cyrilzakka/clinical-trials huggingface dataset:
The Effect of Rubber Band Ligation in Bleeding Internal Hemorrhoids.

In this study, the researchers planned to compare the treatment results of patients undergoing rubber band ligation in addition to drug therapy in hemorrhagic internal hemorrhoids patients and those treated only with anti-hemorrhoidal drugs.

Introduction: Band ligation is one of the most frequently used methods in the treatment of hemorrhagic internal hemorrhoidal disease. Also, phlebotonic use and surgical excision options are available as an anti-hemorrhoidal drug in the treatment of the disease. Many studies have shown that these methods are safe to use. Band ligation is used quite often in our clinic. Whether or not band ligation is performed, these patients are prescribed phlebotonics as an anti-hemorrhoidal drug.

Purpose: In this study, investigators aimed to investigate the benefit of adding rubber band ligation to treatment in hemorrhagic internal hemorrhoidal disease treated with the anti hemorrhoidal drug.

Method: The study was planned prospectively and observationally. Patients are not assigned to groups by the researcher. The researcher cannot interfere with the treatment method given to the patient. The method of treatment is the method approved by the patient's doctor.

Patients diagnosed with internal hemorrhoids will be examined in a group of patients who are prescribed anti-hemorrhoidal drugs and rubber band ligation in the context of routine treatment.

In the other group, again, in the form of routine treatment, patients who are not given rubber band ligation and who are given only anti-hemorrhoidal drugs will be examined.

Group 1: Patients who have been prescribed 450 mg diosmin + 50 mg hesperidin as an anti-hemorrhoidal drug and rubber band ligation will be included in this group.

Group 2: Patients who have been prescribed only 450 mg of diosmin + 50 mg of hesperidin as treatment, without rubber band ligation will be included in this group.

Patients will undergo a control examination in the 21 days after treatment.

* Whether the bleeding continues?
* Which bleeding day stopped?
* The comfort of the anal area will be evaluated
* Did the side effect develop?
* Did any complications occur? The above information will be entered into the SPSS program, and statistical analysis will be done.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with internal hemorrhoids with an anamnesis + examination + rectoscope.

Exclusion Criteria:

* Patients under 18 years old
* Patients over 65 years old
* Pregnant
* Chronic liver patients
* Those with bleeding disorders
* Patients taking anti-coagulants and anti-aggregates
* Patients with colorectal cancer.
* Those who have had hemorrhoid surgery before
Cancer Diagnoses From Exhaled Breath With Na-nose

Early diagnoses of malignant tumors are pivotal for improving their prognoses. The Exhaled Breath is made up of oxygen, carbon dioxide, nitrogen, water, inert gases and volatile organic compounds (VOCs). Theoretically, the concentration of VOCs in exhalation produced by metabolism in human body is only about nmol/L-pmol/L, which can significantly increase under certain pathological conditions. A series of studies of VOCs diagnosing solid tumors the investigators had been conducted in the past decade. It was found that VOCs in exhaled breath can not only distinguish different types of tumors, but also can make a clear distinction between different stages. Our long-term collaborator, Professor Hossam Haick (Israel Institute of Technology) has developed a nano sensor array, so called Na-nose, which can detect VOCs of the exhaled breath by binding gases to specific chemiresistors coated with gold nanomaterials. The Na-nose has the advantages of low cost, easy to use, good reproducibility and real-time detection for large scale clinical application. This study was to use large clinical samples to validate the diagnostic efficacy of the newly developed Nano-nose( Sniffphone and Breath Screener) for malignant tumors .

Israel Institute of Technology provides two type of Na-nose. One is Breath Screener used for large-scale sampling and feature VOCs extraction to establish database. The other is called Sniff Phone aim at clinical real-time VOCs detection assisted by software. About 10,000 patients will participate in the subject of Breath Screener in batches. First, 7000 patients will have a definitive diagnosis and exhaled breath collected. Feature VOCs of specific tumors will be extracted from these samples and employed to build predictive model by using discriminant factor analysis (DFA). After the predictive model had been completed, 3000 definitively diagnosed patients will participate in validating the specificity and sensitivity of the prediction model. With the assistance of Breath Screener clinical database and software services, Sniff Phone is more suitable for clinical real-time detection for its small and convenient design characteristics. At last, Breath Screener and Sniff Phone will continue enriching databases and improve diagnosis efficacy in their clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years
* Cancer/benign disease having been diagnosed by pathology
* ECOG \< 2

Exclusion Criteria:

* Concomitant malignancies other than one malignant tumor
* Diabetes, Fatty liver
* Autoimmune disease
* Ventilation and transaired function obstacle
Phase II Study of Bone Marrow Transplantation Using Related Donors in Patients With Aplastic Anemia

OBJECTIVES: I. Evaluate the efficacy of related, HLA-identical bone marrow transplantation following cyclophosphamide (CTX) and antithymocyte globulin in patients with aplastic anemia.

II. Evaluate the efficacy of related, HLA-nonidentical bone marrow transplantation following CTX and total-body irradiation/total-lymphoid irradiation in patients with aplastic anemia.

PROTOCOL OUTLINE: Patients with HLA-identical donors receive cyclophosphamide/mesna, antithymocyte globulin (ATG), and methylprednisolone (MePRDL), followed by allogeneic marrow transplantation.

Patients with HLA-nonidentical (5/6 or 4/6) donors and those with a systemic reaction to ATG receive the same dosage of myeloablative chemotherapy and rescue. In addition, these patients are treated with total-body irradiation, total-lymphoid irradiation, and methotrexate.

All patients received MePRDL and cyclosporine for graft-versus-host prophylaxis.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Severe aplastic anemia with 2 of the following criteria: Polymorphonuclear neutrophils no more than 0.5 x 10 to the ninth/L Platelets no more than 20 x 10 to the ninth/L Reticulocytes no more than 30 x 10 to the ninth/L Hypocellular bone marrow Related donor aged 6 weeks or more, matching at least 4 of 6 HLA A, B, and DRI loci, as follows: HLA-identical family member for patients aged less than 40 years HLA-nonidentical family member for patients aged less than 55 years failing antithymocyte globulin or other immunosuppressive therapy The following eligible for transplantation as initial therapy: Patients aged less than 40 years with HLA-matched donor Patients aged 40-45 years with HLA-identical donor No neoplastic or preneoplastic evolution --Patient Characteristics-- Age: Under 40 (55 if ATG failure) Hepatic: No severe liver dysfunction Renal: No severe renal dysfunction Cardiovascular: No severe cardiac dysfunction Other: No other organ dysfunction that would compromise survival after transplant No HIV infection
A Clinical Investigation of the Oxford® Partial Knee System

The purpose of this prospective data collection is to document the performance and clinical outcomes of the Oxford® Partial Knee System.


Eligibility Criteria:
Inclusion Criteria:

* For use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee. The implant is intended to be implanted with bone cement.

Exclusion Criteria:

* Infection
* Use in the lateral compartment of the knee
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
* Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
* Disease or damage to the lateral compartment of the knee
* Uncooperative patient or patient with neurologic disorders who is incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
* Charcot's disease
* A fixed varus deformity (not passively correctable) of greater than 15 degrees
* A flexion deformity greater than 15 degrees
Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma

The aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people.

The aim of the study was to evaluate if there were differences in oral findings between patients diagnosed with allergic rhinitis and/or asthma and a control group of health people. At the oral evaluation, the following indexes were calculated: PSR, Periodontal Screening and Recording; PI, Plaque Control Record and DMFT, Decayed Missing Filled Teeth Index. Absence or presence of mouth breathing was also recorded. Linear regressions were calculated to compare the oral findings with gravity of allergic rhinitis, to asthma compensation and to asthma treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 5-14 years old
* presence of allergic rhinitis diagnosed according to ASIA guidelines and/or presence of asthma diagnosed according to GINA guidelines

Exclusion Criteria:

* refuse to participate to the study
* presence of systemic diseases that could alter oral conditions (Sjögren syndrome, celiac disease, calcium disorders).
Thrombolysis and RIPC in Acute Ischemic Stroke

Remote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against ischemia in various settings. However, the effect of RIPC in patients with acute ischemic stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized controlled trial, we examined the effect of RIPC on the resolution of nerve function deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis. The primary endpoint was the recovery of nerve function deficient assessed by National Institutes of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS), CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF).


Eligibility Criteria:
Inclusion Criteria:

* In accordance with the Guideline of Thrombolysis in Acute Ischemic Stroke and accomplish intravenous thrombolytic therapy using alteplase;
* The consciousness of patients are conscious,somnolence,confusion and stupor，can comply better with the RIPC treatment;
* Acute ischemic stroke confirmed by cranial CT/MRI;
* Provision of written informed consent.

Exclusion criteria:

* History of cerebral embolism,cerebral hemorrhage, brain tumor, brain trauma or other brain lesion;
* Severe cardiac, liver, or kidney disease, malignancy, systemic organ dysfunction;
* Blood pressure \<90/60 mmHg or \>200/110 mmHg after treatment;
* Dementia or mental illness;
* History of major surgery or trauma 4 weeks prior to admission;
* Failure to provide informed consent.
The Effectiveness of Chuna Maintenance Therapy for Chronic Bothersome Neck Pain

This study is a pragmatic randomized controlled study that assessed 250 subjects complaining of chronic bothersome neck pain with mild discomfort in a 1:1 ratio: chuna maintenance therapy group (125 subjects, 1 time/2 weeks, total 20 weeks) and lifestyle management \& self-exercise group (125 subjects, exercise method education 1 time/4 weeks, total 20 weeks).


Eligibility Criteria:
* Inclusion Criteria:

  1. Aged 19 or older but under 70.
  2. Neck pain with pain duration of 12 months or longer
  3. NRS of neck pain over the past month is 2 or more but less than 4
  4. Patients who have agreed to trial participation and provided written informed consent
* Exclusion Criteria:

  1. Patients diagnosed with serious pathology(s) which may cause neck pain (e.g. spinal metastasis of tumor(s), acute fracture, spinal dislocation)
  2. Patients with progressive neurologic deficit or severe neurologic symptoms such as spinal cord injury
  3. Patients whose pain is due to soft tissue disease not the spine (e.g. tumors, fibromyalgia, rheumatoid arthritis, gout)
  4. Patients with other chronic disease(s) which may interfere with treatment effect, safety, or interpretation of outcome (e.g. stroke and myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy)
  5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
  6. Pregnant patients or patients with plans of pregnancy or lactating patients
  7. Patients within 3 months after cervical surgery
  8. Patients with experience of participating in another clinical study within 1 month or plan to participate in another clinical study during the study participation and follow-up period within 6 months from the participation date
  9. Patients having difficult to completing the written informed consent
  10. Patients who are deemed unsuitable by the researchers
Study to Evaluate the Safety and Immunogenicity of Fluarix™ 2006/2007 in Adults Aged 18 Years or Above

Vaccination is currently the most effective mean of controlling influenza and preventing its complications and mortality in persons at risk. Because of the variable nature of influenza viruses, the composition of influenza vaccines changes almost every year, to target the 3 main circulating strains. Each year the influenza vaccine formulation may thus be different and clinical studies are mandated to ensure that the immunogenicity and safety of the vaccine formulated from the three annual circulating strains are similar to what was observed during the previous years.

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™ vaccine containing the influenza strains recommended for the 2006-2007 season.


Eligibility Criteria:
Inclusion Criteria:

* A male or female aged 18 years or above at the time of the vaccination;
* Healthy subjects or with well-controlled chronic diseases;
* If the subject is female, she must be of non-childbearing potential

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
* Administration of an influenza vaccine within 6 months preceding the study start.
* Administration of an influenza vaccine other than the study vaccine during the entire study
* Clinically or virologically confirmed influenza infection within 6 months preceding the study start
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Not stabilized or clinically serious chronic underlying disease
* Lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
To Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease

To evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population.

This is a prospective, multicenter, single-arm, pre-market study.The aim of this study is to evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population, to support the regulatory approval by CFDA. The study will enroll 60 patients in 3 investigational sites in China. The primary endpoint is procedure success rate of LithoVue ureteroscope system, the procedure success is defined as:Scope condition is suitable to complete the procedure and not requiring immediate scope substitution; it is also considered as a procedure success if the clinical effect is the same as that from the LithoVue scope per investigator's judgement in the case of a scope change (non-LithoVue).

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent to participate in the study
2. Willing and able to comply with the study procedures
3. Diagnosed as urinary disease and indicated for flexible ureteroscope procedure
4. For stone cases, the diameter of stones is less than or equal to 2cm in order to avoid staged procedures

Exclusion Criteria:

1. Surgeries are contraindicated
2. Flexible ureterocope procedure is contraindicated
3. Based on doctor's evaluation, the patient's medical condition doesn't fit for this study
4. For stone cases, the diameter of stones is greater than 2cm
5. Women of childbearing potential who are or might be pregnant at the time of this study
AMT-260 Gene Therapy Study in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy

This is a study of AMT-260 in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE). It is designed to investigate the Safety, Tolerability, and Efficacy of AMT-260 in Adults with MTLE Administered via Magnetic Resonance Imaging (MRI)-guided Convection-enhanced Delivery (CED).

The first-in-human Phase I/IIa U.S. trial consists of two parts. The first part is a multi-center, open-label trial with two dosing cohorts of six patients each to assess safety, tolerability, and first signs of efficacy of AMT-260 in patients with refractory unilateral MTLE. The second part is expected be a randomized, controlled trial to generate proof of concept (POC) data.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of unilateral refractory MTLE
2. History of seizures with on average ≥ 2 focal onset impaired awareness seizures in the 3 months prior to screening.
3. On a stable type and dose regimen of up to a maximum of 4 approved Anti Seizure Drugs for at least 6 months prior to screening.
4. Confirmed unilateral hippocampal pathology and concordant unilateral seizure focus
5. No evidence of focal neurocognitive dysfunction, inconsistent with disease pathology- related MRI and (18F)FDG-PET findings.
6. Women of childbearing potential (WOCBP) and fertile male subjects must be willing and able to use highly effective methods of birth control consistently and correctly throughout the study and for at least 1 year following AMT-260 administration.
7. For WOCBP only: Negative pregnancy test.

Exclusion Criteria:

1. Implanted devices that would contraindicate MRI; MRI-compatible devices must be implanted ≥3 months prior to Screening (vagus nerve stimulation devices will be up to discretion of the Investigator).
2. Any other contraindications for generalized anesthesia or surgery.
3. Medications that could confound clinical (e.g., antipsychotic medication and anti-viral therapy) and laboratory evaluations or could affect a patient's safety or their ability to undergo the neurosurgical procedure or comply with the procedures and study visit schedule.
4. Any psychogenic nonepileptic seizures within the last year.
5. Any seizures with contralateral or extra-temporal ictal onset on EEG.
6. Previous major disease-unrelated neurosurgical intervention due to intracranial tumor, trauma, or bleeding and/or history of previous intracranial surgery for treatment of epileptic seizures.
7. Magnetic resonance imaging evidence of epileptogenic, extra-temporal lesions, or dual temporal lobe pathology.
Incidence and Predictors of Delirium in the Trauma Intensive Care Unit：Prospective Study

Background Delirium is an acute neuropsychiatric syndrome, and its causes remain complex and not fully comprehended. Patients in trauma intensive care units are at high risk for delirium and are greatly affected by its adverse outcomes. As there are currently no effective pharmacological treatments or approaches for delirium, it is crucial to focus on identifying the risk factors for delirium and implementing early prevention strategies.

Objective Analyzing the incidence and risk factors of delirium in trauma intensive care unit patients.

Method This study is a prospective research that focuses on all patients in the trauma intensive care unit of a medical center. Data collection will be conducted through questionnaires and electronic medical records. A total of 200 participants will be conveniently selected for the study. Upon admission to the intensive care unit, each patient will complete a basic information questionnaire, and their medical records will be collected daily until they are discharged from the intensive care unit. The study incorporates various assessment scales including Intensive Care Delirium Screening Checklist (ICDSC), Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), Acute Physiology and Chronic Health Evaluation II (APACHE-II), Injury Severity Score (ISS), and Malnutrition Universal Screening Tool (MUST). Statistical analysis will be done by using IBM SPSS 24.0 for Windows. Descriptive statistics including mean, standard deviation, and percentages will be used to present demographic information. Logistic regression analysis will be applied to identify the key predictive factors for delirium risk.

Expected outcome and clinical application This study anticipates that the non-modifiable risk factors for trauma intensive care unit patients include age, substance use, chronic diseases, traumatic brain injury, prior surgery, frailty, APACHE II score, ISS, and ASA anesthesia classification. The modifiable risk factors include malnutrition, polypharmacy, electrolyte deficiency, metabolic acidosis, pain, mechanical ventilation, physical restraints, total surgical duration, intraoperative blood loss, and low hemoglobin. By understanding these risk factors, high-risk patients can be identified and preventive measures can be implemented to reduce the occurrence of delirium. Furthermore, addressing modifiable risk factors can help in reducing the risk or severity of delirium.


Eligibility Criteria:
Inclusion Criteria:

* Patients who admitted to trauma intensive care unit.
* Age ≥18.
* Patients who belongs to surgical or trauma subject.

Exclusion Criteria:

* Patients who stay in trauma ICU less than 24hrs.
* Patients who can not communicate with Chinese or Taiwanese.
* Patients who was diagnosed dementia.
* Patients who was evaluated -4 or -5 on Richmond Agitation-Sedation Scale.