cyrilzakka/clinical-trials huggingface dataset:
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis

This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.

This is a Phase 2, multicenter, randomized, double-blind, double-dummy, active-controlled, dose-ranging study of female subjects with moderate to severe Acute Vulvovaginal Candidiasis. Subjects will be randomized to either the investigational arm (SCY-078) with 5 different dose regiments ranging from 1 to 3 days of treatment or to the active-control arm (fluconazole) for 1 day of treatment. After randomization subjects may be seen on study Day 3 (on site visit for PK subjects) , Day 10 (±2,) and Day 25 (+4).

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject is a female of at least 18 years of age
2. Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or budding yeasts, and vaginal pH (≤4.5)

Key Exclusion Criteria:

1. Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or evaluation of response to therapy, such as suspected or confirmed concurrent causes of vulvovaginitis and/or cervicitis (mixed infection)
2. Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or over-the-counter products during the study and treatment for VVC 28 days prior to randomization
3. Subject is actively menstruating at the time of the Baseline visit.
4. Subject has uncontrolled diabetes mellitus.
5. Subject has a vaginal sample with pH \>4.5.
6. Subject has a history of or an active cervical/vaginal cancer.
Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression

Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study we are using a novel drug to target improved function of the kidneys.

Chronic kidney disease has been linked to impaired activity of mitochondrial dysfunction along with oxidative intracellular mechanisms that result in the cascade of progressive damage within renal tubular cells. Several treatment options for mitochondrial dysfunction have been suggested to target the loss of nephrons via renal fibrosis and tubular senescence of the kidney cells by enhancing the mitochondrial activity of these cells via the NAD/NAD+ redox pathway as well as reduce the presence of fibrogenic intracellular inflammatory markers .

QRX-3 is a formulated novel drug designed to supply and optimize NAD+ mitochondrial availability and prevent this nephron loss .

In this study we evaluate the effect of intervention with this novel drug therapy on chronic kidney disease CKD population with slowly declining renal function.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria

  * Patient with Chronic kidney disease
  * Estimated Glomerular function by MDRD of less than 60mls/min
  * Patients with declining renal function ( as measured by eGFR by MDRD )
  * Rate of decline of eGFR over the last one year of less than 20%
  * Negative Serology markers for CKD etiology
  * Provider perceived adherence to study follow up

Exclusion Criteria:

Rapid rate of decline in kidney function of \> 20 % over last one year

* Symptomatic renal failure
* Presence of any suspected Acute renal failure superimposed
* Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI
* No known reversible cause of renal decline
Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.

Aim of The Work:

1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of:

1. Primary endpoint:

   • Reduction in Asymmetrical Dimethylarginine (ADMA)
2. Secondary endpoints:

   * Assessing the change in serum High sensitivity C-reactive protein (hsCRP)
   * Assessing the change in serum Uric acid - The criteria for inclusion:

     1. Outpatients on maintenance hemodialysis.
     2. Age from 18-70 years old.
     3. Serum UA level 7.0 mg/dL or more.
     4. Stable clinical condition (no hospitalization in the previous 3 months)

The exclusion criteria:

1. Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
2. History of hypersensitivity to febuxostat.
3. Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
4. Participant in an another clinical trial within the past 4 weeks.
5. Judged to be unsuitable as a subject by the attending physician.

After two months , the patient will be reassessed regarding:

A. ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients on maintenance hemodialysis.
* Age from 18-70 years old.
* Serum Uric Acid level 7.0 mg/dL or more.
* Stable clinical condition (no hospitalization in the previous 3 months)
* Informed consent in accordance with the Declaration of Helsinki.

Exclusion Criteria:

* Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
* History of hypersensitivity to febuxostat.
* Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
* Participant in an another clinical trial within the past 4 weeks.
* Judged to be unsuitable as a subject by the attending physician
Effect of Functional Treatment on Mandibular Asymmetric Growth

Temporomandibular joint (TMJ) arthritis is known to alter the mandibular development in children diagnosed with juvenile idiopathic arthritis. In a number of cases a genuine breakdown of cartilage and bone is seen in the affected joint which leads to asymmetric mandibular growth in the affected side. In cases of unilateral TMJ involvements severe mandibular asymmetric mandibular growth deviations are seen. We hypothesize that these growth deviations can be minimized and controlled by the use functional orthodontic appliance therapy.

This is a retrospective study design with the aim to evaluate the clinical procedures we have used the last 15 years to treat JIA patients with unilateral TMJ arthritis. More specifically, the purpose is to evaluate the mandibular growth in all JIA patients with unilateral TMJ arthritis and an asymmetric mandibular growth pattern treated with non-surgical distraction splint therapy between 1994 and 2010 at the dep. of Orthodontics, Aarhus University, Denmark. The evaluation is based on radiological examinations at the beginning of their non-surgical distraction treatment as well as after the patients have finished their distraction-splint therapy.

Eligibility Criteria:
Inclusion Criteria:

* Juvenile Idiopathic arthritis patients diagnosed with unilateral temporomandibular joint arthritis and an asymmetric mandibular growth pattern

Exclusion Criteria:

* Juvenile Idiopathic arthritis patients diagnosed with bilateral temporomandibular joint arthritis
* Juvenile Idiopathic arthritis patients with no mandibular growth potential left.
Intratracheal Suctioning and Oxygenation at Extubation

Data analysis of routinely applied extubation procedures on the ICU: i.e. extubation with 100% O2 vs. 35% O2 with/without suctioning.


Eligibility Criteria:
Inclusion Criteria:

* All adult (≥18 years) ICU patients with routine extubation on the ICU during the 2-month observational interval.

Exclusion Criteria:

* Age \< 18 years
* Patients on comfort therapy and/ or terminal extubation or accidental extubationtracheostomized patients
* Patients with refusal to general consent or withdrawal of general consent (DLF and/or internal database)
* Patients dying without next-of-kin available
Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace.

Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.

The current method to set brace tension is subjective; it is limited to the attending clinician making a mark on the brace straps, to which the patient tightens the straps during daily wear. Once the strap is set in place, the current standard-of-care does not involve any more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing may be unknowingly compromised by many as yet unidentified variables. In recent years, a small number of studies have emerged related to the strap tension of bracing yet no clear guidelines on correct strap tension currently exist. Considering the potential effects on preventing scoliosis progression and brace-associated complications, the need for guidelines regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring study, continuous monitoring of tension at brace fitting, throughout the day, and related to positional changes will be possible with a very minimal device and smartphone application. The tremendous amounts of data generated by the device and its app will be used to create a database from which our team will gather information about brace wear compliance and use tension information for the development of standards for effective strap tension associated with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with his or her brace - through the smartphone app - will be examined. It is well established in the literature that observation increases compliance, but no studies investigating patient self-monitoring through personal devices currently exists. This is a vital area of investigation given the recent explosion in personal health-assessing devices e.g. the Apple watch, Up band, fitbit, etc.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
* Sanders skeletal stage 4 or earlier
* Clinician-recommended Rigo bracing
* Patient receiving brace treatment

Exclusion Criteria:

- Prior spine surgery
GISAR German Interdisciplinary Sarcoma Registry

GISAR has an open and modular setup. It is sought to include as many German sarcoma and CS patients (i.e. sarcoma and CS patients treated in Germany) in the registry as possible. A basic data set should be collected on every included patient). In order to adress specific scientific questions, additionally detailed data can be collected in defined patient groups (e.g. effectiveness / adverse effects of systemic therapies in defined situations) within the context of sub-project add-on modules. This data collection can be prospective or retrospective depending on the sub-project

Sarcomas are rare malignant tumors that affect people of all ages. They can be divided into different subtypes yet having more than 80 different forms of soft tissue sarcomas only. In these terms, it is not remarkable that this high number of subtypes is accompanied by various treatment strategies, often representing multimodal treatments.

In addition, in a growing amount of patients tumors are diagnosed, whose malignant cells have histological, cytological, or molecular properties of both epithelial tumors ("carcinoma") and mesenchymal tumors ("sarcoma").

Such "mixed" sarcomatoid/epithelial tumors ("CS") are categorized as carcinoma considering their epithelial origin. But in most cases, CS seem to be more aggressive, than other carcinomas with the same origin; often they are characterized by rapid growth, invasion, disease recurrence and metastases.

Due to the rarity of CS, only limited information is available about their clinical course and best therapeutic approaches. Because of these uncertainties and the sarcoma-component of the tumors, several CS-patients are referred to sarcomacenters. As many experiences with single CS-cases as possible should be collected and evaluated to better understand the different CS-forms.

Due to the complexity of diagnosis and therapy of sarcomas and of CS it is of high relevance to depict the current treatment landscape and the effects and course of different treatment options to illuminate the best option for each specific patient. This is compassed by this registry, as it aims to collect information and data on treatment and outcome of most of future German sarcoma cases along with retrospective data collection to achieve a most comprehensive data set as well as the possibility to identify alterations / trends in the procedures used for sarcoma diagnosis and therapy over time.

Eligibility Criteria:
Inclusion Criteria:

* Histological verified bone or soft tissue sarcomas including bone and soft tissue tumors with borderline histological results or with unclear histological dignity like giant cell tumors of the bone (GCTB), desmoid tumors, atypical lipomatous tumors etc. - independent of therapy form and therapy line - or Histological verified sarcomatoid carcinomas/ carcinosarcomas: tumors with histological, cytological, or molecular properties of both epithelial tumors ("carcinoma") and mesenchymal tumors ("sarcoma") - independent of therapy form and therapy line.
* Signed informed consent form or equivalent (s. chapter 10)
* Age ≥18 years

Exclusion Criteria:

* none
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment

The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.

* Double-blind, randomized, multicenter
* Maximal experiment duration: 9 days
* 02 or 03 visits and a phone contact
* Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent compared to the one muscle relaxant agent isolated in the treatment of osteomuscular pain in adults.
* Adverse events evaluation

Eligibility Criteria:
IInclusion Criteria:

* Signed Consent of the patient;
* Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis;
* Renal or hepatic impairment.
Capturing Outcomes of Clinical Activities Performed by a Rounding Pharmacist Practising in a Team Environment

We, the researchers, propose to link a clinical pharmacist with an internal medicine or family medicine team to provide pharmaceutical care to all patients assigned to the team. The hypothesis is that through this team based approach, pharmacists will act as a resource for providing pharmacotherapeutic advice during the drug therapy decision making process and promote optimal drug use by identifying and resolving actual and potential drug related problems. This study is designed to test this hypothesis, by assessing the impact of this intervention on evidence based, quality of drug therapy indicators, for patients admitted with heart failure (HF), chronic obstructive pulmonary disease (COPD), community acquired pneumonia (CAP), type 2 diabetes mellitus (T2DM), and stable coronary artery disease (CAD).

The overall goal of the COLLABORATE study is to improve processes of care and patient outcomes by optimizing drug therapy via a hospital pharmacy practice model that integrates clinical pharmacists into the patient care team.

The intervention consists of a clinical pharmacist assigned to the patient care team for the purpose of providing proactive clinical pharmacy services. The study pharmacist will be available during normal office hours 5 days per week to provide clarification of the patient's medication history, identify and resolve actual and potential patient specific drug related problems/issues, participate in patient care rounds, provide drug information to the patient care team, provide patient education and discharge medication counselling, and provide physician and/or nursing staff education. The anticipated pharmacist to patient ratio is approximately 1:20.

Control patients will receive usual care. Usual care consists of reactive clinical pharmacy services (i.e. drug related issues identified as orders are received, or by patient profile review) provided by a ward based, not team based, clinical pharmacist.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients \> 18 years of age admitted to participating internal and family medicine teams during the 1 year study period will be eligible to receive the pharmacist intervention. For the purposes of data analysis, patients with a most responsible or primary diagnosis of HF, COPD, CAP, T2DM, and CAD will be included.

Exclusion Criteria:

* Residence outside the Capital Health catchment
* Admitted for ≤ 2 days
* Palliative care
* Transferred to another team
Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

The primary objectives of this study are twofold:

Firstly, to investigate the current status of bowel preparation protocols and their quality across hospitals at various levels in China, particularly following the release of the updated 2023 bowel preparation guidelines. This aims to standardize and optimize bowel preparation protocols nationwide.

Secondly, to identify and analyze risk factors contributing to suboptimal bowel preparation quality in patients undergoing colonoscopy. The study will examine the correlation between these factors and bowel preparation scores, establish a risk prediction model for preparation failure, and provide a theoretical foundation for developing personalized bowel preparation regimens tailored to individual patient characteristics.

The project is divided into three key phases:

1. Initiation Phase:

   Develop a Bowel Preparation Assessment Questionnaire (BPAQ) to standardize data collection.

   Establish collaborative centers (multicenter hospitals) nationwide for coordinated implementation.
2. Implementation Phase:

   Conduct on-site audits to evaluate bowel preparation practices across participating centers.

   Deliver protocol-specific training to healthcare providers, emphasizing compliance with the 2023 guidelines.

   Systematically collect bowel preparation data, including patient demographics, protocol adherence metrics, and clinical outcomes.
3. Conclusion Phase:

Prioritize data quality assurance through dual-entry validation and logic checks to ensure authenticity, comprehensiveness, and objectivity.

Generate consolidated reports to identify systemic gaps and propose evidence-based optimization strategies.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years, regardless of gender, scheduled for colonoscopy
* Written informed consent has been obtained

Exclusion Criteria:

* History of acute myocardial infarction (within 6 months), severe cardiac/hepatic/renal insufficiency, or psychiatric disorders
* Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders
* Pregnancy or lactation;
* History of inflammatory bowel disease or acute intestinal infection within the past 2 weeks;
* History of colorectal cancer, familial adenomatous polyposis (FAP), or Peutz-Jeghers syndrome;
* History of intestinal obstruction, perforation, stricture, or other conditions precluding completion of colonoscopy;
* Non-compliance with bowel preparation protocols (e.g., ingestion of \<80% of prescribed polyethylene glycol (PEG) electrolyte solution);
* Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the study;
* Prior enrollment in this study with a repeat colonoscopy appointment;
* Current participation in other clinical trials or participation in any trial within the preceding 60 days;
* Refusal to provide written informed consent.