cyrilzakka/clinical-trials huggingface dataset:
A Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals

The purpose of this study is to determine whether Lactospore is safe in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* If female, subject is not of child bearing potential or female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
* Healthy as determined by laboratory results and medical history
* Normal BMI 18.5 - 29.9 kg/m2
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
* Subject has any clinically significant medical conditions
* Subject requires the use of prescribed medications (other than birth control)
* Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
* Participation in a clinical research trial within 30 days prior to randomization
* Clinically significant abnormal laboratory results at screening
* Allergy or sensitivity to test product ingredients
* Individuals who are cognitively impaired and/or who are unable to give informed consent
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Reducing Decannulation Time: Limitation of Decannulation Capping Trials (REDECAP)

Multicenter randomized trial centered on critically-ill tracheostomized patients, comparing two different decannulation protocols:

1. based on capping trials to decide decannulation,
2. based on the aspiration frequency to decide decannulation time. High-flow conditioned oxygen therapy will be applied to all patients through the tracheal cannula. In patients included in the suctioning frequency based protocol along the study period and in patients included in the capping trial protocol along periods out of capping trials.


Eligibility Criteria:
Inclusion Criteria:

* Critically-ill tracheostomized patients weaned from mechanical ventilation (24 consecutive hours disconnected).

Exclusion Criteria:

* Patients consedered non-decannulable at time of randomization:

  1. unconscious patient (motor component of GCS score \<6 points).
  2. Severe swallowing function (based on drink test).
  3. Airway patency problem (based of intolerance of occlusion test).
  4. Neuromuscular diseases.
  5. Patients with a Sabadell score \>2.
Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention

The purpose of this study is to evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 80 years
* Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks
* Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy
* mild gastrointestinal symptom
* Creatinen in blood ≤ 3mg/dl
* BUN ≤ 50mg/dl
* Birilubin ≤ 3mg/dl
* AST and ALT ≤ 80U/L

Exclusion Criteria:

* Pregnant or breast feeding
* History of Stomach or esophagus surgery
* Peptic ulcer or reflux esophagitis
* Zollinger-Ellison syndrome or primary esophageal motility disorders
* Malignant tumor
* Bleeding tendency or coagulopathy
* Contraindication of ALBIS
* Long term use of aspirin or P2Y12 receptor antagonist within 1month
* Patients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed)
* Terminal patient
Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
* Current or former cigarette smokers

Exclusion Criteria:

* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
* History or presence of asthma verified from medical records
* Chronic use of oxygen therapy greater than or equal to 15 hours per day
* Patient with uncontrolled infection due to HIV and/or active hepatitis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics
* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)

The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥18 years old;
2. Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);
3. The tumour harbours one of the most common EGFR mutations (19del or L858R);
4. The programmed death-ligand 1 (PD-L1) tumoral expression is positive;
5. No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
6. According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline;
7. ECOG performance status score 0-2；
8. Subjects have voluntarily participated, signed and dated informed consent.

Exclusion Criteria:

1. Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;
2. Subjects have no measurable tumor lesion at baseline;
3. Subjects with spinal cord compression or symptomatic brain metastases;
4. Subjects are suitable for surgery;
5. Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;
6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)\>2.5 × ULN, or serum total bilirubin (TBIL)\>1.5 × ULN, or Cr\>1.0×ULN;
7. Absolute value of neutrophil (ANC)\<1.5 × 109/L, or platelet (PLT) count\<75 × 109/L, or hemoglobin (HGB)\<90 g/L;
8. Any of the following disease within 12 months: myocardial infarction, severe/unstable stenocardia, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident;
9. Women who are pregnancy or lactation, or fertile but not using contraception;
10. Suffering from other serious acute or chronic physical or mental problems;
11. Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
An Observational Cohort Study in Patients With Chronic Hepatitis B Receiving Pegasys

This observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis B receiving standard of care Pegasys therapy. Efficacy and safety parameters will also be evaluated. Patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.


Eligibility Criteria:
Inclusion Criteria:

* adult patient, \>/= 18 years of age
* chronic hepatitis B
* treatment with peginterferon alfa-2A

Exclusion Criteria:

* coinfection with HAV, HCV and HIV
Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers

A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.

A Clinical and Biological Database is a collection of reliable, prospective and representative datas.

This collection, provided to the scientific community, will help to develope research programs such as :

* Cinicals and biological predictive factors of treatments response
* Identification of biological tumoral markers associate with survival
* Identification of prognosic factors after recidivism
* Diagnostics tests optimisation and follow-up from blood samples ( Circulating Tumor Cells (CTC) )
* Developing strong preclinical models. Those models would be later used to test alternative treatments and would help to identify new biomarkers

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer
* Patient eligible for, at least, one surgery and a chemotherapy
* Patient having given his informed, written and express consent

Exclusion Criteria:

* Patient not affiliated to a social protection scheme
* Pregnant and / or nursing women
* Subject under tutelage, curatorship or safeguard of justice
* Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons
PTHrP and Osteoporosis

PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name implies, it is closely related to another hormone discovered in the 1920's named parathyroid hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both animals and humans. PTHrP has been shown to be effective in treating osteoporosis in laboratory animals, and there are strong scientific reasons to think that it may be effective in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have been performed. The studies in this trial are focussed on determining whether PTHrP can indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily by subcutaneous injection for three months.


Eligibility Criteria:
Inclusion Criteria:

* Healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or DXA.
* ON estrogen replacement treatment for at least three years.

Exclusion Criteria:

* Heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are exclusion criteria.
* High blood pressure
* Pregnancy
* Cancer
* Alcohol or drug dependence
* Prior use of a drug treatment for osteoporosis such as PTH, bisphosphonates, raloxifene, or calcitonin within the preceding five years
Interventions to Improve Asthma Management/Prevention at School

To design, develop, implement, and test the effectiveness of a three component health services and health education intervention for primarily Hispanic inner-city elementary school students at high risk for asthma morbidity and mortality.

BACKGROUND:

The study was part of an initiative "Interventions to Improve Asthma Management and Prevention at School". The Broad Agency Announcement was released in June, 1994.

DESIGN NARRATIVE:

The study used a randomized intervention trial to test the effectiveness of a comprehensive school-based asthma program to increase linkages with primary care physicians, to increase self-management activities, and to reduce morbidity associated with asthma. The study used a nested design in which the schools were the unit of design, allocation, and analysis. Effects were measured from aggregate data about students and data from school measures to control asthma. There were three components to the intervention. First, case finding for asthma through screening in both intervention and control schools. Second, a linkage management system that connected the child with a source of primary care and enhanced communication among the school nurse, the primary care physician, and parents. Third, the development and implementation of interactive multimedia and decision support system techniques to tailor individualized learning opportunities for children with asthma. The interventions occurred in the school setting and included tailored feedback for children, teachers, nurses, primary care providers, and the family. Assessments were made of the potential for diffusion of the components to target audiences.

Eligibility Criteria:
Inclusion:

School-aged children enrolled at participating schools
PET/CT Imaging of uPAR-expression in Patients With Neuroendocrine Tumors Using 68Ga-NOTA-AE105

The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of uPAR PET/CT with the radioligand 68Ga-NOTA-AE105 in patients with neuroendocrine tumors (NETs).

68Ga-NOTA-AE105 is a radioligand targeting urokinase plasminogen activator receptor (uPAR), which is a promising imaging biomarker of tumor aggressiveness. A total of 120 NET patients will be subjected to a uPAR-PET/CT scan. Follow-up will be performed (from the time of the angiogenesis PET/ CT) at 6 months for disease specific survival (DSS) and a 1 year follow-up for PFS and OS. The uptake of 68Ga-NOTA-AE105 in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with gastro-entero-pancreatic Neuroendocrine Tumors (GEP-NET; grade: G1-G3) or broncho-pulmonary NET.
* WHO performance status 0-2
* Must be able to read and understand the patient information in Danish and to give informed consent

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Weight more than the maximum weight limit for the PET/CT bed of the scanner (140 kg)
* History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2
* In case of broncho-pulmonary NET, the subtype must not be small cell lung cancer (SCLC)
Effectiveness And Safety Of Dalteparin In Patients With Acute Coronary Syndromes Without ST Elevations In Clinical Practice

To collect data on safety and effectiveness of dalteparin in the management of non-ST segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention \[PCI\] or coronary artery bypass graft \[CABG\] within 48 hours).

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Eligibility Criteria:
Inclusion Criteria:

* Male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of Fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without PCI or CABG within 48 hours) during the index hospitalization.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients who are contraindicated to receive this agent per the local approved prescribing information.
Effect of BIIL 284 BS on the Pharmacokinetics of Theophylline in Healthy Male Volunteers

To evaluate the effect of multiple doses of BIIL 284 BS on the pharmacokinetics of a single dose of theophylline.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent signed and dated prior to participation into the study (including medication washout)
* All volunteers in the study should be healthy males, aged 18-50 years (inclusive) and willing to use condoms until 60 days after the last dose
* All volunteers should be within +- 20% of their ideal body weight (Metropolitan Scale, 1983)
* Non-smokers (volunteers who have never smoked) or ex-smokers for at least one year with a smoking history, no greater than five pack-years (1 pack year = 20 cigarettes per day for one year)
* Ability to comply with the concomitant therapy restrictions
* Volunteers will be off all prescription drugs. O.T.C. drugs must be discontinued for at least two weeks prior to the first dose of study drug. If throughout the study, volunteers need any O.T.C. medication, the investigator will call the clinical monitor and this will be reviewed on a case-by-case bases. Restrictions for different medications apply
* Volunteers will have no evidence of a clinically relevant concomitant disease based upon complete medical history, physician global assessment, complete physical examination, ECG, and clinical laboratory tests

Exclusion Criteria:

* Viral respiratory tract infection, respiratory tract infection within the six weeks preceding the first day of dosing with study medication
* Small of difficult to locate arm or hand veins that would impair the clinician's ability to draw blood samples or to place a venous catheter
* Volunteers with a known drug or alcohol dependence (presence of dependency for 10 years) or who drink more than 60 g of alcohol per day
* History of significant allergic reactions to drugs or sensitivity to aspirin or positive drug screen
* Use of an investigational new drug in the preceding 3 months or six half-lives (whichever is greater) prior to the first screen at Visit 1
* Donation of blood during the preceding 3 months of Visit 1
* Volunteers receiving hyposensitization therapy whom are not on a stable dose for the last three months before Visit 1
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
* Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
* Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
* Volunteers with chronic or relevant acute infections
* Volunteers with history of allergy/hypersensitivity (including drug allergy) with is deemed relevant to the trial as judged by the investigator
* Volunteers with eosinophilia \> 7%
* Volunteers who received any other drugs which might influence the results of the trial during the week previous to the start of the study
* Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes

Partial Nephrectomy is the standard care for small (\<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods


Eligibility Criteria:
Inclusion Criteria:

* patients referred to partial nephrectomy

Exclusion Criteria:

* Contra-indication for laparocopic surgery
* Complexed , large tumors, single kidney, chronic renal failure
Engineering Evaluation of a Breast Pump Device

This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes.

This engineering evaluation involves the voluntary participation of healthy adult lactating women for feasibility testing of breast shield designs. Participants will be asked to rate the breast shield design for fit, comfort, and the ease of use. In addition, participants will be asked to rate a comparison of the device relative to their experiences with their current commercial breast pump and breastfeeding their baby.

Eligibility Criteria:
Inclusion Criteria:

* History of good health
* Currently lactating and planning to continue breastfeeding for the next 3 to 4 months
* Currently using a commercial electric breast pump at least several times a week
* Sufficient milk supply for one missed infant feeding per device testing visit
* Willing to attend five device testing visits over 3 to 4 months
* Willing to be video recorded during device testing
* Willing to discard milk collected during testing

Exclusion Criteria:

* No active breast or nipple injury, breast inflammation or infection, or nipple piercing
* No prior history of breast implant, reduction or reconstruction surgery
* Not currently pregnant
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)

For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized, single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at two sites, one site per study part. The primary objective of Part 1 was to assess the bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch A"). The primary objective of Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch B").


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy postmenopausal females between the ages of 45 and 70 years, inclusive, having a Body Mass Index (BMI) between 18 and 32, inclusive;
* Free of any clinically significant disease that would interfere with the study evaluations.

Key Exclusion Criteria:

* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug;
* History of any infectious disease that affected the subject's ability to participate in the trial;
* History of alcohol or drug abuse in the past 2 years;
* Previously received NOMAC-E2;
* Current participation in another clinical study or had participated in a clinical study (eg, laboratory or clinical evaluation) within 30 days of baseline;
* Smoked more than 10 cigarettes or equivalent tobacco use per day;
* History of malignancy;
* Contraindications for the use of contraceptive steroids;
* Recent history of medication use of certain medications specified in the protocol.
Role of Respiratory Rate Derived From Capnography in Sedated Patients

Although appropriate sedation is recommended during colonoscopy, patients are at risk for adverse events e.g hypoventilation and hypoxemia due to inadvertent oversedation. The aim of this study was to evaluate the benefit of additional quantitative capnography monitoring ( respiratory rate )in management of patient undergoing colonoscopy under sedation in preventing or reducing the incidence of adverse events and also determine when to start the procedure and when to give and not to give increments of sedative drugs during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and 2 adult patients
* Age from 20 to 50 years old
* elective colonoscopy

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) above Class II
* History of psychiatric or neurological disease