cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses

This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T cell immune activation and immune activation in HIV-infected immunological non-responders. The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV immunological non-responders.

The investigators recruited 23 patients from Peking Union Medical College Hospital Outpatient clinic. They were all immunological non-responders. Nineteen patients will receive Triptolide wilfordii Hook F extract (10mg tid po) plus current cART, while 4 patients will continue their current cART. This study will last for 12 months. Patients will be followed up at month 0, 3, 6, 9, and 12. During each follow-up time point, adverse effects, T cell subsets, T cell activation markers and other routine tests will be ordered. The investigators hypothesis that TwHF might boost CD4 cell recovery by reducing immune activation.

Eligibility Criteria:
Inclusion Criteria:

* Continuous antiretroviral therapy \> 18 months, and consistent HIV-RNA\< 40 copies/mL more than 12 months;
* 18-65 years old;
* Male or female;
* Good adherence and promise to follow-up;
* Inform Consent signed;
* CD4 T cells less than 300/ul .

Exclusion Criteria:

* Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
* Hemoglobin (HGB) \< 9 g/dl, white blood cell (WBC) \< 2000/ul, granulin (GRN) \< 1000 /ul, platelet (PLT) \< 75000 /ul, Cr \>1.5x ULN, ALT or AST or alkaline phosphatase (ALP) \>3x upper limit of normal (ULN), total bilirubin (TBIL) \>2x ULN, creatine kinase (CK) \> 2x ULN;
* Pregnant or breastfeeding woman or woman with pregnancy plan;
* Active drug-user;
* Severe neurological defects;
* Active alcohol abuse;
* Severe gastrointestinal ulcer .
* End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc Those who are undertaking steroids, immunomodulator, anti-inflammatory agents
Effect of a Newly Developed Brace on Foot Biomechanics.

For this interventional study the investigators will recruit a number of healthy volunteers with no symptoms in their lower limbs in the past 6 months and without history of foot and/or ankle conditions and/or surgery. These volunteers will undergo a single Dynamic Computerized Tomography scan session before and after the support is carried, to find out if there is a change in the kinematics of the foot. The results will be analyzed statistically.

For this study the investigators will recruit 15 healthy volunteers who will be undergone a single Dynamic Computed Tomography (4DCT) scanning session before and after wearing a brace, in order to find out if there is a change in foot kinematics. Between the two scans, the subjects will wear the brace and walk for 1 minute. Data collected with the 4DCT will be processed to get 3D imaging of the Subtalar and Midtarsal Joints, needed to quantify the rotations in the three planes of the space (Cardan Angles).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers;
* 18\<Age\<60;
* No gender restrictions;

Exclusion Criteria:

* Symptoms in their lower limbs in the past 6 months
* History of foot and/or ankle conditions and/or surgery
* Pregnancy
Effect of Cytosorb on Blood Levels of Inflammatory Biomarkers of Sepsis.

Background: There is still an evident need for useful biomarkers and effective therapeutic approaches regarding the challenging management of sepsis. The aim of the study is to evaluate the effect of each Cytosorb hemoadsorption therapy course on blood levels of inflammatory biomarkers of sepsis including endocan, copeptin, interleukin-6, procalcitonin, C-reactive protein.

This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy between June 1st, 2016 and June 30th, 2017. Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Exclusion criteria of the study were: (i) cardiovascular disease, (ii) multiple traumas, (iii) malignancies, (v) incomplete clinical data.

Approval of the ethical committee (ethical committee approval number 2018/04-02) was obtained. Written informed consent was taken from each patient or their next-of-kin. Patient demographics including age, gender, and origin of sepsis were recorded. Arterial blood samples were taken from patients before and immediately after the Cytosorb therapy course.

Eligibility Criteria:
Inclusion Criteria:

* Patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy (Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))

Exclusion Criteria:

* cardiovascular disease,
* multiple traumas
* malignancies
* incomplete clinical data.
South Korean Study to Prevent Frailty and Aging-related Diseases Through Lifestyle Intervention

The goal of this feasibility randomized controlled trial is to investigate the applicability of software that aims to improve symptoms of frailty by implementing customized interventions such as physical exercise and cognitive training implemented through a mobile app for 16 weeks for patients diagnosed with frailty or prefrailty. The primary outcomes are adherence, retention rates, and recruitment rates. Participants will participate in customized interventions including physical exercise, cognitive training, nutritional guidance, and management of disease related to frailty for 16 weeks.

The physical exercise program will comprise aerobic exercise, balance-improving exercises, flexibility-enhancing activities, and strength-building exercises targeting major muscle groups through a mobile app . Customized cognitive training, performed using a mobile app, targets the cognitive domains of prospective memory and executive function. Nutritional intervention will be performed to treat frailty symptoms and disease related to frailty through a mobile app. Education and management of disease related to frailty will be done through a mobile app.

Eligibility Criteria:
Inclusion Criteria:

* 60-90 years of age
* Residing in the community
* Total score of Modified Fried frailty phenotype score ≥ 1 point
* Korean Mini-Mental State Examination-2 z-score ≥ -1.5
* Can read and write
* Being able to use the a mobile app through education or having someone help a participant use the mobile app
* Having a reliable informant who could provide investigators with the requested information.
* written informed consent

Exclusion Criteria:

* Major psychiatric illness such as major depressive disorders
* Dementia
* Other neurodegenerative disease (e.g., Parkinson's disease)
* Malignancy within five years
* Cardiac stent or revascularization within one year
* Serious or unstable symptomatic cardiovascular disease
* Other serious or unstable medical disease such as acute or severe asthma, active gastric ulcer, severe liver disease, or severe renal disease
* Severe loss of vision, hearing, or communicative disability
* Significant laboratory abnormality that may result in cognitive impairment
* Any conditions preventing cooperation as judged by the study physician
* Unable to participate in exercise program safely
* Coincident participation in any other intervention trial
EMBARK Follow-up Project

The purpose of the EMBARK Follow-up Project (EFP) is to determine if there is a significant correlation between post-study massage-seeking and changes in pain reported by participants during the Exploring Massage Benefits for Osteoarthritis of the Knee (EMBARK) parent study (NCT00970008). The EFP hypothesizes that a positive correlation exists between pain relief during the parent study and post-study massage-seeking behavior.


Eligibility Criteria:
Inclusion Criteria:

* Completed in the EMBARK parent study.

Exclusion Criteria:

* Did not complete the EMBARK parent study.
Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy

Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family.

The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction.

There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.


Eligibility Criteria:
Inclusion Criteria:

* subjects with diagnosis of cow's milk allergy

Exclusion Criteria:

* age \<5 months
* age \>12 months
* other concomitant chronic diseases
* malformations
* other food allergies
Pathways of Patients Followed in Palliative Care at the University Hospital of Strasbourg: a Retrospective Pilot Study

In view to develop a study design for a study that would analyze the pathways of palliative care prospectively, this work will identify the individual factors that would be significantly associated with typical pathways of palliative care.


Eligibility Criteria:
Inclusion Criteria:

* Patient met by the palliative care mobile team or admitted in palliative care unit
* Patient who died between January 2020 and December 2020.

Exclusion Criteria:

* Minors and incapacitated adults, or deprived of liberty
* Patient who explained their disagreement with the use of medical data for research purposes.
Specific Verbal vs. Usual Instructions for Inpatients Undergoing Colonoscopy

To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.

Introduction Adequate bowel preparation constitutes one of the most important endoscopy quality indicators: it is related with increased detection of pathologic findings, reduces the need for repeated colonoscopies and leads to burden lightening for both patients and endoscopy departments. Different factors have been related to inadequate preparation. Among them, inpatient status has been identified as a major independent risk factor.

It has been shown that providing outpatients with simple, but specific instructions regarding the importance and mode of adequate preparation - either through a leaflet, a sms or on the web - improves significantly the level of bowel cleanliness. However, data regarding the success of such an intervention in inpatients lack.

Aim To study the impact of providing specific verbal instructions in inpatients (and/or their relatives) undergoing colonoscopy on the quality of bowel preparation.

Patients - Methods Study Design This is a prospective, randomized, single-blinded study. Four Greek academic endoscopy departments will competitively enroll patients during a period of 6 months.

Randomization A central randomization list will be computer-assisted, created and sent to one collaborator of each center. Endoscopists will be blinded to participant's group.

300 patients will be randomized in 2 groups, in blocks of 10 with an analogy 1:1. They will also be stratified in a 60%-40% percentage depending on whether the patient is bedridden or not at the time of the examination

Statistical Analysis According to the literature similar interventions showed a gain of 20% in favor of the intervention. Statistical significance level α is defined 5% and the study is powered at the level of 80%. According to data from Hepatogastroenterology Unit of Attikon University General Hospital regarding the adequateness of bowel preparation of patients undergoing colonoscopy and with an expected 10% drop out, 300 patients are needed (including a 10% drop out) in order to succeed 18% improvement of the primary endpoint (from 66% for inpatients during 2015 to 84% for outpatients during the same period) favoring the intervention group. Interim analysis and sample size re-estimation will be undergone after data collection from 90 patients.

Both an intention to treat (ITT) and a per protocol (PP) analysis are planned. Data will be recorded in predefined CRFs.

Eligibility Criteria:
Inclusion Criteria:

* assignment of informed consent

Exclusion Criteria:

* inability to provide informed consent
* history of colectomy
* indication for rectosigmoidoscopy
* lack of knowledge of the Greek language.
Efficacy of Intravenous Dexketoprofen and Tenoxicam on Propofol Associated Injection Pain

Propofol remains the most common drug for induction of general anaesthesia, although it causes considerable pain or discomfort on injection. Anesthesia providers have attempted a large number of remedies to prevent this pain on injection. Previously explored ideas include injecting propofol into larger veins, warming of the hand with hot packs, and intravenous pretreatment with numerous other medications. No studies to date have looked at the dexketoprofen and tenoxicam for the pretreatment of pain on injection caused by propofol. The investigators propose studying the use of dexketoprofen and tenoxicam for pretreatment of propofol related pain on injection.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 and 2
* 18 - 65 years
* general anesthesia scheduled for elective surgery

Exclusion Criteria:

* age \< 18 years, \> 65 years
* pregnancy
* patients requiring a rapid sequence induction
* refusal to participate and patients already participating in another study
* allergy to study drugs
* communication difficulty
* psychiatric and neurolojic disorders
* use of analgesics or sedative drugs within 24 hours before surgery.
* emergency surgery
* history of drug or alcohol abuse
* ASA 3 and above
Oral Nadolol for the Treatment of Adults With Mild Asthma

The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* Pre-bronchodilator FEV1 80% or greater than the predicted value.
* PC20 FEV1 ≤4 mg/ml on methacholine challenge test.
* Blood Pressure ≥ 100/65mm Hg.
* Pulse rate ≥ 60 beats/min.
* No significant health issues.
* Non-smoker or X-smoker \< 10 pack/year.

Exclusion Criteria:

* History of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit.
* Currently diagnosed with chronic obstructive pulmonary disease (COPD).
* Used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.
The Role of Wearable Devices in Cardiothoracic Surgery: Predicting and Detecting Early Postoperative Complications

The overarching goal of this research is to use machine learning analysis of high-resolution data-collected by wearable technology-of cardiothoracic surgical patients to assess recovery and detect complications at their earliest stage

This is a single-center non-randomized prospective cohort study using wearable devices in cardiothoracic surgery patients to detect post-operative complications. Patients undergoing cardiothoracic surgery who meet the inclusion and exclusion criteria will be enrolled consecutively with verbal informed consent from the time this protocol is approved by the IRB until 1,200 subjects are enrolled. At \~30 days preoperatively the subjects will have a wearable device (such as a Fitbit) placed on their wrist and will wear the device until \~180 days post-operatively. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear and data will be analyzed by our collaborators at Case Western Reserve University.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older undergoing cardiothoracic surgery that is male or a non-pregnant female and are amenable to using one of the wearable devices of interest (Fitbit, iWatch, Biostrap).
2. Individuals willing to provide informed consent and who have capacity for all study procedures

Exclusion Criteria:

1. Individuals with mental incapacity and/or cognitive impairment that would preclude adequate understanding of, or cooperation with the study protocol.
2. Any pregnant participant.
3. Severe irreversible pulmonary hypertension.
4. Congenital heart disease
5. Chronic renal insufficiency or undergoing chronic renal replacement therapy
6. Liver cirrhosis
Prevention of Paclitaxel Neuropathy With Cryotherapy

The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.


Eligibility Criteria:
Inclusion Criteria

1. Women 18 years of age or older
2. Histologically or cytological proven diagnosis of breast cancer Stage I- III.
3. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting.
4. May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
6. Patient signed informed consent.
7. Patient willing and able to comply with scheduled visits and treatment plan.

Exclusion Criteria

1. Patient presents with Grade 2 or greater peripheral neuropathy.
2. History of Raynaud's Disease.
3. Patient presents open or poorly-healing wounds on the hands or feet.
4. Patients with cold intolerance.
5. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.
MRI and Biological Markers of Acute E-Cigarette Exposure in Smokers and Vapers

To examine vascular reactivity and inflammatory biomarkers via quantitative magnetic resonance imaging (MRI) and blood serum, respectively, in a crossover study where active vapers (electronic cigarette users) and smokers will undergo three separate acute exposure-episodes of electronic cigarette +/- nicotine and tobacco-cig. The MRI exams and blood draws will be performed pre- and post-exposure. The results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will also undergo a blood draw and MRI.

This work is an extension of prior funded work on the acute effects of nicotine free electronic cigarette aerosol on vascular function and inflammatory biomarkers in healthy non-smokers. Here, the investigators will examine vascular reactivity and inflammatory biomarkers using quantitative magnetic resonance imagine (MRI) and blood serum in a crossover study, with active vapers (electronic cigarette users) and smokers undergoing three, separate-day, acute exposure-episodes of smoking a tobacco cigarette, an electronic cigarette without nicotine, and an electronic cigarette with nicotine. Participants will undergo an MRI exam and a blood draw pre- and post-exposure-episode.

The investigators hypothesize that all three paradigms will cause a transient response but greatest for tobacco and nicotinized electronic cigarettes. The results will be compared against baseline values derived from a group of non-smokers/non-vapers, who will undergo a blood draw and MRI only. Eligible participants will be healthy, males and females, current, habitual users of electronic or tobacco cigarettes (except for the non-smoking/non-vaping comparison group), 21 to 45 years of age, and without co-morbidities.

Eligibility Criteria:
Inclusion Criteria:

* BMI: 18.5 to 30
* Current users of electronic cigarettes or tobacco cigarettes with a use history of six months or greater.

Exclusion Criteria:

* Cancer
* HIV
* Mental illness in which the participant is not of proper cognizance
* Overt cardio- or neurovascular disease (prior heart attack, stroke, transient ischemic attacks)
* Serious arrhythmias
* Bronchospastic disease
* Upper respiratory tract infection within the past six weeks
* Medication affecting vascular function
* Antibiotics
* Magnetic resonance imaging contraindications (metallic implants/intraocular foreign bodies, claustrophobia, cardiac/cochlear implantable electronic devices, etc.)
Diluted Aqueous Povidone-Iodine Compared to Saline to Decrease Surgical Site Infections

This is a multicenter randomized controlled trial of 1100 patients to evaluate the superiority of combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine compared to normal saline in male and female patients between the ages of 18 and 80 years old undergoing emergency laparotomies with Centers for Disease Control (CDC) class 2 and 3 wounds.

The main objective is stated in the Brief Summary. The secondary objective is to determine the safety and adverse events of povidone-iodine compared to normal saline for irrigation in patients undergoing emergency laparotomies for CDC class 2 and 3 wounds.

The main questions this study aims to answer are:

* Does combined intraoperative wound irrigation with intraoperative peritoneal lavage with dilute aqueous povidone-iodine decrease surgical site infections?
* Is combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine safe to use compared to normal saline?
* Are there any adverse effects of combined intraoperative wound irrigation and intraoperative peritoneal lavage with dilute aqueous povidone-iodine usage on CDC class 2 and 3 wounds compared to normal saline?

Subjects will be followed over 18 months with follow-up of each patient up to 30 days postoperatively. Randomization of patients will occur prior to going to beginning the emergency laparotomy.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years of age
* undergoing an exploratory laparotomy for Centers for Disease Control class II and III wounds

Exclusion Criteria:

* Pregnancy
* Preoperative abdominal wall skin/soft tissue infection
* Iodine allergy
* Patients unlikely to survive beyond 30 days
* Patients with mesh placement or placement of a foreign body except for drains