cyrilzakka/clinical-trials huggingface dataset:
Safety Study of Anti-IgE Immunotherapy in Allergic Patients

The purpose of the study is to evaluate safety and efficacy of three doses and two dosing regimens of RP01 as an anti-IgE immunotherapy in allergic patients.

Immunotherapy is based on the principle of eliciting an immune reaction in order to block the negative effect of a specific disease-causing protein. The potential to treat diseases by means of immunotherapy instead of using conventional drugs represents an attractive opportunity in a number of chronic disease areas, including asthma and allergy. Resistentia's model to treat allergic diseases, and ultimately asthma, is to use the immune system to produce antibodies against the IgE molecules themselves. The resulting anti-IgE antibodies intercept and form complexes with the IgE molecules before they can bind to the mast cells and basophils and are thus able to block any allergen-triggered inflammatory reaction. The approach works in all types of IgE-mediated allergies independently of allergen, and also in patients sensitive to multiple allergens.

Comparisons: Three doses and two dosing regimes of RP01 will be compared as regards safety and effect.

Eligibility Criteria:
Inclusion Criteria:

* Allergy to at least one aero allergen
* Increased serum IgE level

Exclusion Criteria:

* Diagnosis of asthma
* Recent use of systemic corticosteroids or immunosuppressive treatment
* Allergy vaccination therapy
Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis

Vascular closure device, hemostatic bandage and manual compression can achieve hemostasis after angiographic examination. These three methods of hemostasis changed the rate of hemostasis, early ambulation, hematoma , hemostasis failure rate, and expense. Therefore, shared decision making (SDM) is necessary to aid patients to choose hemostasis.The investigators have developed a decision aids (DA) and planned a randomized controlled trial (RCT) to evaluate its impact on angiographic patients. The measurements include a battery of interview-based questionnaires and evaluations of decision conflicts. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and choice conflicts.during and after thier Hemostasis procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients who needs an angiographic examination or treatment.
* Patients with angiographic indications
* Patients who were able to give consent and complete the interview

Exclusion Criteria:

* The angiographic procedure uses patients with a catheter size more than 7fr.
* Patients in critical situations requiring urgent treatment
* Patients had cognitive impairment
* Patients were physically unfit to be interviewed
* Patients were non-Mandarin or -Taiwanese
Effect of Low Flow Anesthetics on Neurocognitive Decline in the Elderly

This study aims to investigate the effect of inhaled anesthetics with a low fresh gas flow on cognitive function of elderly patients undergoing elective surgery

Geriatric patients scheduled to undergo surgery were tested with Mini Mental State Examination (MMSE) in the preoperative visit. MMSE was repeated postoperatively at the 6th hour, the 1st, 3rd, and 7th day. Visual analogue scale (VAS) test was performed simultaneously on the postoperative 6th hour, the 1st, 3rd, and 7th day. Two cohorts were created according to the amount of fresh gas flow (low flow vs high flow) in the maintenance phase of the inhalational anesthetic. MMSE scores were compared between cohorts and baseline. VAS scores were compared between cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Age\>65
* Consenting to participate
* Scheduled for surgery longer than 2 hours under GA
* Able to read and write

Exclusion Criteria:

* Age\<65
* Refusing to participate
* Existing visual impairment preventing the patient from reading or writing
* Unable to read and write
* Existing major neurocognitive disorder
* Use of TIVA or regional techniques
* Allergies to the volatile agents
* Uncontrolled DM, acute alcohol intoxication
* Conditions increasing tissue oxygen consumption (sepsis, thyrotoxicosis, etc.)
* Anticipation/existence of major hemorrhage
* Haemodynamic instability \> 10 min or more than 5 times intraoperatively
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic

This is Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/ subjects will provide their Informed Consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™.

Secondary Objective:

* To identify adherence subject profiling
* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to the Summary of Product Characteristics (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care.

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in an interventional clinical study
Cushing's Syndrome Before and After Treatment (CORRECT)

The purpose of this study is to prospectively study patients with Cushing's syndrome before and after treatment, with a special emphasis on physical function, quality of life, and circadian rhythms.

The hypotheses are:

* Cushing's syndrome negatively impacts health-related quality of life (HRQoL) and physical functioning
* Cushing's syndrome is associated with altered circadian rhythms at the whole body level and in peripheral target tissues.
* These complications partially reverse following disease control.


Eligibility Criteria:
Inclusion Criteria:

* New (≤ 2 months) diagnosis of Cushing's syndrome (CS) of endogenous etiology:

  * ACTH-dependent CS
  * ACTH-independent CS
* Age \>18 years
* Written informed consent

Exclusion Criteria:

* Active cancer
* Iatrogenic or malignant cause of CS such as adrenocortical carcinoma
* Chronic heart failure (New York Heart Association class IV)
* Chronic kidney disease Chronic Kidney Disease stage ≥3 (eGFR \>30 ml/min)
* Liver disease in the form of cirrhosis
* Deemed unable to complete the study safely by investigator
A Study of How MK-0736 Affects Arterial Plaque (0736-006)(TERMINATED)

A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).


Eligibility Criteria:
Inclusion Criteria:

* Participants with peripheral arterial disease
* Participants must be 18 to 85 years of age
* Females must be postmenopausal or sterile

Exclusion Criteria:

* Participans with hepatic, HIV, endocrine, connective tissue, psychiatric disorders or uncontrolled hypertension
Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation

Each year, between 50,000 and 60,000 children are born prematurely in France. Among them, 10% are born at 26 - 30 week's gestation and 5% are born before 26 week's gestation.

Bronchopulmonary dysplasia (BPD) affects at least one-quarter of infants born with a birth weight less than 1500 grams.

BPD is defined by the need for oxygen after 28 days of life in any children born prematurely. In addition, the severity of BPD can be categorized as mild (room air tolerated at 36 weeks), moderate (oxygen requirement between 22 and 29 %) and severe (oxygen requirement 30% or need for ventilation support).

Bronchopulmonary dysplasia is responsible for significant respiratory morbidity and impaired neurological outcomes.

Pulmonary imaging such as tomodensitometry, MRI or scintigraphy can be abnormal and therefore coud theorically be helpful for an early diagnosis. Unfortunatelly, theses examinations are irradiating, expensive or difficult to perform in an everyday practice. Therefore lung imaging for BPD diagnosis. Is not recommanded in current official guidelines.

Pulmonary ultrasound has already been studied in premature newborns. A pilot study carried out on 21 patients showed that pulmonary ultrasonography at one and two weeks of life could predict the risk of bronchopulmonary dysplasia. The score used in this study was the LUS score previously validated by Brat et al. Advantages of this examination are to be non-invasive and easily performed at the patient's bedside. Nevertheless this study focused on a small population with a low number of moderate / severe dysplasia.

In addition, Czernik et al. have highlighted that the index of myocardial performance of the right ventricle was increased at seven and ten days of life in children who subsequently developed BPD.

The investigators propose in this study to evaluate a new prediction score for DBP, the modified LUS score, associating the LUS score with an echographic evaluation of the right heart (myocardial performance index).


Eligibility Criteria:
Inclusion Criteria:

* Premature neonates with gestational age less than or equal to 34 weeks of amenorrhea.
* Hospitalized in the NICU or neanatology unit at Limoges University Hospital at day 9 +/- 2 and day 15 +/- 2 of life
* participation agreement of at least one of the parents.

Exclusion Criteria:

* Cardiac malformations
* Congenital lung malformation.
Evaluation of the Effect of Metformin on Metastatic Breast Cancer as Adjuvant Treatment

This study aims to determine the effect of metformin along with standard cancer treatment, and its effect on the prognosis of the metastatic breast in non-diabetic patients.

the role of metformin when combined with traditional metastatic breast cancer treatment in non-diabetic patients compared to diabetic patients who are not using metformin. In this randomized control study, there will be a demonstration either it is effective to suppress tumor burden or not through normal screening for tumor.

Eligibility Criteria:
Inclusion Criteria:

* The non-diabetic patients will be included in the study if they meet the following criteria:

  1. Confirmed metastatic breast cancer (IV stage) radiologically or by clinical evaluation receiving chemotherapy
  2. Age between 18- 70 years.
  3. Life expectancy at least 6 months

Exclusion Criteria:

* The patients will be excluded from the study if they have the following criteria:

  1. Bad prognosis disease: Criteria defined as the following

     * If patient \>70 years
     * If patient has bad site metastasis (brain)
  2. Hypersensitivity for metformin: if happened patient will be treated as following

     • Pheniramine Maleate 3 times daily for 7 days and Tablet Dexamethasone 1mg daily in 2 divided doses for 5 days \[16\].
  3. Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association {NYHA} Class III or IV functional status; the history of acidosis of any type, severe infections, kidney or liver disease, respiratory disease, seizures .
  4. Diabetic patients.
The vPPG-detecting Software Guided Management of Cirrhotic Portal Hypertension

The aim of this study is to investigate the possibilities and effectiveness of managing cirrhotic portal hypertension using the non-invasive portal pressure gradient (PPG) detecting software. In this study, the three-dimensional reconstruction and natural follow-up methods have been respectively applied in the experimental (1st) and active comparator (2nd) group. The virtual PPG is calculated with anatomical and hemodynamic information of portal system collected by ultrasound and CT tests. Cirrhosis patients in the 1st group, with calculated vPPG values, are managed with upper GI endoscopic results. Besides, patients in the 2nd group, are managed according to the most updated Chinese clinical guideline for cirrhotic portal hypertension, namely, patients with either liver stiffness measurement (LSM) \>15kPa or PLT count \<150\*10\^9 should be screened and treated with upper GI endoscopy. The morbidity of decompensated cirrhotic events and mortality of patients in two arms will be compared. The cutoff values of vPPG to spare endoscopies with low missed VNT (varices needing treatment) are preliminarily determined with the cohort data.


Eligibility Criteria:
Inclusion Criteria:

Inpatients (Shanghai Tongji Hospital) with cirrhosis, which is confirmed by the imaging tests (upper abdominal ultrasound/CT/MRI) or liver biopsy pathology.

Exclusion Criteria:

* 1. Portal vein embolism;
* 2. Splenectomy;
* 3. Hepatic encephalopathy;
* 4. Hepatic space occupying lesions (such as hepatic cysts, hemangiomas, etc.) with diameter \> 3cm and local compression effect;
* 5. Contraindications of enhanced CT test, such as iodine allergy, peripheral veins are too thin to inject contrast medium;
* 6. Contraindications of upper GI endoscopy
Safety, Tolerability, and Pharmacokinetics of Inhaled Virazole Administered Via Air-Jet Nebulizer in Healthy Volunteers

This study is a Phase 1a, randomized, double-blind, placebo-controlled, safety, tolerability, and PK study in healthy adult volunteers.

Participants were screened for eligibility within 14 days prior to enrollment. Four successive cohorts were enrolled, with each cohort receiving a single dose of Virazole or placebo using different delivery regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female ≥ 18 and ≤65 years of age.
2. For a female, must be of non-childbearing potential according to 1 of the following criteria at least 6 months prior to screening:

   * hysteroscopic sterilization;
   * bilateral tubal ligation or bilateral salpingectomy;
   * post-menopausal with spontaneous amenorrhea for ≥ 12 consecutive months with follicle-stimulating hormone \[FSH\] \> 25.8 mIU/mL; or
   * having had bilateral oophorectomy (with or without hysterectomy).
3. For a male subject must be vasectomized with confirmed postvasectomy semen analysis or a male subject with a documented diagnostic of infertility.
4. Subject willing and able to provide written informed consent.
5. Subject has a body mass index (BMI) ≥ 18.50 and \< 30.00 kg/m2.
6. Subject is in good general health without clinically significant haematological, cardiac, respiratory, renal, endocrine, gastrointestinal, psychiatric, hepatic, or malignant disease, as determined by the Investigator.
7. Subject has suitable venous access for blood sampling

Exclusion Criteria:

1. Subject has a history of hypersensitivity to ribavirin.
2. Subject has a history of asthma, COPD, or bronchospasm.
3. Subject has anemia defined as hemoglobin or RBC \<75% of the institutional lower limit of normal for age and gender.
4. Subject has any major illness or systemic infection (including COVID-19) within 4 weeks of the Screening Visit or has a clinically relevant history or is currently suffering from a disease or condition that, in the opinion of the Investigator, may affect the evaluation of the study drug or place the subjects at undue risk.
5. Subject is seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), or positive for SARS-CoV-2 at Screening.
6. Subject has a clinically relevant history of or current evidence of abuse of alcohol or other drug(s).
7. Subject is currently a tobacco smoker or was a tobacco smoker within 6 months of the Baseline Visit.
8. Subject has donated 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, Clinical Studies, etc.) in the previous 56 days prior to the Baseline Visit.
9. Subject is currently participating in any drug or device clinical investigation or has received an investigational agent or approved drug that, in the Investigator's judgement, may have a chemical or pharmacological interaction with Virazole if administered within 5 half-lives or 30 days of the Baseline Visit.
10. Subject has any condition that could cause noncompliance with treatment or may otherwise contraindicate the subject's participation in the study
Effects Of tDCS With Physical Therapy On Rehabilitation In Parkinson's Disease

The present study aims to investigate the effect of transcranial direct current stimulation (tDCS) associated with physiotherapy in parkinson´s rehabilitation. Previous studies showed that tDCS could reduce the bradykinesia, one of the symptom of Parkinson disease. In this way, this study will combine tDCS with physiotherapy in order to enhance the motor rehabilitation and the quality of life.

12 patients were participated of this study.After screening to check the eligibility criteria and giving informed consent, they were randomized in two groups. All patients were submitted to a 10 therapeutic sessions that occurred 3 times per week.

Before, immediately after and 1 month after the last session patients were submitted to an evaluation with the follow tests: Unified Parkinson´s Disease Rating Scale(UPDRS), Jebsen Taylor Test (JTT) and Parkinson's Disease Quality of Life (PDQL). Furthermore, before and after each session the patients were submitted to transcranial magnetic stimulation (TMS) to evaluate cortical excitability through motor threshold and motor evoked potential.

In experimental sessions, the subjects always received physiotherapy with conventional techniques, the protocol followed the clinical practice guideline for physical therapy in Parkinson disease with the Royal Dutch Society Therapy. During tDCS protocol the patients seated in a comfortable chair with head and arm rests. Continuous current was applied using a pair of saline-soaked surface sponge electrodes (surface 35 cm2), the anode electrode was placed over the primary motor cortex and cathode above contralateral orbit. tDCS was applied of twice stimulation of 13 minutes with 20 minutes of interval between them and a current strength of 1mA. Sham tDCS was applied by current flow of 30s.

Eligibility Criteria:
Inclusion Criteria:

Parkinson disease comproved by a neurologist Regular treatment with dopamine or other drugs against parkinson -

Exclusion Criteria:

pregnant history of convulsion metal implant in the region of skull or face change in medication during the study realize other physical therapy in the same time of the study previous surgery for parkinson disease

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To Investigate the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Dosing in Healthy Volunteers

AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Healthy volunteers able and willing to comply with all study requirements.

Exclusion Criteria:

* An ongoing or history of a medical or psychiatric disease/condition which may put the healthy volunteer at risk or interfere with the study objectives because of participation in the study, as judged by the investigator(s).
* History of psychotic disorder among first degree relatives.
Fluoride Varnish Randomized Clinical Trial

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.

Eligibility Criteria:
Inclusion

* Children \< 44 months old
* Caries-free
* 4 erupted maxillary incisors
* Residing in fluoridated community (San Francisco)

Exclusion

* Cleft Palate
* Developmental or learning disabilities
* Children with transient residence (homeless, migrant, foster home)
* Children with an another household member participating in the study
IMS® DIAREG Diabetes Registry - Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus

This observation plan outlines the approach to build a diabetes registry to collect data on daily routine of treatment of Type 2 Diabetes Mellitus.

The choice to establish such a (general and specific) disease patient registry was based on several scientific and practical considerations as described in the AHRQ user's guide: registries for evaluating patient outcomes (www.ahrq.gov, 2007). From a public health point of view, such a register should monitor naturalistic (i.e., unbiased) use of diabetes treatment in the community and should primarily guide and assist medical professionals to make optimal choices in combating diabetes. The primary focus of this registry is therefore to monitor the medical and lifestyle treatment of diabetes in order to enable comparison of different treatment options and to provide data for future discussions of optimal treatment.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent
* Age of 18 years or older
* Diagnosis of Type 2 Diabetes Mellitus (T2DM)

Exclusion Criteria:

Only patients who don't fulfill the inclusion criteria will be excluded. There will be no further possibility for the treating physician to exclude individual patients.