cyrilzakka/clinical-trials huggingface dataset:
Comparison of Anticoagulation Prolongation vs. no Anticoagulation in STEMI Patients After Primary PCI

The RIGHT study is a large randomized study dedicated to post-PPCI anticoagulation in STEMI patients. The investigators propose to evaluate the clinical efficacy and safety of anticoagulation prolonged for at least 48 hours after the procedure vs. no prolongation of anticoagulation after procedure in patients with STEMI treated with bivalirudin during PPCI (primary hypothesis). When allocated to anticoagulation prolongation by randomization, the subject will be assigned to UFH, enoxaparin or bivalirudin (same regimen allocated by centre) for at least 48 hours after PPCI. The results from this study are expected to provide guidance on the risk/benefit of post-procedural anticoagulation in patients with STEMI.

A minor change of time of randomization after prolongation of bivalirudin infusion at PCI dose up to 4 hours on protocol at September 19,2018. Reasons: a minor change concerning the timing of randomization considering the current local practice in some centers that use the 4 hour infusion of bivalirudin just after PCI. It remains in agreement with the current international guidelines and with the drug label in China. There is no change in drugs used and doses of these drugs once the randomization occurs.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* STEMI with PPCI of culprit lesion
* Bivalirudin therapy during PPCI
* Signed informed consent form

Exclusion Criteria:

* Patients with a formal indication for anticoagulation after PPCI (e.g. atrial fibrillation, left-ventricular thrombus, intra-aortic balloon pump, pulmonary embolism, mechanical heart valve)
* Patients with any indication for chronic anticoagulation
* Patient with previous lytic treatment
* Patient with previous coronary artery bypass graft surgery
* Cardiogenic shock, malignant ventricular arrhythmia, or mechanical complications
* Any anticoagulation other than bivalirudin started after the procedure before randomization
* Estimated body weight of \>120 kg or \<45kg
* BP ≥180/110mmHg at randomization
* Any bleeding diathesis or severe hematologic disease or history of intracerebral mass, aneurysm, arteriovenous malformation, recent (\<6months) ischemic stroke or TIA, recent (\<6months) intracranial hemorrhage or, gastrointestinal or genitourinary bleeding within the past 2 weeks
* History of heparin-induced thrombocytopenia
* Suspected acute aortic dissection (AAD)
* Major surgery within 1 month
* A planned elective surgical procedure that would necessitate an interruption in treatment with P2Y12 inhibitors in the next 6 months after enrollment
* Known PLT≤100×109 or HGB≤10g/L
* Known transaminase \>3-fold ULN, or CCr\<30ml/min
* Known allergy to any study drug
* Pregnancy or lactation
* Noncardiac coexisting conditions that could limit life expectancy to less than 1 year
* Current participation in an investigational drug or device trial
Performance of Rigid Gas Permeable (RGP) Scleral Contact Lenses With a Passive Artificial Iris

Data from 15 healthy subjects will be recorded in two testing sessions spread on two days, using three lens designs (A, B and C). Before the measuring days, each subject will undergo an extra fitting session of a large-diameter scleral contact lens on the dominant eye, assessed by an experienced practitioner. The fitting data will be used to custom-make the three lens designs for each subject, thus ensuring their comfort and safety during the days of the experiments. During the experiment days baseline measurements will be obtained before and after pupil dilation and contact lens wear. During the first testing session data from the lens design A (reference lens without artificial iris) will be recorded. During the second testing session data from the lens designs B and C (lenses with artificial iris with different transmittances) will be recorded. In each testing session, contrast sensitivity and visual acuity will be evaluated and non-invasive imaging measurements will be undertaken (optical coherence tomography and slit lamp). A specific questionnaire will be given to the subject to assess comfort, light sensitivity, the horizontal visual angle and overall experience of the scleral lens and in combination with a pair of sunglasses category 3-4.

First, the participant will be subjected to an RGP scleral contact lens fitting session, then during the second and third visits the participant will be subjected to several non-invasive procedures specific to the study in order to assess contrast sensitivity and visual acuity using the fitted and uniquely fabricated investigational medical devices. The tests will be performed after eye drops are supplied to dilate the pupil of the subjects (eye drops: tropicamide and phenylephrine). Besides the clinical experiments, the participant will be given a specific questionnaire in order to assess comfort, light sensitivity, horizontal visual angle and overall experience of the investigational medical device and in combination with a pair of sunglasses category 3-4. The investigators will document the occurrence of any adverse events and specific side effects during Day 2 and 3 (testing sessions with the investigational devices) in order to effectively assess their safety.

Eligibility Criteria:
Inclusion Criteria:

- Age between 18 and 45 years old

Exclusion Criteria:

* Iris disorders (i.e. ocular albinism, coloboma, aniridia).
* Known disease-related ocular surface problem (i.e. microbial keratitis).
* Known ocular pathologies (except refractive disorders).
* Coexistent ocular diseases impeding contact lens correction (i.e. glaucoma, previous ocular surgery).
* Corneal scarring.
* Low corneal endothelial cell count (\< 1500 cells per mm2), with potential of corneal hypoxia-induced corneal edema induced by contact lens wear.
* Wearing of contact lenses in the last 24 hours (prior to the interventions).
Effect of Transcutaneous Electrical Nerve Stimulation Versus Capsicum Plaster on Emesis Gravidarum

This study will be conducted to determine the difference between the effect of transcutaneous electrical nerve stimulation and capsicum plaster on emesis gravidarum.

Almost 50-90% of pregnant women experience nausea vomiting in the first trimester. Nausea vomiting occurs in 60% -80% primigravida and 40% -60% in multigravida.It is revealed that 50% of affected women have a significant reduction of their work efficiency.

Transcutaneous acupoint electrical stimulation (TAES) at the Nei-Guan P6 acupoint may be a useful alternative to antiemetic drugs. It is effective in the treatment of both motion sickness and pregnancy induced nausea and vomiting , as well as emesis associated with chemotherapy.

Capsicum plaster is an alternative to acupuncture. It is applied to the acupuncture points and has been reported to be an effective method for preventing postoperative nausea and vomiting (PONV), postoperative sore throat, and postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women complaining of emesis gravidarum
* Their ages will be ranged from 20 to 35 years old.
* Their body mass index will not exceed 35 kg/ m2.
* Their gestational age will be less than 20 weeks.
* All women having mild to moderate nausea and/or vomiting
* All women having singleton pregnancy

Exclusion Criteria:

Women will be excluded from the study if they have:

* Previous carpal tunnel syndrome.
* Skin abnormalities
* Acute viral disease
* Hyperemesis gravidarum.
* Previous history of nausea or vomiting before pregnancy.
Autogenous Tooth Graft for Ridge Augmentation

This study is designed to evaluate the clinical and radiographical outcome of tooth shell for alveolar ridge reconstruction in maxilla as an alternative to traditional autologous bone shell graft.

twenty eight patients with one or two maxillary extracted teeth in need for horizontal bone augmentation and implant placement will be selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University patients will be divided into two equal groups:

• Group I: Horizontal bone augmentation will be done by bone shell technique.

• Group II: Horizontal bone augmentation will be done by autogenous tooth shell technique.

Evaluation:

A-Clinical evaluation:

* All patients were followed up on a weekly basis for the first postoperative month, then monthly for the rest of the postoperative period (6months) until implantation.
* The patients were evaluated regarding pain, edema and hematoma at recipient and donor sites as well as healing of the mucosa.
* A neurosensory evaluation was carried out at each clinical check up by asking the patient if there were any areas of hypoesthesia, numbness or tingling in the lower lip and chin at the side of the donor site.

B-Radiographic evaluation

•Cone beam computed tomography (CBCT) were made immediately and 6 months post-operative to assess the alveolar bone in all three planes of space before implant placement. According to the measurements obtained from CBCT, appropriate implant size and length will be chosen and placed 6 months postoperative after removal of the micro screws.

Radiographic analysis:

Linear measurements of alveolar bone width were taken using CBCT scan at three stages; prior to grafting (T0) and immediately (T1), and 4 months post grafting (T2). Then three horizontal alveolar width measurements (crestal, middle and apical) were recorded at T0, T2 and T1. The measurement was performed with fixed points each time, the buccolingual width was measured at different levels. At the bone crest, 3mm from the bone crest and 6mm from the bone crest. The measurements were tabulated for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

- 1- One or two maxillary extracted teeth with crestal bone width of 4 mm or less.

2- Age ranging from 18_50 years 3- 3- Adequate oral hygiene. 4- Non smoking patients. 5-Free from any pathological lesions related to the tooth to be extracted. 6- Physically fit to withstand the whole procedure.

Exclusion Criteria:

* 1- Active infection in the site to be treated. 2- Patients on chemotherapy or radiotherapy. 3- Alcohol or drug abuse. 4- Patients who have systemic disorders that interfere with bone healing {uncontrolled diabetes mellitus, autoimmune disease,

  * etc.} 5- Pregnancy. 6- Patients with bone disease. 7- Patients with parafunctional habits
Treatment of Patients With COVID-19 With Convalescent Plasma

The COVID-19 pandemic has been spreading continuously, and in Brazil, until May 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of COVID-19 in a multicenter, randomized, open-label and controlled study

Eligible patients will be randomized 1:1:1 into 3 treatment groups: A- standard (control); B- standard and convalescent plasma in a volume of 200ml (150-300ml); C- standard and convalescent plasma in a volume of 400ml (300-600ml). The Bayesian multi-arm and multi-stage model will be used, which will allow an interim analysis after the inclusion of 30 patients, with repeated interim analyses for every 30 additional patients. With this, we expect to define not only the efficacy of convalescent plasma, but also the volume of plasma needed if efficacy is proven. The study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. The same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Age = or \> than 18 years; .
* Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening; - . Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) -
* Presence of one of the following criteria:
* Need for\> 3L of O2 in the catheter / mask or\> 25% in the Venturi mask to maintain O2 saturation\> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 \<300mmHg If intubated, within 48 hours of orotracheal intubation
* Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .Participation approval by the research clinician

Exclusion Criteria:

* Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-19.
* IgA deficiency
* Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion
* Pregnancy or breastfeeding
* Receipt of immunoglobulin in the last 30 days
* Presence of significant risk of death within the next 48 hours at clinical discretion.
Whey Protein Effect on Glycaemic and Appetite Responses in T2D

The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses.

Whey protein accounts of \~20% of whole milk protein. Ingestion of whey protein at meal times generates insulinotrophic/β-cell stimulation via amino acid absorption and the bioactive peptides generated during gastrointestinal digestion, resulting in attenuation of postprandial blood glucose. The bioactive peptides stimulate the release of incretin hormone, GLP-1, and inhibit DPP-IV activity potentially decreasing the rate of GLP-1 degradation.

The current study will employ a randomised, double-blind, counter-balanced, cross-over design, whereby participants will each complete three trials; a) whey protein, b) hydrolysed protein, and c) placebo intervention. Hydrolysed protein provides amino acid content, without bioactive peptides associated with incretin release, therefore, demonstrating insulinotrophic properties, only.

Many studies within the literature are limited for practical reasons, such as investigating high dosages (30-50 g) of whey protein, or high glycaemic index meal types which would be unlikely to form part of habitual dietary activity of type II diabetics. Therefore, the current study will objectively measure postprandial glycaemic and appetite responses following the ingestion of whey/hydrolysed protein, whilst ensuring ecological validity, dosages (18 g) and test meals applicable to everyday life, and true clinical utility for managing type-II diabetes by integrating interventions into the habitual lives of type-II diabetic individuals.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetic males aged 18-65 years old.
* Treated with metformin, or diet and lifestyle modification, only.
* BMI \< 40 kg/m2.
* Stable physical activity pattern during the three months immediately preceding study.

Exclusion Criteria:

* Not treated with insulin.
* No metabolic disease other than diabetes.
Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy

Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.

Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were admitted to the intensive care unit and required CRRT

  1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
  2. activated partial thromboplastin time \> 60 s,
  3. prothrombin time-international normalized ratio \> 2.0,
  4. thrombocytopenia (\<100,000/µL), and
  5. surgery within 48 h before CRRT.

Exclusion Criteria:

* Pregnant or possibly pregnant women
* Patients who were allergic to nafamostat mesilate
* Patients who were hypercoagulable
Deep Transcranial Magnetic Stimulation for Treatment of Alzheimer's Disease

The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C,FAB, ADL, Neuropsychological computerized test(time frame baseline, 2 months, 4 months.

Estimated enrollment: 40 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2009 Number of arms: 2

Ages: 50-85 Genders: both

Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 50-85.
2. Diagnosed with Alzheimer's disease for at least one year (by the DSM-IV criteria).
3. Scored below 24 on the MMSE.
4. Received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response.
5. Answered in the negative to all questions in the pre-TMS treatment safety questionnaire.
6. Gave their oral and written consent to participate in the trial.

Exclusion criteria:

1. An additional neurological or psychiatric disorder.
2. Severe personality disorder.
3. Uncontrolled hypertension.
4. History of epilepsy, seizure, or heat convulsion.
5. History of epilepsy or seizure in first degree relatives.
6. History of head injury or stroke.
7. History of metal implants in the head (except dental fillings).
8. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps.
9. History of migraines in the last six months.
10. History of drug or alcohol abuse.
11. Inadequate communication with examiner.
12. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it.
13. Inability to sign a consent form.
Bergonie Institut Profiling : Fighting Cancer by Matching Molecular Alterations and Drugs in Early Phase Trials

This is a biology driven, monocentric study designed to identify actionable molecular alterations in cancer patients with advanced disease.

In this trial, high throughput analysis will be carried out using next generation sequencing, and immunological profiling.

Patients included in the BIP study and for whom a targetable genomic alteration had been identified might be subsequently included in an early phase trials running at Institut Bergonie or another French hospital.

The need to 'personalize' cancer therapy has been recognized, with specific biomarkers which will be used to direct targeted agents only to those patients deemed most likely to respond. This "personalized cancer medicine" requires two critical steps: first, a comprehensive assessment of the biological characteristics of tumors from each individual, and second, validated biomarkers to identify the subgroups of patients who are most likely to benefit from a given therapy and the next-generation sequencing provides unprecedented opportunities to draw a comprehensive picture of genetic aberrations involve in immunotherapy sensitivity and ultimately enable individualized treatment.

The main objective of this study is to use next generation sequencing technologies to identify actionable molecular alterations in cancer patients with advanced disease included in the study. This study will provide a fully integrated view of the molecular profile of the tumor for each patient included in the study. Such tumor profile will be used by clinicians to tailor therapies of patients in specific early phase clinical trials.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years,
2. Histology: solid malignant tumor or hematological malignancy,
3. Deleted MSA9
4. Deleted MSA9,
5. Deleted MSA9,
6. Deleted MSA9,
7. Patient with a social security in compliance with the French law relating to biomedical research (Article L.1121-11 of French Public Health Code),
8. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

1. Deleted MSA9
2. Deleted MSA9
3. Deleted MSA9
4. Deleted MSA9
5. Deleted MSA9
6. Deleted MSA9
7. Deleted MSA9
8. Deleted MSA9
9. Individuals deprived of liberty or placed under guardianship
10. Pregnant or breast feeding women,
11. Previous enrolment in the present study.
An Exploratory Investigation of a Novel Skincare Regimen

This trial will assess the effectiveness of the Aria Trio Complete Facial system in being able to reduce blemishes, lines, and wrinkles. This skincare system that has three different functions in association with three unique serums. It is hypothesized that this customized skincare system will improve skin quality, reduce wrinkles, and reduce other skin related issues.


Eligibility Criteria:
Inclusion Criteria:

* Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
* Must experience early-stage wrinkles that are not treated by over the counter products (e.g. Adapalene/Differin)
* May experience hyperpigmentation and/or dark spots
* In good general health
* Willing to follow the study protocol skincare routine
* Willing and able to share feedback and take skin pictures via the technology portal
* Discontinue use of any alpha-hydroxy acids (AHAs) or over the counter exfoliating, polishing, or peeling topical skincare treatments 1 week before and for the duration of the study.

Exclusion Criteria:

* Anyone with a diagnosed skin condition on their face
* Use of prescription medication relevant to the skin
* Undergoing any cosmetic procedures during the study including Botox, laser, or chemical peel treatments
* Use of oral acne treatment (e.g., Accutane)
* Severe chronic conditions, including oncological conditions or psychiatric disorders.
* Is pregnant, attempting pregnancy, or breastfeeding
Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing "Virus-like particles" (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.


Eligibility Criteria:
Inclusion Criteria:

* adult kidney transplanted patients
* Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation.

Exclusion Criteria:

* Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)