cyrilzakka/clinical-trials huggingface dataset:
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects With Mild and Moderate Hepatic Impairment Relative to Subjects With Normal Hepatic Function

This is a phase 1, open-label, parallel-group, single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects should understand the study procedures and sign the informed consent form prior to Screening.
2. Subjects must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
3. Weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 18 and 32 (inclusive), BMI = weight (kg)/height (m)2.
4. Serum creatinine (Cr) ≤ 1.5 × ULN, or Creatinine clearance (Crcl) ≥ 60 mL/min (Cockcroft-Gault formula).

Exclusion Criteria:

1. Known allergy or hypersensitivity to any components of the investigational drug product;
2. Has a history of cancer in five years (malignancy), exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinomas in situ;
3. Has factors that significantly affect the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small bowel resection, etc.
4. Has a history of portosystemic shunt.
5. Participation in any clinical study of an investigational drug/device within 3 months of the drug prior to Day -1;
6. Received live vaccines or live-attenuated virus vaccine within 3 months prior to screening, or plan to get vaccinated during the study;
7. Previously participated in this study or any other study related to pimicotinib and received pimicotinib;
TRIAL READY (Clinical Trial Readiness)

This study, being conducted under the auspice of the CReATe Consortium, will enroll patients with ALS and related disorders as well as healthy controls, with the goal of facilitating clinical validation of leading biological-fluid based biomarker candidates that may aid therapy development for patients with ALS and related disorders.

This multi-center study aims to clinically validate leading biological-fluid-based biomarker candidates as potential prognostic and pharmacodynamic biomarkers that have the potential to facilitate therapy development for patients with ALS and related disorders. Biomarker candidates that will be considered include: urinary p75 neurotrophin receptor extracellular domain (p75ECD), blood and cerebrospinal fluid (CSF) phosphorylated neurofilament heavy (pNfH), blood and CSF neurofilament light (NfL) and, in the population with a C9orf72 hexanucleotide repeat expansion, peripheral blood mononuclear cell (PBMC) and CSF levels of the dipeptide repeat protein poly(GP). In pursuit of these goals, the CReATe Consortium is already collecting longitudinal biological samples from patients with ALS and related disorders through the ongoing Phenotype-Genotype-Biomarker (PGB) study. TRIAL READY aims to identify additional patients with the C9orf72 hexanucleotide repeat expansion mutation (HREM), the most common genetic cause of ALS, who may be further followed through the PGB study. This study will also enroll and longitudinally evaluate a cohort of age- and gender-match healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Member of at least one of the following categories:

  1. Individuals with a clinical diagnosis of ALS or a related disorder, including FTD, ALS-FTD, PLS, and PMA.
  2. Individuals never diagnosed with and not at particular risk of developing ALS or a related disorder.
* Able and willing to comply with relevant procedures.

Exclusion Criteria:

* A condition or situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol. This includes (but is not limited to) neurological, psychological and/or medical conditions.
Sleep Enhancement Training Study for Experienced Shiftworkers

The purpose of this study is to determine if a modified version of the Sleep Enhancement Fatigue Reduction Training (SEFRT) system can improve sleep and health-related symptoms and quality of life in experienced shift-working nurses.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking nurses
* scheduled to work at least 2 consecutive night shifts per week during the next 3 months
* ≥40 years of age
* experiencing disturbed sleep related to night-shift

Exclusion Criteria:

* current diagnosis of sleep disorder or affective illness
Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV

According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV.

Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events.

Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.

Eligibility Criteria:
Inclusion criteria

1. Informed consent form signed;
2. Age: 18-45 years;
3. Able to swallow capsules;
4. Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;
5. Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;
6. Willing to communicate intimate history for the study purposes;
7. Consent not to use spermicides for 4 months after starting TDC;
8. Stated availability throughout the study period and a mobile phone.

Exclusion criteria

1. Post-menopausal;
2. Pregnancy or high risk of;
3. Breast feeding;
4. Currently active STD as determined by history, physical examination, and laboratory tests;
5. Diabetes mellitus;
6. Inflammatory bowel disease;
7. Alcohol or drug addiction as guessed by investigator;
8. Absence of refrigerator;
9. Known moderate to severe disease of any systems;
10. Difficulty to comprehend study requirements as judged by physician;
11. Any erosions, herpes like lesions, cervicitis during vaginal examination;
12. Treatment of BV with other than metronidazole antibiotic;
13. Use of any investigational drug within the previous 30 days;
14. Use of drugs that suppress the immune system.
Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)

The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are:

* Does the Garmin Vivosmart increase physical activity (PA)?
* Does the Garmin Vivosmart improve T1D status

Participants will:

* Wear the Garmin Vivosmart (4 or higher) for a year
* Complete surveys at the beginning, middle and end of participation asking about your T1D, T1D management, and PA
* Parents of children will also complete similar surveys about T1D


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 8-21 years of age and/or parent of participant aged 8-17 years of age
* Participants diagnosed with T1D greater than 6 months ago
* Participants must be patients at the Children's Mercy Kansas City network

Exclusion Criteria:

* Participants who do not meet age criteria above
* Participants who do not have T1D
* Participants who are unwilling to wear the device for at least 6 months
In Vitro Interaction Between Ticagrelor and Its Active Metabolite and Their Effects on Salicylic Acid

This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;

* Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite.
* Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite and their effect on the pharmacodynamics of salicylic acid on platelet aggregation tests with the agonist of arachidonic acid.

This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;

* Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of adenosine diphosphate(ADP) will be assessed on the in-vitro mixtures of blank plasma and randomized paired concentrations of ticagrelor + AR-C124910XX.
* Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of arachidonic acid will be assessed on the in-vitro mixtures of blank plasma plus randomized paired concentrations of ticagrelor and AR-C124910XX and the invitro mixtures with blank plasma and ticagrelor + AR-C124910XX + salicylic acid.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with body weight more than 50 kg and within 20% of the ideal body weight: ideal body weight = (height\[cm\] - 100)\*0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects who have a history or presence of any clinically significant diseases.
* Subjects who have any congenital or acquired haematological diseases.
* Subjects who had whole blood donation within the last 2 months and component blood donation within the last month.
* Subject who took any concomitant medication including non-steroidal antiinflammatory drugs(NASIDs) and vitamins currently or within 7 days prior to blood sampling.
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)

The primary objective of this study is a comparison between MK0787B and standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Patient is diagnosed with nosocomial pneumonia

Exclusion Criteria:

* Immunological deficient patients
* Pregnant women and nursing mothers
* A fungus is identified before the study enrollment
* Received vancomycin or imipenem for more than 5 days before icu admission
Circulating Tumor Cell Capture for Early Diagnosis and Postoperative Tumor Recurrence Monitoring of Liver Cancer

Through the screening of CTCs in patients with suspected liver cancer and liver tumor resection or liver transplantation, the number of CTCs in the blood of liver cancer patients before and after surgery is monitored, and the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in liver cancer patients is evaluated.

1. Screen patients with suspected liver cancer Long-term exposure to liver cancer risk factors (hepatitis B carriers, past history of schistosomiasis, long-term diet of Aspergillus food, history of liver cirrhosis, etc.), patients with liver cancer are initially suspected.
2. Monitor the number of CTCs in the blood of patients with liver cancer before and after surgery Imaging examinations show that liver space is occupied by patients with suspected liver cancer. Use CTCBIOPSY® technology to monitor patients' surgical operations (including interventional therapy, tumor resection, or liver cancer liver transplantation) at different times 1-3 days before, 1 month after surgery, and 6 months after surgery The number of CTCs in peripheral blood.
3. To evaluate the clinical application significance of CTCs in liver cancer screening and postoperative recurrence monitoring in patients with liver cancer Combined with clinicopathology, tumor marker examination and imaging examination, clinical follow-up and follow-up, analyze the clinical significance of CTCs detection in liver cancer patients, and focus on evaluating the relationship between circulating tumor cells in liver cancer screening and postoperative recurrence, and establish a new The liver cancer prediction model improves the prognosis of liver cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Primary diagnosis of suspected hepatocellular carcinoma; or liver cancer patients who have undergone liver transplantation, radical resection or ablation of liver cancer;
2. Age 18-75 years old;
3. ASA (risk of anesthesia) score I-II;
4. The ECOG score is 0-1;

Exclusion Criteria:

1. In addition to hepatocellular carcinoma, patients diagnosed with other types of tumors;
2. Patients with extrahepatic or lymphatic metastasis;
3. Patients who still have serious complications 4 weeks after surgery;
4. Patients who cannot provide informed consent;
Safety Study of an Antipsychotic, Sertindole, to Treat Schizophrenia

The purpose of this study is to permit the patients with schizophrenia who received Sertindole during a previous randomised trial, study 99824, to continue with this treatment.

Schizophrenia is a disabling and often chronic disorder that may require long-term treatment. This protocol is an extension study of a randomised study comparing the safety of Sertindole versus Risperidone. Patients who were randomised to Sertindole and who completed the previous study have the possibility to receive continued Sertindole treatment in this open one-arm study. Sertindole is generally well tolerated and is approved in the EU, but not yet marketed in France. The follow-up of the patients will be similar to that in the previous study and requires quarterly visits. Patient management reflects routine clinical practice in accordance with the Sertindole label. Any severe safety issue is reported to the company.

Eligibility Criteria:
Inclusion Criteria:

* Participation in the previous SCoP study, 99824
* Still fulfils the EU SPC requirements for Sertindole

Exclusion Criteria:

* Withdrawn before the end of the SCoP study, 99824
* Become homeless
* Participation in another clinical trial at the same time
* Unlikely to comply with the clinical study protocol or is unsuitable for any reason
Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids

The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are:

* Will the total dose of intraoperative opioid be reduced?
* Will there be difference in pain scores between groups? Participants will be managed with the Nociceptive Level Index algorithm to guide intraoperative analgesia.

The Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion.

Rescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.

Opioid Free Anaesthesia has attracted the attention of clinicians since the outbreak of the opioid pandemic in the USA. It has been correlated with less intraoperative and postoperative opioid use. The Nociceptive Level Index algorithm allows for intraoperative monitoring of the nociceptive pathways and targeted pain management. Furthermore, it is known that morbidly obese patients may benefit from opioid sparing techniques.

Our aim is to investigate the effect of Opioid Free versus Opioid Based Anesthesia on postoperative pain in patients undergoing sleeve gastrectomy.

In this randomized, double blind clinical trial, patients will be allocated into two groups based on intraoperative pain management. Apart from recording postoperative pain scores, blood samples will be collected intraoperatively to evaluate the stress response among the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18y and \<75y
* morbid obesity confirmed diagnosis
* American Society of Anesthesiologists (ASA) II-III
* elective laparoscopic sleeve gastrectomy surgery
* signed informed consent

Exclusion Criteria:

* bradycardia, bundle branch block, hypotension, postural hypotension
* obstructive sleep apnoea
* history of depression
* chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent
* refusal to participate
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).


Eligibility Criteria:
Inclusion Criteria:

* Have Lipoprotein(a) \[Lp(a)\] ≥175 nanomoles per liter (nmol/L).
* Meet criteria of either 2a or 2b:

  2a: Individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ASCVD) with an event or revascularization.

  2b: Individuals 55 years of age or older who are at risk for a first cardiovascular (CV) event and either: Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors.

Exclusion Criteria:

* Have had a major cardiovascular event or surgery, such as myocardial infarction (MI), stroke or coronary or peripheral revascularization, \< 60 days before screening
* Have uncontrolled hypertension
* Have New York Heart Association class IV heart failure.
* Have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study.
* Have severe renal failure, defined as

  * Estimated glomerular rate (eGFR) \<15 milliliters per minute per 1.73 meters squared (mL/min/1.73m2) at screening Visit 1, or ongoing dialysis.
* Have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (UACR) of ≥5000 mg/g at screening Visit 1.
* Have acute or chronic hepatitis, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening.
Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in Ischemic Stroke

This observational study aims to detect levels of iron, alpha-synuclein, and soluble lymphocyte activation gene 3 in acute ischemic stroke patients. And to see expressions of iron, alpha-synuclein, and lymphocyte activation gene 3 in the brain tissue of ischemic rats. The main questions it aims to answer are:

* Is there an association between iron and alpha-synuclein accumulation in ischemic stroke?
* Is there any change in soluble lymphocyte activation gene levels in ischemic stroke and if these levels are related to stroke severity and infarction size? . Can soluble lymphocyte activation gene levels be used as an early biomarker to diagnose ischemic stroke?


Eligibility Criteria:
Inclusion Criteria:

1. Patients at the age between 50-70 years.
2. Patients having neurological symptoms of acute ischemic stroke.

Exclusion Criteria:

1. Patients with acute hemorrhagic stroke.
2. Patients with Parkinson's disease (PD).
3. Patients with dementia, and Alzheimer's disease.
4. Patients with any type of malignancy.
5. Patients with central nervous system infection.
Bronchial Thermoplasty 10+ Year Study

To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.

Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment.

Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.

Eligibility Criteria:
Inclusion Criteria

* Subjects previously enrolled in AIR, RISA or AIR2
* Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
* Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
* Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements

Exclusion Criteria:

* Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.
Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs (one group to treat with RTA and a matched untreated control group) will be evaluated in term of TN volume, thyroid hormones and clinical symptoms.

Thyroid nodules (TNs) are very common in the general population, with a prevalence of about 50% in subjects older than 60 years undergoing neck ultrasound examination.

The great majority of TNs are benign, but they can be responsible for pressure symptoms in the neck and result in discomfort and decreased quality of life. Large compressive TNs may result in life-threatening conditions because of the potential acute onset of respiratory crisis. Percutaneous radiofrequency thermal ablation (RTA) is a minimally invasive procedure which has been firstly develop to treat patients with liver cancer and has been then used to treat both malignant and benign tumor nodules in many organs. RTA also represents a promising new approach for the management of TNs.The current prospective comparative study investigated the long-term effectiveness of RTA in patients with both toxic and non-toxic compressive TNs.

Forty consecutive patients with TNs with pressure symptoms were prospectively enrolled in this study. Patients were randomised as follows: 20 patients were treated with a single RTA session (group A) and 20 patients did not receive any treatment and were only followed-up (group B).

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years;
* benign thyroid nodules (TYR 2)
* solid or predominantly solid (colloid component \< 30%) large (\> 4.0 mL) thyroid nodules
* refusal and/or inefficacy of surgery and/or radioiodine therapy.

Exclusion Criteria:

* pregnancy
* malignant or suspicious thyroid nodules.