cyrilzakka/clinical-trials huggingface dataset:
Abundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)

Nonalcoholic fatty liver disease (NAFLD) is the most common type of liver disease in the United States. The incidence of NAFLD is very similar to that of obesity, type 2 diabetes, and the metabolic syndrome. The investigators hypothesize that there may be a relationship between over-nutrition, decreased physical activity and the development of fatty liver. The purpose of this study is to identify the types of fats and proteins, and the quantity of each, that are associated with increased severity of NAFLD.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 year of age
* Undergoing elective abdominal or bariatric surgery
* May have normal or elevated ALT/AST levels

Exclusion Criteria:

* Presence of viral hepatitis
* Significant alcohol use
* Intercurrent infections
* Use of any thiazolidinediones
Efficacy Testing of Crassocephalum Rabens Extract Capsules

This study is to investigate the improveing effects of the Crassocephalum rebens extract on skin conditions in normal people.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 20 years
2. Healthy people

Exclusion Criteria:

1. Non-volunteer
2. Pregnant and lactating women
3. Hypersensitivity to the assigned product
4. Diagnosed with skin diseases, liver diseases, kinedy disease, and other severe diseases
5. Cosmetic, drug, or food allergies
6. Concurrent aesthetic treatments (e.g., intense pulse light, medical peelings, or laser therapy)
7. Aceepted aesthetic treatments one month ago before the study
8. Chronic sun exposure (over 3 hours/day)
9. The members of the research team
A Clinical Study of TQB3616 Capsules Combined With Anlotinib Hydrochloride Capsules or Standard Chemotherapy Second-line and Above in the Treatment of Advanced Lung Cancer

This is an open, multi-cohort, exploratory phase II study on the safety and efficacy of TQB3616 combined with Anlotinib hydrochloride capsules or standard chemotherapy in the treatment of advanced lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with pathologically proven small cell lung cancer(SCLC) or/and locally advanced ( Stage ⅢB/ ⅢC), metastatic or recurrent (Stage IV) non small cell lung cancer(NSCLC).
2. Cohort 1: Subjects with SCLC who had previously received at least one chemotherapy containing platinum or got disease progression during chemoradiotherapy or after the last treatment.
3. Cohort 2: Subjects with locally advanced, metastatic/relapsed NSCLC who had previously received only one PD (L) 1 inhibitor alone or in combination with platinum-based chemotherapy.
4. Subjects with measurable lesions as defined by RECIST 1.1.
5. Aged ≥ 18 years ; Eastern Cooperative Oncology Group (ECOG) score: 0 \~ 1; Expected survival ≥ 3 months.
6. Laboratory indicators meet the requirements.
7. Non-pregnant or non-breastfeeding women; Negative pregnancy subjects.
8. Subjects voluntarily joined the study and signed the informed consent form.

Exclusion Criteria:

1. Subjects who received prior therapy with anlotinib hydrochloride capsules.
2. Cohort 2: Subjects with epidermal growth factor receptor(EGFR) mutation and anaplastic lymphoma kinase(ALK) translocation.
3. Subjects with central squamous cell carcinoma with a risk of hemoptysis.
4. Subjects who have developed or is currently suffering from other malignancies within 5 years, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ.
5. Subjects who have brain metastases with symptoms or control of symptoms for less than 2 months.
6. Subjects with difficulty taking oral medication.
7. Subjects with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
8. Subjects with spinal cord compression who have failed to be cured or relieved by surgery and or radiotherapy.
9. Subjects who have received chemotherapy, radiotherapy or other experimental anticancer therapy within 4 weeks prior to the first dose of the drug.
10. Subjects who have not recovered to ≤ CTCAE Grade 1 (excluding alopecia) due to the adverse event of prior therapy.
11. Subjects with significant surgery or significant traumatic injury within 28 days before randomization.
12. Subjects with arterial/venous thrombosis within 6 months.
13. Subjects with a history of psychotropic substance abuse who cannot be withdrawn or have mental disorders.
14. Subjects with any severe and/or uncontrolled disease.
15. Subjects whose large vessels are involved by tumor from imaging (CT or MRI).
16. Subjects who have hemoptysis and maximum daily hemoptysis ≥ 2.5ml within 1 month before the first dose.
17. Subjects with other factors that might cause the study to be terminated halfway per the judgement of the investigator.

    -
Long-term Benefits of Cardiac Rehabilitation Programme

A retrospective observational study was conducted on a cohort of 213 patients referred to the Cardiac Rehabilitation programme of Santa "Caterina" Hospital ("Girona", Spain) following acute coronary syndrome (ACS). We evaluated the long-term control of Cardiovascular Risk Factors and the occurrence of major adverse cardiac events (MACE) in a 3-year period of follow-up.

A retrospective observational study was conducted on a cohort of 213 patients referred to the Cardiac Rehabilitation programme of "Santa Caterina" Hospital ("Girona", Spain) following acute coronary syndrome (ACS). We evaluated the long-term control of Cardiovascular Risk Factors and the occurrence of major adverse cardiac events (MACE) in a 3-year period of follow-up.

we found that short-term CVRF control was significantly improved after discharge from the CR unit for all CVRF analysed (LDLc, Systolic blood pressure, tobacco consumption, HbA1C and BMI (body mass index)). Long-term control of low-density lipoprotein cholesterol (LDL-c) and tobacco consumption was maintained from post-CR to year three, although both showed a trend towards deterioration. There was a significant increase in systolic blood pressure and glycosylated haemoglobin (HbA1C) and body mass index (BMI) from post-CR to year three.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in the hospital-based Cardiac Rehabilitation programme of Santa Caterina Hospital of Girona from January 2008, with a 3-year period follow-up.
* Patients diagnosed with ACS - including STEMI, NSTEMI and unstable angina (UA) admitted in the cardiology unit of Santa Caterina Hospital of Girona and Hospital Universitari Dr. Josep Trueta of Girona.
* Patients able to read the information paper and to provide written informed consent of the Cardiac Rehabilitation programme of the Santa Caterina Hospital.

Exclusion Criteria:

* Patients enrolled in the hospital-based Cardiac Rehabilitation programme of Santa Caterina Hospital of Girona with a different diagnosis of heart disease: cardiovascular surgery, congestive heart failure, heart valve disease, etc.
* Data unavailable for a 3-year follow-up study ± 6 months.
* Patients with severe comorbidities or limitation for physical activity, and thus, inability to undergo Cardiac Rehabilitation programmes.
* Stress test with induced significative ischemia with low charge of exercise, arrhythmia induced with the exercise or hypotension response to this.
* Ventricular arrhythmias and other malignant arrhythmias
The Experiences of People Prescribed Opioid Pain Medicines

Opioids are morphine-type medicines which come from the opium poppy or are similar-to morphine. They are very effective for short-term pain, cancer pain, and pain at the end of life. Opioids are thought to be less useful for treating long-term non-cancer pain. Side effects are common and can be serious. People who take opioids for longer periods are at risk of tolerance (needing a higher dose to get the same effect), dependence (unable to cut down or stop without withdrawal effects), and addiction (uncontrollable use despite harmful consequences).

In the UK, opioid prescribing has increased substantially over the last two decades. Doses are higher and opioids are taken for longer, suggesting many people are at risk of harmful effects without useful pain relief. Research into opioid dependence and addiction has found people do not always fully understand the risks of these medicines at the start of treatment. Local Community Pharmacists could be used to improve information and support for those prescribed opioids.

This study aims to get a better understanding of the experiences of people prescribed opioids and their information and support needs, and to investigate whether information and support could be improved using Community Pharmacists. Findings may improve care for people prescribed opioids in the future.

The study will involve questionnaires and interviews with adults prescribed an opioid medicine for pain, not caused by cancer, over a period of at least 3 months. Participants will be recruited from GP practices in England.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Adults aged 18 years and above, with no upper age limit
* Prescribed any opioid analgesic (defined as any opioid or opioid/paracetamol combination analgesic from sections 4.7.2 and 4.7.1 British National Formulary) for non-cancer pain for a period of ≥3 months (defined as ≥ 2 opioid prescriptions issued in the previous 3 months with a minimum interval of 60 days between the first and last prescription)

Exclusion Criteria:

* Cancer pain
* Terminal illness
* Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents)
* Unable to understand English
* Deemed by their GP to be inappropriate to contact
A Study to Explore If Long-term Use of Mucinex Can Help with Symptoms in Patients with Stable Chronic Bronchitis.

This is an open-label, multicenter, single-group study designed to determine the effectiveness of Mucinex® when used by patients to treat SCB over a 12-week period, following a 2-week run-in period of no treatment (to establish a baseline).

Data will be collected via the Vitaccess Real\[TM\] platform from adult patients with SCB and HCPs based in the US. During the 12-week period of receiving treatment, patient participants will take Mucinex® 12h, 2 x 600 mg (1200 mg total) twice daily and complete weekly bespoke surveys and the CASA-Q instrument. Patient-reported data will include prior usage of Mucinex®, treatment compliance, treatment satisfaction, and symptoms.

During this same period of time, HCPs will report treatment satisfaction via electronic case report forms (eCRFs), and will also have the ability to spontaneously report any treatment-emergent adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of SCB at recruitment, male and female, over 40 years of age
* A Pulmonary Function Test with FEV1/FVC less than 0.7 (70%) at the time of enrollment or at least a 10 year history of cigarette abuse.
* Patients who have chronic sputum production 3 months out of the year for 2 consecutive years and a productive cough as part of their symptoms.
* Patients who understand and are able to fill out a questionnaire and ePRO weekly
* Patients who have not used guaifenesin containing products within one month of the time of study enrollment
* Patients with 6 to 12 (ideally 12)-month historical data - retrieved from either electronic medical records (EMR), electronic health records (EHRs), or provided by the patient via interview.

Rescue medicine:

• No rescue medicine will be provided. Information regarding concurrent rescue medications, either OTC or via prescription, will be collected.

Exclusion Criteria:

* Patients who are pregnant or breastfeeding
* Participation in another study involving an investigational product within 30 days of the baseline visit
* Pulmonary diagnosis other than CB, (such as cystic fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, or pulmonary fibrosis)
* Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment including chemotherapy or radiation. If the patient has a history of lung cancer, they must be in remission
* Psychiatric disorder that precludes participation in the study
* History of alcohol and/or drug abuse within one year of study start
* Patients taking intermittent antibiotics and patients taking oral and systemic corticosteroids (e.g., prednisone at a dose of \> 10 mg/day).
* Patients on a chronic stable dose of macrolide antibiotics at the start of the study may be included at the discretion of the Principal Investigator.
* Patients who had an acute exacerbation of chronic bronchitis within a period of one month of starting the study that required systematic steroids or antibiotics
* Hypersensitivity to guaifenesin, or any other excipient listed in the product.
An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.


Eligibility Criteria:
Inclusion Criteria:

* Chronic urticaria \[rash (erythema, wheal) for more than 1 month without any known cause\]
* Out-patient

Exclusion Criteria:

* Stimulation-induced urticaria \[physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)\]
* Hypersensitivity to antihistamines or ingredients of a study drug
Corneal Specular Microscopy in Infectious and Noninfectious Uveitis

The purpose of this study is to determine whether some endothelium morphologic variables are different between infectious and noninfectious uveitis group using a noncontact specular microscopy device.


Eligibility Criteria:
Inclusion Criteria:

* Patients with infectious and noninfectious uveitis in any activity level and presence of keratic precipitates.

Exclusion Criteria:

* Patients with previous ocular surgery, trauma, contact lens history, corneal dystrophy, corneal edema and high intraocular pressure
* Any other anterior segment disorders affecting the corneal endothelium.
Different Techniques of Crestal Sinus Lift

Sixteen patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University with age range from 20-50 years seeking implantation of their lost posterior maxillary teeth, \[premolar and molars\] with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization.

Group I (N = 8): The sinus membrane will be elevated by using balloon technique with simultaneous Implant placement.

Group II (N = 8): The sinus membrane will be elevated by using Densah burs with simultaneous Implant placement.


Eligibility Criteria:
Inclusion Criteria:

* Patent ostium of maxillary sinus.
* Patient with missing one or more posterior maxillary teeth.
* A ridge height at the site of implantation of 4-7 mm.
* A ridge width at the site of implantation of 6 mm.
* Good oral hygiene.
* Patients in the age frame between 20 years and 50 years old.
* No gender preface in selection of the patients.
* Acceptable inter-arch space for the future prosthesis.

Exclusion Criteria:

* Any pathological condition at the site of surgery.
* Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
* Heavy smoking and alcoholism.
* Parafunctional habits such as bruxism and clenching.
* Signs of acute infection or pus discharge
* Disturbed occlusion.
* Maxillary sinus inflammation.
Pharmacokinetic (PK) and Safety Study of Meropenem in Young Infants With Intra-abdominal Infections

Meropenem is an antibiotic that is commonly used to treat serious infections. Although it is used in premature and young infants, the correct dose is not known. The purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.

This study will evaluate the safety, tolerability and Pharmacokinetics - Pharmacodynamics (PK-PD) of meropenem in infants \<91 days of age with suspected and complicated intra-abdominal infections.

The specific aims of this trial are:

1. To characterize meropenem single-dose and multiple-dose PK in subjects with suspected and complicated intra-abdominal infections.
2. To characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections.
3. To assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Eligibility Criteria:
Inclusion Criteria:

1. Written permission from parent or legal guardian
2. Age younger than 91 days
3. Likely to survive beyond the first 48 hours after enrollment
4. Sufficient intravascular access (either peripheral or central) to receive study drug.

   AND ONE OF THE FOLLOWING
5. 1) Physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection. These include peritonitis, NEC (Necrotizing Enterocolitis) Grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous perforation, meconium ileus with perforation, bowel obstruction with perforation, as evidenced by free peritoneal air on abdominal radiograph, intestinal pneumatosis or portal venous gas on abdominal radiographic examination.

OR 2) Possible NEC OR 3) Otherwise receiving meropenem per local standard of care

Exclusion criteria:

1. Renal dysfunction evidenced by urine output \<0.5 mL/hr/kg over the prior 24 hours
2. Serum creatinine \>1.7 mg/dL
3. History of clinical seizures or EEG (Electroencephalogram) confirmed seizures
4. Concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent
5. Any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study
Weight Implements to Improve Throwing Speed and Shoulder Mobility in Baseball Pitchers

Increasing the speed of pitches is key in baseball performance. The interventions by means of the implement of weights are used to improve the strength and to strengthen the muscles of the shoulder.

The objective of the study is to assess the effectiveness of an exercise protocol with weight implements in increasing the speed of throws and shoulder mobility in pitchers aged 18 to 40 years.

Randomized pilot study. 12 pitchers will be randomized to the study groups: experimental (intervention with launches with weight implement) and control (without any intervention). The intervention will last 4 weeks, with 2 weekly sessions of 15 minutes each. The study variables will be the range of shoulder movement (goniometry) and the speed of the throws (speed radar). A descriptive statistical analysis will be performed calculating median and interquartile range. With the Shapiro-Wills test, the sample distribution will be calculated. If there is homogeneity, with the t-student test the changes will be calculated after the intervention in both groups. The intra and intersubject effect will be calculated with the ANOVA of repeated measures. The effect size will be obtained with Cohen's mean difference formula.

It is expected to see improvement in the speed of the throws and in the range of shoulder movement.


Eligibility Criteria:
Inclusion Criteria:

* Male baseball pitchers
* With an age range of 18 to 40 years
* With more than three years of sports practice as a pitcher
* That currently practice in regional or professional competitions

Exclusion Criteria:

* Subjects who have undergone some surgery on the dominance arm with which they launch in the last 12 months
* Who are receiving a specific shoulder mobility intervention
* Have not signed the informed consent document
Biomarker Study of Pancreatic Neuroendocrine Tumours

The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, DOTATOC-PET, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 68Ga-DOTATOC and 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in DOTATOC as well as FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Informed consent
* Pathology confirmed diagnosis of pancreatic neuroendocrine tumor WHO grade 1-3 or neuroendocrine carcinoma grade 3.

Exclusion Criteria:

* Patient does not consent
* Pregnancy or no contraceptive in fertile women.
Parental Presence During Fracture Reduction in Children at the Emergency Department; A Randomized Controlled Trial

Though much attention has been given to the practice of parental presence during invasive procedures in children in the ED, few studies have examined the patient's perspective. The only study to have addressed this issue used a single visual analog scale, which is not a well validated tool to assess children's distress level. Furthermore, no studies have assessed parental presence during fracture reduction; only a few incidental cases were reported in the literature. Finally, most studies evaluating parental presence had methodological limitations because of the absence of a control group.

The investigators seek to assess whether parental presence during fracture reduction under sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and children.


Eligibility Criteria:
Inclusion criteria for patients:

* Patients aged 8 to 18 years old.
* Patients requiring fracture reduction under conscious sedation by emergency department attending physician.
* Patients able to understand basic spoken English or French.

Inclusion criteria for parents:

* Parents able to understand basic spoken English or French.

Exclusion criteria for patients:

* Patients with moderate to severe mental retardation
* Patients with altered mental status or intoxication
* Patients with hemodynamic instability or several traumatic injuries (other than fractures) - these patients require several treatments and may not have time to complete our study.

Exclusion criteria for parents:

* Parents presenting unacceptable behaviors for family presence

  * Uncooperative
  * Physically aggressive, combative
  * Threatening and argumentative
  * Unstable emotionally or cannot be calmed
  * Intoxicated or altered mental status
  * Suspicion of child abuse
  * Suspected perpetrator of violent crime
* Parents with moderate to severe mental retardation.
* Pregnant parent