cyrilzakka/clinical-trials huggingface dataset:
Glycemic Response in Persons With Type 2 Diabetes Mellitus

This will be a randomized crossover design. The subjects will be randomized to one of six interventions on six separate study days, one week apart.


Eligibility Criteria:
Subject inclusion criteria

All subjects must comply with all the following inclusion criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Subject exclusion criteria Subjects representing one or more of the following criteria are excluded from participation in the study.

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial
* Patients with anemia
Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan

The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Be Japanese and live in Japan;
* History of allergic conjunctivitis;
* Positive skin test reaction to Japanese cedar at Visit 1;
* Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;
* Able and willing to avoid all disallowed medications during the specified period;
* Able to discontinue wearing contact lenses during the specified period;
* Sign Informed Consent;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of hypersensitivity to the study drug or compounds;
* Any ocular condition that, in the opinion of the investigator, could affect the patient's safety;
* Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study;
* Presence of active ocular infection;
* Use of disallowed medications as specified in the protocol;
* Pregnant, nursing, or planning to become pregnant during the study;
* Other protocol-defined exclusion criteria may apply.
Oriental Research AlliaNce of Acute Ischemic Stroke Given Endovascular Treatment

To determine the safety and efficacy of in situ ischemic postconditioning immediately after successful reperfusion in AIS patients underwnet EVT.

For acute ischemic stroke (AIS) patients with large vessel occlusion in the anterior circulation receieved successful reperfusion, in situ ischemic postconditioning (ISIPC) was performed immediately after successful reperfusion with 5 circules of balloon inflations in the ipsilateral internal carotid artery, each circulation includes inflation lasting 15 seconds followed by 15 seconds of deflation.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (age ≥ 18 to 95 years) patients with an occlusion of the internal carotid artery or M1 or M2 segment of the middle cerebral artery,;
2. Patients with a score of at least 6 on the National Institutes of Health Stroke Scale (NIHSS) at admission and a score of 0 or 1 on the modified Rankin scale before the onset of stroke;
3. Patients with a score of at least 6 on the Alberta Stroke Program Early CT score (ASPECTS) value;
4. Baseline multimodal-CT imaging, including NCCT, CTA and CTP, performed at the trial-site hospital
5. The modified thrombolysis in cerebral infarction (mTICI) scale 2b to 3 achieved in the infarct-related artery after the last thrombectomy attempt

Exclusion Criteria:

1. Stoke of large artery atherosclerotic origin or other determined factors (such as dissection) or tandem occlusion;
2. Patients underwent rescue angioplasty or stenting after thrombectomy
Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis

The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.

The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

Eligibility Criteria:
Inclusion Criteria:

* immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty

Exclusion Criteria:

* patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use
Bimanual Training in Children With Hemiplegia With Lower Limb and Postural Stimulation (HABIT & Leg)

A randomized control trial of "HABIT-ILE" therapy compared with regular / conventional intervention (same amount of hours). The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University.

A randomized control trial of "HABIT-ILE" therapy at intensive frequency contrasted with regular frequency intervention. The protocols have been developed on the basis of bimanual therapy (HABIT) developed at Columbia University. The intervention takes place either in a 2 weeks day and night camp, either in regular/conventional intervention (1 to 5 hours a week). Children of all groups will benefit from 90h of intensive treatment (children in regular frequency will be crossed over afterwards to benefit from HABIT-ILE. Both in the camp and the regular interventions, there is at least one therapist for each child.

Eligibility Criteria:
Inclusion Criteria:

* willingness to enter the research program and the testing procedures

Exclusion Criteria:

* uncontrolled epilepsy
* upper limb injections in the upper limb during the last six months / or intend to receive during the training period
Second-line Therapy Versus Supportive Care for Pretreated Advanced Gastric Cancer

Because well-designed, randomized, controlled clinical trials are lacking in patients with advanced gastric cancer (AGC), and because randomly allocating patients to treatments that do not accord with their preferences may influence trial validity, the investigators employed a patient preference randomized trial design to compare the efficacy of second-line chemotherapy and best supportive care.

Fluoropyrimidine and/or platinum-based chemotherapy is now regarded as a standard first-line treatment in AGC patients because it has shown superiority in terms of response rate and time to disease progression compared with 5-FU monotherapy and other combinations in phase III trials. Despite the lack of evidence for benefit associated with administering salvage chemotherapy, it is a common practice to offer further chemotherapy for AGC patients after first-line failure. For patients who failed after fluoropyrimidine and platinum, taxanes (paclitaxel or docetaxel) and irinotecan have been evaluated extensively in the second-line setting.

Currently, there is no evidence that SLC in patients with AGC will result in substantial prolongation of survival and there is potential for toxicity from the treatment.

Eligibility Criteria:
Inclusion Criteria:

* aged 75 year or younger
* advanced gastric cancer
* ECOG performance status 0 or 1
* previous failure after chemotherapy with fluoropyrimidine and platinum
* adequate major organ functions

Exclusion Criteria:

* severe concurrent illness and/or active infection
* previously treated with taxanes and irinotecan
* active CNS metastases
* pregnant or lactating women
* who have not recovered from prior treatments
School-Based Assessment of Micronutrient Interventions in Adolescents in Burkina Faso

This purpose of this study is to assess effects of iron and folic acid supplementation and multiple micronutrient supplementation on anemia status, school performance/attendance and development outcomes among adolescents in Burkina Faso.

This study aims to implement and evaluate micronutrient supplementation interventions to improve adolescent nutrition, health and education in Burkina Faso. Findings from this study will clarify the optimal supplementation strategy (iron and folic acid alone or adding other essential nutrients) and provide a basis for scale up of national micronutrient supplementation programs to benefit the adolescent population as a whole in Burkina Faso.

This will be a cluster randomized study with 3 arms. 42 schools per country will be enrolled (14 schools per arm) to receive either 1) daily Multiple Micronutrient Supplements (MMS) and weekly Iron and Folic Acid (IFA) for the first 5 weeks and daily MMS for the remainder of the study; or 2) weekly IFA; or 3) to serve as controls. As recommended by the World Health Organization in settings where continuous supplementation is not possible, supplementation will be intermittent. Supplementation will be provided for 3 months, stopped for 3 months over the school summer holidays and resumed for 3 months once students return to school after the holiday. Students in intervention schools will receive supplementation and students in control schools will receive the usual care (which does not include supplementation but does include existing curriculum on nutrition and water, sanitation and hygiene \[WASH\]). The program will be evaluated comparing effects of weekly IFA and daily MMS on anemia status and school attendance/retention.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 10-17 years
* Enrolled in secondary school form 1 at study initiation
* Member of one of the selected classes in a participating school
* Consent provided by the parent
* Assent provided by the adolescent
* Fluency in French

Exclusion Criteria:

* No informed consent from parent or assent from adolescent
* Self-reported Pregnancy
ICD-ON Registry: Periop Management of Cardiac Devices

The purpose of this registry is to document incidence of electrical magnetic interference (EMI), change in programmed parameters or device related events in patients with Pacemakers (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol) will be used.

Patients with PMs and ICDs have traditionally been considered at risk for electrical magnetic interference (EMI) from electrocautery. EMI can cause oversensing, pacing inhibition, or inappropriate ICD therapies. In July 2011, the Heart Rhythm Society /American Society of Anesthesiologists (HRS/ASA) published an Expert Consensus Statement on the perioperative management of PM and ICDs.

The purpose of this registry is to collect data on patients with PMs and ICDs undergoing procedures requiring electrocautery using a standardized device management protocol (ICD-ON Protocol). Decisions about management of patients with these devices will be made based on surgical location, programmed magnet response and pacemaker dependence.

This registry will document incidence of EMI, changes in programmed parameters or device related events associated with the procedures. Observational data will be collected on participants including: medical history, device parameters, surgical/cautery data, and postoperative device follow-up. For procedures not requiring reprogramming, postoperative PM and ICD interrogation will be either routine in office follow-up or remote monitoring, as per the subject's routine.

Eligibility Criteria:
* Have a implanted PM or ICD
* Be scheduled for a procedure with anticipated electrocautery
* Be able to speak, read and understand English
* Be willing to sign consent form

Exclusion Criteria:

* Have an ICD from Boston Scientific under Product Advisory related to magnet performance
* Have an ICD or PM from Biotronik or Sorin
* Surgical procedures with two or more electrocautery operators.
Intra-Hospital Transport of Critically Ill Patients in Intensive Care Unit

Intra-hospital transport is a frequent procedure in the ICU, involving patients with the highest severity scores. Although some studies estimate the rate of adverse events to be around 33% during intra-hospital transport, including 4% of serious adverse events, the epidemiological data available is small, heterogeneous, and probably subject to methodological bias.

The aim of this study observational prospective observatoinal study is to determine:

* the different practices existing between ICUs ("practice survey")
* the occurrence of adverse events during intra-hospital transport provided by intensive care units (epidemiological study)

This is a multicenter prospective observational study on evaluation of practices between ICUs and to describe the occurence of adverse events during intra-hospital transport provided by ICUs (epidemiological study)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old
* Hospitalized in ICU
* Requiring an intra-hospital transport (e.g imagery, operating room, etc) by the ICU team
* With a departure from ICU and arrival to ICU

Exclusion Criteria:

* Person under guardianship
* Protected Majors
* Already included in the study
* Transport for an ICU discharge in a medical or surgical ward
* Transport with another team than the ICU team
* Not affiliated to French social security
Study of Aspirin in Patients with Vestibular Schwannoma

This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients.

This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients. In the Randomized Treatment Phase, patients aged 12 years or older with VSs will be identified and recruited into one of two randomized groups who receive either 1) 325 mg aspirin twice daily (81 mg aspirin twice daily for pediatric patients \<50 kg); or 2) a placebo. Patients will stay on aspirin/placebo as long as there is no more than 20% increase in VS volume. At tumor progression, patients will enter the Open Label Follow Up Phase. Patients who progress on placebo will be given the option to receive unblinded aspirin and will be followed until further progression, receiving a definitive treatment (e.g, surgery or radiation), or 42 months post-baseline, whichever occurs first. Patients who progress on aspirin (either blinded or unblinded) will be taken off study drug and followed until they receive a definitive treatment (e.g., surgery or radiation) or reach 42 months post-baseline, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic).
* Age≥12 years.
* Ability to provide informed consent.Pediatric patients must provide assent in addition to their parents'/guardians' consent. Adult patients who cannot consent for themselves will not be eligible to participate in this study.
* Ability to swallow tablets.

Exclusion Criteria:

* Inability to perform volumetric measurements of vestibular schwannoma(s).
* Inability to tolerate MRI with contrast.
* Daily use of aspirin within the last two months. Occasional use of aspirin for pain relief is not exclusionary.
* Known allergy to aspirin.
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin.
* Pregnant or lactating women.
* Patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial.
* Active bleeding diathesis.
* Hydrocephalus from brainstem compression.
* Febrile illness or flu-like illness in children and adolescents less than 18 years of age.
Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based

The present investigation is a pilot feasibility study that aims to compare a physical exercise intervention in a face-to-face context (considered state of the art) with a physical exercise intervention in a distance context (online), both supervised, in women, of legal age, physically inactive, breast cancer survivors after primary treatment with curative intent.

Before and after the intervention these women will have a physical and functional assessment, as well as a pre-trial cardiopulmonary exercise test, to check if there are safety conditions to participate and also to self tailor the exercise prescription.

The prescription follows the ACSM´s exercise guidelines for cancer survivors and will comprise a 8 week combined exercise training, 3 times per week, in which two of them will be supervised and the third session of the week (cardio session) won´t.

Chat´s and weekly personal messages, as well as education, will be used to promote retention and exercise adherence.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Over legal age
* With diagnosis of breast carcinoma between stages 0 and IIIc
* ECOG 0 to 1
* Undergoing primary treatment with curative intent (surgery associated or not, with chemotherapy and / or adjuvant radiotherapy) for at least one month
* With follow-up on medical oncology consultation at CHVNG/E
* With consent of the attending oncologist for the practice of physical exercise
* Non-compliance with current physical activity guidelines recommended by the ACSM (moderate aerobic activity\> = 150 min / week or vigorous\> = 75 min / week and \> = 2 strength training sessions / week)
* With cognitive capacity to understand the project proposal

Exclusion Criteria:

* Severe anaemia seen in the last 3 months (Hb \<= 8g / dl) or moderate (Hb\> 8 and \<= 10 g / dl) symptomatic (sustained tachycardia, exertional dyspnea, chest pain or syncope),
* Uncontrolled arterial hypertension (HTN grade 3-4 (CTCAE v.5)) (SAD\> = 160mmHg and / or DAD\> = 100mmHg) and / or potentially fatal consequences (malignant HTN, transient or permanent neurological deficit or hypertensive crisis)
* Uncontrolled diabetes mellitus
* Known cardiac or respiratory pathology
* Any other contraindication given by the physiatrist and / or assistant surgeon
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologic confirmation of one of the 5 tumors \[renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)\] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
* Women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Active, known or suspected autoimmune disease
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
* Other active malignancy requiring concurrent intervention

Other protocol-defined inclusion/exclusion criteria apply
Statins Role in Acute Ischemic Stroke

Strokes is amajor cause of death and disabilities in different countried

Stroke is a major cause of mortality and disability in modern societies. Statins are effective medications in decreasing cardiovascular events through lipid lowering and pleiotropic effects. Ischemic stroke is burdened with a high morbidity and mortality in our society. However, there are few effective and largely available therapies for this devastating disease. In additon to advancing acute reperfusion therapies, there is a need to develop treatments aimed to promote repair and regeneration of brain tissue damaged by ischemia (neurorecovery)(1,2,3). Therapeutic angiogenesis and vasculogenesis represent novel approaches of regenerative medicine that may help in the cure of patients with acute ischemic stroke. Translation of our knowledge about these processes from the bench to bedside is still underway. Although angiogenesis (the sprouting of new blood vessels from pre-existing vascular structures) is likely to contribute to neurorepair, the finality of the angiogenic response in acute ischemic stroke has not been fully elucidated. The first therapeutic approach to angiogenesis after ischemic stroke would be the modulation of the endogenous angiogenic response. In this setting, early instauration of physical activity, statins, and peroxisome proliferator-activated receptor-γ agonists may enhance angiogenesis and neuroregeneration Statins have been shown to improve the functional outcome of patients after an ischemic stroke. We hypothesized that daily statin intake improves functional outcome after an acute ischemic stroke (4,5,6,7,8) Duplex sonography is the best noninvasive modality for investigation of possible carotid artery stenosis to evaluate the intema media thickness of carotid artery in patients of acute ischemic stroke before and after receiving high dose of statins to evaluate its effectiveness in management and appropriate dose of statins (9.10.11.12,13,14)

Eligibility Criteria:
Inclusion Criteria:

* .patients.have acute ischemic stroke within 24 hours of onset. 2.patient not received intravenous thrombolysis or mechanical thrombectomy3.patients with no contraindications or hypersensitivity to statins

Exclusion Criteria:

* 1. Patient received IV thrombolysis or underwent mechanical thrombectomy 2. patient have acute ischemic stroke with onset of more than 24 hours 3.patients have hypersestivty or contraindication to statin 4:patients refuse to participate in the study
Evaluation of the Role of Latent Toxoplasmosis in Female Patients With Active Acne Vulgaris

Acne vulgaris is one if the most common chronic inflammatory skin disorders.Acne is characterized by forming of inflammatory and non inflammatory lesions mainly on the Face,neck,arms, upper trunk and back

One of the hidden hormonal imbalance is Toxoplasma infection.Toxoplasmosis is a zoonotic infection the definite host is feline whereas human and other warm blooded animals are intermediate host . Endocrine alterations occuring during toxoplasmosis can be a hidden cause of acne vulgaris

Eligibility Criteria:
Inclusion Criteria:

- Female patients with active acne vulgaris

Exclusion Criteria:

* Patients with history of hormonal treatment Patients received anti toxoplasma therapy Patients with dermatological diseases caused by hormonal disturbances Pregnant and lactating patients