cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of oral Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy. The study will consist of 2 parts, Part A and Part B. Part A will include a 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B of the study will consist of a 12-month observational Follow up Period; no study drug will be administered during Part B. Part A and B will be blinded. Safety will be monitored by an independent Data Safety Monitoring Board.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male patients ≥18 years
2. Biopsy-verified IgA nephropathy
3. Stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or Maximum Tolerated Dose (MTD) according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) guidelines
4. Urine protein creatinine ratio ≥1 g/24hr
5. eGFR ≥35 mL/min per 1.73 m2 and ≤90 mL/min per 1.73 m2 using the Chronic Kidney Diseae Epidemiology Collaboration (CKD-EPI) formula
6. Willing and able to give informed consent

Exclusion Criteria:

1. Systemic diseases that may cause mesangial IgA deposition.
2. Patients who have undergone a kidney transplant.
3. Patients with acute or chronic infectious disease including hepatitis, tuberculosis, human immunodeficiency virus (HIV), and chronic urinary tract infections.
4. Patients with liver cirrhosis, as assessed by the Investigator.
5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
6. Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator;
7. Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator
8. Patients with diagnosed malignancy within the past 5 years.
Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic genotype 1 HCV infection
* Patient has had a liver biopsy without evidence of cirrhosis
* Patient has had an eye exam prior to the start of study
* Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study

Exclusion Criteria:

* Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV
* Female patient is pregnant or breastfeeding
* Patient has chronic hepatitis not caused by HCV
* Patient has evidence of cirrhosis of the liver
* Patient has HIV
* Patient has active hepatitis B infection
* Patient has non-genotype 1 HCV infection
* Patient consumes excessive amounts of alcohol
Double-blind, Placebo-control, Study to Evaluate the Safety and Pharmacokinetics of CT-044 HCl, in Healthy Volunteers

This study will be conducted to assess safety, tolerability, and PK of CT-044 HCl in normal healthy volunteers, in a traditional sequential multiple ascending dose paradigm. The multiple-dose escalation is designed to mimic the manner in which the product (CT-044 HCl) would be used to manage ongoing pain in patients (i.e., multiple dosing).

Subjects meeting all inclusion and exclusion criteria will be randomized to receive CT-044 HCl or placebo in three successive dose escalating cohorts of 8 subjects each (2 placebo and 6 active drug per dose level). Subjects will receive multiple oral CT-044 HCl doses for 7 days. Subjects will be monitored in-house for vital signs, physical examination, electrocardiogram (ECG), safety laboratory testing and documentation of adverse signs and symptoms. Serial blood and urine samples will be collected to evaluate CT-044 HCl levels in plasma and urine.

Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing (Day -1) and remain in house until Day 9 (discharge day). Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up (Day 13, ± 1 day).

Eligibility Criteria:
Inclusion Criteria:

* Body mass index within the range 18.5 to 32.0 kg/m2 (inclusive).
* Healthy subjects as determined by medical history, physical examination including neurological examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
* Negative tests for hepatitis B surface antigen, hepatitis C virus antibodies and human immunodeficiency virus (HIV-1 or HIV-2) antibody, and syphilis.
* Nonsmokers (use of any nicotine containing product) or ex-smokers (have ceased smoking for at least 3 months and do not use any drug for smoking cessation.
* Negative screen for alcohol and drugs of abuse.
* Women must not be of childbearing potential by reason of surgery or at least 1 year post-menopausal (i.e., 12 months without menstrual period), or menopause.
* Men must be infertile (at least 3-months post-vasectomy), or truly abstinent of heterosexual intercourse, or heterosexual partner is not of childbearing potential or must agree to use an effective method of contraception. Men must agree to not provide sperm donation during that same period.
* Able and willing to be available for the duration of the study.
* Willing and able to give written informed consent to participate.
* Able to understand and comply with protocol instructions.
Long-term Efficacy and Safety Research of Left Bundle Branch Pacing

Patients with successful left bundle branch pacing in our center were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group; Purkinje potential group; and no-potential group. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

A total of 136 patients with a high percentage of ventricular pacing and successful left bundle branch pacing were included in this study from April 2018 to December 2019. Baseline data was collected, and pacing parameters, ECG and echocardiographic results were analyzed during 3 years follow-up. According to whether or not a potential was recorded and the specific potential characteristics at implantation, the patients were divided into 3 groups: left bundle branch potential group (L group) 31.6%; Purkinje potential group (P group) 10.3%; and no-potential group (N group) 58.1%. During the 3 years follow-up, the investigators collected the ECG、UCG and pacemaker parameters to analyze.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were predicted to require a high percentage of ventricular pacing in our center were enrolled in this study

Exclusion Criteria:

* Low rate of pacing, and loss to follow-up
Assessment of Near Vision Capacity in Different Light Intensities

Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa patients who underwent presbyopic correction with bilateral bifocal intraocular lenses implantation


Eligibility Criteria:
Inclusion Criteria:

* Presbyopia

Exclusion Criteria:

* Glaucoma
* Corneal pathology
* Fundus pathology
* Severe neurological/mental diseases that interfere with visual acuity
Deep Brain Stimulation for Morbid Obesity

This is an open-label, phase I pilot trial designed to evaluate the safety and feasibility of deep brain stimulation (DBS) for the treatment of refractory morbid obesity. Patients with diagnoses of morbid obesity will be recruited and enrolled. All patients will receive DBS targeting two brains areas involved in the pathophysiology of obesity and will be followed post-operatively for 12 months.

This study will establish 1)the safety of deep brain stimulation (DBS) in a patient population with treatment refractory morbid obesity. DBS has been used safely and effectively in thousands of patients for numerous disorders. Recent evidence (outlined above) has shown that DBS can also be used to manage refractory psychiatric conditions, such as depression and obsessive-compulsive disorder, as well as in eating disorders such as anorexia nervosa. Such studies indicate that a targeted therapy informed by the neuroanatomic and circuitry literature can be effective in altering pathological mood and behaviour. 2) evaluate the effectiveness of the procedure, which will be evaluated by the actual weight loss and resolution of the core symptoms of morbid obesity, including BMI, as well of, depression, self-esteem, and binge eating scores surrounding with loss or weight gain.

Eligibility Criteria:
Inclusion Criteria:

1. Female or Male patients between age 20-60
2. Diagnosis of Morbid Obesity (defined as a BMI\>40kg/m2 or BMI\>35 with 1 obesity related comorbidity) OR a diagnosis of Binge Eating Disorder not responsive to recommended treatments (as defined by the DSM-5)
3. Failure or non eligibility of bariatric surgery with \<50% of excess weight loss, with or without BMI\>35 kg/m2, at 18 months or more after the operation; OR diagnosis of binge eating disorder for over 18 months
4. Diagnosis of food dependence via Yale Food Addiction Scale (YFAS) criteria
5. Normal neurological exam
6. Normal head CT scan and cerebral MRI
7. Patient informed and able to give written consent
8. Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

1. Active neurologic disease such as epilepsy
2. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
3. Any contraindication to magnetic resonance imaging (MRI) or positron emission tomography (PET) scanning
4. Likely to relocate or move during the study's one year duration
5. Presence of cardiac arrhythmias, or other cardiac, respiratory, renal or endocrine conditions as a result of morbid obesity, that will result in significant risk from a surgical procedure.
6. Presence of epilepsy, stroke or degenerative disorder of the nervous system
7. Pregnancy
Bacteriological Study of Diabetic Foot and Antibiotic Sensitivity Pattern in Eastern India

The pattern of organism causing diabetic foot infection are presumed to vary from location to location depending on the antibiotic prescription practice, geographical locations, environmental variations and therapeutic interventions for various patients. Our hypothesis is look to finding out common similarities with diversified subgroups spread across various geographical locations of eastern part of India, thus to create a data base for treating patient with diabetic foot infections.The sensitivity pattern is anticipated to be different from institution to institutions and place to place but the gross sensitivity data of local pathogen could guide physician for choosing right empirical antibiotic. Practice guideline could be postulated from the collated data of distribution of pathogens, their sensitivity pattern as well as co-morbid conditions of the sufferers.


Eligibility Criteria:
Inclusion Criteria:

* diabetic foot patients with Wagner's grade 2 or more foot infection.
Study on the Role of Treatment With Vitamin E on Asthmatic Responses in Allergic Asthmatics

Asthma is a common respiratory disease of unknown etiology which currently affects approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the airways. Airway inflammation is evident not only in patients with fatal asthma but also in mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation, and has also been documented in asthma ( , ). However, the current understanding of the relationship between the inflammation and the oxidant stress in asthmatic airways is poor. Does oxidant stress contribute to the expression of asthmatic phenotypes independently of inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These questions have been nagging us since our laboratory provided credible evidence of oxidant injury in the airways of allergic asthmatics ( ). The purpose of our study is to more precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of antioxidant therapy using vitamin E in allergic asthma.


Eligibility Criteria:
Inclusion Criteria:

* Normal health status except for allergic asthma
* Physician diagnosis of mild allergic asthma
* Positive allergen skin tests to common aeroallergens

Exclusion Criteria:

* Use of systemic or high doses of inhaled corticosteroids, \>840 mcg of inhaled beclomethasone of its equivalent (as defined in the consensus report (6))
* Past history of severe asthma (as defined in the consensus report (6))
* History of asthma exacerbation within the past month
* History of recent upper respiratory infection within the past month
* Active immunotherapy for allergic diseases
* Significant disease other than allergic asthma and allergic rhinitis, such as coronary disease, hypertension, renal failure, anemia, immunodeficiency, cancer, diabetes
* Present or remote tobacco smoking
* Use of Over The Counter drugs including acetaminophen and pseudoephedrine, herbs, or vitamins
* Psychiatric illness that would make adherence to protocol difficult
* Inability to give informed consent
* Nursing or pregnant women
* Woman planning to become pregnant during the study or not using adequate birth control methods (barrier or hormonal methods)
* H/o sensitivity to tocopherol-derivatives or medications used during bronchoscopy
* Inability to comply with the research protocol
Usability of Zubsolv Sublingual Tablets 5.7/1.4 to Suboxone Sublingual Film 8/2 In Buprenorphine/Naloxone Treated Opioid Dependent Population

The primary objective of this study is to compare overall patient preference for either Suboxone® sublingual film 8/2 or Zubsolv® sublingual tablets 5.7/1.4. Suboxone sublingual film 8/2 contains 8mg buprenorphine and 2mg naloxone. Zubsolv sublingual tablets contain 5.7 mg buprenorphine and 1.4 mg naloxone. Both interventions act as a substitute for opiate drugs like heroin, morphine or oxycodone and help withdrawal from opiate drugs over a period of time.


Eligibility Criteria:
Inclusion Criteria:

* currently on a single daily dose of 8/2 of Suboxone or generic equivalent, or 5.7/1.4 mg Zubsolv for treatment of opioid dependence that has been medically confirmed.
* in good general health with no specific contraindication for treatment with buprenorphine or naloxone.
* the ability to understand, sign and date written consent and Health Information Portability and Accountability Act (HIPAA) authorization forms, which must be obtained prior to any study related procedures being completed.
* Female subjects must be postmenopausal for at least 2 years, surgically sterile (i.e. tubal ligation, hysterectomy, or bilateral ovariectomy), or practicing an effective method of contraception during the study with one of the following methods: oral contraception, intrauterine device (IUD), abstinence, contraceptive injections, conscientious use of a diaphragm or condoms and spermicidal foam, systemic (implant) contraception or partner has had a vasectomy.

Exclusion Criteria:

* Subject is taking other opioids (other than buprenorphine/naloxone) that may interfere with the study evaluations or compromise the safety of the subject.
* Subject is not able to read or have other impairments that may prevent completion of questionnaires or other study evaluations
* Subject has open sores present in the oral cavity.
* Subject has participated in any previous clinical testing involving investigational drug within the 4 weeks prior to study start.
* Subject is pregnant, lactating or planning a pregnancy
* Subject is currently participating in any other type of clinical testing.
* Subject has a medical condition that in the Investigator's opinion could affect the taste assessments required by the study
* Subject is judged by the Investigator after reviewing medical history to be unsuitable for any other reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes.
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity

This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.


Eligibility Criteria:
Inclusion criteria:

* Male or female.
* Age above or equal to 18 years at the time of signing informed consent.
* Body mass index (BMI) greater than or equal to (\>=) 35.0 kilograms per meter square (kg/m\^2).

Exclusion criteria:

* Glycated haemoglobin (HbA1c) \>= 6.5 percent (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening.
* History of type 1 or type 2 diabetes.
Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm Infants

A prospective cohort study investigating the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

The purpose of this study was to investigate the effect of the formation of gut microbiome on the neonatal disease and the prognosis of neurodevelopment in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants
* born less than 28+0 weeks gestation

Exclusion Criteria:

* Major congenital anomalies
Docetaxel, Cisplatin, and S-1 (TPS) Induction Chemotherapy in Locally Advanced Head and Neck Cancer

The purpose of this study was to evaluate the tolerability and efficacy of a combination of weekly docetaxel, cisplatin, and S-1 (weekly TPS) as induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

Combination chemotherapy with cisplatin and fluorouracil (CF) is the standard treatment for patients with locally advanced squamous cancer of the head and neck. CF chemotherapy has been reported to increase survival and disease free survival in patients with unresectable disease when given before definitive radiotherapy, showing overall response rate as 75-85% including of CR rate of 25-35%. To improvement of treatment, docetaxel was incorporated into CF as induction treatment and it showed the prolongation of progression free survival and overall survival in large scale of randomized phase III trials, therefore triple combination induction regimen would be standard treatment in advanced head and neck cancer. Recently, the introduction of oral fluoropyrimidine showed similar or enhanced response rate, also favorable safety and convenience than intravenous fluoropyrimidine in advanced gastric cancer. Of the oral fluoropyrimidines, S-1 showed promising preliminary result in combination chemotherapy with cisplatin in head and neck cancer. In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid, 60mg/m2 (D1) and 60mg/m2 (D1), respectively. Therefore, the aim of this study was to evaluate the efficacy and safety of docetaxel, cisplatin and S-1 combination chemotherapy according to above dosage.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced stage III or IV squamous cell carcinoma of the larynx, oropharynx, or hypopharynx
* ≥18 years old
* absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL
* serum bilirubin \<2.0 mg/dL
* creatinine \<1.5 mg/dL
* serum transaminase levels less than twice the upper limit of normal

Exclusion Criteria:

* received previous chemotherapy
* another malignancy
* current or history of distant metastasis
* history of clinically significant cardiac disease within 6 months
* active serious infection
* nasopharyngeal carcinoma
* psychiatric illness that would preclude obtaining informed consent