cyrilzakka/clinical-trials huggingface dataset:
Tranexamic Acid for Upper Gastrointestinal Bleeding

This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.

Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Chief complaint of hematemesis, melena or hematochezia
2. and objective signs of upper gastrointestinal bleeding

Exclusion Criteria:

1. Pregnant woman, age less than 18
2. Patients whose use of the study drug is contraindicated

   * Increased thromboembolic risk

     * History of thromboembolic disease
     * Alleged inherited thrombophilic disorders
     * Malignancy (except those cured and has not recurred more than two years)
     * Nephrotic syndrome
     * Estrogen use
     * Pregnancy
     * HIT, APA
   * High-risk for cardioembolism

     * Underlying structural heart disease where anticoagulation is indicated
     * Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter)
   * Possibilities of ongoing DIC

     * Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature \> 38 degree)
     * Any malignancy except those cured and has not recurred more than two years
   * Patients with history or presence of subarachnoid hemorrhage
   * Acquired color vision impairment, visual loss and retinal venous and arterial occlusions
   * Past history of seizure or organic brain lesion that predispose to seizure disorder
3. Previous history of variceal bleeding
4. Cases where informed consent is unobtainable
Safety, Tolerability, and Pharmacokinetics of CSX-1004

This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up.

The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects.

The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.


Eligibility Criteria:
Major Inclusion Criteria:

* Healthy male or female subjects, aged 18 to 50 years, inclusive,
* Minimum weight of 50.0 kg and maximum weight of 100.0 kg
* Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive

Major Exclusion Criteria:

* Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase
* Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined by non-daily use of nicotine-containing products, is permitted.
* History or presence of any clinically significant cardiac, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other major disease or illness at Screening, which in the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.
Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke

The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.

We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.

We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.

Eligibility Criteria:
Inclusion Criteria:

* a history of acute phase of stroke (less than 12 months post onset),
* first stroke episode,
* no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
* no contracture of the affected wrist or fingers (Modified Ashworth\<3),
* no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
* for P-ROM patients, the absence of active hand movements,
* for the A-ROM patients, the presence of active hand movements.

Exclusion Criteria:

* unstable medical disorders,
* active Complex Regional Pain Syndrome (CRPS),
* severe spatial neglect,
* aphasia,
* cognitive problems.
Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine

the study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.

Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75- 150 minutes.2 Therefore, various additives have been used with bupivacaine to prolong its effects and improve the quality of analgesia.(1) Opioids are the most popular used adjuvants added to bupivacaine in spinal blockade to obtain a sufficient intraoperative visceral analgesia and increase the duration and quality of postoperative analgesia, with less sympathetic block and hemodynamic effect .(2) morphine is commonly used for analgesia, but is frequently associated with postoperative nausea and vomiting (PONV) and pruritus, These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine.

Nalbuphine is a mu receptor antagonist and a ĸappa receptor agonist.10 When added as an adjunct to intrathecal local anesthetics, it provides good analgesia with decreased incidence and severity of mu receptor side effects(3) Morphine binds most readily to the mu-opioid receptor and less well to the kappa-opioid receptor. So, the undesirable adverse events of morphine are thought to result from agonism at the mu-opioid receptor.5 Many drugs have been tried with morphine to potentiate its analgesic effects or to reduce the adverse events.6 Nalbuphine is a mixed opioid agonist-antagonist that acts mainly through kappa-opioid receptors, and it may attenuate mu-opioid receptor related side effects.3 Moreover, recent studies suggested that the analgesic effects of morphine and nalbuphine may be additive.

The addition of nalbuphine to intrathecal bupivacaine plus morphine significantly reduced the incidence and severity of postoperative nausea and vomiting and pruritus without affecting analgesic potency..(4)

Eligibility Criteria:
Inclusion Criteria:

* patients of aged 15-70years old
* males
* Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia.
* ASA grade 1,2
* normal cardiac and renal function

Exclusion Criteria:

* Patient refusal
* Allergy to the studied drugs.
* Patients with contraindications to spinal anesthesia
* ASA grade 3,4
CT 327 in the Treatment of Atopic Dermatitis

This study will look at how safe and effective, a novel agent, CT 327 cream is in treating patients with mild to moderate atopic dermatitis (AD). Patients will be treated twice daily for 14 days on specific lesions of AD and safety and symptoms of AD will be assessed throughout the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female subjects aged \>18 year
* Written informed consent
* Mild to moderate AD at baseline (EASI score of at least 2 or 3)
* Active AD (visible eczema, erythema and pruritus)
* Presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends)

Exclusion Criteria:

* If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
* If female, are pregnant or lactating, or intend to become pregnant during the study period
* Allergy to test drug or excipients
* Usage of topical corticosteroids or other topical treatments for AD within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment
* Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
* Presence of major medical illness requiring systemic therapy including cancers
* Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
* Any clinical relevant ECG abnormality
* Have any clinically significant abnormal clinical laboratory test results at screening
* Received any investigational drug or taking part in any clinical study within three months prior to this study
* History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
Measure of Acceptance of chRonic Visible sKin conditionS

The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).

The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).

The investigator will screen the patients and give them a link to complete the questionnaire (according to the age), that includes a pre-scale of acceptation of 50-55 items.

Eligibility Criteria:
Inclusion Criteria:

1. Targeted pathologies:

   * Flat angioma
   * Primary hypopigmentation and early vitiligo
   * Primary hyperpigmentation
   * Refractory alopecia areata or congenital alopecia
2. Persons concerned:

   * Children (≥ 6 years old) suffering from one of the aforementioned pathologies
   * Adults suffering from one of the above-mentioned pathologies
   * Parents of children suffering from one of the aforementioned pathologies
   * Parents of young adult patients if they live under the same roof
3. Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor)

Exclusion Criteria:

1. Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.)
2. Major psychiatric disorders
BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC

Lung cancer is the leading cause of cancer death in Korea as well as in other countries. About 80% of lung cancer is non-small cell lung cancer(NSCLC). The majority of patients with NSCLC require cytotoxic chemotherapy in the course of their illness. Combination chemotherapy using third generation anticancer drugs (paclitaxel, docetaxel, gemcitabine) with platinums(cisplatin or carboplatin) reached a plateau in their efficacy. Oxaliplatin, another platinum being used for colorectal, gastric and pancreatic cancer has lower adverse effects such as nausea and nephrotoxicity. In this phase II trial, we will observe efficacy and safety of docetaxel and oxaliplatin for patients with NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Stage IIIB/IV or Relapsed NSCLC
* Age \>= 18 years
* At least one measurable lesion by RECIST (version 1.1)
* ECOG PS 0, 1, 2
* Hematologic profile

  * Hgb \> 8 g/dL, ANC \>= 2,000/m3, Platelet \>= 100,000/m3
* Hepatic profile

  * Total bilirubin \<= 1.5 x upper normal value
  * Transaminases \<= 3 x upper normal value \<= 5 x upper normal value in case of liver metastasis
* Creatinine \<= 1.5mg/dL
* Patients should be recovered from toxicities of previous treatment.
* Written informed consent by patient or surrogates

Exclusion Criteria:

* Patients who had been previously treated with chemotherapy for NSCLC
* Active infection requiring antibiotics treatment
* Prior diagnosis of other malignancy except radically treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the uterine cervix
* Peripheral neuropathy \>= grade 2 by NCI CTCAE 4.0
* Uncontrolled hypertension, Acute myocardial infarction within 6 months Unstable angina, Congestive heart failure \>= NYHA grade 2 Uncontrolled significant arrhythmia
* Patients who entered other clinical trials within 4 weeks
* Pregnant or lactating women. women with child bearing age who are not willing to a contraceptive measure
BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect

This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design. In addition the influence of food on the pharmacokinetics of BAY1902607 and the bioavailability between different pharmaceutical formulations will be investigated


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects.
* Age: 18 to 45 years (inclusive) .
* Body mass index (BMI) : ≥18 and ≤30 kg/m\^2.
* Race: White.

Exclusion Criteria:

* Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) deviating from normal and deemed by the investigator to be of clinical relevance.
* Relevant diseases within the 4 weeks before the first drug administration.
* Febrile illness within the week before the first taste test is conducted.
Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients

This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2 expression, patients can participate in the trial after obtaining informed consent.

Patients will be treated with weekly paclitaxel-trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage IV non-squamous NSCLC patients.
* Patients must have been detected with an activating EGFR mutation at baseline and must have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of 150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).
* Rebiopsy after having acquired resistance to TKI-treatment must have been performed and HER2-overexpression (positive immunohistochemistry staining) must have been detected.
* There must be at least one measurable disease site, according to RECIST 1.1 criteria.
* WHO performance status 0-2.
* Willing and able to comply with the study prescriptions.
* 18 years or older.
* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.
* Ability to give written informed consent before patient registration.

Exclusion Criteria:

* No uncontrolled infectious disease.
* No other active malignancy.
* No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
* No treatment with investigational drugs.
* No known hypersensitivity to trastuzumab-paclitaxel
* No symptomatic brain metastases.
* History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection Fraction (LVEF) of \<45%.
Implementation of a Pharmacy-Intervention to Enhance Prescription and Use of Lipid-Lowering Drugs

The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease.

Cardiovascular disease is the main cause of death in large parts of the world. Next to life style changes, pharmaceutical treatment is a keystone in the treatment of cardiovascular disease. Despite the strong evidence for the effectiveness of lipid-lowering therapy, less than half of the people eligible are treated. With specific medication searches in the community pharmacy database, an easy tool for detecting patients who are undertreated is available. Based on this tool, a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease was constructed.

Moreover, it is not known yet how to implement this pharmaceutical care model in community pharmacies effectively. With multifaceted interventions the behaviour of health professionals can be changed. In this study the effectiveness of a maximal support strategy, including interactive educational meetings, reminders, audit and feedback, is compared to a minimal implementation strategy.

Eligibility Criteria:
Inclusion Criteria:

* pharmacies: resident in the south of the Netherlands
* patients: with antiplatelet therapy and without lipid-lowering medication

Exclusion Criteria:for patients:

* terminal disease
* severe mental disorder
Determination of the "Tissue Transit Time" (TTT)

Determination of Tissue Transit Time (TTT) as a parameter with high prognostic value to predict the functional course of the differential renal function and the development of the differential renal function after pyeloplasty

The ureteropelvic junction obstruction occurs in around 13% of children with antenatally diagnosed hydronephrosis. It remains a controversial topic what prognostic factors may be predictive for deterioration of the differential renal function.

The tissue transit time (TTT) in the 99mTc- MAG3 diuretic renogram seems to be a predictive factor for the deterioration of the differential renal function in these patients. We therefore analyze the tissue transit time in the 99mTc- MAG3 diuretic renogram in a prospective multicenter observational study to determine it as a prognostic and diagnostic factor. Aim of the study is to differentiate which children could be treated conservatively and which will benefit from operative pyeloplasty

Eligibility Criteria:
Inclusion Criteria:

* unilateral, isolated hydronephrosis \>= grade III (SFU)
* age \<= 3 months

Exclusion Criteria:

* associated malformation of the urogenital tract
* global kidney insufficiency proven by creatinine examination
* prematurity
* no informed consent
Russian Cardiovascular Registry of COVID-19

This is a Russian multicenter observational study aimed to assess the mid-term and long-term prognosis in patients recovered from COVID-19 with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases.

This open multi-center observational study (registry) is designed to enroll consecutive eligible patients hospitalized with and recovered from COVID-19 (ICD-10 codes U07.1 or U07.2) with the involvement of the cardiovascular system or with baseline severe cardiovascular diseases. Data collection is ongoing for the duration of the pandemic. This study aims to assess the mid-term and long-term prognosis in this patient population. Analysis of this information may help to better predict the prognosis for patients and socio-economic burden of the coincidence of COVID-19 and cardiovascular diseases and to better inform about the optimal surveillance programs in recovered patients.

The de-identified participant data will be abstracted from the medical chart prospectively on the day of discharge or retrospectively (on the day of the first outpatient visit) and entered into an electronic database. The information will be stored in a database, and used at a later time for research studies.

Patients will be followed up for at least 12 months. Data on standard clinical assessment, echocardiography, laboratory results, assessment of the current therapy, specific cardiovascular assessment (depending on the cardiovascular disease), and outcomes will be collected, as well as additional blood samples for biomarkers substudy and central core laboratory imaging assessment (when applicable) at 3, 6 and 12 months. The investigators will contact patients by telephone to obtain information about outcomes in case of inability to visit in person.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years of age
2. Hospitalization with confirmed or suspected COVID-19 (ICD-10 codes U07.1 or U07.2)
3. Involvement of the cardiovascular system or baseline severe cardiovascular diseases defined as at least of the following:

   * proven or suspected myocarditis;
   * heart failure (NYHA functional class II-IV) before or during hospitalization with COVID-19;
   * combination of COVID-19 with ACS or development of ACS during hospitalization with COVID-19 or performed percutaneous coronary intervention;
   * proven pulmonary embolism;
   * hemodynamically significant arrhythmias (atrial fibrillation, high-grade ventricular premature beats, paroxysmal ventricular arrhythmias), including those associated with the QT interval prolongation

Exclusion Criteria:

* None
Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis

Participants will receive intensive therapy through a video game in their own homes for 1 month. The game is operated by movements of the body (no controller needed) and acts like a virtual therapist. Participants will agree to play the game for 30 hours. They will also receive 4 home visits from a therapist designed to increase use of their arm for daily activities that are important to them. Participants will also receive a smart watch that will measure use of their weaker arm and alert them when their arm is not participating in activities. Arm strength and function will be measured before and after the therapy program.

Randomized waitlist control trial. One group will receive treatment immediately (50%) and the other group will receive treatment following a three-week delay (50%). Group 1 will be assessed by physical/occupational therapists and rehabilitation psychologists (blinded to treatment phase) before and after the virtual gaming treatment. Group 2 will receive two baseline assessments (baseline followed by three weeks of usual and customary care and then another baseline before starting the gaming treatment), and again after three weeks of virtual gaming treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have progressive multiple sclerosis resulting in upper extremity motor impairment.
* Have the ability to comprehend and participate in basic elements of the therapy.
* Have substantial non-use in the more affected upper extremity.

Exclusion Criteria:

* Are currently participating in other experimental trials.
* Are currently participating in additional upper extremity therapy.
* Experienced relapse within the past 6 months.
* Too frail to undergo intensive rehabilitation,
* Those with serious, uncontrolled medical problems.