cyrilzakka/clinical-trials huggingface dataset:
A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis of aRCC with clear-cell component
* Participants with no prior systemic treatment for aRCC with clear-cell component;
* Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels;

Exclusion Criteria:

* Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study;
* History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)

The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.

Safety and PK data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or progressive advanced solid tumor malignancies
* Measurable or non-measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy greater than 3 months
* Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
* Adequate bone morrow and kidney function
* No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
* Agree to use adequate contraception

Exclusion Criteria:

* Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
* Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
* Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
* UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1\*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1\*37)
* Major surgery within 4 weeks prior to day 1
* Undergone a liver or other organ transplant
* Concurrent treatment with other anti-cancer therapy
* Untreated central nervous system metastases
* Ongoing or active infection
* Chronic or acute GI disorders resulting in diarrhea
* Pregnancy or lactation
Monitoring Large Vessel Vasculitis With PET/MR Imaging

Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and complications such as aneurysm formation and stroke. Treatments used can have significant side-effects. Doctors find it difficult to determine when to start and stop treatment, often leading to over- or under-treatment. A new test is required to determine disease activity that will guide treatment more accurately. This study will recruit participants with active LVV from throughout Scotland in order to assess the ability of two new types of scan - positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) - to determine disease activity. In addition, I will investigate the link between LVV and heart disease.

Large vessel vasculitis (LVV) is a multi-system, autoimmune disease characterised by non-specific symptoms, pain and high glucocorticoid requirements. The lack of a robust biomarker that tracks disease activity makes disease monitoring difficult. This leads to both disease over-treatment, resulting in adverse effects of glucocorticoids, and under-treatment, with the potential for significant vascular complications. Additionally, the link between LVV and cardiovascular disease (CVD), which is the main cause of death in these patients, remains poorly characterised. An imaging tool which is capable of accurately monitoring disease activity over time is urgently required. Positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) have the potential to meet this need. PET/MR is uniquely useful for imaging CVD and utilises \~50% of the radiation dose of PET with computerised tomography. OCT is a novel potential biomarker of microvascular dysfunction, systemic inflammation and CVD risk in small vessel vasculitis. Participants with a new diagnosis or recent flare of LVV will undergo serial PET/MR and OCT scanning alongside established measures of CVD risk. Results will be compared with current clinical measures of disease activity and with banked control data.

Eligibility Criteria:
Inclusion Criteria:

* A new diagnosis of LVV or a known diagnosis of LVV presenting with disease relapse

Exclusion Criteria:

* Predominantly cranial symptoms
* LVV secondary to other conditions
* Treatment with high dose glucocorticoids for \>2 weeks at time of recruitment
* Contraindication to MR or PET
* Unable to travel to Edinburgh
* Estimated glomerular filtration rate (eGFR) \<30 ml/min/1.73m2
* Unable to provide informed consent
* Pregnant or breastfeeding
Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis

The objective of this study was to evaluate the role of Klaricid XL (clarithromycin modified release) in the treatment of acute exacerbation of chronic bronchitis (AECB) and its impact on improving the quality of life.

Participants in this observational study had a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation, clinically diagnosed by the sudden worsening of symptoms characterized by extreme breathlessness and increased chest tightness, wheezing, cough, or sputum changes. A sequential non-systematic sample of patients with AECB from May 2011 until January 04, 2012 is included in this observational study.

The observation period for each individual patient started with the diagnosis of the acute exacerbation of chronic bronchitis and prescription of antimicrobial medication per routine clinical care. This observational period continued during the treatment period and ended on at least one follow-up visit at the end of the treatment. Duration of treatment was based on physician's judgment of severity of the patient's condition. The usual treatment period ranges from 5 to 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute exacerbation of chronic bronchitis who required antimicrobial therapy and treated with Klaricid XL (clarithromycin modified release)
* Male and female patients age 35 years and older

Exclusion Criteria:

* Patients with clinical signs and symptoms suggesting pneumonia
* Patients with asthma
* Patients with any concomitant illness that may confound the interpretation of the effect of study medication (e.g., pulmonary malignancy, congestive heart failure, bronchiectasis, pneumothorax)
* Immunocompromised patients; however, patients receiving systemic steroids at baseline for the treatment of chronic obstructive pulmonary disease can be enrolled
* Pregnant females
* Nursing mothers
* Patients who are allergic to clarithromycin
A Dose-Escalating Study of Ro 31-8959 ( HIV Protease Inhibitor ) in Patients With HIV Disease.

To investigate the toxicity, antiviral activity, and pharmacokinetics in HIV-infected patients receiving 16 weeks of oral saquinavir mesylate ( Ro 31-8959 ) at one of two doses.

Cohorts of 16 patients receive 1 of 2 doses of Ro 31-8959 for 20 weeks. Administration of the higher dose will proceed only after 2-week safety data for the first eight patients on the lower dose has been reviewed.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4 count 200 - 500 cells/mm3.
* No evidence of viral resistance.
* HIV RNA quantifiable by PCR.
* Negativity for HBsAg, HBeAg, and anti-HBc.

NOTE:

* Fifty percent of patients must have measurable p24 antigen levels (\> 31 pg/ml).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active opportunistic infection requiring immediate treatment, such as tuberculosis, cytomegalovirus, cerebral toxoplasmosis, and Pneumocystis carinii pneumonia.
* Unable to maintain adequate oral intake.
* Clinically significant vomiting and/or diarrhea.
* Malignancy, visceral Kaposi's sarcoma, or lymphoma that will require systemic chemotherapy within the next 12 months.
* Unable to comply with protocol requirements, in the judgment of the investigator.
* Any grade 3 or worse laboratory or clinical abnormality.

Concurrent Medication:

Excluded:

* Antineoplastic agents.
* Concomitant or maintenance treatment with excluded experimental drugs and drugs with known nephrotoxic or hepatotoxic potential.

Concurrent Treatment:

Excluded:

* Radiation therapy other than local skin radiation therapy.

Patients with the following prior conditions are excluded:

* Unexplained temperature \>= 38.5 C (101.5 F) persisting for 14 days or more within a 30-day period.
* Unexplained, chronic diarrhea persisting for 14 days or more within a 30-day period.

Prior Medication:

Excluded:

* Prior treatment with an HIV proteinase inhibitor.
* AZT within 30 days prior to study entry OR lasting more than 1 year.
* Other antiretroviral therapy (besides AZT) within 30 days prior to study entry OR lasting more than 14 days.
* Acute therapy for an opportunistic infection within 14 days prior to study entry.
Sufentanil Used by Paramedics to Treat Pain in Acute Trauma

The new competence of paramedics to administer opioid analgesics in acute trauma patients without presence or phone-call consult with an emergency medical doctor will be assessed in this study.

The administration and indication of an opioid analgesics is carried by a medical doctor in most European emergency services. However, trips to majority of less serious traumas are realized by ambulances with paramedic crews without a medical doctor present on site. In this study will be assessed the new competence of paramedics to administer opioid analgesics without presence or phone-call consult with an emergency medical doctor.

This study will address the safety and efficacy of sufentanil administered by the paramedics in the field to patients with acute trauma without any consultation with medical doctors.

Eligibility Criteria:
Inclusion Criteria:

* acute trauma with severe pain (VAS/NRS \> 4)
* age \> 18 years
* conscious patient (GCS = 15; alert in AVPU)
* haemodynamically stable patient (\> 100mmHg of systolic blood pressure, \> 60/min of heart rate)

Exclusion Criteria:

* doctor on site
* paediatric patient
* predominantly chronic but not acute pain
* incomplete documentation
* other than traumatic reasons for opioid administration (eg. acute coronary syndrome)
Prediction of New Regression Equation Among a Group of Egyptian Children

Aim of the study:

Prediction of new regression equation using digital analysis for determination of mesiodistal width of permanent teeth among a group of Egyptian children.

Research question What is the combined mesiodistal dimensions of canines and premolars in a group of 12-15 years old Egyptian children and from it Can the new regression equation predict the size of unerupted canines and premolars?

Tooth size varies significantly between racial groups so mesiodistal dimension in permanent teeth of Egyptian children differ from any international equation, and to the present data, few studies on the mesiodistal dimension of teeth for Egyptian population (Salem et al., 2023).

Tooth size and shape varies from one person to another, from males and females and from one ethnic group to the other depending on genetic factors (Aljuaid et al., 2021).As mandibular incisors are the first teeth to erupt in the permanent teeth and if their dimensions could perhaps be used for predicting the width of unerupted teeth, then it may be advantageous for analysis of mixed dentition at an early age (Moyers, 1976).Environment and genetics both affect tooth size and it's strongly linked to sex and ethnicity. Males' teeth are larger in size than those of the females and Africans have larger teeth than Europeans (Aldeeb, 2021).

Rationale Tooth size differs among and within populations. Tooth size specifically the mesiodistal dimension has an important role in normal occlusion and in arch space analysis as it affects treatment planning and the final results in orthodontic treatment. (Abozeid et al., 2019). Malocclusion is a common esthetic and functional problem in the world. It's a developmental condition caused by alteration in normal development (Ghorbani et al., 2018). The majority of malocclusion, which starts during the mixed dentition period, can be treated and eliminated in its severity if it was managed early (Abozeid et al., 2019).Predicting the size of canines and premolars that have not yet erupted is essential for accurate diagnosis and planning of the optimal course of action throughout the mixed dentition. The exact forecast reveals the difference between the amount of space needed and that which is now available, providing the first component of a successful therapy (Salem et al., 2023)

Eligibility Criteria:
Inclusion Criteria:

- 1. Subjects age between 12-15 years. 2. Positive subjects acceptance for participation in the study. 3. Full set of the permanent dentition from left 1st permanent molar to right 1st permanent molar.

4. Subjects selected with no previous orthodontic treatment to eliminate possibility of any interproximal reduction. 5. Intact marginal ridge

Exclusion Criteria:

- 1. Subjects with history of systemic diseases. 2. Subjects who have any sensitivity or adverse reactions to any of used materials.

3. Subjects with morphologic anomalous.
A Study to Assess the Efficacy and Safety of Two Dosing Regimens of Alefacept in Subjects Weighing Between 100kg and 150kg With Moderate to Severe Chronic Plaque Psoriasis

Comparison of two dosing regimens of Alefacept in subjects weighing between 100kg and 150kg with moderate to severe Chronic Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 100kg and 150kg
* Diagnosis of Chronic Plaque Psoriasis with Body Surface Area (BSA) involvement of ≥ 10%
* Candidate for phototherapy or systemic therapy for Psoriasis
* CD4 + T lymphocyte counts \> lower limit of normal

Exclusion Criteria:

* Clinically significant abnormal hematology values or blood chemistry values
* ALT or AST value of ≥ 3x the upper limit of normal
* Other types of Psoriasis
* Serious infection within 3 months prior to 1st dose of study drug
* Antibody positive for HIV
* History of malignancy
* History of severe allergic or anaphylactic reactions
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease
Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.

Combined single and repeated dose groups with 3 escalating doses

Eligibility Criteria:
Inclusion Criteria:

* Male or female Japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
* Body mass index in the range 18.0-25.0 kg/m2
* Willing to use reliable contraception
* Able to give fully informed written consent.

Exclusion Criteria:

* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception
* Clinically relevant abnormal findings at the screening assessment
* Clinically significant vital signs outside the acceptable range at screening
* Clinically relevant abnormal medical history, surgery or concurrent medical condition
* Acute or chronic illness
* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2
* Severe adverse reaction to any drug or sensitivity to the trial medication or its components
* Significant food allergy; vegetarian or vegan
* Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol \[acetaminophen\]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication
* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication
* Drug or alcohol abuse
* Smoking of more than 5 cigarettes daily
* Possibility that subject will not cooperate
* Positive test for hepatitis B \& C, HIV
* Objection by a General Practitioner.
Study to Gather Information About the Safety of Oral Anticoagulation Drugs and How Well These Drugs Work in Real World for Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem)

Oral anticoagulant (OAC) treatment with either vitamin K antagonists (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) is essential in patients with atrial fibrillation for the prevention of stroke or systemic embolism (SE) a condition that happens when a blood clot forms elsewhere in the body and travels through the blood stream to plug another vessel. While there are significant number of real-world publications on the use and outcomes of NOACs for stroke prevention, evidence from routine clinical practice on the use and outcomes of reduced doses of NOACs is scarce. By evaluating routine clinical practice data from national registers in Denmark, Finland, Norway and Sweden, researchers want to gather information about the safety and how well reduced doses of NOACs work in patients with irregularly heartbeats which are not caused by a heart valve problem (non-valvular atrial fibrillation, NVAF). As a primary aim of this study, treatment with low doses of NOACs (Xarelto \[generic name rivaroxaban\], Eliquis \[generic name apixaban\] or Pradaxa \[generic name dabigatran\]) will be compared with VKAs (warfarin) in Nordic patients with NVAF to assess the occurrence of stroke and systemic embolism \[effectiveness\]) and intracranial hemorrhage a type of bleeding that occurs inside the skull \[safety\]).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a qualifying oral OAC dispensed during the study period
* A primary diagnosis indicative of atrial fibrillation during the baseline period

Exclusion Criteria:

* Age \< 18 years at index date
* Died on index date
* A diagnosis of valvular disease, pregnancy, transient cause of atrial fibrillation or venous thromboembolism in the baseline period or on the index date
* Hip or knee replacement surgery in the 60 days prior to or on the index date
* A dispensed prescription of heparin or fondaparinux in the 60 days prior to or on the index date
* A diagnosis of end-stage kidney disease or renal replacement therapy in the baseline period or on the index date
* More than one dispensed OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) on the index date
* A dispensed prescription of an OAC (any dose of rivaroxaban, apixaban, dabigatran, edoxaban, or warfarin) during the baseline period
Influence of U-relax on Vaginal Health Promotion and HPV DNA Test Change From Positive to Negative

The purpose of this study is to understand the effect of using oral U-relax on HPV infected women for vaginal environment health promotion, and the HPV DNA Test Index change from positive to negative. Long-term infection of HPV is associated with cervical cancer. U-relax contains Lactobacillus GR-1 and Lactobacillus RC-14 and has been approved of its benefits on treatment of BV, UTI, IBD and can improve vaginal environment health. Patients with positive result of HPV DNA test have no appropriate and aggressive treatment to reduce the risk of cervical cancer. This clinical trial tries to reveal the influence of oral U-relax and patients with HPV DNA test positive result.

This study is a prospective, double blind, randomized clinical trial. Vaginal health screening and HPV DNA Test are carried out from 80 patients with positive HPV DNA Test after conization for 6 months. All these patients will participant this study during the 360-day trial period. All health related conditions will be monitored at the same time.

Eligibility Criteria:
Inclusion Criteria:

* female
* age over 30
* PAP Test with NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY result
* HPV DNA Index Test with POSITIVE result after conization for 6 months
* not pregnant

Exclusion Criteria:

* cervical intraepithelial neoplasia before conization
* cervical cancer patient
* with GI surgery
* GI dysfunction
* need for long-term antibiotics treatment
A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed.

Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes investigation products as randomized.

Eligibility Criteria:
Inclusion Criteria:

* Need to take NSAID pills for longer than four weeks
* should be normal diagnosed by the endoscopy test

Exclusion Criteria:

* The patients have gastric ulcer or duodenal ulcer within 30 days
* The patients have a gastro-intestinal surgery within a year
* The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)