cyrilzakka/clinical-trials huggingface dataset:
Investigation of Novel Procedure for Methacholine Challenge Testing

The study will compare a novel volumetric method (performed with the Aerogen Solo vibrating mesh nebulizer) with the standard two-minute tidal breathing protocol (performed with the Wright jet nebulizer) for methacholine challenge testing. The results will then give an indication as to whether the novel technique accurately assesses a given dose of methacholine with the new Aerogen Solo device. In addition, the reproducibility of test results with each method will be examined. Altogether, the findings from this investigation may provide means for better standardization of current testing guidelines.

Fifteen asthmatics will be recruited and tested at the University of Saskatchewan for this randomized, two-way crossover study. Two testing methodologies will be performed, the volumetric method with the Aerogen Solo nebulizer and the two-minute tidal breathing method with the Wright nebulizer.

Participants will undergo four methacholine challenges plus a screening methacholine challenge. However, screening is omitted with participants who have completed a methacholine challenge in the last six months. Of the four study challenges, two will utilize the Wright nebulizer with the two-minute tidal breathing method outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing. The remaining two challenges will utilize the Aerogen Solo nebulizer with the volumetric method. The timing of the spirometric manoeuvers and the duration of each inhalation cycle will be consistent with both testing methods. Each challenge will be stopped when the participant's forced expiratory volume in 1 second (FEV1) drops by at least 20%. This allows determination of aPC20 (provocative concentration of methacholine causing a 20% fall in FEV1), which will be converted to aPD20 (provocative dose). A minimum 24-hour washout period between challenges will be used.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 or older
* Stable asthma
* Baseline methacholine PC20 less than or equal to 16mg/mL
* Baseline lung function equal or greater than 65% of predicted FEV1

Exclusion Criteria:

* Use of long-acting bronchodilators within 7 days of visit 1
* Pregnant or nursing women
* Cardiovascular problems
* Upper respiratory tract infection within 4 weeks of visit 1
* Allergy-induced asthma exacerbation within 4 weeks of visit 1
Clinical Study on the Treatment of MAFLD with Ganzhixiao Capsules

This trial is expected to enroll 138 MAFLD patients in one clinical center, who will be randomly divided into a placebo group and a Ganzhixiao capsule group in a 1:1 ratio. There will be 69 patients in the Ganzhixiao group and 69 patients in the placebo group. Administer Ganzhixiao capsules or mimetics separately, intervene for 16 weeks, and compare the liver fat content、 ALT、 Changes in indicators such as cytokeratin 18 fragment, FIB-4 score, and LSM score. Among them, MRI-PDFF is the main efficacy evaluation index to evaluate the clinical efficacy of Ganzhixiao capsules in the treatment of MAFLD.

All participants in the trial were required to have a low-fat diet and engage in aerobic exercise for 150 minutes per week.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years old, with a body mass index (BMI) of at least 24kg/m2;
* Diagnosis of NAFLD determined by imaging \[ultrasound, computed tomography or magnetic resonance imaging (MRI-PDFF)\] or liver biopsy, showing MAFLD or simple steatosis within the last 24 months prior to screening;
* MAFLD patients conform to the damp heat syndrome type; ④ Voluntary signing of informed consent form

Exclusion Criteria:

* Blood biochemical indicators ALT, AST, BUN are greater than 1.5 times the upper limit of normal values, Cr is greater than the upper limit of normal values, eGFR\<60ml/min/1.73m2;
* Alcoholic fatty liver, other chronic liver diseases, cirrhosis, liver malignant tumors, etc.;
* Type 2 diabetes and pancreatic diseases;
* Taking some hypoglycemic, lipid-lowering, liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months;
* Patients with severe infections, cardiovascular, respiratory, renal, hematological, rheumatic connective tissue disease, neuropsychiatric, and non liver malignant tumors;
* Pregnant or lactating women;
* Those who require long-term hormone therapy;
* Researchers anticipate poor compliance or inability to cooperate;
* There are contraindications for MRI examination, including pacemakers or cochlear implants, postoperative artificial valve replacement, presence of ferromagnetic vascular clips in the body, metal foreign bodies in the eyeball, insulin pumps, ferromagnetic objects in the scanning field, metal dentures, intrauterine devices, and patients with claustrophobia.
Biventricular Pacing in Hypertrophic Cardiomyopathy After Aortic Valve Replacement

Biventricular Pacing has been shown an improvement of symptoms in patients with heart failure.

A temporary pacing is necessary in patients after cardiac procedures. In patients with hypertrophic cardiomyopathy, a single right ventricular pacing can decrease the cardiac output and blood pressure.

The investigators propose that biventricular pacing in these patients and conditions results in an improvement of symptoms instead of single right pacing.


Eligibility Criteria:
Inclusion Criteria:

* 18 years
* Hypertrophic Cardiomyopathy
* Aortic valve replacement

Exclusion Criteria:

* Atrial fibrillation
* Pericarditis
* postoperative low output
* Preoperative permanent pacemaker placement
Early Angiotensin II in the Emergency Department

This pilot study will enroll 20 patients with septic shock and require emergent vasopressor support in the emergency department (ED). The primary objective of the study is to determine the feasibility of early peripheral administration of angiotensin II for treatment of septic shock in the ED

Following informed consent, patients will receive intravenous angiotensin II (AT-II) infusion for blood pressure support. The patient will remain on the AT-II infusion for 60 minutes prior to determining patient response which will be determined by recording the concurrent dose of norepinephrine and MAP every 10 minutes from initiation. If a positive response (e.g., norepinephrine dose reduction) is witnessed, the AT-II infusion will be titrated off after a maximum of 6 hours or when infusion is completed, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria

1. Age ≥18; and
2. Requiring norepinephrine at a dose of 0.05-0.25 mcg/kg/min mcg/kg/minute despite adequate fluid resuscitation; and
3. Receiving intravenous antibiotics or clinician's intention to administer antibiotics at the time of enrollment; and
4. Can provide written informed consent (or legally authorized representative).

Exclusion Criteria

1. Acute coronary syndrome;
2. Cardiogenic shock;
3. Patients with a history of mesenteric ischemia;
4. Patients with a history of having an aortic dissection or abdominal aortic aneurysm;
5. Patients with an expected lifespan of \<12 hours;
6. Patients with hemorrhagic shock (e.g., actively receiving transfusion of packed red blood cells);
7. Active administration of two vasoactive agents before enrollment; and
8. Pre-existing thromboembolic disease or inability to tolerate pharmacologic VTE prophylaxis.
An Efficacy and Safety Study of ICP-192 in Subjects With Bladder Urothelial Cancer

This is a phase 2, multicenter, single arm, open-lable study of ICP-192. The purpose of this study is to evaluate efficacy of ICP-192 in subjects with surgically unresectable or metastatic bladder urothelial cancer.

bladder urothelial cancer

Eligibility Criteria:
Inclusion criteria：

1. Signed the ICF and Age ≥ 18 years old, either sex.
2. ECOG ≤ 1.
3. Life expectancy of at least 3 months.
4. Histologically confirmed unresectable or metastatic bladder urothelial cancinoma.
5. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1

Exclusion Criteria:

1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
Study to Assess the Safety, Tolerability, and Pharmacokinetics of E2082 in Healthy Male Subjects

This study will be conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single ascending oral doses of E2082 in healthy Japanese adult and elderly male participants, and to evaluate the safety, tolerability, and PK of multiple ascending oral doses of E2082 in healthy Japanese and Caucasian adult male participants.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

* Non-smoking, age ≥20 years and \<55 years old adult male (Cohorts 1 to 9 of Part A and all cohorts of Part B), or age ≥55 years and ≤85 years old elderly male (only Cohort 10 of Part A) at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
* Body mass index ≥18 and \<30 kilograms per meters squared at Screening

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

* Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism
* Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of E2082, example, hepatectomy, nephrectomy, and digestive organ resection
* Any clinically abnormal symptom or organ impairment found by medical history, physical examinations, vital signs, electrocardiogram finding, or laboratory test results that require medical treatment at Screening
Effect of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory on Postoperative Pain After Video-assisted Thoracoscopic Surgery

At present, surgical resection remains one of the main methods for the radical treatment of lung cancer. Compared with traditional thoracotomy, Video-assisted Thoracoscopic Surgery (VATS) offers obvious advantages, such as less surgical trauma and rapid postoperative recovery. However, a certain proportion of patients will still experience moderate to severe pain after undergoing VATS. Postoperative acute pain can lead to increased postoperative pulmonary complications, prolonged hospital stays, and increased treatment costs. Additionally, it is also associated with the development of postoperative chronic pain. Therefore, effective pain management after VATS is crucial.

Researchers will compare Transcutaneous Electrical Nerve Stimulation (TENS) based on Wrist-Ankle Acupuncture theory (TENS-WAA) with a sham stimulation regimen to determine whether TENS-WAA can relieve postoperative pain in patients undergoing thoracoscopic lung resection. This study aims to enrich the existing postoperative analgesia schemes and provide a reliable basis for its clinical promotion.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* American Society of Anesthesiologists (ASA) physical status of I-III
* Patients scheduled for elective unilateral lobectomy via video-assisted thoracoscopic surgery (VATS) for lung cancer under general anesthesia
* Informed consent signed

Exclusion Criteria:

* History of liver, kidney, heart, lung, or brain disease
* Psychiatric disorder or cognitive impairment
* Chronic pain, daily use of analgesics, or alcohol dependence
* Routine or recent acupuncture treatment
* Contraindications to TENS (with pacemaker or metallic implants, allergy to surface electrodes, with skin sensory disorders, skin ulceration, unhealed scars, or adhesions)
Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.


Eligibility Criteria:
Ricovir® Group

Inclusion Criteria:

* Male or female aged more than 20 years old;
* CHB patients who have been treated with Viread® for more than 1 year;
* Serum HBV DNA level is undetectable (not detected or \<20 IU/mL) at screening;
* Informed consent must be obtained before the commencement of any screening procedures or study drugs

Exclusion Criteria:

* Patients with active HCC or other types of malignancy;
* Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
* Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
* Patients with alcohol dependence or addiction;
* Patients with autoimmune hepatitis;
* Patients with primary biliary cholangitis (PBC);
* Pregnancy, planning on getting pregnant, or breast-feeding;
* History of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug;
* Not suitable for participating in this trial at the investigator's discretion.

Historical Control Group

Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:

* Male or female aged more than 20 years old;
* CHB patients who had been treated with Viread® for more than 1 year;
* Patients who had discontinued Viread® therapy for at least 24 weeks during the period from January 2014 to December 2021 and had undetectable HBV DNA (not detected or \<20 IU/mL) in serum at the time of discontinuation;
* Patients who have the data of HBV DNA level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed;
* The informed consent requirement will be waived based on the approval of IRB.
Healing Touch in Treating Patients Receiving Chemotherapy for Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

RATIONALE: Supportive care, such as healing touch, may improve quality of life in patients receiving chemotherapy for acute leukemia.

PURPOSE: This clinical trial is studying how well healing touch works in treating patients receiving chemotherapy for acute myeloid leukemia or acute lymphocytic leukemia.

OBJECTIVES:

* Determine the feasibility of conducting a randomized controlled trial, in terms of recruiting and retaining participants, to a study of healing touch (HT) as supportive care in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.
* Examine potential barriers to participation and ascertain reasons for study drop-outs in these patients.
* Demonstrate whether these patients will comply with treatment sessions and remain in the study.
* Obtain preliminary data on the effectiveness of HT on psychological distress and treatment-related symptoms focusing on fatigue and sleep disturbances in these patients.
* Determine if the HT protocol needs to be refined, modified, or eliminated, based on pilot participant feedback, for a randomized clinical trial.

OUTLINE: This is a pilot study.

Within 1 week of admission to the hospital, patients are interviewed by a research assistant about previous use of complementary or alternative medicine therapies, knowledge of healing touch (HT), previous experience with HT, willingness to participate in a study of HT for acute leukemia patients, and willingness to be randomized in a HT study. The first 12 patients interested in undergoing HT undergo a 30-minute session of HT therapy 3 times a week during weeks 2, 3, and 4 of induction or reinduction chemotherapy. Patients are also asked to rate current distress, pain, fatigue, and nausea before and after the second HT session during weeks 2, 3, and 4. Patients also complete self-report questionnaires at baseline, during week 5 of induction or reinduction chemotherapy or prior to discharge from the hospital, and during the first week of consolidation chemotherapy (approximately week 9-13).

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of one of the following acute leukemias:

  * Acute lymphocytic leukemia
  * Acute myeloid leukemia
* Hospitalized for induction (newly diagnosed patients) or reinduction (relapsed patients) chemotherapy
* Must be oncology inpatients at Wake Forest University Baptist Medical Center

PATIENT CHARACTERISTICS:

* Must know adequate English to understand the consent form, complete questionnaires, and converse with study staff

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
RESTORE-TAVI Pilot

This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care.

The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 70 years
2. Ability to provide written informed consent
3. Ability to speak English

Exclusion criteria:

1. Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
2. Active delirium (4AT score ≥ 4) at time of recruitment
3. Parkinson's disease (Hoehn \& Yahr stage 3-5)
4. Recent stroke (within 7 days preceding recruitment)
5. Terminal condition (e.g. metastatic cancer) with life expectancy \< 12 months
6. Clinical unsuitable for recruitment to trial according to the discretion of the research team
Ultrastructure Analysis of Excised Internal Limiting Membrane in Eyes of Highly Myopia With Myopic Traction Maculopathy

The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane peeling for myopic traction maculopathy and had a follow-up for more than 6 months.

Exclusion Criteria:

* The patients with follow-up less than 6 months
Cell Phone Technology Targeting ART Adherence and Drug Use

The objective of the current research is to improve treatment for injection opioid users by augmenting pharmacotherapy with an innovative text-messaging strategy to promote relapse prevention skills, reduce HIV-risk behaviors, and improve HIV treatment regimen adherence.

the specific aims of this research are 1) To develop and refine, with user feedback, a cognitive behavioral therapy-based text-messaging intervention (TXT-CBT) for HIV-infected adults with opioid dependence; 2) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of TXT-CBT over and above standard care (SC) on opioid use, HIV medication adherence, and healthcare outcomes. Both SC and SC+TXT-CBT participants will be assessed at baseline, treatment-end, and 12 weeks post-treatment; and 3) To examine potential mechanisms of action of TXT-CBT, including self-efficacy, affect regulation, and social support. The investigators hypothesize that TXT-CBT delivered in conjunction with SC will produce greater reductions in opioid use and HIV-risk behaviors, and will improve HIV treatment regimen adherence, relative to MM alone. Further, the investigators expect that SC+TXT-CBT will facilitate greater changes in negative affect, self-efficacy, and social support, and these changes will be associated with substance use outcomes. TXT-CBT incorporates specific substance- and adherence-focused cognitive therapy techniques with a concurrent emphasis on reducing HIV-risk behaviors. By providing support to maximize HIV treatment regimen adherence, coupled with coping skills to address withdrawal symptoms and stress, two important factors in opioid relapse, TXT-CBT may provide a promising, cost-effective, and easily deployable augmenting strategy for the treatment of opioid users who are HIV-infected.

Eligibility Criteria:
Inclusion criteria for participants in both Phase I and Phase II will be:

1. Age 18 or older;
2. DSM-IV diagnosis of Opioid Dependence;
3. HIV-infected serostatus;
4. Able to provide informed consent;
5. Willing and able to participate in study procedures,
6. Good general health or, in the case of a medical/psychiatric condition needing ongoing treatment, potential participant should be under the care of a physician who provides documented willingness to continue participant's medical management and coordinate care with the study physicians.

Exclusion Criteria:

1. Lack of proficiency in English;
2. Currently homeless (unless residing in a recovery home for which contact information can be provided);
3. Dependence on an illicit substance for which medical detoxification is imminently needed.
4. Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis, acute mania, or suicide risk that would require immediate treatment or make study compliance difficult.

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Quality Control of CE-Certified Phonak Hearing Aids - 2017_37

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features and functions. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).


Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with at least 3 months experience with hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders