cyrilzakka/clinical-trials huggingface dataset:
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.


Eligibility Criteria:
Inclusion Criteria:

* Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks
* Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization
* Written informed consent obtained

Exclusion Criteria:

* Subject has history of deep vein thrombosis and/or pulmonary embolism
* Subject has a hemorrhagic disorder and/or coagulation disorder
* Subject has had clinically important bleeding occurred within 90 days prior to obtaining informed consent
* Subject has an acute bacterial endocarditis
* Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke
* Subject is receiving anticoagulants/antiplatelet agents
* Subject has a body weight less than 40 kg
* Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods
A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with active UC on either 5-ASA,corticosteroids,azathioprine(AZA) and or/6-mercaptopurine(6-MP);
* Mayo score of 6 to 10 points with moderate to severe disease on endoscopy
* Subjects on the following medications;

  1. prednisolone ≤ 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration)
  2. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration)
  3. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration)
  4. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug)

Exclusion Criteria:

* Anti-TNF therapy within 8 weeks before study drug administration
* Contraindication to colonoscopy or sigmoidoscopy
* Primary or secondary immunodeficiency
* Autoimmune disease besides UC, with the exceptions of Sjogren's syndrome or hypothyroidism
* History of malignancy, excluding adequately treated and cured basal or squamous cell of the skin, or cervical carcinoma in situ
* Evidence of acute or chronic infection
* Clinically significant disease requiring medication
Adebrelimab and Concurrent Radiochemotherapy as First-line Treatment for Extensive-stage Small-cell Lung Cancer

Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.

In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab （Q3W）.

The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.

Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy + Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75 years;
2. Histologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) ;
3. Must sign a written informed consent form prior to any study specific procedures;
4. No prior treatment for ES-SCLC;
5. No more than 5 lesions (including metastases),and at least one measurable lesion that meets RECIST 1.1 evaluation criteria;
6. Life expectancy more than 3 months;
7. ECOG PS 0-1

Exclusion Criteria:

1. Previous treatment with radiochemotherapy for limited-stage small cell lung cancer;
2. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy ;
3. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
4. Active brain metastases, Leptomeningeal metastasis(untreated central nervous system (CNS) metastases unless asymptomatic and lesion size\<1cm;
5. Patients with spinal cord compression;
6. Patients with multiple liver metastases(except isolated lesion and lesion size\<2cm);
7. Uncontrollable third cavity effusion (e.g. a large amount of pleural effusion, ascites, or pericardial effusion, etc.) requiring repeated drainage, which was judged by the investigator to be unsuitable for study;
8. The investigator judges that there are any patients who endanger the patient's safety, interfere with the study assessment, and have poor compliance.
Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases

Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years.

Restorative materials and curing device In the current study, the manufacturer's instructions were followed for the use of the nanofilled composite resin (Estelite Asteria, Tokuyama Dental, Japan) for direct laminate veneers and IPS e.max Press (Ivoclar Vivadent, Amherst, NY, USA) for indirect laminate ceramic veneers. A light curing device with an output density of 655 mW/cm2 (LED Bluephase C5, Ivoclar, Vivadent, Amherst, NY, USA) was used. Demetron LED light meters were used to measure the light curing unit's intensity regularly (Demetron Research Corp., Danbury, CT, USA). Brand name, description, chemical composition, and manufacturers of the materials are presented in Table 1.

Study design, blinding \& randomization The Consolidated Standards of Reporting Trials statement was adhered to in the description of the experimental design. This study was a randomized controlled clinical trial that was double-blinded for both trial participants and outcome assessors. Randomization was performed using the flip of a coin for the choice of material. Using computerized sequence generating (www. randomizer.org), participants were divided into two groups with a 1:1 allocation ratio.

Eligibility Criteria:
Inclusion Criteria:

* Patients needed diastema closure.
* Patients with normal and full occlusion.
* Patients must have a good oral hygiene.
* Patients with a tooth respond positively to an electric pulp tester.

Exclusion Criteria:

* High caries risk patients with extremely poor oral hygiene.
* Patients with periodontally-involved teeth.
* Patients with heavy bruxism habits and clenching.
* Patients involved in orthodontic treatment.
Gustin Gene Polymorphism and 6-n-propylthiouracil (PROP) Taste

The investigators evaluate the possible association of PROP taste with gustin gene polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI. In addition, it has also been evaluated PROP taste sensitivity by recording monophasic potentials from the tongue.

The investigators evaluate the possible association of PROP taste with gustin gene polymorphism rs2274333 (A/G), salivary zinc ion concentration and BMI.

Furthermore, we apply direct measures of the gustatory system activation following stimulation with PROP, obtained by electrophysiological recordings from the tongue of subjects classified for taster status, genotyped for the specific receptor gene (TAS2R38), and in which papilla density was determined.

Eligibility Criteria:
Inclusion Criteria:

* no variation of body weight \> 5 kg over the last 3 mo BMI within 20-25 Age between 20-30

Exclusion Criteria:

* gustatory impairment following a prescribed diet or using medications that might interfere with taste perception food allergies smokers
Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System

The purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).

The data will be analyzed for medical education, societal presentation and/or publication by the investigator.

The primary objectives of this study are to evaluate the safety and clinical performance of the Magellan Robotic System with the 6 Fr catheter, Vascular Accessories 6 Fr and Microcatheter Driver in patients who are indicated for an embolization procedure or other endovascular procedure in the peripheral vasculature.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able and willing to provide written informed consent
* Eligible for an embolization procedure or other endovascular procedure in the peripheral vasculature
* Not participating in an investigational study involving the peripheral vasculature

Exclusion Criteria:

* Vasculature cannot accommodate the Magellan Robotic Catheter or required accessories
* The required delivery of therapeutic device(s) "through" the Magellan Robotic Catheter in which the diameter for the therapeutic device(s) is/are incompatible with the Magellan Robotic Catheter
* An endovascular approach to the treatment of peripheral vasculature disease is contraindicated
* Sepsis
* Major coagulation abnormalities
* Presence of significant co-morbid illness that contraindicates surgery or an interventional radiological procedure
* Unmanageable contrast agent hypersensitivity
* Patients who are prisoners
* Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or are deemed unreliable or unstable by the investigator or with a cognitive impairment
* Pregnant or breastfeeding
Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus

There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women.

Indeed, many pregnant women are still over-exposed to tobacco, either through personal use or passive exposure to cigarette smoke. This passive exposure often comes from the consumption of their loved ones, such as their future co-parent or family.

However, throughout our lives, health professionals, associations, and the government send a lot of information and messages about the negative effects of tobacco on health, pregnancy, and the fetus.

This information and the possibility of receiving help from a professional trained in tobacco use exist throughout the entire pregnancy.

However, many women and their partners still do not take the necessary precautions to reduce or stop smoking. Do couples who smoke during pregnancy really have an understanding of the smoking's effects on women and their fetuses? Could they realize it and would they reduce or stop their consumption, in case they knew these negative effects?

The aims are:

* To describe the knowledge of pregnant women who smoke or are exposed to tobacco smoke about the effects of active and passive smoking on the obstetrical and fetal systems.
* To identify the information that has been received by pregnant women who smoke or are confronted with tobacco smoke about the effects of tobacco on pregnancy.
* To identify information sources for pregnant women who smoke or are exposed to tobacco smoke about the negative effects of tobacco on pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women after 32 weeks of amenorrhea
* Primigravida women
* women exposed to passive or active smoking
* women aged over 18 years
* Accepting to participate in the study

Exclusion Criteria:

* Minors
* protected by law (guardianship, custodianship, judicial protection)
* refusing to participate in the study
Pharmacodynamic-pharmacokinetic Trial, of Slow Release ASA, in the Platelet Functionalism.

The purpose of this study is to evaluate the platelet antiaggregant effect that a chronic treatment with ASA (150 mg) produces,comparing this effect between two formulations of ASA: normal and the one of sustained release, in patients with stable coronary disease.

A large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication.

Without doubt, the acetylsalicylic acid (ASA) is the most used antiaggregant product, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanism of action implicated, the association with other drugs, and the pharmaceutical form in order to improve the efficacy and the safety of the ASA.

Some previous studies indicate that the slow release form of ASA has a different behaviour in the platelet effect in comparison with plain formulation.

The aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation of ASA.

Eligibility Criteria:
Inclusion Criteria:

* Previous episodes of myocardial infarction
* Previous episodes of instable angina pectoris
* Previous coronary revascularization
* Significant arterial coronary disease

Exclusion Criteria:

* Patients with other pathologies that requires treatment with other antiaggregants
* Patients in treatment with low molecular weight heparin or oral anticoagulant
* Patients with antecedents of hypersensibility to ASA
Effect of GM1 in Prevention of Oxaliplatin Induced Neurotoxicity in Stage II/III Colorectal Cancer

The primary objective of this study is to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Oxaliplatin is a key agent in the treatment of colorectal cancer. However, peripheral neuropathy markedly limits the use of oxaliplatin. Many drugs have been tried to decrease the development of oxaliplatin induced peripheral neurotoxicity, however, the results remain disappointing. This multi-center, randomized, placebo-controlled trial was performed to assess the efficacy of monosialotetrahexosylganglioside (GM1) for preventing oxaliplatin induced neurotoxicity in colorectal cancer patients who received oxaliplatin-based adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years old, male or female
* Histologically confirmed diagnosis of colorectal adenocarcinoma with a phase II or III disease, within 2 months from radical resection, and intends to receive 6 months of adjuvant chemotherapy with mFOLOFX6 or XELOX, without adjuvant radiation indications
* No prior any level of peripheral nerve system disease
* Patients have not received any other possible neurotoxic-reaction-causing drugs (such as oxaliplatin, cisplatin and paclitaxel drugs etc)
* With the capability to accurately record the occurrence and severity of neurotoxicity by questionnaire
* With normal functions of major organs
* No contraindication to chemotherapy
* Life expectancy ≥ 3 months
* Patients have provided a signed Informed Consent Form

Exclusion Criteria:

* Patients who received radical resection, but are expected not be able to complete 6 months of adjuvant chemotherapy
* Patients who receive palliative chemotherapy
* Patients who need adjuvant or palliative radiotherapy during chemotherapy
* Be allergic to GM1
* Hereditary abnormal metabolism of glucose and lipid
* Doctors believe that patients are not suitable for receiving GM1 treatment
* With confirmed history of neurological or psychiatric disorders, including epilepsy and dementia
* With concomitant diseases that will seriously harm the patients' safety or impact the completion of the study
* Patients (male or female) have fertility possibility but not willing or not to take effective contraceptive measures
Expectations Regarding Mobility and Self-Care

The goal of this research study is to learn if there is a difference between your expectations of how well you will perform daily living activities after short-term inpatient rehabilitation and the doctor's expectations of how well you will perform daily living activities.

If you agree to take part in this study, you will complete questionnaires before your inpatient rehabilitation and after you complete inpatient rehabilitation. The questionnaires will ask about how well you currently perform daily living activities, your expectation of how well you will perform daily living activities after you complete inpatient rehabilitation, your symptoms in the past 24 hours, and your physical, functional, social, and emotional well-being. These questionnaires should take about 15 minutes total to complete.

Information from your medical record (such as your age, gender, religion, cancer diagnosis, stage of cancer, and so on) will be collected.

Length of Study:

You participation on this study will be over after you complete the questionnaires.

This is an investigational study.

Up to 111 participants will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Participants are willing and able to give written informed consent and to comply with all of the study visits and surveys
2. Patients with any type of cancer admitted on the acute inpatient rehabilitation unit who can tolerate 3 hours of rehabilitation therapies per day
3. Patients 18 years and older
4. Patients must be able to understand, read, write, and speak English.

Exclusion Criteria:

1. Patients who have delirium, severe symptom distress, or cognitive impairment.
2. Patients who return to primary service prior to discharge from the acute inpatient rehabilitation unit.
Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)

Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.


Eligibility Criteria:
Inclusion Criteria:

1. Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
2. Dyspnea at rest or minimal exertion per the patient
3. Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.
4. Elevated BNP level \>200 pg/ml, or NTproBNP \> 1000pg/mL
5. Able to administer study drug within 8 hours from triage time

Inpatient Hospitalized Inclusion Only:

Co-peptin level \> 27 pmol/L

Exclusion Criteria:

1. Unable to provide informed consent
2. Unable to have 30 day telephone follow up
3. Not expected to survive past 6 months
4. On Renal replacement therapy or creatinine \>3.5
5. History of allergy or intolerance to Tolvaptan
6. Suspected Pregnancy
7. Cardiogenic Shock
8. Participation in any interventional trial in prior 30 days.
9. Receiving or planned to receive IV Inotropic therapy
10. ACS now or in the past 30 days
11. Treatment with IV infusion vasoactive drugs in the hour prior to enrollment
12. Temperature \> 100.5
13. Heart Failure due to atrial fibrillation with Rapid Ventricular Response
14. SBP \< 90 mmHg
Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM).

Venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation.

A patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients.

Current assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.
* Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.
* Vascular malformation symptoms significant enough to seek treatment.

Exclusion Criteria:

* Patients with extensive VM not suitable for sclerotherapy.
* Prior therapy for treatment of a VM within 3 months.
* Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).