cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions

The objective of this study was to evaluate the relative bioavailability of the test formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation PROSCAR® 5 mg Tablet (Merck \& Co., Inc.)under fed conditions in healthy adult male subjects.

This randomized, single-dose, two-treatment, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 5 mg finasteride tablets under fed conditions. The study was conducted with 26 (24 completed) healthy adults. The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Males, 18-65 years of age (inclusive).
2. A body mass index (BMI) of 18-30 kg/m2 inclusive as calculated according to Novum Standard Operating Procedures.
3. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
4. Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

1. Female.
2. History of allergy or sensitivity to finasteride, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
4. Presence of gastrointestinal disease or history of malabsorption within the last year.
5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
6. Presence of a medical condition requiring regular treatment with prescription drugs.
7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
8. Receipt of any drug as part of a research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months.
10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
12. Positive test results for drugs of abuse at screening.
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy

The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).

Esophageal squamous cell carcinoma (ESCC) is a common type of esophageal carcinoma in China, which is characterized by rapid development and fatal prognosis in most patients. Neoadjuvant chemoradiotherapy (nCRT) has been explored for many years in western countries and Japan, and proved to get survival benefit, especially for locally advanced esophageal cancer. However, the recurrence is the major cause of treatment failure in patients with ESCC. Our hypothesis is that inadequate radiation dose leads to recurrence of ESCC with nCRT and PORT lower recurrence rate and improved OS. As is known, there are no any studies concentrating on PORT in ESCC with nCRT. Patients are randomly assigned to PORT (Group A) or without PORT (Group B) with a 1:1 allocation ratio. The primary outcome is OS assessed with a minimum follow-up of 60 months. Secondary outcomes are progression-free survival (PFS), recurrence-free survival (RFS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;
2. Tumors of the esophagus are located in the thoracic cavity;
3. Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
4. Male or non pregnant female
5. Age is between 18 years and 65 years,
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
7. Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
8. Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
9. Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
10. The patient has provided written informed consent and is able to understand and comply with the study.

Exclusion Criteria:

1. Patients with non-squamous cell carcinoma histology;
2. Patients with advanced inoperable or metastatic esophageal cancer;
3. Patients with another previous or current malignant disease；
4. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
5. Age \>65 years;
6. Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
7. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
8. Patients who refuse surgery after neoadjuvant chemotherapy;
9. Unsuitable to be enrolled in the trial in the opinion of the investigators
First-in-Human Study of MS201408-0005A as Single Agent and in Combinations

This is a Phase I, open-label study to determine the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and preliminary antitumor activity of MS201408-0005A as single agent (Part IA only) and in combination with MS201408-0005C or MS201408-0005B (Part IB, Part IC).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with histologically or cytologically proven advanced or metastatic solid malignancies for whom no effective standard therapy exists or has failed or subjects who are intolerant to established therapy known to provide clinical benefit for their condition (dose escalation cohorts; Part I).
* An eastern cooperative oncology group performance status (ECOG PS) of 0 to 1 at screening and adequate hematological, renal and hepatic function as defined by protocol specified criteria.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Intolerance to immune checkpoint inhibitor therapy as defined by the occurrence of an adverse drug reaction requiring drug discontinuation (dose escalation cohorts), concurrent anticancer treatment or immunosuppressive agents.
* Prior organ transplantation including allogeneic stem cell transplantation, brain metastases (except those meeting certain protocol specified criteria which are acceptable), significant acute or chronic infections, a history of cardiovascular/cerebrovascular disease.
* Current significant cardiac conduction abnormalities and hypokalemia as specified in the protocol.
* Warfarin or other Vitamin K antagonists treatment, strong inhibitors or inducers of cytochrome P450 (CYP)3A4, and drugs with a narrow therapeutic index, which are predominantly metabolized by CYP3A4 and drugs known to have a high risk to prolong QTc as per label.
* Pregnancy or lactation.
* Severe hypersensitivity reactions to monoclonal antibodies, known hypersensitivity to the investigational medicinal products or to one or more of the excipients, autoimmune diseases (inflammatory bowel diseases, interstitial lung disease, or pulmonary fibrosis), and live vaccines within 28 days prior to study entry.
* Pneumonitis and history of pneumonitis.
* Other protocol defined exclusion criteria could apply.
Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection

Two groups of women with preterm labor will be included. One will receive magnesium sulfate for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.

The study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices \[Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)\] will be recorded before and after treatment in both groups. Results of Doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with preterm labor
* gestational age less than 32 weeks
* singleton pregnancy

Exclusion Criteria:

* contraindication or hypersensitivity to magnesium
* preeclampsia
* multiple pregnancy
* intake of magnesium sulfate in this pregnancy before
Relation Between Tumor-draining Lymph Nodes Metastasis Pattern and Non-small Cell Lung Cancer Neoadjuvant Immunotherapy Effectiveness

The goal of this retrospective cohort analysis is to discover the impact of the involvement extent of tumor-draining lymph nodes (TDLNs) in patients who received neoadjuvant immunochemotherapy. The main question it aims to answer is the role of TDLN in the prediction of treatment effectiveness. Researches will compare tumor-draining lymph nodes metastasis (mTDLNs) group and non-draining lymph nodes metastasis (mNDLNs) group to see whether different metastatic patterns of mediastinal lymph nodes can indicate the treatment effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* pathologically-confirmed diagnosis of NSCLC by pretreatment biopsy
* clinically staged as T1-4N0-2M0
* having undergo neoadjuvant chemoimmunotherapy
* the agents of immune checkpoint inhibitors (ICIs) belong to PD-1/L1 inhibitors
* having undergo surgery with lymph nodes (LNs) dissection
* having postoperative pathology reports with evaluation of primary tumor and LNs response
* having accessible pretreatment and preoperative radiology examinations imaging or reports

Exclusion Criteria:

* using PD-1/L1 inhibitors in the phase of clinical trials
* the agents of neoadjuvant therapy including angiogenesis inhibitors
* having undergone radiotherapy to treat primary tumor or metastatic LNs before surgery
Acupoint Transcutaneous Electrical Nerve Stimulation in Hospitalized COPD Patients With Severe Dyspnoea

Introduction:

Chronic obstructive pulmonary disease (COPD) presents with a gradual reduction and little bitterness reversible airflow causing shortness of breath, chronic cough and sputum abnormal. Patients with COPD often suffer exacerbations of their symptoms, particularly dyspnea, causing hospital admissions. Recent studies have shown that acupuncture stimulation transcutánea (AcuTENS) Dingchuan point (EX-B1) could help reduce dyspnea in patients with COPD.

Objective:

The aim of this study was to evaluate the possible utility of adding to the usual treatment stimulation AcuTENS in COPD patients admitted with severe dyspnea.

Methodology:

Patients who agree to participate will be randomly divided into two groups. The intervention group will receive a daily treatment, during the period of hospitalization, 45 minutes stimulation at acupuncture point AcuTENS Dingchuan (EX-B1), while the control group performed the same procedure with a device TENS simulated. The extent of dyspnea in both groups as well as the number of days of hospitalization and the number of drugs consumed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 45 and 70 years, with a diagnose of COPD according to the GOLD guidelines.
2. Patients with one episode of hospitalization for COPD exacerbation in the past year, but not more than three episodes.
3. Smoking habit history of more than 10 packages-year.
4. Patients able to correctly understand and answer the modified Borg scale.
5. Patiens with an initial degree of dyspnoea with a score of at least 5 in the modified Borg scale.
6. Patients recruited for the study during the first 48 hours of their hospitalization.
7. Patients who accept to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Patients with any contraindication for transcutaneous electrical stimulation (patiens with pacemakers, skin injury in the application area ...).
2. Patiens with any cardiovascular, neurological or psychiatric disease that may affect the perception of dyspnea.
PECS I Block for Breast Subpectoral Implant Surgery

Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.


Eligibility Criteria:
Inclusion Criteria:

* Every female who will benefit of a bilateral subpectoral breast augmentation
* Age more than 18 years
* Social insured

Exclusion Criteria:

* refusal of the patient
* Age less than 18 years
* Inability to consent
* History of thoracic surgery or breast implants
* Pregnancy
* Inability to use a patient controlled analgesia
* Contraindication of the use of opioids or local anesthetics
* Pathology of hemostasis, infection
* Can not use a PCA
* Patients under long-term opioids (WHO pain ladder 2 and 3)
* Patient presenting neuropathic pain during the preoperative period (score greater than or equal to 4 to the DN4 questionnaire, or taking anti-epileptic or antidepressant treatments for neuropathic pain)
Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression

The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.

The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression. The response rate (improvement in motor function or prevention of progression) will be assessed at one month following radiotherapy.

In addition, the following endpoints will be evaluated:

1. Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy
2. Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy
3. Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy
4. Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy
5. Pain assessment directly and at 1, 3 and 6 months after radiotherapy
6. Overall survival up to 6 months following radiotherapy
7. Local Progression-free survival up to 6 months following radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
* Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
* Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
* Written informed consent

Exclusion Criteria:

* Prior radiotherapy or surgery of the spinal areas affected by MESCC
* History of symptomatic brain tumor or symptomatic brain metastases
* Metastases of the cervical spine only
* Other severe neurological disorders
* Pregnancy, Lactation
* Indication for decompressive surgery + stabilization of the affected spinal areas
FranceLEVO - Zimino Registry (FZR)

The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

This is a real-life, non-interventional, observational, multicentre study in all patients (including children) receiving Zimino® in France.

The patients will be evaluated during the index hospitalisation and on follow-up days 30 (±15) and 90 (±15) after hospital discharge. The follow-up can be a phone call or a visit to the hospital. Patients who meet the eligibility criteria will be identified consecutively at each hospital. The participating hospitals will vary in size and medical activities, depending on their location and the population size they serve.

The physician will determine the patient's treatment strategy. Drug prescriptions and the indications to perform diagnostic or therapeutic procedures will be left completely to the discretion of the physicians.

The estimated enrollment period is 12 months (enrollment of the first patient - enrollment of the last patient), or less if the cohort (n=600) is completed earlier, and the maximum total data collection period is 15 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving Zimino® treatment
* Patients or patient's families not objecting to the patient's participation in the study.

Exclusion Criteria:

* None
Ultrasound to Evaluate Failure of Liberation From Mechanical Ventilation

This study will evaluate the heart, lungs and diaphragm of patients who fail a trial of spontaneous breathing to determine the physiological mechanism of weaning failure.

The transition to unassisted breathing after invasive ventilation often proves challenging, with over 40% of patients failing their first attempt of unassisted breathing. Persistent ventilator dependence predisposes patients to nosocomial complications and increases the economic burden of critical illness. Ventilator-dependence results from an imbalance between the load and capacity of the respiratory muscle pump. Patients who fail a trial of spontaneous breathing commonly exhibit excess respiratory loads secondary to weaning-induced pulmonary edema, atelectasis or dynamic hyperinflation. Many patients who are dependent on the ventilator also show a striking loss of pump capacity due to diaphragm dysfunction. Though each of these mechanisms respond to specific interventions, it is often difficult for physicians to discern which mechanisms are at play at the bedside. Bedside ultrasound is a potentially useful means of evaluating cardiac, pulmonary and diaphragm function during weaning failure. It is readily available, highly feasible and already widely employed in clinical practice. As yet, no study has evaluated the accuracy and feasibility of combining echocardiography with lung and diaphragm ultrasound to comprehensively evaluate the physiological mechanisms of weaning failure. The objectives of this study are to establish the utility of a rapid thoracic ultrasound exam to diagnose mechanisms of ventilation liberation failure and to assess the relationship between cardiothoracic variability during spontaneous breathing and different physiological mechanism of weaning failure.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years of age receiving invasive mechanical ventilation for at least 24 hours
* patients who fulfill standard criteria for readiness for a trial of spontaneous breathing (no or minimal sedation, patient awake and interactive; minimal vasopressor/inotrope requirements (Norepinephrine \< or = 0.1, Dopamine \< 10, Vasopressin/Epinephrine off); fraction of inspired oxygen \< or = 50%; spontaneous inspiratory efforts as indicated by patient-triggered breaths; positive end-expiratory pressure \< or = 10 cm H20)
* patients who fail a trial of spontaneous breathing (transient reduction of ventilator support for any duration up to 2 hours as per local ICU practice - typically PS 5 with PEEP 5 OR CPAP 5 OR T-piece)

Exclusion Criteria:

* patients with a coagulopathy (INR \> 2.5, platelet count \< 30x10\^6/L) or previously diagnosed bleeding diathesis or are receiving anticoagulant drugs at therapeutic doses (ie. excluding venous thromboembolic prophylaxis)
* patients with a contraindication to nasogastric tube insertion (esophageal varices, upper GI tract surgery, facial trauma, etc.)
* patients receiving extra-corporeal life support
Prognosis of Lung Transplant Candidates

The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Eligibility Criteria:
Inclusion Criteria:

* New lung transplant candidates

Exclusion Criteria:

* Heart and lung transplant candidates
* Uncontrolled severe comorbidities
A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes

The purpose of this clinical research study is to support earlier observations that Glucovance controls glucose levels after a mean, and improves overall glucose control better than metformin or glyburide therapy alone in adults with type 2 diabetes.


Eligibility Criteria:
Adults 20-75 with a diagnosis of type 2 diabetes mellitus who are not adequately controlled with diet and exercise, and have an HbA1c greater than 6.7%
Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids

Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive forms of cancer. Despite advances in the understanding of the mechanisms underlying PDAC pathogenesis, the impact on patient benefit is lagging. As a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics.

Organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology.

3D organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. In this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle Aspirations (FNA) and fine needle biopsies (FNB).


Eligibility Criteria:
Inclusion Criteria:

* Patients with indication for EUS-guided FNA or FNB of a suspected pancreatic malignancy

Exclusion Criteria:

* \< 18 years
* patients unable to give consent
Incarcerated Right Inguinal Hernia Containing Sigmoid Colon: An Unusual Case Report

Incarcerated inguinal hernia is an irreducible but the blood supply to the contained part is intact, but developing towards strangulation. Here the lumen of the portion of colon occupying a hernia sac is blocked with faeces.

A special data collection sheet designed to collect data regarding the diagnosis, age, sex and treatment from the profile of patient retrospectively. Data entry was performed by using Microsoft Excel and all the data were analysed by SPSS.

Eligibility Criteria:
Inclusion Criteria:

* inguinal hernia that requires emergency operation

Exclusion Criteria:

* hernia does not need emergency operation.