cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy

The purpose of the study is to evaluate the clinical effects of the investigational drug, SB-509, in subjects with diabetic neuropathy.

SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around the injection site and causes these cells to make a protein. This protein causes your cells to increase production of another protein called vascular endothelial growth factor (VEGF), which may improve the structure and function of nerves. In addition, there are changes in the levels of additional proteins in your cells. These proteins function to promote the growth of cells, are structures in cells, help synthesize products, and affect immune cells, and some have unknown functions. This increase in your own VEGF proteins may protect and repair the damaged nerves caused by diabetic neuropathy.

Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of Diabetes Mellitus Type I or II for at least 12 months
* Clinical signs and symptoms of moderate to severe diabetic sensory-motor polyneuropathy of the lower extremities for at least 6 months that are not otherwise attributed to an etiology other than diabetes
* Measurable sural and peroneal response bilaterally
* HgbA1C level ≤ 10%
* LDL cholesterol ≤ 160 mg/dL
* Blood pressure ≤ 140/90 mm Hg
* Body mass index (BMI) ≤ 38

Key Exclusion Criteria:

* Moderate to severe ischemic heart disease or any history of congestive heart failure, or have had a myocardial infarction within the previous 6 months
* Evidence of cardiac enlargement and/or congestive heart failure
* Current diabetic foot or leg ulcer, gangrene in the lower extremity, or any amputation of the lower extremity
* History of malignancy, except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for at least 5 years
* Immune or immunodeficiency disorders or expected to require immunosuppressants for 30 days prior to, during, and for 30 days following administration of the investigational drug product
* History of or current proliferative retinopathy, macular edema or retinal neovascularization
* Pre-cancerous conditions or benign tumors which have the potential for clinically significant growth due to VEGF stimulation
* Family history of inherited neuropathy (e.g. Charcot Marie Tooth, Hereditary Predisposition to Pressure Palsy)
Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial

Objectives

To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:

1. To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
3. To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.

Hypothesis

Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* able to give informed consent
* postpartum women delivering at the University of New Mexico Hospital
* Intend to breastfeed
* Plan to use oral contraceptives as her family planning method
* Willing to be randomized to either progestin-only pills or combined pills

Exclusion Criteria:

* medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches
* preterm birth (\<37 weeks)
* small for gestational age infant (\<2500 grams)
* large for gestational age infant (\>4500 grams)
* infant with major congenital anomaly
EPOMI Study: ErythroPOietin in Myocardial Infarction

EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.


Eligibility Criteria:
Inclusion Criteria:

* ST-Segment elevation myocardial infarction \<6h
* Infarct related artery : proximal circumflex artery , proximal and mid left anterior descending artery, 1st segment of the right coronary artery
* TIMI 0 or 1 before angioplasty
* Successful PCI defined by residual stenosis \< 50% and TIMI 2 or 3 flow grade
* Body weight : \[50-110\] kg
* Informed, written consent

Exclusion Criteria:

* Age \< 18
* Pregnant, or parturient or breast-feeding women;
* Sexually active women without efficient contraception;
* Inability to fully cooperate with the study protocol
* Pre-treatment with fibrinolysis ;
* Previous Q-wave myocardial infarction or previous aorto-coronary bypass;
* History of deep vein thrombosis or pulmonary embolism;
* Contraindication to aspirin or clopidogrel ;
* Cardiogenic shock ;
* Cardiac resuscitated before angioplasty ;
* Past or active erythropoietin therapy;
* Contraindications to erythropoietin therapy: uncontrolled hypertension, known hypersensitivity to benzoic acid, chronic liver insufficiency, hemoglobin\> 16g / l, thrombocytosis, refractory anemia with excess of blasts;
* Renal insufficiency (creatinine clearance \<30ml/mn.);
* Active Malignancies
* Any contraindications to magnetic resonance imaging: pacemaker and automatic cardiac defibrillator, hearing aid, neurostimulator, infusion pump etc metallic splinters in the eye, ferromagnetic haemostatic clips in the central nervous system cochlear implants, claustrophobia;
* Allergy to gadolinium ;
* Patient refusal / patient not having provided written informed consent.
IPC-CALF Versus GEKO in Post-op Total Hip Patients

This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Male and Female
2. Aged over 18-80 years
3. Be in good general health and fitness other than the clinical requirement for a planned hip replacement.
4. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders.
5. No history or signs of drug abuse (including alcohol), licit or illicit.
6. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator (PI) during the thirty (30) days preceding the study.
7. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
8. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Are requiring hip revision surgery
2. History or signs of significant haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism).
3. Significant Peripheral arterial disease (ABPI \< 0.8), varicose veins or lower limb ulceration or ischemia.
4. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
5. Recent trauma to lower limb.
6. Chronic Obesity (BMI Index \>40kg/m2).
7. Pregnancy.
8. Significant history of following diseases i. Cardiovascular: Recent MI (\< 6 months) ii. Percutaneous Coronary Intervention (PCI) with stent (\< 3 months for Bare metal stent (BMS) and \< 12 months for Drug Eluding Stent (DES) iii. Moderate to severe CCF, uncontrolled AF iv. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies v. Renal: Moderate to severely impaired renal function vi. Hepatic: Moderate to severely impaired hepatic function vii. Psychiatric disorders viii. Dermatological conditions affecting lower limbs ix. Haematological conditions i.e. coagulation disorders, sickle cell disease
9. A pulse rate of less than 40 beats/minute
10. A sitting systolic blood pressure \>180 and \<100 mmHg and/or a sitting diastolic pressure of \>100 mmHg.
11. Any significant illness during the four (4) weeks preceding the hip replacement surgery.
12. Participation in any clinical study during the eight (8) weeks preceding the screening period
Mindfulness for Intense Emotions: A Feasibility Trial

This study explores the feasibility of a mindfulness-based intervention for people with a diagnosis of borderline personality disorder.

This is an uncontrolled feasibility trial of an eight-week mindfulness-based intervention for people with a diagnosis of borderline personality disorder. A battery of measures will be administered at baseline, in a time window of six to zero weeks prior to the start of the intervention. Outcome measures will be repeated in the two weeks after the end of the eight-week intervention, along with a qualitative interview.

Eligibility Criteria:
Inclusion criteria:

* Are on the caseload of a United Kingdom National Health Service Assessment and Treatment Service in the recruitment area and have had contact with that service in the past three months
* Have received the diagnosis of Borderline Personality Disorder from a suitably qualified health care professional, and continue to meet criteria for this diagnosis according to the SCID-II (Structured Clinical Interview for DSM Disorders Version II) at their screening assessment
* Have sufficient English language speaking and comprehension abilities to access group discussions and hand-out materials
* Have not previously engaged in a mindfulness-based intervention. As in other similar trials, a minimum dose has been operationally defined as having undertaken 50% or more of a mindfulness-based intervention delivered face-to-face by a suitably qualified health care professional
* Are not currently receiving, nor have plans to receive any other form of psychological therapy during the course of the study

Exclusion criteria:

* Have psychosis
* Misuse alcohol or drug to a level that requiring detox
* Have a intellectual disability
* Present a high level of risk requiring inpatient management at the time of their screening assessment
Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults (≥18 years old).
2. Reversibility test defined as ΔFEV1 ≥ 12% and ≥ 200 mL .
3. FEV1 \> 80% of the predicted values .
4. Asthma Control Questionnaire score \< 1.25.
5. Asthmatic patients
6. Non- or ex-smokers

Exclusion Criteria:

1. History of near fatal asthma.
2. COPD patients
3. Asthma exacerbation within 1 month prior to the screening visit or asthma exacerbation during the run-in period.
4. Lower respiratory tract infection within 1 month prior Visit1 (V1).
5. History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
6. Diagnosis of restrictive lung disease.
7. Patients treated with oral or parenteral corticosteroids in the previous 2 months before V1
8. Intolerance or contra-indication to treatment with beta 2-agonists and/or inhaled corticosteroids or allergy to any component of the study treatments.
9. Significant medical history of and/or treatments
10. Active cancer or a history of cancer .
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a diagnosis of rheumatoid arthritis (RA) \[2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria\] , and are ACR functional class I-III.
* Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
* Ongoing treatment with a stable dose of MTX

Key Exclusion Criteria:

* Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Open Label Pharmacokinetic Study of SAR302503 in Subjects With Hepatic Impairment

Primary Objective:

To study the effect of mild and moderate hepatic impairment on the pharmacokinetics of SAR302503.

Secondary Objective:

To assess the tolerability of SAR302503 given as a single dose up to 300 mg in subjects with mild and moderate and hepatic impairment and in matched subjects with normal hepatic function.

Study duration=17-35 days

Eligibility Criteria:
Inclusion criteria :

* Male or female subjects, between 18 and 75 years of age, inclusive.
* Body weight between 50.0 and 115.0 kg, inclusive if male, and between 40.0 and 100.0 kg, inclusive if female, body mass index between 18.0 and 34.9 kg/m2, inclusive.
* Stable chronic liver disease with Child-Pugh classification score between 5 and 9 assessed by medical history, physical examination, laboratory values
* 12-lead ECG without clinically significant abnormality
* Laboratory parameters within the acceptable range for subjects with hepatic impairment
* Using a double contraception method

Exclusion criteria:

* Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
* Hepatocarcinoma.
* Acute hepatitis
* Any significant change in chronic treatment medication within 14 days before inclusion
* Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers CYP3A4 sensitive or narrow therapeutic index substrate of CYP3A4
* Concomitant treatment gastric pH modifying agent
* Positive result on any of the following tests: anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
* Positive result on urine drug screen
* Positive alcohol test.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Trial of MB-6 for Reduction of Neutropenia Induced by Chemotherapy in Patients With Stage III Colorectal Cancer.

This is a randomized, double-blind, placebo-controlled multi-center phaseⅢstudy to evaluate efficacy and safety of oxaliplatin-based chemotherapy plus MB-6(320 mg/capsule, 6 capsules tid) in patients with stage 3 colorectal cancer who underwent surgical excision of their primary tumor.

The investigational new drug, MB-6, in the proposed clinical trial is to be used as an adjuvant therapy for metastatic colorectal cancer patients. All of six extracts have been used in human with a long history, and many literatures reported the medicinal use either individually or as ingredients of formulations. MB-6 may provide its therapeutic benefits via inhibition of tumor induction or enhancing the efficacy of chemotherapy in colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women 20 years of age or older.
2. Histologically or cytologically confirmed stage 3 colorectal adenocarcinoma.
3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease.
4. No more than 8 weeks have elapsed from the time of surgery and have recovered from the effects.
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) \< 2 at the time of screening.
6. Hematological function: ANC≥1500/mm3, Hemoglobin ≥9.0 g/dL, Platelet count ≥100000/mm3.
7. Kidney function:Serum creatinine \<2 mg/dL.
8. Liver function: AST ≤3 times ULN, ALT ≤3 times ULN, Total Bilirubin ≤2 times ULN.
9. Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
10. Men and women of childbearing potential must agree to employ adequate contraception during the study period.

Exclusion Criteria:

1. History of second primary malignancies except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
2. Systemic chemotherapy, immune therapy or experimental or approved antibodies/proteins (e.g. bevacizumab) administered after surgery and prior to randomization.
3. Concurrent treatment with any other anticancer therapy.
4. Radiotherapy ≤14 days prior to randomization.
5. Any unresolved toxicity \> CTC (Common Toxicity Criteria) grade 1 from previous anti-cancer therapy (including radiotherapy) except haematological toxicity and alopecia.
6. Patients with congestive heart failure, epilepsy, or other significant medical conditions as judged by the investigator.
7. Contraindications to FOLFOX chemotherapy: peripheral neuropathy NCI CTC \>1, liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months before randomization.
8. Patient of child-bearing potential is evidently pregnant or is breast feeding.
The Clinical Study on Isoflavone Genistein in Restructuring the Gut Microbiota of Hyperlipidemia Patients

: In preliminary animal experiments, we found that the soybean isoflavone compound Genistein could reduce serum TMAO levels in high-fat diet (HFD) mice, and this effect was dependent on the gut microbiota. Furthermore, we discovered that Genistein's regulatory effect on the gut microbiota in high-fat diet mice relies on the host colonic PKI-Nos2 pathway. Genistein is an isoflavone compound extracted from soybeans and is the most effective functional ingredient in soybean isoflavone products. It has multiple physiological functions, and several randomized controlled trials (RCTs) have shown that the intake of Genistein can effectively alleviate hyperlipidemia, obesity, metabolic syndrome, and cardiovascular diseases, suggesting its safety and efficacy as a clinical health supplement. Therefore, we aim to conduct clinical trials to further demonstrate that Genistein also influences the gut microbiota in hyperlipidemia patients, thereby reducing serum TMAO levels.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 30-65 years old, regardless of gender
* Abnormal donation and loan: including elevated total cholesterol and triglycerides, high triglycerides, and high triglycerides
* Volunteer to participate in clinical trials, understand and sign the informed consent form

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
* Patients with gastrointestinal or chronic infectious diseases (i.e., diarrhea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticular disease, gastric or duodenal ulcer, hepatitis, HIV, cancer, etc.), or with a history of such diseases
* Chronic or acute kidney disease, eGFR \< 50 in two or more laboratory tests in the past 6 months; diagnosis of cirrhosis or liver failure; hyperkalemia (defined as potassium \> 5.4 in two or more laboratory tests in the past 6 months)
* Severe immunodeficiency (HIV positive, transplant patients, taking anti-rejection drugs, taking steroids for \> 30 days, or receiving chemotherapy or radiotherapy in the past year)
* Alarm features such as weight loss, rectal bleeding, recent changes in bowel habits (\< 3 months), or abdominal pain
* Patients with malignant diseases or any concomitant end-stage organ diseases
* Patients who have taken any antibiotics or dietary supplements (prebiotics, probiotics, fiber, resveratrol, fish oil, seed oil, ginkgo leaf, ginseng, fruit powder extract and DHA) within one month
* Patients who have taken any Chinese patent medicine or Chinese herbal decoction within one month
* Avoid eating seafood or fish 24 hours before each visit
* Vegetarian/vegan diet or food allergies or other food problems that will prevent the intake of research products
* Pregnant or preparing for pregnancy and breastfeeding women
* Allergic constitution, or known allergy to isoflavone genistein
* Participating in other drug clinical studies within 1 month
* According to the investigator's judgment, the patient cannot complete this study or cannot comply with the requirements of this study (due to management reasons or other reasons)
Anatomical Resection of the Liver for Hepatocellular Carcinoma: a New Ultrasound Guided Approach

Anatomical resection is the gold standard approach for liver resection in patients with HCC. A new method for that by means of IOUS-guided finger compression has been devised.

We herein describe a novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to systematically accomplish anatomical segmental and subsegmental resections.

Using the IOUS, the tumor and the level targeted for compression are identified. Than, under the IOUS guidance, the surgeon compresses bilaterally the liver at the targeted position resulting in the compression of the portal pedicle feeding the tumor previously identified. This maneuver is constantly monitored in real-time just using the same microconvex probe, and it is maintained until the surface of the targeted liver area begins to discolor, at that time the first assistant marks the discolored area with the electrocautery, and the compression is released. Once the area is demarcated, liver dissection is started under intermittent Pringle's maneuver.

Eligibility Criteria:
Inclusion Criteria:

* Patients suitable for surgical approach carries of HCC
* Serum bilirubin level lower than 1.5 mg/dl

Exclusion Criteria:

* Presence of ascites
* Serum bilirubin level equal or higher than 1.6 mg/dl
* Conditions (size, vascular relation, or infiltration) demanding resection larger than a segmental area
* Tumor thrombus in portal or hepatic veins