cyrilzakka/clinical-trials huggingface dataset:
Paravertebral Block for Breast Surgery

The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain (\[VAS\] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.

Eligibility Criteria:
Inclusion Criteria:

* Breast surgery

Exclusion Criteria:

* Infections
* Coagulation disorder
* Allergy
Long-shaft Vitrectomy Probe in Highly Myopic Eyes

This study aimed to compare the safety and efficacy of vitrectomy probe with different shaft lengths in vitreoretinal surgery of highly myopic patients. In this randomized controlled study, highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery will be enrolled. The enrolled patients will be randomized into "30 mm shaft length group"(trial group) and "27mm shaft length group"(controlled group). We will compare the rate of wound leakage, hypotony, subconjunctival hemorrhage, probe bending, trocar removal, and endophthalmitis between the two groups. We would like to evaluate the efficacy and safety of the 30 mm shaft length vitrectomy probe.


Eligibility Criteria:
Inclusion Criteria:

* Highly myopic patients (axial length \> 26mm) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy

Exclusion Criteria:

* Previous history of pars plana vitrectomy
* Surgical plan combining encircling buckle
* Silicone oil or perfluorocarbon liquid use intraoperatively
* Previous history of pterygium surgery, trabeculectomy, glaucoma surgery
* Previous history of corneal, conjunctival, or scleral laceration
* History of connective tissue disease
Diuretic Efficacy of Aminophylline and Furosemide Combination vs Furosemide Alone in Critically Ill Adults

The goal of this RCT is to compare the effectiveness of aminophylline and furosemide combination vs furosemide alone in producing effective diuresis in critically ill adults in ICU. ICU patients with the need of improved diuresis will be recruited and given either infusion of aminophylline and furosemide combination or furosemide alone, and their hourly urine output will be monitored to compare their effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years old and above who are admitted to the ICU of UMMC during the study period
* Oliguric patients, with the need for improved diuresis at clinician discretion - defined as urine output \<0.5ml/kg/hour

Exclusion Criteria:

* Patient refusal for participation of study
* Patients with known hypersensitivity reaction to aminophylline or furosemide
* Patients with history of tachyarrhythmias, seizures, aspartate aminotransferase or alanine aminotransferase \> 3 times normal, or hypothyroidism.

Patient with existing peptic ulcer disease or coagulopathy with INR \> 1.5
A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome

This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye;
* Have a history of use or desire to use eye drops;

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used Restasis® within 30 days of Visit 1;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be unwilling to submit a urine pregnancy test if of childbearing potential;
* Have a known allergy and/or sensitivity to the test article or its components;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.
Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells

Subjects will receive standard chemotherapy and Tumor Treated Fields (TTFields) and will also receive Carvedilol for 4 cycles of treatment. Carvedilol will start at 6.25 mg orally twice a day and be increased to 12.5 mg orally twice daily after 1 to 2 weeks if tolerated. Peripheral glioma circulating tumor cells (CTC) and brain MRI with and without contrast will be obtained at baseline, 2 cycles, and 4 cycles to determine the efficacy and direction of change of the CTC using a new assay tool. Preliminary assessment of the tolerability of Carvedilol with standard chemotherapy will also be evaluated.

This will be a feasibility study to assess the use of a new PCR assay with response to standard chemotherapy treatment in the second line setting in glioblastoma multiforme (GBM). The change in direction with the combination of carvedilol with standard of chemotherapy based upon brain MRI results will be assessed and associating that with also the change in the quantity of tumor cells with a new invented assay device. Six subjects will be enrolled in the study who have recurrent GBM and will be receiving second line treatment.

The subjects will receive standard therapy per the discretion of the treating oncologist. Carvedilol will start at 6.25 mg orally twice daily for 1-2 weeks to confirm tolerance. The subjects will then receive carvedilol at 12.5 mg orally twice daily as the maximum dose and take it continuously for 4 cycles of therapy. At the completion of 4 cycles, patients will stop taking carvedilol. If the patients were on previous anti-hypertensive medications, they will be instructed to restart those medications if stopped on this trial for carvedilol.

Peripheral blood samples will be collected at baseline before initiation of treatment, on first day of every cycle for four cycles and after the last cycle is completed to obtain peripheral glioma circulating tumor levels. Subjects will be re-evaluated for response every 2 cycles of therapy with brain MRI with and without contrast.

Eligibility Criteria:
Inclusion Criteria:

* Grade IV Glioblastoma, receiving chemotherapy with or without TTfields.
* Progressive or recurrent disease requiring second line treatment
* evidence of progression of disease by brain MRI and are planned to receive chemotherapy

Exclusion Criteria:

* Current use of another beta blocker that cannot be switched to carvedilol at the onset of the trial.
* Systolic blood pressure \<90 mmHg and/or heart rate \<60 bpm without hypertensive medications
* Allergy to beta blockers
* Severe or uncontrolled asthma or COPD (chronic obstructive pulmonary disease)
Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)

The purpose of this study is to determine whether an investigational medication will be more effective than an approved medication in reducing cholesterol levels.


Eligibility Criteria:
Inclusion Criteria:

* Elevated cholesterol levels

Exclusion Criteria:

* Liver disease
* Unstable medical conditions
Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

Suppression of the adrenal function is a common, potentially dangerous and unpredictable consequence of short term high dose glucocorticoid treatment. Identification of patients at risk would be of high clinical importance. The investigators hypothesized that the dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced adrenal insufficiency.

The objective of this study is to evaluate if adrenal axis integrity investigated by the dexamethasone-suppression-test will predict the development of adrenal insufficiency after 14 days treatment with 0.5mg/kg of body weight prednisone in healthy volunteers. The investigators hypothesize that subjects with a more suppressed cortisol level after dexamethasone will be more likely to develop adrenal insufficiency after 14 days intake of prednisone o.5mg/kg/body weight than subjects with less suppression of their cortisol levels after dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers over 18 years

Exclusion Criteria:

* No informed consent
* Intake of any kind of medication
* BMI over 30kg/m2
* Acute or chronic illnesses
Value of the Combination Ultrasonography With Ti-RADS Score / Dual Tracer Scintigraphy MIBI-Tc99m/Iodine-123 in the Detection of Malignancy of Thyroid Nodules (≥15 mm) Classified Bethesda III or IV on Cytology

The main objective of the study is to show that the addition of ultrasonography to the dual tracer scintigraphy MIBI-Tc99m/Iodine-123 will increase (at least +5%) the negative predictive value compared to the dual tracer scintigraphy alone in detection of malignancy in thyroid nodules ≥15 mm classified as Bethesda III-IV on cytology.


Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years with a thyroid nodule ≥15 mm (maximal diameter measured on US) with a Bethesda class III or IV (FNA less than 6 months before the surgery).
* Given signed, written informed consent
* Affiliation to a social security system.
* Neither-pregnant nor breast-feeding women.
* Use of efficient contraception for patient with pregnancy potential (if needed).

Exclusion Criteria:

* Underage and adults under guardianship.
* Pregnant, without efficient contraception (if needed) or breast feeding women.
* Administration of iodinated contrast in the previous 3 weeks.
* Contraindication to scintigraphy or to Iodine123/ MIBI 99Tc administration
* Treatment containing iodine (i.e. : Amiodarone)
* Hypo or hyperthyroidism treated or not.
* Nodules inferior 15 mm.
* Refusal to sign the consent.
* Refusal of surgical treatment or contraindication for surgery or anesthesia
* Morbid obesity (BMI Superior 40 kg/m2).
* Hyperparathyroidism.
* History of cervicotomy.
Collar Use for Cervical Radicular Pain

To evaluate the effectiveness of treatment in subjects with cervical radicular pain with Vista Therapy Collar, using a Visual Analog Scale, a Neck Disability Index and the SF-36 quality of life survey.

To evaluate the effective of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to a 'wait and see' approach.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:

   * Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
   * Muscle weakness in one or more adjacent myotomes.
3. Neck Disability Index (NDI) score \>= 10 points
4. VAS for neck pain \>= 40
5. Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted
6. Subject is willing and able to attend visits as scheduled and to comply with the study protocol

Exclusion Criteria:

1. Serious somatic or psychiatric disorder
2. Previous Neck Surgery
3. Whiplash as the primary incident
4. History of spinal tumor or infection
5. Cervical Instability per opinion of PI
6. Morbid Obesity (BMI\>40)
7. TMJ issues
8. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
9. Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
10. Subject is involved in Worker's Compensation litigation
11. Non-English speaking
Gameplay as a Source of Intrinsic Motivation in a Randomized Controlled Trial of Auditory Training for Tinnitus

Tinnitus refers to a the perception of a ringing, hissing or buzzing sound despite there being no such sound in the external world. It is prevalent and for many individual is a distressing condition. Recent advances in the understanding of changes in the hearing brain and their relation to tinnitus perception has led to a focus on forms of active auditory training which might provide effective techniques for tinnitus management. Our recent trial of auditory training provided evidence that training using sounds where there is no hearing loss has benefit in terms of reduced tinnitus intrusiveness, above training at where there is some level of hearing loss. Our next challenge is to build on this finding in ways that might maximize the benefits we observe.

The training software we used previously was developed for use with children. Past participants have given mixed reviews of this software. While some enjoyed the training or found it soporific, others reported that they found it too monotonous and un-motivating. We therefore wish to explore the impact of different game mechanics in the delivery of auditory training and have designed two different interactive games in the context of training for tinnitus benefit. These games will deliver the same type of auditory training as the software we currently use, but should be intrinsically motivating, i.e. be a game that the people are motivated to play irrespective of any potential benefit for tinnitus. The game we previously used is reactive, i.e. the sounds play and the player selects what they think is the correct answer (odd one out).

The two new games we wish to test can be described as interactive, i.e. players control the sound delivery and actively seek the correct answer: this may have additional benefit for tinnitus.


Eligibility Criteria:
Inclusion Criteria:

(i) Chronic subjective tinnitus (experienced for over 6 months)

(ii) Aged 18 + years old

(iii) Not currently receiving treatment for tinnitus from the National Health Service or other sources

Exclusion Criteria:

(i) Significant distress (Beck anxiety score \>25, Beck depression score \>13)

(ii) Hyperacusis (Khalfa Hyperacusis Questionnaire score \>27)

(iii) Significant bilateral hearing loss (\>39 decibel at all tested frequencies)
PEP-1324: Glycemic Response Testing

The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-75 years of age
* Subject is male or non-pregnant females, 18-75 years of age, inclusive
* Subject has a body mass index (BMI) ≥ 20.0 and \< 35 kg/m² at screening (visit 1).
* Subject has to be non-smoker.
* Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
* Subject is willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
* Subject has normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
* Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
* Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

Exclusion Criteria:

-
S-cystatin C vs.Injection Clearance Measurements to Estimate Kidney Function in Patients With Spinal Cord Injuries

* In individuals with spinal cord injury (SCI) kidney function defined as Glomerular Filtration Rate (GFR) is monitored by injection of e.g.99mDTPA and subsequent blood sampling (DTPA-clearance)
* GFR calculated from plasma samples of the endogenous substance s-Cystatin C (eGFR cystatin C) was compared to DTPA-clearance in 248 individuals with SCI.
* It is concluded that eGFR based on plasma s-cystatin C can replace the more tedious 99mDTPA-clearance procedures in individuals with SCI


Eligibility Criteria:
Inclusion Criteria:

Neurogenic bladder dysfunction due to spinal cord injury

Exclusion Criteria:

None
Study of AZD5863 in Adult Participants With Advanced or Metastatic Solid Tumors

This research is designed to determine if experimental treatment with AZD5863, a T cell-engaging bispecific antibody that targets Claudin 18.2 (CLDN18.2) and CD3, is safe, tolerable and has anti-cancer activity in patients with advanced solid tumors.

This is a first-time in human, modular Phase I/II, open-label multicentre study of AZD5863 monotherapy administered intravenously (Module 1), or AZD5863 monotherapy administered subcutaneously (Module 2) in patients with advanced or metastatic solid tumors. Each module contains dose-escalation (Part A) and dose-expansion (Part B).

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 at the time of signing the informed consent
* Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
* Must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Must show positive CLDN18.2 expression in tumor cells as determined by central immunohistochemistry (IHC)
* Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
* Predicted life expectancy of ≥ 12 weeks
* Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
* Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
* Must have received at least one prior line of systemic therapy in the advanced/metastatic setting

Key Exclusion Criteria:

* Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
* Participant experienced unacceptable cytokine release syndrome (CRS) or Immune Effector Cell Associated Neurotoxicity (ICANS) following prior T cell engagers (TCE) or chimeric antigen receptor T (CAR-T) cell therapy
* Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
* Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
* central nervous system (CNS) metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
* Infectious disease including active human immunodeficiency virus (HIV), active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
* Cardiac conditions as defined by the protocol
* History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
* Participant requires chronic immunosuppressive therapy
* Participants on anticoagulation therapy
The Effect of Chia Seeds on HDL Cholesterol

The purpose of this clinical trial is to demonstrate the effect of daily consumption of chia seeds, if any, on HDL cholesterol levels and compare this to the effects of oats on HDL levels in adult populations.

Chia seeds are touted as a health food capable of a beneficial effect on HDL cholesterol. Similar claims have been made for oats in various forms, claiming they improve cholesterol or are in some way heart healthy.

The investigators wish to demonstrate the effect of daily consumption of chia seeds, if any, on HDL cholesterol levels and compare this to the effects of oats on HDL levels.

This pilot study was a randomized controlled trial at an academic primary care center. Participation was voluntary and all participants provided written consent prior to enrollment. There were no exclusionary criteria other than that participants must be adults willing to come in to get their cholesterol profiles checked at the beginning and end of the study. Participants consumed their assigned breakfast in a standard serving size for a month with blood draws and weights recorded before and after the diet. Patients' cholesterol profiles were also compared with their weights. To standardize the delivery of chia seeds, the group consuming chia seeds mixed the chia with oatmeal. The three groups thus consisted of Cheerios, oatmeal and oatmeal with chia seeds. Initially, there were a total of 11 subjects, three in the Cheerios group, four in the oatmeal group, and four in the oatmeal with chia seeds group. Two subjects were lost to follow-up, one each from the Cheerios and oatmeal groups, respectively. Statistical analysis including one way analysis was done with means, Wilcoxon/Kruskal Wallis test and 1 way test.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to give voluntary consent
* Must be greater than or equal to 18 years old
* Must be willing to give blood twice
* Must be able to eat assigned breakfast

Exclusion Criteria:

* "Subjects between the ages of 18 and 50 years old without a history of food allergies to either chia seeds or oats, kidney stones or a history of hyperlipidemia or treatment for hyperlipidemia will be eligible."
AssesSment of Early-deteCtion basEd oN liquiD Biopsy in Biliary Tract Cancer (ASCEND-BTC)

ASCEND-BTC is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free DNA (cfDNA) methylation. The study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.


Eligibility Criteria:
Inclusion Criteria for Cancer Arm Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent
* Pathologically confirmed biliary tract cancers.
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw.

Exclusion Criteria for Cancer Arm Participants:

* Pregnancy or lactating women.
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.
* Recipients of blood transfusion within 7 days prior to study blood draw.
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.
* With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Arm Participants:

* Age 40-75 years at the day of consenting to the study.
* Able to provide a written informed consent.
* Confirmed diagnosis of benign biliary tract diseases.
* No prior radical treatment of the benign diseases prior to study blood draw.

Exclusion Criteria for Benign Arm Participants:

* Pregnancy or lactating women.
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant.
* Recipients of blood transfusion within 7 days prior to study blood draw.
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers.
* Confirmed diagnosis of malignancies or precancerous lesion.
* A history of malignant tumors.