cyrilzakka/clinical-trials huggingface dataset:
Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia

The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial neoplasia.

The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of the ocular surface. Classic treatment is complete excision with safety margins, however, usually the edges are not sharp and difficult clinical differentiation between healthy areas that are not; to this treatment has joined him carrying out cryotherapy bedding and borders . Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been used either as adjuvant or primary treatment . Among the drugs used the investigators have mitomycin C (MMC) and interferon alpha 2b (INFα 2b).

Controlled clinical trial , single-blind , randomized . Non-probability sampling of consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic clinical evaluations and photos will be made. Time of resolution, resistance and adverse effects will be determined.

Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).

Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of corneal and conjunctival intraepithelial neoplasia (CIN) with no history of ocular neoplasia

Exclusion Criteria:

* Patients who did not agree to participate in the study.
* Patients with corneal abrasion
* Patients who have the diagnosis of CIN, but are pregnant
Efficacy and Safety of Daclatasvir Plus Asunaprevir in Chronic Hepatitis C

We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Males and females, ≥ 18 years of age
3. HCV Genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, OR intolerant or ineligible to P/R due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, OR treatment naive
4. HCV RNA ≥ 10,000 IU/mL
5. Subjects with compensated cirrhosis are permitted
6. Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg)
7. Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug. Additionally, all fertile males with partners of childbearing age and all females with childbearing potential must use reliable contraception method during the study and for 3 months after treatment completion.

Exclusion Criteria:

1. Inability or unwillingness to provide informed consent or abide by the requirements of the study
2. Other than genotype 1 infection
3. Prior treatment of HCV with HCV direct acting antiviral agents (DAA)
4. Patient who has any history of major organ transplantation with an existing functional graft or Patient who has plan to receive organ transplant
5. Diagnosed or suspected hepatocellular carcinoma or other malignancies
6. Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
7. Evidence of a medical condition contributing to chronic liver disease other than HCV
8. Uncontrolled diabetes or hypertension
9. Women with ongoing pregnancy or who are breast feeding
10. Evidence of alcohol and/or drug abuse
11. Patient who has NS5A resistance associated variant
Subclinical Nail Involvement in Relevant Skin Diseases

Onychopathies constitute one of the major challenges faced by a dermatologist in terms of its early detection and diagnosis .

Many disorders can affect the nails, including deformity and dystrophy, infections, and ingrown toenails. Infections can involve any part of the nail and may or may not change the nail's appearance. Most nail infections are fungal (onychomycosis), but bacterial and viral infections occur .

Nails are characteristically affected in skin diseases such as psoriasis (speckling, psoriatic oil spot, crumbling nails, pachyonychia) ,lichen( anonychia, dystrophy) ,alopecia areata (speckling, trachyonychia, longitudinal grooves, leukonychia), atopic dermatitis (shiny nails, transverse grooves, speckling, paronychia) and other diseases.

Nail disorders are assessed by clinical inspection, dermatoscopy , microbiological (including mycological) testing, and histopathological examination by nail biopsy .

Utility of dermoscope as a tool for detection is increasing by the day and its use in onychopathies needs to be explored .

Nail dermoscopy has initially been used for the assessment of nail pigmentation . But its utilization has expanded for the diagnosis of all nail disorders; it became a routine diagnostic instrument, as its reveals helpful information. Dermoscopy can be applied to all visible parts of the nail unit, and even the nail matrix can be studied, in conjunction with intraoperative methods .

Nail dermoscopy offers many advantages. Mostly, it enhances visible nail features; however, it can also help identify additional unique and fascinating features, not visible to the naked eye. It is practical, noninvasive and still opens up a second microscopic level of inspection. It contributes toward confirmation of diagnosis and assessment of treatment response as well as prognosis.

In a cross-sectional study to detect signs of subclinical nail involvement in 68 patients with chronic plaque psoriasis, Forty-six patients showed nail dermoscopic findings. Coarse pits, onycholysis, oil drop sign and splinter hemorrhages were seen .

To the best of the investigator's knowledge, no available studies in the literature evaluate subclinical nail affection in skin diseases as lichen planus, atopic dermatitis and auto immune bullous diseases. Hence, with the help of a dermoscope,early diagnosis and appropriate treatment can be instituted.

Eligibility Criteria:
Inclusion Criteria:

- Patients complaining of common skin diseases ( psoriasis, atopic dermatitis, alopecia, lichen planus, and bullous diseases)

Exclusion Criteria:

* Patients who had gross visible nail changes will be excluded
Effects of Canagliflozin on Intravascular Volume and Hemodynamics

RESEARCH HYPOTHESIS

* In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks.
* Treatment with canagliflozin will be well tolerated over 4 weeks.

This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (Figure 1). Thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (QD) or placebo. The study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase.

Eligibility Criteria:
Inclusion Criteria:

* on stable doses (more than 3 months) of antihyperglycemic agents (except for an SGLT2 inhibitor and insulin)
* have an A1c ≥7% and ≤11%
* Estimated glomerular filtration rate (eGFR) must be ≥45 ml/min•1.73 m2
* have an NT-proBNP ≥500 pg/mL
* be on a stable dose of guideline-directed HF medication (i.e., angiotensin converting enzyme \[ACE\] inhibitor, angiotensin II receptor blocker \[ARB\], or angiotensin receptor neprilysin inhibitor \[ARNI\], β-blocker, diuretics, and/or mineralcorticoid receptor antagonist) for at least 4 weeks
* be on stable antihypertensive therapy for at least 2 months

Exclusion Criteria:

* T1DM
* repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose measurements ≥240 mg/dL or both
* during the pretreatment phase, NYHA Class IV HF status, uncontrolled hypertension as defined as systolic blood pressure (SBP) \>160 or diastolic blood pressure (DBP) \>100 mmHg
* liver disease (ALT or AST \>3 x ULN)
* anemia Hb\<10
* anticipated cardiac surgery or coronary intervention within the next 3 months
* severe unremediated valvular heart disease
* major CV event (e.g., MI, cerebrovascular accident) within 3 months prior to screening visit
* hospitalization for HF within 2 months prior to screening visit
* documented atrial fibrillation
* history of atraumatic amputation within past 12 months of screening or critical ischemia of the lower extremity within 6 months of screening
* an active skin ulcer, osteomyelitis, or gangrene
* have an allergy to iodocyanine green and inulin
A Mobile Phone Based Medication Reminder Program

This study evaluates the feasibility and acceptability of using mobile applications to improve medication adherence. Participants in the experimental group will receive educational materials and daily reminders through mobile applications. While, participants in the control group will receive only educational materials. After the intervention, interviews will be conducted among participants through phone calls.

The purpose of this study is to improve medication adherence for Chinese patients with coronary heart disease (CHD) by using mobile applications. An exploratory randomized controlled trial (RCT, N=49) and interviews (n=15) will be included in this pilot study. The RCT will compare the effects of the medication adherence (MA, n=24) intervention and control condition (n=25) on the MA score (percent of prescribed antihypertensive drugs taken), and health outcomes (SBP and DBP obtained) of patients. The health outcomes will be assessed at enrollment and every three days after the intervention begins for thirty days. Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study). Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through focus group interviews. All analyses will be performed using SAS 9.3 (Cary, NC). The potential risks of this study are minimal.

Eligibility Criteria:
Inclusion criteria for participants are:

* having a medical diagnosis of CHD
* being eighteen years old or older
* having an antihypertensive medication regimen that lasts for forty-nine days or more at the enrollment
* being able to read messages through mobile phone
* having a mobile phone which can receive messages from WeChat, and can receive daily reminders from BB Reminder
* having no obvious cognitive impairment
* patients with comorbidities can be included in the study, but during the study, antihypertensive medications are their only prescribed medications (this will be screened by the cardiologist).
Effects of InFat™ Product on Stool Biochemistry and Stool Characteristics in Formula-fed Term Chinese Infants

The purpose of this study is to demonstrate the efficacy of infant formula having proportion of palmitate in the sn-2 position comparable to human milk in Chinese term infants.

In human breast milk, and in most infant formulas more than 98% of this milk fat is in the form of triglycerides, which contain saturated and unsaturated fatty acids esterified to glycerol. Fatty acids in human milk-fat have a highly specific positional distribution on the glycerol backbone and this specific configuration is known to have a major contribution to the efficacy of this nutrient absorption.

Palmitic acid (C16:0), the major saturated fatty acid, is predominantly esterified to the sn-2 (β) position of the triglyceride in human milk. In contrast, palmitic acid in standard infant formulas is esterified to the sn-1 and sn-3 positions.

Infants fed with high sn-2 palmitic acid formula had softer stools, less constipation and better calcium absorption as compared to standard infant formula.

InFat™ is structured triglyceride fat ingredient with high levels of palmitic acid at sn-2 position.

The primary objective of this trial is to demonstrate that feeding Chinese term infants, with formula having proportion of palmitate in the sn-2 position comparable to human milk, reduces calcium-soaps formation.

Eligibility Criteria:
Inclusion Criteria:

* Term infants: gestation 37-40 weeks
* Birth weight 2500-4000 g
* Apparent good health
* The infant is a product of normal pregnancy and delivery.

Exclusion Criteria:

* Any maternal disease (psychological or disabled) or socioeconomic problems that may interfere with the mother's ability to take care of her infant
* Major congenital abnormality or chromosomal disorder with a clinical significance that can be detected at birth, clinically significant
* Disease requiring mechanical ventilation or medication treatment at the first week (not including photo treatment for infantile hepatitis)
* Born with a 5- or 10-minute Apgar score \<7
* Any suspected or known metabolic or physical limitations interfering with feeding or normal metabolism (require a special formula)
* Breast-feeding for a week or over.
* Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study.
A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM

This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes according to World Health Organization (1999) diabetes diagnosis standard;
* Age 18-75 years, men and women;
* BMI 19-35 kg/m2;
* HbA1c 7.0%-9.5%;
* Before screening, a stable Metformin dose（≥1000mg/day）should be maintained for at least 8 weeks.
* Signed informed consent from the patient;
* Agree to use contraceptive measures from the date of signing the informed consent to 1 month after the end of the last medication.

Exclusion Criteria:

* FPG \> 13.9 mmol/L;
* Insulin treatment required in the investigator's opinion;
* Administration of antidiabetic drugs (except for metformin) including insulin, rosiglitazone, pioglitazone, DPP-4 inhibitor, Glucagon like peptide-1 (GLP-1) receptor agonist for 8 weeks before screening;
* Acute complications of diabetes (including diabetic ketosis and ketoacidosis, hyperosmotic nonketotic diabetic coma, lactic acidosis and hypoglycemia coma);
* Severe hypoglycemia;
* Serious diabetic complications (such as diabetic foot, etc.);
* History of acute or chronic pancreatitis, or related diseases that are most common cause of acute pancreatitis (such as recurrent cholelithiasis, etc.);
* History of being allergic to DPP-4 inhibitors;
* Untreated hyperthyroidism and other diseases which may cause secondary hyperglycemia;
* Previous treatment with glucocorticoids (except for external use and inhalation) within 4 weeks before screening or may be used for more than 14 consecutive days during the study;
* Inflammatory bowel disease, partial intestinal obstruction or chronic bowel disease related to obvious digestive and absorption disorders;
* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 3\*upper limit of normal (ULN), or total bilirubin \> 1.5ULN;
* Abnormal renal function;
* White blood cells (WBC) \< 3.0109/l, neutrophil count of peripheral blood \< 1.5109/l, hemoglobin \< 100g / L, triglyceride \> 5.7 mmol/l;
* HBsAg, HBeAg or HBcAb positive, or any one of hepatitis C antibody, anti-HIV antibody and nonspecific antibody of Treponema pallidum positive;
* Pregnant or lactating women;
* History of alcohol or drug abuse;
* Participation in other clinical trials or administration of any other investigational drugs or devices within 3 months before screening;
* Significant unstable diseases;
* Any condition that in the investigator's opinion might render the patient unable to participate the trial.
Surface Mechanomyography Using a Parasternal Patch to Measure and Detect Respiratory Drive and Effort

Surface mechanomyography (sMMG) has been proposed as a tool to study muscle mechanical activity. sMMG is a noninvasive technique using specific transducers to record muscle surface oscillations due to mechanical activity of the motor units . It could be of major interest for the detection of respiratory efforts in patients with respiratory failure. This study aims at assessing the performances of sMMG to measure and detect respiratory drive and effort in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer
* Age \> 18 and \< 60
* Informed consent
* Fasting
* Subjects covered by or having the rights to medical care assurance

Exclusion Criteria:

* Obesity (BMI \> 30 kg.m-2)
* Respiratory disease
* Cardiovascular disease
* Contraindication to the insertion of a nasogastric tube
* Incapacity to consent
* Pregnancy, breastfeeding
* Bad understanding of the French language,
* Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act.
Multifocal Electrophysiologic Findings After Intravitreal Bevacizumab(Avastin)Treatment

Purpose: Determine the short-term safety of intravitreal bevacizumab by multifocal electroretinography (mf-ERG).

Methods: 120 eyes with choroidal neovascularization, proliferative diabetic retinopathy and retinal vein occlusion received intravitreal bevacizumab (2.5mg/0.1cc). All patients underwent best corrected visual acuity, fluorescein angiography, optical coherent tomography and mf-ERG before and 1 month after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Proliferative diabetic retinopathy, vascular vein oclussion, choroidal neovascularization
* Multifocal electroretinogram before intravitreal bevacizumab and at 1,3, and 6 months after treatment
* Completely studies

Exclusion Criteria:

Complications

* Tractional Detachment
* Endophthalmitis
TB-CAPT MTB/XDR Study

The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.


Eligibility Criteria:
Inclusion Criteria:

* Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra

Exclusion Criteria:

* Residual SR-sputum mix not retained or not found
* Patient previously included in the study

Exclusion for diagnostic accuracy and time-to-result endpoints:

* Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (\<2 ml)
* Xpert MTB/XDR unsuccessful
* No second / follow-up specimen received
* Second / follow-up specimen culture-negative, contaminated or not available
* Reference standard uninterpretable (phenotyping or WGS)

  * Where phenotypic susceptibility testing results are uninterpretable, specimens will still be included in WGS comparison
  * Where WGS results are uninterpretable, specimens will still be included in phenotypic susceptibility testing comparison
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed
2. Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
3. Males or females aged ≥18 years
4. Diagnosed Chronic hepatitis C virus infection

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3. Hepatitis B surface antigen (HBsAg) positive
4. Human immunodeficiency virus (HIV) positive

Other protocol-defined inclusion/exclusion criteria apply.
Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

Currently, Placenta Accreta Spectrum (PAS) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology).

The present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. Patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum.

A sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.

Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial.

We performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1step conservative surgery. In addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes.

Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over 18 years of age.
* History of previous cesarean section and anterior placenta previa
* Patients with prenatal diagnosis by ultrasound or MRI of PAS, regardless of the suspected degree of severity of the disease.
* Requirement for surgical management of placental accreta on a scheduled basis.
* Patients without active vaginal bleeding in the period immediately before surgery (Patients entering the operating room without active bleeding).

Exclusion Criteria:

* Women without previous living children.