cyrilzakka/clinical-trials huggingface dataset:
Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure

This study designed is compare the pulse response to the Valsalva maneuver between a photoplethysmography sensor (PPG) and non-invasive blood pressure sensor for the purpose of validating the PPG methodology in deriving a value for the Valsalva pulse response. The aim is to show that the PPG method captures the same phase responses as the blood pressure monitor and the primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse.

With both a photoplethysmography (PPG; Indicor, Vixiar Medical,. Baltimore, MD) and non-invasive blood pressure (Caretaker, Caretaker Medical, Charlottesville, VA) sensors in place on the index and middle fingers, respectively, each patient will be asked to perform three mild, 10-sec Valsalva maneuvers with at least 45 seconds between. Pulse recordings will be collected from each device to compare phases of the Valsalva pulse response including pulse amplitude changes and baseline movement. The primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable adults, including heart failure patients visiting an outpatient clinic

Exclusion Criteria:

* Atrial flutter or atrial fibrillation with an irregular ventricular response
* Significant atrial or ventricular ectopy
* History of paradoxical emboli
* Hypertrophic obstructive cardiomyopathy
* Known intracardiac shunt
* Known severe aortic valve stenosis
* Known severe mitral valve stenosis
* History of embolic CVA
* Myocardial infarction within one week of intended Indicor testing
* Uncontrolled hypertension (systolic BP \>160mmHg or diastolic BP\>100mmHg)
* Hypotension (systolic BP \<90mmHg)
* Symptomatic bradycardia
* Known cholesterol emboli
* Poor left ventricular function with left ventricular thrombus
* Unstable angina
* Significant aortic valvular disease
* Patients weighing less than 40kg
GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer

To evaluate safety and efficacy of the combination cisplatin plus irinotecan in the treatment of biliary tract cancer.


Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven gallbladder or biliary tract cancer;
* Recurrent, metastatic or unresectable disease;
* Chemo-naïve.
* Not candidates to curative-intent treatment, such as surgery or radiation-therapy;
* Measurable disease according to RECIST 1.1;
* ECOG 0-2;
* Adequate hematologic and biochemistry tests;
* Creatinine clearance \>= 60ml/min.

Exclusion Criteria:

* Known hypersensibility or previous therapy with cisplatin, gemcitabine or irinotecan;
* Chronic immunosuppressive therapy;
* Known CNS metastasis;
* Previous diagnosis of other cancer;
* Chronic or acute active infection, except asymptomatic HIV infection;
* Active bleeding;
* Any severe medical condition;
* Pregnant or lactating women, or with childbearing potential;
Refinement and Adaption of Reinforcement Learning to Personalize Behavioral Messaging for Healthy Habits

Reinforcement learning is an advanced analytic method that discovers each individual's pattern of responsiveness by observing their actions and then implements a personalized strategy to optimize individuals' behaviors using trial and error. The goal of the proposed research is to refine, adapt and perform efficacy testing of a novel reinforcement learning-based text messaging intervention to support medication adherence for patients with type 2 diabetes within a community health center setting. This study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults in a community setting aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels over 6 months.

The goal of the proposed research is to refine, adapt and perform efficacy testing of a novel reinforcement learning-based text messaging intervention to support medication adherence for patients with type 2 diabetes within a community setting. Type 2 diabetes is an optimal condition in which to refine this program, as it is one of the most prevalent chronic conditions in the US adult population and requires most patients to be on daily or twice daily doses of medications. This study will be a parallel randomized pragmatic trial comparing medication adherence and clinical outcomes for adults in a community setting aged 18-84 with type 2 diabetes who are prescribed 1-3 daily oral medications for this disease. Participants will be randomized to one of two arms for the duration of the study period: (1) a reinforcement learning intervention arm with up to daily, tailored text messages based on time-varying treatment-response patterns; or (2) a control arm with up to daily, un-tailored text messages. Outcomes of interest will be medication adherence, as measured by electronic pill bottles, and HbA1c levels over 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus (T2DM)
* Prescribed between 1-3 daily oral medications for diabetes
* Most recent HbA1c level of 7% or greater
* Suboptimal adherence, defined by proportion of days covered (PDC) \< 0.90 based on chart review
* Must have a smartphone for which they are the sole user
* Must have a basic working knowledge of English or Spanish

Exclusion Criteria:

* Currently using a pillbox and/or not willing to use electronic pill bottles for 6 months
* Receive help at home on a daily basis with taking medications
Novel Technique in Closure of Mesenteric Defects After Laparoscopic Roux-en-Y Gastric Bypass and Its Effect on Internal Hernia: a Case-control Study

This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue.

Background Internal hernia complicated by bowel obstruction is a well-recognized complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study aims to investigate the role of cyanoacrylate glue in the prevention of internal hernia (IH) after LRYGB and compare it with the open technique of managing mesenteric defects by leaving the mesentery intact without closure of mesenteric defects. Data from six UK hospitals have been involved in this study. Operations were done under the supervision of a single senior consultant surgeon of bariatric surgery.

Methods The prospectively collected data of 813 patients with morbid obesity who underwent LRYGB were retrospectively analyzed. Patients were subdivided into two groups: group I comprising 185 patients who had the mesenteric defects closed with cyanoacrylate glue and group II comprising 628 patients who were managed by the open technique of leaving the mesentery intact without closure of the mesenteric defects.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent antecolic LRYGB without closure of mesenteric defects using cyanoacrylate glue or without closure of the mesenteric defects.

Exclusion Criteria:

* Open RYGB, laparoscopic converted to open RYGB, laparoscopic retro-colic RYGB, laparoscopic ante-colic RYGB with closure of the defect using sutures or RYGB done for non-bariatric purposes e.g. idiopathic gastroparesis.
Temporomandibular Dysfunction in Patients With Cervical Disc Herniation

Cervical spine problems are associated with temporomandibular joint (TMJ) and related muscles.The aim of the present study was to investigate temporomandibular joint dysfunction (TMD) and pain in individuals with cervical disc herniation (CDH) according to the level of neck disability.

The study included diagnosed with cervical disc herniation. The participants were divided into two groups based on their The Neck Disability Index (NDI) score: Group 1 with no disability and mild disability and Group 2 with moderate and severe disability. Temporomandibular dysfunction and its severity, intensity of neck and temporomandibular joint pain was assessed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervical disc herniation aged between 18 and 65,
* who could read and write in Turkish

Exclusion Criteria:

* Individuals with a history of head and neck surgery, fracture, physiotherapy or medical treatment cervical or temporomandibular joint treatment within the last six months,
* presence of any inflammatory rheumatic diseases, such as ankylosing spondylitis and rheumatoid arthritis, facial paralysis, infection, advanced osteoporosis
Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram

Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.

Patients received sevoflurane for anesthesia induction and maintenance at preselected concentrations according to an 'up and down' design, with 0.2% as a stepsize. General anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated with cisatracurium. After a steady-state period of 30min without surgical stimulation, the state of isoelectric EEG was considered as significant when a burst suppression ratio of 100% last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor requirement to maintain cardiovascular system were also analysed according to the EEG state.

Eligibility Criteria:
Inclusion Criteria:

* 45-65yr
* upper abdominal surgery in general anaesthesia
* ASA physical status classification of I or II

Exclusion Criteria:

* neurological disease
* received central nervous system-active drugs
* cardiac ejection fraction less than 40%
* history of difficult intubation or anticipated difficult intubation
* daily alcohol consumption
* obesity, defined as a body-mass index of more than 30
* without informed consent
Influence of a Standardised High Fat Breakfast on the Bioavailability of BI 14332 CL in Healthy Male Volunteers

To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a standardised high fat breakfast


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria:

Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests

* Age ≥21 and Age ≤65 years
* Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* 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 or that prolong the QT/QTc interval 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 trial site
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
* A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Cog-Fun Ageing Participation-centered, Health Promotion for Older Adults

The goal of this feasibility study is to test the feasibility of a group intervention program based on health management principles for older adults with Subjective Cognitive Decline (SCD). SCD is a condition where individuals feel that their memory is worsening, although standard tests do not detect it. This perceived memory decline can lead to negative feelings and self-perception, causing people to withdraw from meaningful activities.

This study aims to answer three main questions:

1. Is the intervention feasible in terms of fidelity, adherence, and participant satisfaction?
2. Are the assessments used sensitive enough to identify the unique challenges faced by the SCD population and detect changes after the intervention?
3. What are the preliminary effects of the intervention on participants' perceptions of how SCD affects their daily life, mental health, and quality of life?

Participants will:

1. Take part in 14 weekly group sessions focused on managing the challenges of living with SCD and improving participation in daily activities.
2. Complete assessments before and after the intervention to measure their satisfaction with the program, and track changes in their perceptions of daily life, mental health, and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported memory changes,
* A score of 23 or higher on the Montreal Cognitive Assessment (MoCA)
* Proficiency in Hebrew to participate fully in a Hebrew-speaking group.

Exclusion Criteria:

* Presence of a significant health condition that affects functioning
* Residence in a medical institution or nursing home
* Current participation in another SCD treatment
Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with Parkinson's disease.

IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
* Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.

Exclusion Criteria:

* Diagnosed with atypical parkinsonism.
* Allergic or non-responsive to previous carbidopa-levodopa therapy.
* Active or history of narrow-angle or wide-angle glaucoma.
* History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
* Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
* Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
* Treatment with any dopaminergic blocking agent within the previous 6 months.
Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy

The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Males or females
* Age \>= 18 years
* Total or subtotal gastrectomy
* Females having negative pregnancy test or being surgically sterile or 1 year postmenopausal; women of childbearing age must use effective birth control.

Exclusion Criteria:

* Diseases or conditions limiting the participation in, or completion of, the study
* Progressive tumors/metastasis
* Complications leading to insufficient peroral nutrition
* Known allergy to pancreatin
* Known exocrine insufficiency
* Experimental drug intake
Clinical and Genetic Analyzes of Age-related Macular Degeneration

The purpose of this collection is to search for susceptibility genes for age-related macular degeneration (AMD) alone or in combination with environmental factors and to look for genes that modulate the AMD phenotype (particularly the response to treatment).


Eligibility Criteria:
Inclusion Criteria:

* Age\> 55 years
* Diagnosis of exudative or atrophic AMD in at least one eye
* Patient informed of the objectives of the study and having freely signed the informed consent letter
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Other retinal or choroidal lesion in the studied eye
* History of severe systemic disease that could potentially hinder patient adherence to the study protocol: mental disorder, cancer, recent stroke or heart failure less than 3 months old.
* Known allergy to fluorescein, indocyanine green, iodine or ranibizumab
Safety and Tolerability of Zipsor® in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute

As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.

Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects between 12-17 years of age.
* Subjects must be post-op, having mild or moderate acute pain.

Other inclusions apply.

Exclusion Criteria:

* Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
* Subject has been taking analgesic for 48-72 hours prior to Screening.
* Subject has a history of any GI event greater than 6 months before Screening.
* Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
* Subject has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication.
* Subject is requiring treatment for pre-existing hypertension.

Other exclusions apply.
Study of Ridaforolimus (MK-8669) in Participants With Solid Tumors (MK-8669-003)(COMPLETED)

A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus (MK-8669) in participants with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically - Or Cytologically- Confirmed Metastatic Or Locally Advanced Solid Tumors That Have Failed To Respond To Standard Therapy, Or For Which Adequate Standard Therapy Does Not Exist
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Adequate Organ Function

Exclusion Criteria:

* Participant Who Has Had Chemotherapy, Radiotherapy, Or Biological Therapy Within 4 Weeks (6 Weeks For Nitrosoureas Or Mitomycin C) Prior To Registration
* Any central nervous system Metastasis Which Has Symptoms Or Requires Treatment
* Any Primary Central Nervous System Tumor
* Any Symptomatic Ascites Or Plural Effusion Which Requires Treatment
* A History Or Current Evidence Of Any Clinically Significant Disease That Might Confound The Results Of The Study, Complicate The Interpretation Of The Study Results, Interfere With The Participant's Participation, Or Pose An Additional Risk To The Participant
Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

The aim of this study is to determine whether azathioprine is effective for mucosal healing in UC patients who achieved clinical remission by the first course of corticosteroids but not mucosal healing in endoscopy.

The sample size was calculated based on the previous study showing the difference of mucosal healing rate between azathioprine (58%) and 5-aminosalicylate (21%). With a two-tailed test of α = 0.05 and 1 - ß = 0.8, 52 patients were required.

The placebo drug which is identical to azathioprine will be provided by Celltrion drug company.

Differences in the categorical variables between the groups are examined with χ2 or the Fisher exact test. For comparisons of continuous variables, a Student t test is used.

Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis patients with moderate to severe activity who achieved a clinical remission by the first course of corticosteroids
* Newly diagnosed or without steroid use during last 1 year
* Endoscopic Mayo subscore \>0

Exclusion Criteria:

* Patients with azathioprine or biologics therapy
Lymphedema Evaluation After Adjuvant Hypofractionated Radiotherapy for 1-2 Macrometastatic Sentinel Lymph Nodes

In this observational prospective studi patients with invasive breast cancer no more than 5 cm and clinically node negative, scheduled for conservative surgery and Sentinel Node Biopsy (SNB), are enrolled in the protocol if they have 1-2 sentinel lymphnodes (SLNs) with macrometastases. SLN status will be checked on definitive sections.

In recent years, breast oncologic surgery has aimed to omit axillary dissection in cases where no more than two sentinel lymph nodes are positive, particularly when complementary radiotherapy to the whole breast is planned.

Radiation therapy to the axillary lymph nodes ensures excellent locoregional control in patients with primary tumor no more than 5 centimeter and 1-2 macrometastatic sentinel lymph nodes, and appears to carry fewer side effects than axillary dissection.

Arm lymphedema is indeed one of the most well-known long-term complications of breast cancer treatment, impacting the quality of life for patients undergoing lymphadenectomy. In this scenario, the study proposes a treatment of hypofractionated intensity-modulated radiotherapy (IMRT) to the breast and axillary lymph nodes with the aim of further containing the risk of developing ipsilateral arm lymphedema. IMRT improves the dosimetric profile of surrounding organs at risk in the treated area, with better dose conformity to the target volume compared to tangential fields used in conventional 3D conformal techniques (as employed in most trials described so far).

Eligibility Criteria:
Inclusion Criteria:

1. Histological proven invasive breast cancer
2. Breast conserving surgery with no axillary dissection
3. Tumor dimension no more then 5 cm and no more than 2 positive sentinel node

5) Negative surgical margin (no tumor cell on ink) 6) Performance Status (PS) \<2 7) Age \>18 8) Written informed consent

Exclusion Criteria:

1. Previous thoracic RT
2. Mixed connective disorders
3. Distant metastases
4. Severe lung or cardiac diseases
5. Neoadjuvant systemic therapies
6. Axillary dissection
7. No surgical axillary investigation
8. Mastectomy
9. Axillary micrometastasis or isolated tumor cell