cyrilzakka/clinical-trials huggingface dataset:
On-line Neuromuscular Exercise and Education for Knee Osteoarthritis

Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee osteoarthritis.

Due to the extraordinary events of the 2020 COVID-19 pandemic, finding alternative delivery-models of treatment has come to the forefront of public health services worldwide. Consequently, on-line treatment is rapidly becoming an integral part of public health service. For patients with knee osteoarthritis (OA), where non-pharmacological and non-surgical treatment is considered first-line treatment, on-line delivered exercise has already shown promise and may be a viable treatment option, especially when traditional on-site exercise delivery models are unavailable. However, further studies are needed to clarify the relative effectiveness of on-line exercise and education when compared to on-site exercise and education programs.

This study aims to evaluate the effects of on-line exercise and education in knee OA compared to a cohort of similar knee OA patients completing the same exercise and education program through on-site delivery.

This study includes two cohorts of knee OA patients receiving the same exercise and education program through different delivery models (on-line vs. on-site). The on-line cohort is a new treatment delivery initiative, born out of the COVID-19 enforced shutdown of all non-critical on-site health care. The on-site cohort is comprised of knee OA patients from a patient registry, collecting outcome data as part of the exercise and education program.

The exercise and education program is called Good Life with osteoArthritis in Denmark (GLA:D), and consists of two to three disease-specific educational sessions and 12 neuromuscular exercise sessions (NEMEX-TJR). GLA:D originates from Denmark and has currently been implemented in Australia, Canada, China, Switzerland and New Zealand.

This study will primarily compare outcomes of pain, function and quality of life between the two different treatment delivery models and will provide important insights in effectiveness of alternative delivery models of recommended first-line care for patients with knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Knee OA symptoms resulting in contact with the health care system

Exclusion criteria (both study groups):

* Another reason than OA for the problems; includes tumour or inflammatory joint disease
* Other symptoms that are more pronounced than the OA symptoms; i.e. chronic, generalised pain or fibromyalgia.

In addition, for the on-line study group:

* Previous participation in similar exercise and education programs (i.e. the on-site version)
* Lack of necessary equipment or skills to administer on-line participation
Signal Relief Patch in Musculoskeletal Pain

assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain

The Signal Relief Patch is an innovative, non-invasive technology that exists as a thin, flexible patch. The patch contains no drugs, wires, or batteries. Nano-capacitors utilized within the Signal Relief Patch were originally developed to replace military antenna systems with no additional power supply. Since development, it was incidentally found that these nano-capacitors may help control pain by working with the body's electrical system. Although the details of how these nano-capacitors facilitate the alleviation of pain are still under investigation, the possibility of reducing pain through a non-invasive, nonpharmacological method is extremely appealing.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject aged ≥ 18 years.
2. Currently seeking treatment for chronic musculoskeletal pain management.
3. Visual analog scale score \> 4 at baseline.
4. Willing to refrain from the use of prescription pain medications during study participation.
5. Able and willing to provide informed consent.

Exclusion Criteria:

- 1. Receiving other investigational agents or on another clinical trial. 2. In emergent need for pain management. 3. Acute injury requiring rapid intervention or treatment. 4. The subject is using prescription medications (e.g., celecoxib, codeine, oxycodone, prednisone, etc.) for pain management regularly or PRN.

5. The subject is currently undergoing or planning to begin physical therapy. 6. The subject is planning to begin a new exercise routine. 7. Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device 8. Known to be pregnant.
Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease

The goal of this study is to find out if there is any association between a mother's exposure to bacteria that normally causes "strep throat" and her baby's developing heart disease/heart defect.

The primary objective of this study is to:

1. measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS) mothers.
2. define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at \<18 weeks gestation and followed to term.
3. Measure antibodies that may cross react to select valvular/myocardial antigens in HLHS/Congenital Heart Defect(CHD)-other neonates born to mothers in the study
4. determine serum and/or tissue reactivity against antibodies in matched maternal serum.

The secondary objectives of this study is to:

1. measure maternal ß-hemolytic streptococcal serology using standard serology testing among HLHS mothers.
2. determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.
3. Determine "baseline" strep serologies and history of strep exposure among a cohort of asymptomatic pregnant women, identified at \<18 weeks gestation and followed to term.

   The overall purpose of this study is to evaluate the history of β-hemolytic streptococcal pharyngeal exposure, groups A, G and C ("strep throat") in pregnant women whose pregnancies have been complicated by the diagnosis of congenital heart disease. Our short-term goal is to identify a potential association of an antecedent maternal strep throat exposure in pregnancy to identify a subset of heart defects
4. To determine if co-infections play a role in congenital heart defects

Eligibility Criteria:
Inclusion Criteria:

* For Fetal pts:
* HLHS or variant diagnosis
* Other Congenital Heart Disease
* Greater than or = 20wks gestation
* For Healthy moms:
* No diagnosis of Congenital Heart Disease
* Greater than or = 20wks gestation

Exclusion Criteria:

* For fetal pts \& healthy controls:
* Mom less than 18 years old
* Twins or multiple gestations
* Pregnancy affected by 2 or more congenital anomalies( in addition to heart defects)
* Pregnancy affected by OB complications like pre-eclampsia
* Known history of chromosomal anomaly or carrier status
* Pregnancy result of fertility treatment including in vitro fertilization
* Emotionally distress
* Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.
Angiogenic Factors in the Conservative Management of Gestational Hypertension

Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit. One of the most controversial scenarios is gestational hypertension, a group of hypertensive disorders considered the mildest form of the pre-eclamptic spectrum, where current recommendations indicate termination of pregnancy at 37 weeks. However, the decision is based on outdated guidelines developed at a time when angiogenic factors were just beginning to be known. The purpose of the study is to use angiogenic factors as a guide to decide the most appropriate gestational age for termination of pregnancy in patients diagnosed with gestational hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24 and 40 weeks of gestation.
* Diagnosis of Gestational Hypertension based on ACOG criteria
* index sFlt-1/PIGF equal or below 33

Exclusion Criteria:

* Multiple gestation
* Maternal vasculitis
* Previous cesarean section (3 or more)
* Neurological conditions
* Chronic renal disease
* Purpura
* Heart disease
* Index sFlt-1/PIGF of 34 or more
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations

This is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy male and female subjects 18 to 75 years of age
* Body mass index (BMI) between 22-35 kg/m2
* Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5.
* Fasting triglyceride ≥100 mg/dL and ≤ 500 mg/dL
* Not pregnant

Exclusion Criteria:

* Significant underlying medical conditions
* Clinical laboratory test values outside the accepted range
* Smokers, tobacco users, or subjects currently using nicotine products
* Substance abuse
* History of allergic response(s) to diazoxide or related drugs
* Recent significant weight loss
* Use of medication affecting body weight, lipid or glucose metabolism
* Unable to comply with study procedures
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

POLYGYNAX® is a broad spectrum combination of nystatin, neomycin and polymixin B indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. POLYGYNAX® has been marketed in France since 1969.

Nevertheless, despite the well established use of POLYGYNAX®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone.

The aim of this project is to demonstrate that POLYGYNAX® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis:

  * bacterial vaginitis
  * non-specific vaginitis (atypical symptoms)
  * mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an empirical local treatment

Exclusion Criteria:

1. Recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion
2. Vaginal infection justifying systemic therapy
3. History of atrophic vaginitis or suspected atrophic vaginitis at inclusion
4. Patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (VIN))
5. Patient with current Sexually Transmitted Infection (STI) and/or patients with clinical suspicion of STI
6. Disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments)
7. Systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion
8. Patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion
9. Pregnant or lactating women or delivery within last 1 month
COMPREHENSIVE ANALYSIS OF NUTRITIONAL PARAMETERS IN PATIENTS WITH IDIOPATHIC ACHALASIA: A PROSPECTIVE STUDY.

A total of 100 patients aged 18-60 years with confirmed diagnosis of achalasia cardia will be recruited prospectively. In this study, patients diagnosed with achalasia cardia (prior to per oral endoscopic myotomy treatment) will undergo comprehensive evaluation of their nutritional status. All the participants will be asked about the details enlisted in pre-tested proforma.The evaluation will include demographic data(age, gender, food preferences, socio economic status,underlying diseases such as hypertension diabetes mellitus etc) anthropometric assessment (height, weight, Body Mass Index, weight loss and duration, percentage weight loss, midupperarm circumference , triceps skin fold, hand grip strength) and biochemical assessment (Hemoglobin, serum albumin and serum pre-albumin,total protein, serum Vitamin D, calcium, B12, serum iron). Each patients' dietary habits will be assessed by SUBJECTIVE GLOBAL ASSESMENT questionnaire (weight change, dietary intake, gastrointestinal symptoms, functional capacity, oedema, subcutaneous fat,muscle wasting, ascites.The obtained data will be statistically analyzed and interpreted. As we are in the midst of COVID-19 pandemic, we will be taking utmost safety precautions to prevent cross-infection. The doctor performing the study and the accompanying technician will be donning the personal protection equipment all throughout the study.

1. .STUDY DESIGN: This study is a Prospective single arm observational study.
2. .STUDY PERIOD: Jan 2021-May 2021. 3. SAMPLE SIZE: 100 participants.

INCLUSION CRITERIA:

1. Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
2. Patients who are co-operative, can communicate verbally and willing to give informed consent.

   EXCLUSION CRITERIA:
3. Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
4. Previously treated and asymptomatic cases with achalasia

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
2. Patients who are co-operative, can communicate verbally and willing to give informed consent.

Exclusion Criteria:

1. Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
2. Previously treated and asymptomatic cases with achalasia
COVID-19 : Study of INFLAmmasome and PLAtelets Functions

COVID-19 pandemic is a severe viral sepsis characterized by the occurrence of Acute respiratory distress syndrome (ARDS) whose pathophysiology is little described

The new Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemic started on December 2019 in China and spreaded in worldwide. The Coronavirus disease 2019 (COVID-19) is responsible of case of severe pneumonia whose the major risk is the development to ARDS. Concerning the pathophysiology, there appear to be hemostasis abnormalities including thrombocytopenia and coagulopathy. In recent studies, this thrombocytopenia is described as a risk factor to develop severe COVID-19 infection. Sepsis is associated with a major systemic inflammatory response with an increased production of pro-inflammatory cytokines. Since their discovery, inflammasomes have an important role during inflammatory response following an aggression. There are intracytoplasmic multiprotein complex activated by cellular stress or infections and is responsible for the release of pro-inflammatory cytokines, including IL-1β. Most studies have analysed inflammasomes in nucleated cells, nevertheless, little is known about inflammasomes in platelets.

Thus, the present work aims to study the activation of the platelet NLRP3 inflammasome and the platelet functions and coagulation during a SARS-CoV-2 viral pneumonia according to different levels of severity

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from COVID-19, hospitalized in intensive care unit and in standard care unit.

Exclusion Criteria:

* Patients suffering from malignant blood disease, cryopyrinopathy, sickle cell disease, rheumatoid arthritis and Crohn's disease
Laser Acupuncture Against Nausea in Children

To investigate whether nonthermal low level laser acupuncture has beneficial effects on nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant solid tumor. In a previous crossover study comparing needle acupuncture to no intervention in an otherwise similar setting we found beneficial effects, but this trial was not even single-blinded and therefore the results are questionable. The hypothesis is that active laser acupuncture is more effective than placebo laser acupuncture concerning episodes of retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary outcome measure) with a fix standard antiemetic medication


Eligibility Criteria:
Inclusion Criteria:

* Age 0-17,
* Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)

Exclusion Criteria:

* Age older than 17 years,
* Participation in another clinical trial on supportive care
Measuring Abdominal Wall Compliance During Gynecologic Laparoscopic Surgery

To measure abdominal wall compliance (AWC) during gynaecologic laparoscopy and assess its relation to the pelvic organ prolapse quantification (POP-Q) score of the same individual, and determine a relationship if present.

To characterize abdominal wall compliance (AWC), sterile reflective markers are attached to the abdominal wall by means of surgical tape, and the movement of these markers will be tracked with an optical tracker device. As during normal surgery, the intra-abdominal pressure (IAP) measured by the insufflator device will be recorded and stored on a secure computer with dedicated software. The pelvic organ quantification (POP-Q) score for each patient is determined pre-surgery as part of the standard of care. A biomechanical model will use reflective marker displacement (RMD) and IAP to calculate AWC. The POP-Q score will then be used to investigate a relation between AWC and degree of prolapse.

It is important to state that the trial does not intervene with the standard of care before- and during surgery. The used equipment is non-invasive and only requires about 5 minutes to be set up before the start of surgery. This set up comprises placing the optical tracker in the operating room such that it has a line of sight on the patient's abdomen and attaching the sterile markers to the abdominal wall. Therefore the trail does not add any additional risk to the surgery.

Each patient scheduled for gynecologic laparoscopy will be asked to participate in the study. If the patient wants to participate, she is presented the informed consent form (ICF). If both patient and clinician in charge sign the ICF, the patient is included in the study. The table below shows the patient specific information stored as part of the study.

Sample size calculation is based on a previous study (S61346), where we measured vaginal wall stiffness (the inverse of compliance) in patients with varying degrees of prolapse. 20 POP patients and 20 control group patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* All patients assigned to gynecologic laparoscopic surgery at UZ Leuven.

Exclusion Criteria:

* Patients that are unable to give consent: In case of dementia or other cognitive disorders.
* Patients that are unable to give consent: When they are unable to read and/or interpret the content of the informed consent form (ICF), which is written in Dutch.
* Patients that had had an earlier abdominoplasty or abdominal wall mesh implantation, or other operations that directly affect the biomechanical properties of the abdominal wall.
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.

ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events.

Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:

* ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
* ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).

Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.

Eligibility Criteria:
Inclusion Criteria:

Should fulfill the eligibility criteria for ACTIVE A or ACTIVE W trial and:

* have a systolic blood pressure of at least 110 mmHg
* not already receiving an angiotensin receptor blocking agent, unless they are willing and able to be changed to another antihypertensive agent
* no previous intolerance to angiotensin receptor blocking agents
* no proven indication for angiotensin receptor blocking agents, unless an Angiotensin Converting Enzyme (ACE) inhibitor can be substituted

Exclusion Criteria:

Patients will be excluded from ACTIVE study if any of the following are present:

* requirement for clopidogrel (such as recent coronary stent procedure)
* requirement for oral anticoagulant (such as prosthetic mechanical heart valve)
* prior intolerance to acetylsalicyclic acid (ASA) or clopidogrel
* documented peptic ulcer disease within the previous 6 months
* prior intracerebral hemorrhage
* significant thrombocytopenia (platelet count \<50 x 10(9)/L)
* psychosocial reason making study participation impractical
* geographic reason making study participation impractical
* ongoing alcohol abuse
* mitral stenosis
* pregnant or nursing woman or woman of child bearing potential and not on effective birth control for at least one month prior to start of study or not willing to continue on birth control for duration of study
* severe comorbid condition such that the patient is not expected to survive 6 months
* patient currently receiving an investigational pharmacologic agent
* requirement for chronic (\> 3 months) non-cyclooxygenase-2 (non-COX-2) inhibitor nonsteroidal anti-inflammatory drug (NSAID) therapy unless willing enrolled in ACTIVE A