cyrilzakka/clinical-trials huggingface dataset:
Procalcitonin to Predict Infection After Gastrectomy for Gastric Cancer

To investigate the diagnostic accuracy of procalcitonin as an early predictor of infection after radical gastrectomy for gastric cancer.

From June 2018 to May 2019, consecutive eligible patients who underwent surgery for gastric cancer in the Department of Gastroduodenal and Pancreatic Surgery, Hunan Cancer Hospital and the treatment group of Professor Kai-xiong Tao in the Union Hospital of Tongji Medical College were invited to participate in the study. After surgery, routine blood test were measured morning on post-operative day (POD) 1, 3, 5, and 7, and serum level of procalcitonin was measured morning on POD 3 and 5.

The primary outcome of the present study was the accuracy of white blood cell (WBC) and neutrophil count, the neutrophil to WBC ratio (N%) and procalcitonin to detect post-operative infection (including intra-abdominal infection (IAI), surgical site infections (SSIs), pneumonia, urinary tract infection, catheter-related infection, and sepsis not specified) within 30 days after surgery. The main secondary outcome was their ability to detect any post-operative complications (such as intestinal obstruction, bleeding, ascites, cardiovascular and cerebrovascular events) within 30 days after surgery. Other secondary outcomes were the choice of the best timing to measure each inflammatory marker, the choice of a clinically meaningful cut-off value for the most accurate marker.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years
2. pathologically diagnosed gastric adenocarcinoma
3. radical gastrectomy with lymphadenectomy.

Exclusion Criteria:

1. ongoing infection at surgery
2. pregnancy status
3. underwent non-resection surgery
4. underwent palliative gastrectomy
5. emergency surgery
6. taking corticosteroid or other immunosuppressive drugs
Effects of Immune Function on Prognositic Outcome in Critical Ill Patients With Acinetobacter Baumannii Infection

The purpose of the present study is to evaluate the effects of immune function on prognositic outcome in critical ill patients with Acinetobacter baumannii infection.

This is a single-center, observational study. Patients with Acinetobacter baumannii infection in the intensive care unit of Zhongda Hospital were enrolled. We recorded the data of age, ICU admission diagnosis, underlying diseases, APACHE II score and infection site. Body temperature, heart rate, white blood cell counts, procalcitonin, C-reactive protein, SOFA score and the level of CD4+, CD8+, Th1, Th2 and HLA-DR in the blood measured by flow cytometry on the D1, D3 and D7 were also recorded.We can get the results of the change of immune function of critical ill patients after Acinetobacter baumannii infection. After compare the patients who die of survive at 28 day after infection, we can get the results of the relationship between the immune function and the outcome. We also can calculate the effect immune function on prognositic mortality in patients with Acinetobacter baumannii infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU
* Infection with Acinetobacter baumannii
* Agree to participate the study

Exclusion Criteria:

* Age less than 16 years old or older than 80 years old
* pregnancy
* immunosuppression patients which include

  1. therapy 0.5mg/kg/day of prednisoneover(equivalent dose of other glucocorticoids) for at least 1 month within recent 3 month
  2. Cancer chemotherapy within recent 3 month
  3. Receive immunosuppression treatment because of solid organ transplant or Autoimmune diseases
  4. allogeneic bone marrow transplantation or allogeneic haematopoietic stem cell transplantation.
  5. HIV infection
Pharmacokinetics of Posaconazole in Allogeneic Transplant Patients With Mucositis

The goal of this study is to calculate pharmacokinetic parameters and to evaluate the trough levels of posaconazole reached in patients with different stages of mucositis, due to chemotherapy and total body irradiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving allogeneic stem cell transplantation - Treated with prophylactic posaconazole: oral suspension (200mg three times daily) or tablet (300mg once daily) to prevent invasive fungal infections

Exclusion Criteria:

* Gastroparesis
* Vomiting or diarrhea within 2 hours after intake of posaconazole
* Concomitant administration of potent inducers of the enzyme UGT1A4: carbamazepine,phenytoin, phenobarbital, rifabutin, rifampicin,...
* Age under 18 years
Study of Aripiprazole in Patients With a History of Bipolar Disorder

The purpose of this study is to learn if aripiprazole is effective in the treatment of patients with a history of bipolar disorder.


Eligibility Criteria:
Patients with a history of Bipolar I Disorder
Metformin as Added on Therapy in Patients With Ulcerative Colitis

Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is marked by increased intestinal motility and bloody diarrhea. The clinical value of existing therapeutic strategies of UC, including glucocorticoids, anti-tumor necrosis factor α (TNF-α), mesalamine, and thiopurines is still limited. Therefore, the discovery of new therapeutic approaches is essential to improve the effectiveness of the treatment.Adenosine monophosphate (AMP)-activated protein kinase (AMPK) is a conserved fuel-sensing enzyme that plays an important role in the regulation of cellular metabolism where it increases glucose and fatty acids uptake and activates the oxidation process to improve the cellular energy utilization


Eligibility Criteria:
Inclusion Criteria:

- Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception Mild and moderate UC patients diagnosed and confirmed by the endoscope

Exclusion Criteria:

- Breastfeeding Significant liver and kidney function abnormalities Diabetic patients Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids
Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)

The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active women, at risk for pregnancy and not planning to use condoms.
* Women in need for contraception and willing to use an oral contraceptive (OC) for 12 months (13 cycles).
* At least 18 but not older than 50 years of age at the time of screening.
* Body mass index (BMI) of \>/= 17 and \</= 35.
* Good physical and mental health.
* Willing to give informed consent in writing.

Exclusion Criteria:

* Contraindications for contraceptive steroids.
* In accordance with the Summary of Product Characteristics (SmPC)/Package Insert of DRSP-EE, additional

contraindications related to the antimineralocorticoid activity of drospirenone

(conditions that predispose to hyperkalemia):

* Renal insufficiency
* Hepatic dysfunction
* Adrenal insufficiency
* An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[CIN\],

Squamous Intraepithelial Lesion \[SIL\], carcinoma in situ, invasive carcinoma) at screening.

* Clinically relevant abnormal laboratory result at screening as judged by the investigator.
* Use of an injectable hormonal method of contraception; within 6 months of an injection with a 3-month duration, within 4 months of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration.
* Before spontaneous menstruation has occurred following a delivery or abortion.
* Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
* Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, sex steroids (other than pre- and posttreatment contraceptive method) and herbal remedies containing Hypericum perforatum (St John's Wort).
* Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
Evaluation of Post-covid 19 Patients Who Receive Ozonetheraphy With Thorax CT

It is known that enhances wound healing by oxidative stress and supports immune system besides it is cheap and has not any side effects. Aim of the study is to prevent pulmonary fibrosis by using ozone therapy as a supportive therapy on the patients who have pneumonia and ground glass opacity on thorax CT both in ICU and wards. Patients will follow for a year.

The patients accepted with the diagnosis of pneumonia in Gaziosmanpaşa TREH, both in ICU and wards have treated with additional ozone therapy beside the normal treathments. In these patients the findings like ground glass opacity in thorax CT regarding to covid 19 were progressed or non changed. In the concern of these opacities turn to pulmonary fibrosis, ozone therapy has used to prevent this undesirable effect. It is known that enhances wound healing by oxidative stress and supports immune system besides it is cheap and has not any side effects.

25 patients included this study. The patients were diagnosed with Covid-19 pneumonia and treated with ozone therapy in intensive care unit and ward. After treatment was done, findings of at least %20-25 ground-glass opacity on thorax ct were the main criteria for enrollment.

The patients' follow-up program time after hospital discharge will be on 1st, 3rd, 6th and 12th month. They will continue to recieve ozon therapy once in a month during one year follow up. Ground-glass opacity rate of thorax ct scan will be recorded as less then %25, %25-50, %50-75 and above %75. Tomographies will be compared with each other and also last thorax ct before hospital discharge. These tomographies will be applied under 80 KV and this will give %40 less dosage according to routine 120 KV scans. If there is an increase in ground-glass opacities compared to the previous one, the scan will be done again on prone position and suspected lesions will be reevaluated. The pulmonary fibrosis findings of the scan will be diagnosed by a well trained radiology doctor. The evaluation of dyspnea will also done during follow-ups. mMRC(medical research council) dyspnea scale will be used for dyspnea status. SpO2 values in room-air will also recorded. FEV1, FVC and FEV1/FVC values will also be recorded to demonstrate respiratory functions.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years covid 19 pneumonia patients who have ground glass opacity on thorax CT, receiving ozone as adjuvant therapy.

Exclusion Criteria:

* pregnant patients patients who doesnt treated with ozone(hyperthyroid,pulmonary hypertension, right ventricule failure,glucose 6 P dehydrogenase defficiency
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer

This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
* HER2+ status defined as IHC 3+ staining or in situ hybridization positive
* Patients with resistance to trastuzumab
* Prior taxane therapy
* Patients with an ECOG performance status of 0 - 2
* Patients with measurable disease as per RECIST criteria
* Documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. Sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
* Patients must meet laboratory criteria defined in the study within 21 days prior to randomization

Exclusion Criteria:

* Prior mTOR inhibitors or vinca alkaloid agents for the treatment of cancer
* More than three prior chemotherapy lines for advanced disease.
* Symptomatic CNS metastases or evidence of leptomeningeal disease. Previously treated asymptomatic CNS metastases are allowed provided that the last treatment for CNS metastases was completed \>8 weeks prior to randomization
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
* Peripheral neuropathy ≥ grade 2 at randomization
* Active cardiac disease
* History of cardiac dysfunction
* Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
* Known hypersensitivity to any study medication
* Breastfeeding or pregnant
The Effect of Inhalation Agent on the QTc Interval During Liver Transplantation: Sub Study (NCT01886664)

The purpose of this study is to assess the effects of inhalation agent on corrected QT interval duration during liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* elective liver transplantation

Exclusion Criteria:

* age \< 18, age \> 65
* patient refusal
* re-transplantation
Effects of Resistance Training in Multiple Sclerosis: a Randomized Trial.

This is a longitudinal study to examine the effects of a short-term training program on neurofilamet and GFAP plasma levels. Participants will be divided in two groups: control group (moderate aerobic training) and active group (resistance training). The change in biomarkers will be analyzed pre and post intervention in both groups. Differences between groups will be also evaluated by investigators.

Multiple sclerosis is a dysimmune and neurodegenerative disease of the central nervous system. Despite highly effective drug, multiple sclerosis represents the main cause of non-traumatic disability in young people. Interventions based on physical exercise have a positive impact on the course of the disease, although the pathophysiological mechanisms responsible for this benefit remain unknown. This project aims to investigate the impact of physical exercise on neuronal destruction in patients with multiple sclerosis.

To do this, the investigators will study the evolution of the concentrations of two markers of neuronal injury, acidic gliofibrillary protein (GFAP) and light chain neurofilaments (Nfl) in two groups of patients: a control group and a second group subjected to a supervised resistance physical exercise program performed during 10 weeks. Marker values will be compared before and after the intervention and between groups. The results will allow the investigators to delve into the pathophysiology of multiple sclerosis and the mechanism through which physical exercise impacts on the disease. In addition, the investigators will generate knowledge that will allow us to reinforce the idea of integrating physical exercise as part of the treatment in multiple sclerosis.

Project within the framework of the GRS(Gerencia Regional de Salud, Castilla y Léon) 28/10/A1/2023

Eligibility Criteria:
Inclusion Criteria:

1. - Diagnosis of multiple sclerosis according to the 2017 Mc Donald criteria (Thompson A et al).
2. - Age \> 18 years - up to no age limit
3. - Disability assessed by the EDSS (Expanded disability status scale) with a score less than or equal to 4.
4. - Clinical stability. Not having had an outbreak of the disease in the last 6 months.
5. - No changes in the disease-modifying treatment in the last 6 months or no treatment.
6. - Radiological stability. Patients with last MRI (magnetic resonance imaging) performed without inflammatory activity (absence of new lesions on T2 sequences or lesions that enhance with gadolinium).
7. - They must sign the informed consent

Exclusion Criteria:

1. - Patients with a high level of physical activity according to the International Physical Activity Questionnaire(IPAQ) or latest WHO (World Health Organization) recommendations on physical activity
2. - Pregnant or breastfeeding patients.
3. - Concomitant pathologies that limit the performance of physical exercise
Evaluation of the Effect of Local Propolis Application on the Healing of Pressure Ulcers

The study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. A total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. While the control group received the clinic's standard wound care treatment protocol, the propolis group was administered 30% pure propolis extract in addition to the standard wound care treatment protocol. For data collection, the following tools were used: the Introductory Characteristics Form, which includes patients' socio-demographic and medical information; the Propolis Application Follow-up Form; the Pressure Ulcer Healing Assessment Scale; pain assessment tools including the Visual Analog Scale (VAS) for conscious patients and the Face Pain Scale for unconscious patients; Katz's Index of Activities of Daily Living; and the Charlson Comorbidity Index (CCI).


Eligibility Criteria:
Inclusion Criteria:

The patient or their caregiver is able to communicate verbally, Hospitalized in palliative care or intensive care units for at least one week, Has a Stage 1, 2, or 3 pressure ulcer according to NPUAP (13), The wound has not been closed by a physician, Agrees to participate in the study, Expected to stay in the hospital for at least 21 days.

Exclusion Criteria:

The patient or their caregiver is unable to communicate verbally, Has a Stage 4 or unstageable pressure ulcer according to NPUAP, The wound has been closed by a physician, Does not agree to participate in the study, Expected to stay in the hospital for less than 21 days.
Efficiency, and Emergency Department Nurse Preference Between 2 Methods of Visualization: A Pilot Study

The purpose of this study was to assess the impact of a continuous needle tracking system on the accuracy, speed, and quality of ultrasound-guided peripheral venous catheter insertion.

A pilot study using simulated tissue was conducted with 49 US-based emergency department nurses to compare insertion of a midline catheter using traditional ultrasound guidance versus an advanced needle-tracking technology along with traditional ultrasound guidance.

Eligibility Criteria:
Inclusion Criteria:

* US-based emergency department nurse who have placed 10 peripheral intravenous catheters in the past 60 days
* have placed less than or equal to 15 ultrasound-assisted vascular access devices in the past 60 days and have been practicing ultrasound-assisted vascular access no more than 18 months

Exclusion Criteria:

* Nurses that don't meet that predetermined inclusion criteria
Robotic-assisted Exercise Training in Heart Failure

Background:

Regular physical activity is an evidence-based adjuvant therapy of chronic heart failure or chronic lung diseases. Structured exercise training is safe, increases exercise capacity and quality of life, relieves symptoms and reduces hospitalization rates. Even a trend towards reduction of mortality has been identified. However, dyspnea and fatigue, typical symptoms of heart or lung failure, force patients to physical inactivity which fatally aggravates deconditioning and exercise intolerance, leading to an increased risk of hospitalization and a loss of independence and quality of life. To break through this vicious circle physical activity must be restored, since exercise intolerance can be successfully improved by physical training.

Purpose:

This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (fig. 1) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The investigators hypotheses that an exosuit-supported training increases exercise capacity and quality of life in a greater degree than non-supported training.

Methods:

The study will consist of two parts investigating i) the feasibility, tolerance and safety (n= 30) and ii) the efficacy of an exosuit device-supported training (n=30). In i) patients will perform a walking test and a set of everyday life skills or participate in a standardized rehabilitation sports program. In ii) patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* \>17 years old
* written informed consent
* chronic end-stage systolic heart failure without ventricular assist device, LVEF ≤ 45% OR chronic advanced pulmonary diseases
* clinically stable for at least 6 weeks
* ability to mobilize into standing and walking of at least 10 meters with or without rollator
* ability to get up from a chair without rotating the upper body \>45° sagittally

Exclusion Criteria:

* addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
* lack of knowledge of German to fully understand study information
* pregnancy, pre-menopausal women
* contraindications of cardiopulmonary exercising
* BMI \> 35 kg/m², waist size \> 135 cm.
* Height \<150 cm, \>195 cm
* Weight\<45 kg, \>110 kg
* Functional Reach Test \<15,24 cm
* Flexion contracture in the knee/hip joint \>10°
* Chronic colonization or active infection with multi-resistant pathogens
Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations

Assessment of maxillary canine retraction using self-ligating brackets system assisted with micro-osteoperforations: A prospective controlled clinical study


Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients between the age (14-20 y).
* Patients indicated for maxillary first premolar extraction.
* Angle's Class I bimaxillary, Class II Division 1 malocclusion (ANB \<5).
* Irregularity index \< 4 mm.
* No previous orthodontic treatment.
* Fully erupted dentition.

Exclusion Criteria:

* Patients not indicated for non-extraction approach.
* Prominent canine root (in labial cortical bone).
* History of systemic and medical illness that could interfere with OTM.
* Previous orthodontic treatment.
* Extreme skeletal class II occlusion (ANB \>5).
* Poor oral hygiene or periodontally compromised patient