cyrilzakka/clinical-trials huggingface dataset:
Intelligent Physical Exercise Training (IPET) in the Offshore Wind Industry: A Feasibility Study

A study to assess the feasibility of a 12-week exercise intervention aiming at improving the physical capacity and health of wind technicians.

it was hypothesized that the intervention would be well-accepted by workers and show high compliance and clinically relevant increases in physical capacities among wind technicians.

One-arm feasibility study, including a within-group control period, to test compliance, practicality, acceptability and preliminary efficacy of implementing intelligent physical exercise training (IPET) in the offshore wind industry among wind technicians. The exercise program was individually tailored based on the findings from a pre-screening health and physical capacity check and the occupational demands of wind technicians. Primary outcomes were compliance, adherence, adverse events and satisfaction. Secondary outcomes were physical capacity and musculoskeletal disorders. Prior to the feasibility study, intervention mapping was used as a theoretical tool to plan the intervention. The intervention consisted of 1-hour weekly individually tailored exercise training during working hours. Exercise sessions were supervised during the first 8 weeks of the intervention and self-administered the last 4 weeks. The design included a 6 month control period prior to initiating the intervention. Thus, included technicians (n:24) had their health and physical capacity assessed 6 months prior to intervention start (T1), at intervention start (T2) and 12 weeks after (T3) and they responded to questionnaires on musculoskeletal symptoms at all three occasions. Further, a questionnaire customized to the specific intervention was distributed to all technicians 8 weeks after intervention start to assess satisfaction with the exercise program.

Eligibility Criteria:
Inclusion Criteria:

Wind technician Valid fitness and medical certificate Adult \>18 years

Exclusion Criteria:

Hypertensive with blood pressure above 165 mmHg systolic and 105 mmHg diastolic.

Severe pain would exclude technicians from strength measurements
An Investigation of rhTPO With Different Frequencies in the Management of ITP

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 30 primary ITP adult patients from 3 medical centers in China. They will be randomly assigned in a 1:1:1 ratio into three groups .The patients in group A (total 10 patients) will receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days;The patients in group B will receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.The patients in group C will receive rhTPO at a dose of 300Units/kg ,daily for 7 consecutive days .All the patients will follow with a flexible dosage depending on platelet count during the following 12 weeks.

Platelet counts, bleeding and other symptoms were evaluated before and after treatment, in order to evaluate the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years old, may be male or female.
2. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
3. Patients who have no response or relapsed after Corticosteroid.
4. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
5. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
8. Patients who are deemed unsuitable for the study by the investigator .
Locally Applied Pressure-induced Vasodilatation

Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).

Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). The purpose of this study is to perform measurements of the methodological points made.

The study will investigate :

* The effect of the duration and intensity of the pressure
* The reproducibility of measurements
* The correlation with ischemic hyperemia post

Eligibility Criteria:
Inclusion Criteria:

* subjects without vascular pathology

Exclusion Criteria:

* pregnancy
* allergy tape
Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition

The objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).

During digestive surgery: oncological and bariatric surgery, it is possible to collect a small volume of subcutaneous and epiplonic adipose tissue (10-20 cc). We wish to collect these samples in order to develop the technique of oxygenography on permeabilized adipocytes. In order to characterize these measurements, they will be related to the clinical data of the patients usually collected in the framework of the preoperative assessment including the body mass index (BMI). The measured adipocyte data will thus be normalized to three BMI classes: ≤ 20, \> to 20 \< 30, and ≥ to 30 kg∙m-2.

Primary end point is to validate the measurement of mitochondrial respiration under oxidophosphorylating conditions by determining indicators of the distribution of mitochondrial respiration values (mean, standard deviation, skewness, kurtosis, coefficient of variation) as a function of patients' body mass index.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing oncological, bariatric, parietal surgery
* Patients able to give an informed consent
* Patients affiliated to an Health Care insurance
* Patients aged over 18

Exclusion Criteria:

* Patients under guardianship, curatorship or deprived of freedom
* Pregnant or breastfeeding women
* Participation refusal
* Patients under chemotherapy
* Patients with peritonitis and infectious parietal processes
Efficacy of Communication Modalities for Promoting Flu Shots

The purpose of this study is to test which modalities (mailed letter, short message service \[SMS\] text, or patient portal messages) are most effective for encouraging flu shots in high-risk patients.

The Centers for Disease Control (CDC) recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. Flu shots are particularly important for patients at high risk of experiencing severe outcomes.

During the 2020-21 and 2021-22 flu seasons, the study team sent messages to Geisinger patients in the top 10% of risk for flu and complications according to an artificial intelligence algorithm. Messages that told patients they were at high risk significantly increased their likelihood of getting vaccinated.

The present study will extend previous work by testing which modality or modalities are most effective at boosting flu shot rates in patients at high risk. In previous campaigns, patients received messages via all communication modalities patients were eligible for (mailed letter, SMS text, and/or patient portal message). In this study, patients will be randomized to receive high-risk messages in one or more modalities.

Eligibility Criteria:
Inclusion Criteria:

* Included on a list of active Geisinger patients (all patients on this list attended at least one primary care appointment at Geisinger between 10/1/2008 and 4/13/2022, and either had a Geisinger primary care provider assigned as of April 2022, or were in the Electronic Health Record \[EHR\] since at least September 2021 and had at least one encounter in 2020-2022)
* Aged 18 or older
* In the top 10% of risk for flu and flu complications, according to Medial's flu complications machine learning algorithm (which operates on coded EHR data)
* Has a Geisinger PCP assigned as of August 2022
* Has had an encounter in the last 2 years as of August 2022

Exclusion Criteria:

- Cannot be contacted via any of the communication modalities (e.g., letter, patient portal, SMS) being used in the study, either due to insufficient/missing contact information in the EHR or because they opted out of all modalities
Effect of Implementation of Enhanced Recovery After Surgery on 3-year Survival After Colorectal Surgery for Cancer

Several recent studies have shown that the Enhanced Recovery After Surgery (ERAS) protocol reduces morbidity and mortality and shortens the length of stay compared to conventional recovery strategy (pre-ERAS). The aim of this study was to evaluate the effect of the implementation of this protocol on 3-year overall survival and postoperative outcome in patients undergoing colorectal resection for cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aadult patients, who had undergone resection for colorectal cancer or a precancerous lesion and were cared for using the ERAS protocol or received conventional care (pre-ERAS).
* Informed patients

Exclusion Criteria:

* Patients presenting or developing peritoneal cancer,
* Patients having resection for palliative reasons,
* Patients those under curatorship or tutelage
* Opposed patients
Advanced Hemodynamic Monitoring in Free Flap Surgery

Background: Anesthesia in free flap surgery is challenging. Monitoring of hemodynamic changes and their influence on the cardiovascular system in permanent feedback loops allow control, which is what anesthesiologists aim for to ensure an adequate blood flow and tissue oxygenation. The circulatory support and inferable volume administration are managed via heart rate (HR) and mean arterial pressure (MAP), but both parameters are influenced by variable components and are thus unfavorable for volume management. The aim of this study was to evaluate whether volume requirement may be assumable to additional monitoring parameters.

Methods: 31 patients were enrolled prospectively. HR, MAP, central venous pressure and O2 saturation were comprehended based on the protocols. We expanded the data set by a permanent blinded intraoperative monitoring with registration of the Cardiac Index (CI) and Stroke Volume Variation (SVV) and semi-invasive pulse-contour analysis utilizing the Pro-AQT-Device.

We conducted a prospective cohort study in accordance with the WMA Declaration of Helsinki. Standard general anesthesia with intubation and administration of sufentanil, propofol and esmeron relaxant was performed in all patients undergoing primary free flap reconstruction in course of a head and neck tumor reconstruction. Hemodynamic monitoring measurement of cardiac index and the parameter stroke volume variation as surrogate for cardiac pre-load was performed using a Pro-AQT Monitor. Using an arterial catheter previously set by the Seldinger technique as part of the standard equipment, the mean, diastolic and systolic arterial pressure was measured as part of the standard monitoring as presented. This tube was previously deaerated and flushed with 2% NaCl and connected in series with a sensor, which passes over electric line signals to the Pro-AQT-Monitor®. Based on previously entered patient data and an analysis of the arterial pulse curve characteristics, a cardiac index (CI) start-value is determined by the system. The sampling of the arterial pressure characteristics is affected by a signal having a frequency of 250 Hz. The start value is the basis for the further determination of HI trend values. The arterial pulse contour is continuously tapped and analyzed and offset against the determined start value. To calculate the cardiac index, the PICCO®-pulse contour algorithm is applied. Every 12 seconds, a new measurement is performed and documented by the system.

From the read logs ProAQT Monitor® the values of the CI, MAP, HR, stroke volume index (SVI), the stroke volume variation (SVV) and the systemic resistance index (SRI) were recorded at different measurement intervals throughout the operation. All parameters were evaluated for volume control in the course of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age, free flap surgery, oral squamous cell carcinoma, informed consent

Exclusion Criteria:

* \<18 years of age, no informed consent
Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization

Uterine artery embolization (UAE) is a minimally invasive treatment for women with symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. However, the majority of women undergoing UFE experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. Pain is the more common cause of prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce post-procedural pain.

For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention. Hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups.

This is the first Canadian study evaluating lidocaine use for pain control in UFE patients. Results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. It could have a great impact on pain management in women undergoing UFE in all practice settings.


Eligibility Criteria:
Inclusion Criteria:

* Indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual bleeding attributed to fibroids, with imaging confirmation;
* Patient must be able to provide written, informed consent

Exclusion Criteria:

* Documented of allergy or intolerance to lidocaine or other amide-type anesthetics;
* Personal or familial history of malignant familial hyperthermia;
* Documented history of second or third atrio-ventricular heart block
* Contra-indication to uterine fibroid embolization : active infection, suspected malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid.
* History of previous uterine fibroid embolization.
Optimizing Ovarian Stimulation for IVF and ICSI

Monitoring ovarian stimulation for in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) can be simplified by reducing the procedure to measuring follicles by ultrasound. Proponents of a simplified procedure claim that the procedure can be reduced to simple monitoring by ultrasound while maintaining results (numbers of mature oocytes, percentage of pregnancy and live birth rates). On the other hand simultaneous blood sampling for measuring hormone levels is still the state of the art in many clinics. A large review (Cochrane review) stated that "although there was no clear evidence for a better outcome, combined cycle monitoring was still recommended until it could be proven that ovarian hyperstimulation can be avoided without hormonal monitoring". Investigators therefore perform a study that compares the results between 2 groups: those with ultrasound monitoring and those with combined monitoring. Deciding when to plan the retrieval of the oocytes can depend on subtle differences in the number of large follicles measured by ultrasound, but also on hormonal levels in the blood of the patient. Therefore the investigators planned a randomized study in the group of patients with combined monitoring. The investigators examined if delaying the moment for planning the moment of oocyte retrieval by 24 hours had any effect on the number of mature oocytes and pregnancy rates and what the effect of rising progesterone levels might be. The investigators hypothesis was that combined monitoring could lead to better results since recent studies have thought that rising progesterone levels, if found, have a negative impact on pregnancy rates. On the other hand the investigators expect to find that waiting for larger follicles in cases with normal progesterone levels lead to a better oocyte yield.


Eligibility Criteria:
inclusion criteria:

* absence of ovarian cysts
* both ovaries present

exclusion criteria:

* ovarian cysts
* not both ovaries present
Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate the pharmacokinetics and safety of the Auto-injector and Pre-filled syringe of CT-P47 in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
2. Subject with a body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth.

Exclusion Criteria:

1. A medical history and/or condition that is considered significant
2. Clinically significant allergic reactions, hypersensitivity
3. History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
4. Active or latent Tuberculosis
5. History of malignancy
6. Previous exposure to tocilizumab or any drug that targets IL-6
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy

Patients who meet the enrollment criteria will be randomized 1:1 to either the transcutaneous electrical acupoint stimulation (TEAS#or the sham groups. In the TEAS group, the acupoints are bilateral neiguan (PC6) , Hegu(L14), Yanglingquan(GB34), Zusanli(ST 36) and Renying(ST9) acupoints. Patients will receive TEAS 30min before anesthesia until being discharged from the post-anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd days after surgery.The stimulation intensity will be adjusted in accordance with the maximal level tolerated by each patient.

Patients in the sham group will receive electrode attachment but without stimulation.

Eligibility Criteria:
Inclusion Criteria:

Age 18-80 years old; ASA physical status classⅠ-Ⅲ; Patients scheduled for elective hepatectomy.

Exclusion Criteria:

Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in other organs;
Alloimmune Response to Citrullinated Shared Epitope Sequence in Patients With Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune and sistemic disease,characterized by joint sinovitis and the production of autoantibodies (Ab). The Ab against citrullinated peptides (ACPA) are the most specific (92-98%), and high sensitivity (75-81%) and they are of prognostic value. ACPA are already in the beginning of the disease in most cases, having been found years before its onset. Recent studies have suggested that ACPA may have a role in perpetuating inflammation, in the generation of bone erosions and in pain in RA.

Citrullination is a post-translational modification mediated by the PAD, which transforms an arginine into a citrulline. In vivo, this enzyme acts in proinflammatory environments. Despite being widely studied, none of the natural citrullinated substrates have been shown to be the triggering and/or perpetuating factor in the response of B cells in RA, understanding this response as the production of ACPA. In fact, the most specific and sensitive commercial test for the detection of ACPA uses synthetic peptides protected by a patent.

In the other hand, the genetic factor that most increases susceptibility to develop RA is a shared sequence of aminoacids (QKRAA, QRRAA i RRRAA), in the HLA-DRB1 gene, known as the shared epitope (SE). Also, SE, confers prognostic value, and is associated with the presence of ACPA. These SE sequences contain arginines (R), which are susceptible to be citrullinated by the PAD enzyme.

We propose the hypothesis that citrullinated SE act as an antigen capable of activating the inflammatory response mediated by B and T cells in RA. The recognition of an HLA as a foreign one, would originate an answer of alloimmune type, not valued to date.

The objective of the study is to test the immune response mediated by B cells and T cells, in cases and control samples, through an in vitro model that confronts them with peptides containing the citrullinated-SE sequence. In addition, we will evaluate the association between these results with the clinical features of cases (RA included in the study). Their role as a biomarker, as well as their potential to improve the tests currently available to detect ACPA will be explored.


Eligibility Criteria:
Inclusion Criteria:

* Patients with RA who meet 1987 ACR criteria Patients with arthritis no RA

Exclusion Criteria:

* Having an intellectual disability that allows understanding the informed consent to participate in the study
Effects on Balance of Suspension Exercise vs. Exercise on Unstable Surfaces

Most human movements are executed while in a state of postural instability. For this reason, instability training is a highly-specific method that is intended to improve balance and postural control. This research aimed to determine the effect of instability training on the balance of individuals with similar baseline abilities, who initiated training within different stability conditions. Research question: Does different type of instability training determine improvements in balance?


Eligibility Criteria:
Inclusion Criteria:

* University students aged 18-35 years.

Exclusion Criteria:

* Muscle skeletal injury in the preceding 6 months.
* Athletes from any field.
* Those with known blance disorders (e.g. vertigo and central or vestibular disorder).