cyrilzakka/clinical-trials huggingface dataset:
To Determine the Minimum Amount of Alternaria Alternata Allergen Extract Producing a Positive Skin Reaction.

The objetive of this study is to determine the minimum amount of Alternaria alternata allergen extract producing in a positive skin reaction.

This is an open, unblinded and non-randomized biological assay. The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.

Eligibility Criteria:
Inclusion Criteria:

Positive clinical history of inhalatory allergy to Alternaria alternata. Subject has provided written informed consent, appropriately signed and dated by the subject.

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 Alternaria alternata allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or wheal area ≥ 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study.

A positive test for specific IgE to alternaria alternata (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

The mean wheal diameters of the obtained with histamine dihydrochloride (10 mg / ml) in the forearm ≥ 3 mm.

Exclusion Criteria:

Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (for example: fungal extracts) Use of drugs that may interfere with the skin reactions (e.g., antihistamines). Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).

Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 1 or 2.

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 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. Subjects who have received anti-IgE (Omalizumab).
Safety, Tolerability, and Pharmacodynamics of RDX5791 in Healthy Volunteers

A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerabiltiy, and pharmacodynamics of different multiple dose regimens of RDX5791 in healthy volunteers.

The starting doses for this study are based on the results from the multiple ascending-dose study performed on RDX5791 (Protocol RDX5791-101). Subjects will be screened within 3 weeks of check in to the CPU. Each cohort of 15 subjects (12 RDX5791, 3 placebo) will check in to the CPU on Day -5 before dinner. Each subject will receive a diet standardized for Na+ content while in the CPU. Subjects will receive doses of RDX5791 with approximately 240 mL of non-carbonated water on Days 1 to 7 (just prior to meals, depending on QD, bid, or tid regimens). Subjects will be provided standardized meals within 10 minutes after dosing. Doses can be administered with breakfast, lunch, or dinner.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 29.9 kg/m², inclusive
* No clinically significant abnormalities in medical history
* Females must be non-pregnant, non-lactating, and either postmenopausal for at least 12 months or have agreed to use an effective form of contraception from the time of signing the informed consent until 45 days after end of study
* Men must be either sterile, abstinent, or agreed to use an approved method of contraception from check-in until 45 days after final study visit

Exclusion Criteria:

* Diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the GI tract
* Any surgery on the small intestine or colon, excluding appendectomy
* Loose stools (Bristol Stool Form Score of 6 or 7) ≥2 days in the past 7 days
* Hepatic dysfunction (\[ALT\] or \[AST\]) \>1.5 times the upper limit of normal or renal impairment
* Any evidence of or treatment of malignancy, excluding non-melanomatous malignancies of the skin
* Use of diuretic medications, medications that are known to affect stool consistency and/or GI motility
* Use of an investigational agent within 30 days prior to Day -2
* Positive virology, alcohol, or drugs of abuse test during screening
* Use of any prescription medication within 7 days before admission to the CPU
* Have had significant blood loss (\>450 mL) or have donated 1 or more units of blood or plasma within 8 weeks prior to study entry
Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Soft contact lens wear on a daily wear basis
* Able to wear lenses at least 8 hours
* Generally healthy with normal ocular health
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Use of additional lens cleaners
* Known sensitivities to any ingredient in any of the study products
* History of ocular surgery/trauma within the last 6 months
* Other protocol-defined exclusion criteria may apply
Immunobiology of Diabetes and Tuberculosis

The study hypothesis is that type 2 diabetics have abnormal cell-mediated immunity to tuberculosis manifesting as altered cytokine responses by peripheral blood mononuclear cells (PBMCs). This hypothesis will be tested using the live tuberculosis vaccine, Bacille Calmette-Guerin (BCG), in U.S.-born type 2 diabetics and nondiabetics. The investigators will control for potential confounding by age, sex, race, comorbidities, and select medications. Expression of key cytokines will be measured with real-time polymerase chain reaction.

The project has three specific aims:

Specific Aim 1: To assess differences between the study groups in cytokine expression before and after BCG vaccination. The investigators will determine within-individual variability in cytokine measurements and describe the kinetics of cytokine response to BCG. Peak response levels, time to peak, and patterns of cytokines expressed will be compared.

Specific Aim 2: To evaluate the effect of hyperglycemia on the cytokine response of type 2 diabetics. The investigators will evaluate whether levels of hemoglobin A1C (HbA1C) are associated with degree of cytokine response and test if type 2 diabetics who have good glucose control are different from nondiabetics.

Specific Aim 3: To evaluate the effect of testing PBMCs from diabetics outside of their diabetic milieu. Investigators will compare the BCG-specific cytokine responses of PBMCs stimulated in normal medium, PBMCs stimulated in glucose correlating to the person's most recent HbA1C, and whole blood samples.

Eligibility Criteria:
Inclusion Criteria:Type 2 diabetes or healthy individual Able to give consent US-born Age 30-65 Exclusion Criteria:\* Immunosuppressive disease

* Immunosuppressive medications
* Pregnancy
* Renal failure
* Advanced pulmonary disease
* Prior BCG vaccination
* Prior TB infection
* Type 1 diabetes
Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage

This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

This present study aimed to evaluate:

Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

1- Technical Design: The technical design included research design, setting, subject and tools for data collection.

Research design:

A descriptive exploratory design was followed to achieve the aim of the study. Study setting: This study was conducted between Tropical department in AinShams university and Gastroenterology and Hepatology department in TheodorBilharz Research Institute.

Sample size: EPI - INFO program version 6 was used for sample size calculation guided by power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk ratio = 5.5 - total sample minimum accepted = 50 This study included 50 recipients and done Tropical department in Ain Shams university and Gastroenterology and Hepatology department in .

Theodore Bilharz Research Institute

Eligibility Criteria:
Inclusion Criteria:

* Adult Egyptian patients.
* Patients with acute upper G.I hemorrhage.
* Informed consent.

Exclusion Criteria:

* Refuse to participate in this study.
Safety and Feasibility of Kefir Administration in Critically Ill Adults

The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.


Eligibility Criteria:
Inclusion Criteria:

* Critically ill adult patients receiving antibiotics.
* Functional GI tract (able to tolerate oral diet or tube feeding).

Exclusion Criteria:

* Received antibiotics for \>72 hours prior to enrollment.
* Known immunosuppression (due to medications including chronic steroids, TNF-alpha inhibitors, monoclonal antibodies, immunosuppressive antimetabolites, etc.).
* Compromised gut integrity (bowel resection, GI malignancy, GI bleed, inflammatory bowel disease).
* History of CDI within 60 days.
* Liver failure or pancreatitis.
* Dairy intolerance or milk allergy.
* Patients consuming probiotics at baseline.
* Artificial heart valve.
* Extremely poor prognosis and not expected to survive the treatment period.
Pharmacokinetic, Pharmacodynamic and Safety Evaluation After Single Oral Administration of KRN1493

Randomized, open, single ascending dose, parallel study to evaluate the pharmacokinetics, pharmacodynamics and safety of KRN1493 after single oral administration in healthy Korean male volunteers.

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug orally with 240 ml water around at 9 a.m. of Day 1 and they were fasted until 4 hours post-dose. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. During admission, subjects were served low calcium diets. Subjects were discharged on Day 2, and visited Clinical Trials Center on Day 3, Day 4 and Day 5. Study participation was terminated on post-study visit (Day 7 - 10).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 20 - 35 years
* A body mass index (BMI) in the range 19-27 kg/m2
* Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures.
* Subject who didn't drink grapefruit within 3 days prior to the test drug dosing
* Subject judged eligible for study participation by investigator considering screening result except PTH

Exclusion Criteria:

* Clinically relevant abnormal medical history that could interfere with the objectives of the study.
* A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
* Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
* Presence or history of drug or alcohol abuse.
* Participation in other clinical trial within 3 months (in case of bioequivalence study or other clinical trial) or within 4 months (in case of phase 1 study) or with 1 month (in case of patch) prior to scheduled study drug administration (measured from the final dosing day in the previous trial)
* Use of a prescription medicine, herbal medicine or over-the-counter medication within 7 days before first dose
* Use of medication or food which induces or inhibits CYP2D6 or CYP3A4 within 1 month prior to the test drug dosing (except food contain grapefruit)
* Loss of more than 400 mL blood during the 3 months or 200ml during the 1 month before the study, or apheresis during 2 weeks before the study.
* Subject judged not eligible for study participation by investigator
BLI, NBI or White Light Colonoscopy for Proximal Colonic Adenoma

This is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (BLI), narrow band imaging or white light colonoscopy.

Study population:

Consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital are invited to participate in this prospective randomized study. Patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes. Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. In addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is \<2.

Study design and randomization:

This is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of BLI (ELUXEO endoscopic system) vs NBI (290 video system) vs WLI which is conducted in the Endoscopy Center of the Queen Mary Hospital of Hong Kong. Eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. The three groups are: (1) NBI follow by WLI; (2) BLI follow up WLI; (3) WLI follow by WLI. Randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). All procedures are performed with high-definition endoscopes. The patients are blinded to the group assignment.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 or above
* scheduled for colonoscopy

Exclusion Criteria:

* unable to provide informed consent
* have undergone previous colorectal resection,
* personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome, or other polyposis syndromes.
* Patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses
* poor bowel preparation
Left Radial comparEd to Femoral Approach for CORonary Angiography in Patients With Previous CABG StuDy

This randomized, multicenter, prospective study seeks to compare left radial and femoral access during cardiac catheterization of patients with prior history of CABG surgery, with the primary objective of demonstrating that the two access techniques do not differ in the net procedure time (non-inferiority study) expanding the documented benefits of radial access to this group of patients.

Patients from 4 different centers with a history of CABG are randomized 1:1 to left radial or femoral access. Based on the literature, a randomized study sample of a total of 150 patients was calculated with assumptions of 30 +/- 10-minute duration of the procedure, alpha = 5%, beta = 10% (power 90%) and non-inferiority limit Δ = 5 minutes. The primary endpoint of the study is the time it takes after placing the sheath at the initial puncture site until the completion of the diagnostic procedure (Net procedure time). Secondary endpoints include total time of the procedure, fluoroscopy time, total patient exposure radiation, amount of contrast used, possible vascular complications, major cardiovascular events and need for crossover access site.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years
2. Written informed consent
3. Clinical indication for coronary angiography in a patient with prior history of CABG
4. Left radial artery has not been used as a graft during CABG

Exclusion Criteria:

1. Age over 90 years
2. Patient's refusal to participate in the study
3. Hemodynamic instability of the patient
4. Failure to place a sheath at the randomization access site
5. Arteriovenous fistula at the left upper limb
6. Use of right internal mammary artery as a graft during CABG
7. Creatinine clearance \<30 ml/min
Effect of Yoga Vs. Stretching on Chronic Back Pain

This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.


Eligibility Criteria:
Inclusion Criteria:

* Group Health Cooperative enrollee
* Uncomplicated low back pain
* At least moderate pain levels

Exclusion Criteria:

* Sciatica persisting 3 or more months after physician visit
* History of cancer (other than nonmelanoma skin cancer)
* Severe disk problems
* Unstable medical conditions
* Back surgery within past 3 years
* Physically unable to do the yoga or exercise classes and homework
* Unable to attend classes
* Currently doing yoga
* Taken yoga or exercise class for back pain within past year
* Currently in litigation for back pain
* Seeking other treatment for back pain
Study of AZD9150 and MEDI4736 (Durvalumab) in Japanese Adult Patients With Advanced Solid Malignancies

This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of AZD9150 monotherapy and AZD9150 in combination with durvalumab in Japanese patients with advanced solid malignancies.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients must be at least 20 years of age.
* Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
* Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases).
* Adequate organ and marrow function
* Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol

Key Exclusion Criteria:

* Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment.
* Patients must have completed any previous cancer-related treatments before enrolment.
* Has active or prior autoimmune disease within the past 2 years
* Has active or prior inflammatory bowel disease or primary immunodeficiency
* Undergone an organ transplant that requires use of immunosuppressive treatment
* Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
* Prior exposure to AZD9150 or any other anti PD (L)1 antibody.
Risky Decision Making in Methamphetamine Users: The Role of Opioid Blockade

The purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. The investigators would like to know if a medication called naltrexone changes how people make decisions. The investigators would also like to know whether changes in decision making can be observed by MRI (magnetic resonance imaging).

The research is conducted in Portland, OR.


Eligibility Criteria:
Summary Inclusion Criteria:

* Diagnostic and Statistical Manual (DSM)-IV Methamphetamine Dependence
* Deemed healthy enough to participate by study physician
* Age 18-55
* Right handed
* English-speaking

Summary Exclusion Criteria:

* Current opioid use in the last 30 days; opioid abuse or dependence within past 5 years
* Pregnancy
* MRI contraindications (e.g. metal in head).

The research is conducted in Portland, OR.
To Determine the Relative Bioavailability of Different Formulations of AZD9291 and the Effect of Food.

To determine the relative bioavailability of different oral formulations of AZD9291 and the effect of food in healthy volunteers.

A Phase I, Open-label, Single-center, Sequential Design Study in Healthy Volunteers to Determine the Relative Bioavailability of Different Oral Formulations of AZD9291 and the Effect of Food

Eligibility Criteria:
Inclusion Criteria:

1, Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg. 2, Volunteers must be willing to use a condom, unless their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. 3. In addition, volunteers must agree to continue to take similar contraceptive precautions until 4 months after the last dose of AZD9291.

Exclusion Criteria:

1. Any clinically relevant abnormalities in physical examination, vital signs, hematology, clinical chemistry, urinalysis or ECG at baseline in the opinion of the Investigator.
2. Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to dosing.
3. History of severe allergy/hypersensitivity or or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to AZD9291, its excipients, or drugs with a similar chemical structure or class.
Endocannabinoids in End Stage Renal Disease

To investigate the relationship between dietary intake, body habitus, and endocannabinoid levels in end stage renal disease patients as compared to matched controls.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patient, able to give informed consent

Exclusion Criteria:

* hospitalization in past 3 months