cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above

The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults greater than or equal to sixty years of age.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* A male or female greater than or equal to sixty years of age, presenting with HZ at the time of enrollment.
* HZ diagnosis.

  * Is the subject's first outpatient diagnosis for this HZ episode. OR
  * Took place up to seven days prior to the initial visit for the present study. Note: Recurrent HZ cases may be enrolled as new cases based on the investigator's clinical practice.

Exclusion Criteria:

• Not applicable.
Telehealth & HPV Self-Collection

This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) sample collection and determining preference for self-collection verses provider collection, comparing role of telehealth in pre- and post- menopausal women's comfort with self-collection, comparing self-collection completion rates for women with and without telehealth visits.

This will be a prospective, randomized study of women ages 25 and older, stratified by menopausal status (defined as 12 months or greater without menses or time at which both ovaries have been surgically removed), who are eligible for cervical cancer screening.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines.
* Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus.

Exclusion Criteria:

* Individuals without a cervix
* Have had prior pelvic radiation therapy or brachytherapy
* Active or former diagnosis of ovarian, uterine, or cervical cancer unless determined eligible by PI upon further review of history and treatment
* Individuals less than age 25 or no longer eligible/recommended to undergo cervical cancer screening
* Adults who are unable to consent or are decisionally impaired
* Individuals who are not English speaking
PRCT-study of Different Non-operative Treatment Protocols of ER-stress Negative Weber-B Unimalleolar Ankle Fractures.

PRCT multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Prospective randomized controlled multicenter study to evaluate non-operative treatment protocols for treating ER-stress negative unimalleolar Weber-B type fibular fractures. Groups are: 1. 3 weeks in a removable splint 2. 3 weeks in a cast and 3. 6 weeks in a cast. Follow-up visits at 3, 6 and 12 weeks and after 1 and 2 years after injury. In each time X-rays laterally and mortise projections. Ankle functional outcome questionnaires: Olerud-Molander score, FAOS RAND-36 and VAS in follow up-visits 6 and 12 weeks and 1 and 2 year.

Eligibility Criteria:
Inclusion Criteria:

* Stable Weber-B type fibula fracture
* ER-stress negative
* 16 or over years old
* Willingness to participate on study proved by a signature and date
* Walking without aid before accident
* Treatment started within 7 days from injury

Exclusion Criteria:

* Prior ankle fracture or significant fracture in the area of ankle or leg
* Bilateral ankle fracture
* Pathological fracture
* Diabetes mellitus or an other significant periferial neuropathy
* municipality of Residence in some else catchment area than Oulu university hospital or Tampere university hospital
* Patient's understanding or co-operation inadequate
Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty

Total knee arthroplasty surgery is associated with severe postoperative pain and adequate pain management is necessary for early postoperative mobilization and rehabilitation. Although good postoperative pain control may be achieved by continuous epidural anesthesia or femoral nerve block, both methods have adverse effects such as muscle weakness, which may delay postoperative mobilization.

The adductor canal block (ACB) is a relatively new block providing analgesia for knee surgery, which not only blocks the largest sensory branch of the femoral nerve but also results in less reduction of quadriceps muscle strength, compared with the femoral nerve block (FNB) in adult patients.

Randomized controlled trials have revealed that ACB provides at least equal analgesia as FNB, preserves quadriceps muscle strength better than FNB, and thus allowing for functional recovery within the first 24-hour post-TKA. However, one important limitation of single-shot peripheral nerve block is the short duration of analgesia. Because the average duration of severe pain after TKA takes 2-3 days, a continuous ACB via catheter would seem to be a good choice. Unfortunately, perineural catheters may be technically difficult to insert, are prone to premature dislodgement, and may increase infection risk. There also were some case reports of local anesthetic-induced myotoxicity after continuous ACB.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* undergoing elective primary total knee arthroplasty surgery under spinal anesthesia.

Exclusion Criteria:

* Patients with a known history of significant hepatic,
* renal, heart disease, autoimmune disease,
* any known convulsive disorder, any psychiatric disorders, chronic pain,
* pregnant females, regular use analgesics, anti-depressants, or opioids in the previous 2 months, revision surgery, morbid obesity, allergy to local anesthetics or morphine
Chewing Performance Level and Gross Motor Function in Children With Cerebral Palsy

The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP). A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children. Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).

The purpose of this study is to determine the association between gross motor function and chewing performance level in children with cerebral palsy (CP). A cross-sectional study was conducted in 152 children (ages 2-10y, 51.3% male) with a diagnosis of spastic CP. The Gross Motor Function Classification System (GMFCS) was used to determine gross motor function levels of children. Chewing performance level was determined by using the Karaduman Chewing Performance Scale (KCPS).Children with a diagnosis of spastic CP aged 2 to 12 years who were referred due to chewing/swallowing problems by pediatric neurologists were included. The inclusion criteria were above the age of 24 months, and had complaints about chewing function. Children under the age of 24 months, requiring tube feeding or taking any oral nutritional supplements, and used any medicine and/or oral appliances that could affect the chewing performance, were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Above the age of 24 months
* Having complaints about chewing function.

Exclusion Criteria:

* Under the age of 24 months
* Requiring tube feeding or taking any oral nutritional supplements
* Using any medicine and/or oral appliances
The Prevalence of Erectile Dysfunction (ED) and Premature Ejaculation (PE) in Poland

The first large population-based study to evaluate erectile dysfunction (ED) and premature ejaculation (PE) in Poland. The study objective is to assess the prevalence and bother of ED and PE in the representative group of male population of Poland.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18
* A sufficient level of education to understand study procedures and be able to communicate with site personnel

Exclusion Criteria:

• Age \<18
A 12-week, Multicentric Study to Evaluate the Safety and Efficacy of Bisoprolol in Filipino Hypertensive Subjects With Diabetes

The aim of this 12-week, multicenter, interventional, prospective, open-label and single-arm study is to evaluate the safety and efficacy of 5 milligram per day (mg/day) and 10 mg/day bisoprolol in Filipino hypertensive subjects with diabetes as monotherapy or as an add-on therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with hypertension, either newly diagnosed or treated but currently uncontrolled as defined by Joint National Committee (JNC) 7 for subjects with Type 2 diabetes mellitus (T2DM) (that is, greater than or equal to \[\>=\] 130/80 mmHg)
* Aged at least 18 years old
* Diagnosed with T2DM and already on anti-diabetic therapy, and with glycosylated hemoglobin of less than 7 percent

Exclusion Criteria:

* Subjects who were already on beta-blocker therapy at the time of recruitment
* Subjects with heart rate of at most 60 beats per minute (bpm) at rest
* Subjects with secondary hypertension, congenital heart disease, coronary artery disease, peripheral arterial disease or congestive heart failure in any stage
* Subjects with coronary conduction disorders (bundle branch block)
* Subjects with signs of definitive target organ damage consistent with World Health Organization (WHO) Stage III or with severe renal or hepatic disease
* Subjects who are pregnant or expect to be pregnant within the 24-week study period
* Subjects on oral contraceptives
* Subjects with asthma or a history of asthma
* Subjects with documented severe renal disease
* Subjects on anti-neoplastic drugs
Perioperative Care in the Cancer Patient -1, ARCA-1 Study

This study investigates the association of blood transfusions given around the time of surgery (perioperative) with complications after surgery (postoperative), cancer progression, and mortality after major oncologic non-cardiac surgery. The administration of blood products is an important clinical therapy to treat life-threatening blood (hematological) disorders (i.e. anemia, coagulation disorders or thrombocytopenia) in patients with cancer undergoing major non-cardiac surgery. On the other hand, the unnecessary exposure of those patients to blood products can be associated with the occurrence of unwanted severe complications and potentially increase the risk of death. An accurate understanding of the short and long-term outcomes, the patterns of blood transfusions, and the triggers of blood product administration may help researchers design and test the safety of perioperative blood transfusions in patients with cancer.

PRIMARY OBJECTIVE:

I. To evaluate if perioperative blood transfusions are associated with 1-year mortality.

SECONDARY OBJECTIVES:

I. To evaluate the association of blood transfusion with postoperative complications, 30 days mortality and cancer progression after major oncologic non-cardiac surgery.

II. To gain knowledge on prevalence and patterns of blood product administration worldwide, the incidence and management of perioperative anemia and the incidence and treatment of perioperative coagulopathies.

OUTLINE:

Patients undergo standard of care treatment and their medical records are reviewed at 30 days and at 1 year after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing major cancer surgery with curative intent
* Planned length of stay 24 hours after surgery or longer
* American Society of Anesthesiologists physical status (ASA) 1-4
* Scheduled, non-emergency surgery

Exclusion Criteria:

* Emergency surgery
* Palliative surgeries for metastatic disease (non-curative intent)
* Patients undergoing surgery with minimum risk (\< 1%) of blood transfusion according to each center practice (i.e. simple mastectomy, thyroidectomies or wide-local excisions)
* Patients undergoing surgery under local anesthesia
* Patients undergoing ambulatory surgery or planned hospital admission of less than 24 hours
Cardiovascular Evaluation of Patients With High Cholesterol and Normal Volunteers

Homozygous familial hypercholesterolemia is a rare inherited disease of metabolism. It occurs in less than 1 in 1 million people within the United States. Patients with the disease are typically children and young adults who develop heart disease early in life. Children less than age 5 years with this disease have suffered heart attacks and death.

The normal process that removes cholesterol particles from the blood stream does not work in patients with this disease. It causes cholesterol to build-up in the arteries and leads to hardening of the arteries (atherosclerosis).

The goal of this study is to detect and measure atherosclerosis in these patients before it becomes permanent and potentially life threatening. Patients with this disease can participate in this study. Researchers plan to evaluate patients with homozygous familial hypercholesterolemia using new and standard methods for detecting atherosclerosis.

Researchers plan to use information gathered during this study to develop new, promising treatments such as liver transplantation and gene therapy.

Familial hypercholesterolemia is an autosomal co-dominant disorder resulting in abnormal LDL receptor function, profoundly elevated concentrations of low density lipoproteins, accelerated atherosclerosis and death by early adulthood. This disease is heterogeneous in both the degree of LDL receptor dysfunction as well as the age of death. Liver transplantation has been demonstrated to virtually normalize plasma lipoprotein concentrations in homozygous FH and the recent cloning of a functional LDL receptor gene holds promise in the definitive treatment of this condition. We propose performing longitudinal sequential cardiologic studies utilizing noninvasive techniques in homozygous patients with well-characterized LDL receptor defects. Sequential cardiovascular study of these patients will not only characterize the progression of atherosclerosis heart disease in this disease, it may also permit the identification of individuals with would be likely to benefit from liver transplantation and/or genetic engineering.

Eligibility Criteria:
* INCLUSION CRITERIA:

Fasting cholesterol greater than 500 mg/dl, low density lipoprotein cholesterol greater than 400 mg/dl, and triglycerides less than mg/dl.

Family history of hypercholesterolemia and/or cardiovascular disease before the age of 60 years.

Tendinous and tuberous xanthomas.

Arcus corneae before the age of 30.
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Must meet all AAO-HNS 2020 criteria for definite or probable Meniere's Disease
* Must have a skin test positive for allergy
* Is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatments

Exclusion Criteria:

* Had a previous surgical procedure for treatment of vertigo
* Currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker
* Pregnant or recent pregnancy ((≤ 8 weeks postpartum), or lactation)
* Current hospitalization for any reason
* Any active, acute, or chronic pulmonary disorder other than asthma
* History of intubation for asthma
Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor

The purpose of this study was to conduct a side by side comparison of the accuracy of respiratory rate (RR) between our investigational Rainbow Acoustic Monitoring (RAM) small sensor and the FDA-cleared RAM Revision D sensor in healthy volunteers under controlled conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed written informed consent

Exclusion Criteria:

* ASA physical status of III, IV, and V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participating in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
Hypochlorous Acid Disinfection Prior to Cataract Surgery

Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing cataract surgery.

Exclusion Criteria:

* Age \<18 years old
* Vulnerable subjects
* Non-English Speakers
IMproved PREdiction of Severe Sepsis in the Emergency Department

The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years
* Suspected Infection
* one or more SIRS criteria
Developing a Decision Tool for Diverticulitis in the Emergency Department Using Ultrasound

The purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. The accuracy of the decision tool will be evaluated. This study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis


Eligibility Criteria:
Inclusion Criteria:

* Emergency department patient
* Provider suspicion of diverticulitis
* CT scan ordered

Exclusion Criteria:

* Pregnant patient
* Prisoner
* Non-English speaking
* Inability to provide informed consent
* Hemodynamically unstable as determined by provider
* Previous abdominal surgery within last 7 days
* Unable to lay flat for ultrasound exam
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients

The study is designed to evaluate effects of NSAIDs on immune activity inside and close to tumor tissue in patients with colorectal cancer.

Study and control patients are randomized to receive preoperative treatment with indomethacin or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for analyses of tumor immunity and gene expression.

Eligibility Criteria:
Inclusion Criteria:

* Colon carcinoma scheduled for curative operation

Exclusion Criteria:

* Diabetes, steroid medication, liver and kidney impairment
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagliflozin (1 x 300 mg) and Metformin IR Tablets (2 x 850 mg) in Healthy Volunteers

The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.

This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.

Eligibility Criteria:
Inclusion Criteria: - Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less than 50 kg. Exclusion Criteria: - History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Feasibility@48: Cross Sectional Study of Intensive Care Unit Mobility Practices Across the United Kingdom

Intensive Care Unit (ICU) patients commonly experience muscle loss at a rate of 2-3% day. Traditionally, critically ill patients have been managed in bed, however current research suggests that prolonged bedrest cause mechanical silencing of the muscles and exacerbates this muscle wasting. This ICU acquired weakness (ICUAW) leads to poor functional outcome and higher mortality. Research suggests that early out-of-bed mobilisation should occur within 48-hours of ICU admission to militate against this risk, however, this is only achieved in 30% of cases. Common barriers to mobilisation are unstable blood pressure, ventilation, sedation and fatigue. It is plausible that 48-hours is an unrealistic timeframe for mobilisation.

The aim of this study is to explore the mobility practices on a given day in UK adult ICUs. The objectives are to:

1. Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK.
2. Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise
3. Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours
4. Explore clinician decision making about mobilisation

This is a multi-centre cross-sectional study on one-day only. Over a 24-hour period data will be collected for all ICU patients at the participating centres. The lead physiotherapist will record the highest level of mobility achieved that day, and the physiological parameters from clinical observations. The reasons for the level of mobility achieved will be ranked in order of importance. These data are routinely collected. Data will be anonymised.

Data will be analysed to determine feasibility of mobilisation at 48hours and develop a flow diagram of mobilisation decision-making.


Eligibility Criteria:
Inclusion Criteria:

All patients who are admitted to a participating ICU on the study day will be included

Exclusion Criteria:

None