cyrilzakka/clinical-trials huggingface dataset:
Food Challenge With Barley Starch as Active Comparator

Aim of the present study is to verify in a double-blind placebo controlled food challenge (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. Hypothesis is that none of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain allergic reaction neither to placebo nor to the test ingredient. Scoring of symptoms during the challenges will be based on PRACTALL.


Eligibility Criteria:
Inclusion Criteria:

* Age = 1-20 years
* Diagnosed or suspected cereal allergy (at least to one of the following cereals wheat, barley or rye)
* Response to cereal proteins confirmed within 2 months in an oral food challenge (OFC)\* OR response to cereal proteins confirmed in an OFC more than 2 months ago but clinically verifiable and documented ongoing cereal allergy at the time of inclusion OR diagnosis confirmed in an OFC with wheat performed as part of the study procedures.
* Voluntarily signed informed consent (including willingness to refrain from cereal containing foods for 1 week before intervention period and be exposed to cereal proteins in the test for eligibility)

Exclusion Criteria:

* Complex food allergy which make elimination diet impossible to accomplish
* Patients experiencing unstable or exacerbated atopic disease, such as asthma, atopic dermatitis (AD), urticaria, or allergic rhinitis.
* Diseases and conditions that might affect safety. Patients should not be challenged if they have chronic medical the event of anaphylaxis/treatment of anaphylaxis. Examples of such conditions include unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease.
* Pregnancy should be ruled out by testing or based on history (e.g, before menarche) as appropriate
* Use of oral corticosteroids. Inhaled and topical steroids or anti-inflammatory medications, such as calcineurin inhibitors or leukotriene antagonists and b-agonists, used at the lowest doses possible and on an established schedule by using fixed doses of medication to maintain a low and stable baseline of atopic disease. Latter medication can usually be continued because their use is unlikely to significantly influence challenge outcomes and their withdrawal might result in exacerbations, affecting disease management and challenge interpretation.
* Use of antihistamines during the last 4 days before DBPC challenge or period of 5 half-lives of specific agent.
* Prolonged high dose steroids, omalizumab, or possibly other new drugs to control atopic disease upon decision of investigator.
* Aspirin/nonsteroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, alcohol, antacids and β-blockers upon the decision of the investigator
* Any chronic condition or its medication that affect immune system
Radiofrequency Ablation and Steroid Versus Steroid Alone for Relief of Pain in Patients With Advanced Knee and Hip Osteoarthritis

The purpose of this trial is to determine if radiofrequency ablation plus steroid perineural injections at the knee or hip provide longer pain relief and better function to patients than the current standard of care, perineural steroid injections alone.

This pilot study is a prospective two arm randomized trail, all participants will be recruited from the University of Texas Southwestern Medical Center (UTSW) outpatient orthopedic clinic. 40 participants (20 hip and 20 knee OA) will be enrolled into the standard of care arm (treated with steroid injections alone) and 40 participants (20 hip and 20 knee OA) will be enrolled into the investigational arm (treatment with a combination of radiofrequency ablation (RFA) plus steroid injections) for a total of 80 enrolled participants. All subjects will complete a function and pain assessment at the time of injection and three additional time points: 2 weeks, 3 months, and 6 months post injection. This study will use the same knee function questionnaire and frequency currently used in clinic per standard of care. In addition, all participant's surgical history and prior injection history will be reviewed via the Electronic Medical Record (EMR).


Eligibility Criteria:
Inclusion Criteria: (1 \& 2 or 3)

1. Males or females age 18 to 100 years
2. Osteoarthritis of the knee Kellgren-Lawrence grade 3-4 OR
3. Osteoarthritis of the hip Tonnis grades 2 or higher

Exclusion Criteria:

1. History of knee or hip replacement
2. History of intra-articular steroid injections within the past 6 weeks
3. Active infection
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon

This study aims to evaluate potential predictors of adherence by investigating a representative cohort of MS patients in Germany treated with Betaferon


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome
* Patients on treatment with Betaferon or the decision to treat patients with Betaferon has been made by the attending physician
* Patients using or willing to use the BETACONNECT autoinjector for Betaferon application
* Written informed consent

Exclusion Criteria:

* Patients receiving any other disease modifying drug
* Contraindications of Betaferon described in the Summary of Product Characteristics
* Patients participating in any other clinical or non-interventional study, evaluating MS therapy
Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections

The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1.

The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.

Former description of the study (now completed)

Osteoarticular infections related to orthopaedic implants are associated with substantial morbidity, prolongation of hospital stay, and additional costs. Due to the increasing number of patients with orthopaedic implants in Switzerland, similar to the rest of Europe and elsewhere, the number of infections is expected to increase. While the surgical treatment of these infections has been well studied, the ideal duration of antibiotic therapy after removal (explantation) of the infected implant remains unknown. For almost 40 years, the recommended total duration of post-explantation antibiotic therapy has been 6 weeks. This recommendation is based on expert's personal experience rather than on prospective randomized studies. Shorter treatment would decrease antibiotic-related adverse events and costs hospital stay for patients awaiting an eventual reinsertion of a new implant. If physicians and surgeon prescribe antibiotics for 6 weeks, this duration should be at least supported by evidence.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥17 years old)
* Total removal of the implant

Exclusion Criteria:

* Primary native joint septic arthritis;
* Co-trimoxazole prophylaxis because of immunosuppression;
* Left-side endocarditis;
* Persistent implant material in the infected area.
* Infections with tuberculosis; mycobacteria; fungi; brucellosis; borreliosis; nocardiosis; and mycoplasmal osteosynthesis infections
Supra-Annular vs. Annular ValvEs for Small Annuli

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Patient prothesis mis-match (PPM) remains a clinical dilemma in transcatheter aortic valve replacement (TAVR) and has been linked to higher rates of morbidity and mortality. Supra-annular self-expanding valves have been linked to lower gradients and lower rates of patient prosthesis mismatch versus annular valves but they have not been directly compared. Patients with small annuli are particularly vulnerable to PPM, therefore, the aprior hypothesis is that implantation of supra-annular valves for small annuli may show differences in PPM rates and outcomes when compared to annular valves.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic subjects with severe native aortic valve stenosis
* aortic valve annulus mean diameter ≤23 mm
* Patient meet commercial indication for transcatheter aortic valve replacement (TAVR)
* Institutional heart team determines that TAVR is appropriate
* Patient's anatomy is appropriate for either Medtronic Evolute or Edwards Sapien 3 Ultra

Exclusion Criteria:

* Subject unable or unwilling to provide informed consent
* Intended concurrent structural heart procedure (e.g. transcatheter mitral valve repair or replacement, left atrial appendage closure)
* Renal function precluding the administration of iodinated contrast (eGFR \< 30ml/min/1.73m2). An exception to this exclusion criterion is made if the subject is established on renal replacement therapy and is therefore able to receive intravenous iodinated contrast media
* Pregnancy or intent on becoming pregnant prior to completion of all proctocol follow-up procedures
* Patients at high risk for coronary obstruction
* Patients with low-flow low gradient aortic valve stenosis
* patients at high risk for annular rupture with implantation of a balloon expandable valve
Vital Pulp Therapy With Different Materials for Young Permanent Teeth

This study will be conducted to:

Evaluate clinically and radiographically apexogenesis in immature permanent molars using:

1. Calcium Hydroxide.
2. MTA.
3. Laser.
4. Laser combined with MTA.

Calcium Hydroxide has been the most commonly utilized pulpotomy agent for vital pulp therapy. It is the earliest medicament employed in pulpotomy that possesses the ability to stimulate tertiary dentinogenesis. This is attributed to its high alkalinity after mixing with water. Calcium hydroxide has a high pH, and its dental use relates chiefly to its ability to stimulate mineralization and also to its antibacterial property.

Biocompatibility and sealing ability are the most important properties, which account for optimal healing response in vital pulp therapy. Unlike conventional materials, MTA has low solubility and maintains its physical integrity after placement. It has several desirable characteristics in terms of biocompatibility, bioactivity, hydrophilicity, radiopacity, sealing ability and low solubility.

Diode laser in a young permanent tooth with traumatically exposed pulp has proved to be an effective technique for Pulpotomy in an immature tooth. Therefore, the use of soft-tissue diode lasers can influence the treatment outcome and should be seen as a predicable tool for vital pulp therapy.

Eligibility Criteria:
Inclusion Criteria:

* Medically free
* Vital teeth

Exclusion Criteria:

* Medically compromised
* Chronic abscess
* Non-vital teeth
Sevoflurane Induced Emergence Agitation

Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.


Eligibility Criteria:
Inclusion Criteria:

* 1- 8 years
* American Society of Anesthesiologist (ASA) I-II,
* Patients undergoing procedures below the umbilicus

Exclusion Criteria:

* cardiac diseases
* pulmonary diseases
* hepatic diseases
* renal diseases
* psychological or emotional disorders
Zanubrutinib Combined With R-CHOP in Newly-diagnosed Intravascular Large B-cell Lymphoma

This is a prospective single-arm phase II study, and the purpose of this study is to evaluate the efficiency of zanubrutinib combined with R-CHOP regimen in newly diagnosed primary intraocular lymphoma. Progression-free survival (PFS) of the cohort is the primary endpoint.

All the eligible patients will be treated with ZR-CHOP regimen (Rituximab 375mg/m2 IV d1, cyclophosphamide 750mg/m2 IV d1, epirubicin 70mg/m2 IV d1, vindesine 4mg IV d1，prednison 60mg/m2 d1-5 PO). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of ZR-CHOP.

The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.

During the following-up, surveillance physical examination and CT scans should be performed every 6 months for 2 years to determine the status of disease.

Eligibility Criteria:
Inclusion Criteria:

* The patient volunteered to participate in the study and signed the Informed Consent
* Age ≥18 years old ≤70 Years old, male or female
* Expected survival ≥ 12 weeks
* Intravascular large B-cell lymphoma confirmed by cytology or histology according to WHO2016 criteria
* Never received any anti-tumor therapies.
* Adequate organ function and adequate bone marrow reserve

Exclusion Criteria:

* Malignant tumors other than IVLBCL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery
* Active HIV, HBV, HCV or treponema pallidum infection
* Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
* Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after their cell transfusion
* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment
Evaluation of Innovative Tools in Development of Antibiotics

The investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and macrodose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 55 years
* Good state of health (mentally and physically)
* Body mass index within a range of 18 to 28kg/m2 inclusive.
* Non-Smoker
* A signed and dated written informed consent form.
* The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
* Negative serology (human immunodeficiency virus, hepatitis B-AG and C-AB) at screening.
* Vital signs should be within the following ranges:
* Oral or tympanic temperature between 35 and 37.5°C.
* Systolic blood pressure, 90-140 mmHg.
* Diastolic blood pressure, 50-90 mmHg.
* Pulse rate, 50-90 bpm.

Exclusion Criteria:

* Any acute or chronic illness or clinically relevant (Investigator's judgement) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject.
* All subjects with known seizure disorder, with the exception of a febrile seizure in childhood
* Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication.
* Any intake of grapefruit juice within 1 week prior to the first dose.
* Allergies (except for mild forms of hay fever), a history of hypersensitivity reactions including psychological or neurological symptoms or signs, or anaphylactic shock following administration of any medicine.
* Allergy to or any contraindication against the active or inactive ingredients in the study medication (ciprofloxacin, imipenem, cilastatin, propofol, midazolam, remifentanil, xylocain, and sevoflurane) and radioactive labelling with 14C.
* Smoker
* Alcohol or drug abuse
* Participation in a trial with any drug within 30 days or five half-lives (whichever is longer) before the start of the study.
* Donation of blood within a period of 4 weeks prior to dosing.
* Creatinine clearance ≤70mL/min/1.73m3
* Any other reason that the Investigator considers to make the subject unsuitable to participate.
Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients

Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.

To gather safety information and adverse events on the use of Gardasil® in mild to moderate and minimally active or inactive SLE.

To gather information on SLE disease activity flares after vaccination with Gardasil®.

To gather information on the immunogenicity or development of protective anti HPV antibodies SLE after vaccination with Gardasil®.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of systemic lupus erythematosis (SLE) by the American College of Rheumatology (ACR) Criteria.

History of a positive antinuclear antibody (ANA) test result at any time in the past.

40 participants with history of mild to moderate SLE disease Minimally active or inactive SLE disease, i.e., (Safety of Estrogens in Lupus Erythematosis National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), SELENA-SLEDAI ≤2 at the start of the study.

Age ≥ 18 years and ≤ 50 years. Gender: females Ability to provide informed consent. Maintenance Prednisone dose ≤ 15 mg/day. Plaquenil ≤ 400 mg/day.

Exclusion Criteria:

Hypersensitivity to any vaccine component Active infections including but not limited to human immunodeficiency virus (HIV positive), Hepatitis B or C, tuberculosis.

Positive purified protein derivative (PPD) test results without evidence of prior treatment or administration of bacilli Calmette-Guerin (BCG) vaccine. A positive PPD is defined as ≥ 5 mm induration 24-38 hours after receiving 5TU (TU=tuberculin units) of PPD.

Pregnancy or desire to become pregnant during the study period. Breast feeding. Inability to complete the immunization series. Received any blood product or component in the previous 6 months before enrollment.

Received any inactivated vaccine product within 14 days before enrollment. Received any live vaccine product within 21 days before enrollment.

Fever (temperature \> 100°F) at the time of enrollment. Inability to provided informed consent.
Inhaled and Intravenous Milrinone in Patients With Severe Pulmonary Hypertension

The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Milrinone is widely used in cardiac surgery as an inotrope and pulmonary vasodilator agent But , intravenous milrinone has been associated with systemic hypotension and increased requirement for vasoactive drugs

The investigator compared difference between inhaled and intravenous milirinone in patiens with severe pulmonary hypertension undergoing cardiac surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo mitral valve surgery by cardiopulmonary bypass with estimated mean pulmonary artery pressure =\>55 estimated by using preoperative Doppler echocardiography

Exclusion Criteria:

Patients were excluded if they had surgery without CPB, preoperative hemodynamic instability (deﬁned as acute requirement for vasoactive support or mechanical device),Patients with severe LV dysfunction (LV ejection fraction of less than 30% congenital heart disease, a contraindication to transesophageal echocardiography (TEE), emergency surgery or re-do surgeries severe renal or hepatic disease

, coagulopathy, and thromboembolic disease treated with anticoagulants
Treatment of Gambling Disorder With Fast Acting Opiate Antagonist, Naloxone Nasal Spray

Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. Brief intervention.

Non-controlled pilot study. Two groups: Group A: naloxone nasal spray max 8 mg/per day; Group B: naloxone max 16 mg/per day. Study duration 8 weeks. No supportive therapy, but brief self-help booklet. Primary outcomes: adverse events, adherence and drop out analysis. Secondary outcome: gambling expenditure.

Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old
* South Oaks Gambling Scale (SOGS) 5 or over points
* possibility to keep a record with phone and send text messages
* fluent in Finnish Language

Exclusion Criteria:

* active drug use (specially opioids) current use - drugs screen
* nasal abnormality or mucosal irritability
* hepatitis c virus, kidney insufficiency
* psychosis, unstable mental health, risk suicide (Beck Depression Inventory)
* pregnancy and/or breast feeding
* persons according to Finnish Medical Law 188/1999 §7-10
Late Phase 2 Study of OPC-12759 Ophthalmic Suspension

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients


Eligibility Criteria:
Inclusion Criteria:

1. Outpatient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant, possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months