cyrilzakka/clinical-trials huggingface dataset:
VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.

Eligibility Criteria:
Inclusion Criteria:

1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable)
2. Subject must be an ambulatory male at least 18 years of age.
3. Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
4. Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.

Exclusion Criteria:

1. Subject has undergone a prostatectomy
2. Subject exhibits symptoms of urinary tract infection.
3. Subject exhibits severe neurologic damage or has undergone prostatectomy.
4. Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
5. Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
6. Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
7. Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
8. Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
9. Subjects with co-morbid lower urinary tract symptoms (LUTS).
10. Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
11. In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study.
12. Subjects who have received prior pelvic radiation.
13. Subjects with history of severe hepatic impairment.
14. Subjects with history of Congenital or Acquired QT prolongation.
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:

* Is total neoadjuvant treatment in this design safe \& tolerable?
* Impact of this design on treatment related outcomes in terms of pathological and clinical responses.

Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

Eligibility Criteria:
Inclusion Criteria:

* Histopathological proof of rectal adenocarcinoma.
* Tumors located within 15 cm and not less than 4 cm from anal verge.
* Age: ≥ 18 years.
* Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
* ECOG Performance Status: 0-2.

Exclusion Criteria:

* Non-epithelial rectal malignancy such as sarcoma or lymphoma.
* Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
* Recurrent rectal cancer.
* Previous history of malignancy within the last 5 years.
* Previous pelvic irradiation.
* Psychiatric or addictive disorder that would preclude study therapy.
* Concurrent uncontrolled medical conditions.
* Pregnancy or breast feeding.
* Any contraindication to surgery.
* Extensive peripheral neuropathy.
Effect of 12-week Probiotic Consumption Immobilized on Oat Flakes on Blood and Urine Biomarkers and Human Microbiome

The purpose of this clinical trial was to evaluate the effects Lactococcus cremoris spp. im-mobilized on oat flakes on human microbiome and blood and urine biomarkers of associated with human health.

All eligible and consenting individuals were assigned a unique code for identification purposes. They were then randomly assigned to either the probiotic or placebo group. The probiotic group received oat flakes containing immobilized Lactococcus cremoris, while the placebo group received oat flakes indistinguishable in color, smell, and taste from the flakes with immobilized probiotics.Participants received written instructions on storing the product, which required refrigeration. They were instructed to consume 5 g of oats daily with a meal, ensuring the meal's temperature remained below 35 °C and was non-acidic (e.g., with yogurt). Biological samples were collected at three time points; before intervention, at 6th and 12th week.

Eligibility Criteria:
Inclusion Criteria:

* participants to be aged between 18 and 65 years
* clinically tested with fasting plasma glucose less than 100 mg/dL
* clinically tested withcholesterol less than 220 mg/dL
* otherwise healthy

Exclusion Criteria:

* body mass index \[BMI\] higher than 40 kg/m2 (morbidly obese)
* following a diet plan for weight loss
* following a contraceptive treatment or taking probiotic supplements
* following medication with an effect on lipaemia or glycemia indicators
* having any allergies/intolerances to trial ingredients
* pregnant or planning to become pregnant or breast feeding
* users of illicit drug, having a chronic alcoholism or total daily alcohol intake more than 50 g per day
* diagnosed with a chronic condition (cancer, active liver disease, severe kidney dysfunction, severe stroke in the last six months and conditions associated with an increased risk of bleeding) or any other serious medical condition that may affect the individual's ability to participate in a dietary intervention study
* considered unreliable by the researcher or having a shorter life expectancy than the expected duration of the study due to some illness or if they were in any situation in which by the researcher's opinion their participation in the study was not considered safe (e.g. drug addiction, alcohol abuse).
Tzanck Smear With Methylene Blue Stain for Herpes

To compare the sensitivity of Tzanck smear with methylene blue stain versus traditional Giemsa stain in patients with herpes infection.

A smear from the lesional skin of the patients suspected having Herpes simplex, Herpes zoster and Varicella zoster skin infections will be collected (in a clinical routine setting). The specimen will be stained with methylene blue in addition to the Giemsa stain. Polymerase chain reaction study for herpes antigen will be performed in some of the specimens. The sensitivity, specificity, positive predictive value and negative predictive value will be calculated from the results of the study.

Eligibility Criteria:
Inclusion Criteria:

* patients with clinically suspected of having herpes simplex, herpes zoster, varicella zoster skin infections.
* Those who have vesicular skin lesion such as acute eczema, Paederus dermatitis.
* Those are well cooperative.
* Age \> 18 years old.

Exclusion Criteria:

* Those who are not willing to have specimen from skin lesions to be collected.
Ultrasound by Nurses in Heart Failure Patients

Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.

Patient inclusion: Outpatient heart failure clinic. Patients are eligible for inclusion if the are referred with heart failure and concent to participate in the study. No other exclusion criteria other than no willing/able to give their concent.

Study population: Approximately 80 patients Intervention: All participants will undergo careful medical history, physical examination and blood tests led by nurses. All patients will be examined twice (by two nurses), one will routinely add ultrasound examination of the pleural space and the inferior vena cava to assess volume state, the other nurse will not perform ultrasound examination. Full cross-over design were nurses do ultrasound examinations at a random matter.

Patients will then be examined by echocardiography by experience cardiologist's echocardiographers. Outcome measures:Change in therapy after routinely performed ultrasound examinations vs controls, detection of volume state when performing ultrasound examinations compared to controls with cardiologist's echocardiographic examination as a gold standard.

Descriptive data of patients before, under and after examinations.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the outpatient heart failure clinic at the local hospital

Exclusion Criteria:

* Not able or not willing to concent
Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients

The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* The patient is on hemodialysis because of chronic renal insufficiency
* The patient's vascular access is an arterio-venous fistula
* The patient has a venous stenosis in the fistula (first event in the studied zone)
* The patient is scheduled for angioplasty

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient cannot fluently read French
* The patient cannot understand French
* The patient is pregnant
* The patient is breastfeeding
* Short term dialysis
* The vascular access is a "graft"
* The stenosis in question is a recurrence, and not a first event in the studied zone
* The life expectancy of the patient is \< 12 months
* Medical emergency situation
* Peritoneal dialysis
* At-home dialysis
Impact Program for Multiple Sclerosis

The purpose of this study is to explore the effects of a four week diet coaching program on pain, fatigue, mood, and dietary habits among adults with multiple sclerosis.

Multiple Sclerosis (MS) is the most common chronic disabling central nervous system (CNS) disease in young adults, affecting 1 in 1,000 people in Western countries. Disproportionate and unpredictable impacts of co-morbid health conditions enhances the needs for comprehensive MS management and wellness strategies.

However, comprehensive care is limited, forcing many people to neglect critical aspects of their wellness. This creates a profound need for health and wellness programs that provide education, connection, and activation.

Research shows a consistent need for more access to reliable information regarding symptoms, management, access to healthcare professionals, and rehabilitation. There is also a primary unmet need for more information on exercise, nutrition, insurance, transportation, and employment.

People living with MS often receive more information from advocacy organizations than their MS nurse or neurologist. Decreased access to healthcare professionals since the COVID-19 pandemic has heightened the need for credible information from organizations like Can Do MS. Over the past year, Can Do MS has seen significant growth in virtual program attendance, with participant identifying "learning new information" as a critical objective.

A multipronged approach utilizing auditory, visual, and kinesthetic learning styles is the preferred method for delivering information. There is also a need to appeal to multiple sensory channels through complimentary mediums (e.g. video, audio, written materials, tactile activities).

We will study the effects of the four week coaching program on dietary patterns in MS patients. This will be done through surveys the participants will complete through Qulatrics.

Eligibility Criteria:
Inclusion Criteria:

All participants will be adults ages 18 to 65 diagnosed with any form of MS. Caregivers are also invited to attend the program if they would like to. No restrictions will be made based on sex, gender or other condition.

Exclusion Criteria:

* If the subjects are outside of the age range they will not be able to participate.
Effect of Cryotherapy on Postoperative Pain

the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-40 years old.
* Systemically healthy patient (ASA I or II).
* mandibular first molar teeth with:
* Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
* Ability for isolation with rubberdam.
* Restorable teeth
* Ability to fill the root canals in single visit treatment.

Exclusion Criteria:

* Teeth without good apical constriction, such as wide or open apex
* Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.
* Patients having significant systemic disorder (ASA III or IV).
* Teeth that have :

Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability
Hydrocortisone in Hormone Replacement Therapy for Large Pituitary Neuroendocrine Tumors

The goal of this clinical trial is to assess the need for hydrocortisone replacement therapy during the perioperative period for large pituitary neuroendocrine tumors. The main questions it aims to answer are:

• Does hydrocortisone replacement therapy reduce the incidence of adrenal insufficiency in participants? Researchers will compare hydrocortisone to a placebo (a look-alike substance that contains no drug) to see if hydrocortisone works to reduce the incidence of adrenal insufficiency.

Participants will:

* Take or intravenous infusion drug hydrocortisone or a placebo every day for 2 weeks
* Visit the clinic three months after surgery for checkups and tests
* Keep a diary of their symptoms


Eligibility Criteria:
Inclusion Criteria:

* (1) Age range: 18-70 years old;
* (2) Accept PitNETs patients who can be treated with endoscopic transsphenoidal surgery;
* (3) The maximum diameter of the tumor is ≥ 2 centimeters;
* (4) Preoperative hypothalamic pituitary adrenal axis integrity;
* (5) The subject or their legal representative signs the informed consent form

Exclusion Criteria:

* (1) Patients with a history of Cushing's disease or adrenal insufficiency;
* (2) Emergency and combined hormone therapy patients;
* (3) Pituitary stroke patients;
* (4) Patients lacking head magnetic resonance imaging;
Vertebral Marrow Attention Trial (VMAT)

The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient \> 18 years
* Patients with AJCC (American Joint Committee on Cancer) 8 T1-T4, N1-N3, M0 stage IIIA-IIIC NSCLC (non small cell lung cancer)
* Patients with oligometastatic disease stage IV, M1 disease, in which definitive concurrent chemoradiotherapy to the thorax is planned
* CBC/CMP within these limits
* Absolute lymphocyte count\>500/ml
* Hemoglobin\>8 g/dL
* AST (aspartate aminotransferase)/ALT (alanine transaminase) \<2.5 times of ULN
* Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* History of thoracic irradiation
* History of palliative radiation for the current malignancy under consideration
* Patients not being treated with definitive standard of care to the chest
* History of bone marrow disease and or leukemia
* History of prior cytotoxic chemotherapy for a disease other than for the current malignancy
* Polymetastatic disease, defined here as ≥3 or more extrathoracic metastases
* Administration of concurrent immunotherapy during radiation therapy, either as part of another clinical trial or otherwise
Dosing Strategy of Intravitreal Ranibizumab for Pathological Myopia Choroidal Neovascularization

The purpose of this study is to compare the efficacy (times of injection, change of visual acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological myopia choroidal neovascularization (PM-CNV).

PM is a common disease in east asia, while PM-CNV affect 5%-10% PM patients.PM-CNV has specific characteristics, including small dimensions and limited exudative manifestations comparing with age-related macular degeneration. However, treatment regimen and re-treatment criteria follow the PrONTO protocol. The question of the optimal dose and treatment regimen in myopic CNV management is still unresolved. There is no unequivocal evidence suggesting hat PRN treatment is more effective than a loading phase followed by an as-needed variable dosage regimen.

Eligibility Criteria:
Inclusion Criteria:

* older then 18 years old
* refractive error ≥ -6.0 diopters or axial length ≥ 26.0mm
* active CNV due to high myopic which is the only reason cause visual loss confirmed by fluorescein fundus angiography
* BCVA ≥ 24.0 and ≤73 letters at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study visual acuity chart.

Exclusion Criteria:

* history of (a) stroke,(b) laser photocoagulation involved macular area in study eye, (c) intraocular treatment with corticosteroids or intraocular surgery or anti vascular endothelial growth factor or verteporfin photodynamic therapy within 6 months in study eye, or (d) hypersensitivity to ranibizumab or fluorescein
* presence of active infectious disease or confirmed intraocular pressure ≥ 21.0 mmHg
* pregnant or nursing women
* uncontrolled high blood pressure ≥ 150/90 mmHg or uncontrolled fasting blood glucose ≥ 7 mmol/L
A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma

The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.

Interleukin-13 (IL-13) is a pleiotropic cytokine that promotes inflammation, airways hyper-responsiveness (directly and through recruitment and activation of inflammatory cells), mucus hypersecretion, airway remodeling via fibrosis, increased immunoglobulin E (IgE) synthesis and mast cell activation.Tralokinumab (CAT-354) is a human immunoglobulin G4 (IgG4) anti-IL-13 monoclonal antibody that has been shown to potently and specifically neutralize IL-13 in preclinical models.This study will evaluate the PK profile of a single dose of tralokinumab administered subcutaneously at a dose of 300 mg in adolescent subjects with asthma to be compared with the PK data from completed studies in adults.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-17 years (inclusive)
* Weight greater than (\>) 30 kilogram (kg)
* Asthma for a minimum of 6 months prior to Screening
* Effective birth control for both male and female participants in line with protocol details.
* Exclusion Criteria:
* Previously taken tralokinumab (the study drug)
* Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals
* Pregnant or breastfeeding women
* Current smoker or cessation less than (\<) 3 months prior to screening
* Known immune deficiency excluding asymptomatic selective immunoglobulin A
* History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
* Any disease which may cause complications whilst taking the study drug.