cyrilzakka/clinical-trials huggingface dataset:
Head Repositioning Accuracy During Experimental Neck Pain

This study investigates if/how an experimentally applied neck muscle pain influences head repositioning error in healthy participants.

Healthy volunteers will participate in a single session study with a crossover design.

During the study healthy participants will be randomized to either receive a injection of hypertonic saline (painful injection) or isotonic saline (control injection) in a neck muscle.

Head repositioning accuracy will be assessed with and without performing a cognitive task.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18-50 years
* Right handed
* Able to speak, read and understand Danish or English
* Normal pain free neck and shoulder range of motion

Exclusion Criteria:

* Pain from the neck or shoulder area
* Prior surgery in neck or shoulder
* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Self reported neurologic, musculoskeletal or mental illnesses
Role of Pain Modulation in GERD Patients Who Failed Standard Dose Proton Pump Inhibitors (PPI)

The main objective of this study is to evaluate the role of pain modulation in GERD patients who fail to obtain clinical relief with standard dose (once daily) PPI. The study will compare the efficacy of 1) standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.

To evaluate the role of pain modulation in gastroesophageal reflux disease(GERD)patients who fail to obtain clinical relief with standard dose (once daily) proton pump inhibitor(PPI). The study will compare the efficacy; of 1)standard dose PPI plus low-dose tricyclic antidepressant (TCA) to, 2) double dose PPI to, 3) standard dose PPI and placebo to determine the relative symptom resolution and health related quality of life in GERD patients who fail standard dose PPI and are randomly assigned to one of these three groups.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Ages 18 to 75
* At least two episodes of heartburn per week while on PPI once daily
* Able to communicate with the investigator and comply with the requirements of the study
* Subjects who give written informed consent after being given a full description of the study.

Exclusion Criteria:

* Known allergy or intolerance to TCA
* Use of antidepressant or a diagnosis of depression
* History of serious arrhythmia or use of anti-arrhythmics
* History of seizures
* Subjects with significant co-morbidity, e.g., cardiovascular, respiratory, urogenital, renal, gastrointestinal, hepatic, hematologic, endocrine, neurologic or psychiatric.
* Evidence or history of drug abuse within the past 6 months
* Erosive esophagitis, esophageal ulceration, peptic stricture, Barret's esophagus, or adenocarcinoma of the esophagus on endoscopy.
* History of esophagogastric surgery
* Gastric or duodenal lesions (ulcer, tumor, etc)
* Women who are pregnant or of childbearing age who are not on contraception
* Patients who are unwilling or unable to provide informed consent
Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients.

Acute aerobic exercise improves affective stats in patients with mental illnesses. Brain derived neurotropic factor (BDNF) may be a biological mechanism that contributes to the affective benefits. The magnitude of the increase of serum BDNF might be exercise intensity dependent, but no study has compared low high-aerobic-intensity training at 90-95 % of the maximal heart rate (HRmax) with long-slow-distance training at 70 % of the HRmax in patients with depression.

The aim of this study is to compare changes in serum BDNF levels after high-aerobic-intensity training and long-slow-distance training in a intra-individual design in patients suffering from depression. The results will give indications of a possible difference in BDNF response between aerobic intensities and may be uses as pilot data for calculating sample size.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe depression (ICD10: F32-F33)

Exclusion Criteria:

* Bipolar disorder.
Study of Lyme Neuroborreliosis

The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.


Eligibility Criteria:
Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):

1. Neurological symptoms suggestive of LNB without other obvious reasons
2. CSF pleocytosis (\>4 leukocytes per mikrol)
3. Intrathecal production of B. burgdorferi specific antibodies
4. Detection of B. burgdorferi DNA in central spinal fluid

Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):

1. Neurological symptoms suggestive of LNB wihtout other obvious reasons
2. Production of B. burgdorferi spesific antibodies in serum
3. Erythema migrans during the previous three months

Exclusion Criteria:

* pregnancy and breastfeeding
* women planning to get pregnant in two months
* age under 18
* handicapped persons
* prisoners
* use of any antibiotics two weeks before study treatments begins
* allergy for tetracyclines or cephalosporins
BAY14-2222 Continuous Infusion in Surgeries

Phase III study, to evaluate the efficacy and safety of continuous infusion of rFVIII-FS in the treatment of patients with hemophilia A undergoing major elective surgery by achieving the required therapeutic concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A (FVIII:C \</=1%)
* No history of FVIII inhibitor formation and no current evidence of inhibitor antibody (Bethesda Assay \< 0.6 BU)
* Elective major surgery requiring at least 6 days of rFVIII-FS therapy
* Subjects should have been previously treated with FVIII concentrates for at least 150 exposure days. Previous treatment could have been with any type of rFVIII or with plasma-derived FVIII concentrate or cryoprecipitate

Exclusion Criteria:

* Abnormal renal function (serum creatinine \>1.3 mg/dL)
* Any treatments, which may change the clearance of FVIII (dialysis, plasma exchange)
* Anemia (hemoglobin \<11 g/dL)
* Known AIDS (HIV seropositive patients may be enrolled)
* Active liver disease (transaminases \> 5 times the upper limit of normal)
* History of severe reaction to FVIII concentrates
* Interferon treatment within the last 3 months
* Thrombocytopenia (\< 100,000 platelets/mm3) or other known hematological/bleeding problems other than hemophilia A
* Intake of other investigational drugs within 1 month prior to study entry
* Need for pre-medication for FVIII infusions (e.g. antihistamines)
* Diastolic blood pressure \>100 mm/Hg, which could not be controlled with antihypertensive medications
Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery

A large number of studies on MVs from syncytiotrophoblasts support the hypothesis of their involvement in pre-eclampsia, via their multiple effects, among others as pro-coagulant, immuno-stimulatory and anti-angiogenic factors.

The main objective is to compare the total concentration of the main populations of MVs in the maternal blood of a population of pre-eclamptic patients to those of a population of non-pre-eclamptic patients.

Activated or apoptotic cells release membrane fragments called microvesicles, microparticles, extracellular vesicles or exosomes into the extracellular environment. The term microvesicle (MV) used in this project encompasses all membrane fragments secreted by cells, regardless of their cellular origin, their size or the membrane compartment from which they originate.

The presence on the surface of MVs and in their reservoir of elements from their parent cell, such as surface receptors, mRNAs or microRNAs, led to the hypothesis that MVs could serve as biomarkers, revealing the existence of tissues in distress in the body.

Under physiological conditions, blood plasma contains mainly MVs from red blood cells and platelets, the main circulating cell populations. During pregnancy, the presence of membrane fragments of placental origin in the maternal circulation has long been established. A large number of studies on syncytiotrophoblast-derived MVs support the hypothesis of their involvement in pre-eclampsia, via their multiple effects, among others as pro-coagulant, immuno-stimulatory, anti-angiogenic factors.

The "Membrane Repair and Extracellular Vesicles" team within the CBMN laboratory of the University of Bordeaux has developed original approaches to characterize and quantify MVs, mainly by cryo-electron microscopy, immunogold labeling and flow cytometry. In addition, recent developments from this team allow the analysis of MVs in whole blood, which is a major advantage.

The main objective is to compare the total concentration of the main populations of MVs in the maternal blood of a population of pre-eclamptic patients to those of a population of non-pre-eclamptic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Singleton pregnancy (or spontaneously reduced twin pregnancy before 14 SA)
* Gestational age at inclusion between 23 and 31+6 SA
* Collection of the patient's non-opposition
* Affiliated or beneficiary of a social security system
* Specifically for the non-pre-eclampsia group: non-pre-eclamptic patient hospitalized for isolated threat of preterm delivery, whatever the origin, and without clinical (absence of maternal hyperthermia defined by a maternal temperature \< 38.0°C) or biological markers of inflammation (CRP\<5)
* Specifically for the pre-eclampsia group : diagnosis of severe pre-eclampsia before 32 weeks' gestation

Exclusion Criteria:

* Patient's inability to understand the nature, risks, meaning and implications of the clinical investigation or refusal to give consent
* Patient under legal protection.
Clinical Study of Pregnant Women With COVID-19

A new pandemic, COVID-19, has spread rapidly around the world. She does not spare pregnant women. Little is known about the clinical course of pregnant women infected with COVID-19. As of April 1, 2020, six case series and one case report for a total of 61 pregnancies affected by COVID-19, all from the pandemic epicenter in China, except for one state case report -Unis, have been published. These preliminary reports suggest that pregnant women are not more seriously affected than the general population and show a certain gap with what we have observed in the care of pregnant women at HUS. For these reasons, additional information, especially from parts of the world other than China, as the severity of the disease can vary from country to country, is urgently needed to determine whether pregnant women with the disease of COVID-19 will not present with severe pneumonia to COVID-19.


Eligibility Criteria:
Inclusion criteria:

* Adult woman (≥18 years old)
* Pregnant woman
* Suffering from a confirmed or suspected COVID-19 infection
* Patient who has been medically treated at Strasbourg University Hospitals as well as for his newborn baby, between 03/01/2020 and April 30, 2020
* Woman having given, after information, her agreement for the reuse of her data for the purposes of this research

Exclusion criteria:

* Patient who expressed her opposition to participating in the study
* Patient under guardianship or under guardianship
* Patient under legal protection
K1-70 - A Study in Subjects With Graves' Disease

This study is the first time that K1-70 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data when K1-70 is administered as an IM injection or as an IV infusion to subjects with Graves' disease.

Current therapy for Graves' disease includes treatment with anti-thyroid drugs, destruction of the thyroid using radioiodine, or total surgical thyroidectomy. Beta-blockers and calcium antagonists may be used to control some of the symptoms of hyperthyroidism.

K1-70 is a thyroid stimulating hormone receptor antagonist that may provide new in vivo diagnostic and therapeutic tools for the management of patients with Graves' disease, patients with thyroid cancer and patients who would benefit from controlling receptor activity.

Graves' disease is one of the most common overt autoimmune disorders. Patients with Graves' disease have thyroid over activity and hyperthyroidism. Symptoms of hyperthyroidism include goitre, fatigue, heat intolerance, sweating, weight loss despite good appetite, shakiness, inappropriate anxiety, palpitations of the heart, shortness of breath, tetchiness and agitation, poor sleep, thirst, nausea and increased frequency of defaecation.

The rationale of this study is to obtain safety and tolerability data when K1-70 is administered as an intramuscular injection or as an IV infusion to subjects with Graves' disease.

This information, together with the pharmacokinetic data, will help establish the doses and dosage regimen suitable for repeat administration to patients.

This is an open-label study. The expected duration of each subject's participation in the study is approximately 18 weeks (including a screening period of up to 4 weeks).

Eligibility Criteria:
Main Inclusion Criteria:

* age 18-75 years
* have Graves' disease and are being treated with anti-thyroid medications OR not treated with anti-thyroid medications (due to side-effects) and who are clinically and biochemically euthyroid or hyperthyroid
* have a body mass index (weight \[kg\]/height \[m\]2) between 18.5 and 35.0 kg/m2

Main Exclusion Criteria:

* current or chronic history of liver disease
* history of cancer within the last 5 years except localised skin cancer
* Graves' orbitopathy with clinical activity score \>3/7
* evidence of optic neuropathy and/or corneal breakdown
* significant systemic infection
* history of recurrent or current infection
* splenectomy
* recently had major surgery or plan major surgery
* had thromboembolic event due to a blood clot in the last 12 months
* have clinically significant laboratory tests
* a clinically significant allergic condition (excluding hay fever)
* currently receiving corticosteroids
* smoke more than 10 cigarettes (or its equivalent in nicotine (including use of e-cigarettes)) per day
* history of drug abuse
Multi-center Validation of a Deep Learning Based Bowel Preparation Evaluation System

A deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase has been constructed previously. This multi-center study is going to perform a prospective observational study to validate the threshold of the adequate proportion.

Inadequate bowel preparation is insufficient for identification of polyps greater than 5 mm. However, bowel preparation assessment involved subjectivity and uncertainty. We constructed a deep learning based system to calculate the proportion of Boston Bowel Prep Scale (BBPS) score of 0-1 during withdrawal phase and performed a prospective observational study to validate the threshold of the adequate proportion.The multi-center study is aimed to verify the extrapolation and robustness of the scoring threshold based on artificial intelligence intestinal cleanliness evaluation system explored in the early stage, and propose a more accurate and quantifiable threshold for evaluating the eligibility of intestinal preparation.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or above;
* Ability to read, understand and sign informed consent forms;
* The researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures.

Exclusion Criteria:

* Patients with contraindications to colonoscopy (obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, severe heart failure, etc.);
* Patients with galactosemia;
* Pregnant or lactating women;
* Patients used lactulose, a stimulant, or laxative within 7 days;
* Patients refused to sign informed consent forms.
Comparison of Early Whole Body Vibration and Progressive Resistance Training in Fast-Track Total Knee Arthroplasty.

Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. Final evaluations will be made at the end of the post-operative 10th week, following the 6-week training.

Patients who have undergone total knee arthroplasty (TKA) with Fast-Track recovery protocol at the Department of Orthopedics and Traumatology at the Local University Hospital and meet the inclusion and exclusion criteria will constitute the study sample. The patients will be divided into 2 groups using the computerized randomization method in the post-operative 4th week; Whole Body Vibration Group and Progressive Resistance Exercise Group. The first evaluation of the participants will be made at the end of the post-operative 4th week. After 2 days and 6 weeks of training a week, final evaluations will be made at the end of the 10th postoperative week. Evaluations will include measures of impairment in body functions and structures, activity limitation measures, balance assessment, and quality of life assessments. Evaluations will be made by a blind researcher. The study will be started with a total of 28 patients, including 14 participants in both groups. The sample size was determined by performing a power analysis. The purpose of the study will be explained to the patients by the researcher and the patients who agree to participate in the planned study will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing unilateral TKA surgery due to knee OA,
* Being between the ages of 50-75,
* To be able to understand the verbal and written information given.

Exclusion Criteria:

* To undergo revision TKA surgery.
* Participating in any exercise or strengthening training within the last 3 months.
* Having undergone major surgery on the extremity to be operated on.
* Having a comorbid disease such as rheumatoid arthritis, cancer.
* Having a neurological disease that causes functional insufficiency.
* Having a diagnosed psychiatric disorder.
* Having received anaesthesia for any reason in the last 1 month.
* Regularly using hypnotics or anxiolytics.
* Having dementia.
* Having a hearing or vision impairment that cannot be corrected with a hearing aid or glasses.
* Being morbidly obese (Body mass index\> 40 kg/m2).
* Having implanted pacemakers or defibrillators.
* Having dermatological problems affecting the thigh.
* Having a score above 3 in the American Society of Anesthesiologists classification score.
A Platform Study to Evaluate Investigational Therapies in Chronic Hepatitis B Infection

This is a Phase 1b/2 platform study framework to evaluate the safety and efficacy of investigational candidate(s) and their combinations as potential treatments for adults with chronic hepatitis B virus infection.

VIR-SHB1-V201 (STRIVE) Sub-Protocol A is a Phase 2 study under the PREVAIL platform trial. This is a multi-center, open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434, VIR-2218, PEGASYS (PEG-IFNα), and nucleotide reverse transcriptase inhibitors (NRTI) in noncirrhotic adult participants with chronic HBV infection that have not received prior NRTI or PEGASYS treatment.

VIR-SHB1-V202 (THRIVE) Sub-Protocol B is a Phase 2 study under the PREVAIL platform trial. This is a multi-center open-label study designed to evaluate the safety and efficacy of regimens containing VIR-3434 and NRTI with or without VIR-2218 in noncirrhotic adult participants with low viral burden of chronic HBV infection.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 or older
* Chronic HBV infection for \>/= 6 months
* Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or current laboratory documentation
* STRIVE: HBeAg positive or negative, HBV DNA \> 2,000 IU/mL, ALT \> ULN and ≤ 5x ULN
* THRIVE: Must be/have the following, within the 1-year period prior to screening: HBeAg negative, HBV DNA ≤ 2,000 IU/mL, ALT ≤ ULN

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
* History of clinically significant liver disease from non-HBV etiology
* History or current evidence of hepatic decompensation
* Co-infection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus (HEV).
* History or clinical evidence of alcohol or drug abuse
* STRIVE and THRIVE: Significant fibrosis or cirrhosis
* STRIVE and THRIVE: History of immune complex disease
* STRIVE and THRIVE: History of autoimmune disorder
* STRIVE and THRIVE: History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
* STRIVE: Prior NRTI or PEG-IFN therapy
* STRIVE: History of known contraindication to any interferon product
* THRIVE: Prior NRTI therapy \< 24 weeks of study or any prior PEG-IFN therapy
Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment

This study is being done to better understand how genetic information related to drug dosing and use can affect medical care of patients. By doing this study, the investigators are developing and improving ways to incorporate information about drug related genetic variants into the medical record.

The purpose of this research is to initiate a test of the concept that sequence information can be coupled to electronic medical records (EMRs) for use in healthcare.The focus of this study is on pharmacogenomics, given the role of adverse drug reactions (ADRs) as major causes of morbidity and mortality, the increasing number of recognized variants included in FDA labels as mediators of both efficacy and toxicity, and the relative lack of stigma attached to carriers of variants in "pharmacogenes". Preemptive sequencing of patients interrogates large numbers of PGx variants and integrates clinically actionable results in a patient's electronic health record (EHR) for use by clinicians at the point-of-care. It is unknown, however, whether integration of preemptive PGx data into the EHR will significantly improve patient outcomes and reduce healthcare costs. Therefore, the Right Drug, Right Dose, Right Time Using Genomic Data to Individualize Treatment Protocol (RIGHT Protocol) study was designed to recruit a large group of patients for preemptive PGx testing, to develop the EHR infrastructure to deliver clinical decision support in real time, and to study the effects of integrating preemptive PGx testing into clinical practice on patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Biobank participants who receive the majority of their care at Mayo Clinic based on EHR length and depth.

Exclusion Criteria:

* Not in the Mayo Clinic Biobank. Do not receive the majority of their care at a Mayo Clinic site.