cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients

The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)

The study will include the first 188 subjects who are randomized. The purpose of study is to collect efficacy results to evaluate treatment effect on the primary endpoint. The second endpoints is to evaluate drug safety on the incidence of the primary endpoint through the treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20-65 years (inclusive) of either gender
2. With evidence of HBV infection confirmed by positive for Hepatitis B virus antigen (HBsAg)
3. With Barcelona Clinic Liver Cancer (BCLC) intermediate stage (BCLC-B) hepatocellular carcinoma (HCC)
4. Having received radiofrequency ablation (RFA) or transarterial embolization (TAE) for hepatitis B virus (HBV) related hepatocellular carcinoma at least 4 weeks before Screening
5. With liver stiffness measurement (assessed by Fibroscan®) of 7-20 kPa
6. Able to understand and willing to sign the informed consent

Exclusion Criteria:

1. Evidence or history of chronic hepatitis caused by Hepatitis C virus (HCV)
2. With abnormal organ functions such as absolute neutrophil count (ANC) \< 1500 /μL, hemoglobin \< 9 gm/dL, platelets \< 50,000 /μL, creatinine \> 2 mg/dL, alanine aminotransferase (AST) or ALT \> 5 X upper normal limit of the current institution; bilirubin \> 2.5 mg/dL, prothrombin time (PT) prolongation \> 4 sec above upper limit of normal
3. With uncontrolled infection or serious infection within the past 4 weeks
4. With any other carcinoma except skin cancer
5. Women who are pregnant or breast-feeding or with child-bearing potential but unable or unwilling to practice a highly effective means of contraception
6. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the patient to comply with the protocol
7. History of allergy to any substance of investigational products
8. With known human immunodeficiency virus (HIV) infection
9. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
10. With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
11. Administered with any anti-HBV drugs within 4 weeks of entering this study. (Note: Anti-HBV treatments are allowed to be taken during study period when necessary.)
12. Having participated other investigational study within 4 weeks of entering this study
Effect of Aerobic Exercise on Polycystic Ovary Syndrome

The development of Polycystic Ovary Syndrome has been linked to chronic low-grade inflammation (PCOS). In this context, the current study looked into the effects of aerobic exercise on IL6, TNF, and C-reactive protein (CRP) in PCOS women. This was a randomized clinical trial including 40 females diagnosed with PCOS who were between the ages of 25 and 35. The participants were divided into two groups, each with an equal number of individuals: aerobic exercise (AEM) and Metformin (M). At baseline and after 12 weeks of intervention, participants' levels of IL6, TNF, and CRP were measured.


Eligibility Criteria:
Inclusion Criteria:

* Mean age of 26.7 ± 2.3, body mass index (BMI) 23.6±3.5 kg/m2) .
* confirmation by medical history of hyperandrogenic oligo amenorrhea (\<8 menses per year)
* PCO on ultrasonography of more than 10 ovarian follicles 2-9 mm in diameter

Exclusion Criteria:

* Disorders known to cause hyperandrogenisms, such as congenital adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia.
* Renal or hepatic dysfunction
Evaluation of CAMBRA Versus ICCMS Caries Risk Assessment Models Acquisition On Treatment Plan

randomized clinical study to evaluate 'caries management by risk assessment' Versus 'international caries classification and management system' Caries Risk Assessment Models Acquisition On Treatment Plan In Young Adult Population with null hypothesis that International Caries Classification and Management System (ICCMS™) will have the same clinical performance as Caries management by risk assessment (CAMBRA)

. (ICCMS™) Comprehensive Patient Care Pathway considered as significant development from the traditional system of treatment plan. Comprehensive patient care should include all recent information related to the biological, social, behavioral, cultural, systemic, and dental/oral risk factors which help development and progression of dental caries. (ICCMS™) also report all essential decisions that aid to preserve tooth structure; as diagnosis, prevention and restoration only if indicated \[9\]. Moreover ( ICCMS™) deals with caries as a disease and not as a lesion, prevent development of initial caries lesions, and restore moderate or extensive caries lesions with the aim of preserving of tooth structure as much as possible.

Follow up period is selected to be 12 months, since risk category is changed for better or worse over 1-2 year.

Eligibility Criteria:
Inclusion Criteria:

* New patients
* Able to give informed consent in Arabic
* Unlikely to move from the area within 1y for work educational, or personal reasons (determined by residential history and questioning);
* Willing to participate regardless of group assignment
* Willing to comply with all study procedures and protocol
* ≥16 permanent teeth

Exclusion Criteria:

* Patient not willing to have dental radiographs taken
* Patient with significant past or current medical conditions that might affect oral health or oral flora (i.e., diabetes, human immunodeficiency virus, heart conditions requiring antibiotic prophylaxis)
* Patient with medication use that might affect the oral flora or salivary flow (e.g., antibiotic use in the past 3 months, drugs associated with dry mouth/xerostomia)
* Patient with root caries at enrollment
* Patient with periodontal disease requiring surgery, chemotherapeutic agents, or frequent prophylaxis
Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants

The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.

This research study is a randomized, single-center, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD), first-in-human study in healthy participants.

This study consist of 2 segments: Segment 1 will be the SAD portion and Segment 2 will be the MAD portion.

Segment 1 will include up to 5 sequential cohorts. Up to 40 healthy male or female subjects, ages 18 - 45 years (inclusive) old at screening will be enrolled.

Segment 2 will include up to 3 sequential cohorts. The dosing will be administered for 14 consecutive days. Up to 24 healthy male or female subjects, ages 50 to 80 years (inclusive) old at screening will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): 18.0 to 30.0 kg/m2 for Segment 1 and 18.0 to 32.0 kg/m2 for Segment 2, inclusive, at screening and weight at least 50 kg and no more than 100 kg.
* Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to each admission to the clinical facility until study discharge.
* All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator, at screening and at admission.

Exclusion Criteria:

* Females who are pregnant, lactating, planning to become pregnant, or planning to donate ova/oocytes during this study or within 30 days after last administration of study drug.
* Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of admission to the clinical site.
Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction

The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.

In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* biliary stenosis of unknown etiology
* unsuccessful or unfeasable ERCP
* indicated percutaneous transhepatic drainage

Exclusion Criteria:

* histologically verified biliary stenosis
* INR ≥ 1,5
Effect of Cola on Urinary Stone Risk Factors

Examine the effects of cola on risks of kidney stones

Prospective crossover study examining the risks of cola on stone risk factors.

Eligibility Criteria:
Inclusion Criteria:

* urolithiasis, healthy volunteer

Exclusion Criteria:

-
Home Reported Outcomes in PNH

The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-Related Quality of Life (HRQoL) experienced by PNH patients. By primarily utilizing home reported outcomes (HRO) data on symptom burden and treatment usage, supplemented with patient-reported outcome (PRO) measures, the study seeks to establish a new real-world data (RWD) source to understand symptom variability and HRQoL among PNH patients, including those receiving orally administered iptacopan.

The study will be prospective and observational, conducted over an initial period of six months per individual from the point of study enrollment. Participants will utilize the Folia mobile app to enroll, consent, and complete all study activities. A hybrid recruitment method of clinic referrals and community referrals will be employed to identify participants, who will be asked to track routine treatment, symptoms, changes in treatment plans, and HRQoL using the Folia Health mobile app. Monthly survey check-ins will be conducted to capture additional data inputs, with the possibility of integrating electronic health record (EHR) and/or claims data.

Eligibility Criteria:
Inclusion Criteria:

Study participants eligible for inclusion in this study must meet all of the following criteria:

* Aged 18 or older
* US-based with a proficient understanding of and ability to read the English language
* Any patient with a diagnosis of PNH, regardless of symptom or treatment history

Exclusion Criteria:

Study participants who do not fit all inclusion criteria listed above are unable to participate in this study. Outside of required inclusion criteria, there are no other exclusion criteria in order to meet the exploratory nature of the primary endpoint.
Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients With Cystic Fibrosis

OBJECTIVES:

I. Determine the maximum tolerated dose of recombinant adeno-associated virus-CFTR vector in patients with cystic fibrosis.

II. Assess the safety of this gene therapy in these patients.

III. Assess the in vivo gene transfer of this vector in these patients.

IV. Assess the CFTR gene expression and physiologic activity following gene transfer in these patients.

V. Assess the clinical impact of CFTR gene expression following gene transfer in these patients.

VI. Monitor patient immune response directed against CFTR or vector components following vector administration.

PROTOCOL OUTLINE:

This is a randomized, dose escalation, double blind, placebo controlled, multicenter study. Patients are randomized to receive either adeno-associated virus-CFTR (AAV-CFTR) vector or placebo.

Patients undergo tests on days -10 to -4 to rule out adenovirus and adeno-associated virus infections. Patients then receive AAV-CFTR vector intranasally to the right or left inferior turbinates and placebo to the other side of the nose. The next day, patients receive an endobronchial dose of AAV-CFTR vector to the superior segment of the right lower lobe.

Cohorts of 2-4 patients each receive escalating doses of AAV-CFTR vector until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose level immediately preceding the dose at which at least 2 subjects develop dose limiting toxicity.

Patients are followed at day 10, then at 1, 2, 3, 6, 9, and 12 months.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of cystic fibrosis (CF) with mild to moderate lung disease; FVC at least 60% predicted; Schwachman-Kulczycki score at least 65; Sweat chloride greater than 60 mEq/L

All CF genotypes allowed

No sputum colonization with Burkholderia cepacia or another multiply resistant organism

No recurrent or intermittent hemoptysis; At least 1 year since significant hemoptysis requiring transfusion or embolization OR Coughing of greater than 30 mL of blood more often than once a week

--Prior/Concurrent Therapy--

At least 30 days since hospitalization or home intravenous antibiotic therapy for pulmonary exacerbation

No concurrent investigational drugs or therapy

--Patient Characteristics--

Other: No concurrent cigarette smoking; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media

The prevalence of nausea and vomiting after the administration of non-ionic contrast media has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk factors of nausea and vomiting after the exposure to the non-ionic contrast media for computed tomography examinations in adults.

There is no robust evidence or guideline for fasting prior to contrast-enhanced CT scan in patients. Substantial heterogeneity exists on fasting prior to contrast-enhanced CT worldwide. Through dedicated questionnaires, the investigators plan to prospectively assess the prevalence and the risk factors for nausea and vomiting after the exposure to the non-ionic contrast media agent in adult patients undergoing computed tomography examinations.

Eligibility Criteria:
Inclusion criteria:

* Patients undergoing contrast-enhanced CT examination with non-ionic contrast media during regular working hours
* Adult patients (20 years old or older)
* Patients with informed written consent
* Patients under observation by medical staffs during and after CT examination up to 30 minutes.

Exclusion criteria:

* Patients without informed written consent
* Age of patients younger than 20 years old
* Uncooperative patients
* Pediatric, pregnant, and emergent patients
* Patients without sufficient observation by medical staffs during and after CT examination up to 30 minutes.
Pharmacology and Physiology of the Lower Urinary Tract

The function of the lower urinary tract is simple - urine storage and voiding. However, despite this simplicity of function, the control of the lower urinary tract is a rather complex, multilevel process (urothelium, detrusor, peripheral nerves, spinal cord and higher cerebral centres) and the mechanisms involved remain poorly elucidated.

This study is designed to gain a more in depth understanding of the lower urinary tract function. Using bladder biopsies, tissue staining for characteristic markers present on nerves and other cells will be performed. We hypothesize that certain markers are altered in disease and turn back towards the control level of healthy people or patients with successful medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lower urinary tract dysfunction
* Controls with normal lower urinary tract function

Exclusion Criteria:

* Age \< 18 years old
* Pregnancy
Resynchronisation Therapy of Right Ventricle in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension is a disease characterised by pathological changes in the pulmonary arteries leading to a progressive increase in pulmonary vascular resistance and pulmonary artery pressure. Right ventricular failure is the main cause of death in patients with pulmonary arterial hypertension, and the ability of the right ventricle to adapt to the progressive increase in pulmonary vascular resistance associated with changes to the pulmonary vasculature in pulmonary arterial hypertension is the main determinant of a patient's functional capacity and survival.

Right ventricular dyssynchrony was present in a substantial proportion of patients with pulmonary arterial hypertension and this dyssynchrony adversely affected right ventricular function.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary hypertension type I, III, IV, V Dana Point classification
* NYHA classification equal or superior to stage II
* During right catetherization : cardiac index inferior or equal 2.5 L/mn/m2 and atrial pressure superior or equal 10 mmHg OR cardiac index equal or inferior to 2.2 L/mn/m2
* Optimal therapy considered by the referring specialist practioner of the patient

Exclusion Criteria:

* Minor or incapacitated adult
* Pregnancy
* Unability to give free and informed consent
* Pulmonary hypertension type II Dana Point classification
* Eisenmenger syndrome
* Patent foramen ovale
* Left bundle-brach block
* Pulmonary hypertension exacerbation
* Medical clinical situation considered inappropriate by the investigator
* Patient eligible for a heart-lung transplant
* Patient eligible for pulmonary endarterectomy
* Patient with poor echogenicity
* Filter in the inferior vena cava
Expanded Access Study of Exebacase in COVID-19 Patients With Persistent MRSA Bacteremia

This is an open-label, expanded access study of exebacase used in addition to antistaphylococcal antibiotics in adult patients with persistent methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections (BSI), including right-sided endocarditis (R-IE), who are hospitalized with coronavirus disease 2019 (COVID-19). Patients with left-sided endocarditis (L-IE) are excluded. Patients will receive a single dose of exebacase. Patients will continue to receive antistaphylococcal antibiotics as prescribed by the treating physician. Exebacase Phase 3 study sites (Study CF-301-105) may participate in this Expanded Access study (Study CF-301-107).

Exebacase, a direct lytic agent, is an entirely new treatment modality against S. aureus. Exebacase is a recombinantly-produced, purified cell wall hydrolase enzyme that results in rapid bacteriolysis, potent biofilm eradication, synergy with antibiotics, low propensity for resistance, and the potential to suppress antibiotic resistance when used together with antibiotics. Exebacase represents a first-in-field, first-in-class treatment with the potential to improve clinical outcome when used in addition to standard-of-care antibiotics to treat S. aureus BSI including IE.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older.
* Hospitalized with known COVID-19 infection confirmed by positive diagnostic test.
* Not eligible for the exebacase Phase 3 study (CF-301-105).
* Blood cultures positive for MRSA for ≥3 days.
* Patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to remain abstinent or use contraception if of reproductive potential.

Exclusion Criteria:

* Known or suspected left-sided IE.
* Intubated for COVID-19.
* Presence of prosthetic valve or cardiac valve support ring, or presence of known infected orthopedic hardware, prosthetic joint, or cardiac device.
* Known or suspected brain abscess or meningitis.
* Participation in an investigational study or expanded access protocol for another antistaphylococcal antibacterial agent.
The Effect of Food and Beverage Based Nutritional Supplements in Recipients of Home Care Services at Risk of Malnutrition

Malnutrition increases the risk of complications and predisposes ti infections through impaired immune response and wound healing. Healthcare costs related to the management of malnourished patients is estimated to be more than double the amount spent managing non- malnourished

The objective of this study is to examine the effect of newly developed energy and nutrients-dense beverage product on the nutritional status among patients at risk of malnutrition.

Malnutrition is a complex state described as a deficiency of energy, protein and other nutrients causing measurable adverse effect on body tissue, function and clinical outcome.

Oral nutritional supplementation has in multiple individual trials and meta-analyzes shown an increased total energy intake and protein intake in patients in hospital settings as well as in the community.

The largest producer of dairy products in Norway, TINE AS released a new milk based energy- and nutrient dense product, called E+. The initiative behind this was Haukeland University Hospital and the municipality of Bergen. The product were developed to prevent malnutrition in the elderly and patients with a low food intake and high energy requirements.

The overall contribution to this study will be to provide new insight on how to offer malnourished patients the best available treatment.

Eligibility Criteria:
Inclusion Criteria:

* Recipients of homecare services in the municipality of Bergen
* Recipients determined as at-risk of malnutrition based on screening with MNA (mini-nutritional assessment)
* Informed consent by participant
* Informed consent by participants and close relatives or guardian in case of dementia

Exclusion Criteria:

* Terminal care patients with \< 3 month life expectancy
* Patients using parenteral or enteral nutrition
* Patients prescribed oral nutritional supplementation before recruitment
* Pregnancy
* Diabetes Mellitus
* Lactose intolerance
* Patients without a norwegian personal identification number
* Psychiatric patients