cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

The study hypotheses to be tested in this study are:

* Conversion to everolimus at 3 months post-transplantation is safe and effective;
* Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;
* Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing their first living- or deceased-donor kidney transplant who maintain a functioning graft 3 months post-transplant;
* Older than 18 years;
* Panel-reactive antibodies lower than 20%;
* Baseline immunosuppression with tacrolimus, mycophenolate sodium (MPS) and prednisone at randomization at 3 months.

Exclusion Criteria:

* eGFR \< 35 mL/min at randomization;
* Urine protein-to-creatinine ratio \> 0.8 at randomization;
* Episode of acute rejection with Banff histological classification \> 1A in the first 3 months post-transplant;
* Cholesterol \> 350 mg/dL or triglycerides \> 400 mg/dL with therapy at randomization;
* Active infection at randomization;
* Chronic liver disease;
* Refusal to participate in the study;
* Contraindications to kidney biopsy;
* Biopsy findings at 3 months post-transplant including borderline rejection, cellular rejection or antibody-mediated rejection.
Multifocal-toric IOL Compared to Multifocal IOL Combined With Limbal Relaxing Incisions for Correction of Moderate Astigmatism During Cataract Surgery

The purpose of the present study is to compare the outcome of multifocal toric intraocular lens with standard multifocal lens plus incisional surgery in patients undergoing bilateral cataract surgery.

This is a randomized controlled trial with intra-patient comparison, 60 eyes (30 patients) with cataract and corneal astigmatism of 1.00 to 2.50 D (doctrine) took part in the trial. The trial assessed the efficacy of multifocal IOL (intraocular lens) with corneal pre-existing astigmatism and compare the outcomes of a multifocal toric IOL or a standard multifocal IOL combined with limbal relaxing incisions.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral cataract and be planning to have both eyes operated on.
* Age 21 and older
* Have cataracts that allow IOL master biometry
* Regular corneal astigmatism 1.00 up to 2.50 D
* Difference of corneal astigmatism in both eyes to be equal to or less than 0.75D
* written informed consent to surgery and participation in the study
* Speak English

Exclusion Criteria:

* Relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* Irregular corneal astigmatism on Pentacam topography
Comparison of Success Rate Between Distal Radial Approach and Radial Approach in STEMI

ST-segment elevation myocardial infarction (STEMI) is an emergent disease to treat as soon as possible. 2017 ESC guidelines for the management of STEMI recommend using radial approach (RA) rather than femoral approach (FA) to reduce mortality and bleeding complications if the operators are expert for RA. Recently, Ferdinand Kiemeneij reported that distal radial approach (DRA) could be a feasible and safe route for coronary angiography (CAG) and percutaneous coronary intervention (PCI) in 70 patients. The right-handed patient could feel more comfortable in left DRA than right RA. Left DRA also could provide a better comfortable position for the operator compared to left RA. Distal radial artery is located around the anatomical snuffbox, which doesn't contain nerve and vein beside artery. Therefore, the possibility of procedure-related complications such as nerve injury or arteriovenous fistula is very low. Also, the superficial location of DRA could make easier hemostasis. There were no vascular-related complications from the report of Kiemeneij. But, the rate of puncture failure was 11%, which was higher than RA-based study (5.34% in STEMI patients of RIVAL trial, 6% in RIFLESTEACS trial and 5.8% in MATRIX trial). Nevertheless, this study was a pilot study with a small number of patients. There is no clinical study to compare the feasibility and safety for CAG and PCI between DRA and RA in patients with STEMI. Therefore, this study aimed to evaluate whether DRA is feasible and safe compared to RA in STEMI setting.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years
* ST-segment elevation myocardial infarction
* Palpable unilateral distal radial and radial artery

Exclusion Criteria:

* Cardiogenic shock
* Thrombolysis before primary percutaneous coronary intervention
* Inability to obtain written informed consent
* Patient with ipsilateral arteriovenous fistula
* Participation in another ongoing clinical trial
* Pregnancy
* Expected lifespan \<12 months

  \* Eligible operator criteria
* Qualified operator who had experienced ≥ 100 cases of distal radial artery puncture
Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye for at least 6 months prior to enrollment;
* Have a history of use of eye drops

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception
Nectin-4 Targeting ADC Probe for PET Imaging in Solid Tumors

To study the normal physiological distribution of the probe 124I-EV in human body and its ability to detect overexpression of Nectin-4 in tumor lesions.

Nectin-4 is highly expressed in different types of cancer and is involved in various aspects of tumor proliferation, angiogenesis, metastasis, tumor recurrence, and DNA repair. Therefore, the development of nuclear medicine molecular probes targeting Nectin-4 is of great significance for improving the specificity and accuracy of Nectin-4 related cancer diagnosis.

EV (Enfortumab vedotin) is the first and only drug targeting Nectin-4 so far. By exploring the diagnostic efficacy of 124I-EV in tumors with high nectin-4 expression, it will not only provide evidence for the early diagnosis of tumors. At the same time, the Nectin-4 expression in tumors can be used to develop effective and precise treatment for patients.

Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old, male or female;
2. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
3. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.
4. Normal heart function;
5. Good follow-up compliance;
6. presence of at least one measurable target lesion according to RECIST1.1 criteria
7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before the start of the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;
2. Pregnant patients;
3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
The GEM (Goals for Eating and Moving) Study

The GEM intervention leverages the patient-centered medical home model by using the GEM tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.

To establish the efficacy of the GEM intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with Medical Home models of care to compare the GEM intervention (intervention arm) with Enhanced Usual Care (educational materials; control arm).

The specific aims of this study are:

* Test the impact of the GEM intervention on weight change, and clinical and behavioral outcomes.
* Identify predictors of weight loss in the GEM intervention arm related to: a) goal-setting processes and b) intervention components
* Determine the impact of the GEM intervention on obesity-related counseling practices and attitudes in primary care providers.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-69 years of age,
* Body mass index of ≥30kg/m2 OR
* Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
* Hypertension
* High Cholesterol
* Sleep Apnea
* Osteoarthritis
* Metabolic Syndrome
* Prediabetes
* Under primary care team care with at least one prior visit with their provider in the past 24 months
* Access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months

Exclusion Criteria:

* Patients who do not speak English or Spanish,
* Have active psychosis or other cognitive issues,
* Psychoactive substance use
* Diabetes
* Taking prescription weight-loss medication
* Health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis
* Participated in MOVE!, DPP, or another intensive weight management program (\>3 sessions) in the past year,
* Have a history of bariatric surgery,
* Are pregnant, or become pregnant during the intervention period,
* Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment,
* Have a provider who states they should not participate,
* Patients who do not want to lose weight
* Have self-reported inability to read at 5th grade level.
Prognostic Impact of an Oral Triglyceride Tolerance Test in Patients After Acute Ischemic Stroke

Non-fasting triglyceride levels are thought to play a role in stroke. The investigators hypothesise that the results of a standardised oral triglyceride tolerance test in the subacute setting (3-7 days) after the first ischaemic stroke are associated with the risk of recurrent stroke within 12 months after the index event.

Since high postprandial triglycerides levels may be a risk factor for stroke, we use a combined oral triglyceride and glucose tolerance test in patients who had a first ischemic stroke. Follow-up after one year primarily assesses wether or not a recurrent stroke has occured. The glucose tolerance test is meant to identify patients with metabolic syndrome (and diabetes), since this condition is per se associated with increased levels of triglycerides. Potentially, the post-challenge triglyceride levels only play a role in patients without diabetes or metabolic syndrome. For further details see Ebinger et al. 'The Berlin 'Cream\&Sugar' Study: the prognostic impact of an oral triglyceride tolerance test in patients after acute ischaemic stroke', IJS; 2010,5, 47-51.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* First ischemic stroke
* Incidence within less than 7 days
* Informed consent obtained

Exclusion Criteria:

* Aphasia (if hampering informed consent)
* Swallowing disorder
* Pregnancy
* Renal or hepatic failure
* Pancreatitis
* Cholecystolithiasis
* Malabsorption
* Lactose intolerance
* Psychosis
* Drug and/or alcohol addiction
* Expected life expectancyr12 months
* Inability to sign informed consent
* Acute coronary syndrome
* Severe heart valve disorder
* Heart failure (NYHA III-IV)
* Severe infectious/rheumatic disease
* Sever metabolic disease
* No oral glucose tolerance test in case of known diabetes
GlObal Secondary Prevention strategiEs to Limit Event Recurrence After Myocardial Infarction. GOSPEL Study

Cardiac rehabilitation programmes are a proven treatment for individuals with recent myocardial infarction, resulting in reduced morbidity and mortality compared to usual care. Unfortunately, following completion of a cardiac rehabilitation programme, risk factors and lifestyle behaviours may deteriorate. The GOSPEL study investigates the benefits of a programme of continued educational and behavioural intervention to achieve optimal long-term secondary prevention goals.

Study partially sponsored by Società Prodotti Antibiotici

Eligibility Criteria:
Inclusion Criteria:

* Recent myocardial infarction (within 3 months after the index event)
* Standard rehabilitation program of 3-6 weeks performed
* Informed consent (obtained before any study specific procedure)

Exclusion Criteria:

* Age \> 75 years
* Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or be associated with poor adherence to the protocol;
* Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy
Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).

To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

Eligibility Criteria:
Inclusion Criteria:

* Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

* Previous PPV
* Vitreous hemorrhage of non-PDRP origin
Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor

Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis.

This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).

The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility\&Sterility 2017).

The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).

Eligibility Criteria:
Inclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:

* Women's Age: 38- 41 years old (both included)
* Men's Age: 18-60 years old (both included)
* Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid)
* Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified)
* Quality of semen: ≥ 5 millions spermatozoids/ml

Exclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:

* Number of Oocytes metaphase II (MII): \<5 oocytes
* Number of Oocytes obtained: \>20
* Estradiol on the day of human chorionic gonadotrophin (hCG) \>3000 pgr/ml administration.
* Progesterone on the day of hCG \>1,5 pmol/l administration
* ≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination)
* Any un corrected alteration in a previous study.
* Other indications of (Preimplantation Genetic Diagnosis.Screening) PGD-S, such as monogenic illnesses, translocations, repeated implantation failure, repeated miscarriages, etc.
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain

Postoperative pain after thoracic surgery is associated with adverse outcomes. The current strategy to prevent postoperative pain is the use of regional anesthesia and analgesic agents. In video-assisted thoracic surgery (VATS), thoracic paravertebral block has become the standard analgesic regimen which results in decreased postoperative pain and opioid consumption.

The investigator would like to study the analgesic efficacy of low dose intravenous ketamine infusion during surgery in combination with thoracic paravertebral block on postoperative pain after VATS in a randomized study.

Inadequate pain control after thoracic surgery is associated with adverse events such as postoperative pulmonary complications (PPC), and chronic post surgical pain.

Although the less invasive video-assisted thoracic surgery (VATS) has been used extensively as it produces optimal surgical outcomes and possible less postoperative pain, there are reports of inadequate pain control.

Thoracic paravertebral block (TPVB) has been introduced as an effective method in postoperative pain management after VATS. It is associated with improved pain control and the reduction of opioid analgesic consumption in several studies.

The use of intravenous low dose ketamine infusion during and after surgery has been shown to produce superior postoperative pain control in upper abdominal surgery and thoracotomy.

The aim of the present study is to study the efficacy of intravenous low dose ketamine infusion during surgery on acute and chronic pain after VATS.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status 1-3
* Scheduled for elective video-assisted thoracic surgery
* Able to operate a patient-controlled analgesia device (PCA)

Exclusion Criteria:

* History of morphine allergy
* History of bupivacaine allergy
* Contraindication for ketamine infusion
* Contraindication for thoracic paravertebral block
* Anticipated postoperative positive pressure ventilation
* Body mass index more than 35
* Any known psychiatric disorder
Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip

This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.

This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of respiratory illness caused by Coronavirus 2019 infection.

A total of 80 subjects will be randomized 2:1 in this study. 50 patients will be assigned to receive daily oral doses of 4,5 g of Viusid every 12 hours and 10 ml of Asbrip every 12 hours and standard care with antivirals or not. Other 30 patients will be assigned to receive only standard care.

Treatment duration: 21 days

Objective of the study: to increase the effectiveness of therapy for patients with Covid-19 using food supplements Viusid and Asbrip.

Research objectives:

1. To assess the clinical symptoms of Covid-19 in patients on the background of combination therapy with the inclusion of food supplements Viusid + Asbrip.
2. To investigate the dynamics of indicators of laboratory diagnostics against the background of complex therapy with the inclusion of food additives Viusid + Asbrip in the complex treatment of Covid -19.
3. To study the dynamics of indicators of instrumental methods of treatment.
4. To develop an algorithm for the management of patients with coronavirus infection in order to increase the effectiveness of therapy and rehabilitation of patients with this pathology.

Eligibility Criteria:
The eligibility criteria for inclusion in the study were as follows:

* Male and female hospitalized patients who have signed an informed consent.
* Aged between 18-85 years old.
* RT-PCR confirmed COVID-19.
* Fever (over 37.2 Celsius degrees).
* CT scan percentage area of lung involvement with ground-glass opacities \< 50 %.
* Respiratory rate \< 20-30 /min
* SpO2 ≥ 95%.

The exclusion criteria were as follows:

* Oxygen support (ventilation and non-invasive)
* Uncompensated or exacerbated concomitant diseases or conditions that may complicate or make the patient's participation in the study impossible, or make it difficult to explain clinical findings.
* Any known intolerability to any of the study regimens' components.
* Patient's family or official relations with a member of staff of the clinical site.
* Patient's failure to assess his/her physical and/or emotional condition.
* Patient's failure to comply with the study requirements.
* Patient's refusal to participate in the study.
* Pregnancy or breastfeeding.