cyrilzakka/clinical-trials huggingface dataset:
Clonidine Added Lidocaine in Intraocular Pressure and Hemodynamics Ocular in Sub-Tenon's and Peribulbar Anesthesia

Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and peribulbar anesthesia.

In this prospective randomized and double blind clinical study, involving 80 patients with ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of 2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1), five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications related to the sub-Tenon's and peribulbar anesthesia were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 30 and 86 years old
* Both genders
* Physical status ASA (American Society of Anesthesiologists) I and II
* Cooperative patients undergoing cataract surgery by phacoemulsification

Exclusion Criteria:

* Patients with communication difficulties
* Allergic to any medication protocol
* Chronic therapy with clonidine
* In use of antihypertensive medication
* Diabetes
* Glaucoma
* Previous surgery in the same eye
* Abnormalities in coagulation
Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management

Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial

Protocol of therapy Niclosamaide Add on group

* NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. \[ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days\]
* If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.

Control group The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient:

* Acetaminophen 500mg on need
* Vitamin C 1000mg twice/ day
* Zinc 75-125 mg/day
* Vitamin D3 5000IU/day
* Azithromycin 250mg/day for 5 days
* Oxygen therapy/ C-Pap if needed
* Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
* Mechanical ventilation, if needed

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age above 18 years and of any gender.
2. Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18).
3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases.
4. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. Patients refuse to enrol in the study
2. Patients with hypersensitivity or severe adverse effects to niclosamide
3. Renal impairment
4. Hepatic impairment
5. Pregnancy or a desire to become pregnant
6. Breast feeding
Hand ScleroDerma Lived Experience Scale in Individuals with Systemic Sclerosis

The aim of this study was to examine the Turkish validity and reliability of the Hand scleroDerma lived Experience Scale (HAnDE Scale) Questionnaire in individuals with SSc.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Systemic Sclerosis by a rheumatologist
* Being 18 years of age or older,

Exclusion Criteria:

* Presence of neurological disease
* Presence of any orthopedic problem that will affect functionality
* Presence of orthopedic surgery history
* Inability to speak or understand Turkish fluently.
* Presence of psychiatric disease that will affect cooperation.
* Severe neurological disease that will affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident).
* Heart failure and lung pathology that will affect daily living activities.
The Offer of Neurosurgery Care in the Grand Est of France During the Health Crisis Linked to Covid-19

During this exceptional health crisis, this study of the current care of a neurosurgical activity, which is essential in a University Hospital Centre, will enable us to better understand how we function, the response given to a population with the means at our disposal, the implementation of new therapeutic strategies and their limits, ethical reflection, and, how to pursue a distributive and quality medicine.

The restriction of conventional medical resources to our care activity (resuscitation, personnel, operating theatre, constraints linked to the risk of contamination...) is leading to a new medical organisation imposing new Covid-19 standards, the description of which seems essential to us.

A knowledge of the strategies to be adopted during a disaster health situation in order to continue providing care to the civilian population. How can we prevent the setting up of health care systems outside the cause of the health crisis? n triage medicine, Avoiding the "burn-out" of doctors struck by the health crisis.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged over 18;
* Entering the neurosurgery care sector requiring support between 03/16/2020 and 06/15/2020;
* Having not expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ribavirin 400 mg, after administering a single oral dose, to healthy adult subjects under fed conditions.

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) each phase, under fed conditions, with a wash-out period of 42 days.

Ribavirin plasma concentration was determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for the study
* Age 18 - 55 years
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator.
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
Allium Extracts on the Intestinal Microbiota in Healthy Resident Volunteers.

To evaluate the effect of daily consumption of a combination of garlic and onion extracts on the intestinal microbiota and the production of short chain fatty acids in elderly healthy volunteers living in a residence.

Likewise, any incident related to health that occurred during that period will be noted.

This study is a continuation of another (C002, registration number NCT04647071).

The volunteers from study C002 were invited to participate in this new study and, by the end of C002, all gave 2 stool samples.

After 4 weeks of washout, the control group volunteers in C002 will begin consuming 1 capsule per day of garlic and onion extract after lunch. The intervention group volunteers in C002 will not consume anything.

During 36 weeks any incident related to the health of the volunteers will be noted. Likewise, during this time, the volunteers will maintain their lifestyle and eating habits.

At 36 weeks, 2 stool samples will be taken from all volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 65 years or older who participated in study C002.
* 2. Living in the Claret Residence for the Elderly in Granada during the study.
* Accept being vaccinated for the flu.
* Freely accepted to participate in the study and sign the informed consent document.
* Have the consent of the family.

Exclusion Criteria:

* Having any disease that affects the development and results of the study.
* Be unable to understand the study and sign voluntarily and freely the informed consent.
* Have a low expectation of compliance with the study protocol.
Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season


Eligibility Criteria:
Inclusion Criteria:

* moderate to severe allergic rhinoconjunctivitis to birch pollen:

  1. Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
  2. Previous use of anti-allergy medications during the two preceding birch pollen seasons
  3. Positive SPT to birch pollen extract
  4. Positive specific IgE CAP test for Bet v 1

Exclusion Criteria:

* uncontrolled asthma, FEV1 \< 80% of predicted
* previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
* clinical symptoms due to allergens other than birch pollen during the whole trial period
* history of anaphylaxis
* positive skin prick test to AllerT
* any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximeum 14 days within the last 3 months)
* Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or other insulin secretagogue e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to the summary of product characteristics (SPC) or locally approved PI
* HbA1c 7.0-11.0 % (both inclusive)
* Body Mass Index (BMI) 23-42 kg/m\^2 \[lb/in\^2 x 703\] (both inclusive)

Exclusion Criteria:

* Metformin contraindication according to local practice
* Thiazolidinedione (TZD) treatment within previous three months prior to visit 1
* Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) three months prior to randomisation
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial drug
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

This is a study to compare the efficacy of bimekizumab versus placebo and an active comparator in the treatment of subjects with moderate to severe chronic plaque psoriasis (PSO).


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit
* Psoriasis Area Severity Index (PASI) \>=12 and body surface area (BSA) affected by PSO \>=10% and Investigator's Global Assessment (IGA) score \>=3 on a 5-point scale
* Subject is a candidate for systemic PSO therapy and/or phototherapy
* Female subject of child bearing potential must be willing to use highly effective method of contraception

Exclusion Criteria:

* Subject has an active infection (except common cold), a recent serious infection, or a history of opportunistic or recurrent chronic infections
* Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
* Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB infection, or has current or history of nontuberculous mycobacterium (NTMB) infection
* Subject has any other condition, including medical or psychiatric, which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study
* Presence of active suicidal ideation or positive suicide behavior
* Presence of moderately severe major depression or severe major depression
* Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, or in situ cervical cancer
BlueCQ Bioavailability

Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations - and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood, plasma and urine.

Intraindividual cross over open comparison in healthy male and female individuals (6:6) with different MB formulations in randomised order for the determination of the absolute bioavailability of MB (part 1), followed by an explorative randomised parallel group comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1 (part 2).

Maximum whole blood methylene blue (MB) concentrations after i.v. and oral administration may differ in the magnitude of 100:1. For achieving MB concentrations possibly effective against malaria when using different pharmaceutical formulations, determination of oral bioavailability of MB is necessary. To investigate this 12 healthy subjects (6 females, 6 males) will receive in a randomised cross over design MB 50 mg i.v. and MB 500 mg as a oral solution.

For generating this information for a planned phase II/III study in Africa, an intravenous and an oral MB preparation will be investigated.

A second part of the study will explorative investigate the influence of MB on chloroquine (CQ) plasma concentrations. During this part 6 healthy subjects (3 females, 6 males) will receive either CQ alone or in combination with MB 500 mg, the design of this part will be a parallel design.

Eligibility Criteria:
Inclusion Criteria:

Good state of health physically and mentally

Exclusion Criteria:

Any regular drug treatment currently or past (within the last 2 months) except for oral contraceptives in females Treatment with a known inhibitor or inducer of drug metabolising enzymes or transport proteins within a period of less than 10 times the respective elimination half-life

Any acute or chronic illness, especially:

Glucose-6-phosphate dehydrogenase deficiency Allergic disposition or history of hypersensitivity reactions Smoking Alcohol or drug abuse
Phase 2 Study of NX9 for Delineation of Bowel Anatomy

This study will evaluate marking and distention of the bowel of the oral contrast agent, NX9, at CT of the abdomen and pelvis, VLDCT with no contrast will be followed by VLDCT with NX9 contrast followed by CT with NX9 and standard IV contrast. Eligible subjects will have cancer or other GI disorders for which CT is typically used to assess their disease. This is an open label study with efficacy evaluated in a masked fashion following completion of the entire study. Results of the NX9 scans will not be used for treatment decisions. PK will be evaluated in a subset of subjects at a single center.


Eligibility Criteria:
Inclusion Criteria:

1. Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures
2. Subject is between the ages of 18 to 85 years old, inclusive
3. Has had CT of the abdomen and pelvis with IV contrast within 6 months
4. Has a concern for disease involvement of the bowel or structure adjacent to bowel (e.g. peritoneal disease, carcinomatosis, omental cake, bowel inflammation, lymphadenopathy, or fluid collection).
5. Is willing and able to comply with protocol-specified CT scanning and visits to the clinic
6. Is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds
7. Is able to drink 1.2 liters of fluid within 45 minutes
8. Has good venous access as determined by the Investigator at screening
9. Is an outpatient who is able and willing to come to the clinic for study visits

Exclusion Criteria:

1. Has any co-morbidity that the Investigator judges will interfere with their ability to complete the study or undergo a quality CT scan, e.g. high risk of aspiration
2. Has a history of or is currently suffering from a known gastrointestinal motility disorder, e.g. severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc.
3. Has symptoms of a possible current bowel obstruction
4. Has a moderate to high risk of current bowel perforation
5. Subject should not schedule a GI diagnostic surgery or hospitalization for any procedure until after the study follow-up on Day 14 day. However, if at the time of study entry, the subject has pre-planned a surgery or hospitalization, it may be allowed at the discretion of the PI provided it does not take place until after the subject completes the Day 3 visit.
6. Has a contraindication (i.e. allergy) to IV or Oral CT contrast
7. If of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening
8. Has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.
Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility Criteria:
Inclusion Criteria:

* One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
* \> 30 years old
* have at least a recorded heart rate measurement during the study period

Exclusion Criteria:

- Evidence of prior atherosclerotic or cardiac disease
A Study of Albuferon With Ribavirin in Interferon Treatment Experienced Subjects With Chronic Hepatitis C

This is a Phase 2, multi-center, randomized, open-label study to evaluate the safety, tolerability, and efficacy of Albuferon in subjects with hepatitis C (HEP C) who failed to respond to previous interferon alfa therapy.


Eligibility Criteria:
Major Inclusion Criteria:

* Have a clinical diagnosis of chronic HEP C established on the basis of detectable viral load, as measured by a serum HCV RNA test during the screening period.
* Have previously failed to respond to treatment with any interferon alfa (IFNa) product
* Have compensated liver disease with the following minimum criteria: white blood cell count \> 3,000/mm3, absolute neutrophil count (ANC) \> 2,000/mm3, platelets \> 125,000/mm3, and hemoglobin (Hb) \> 13 g/dL for males or \> 12 g/dL for females.

Major Exclusion Criteria:

* Evidence of decompensated cirrhosis or portal hypertension.
* Pregnant or lactating female.
* History of any other medical disease or condition that would make the subject (in the opinion of the investigator) unsuitable for the study.
* A current drug or alcohol addiction
Prospective, Non-Randomized Evaluation of Carbon Dioxide Gas as a Contrast Agent in Comparison With Iodinated Contrast in Endovascular Aneurysm Repair

Endovascular repair of infrarenal abdominal aortic aneurysms (AAA) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. Iodine contrast has traditionally been used, but has the potential to harm the kidneys. Another contrast agent is carbon dioxide gas. It has been proven safe to use, but the quality of the images it creates needs to be compared to iodine contrast. Patients in this study undergo the endovascular AAA repair as they normally, with the iodine contrast. At the end of surgery carbon dioxide gas contrast is given as an extra step. The images will be later evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Infrarenal abdominal aortic aneurysm amendable to endovascular repair

Exclusion Criteria:

* renal failure or contraindication to receiving iodine contrast.