cyrilzakka/clinical-trials huggingface dataset:
National Cooperative Growth Study in CKD

The purpose of this study is to learn whether growth hormone being administered to children with Chronic Kidney Disease is effective and if it has any side effects.


Eligibility Criteria:
Inclusion Criteria:

* Must be a patient of the UC Davis Medical Center pediatric clinic with Chronic Kidney Disease

Exclusion Criteria:

* Greater than 18 years old
* Not a patient at the UC Davis Medical Center pediatric clinic
A Study to Compare the Pharmacokinetics and the Safety Between a Fixed-dose Combination Administration of "BR3005" and Co-administration of "BR3005-1" and "BR3005-2" Under Fed Conditions in Healthy Adult Volunteers

The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit

  * In case of a male subject, Those who weigh 50 kg or more
  * In case of a female subject, Those who weigh 45 kg or more
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs, etc.)
* Those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(However, the termination for participation in other clinical trials are based on the last administration date of their investigational products)
* Those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (Except for simple appendectomy, hernia surgery)
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Right-handed subjects
* Type 1 diabetes mellitus for at least 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
* Visual impairment or auditory impairment
Comparative Study of the Effects of Two Local Anesthetics Administered Intrathecally: 0.5% Levobupivacaine and Ropivacaine 0.5%

This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.

Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions.

Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* patient admitted to the emergency for lower limb trauma,
* age over 18 years and below 65 years
* lower limb trauma surgery can be performed under spinal anesthesia.

Exclusion Criteria:

* Refusal of patients to participate in the study,
* Patient with cons-indication to spinal anesthesia:

  * Local anesthetic allergy agents (1/13000)
  * bleeding disorders, including pharmacological origin
  * infection at the puncture site,
  * refusal of spinal anesthesia by the patient,
* Patient trust,
* Patients whose coagulation is abnormal.
* Patients with cognitive impairment or incapacitated adult,
* Multiple trauma,
* Porphyria,
* Central preexisting neuropathy,
* A history of spinal surgery,
* Epilepsy uncontrolled by treatment,
* Hypovolemia,
* Pregnant or lactating women,
* Participation in another ongoing clinical trial,
* Patient on anticoagulant therapy,
* Patient not affiliated with a social security system.
Efficacy Observation on Tian Jiu Therapy for Asthma

Objectives:

To further evaluate the immediate, long-term and cumulative effects of Tian Jiu Therapy on asthma.

Hypothesis to be tested:

The efficacy of Tian Jiu Therapy on asthma is also long-term and will be accumulated.

Design and Subjects:

Recruiting 167 asthma participants who received Tian Jiu Therapy under the primary study of HKCTR-1128. All subjects should be above age 13 and receive the same Tian Jiu Therapy, 3 times per year from 2013 to 2015. A one-year follow-up after the last Tian Jiu treatment will be conducted.

Study instruments:

Modern USB PC-based Spirometer and Fingertip Pulse Oximeter.

Interventions:

Plastering some stimulating Chinese herbal cubes on certain acupoints in the three hottest days of each year, for three consecutive years.

Main outcome measures:

Pulmonary Function Test, Blood Oxygen Test, Quality of Life and Standardized Questionnaire on asthma attack and symptoms will be administered before treatment, after treatment of each year and one-year follow-up after the last treatment.

Data analysis:

All the parameters will be analyzed, the physical improvement (Cured, Remarkably effective, Effective and Ineffective) will be recorded, and the differences in different treatment courses will be investigated and compared with previous data obtained in the primary study of HKCTR-1128 by using standard statistical analysis.

Expected results:

The effect of Tian Jiu Therapy on Asthma is not only immediate but also long-term and will be gradually accumulated.

The Tian Jiu Therapy will acquire better efficacy on asthma if this treatment was conducted more years continuously.


Eligibility Criteria:
Inclusion Criteria:

- History of Asthma

Diagnostic Criteria of Asthma according to U.S.DHHS(2007):

1. Episodic symptoms of airflow obstruction
2. Difficulty breathing
3. Chest tightness
4. Cough (worse at night)
5. Symptoms occurring or worsening at night, awakening the patient
6. Symptoms occurring or worsening with exercise, viral infections, changes in weather, strong emotions, or mens; or in the presence of animals, dust mites, mold, smoke, pollen, or chemicals
7. Wheezing
8. Airflow obstruction at least partially reversible Medically stable and acute medical care does not require. E.g. intensive monitoring, invasive ventilation, haemoid-dialysis, cardiac support.

Exclusion Criteria:

1. Patients currently experiencing Acute asthma attack
2. Infants and child under thirteen years old 3.Pregnant women

4. Patients with

1. Fever and pharyngitis
2. Tuberculosis
3. Severe cardiac and pulmonary diseases
4. Diabetes Mellitus
5. Hypersensitive skin condition
6. Allergy to topical medication
7. Keloid
8. Bleeding disorders
9. Severe heart diseases and with pacemaker.
Glycemic Index of Commonly Consumed Sweeteners

The purpose of this study is to determine the glycemic index of commonly consumed sweeteners.

This three arm study is intended to add to scientific knowledge by providing accurate assessments of the glycemic index commonly consumed food items. This will be used in the scientific literature to assess the glycemic index of foods containing various sweeteners. Participants will be monitored for a total of 10 weeks.

The glycemic index is defined as the "incremental area under the glucose response curve after standard amount of carbohydrate relative to that of a control food (white bread or glucose) is consumed." In general, the glycemic index quantifies the relative effect of the carbohydrate content of the food on resultant blood glucose.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-24.9 (lean)
* no medications
* no weight changes over the previous 6 months (defined as \>=10% change in body weight)

Exclusion Criteria:

* current active participation in a weight loss program (dietary or physical activity focused)
* prior bariatric surgery
* significant medical condition such as cardiac or pulmonary disease, coagulopathy, gastrointestinal disorder, or known history of Type 1 or Type 2 diabetes
* women who are pregnant or lactating
* medications (except for oral contraceptives, thyroxins, drugs for hypertension, drugs for osteoporosis, or vitamins and minerals)
* no major medical or surgical event requiring hospitalization in the past 3 months
* no disease or drugs that influence digestion
Benefit of CFAE Ablation

The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.


Eligibility Criteria:
Inclusion Criteria:

* persistent atrial fibrillation

Exclusion Criteria:

* previous catheter or surgical ablation for atrial fibrillation
* pregnancy
Hyperbaric Oxygen as an Adjuvant Treatment for Patients With Covid-19 Severe Hypoxemia

The severity of COVID-19 is related to the level of hypoxemia, respiratory failure, how long it lasts and how refractory it is at increasing concentrations of inspired oxygen. The inability to perform hematosis due to edema that occurs from acute inflammation could be attenuated by the administration of hyperbaric oxygen (HBO). Recently, it has been reported benefits in this matter in patients with SARS-CoV-2 hypoxemic pneumonia in China; where the administration of repeated HBO sessions decreased the need for mechanical ventilation (MV) in patients admitted to the Intensive Care Unit due to COVID-19. Hyperbaric oxygen is capable of increasing drastically the amount of dissolved oxygen in the blood and maintain an adequate supply oxygen to the tissues. In addition to this, it can influence immune processes, both humoral and cellular, allowing to reduce the intensity of the response inflammatory and stimulate antioxidant defenses. HBO is considered safe and it has very few adverse events, it is a procedure approved by our authorities regulatory for several years. In the current context of the pandemic by COVID-19 and worldwide reports of mortality associated with severe cases of respiratory failure, it is essential to propose therapeutical strategies to limit or decrease respiratory compromise of severe stages by COVID-19. That is why, it is proposed to carry out this research to assess whether HBO treatment can improve the evolution of patients with COVID-19 severe hypoxemia.


Eligibility Criteria:
Inclusion Criteria:

* 18 years, all sexes.
* No previous hospitalizations in the last 6 months.
* Positive diagnostic test for COVID-19 according to the guidelines of the Argetine Ministry of Health at the time of enrollment.
* Patient in Intensive Care Unit with oxygen need: Need for continuous supply of oxygen to maintain saturation by oximetry pulse (SpO2) greater than or equal to 93% or arterial gas with PaO2 value greater than 60 mmHg

Exclusion Criteria:

* 18 years of age.
* Person unable to give consent.
* Person who refuses to participate.
* Pregnancy and lactation
* Participating in other study
* Requirement for mechanical ventilation.
* Inability to maintain prolonged sitting position (at least 2 hours)
* Subject with contraindications to HBOT (pulmonary shock, bullae, emphysema or untreated pneumothorax, severe seizures, uncontrolled hypertension, chronic obstructive disease of grade III or IV).
Genotype-guided Warfarin Individualized Treatment

The purpose of this study is to determine whether the international pharmacogenetic algorithm is better than the standard initiation dosing and whether the two algorithms are suitable for Chinese elderly patients.

The study protocol is a multicenter, randomized, patient-blinded and controlled trial, comparing two approaches among 864 enrolled AF(atrial fibrillation) or DVT(deep venous thrombosis) patients for guiding warfarin initial anticoagulation in Chinese elderly patients: the intervention group using the algorithm of International Warfarin Pharmacogenetic Consortium and its dose revision, and the control group using a standard initiation dose (2.25 mg).The study hypothesis is that the intervention group relative to the control group will increase the percentage of time in therapeutic INR (international normalized ratio) range during the first 3 months.This trial is the first prospective large-scale randomized controlled trial for elders in China. It is of great significance for promoting special crowd individualization of anticoagulants at home and abroad.

Eligibility Criteria:
Inclusion criteria：1) Chinese male or female aged ≥18 years; 2) Requiring at least 12-week warfarin therapy as judged by clinicians; 3) Subjects with DVT/AF and a post-therapy target INR of 1.5-2.5; 4) Capable of providing written informed consent; 5) Capable of maintaining excellent communications with investigators and completing trial in accordance with trial stipulations.

Exclusion criteria：1) Subjects previously taking warfarin; 2) Known genotypes of CYP2C9 or/and VKORC1; 3) Subjects receiving or expecting to receive other therapies or other anticoagulants; 4) Subjects with contraindications for warfarin; 5) Subjects with severe cognitive dysfunctions; 6) Baseline INR ≥1.5; 7) Subjects with drug or alcohol dependence within the last 12 months; 8) Subjects receiving blood transfusion or bone marrow transplantation within the last 2 weeks; 9) Planning to receive invasive examinations (except for standard endoscopy) with a hemorrhagic tendency or undergoing surgery during trial.10) Prior to randomization, subjects receiving any trial drug or device within the last 3 months or planning to receive such an investigational therapy during trial; 11) Subjects with the following diagnoses or conditions: active malignant carcinomas (diagnosed within the last 5 years), but excluding adequately-treated non-melanoma skin cancer or other non-invasive or in situ cancer (e.g. cervical cancer in situ); anti-neoplastic therapy within the last 5 years (medication, radiotherapy or/and surgery); overt active disease or infection; life expectancy \<6 months; 12）Other clinical reasons for unsuitable recruitment as judged by clinicians.
Surveillance for Antiviral Resistant Variants in Chronic Hepatitis C Patients

This is a multi-centre prospective longitudinal cohort study with the aim of collecting and storing clinical data, patient blood, DNA and PBMCs to examine outcomes related to drug resistance, drug monitoring and host genetics in the era of directly acting antiviral drugs for hepatitis C therapy.

1. To analyse for resistance-associated HCV variants in DAA-naïve HCV patients using population and ultra-deep pyrosequencing (UDPS). Resistance associated variants will be analysed by qualitative and quantitative methods both pre-treatment and on-treatment.
2. To determine whether in the absence of drug pressure there is variation in the prevalence of naturally occurring resistance associated variants.
3. To correlate the presence and frequency of baseline resistance-associated variants with the response to therapy with DAA-based triple therapy regimens for HCV.
4. To identify predictors of emergent DAA resistance and treatment failure during therapy with DAA-based combination strategies, including virological, clinical and immunological factors.
5. To characterize the natural history of HCV resistance associated variants that are selected during antiviral therapy after the withdrawal of treatment.
6. To establish a cohort of DAA-treatment failure patients suitable for re-treatment studies.
7. To establish a tissue repository of serum and PBMCs from well-characterized patients treated with DAA-based triple therapy to allow future examination of the role of other variables that may potentially impact on the outcomes of DAA based therapy and development of RAVs.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C infection
* Commencing or expected to commence DAA-based HCV treatment within the next year
* IFN treatment-naïve or IFN treatment-experienced
* Provision of written, informed consent

Exclusion Criteria:

* In the opinion of the investigator that the patient is not able to provide informed consent
* Inability or unwillingness to comply with study collection requirements
Feasibility and Efficacy of Coronary Sinus Narrowing in Patients With Coronary Microvascular Dysfunction

This study is being done to evaluate the role of a novel implantable device, called The Neovasc Reducer™ System, in improving microvascular function, symptoms and quality of life in symptomatic patients with coronary microvascular dysfunction.


Eligibility Criteria:
Inclusion Criteria

* Age \>18
* Able to provide written informed consent and willing to participate in all required study follow-up assessments
* Symptomatic CAD with refractory angina defined as CCS class II to IV, despite optimal tolerated medical therapy
* Abnormal coronary microvascular function indices: CFR≤2.5 and/or IMR≥25

Exclusion Criteria

* Recent (within 3 months) acute coronary syndrome
* Patients with prior coronary artery bypass surgery
* Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
* Subjects in cardiogenic shock (systolic pressure \< 80mm/Hg, on vasopressors or intraaortic counter pulsation) at the time of consenting. Subjects who recover from cardiogenic shock by the time of consenting are eligible.
* Obstructive CAD on coronary angiography (\>70% stenosis or 50-70% stenosis with iFR\<0.89 or FFR\<0.8 in epicardial artery)
* Inability to perform invasive coronary flow evaluation and/or measure CFR and IMR in the LAD
* Severe valvular heart disease
* LVEF\<30%
* Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
* Patient with a pacemaker electrode in the CS
* Mean right atrial pressure \>15 mmHg
* Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava (SVC) as demonstrated on angiogram
* CS diameter at the site of planned implantation greater than 13mm or less than 9.5 mm as measured by angiogram
* Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
* Tricuspid valve replacement or repair (tissue or mechanical)
* Chronic renal failure (serum creatinine \>2mg/dL), and or on chronic hemodialysis
* Moribund, or with comorbidities limiting life expectancy to less than one year
* Known severe reaction to required procedural medication
* Known allergy to stainless steel or nickel
* Magnetic Resonance Imaging (MRI) within 8 weeks of Reducer implantation
* Participation in another ongoing investigational trial
* Additional factors deemed unsuitable for trial enrollment per discretion of principal investigator
* Inmates
Molecular Characteristics and Prevalence of Viral Hepatitis E in Human Tissue and Cell Donors

In this study, the researchers want to focus on the prevalence of anti-HEV antibodies by a new generation test, direct detection of HEV RNA, and its genotypic analysis in a group of human tissue and cell donors.

At the Department of Laboratory Medicine of the Faculty of Medicine of the Faculty of Medicine of the National University of Health Sciences, human tissue and cells from donors will be examined for the assessment of health eligibility and donor selection according to Decree No. 422/2008 Coll. According to the current legislation, the determination of IgG and IgM antibodies against HEV or the HEV RNA method is not part of the standard examination of human tissue and cell donors for the assessment of their health eligibility.

Eligibility Criteria:
Inclusion Criteria:

- patients indicated for organ or cell donation

Exclusion Criteria:

- none
Special Investigation of Kaletra in Pregnant Women

This non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (Kaletra), in clinical practice, in pregnant women and their children in Japan.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who have received Kaletra for the treatment of HIV infection were eligible for this study

Exclusion Criteria:

* Contraindications according to the Package Insert:

  * Patients with a history of hypersensitivity to any ingredient of Kaletra
  * Patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol