cyrilzakka/clinical-trials huggingface dataset:
Blood Indices of Systemic Inflammation in Critically Ill Patients With Abdominal Sepsis

This study aims to clarify the role of blood indices of systemic inflammation in ICU-admitted patients with abdominal sepsis to assess their diagnostic significance as well as their prognostic value.

Sepsis is a complex, multifactorial syndrome which can evolve into conditions of varying severity. If left untreated, it may lead to the functional impairment of one or more vital organs or systems. Severity of illness and the inherent mortality risk escalate from sepsis, through severe sepsis (defined as sepsis associated with at least one acute organ dysfunction, hypoperfusion, or hypotension) and septic shock up multi-organ failure. Previous studies have demonstrated that mortality rates increase dramatically in the event of severe sepsis and septic shock.

Abdominal infection is a common indication for admission to the intensive care unit (ICU) and the abdomen is the second most common site of invasive infection among critically ill patients in epidemiological and therapeutic studies. Abdominal infections are more often associated with septic shock and acute kidney injury than are infections in other sites. The spectrum of disease and severity is broad and management of these infections is challenging.

The inflammatory response in patients with sepsis depends on the causative pathogen and the host (genetic characteristics and coexisting illnesses), with differential responses at local, regional, and systemic levels.

On the systemic level, several indices have been used as a mirror to outcome in patients with various pathologies, of which are the Blood Indices of Systemic Inflammation.

As these blood indices are easy and available investigation that may be promising predictors in sepsis, we aim in this study to evaluate their role in abdominal sepsis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients above the age of 18 years old.
2. Patients fulfilling the Systemic Inflammatory Response Syndrome (SIRS) criteria.
3. Patients with an established diagnosis of abdominal sepsis, clinically and by investigations.

Exclusion Criteria:

1. Patients below the age of 18 years.
2. Patients with haematological disorders.
3. Patients with concomitant severe morbidity affecting the prognosis other than sepsis e.g. hypovolemic shock, brainstem infarction, pulmonary embolism, etc.
Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis

A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Good physical condition (WHO performance status score 0-1).
3. Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors
4. Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.
5. The LENT-SOMA score was ≥1 during the screening period.
6. All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.

Exclusion Criteria:

1. Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.
2. Patients with allergic constitution or severe systemic autoimmune diseases.
3. Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.
4. Pregnant or lactating women.
5. Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
6. Patients with a LENT-SOMA score of 4 during the screening period.
7. Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
8. Patients with uncontrolled tumors, tumor recurrence or metastasis.
9. Subjects received any investigational drug within 3 months prior to the screening.
10. Subjects received stem cell treatment.
11. Participants considered inappropriate to participate in this clinical trial
Comparison of Vortic Catch V Basket Catheter and Ordinary Basket Catheter for the Removal of Bile Duct Stones

Investigators will perform randomized trial of the removal ability with Vortic Catch V basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).


Eligibility Criteria:
Inclusion Criteria:

* patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm)
* endoscopic papillary balloon dilation (EPLBD) was performed.

Exclusion Criteria:

* septic shock
* coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control),
* \<platelet count 50,000 / L
* suspected or confirmed malignancy
NovellusDx Functional Profiling of Oncogenic Mutations in Lung Cancer Patients

NovellusDx technology identifies tumor-specific driver mutations, but unlike sequencing-based tests, NovellusDx has a functional assay that detects dis-regulated translocation of mutated signaling proteins to the nucleus. This allows NovellusDx to identify functionally-impactful driver mutations regardless of whether the mutation has previously been described or linked to a tumor type.


Eligibility Criteria:
Inclusion Criteria:

* Patients that are suspected to have lung cancer and are eligible for biopsy, surgical intervention or pleural fluid suction

Exclusion Criteria:

* Patients without lung cancer
Exercise Training in Heart Failure With Preserved Ejection Fraction - a Long-term Follow-up

Exercise training is an effective therapy for patients with heart failure with preserved ejection fraction. However, it is unclear, whether a one-year intervention has a sustainable effect beyond the active study phase. Hence, this study is a long-term follow-up of patients that were recruited for the OptimEx-Clin and Ex-DHF trials in Munich.


Eligibility Criteria:
Inclusion Criteria:

* Patients that were previously randomized to OptimEx-Clin or Ex-DHF in Munich
* Written informed consent

Exclusion Criteria:

* Pregnancy / breastfeeding
Africa and Middle East Cardiovascular Epidemiological Study

This is a cross-sectional, epidemiological study to determine the prevalence of cardiovascular risk factors such as obesity, smoking, dyslipidemia, diabetes mellitus and hypertension in patients attending General Practice clinics in the Africa and Middle East region. A total of 4300 patients will be evaluated. In patients who are found to have previously been diagnosed with cardiovascular (CV) risk factors such as dyslipidemia or hypertension, the level of control of their respective conditions will also be evaluated.

This is a cross-sectional, epidemiological study. In the course of this study, 4,300 persons from general practice, and other non specialist clinics of selected countries of the Africa and Middle East region, will be evaluated for the presence of cardiovascular (CV) risk factors such as obesity, smoking, dyslipidaemia, diabetes mellitus and hypertension. The degree of control of hypertension and dyslipidaemia in those previously diagnosed with these conditions will also be assessed. All medications used for CV risk factor control will also be ascertained.

Patient evaluation will be done by physicians in charge of the selected clinics (who will be trained for case report forms completion) over one visit, through history taking, clinical examination as well as laboratory investigations. Every fifth patient seen on a particular day, fulfilling the inclusion and exclusion criteria would be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged 18 or above

Exclusion Criteria:

* Pregnant women and/or lactating mothers
* Subjects presenting with any life threatening disease/condition
Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy

To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Asymptomatic HIV infection.
* CD4 count 100-400 cells/mm3.
* No HIV-associated neurologic abnormalities or constitutional symptoms.
* No oral hairy leukoplakia.
* At least 6 months of prior AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Abnormal chest x-ray, consistent with active opportunistic infection.
* Hypersensitivity to thymopentin.
* Significant chronic underlying medical illness.
* Grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

* HIV vaccines.
* Investigational or non-FDA approved medication.
* Immunomodulatory therapies.
* Experimental therapies.
* Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.

Patients with the following prior conditions are excluded:

* Herpes zoster (within the past year).
* Recurrent (\> one episode) oral candidiasis (confirmed).
* Vulvovaginal candidiasis (persistent, frequent, or poorly responsive to therapy).
* Bacillary angiomatosis.
* Listeriosis.
* Idiopathic thrombocytopenia purpura.

Prior Medication:

Excluded at any time prior to study entry:

More than one dose of thymopentin.

Excluded within 30 days prior to study entry:

* HIV vaccines.
* Investigational or non-FDA approved medication.
* Immunomodulatory therapies.
* Experimental therapies.
* Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.

Required:

* Prior AZT (\>= 300 mg/day) for at least 6 months; on current regimen (any combination of approved nucleoside analogues) for at least 4 weeks.

Significant active alcohol or drug abuse.
WOE of Anti-CD20 Therapies

The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. The current study will explore the wearing-off effect associated with OCR and OMB, using a variety of validated scales assessing MS symptoms (i.e., fatigue, mobility, pain, depression, cognition), as well as some global questions on wearing-off. In addition, impact of worsening of MS symptoms on patients' health-related quality of life (HRQoL) and their work productivity will be assessed using relevant MS-specific validated scales

This will be a non-interventional, primary data collection study in patients with MS treated with an established anti-CD20 treatment regimen (OCR or OMB) in the United States. Patients who satisfy the inclusion criteria and consent to participate in the study will be surveyed at four timepoints at the beginning and the end of OCR or OMB treatment cycles according to the following assessment schedule:

* Assessment 1. 0-10 days before 1st dose post-enrollment (index dose)
* Assessment 2: 5-14 days after index dose
* Assessment 3: 0-10 days before 2nd dose post-enrollment (follow-up dose)
* Assessment 4: 5-14 days after follow-up dose dose

Eligibility Criteria:
Inclusion Criteria:

OCR sample:

* Self-reported diagnosis of RMS, SPMS or CIS
* ≥21 years old at the time of initial contact
* Under treatment with OCR at the time of initial contact
* Have been on OCR for ≥ 1 year at the time of initial contact (i.e., prevalent users)
* Able to answer the questionnaires in English

OMB sample

* Self-reported diagnosis of RMS, SPMS or CIS
* ≥21 years old at the time of initial contact
* Under treatment with OMB at the time of initial contact
* Have been on OMB for ≥6 months at the time of initial contact (i.e., prevalent users)
* Able to answer the questionnaires in English

Exclusion Criteria:

OCR sample:

* Currently participating in a clinical trial involving MS drugs
* Last Ocrevus infusion was less than 3 months back

OMB sample:

Currently participating in a clinical trial involving MS drugs
Intra-procedural Transthoracic EChocardiogram to Facilitate Left Bundle Branch Area Pacing (LBBAP)

The goal of this observational study is to learn more about whether or not the use of heart ultrasound during pacemaker implantation is helpful. The main questions this aims to answer are:

1. Does this help the doctors with figuring out the wire location during implantation?
2. Does this reduce the wire placement procedure time?
3. Does this reduce the x-ray imaging time during the procedure?

Participants will be asked to:

1. Have a physical exam and Echocardiogram (ECG) at initial visit, 2 weeks post implant, and 3 months post implant.
2. Have a urine pregnancy test (if applicable)
3. Have a heart ultrasound during implant procedure
4. Answer questions related to heart failure symptoms to see what stage of heart failure is present
5. Have device interrogation (a wand placed over the chest to see that the device is working properly) at a visit 2 weeks post implant and at 3 months post implant.

The EC-LBBAP study is a prospective, single-enter, observational research study. The study team will identify all patients who satisfy the inclusion and exclusion criteria. The study team will evaluate the feasibility and success rates of echocardiogram guided LBBAP lead implantation.

Eligible patients will undergo LBBAP using Medtronic 3830 lead and C315His sheath. LBBAP will be confirmed at implant using left bundle potentials recorded from the lead, ECG morphology during unipolar and bipolar pacing, peak Left Ventricular Pacing (LV) activation time and lead depth in the 2D transthoracic echo at implant.

During implant procedure, transthoracic echo windows will be identified and documented: Parasternal short and long axis, apical 2 and 4 chamber views and subcostal views to visualize the proximal interventricular septum. Following venous access using cephalic vein cut-down or ultrasound guided axillary vein access, the lead implantation in the left bundle branch region will be guided by echocardiography.

Retrospectively, the study team will identify 20 consecutive previous patients who satisfy inclusion and exclusion criteria (control patients). The study team will compare the difference in procedural success between case and control patients.

Eligibility Criteria:
Inclusion Criteria:

* patient with indication for permanent pacemaker or Implantable Cardioverter Defibrillator (ICD) utilizing conduction system pacing lead for bradycardia or cardiac resynchronization therapy
* patient is willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Inability to provide informed consent
* pregnant
* enrolled in a concurrent study that may confound the results of this study
Safety, Tolerability and PK/PD of JMT103 in Patients With Bone Metastases From Tumors

JMT103 is a novel, full human IgG4 monoclonal antibody targeting RANKL. In preclinical studies, JMT103 demonstrated strong activity through blocking RANKL receptor, RANK on the surface of osteoclasts, leading to inhibit osteoclast differentiation, activation, and maturation and reduce bone resorption.

This first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) ,to evaluate the safety, pharmacokinetics and preliminary efficacy (bone turnover markers) of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) in patients with bone metastases from tumors at single doses and multiple doses.

About 36 cases patients are to be recruited.

This is a Phase I, first-in-human, multi-center, open-label dose escalation clinical study of recombinant fully human Anti-RANKL Monoclonal Antibody (JMT103) administered subcutaneously to patients with bone metastases from tumors.

The study includes two phases: dose escalation study and expansion study. The dose-escalation stage is designed to evaluate the safety, tolerability, and pharmacokinetics of single dose and following repeat doses of JMT103 given every 4 weeks (Q4W) for three times. The expansion study stage is designed to evaluate the safety, tolerability, and pharmacokinetics of repeat doses of JMT103 given every 4 weeks (Q4W) for three times.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed malignant solid tumors;
* imaging examination shows at least one site with bone metastases from tumors;
* ECOG performance status of score 0 or 1;
* Expected survival time ≥ 7.5 months.

Exclusion Criteria:

* Previous or present osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgery wounds; acute disease of the tooth or jaw requiring oral surgery; and invasive dental surgery planned to be received during the study;
* It is planned to perform therapeutic radiotherapy or orthopedic surgery for patients during the study;
* Known active brain metastases or leptomeningeal metastases. The subjects with neurological symptoms should receive brain CT/MRI to ensure that there have no metastases;
* Patients with bone metabolic diseases (Paget's disease, Cushing syndrome and hyperprolactinemia), rheumatoid arthritis, and current hyperparathyroidism or parathyroid dysfunction;
* Uncontrolled complications
* Active bacterial or fungal infections requiring systematic treatment within 7 days before the screening;
* Patients with HIV infections or active hepatitis;
* Pregnancy (positive serum β-HCG result) or lactation;
Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are several treatment options for this condition, including the use of antifungal agents such as nystatin and miconazole. The side effects and the increasing number of resistant species caused by the use of these drugs encourage the development of alternative therapies. Photodynamic Therapy (PDT) has been used as a promising treatment of stomatitis. In this randomized clinical trial, the effectiveness of PDT was evaluated. Patients in this study were allocated to two groups. One group was treated with nystatin, and the other group was treated with PDT.

Different Candida species, including albicans, tropicalis, and parapsilosis, are present in the human oral microbiota, gastrointestinal tract and vagina. These species are typically harmless commensals. Candida albicans, the most prevalent species, may be present in up to 80% of healthy individuals. This species is found with high frequency in dental prostheses and is thought to be the main pathogen associated with stomatitis in elderly denture wearers. Biofilms of Candida albicans are usually found in intravenous catheters, prostheses, and these biofilms promote a high resistance to antifungal drugs. The standard treatment of stomatitis is topical antifungal agents, including nystatin and miconazole. The use of topical antifungal agents has caused some problems. Poor responses to these agents are the result of dilution and fast elimination of the drug because of the action of the saliva, which reduced the drug's concentration. The drug's toxicity can cause mild and transient gastrointestinal side effects, such as nausea, vomiting and diarrhea. Alternative treatments or adjuvant treatments have been used to treat these diseases, such as the use of probiotic bacteria and photodynamic therapy (PDT) using a non-toxic dye (photosensitizer - PS) in combination with a source of visible light with a peak wavelength suitable for absorption by the PS. The photodynamic process rapidly generates reactive oxygen species (ROS) such as peroxides, hydroxyl radicals, superoxide ions and singlet oxygen. Singlet oxygen has been implicated as the major causative agent of cellular damage in the photodynamic process, but it does not cause cellular damage in host tissues. The amount of ROS formation is the main predictor of yeast killing.

This study aimed to evaluate the effectiveness of photodynamic therapy (PDT) in the treatment of denture stomatitis in complete denture wearers.

Eligibility Criteria:
Inclusion Criteria:

* patients presenting denture-related stomatitis, confirmed by clinical and microbiological evaluation

Exclusion Criteria:

* were based on the patients' medical history, and were excluded patients with a history of head and neck cancer, those with type III DS (classification proposed by Newton), and individuals who had received or were receiving treatment with antibiotics, antifungal agents or steroids for the past three months.
Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia

50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia

50 pregnant females were divided in two groups, twenty five as a control group and twenty five as high risk group; they were subjected to uterine artery Doppler, measurement of maternal serum (pp-13) and detection of (MTHFR) gene polymorphisms in first trimester at 11 to 14 weeks of gestation, all pregnancies were followed until 40 weeks for development of pre-eclampsia

Eligibility Criteria:
Inclusion Criteria:

* pregnant women at 11 to 14 weeks of gestation

Exclusion Criteria:

* fetal anomalies other medical diseases as diabetes mellitus, renal or liver diseases