cyrilzakka/clinical-trials huggingface dataset:
Biological Standardization of Chenopodium Album Allergen Extract

The objective of this study is to determine the biologic activity of a Chenopodium album allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
* Subject can be male or female of any race and ethnic group.
* Age \> and =18 years and \< and =60 years at the study inclusion day.
* Positive skin prick test with a standardized commercially available preparation of chenopodium album allergen extract.
* A positive test for specific IgE to chenopodium album (CAP-RAST major or equal to 2).
* Allergic symptoms during the pollen season of Chenopodium album.
* Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album.

Exclusion Criteria:

* Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested.
* Use of drugs that may interfere with the skin reactions (e.g., antihistamines).
* Treatment with any of the following medications: tricyclic or tetracyclic

  o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (\> 10 mg/día de prednisone or equivalent).
* Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
* Dermographism affecting the skin area at the test site at either study visit.
* Atopic dermatitis affecting the skin area at the test site at either study visit.
* Urticaria affecting the skin area at the test site at either study visit.
* Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
* Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
* Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
* Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)
* Severe psychiatric, psychological or neurological disorders
* Abuse of alcohol, drugs or medicines in the previous year.
Reliability of BASDAI and BASFI Applied by Tele-Assessment Method in Axial SpA Spondyloarthritis

The goal of this observational study is to investigate the reliability of BASDAI and BASFI questionnaires applied via tele-assessment in axial spondyloarthritis patients.

Telehealth is the provision of healthcare services and clinical practices remotely through information and communication technologies. In recent years, the use of telehealth applications has increased worldwide. Telehealth is an umbrella term that covers practices such as telemedicine, telerehabilitation, and tele-assessment. Tele-assessment has gained importance in terms of monitoring patients with chronic diseases. Although BASDAI and BASFI have been shown to be valid and reliable in AS patients, there is no study in the literature examining the reliability of BASDAI and BASFI applied via tele-assessment. The aim of our study is to investigate the reliability of BASDAI and BASFI questionnaires administered via tele-assessment in axial SpA patients.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Axial spondyloarthritis according to the Assessment in SpondyloArthritis international Society (ASAS) criteria
* Volunteering to participate in the study
* Being between the ages of 20-60

Exclusion Criteria:

* Having another systemic, orthopedic, neurological or cognitive disease other than axial spondyloarthritis
* Pregnancy
* The patient wishes to withdraw from the study
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.


Eligibility Criteria:
Inclusion criteria:

* Male or non-pregnant, non-lactating female patients at least 18 years of age
* Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
* Rheumatoid factor and anti-CCP antibodies negative
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

Exclusion criteria:

* Chest X-ray with evidence of ongoing infectious or malignant process
* Subjects who have previously been treated with more than 3 different TNFα inhibitors
* Subjects taking high potency opioid analgesics
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
A Study of ZW171 in Participants With Advanced or Metastatic Mesothelin-expressing Cancers

This study is being done to find out if ZW171 is safe and can treat participants with advanced (locally advanced \[inoperable\] and/or metastatic) mesothelin-expressing cancers.

Part 1 of the study will evaluate the safety and tolerability of ZW171. Part 2 of the study will evaluate the anti-tumor activity of ZW171 while continuing to evaluate the safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable) and/or metastatic disease. Cancers that are refractory to all available standard of care (SOC) treatment, cancers for which no SOC treatment is available, or the participant cannot tolerate or refuses SOC therapy.
* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Adequate cardiac left ventricular function, as defined by left ventricular ejection fraction ≥ 50% as determined by either echocardiogram or multigated acquisition scan.
* Adequate organ function.

Exclusion Criteria:

* Known additional malignancy that is progressing or that has required active treatment.
* Undergone prior allogenic tissue (e.g., hematopoietic stem cell) or solid organ transplantation within the last 5 years.
* Ongoing, clinically significant toxicity (Grade ≥ 2) associated with prior cancer therapies, with the exception of alopecia.
* Advanced/metastatic, symptomatic, visceral spread, at risk of life-threatening complications in the short-term (including participants with massive uncontrolled effusion \[pleural, pericardial\], pulmonary lymphangitis, active unresolved bowel obstruction, massive ascites \[requiring paracentesis \>2 times within 2 weeks prior to the first dose\], and over 50% liver involvement).
* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of participants with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment).
* Active or recurrent clinically significant autoimmune disease requiring systemic high-dose corticosteroids or immunosuppressive drugs.
Agility Training in Parkinson's Disease

To determine the effects of an unusually highly intensity and individualized sensorimotor and visuomotor agility exercise program on non-demented PD patients' clinical symptoms, mobility, and postural stability.

Design: Intervention study

Setting: Outpatient rehabilitation center

Participants: 55 Parkinson's disease (PD) patients completed the trial and 42 serves as comparison healthy controls

Intervention: An initial screening established specific dysfunctions of PD patients with Hoehn-Yahr stage 2-3 who were then randomly assigned to standard care (n = 20) or standard care plus at-limit intensity, individualized agility program (15 sessions, 3 weeks, n = 35).

Main outcome measures: Movement Disorder Society Unified Parkinson Disease Rating Scale, Motor Experiences of Daily Living, a measure sensitive to changes in a broad spectrum of PD symptoms

In group time, repeated measurements of variance analysis were compared to the picture parkinson's disease based on MDS-UPDRS M-EDL, Beck depression score, PDQ-39, EQ5D VAS, Schwab \& England scale. The TUG test and 12 static posturographic measurements are compared and compared to the healthy group as a standard.

An at-limit and individualized sensorimotor and visuomotor agility exercise program vs. standard care, will improve non-demented, stage 2-3 PD patients' clinical symptoms, mobility, and postural stability by functionally meaningful margins.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Hoenh Yahr scale of 2-3
* Instability problem

Exclusion Criteria:

* Severe heart problems
* Severe demeanor
* Alcoholism
* Drug problems
Safety and Tolerability of ACU-4429

The purpose of this study is to evaluate the safety and tolerability of a new investigational drug (ACU-4429) in healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Is male or female with age ≥ 55 and ≤ 80 years at the time of consent
* Is healthy as determined by medical history and physical examination

Exclusion Criteria:

* Is receiving or has recently received treatment with a medication disallowed per the protocol
Intra-operative Radiotherapy For Breast Cancer Women After NSM

The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.

Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* Tumor diameter ≤3 cm
* Tumor from the papilla\>2cm
* Low grade ductal carcinoma in situ
* Candidate for breast-conserving surgery
* Must have undergone lumpectomy with negative margins or minimal margin involvement
* Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection
* No evidence of metastatic disease
* Informed consent

Exclusion Criteria:

* No informed consent
* Tumor size \> 3 cm
* Tumor from the papilla≤2cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost
Effectiveness, Safety and Tolerability Study of RP-G28 for Symptoms Associated With Lactose Intolerance

This is a Phase 2 study designed to assess the ability of RP-G28 to improve lactose digestion and tolerance.

Lactose intolerance is a common gastrointestinal (GI) disorder that develops in lactose maldigesters when consuming too much lactose or when lactose is added to a previously low-lactose diet. Lactose intolerance is characterized by one or more of the cardinal symptoms that follow the ingestion of lactose-containing foods. These symptoms include; abdominal pain/cramps, bloating, flatulence \[gas\] and diarrhea. As such, most lactose intolerant individuals avoid the ingestion of milk and dairy products, while others substitute non-lactose containing products in their diet.

Based on the health implications from insufficient calcium intake over a lifetime, including increased risk of osteoporosis and hypertension, there is need in the medical community for a tolerable and convenient treatment that allows for all levels of milk and dairy product consumption in people suffering from mild to severe lactose intolerance. This study will evaluate a treatment that provides a simplified dosing regimen as well as the potential for extended relief from symptoms following a limited therapy regimen.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects. Female subjects must be non-pregnant and non-lactating.
* 18 to 64 years of age inclusive at Screening
* Current or recent history of intolerance to milk and other dairy products
* Acceptable Baseline Lactose Intolerance Symptom Scores
* Acceptable Result on Baseline Hydrogen Breath Test
* Subjects must agree to refrain from all other treatments and products used for lactose intolerance during the study

Exclusion Criteria:

* Disorders known to be associated with abnormal GI motility
* History of surgery that alters the normal function of the gastrointestinal tract
* Past or present; organ transplant, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, Celiac disease, inflammatory bowel disease (IBD), ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS)
* Active gastric or duodenal ulcers or history of severe ulcers
* Diabetes mellitus (type 1 or type 2)
* Congestive Heart Failure
* History of Human Immunodeficiency Virus (HIV), Hepatitis B or C
* Use of concurrent therapy(ies) for symptoms of lactose intolerance
* Uncontrolled BP defined as sitting systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥95 mmHg at Visit 1
* History of ethanol abuse in the past 12 months
* History of drug abuse within 12 months
* History or presence of malignancy within the past 5 years (except basal cell or squamous cell carcinoma removed from a sun-exposed area)
* Use of any investigational drug or participation in any investigational study within 30 days prior to Screening
Detection of Circulating Endothelial Progenitors Cells (EPCs) in Non-small Cell Lung Cancer (NSCLC)

Bone-marrow-derived progenitor cells (EPCS) play an important role in neovascularization and tumor growth. In lung cancer, angiogenesis is an important event in mechanisms of tumor proliferation and metastasis. Recent evidences suggest that EPCS can be recruited and differentiate in mature endothelial cells to form new blood vessels. The role of EPCs in NSCLC is unclear. In contrast, angiogenic drugs are proposed combined to systemic chemotherapy in NSCLC. The aim of this study is to identify EPCs in peripheral blood from patients with NSCLC, by comparison to Chronic Pulmonary Obstructive Disease (COPD), an inflammatory disease.

The aim of this study is to study blood circulating levels bone-marrow-derived progenitor cells (EPCS).

In a first phase, EPCs will be detected in healthy non-smokers volunteers to validate flow cytometry method (n=25). In addition, EPC will e characterized by primary cultures to analyze EPC-specific markers.

In a second phase, EPCs will detect in peripheral blood from 50 patients with Chronic Obstructive Pulmonary Disease (COPD) and 50 patients with non-small cell lung cancers (NSCLC). Primary cultures will be made to confirm EPCS isolation.

Methods: EPCs will be numerated by flow cytometry using CD133, CD146, CD34, CD45 and VEGFR2 antibodies. Primary cultures will be used to identify EPCs at 5-days culture by the same markers. In addition, for BPCO et NSCLC patients, Vascular endothelial cell growth factor (VEGF) concentration will be measured in peripheral sera by ELISA commercial test.

Overall survival will be analyzed for NSCLC in function of initial EPCs concentration. Correlation will be studied between initial VEGF serum concentration and EPCs level.

This study focus on the possibility that EPC determination in peripheral blood could be used as a surrogate marker of standard or antiangiogenic treatment in NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Signed written consent
* Subject \> 18 year old
* No precedent therapy for cancer
* Non-smoker healthy subject or current smoker COPD patients or NSCLC patients

Exclusion Criteria:

* Small-cell lung cancer patient
* Radiotherapy, chemotherapy or target therapy for NSCLC
Implementation of a New Strategy to Identify HNPCC Patients

The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.

The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer before the age of 50 years
* Second colorectal cancer at any age
* Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis
* Adenoma with high grade dysplasia diagnosed before the age of 40 years
Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis

Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.

Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).

Eligibility Criteria:
Inclusion Criteria:• Age more than 20 years

* Acceptable performance of alimentary system
* Ability to drink at least 200 ml of water per day
* No history of being allergic to fungi and yeast
* Absence of acute medical illness
* life expectancy more than 3 months
* Accept and sign the consent

Exclusion Criteria:

* Patient's unwillingness to participate in the study
* History of smoking, peritoneal dialysis (PD) or previous kidney transplantation
* Lactation or pregnancy
* Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.
Vaginal Hysterectomy, Laparoscopic Hysterectomy, Postoperative Pain

The previous studies have shown that recovery after laparoscopic or vaginal hysterectomy is faster than after abdominal approach. The aim of this study is to evaluate postoperative pain after vaginal or laparoscopic hysterectomy. The primary outcome measurement is opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 -69 years
* Gender . female
* ASA status 1-3
* Vaginal hysterectomy or laparoscopic hysterectomy

Exclusion Criteria:

* Body mass Index over 35
* Diabetes Mellitus
* Liver disease
* Allergies to pharmaceuticals used in the Study
* Present use of opioids
* Vaginal prolapse
Diagnostic Accuracy of Rapid Antigen Test Based on Anterior Nasal Swab Compared With RT-PCR for SARS-CoV-2 Detection.

The aim of this study was to determine the accuracy of anterior nasal swab in rapid antigen (Ag)-tests in a low SARS-CoV-2 prevalence and massive screened community.


Eligibility Criteria:
Inclusion Criteria:

* Citizens, above 18 years of age, who had self-booked an appointment for COVID-19 test at Testcenter Taastrup, Copenhagen, Denmark, in the period of 2nd of March to 22nd of March were offered to participate in the project

Exclusion Criteria:

* Patients referred to COVID-19 testing by a doctor with symptoms of COVID-19 were tested in a separate section of the test centers and are not included in this study
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD

Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana (methylphenidate) patch for a longer time then 9 hours, many children report short sleep latencies and better quality of sleep.

Once the optimal dose of Daytrana that controlled the ADHD symptoms is established. The patch will be removed 1, 2, and 3 hours before bed time in a random fashion, at weekly intervals, and parents will keep a sleep diary.

25 patients will be enrolled in order to obtain statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* ADHD without significant comorbidity

Exclusion Criteria:

* Cardiac disorder
* Hypertension
* Thyroid disease
* Glaucoma
* History of sudden death, motor tics and/or Tourette's syndrome
* Hypersensitivity to methylphenidate
Bariatric Surgery for the Reduction of CArdioVascular Events Randomized Controlled Trial

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health, cardiac structure and function, genomics, proteomics and metabolomics.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index ≥30 kg/m2; OR BMI ≥30 kg/m2 to 34.9 kg/m2 and have type 2 diabetes or are \&gt;55 years of age
2. Age ≥18 years
3. High-risk CVD, defined as the presence of any one of the following:

   1. High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)
   2. Left ventricular ejection fraction (LVEF) \&lt; 40%
   3. Heart failure with preserved ejection fraction (LVEF \&gt; 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \&gt; 300 pg/ml or BNP \&gt; 100 pg/ml in the past 12 months
   4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score
   5. History of any stroke
   6. Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)

Exclusion Criteria:

1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization
2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.
3. Pregnancy
4. Contraindication to bariatric surgery
5. Prior bariatric surgery, other than gastric banding
6. Life expectancy \&lt;2 years from non-cardiovascular causes
7. Inability to provide informed consent