cyrilzakka/clinical-trials huggingface dataset:
Circulating Ghrelin as a Biomarker for Dementia

The primary objective of this study will explore whether circulating acyl-ghrelin (AG) and unacylated-ghrelin (UAG) are reduced in neurodegenerative disease associated with cognitive impairment. It will focus on validating pilot data generated following the analysis of Parkinson's disease (PD), Parkinson's disease dementia (PDD) and healthy cohorts (IRAS project ID: 250933). In addition to the advantages of study replication we will extend the analysis to include two further patient groups that are associated with cognitive impairments, namely, Alzheimer's dementia (AD) and dementia with Lewy bodies (DLB). This study will increase confidence in the replication of our findings.

This will be a cross-sectional study using peripheral venous blood.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Subject or carer / legal representative is willing to sign consent document

Specific criteria for each group;

Parkinson's Disease

* PD diagnosed by a movement disorder specialist and meets the diagnosis of PD
* MoCA \> 26/30
* No evidence of cognitive symptoms causing functional impairment

Parkinson's Disease Dementia

* PD diagnosed by a movement disorder specialist
* Duration of motor symptoms \> 1 year
* Meets MDS task force criteria for PDD
* MoCA \< 21/30

Dementia with Lewy Bodies

* Meets criteria for probable DLB as defined by the 4th report of the DLB consortium

Alzheimer's Disease

* Meets criteria for probable AD dementia (consistent with NIA/AA core clinical criteria for probable AD dementia)

Exclusion Criteria:

* Age \< 60 years
* Current major depression
* Use of anti-psychotic medication
* Type I or Type II diabetes mellitus (DM) (excluding diet-controlled DM)
* Tobacco use
* BMI \<15.0 kg/m2
* BMI \> 30 kg/m2
* Comorbid gastrointestinal disease i.e. includes Coeliac, active Inflammatory Bowel Disease (Colitis), evidence for active gastric ulcers within the last 12 months, but excludes gastroesophageal reflux and hiatus hernia.
* \>5 kg weight change over the preceding 3 months (determined by researcher from previous clinic visit and discussion with partner/carer)
* Significant active comorbidity
* Difficult venous access
* Vagotomy

Additional disease specific exclusions;

* Parkinson's Disease exclusion criteria
* Evidence of dementia or mild cognitive impairment
* Deep brain stimulation (DBS)
* Use of Duodopa

Parkinson's Disease Dementia exclusion criteria

* Dementia within 12 months of diagnosis of PD
* DBS

Dementia with Lewy bodies exclusion criteria

* Onset of motor Parkinsonism symptoms greater than 12 months prior to dementia diagnosis

Alzheimer's dementia exclusion criteria

* Presence of PD, PDD, DLB, or Frontotemporal Dementia (FTD)

Controls exclusion criteria

* Evidence of parkinsonism
* Evidence of dementia or mild cognitive impairment
* MoCA \<26/30
Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction

The aim of the study is to investigate the adherence to prescribed post-infarction medication and to cardiac rehabilitation in patients after acute myocardial infarction. In addition, their impact on cardiovascular events will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction
* Willingness to participate

Exclusion Criteria:

* Inclusion in an interventional study interfering with standard of care medication
Quality of Life in Temporomandibular Joint Dysfunction

It is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics.

A recent study showed that individuals with TMD have a lower quality of life than healthy controls. In addition, it was determined in the study that investigating the quality of life is insufficient. Future studies should search for psychosocial aspects related to TMD. The aim of this study is to individual the physical and psychosocial characteristics of individuals with Axis I TMD and examine their relationship with quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Being in group I according to RDC/TMD Axis I,

Exclusion Criteria:

* Any treatment for temporomandibular joint dysfunction (TMD) in the last six months
* Having dental problems
* Having any disorder and/or disease involving structures and/or masticatory muscles associated with TMD
* Having a history of trauma in the head and neck region,
* Having previously undergone temporomandibular joint surgery,
* Using corticosteroid and anticonvulsant drugs
* Patients who have received physiotherapy and rehabilitation related to the temporomandibular joint in the last six months
Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease

The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population.

Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture.

Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent.

800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with coronary artery disease

Exclusion Criteria:

* Already diagnosed or treated abdominal aortic aneurysm
* Patient's denial to participate
* Malignant disease
AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)

The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.

Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG. Group AKI (+) - patients with acute kidney injury after on-pump CABG. AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline). The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU. Clinical Outcomes and 30-day mortality was evaluate in this patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent on-pump coronary artery bypass grafting
* Patients with at least two serum creatinine values within 48 hours.

Exclusion Criteria:

* Patients with end-stage kidney disease requiring renal replacement therapy.
Screening for Hypercholesterolemia in Children Using Dried Blood Spot

Purpose:

Heterozygous Familial Hypercholesterolemia (HeFH) is a common genetic disease responsible for premature atherosclerosis. Therefore, early diagnosis and initiation of a treatment early as at the age of eight years old are recommended to reduce cardiovascular risk. Child-parent screening based on plasma LDL-cholesterol has been proposed to identify patients with hypercholesterolemia. However, in children, venipuncture is often an obstacle for screening. This study aims to evaluate the performance and feasibility of a dried blood spot collection to screen hypercholesterolemia.

Method: The lipid profile of 30 healthy and 30 hypercholesterolemic patients will be determined using Dried Blood Spot (DBS) collection and veinipuncture.

The study is conducted in accordance with the principles of the Declaration of Helsinki. The children, their parents and patients will be informed about this study according to the French bioethics law and will be included only after their agreement

Hypothesis

* to evaluate the performance of the determination of total and LDL-cholesterol using a dried blood spot collection to screen hypercholesterolemia
* to evaluate the feasibility of a dried blood spot collection to screen hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* patients/kindreds in family with a documented history of hypercholesterolemia
* healthy subjects for controls

Exclusion Criteria:

* refusal to participate in the study
* For control patients: to have a known dyslipidemia
Effects of Home-based Inspiratory Muscle Training in Patients With IPF

The aim of this study is to investigate the effects of the home-based inspiratory muscle training program on lung functions, dyspnea, inspiratory muscle strength, functional capacity and quality of life in patients with idiopathic pulmonary fibrosis. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training was set to 50% of each patient's maximal inspiratory pressure measured every week and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosing Idiopathic Pulmonary Fibrosis by a pulmonologist;
* Aged between 40 and 75 years;
* Volunteering to research;
* Stable clinical condition (same medication routine and/or no acute exacerbation in the last for the last 4 weeks).

Exclusion Criteria:

* Inability of the participant to understand or perform the procedures proposed during the evaluations or training program.
* Participating in any pulmonary rehabilitation programs;
* A previous pneumonectomy or lobectomy operation;
* Pneumonia in the last 4 weeks;
* Any pulmonary infection during the study;
* Requirement for supplemental oxygen therapy while resting.
* Having Covid-19 disease (during the study or in the past)
* Orthopaedic or neurological conditions affecting the ability to independent walking
Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis

Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008.

When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation.

The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician.

Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test:

A) Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.

Exclusion Criteria:

* Not referred from general practice
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR

The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.

This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville, Indiana)

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive
* Ages 18 to 55, inclusive

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Major surgical procedure within 4 weeks prior to randomization
* Positive serology test for HIV, HBV or HCV
* Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease
* History of gastrointestinal disease within the past 3 months
* Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator
* Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
* Unable to tolerate oral and/or intravenous (IV) medications
* Unable to tolerate the puncturing of veins for drawing of blood
* Known allergy or hypersensitivity to any component of the study medication
* History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
* Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
* Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization
* Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization
A Study of Effects of Selpercatinib (LY3527723) on Midazolam in Healthy Participants

The main purpose of this study is to assess the effect of selpercatinib on how fast midazolam gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study will last up to about 6 weeks, inclusive of screening period.


Eligibility Criteria:
Inclusion Criteria :

* Male and female participants of non-childbearing potential who are agreeable to take birth control measures until study completion
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study screening
* Require treatment with inducers or inhibitors of cytochrome P450 (CYP) CYP3A within 14 days before the first dose of study drug through the end of Period 2
Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b \[PegIFN-2b\] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve patients with chronic hepatitis C
* Adults (\>18 years of age)
* Prescribed Pegetron Redipen
* Must meet all requirements for treatment with Pegetron Redipen
* Must be able to obtain reimbursement of medication through private or provincial coverage

Exclusion Criteria:

* Active hepatitis B virus (HBV) infection (hepatitis B surface antigen \[HBsAg\] positive)
* HIV antibody positive
* Post liver transplant patients
* Any other exclusion criteria as per the product Monograph
An Open-Label Safety Program for the Use of Zalcitabine (Dideoxycytidine; ddC) in Pediatric Patients With Symptomatic HIV Infection Who Have Failed or Are Intolerant to AZT Monotherapy, or Who Have Completed Other ddC Protocols, or Are Ineligible for Other Ongoing Clinical Studies

To allow, on a compassionate use basis, zalcitabine (ddC) for pediatric patients with symptomatic HIV disease who have failed treatment or who are intolerant to zidovudine (AZT), or who have completed other ddC protocols, or who are ineligible for ongoing clinical trials.

Patients receive ddC and are evaluated at study entry and every 3 months thereafter, until 3 months after ddC becomes approved for pediatric patients or the sponsor deems it necessary to terminate the protocol.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Symptomatic HIV infection.
* Failure on or intolerance to AZT monotherapy OR completed other ddC protocols OR been ineligible for other ongoing clinical trials.
* Consent of parent or guardian required.

Note:

* Patients who do not meet the eligibility requirements may discuss their cases with the medical monitor.
The Momba Mobile Application-based Community

The investigators' mobile application-based community, termed Momba, will provide a bi-directional flow of information on maternal and infant mental health to traditionally underrepresented groups of mothers and their infants. The overall goal of this mobile application-based community of low-income postpartum women and infants is to increase the social support, social networks, and social capital of low-income mothers; thereby, leading to a positive change in the health behaviors, utilization of health services, and mental health status of both mothers and their infants.


Eligibility Criteria:
Inclusion Criteria:

* Women will be recruited in their third trimester of pregnancy from Yale-New Haven Hospital (YNHH) and followed for 8 months postpartum.
* Women are eligible if they are over the age of 18, in their third trimester of pregnancy, will deliver a baby at YNHH and receive prenatal care at the Women's Center.
* Meet criteria for minor or major depressive disorder.

Exclusion Criteria:

* Mothers are not eligible to participate if they have previously given birth
* Are placing the baby for adoption
* Are planning to move in the next 18 months
* Are actively suicidal, psychotic or unable to provide informed consent
Talocrural Joint Manipulation in Stroke

The primary aim of the study is to investigate the effect of talocrural joint manipulation on the static balance of patients with stroke. The secondary aim of this study is to investigate the effect of talocrural joint manipulation on the dorsiflexion range of motion of patients with stroke.

The study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. Patients included in the study will be randomly assigned to receive both placebo talocrural joint manipulation and talocrural joint manipulation treatments.

Eligibility Criteria:
Inclusion Criteria:

* 1. Two months or longer elapsed since the stroke,
* 2. A Mini-Mental State Examination score of 24 or higher,
* 3. The ability to stand independently for 20 seconds or more,
* 4. The ability to walk independently for 10 meters with the use of walking aids or orthoses if necessary,
* 5. Being between 45 and 75 years of age,
* 6. Having a Brunnstrom stage of 4 or above

Exclusion Criteria:

* 1. The presence of severe osteoarthritis in the lower extremity,
* 2. The presence of cancer or diabetic neuropathy,
* 3. The presence of vestibular disorder,
* 4. The presence of lower extremity ulceration or amputation,
* 5. History of vertigo,
* 6. Alcohol consumption within the last 24 hours,
* 7. Hemodynamic instability,
* 8. Diagnosis of posterior circulation stroke involving the basilar artery and cerebellum,
* 9. The presence of other neurological disorders (such as multiple sclerosis, Parkinson's disease),
* 10. Having experienced an acute lower extremity injury in the last six weeks,
* 11. History of lower extremity surgery
Uterocervical Angle in the Pregnancy Termination of Multiparous Women

To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women.

Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on multiparous women who are taking Foley baloon for the cervical preparation and aim to measure their UCA.

Eligibility Criteria:
Inclusion Criteria:

* multiparous singleton pregnancy
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* history of dilatation and curettage (D\&C)
* history of LEEP and cervical conization
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Epilepsy
* completion of double blind trial

Exclusion Criteria:

* taking other investigational drug than Lacosamide
* meeting withdrawal criteria from double blind trial