cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Test How Well Two Drugs, QAW039 and Montelukast Work Both Individually and Together, to Target Allergic Rhinitis Using an Environmental Exposure Chamber

This study will assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two grass pollen allergy seasons.
* A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick test within 12 months prior to Visit 1 is also acceptable.
* FEV1 measured by spirometry must be ≥80% of their predicted value at screening. If the patient does not achieve ≥80% of their predicted value this may be repeated prior to the EEC challenge at visit 2.
* TNSS score ≥6 on at least one assessment during the 2h EEC challenge at Screening.

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
* Pregnant or nursing (lactating) women,
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept

Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.

For the measures of patient's satisfaction with and perceptions of, their device, standard Likert scales are used. This allows the magnitude of individual's perceptions and satisfaction to be measured on a multipoint scale anchored at each end. In addition, the study will describe patient perceptions related to device attributes, which are of importance in describing overall patient perception. A range of potential device benefits (e.g. ease of use, convenience, injection site pain, injection anxiety, injection confidence) will be captured using a questionnaire. The study aims to characterize patient attributes that will indicate when one device may result in greater patient satisfaction than another. Patient attributes are composed of patient characteristics (e.g. age, sex, demographics, social and educational status psychological status, willingness to self-manage, injection experience) and Psoriasis characteristics (e.g. disease severity, disease duration, co morbidities, prior treatment, quality of life). The study will also take the opportunity to measure health outcome measures as there may be important differences in cost of training and patient support between the two devices.

Eligibility Criteria:
Inclusion Criteria:

* Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
* Eligible for treatment with etanercept according to Summary of Product Characteristics (SmPC), and applicable local guidelines.
* Aged 18 years or more
* Willing and able to self-inject etanercept.
* Able to store test drug at 2-8oC.
* Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test at baseline (week 0) for all women of childbearing potential. Sexually active women of childbearing potential must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Sexually active men must agree to use a reliable form of contraception during the study.
* Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed.

Exclusion Criteria:

* Prior experience of biologics and anti-TNF treatment for their Psoriasis including etanercept.
* Sepsis or risk of sepsis.
* Current or recent infections, including chronic or localized.
* Latex sensitivity.
* Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study.
Evaluation of Galcanezumab in the Prevention of Chronic Migraine

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

Main Study:

* Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Israel addendum:

* Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
* Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.

Exclusion Criteria:

* Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
* Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
* Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
* History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Optimum Insufflation Capacity in NMD

Patients with underlying neuromuscular disorder (NMD) often suffer from weakness in the inspiratory and expiratory muscles. Consequently they do not have the strength to generate the minimum flow of 160 to 300 liters/minute for an efficient cough function. The restricted cough function allows secretion to accumulate, which in turn causes narrowing of the airway lumen and makes ventilation of the neuromuscular patient even more difficult. The patient's susceptibility to infection increases again and the vicious circle repeats itself. Severe secretion retention may even lead to ventilator failure. Effective secretion and cough management instead reduces the risk for stay in hospital. Therefore, secretion and cough management is a mandatory part of the therapeutic concept for treating patients with neuromuscular disease.

The therapeutic efficacy of the Lung Insufflation Assist Maneuver(LIA) integrated in the ventilator VENTIlogic LS-plus manufactured by Weinmann GmbH+Co KG was studied in a pilot study carried out by the Dep. for Pediatric Pulmonology and Sleep Medicine at the University Hospital of Essen/Germany in cooperation with Research \& Development at Weinmann GmbH \&Co KG, Germany . The objective of the pilot study was to examine the therapeutic efficacy of LIAM as a cough support function in patients with neuromuscular disease and indications for mechanical ventilation.

We hypothesized that i) a certain insufflation maneuver pressure may be optimal to achieve the highest individual peak cough flow and ii) that this pressure is below the pressure needed to achieve the maximum insufflation capacity. We define the lowest insufflation capacity at which the best individual PCF can be achieved as optimum insufflation capacity (OIC). The study was performed using two different techniques in order to demonstrate that findings are not dependent on maneuver details but are rather based on effects of maneuver pressure. The protocol was limited to techniques which do not require breath stacking: i) insufflation with an Intermittend Positive Pressure (IPPB) device and ii) with the VENTIlogic LS using LIAM.


Eligibility Criteria:
Inclusion Criteria:

* neuromuscular disorder
* respiratory insufficiency
* use of home mechanical ventilation

Exclusion Criteria:

* acute illness
* history of pneumothorax
A Study of People With Type 2 Diabetes Who Have Diseases That Affect the Heart and Blood Vessels. The Study Will Also Look at the Treatment of a Group of These People in Hospitals in Portugal

This study aims to estimate the number of patients with cardiovascular disease and risk factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously, this study also intends to obtain more information about the management of type 2 diabetes mellitus patients with established cardiovascular disease. This study is non-interventional, which means that will not require participant's further related visits or procedures. The study will collect the participant's clinical data from the current visit and, when applicable, within the last 3 years.


Eligibility Criteria:
Inclusion Criteria:

Main study population (Data collection - Prevalence):

* Signed Informed Consent Form (ICF) obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
* Male or female patient, age greater or equal to 18 years at the time of signing ICF
* Patients diagnosed with type 2 diabetes

Subgroup (Data collection - Patient management):

* Patients followed at the hospital setting by the endocrinologist or internal medicine specialist (ambulatory diabetes management) and with available medical records, retrospectively within the last three years
* Patients with type 2 diabetes mellitus and established cardiovascular disease diagnosed at least three years ago

Exclusion Criteria:

* Previous participation in this study. Participation is defined as signed ICF
* Female patient who is pregnant or breast-feeding
* Patients with type 1 diabetes
* Participation in a clinical trial within the last 3 years
Evaluation of the Salivary-free Amino Acids Levels (Glycine , Proline , Lysine , and Alanine ) With Caries Activity

This study will be aimed to investigated the correlation between levels of salivary amino acids (glycine , proline , lysine , alanine ) in the saliva of healthy children with and without active carious lesions and to estimate the predictive capacity of caries susceptibility

80 healthy children (8-10 years old) will be recruited from primary schools of Baghdad city/ Iraq, will be classified according to their level of caries activity (high caries activity, n = 40; negative caries activity, n = 40). Total stimulated and unstimulated saliva will be collected to estimate the caries activity by using the Snyder test, and Amino acid analysis of the saliva will be performed by reversed phase - high performance liquid chromatography (RP-HPLC), respectively.

Eligibility Criteria:
Inclusion Criteria:

* Children aged (8,9,10) years with different caries
* Absence of signs of gingivitis or periodontal disease.

Exclusion Criteria:

* Children out the range of age
* Children with any systemic discases.
* Children with appliances in the mouth.
* Children with appliances in the mouth.
* Children with antibiotic treatment or any other drug over the last two weeks. B
Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study

This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.

Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.

Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.

Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.


Eligibility Criteria:
Inclusion Criteria:

* Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner

Exclusion Criteria:

* Endometriosis grade 3 or higher, untreat hydrosalpinx;
* Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);
* Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
* Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
* Women who received other supplement drugs during ovarian stimulation
Local Measures to Prevent Diabetes in the Værnes Region.

This is a development project involving four different municipalities in Central Norway. The aim is to identify adults with overweight and with an increased risk of developing diabetes mellitus type 2, then to prevent the disease to develop by the means of a behaviour change programme. The programme is group based.


Eligibility Criteria:
Inclusion Criteria:

* Living in Central Norway
* Find Risc score \> 15
* Written, informed consent

Exclusion Criteria:

* Severe mental disorder
* Not being able to function in the group programme
The Treatment Efficacy of Combination Atypical Antipsychotics With Sertraline in Patients With Schizophrenia

A randomized, double-blind trial of the treatment effect of dose-low antipsychotics combined with low-dose sertraline in 1640 schizophrenia patients

OBJECTIVE: This study aimed to evaluate the treatment effect of combination low-dose antipsychotics with low-dose sertraline in 1640 schizophrenia patients

METHODS:

1. atypical antipsychotics and dose: including four atypical antipsychotics to form eight treatment groups: 1) olanzapine (7.5-10mg/day) combined with sertraline (50-100mg/day) group 2) only olanzapine (12.5-20mg/day) group 3) risperidone (2-3.5mg/day) combined with sertraline (50-100mg/day) group 4) only risperidone (4-6mg/day) group 5) paliperidone (3-4.5mg/day) combined with sertraline (50-100mg/day) group 6) only paliperidone (6-9mg/day) group 7) ziprasidone (60-100mg/day) combined with sertraline (50-100mg/day) group 8) only ziprasidone (120-160mg/day) group
2. blood biochemical examination: including blood routine examination, liver function, renal function, thyroid function, glucose and lipid level, prolactin, and related hormones and proteins
3. electrophysiological examination: including electrocardiograph, electroencephalography (EEG), and brain evoked potential
4. scale assessment: each patient was assessed by four clinical psychiatrists using the following scales: 1) psychopathology: positive and negative symptoms scale (PANSS) and clinical global impression scale (CGI-S) 2) emotional symptoms: Hamilton depression rating scale (HAMD) and Hamilton anxiety rating scale (HAMA) 3) social function: personal and social performance scale (PSP) 4) side-effect: treatment emergent side-effect scale (TESS) and rating sale for extrapyramidal side-effect (RESES)
5. blood drug concentration assay: including the drug concentration of olanzapine, risperidone, paliperidone, ziprasidone and sertraline, respectively
6. Weigh gain measurement: to measure height, weight for each patient

The above measurement data were collected at baseline, week4, week8, week 12 and week24.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia by two senior psychiatrists
* Between 18 and 60 years and Han Chinese

Exclusion Criteria:

* A Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV Axis I diagnosis other than schizophrenia
* Documented disease of physical diseases including, but not limited to seizure, epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease, Huntington's disease, multiple sclerosis
* Acute, unstable and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
Transcrestal Maxillary Sinus Floor Elevation With Injectable Bone Substitute

To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Patients needing unilateral sinus floor elevation (residual crestal height \<5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.

Purpose: To investigate clinical outcomes of transcrestal maxillary sinus floor elevation performed with an injectable xenograft in gel form, analyzing variables possibly influencing the results. Methods: Patients needing unilateral sinus floor elevation (residual crestal height \<5 mm) for the placement of a single implant were enrolled. Xenograft in gel form was injected through a crestal antrostomy in order to elevate sinus membrane and fill the sub-antral space. Simultaneous implant placement was performed when adequate primary stability was achievable. Graft height was measured immediately after surgery (T0) and after six months of healing (T1). Univariate and multivariate regression models were built to assess associations between clinical variables with implant survival and graft height at T1.

Eligibility Criteria:
Inclusion Criteria:

* residual bone crest height \<5 mm and width ≥6 mm in the planned implant site;
* healed bone crest (at least 6 months elapsed from tooth loss/extraction);
* age \>18 years;
* written informed consent given

Exclusion Criteria:

absolute medical contraindications to implant surgery;

* uncontrolled diabetes (HBA1c \> 7.5%);
* treated or under treatment with antiresorptives;
* irradiated in the head and neck area in the last five years;
* pregnant or breastfeeding;
* substance abusers;
* psychiatric problems or unrealistic expectations;
* patient not fully able to comply with the study protocol.
* large sinus cavity (distance \>12 mm between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest);
* maxillary sinus conditions contraindicating sinus floor elevation;
* poor oral hygiene and motivation (Full Mouth Plaque Score \>20% and or Full Mouth Bleeding Score \>10%)
Impact of Decision Aids on Breast Cancer Surgery Choice: A Randomized Controlled Trial

Both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar survival rates in breast cancer. These two treatment strategies have diverted cosmetic outcome and convenience. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. We have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on cancer patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and postsurgical depression. We expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after thier treatment sessions.

Background:

For women with early-stage breast cancer, both simple mastectomy and breast conservation therapy (BCT) with radiotherapy yield similar survival rates, making psychological adjustment and quality-of-life issues pivotal in treatment choice. Using decision aids (DAs) is one way to provide information to patients and to involve them in making decisions about their treatment. We have developed a DAs to be administered after consultation for Taiwanese women deciding on breast surgery, and plan to conduct a randomized controlled trial (RCT) to evaluate the benefit of DAs on breast surgery decision making.

Patients and Methods:

Decision aids are interventions designed to help patients with early breast cancer to make deliberate choices among treatment options by providing information on those options and any potential outcome relevant to different breast cancer surgeries. Women considering breast cancer surgery are randomly assigned to receive a DAs or the standard oral conversation (control condition) after initial consultation, wherein surgeons disclosed the diagnosis and discussed treatment options with patients. Participants complete interview-based questionnaires 1 day before and 4 weeks after surgery. Primary outcome measures 1 day before surgery are decisional conflict and decision-making difficulties after consultation. Secondary outcomes are decision regret and postsurgical depression 1 month after surgery.

Hypothesis:

The DAs group are predicted to lower decisional conflict scores before surgery, and lower decision regret scores and depression scores 1 month after surgery compared with women in the control arm. Our study hopes to support the efficacy of DAs in helping breast cancer women to arrive at their breast surgery decision.

Eligibility Criteria:
Inclusion Criteria:

* Taiwanese women newly diagnosed with stage 0 to 3 breast cancer (including patients with ductal carcinoma in situ), who were suitable for breast surgery
* Patients who were able to give consent and complete the interview

Exclusion Criteria:

* Patients were diagnosed with nonmalignant breast disease
* Patients were offered neoadjuvant chemotherapy
* Patients had cognitive impairment
* Patients were physically unfit to be interviewed
* Patients were non-Mandarin or -Taiwanese