cyrilzakka/clinical-trials huggingface dataset:
Comparison of Tocilizumab Plus Dexamethasone vs. Dexamethasone for Patients With Covid-19

The overall objective of the study is to determine the therapeutic effect and tolerance of Tocilizumab combined with Dexamethasone in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19).

Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding sIL-6R and mIL-6R.

The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Dexamethasone alone or Dexamethasone +Tocilizumab administration to patients enrolled in the CORIMUNO-19 cohort.

Tocilizumab will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation.

Patients who will chose not to receive Tocilizumab will receive standard of cares.

Outcomes of Tocilizumab-treated patients will be compared with outcomes of standard of care (including Dexamethasone) treated patients


Eligibility Criteria:
Inclusion Criteria:

1. Patients included in the CORIMUNO-19 cohort
2. Patients belonging to the following group:

   * Requiring ≥ 3L/min of oxygen
   * WHO progression scale = 5
   * No NIV or High flow

Exclusion Criteria:

* Patients with exclusion criteria to the CORIMUNO-19 cohort.
* Known hypersensitivity to Tocilizumab or DXM or to any of their excipients.
* Pregnancy
* Current documented bacterial infection not controlled by antibiotics.
* certain evolving viral diseases (especially active herpes, chickenpox, shingles),
* psychotic states still not controlled by treatment,
* live vaccines in the previous 4 weeks,
* Active tuberculosis or disseminated strongyloidiasis
* Patient with any of following laboratory results out of the ranges detailed below at screening should be discussed depending of the medication:

  * Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
  * Haemoglobin level: no limitation
  * Platelets (PLT) \< 50 G /L
  * SGOT or SGPT \> 5N
Clinical Study on Electroacupuncture Therapy for Chronic Neck Pain

Purpose of this test is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

According to statistics, the incidence of chronic neck pain has significantly increased year by year, particularly tending to younger people, as social competition increase fiercely and the pace of people's daily work and life accelerate. Studying the effective treatment and prevention of chronic neck pain has obvious medical, social and economic significance. Purpose of this trial is to observe and objectively evaluate electroacupuncture (EA) therapy on the clinical efficacy in patients with chronic neck pain, and provide a reliable clinical basis for the chronic neck pain treatment and evaluation of efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Age of a subject is older than 18 and is younger than 65.
2. With more than 3 months history of neck pain.
3. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. With serious protopathy or disease ofcardiovascular,liver,renal,gastrointestinal, hematological systems and so on.
2. Psychotic，patients with allergic constitution or easily getting infected or bleeding.
3. Patients have used drugs for preventing neck pain in the last four weeks.
4. Pregnant women or women in lactation.
A Pilot Study to Explore the Role of Gut Flora in Parkinson's Disease

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Parkinson's Disease.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. Diagnosis of Parkinson's Disease

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
Early Detection of Primary Antibody Deficiencies in Primary Care Facilities by an Algorithm Driven Selection of Serologic Testing in Individuals at Risk.

Rationale: Primary antibody deficiencies (PAD) encompass a group of rare heterogeneous diseases. The clinical presentation may vary widely, including infectious and autoimmune symptoms and increased risk of malignancy. Due to the rarity of the diseases and this wide array of symptoms there is often a delay in diagnosis, of up to 12 years on average1-4. Timely diagnosis of PAD reduces morbidity, mortality and health care costs as effective therapies are available. The currently available screening systems for the broader group of primary immunodeficiencies (PID) have been shown to have poor diagnostic performance5-10 and are time consuming. We have thus developed an algorithm to screen patient records in a primary care setting for risk factors specifically for PAD. Patients with a high risk may undergo a laboratory assessment and referral if necessary, thus reducing the diagnostic delay of PAD. The aim of the current study is to validate this algorithm.

Objective:

Main objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands.

Study design: Mono-centre cohort study based on regular care data

Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Age between 12 and 70 years
* A total algorithm score that is within the highest 0.66% of the algorithm scores within a single general practitioner's clinic
* Signed informed consent
* Did not meet exclusion criteria during manual evaluation of the health care record

Exclusion Criteria:

* Secondary causes of immunodeficiency as registered by ICPC codes for: multiple myeloma, HIV-infection, anorexia nervosa, bulimia, cystic fibrosis.
* The presence of one of the following during manual screening of the health care record: nephrotic syndrome, current systemic chemotherapy and stage 3-4 liver cirrhosis will be excluded. This could not be done by the algorithm as there is no ICPC code available.
Vapocoolant Spray Used Prior to Intravenous (IV) Insertions

The primary purpose of this study is to determine if by offering a vapocoolant (cold spray) to hospital outpatients prior to an intravenous catheter (IV) insertion will increase patient satisfaction of IV insertion as well as determine if pain of insertion is decreased.

This is a single blind interventional study with a post design using a convenience sample of patients undergoing a Nuclear Medicine Stress Test. The patient selection and intervention will be randomized in order to ensure a high validity study. The interventional treatment used will be a ethyl chloride mist spray manufactured by the Gebauer Company. The placebo spray that will be used is manufactured by BioLogic Aqua Research Technologies International Inc. The spray is called Nature's Tears Mist and is a sterile water. The patient's for this study are required to have intravenous cannulation (IV) access. This is a painful and invasive procedure in which a vapocoolant may confer benefit for the relief of pain.

Eligibility Criteria:
Inclusion Criteria:

* Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals

Exclusion Criteria:

* If it is the first time the patient has had an intravenous catheter inserted
* Any patient who is or may be pregnant
* Any patient who is breast-feeding
* Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8 hours of intervention time.
* Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome.
* Any patient who has an allergy or hypersensitivity to Ethyl Chloride.
* Any patient under the age of 18 and/or any patient over the age of 85
* Any patient who is illiterate
* Any patient who is non-English speaking
* Any patient with prior experience with a vapocoolant spray.
MAGIC Study: More Access to Group Integrative Care

Chronic pain impacts about 20% of US Adults. Though non-pharmacologic, integrative pain management therapies are now considered first-line treatment by clinical guidelines, these therapies are still rarely covered by health insurance and therefore inaccessible to lower-income individuals. The Integrative Medical Group Visit (IMGV) program was developed to offer low-income, diverse patients with chronic pain an introduction to integrative pain management approaches, through a model that is covered by health insurance under existing billing codes. An initial pragmatic randomized control trial found that IMGV led to significant improvement in mental health related quality of life and lower use of high-cost care. However, there has been little research investigating the implementation of IMGV, and none in Federally-Qualified Health Centers (FQHCs), where the program was initially designed to be implemented. In this study, the investigators test strategies to implement IMGV in FQHCs, including training and coaching clinic staff, and measure the effectiveness of the IMGV on health outcomes for patients with chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Staff and clinicians at each clinic who are involved in implementation of the IMGV.
* Only patients who have enrolled in the Integrative medical group visit (IMGV) programs for patients with chronic pain at their Federally Qualified Health Center will be eligible for enrollment in the study. Physicians at each clinical site will determine enrollment criteria for their IMGV program specific to their clinical site--patients who are enrolled in the program will then be invited to participate in the research study.

Exclusion Criteria:

* All staff, clinicians, and patients who are not involved in the IMGV at the specific clinical sites are excluded from participation.
Effect of Sipjeondaebo-tang for Cancer Related Anorexia in Cancer Patients

To determine efficacy and safety of Sipjeondaebo-tang for Cancer patients suffering from anorexia after chemotherapy. Sipjeondaebo-tang will be administered for 4 weeks, 3 times per day after a meal. Changes of FAACT scale, Anorexia VAS, Weight, BMI, Clinical laboratory test such as ACTH, Cortisol, Chrelin, IL-6, ESR, CRP will be measured and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 20 to 80 years
* Individuals who are suffering from cancer-associated anorexia
* Patients within 1 month after completion of chemotherapy
* No plan for additional chemotherapy or radiotherapy
* Anorexia visual analogue scale (VAS) ≥ 40/100mm
* Qi deficiency scale ≥ 30 or Blood deficiency scale ≥ 30
* Neutrophil ≥ 1,500/㎕, platelet ≥ 100,000/㎕
* Total bilirubin lower than upper limit of normal (1.2 mg/㎗)
* ALT, AST lower than 2-fold the upper limit of normal
* Creatinine lower than 1.5 fold the upper limit of normal(1.09 mg/㎗)
* Written informed consent for participation in the trial

Exclusion Criteria:

* Patient impossible to oral intake
* Patient 5 years after cancer diagnosis
* ECOG performance status score \> 3
* Patient with dementia, delirium, depression
* Patient who complain of more than 7 points when we use Numeric Rating Scale, which can affect appetite or calorie intake, within 2 weeks of screening
* Patient with diseases which can influence on appetite (such as hypoadrenalism, etc)
* Patient who are taking appetizers (such as megestrol acetate, corticosteroids, thalidomide)
* Women who has possibility of a pregnancy
* Others who are judged not to be appropriate to study
Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).

The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.

Eligibility Criteria:
Inclusion criteria for veterans into the study will include:

* Applied for and approved to receive a dog from K9s For Warriors
* Military service on or after September 11, 2001
* Honorable discharge or current honorable service
* Diagnosis of PTSD
* No conviction of any crimes against animals.
Hepatitis B Vaccine Clinical Trial

To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.

BACKGROUND:

Although most carriers of HBsAg are asymptomatic, a substantial proportion eventually develop chronic active hepatitis and cirrhosis. There is also overwhelming evidence that the hepatitis B virus is the single most important causative factor of hepatocellular carcinoma. Thus, mass immunization programs against HBV infection may ultimately affect not only the incidence of acute hepatitis B and the pool of chronic carriers but may also reduce the morbidity and mortality from chronic active hepatitis, cirrhosis, and hepatocellular carcinoma.

Krugman and his co-workers laid the groundwork for active immunization against hepatitis B in 1970 to 1973. They discovered that a 1:10 dilution of hepatitis B infective serum lost its infectivity when boiled for one minute but retained its antigenicity and prevented hepatitis B in 70 percent of vaccinated subjects. Hilleman and his colleagues at the Merck Institute of Therapeutic Research developed a more sophisticated vaccine consisting of highly purified, formalin-inactivated HBsAg particles derived from the plasma of chronic carriers of the antigen. By 1978, data were sufficient to permit testing in a clinical trial.

The first subject was inoculated in November 1978, and by October 1979, recruitment had ended. In May 1980, all trial events were reviewed and classified by an expert panel. In June 1980 the code of vaccine and placebo allocation was broken.

DESIGN NARRATIVE:

Randomized, double blind, fixed-sample. A total of 549 subjects were allocated to the vaccine group in which they were treated with highly purified formalin-inactivated virus subunits derived from the plasma of chronic carriers of hepatitis B. A total of 534 were allocated to the placebo group. Both groups received injections at 0, 1 month, and 6 months unless evidence of infection developed before the series was completed.

Eligibility Criteria:
Men at high risk for hepatitis B virus infection, 36 years of age or younger, no recent symptoms of hepatitis, blood specimen negative for HBsAg, anti-HBs and anti-HBe.
Time-restricted Eating and Interval Training With Digital Follow-up

This study will investigate the effects of seven weeks of time-restricted eating combined with high-intensity interval training compared with a control group on body composition in adults with overweight/obesity. Participants in the intervention group will complete the intervention remotely and will receive weekly follow-up through online platforms (telephone, video call). Before and after the intervention, the investigators will measure the participants' body composition, physical fitness, fasting blood glucose and insulin, blood lipids, and blood pressure. Physical activity, diet, sleep quality, appetite, and adherence to the intervention will also be measured. Secondary sub-analyses of sex differences in the responses to the intervention will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index ≥ 27 kg/m²
* Able to walk or ride a bike \> 60 min

Exclusion Criteria:

* On-going pregnancy
* Lactation within 24 weeks of study commencement
* High-intensity exercise ≥ 1/week
* Habitual eating window ≤12 hours/day
* Taking hypertension, glucose-, or lipid-lowering drugs
* Body mass variation ≥ 4 kg three months prior to study commencement
* Known diabetes mellitus (type 1 or 2) or cardiovascular disease
* Working night shifts
Physical Training and the Incretin Effect

It is well known that continuous physical exercise leads to a number of changes in the body. Maximal oxygen uptake; the heart's pumping ability and muscle mass and strength increases. Also the metabolism adapts: The ability to oxidize fat increase and the insulin sensitivity in primarily in muscle, but also in the liver increase.

Also endocrine glands adapts according to the level of physical activity. It is known that in healthy, younger people the insulin secretion from the pancreas after administration of sugar consumed orally or given directly into a vein, is significantly lower in trained individuals compared with untrained. This change does, however, not only apply to glucose, as also stimulation by the amino acid arginine, shows the same pattern.

It seems plausible that the endocrine glands/cells adapts to the level of physical training, but this has not yet been investigated.

The gastrointestinal tract is the birthplace of a variety of hormones. One group of these is called incretin hormones. They stimulate the glucose dependant insulin secretion in the pancreas and affect hunger/satiety. Whether the incretin production and thus their concentration in the blood is regulated by physical training is unknown.

Obese and patients with type 2 diabetes, has, in contrast to well-trained, decreased insulin sensitivity. As a consequence their (type 2 diabetics, at least early in their disease course) meal stimulated insulin release is greater than in healthy, normal weight individuals. This in spite of the fact that the incretin effect is reduced in obese people and patients with type 2 diabetes compared to healthy, normal weight.

Whether physical training affects both the secretion of incretins and the incretin effect has not yet been studied.

The purpose of this study is to investigate whether incretin hormones in physical well-trained young men have a changed effect on insulin secretion from the pancreas compared to untrained young men. A difference may indicate that the body's endocrine glands adapts to training mode.

The investigators hypothesis is that incretin hormones have a decreased effect on the glucose dependant insulin release in physically trained persons and thus results in a lower insulin release at any given plasma glucose level.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary: 50\>Maximal oxygen uptake (VO2max), ml\*min-1\*kg-1 OR endurance trained VO2max, ml\*min-1\*kg-1\>60
* 20-30 years
* BMI: 18,5-25kg/m2
* Caucasian
* Healthy

Exclusion Criteria:

* Any kind of medication or diabetes in the family (parents, siblings),
* Non-caucasian
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.

Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed.

Eligibility Criteria:
Inclusion Criteria:

Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.

For inclusion in the study subjects must fulfill ALL of the following criteria:

Pre-EPS inclusion criteria:

1. Patients with a clinical history of AVNRT who are referred for ablation.
2. Patients willing to provide written informed consent.

Post-EPS inclusion criteria:

1. Patients with EPS-documented AVNRT

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

1. Patients with any pre-existing AV block.
2. Patients with known cryoglobulinemia
Injury Prevention in Danish Youth Handball

The primary aim of this hybrid-effectiveness-implementation cluster randomised study is to investigate if a supported implementation of an injury prevention exercise program (Happy program) involving a train-the-trainer workshop and coach support during the season is superior to an unsupported implementation of the Happy program involving the availability of the program on webpages, in improving adherence (volume, frequency, duration) of the Happy program among coaches for young (11-17 years of age) Danish female and male handball players during one handball season. Secondary aims are to investigate if the supported implementation is superior to the unsupported implementation in improving behavioural outcomes among the coaches and in reducing the risk for new ankle, knee, and shoulder injuries among young (11-17 years of age) Danish female and male handball players during one handball season. Further, the investigators aim to evaluate how and why adherence and behavioural determinants towards use of the Happy program might improve (or not).


Eligibility Criteria:
Inclusion Criteria:

* playing in youth teams from the age groups under (u)13, u15, and u17
* playing in handball club with at least four teams in the desired age groups

Exclusion Criteria:

-