cyrilzakka/clinical-trials huggingface dataset:
Effect of Choline Fenofibrate (SLV348) on Macular Edema

The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)


Eligibility Criteria:
Inclusion Criteria

* With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, confirmed after central reading of the OCT;
* When laser treatment can be safely postponed by up to at least 3 months;
* With established T2DM and HbA1c \< 10%;
* With systolic blood pressure (SBP) or diastolic blood pressure (DBP) \< 160/90 mmHg;
* With documented elevated triglyceride levels (TG \>=150 mg/dL \[1.70 mmol/L\]) at the screening visit or in the previous 3 months.

Exclusion Criteria

* Previous laser photocoagulation;
* Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma;
* Poor visual acuity: visual acuity of 20/800
Bioequivalence Study of Torrent Pharmaceutical Limited's Isosorbide Mononitrate 120 mg ER Tablets Under Fed Conditions

Objective:

to compare the single dose bioavailability of Torrent's Isosorbide Mononitrate 120 mg ER Tablets (Test) and Isosorbide Mononitrate 120 mg ER Tablets (Reference) of Kremers Urban, USA under fed condition. Dosing periods were separated by a washout period of 8 days.

Study Design:

randomized, two-way crossover, single-dose, open-label study in healthy human adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy males within the age range of 18 to 55 years.
* A body mass index within 18-25 Kg/m2.
* Given written informed consent to participate in the study.
* Absence of diseases markers of HIV 1 \& 2, Hepatitis B \& C virus and RPR.
* Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history and physical examination during the screening.
* A normal 12-lead ECG.
* A normal chest X-Ray.
* Comprehension of the nature and purpose of the study and compliance with the requirements of the entire protocol.
* No history or no evidence of hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.
* No history of allergic rash.
* No history of significant systemic diseases.
* No history of psychiatric disorders or addiction to any recreational drug or drug dependence.
* No donation of blood within 56 days prior to study check-in.
* No participation in any clinical study within the past 56 days.
* No receipt of any prescription drugs or OTC products, with in two weeks prior to study check-in.
* No history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to study check-in.
* No family history of neurological disorders.
* Not consumed alcohol and xanthine containing food and beverages, cigarettes and tobacco products, for at-list 48 hours, prior to study check-in.
* Negative results for drugs of abuse in urine and alcohol breath analysis during check-in of each period.
* Not consumed grape fruit juice within the 48 hours prior to study check-in.

Exclusion Criteria:

* Blood pressure Systolic\> 140 mm Hg and \< 110 mm Hg Diastolic\< 70 mm Hg \> 90 mm Hg
* History of seizures
* History of alcohol consumption for more than 2 units/day.
* High caffeine or tobacco consumption
* History of difficulty with donating blood or difficulty in accessibility of veins.
* Any unusual or abnormal diet, for whatever reason e.g. fasting due to religious reasons.
* Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
Early CPAP in Respiratory Distress Syndrome

The purpose of this study is to establish if a strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.

The application of CPAP has been described as an alternative respiratory support for premature newborns with respiratory distress.Many studies support that the early use of CPAP results in a better respiratory evolution and less need for mechanical ventilation.

Hypothesis:

- The hypothesis is that EBCPAP will decrease the need for this more invasive therapy.

The primary endpoint in this multicenter controlled study is to establish if an strategy of EBCPAP application in a subgroup of VLBWI, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. .

As secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (BPD) at 28 days and 36 weeks corrected gestational age.

Comparison(s):

Early Bubble CPAP (EBCPAP)with Standard Therapy which is oxygen.

Eligibility Criteria:
Inclusion Criteria:

* All infants born at the units belonging to the South American Neocosur Network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with Neopuff or transient intubation are eligible.
* An informed consent form should be obtained preferable prenatal.

Exclusion Criteria:

* Acute life threatening congenital malformations or genetics diseases.
* Apgar score equal or less than 3 at 5 minutes
* Disapproval of informed consent.
IBSR Intervention for Adults Who Stutter

Stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. It is often accompanied not only by verbal difficulties but also by negative impact on several psycho-social aspects in the life of the people who stutter.

Recently, clinical evidences have shown the effectiveness of Inquiry Based Stress Reduction (IBSR) technique to improve psychosocial symptoms and enhance well-being in clinical and non-clinical samples. IBSR, the clinical application of Byron Katie's "The Work", enables individuals to mindfully spot and investigate in a systematic and comprehensive manner thoughts that lead to stress and suffering by a series of questions and turnarounds. IBSR was found to have significantly positive influence on the quality of life, mental well-being and stress management in a variety of populations which suffer from elevated levels of stress, suffering, tension and anxiety, and to enhance resilience of non-clinical general population.

In our research we hypothesized that:

1. Adults who stutter will have high levels of anxiety, and low levels of psychological flexibility and satisfaction with life.
2. IBSR intervention will improve experience of stuttering in adults who stutter.
3. IBSR will decrease anxiety levels and enhance psychological flexibility and satisfaction with life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either developmental or acquired stuttering.
* Age of 18 years or above.
* Capability to understand and fill out the study outcome instruments and informed consent form.

Exclusion Criteria:

* Diagnosis of severe mental illness.
* Inability to understand or read Hebrew.
* Subjects who declare they can not take a part in the trial throughout its whole duration.
A Phase III Trial For Patients With Metastatic Breast Cancer

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
* Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
* Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
* Patients must have either measurable or non-measurable (evaluable) disease
* Prior radiation therapy allowed of less than 25% of the bone marrow

Exclusion Criteria:

* Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
* Parenchymal or leptomeningeal brain metastases
* Peripheral neuropathy greater than or equal to grade 2
* Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
* Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
* Concomitant Herceptin is not allowed
A Phase II Study of SSGJ-707 Combination Therapy in Advanced NSCLC Patients

This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC.

This study is a study of SSGJ-707 combination therapy in First-line advanced NSCLC Patients. This study includes two parts, part A is for non-squamous NSCLC and part B is for squamous NSCLC. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-707 in advanced NSCLC Patients.

Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented local advanced or metastatic NSCLC .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clinical Investigation of Non Invasive Fat Reduction

The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.


Eligibility Criteria:
Inclusion Criteria:

* A healthy non-smoking male or female between 20-60 years of age
* Subjects presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
* Subjects who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
* Understand and accept the obligation associated with the procedure
* Subjects with Fitzpatrick skin types I to III.
* Subjects who are willing to consent to participate in the study will be asked to undergo biopsies, ultrasound measurements, and blood testing as outlined for each group and defined in section 6.0.
* Subjects must agree to maintain the same diet and exercise regime throughout the study

Exclusion Criteria:

* Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
* A history of allergic reactions to medications or anesthesia required for the procedure
* A history of thrombophlebitis
* A history of acute infections
* A history of heart failure
* Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
* Intolerance to anesthesia or medications to be prescribed before or after the procedure.
* Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study including EMLA cream or percocet
* Taking medications that are photosensitive
* A history of keloid formation
* A study subject must not be pregnant or have been pregnant in the last 3 months
* The physician has the right to make determination of eligibility as he/she deems clinically significant based on standard of care treatment
Comparison of Clinical Outcome Among Vaccinated and Unvaccinated Coronavirus Disease Patients in Critical Care Unit.

Corona virus disease has been a pandemic since its beginning. The problem has scaled to break health care system of multiple countries. One of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. No vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. The investigators are conducting a study comparing outcome among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital, Kathmandu , Nepal .

Coronavirus disease has been a pandemic since its beginning. The problem has scaled up and health care system of multiple countries have reached to a breaking point . One of the prime strategy of preventing this disease has been large mass scale vaccination campaign ongoing worldwide. No vaccine has been proven to 100 percent effective in preventing the infection with coronavirus disease so far. The investigators are conducting a study comparing difference in outcome with regard to mortality and length of critical care unit stay among vaccinated and unvaccinated population admitted to critical care unit of civil services hospital , Kathmandu , Nepal.

Since different groups of population received different vaccine according to age profession and other factors investigators are trying to study the effectiveness of vaccine with regards to type of vaccine.

Eligibility Criteria:
Inclusion Criteria:

patients proven to have covid 19 infection patients more than 18 years of age patients admitted to critical care unit

Exclusion Criteria:

* patient below 18 years of age patients who do not have covid 19 infection
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures

The purpose of this study is to determine how frequently children undergoing elective neurosurgical procedures develop blood clots in the deep veins of the legs while hospitalized. The information gained from this study will help us determine when children children need to receive therapy to help prevent this type of blood clot from forming.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 1 month-12 years undergoing elective neurosurgical procedures.

Exclusion Criteria:

* Patients undergoing outpatient neurosurgical procedures
* Patients with known DVT
* Patients with known hypercoagulable state
* Patients at high risk for DVT (discretion of surgeon in consultation with the hematology service)
Voice Analysis for Monitoring Patients With Heart Failure

This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with Acutely Decompensated Heart Failure.
* At least 18 years of age.

Exclusion criteria:

* Disabling mental diseases (e.g., Alzheimer's disease)
* Clinically diagnosed chronic obstructive pulmonary disease (COPD)
* Treatment in ICU or IMU
* Dialysis treatment
* Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
* Neurodegenerative diseases
* Pregnancy
* Inability to provide consent
TelePremie: Telehomecare for Step-down Care Post-NICU Discharge

Telehealth is a means of providing care from a distance, at the convenience of the patient. This study will be testing the addition of Telehealth visits (TH) to the standard of care (SOC) following discharge from the neonatal intensive care unit (NICU). This study will be used to determine whether Telehealth appointments post-NICU discharge can improve the experiences of parents in caring for their infant and reduce the number of health care visits they have with their infant within three months post-NICU discharge.

Participants in this study will be randomly assigned to two groups. One group will receive the standard of care, which means they will have an appointment in place with a primary care provider, pediatrician or return visit to the NICU post discharge. The second group will have the standard of care described above and two Telehealth visits within the first week at home with their infant.

The study will explore the experiences of parents of NICU infants following their discharge from NICU, both those receiving standard of care (SOC) and the Telehealth monitoring intervention. Participants will be required to complete surveys online at 5 time periods: when parents decide to be part of the study, prior to discharge from NICU, 1 day after discharge, 2 days following the primary care provider visit and at 3 months following discharge from NICU. The questionnaires used will measure parental anxiety levels and parental confidence. The number of infant visits to the primary care provider, pediatrician, emergency department and NICU will also be collected at three months post-NICU discharge.

A subset of participants (from both SOC and TH groups) will further participate in semi-structured interviews about their experiences in the NICU and caring for their children after discharge. NICU clinicians who consent will participate in semi-structured interviews about their experiences with the Telehealth intervention.

The cost-effectiveness of the Telehealth intervention will be analysed in comparison to SOC.


Eligibility Criteria:
Inclusion Criteria:

* Parent-infant pairs admitted to neonatal intensive care unit where study is conducted.
* Parent has internet access.
* Parent has literacy level such that they are comfortable reading and filling out surveys.
* Infant is likely to survive.

Exclusion Criteria:

* Infant discharged to foster care.
* Infant transferred or discharged within 3 days of admission to neonatal intensive care unit.
A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine with or without aura according to the recent IHS criteria.
* Migraine headaches must have been present for more than one year.
* History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.

Exclusion Criteria:

* Subjects with current or past history of coronary artery disease.
* Pregnant or breastfeeding women.
* Subjects who have chronic daily headaches.
TACE Combinated With Sorafenib in Treating Patients With Unresectable Hepatocellular Carcinoma

TACE is widely used in patients with unresectable HCC. However, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. Sorafenib is regarded as standard treatment for advanced HCC. It is the first systemic therapy to demonstrate a significant survival benefit in HCC patients.The hypothesis is that the combination of TACE with sorafenib could improve the survival of patients with unresectable HCC.


Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
* BCLC stage B or C
* Child-Pugh class score≤8
* ECOG performance status ≤2
* Etiology: Hepatitis B virus(HBV) infection
* Written informed consent (approved by the Institutional Review Board \[IRB\]obtained prior to any study specific screening procedures
* Patient must be able to comply with the protocol
* Age 18-75 years
* Haematology:Absolute neutrophil count (ANC) \> 1.5 x 109/L, Platelet count \> 50 x 109/L, Haemoglobin \> 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio \< 1.5
* Biochemistry:Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\< 5 x the upper limit of normal,Total bilirubin \< 3 x the upper limit of normal,Serum creatinine \< 1.5 x the upper limit of normal,Cholinesterase\>0.5x the lower limit of normal，Prealbumin\>0.5x the lower limit of normal.
* Life expectancy of \> 3 months

Exclusion Criteria:

* BCLC stage D
* Child-Pugh Score≥9
* Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment
* Preexisting or history of hepatic encephalopathy
* uncontrolled hypertension
* Pregnancy (positive serum pregnancy test) or lactation
* Serious, non-healing wound, ulcer, or bone fracture
* Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
* Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
* Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications
* Other severe concomitant disease that may reduce life expectancy
* Risk of allergic reactions to the study drugs
* Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results
Reliability for the Detection of Sperm DNA Damage by a Sperm Chromatin Dispersion Test (Halosperm)

It is proposed to measure sperm DNA damage by sperm chromatin dispersion test. This measurement helps to better diagnose male infertility and seems easy to apply in routine. However, the reliability of this method needs to be evaluated before applying for clinical practice in andrology laboratory.

The aim of this study is to measure the inter and intra-observer reliability for the measurements of sperm DNA damage by sperm chromatin dispersion test (halosperm). The gold standard to measure sperm DNA damage is TUNEL (Terminal desoxynucleotidyl end labelling) method. However, this method is not easy to apply in routine. Therefore we investigate to analyse the inter-method reliability between sperm chromatin dispersion test and TUNEL.

Eligibility Criteria:
Inclusion Criteria:

* infertile men
* \<50 years
* with at least 5.106spermatozoa/ml in the ejacu

Exclusion Criteria:

* azoospermia