cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)

The purpose of this study is to assess the cholesterol lowering effects of an investigational drug in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-79 years of age with high cholesterol and high triglycerides.

Exclusion Criteria:

* Individuals who do not meet specific cholesterol or triglyceride levels as required by the study.
Endoscopic Therapy of Early Cancer in Barretts Esophagus

This study is being done to see if treatment for esophageal cancer can be done using endoscopy for patients ineligible for surgical or radiological therapy. The standard method of treating this type of cancer is surgical removal of the esophagus. The study will determine if removing just the cancer with endoscopy is enough treatment or if the addition of another treatment called photodynamic therapy (treatment with a red light and a drug called sodium porfimer) is needed.

Participant visit requirements: Screening visit which will last 1 - 2 days, if assigned to photodynamic therapy, there will be a 3 day visit for treatment. Participants must return for a 1 day visit every three months for one year.

Eligibility Criteria:
Inclusion Criteria:

* Non-recurrent adenocarcinoma in Barrett's Esophagus confirmed by two experienced gastrointestinal pathologists
* No evidence of submucosal invasion
* No evidence of metastatic disease in either regional or distal lymph nodes, or other organs
* Pre-entry CT scans of the upper abdomen and chest and Endoscopic Ultrasound (EUS) of the tumor and regional lymph nodes are required. Fusion PET scans are suggested for any indeterminate lesions
* Zubrod Performance Status 0-1
* Participants must be have oral intake of greater than 1700 calories a day
* Patient must not have had a second malignancy, other than curable non-melanoma skin cancer or cervical cancer in situ, unless disease free for greater than or equal to 3 years and deemed cured by their hematologist and/or oncologist
* Staging procedures should be performed prior to study entry
* All patients or legally authorized representative must sign a study-specific informed consent prior to randomization.

Exclusion criteria:

* Prior major esophageal surgery
* Patients who are unable to tolerate endoscopic procedures
* Due to the possible toxic effects of photodynamic therapy and endoscopic sedation to embryos, pregnant or lactating women or men unable or unwilling to practice contraception are excluded
* Patients with an uncontrolled diabetes, heart disease, or hypertension
* Patient and/or legally authorized representative who are unable to comprehend the study requirements or who are not likely to comply with the study parameters.
Risk Identification of the GlucoTab System in Routine Use

Identification of risks of the GlucoTab system in routine use.

A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Eligibility Criteria:
Inclusion Criteria:

* informed consent obtained after being advised of the nature of the study
* type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
* diabetes therapy supported by GlucoTab system

Exclusion Criteria:

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* gestational diabetes or pregnancy
* known or suspected allergy to certain insulin types, named in the user manual
* total parenteral nutrition (TPN)
* any mental condition rendering the patient incapable of giving his consent
Pilot Study of a Self-help Intervention for Depression in Patients With a Chronic Disease

A feasibility pilot trial of the self-help, "Cognitive behavioural therapy" based "Living Life to the Full" Materials for use by patients with diabetes type 2 and / or coronary heart disease.

Depressed mood is common in patients with chronic disease and physical disability. It adversely affects quality of life, adherence to treatment and clinical outcome. Depression is expensive to the person, their family, employers and society. Recent developments in the UK General Practitioners' Contract mean that patients with two chronic diseases (Coronary Heart Disease- CHD and Diabetes - DM) are routinely screened for depression using a simple screening tool. We propose a study using an existing self help intervention in the specific context of patients with mild to moderately severe depression identified in this way.

This RCT is the second phase of a 2 phase mixed methods study examining the feasibility of a Full RCT. The first involved focus group with patients and health practitioners.

Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of diabetes mellitus type 2 and / or coronary heart disease.
* Be aged 35 or over.
* Be attending a participating primary care practice.
* Have a depression severity scale rating indicating moderate to moderately severe depression, such as:Prime-MD-PHQ9 of 10-21; HADS-D of 8-15;BDI-2 of 23-44

Exclusion Criteria:

* Unable to provide informed consent to participate
* Already receiving psychological treatment for their depression
* Have commenced treatment with an SSRI within the past 8 weeks
* Likely to have difficulty communicating by telephone
* Likely to have difficulty completing the forms and questionnaires
* Have a serious physical disorder
* Have a serious mental disorder
* Express significant suicidal thoughts (PHQ9 or BDI-2 question 9 scoring \>1)
* Took part in an earlier related focus group
Inflammatory Targeted Laser Treatment of Knee Osteoarthritis

This study is conducted to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct to exercise therapy in knee osteoarthritis (KOA).


Eligibility Criteria:
Inclusion criteria:

* Any gender
* Age ≥ 50 years
* Pain on movement ≥ 40 mm Visual Analog Scale
* Knee pain for the last ≥ 3 months
* KOA verified with the American College of Rheumatology criteria using a history and physical examination, i.e. knee pain and at least three of the following: ≥ 50 years old, ≤ 30 minutes of morning stiffness, crepitus on active range of motion, bony tenderness, bony enlargement, and no palpable warmth of synovia

Exclusion criteria:

* Knee alloplastic
* Total meniscectomy
* Intra-articular steroid injection and/or oral steroid treatment within the last six months
* Cancer
* Rheumatoid arthritis
* Severe cognitive deficit
* Neurological deficits affecting the knee
* Inability to speak and understand English/Norwegian
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Study Design :

* A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study

Primary Objective:

* To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Secondary Objective:

* To evaluate the safety and tolerability of these formulations.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Healthy Caucasian volunteers
* Non smokers or mild smokers

Exclusion criteria:

* Pregnancy and/or breast-feeding
* Participation in another clinical trial within 60 days prior to Period 1.
A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment

A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.

This trial will evaluate

1. in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions.
2. in healthy adult subjects: the safety, pharmacokinetics and pharmacodynamics of 2 single doses of URC102 in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.

Eligibility Criteria:
Inclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

1. Age 19\~65
2. BMI 18.0\~30.0 kg/m\^2 (Body mass index)
3. 30 ≤ eGFR \< 60 mL/min/1.73m\^2 (estimated glomerular filtration rate)
4. voluntarily given written informed consent

For Control Group - healthy subjects

1. Age ≥ 19
2. BMI 18.0\~30.0 kg/m\^2
3. eGFR ≥ 90 mL/min/1.73m\^2
4. voluntarily given written informed consent

Exclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

1. Medical history

   * Subjects with lactic acidosis or marked hepatotoxicity
   * Not controlled diabetes, hypertension, dyslipidemia
   * requiring dialysis
2. Clinical examination

   * AST, ALT \> 2, Bilirubin total, γ-GTP \> 1.5, CK \> 2 times the upper limit of normal ranges (Aspartate transaminase, Alanine transaminase, gamma-Glutamyl transpeptidase, Creatine phosphokinase)
   * Positive serologic results
3. Drug hypersensitivity and drug abuse

For Control Group - healthy subjects

1. Medical history

   * History of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding
   * Subjects with lactic acidosis or marked hepatotoxicity
2. Clinical examination

   * AST, ALT \> 2, Bilirubin total, γ-GTP \> 1.5, CK \> 2 times the upper limit of normal ranges
   * Positive serologic results
3. Drug hypersensitivity and drug abuse
Exome Evaluation in Patients Living with Diabetes Complicated by Charcot Neuroarthropathy.

Diabetes, like obesity, has reached worldwide proportions such that we're talking about a pandemic. These two diseases are a major cause of mortality and multiple complications. The medical and financial stakes involved make these two diseases a major public health issue. Two groups of factors contribute to these diseases: the environment and genetics. The use of next-generation sequencing (NGS) is a highly relevant tool for identifying mutations in already known genes, or new genes involved in the disease, for diagnostic purposes. This approach makes it possible to validate previously described genes and/or discover new loci linked to new signalling pathways involved in the pathophysiology of Charcot's foot in patients with diabetes

In patients living with diabetes, a rare and devastating joint complication known as Charcot's neuroarthropathy (CN) has been observed. The clinical presentation of this complication is characterized by activation of inflammation and bone remodeling markers, disruption of the osteoblast and osteoclast system, activation of the RANKL (Receptor activator of nuclear factor-kappa B ligand) system and its antagonist osteoprotegerin (OPG), and often a fatigue fracture due to physical activity.

The pathogenic mechanisms of CN have been the subject of much debate, and there are a number of competing theories which are not necessarily exclusive.

CN patients have been shown to have reduced bone density in the lower limbs compared with neuropathic subjects. Studies using bone markers to assess bone formation and resorption demonstrated that there is an increase in osteoclastic activity relative to osteoblastic activity in both acute and chronic forms of CN. In 2007, W.J. Jeffcoate described CN as an increased inflammatory response to injury inducing increased bone lysis. Since the emergence of this theory, a significant number of studies have evaluated inflammatory factors and bone modeling in patients with CN, such as C-reactive protein, TNF α and IL6. Three studies showed an increase in their levels in the setting of CN.

otherwise known genes, or new genes implicated in the disease, for diagnostic purposes This approach makes it possible to validate previously described genes and/or discover new loci linked to new signalling pathways involved in the pathophysiology of Charcot's foot in patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 to 70
* with type 2 diabetes for at least one year
* with active or chronic Charcot neuroarthropathy (Group 1) OR
* never had Charcot neuroarthropathy (Group 2)
* Have agreed to participate in the study and have signed an informed consent form.

Exclusion Criteria:

- Subject under guardianship or curatorship.
[18F] - FD17 PET Imaging of α-synuclein: A Clinical Study in α-synucleinopathy Patients

The main objective of this study is to establish a standardized method for \[18F\] - FD17 PET imaging in α-synucleinopathy patients, and to analyze its physiological distribution in healthy individuals as well as its pathological distribution in α-synucleinopathy patients, including Parkinson's disease (PD), multiple system atrophy (MSA), and idiopathic rapid-eye-movement sleep behavior disorder (iRBD). Specifically, \[18F\] - FD17 PET imaging focuses on evaluating the deposition of α-synuclein and exploring the diagnostic value of \[18F\] - FD17 PET in PD, MSA, and iRBD patients. In addition, for PD, MSA and RBD patients, dopamine transporter(DAT)-PET imaging was performed to evaluate the distribution and density of DAT in brain. The study aims not only to clarify the specific binding mode of the imaging agent in different α-synucleinopathies, but also to evaluate its efficacy and potential application prospects in early diagnosis , providing new methods for the diagnosis and treatment of neurodegenerative diseases. This study is expected to contribute to early pathological detection and accurate diagnosis in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* 1: Normal cognitive function, CDR score=0（for healthy subjects）

  2: Without neurological disorders, major chronic diseases, malignant tumors, or acute infectious diseases (for healthy subjects）

  3: Without the family history of neurological disorders related to motor or cognitive impairments(for healthy subjects）

  4: Clinical diagnosis of idiopathic PD (for PD patients)

  5: Clinical diagnosis of MSA (for MSA patients)

  6: Clinical diagnosis of idiopathic RBD (for RBD patients)

  7: An informed consent form signed in writing by the subject or their legal guardian or caregiver.

  8: Must be abled to be accompanied by nursing staff

  9: Must be able to understand and sign a informed consent form before any evaluation and examination

  10: Must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or menopause for more than one year.(for female subjects)

  11: Must adopt isolation contraception measures within 3 months after the start of this study.(for female subjects)

  12: Willing and capable to cooperate with all projects of this study.

Exclusion Criteria:

* 1: Other severe neurological disorders. Gastrointestinal, cardiovascular, liver, kidney, hematological, tumor, endocrine, respiratory, immunodeficiency, and other serious diseases.

  2: Received ionizing radiation outside the scope of this experiment, resulting in an annual radiation exposure dose exceeding 50 mSv in the past year,

  3: History of drug abuse or alcoholism

  4: Pregnant or lactating women

  5: Poor venous conditions, unable to tolerate repeated venipuncture

  6: Received experimental drug or device treatment with unclear efficacy or safety in last 1 month.

  7: Any situation that the investigators believe may cause harm or potential harm in any aspect related to this study
Study to Assess the Efficacy and Safety of Somatostatin in the Treatment of Acute Severe Upper Gastrointestinal Bleeding

To assess the efficacy and safety of the early administration of somatostatin in infusion during 72 hours plus 2 boluses, compared to placebo in the control of acute severe UGIB with suspicion of PUB.


Eligibility Criteria:
Inclusion Criteria:

* Male or female non-cirrhotic patients at least 18 years old suspected to bleed from PU.
* Patients with haematemesis and/or hematochezia and/or melena which have been observed by a member of a clinical team (GP, hospital physician, nurse, ...).
* Either, documented signs of hypovolemia related to the current bleeding episode Or, occurrence of symptoms of hypovolemia

Exclusion Criteria:

* Treatment of the present bleeding episode with somatostatin or its analogues, vasoactive drugs, or endoscopic therapy.
* Any treatment with PPIs (IV or per os) within the last 48 hours preceding randomisation.
* Treatment (endotherapy or pharmacotherapy) for upper gastrointestinal ulcer bleeding in the last 30 days.
* Deficient haemostasis (platelets \< 40 x 109/l, international normalised ratio of the prothrombin time \> 1.5 (or prothrombin time \< 70%), or activated partial thromboplastin time \> 40 seconds (or according to the normal ranges validated, from local lab))
* Anticoagulant therapy (vitamin K antagonists or heparin including LMW heparins)
* Terminal stage illness in which endoscopy is contraindicated
Intervention for Substance Use and Sexual Risk Behavior in Homeless Youth

This study will evaluate a program called AWARE, which is a voluntary four session group-based motivational interviewing (MI) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. The hypothesis is that participants who receive AWARE will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and English speaking.

Exclusion Criteria:

-
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18, male or female
2. Maintenance hemodialysis duration\>3 months
3. Regular hemodialysis,3 times a week,4 hours per session
4. Sign the written informed consent

Exclusion Criteria:

1. Acute kidney injury
2. Prepare to transfer to kidney transplantation or peritoneal dialysis in a year.
3. Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV
4. Pregnancy or lactation
5. Under other drug trial
6. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
7. Can not be treated in accordance with the research program
Linking Cardiac Autonomic Dysfunction and InfLammation in Patients With Acute Coronary Syndromes

Subclinical inflammation plays a critical role in all stages of the atherosclerotic process, from the initiation of the fatty streaks to the development of plaque instability and rupture, causing myocardial ischemia and acute coronary syndromes (ACS).

A few studies have suggested that the autonomic nervous system (ANS) and the inflammatory response are intimately linked. Accordingly, a relation between impaired cardiac autonomic tone and increased markers of inflammation has been reported in healthy subjects as well as in patients with type 1 diabetes mellitus, chronic coronary syndrome or decompensated heart failure.

To get insight in the controversial relationship between cardiac autonomic dysfunction and inflammation in patients with ACS both with and without obstructive CAD and assess the precise mechanisms and molecular pathways by which these two pathophysiological conditions mutually influence each other, to characterize their prognostic implications and identify possible targets for novel therapeutic strategies.

A comprehensive assessment of cardiac autonomic function and inflammatory profile will be performed in ACS patients with obstructive CAD (n=45) or with NO-CAD (n=45) at coronary angiography. In the sub-acute phase (1 to 6 months after the ACS) all patients will undergo a global echocardiographic evaluation, a 24-hour ECG Holter recording to assess HRV and blood samples collection for neurotransmitter measurements, platelet activation and reactivity evaluation and inflammatory profile assessment by proteomics analysis, inflammasome activity evaluation, NLRP3, pro-IL-18 and pro-IL-1β expression level by qPCR and epigenetic analysis. A follow-up to establish clinical conditions of patients will be done after 12 months by direct clinical visit, trans-thoracic echocardiogram to evaluate cardiac remodeling, HRV assessment by 24-hour ECG Holter recording and blood sample collection to evaluate the inflammatory profile as it was assessed at baseline.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Evidence of previous complete percutaneous revascularization;
* ACS, with or without CAD, experienced in the previous 3 months ±15 days;
* Signed written informed consent.

Exclusion Criteria:

* History of previous acute myocardial infarction (AMI);
* Prior surgical myocardial revascularization via coronary artery bypass graft (CABG);
* Previous incomplete percutaneous myocardial revascularization, as indicated by documentation of residual stenosis \>50% or FFR ≤0.8 in any epicardial vessel;
* Killip class III-IV in admission;
* Established cardiovascular disease (assessed by clinical evaluation, physical exam, 12-lead ECG, or transthoracic echocardiogram), such as congenital heart disease, cardiomyopathy, and severe valvular heart disease;
* Serious medical conditions, including severe renal insufficiency (eGFR \> 30 ml/min), hepatic insufficiency or cirrhosis, malignancies, COPD (GOLD stage III-IV), and acute or chronic inflammatory diseases;
* Refusal to sign the written informed consent to participate in the study.