cyrilzakka/clinical-trials huggingface dataset:
A Research Study Looking at the Effect of Food Intake on How the Medicine NN0385-0434 Behaves in the Body of Healthy Participants

In this study participants will receive NNC0385-0434. NNC0385-0434 is being developed for the treatment of hypercholesterolemia, a fat metabolism disorder characterized by high levels of cholesterol in the blood. The dose to be tested in this study is 40 mg NNC0385-0434.

NNC0385-0434 is a new potential medicine that is currently being tested for intake as a tablet. It is not yet approved and cannot be prescribed yet. Besides 40 mg of NNC0385-0434, each tablet also contains 500 mg of the absorption enhancing agent SNAC, which helps to move NNC0385-0434 from the stomach into the blood.

The aim of this study is to investigate the effect of food intake on the amount of NNC0385-0434 in the blood after multiple tablet intake. For this purpose, NNC0385-0434 is given either after a high-fat breakfast or on an empty stomach. After dosing, participants must either fast for another 4 hours or receive a meal 30 minutes after dosing, depending on the group participants are assigned to. After taking the NNC0385-0434 tablets, the amount of NNC0385-0434 (and of SNAC) in the blood will be measured. The effect of food intake on the uptake of NNC0385-0434 into the body will be investigated so that correct and safe intake recommendations and medicine labels can be given.

The study can last for up to approximately 14 weeks for each participant, with a total of 7 clinic visits. This includes a screening period (up to 4 weeks) and one in-house treatment period (together a total of 13 consecutive days). It also includes a follow-up period with 5 ambulatory visits at the clinic (for approximately 7 weeks \[total of 50 days\] after the last dosing). participants will have blood tests at every clinic visit. Participants must be healthy and have a body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive). Only men can participate in this clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Male.
* Aged 18 to 55 (both inclusive).
* Considered to be generally healthy based on medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Body weight minimum 54 kg.
* Body mass index (BMI) between 20.0 and 34.9 kg/m\^2 (both inclusive).

Exclusion Criteria:

* Any disorder, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
* Meal habits and diet requirements which are contradictory to the meals provided or unwillingness to eat the food provided in the study.
* Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Predictive Analysis of Diabetic Foot Ulcer

The purpose of this study was to retrospectively analyze the wound condition, limb condition, ulcer recurrence and cardiovascular and mortality of patients with diabetic foot ulcer after admission to our hospital from 2009 to 2014, so as to understand the changes in the condition of patients with diabetic foot ulcer after treatment, provide evidence for the treatment of diabetic foot, and clarify the risk of diagnosis and treatment of diabetic foot.

Diabetic foot ulcer (DFU) is one of the most common and serious complications in patients with diabetes. Due to its high incidence and complicated treatment process, DFU often has a significant impact on patients' quality of life. In order to gain an in-depth understanding of the wound changes of diabetic foot patients after admission, this study aims to systematically analyze the data of the database of diabetic foot patients in Ruijin Hospital, analyze the wound healing, ulcer recurrence and limb changes of diabetic foot patients, including amputation and other conditions, and then further determine the main factors affecting diabetic foot ulcer healing. Guide clinicians to develop more effective treatment plans; Provide data support to help optimize the treatment flow of diabetic foot and reduce length of stay and recurrence rates; To improve the overall treatment effect of diabetic foot patients and improve their quality of life.

Objective:

1. The wound condition, limb condition, ulcer recurrence and cardiovascular and mortality changes of patients with diabetic foot after treatment were analyzed to clarify the risk of diagnosis and treatment of the disease and provide evidence for the treatment of diabetic foot.
2. To assess the progress of wound healing in patients with diabetic foot after admission to hospital and identify key factors that promote or delay healing.
3. By comparing the effects of different treatment methods (such as drug therapy, surgical intervention, adjuvant therapy, etc.), the most suitable treatment strategy is found.
4. The incidence of complications during and after treatment was analyzed, and effective management strategies were discussed.

Methods:Through systematic analysis of the data from the database of diabetic foot patients in Ruijin Hospital, the wound healing, ulcer recurrence and limb changes of diabetic foot patients, including amputation, were analyzed, and then the main factors affecting diabetic foot ulcer healing were further determined.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Gender: males and females
3. Patients diagnosed with diabetic foot ulcers (including those on the Wagner scale 0-5)
4. Receive inpatient treatment during the designated study period

Exclusion Criteria:

1. Patients with severe systemic disease (such as end-stage renal disease, advanced cancer, etc.) may have influenced the study results
2. Patients unable to complete follow-up or with incomplete data
A Systematic Review of Factors Associated With Pulmonary Arterial Hypertension in Systemic Sclerosis

This protocol is of a systematic review for risk factors of pulmonary arterial hypertension in systemic sclerosis.

A systematic review was conducted to determine the risk/associated factors for pulmonary arterial hypertension in systemic sclerosis, including clinical/disease characteristics, antibody status, test results and biomarkers. The frequency of publications featuring a risk/association were reported. The following databases were searched: Medline, EMBASE, the Cochrane Library, Web of Science, and SCOPUS.

The following search terms were used:

( essential pulmonary hypertension or familial primary pulmonary hypertension or hypertension, pulmonary or hypertension,lung or hypertensive pulmonary vascular disease or idiopathic pulmonary arterial hypertension or lung arterial hypertension or lung artery hypertension or lung hypertension or primary pulmonary hypertension or pulmonary arterial hypertension or pulmonary artery hypertension or pulmonary fixed hypertension or pulmonary hypertensive disease or pulmonary hypertensive diseases or pulmonary hypertensive disorder or pulmonary hypertensive disorders )

AND

( generalised scleroderma or generalized scleroderma or progressive scleroderma or progressive sclerodermia or progressive sclerosis,systemic or progressive systemic sclerosis or scleroderma, generalised or scleroderma, generalized or scleroderma, progressive or scleroderma, systemic or sclerosis,progressive systemic or sclerosis,systemic or sclerosis,systemic progressive or systemic progressive sclerosis or systemic scleroderma or systemic sclerosis,progressive or

scleroderma, limited or limited scleroderma or limited cutaneous scleroderma or

diffuse scleroderma or progressive diffuse scleroderma or scleroderma, diffuse )

AND

( prevalence or prevalence study or relative risk or risk factors )

Eligibility Criteria:
Inclusion Criteria:

* Studies were included they were (1) in patients with SSc; and if they (2) determined PAH with right heart catheterization; (3) involved a comparison of SSc patients with and without PAH; and (4) had sample size larger than 20.

Exclusion Criteria:

* Studies were excluded if they were review articles, and if the study was written in languages other than English. When the same patients were used in more than one analysis, the most recent or largest sample-size study was included.
Chromoendoscopy for Ulcerative Colitis Surveillance

Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.

Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.

Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.

Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis, pancolitis \> 8 years; left-sided \> 15 years or
* history of PSC or
* history of previous dysplasia on colon biopsies or
* family history of colon cancer in first degree relative

Exclusion Criteria:

* any condition that precludes colonoscopy
* expected survival less than 1 year
Prediction of Pain After Breast Cancer Surgery With EEG

1. Rationale The inter-individual pain experience immediately after surgery is considerable. In addition, a number of patients develop chronic post surgery pain (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic back pain, it was demonstrated how subjectively reported pain is associated with specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the pain event-related potential (ERP). It was concluded that ERP was associated with self-reported pain in daily life up to two weeks after the measurement. This resulted in the current hypothesis that EEG may be a predictor for postoperative pain.
2. Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be repeated 6 months postoperatively.

   Study population: Female patients with breast cancer who will undergo breast surgery, between the ages of 18 to 65 years.
3. Main study parameters/endpoints Primary outcome is postoperative pain, measured in a pain diary 4 days postoperatively. Secondary outcomes are development of chronic post surgery pain and quality of life. The main goal is to develop a comprehensive prediction model for acute and chronic postoperative pain after breast cancer surgery, based on the EEG results of the five vulnerability experiments.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years.
* ASA 1-2.
* Sufficient comprehension of the Dutch spoken and written language.
* Elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
* Stage I and II breast cancer.
* Written informed consent is obtained

Exclusion Criteria:

* Previous breast surgery, both ipsilateral and contralateral.
* Stage III-IV breast cancer.
* Chronic pain (\>3months) with an average severity of at least a VAS score 4 during the last two weeks.
* Chronic pain for which invasive treatment is needed.
* Use of (weak / strong) opioids in the last week.
* A history of opioid addiction.
* Regular use of the following medications in the last year:

antiepileptics,antipsychotics and anxiolytics.

* ASA 3 or higher.
* Consumption of alcohol (\>4 units) and / or drugs the evening before.
* Alcohol consumption (\>= 5 units/day).
* Illiteracy, problems with self expression, language barrier.
* Serious vision and / or hearing problems, interfering the performance of the experimental tasks.
* A history of psychiatric complaints and/or epilepsy .
* A medical history of CVA or TIA.
Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.

This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 17 years of age and has full legal capacity to volunteer;
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had an ocular examination in the last two years;
* Is a current soft lens wearer using either two-week or monthly replacement lenses;
* Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
* Has normal binocular vision (no strabismus, no amblyopia);
* Has clear corneas and no active ocular disease;
* Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
* Has astigmatism less than or equal to -1.00 D;
* Agrees to wear the study lenses on a daily wear basis.

Exclusion Criteria:

* Has any active ocular disease;
* Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
* Has undergone corneal refractive surgery;
* Has a systemic condition that may affect a study outcome variable;
* Is using any systemic or topical medications that may affect ocular health;
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Is pregnant or lactating;
* Is participating in any other clinical or research study that may affect a study outcome variable;
* Currently wears daily disposable lenses or extended wear lenses.
Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor

MEK113583 is a Phase II open-label, multi-site study to investigate the objective response rate, safety, and pharmacokinetics of GSK1120212 in subjects with BRAF mutation-positive melanoma who were previously treated with or without a BRAF inhibitor. GSK1120212 is a potent and highly selective inhibitor of MEK activation and kinase activity.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic cutaneous melanoma that was previously treated with: (Cohort A) a BRAF inhibitor either with or without other prior therapy. (Cohort B) at least 1 prior chemotherapy or immunotherapy, without treatment with a BRAF inhibitor.
* Documented positive BRAF mutation (V600E, V600K, or V600D).
* Subjects must provide archived tumor tissue or undergo fresh tumor biopsy prior to enrollment.
* The subject must have a radiographically measurable tumor.
* The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
* Able to swallow and retain oral medication.
* Sexually active subjects must use acceptable methods of contraception during the course of the study.
* Adequate organ system function and blood cell counts.

Exclusion Criteria:

* The subject has had major surgery or received certain types of cancer therapy within 21 days before starting the study.
* Previous treatment with a MEK inhibitor.
* Current use of a prohibited medication listed in the protocol.
* Uncontrolled glaucoma.
* Brain metastasis, unless previously treated with surgery or stereotactic radiosurgery, and the disease has been stable for at least 2 months prior to enrollment.
* Current severe or uncontrolled systemic disease.
* History of clinically significant heart, lung, or eye/vision problems.
* Significant unresolved side effects from previous anti-cancer therapy.
* The subject is pregnant or breastfeeding.
BAX 326 Pediatric Study

The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in pediatric patients.

The secondary outcome measure: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours (h) Post-infusion analysis was not done due to the different time-points for the last PK blood sample, AUC0-72 h was redundant and only total AUC was included in the PK analysis.

Eligibility Criteria:
Main Inclusion Criteria:

* Participant and/or legal representative has/have voluntarily provided signed informed consent
* Participant has severe (FIX level \< 1%) or moderately severe (FIX level ≤ 2%) hemophilia B
* Participant is \< 12 years old at the time of screening
* Participant has no evidence of a history of FIX inhibitors (based on the participant's medical records)
* Participant is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm\^3

Main Exclusion Criteria:

* Participant has a detectable FIX inhibitor at screening, with a titer ≥ 0.6 Bethesda Unit (BU)
* Participant has a history of allergic reaction, e.g. anaphylaxis, following exposure to FIX concentrate(s)
* Participant has evidence of an ongoing or recent thrombotic disease
* Participant has an inherited or acquired hemostatic defect other than hemophilia B
Epiphrenic III Pilot Trial

The Epiphrenic III Pilot Trial investigates whether a diaphragmatic stimulation by interventionally placed electrodes may improve heart function, symptoms and functional capacity in patients with severe heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure (NYHA functional classes II, III or IV)
* Reduced left ventricular ejection fraction (LVEF) \<35%
* Guideline-recommended drug therapy

Exclusion Criteria:

* Patient refuses study participation
* Life expectancy presumably \<1 year
* Pregnancy
Drug Use and Sexual Risk Behaviors Among Emerging Adults in the ER

This project will develop a technology-augmented HIV and substance use risk reduction intervention for delivery in the Emergency Department, a medical setting where at-risk emerging adults who use drugs and engage in HIV-related risk behaviors are likely to present.

Research regarding substance use (including illicit drugs and non-medical use of prescription drugs) and HIV-related sexual risk behaviors (HIV SRBs; e.g., inconsistent condom use, multiple partners, sex while intoxicated; and prevention of injection drug use) among emerging adults (EAs; ages 18-25) has generally focused on alcohol use among college students from campus settings; however, substance use and HIV (and other associated Sexually Transmitted Infections) disproportionately occur among young people living in urban, low-resource communities, particularly individuals of racial minorities. The Emergency Department (ED) is a critical venue for accessing at-risk EAs engaging in substance use and HIV risk behaviors. Research shows high rates of substance use and HIV SRBs among EA patients in the ED, yet no intervention exists for EAs in this setting. The ED may be the only opportunity to intervene with these young people because EAs in urban, low-resource settings often lack a primary care provider during the transition from pediatric to adult medicine, may be un-insured or under-insured, and may not be involved in a traditional college campus setting. Further the use of technology (e.g., mobile phones) is relatively ubiquitous among this age group, and most prefer technology-based communication (e.g., text messaging or instant messaging via apps), therefore interventions for EAs may be enhanced by this type of technology. In this phase we will test a tailored intervention for EA patients in the ED focusing on reducing substance use and HIV SRBs, which will be enhanced through the use of mobile app notifications.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable
* Mentally and physically able to consent
* English-speaking
* Between ages 18-25
* Past-month substance use (including illicit drugs and/or non-medical prescription drug use) and inconsistent condom use in the past month
* Ownership of a smartphone

Exclusion Criteria:

* ED presentation suicidality and/or acute psychosis, being in police custody, or present with psychological distress requiring intensive social work (e.g. sexual assault)
* Patients with a significant other that they live with who is currently participating in study
* Actively participating in another study
* Participated in prospective and intervention development phases of the study
* Married
* Do not wish to consent to audio-taping the in-person portion of the ED-based intervention session
Safety and Outcomes Associated With Continuous Versus Intermittent Infusion Vancomycin

Evaluate the safety and outcomes associated between the two treatment modalities

Assess the risk of vancomycin-associated nephrotoxicity and outcomes associated with continuous infusions (CI) versus II dosing in the outpatient parenteral antibiotic therapy (OPAT) setting

Eligibility Criteria:
Inclusion Criteria:

* Adult patients at least 18 years of age
* Receiving Wake Forest Baptist Health Outpatient parenteral antimicrobial therapy (OPAT) services
* Will receive vancomycin therapy from Wake Forest Baptist Health Specialty Home Infusion Pharmacy
* Planned therapy with vancomycin in the outpatient setting for at least 2 weeks in duration
* Prescribed vancomycin with a frequency of either every 12 hours or every 8 hours dosing at the time of enrollment

Exclusion Criteria:

* Presence of diseases or conditions known to affect the pharmacokinetics of vancomycin: Pregnancy/Ascites/Burn injury/Cystic fibrosis /Weight greater-than or equal-to 150 kg
* Pre-existing leukopenia: White Blood Cell (WBC) \< 4,000 x 103 cells/µL
Electrical Muscle Stimulation in the Development of Acquired Weakness in Patients With Severe Sepsis and Septic Shock

The aim of this study is to compare the effect of EMS and conventional physical therapy on strength and muscle mass and development in adult patients with severe sepsis and septic shock.

Septic patients are at high risk of developing intensive care unit acquired weakness (ICUAW). Electrical muscle stimulation (EMS) has become an alternative exercise for critical and non-cooperative patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects admitted to the ICU of the HCUCH in the period between November 2016 to August 2017 and January to June 2018
* Diagnosis of severe sepsis or septic shock
* More than 48 hours in VMI
* With sedation and / or neuromuscular blockade
* Autovalent prior to admission to the ICU

Exclusion Criteria:

* Subjects from other hospitals / clinics or units of the hospital
* Multiple trauma
* Previous neuromuscular pathology
* Pacemaker users
* Pregnant women
* BMI\> 35
* Epilepsy
* Those who have refused to sign informed consent