cyrilzakka/clinical-trials huggingface dataset:
Micronized Purified Flavonoid- Fraction (MPFF) in the Management of Radiation Proctitis

national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings

Radiation proctitis is an inflammation of rectal mucosa, a complication following radiation therapy for cancers of the prostate, cervix, uterus, bladder and other malignancies in the pelvic area. Around 20 % of radiation patients develop radiation proctitis. There is a significant lack of trial treatments for radiation proctitis, even more, the studies often are small and single center designed or case series. In 2 recent reviews pointing out the management of radiation proctitis (2018 and 2016) a summary of current options in therapy according to current scientific knowledge is given. Unfortunately, these studies are about interventional options with the serious risk of complication. Only little data and lack of significance in smaller series on conservative strategies are given.

The goal of the trial is to implement a specific medication in the management and every grade of radiation proctitis - concomitant to eventual need of MMPF is described with potent anti-inflammatory mucosal capacity reducing bleeding, pain and urgency symptoms in patients with hemorrhoidal and/or postoperative symptoms. By using a placebo instead of comparative oral medications (with low evidence) this study might illustrate clinical significance of expected results as well as information on the natural history of radiation proctitis.

The goal of the study is to compare the number of necessary interventions required to stop bleeding in chronic radiation proctitis in patients receiving MMPF in comparison to patients in the control group receiving Placebo within 12 months of medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent form
* male and female patients
* age ≥ 18 years
* patients with diagnosis of radiation proctitis with macroscopic bleeding
* end of radiotherapy ≥ 3 month = 90 days ago

Exclusion Criteria:

* infectious proctitis
* ulcerative proctitis (inflammatory bowel disease)
* persons unable to understand the informed consent
* persons, who are in dependent relationship with the study investigators or Sponsor
* pregnant or lactating women
* participation in an interventional study
Effects of an Apple Derived Fibre Supplement on Constipation

We will conduct a 2 months clinical intervention in which a 20 g appled derived fibre supplement will be compared with a placebo without fibre. The main outcome will be the reduction in the Gastrointestinal System Rating Scale

Participants with constipation and mild gastrointestinal symptoms will be invited to participate. Those with alarming symptoms such as gastrointestinal bleeding or weight loss, those using laxatives or medications with anticholinergic actions will be excluded from the study At baseline, participants will be weighed and interrogated about Their gastrointestinal symptoms using the "Gastrointestinal symptom rating scale" Their type of stools using the Bristol visual stool scale The number of complete spontaneous bowel movements per week Afterwards, they will be randomized, balancing by age, gender and body mass index to receive in a doubly blind fashion A 20 g/day powder with apple derived fiber A similarly looking placebo powder The intervention will last 8 weeks. Every two weeks, participants will be cited to provide a new supply of the product, retrieve the used vials and be interrogated using the same tools as baseline. At the end of the intervention, participants will be weighed again

Eligibility Criteria:
Inclusion Criteria:

* presence of constipation or functional gastrointestinal symptoms

Exclusion Criteria:

having serious cardiovascular, kidney or hepatic diseases

* gastrointestinal bleeding weight loss use of laxatives use of medications with anticholinergic actions
POGO® Automatic Blood Glucose Monitoring System Clinical Study

The purpose of this study is to determine if the POGO® system delivers accurate blood glucose readings in the hands of the lay user and assess the POGO® system accuracy when used by trained health care professionals.

Subjects will review labeling materials and self-test using the POGO® system. An HCP-assisted test also will be performed; both tests will be compared to a fingerstick capillary sample run on a YSI reference glucose analyzer. Subjects will complete questionnaires on labeling comprehension and POGO® usability.

Eligibility Criteria:
Inclusion Criteria:

* Be diagnosed with diabetes
* Be 18 years of age or older
* Be able to read, write, and understand English fluently
* Be able and willing to give written informed consent and have provided signed, written consent

Exclusion Criteria:

* Any condition which in the opinion of the Investigator may place the subject or site personnel at excessive risk
* A physical condition or limitation that prevents the subject from reading the labeling and using a BGMS on their own
* Previous experience with the POGO® BGMS
* Formal experience with clinical (medical) laboratory equipment or formal training in a relevant medical field
Staging and Grading of Periodontitis: Five Years Later

The goal of this observational study is to investigate the ability of Periodontists, Clinicians with Expertise in Periodontics and General Dental Practitioners to diagnose periodontitis using the 2017 AAP / EFP World Workshop classification of periodontal diseases.

The purpose of this study is to conduct a online survey in order to:

1. investigate Italian dentists' knowledge on the new classification of periodontal diseases.
2. evaluate the reliability of the diagnosis between different examiners in classifying periodontitis;
3. evaluate the accuracy of the use of grading in the diagnosis of periodontitis;
4. evaluate diagnostic accuracy of staging application in classifying periodontitis.

Four well-documentated clincial cases will be presented to Italian dentists (Periodontists, Clinicians with Expertise in Periodontics and General Dental Practitioners) through online survey to obtain a Clinical application of the 2018 classification of periodontal diseases Each participant will be asked to diagnose periodontitis using staging and grading for each clinical case.

Each periodontal case will be documentated according a previous study (Marini et al. 2022) specifing:

Age; Systemic diseases (presence/absence); Cigarette consumption ( \<10 cig/day or \>10cig/day); Tooth mobility (presence/absence) Tooth migration (presence/absence) Number of tooth loss due periodontitis (0; \<4; \> 5) Gingival bleeding (presence/absence) Familiarity for periodontitis

Each periodontal case will be presented showing:

Intra-oral photographs; Full-mouth periapical radiographs; Periodontal chart

Eligibility Criteria:
Inclusion Criteria:

Periodontists, Clinicians With Expertise in Periodontics General Dental Practitioners
Repeated Dosing Clinical Trial of HL151

The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male in the age of 19-45
2. Body weight ≥ 50kg, BMI 18\~29 kg/m2
3. Subject who sign on an informed consent form willingly

Exclusion Criteria:

1. Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
2. Subject with acute disease within 28 days prior to study medication dosing
3. Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
4. Subject with clinically significant chronic disease
5. Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
6. Use of any prescription medication within 14 days prior to study medication dosing
7. Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
8. Subject with clinically significant allergic disease
9. Subject with known for hypersensitivity reaction to bepotastine
10. Subject with any of the following conditions in laboratory test

    * AST/ALT \> UNL (upper normal limit) x 2
    * Total bilirubin \> UNL x 2
    * Renal failure with CLcr \< 50mL/min calculated on Cockcroft-Gault \[Cockcroft-Gault GFR = (140-age) \* (Wt in kg) / (72 \*Cr)\]
    * SBP\<100mmHg or ≥160mmHg, DBP\<60mmHg or ≥100mmHg
    * QTc\>440msec on ECG
    * Serum potassium \< 3.5 mEq/L or \> 5.5 mEq/L
11. Immunological incompetence, immune deficiency or taking immunosuppressants
12. Subject who cannot take standard meal
13. Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
14. Subject with blood transfusion within 30days prior to study medication dosing
15. Participation in any clinical investigation within 90days prior to study medication dosing
16. Continued excessive use of caffeine (caffeine \>five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \>10 cigarettes per day)
17. Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
18. Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
19. Subject who are not using adequate means of contraception
20. Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
21. Subject with history of drug abuse or drug addiction
SAP Block to Reduce Post Mastectomy Pain

To decrease post-operative pain in patients undergoing modified radical mastectomy.

The Serratus anterior Plane (SAP) Block has proven to be an effective component of multimodal analgesic regimens for a variety of thoracic procedures. It is designed to block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax and it may be a viable alternative to paravertebral blockade and thoracic epidural analgesia and may be associated with fewer side effects. It's straight forward to perform, with high success rate and minimal incidence of complications.

It was reported prolonged numbness over the area supplied by the lateral cutaneous branches of the T2-T9 spinal nerves using only 0.4 ml.kg-10.125% levobupivacaine. This is remarkable, because alternative techniques such as intercostal, interpleural and thoracic paravertebral block require relatively high concentrations and volumes of local anesthetics to produce similarly prolonged, multi-dermatomal thoracic analgesia.The duration of Serratus plane block is limited to the effect of administered local anesthetics (LAs). However, recently adjuvants such as epinephrine, ketamine and clonidine are added to LA solution in concentrations advocated for other peripheral blocks to prolong the effect of block with promising results.

Evidence supporting the presence of N-methyl-D-aspartate (NMDA) receptors in skin and muscles have led to the use of magnesium sulphate (MgSO4) (NMDA antagonist) via different routes for brachial plexus block and via neuraxial route. Until date, no study has been done to evaluate the role of MgSO4 as an adjuvant in SAP block. Therefore, the investigators intended this study to evaluate the role of MgSO4 as an adjuvant to bupivacaine in ultrasound (USG)-guided SAP block for postoperative analgesia in patients scheduled for modified radical mastectomy.

While the key requirement for successful regional anesthetic blocks is ensuring optimal distribution of local anesthetic around nerve structures, ultrasound guidance enables the anesthetist to secure an accurate needle position and to monitor the distribution of the local anesthetic in real time.

Eligibility Criteria:
Inclusion Criteria:

* Adult, female patients, ASA physical status I, II, and III aged older than 18 years scheduled for modified radical mastectomy surgery under general anesthesia.

Exclusion Criteria:

Any known allergies to the study drugs. Anatomical abnormalities or infections in the serratus region. Bleeding disorders e.g. thrombocytopenia, high INR, high PT in chronic liver or impaired kidney). Patients on chronic pain medications or regularly receiving analgesics. Pregnant or breast feeding patients. Body Mass Index (BMI) more than 35.
Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED).


Eligibility Criteria:
Inclusion Criteria:

* Male patients of 18 to 60 years of age.
* Patients in a stable, monogamous sexual relationship with a female partner for at least 6 months and willing to maintain this relationship for the duration of the study.
* Patients with established diagnosis of erectile dysfunction (ED) of organic, psychogenic or mixed etiology for at least 6 months duration.
* Patient willing to attempt at least one sexual intercourse in a week for the entire treatment.

Exclusion Criteria:

* Patients with total erectile failure or any other sexual disorder such as hypoactive sexual desire.
* Patients who have previously failed to respond to PDE-5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
* Patients who have used other erectile dysfunction therapies within 14 days (2 weeks) prior to entering into this study (i.e. visit 1).
* Patients with hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or penile trauma.
* Patients with a history of major psychiatric disorder.
* Patients with a history of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease within the past 6 months.
* Patients with a history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or a radical prostatectomy or radical pelvic surgery.
* Patients with hypotension (\<90/50) or uncontrolled hypertension (\>170/100), uncontrolled diabetes, hepatic impairment (SGOT or SGPT levels \> 3 x Upper Normal Limit), renal impairment (serum creatinine \> 2.5mg/dl), hematological disorders such as bleeding disorders.
* Patients with a history of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION).
* Patients with a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism.
* Patients on concomitant treatment with nitrates/nitrites(NO) donor, CYP3A4 inhibitors, CYP3A4 inducers, anticoagulants, androgens, antiandrogens or trazodone.
* Patients with known hypersensitivity to PDE 5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
* Patient with known diagnosis to AIDS or with a positive HIV result at study screening visit.
* Patients with any other serious concurrent illness or malignancy.
* Patients with continuing history of alcohol and / or drug abuse.
* Participation in another clinical trial in the past 30days.
Epigenetics of TNBC in Overweight and Obese Hispanic & Non-Hispanic White Women

A key tenet of this project is that of reaching translational human diagnosis and biomarker end points. To lay a foundation and make progress towards these translational goals, investigators will address the following specific aim:

To determine if BMI/ obesity differentially influence expression and epigenetic signatures in triple negative breast cancer (TNBC) from Hispanic compared to NHW women.

The intended goal of this Project is to develop epigenetic biomarkers to monitor the role of obesity and ethnicity on he development of triple negative breast cancer (TNBC). The proposed approach will seek to clarify for the first time if BMI is a biological factor that regulates aromatic hydrocarbon receptor (AhR) expression and epigenetic activity at breast cancer susceptibility and hormone receptor genes based on Hispanic or non-Hispanic white (NHW) ethnicity. If successful, the proposed experiments have the potential to highlight the role of overweight and obesity for dietary prevention of TNBC and to underscore the consideration of breast cancer screening among overweight/obese Hispanic women. Additionally, this study will provide the opportunity to begin testing the utility of AhR as a biomarker of TNBC development related to BMI and ethnicity.

Eligibility Criteria:
Inclusion Criteria:

* Hispanic or NHW women
* ≥ 18 years of age
* scheduled for a breast procedure as standard of care treatment - benign breast surgery or prophylactic mastectomy\\
* Newly diagnosed TNBC - Patients with TNBC will be eligible regardless of whether their treatment plan is surgery first or chemotherapy first (neoadjuvant chemotherapy)
* Eligible non-white women could be included

Exclusion Criteria:

* BRCA1/2 mutation carriers
* Family history of breast cancer in a first-degree relative and have NOT had genetic testing for BRCA1/2
* Patients who have already undergone radiation or chemotherapy
* Pregnant women
* Male
* Prisoners
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric (from birth to 18-year-old) patients
* Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.
* Life expectancy of at least 3 months based on clinical judgement
* Decision to treat with larotrectinib made by the treating physician prior to study enrollment
* Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date
* Signed informed consent form
* For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required

Exclusion Criteria:

* Any contraindications as listed in the local approved product information
* Pregnancy
* Participation in an investigational program with interventions outside of routine clinical practice
* Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition
* Patients with NTRK gene amplification or NTRK point mutation
Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects

This is an Asian multi-regional clinical trial (MRCT) in which ATG-008 will be administered orally to hepatitis B positive (HBV+) HCC subjects who have received at least one prior line of systemic therapy. It is designed as an open-label phase 2 trial evaluating the pharmacokinetics (PK), safety, tolerability and efficacy of oral ATG-008 administered daily until the radiologic disease progression (according to RECIST 1.1) or intolerable toxicity.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged from 18 to 70 years (inclusive) at the time when the ICF is signed.
2. Confirmed diagnosis of HCC.
3. Unresectable stage B or C HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging.
4. HBV positive by serum test.
5. Received at least one prior line of systemic therapy.
6. ECOG performance status score of 0 or 1.
7. Satisfactory serum chemistry results
8. Adequate bone marrow function
9. Child-Pugh A without encephalopathy.
10. All subjects who participated in the study had to take reliable contraceptive measures within the trial and 3 months of after the trial.

Exclusion Criteria:

1. Symptomatic central nervous system metastases.
2. Locoregional HCC therapy, systemic chemotherapy, hormonal therapy or investigational therapy within 4 weeks prior to Screening.
3. Life expectancy of less than 3 months.
4. Prior therapy with mTOR inhibitors.
5. Prior organ transplant.
6. Persistent diarrhea or malabsorption.
7. Clinically significant bleeding.
8. Known history of human immunodeficiency virus (HIV) infection.
9. Uncontrolled intercurrent illness.
10. Any condition that confounds the ability to interpret data from the trial.
Canakinumab in Patients With Active Hyper-IgD Syndrome

This pilot study is designed to evaluate the efficacy, the safety, and the pharmacokinetics (PK) / pharmacodynamics (PD) of canakinumab treatment in patients with HIDS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of HIDS proven by DNA analysis and/or enzymatic studies.
2. At time of start of drug treatment: active HIDS as evidenced by a physician global assessment of HIDS flare severity ≥ 2 and CRP values \>10 mg/L (normal CRP \< or = 10 mg/L).
3. Patients who have a history of \> or = 3 febrile acute HIDS flares in a 6-month period when not receiving prophylaxis treatment (e.g. anakinra daily treatment) with a duration of each flare lasting \> or = 4 days and limiting the normal daily activities.

Exclusion Criteria:

1. Pregnant or nursing (lactating) women.
2. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.
3. Positive Hepatitis B or Hepatitis C.
4. Live vaccinations within 3 months prior to the start of the trial
5. Positive tuberculosis screening test.

Other protocol-defined inclusion/exclusion criteria may apply
Investigating Reaction Time Among Children Who Snore

The investigators feel that children who have OSA or sleep-disordered breathing may have a different reaction time than normal variants. Children who have OSA are known to have behavioral and sleep patterns that are different. It makes sense their reaction time may be different than normal as well. We plan to measure reaction times via a 10 minute psychomotor vigilance test device in children who snore who are coming in for a sleep study or for adenotonsillectomy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand how to perform reaction time test and complete without assistance.

Exclusion Criteria:

* Children who are unable to understand or perform test or parents refusal.