cyrilzakka/clinical-trials huggingface dataset:
Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands

RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adults

With this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting.

Th RAPID study is a prospective, observational study in Dutch primary care practices during two RSV seasons. As part of routine care, rapid molecular viral diagnostic testing on respiratory samples will be offered to all older adults attending the primary care physician because of symptoms of acute respiratory tract infection (ARTI). RSV positive cases will be included for further study. Participants will be asked to fill out three questionnaires by phone or by online at day 0, 14 and 30 after the GP-visit.

The main endpoint is the burden of medically attended RSV infection in the Dutch primary care setting, quantified using several clinical and socioeconomic parameters, including (but not limited to) clinical symptoms and their duration, medicine use, hospitalisation rate, quality of life and ability to perform normal daily activities. Secondary, data on health care consumption and indirect costs will be collected and we will assess the effect of age and severe comorbidity on clinical course of RSV disease.

A population size of 1000 older adults age \>60 years presenting with acute respiratory symptoms to the general practitioner (GP) during RSV season will be tested for RSV as part of routine care. We expect about 100 RSV+. Based on our sample size calculation, 100 RSV+ cases would provide sufficient accuracy for estimating the relevant outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age (≥60 years of age)
* RSV positive
* Subject is willing and able to give informed consent for participation in the study
* Subject is willing and able to adhere to protocol-specific procedures

Exclusion Criteria:

* Subject is not able to understand and communicate in the local language or English.
* Previous or current participation in RSV interventional trial (vaccine, antivirals)
Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families.

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families. With the high prevalence and disability rates for migraine sufferers, on the other hand, the right treatment for migraine has not yet been obtained to the maximum, it is necessary to deepen the treatment and prevention of migraine is needed, and until now there has been no definitive cure, both for prevention and treatment, so it is necessary to develop therapies that can provide more accurate relief for migraine sufferers. The purpose of this study is to assess the success in managing migraine in reducing the frequency of attacks, reducing the intensity of attacks and reducing the duration of attacks from weeks 0, 4 to 8

Eligibility Criteria:
Inclusion Criteria:

* subjects aged 19-50 years
* subjects with history of clinical diagnosis of migraine (interictal period)
* signed research approval forms, and were willing to take the study to completion.

Exclusion Criteria:

* subjects with pregnancy,
* lesions, wounds, infections and suffering from malignant diseases or tumor and thrombophlebitis in the area at the selected acupuncture point
* increasing liver function three times above normal values.
Therapeutic Exploratory Phase 2 Study to Evaluate the Safety and Efficacy of MB12066 in Patients With Nonalcoholic Fatty Liver Disease(NAFLD) Except Cirrhosis

This is a controlled study to determine the effectiveness and safety of MB12066 in the treatment of adult patients with Nonalcoholic Fatty Liver Disease(NAFLD) except cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* NAFLD Activity Score(NAS) ≥ 3 (Biopsy-proven)

Exclusion Criteria:

* Alcohol consumption \> 20g/day
* Type 1 diabetes or poorly controlled diabetes mellitus (HbA1c ≥ 9%)
* Evidence of other chronic liver disease (e.g. HBsAg positive, anti-HCV positive, autoimmune hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency and etc.)
* ALT, AST \> 5X the upper limit of normal
* Serum creatinine ≥ 2mg/dl
* Fibrosis score ≥ 3 according to the NASH CRN fibrosis staging system
* NQO1 T/T type
* Weight loss of more than 5kg within 6 months
* Bariatric surgery within 6 months
* Known alcohol or any other drug abuse in the last five years
* Insulin sensitizers, hepatoprotective agents, anti-oxidants, lipid-lowering agents, drugs induced fatty liver within 1 month
A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.

This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.

Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
* At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
* Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.

Further inclusion criteria apply.

Exclusion Criteria:

* Previous treatment with Vesicular stomatitis virus (VSV)-based agents
* Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
* Presence of brain metastases
* Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
* Chronic steroid use, regardless of daily dose Further exclusion criteria apply.
Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia

Previously, the preconditioning signaling pathways have been studied on molecular level or in animal model. By using MR spectroscopy and imaging in a dynamic human model of preconditioning, we will have a better understanding how mitochondrial and endothelial function are affected by preconditioning in-vivo.

Ischemic preconditioning is a mechanism that protects tissue against ischemia-reperfusion injury. The protective effect of preconditioning is induced by short periods (1-5 minutes) of non-lethal ischemia to the target tissue, which becomes resistant to a prolonged, otherwise lethal, period of ischemia. Despite its proven potency in experimental models, ischemic preconditioning has not reached widespread clinical application because of the difficulties in applying the stimulus to the target organ (eg Heart, Brain), and even brief ischemia to the target organ can cause dysfunction.

Remote ischemic preconditioning (RIPC) is a more clinically relevant stimulus. It has been shown that preconditioning of one coronary territory induces ischemia protection in other parts of the heart. Subsequently, other studies have shown, in rodent models, that preconditioning of one organ (eg kidney) could induce protection in other organs (eg heart). We recently have confirmed, in a series of animal and human preclinical studies, that this concept can be widened; ultimately showing that four 5-minute episodes of ischemia to the skeletal limb muscles (induced by inflating a standard blood pressure cuff to a level higher than the blood pressure) protects the heart and lungs against ischemia-reperfusion injury in children undergoing cardiac surgery using cardiopulmonary bypass.

The current research is designed to investigate with MRI spectroscopy techonology, the potential physiological mechanisms involved in the protective effects of preconditioning, and the effects of ischemia and exercise.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers
* Post-pubescent non-athletes between the ages of \>16 and \<40 years of age.

Exclusion Criteria:

* Older than 40 year old.
* Younger than 16 year old.
* Major medical condition
* Illness, surgery or medical intervention in the last 48 hours.
* Diabetes Mellitus
* Caffeine intake in the last 48 hours
* Athlete (more than 5 training sessions per week)
Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors

The purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.

OBJECTIVES:

I. Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children?s Oncology Group institutions.

II. Provide a repository for long-term storage of specimens from these patients.

III. Make these specimens available to qualified researchers to understand the biology of pediatric brain tumors.

OUTLINE: This is a multicenter study.

Brain tumor tissue and blood specimens are collected from patients and banked for future study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of brain tumor
* Previously treated at a Children?s Oncology Group (COG) institution

  * Patients are eligible at time of diagnosis, second-look surgery, recurrence, or development of a second malignant neoplasm
* Must have brain tumor biological specimens derived from primary tumors of the CNS available for submission
Multiple Ascending Dose (MDX1105-01)

Collection of survival data, evaluation of PDL-1 expression in tumors, and evaluation of PD-L1 receptor occupancy in peripheral blood has been added.

This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1).

The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1
* The malignancies include relapsed/refractory renal cell carcinoma, non-small cell lung cancer, colorectal adenocarcinoma, malignant melanoma, advanced/metastatic epithelial ovarian cancer, gastric cancer, pancreatic cancer and breastcancer
* Must have measurable disease

Exclusion Criteria:

* Prior therapy with an anti-PD 1, anti-PDL 1, or anti-Cytotoxic T-Lymphocyte Antigen 4 antibody (or any other agents that target T-cell co-stimulation)
Upper Limb Robotic Rehabilitation After Stroke

This is a single arm study aimed at evaluating the acute effects induced by a single session of robot-assisted passive hand mobilization on local perfusion and upper limb function in post-stroke hemiparetic patients. Twenty-three participants with subacute or chronic stroke received 20 min passive mobilization of the paretic hand with robotic assistance. After the intervention, significant improvements were found in forearm perfusion, muscle tone significantly decreased and subjects reported decreased upper limb heaviness, stiffness and pain. This study supports novel evidence that hand robotic assistance promotes local forearm circulation, may help in the management of spasticity and acutely alleviates reported symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.


Eligibility Criteria:
Inclusion Criteria:

* first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position

Exclusion Criteria:

* bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo

This is a randomized prospective trial which addresses the question of whether use of an oral hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will result in achieving euglycemia in a shorter period of time and, in turn, result in less frequent maternal and neonatal morbidities. This study is designed to test the hypothesis that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling alone.


Eligibility Criteria:
Inclusion Criteria:

* A glucose value of ≥140 mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
* An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of ≤105 mg/dl
* Gestational age of less than or equal to 28 weeks and 0 days at the time of consent/randomization
* Singleton gestation

Exclusion Criteria:

* Established pregestational diabetes
* Abnormal gestational diabetes testing (≥140) prior to 24 weeks 0 days of gestation. Women who have a negative glucose loading test (\<140mg/dl) before 24 weeks may still be considered for this study if they present again for glucose tolerance testing between 24 and 27 weeks.
* Multiple gestations
* Known major fetal anomaly or fetal demise
* Any renal disease with serum creatinine of \>1.0
* Known liver disease such as hepatitis
* Maternal or fetal conditions likely to require imminent or very preterm delivery such as preeclampsia, preterm premature rupture of the membranes, preterm labor, and intrauterine fetal growth restriction
* Known hypersensitivity or allergic reaction to Glyburide
Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

The goal of this study is to provide answers to the following four questions:

1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with buccal use tolerable for women?
3. Is buccal administration of misoprostol acceptable to women?
4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or over presenting for abortion services who consent to participate
* good general health
* assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion
* Have ready access to a telephone and emergency transportation;
* Be willing to provide an address and/or telephone number for purposes of follow-up

Exclusion Criteria:

* Conditions which contraindicate the use of mifepristone or misoprostol
* Women presenting for medical abortion who do not consent to participate
Penile Length Maintenance Post-Prostatectomy

The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.

The treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. Beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene.

Penile traction therapy (PTT) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. To date, no studies have evaluated the benefits of using PTT in this clinical setting. The objective of the current study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and funded through Mayo Ventures, in maintaining or restoring reduced penile length.

To accomplish the study, a population of men from Mayo Clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be used with the intent to publish in a scientific journal.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing robotic prostatectomy
* Seen in the post-prostatectomy rehab clinic

Exclusion Criteria:

• Urethral complications from prostatectomy at the time of baseline visit
Azithromycin Plus Chloroquine Versus Mefloquine In the Treatment of Uncomplicated P. Falciparum Malaria.

To compare Azithromycin plus Chloroquine versus Mefloquine to treat uncomplicated plasmodium falciparum malaria.


Eligibility Criteria:
Inclusion Criteria:

* Females and males 18 years of age and older with uncomplicated, symptomatic malaria as as indicated by the presence of both of the following:
* Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites
* Documented fever (38.5 C/101.3 F rectal or tympanic; 37.5 C/99.5 F axillary or 38 C/100.4 F oral) or history of fever (as reported by subject) within the prior 24 hours.

Exclusion Criteria:

* Severe or complicated malaria.
* Pregnant or breast-feeding women.
Apnea of Prematurity Results in Respiratory Distress and Cyanosis. Caffeine Citrate Can Treat It.

High-dose caffeine citrate is more effective than low-dose caffeine citrate in the treatment of apnea of prematurity (AOP). The high-dose group showed fewer apnea episodes, higher extubation success rate, lower extubation failure rate and shorter duration of oxygen therapy

Apnea of prematurity (AOP) is a common condition in preterm infants due to immature respiratory control, affecting up to 80% of those under 1000 grams. It can lead to serious complications, including respiratory distress, pulmonary hemorrhage, and developmental delays. Caffeine citrate, a methylxanthine, is widely used for AOP treatment due to its longer half-life and better absorption compared to theophylline. However, the optimal dosage remains uncertain, with varying practices globally.

Eligibility Criteria:
Inclusion Criteria:

* • Patients with a gestational age of ≥32 and \<37 weeks at birth on LMP.

  * Diagnosis of apnea of prematurity (AOP) established as per operational definition within the first 10 days of life.
  * Either male or female patients

Exclusion Criteria:

* • Patients diagnosed with Hydrops fetalis (evaluated through medical record).

  * Patients presenting with major congenital or chromosomal anomalies such as anencephaly, spina bifida, congenital heart defects (e.g., tetralogy of Fallot, transposition of the great arteries), or chromosomal disorders (e.g., trisomy 18, Turner syndrome).
  * Presence of a confirmed sepsis through blood culture.
  * Presence of a significant underlying neurological disorder evaluated by history and medical records that could contribute to apnea (e.g., intraventricular hemorrhage with posthemorrhagic hydrocephalus, hypoxic-ischemic encephalopathy)
  * Patients who have been previously treated with caffeine or other methylxanthines for apnea.