cyrilzakka/clinical-trials huggingface dataset:
Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor - Optimize Trial

Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected patients from the "real-world" clinical practice receiving the Endeavor ZES for the treatment of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day for 3 months versus 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. patients \>18 years of age,
2. clinical indication for PCI with stent implantation of at least one angiographically documented coronary artery lesion,
3. agreement to undergo all protocol clinical follow-ups. 4 - presence of at least one obstruction \>50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with coronary anatomy suitable for percutaneous treatment with implantation of the Endeavor ZES.

Exclusion Criteria:

1. ST-elevation acute MI presenting for primary or rescue PCI;
2. DES in-stent restenosis;
3. PCI with bare metal stents \<6 months prior to index procedure;
4. previous treatment with any DES;
5. scheduled elective surgery within 12 months post index procedure;
6. contra-indication, intolerance, or known hypersensibility to aspirin and/or clopidogrel;
7. known illness with life expectancy \<36 months; and impossibility to comply with all protocol follow-ups.
8. target lesion(s) located in saphenous vein grafts,
9. coronary anatomy unsuitable for percutaneous treatment with implantation of the Endeavor ZES.
Application Study of Infusing Irritant Medications Through Midline Catheter Based on Real World Study

The goal of this observational study is to learn about the effect on midline catheter outcomes when infusing irritant medications through midline catheter. The main questions it aims to answer are:Identify the current situation of infusing irritant medications through midline catheter;Explore the effect on midline catheter outcomes when infusing irritant medications through midline catheter;Identify specific medications that affect catheter outcomes.

First, the patients were divided into two groups according to whether irritant medications were infused or not,then observed the rate of complications between the two groups.Second, grouped according to the irritant medications, Identify specific medications that affect catheter outcomes through statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥14 years old
* Patients who had a midline catheter

Exclusion Criteria:

* Patients who received vesicant medications through the midline catheter
* Patients who had both a midline catheter and a central vascular access device
Increased Vitamin D Reduces Pulmonary Exacerbations in CF

The investigators study is designed to test the hypothesis that correction of vitamin D in CF patients can increase their lung function and decrease the number of their pulmonary exacerbations.

Vitamin D deficiency is a known problem in CF patients. The CF Foundation Committee published in April 2012 new guidelines for administering vitamin D in CF patients. The investigators' study is designed to look for association between normal serum vitamin D levels and lung function. \~100 CF patients from The Center of Chronic Diseases in Hadassah Medical Organization will be treated according to the new guidelines, and their lung function will be tested once a month during the trial, which will be held for at least one year. In this study, the investigators' goal is to test the efficiency of the new guidelines in correcting serum vitamin D levels, and to follow other related factors such as growth indices (height, weight, BMI), bone mineral density, number of pulmonary exacerbations and number of hospital admissions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and laboratory diagnosis of Cystic Fibrosis
* Complete medical and nutritional follow-up for at least one year before changing the vitamin D dosage and follow up for at least one year afterwards.

Exclusion Criteria:

* Age under 4 years old (because of the inability to assess lung function in a reliable fashion)
The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)

This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and/or OS with lymph node dissection before CCRT when compared to CCRT.

All eligible patients will be equally randomized between the 2 following treatment groups (stratified factors: whether para-aortic lymph nodes were image-positive):

Standard treatment group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy).

Experimental group: open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be performed postoperatively within 28 days.)

Eligibility Criteria:
Inclusion Criteria:

1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
2. Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
3. ECOG score 0\~1
4. Expected survival over 6 months
5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
6. No surgical contraindication

Exclusion Criteria:

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Chronic renal insufficiency or renal failure
5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. A history of pelvic artery embolization
8. A history of pelvic radiotherapy
9. A history of partial hysterectomy or radical hysterectomy
10. A history of severe allergic reaction to platinum drugs
11. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis
Heart Arteries and Sickle Cell Disease / Coeur Artères DREpanocytose

The CADRE study is a multinational observational cohort of patients with sickle-cell disease (SCD) in five west and central sub-Saharan African countries. The aim of this project is to describe the incidence and assess the predictive factors of SCD-related micro- and macro-vascular complications in sub-Saharan Africa.

Sickle cell disease (SCD), one of the lost common genetic diseases worldwide, is caused by a mutation in the β globin gene. Most patients with this disease are homozygous for the βS allele (SS), whereas others have inherited a βS allele with another mutation in the β globin gene. In addition to repeated acute ischemic insults due to the red blood cells sickling in the microcirculation, a chronic vasculopathy leads to organ injuries, such as kidney disease, stroke, pulmonary hypertension, retinopathy, bone infarcts, and leg ulcers.

CADRE is a multinational prospective observational study undertaken in five countries in sub-Saharan Africa. Patients with SCD will be recruited through outpatients' clinics in public, university and private hospitals and research centers in five countries. The CADRE protocol was approved by the relevant national ethics committee in each of the participating countries.

Primary endpoint is to measure the prevalence and the incidence of the main vascular complications in the main types of SCD: glomerulopathy, nephropathy, cardiopathy, pulmonary hypertension, retinopathy, strokes, osteonecrosis and leg ulcers.

Secondary endpoints are:

* to define the clinical and biological predictors of SCD vasculopathy in Africa
* to search for genetic risk factors for the SCD-related cardiovascular complications, in particular alpha thalassemia, persistence of foetal hemoglobin and other candidate genetic polymorphisms
* to search for functional risk factors (pulse wave velocity, capillary vasodilatation, blood visosity) for the SCD-related cardiovascular complications
* to search for new biological determinant of SCD-related cardiovascular complications, in particular alternative markers of hemolysis (microparticules, free heme) and inflammation (cytokines, leucocytes phenotyping, NET (neutrophile extracellular traps))

Eligibility Criteria:
Inclusion Criteria:

* age: five-year-old or more
* signature of informed consent Patients : major sickle cell syndrome confirmed by hemoglobin phenotyping: SS, SC, SBeta+ or Sbeta0 Controls : healthy parents or siblings of the patients, hospital staff or their children, matched on age+/- 3 years and country (1 control for 4 patients)

Exclusion Criteria:

unstable clinical status such as:

* vaso-occlusive crisis in the previous 15 days
* fever or infectious disease in the previous 15 days
* transfusion in the previous 2 months
Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder.

Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.


Eligibility Criteria:
Inclusion Criteria:

* Unipolar depression (diagnosed according to the DSM-IV)
* Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17

Exclusion Criteria:

* Participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression)
* Acute suicidality
* Prior treatment with whole-body hyperthermia
* Contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission
* Participants taking anti-inflammatory or immunosuppressive drugs
* Participants with severe psychiatric comorbidities (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, dementia, ADHD, obsessive-compulsive disorder, PTSD, alcohol or drug addiction)
* Women during pregnancy and breastfeeding
* Lack of ability to consent
The Effect of Virtual Reality on Women Undergoing Hysterosalpingography

The aim of this study is to determine the effect of virtual reality on perceived pain, anxiety, fear, physiological reactions and satisfaction in women during the HSG procedure.

Hypotheses H01; In the HSG procedure, there was no difference between the pain score of the virtual reality group and the pain score of the control group.

H02; In the HSG procedure, there was no difference between the anxiety score of the virtual reality group and the anxiety score of the control group.

H03; In the HSG procedure, there was no difference between the satisfaction score of the virtual reality group and the satisfaction score of the control group.

H04; In the HSG procedure, there was no difference between the vital signs of the virtual reality group and the control group.

H05; In the HSG procedure, there was no difference between the fear score of the virtual reality group and the fear score of the control group.

The study will be carried out in two different groups. The practice will start with meeting the women who apply to the Radiology clinic for an HSG. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Virtual Reality Group In addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. Virtual reality glasses is a device that works on compatible smart mobile phones. After being taken to the gynecological table for the HSG procedure, the women included in the experimental group will be made to watch a video lasting an average of 10 minutes with virtual reality glasses until the procedure is completed. While watching the video, the relaxing music of the video will be played in the practice room with a bluetooth speaker.

Control Group Patients in the control group of the study will not be subjected to any treatment other than the routine procedure.


Eligibility Criteria:
Inclusion Criteria:

* primary infertility
* Agreeing to participate in the research and obtaining written permission,
* No hearing or vision problems
* The first time HSG procedure will be applied

Exclusion Criteria:

* Didn't watch the whole video
* Those with motion-sensitive diseases such as vertigo, meniere
* Using any pharmacological pain-reducing method within 30 minutes
* Difficulty in the HSG process or completing the process with more than one attempt
* Use of antidepressants or sedatives
* Any history of allergy to radio-opaque dye
ACL Reconstruction With/Without ALL Reconstruction

This study will compare Anterior Cruciate Reconstruction with or without Anterolateral Ligament Reconstruction in patients with ACL injury. The purpose of this study is evaluate if addition of ALLr to ACLr provides better clinical, radiological and laboratory outcomes.

This study compare ACL reconstruction and additional tenodesis or ALL recontruction described by Arnold. Patients will be randomized fot this tree group and surgeon will be blinded.

Anterolateral ligament reconstruction could play a role in augmenting rotational stability in the ACL-reconstructed knee and are most likely to benefit hyperlax patients, revision cases, pivoting athletes, and those with IKDC grade III pivot shifts. In our study we will would like to confirm this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

- primary ACL injury

Exclusion Criteria:

* no informed consent to participate in the study
* age under 18 years or above 65
* multilligament injury or single plane knee instability (medial, lateral)
* another musculoskeletal disorders in lower limb
* lower limb deformity requiring axis correction below 4o or above 12.5o
* joints inflammatory diseases
* ASA score \> II
Meningitis Encephalitis: a Metagenomics-Based Etiology & Epidemiology Research

Autoimmune encephalitis (AE) is caused by abnormal immune response mediated by autoimmune antibodies of patients, which can be detected by a serial of autoimmune antibodies\[4,5,6,7\]. At present, the traditional infection diagnosis mainly relies on microbial culture method, which has the characteristics of long cycle, high cost, low detection rate and complex detection process. About 30-60% of encephalitis have unknown etiology\[2,3\]. On the other hand, the diagnosis and classification of noninfectious encephalitis mainly depend on the detection of autoimmune antibodies, the scope of diagnosis and differential diagnosis is limited, and the relationship between autoimmune encephalitis and infection factors is still unclear. Metagenomics sequencing (mNGS) is a new method that does not rely on microbial culture and can directly detect pathogenic nucleic acids. It has the characteristics of fast, accurate, high throughput, no preference for different pathogen detection, and can detect known and unknown pathogens at the same time. Nowadays, mNGS is widely used in the field of pathogen detection.


Eligibility Criteria:
Inclusion Criteria:

* Either meet the items of 1, 2 or 1, 3

  1. The patient's age \>14 years old, acute or subacute onset (less than 3 months), (first onset, treatment with anti-infection drugs and/or immunotherapy ≤5 days);
  2. The patient has the following symptoms:

     1. Dysmnesia,
     2. Seizures,
     3. Mental disorders,
     4. Abnormal behavior,
     5. Unconsciousness or coma,
     6. Dyskinesia or involuntary movement,
     7. lalopathy or be reticent,
     8. Dysphagia, sleep disorders, or autonomic nervous dysfunction,
     9. Ataxia.
  3. Patients with meningeal irritation sign, intracranial hypertension and other manifestations, satisfy at least 3 of the following symptoms:

     1. Headache,
     2. Fever,
     3. Stiff neck,
     4. Disturbance of consciousness,
     5. Kernig sign or brudzinski sign was positive.

Exclusion Criteria:

* 1. Patients with suspected metabolic encephalopathy and toxic encephalopathy have the above manifestations,
* 2. Patients with central nervous system tumor (primary or metastatic) have the above manifestations,
* 3. The patient with non-organic mental illness,
* 4. Patients who had undergone brain surgery within 6 months have the above symptoms after operation,
* 5. Patients with traumatic brain injury have the above manifestations,
* 6. Febrile convulsions caused by non-cerebral causes,
* 7. Patients with above manifestations due to other reasons such as cerebrovascular disease, genetic disease, etc;
* 8. Patients who refuse lumbar puncture or have contraindications to lumbar puncture;
* 9. Patients who withdraw informed consent.
Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial

This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.

The choice of cast length in conservative management of distal radius fractures still represents a much debated controversy. Classic teaching was to immobilize the elbow to reduce risk of secondary displacement; however, short arm casts are felt to be equally effective with less complications and higher patient comfort. There is currently no conclusive evidence for or against immobilization of the elbow in patients treated with cast immobilization.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of distal radius fracture
* Indication to conservative treatment
* Need for manipulation to reduce fracture

Exclusion Criteria:

* Open fractures
* Existence of any skin lesion or wound that would impair cast treatment
* Neurovascular deficits
* Bilateral fractures
* Association with any other fracture of the homolateral arm
Alleviation of Cedar Pollen Induced Allergic Symptoms by Orally Taken Superfine Beta-1,3-Glucan

Intravenous- injection of beta-1,3-glucan in human is known to induce T helper type 1 response, while oral uptake did not. It was examined whether superfine dispersed beta-1,3-glucan (SDG) contrived to absorbed by intestinal mucosa would alleviate allergic symptoms by per-oral ingestion

Beta-1,3-glucan made from Japanese mushroom is commercially available for healthy foodstuffs. Allergy patients were orally administrated either SDG (n=30) or non-dispersed beta-1,3-glucan (NDG, n=30) and allergic symptoms were assessed clinically, by the double-blind, placebo-controlled, randomized study

Eligibility Criteria:
Inclusion Criteria:

* history of seasonal allergic conjunctivitis with or without rhinitis in spring (Japanese cedar pollen season) every year
* positive allergen specific IgE (\> 30 IU/ml) or positive skin prick test result (wheal diameter \> 3mm) to Japanese cedar, Orchard Grass pollen, or house dust-mite extract

Exclusion Criteria:

* Patients who had undergone immunotherapy in the previous 5 years
* a history of other immunological or medically relevant diseases
Tailored Drug Titration Through Artificial Intelligence

ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.

The goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. Chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the United States. Poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. The platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. The results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. The principal investigator has just completed a pilot study in conjunction with Optima Inrwgrated Health, Inc. (i.e. PRECISION) to successfully test the medication management platform technology and its integration with the electronic medical record (EPIC® platform).

Optima-for-Blood Pressure (O4BP) is a cloud-based artificial intelligence clinical decision support system (CDSS) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. O4BP provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. The goal of the study is to test if blood pressure management by using the O4BP CDSS is superior to standard of care (SOC) (i.e. blood pressure management during office visits).

Eligibility Criteria:
Inclusion Criteria:

* Two or more blood pressure readings of ≥ 150/95 mmHg during primary care office visits in the Department of General Medicine within the last 6 months
* Therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit
* At least minimally "tech-savvy" defined as Ownership of a compatible smartphone Ability to access the internet

Exclusion Criteria:

* Inability to operate a blood pressure cuff
* Incompatible smartphone device (Galaxy S5 Android 5.0)
* Less than minimally "tech-savvy," defined as inability to use the Internet
* Non-compliance with medical follow-up (frequent "no shows")
* Planned coronary revascularization in the next 12 months
* Myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days
* GFR \< 30 (CKD stage IV/ V)
* Primary care provider rules out the patient due to comorbidities or other factors