cyrilzakka/clinical-trials huggingface dataset:
Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery

The goal of this clinical trial is to determine the ED50 and ED95 of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients undergoing major abdominal surgery using up-and-down sequential method . The main question it aims to answer is:

What is the effective concentration of prophylactic norepinephrine infusion for preventing post-induction hypotension in elderly patients.

Participants will receive different concentrations of norepinephrine infusion at the beginning of anesthesia induction until 15 minutes after intubation.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 to 80 years
* Undergoing major abdominal surgery
* American Society of Anesthesiologists (ASA) physical status of I/II/III

Exclusion Criteria:

* Patient refusal
* Severe untreated or uncontrolled hypertension despite medications
* Bradycardia (heart rate \< 50 beat per minute)
* Cardiac morbidities, heart block greater than the first degree
* Severe hepatic and renal dysfunction
* hyperthyroidism
* vascular diseases
* BMI\>30
* Monoamine oxidase inhibitors were used 2 weeks before surgery
Peppermint Oil Pharmacokinetics/Dynamics and Novel Biological Signatures in Children With Functional Abdominal Pain

Aim 1 - Determine the pharmacokinetics of PMO (menthol) of three different doses in children with functional abdominal pain (FAP) (n=30).

Aim 2 - Determine pharmacodynamic effect of three different doses of PMO on gut microbiome composition and contractile activity/gut transit rate.

Children with functional abdominal pain (FAP) ages 7-12 years (n=30) will be recruited.

The study participants will be admitted to the Children's Nutrition Research Center. A medical history and a general physical examination performed by the investigator or the research nurse. The height, weight, and vital signs (pulse rate, respiratory rate, and seated blood pressure) will be obtained. After application of a topical anesthetic to the site chosen for study-related blood sampling, a cannula will be inserted e to obtain repeated blood samples.

At approximately 0900, subjects will receive one of three doses of PMO as a single oral dose. Immediately prior to administration of the PMO, a blood sample will be obtained to measure total menthol concentration and leukocytes for isolation of DNA for CYP2A6 and UGT2B7 genotyping.

After PMO administration, repeated blood samples will be obtained over 24 hours.

At 2 hours after PMO administration, participants will be given a standardized meal and will eat ad libitum thereafter.

After completion of the final (24 hours) blood samples, vital signs will be reassessed and the venous cannula removed. Parents will receive a follow-up call from the research coordinator to access/evaluate if any adverse effects from dose or blood sampling received at the overnight study visit.

Prior to and after administration of peppermint oil (PMO) for 1 week at the dose defined above, children will undergo measurement of gut microbiome composition and GI motility and transit time. At the time of the stool collection, the child will also keep a 3 day diet history.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages 7-12 years old
2. They will be able to complete the protocol
3. A child will be recruited if the medical evaluation reveals no organic reason for the abdominal pain

Exclusion Criteria:

1. Children who have had past bowel surgery;
2. A child with documented GI disorders (e.g., Crohn's disease);
3. A child with a serious chronic medical condition (e.g., diabetes);
4. A child with a weight and/or height \< 2 SD for age;
5. Children with chronic conditions with GI symptoms (e.g., cystic fibrosis);
6. Children with autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder;
7. Children who have been treated with antibiotics/probiotics within 2 mo. (because of effects on microbiome analysis).
8. Children who speak only Spanish
Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)

The purpose is to investigate tocilizumab administration in patients with moderately to severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic alternative.

The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment in order to provide a better alternative to surgery for this patients.

Thyroid orbitopathy or Graves´orbitopathy (GO) is manifested for inflammation of the orbital and periorbital soft tissues. Ten percent of patients with GO will have long-term serious eye problems.

The cause of the GO is complex. Autoreactive T cells recognize an autoantigen, the TSH receptor present in the orbit and thyroid follicular cell, secrete cytokines (IL-6), which stimulate the fibroblasts to synthesize glycosaminoglycan, which draws liquid produce periorbital edema and muscle, causing exophthalmos.

This approach suggests that inhibition of IL-6 can be an effective treatment for this problem on the basis that tocilizumab specifically binds to the receptors of the IL-6, both soluble and membrane-bound. Tocilizumab has been shown to inhibit signaling mediated for IL-6Rm IL-6Rs.

Eligibility Criteria:
Principal Inclusion Criteria:

Patients diagnosed GO with CAS ≥ 4 and an index of severity, according EUGOGO guidelines, 1. moderately to severely or 2. sight-threatening GO, after receiving corticosteroid pulse treatment due to:

* Poor response to intravenous corticosteroid pulses Or
* Recurrence of the GO, after treatment with intravenous corticosteroids

Exclusion Criteria:

* Orbital decompression surgery needed immediately
* Active smoker
* Patients who could need treatment with radioactive iodine or thyroidectomy during the study
* Pregnant patient or patient who is planning to become pregnant during the study
* History of chronic recurrent or active infection
* History of intestinal ulceration or diverticulitis
* Patients with a history of chronic liver disease or liver disorders: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)
* History of HIV, hepatitis C or hepatitis B Positive
* Neutrophil count \< 0.5 × 109/L or a platelet count \< 50×103/μL
* Simultaneous use or contraindications to the use of immunosuppressive agents
* A treatment with another investigational drug within four weeks of selection or five half-lives of study drug
* Cardiovascular or cerebrovascular disease clinically significant
* Uncontrolled diabetes mellitus
* Use of corticosteroids during four weeks before to inclusion period
* History of reactions or anaphylactic allergic severe human monoclonal antibodies, humanized or murine
* Uncontrolled pathologies, whose exacerbations are treated with corticosteroids
Influence of the Concentration of the Local Anesthetic Ropivacaine on the Quality of a Ultrasound Guided Intermediate Cervical Block.

Carotid endarterectomy is commonly performed under cervical plexus block. This is presumed to offer advantages over general anesthesia in terms of monitoring neurological function during cross-clamping of the carotid artery since, in conscious patients, speech, cerebration, and motor power provide early measures of inadequate cerebral perfusion. Some studies also claim lower shunting requirements, lower cardiovascular morbidity, and shorter hospital stay.

Traditionally, the common methods of cervical plexus block are termed 'deep' or 'superficial'. The deep block, as described by Moore or Winnie and colleagues, consists of identifying the transverse processes of upper cervical vertebrae C2 - C4 and injecting local anesthetic directly into the deep (prevertebral) cervical space. This may be achieved either as separate injections or as a single injection. The superficial block incorporates a variety of procedures. The simplest is a s.c. infiltration of local anesthetic along the posterior border of sternocleidomastoid muscle by either the surgeon or the anesthetist.

An 'intermediate' block is one where the injecting needle pierces the investing fascia of the neck, deep to the s.c. layer, but superficial to the deep cervical (prevertebral) fascia. It is also possible to use a 'combined block', consisting of a deep injection and a superficial or intermediate injection.

Practitioners may prefer one block to another, but no consensus exists on the efficacy of one block when compared with another. However, it has been suggested that complications of the technique are related to the deep injection and not the superficial (or intermediate) injection. These complications include intrathecal or intravascular injection, respiratory problems related to phrenic nerve paralysis, or local anaesthetic toxicity.

In this study the Influence of the concentration of the local anesthetic ropivacaine on the quality of the intermediate cervical plexus block for carotid endarterectomy will be evaluated. For this purpose two different concentrations of ropivacaine will be compared (3,75% vs 7,5%). The primary endpoint of the study will be the quantity of the additional needed local anesthetic to achieve adequate operative analgesia. Furthermore we will record the frequency of the most common side effects as well as the patient satisfaction with a standardized questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for carotid endarterectomy in regional anesthesia

Exclusion Criteria:

* refusal to participate in the trail
* age \< 18a
* gestation/breastfeeding
* contraindication for regional anesthesia
* inclusion in other trails
Shockwave Lithotripsy (SWL) Versus SWL and Oral Dissolution Therapy (ODT) For Paediatrics Radiolucent Renal Stone

To conduct a RCT comparing SWL versus combined ODT and SWL as non-invasive methods for management of paediatrics radiolucent renal stone.


Eligibility Criteria:
Inclusion Criteria:

* 1-2.5 cm renal stone
* Normal Serum creatinine
* Radiolucent stone with Hounsfield units less than 400

Exclusion Criteria:

* Bleeding diatheses.
* Patients with a pacemaker.
* uncontrolled UTIs.
* Severe skeletal malformations.
* Arterial aneurysm in the vicinity of the stone.
* Anatomical obstruction distal to the stone.
Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ) for Ulcerative Colitis and Crohn's Disease

The purpose of the study is to develop a validated French version of the IBDQ in a cohort of patients suffering from Inflammatory bowel diseases, namely Crohn's disease and Ulcerative Colitis.

Importance of measuring subjective aspects of the patient's health, often referred to as quality of life (QoL), become increasingly recognized and integrated into healthcare. For this purpose, The Inflammatory Bowel Disease Questionnaire (IBDQ) is a widely used questionnaire for QoL assessment specific for patients who suffer from inflammatory bowel diseases. However, the IBDQ was originally developed in a cohort of Canadian patients in English language. Since QoL is impacted by underlying cultural trends, any translation of the IBDQ should be reassessed in relation to its validity, reliability, and sensitivity to detect change in the new language and cultural context. While the linguistic French translation of the original IBDQ has been validated, the French IBDQ has never been tested adequately on a French cohort of patient that we aim to perform.

Eligibility Criteria:
Inclusion Criteria:

* men and women ≥ 18 years of age,
* patient with definite diagnosis of UC or CD for at least 6 months

Exclusion Criteria:

* adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
* inability to comprehend or complete the self-administered questionnaire
* psychiatric diagnosis that prevents participation (many pts will have anxiety or depression and should not be excluded)
* stoma
* malignancy
Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

The aim of this study is to determine the clinical performance of fanfilcon A in comparison to senofilcon A sphere contact lenses.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Has read, understood and signed the information consent letter
* Has had a self-reported eye exam in the last two years
* Is a spherical soft contact lens wearer
* Has a contact lens prescription that fits within the available parameters of the study lenses
* Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses
* Has clear corneas and no active ocular disease
* Is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear)
* Is willing and able to follow instructions and maintain the appointment schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has a history of not achieving comfortable CL (Contact Lens) wear (defined as 5 days per week; \>8 hours/day)
* Is currently wearing senofilcon C (2 weeks lens), senofilcon A 1-Day, senofilcon C (monthly lens) or enfilcon A contact lenses
* Is habitually using rewetting/ lubricating eye drops more than once per day
* Presents with clinically significant anterior segment abnormalities
* Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear
* Presents with slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Significant pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (or history in past year)
  * Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea
* Has presbyopia or has dependence on spectacles for near work over the contact lenses
* Has undergone corneal refractive surgery
Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers

The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female, non-smoking subjects.
2. Willing to use contraception throughout the duration of the study and for 90 days after the study.
3. Capable of consent.

Exclusion Criteria:

Subjects to whom any of the following applies will be excluded from the study:

1. Any clinically significant abnormality, infection, exposure to infection, recent live virus vaccination, or abnormal laboratory test results found during medical screening.
2. History of alcohol or drug abuse, or a positive urine drug screen or breath alcohol test at screening.
3. History of allergic reactions to protein kinase inhibitors, or significant allergic reactions to any drug.
4. Positive pregnancy test at screening.
5. Clinically significant ECG abnormalities.
6. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
7. Use of medication other than topical products without significant systemic absorption:
8. Donation of plasma within 7 days prior to dosing, or significant blood loss within the past 56 days.
9. Subject is pregnant, or breast feeding.
Relative Bioavailability of 1 mg and 10 mg BI 1356 BS as Powder in the Bottle (PIB) to 1 mg and 10 mg BI 1356 BS as Tablets as Single Oral Administration in Healthy Male Volunteers Including the Influence of Food on the Bioavailability of 10 mg BI 1356 BS

Investigation of the relative bioavailability of 1 mg and 10 mg BI 1356 BS as PIB reconstituted with 0.1% tartaric acid vs. 1 mg and 10 mg BI 1356 BS as tablet including a food effect for the 10 mg tablet dose group


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP),Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests

  * No findings deviating from normal and of clinical relevance
  * No evidence of a clinically relevant concomitant disease
* Age ≥21 and Age ≤65 years
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
* No adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilisation, intrauterine device) during the whole study period from the time of the first intake of study drug until one month after the last intake
Clinical Evaluation of the Modified Laterally Stretched Technique (RT2) Gingival Recession vs Tunneling With CT Grafting

Regression analysis in a recent systematic review showed significantly greater mRC and CRC values when modifications are done to the TUN procedure to achieve more coronal advancement of the flap, coronal advancement also helps in covering the underlying graft for better recession coverage outcomes (Tavelli et al., 2018), limited data is present on the possible influence of a covered or partially uncovered graft. However, it has been suggested that minimal exposure of the CTG may aid not only in achieving CRC but also a harmonious gingival margin (John et al., 2015; Rasperini et al., 2011).


Eligibility Criteria:
* Single or multiple RT2 gingival recession site/sites in the lower anterior teeth.
* Age \>/= 18 years.
* Patients with healthy or treated periodontal conditions.
* Patients willing to participate in the study.
* Absence of uncontrolled medical conditions.
* Full mouth plaque score \</= 20% (O'Leary 1972).
* Full mouth bleeding score \<20% (Ainamo and Bay 1975).
* Patients with aesthetic concerns.

Exclusion Criteria:

* Pregnant or lactating females.
* Tobacco smoking.
* Uncontrolled medical conditions.
* Uncooperative patients or unable to complete the study.
* Patients treated with any medication known to cause gingival hyperplasia.
* No occlusal interferences.
HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.
2. Age greater than or equal to 18 years

Exclusion Criteria:

1. Propofol, midazolam, or fentanyl allergy
2. Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)
3. Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.