cyrilzakka/clinical-trials huggingface dataset:
Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

The study will be a single-arm, single center, uncontrolled phase I/II trial to estimate the safety of the combined treatments and then estimate the efficacy in terms of objective response rate in patients with stage IIIC and Stage IV melanoma treated with dabrafenib/trametinib and metformin.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years of age
* Patients with histologically confirmed BRAFV600E melanoma (Stage IIIC or
* Stage IV, American Joint Commission on Cancer)
* Eastern Cooperative Oncology Group Performance Status of 0 to 2
* Life expectancy \> 3 months
* At least 1 site of radiographically measurable disease by RECIST 1.1
* Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
* Absolute neutrophil count \> 1.0 x 10⁹/L
* Platelet count \> 50 x 10⁹/L
* Hemoglobin \> 8 g/dL
* Serum creatinine \< 2 x upper limit of normal
* Total serum bilirubin \< 3 x ULN
* Serum aspartate transaminase or serum alanine transaminase \< 3 x ULN, and \< 4 x ULN if liver metastases are present
* Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician
* Pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of the study drug
* Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \> 1 year
* Before study entry, written informed consent must be obtained from the patient prior to performing any study related procedures

Exclusion Criteria:

* Prior treatment with Vemurafenib or Dabrafenib
* Known hypersensitivity to Metformin or any of its components
* Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation related toxicities to Grade \< 1, except for alopecia
* Pregnant, breast feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures
* Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study
Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults


Eligibility Criteria:
Inclusion Criteria:

* At least 6 years of age
* Diagnosis of asthma
* Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
Amiodarone for the Prevention of Reperfusion Ventricular Fibrillation

This was a prospective, randomized, double blinded study in which patients undergoing a cardiopulmonary bypass (CPB) with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. (CPB is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.) Specifically, we will test the hypothesis that amiodarone is superior to both lidocaine and placebo in the prevention of a severely abnormal heart rhythm when the blood flow is restored to the heart after the aortic cross clamp is removed.

This was a prospective, randomized, double blinded study in which patients undergoing cardiopulmonary bypass with aortic cross clamping were randomly assigned to receive amiodarone, lidocaine, or saline placebo prior to removal of the aortic cross clamp. Specifically, we will test the hypothesis that amiodarone administration decreases the incidence of ventricular fibrillation, the number of defibrillation attempts and the total energy and current required for defibrillation should ventricular fibrillation occur.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta

Exclusion Criteria:

* Women wishing to become pregnant within 6 months of surgery
* Allergy to amiodarone
* History of organ dysfunction due to previous amiodarone use
* Patients who require more than mild systemic hypothermia (\<32 degrees C) during cardiopulmonary bypass
* Patients who require more than one bypass run or more than one period of aortic cross-clamping
Diabetic Retinopathy Screening in General Practice

Diabetic Retinopathy is a microvascular eye complication of diabetes, which can go unnoticed until permanent vision damage has occurred - in worst-case blindness. Timely retinopathy screenings reduce the risk of sight loss since the disease can be treated if detected in time. For people with type 2 diabetes, retinopathy screenings are typically performed by specialist at private ophthalmologists' practices, and individualized screening intervals based on retinopathy level and diabetes regulation are recommended. Unfortunately, 26% of people with type 2 diabetes do not follow their screening interval, and the attendance is too low compared to the national standard of minimum 90% of patients with diabetes who ought to follow the screening program. Consequently, actions must be taken to improve screening attendance in Denmark.

The aim of this study is to investigate patients' acceptance of diabetic retinopathy screenings in general practice. Patients' acceptance is explored through a questionnaire developed for the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Understands Danish
* Age between 18-70

Exclusion Criteria:

* Blindness
* Cannot partake in second screening
A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

This is a phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory study, and the purpose of the study is to evaluate the efficacy and safety of HR190006 for postoperative parenteral nutrition via central venous catheter.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Elective operation of Gastrointestinal;
3. Male or female，aged 18-80 years inclusive;
4. Body Weight at least 40kg, Body mass index (BMI) 18.5-30 kg/m2 inclusive;
5. Nutrition Risk Screening (NRS2002) score at least 3 points.

Exclusion Criteria:

1. Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients;
2. Congenital amino acid metabolism abnormality;
3. Hypothyroidism or hyperthyroidism;
4. Significant abnormal values of clinical laboratory examination;
5. Uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure);
6. General contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency;
7. Subjects with a history of mental system diseases and cognitive dysfunction;
8. Serious complications during or after operation;
9. Previous (\< 2 weeks) received treatment with intravenous nutrition;
10. Previous (\< 4 weeks) or ongoing treatment with growth hormone or corticosteroids;
11. Pregnant or nursing women;
12. No birth control during the specified period of time;
13. Participated in clinical trials of other drugs (received experimental drugs);
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Safety, Tolerability and PK Study of Single Doses of ABT-450 With and Without Ritonavir to Treat Hepatitis C Virus (HCV) Genotype 1

The purpose of this study is to determine the pharmacokinetic and safety profiles of an experimental HCV protease inhibitor with and without ritonavir in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* overall healthy subjects
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* history of gastrointestinal issues or procedures
* history of seizures, diabetes or cancer (except basal cell carcinoma)
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* use of tobacco or nicotine-containing products with the 6-month period prior to study drug administration
* donation or loss of 550 mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
* abnormal screening laboratory results that are considered clinically significant by the investigator
* current enrollment in another clinical study
* previous enrollment in this study
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
* pregnant or breastfeeding female
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
Pre-market Verification of Portable X Ray Machines for Lung Diseases and Orthopedic Limb Lesions

The clinical trial is to evaluate a portable X ray machine (model name: CVXair) for chest and extremities diagnosis, the performance of machine is comparing to the commercial stationary and portable machine both in biological structure way and disease diagnosis way by the image generated.

Currently sold X ray machines in market for hospital are stationary or big size portable, it is not easy for carrying to use and occupied a large space for installation and storage, beside that, CVXair is a small and light machine within 3.2KG and has extremely low dosage. It is the reason we expect to use CVXair as a convenient X ray machine with low radiation dosage for X ray image diagnosis clinically.

This trial has an expected trial period in two years, the accepted patients are limited to thoracic and orthopedics patients no matter out hospital or in hospital. The accepted patients upper limitation number is 123 respectively. The selected patient will be taken X ray shot in same area and position both by CVXair and market sold machine, the images then will be interpreted by 2 qualified radiologist in different biological structure and specified diseases. Then the process will be given by a suitable test score.

The test result will be calculated by defined index for comparing with the market sold X ray machines, and finally we will base on the result to state the machine is equivalent or not by the market sold X ray machines.


Eligibility Criteria:
Inclusion Criteria:

* Patients with lung diseases and orthopedic limb lesions.
* Aged 20 years or older.
* After informed consent, sign the subject consent form.

Exclusion Criteria:

* Patients under the age of 20 years.
* Pregnant women (female subjects of childbearing potential, undergo pregnancy testing prior to irradiation to exclude the risk of pregnancy).
* Other individuals deemed unsuitable for inclusion in the clinical trial upon physician assessment.
Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement

Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of osteoarthritis and listed for an unilateral total knee replacement.
* Subject has a normal cognitive function
* Subject is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Those who have undergone total knee arthroplasty due to gout
* Those who have had total knee arthroplasty due to trauma
* Those who have had total knee arthroplasty due to autoimmune related diseases such as rheumatoid arthritis
* Those who are participating in other clinical trials
* Those who have a history of participating in other clinical trials within one month
* Those who are difficult to write a research consent form
* Those who are judged to be inappropriate for the clinical study by the researchers.
A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients

Work hypothesis

A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years and \< 85
* BMI ≥ 25 and \< 35
* Patients diagnosed with type 2 diabetes at onset or treated only by diet
* HbA1c between 6.0 and 8.0% (based on the last measured and documented laboratory measurement of the previous 3 months)
* Usual consumption ≤ 3 fish per week

Exclusion Criteria:

* T2D treated with antidiabetic oral drugs and/or insulin
* Current or previous (within 3 months) intake of omega 3 suplements
* Known allergy or intolerance to fish or fish protein
* Diagnosis of active neoplasic disease
* Suffering from an acute illness which requires a recovery period higher than one week
* Currently chronic treatment with oral steroids or nonesteroidal anti-inflammatory for more than 5 days, at least 1 month before randomization
* Pregnant or breast-feeding patients
* Serious acute vascular events (cardiac or cerebral) diagnosed previous 2 months before the randomization
* Current or previous (within 6 months) participation in another study
* Chronic renal insufficiency (creatinine \>1,5 mg/dl)
* Any conditions that the investigator considers may render the patient unable to complete the study

During the interventional study, based on current standards of T2D care, doctors will introduce anti-diabetic oral drugs or insulin into the patient's treatment, where they consider it to be necessary.
Oxford Classification and Clinical Remission After Initial Treatments in Patients With IgA Nephropathy

IgA nephropathy (IgAN) is the most common form of primary glomerulonephritis and one of the leading causes of end-stage renal disease in China. The clinical manifestations of IgAN varies widely among individuals, and renal pathology is crucial for determining the severity of renal damage and predicting the renal progression. However, the association between renal pathology and patient response to medication has not been reported, and the majority of earlier RCT studies have not taken renal pathology into consideration when enrolling patients. The Kidney Disease: Improving Global Outcomes (KDIGO) Glomerular Diseases Work Group, one of the most prestigious kidney disease organizations in the world, claims that there is not enough evidence to support the use of Oxford Classification to decide whether to administer immunosuppressive therapy to patients with IgAN.Therefore, the goal of this study was to investigate the relationship between Oxford Classification and clinical remission rates following initial teatments in patients with IgAN, with the aim of providing a basis for individualized clinical treatment plans. This study was a single-center prospective cohort study, and patients who were hospitalized in Shenzhen Second People's Hospital from January 2011 to January 2021 and diagnosed as IgAN by renal biopsy were collected continuously and followed up until December 2022. Cox regression models were used to analyze the effect of different Oxford Classifications on the clinical remission rates of patients at 6, 12, 18, and 24 months of treatments, and the relationship between Oxford Classification and secondary outcome indicators such as long-term renal function and urinary protein changes were analyzed using generalized additive mixed models.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years；
* Initial renal biopsy；
* Glomeruli\>8；
* eGFR\>15ml/min；
* Proteinuria/creatinine ratio（PCR）\>0.5g/g

Exclusion Criteria:

* Secondary IgAN
* Combined with other kidney diseases
* Combined with acute kidney injury
* Combined with tumor
* Followed-up time \<6 months
Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 Diabetes

This trial is conducted in Europe. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different premixed insulin analogues given in combination with an oral anti-diabetic drug.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with insulin
* Currently treated with Metformin
* HbA1c: 7.5-12.0%

Exclusion Criteria:

* Body Mass Index (BMI) \< 25.0 or \> 40.0 kg/m2
* Metformin contraindications according to local practice
* TZDs within 6 months prior to randomisation
Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture

Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.

Patients with verified diagnosis partial rupture of anterior cruciate ligament will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).

Eligibility Criteria:
Inclusion Criteria:

* Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery)
* Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test)
* Patient is familiar with Participant information sheet
* Patient signed informed consent form

Non-inclusion Criteria:

* Knee osteoarthritis grade III and grade IV
* Medical history of autoimmune diseases
* Patients prescribed for immunosuppressive treatment
* Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics
* Subcompensated or decompensated forms of chronic diseases of internal organs
* Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
* Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
* Clinically significant abnormalities in results of laboratory tests
* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
* Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
* Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
* Medical history of heterotopic ossifications
* Patients prescribed for glycoprotein inhibitors treatment

Exclusion Criteria:

* Patient's refusal from the further participation in trial
* Patient's refusal from compliance with the requirements of contraception during the participation in research
* Chronic kidney disease IV - V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
* Confirmed syphilis, HIV, hepatitis B or C infections

Dropout Criteria:

* Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery
* Pregnancy
Alpha-GPC and Physical and Cognitive Performances in Volleyball Players.

In order to attain the elite level on the national scene, volleyball players need several attributes. In addition to mastering technical and tactical skills, great jumping ability is another important asset. Maximal power output needed to achieve height during a jump necessitates coordinated neuromuscular recruitment and muscle mass among others. Interestingly, there are claims that alpha-glycerylphosphorylcholine (A-GPC) increases acetylcholine synthesis and enhances exercise-induced increases in plasma growth hormone concentrations, two factors that could theoretically be associated neuromuscular transmission and muscle mass.

However, until now only a few studies have investigated the role of A-GPC in human exercise performance. Published results were mixed. One recent study showed that isometric peak force was slightly but significantly increased when subjects had ingested a daily dose of 600 mg of A-GPC over a period of 6 days (Bellar et al., JISSN, 2015).

The objective of our study is to evaluate the longer-term effects (4 weeks) using a higher dose (1000 mg/day) of A-GPC on jumping capabilities in elite male and female volleyball players.

Our study design will be a placebo controlled, randomized, double-blind, crossover study. Varsity male and female volleyball players (n=28) will each be asked to participate in both arms of the study, i.e. placebo and A-GPC (1000 mg/kg/day). The duration of each arm of the study will be 4 weeks separated by a 7-day washout period. The order of treatment (placebo or A-GPC) will be determined randomly. Athletes will be asked to maintain their training load during the duration of the experiment.

Eligibility Criteria:
Inclusion Criteria:

* Be a competitive varsity volleyball player

Exclusion Criteria:

* Regular consumption of alpha-GPC within the last 4 months
* Receiving drug treatment except 1) contraception (pill), and 2) treatment against asthma
The REPLACE Registry for Cholbam® (Cholic Acid)

This is a prospective, observational, non-interventional patient registry study designed to document product safety and effectiveness outcomes for 10 years in patients treated with Cholbam, including those who have been using Cholbam for at least 30 days (existing users) and those who are first-time initiators of Cholbam.

No experimental intervention is involved. Patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, of any age.
2. The patient and/or the patient's parent/legal guardian is willing and able to provide signed informed consent, and the patient, if less than 18 years of age, is willing to provide assent as appropriate and in accordance with local regulatory, IRB, and EC requirements.
3. The patient has a diagnosis for which Cholbam is indicated.
4. The patient is or will be treated with Cholbam at the time of signing the informed consent form (ICF) (enrollment).

Exclusion Criteria:

1. Patients who, by judgement of the Investigator, will not be able to comply with the requirements of the protocol will be excluded