cyrilzakka/clinical-trials huggingface dataset:
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection

The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.

This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects may be included in the study if they meet all of the following inclusion criteria:

  * Males or females, 18 years of age or older;
  * ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
  * Cellulitis/erysipelas;
  * Wound infection;
  * Major cutaneous abscess;
  * Lesion with a minimum surface area of 75 cm2;
  * Capable of giving signed informed consent.

Exclusion Criteria:

* Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:

  * History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
  * ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
  * Prior administration of systemic antibacterial therapy within 96 hours before randomization;
  * ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
  * ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
  * Evidence of significant hepatic, hematologic, or immunologic disease;
  * History or evidence of severe renal disease.
Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)

To evaluate second stage safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device, in treating functional mitral regurgitation (FMR) associated with heart failure and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.

Eligibility Criteria:
Inclusion Criteria:

* NYHA(New York Heart Association) Class III - IV
* and, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) in spite of optimal medical treatment.

(For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug)

* and, Chronic Atrial Fibrillation in electrocardiography (Persistent AF or Permanent AF)

Exclusion Criteria:

* Primary Mitral Regurgitation
* LV ejection fraction lower than 30%
* Pulmonary arterial pressure ≥ 60mmHg
* End-diastolic Left ventricular dimension ≥ 70mm
* Subjects with functional MR who need CABG or AVR performed
* Pre-existing stent in a coronary artery that is deemed to be in direct contact with the path of mitral loop cerclage along coronary sinus
* Subjects who have functional MR caused by aortic valve disease
* Subjects who have uncontrollable hyperthyroidism
* Subjects who have severe TR due to primary valve leaflet disease
* Anomaly of Coronary Sinus
* Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker
* 2:1 Atriventricular AV block or higher AV block and ventricular tachycardia
* Subjects with primary MR
* Subjects who cannot be screened by cardiac CT
* Subjects who have possibility of coronary artery pinching even with Mitral Loop Cerclage system judged by cardiac CT
* Subjects who do not have septal vein or have unsuitable septal vein anatomy by cardiac CT or venogram
* Subjects who have thrombosis and embolism
* Creatinine ≥2.0 mg/dL
* Subjects who have coagulation disorders
* Subjects who are unable to take anti-platelet agents
* Pre-existing devices such as Implantable Cardioverter Defibrillator and Pacemaker
* Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
* Subjects who are participated in other clinical trials within 1 month of enrollment
* Subjects who are deemed not to be eligible in this study by physician's discretion
An Observational Study to Assess the Risk of Out-of-Hospital Sudden Cardiac Death in Users of Domperidone, Users of Proton Pump Inhibitors, and Users of Metoclopramide

The purpose of this observational study is to assess the risk of out-of-hospital Sudden Cardiac (heart) Death (SCD) associated with current use of domperidone compared to current use of a Proton Pump Inhibitor (PPI), current use of metoclopramide, or non-use of any of these medications.

This is a population-based, retrospective (a study in which the exposures and outcomes occurred before the study began), and nested case-control study (a study in which the patients with the study outcome \[cases\] and comparison patients without that outcome \[controls\] are observed to assess their exposure to the medication being studied \[domperidone, PPI's and metoclopramide\]). The data will come from the United Kingdom's Clinical Practice Research Datalink. The study will estimate the rate of SCD during periods of exposure to each of the study medications, and during periods of exposure to none of them; and the ratios of these rates. It will also use a "case-crossover" analysis (in which each case serves as his/her own control) to re-estimate these rate ratios in a manner that takes account of personal characteristics such as obesity or smoking that may affect the study findings and are incompletely recorded in the database.

Eligibility Criteria:
Inclusion criteria:

- Patients registered in English practices whose data are linkable to Hospital Episode Statistics (HES) and Office for National Statistics, UK (ONS). Patients are required to have at least 1 year in the Clinical Practice Research Datalink before they can enter the study

Exclusion criteria:

* Patients with a diagnosis of cancer other than non-melanoma skin cancer
* Patients from practices not linkable to HES and ONS data
* Patient time corresponding to the period between hospital admission date and 30 days after discharge date
Acupressure Applied After Cesarean Section on Postpartum Pain

Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.

Pressure applied according to the principles of acupressure limits the pain limit, reduces the secretion of endorphins, which is a neurochemical, reduces the tension in the muscles, reduces the amount of oxygen in the blood flow, and finally provides duration and relaxation. Acupressure application is becoming more and more common nowadays because it is a noninvasive, safe, easy-to-apply and effective method without side effects. It seems that there is a limit to the study in which group acupressure applications in the literature are examined together on pain and comfort after cesarean section. In these basic points, the expectations of achieving postpartum pain and postpartum comfort of acupressure applied after cesarean delivery in this study. The circle of the research; There will be women who will have repeated cesarean section in a private Obstetrics Clinic in Famagusta. Women will be separated from two groups, one group will continue acupressure and the other group will do routine care. Visual analog scale and end-of-birth comfort procedure will be applied to women before and after the application.

Eligibility Criteria:
Inclusion Criteria:

* agreeing to participate in the research,
* be between the ages of 18-49,
* To give birth by cesarean section between 37-40 weeks,
* Having a healthy and live birth at the end of a single pregnancy,
* Receiving spinal anesthesia
* Being able to read and write Turkish and be open to communication.

Exclusion Criteria:

* Absence of pain in the 2nd hour postpartum
* Having a cesarean delivery after a risky pregnancy,
* Having a chronic illness
* Having severe systemic disease
* Not receiving spinal anesthesia
* Having a body mass index over 25,
* Have previous acupressure experience.
Cognitive-motor Telerehabilitation in MS

The primary goal of this project is providing evidence that a home-based combined cognitive-motor training program improves cognition in persons with multiple sclerosis (MS), compared to single cognitive and motor rehabilitation. Secondary goals are to assess the effects on walking performance and to identify the mechanisms of improvement and predictors of treatment response. The main backbone of this project will be a randomized controlled two-centre clinical trial, in which an at-home computerised cognitive-motor rehabilitation program using telemedicine aimed at improving working memory in persons with MS will be evaluated. Based on the information gathered during this trial, possible mechanisms of improvement will be identified by analysing anatomical and neurophysiological changes on structural MRI and resting-state and task-related EEG before and after rehabilitation. Furthermore, factors that can predict treatment response to the rehabilitation program will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Clinically definite multiple sclerosis (revised McDonald criteria 2017)
* Expanded Disability Status Scale (EDSS) below 6.0
* Digit span backwards z-score between \[-3 and -0.5\] standard deviations below the median of the normative values
* Age between 18 and 65
* Able to safely perform motor rehabilitation in the home situation (assessed by rehabilitation physician and/or occupational or physiotherapist)

Exclusion Criteria:

* Cognitive rehabilitation within six months before inclusion
* Inpatient multidisciplinary rehabilitation program within three months before inclusion or planned inpatient program during trial
* Start of or switch in immunomodulator treatment within three months before inclusion
* Less than one month post-exacerbation
* Major psychiatric or medical disorder that could influence cognitive functions
* Combined vision with optimal correction below 0.6 on Snellen Visual Acuity Test
* Unable or unwilling to undergo EEG or MRI
* Refusing informed consent
Biomarkers in Prediction of AMI

Current study will be undertaken to identify combinations of biomarkers that can reliably identify acute mesenteric ischaemia (AMI) and distinguish between non-transmural and transmural ischaemia. Different combinations of biomarkers for different sub-types and severity of AMI, and different time points of measurement after onset of symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Initial decision in favour of further diagnostics of mesenteric ischaemia

Exclusion Criteria:

* Age \<18 years
* Consent declined by patient or next of kin (delayed consent)
* Chronic mesenteric ischaemia without an acute event
* Immediate decision for withdrawal of further diagnostics and active treatment
* Referral from another hospital with already established diagnosis of AMI
* AMI diagnosed at surgery without previously having been considered
Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.

Eligibility Criteria:
Inclusion Criteria:

* Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
* To provide basic information and sign the written informed consent.

Exclusion Criteria:

* Consisted of conditions of mental illness;
* Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
* Severe allergy or hypersensitivity to IV radiographic contrast
* Claustrophobia to accept the PET/CT scanning
* Pregnancy or breast feeding
eMOTION: Examining Affective Mechanisms in Physical Activity Engagement

This early-phase trial will test intervention strategies to influence affective mechanisms underlying physical activity and determine whether changes in those mechanisms result in change in physical activity behavior among inactive adults who are overweight or obese.

This ORBIT model phase 1 trial will examine whether affective mechanisms (1) can be experimentally manipulated in real-world settings; and (2) mediate the relationship between interventions and physical activity behavior. A novel physical activity intervention will be optimized by efficiently disentangling the effects of its core component and two enhancement components on affective mechanisms associated with physical activity engagement.

Eligibility Criteria:
Inclusion criteria:

1. Aged ≥ 18 years
2. Reside in the United States
3. Self-reported BMI ≥ 25
4. Current structured physical activity engagement \< 60 minutes per week
5. Own a personal smartphone device
6. Reside in an area with Internet or Wi-Fi connectivity during the study period
7. Able to speak and read in English
8. Interested and willing to start a physical activity program
9. Willing to wear a Fitbit Versa smartwatch provided by the study team everyday continuously (including at work and during physical activity), in place of any Fitbits or smartwatches previously worn, for the duration of the study period
10. Able to read the small font on a smartwatch screen without glasses, or willing to carry reading glasses during physical activity for the purpose of reading the smartwatch screen

Exclusion Criteria:

1. Inability to provide informed consent due to cognitive disability
2. Inability to engage in one or more key treatment components, including those with medical conditions that preclude physical activity engagement or who cannot wear an accelerometer on the wrist or answer brief surveys on the smartwatch for any reason
3. Current pregnancy
Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia

OBJECTIVES: I. Estimate the efficacy of cortisol replacement therapy during the first 12 days of life for prevention of bronchopulmonary dysplasia.

II. Estimate the effect of cortisol replacement therapy on the signs of acute adrenal insufficiency.

III. Evaluate the effects of cortisol replacement therapy on adrenal hormone concentrations and on the ability of the adrenal gland to respond to ACTH.

IV. Determine the effect of this replacement therapy on markers of inflammation in lung lavage fluid and peripheral blood leukocytes.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Hydrocortisone therapy IV or placebo begins no later than 48 hours after birth and continues every 12 hours for 12 days. Hydrocortisone is given at 2-4 times the basal cortisol secretion rate.

Tracheal lavage on intubated babies is performed at start of study and on day 4 of life to assess concentrations of inflammatory markers.

If larger babies show appropriate response to ACTH by 15-17 days and the less mature babies show a decreased response, then a longer course of therapy is proposed for future studies.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* At risk for development of bronchopulmonary dysplasia

--Patient Characteristics--

* Hematopoietic: No congenital sepsis
* Hepatic: No structural defect of liver
* Renal: No agenesis or structural defect of a kidney
* Cardiovascular: No structural defect of the heart
* Metabolic: No diabetic mothers (e.g., preexisting insulin dependent, noninsulin dependent, and gestational diabetes)
* Pulmonary: No structural defect of the lung
* Other: Newborn birth weight must be 500 to 999 g and have endotracheal tubes in place at 12 hours of age Eligible if treatment can be given before 48 hours of postnatal life No major congenital anomaly causing significant defect in major organ system
Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients

Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.
* Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.

Exclusion Criteria:

* Patients who have a record of intestinal resection in their medical history.
* Patients with a medical background of irritable bowel syndrome.
* Patients with a history of inflammatory bowel disease.
* Patients who regularly take anti-diarrheal medications before commencing radiotherapy.
* Patients experiencing diarrhea at the outset of the study.
* Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications.
* Pregnant or lactating woman.
* Patients allergic to rifamycin.
Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients

The purpose of this study is to evaluate the safety and tolerability of a new inhaled sodium-channel blocker called 552-02 in teens and adults with cystic fibrosis. 552-02 will be inhaled once a day for 14 days using a nebulizer. A small subgroup of patients will donate blood samples for pharmacokinetic analysis to see how 552-02 is absorbed into the blood and eliminated after 14 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged \> 14 years.
2. Patients who are diagnosed with cystic fibrosis.
3. Patients who have a FEV1 ≥ 50% predicted (post-bronchodilator) at screening.
4. Patients who are able to perform reproducible spirometry according to ATS guidelines.
5. Patients who have an oxygen saturation of ≥ 92% on room air as determined by pulse oximetry at screening.

Exclusion Criteria:

1. Patients who have a FEV1 change ≥ 15% after bronchodilator use at screening.
2. Patients who have unstable lung disease as defined by the requirement for intravenous antibiotics during the four weeks prior to screening, a change in medical regimen within 14 days prior to administration of the first dose of study drug or during the 14 day treatment period, a FEV1 ≥ 15% below recent (within six months) clinical measurements, or significant new findings on chest radiograph (pneumothorax, lobar/segmental collapse) that are not considered a part of the usual, chronic progression of cystic fibrosis lung disease.
3. Patients on angiotensin converting enzyme (ACE) inhibitors.
4. Patients with renal insufficiency as evidenced by hyperkalemia (blood potassium levels greater than 5.5 mEq/L) or serum creatinine \> 2.0 mg/dL.
5. Patients who have a history of drug allergies to any medicine chemically related to the study drug (e.g. amiloride, Moduretic, Midamor; triamterene).
6. Patients who are pregnant, have a positive pregnancy test, or are nursing.
7. Patients who have had a lung transplant.
Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

Characterization of the perioperative autonomic nervous system state, cardiovascular and cerebrovascular control and microcirculation in order to predict postoperative atrial fibrillation and acute kidney injury in patients undergoing coronary artery bypass graft surgery

Atrial fibrillation (AF) and acute kidney injury (AKI) are common postoperative complications in patients undergoing coronary artery bypass graft (CABG) surgery. AKI increases postoperative mortality and AF prolongs the hospital stay.

Autonomic dysfunction, baroreflex impairment and an inadequate microvascular perfusion may play a relevant role in triggering AF and AKI.

The perioperative characterization of the autonomic nervous system (ANS) and of the microcirculation might improve risk stratification and help in the prevention and early treatment of AF and AKI in CABG surgery.

The study aims are: i) to collect a number of perioperative indices describing the state of the ANS and of the microcirculation; ii) to assess the correlation among the different indices and their association with AF and AKI; iii) to develop a predictive model of postoperative outcomes (AF and AKI) accounting for perioperative autonomic indices and microcirculatory variables.

Population: 200 adults subjects scheduled for CABG surgery, with or without additional intervention Methods: perioperative (in the operating room) acquisition of ECG, arterial blood pressure, cerebral blood flow velocity as derived from transcranial doppler technique, microcirculation parameters as derived from sidestream dark field images Statistics: receiver operating characteristic (ROC) curve analysis with adequate cut-off values

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* sinus rhythm
* absence of pathologies affecting autonomic nervous system (e.g. diabetes with neuropathy)
* informed consent signed
* elective or urgent surgery

Exclusion Criteria:

* age under 18
* absence of sinus rhythm
* pathologies affecting autonomic nervous system
* emergency surgery (to be operated immediately)