cyrilzakka/clinical-trials huggingface dataset:
A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy

This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~85 years old (including boundary value), male or female.
2. Body mass index \< 35 kg/m2.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
4. Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result and must be non-lactating during the study.
5. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.

Exclusion Criteria:

1. Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
2. Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
5. Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
"Follow-up of Midlines Placed Outside the Intensive Care Unit: What Side Effects? An Observational Study"

Midline catheter is a peripherally-inserted catheter, with the distal tip being placed into the axillary vein. For some indications, it's an alternative to the peripheral insert central catheters in case of limited venous access and infusions less than one month. The Midline catheter is poorly described in scientific literature; therefore, the aim of the study is to determinate the incidence of adverse events (Infections and thrombosis) and risk factors for patients with this device.

The midline is a deep peripheral venous catheter whose insertion is between the lower and upper third of the arm and whose distal end does not extend beyond the axillary vein. It requires the identification of the vein by ultrasound which reserves its installation for professionals trained and authorized to use the ultrasound scanner.

Midline is currently indicated for intravenous treatments \> 7 days and in patients with precarious venous capital. According to the manufacturer's instructions, it can be kept in place for up to 30 days, while the recommendations of the Centers disease of control specify that this period could be extended to 49 days.

Its use is expanding rapidly in France, thus meeting the needs of patients who do not require a central line and whose use of a standard peripheral venous catheter is not possible (low venous capital or treatment duration \> 7 days). Its installation, essentially carried out by qualified anaesthetists, does not increase medical planning and is therefore an attractive alternative to the installation of a central catheter whose complications (thrombosis and infections) are known.

The only data on the complication rate, estimated at 1-2%, are from low-potency observational studies. In the absence of high-level evidence, most of the good practice recommendations published in 2019 are based on expert consensus.

This leads us to conduct a large-scale observational study to assess the complication rate and identify the associated factors. This study will provide professionals with reliable scientific data for the next review of good practice recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* No opposition to the study
* Patient requiring a midline

Exclusion Criteria:

* Patient in Intensive Care Unit or acute care unit.
* Patient with a contra indication to midline insertion: arterio-venous fistula, history of axillary lymph node clearance or radiotherapy in the infusion arm, presence of infectious skin lesions near the infusion area, presence of a prosthesis on the infusion arm or hemiplegic arm.
* Patient under legal protection measure
* Patient already enrolled
* Minor patient;
* Pregnant woman.
Development and Evaluation of a Web Based Decision Aid for Patients With Hip Osteoarthritis

The main goal of this study is assess the effectiveness of a PtDA for patients with hip osteoarthritis

Background: Osteoarthritis (OA) is a health condition sensitive to patient's preferences and values regarding the benefits and risks of the different treatment options. In this sense, patient decision aids (PtDA) can play an important role in helping patients to incorporate their values, needs and preferences into the decision-making process, thus improving Person-Centred Care (PCC). Previous research has focused almost exclusively on knee OA, and therefore the aim of this study is to develop and evaluate the effectiveness of a PtDA for patients with hip OA.

Methods: The general design consists of two phases: 1) design a web-based PtDA for patients with hip OA, following the recommended procedures: systematic review of safety/effectiveness of treatments, and an iterative process of development with the help of an Advisory Committee composed of health professionals and patients; 2) To evaluate the impact of the PtDA on hip OA patients' decision-making process related with their treatment. For that aim, a multicenter randomized controlled trial will be carried out with 124 patients with hip OA in Tenerife (Spain) comparing intervention or usual care.

Discussion: PtDAs have been recommended as a useful and effective resource for improving PCC in many health conditions. The intervention is intended to empower patients by fostering their active participation during the decision-making process about their treatment, and by ensuring they make informed decisions congruent with their values and preferences. This study will contribute to the scientific knowledge about effectiveness of PtDAs in hip OA, in order to improve the quality of health care offered to these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of hip Osteoarthritis

Exclusion Criteria:

* Patients younger than 18 years
* Previous hip arthroplasty
* Patients with terminal illnesses
* Non-fluent Spanish language
* Mental or sensory alterations that impede or hinder the response to the measurement instruments or do not have the capacity to make decisions.
PK Effects of Bifeprunox & Valproate in Bipolar I

The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in subjects with Bipolar I Disorder after multiple dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Males or females
* 18-65 years old
* meeting DSM-IV criteria for Bipolar I Disorder, either manic or mixed episodes, with or without psychotic features

Exclusion Criteria:

* subjects who are acutely manic, acutely depressed, psychotic or subjects with a current Axis I primary psychiatric diagnosis other than Bipolar I Disorder based on DSM-IV TR criteria.
Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers

There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with age between 18 and 75
2. Patient with histology-proven colorectal adenocarcinoma.
3. Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
4. Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
5. Patients with at least 6 months' life expectancy from date of recruitment
6. Patients with positive Hepatitis B Surface-antigen (HBsAg)
7. Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
8. Patients with negative HBV-DNA
9. Patients with no known history of radiological \&/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
10. Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
11. adequate bone marrow, hepatic, and renal function within 14 days before recruitment
12. patients who sign the informed consent
13. Patients with good compliance during chemotherapy and follow-ups

Exclusion Criteria:

1. Patients planned for radiation or radionuclide therapy
2. Pregnant female patients
3. Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
4. Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
5. According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
Characteristics of Abdominal Fluid in Patients With Diverticulitis Hinchey III or IV

Perforated diverticulitis of the colon can be complicated by peritonitis, either purulent or fecal. Both are life threatening conditions requiring emergency surgery. The background in terms of reasons for inflammation (diverticulitis) and perforation to develop is unknown. In this study we focus on specific changes associated with inflammation, both in tissues and of fecal and mucosal microbiota.

A prospective study of abdominal fluid, periferal blood, tissues as well as feces in Patients (perforated diverticulitis with peritonitis undergoing emergency surgery, Group I), and in Controls (patients operated due to colorectal cancer, Group II; patients with mild diverticulitis not needing surgery, Group III).

Immune acitvity in abdominal fluid and periferal blood by immunoassay of 92 individual proteins. mRNA expression of 96 specific genes in tissue samples. Quatification of bacterial diversity in feces and colon mucosa.

Eligibility Criteria:
Inclusion Criteria:

* Signs of perforated diverticulitis with peritonitis and decision to perform emergency surgery (Group I)
* Signs of acute diverticulitis and no decision of emergency surgery (Group II)
* Patients with colorectal cancer planned for elective surgery (Group III)

Exclusion Criteria:

* No surgery performed (Group I and III)
* Withdrawn consent (any group)
Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy, safety, and tolerability of VX-993 in participants with pain associated with Diabetic Peripheral Neuropathy (DPN)


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of diabetes mellitus type 1 or type 2 with

  * Glycosylated hemoglobin A1c (HbA1c) less than or equal to (≤) 9% and
  * Presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year

Key Exclusion Criteria:

* Painful neuropathy other than DPN
* History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
* History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months

Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluating the Need for New Rhinitis Treatment

The proposed study will evaluate the unmet therapy need in seasonal rhinitis by aiming to answer the following research questions

1. What is the first prescription of the hay-fever season and how many of these patients are on some form of combination therapy?
2. To what extent does initial therapy not meet clinical need (as measured by need for additional medical intervention in terms of consultations and changes in therapy)?
3. Does treatment for allergic rhinitis differ for asthma Vs non-asthma and seasonal Vs perennial patients?

Allergic rhinitis is a chronic respiratory disease with a major impact on quality of life. In a study looking at the burden of allergic rhinitis amongst UK patients 75% reported some impact of their allergic rhinitis symptoms on health-related quality of life. Allergic rhinitis currently affects 10-30% of the world population with prevalence and impact continuing to increase. This leads to substantial economic costs both of prescription medication and time taken off work by both patients and carers due to the disease. In view of this, there may be a substantial need for improved therapy or management to ensure that patients with allergic rhinitis can carry out a normal lifestyle.

The proposed study will evaluate the unmet therapy need in seasonal rhinitis by examining the current medication requirements of patients who suffer from seasonal grass-pollen hay fever and determining whether current therapies are sufficient for managing rhinitis.

This study aims to evaluate the unmet therapy need in seasonal rhinitis by -

1. Examining and describing current medication requirements
2. Quantifying the extent of co-prescribing of multiple agents
3. Comparing the effectiveness of current prescription drugs for managing and controlling patient's seasonal rhinitis and using changes in treatment during the hay fever season to determine the effectiveness of current therapy options.

for managing and controlling seasonal rhinitis in primary care patients who suffer from seasonal grass-pollen hay fever.

Eligibility Criteria:
Inclusion Criteria

The analysis will include patients who, at the index date, receive a therapy prescription for allergic rhinitis and have been diagnosed with a hay fever read code during their time at the practice. The following patients will be included within the study population:

(i)Patients receiving therapy: defined as those with a prescription for the increase or initiation of hay fever therapy during the hay fever season

(ii)Hay-fever code recorded ever

Exclusion criteria

(i)Patients taking maintenance oral steroids during the baseline period

(ii)Patients who only received LTRA during the study period and had already been receiving LTRA previously
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:chronic diabetic ulcer -

Exclusion Criteria:steroids, dialysis, vascular disease

-
Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass

The main objective of this study is to evaluate the efficacy of intravenous sodium nitrite compared with placebo in reducing the occurrence of CSA-AK as diagnosed by KDIGO criteria during the first 72 hrs after cardiac surgery in high-risk patients undergoing cardiac surgery. Secondary objectives are to determine whether IV sodium nitrite achieves adequate pharmacokinetics (PK) in patients undergoing cardiac surgery with the use of CPB.

Acute kidney injury is one of the most untoward consequences of cardiac-surgery with the use of CPB. As such it is associated with a high mortality and morbidity and health care expense. Unfortunately, currently, there is no effective preventive or treatment strategy for cardiac surgery-associated (CSA) AKI other than renal replacement therapy.

It is postulated that a major mechanism of CSA-AKI is created by the ischemia reperfusion injury (IRI) resulting from aortic cross clamping and unclamping. This creates a cascade of events culminating in inflammation, microvascular dysfunction and tubular cell maladaptation and eventually renal tissue damage. Current treatment modalities that target the microcirculation such as blood pressure and cardiac output fails to prevent renal abnormalities and as such may be deleterious to the renal tissue microcirculation. The PI hypothesizes that a therapeutic strategy that limits IRI such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) would ameliorate CSA-AKI by limiting inflammatory injury to the kidney.

The anion nitrite (NO2-) releases NO in biological systems and has been demonstrated to inhibit IR injury in the heart, liver and kidneys created by various pathologic states1-3 and improve outcomes in patients with acute myocardial infarction, in patients with pulmonary hypertension and is the putative active mediator of protection in liver-transplantation patients receiving inhaled nitric oxide4.

The objective of this study is to determine whether the NO donor, nitrite will prevent I/R injury in patients at high risk of development of CSA-AKI undergoing open-heart surgery with cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Patients CCFS score ≥ 6 (Table 1)
* Patients admitted to UAB cardiac intensive care unit (CICU) following elective cardiac surgery with cardiopulmonary bypass under general endotracheal anesthesia
* 19 years old
* Estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73 m2

Exclusion Criteria:

* Prisoners directly admitted from a correctional facility.
* Children \< 19 years or under 50 kg body weight if age is unknown.
* Patients enrolled in a concurrent ongoing interventional, randomized clinical trial.
* Patients with end stage renal disease or preexisting GFR \<30 mL/min/1.73 m2 or need for dialysis. 34
* Patients with end stage heart disease on the cardiac transplant list.
* Patients undergoing procedures without the use of CPB
* All transplant patients.
* Patients on ventricular assist devices.
* Patients undergoing emergency procedures.
* Patients with glucose 6-dehydrogenase deficiency
* Pregnancy
Individual vs Cohort Long Distance Advising for Mental Care for Congenital Cataract Guardians

Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.

Congenital cataract (CC) is the leading cause of reversible blindness during childhood, which appears at birth or during the first decade of life. Nowadays, doctors put mental health at a prior place and pay more attention to the psychological problems of ill kids' parents. In our research, we try to find a new modern and efficient psychological counseling mode to improve the mentality of parents and relieve their anxiety and depression. We divide guardians of parents into two groups .One group is given the traditional follow-up by regular phone call every month. The other is in a wechat group. A doctor send the useful information about kids care and answer questions of parents at regular time every month. The self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of parents are marked before and after the long follow up.

Eligibility Criteria:
Inclusion Criteria: the guardians of kids who had a surgery for congenital cataract recently

Exclusion Criteria:

have other major life hit was diagnosed of anxiety and depression before
Methylene Blue Intra-vital Nerve Staining

In previous studies, we know methylene blue (MB) stains nerves, and oxidized MB has near-infrared (NIR) fluorescence for fluorescent observation. In this trial we using MB on human skin and combining MB and third-harmonic generation imaging (THG) to label cutaneous nerve fibers.

Intravital images were obtained before injection and then taken at 0.5, 1, 1.5, 2, 2.5, and 3 h after intradermal 0.03% (0.3 mg/mL, 1500μM) MB (10mg/mL "Astar") injection using a 0.5-mL 29-gauge insulin syringe needle (Becton, Dickinson and Company, USA). The participant lay down and the skin was imaged 10 cm above the ankle in the lower leg and above the wrist in the middle forearm; three sites in each limb were randomly selected for each time point. SHG or THG captured MB signals with two-photon excitation microscope at the Molecular Biomedical Imaging Research Center of National Taiwan University.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* used serotonin agonist medication