cyrilzakka/clinical-trials huggingface dataset:
Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H.Pylori Eradication

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical effiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail.

Helicobacter pylori（H.pylori）is a gastric pathogen, related to various gastrointestinal disorders. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Vonoprazan and high-dose amoxicillin dual therapy is a potential H.pylori eradication regimen. It provides a satisfactory eradication rate of 90%. Nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. The main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. Combining traditional Chinese medicine may be one of the effective ways to solve the above problems.This study aims to compare the efficacy of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old
2. Patients with H.pylori infection
3. Diagnosed as functional dyspepsia
4. Meet the diagnostic criteria of H. pylori cold-heat syndrome in traditional Chinese medicine.
5. Patients who have not received H. pylori eradication treatment before, or who have failed eradication in the early stage but have not received eradication treatment within six months.
6. Volunteer to participate in this experiment and sign the informed consent.

Exclusion Criteria:

1. Allergy to research drugs (penicillin allergy, etc.)
2. Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases.
3. Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases
4. Patients who have received H. pylori eradication treatment within six months.
5. Antibiotics and bismuth were used 4 weeks before the start of study treatment, and histamine H2 receptor antagonist or PPI was used 2 weeks before the start of study treatment.
6. Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants.
7. History of esophageal or gastric surgery
8. Pregnant and lactating women
Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Resectable Gastric and GE-junction Cancer (PANDA)

In this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment.

The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.

In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction.

All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by surgery.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* patients age 18 and older
* primary resectable, histologically confirmed gastric or GEJ adenocarcinoma

Exclusion Criteria:

* no signs of distant metastases
* no active or history of autoimmune disease or immune deficiency
* no significant cardiovascular disease
* no major surgical procedure within 4 weeks prior to initiation of study treatment
* no current treatment with anti-viral therapy or HBV
* no pregnancy or breastfeeding
* no history of malignancy within 3 years prior to screening
Anaemetro I.V. Infusion 500mg Drug Use Investigation

Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice


Eligibility Criteria:
Inclusion Criteria:

* Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study.

Exclusion Criteria:

* No exclusion criteria are set out in this study.
Ribavirin Bioavailability After Telaprevir Exposure

Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatitis C virus infection
* Previous non-response to pegylated-interferon/ribavirin therapy
* Re-treatment with pegylated-interferon/ribavirin and telaprevir

Exclusion Criteria:

* Decompensated liver cirrhosis
An Open Trial of Metacognitive Therapy for Anxiety and Depression in Cancer

Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.

Survival rates in cancer continue to improve, with over 2 million adult cancer survivors in the United Kingdom, projected to increase to 4 million by 2030. Around 25% of these survivors require treatment for clinical levels of emotional distress. There is scope for improvements in the efficacy of current pharmacological and psychological interventions. Reflecting this limited efficacy in the face of the need for psychological treatment, the National Cancer Survivorship Research Initiative highlighted development and evaluation of practically feasible interventions for depression and anxiety in cancer survivors as an urgent research priority. It is recognised that current influential psychotherapeutic approaches need to be modified to meet the specific needs associated with cancer. However modifications have been pragmatic rather than theory-driven and have not improved efficacy.

This study addresses the stages of 'development' and 'piloting and feasibility' in intervention development, albeit with a relatively well-defined starting point given existing evidence for efficacy of MCT in other settings and promising preliminary evidence of applicability in cancer. The investigators will conduct a phase I open trial to test the potential efficacy of MCT in cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis at least 6 months previously
* Scoring \>15 on the Hospital Anxiety and Depression Scale Total
* Stable on, or free from, psychotropic medication

Exclusion Criteria:

* History of psychotic disorder, learning disability, or organic mental disorder
* Risk of self-harm or suicide warranting immediate intervention
* In palliative phase of treatment
* Being considered for risk-reducing or reconstructive surgery within 1 year
* Concurrent psychological treatment
* Cognitive impairment precluding informed consent or participation
Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment

In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed.

The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.

Patients: We will include consecutive patients with a diagnosis of severe OSA (AHI\> 30) without significant comorbidities or excessive daytime sleepiness (Epworth ≤ 12). Patients will be randomized to CPAP treatment or conservative treatment.

Methodology: We will assess at baseline and after 3 months of treatment:

1. Neuroimaging by MRI
2. Neurocognitive function with an extensive neuropsychological battery assessing principally memory, attention and executive functions (Trail-making test A and B, Rey Auditory Verbal Learning Test, Digit span, Digit symbol),
3. Biological markers of inflammation and endothelial dysfunction.

Patients included in the study will be monitored and followed for three months. They will be examined at the time of inclusion, after two and six weeks and at the end (12 weeks) for clinical monitoring and the evaluation of adaptation to treatment and compliance.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 65 years old.
2. Patients diagnosed with OSA with an apnea-hypopnea index per hour \>30.
3. Patients with an Epworth Sleep Scale score ≤ 12 (without excessive daytime sleepiness).
4. Signed written informed consent.

Exclusion Criteria:

1. Patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric.
2. Any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol or may, in the opinion of the investigator, compromise the conclusions.
3. Mini Mental State Exam (MMSE) \<24.
4. Any MRI exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
5. Previous CPAP treatment.
6. Psycho-physical inability to complete questionnaires. Inadequate visual and auditory acuity will be excluded.
7. Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome.
8. Patients with \> 50% of central apneas or the presence of Cheyne-Stokes Respiration.
9. History of alcohol abuse or dependence.
Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin

This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
* The subject must have completed the end of treatment visit of NN1250-3643 with Insulin degludec once daily + metformin.
* Ability and willingness to adhere to the protocol including self measurement of plasma glucose according to the protocol

Exclusion Criteria:

* Participated in NN1250-3643 and treated with insulin glargine
* Previous treatment with glucacon like peptide (GLP-1) receptor agonists (e.g. exenatide, liraglutide)
* Impaired liver function, defined as alanine aminotransferase (ALAT) 2.5 times the upper limit of normal at end of treatment in NN1250-3643
* Impaired renal function defined as serum-creatinine = 125 µmol/l (= 1.4 mg/dl) for males and = 110 µmol/L (= 1.3 mg/dl) for females or according to local label for metformin \[For France: glomerular filtration rate below 60 ml/min, calculated by the Cockroft \& Gault formula\] at end of treatment in NN1250-3643.
OCT and OCT-A Deep Learning in Diabetic Patients Wiht Artificial Pancreas Device

This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.

hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose.

The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.

The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.

Eligibility Criteria:
Inclusion Criteria:

* • age older than 18 years

  * diagnosis of type 1 diabetes
  * treatment with artificial pancreas device
  * absence of previous ocular surgery and congenital eye diseases.
  * absence of errors of refraction
  * absence of lens opacities
  * absence of low-quality OCT and OCTA images

Exclusion Criteria:

* age younger than 18 years
* previous ocular surgery and congenital eye diseases
* errors of refraction
* lens opacities
* low-quality OCT and OCTA images
A Biomarker Identification Trial of Tarceva (Erlotinib) in Patients With Advanced Pancreatic Cancer

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva 150mg/day po, or placebo po daily. Tumor tissue will be used for biomarker analysis. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically or cytologically documented locally advanced-unresectable or metastatic pancreatic cancer;
* measurable disease according to RECIST;
* failure of at least one prior chemotherapy regimen, or who are deemed unsuitable for chemotherapy;
* ECOG performance status of 0-2.

Exclusion Criteria:

* local or locally advanced-resectable pancreatic cancer;
* any other malignancies within last 5 years, except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
* major surgery within 2 weeks prior to randomization.
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).


Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

* Skin intolerance to alcohol or allergy to soy
* Generalized skin disease
* Contraindication to testosterone or androgen products
The Effect of Music-Based Mindfulness to Cope with Acculturative-Related Stress

The purpose of this study is to explore the effect of music-based mindfulness on stress reduction among East Asian international students.


Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Pursuing an undergraduate/graduate degree with an F-1 visa
* Originating from regions including China, Hong Kong, Taiwan, North Korea, South Korea, and Japan
* Living in the United States for no more than 3 years
* Having less than one year of mindfulness practice

Exclusion Criteria:

• Individuals not meeting inclusion criteria
Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)

Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

The purpose of this study is to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.

Eligibility Criteria:
Inclusion Criteria:

* Patient is a male or female who is undergoing primary unilateral surgery or the first surgery of a staged bilateral total knee replacement where the second stage will be at least 6 weeks later
* Patient agrees to be blinded to their treatment group assignment
* Patient is willing and able to return for follow-up over at least a six (6) month post-operative period although longer follow-up may be desired
* Patient agrees to participate by signing an IRB approved Informed Consent Form

Exclusion Criteria:

* Patient will have a staged bilateral total knee replacement with the second stage to be performed less than 6 weeks after the first stage surgery PRP in
* Patient has had previous surgery on the operative knee that will necessitate the removal of existing hardware (e.g. previous osteotomy)
* Patient has a known adverse reaction or sensitivity to bovine (cow) thrombin (used as part of the platelet rich plasma system) or other bovine-derived products
* Patient has hemoglobin \< 12.0 (males), \< 11.0 (females)
* Patient has a clinically significant anxiety disorder
* Patient is on therapeutic anticoagulation medication and has an INR \> 1.3
* Patient has a severe bleeding disorder
* Patient has a known addiction to drugs or alcohol, including, but not limited to: chronic daily use of narcotic medications for more than 90 days prior to surgery
* Patient is pregnant
* Patient is a prisoner
* Patient is involved in a personal litigation (e.g. Worker's Compensation) that relates to their knee surgery
* Patient is actively participating in another medical device, drug, or biologic clinical trial (active defined as having treatment within the last 30 days)
To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking

Study to see how effective different doses of tadalafil are for getting and keeping an erection when sex is attempted after a certain number of hours.


Eligibility Criteria:
Inclusion Criteria:

* At least 3 months history of erectile dysfunction (ED)
* Anticipate a monogamous relationship with a female sexual partner
* Be able to make minimum required sexual intercourse attempts
* Abstain from using any other ED treatment

Exclusion Criteria:

* History of other primary sexual disorder
* Treatment with nitrates
* Have a penile implant or clinically significant penile deformity
* History of certain heart problems
* Do not meet certain lab value reference ranges
The Influence of Seat Height on Hemiplegic-pattern Propulsion of Manual Wheelchairs

This study evaluates the effect of seat height on hemiplegic-pattern wheelchair propulsion. Each subject will act as their own control and measures will be obtained in a one sixty minute session. Five seat heights relative to the subject's leg length will be measured in a random order to see the effect on forward and backwards wheelchair propulsion.

Many people who have suffered a stroke require a wheelchair for mobility. Hemiplegia is a common result of stroke.Many people with hemiplegia propel themselves using their sound-side arms and legs ("hemiplegic-pattern propulsion") in manual wheelchairs.Often people using this pattern are prescribed wheelchairs with a reduced seat height to facilitate foot propulsion. Despite the seeming obviousness of the need to lower the seat height for people who use foot propulsion,there is little available evidence to help establish optimal wheelchair seat height. The study objective is to test the hypothesis that there is an optimum wheelchair seat height (expressed as a percentage of the lower leg length) for hemiplegic-pattern wheelchair propulsion. The investigators expect that the optimum seat height will be lower than that usually used for wheelchairs that are hand-propelled.

A single-subject design with able-bodied participants will be used to investigate 5 randomized seat heights. The 5 seat heights will be set relative to the subjects leg length at a single 60 minute data collection session All measures will be obtained during one session. The optimal seat height will be chosen based on wheelchair propulsion speed, push frequency and effectiveness over 10m going forward on smooth surface, and 5m going backwards over a soft surface.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate
* is right-hand dominant (to simplify wheelchair and laboratory set-up)
* has a subjective unshod height of ≤ 183 cm (6'0")
* is able to be comfortably seated in the manual wheelchair used for the study
* is 18 years of age or older, is alert and cooperative
* is competent to provide informed consent
* is able to communicate in English
* does not have an unstable medical condition

Exclusion Criteria:

-
Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC

Lung cancer (LC) remains a leading cause of death among cancers worldwide. Though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. The purpose of this study is to test the effects of transcutaneous auricular VNS vagal nerve stimulation (taVNS), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in LC patients undergoing radiotherapy.

In this feasibility study 12 patients with NSCLC stage III (A/B) receiving radiotherapy will be enrolled. Our primary endpoint is the effect of vagus nerve stimulation (VNS) on inflammatory levels (such as CRP and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker CEA. Our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Patients with non-small cell lung cancer stage III (A or B)
* Patients receiving radiotherapy or chemoradiotherapy
* Patients with an HRV \< 70 msec

Exclusion Criteria:

* Patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any other implanted electronic device
* Patients with an implanted or wearable defibrillator.
* Patients with myocardial disease
* Patients with arrhythmias
* Patients with an implanted metallic or electronic device in their head.
* Pregnant or breastfeeding women
Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease

This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Signs and symptoms of dry eye disease
* Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.

Exclusion Criteria:

* History of glaucoma, or ocular hypertension
* Diagnosis of ocular infection
* Use of contact lenses in the past 14 days or expected use during the study
* Use of any topical ophthalmic medications in the past 30 days
* Use of corticosteroids in the past 30 days.