cyrilzakka/clinical-trials huggingface dataset:
The Effect of Desloratadine and Levocetirizine on Nasal Obstruction (Study P03609)

This was a study to measure the ability of desloratadine and levocetirizine to decrease nasal obstruction in subjects who had study-induced allergic rhinitis. Study participants had allergic rhinitis symptoms induced in a Vienna Challenge Chamber and then received desloratadine or levocetirizine for 8 days. After at least a 10 to 35-day washout period (time when no drug is given), subjects received the opposite treatment for 8 days. Subjects had their total nasal symptom measured.on the 8th day of each treatment period.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age
* Were free of any clinically significant disease that would interfere with study evaluations.
* Demonstrated hypersensitivity to the grass allergen used in the chamber unless confirmed previously within 12 months.
* Hypersensitivity to the allergen was documented by a positive response to the skin prick test with a wheal diameter at least 3 mm larger than the diluent control and by a radioallergosorbent test (RAST) class of \>=2 (rating scale 0 -6).
* Had a history of SAR for at least 2 years, as diagnosed by the investigator, another physician, or subject-provided history.
* Reported having shown therapeutic efficacy with previous use of an antihistamine (without a decongestant).
* At the screening allergen provocation, the subject had a nasal obstruction symptom severity score of at least moderate (\>=2) and a decrease from baseline in nasal airflow (mL/sec) measured by rhinomanometry of \>=30% within 2 hours of allergen exposure. Also, the subject had a nasal obstruction symptom severity score of none or mild (\<=1) prior to exposure to allergen.

Exclusion Criteria:

* Women who were pregnant or nursing.
* Had a body mass index (BMI) \>=30 kg/m\^2.
* Had asthma; were being treated with inhaled or oral corticosteroids, chromones, theophylline, leukotriene inhibitors, or short-acting inhaled β2-agonists (except during or immediately after the allergen exposures); and could not go through the washout periods and the entire study without needing these medications.
* Developed wheezing or dyspnea during the screening allergen exposure.
* Had a respiratory infection during the 4 weeks prior to pre-dose evaluations.
* Had any clinically significant deviation from normal in the physical examination that, in the investigator's judgment, could interfere with the study evaluation or affect subject safety.
* Had any history of or laboratory evidence of hepatic failure or renal failure with a glomerular filtration rate (GFR) known to be \<30 mL/min.
* Had a known potential for hypersensitivity, allergic, or idiosyncratic reaction to the study drug or excipients.
* Had nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interfered with nasal airflow.
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients

It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.

Allergic reactions to sesame can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.

This pilot study is a randomized controlled trial evaluating the efficacy and safety of oral immunotherapy (OIT) with a low-dose sesame protein in pediatric patients with sesame allergy. The study aims to compare participants undergoing OIT with a maintenance dose of 300mg sesame protein against a control group in a 2:1 randomized allocation. The control group will be recommended a standard treatment, which is a restrictive elimination diet and the use of emergency treatment, including adrenaline, in case of accidental exposure to sesame.

39 participants aged 3-17 with confirmed IgE-mediated sesame allergy will be enrolled into the study. Interventions will be administered once daily for up to 18 months, and the control group will stay under observation for one year.

Primary outcomes include the proportion of participants tolerating a single dose of 4000mg sesame protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of sesame protein in each group.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3 and 17 years,
* IgE-mediated sesame allergy confirmed with positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35-kilo units of Allergen per liter (kUA/l),
* Allergic reaction to sesame protein during oral food challenge (OFC),
* Signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
* Patient's and caregivers' cooperation with the researcher.

Exclusion Criteria:

* No confirmed sesame allergy,
* Negative OFC with sesame protein (maximum dose 4000mg),
* Severe asthma, uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
* Current oral/sublingual/subcutaneous immunotherapy with other allergens in the first year of immunotherapy,
* Eosinophilic gastroenteritis,
* A history of severe recurrent anaphylaxis episodes,
* Chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
* Medication:

  * oral, daily steroid therapy longer than 1 month within the last 12 months,
  * at least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
  * oral steroid therapy longer than 7 days within the last 3 months,
  * any biological treatment,
  * therapy with β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors,
* Pregnancy,
* No consent to participate in the study,
* Lack of patient or caregiver cooperation.
Safety and Efficacy of RAD001 + TACE in Localized Unresectable HCC

This study will evaluate the role of everolimus in combination with local Transcatheter Arterial Chemoembolization (TACE) procedure in patients with localized unresectable Hepatocellular Carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed hepatocellular carcinoma limited to liver and not suitable for resection, liver transplant, or radiofrequency ablation.
* Intermediate stage (stage B) (according to recognized guidelines) and suitable for TACE therapy
* At least one nodule between \> 2cm and ≤ 15cm in diameter with no vascular invasion or abdominal lymph node or distant metastases.
* Must have 1 tumor which can be measured in 1 dimension according to specified criteria (RECIST and mRECIST) and has not previously been treated with any type of therapy.
* ECOG performance status \< 2cm
* Cirrhotic status of Child-Pugh class A or early B
* HBV-DNA or HBsAg positive at screen or baseline: preventative treatment with anti-viral started 1-2 weeks prior to receiving study drug

Exclusion Criteria:

* Any local and/or investigational drugs within 28 days prior to randomization
* Active bleeding during the last 28 days prior to screening including variceal bleeding
* Prior therapy with mTOR inhibitors
* Tumor burden of \> 60% liver involvement
* Prior systemic or local therapy including TACE except for the first TACE at Day 0), surgery or liver transplantation
* Failed first TACE at Day 0, Cycle 1 for any reason
* Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
* Alcohol intake of 80 grams per day
* Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from surgery
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods

Other protocol-defined inclusion/exclusion criteria may apply
Sumor as Adjuvant Therapy in Treatment-resistant Major Depression

Sumor is a food supplement that combines the main coenzymes of the S-Adenosyl methionine (SAMe) cycle, namely vitamins B6, B12 and folate, with SAMe and betaine. Sumor also contains vitamin C, a molecule that has shown promise in the treatment of depression in experimental models, and selenium, an antioxidant agent whose blood deficiency has been associated with depressive symptoms in some preliminary studies. There are no studies in the literature on the efficacy of this combination in the adjuvant therapy of depression. The purpose of this study is to compare the effects of Sumor in co-therapy with an SSRI antidepressant versus co-therapy with placebo in patients with treatment-resistant Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder according to DSM-5 criteria
* Treatment-resistant status, assessed by clinical interview, after four weeks after SSRI therapy prescription as per NICE guidelines (National Institute for Health and Care Excellence, 2009)
* Age between 18 and 65 years
* Signature of informed consent

Exclusion Criteria:

* Presence of intellectual disability or illiteracy
* Diagnosis of a disorder belonging to the spectrum of schizophrenia or other psychotic disorders according to DSM-5
* Diagnosis of a disorder belonging to the bipolar spectrum according to DSM-5
* Concomitant intake of therapy with other antidepressants, antipsychotics or mood stabilizers at the time of evaluation or in the previous 4 weeks
* State of pregnancy
Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management

This study proposed an integrated multi-disciplinary approach including a professional and convenient body composition measurement and an immediate counselling after the measurement, followed by 6-month smart-phone based individualized counselling. We believe that this approach will promote healthy eating behaviors and weight management among middle-aged Chinese in Hong Kong.

This is a two-arm, individual level, 6-month randomized controlled trial. The intervention group will receive convenient body composition measurement and 6-month smart-phone based individualized counselling. No specific intervention will be given to the control group except the common anthropometric and body composition measurement. A pretest-posttest evaluation and between-group comparison will be used to test whether the impact/success of the project has been achieved.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand Cantonese and read Chinese;
* Self-reported vegetable and fruit consumption is less than 5 servings per day (one serving means 125 mL (½ cup) fresh, frozen or canned fruits or vegetables; or 250 mL (1 cup) raw leafy veggies or salad; or 125 mL (½ cup) 100% juice; or 1 fruit;
* Reachable by smart-phone and familiar with the use of smart-phone;
* Would not move from the local area during the study period.

Exclusion Criteria:

* Self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, osteoarthritis, and eating disorder;
* Receiving medically prescribed diet or physical activity intervention;
* For women, currently pregnant;
* Have been taking any medications or long-term supplement such as herbs;
* Cannot provide written informed consent.
A Study of Safety, Tolerability and Pharmacokinetics of Nivolumab in Chinese Subjects With Previously Treated Advanced or Recurrent Solid Tumors

The purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Chinese subjects with advanced or recurrent solid tumors

Exclusion Criteria:

* Subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator
* Subjects with carcinomatous meningitis are excluded
Diagnostic Stewardship for Ventilator Associated Pneumonia

The goal of this pragmatic cluster-randomized crossover trial is to test if less unnecessary antibiotics are prescribed when the lab reports respiratory culture test results in a specific way for patients who have respiratory cultures obtained, but do not meet clinical criteria for ventilator associated pneumonia (VAP). The main question it aims to answer is: Does a modified culture reporting intervention reduce unnecessary antibiotics for ventilated patients in the intensive care unit (ICU)? Researchers will compare antibiotic use outcomes between eligible patients whose test results are communicated using the modified reporting and those with standard reporting of results.

The specific aims of this project are:

Specific Aim 1: In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers, evaluate the impact of a VAP diagnostic stewardship intervention on antibiotic use, VAP diagnoses, and adverse events.

Hypothesis: A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs. control periods across all sites, without a change in adverse events, is expected.

Specific Aim 2: Evaluate overall impact of intervention including clinical and antibiotic outcomes using the "Desirability of Outcome Ranking (DOOR)/ Response Adjusted for Duration of Antibiotic Risk (RADAR)" methodology.

Hypothesis: A change in overall patient outcomes (better DOOR ranking, accounting for duration of antibiotic use) in the intervention vs. control period is expected.

Eligibility Criteria:
Inclusion Criteria:

* Patient located on ICU unit included in the study
* Patient is mechanically ventilated
* Patient had respiratory culture sent \>48 hours after admission
* Patient age ≥ 18 years

Exclusion Criteria:

* Extra corporeal membrane oxygenation (ECMO) at time of respiratory culture
* Heart or lung transplant
* Culture rejected by lab per standard lab protocol
* Prisoners
* Severe immunosuppression as defined by:
* \<6 months from solid organ transplant (SOT) OR \<6 months from treatment for acute rejection following SOT
* Active treatment for lymphoreticular malignancies
* Neutropenic \< 1000
* Receiving lymphodepleting chemotherapy
* Allogeneic stem cell transplants \<6 months
* Autologous stem cell transplants or chimeric antigen receptor T-cell (CAR-T) therapy \<6 months out
* Allogeneic stem cell transplant with graft vs host disease (GVHD) or receiving 2 or more immunosuppressants
* Advanced or untreated human immunodeficiency virus (HIV) infection with CD4 \< 200
* Receiving biologics within 6 months
Maintaining Nonsmoking

The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.

This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols

1. Monthly Brief Contact or
2. Extended Non-Specific Behavioral Treatment or
3. Extended Relapse Prevention Treatment or
4. Extended Relapse Prevention Treatment + availability of varenicline treatment.

Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.

All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Must be smoking 5 or more cigarettes per day

Exclusion Criteria:

* Previous history of bipolar/manic-depressive disorder
* Current diagnosis of schizophrenia
* Acute life threatening diseases
* Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol
* Pregnancy or lactation
* Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
Response Evolution Chart

This study evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227


Eligibility Criteria:
Inclusion Criteria:

* Voluntary assistance
* Clinical diagnosis of overweight
* Clinical diagnosis of obesity
* Patient desire to improve their aesthetic image and health status

Exclusion Criteria:

* This study does not consider patients who tried a diet to lose weight in the previous month or earlier
FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer

The aim of this trial is to investigate the value of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients.

The MIBC diagnostic study was a prospective trial. According to the inclusion and exclusion criteria, patients with suspected MIBC were enrolled and underwent FAPI PET/MRI, FDG PET/MRI and MRI examination, and the imaging data and clinical laboratory and pathologic data were collected, and the postoperative pathological results were used as the gold standard to compare the accuracy of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC.

The MIBC neoadjuvant therapy efficacy assessment study was a prospective trial. Patients with MIBC were enrolled according to the inclusion and exclusion criteria, the regimen was selected individually according to the patient's condition, and the indicators were followed up until the end of time or the occurrence of an endpoint event to obtain information on survival time. FAPI PET/MRI, FDG PET/MRI and MRI were performed once before the start of neoadjuvant therapy and once after the end of therapy, and after the end of neoadjuvant therapy, patients received transurethral cystectomy of bladder tumors or radical cystectomy according to the efficacy and condition, and the combination of the imaging data and the clinical laboratory and pathological data were used to compare FAPI PET/MRI, FDG PET/ MRI and MRI in the assessment of the efficacy of neoadjuvant therapy in MIBC patients to guide clinical treatment options.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for MIBC diagnostic studies

  1. Patients with suspected muscle-invasive bladder cancer;
  2. Completion of FAPI PET/MRI, FDG PET/MRI and MRI;
  3. Complete clinical laboratory and pathological data.
* Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study

  1. Patients diagnosed with muscle invasive bladder cancer;
  2. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy;
  3. Complete clinical laboratory and pathological data.

Exclusion Criteria:

* Exclusion criteria for MIBC diagnostic study

  1. Combined with other malignant tumors;
  2. Not receiving surgical treatment;
  3. Receiving neoadjuvant therapy before surgery;
  4. Previous allergy to contrast components or similar components;
  5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities;
  6. Incomplete clinicopathological data
* Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study

  1. Combination of other malignant tumors;
  2. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy;
  3. Prior hypersensitivity to contrast components or similar components;
  4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function;
  5. Incomplete clinicopathological data.
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)

The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent before any study-related procedures start.
* The patient is previously diagnosed with Generalized Anxiety Disorder.
* The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

Exclusion Criteria:

* Patient has a lifetime history of schizophrenia or other psychotic disorders
* Patient has a history of seizures or seizure disorder.
* Patient is pregnant or breast feeding.
* Patient has received electroconvulsive treatment (ECT) in the past.
ROtational Atherectomy, Lithotripsy or LasER for the Treatment of CAlcified STEnosis

Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.

However there is no direct randomized comparison between these three tools in this scenario.

The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.

Some data exist about the efficacy and safety of rotational atherectomy, intravascular lithotripsy and excimer laser to modify calcified plaques.

However there is no direct randomized comparison between these three tools in this scenario.

The aim of this pilot randomized trial is to compare the safety and efficacy of these three techniques during PCI of moderate to severe calcified lesions.

The primary endpoint will be the percentage of stent expansion measured with optical coherence tomography. Between secondary endpoints we will analyze the strategy success (defined as successful stent delivery and expansion with \<20% residual stenosis and TIMI 3 flow without crossover or stent failure) and presentation of clinical adverse at 1 year follow-up .

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years.
* Stenosis ≥70% in a coronary artery with a diameter ≥2,5 y ≤4 mm.
* Moderate to severe angiographic calcification
* Stable coronary artery disease or NSTEMI.
* Native coronary vessel or bypass graft.

Exclusion Criteria:

* Knwon allergies to aspirin or P2y12 inhibitors.
* STEMI.
* Cardiogenic shock at the time of PCI.
* Treated lesion in a bifurcation with side branch diameter \> 2mm.
* Absence of informed consent.
* Impossibility for 1year follow up.