cyrilzakka/clinical-trials huggingface dataset:
Precision Diagnostics of Functional and Organic Intestinal Pathology Based on Cellular and Molecular Profiling

Differential diagnosis of functional and organic intestinal pathology is carried out in line with approved clinical guidelines and includes a significant list of interventions. However, considering the possibility of an "overlap" between functional and organic diseases, as well as the non-specificity of a number of assessment parameters, it is advisably to define new diagnostic approaches and reliable cell and molecular markers, that will update and ensure the precision diagnostics of intestinal diseases. The integrative functional, cell and molecular markers will create the basis and possibilities for the personalized selection of patient therapy.

The study is intended to develop the methods of precision diagnostics based on cellular-molecular profiling with an assessment of functional parameters of the intestine in functional and organic intestinal diseases.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Gender: Male or Female
* Age: 18-70 years old
* Clinically, laboratory and/or endoscopically confirmed diagnosis of functional (Irritable Bowel Syndrome) and organic (Crohn's Disease, Ulcerative Colitis) intestinal disease
* Healthy volunteers

Exclusion Criteria:

* Age under 18 or over 70;
* Acute intestinal infections;
* Antibiotic-associated intestinal lesions;
* Tuberculosis of the intestine;
* Systemic vasculitis;
* Oncological diseases;
* Diverticulitis;
* Solitary rectal ulcer;
* Ischemic colitis;
* Syndrome of bacterial overgrowth;
* Decompensation of chronic diseases of the cardiovascular system or acute cardiovascular diseases;
* Acute or exacerbation of chronic respiratory diseases, respiratory failure;
* Acute infectious diseases;
* Diabetes mellitus;
* Disorders of the blood coagulation system;
* Mental disorders
* Female patients who are pregnant, planning to become pregnant or lactating
* Participation in a clinical trial in the past 3 months and in any other incomplete clinical trials (including follow up - the period of observation after completion of the study)
* Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study
A Study of Erythromycin and Rivaroxaban in Study Participants With Normal and Reduced Kidney Function

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of rivaroxaban when administered with erythromycin to study participants with mild or moderate renal impairment compared to the pharmacokinetics and pharmacodynamics of rivaroxaban administered to study participants with normal renal function.

This is an open-label study (participants and the study physician \[Investigator\] will know the identity of the assigned treatments) to compare the pharmacokinetics (PK) (how the drugs are absorbed in the body) and pharmacodynamics (PD) (the actions or effects of drugs on the body) of rivaroxaban in study participants with mild or moderate renal impairment (reduced kidney function) receiving multiple doses of erythromycin, to the PK and PD of a single dose of rivaroxaban administered alone in study participants with normal renal function. The study drugs used will be rivaroxaban, a drug that acts to thin the blood to prevent the formation of blood clots, and erythromycin, an antibiotic used to treat patients with bacterial infections. Study participants with normal renal function will receive Treatment A (1 oral \[by mouth\] dose 10 mg rivaroxaban for 1 day) and Treatment C (500 mg oral erythromycin 3x a day (t.i.d.) on Days 1-6 + 1 oral dose of 10 mg rivaroxaban on Day 5). Study participants with mild and moderate renal impairment will receive Treatment A, Treatment B (500 mg oral erythromycin t.i.d. on Days 1-6 + 1 oral dose of 5 mg rivaroxaban Day 5), and Treatment C. Treatments A, B, and C will be separated by up to 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 38 kg/m2, inclusive
* Have a body weight of not less than 50 kg and have been characterized as having normal renal function (creatinine clearance \[CLCR\] \> 80 mL/min), mild renal impairment (CLCR 50-79 mL/min) or moderate renal impairment (CLCR 30-49 mL/min)
* Study participants with renal impairment should have stable renal disease as determined by the Investigator

Exclusion Criteria:

* History of current clinically significant medical illness or any other illness that the Investigator considers should exclude the study participant or that could interfere with the interpretation of the study results
* Additional exclusion criteria for study participants with normal renal function include: diastolic blood pressure \> 95 mm Hg and/or systolic blood pressure \> 150 mm Hg)
* Additional exclusion criteria for study participants with renal impairment include: diastolic blood pressure \> 100 mm Hg and/or systolic blood pressure \> 170 mm Hg, other routine laboratory parameters \> upper limit of normal which could not be explained by the underlying renal disease unless judged to be clinically unimportant by the investigator, have acute renal failure, or be a recipient of transplanted organs
* Have severe renal impairment (CLCR \< 30 mL/min)
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair

Primary aim:

1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.

Secondary aims:

1. Compare VAS pain scores in the two groups of patients over the first 24 hours.
2. Compare opioid intake over the first 24 hours in the two groups of patients.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral open inguinal herniorrhaphy
* Patient must be \>18 years of age
* ASA physical status of I, II, or III
* Patient competent to provide informed consent

Exclusion Criteria:

* Patient \< 18 years of age
* Pregnant or lactating women
* Patient unwilling or unable to provide informed consent
* Contraindications to regional anesthesia
* Allergy to amide local anesthetics
Exercise in Adolescents With Type 1 Diabetes

Regular physical activity is an important part of diabetes management in adolescents with type 1 diabetes (T1D). Increased physical activity has several beneficial effects such as improved lipid profile, insulin sensitivity and quality of life. In addition, a reduced HbA1c is often seen in association to increased physical activity. However, the effect on glycemic control and the acute glycemic response seems to differs between different types of exercise. This issue is poorly studied in adolescents with T1D and the mechanism behind this is not fully understood.

The primary aim of this study was to compare the acute effects on glycemia of resistance and two aerobic continuous and intermittent exercise bouts in adolescents with type 1 diabetes. Secondarily, the investigators want to compare the different exercise according to hormonal changes and expression of mRNA in muscle.

At a baseline visit the participants was tested for maximal oxygen consumption (pVO2peak) and maximal strength (1-RM). The study participants then performed three exercise bouts and one control session (resting), each on 45 minutes, in a randomized order. Measurement was performed during and after the exercise.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Type 1 diabetes
* HbA1c \< 65 mol/mol at inclusion
* Regularly performing physical activity
* Aged 16-18 years old

Exclusion Criteria:

* Less than 0.5 U/kg in insulin requirements
* Duration of diabetes less than one year.
Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer

Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of \[Grade III, LVSI+, Mm\>1/2\] Clear cell or serous carcinoma: stage IB-II
* Age: 20-75
* ECOG PS: 0-2
* Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine \<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
* Informed Consent

Exclusion Criteria:

* Previous chemotherapy or pelvic RT
* Hormone therapy within 4 weeks
* Other malignant disease
* Uncontrolled medical disease
* Infection requiring antibiotics
* Symptomatic CHF, RF, Angina, Arrhythmia, etc.
* Neurosis or psychosis
* Etc.
Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension

High blood pressure, also known as hypertension, affects nearly half of all Americans and increases the risk for heart disease and stroke. Only about half of people with high blood pressure have it under control. New methods to control blood pressure are needed to reduce heart attack and stroke rates. The purpose of this study is to test whether a digital program that includes personalized health coaching and remote patient monitoring with a connected blood pressure cuff, all delivered on a smartphone or website, can improve blood pressure control compared with usual care among patients with high blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension
* 18+ years of age
* English-speaking
* Receives primary care at Stanford Primary Care

Exclusion Criteria:

* \<18 years of age
* Primary language not English
* Active or prior enrollment in Omada Program
Hybrid AbLaTion of Atrial Fibrillation

A randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (AF)

The objective of this randomized study is to evaluate the safety and efficacy of Convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal AF.

Patients will be randomised in a 1:1 ratio. The primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Persistent or Long-standing Persistent AF
* Dilated left atrium
* Suitable for either procedure

Exclusion Criteria:

* Unable to provide written consent
* Previous open-heart surgery
* Active infection, oesophageal ulcer stricture or oesophageal varices
* Prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable)
* Contraindication to anticoagulation, or active thrombus in left atrium despite therapeutic anticoagulation
* Severe valvular heart disease
* Unstable coronary artery disease
* Uncontrolled ventricular arrhythmia
* Heart attack or stroke within the last 90 days
* Pregnant, breast-feeding, or women of childbearing age who plan to get pregnant within six months
* Severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures
Evaluation of RFID Localization System for Marking and Retrieving Breast Lesions

The goal of this investigation is to obtain clinical data to show the Health Beacons Radiofrequency Identification (RFID) Localization System is safe and performs as intended as a localization device for marking and retrieving a non-palpable surgical target from the breast.


Eligibility Criteria:
Inclusion Criteria:

* Have had stereotactic or ultrasound-guided biopsy with marker placement
* Have a lesion or biopsy marker that is visible under ultrasound
* Have surgical target \< 6 cm from the skin when lying supine
* Have a discreet surgical target
* Have a lesion in which the center/focal area is defined
* Be at least 18 years of age or older

Exclusion Criteria:

* Have a palpable lesion that does not require localization
* Require more than one localization needle for localization of the surgical target
* Have undergone previous open surgical biopsy or lumpectomy in the operative breast
* Have an implant in the operative breast
* Have a cardiac pacemaker or defibrillator device
Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

The primary objective is to evaluate platelet function following intravenous diclofenac, oral diclofenac (Cataflam), intravenous ketorolac and oral aspirin.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects.
* Willing and able to stay at the clinical site for approximately 8 nights over 9 days and to return to the clinic approximately 7 days after discharge.

Exclusion Criteria:

* Bleeding abnormalities or cardiovascular events.
* Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa Ependymoma

This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions into the fourth ventricle of the brain. The study's primary objective is to establish the maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients with recurrent ependymoma. The study's secondary objective is to assess the antitumor activity of 5-Azacytidine infusions into the fourth ventricle based upon imaging studies and cytology.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Patients with histologically verified ependymoma, with recurrence or progression anywhere in the brain and/or spine. Patients are also eligible if they have refractory disease, which will be defined as residual tumor which has not been completely cleared despite prior treatments. To be eligible, patients' disease must have originated in the posterior fossa of the brain
* Patient must have either measurable or evaluable tumor as assessed by MRI of the brain and total spine
* An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached to a ventricular access device or agreement to have one placed.
* A minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of 5-AZA into fourth ventricle
* Life expectancy of at least 12 weeks in the opinion of the principal investigator
* Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater if \> 16 years of age
* Existing neurological deficits must have been stable for a minimum of 1 week prior to study enrollment
* Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy
* Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥ 500/μL, platelet count ≥ 50,000/μL (transfusion independent), and hemoglobin ≥ 9.0 gm/dL (may receive RBC transfusions)
* Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent.

Exclusion Criteria:

* Enrolled in another treatment protocol
* Has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to 5-AZA infusion into the fourth ventricle
* Evidence of untreated infection
* Pregnant or lactating women
High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD

The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)

This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent
* Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID
* CAPS score of at least 40
* Males or females between 18-65 years of age
* Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.

Exclusion Criteria:

* Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder
* Patients with HDRS score ≥ 18
* A metallic implant in cranium (except the mouth)
* Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety
* ECT treatment within the last three months
* Patients with a history of epilepsy
* Patients with neurological disorder leading to increased intracranial pressure
* Participation in a new course of psychotherapy during the 24 days of the study
* A new psychiatric medication within 6 weeks of enrolling in the study
* Changes in psychiatric medication within 2 weeks of starting the study
Nuevo Amanecer: Promoting the Psychosocial Health of Latinas

The purpose of this study is to test whether a new program Nuevo Amanecer (A New Dawn), improves the quality of life of Latinas diagnosed with breast cancer. Trained Latina counselors who have had breast cancer provide support to recently diagnosed women. The investigators call these counselors peer support counselors.

This study will assess the effectiveness of a cognitive-behavioral stress management (CBSM) intervention for newly diagnosed Latina breast cancer patients. In our prior work, the investigators established the appropriate content of the intervention, the need for early intervention, and the value of culturally competent peer support. In this study the investigators will adapt an evidence-based CBSM intervention designed to meet these needs. This study will use a randomized controlled trial (RCT) design with a wait-listed usual care control group to adapt the intervention and test its effectiveness in improving breast cancer specific quality-of-life, and decreasing anxiety and breast cancer specific distress. The new, adapted intervention will be called "Nuevo Amanecer" (A New Dawn).

Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Latina
* Diagnosed with Stage 0, I, II, or III in the prior month
* Primarily Spanish-speaking, or Spanish monolingual
* Aged 18 or older
* Diagnosed in Alameda, Contra Costa, San Mateo, San Francisco or Santa Clara counties, California.

Exclusion Criteria:

* Previous cancer diagnosis except for non-melanoma skin cancer
* Terminal illness
* Stage IV breast cancer (distant metastasis)
Safety and Effectiveness of an Auricular Spray

The goal of this clinical trial is to test the safety and efficacy of a medical device in subjects with cerumen in excess. The main questions it aims to answer are:

* Does the medical device induce skin irritation in the ear canal?
* Does the medical device reduce obstruction of ear canal induced by excessive cerumen?

Participants will use the device in each ear, once a day, every 3 days at home. Researchers will compare the medical device group to a control group who will not use the medical device.

Ocean Bio Actif Hygiène de l'oreille is a medical device class IIa indicated for the prevention of the formation of earwax plugs and consequently the pathologies linked to the accumulation of earwax (hearing loss and infection/affection of the external auditory canal).

This clinical investigation is designed to improve the quality and quantity of data available on both the safety and the efficacy of Ocean Bio-Actif, in order to confirm the safety and the efficacy of the product in a post-market environment.

The objective of the current clinical investigation is to confirm the efficacy and safety of topical application to the ear canal of Ocean Bio-Actif.

Eligibility Criteria:
Inclusion Criteria:

* Gender: female and/or male.
* Age:

  30 to 40% having age between 3 to 12 yo, 30 to 40% between 13 to 65 yo, 30 to 40% more than 65 yo.
* Subjects able to use the tested product.
* Subjects having history of cerumen occlusion more than once a year with or without symptoms (reduction of hearing function, obstruction feeling of the ear canal,..).
* Subjects having ear help system or regular users of systems such as anti-noise plugs or headsets (only for the 13yo subjects and more).
* Subjects having a clinical score of ear canal obstruction of 2 or 3 at D0.

Exclusion Criteria:

* Subjects who had chirurgical act on the mastoïde.
* Subjects who had severe troubles of the internal ear (severe dizziness, desorientation, nausea).
* Subjects using regularly a ear spray for washing his/her ears.
* Subjects having a score of ear canal obstruction at 4 at D0.
* Pregnant or nursing woman or planning a pregnancy during the study;
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
* Subject in a social or sanitary establishment;
* Subject suspected to be non-compliant according to the investigator's judgment;
* Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
* Subject suffering from a severe or progressive disease.