cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Assess the Safety and Pharmacokinetics of RDG-17012 Capsule and Pradaxa® Capsule in Healthy Male Volunteers

A randomized, open-label, single-dosing, 2x2 crossover study, the safety and pharmacokinetics of RDG-17012 with Pradaxa® in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age between 19 to 45, healthy male subjects(at screening)
* Subject without a hereditary problems, chronic disease and morbid symptom
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver, kidney,digestive system, pulmonary,hematooncology, endocrine, urinary,neurology,mental disorder, skeletomuscular, immunology, otolaryngology,cardiovascular)
* Exceed 2 times the normal range of AST, ALT, Total Bilirubin at screening test
* History of drug abuse, or a positive urine drug screen
* Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
* Any condition that, in the view of the investigator, would interfere with study participation
Effectiveness of Dry Needling of Active Trigger Points in Neck Muscles in Patients With Chronic Cervical Pain

Randomized Single-Blind Clinical Trial in which the treatment will be administered through 3 sessions of dry needling in the cervical muscles's active trigger points in patients with chronic cervical pain.


Eligibility Criteria:
Inclusion Criteria:

* Be older than 18 years old
* Sign informed consent form prior to participating in this study
* Have chronic cervical pain diagnosis of their primary care doctor.
* Have one or more active myofascial trigger point in the cervical muscles according to the criteria established by Simons et al.

Exclusion Criteria:

* Major trauma on cervical spine stated from the medical history
* Inflammatory, hormonal or neurological disorders
* Have contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, wound in the puncture area, metal allergies, cancer or systemic diseases, or belonephobia)
* Having received physiotherapy treatment for the condition in the past month
Excision Followed by Radiofrequency Ablation for Breast Cancer

The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.


Eligibility Criteria:
Inclusion Criteria:

* Patient is a female, ≥ 50 years of age
* The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam)
* The tumor is unicentric and unilateral
* The tumor is not involving the skin
* Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III
* If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+)
* Patient signs current written informed consent and HIPAA forms

Exclusion Criteria:

* Patient is under 50 years of age
* Patient is male
* Tumor \> 3 cm in diameter
* Bilateral malignancy
* Clinically positive lymph nodes
* Tumor involving the skin
* Pathology confirms invasive lobular carcinoma
* Breast implants
* Less than 2 years disease-free survival from previous breast cancer
* Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy of the study drug tirzepatide in participants with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification.
* Have HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory.
* If on metformin, have been treated with stable doses of metformin for at least 3 months.
* Have a body mass index (BMI) ≥23 and \<50 kilograms per square meter.

Exclusion Criteria:

* Have type 1 diabetes (T1D).
* Have used any glucose-lowering medication other than metformin within 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past.
* Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke).
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
* Have had chronic or acute pancreatitis any time prior to study entry.
* Have an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation.
* Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry.
* Have any condition that is a contraindication for use of the GLP-1 RA class (per country-specific labels) at study entry or develop such condition between study entry and randomization.
Optimising General Practice Long COVID Care - an Educational Intervention.

This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region.

Our first objective is to conduct focus groups with key stakeholders (GPs, other health professionals, patients, families/carers) that will inform the contents of an education intervention. The second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible.

Study outcomes will include:

* Qualitative findings from co-design focus groups and post-intervention semi-structured interviews with GPs.
* Practice and patient study recruitment and retention data.
* GP / Practice characteristics: age \& gender, practice location, general and COVID-19 patient population figures.
* Patient characteristics: Patient age, gender, COVID-19 vaccination status, and medical history details.
* Patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (COVID-19 Yorkshire Rehabilitation Scale (C-19-YRS)).


Eligibility Criteria:
Inclusion Criteria:

1. Age: Aged 18 years or older at the time of enrolment.
2. Registration: Are registered as patients at the study's participating practices.
3. COVID-19 Diagnosis:

   * Previously received a positive COVID-19 PCR or antigen test, or
   * Previously been clinically diagnosed with COVID-19 by a healthcare provider.
4. Persistent Symptoms:

   o Have spoken with their general practitioner (GP) about experiencing persistent symptoms lasting four weeks or more since their COVID-19 diagnosis.
5. Consent: Willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

1. Vulnerability: Deemed by participating GPs to be a vulnerable individual whose best interests are served by not participating in the study, such as (but not limited to):

* People with language difficulties that prevent meaningful communication.
* Individuals with a recognised or diagnosed intellectual, physical, or mental impairment.
* Older adults considered particularly vulnerable.
* Individuals residing in institutions (e.g., care homes or prisons).
* Individuals with an unequal relationship with the researcher(s) (e.g., hierarchical dependence).
* Members of marginalised or disadvantaged groups for whom participation may present undue burden or risk.
Treatment of Severe Asherman Syndrome by Collagen Scaffold Loaded With Autologous Bone Marrow Mononuclear Cells

This study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(ABMNC) to Foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. Half of participants will receive collagen/ABMNC scaffold after hysteroscopic adhesiolysis, while the other half will receive Foley catheter balloon.

Severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. In order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. However, they don't improve the microenvironment of endometrial regeneration. It's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. This study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than Foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. In addition, the study will be carried out in 2 centers, one is the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, the other is Changzhou Maternal and Child Health Care Hospital that is in Jiangsu Province.

Eligibility Criteria:
Inclusion Criteria:

* Having a clear desire to fertility;
* Infertility that is defined as a women fails to become pregnant after having a normal sex life for two years without contraception.
* Hysteroscopy examination confirmed intrauterine adhesions(patients who has at least one of the three symptoms which are amenorrhea, hypomenorrhea or infertility, and hysteroscopy or histologic diagnosis of intrauterine adhesions), meeting American Fertility Society diagnostic criteria Ⅱ-III;
* Normal ovarian function;
* Regular Menstrual cycles and menstruation is normal before abortion or curettage;
* BMI\< 30 kg/m2;
* Sign a consent form;
* Follow the test plan and follow-up process.

Exclusion Criteria:

* Hereditary diseases;
* Simple thin endometrium with no uterine cavity adhesion;
* Simple Uterine scar formation with no uterine cavity adhesion after hysteroscopic adhesiolysis;
* Contraindications to bone marrow collection or assisted reproductive technology;
* History of malignant tumor;
* Other diseases associated with the uterus: uterine fibroids, severe adenomyosis, severe malformations of the uterus;
* Abnormal blood coagulation, liver and kidney dysfunction, or other diseases which the researchers think may affect the study(such as: uncontrolled hypertension, diabetes, sexually transmitted diseases);
* With a positive urine pregnancy test；
* Participating in other clinical studies at the same time;
* Hysteroscopic adhesiolysis more than 3 times in the past.
Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System

To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, of any race, and at least 21 years of age at the time of pre-op exam
2. Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
3. Best Spectacle Corrected Distance Visual Acuity (BSCVA)

   1. Group 1:

      * Natural astigmatism, no cataract - BSCVA of 20/25 or better
      * Pre cataract or phakic IOL surgery - no BSCVA criteria
   2. Group 2:

      * Post IOL surgery- BSCVA of 20/25 or better
4. Uncorrected Visual Acuity (UCVA) of 20/40 or worse
5. Demonstration of agreement: Corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) within \</= 0.75 D in magnitude and 15 degrees axis when cylinder \</= 1.5 D or 10 degrees axis when cylinder \> 1.5 D.
6. Preoperative central pachymetry of \>/=480 um
7. Keratometry between 38.0 D (flat) to 48.0 D (steep)
8. Corneal power (diopters) difference at the 3mm point from topographic center shall be \</= 1D at the steepest meridian
9. Intraocular pressure of 12 to 21 mm Hg with no glaucomatous retinal/optic nerve changes
10. Subjects who have worn a contact lens within the past 30 days must remove the soft lens at least 2 weeks prior and a rigid or toric lens at least 3 weeks prior to baseline measurements
11. Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

1. Angle kappa of greater than 0.5 mm, absolute value
2. Prior implantation of toric or multifocal intraocular lens
3. Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
4. Concurrent use of topical or systemic medications that may impair corneal wound healing
5. History of any ocular or medical conditions that could affect corneal wound healing
6. History of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye
7. Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye
8. Evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis
9. Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
10. Participation in any other conflicting clinical study
Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)

Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer confined to one area.

In order to increase survival rates there is a need to identify cancer and pre-cancer early. This has been difficult to do.

Patients who have lab tests, positive imaging tests or obstructions will usually have a test called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts removed and analyzed, but there are not studies to show how sensitive this may be to determine if the cells are cancer or pre-cancerous. A new scope with a system using light filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and at an earlier stage.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PSC presenting for ERCP where tissue sampling is indicated
* Adults age 18 to 75 years old
* Able to give informed written consent
* Either male or female

Exclusion Criteria:

* PSC with acute cholangitis
* Patients with acute or chronic, debilitating cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation
* Patients with a prior history of liver transplant
* Prisoners
* Unable or unwilling to give informed consents
Gene-Environment Interactions in Alzheimer's Disease

This study will create Alzheimer 's disease risk profiles for defined combinations of genotypes and environmental exposures. This study will carry out a molecular epidemiologic study to identify genetic and environmental risks factors using state of the art techniques. The following will be done during the course of this study 1) Recruit both Alzheimer's patients and cognitively normal aged veterans. 2) Evaluate gene interaction in Alzheimer's disease. 3) Evaluate gene-environment interactions on the risk of Alzheimer's disease. These procedures should initially address the question as to whether certain genes either independently or synergistically modify the risk of Alzheimer's disease. This study will also determine whether certain environmental factors (smoking, alcohol consumption etc.) can modify the risk of AD and whether this effect is dependent on certain genetic backgrounds. This study will provide information that will be useful in designing therapies, develop risk factor profiles to be further tested in future studies, designating patients for specific therapies based on genetic factors and providing data and genetic material for future studies. This study will also provide a cohort of older and well characterized cognitively normal veterans for prospective genetic epidemiological studies on aging.


Eligibility Criteria:
The GRECC located at this hospital represents the leading edge of clinical care focusing on the needs of the aging veteran. We will recruit all 100 patients currently hospitalized at the Dementia Unit. We will also recruit from the outpatient memory clinic. We will enroll 400 AD patients total. Since, cases and controls will be ascertained from the same population, we also expect the socioeconomic status of individuals in these two groups to be the same. In the past year 9600 patients were treated on an outpatient basis. They were almost entirely white and male (\>90%). The age demographics are 23% between 60-69, 23% between 70-79 and 5 % 80 or greater. The outpatients are seen for a wide variety of conditions. We plan to enroll 100 patients a year for 4 years (400 total). They will be seen once and have the same neuropsychological exams as the AD patients. Control subjects will be enrolled if their Mini-Mental score is greater than 24.
Prognostic Potential of Cell Surface Markers and Pim Kinases in Multiple Myeloma

The purpose of this study is to understand if small proteins found on the surface of myeloma cells (called CXCR4 and CD47) or inside the myeloma cells (Pim kinases, sphingolipids, and pS6) can predict how patients will respond to chemotherapy-treatment and if a small molecule inside the myeloma cells (called Pim kinase) can be used as a treatment target for myeloma. A sample from the bone marrow biopsy (a small amount of tissue removed from the body for laboratory testing) and aspirate (a small amount of fluid is removed from the body for laboratory testing) that had been done before the subject entered this study will be provided for research purposes. Based on preliminary data, it is hypothesized that CXCR4, CD47, sphingolipids, and Pim kinases could be used as prognostic/predictive markers and that Pim kinase inhibitors provide a new agent for the treatment of multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of multiple myeloma or possible multiple myeloma who will have a bone marrow biopsy and aspirate
* Planned therapy with standard chemotreatment for multiple myeloma
* Laboratory data such as calcium, beta 2-microglobulin, albumin, creatinine and bone survey available for staging purpose.
* ≥18 years old

Exclusion Criteria:

* \< 18 years old
* Patients who will not receive chemotreatment
* Patients whose treatment records are not available
Efficacy of Biofeedback-Based Serious Game for Pain Alleviation in Middle-Aged and Older Ovarian Cancer Patients: A Randomized Controlled Trial

Consistent pain affects most middle-aged and older ovarian cancer patients. Non-pharmacological pain interventions, such as serious games, offer a promising approach to alleviating this pain by providing an effective sense of immersion. However, current games on the pain alleviation lack examination of its efficacy in middle-aged and older population and real-time monitoring of immersion level, particular since immersion level is highly associated with pain alleviation effect and adjustable to challenging level of game difficulty. This study developed a serious game with biofeedback-driven dynamic difficulty. Then examined its feasibility and efficacy through a two-arm, single-blinded randomized controlled trial. A total of 52 participants were recruited and randomized into intervention group and control group to receive biofeedback-based dynamic-difficulty serious game or fix-difficulty serious game for 15 mins each, respectively. The primary outcome was the assessment of the pain level, measured using the Visual Analog Scale. The secondary outcomes included pain-related anxiety, immersion level, and user experience.


Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic standards established by the International Association for the Study of Pain (IASP) and having a pain severity level between 3 and 6 (classified as mild to moderate) at the time of enrollment,
* Diagnosed with ovarian caner
* Demonstrating clear cognitive and expressive abilities,
* Being aged 45 or older,
* Providing voluntary consent after fully understanding the study's objectives.

Exclusion Criteria:

* Individuals with a history of mental illness or communication disorders,
* Those experiencing vision or cognitive impairments,
* Individuals undergoing pain medication treatment during the intervention period.
A Study of the Safety, Tolerability and Pharmacokientics of RO5545965 in Patients With Schizophrenia on Risperidone

This randomized, double-blinded, placebo-controlled study will investigate the safety, tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to psychiatrically stable patients with schizophrenia receiving risperidone.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged \>/= 18 years and \</= 60 years
* Clinically stable, mild or moderate schizophrenia
* On stable antipsychotic treatment for the last 6 months
* Generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
* Willingness to be hospitalized for approximately 3 weeks
* BMI \> 18.5 kg/m2 and \< 38 kg/m2
* Use of highly effective contraception as defined by the study protocol. Men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding

Exclusion Criteria:

* Treatment with antiparkinson medication including anticholinergic drugs
* Treatment with depot antipsychotic medication within the last three months prior to screening
* Participation in a clinical trial with an investigational drug or device \< 3 months prior to screening
* Smokes more than 20 cigarettes per day
* Current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit
* Any donation of blood or significant blood loss within three months prior to first administration of the study drug
* Use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration