpoints were regional lymph node recurrence free survival, disease-free survival, overall survival, incidence of postoperative upper limb lymphedema, and patient quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Patients With ECOG Score 0-1 Points
2. Patients With Breast Cancer Stage cT1-3N1M0 (According to AJCC Version 7) Pathological Diagnosis of Ipsilateral Axillary Lymph Node Metastasis in Patients With Invasive Breast Cancer
3. Patients With Abnormal Axillary Lymph Nodes ≤ 3 Detected by Imaging Examination
4. Patients With Effective Neoadjuvant Therapy (CR+PR)
5. Patients With Clinical Axillary Negative ycN0 After Neoadjuvant Therapy
6. Patients Without Prior History of Ipsilateral Axillary Surgery and Radiation Therapy
7. Patients Without Previous History of Ipsilateral Breast Cancer (Including Carcinoma in Situ)
8. Patients Without Obvious Contraindications for Surgery or Radiation Therapy
9. No Other History of Malignant Tumors Within 5 Years From Enrollment in the Study
10. Patients Who Participate in Other Clinical Trials at the Same Time and Are Judged by the Researchers Not to Affect the Study Protocol Can be Enrolled Normally
11. The patient voluntarily joined this study and signed an informed consent form.

Exclusion Criteria:

1. Stage IV (metastatic) breast cancer；
2. Simultaneous double breast cancer；
3. Baseline cT4;
4. Baseline cN2-3
5. gestation
6. There are contraindications for SLNB;
7. Suffering from serious comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study
Objective Measures in Implantable Hearing Devices

The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.

Eligibility Criteria:
Inclusion Criteria:

* adults
* mixed hearing loss

Exclusion Criteria:

* children
Tislelizumab in Combination With Pre-operative CRT Versus SOC for Locally Advanced G/GEJ Adenocarcinoma

The purpose of this study is to evaluate the efficacy of Tislelizumab in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

Neoadjuvant and adjuvant Tislelizumab plus chemoradiotherapy, followed by adjuvant Tislelizumab and chemotherapy is superior to neoadjuvant chemoradiotherapy or chemotherapy, followed by adjuvant chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Has previously untreated localized gastric or GEJ adenocarcinoma as defined by T3\~4aN+M0 or T4bNanyM0 （AJCC Version 8）
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1
3. Has adequate organ function.
4. Male participants of childbearing potential must agree to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy.
5. Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 180 days after the last dose of chemotherapy or through 120 days after the last dose of pembrolizumab, whichever is greater.

Exclusion Criteria:

1. Has a known additional malignancy that is progressing or has required active treatment within the past 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
2. Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy.
3. Has an active infection requiring systemic therapy.
4. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
5. Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 14 days prior the first dose of study treatment.
7. Has an active autoimmune disease that has required systemic treatment in past 2 years.
8. Has a known history of human immunodeficiency virus (HIV) infection.
9. Has a known history of Hepatitis B or known active Hepatitis C virus infection (HBsAg positive with HBV DNA≥500 IU/ml；HCV：HCV antigen positive with HCV copies \>ULN).
10. Has had an allogenic tissue/solid organ transplant.
11. Has received a live vaccine within 30 days prior to the first dose of study treatment.
12. Female participants who are breastfeeding.
Discharge Planning in Emergency Department for Frail Older With AHF

Objectives: To demonstrate the efficacy of care transition holistic intervention (Multilevel Guided Discharge Planning, MGDP) in reducing 30-day adverse outcomes among frail older patients with acute heart failure (AHF) discharged from Emergency Departments (EDs) and to validate the results of MGDP in real life.

Method: Investigators will select frail patients ≥70 years with primary diagnosis of AHF discharged from EDs. The intervention will consist of MGDP implementation: 1) checklist that includes clinical recommendations and resources activations; 2) scheduling of early visit with the specialist; 3) communication with primary care; 4) providing a written instruction sheet to patient or caregiver. Phase 1: matched-pair cluster randomized clinical trial. EDs were randomly allocated to intervention (n = 10) or control (n = 10) group. Investigators will compare the outcomes between intervention and control groups. Phase 2: a quasi-experimental study. The 20 EDs will carry out the intervention. Investigators will compare the outcomes between phase 1 and phase 2 of intervention group and between phase 1 and phase 2 of control group. The main outcome is a 30-day composite endpoint (ED revisit or hospital admission for AHF and cardiovascular death) after being discharged.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥70 years.
* Diagnosis of descompensated chronic heart failure.
* Screening for frailty positive (ISAR ≥ 2).
* Planned discharge home from Emergency Department (included observation and short stay unit).
* Written informed consent provided by the patient or proxy.

Exclusion Criteria:

* De novo (new onset) acute heart failure (AHF).
* Severe episode of acute heart failure (≥9th decile of MEESSI-AHF Score).
* Uncorrected clinically significant primary valvular disease.
* Acute coronary syndrome currently or within 30 days prior to enrolment.
* Surgery or implanted device within 30 days prior to enrolment.
* Significant arrhythmias.
* Uncorrected systolic blood pressure \< 100 mmHg, O2 saturation baseline \< 92%, heart rate \< 60 or \>110 bpm, serum sodium \< 130 mmol/l, serum potassium \>5,5 mmol/l or hemoglobin \<9 g/dL prior to enrolment.
* Planned treatment with vasoactive therapies, ventricular assist device, heart surgery or transplant within 6 months.
* End stage renal disease.
* Severe disability.
* Difficulty intervention due to significant dementia, active delirium or psychiatric disorder.
* Condition with a life expectancy \<1 year.
* Length of stay in Emergency Department ≥96 hours.
* Discharged to facility care.
* Inability of outpatient follow-up.
Ghrelin, Growth Hormone and Growth Factors at High Altitude

Regulation of ghrelin, growth hormone and growth factors at high altitude and their change during ascent to high altitude has not been studied in depth yet. The study includes 33 volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after ascent to 5400-5900m.

The investigators hypothesized that during ascent growth hormone levels would increase to compensate for the higher energy needs at high altitude.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and good physical fitness
Comparison of Epinephrine-lidocaine Solution and Dexmedetomidine -Lidocaine Solution

Scalp infiltration with Epinephrine- containing lidocaine solution is common method for craniotomy but it may result in transient but significant hypotension in patients undergoing neurosurgery. Dexmedetomidine, a potent alpha2 adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and catecholamine response, and dexmedetomidine has an effect of peripheral vasoconstriction thus it is thus theologically appropriate for reducing bleeding during scalp incision in craniotomy.

The aim of this study is to compare the effect of dexmedetomidine-lidocaine solution on hemodynamic response, scalp bleeding to epinephrine-lidocaine solution.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Aged between 20 and 70 year
* general anesthesia for craniotomy

Exclusion Criteria:

* Congestive heart failure, coronary artery occlusive disease
* Bradycardia \< 50 BPM, 2nd degree \< AV block
* Poorly controlled hypertension
* ß blocker medication
* Coagulopathy
* Pregnancy, nursing
Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100, wide awake) BIS monitoring allows noninvasive, objective measurement of level of consciousness of a sedated patient. A limited number of studies have used measurements of BIS monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make sedation easy for ERCP procedures. However, the studies evaluating use of BIS for gastrointestinal endoscopy show inconsistent results.

The objective of this study is to evaluate effects of sedation on the dosage of propofol by monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk for respiratory depression using minimal doses of propofol in order to achieve the desired level of sedation with BIS monitoring.


Eligibility Criteria:
Inclusion Criteria:

1. 20-75 years old
2. ASA 1-2

Exclusion Criteria:

1. Emergency Operation
2. Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
3. Patients that are allergic to drugs considered to use
Effects of Music and Affirmation Recital in Women With Breast Cancer

The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer.

Introduction: Music therapy is attracting attention today because it is a person-centered approach that does not require any special skills and/or significant financial investments.

Method: The aim of this study is to determine the effect of music and affirmation recitals on symptom control, psychological resilience and anxiety levels in women with breast cancer. This study will be conducted using a randomized controlled trial design. It is planned to include 75 women in total, 25 patients in the music recital group, 25 patients in the music and affirmation group and 25 patients in the control group. Data in the study will be collected using the Introductory Information Form, Edmonton Symptom Diagnostic Scale, State Anxiety Scale and Psychological Resilience Scale.

Conclusion: It is thought that the findings obtained in this study will contribute to the use of music and affirmation, which are cheap, effective and easily applicable methods, in chemotherapy units as a method to help reduce patients' anxiety. The study is expected to reduce the symptoms of breast cancer patients and reduce their anxiety levels

Eligibility Criteria:
Inclusion Criteria:

* Those diagnosed with breast cancer
* Those who have received at least 1 course of chemotherapy
* Those over the age of 18
* Those who agree to participate in the study

Exclusion Criteria:

* Those who are not receiving curative chemotherapy
* Those who do not have a phone to listen to music and affirmations
* Those who do not agree to participate in the study
* Those with mental and neuropsychiatric diseases
Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.

Eligibility Criteria:
INCLUSION:

* Relapsed or Refractory B cell lymphoma.
* Zubrod status \</= 3.
* Measurable disease.
* No anti-cancer treatment within past 3 weeks.
* ANC \>= 1500/uL, Plt \>/= 50,000, Bilirubin \<2 mg/dL, SGPT \<2.5xULN, creatinine \<2. Patients with ANC\>/1000, PLT\>/30000 will be eligible if due to massive splenomegaly and/or BM involvement.
* HIV negative.
* No active CNS lymphoma.
* No serious intercurrent illness, active infections or cancer except basal cell carcinoma of the skin or in situ cervical carcinoma.
* Not eligible for treatment of a higher priority. Patients may be entered before BMT.
* No pregnancy \& age bearing females must be practicing adequate contraception.
* Age \> 16.

EXCLUSION:

* Patients with platelets \<30x10(9)/L within 14 days before enrollment.
* Patients with ANC\<1.0 x10(9)/L within 14 days before enrollment.
* Patients with peripheral neuropathy \>/= grade 3 within 14 days before enrollment.
The Influence of the 34C>T Variant in the AMPD1 Gene Ischemic Tolerance

Previous epidemiological studies have shown that in cardiovascular patients, the 34C\>T variant in the gene encoding for the enzyme Adenosine Mono Phosphate Deaminase (AMPD1) is associated with prolonged survival.

The 34 C\>T variant encodes a severely truncated, metabolically inactive protein. We hypothesize that during ischemia, in these patients AMP in preferentially converted into adenosine instead of IMP. Adenosine receptor stimulation, in turn, will increase resistance to ischemia-reperfusion in the myocardial tissue.

To test this hypothesis, 7 male healthy volunteers heterozygous for the 34C\>T variant will be selected from 100 healthy volunteers, which we have previously genotyped. These subjects will be compared with 7 matched control subjects. Individual ischemic tolerance will be assessed in the thenar muscle using 99mTc-Annexin A5 scintigraphy.

Briefly, the circulation of the nondominant forearm will be interrupted for 10 minutes by inflation of an upperarm cuff to 200mmHg en concomitantly, the subjects will perform isometric rhythmic handgripping until exhaustion. Immediately upon reperfusion, 400 MBq of 99mTc-Annexin A5 will be administered intravenously. Finally, 1 and 4 hours post-injection, scintigrapghi imaging of both hand will be performed. Targeting of annexin A5 will be expressed as percentage difference between the experimental and control hand.


Eligibility Criteria:
Inclusion Criteria:

* male
* 18-40 years
* healthy
* AMPD1 34C\>T variant (heterozygous) or matched control

Exclusion Criteria:

* cardiovascular / pulmonary disease
* diabetes / hypertension