cyrilzakka/clinical-trials huggingface dataset:
Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome

Coronary heart disease is still the major cause of death in China. Chinese medicine plays more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its major pathological basis. Based on that, the investigator aims to evaluate the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method so as to guide the clinical treatment of CHD.

Coronary heart disease (CHD) is a major cause of myocardial infarct (MI) and death induced by atherosclerosis or coronary artery spasm. Despite improvements in interventional and pharmacological therapy for acute MI, the mortality early after AMI remains high. Nowadays, as our life quality develops and dietary structure changes, the morbidity of hyperlipidemia dramatically increased. Based on the Chinese medicine, hyperlipidemia belongs to phlegm and it's the basis of atherosclerosis, blood-stasis is the pathological basis of ischemia. Therefore, the investigator proposes that phlegm and blood-stasis syndrome is the main differentiation on CHD. Based on that, the investigator prospectively and retrospectively explores the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method.It will provide evidence and guidance to the future clinical treatment using Chinese medicine.

Eligibility Criteria:
Inclusion Criteria:

* Healthy or metabolism syndrome people
* Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure

Exclusion Criteria:

* Any inflammation, fever, trauma, burn or operation within 1 week
* Obstructive pulmonary disease
* Cerebral vascular disease
* Severe renal or hepatic dysfunction
* Malignant neoplasms
* Hematopoietic system disease
* Sever mental disease
Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens

The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of birch pollen allergens in the treatment of birch allergic patients in a representative number of patients.

Type I allergy is an immune-disorder which stems from the formation of IgE antibodies against proteins and glycoproteins from plants, insects, animals and fungi, most of which for healthy subjects are considered to be harmless. However, in allergic patients the cross-linking of specific IgE-antibodies on effector cells by allergens activates an immunological cascade leading to the symptoms of Type I allergy including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Pollens from wind-pollinated plants including trees, grasses and weeds, are amongst the most frequent and potent elicitors of Type I allergy. It is not possible to avoid exposure to these pollens and therefore the symptoms that patients inevitably suffer must be treated with either symptomatic medication or allergen specific immunotherapy.

The Betulaceae family includes the genera Alnus (alder), Betula (birch) and Corylus (hazel). Trees belonging to these genera are widespread in middle and northern Europe and, in combination with the fact that they shed large quantities of wind-borne pollen, leads to their allergenic significance. The prevalence of sensitisation to birch pollen has been studied, and in the case of a middle European (Viennese) population, for example, it has been demonstrated that approximately 40 % of patients with allergic rhinitis are sensitised. Although the pollen season for any one genera seldom lasts for more than a few weeks, the well-documented cross-reactivity between the different Betulaceae and other tree pollens of the Fagales order contributes to a protracted season of symptoms for many allergic patients.

Allergoids are prepared by chemical modification of partially purified native aqueous aller-gen extracts. Native allergen extracts are depleted of components with a molecular mass of less than 5000 Dalton by diafiltration prior to chemical modification with aldehydes. The modification causes a substantial reduction in the allergenicity of the extract as can be judged by skin prick testing, provocation testing, histamine release from sensitised leukocytes and measurement of IgE-binding activity by RAST-inhibition. However, immunogenic activity and T-cell reactivity are retained. These properties enable allergoids to be used as a basis for allergen specific immunotherapy with a reduced risk of inducing IgE-mediated side-reactions and the possibility of administering larger doses of immunogen over a shorter time course than with native allergens.

Eligibility Criteria:
Inclusion Criteria:

* Rhinitis
* Rhinoconjunctivitis
* Positive skin prick test to birch pollen
* Positive radioallergosorbent test (RAST) to birch pollen
* Positive provocation test result to birch pollen

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
Efficacy of Transference-Focused Psychotherapy for Borderline Personality Disorder

The purpose of this study is to find out whether Transference-Focused Psychotherapy (TFP) is effective in the treatment of Borderline Personality Disorder.

Borderline personality disorder represents a sever clinical condition that affects 1-2% of the community and is characterized by a pervasive instability of interpersonal relationships, self-image, and affects, as well as a marked impulsivity; up to 10% of the patients commit suicide.

Transference-Focused Psychotherapy (TFP) is one psychotherapeutic approach among five that have been manualized and evaluated in RCTs. So far, TFP has not been compared to a control condition which is a crucial step in the evaluation of the efficacy of a psychosocial intervention.

This study is an RCT that compares one year of outpatient TFP to treatment by experienced community psychotherapists for borderline personality disorder.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to the participation in the study
* Diagnosis of BPD according to DSM-IV as assessed using the SCID-II
* Age between 18 and 45 years
* Sufficient knowledge of the German language

Exclusion Criteria:

* Diagnosis of schizophrenia, bipolar disorder, severe substance abuse, organic pathology, or mental retardation according to DSM-IV as assessed using the SCID-I
* Diagnosis of antisocial personality disorder according to DSM-IV as assessed using the SCID-II
Relationship Between BMI, Physical Fitness and Motor Skills in Children With Down's Syndrome

Down syndrome is a congenital condition which includes physical mental, and functional abnormalities. It arises from defect involving chromosome 21, usually an extra copy (trisomy 21). Purpose of this study will determine the relationship between BMI, physical fitness and motor skills in youth with down syndrome

This will be a cross-sectional study. The sample size is 169. The inclusion criteria will be Diagnosed with trisomy 21, Aged 6-11 years, Abel to follow a minimum of two-step instructions, The minimum motor ability of participants with DS is independent locomotion where as the exclusion criteria will be medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, orthopedic instability, including those associated with DS (e.g., Atlanto-axial instability), behavioral issues that hindered instruction. The BMI will be assessed using a person's height and weight. The formula is BMI = kg/m 2 where kg is a person's weight in kilograms and m 2 is their height in meters squared. Physical Fitness by using SAMU Disability Fitness Battery (SAMU-DISFIT). the Timed Up and Go test (TUG), the Deep Trunk Flexibility test (DTF), the Hand Grip test (HG), the Timed Stand Test (TST), the 30-s Sit-Up (SUP), the 6-Min Walk Test (6MWT) and Motor Skills using Test of Gross Motor Development (TUG-2) Data will be analyzed using SPSS 22.0. Frequency tables and bar charts will be used for descriptive statistics Chi-Square will be used to find the Association

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with trisomy 21.
* Aged 5-15 years.
* Abel to follow a minimum of two-step instructions.
* The minimum motor ability of participants with DS is independent locomotion.

Exclusion Criteria:

* Medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems.
* Orthopedic instability, including those associated with DS (e.g., Atlanto-axial instability).
* Behavioral issues that hindered instruction
Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range

The primary aim of this study is to evaluate whether pulse oximetry based noninvasive hemoglobin (SpHb) monitoring can reduce the incidence of hemoglobin (Hb) level out of the target range in adult patients undergoing major surgery with the potential risk of bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ASA physical status class I, II, III, who scheduled to undergo elective non-cardiac major surgery with more than moderate risk of bleeding under general anesthesia or spinal anesthesia.
* Eligible Surgery include: Spine surgery, bone tumor surgery, Total Hip Replacement, ovarian cancer surgery, cervical cancer surgery, radical cystectomy, open retroperitoneal mass excision, Radical Retropubic Prostatectomy, explorative laparotomy for abdominal mass excision, abdominal aortic aneurysm repair
* Patients who are requiring an arterial catheter as a part of their standard care.

Exclusion Criteria:

* Patients with preexisting deformity or skin condition that would impede sensor placement
* Patients with allergies to the adhesive sensor material
* Patients with uncorrected preoperative anemia (preoperative hemoglobin \< 7 g/dL)
* Patients who were not suitable for participation in the opinion of the study investigator.
Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
* Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
* ECOG performance status 0 to 2.
* Adequate organ function
* Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
* Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.

Exclusion Criteria:

* Currently receiving crizotinib or any investigational products.
* Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
* Carcinomatous meningitis or leptomeningeal disease.
* Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
* Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
* Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
* History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
* Pregnant female patients; breastfeeding female patients.
* Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices
Extension Study of Long-term Safety and Efficacy of Myozyme in Patients With Pompe Disease Who Were Previously Enrolled in Genzyme Sponsored Enzyme Replacement Therapy (ERT) Studies

This extension study was to monitor the long-term safety and efficacy of rhGAA treatment in patients with infantile-onset Pompe disease who were previously treated with rhGAA derived from the Synpac cell line


Eligibility Criteria:
Inclusion Criteria:

* The patient was enrolled in Protocol AGLU-008-01, AGLU-009-02, or AGLU01502
* The patient's legal guardian(s) provided written informed consent prior to any study related procedures being performed
* The patient and his/her guardian(s) were able to comply with the clinical protocol, which required extensive clinical evaluations for an extended period of time.

Exclusion Criteria:

* Patients were excluded from this study if they did not meet the specific inclusion criteria, or if the patient experienced any unmanageable AE in Protocol AGLU-008-01, AGLU-009-02, or AGLU01502 (as determined and agreed upon by the Principal Investigator and Genzyme Corporation), due to Synpac rhGAA therapy, that would preclude continuing therapy
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

Investigation of safety and tolerability of BI 1034020 in healthy male volunteers following intravenous (IV) infusion of subcutaneous (SC) injection of single doses and exploration of the pharmacokinetics and pharmacodynamics of BI 1034020 after single dosing and determination of the bioavailability of subcutaneous injections of BI 1034020


Eligibility Criteria:
Inclusion criteria:

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age within the range of 18 to 40 years
3. Body mass index within the range of 18.5 and 29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement
2. Any evidence of a clinically relevant concomitant disease.
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
4. Surgery of the gastrointestinal tract (except appendectomy).
5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
6. History of relevant orthostatic hypotension, fainting spells or blackouts.
7. Chronic or relevant acute infections.
Atrial Fibrillation in Patients Receiving Ibrutinib

Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.


Eligibility Criteria:
Inclusion Criteria:

* All patients deem to start ibrutinib therapy

Exclusion Criteria:

* Past history of ibrutinib therapy
Axitinib Therapy Management Study

The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI

not mandatory

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point
* Age 18 years or older at the time of aRCC diagnosis
* Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line

Exclusion Criteria:

* none
Efficacy of Hall Technique in Atypical Lesions on Primary Teeth

Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. However, most of them have shown a great failure percentage. A randomized clinical trial will be developed with the objective of assessing the Hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. Selected teeth will be randomly allocated into two groups. Teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (Hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months.

Treatment's efficacy will be assessed by means of four main outcomes:

1. Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression;
2. Patient-focused criteria (satisfaction, discomfort and quality of life impact);
3. cost-efficacy; and
4. Treatment-related parents', children' and operators' perception.

Other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank test. Cox Regression will be used to enable the assessment of other variables' influence in the results. Significance value of 5% will be adopted for all analysis.


Eligibility Criteria:
Inclusion Criteria:

* children must have at least one molar with atypical caries lesion (involving more than two surfaces);
* parents or legal guardians accept and sign the informed consent form.

Exclusion Criteria:

* children with special needs and/or systematic diseases with oral impairment;
* teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.
Effect of Virtual Reality on Pain, Anxiety, and Vital Signs of the Patients Undergoing Port Catheter Implantation

This study aimed to determine the effect of virtual reality on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. A patient identification form, state anxiety inventory, a table for vital signs, and a visual analog scale for pain severity were used for the data collection. Data were collected from the patients before, during, and after the implantation. In the intervention group, a virtual reality device, movies, and relaxing music were provided to the patients.

To determine the effect of virtual reality (VR) on pain, anxiety, and vital signs of oncology patients undergoing port catheter implantation. The study was a randomized controlled study. The study was carried out with 139 participants (69 intervention, 70 control) between September 2019 and January 2020. Data were collected before, during, and after the implantation by using a patient identification form, State Anxiety Inventory (SAI), a table for vital signs, and a visual analog scale for pain severity. In the intervention group, a virtual reality device, movies, and relaxing music were provided and patients were instructed to use it during the implantation and when they felt pain after the implantation. Data of the study were analyzed with IBM SPSS v25.0.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years and older, can communicate in Turkish, being diagnosed with cancer, and undergoing port catheter implantation.

Exclusion Criteria:

* being have chronic pain or anxiety disorders, using any type of analgesic or anxiolytic, and diagnosed with epilepsy were excluded from the study. The patients who have a visual impairment or also excluded from the study. Patients diagnosed with brain cancer or have brain metastasis were excluded from the study considering the potential seizures. During the intervention, the interventions were ended for the patients who experienced headache or dizziness (two most common problems caused by VR) and data of these patients were not included in the analysis.
Tau PET/CT in Various Tau-Related Disease Patients

To evaluate the potential usefulness of 18F-S16/T807 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.

Subjects with various Tau-related disease patients underwent 18F-S16/T807 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-S16/T807 PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Tau PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.