cyrilzakka/clinical-trials huggingface dataset:
Effect of Remote Ischemic Conditioning on Cerebral Hemodynamics in Patients After Intravenous Thrombolysis (RICCH-IVT)

The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis

In this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. The RIC group receive basic treatment and remote ischemic conditioning for 200mmHg at 6 and 18-24 hours after intravenous thrombolysis. The sham-RIC group receive basic treatment and remote ischemic conditioning for 60mmHg at 6 and 18-24 hours after intravenous thrombolysis. Both groups underwent cerebral hemodynamics after RIC and recorded the relevant indexes. The investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 and \< 80 years, both sexes;
2. a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-PA (0.9 mg/kg) IVT within 4.5 h of stroke onset;
3. pre-onset modified Rankin Scale (mRS) score ≤1;
4. baseline National Institute of Health Stroke Scale (NIHSS) score ≥5 and ≤25;
5. Glasgow Coma Scale score ≥8.

Exclusion Criteria:

1. having received bridging therapy (IVT plus mechanical thrombectomy);
2. previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation;
3. contraindications to RIC treatment or previous RIC treatment or similar treatment;
4. pregnancy or breastfeeding;
5. life expectancy of ≤3 months or inability to complete the study for other reasons;
6. unwillingness to be followed up or poor treatment compliance or participation in other clinical studies;
7. had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.
Natural History Study for Charcot Marie Tooth Disease

The goal of this Natural History Study for Charcot-Marie-Tooth is to acquire, record, and analyze patient-reported data and associated genetic reports, Electronic Health Records (EHRs) and clinical notes to identify the burden, diagnostic journey, and prevalence of disease that will aid scientists in their work toward finding a cure.

Participants will be asked to complete a Natural History Survey.


Eligibility Criteria:
Inclusion Criteria:

Patients will be made aware of the study by HNF and others (referenced above) and invited to participate. Once patients have reviewed and signed electronically the informed consent document, it is attached to their file.

All affected individuals with CMT/IN are eligible to participate in GRIN with proper informed consent.

Children, adolescents and adults with either a confirmed diagnosis or suspected to have CMT/IN are eligible with parent and/or guardian consent.

Individuals that have been clinically diagnosed through family history and/or standard clinical testing (e.g. neuro exam, EMG, NCS) and/or genetically tested or suspected to have CMT/IN (note: many mutations have not been identified yet) are eligible.

Exclusion Criteria:

People that do not have Charcot-Marie-Tooth or other Inherited Neuropathies
Continuous Glucose Monitor Use in School

The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes.

The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. Recent technological advancements in diabetes management have resulted in increased use of devices during class/school. Although many studies have examined the quality of life and the impact on the family and subject of these devices, to our knowledge this is the first study that will examine the impact of the continuous glucose monitor during class/school. To our knowledge, this is first study to involve the teachers. The results of this study is particularly important since the future of diabetes therapy will be to use continuous glucose monitors and insulin pumps to develop a closed loop system of insulin therapy or "artificial pancreas."

Eligibility Criteria:
Inclusion Criteria:

Diabetes use continuous glucose monitor in school

Exclusion Criteria not using a continuous glucose monitor
MIELITEKO Lifestyle Intervention Study

Mental health problems cause individual, social and economic burden to the society. The mental health problems are among the highest levels in North Savo compared to the general Finnish population. The COVID-19 pandemic has emphasized the urgent need for tackling mental health problems and developing an effective and comprehensive approach to prevent mental health problems. The aim of this MIELITEKO pilot study is to test and develop an effective and comprehensive programme to prevent mental health problems and promote mental wellbeing among disadvantaged groups.

The pilot study is a multilayered intervention study with an RCT study design, which will be conducted in selected cities and areas in North Savo such as Kuopio, Iisalmi, Varkaus and Siilinjärvi. The disadvantaged groups of this study include people aged between 18 and 64 years who are unemployed or are outside the workforce. The participants are randomized 1:1 into intervention (N=250) and control groups (N=250). The intervention group will receive the multilayered intervention whereas the control group is assumed to continue with current health information and use of services "as usual" but remain in the waiting list. Multilayered intervention includes individual-level digital healthy lifestyle intervention, group-based healthy lifestyle intervention and green power intervention as well as mini-intervention for substance use.

The data collection of self-reported validated measure of health and wellbeing as well as relevant background factor will be conducted using digital and online survey tools in baseline (T0), and after 6 months (T1) and 12 months (T2) after the onset of the study from both intervention and control groups. Register data on the use of services and pharmaceuticals that will be gathered from the national registers at National Institute for Health and Welfare and Kela or from local registers administered by municipalities in North Savo. Pilot study will utilize quantitative and qualitative statistical analyses to evaluate the process, effects and effectiveness as well as cost-effectiveness of the intervention to promote mental health and wellbeing as well as to healthy lifestyles.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 64 years
* unemployed or outside the workforce (such as students)
* living in Northern Savo

Exclusion Criteria:

- no access to personal mobile devices or to the internet
Effectiveness of Intrapartum Group B Streptococcus (GBS) Polimerase Chain Reaction Reaction (PCR) Screening

Study hypothesis: Intrapartum polimeraze chain reaction (PCR)of group B streptoccocus (GBS) test is more accurate than Culture of GBS at 35-37 weeks gestation for GBS carriage.

The investigators will compare GBS culture and PCR results taken at 35-37 weeks gestation to intrapartum PCR GBS and GBS cultures status.

The larger perspective of this trial is to check the possibility of replacing the GBS culture screening program at 35-37 weeks gestation with a more accurate examination (PCR), avoiding the changing GBS carriage status from the time of culture at 35-37 weeks to delivery.


Eligibility Criteria:
Inclusion Criteria:

* Unknown GBS pregnant women at 35-37 weeks

Exclusion Criteria:

* Known GBS pregnant women at 35-37 weeks
Control of Myopia Using Novel Spectacle Lens Designs

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.


Eligibility Criteria:
Inclusion Criteria:

* Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
* SER error between -0.75 and -4.50 D
* SER power between the two eyes must be less than or equal to 1.50 D
* Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria:

* Previous or current use of contact lenses
* Previous or current use of bifocals, progressive addition spectacles lenses
* Previous or current use of myopia control treatment
* Astigmatism worse then -1.25 DC in either eye
Prevention of Postoperative Ventral Hernias

The research is aimed at identifying factors of herniation after median laparotomy and developing surgical methods for preventing postoperative ventral hernias and eventrations.

At the first stage, an analysis of the prevalence of postoperative ventral hernias in patients after median laparotomies in urgent surgery will be performed, with the identification of factors contributing to the development of postoperative ventral hernias. At the next stage, the investigators will search for the most reliable methods of suturing the white line of the abdomen, taking into account the risk of hernia formation, with their implementation in patients operated in an emergency through median laparotomic access in comparison with traditionally used methods. In conclusion, an algorithm will be developed for selecting the method of surgical prevention of postoperative ventral hernias, taking into account the risk of their development.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged 18 years and older who are expected to perform median laparotomy on a planned or emergency basis.
2. Patients who have signed an informed consent to participate in the study, after the purpose and meaning of the study have been explained to them.
3. Patients who follow the doctor's instructions.

Exclusion Criteria:

1. The death of the patient.
2. Stage IV cancer
3. Hernia repair with hernioplasty, including simultaneous surgery
4. Refusal of the patient to cooperate with the researcher.
Biomarkers of Resiliency in Childhood Cancer Surgery

This observational study is to better understand how children and their families recover after the stress of major surgery for cancer so that investigators can create ways to improve resilience during recovery. The main questions it aims to answer are:

1. Can information obtained from patients and their caregivers wearing smartwatches and answering questionnaires be used to measure how patients are recovering from surgery?
2. Are there specific patterns in patients' circulating proteins and metabolites that are associated with stress after surgery?

Participants, including pediatric patients undergoing surgery for cancer and their primary caregiver, will be asked to:

* wear a smartwatch
* complete questionnaires
* allow for extra blood to be drawn for this research study when they are having their regular blood draws for clinical purposes

These actions will occur at baseline prior to patients' surgery and then afterwards for up to one year. There are no changes to participants' clinical care or surgical care as a result of the study. Investigators will also collect participants' clinical information and cancer-specific outcomes. Participants will be remunerated for their time.


Eligibility Criteria:
Inclusion Criteria:

* 3-18 years old at enrollment
* With solid tumors of the chest, abdomen, and extremities including neuroblastic tumors, sarcoma including soft tissue and bone, kidney tumors, liver tumors, ovarian tumors, lung and pleural-based tumors, and intestinal tumors

-OR-

* Guardian or primary caregiver of patient 3-18 years old with one of the aforementioned tumors.

Exclusion Criteria:

* Patients who are known to be pregnant or prisoners.
External Cooling in Septic Shock Patients

The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.

The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Documented or suspected infection
* Body temperature \> 38.3°C
* Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure \> 65 mmHg.
* Invasive mechanical ventilation
* Intravenous sedation

Exclusion Criteria:

* Temperature \> 41°C
* Age \< 18 years
* Pregnancy
* Continuous renal replacement therapy
* Paracetamol or NSAI administration within 6 hours before inclusion
* Need for paracetamol and/or NSAI therapy during the study period
* Burns or Lyell syndrome
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD

Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant (HSCT), that have failed to respond to treatment with systemic corticosteroid therapy.

This is a safety follow-up study through 180 days of remestemcel-L treatment in participants who took part in MSB-GVHD001. This study will also explore duration of response over time. Participants who took part in in MSB-GVHD001 and received at least one dose of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 for safety endpoints. Participants who took part in Protocol MSB-GVHD001 and received the first 8 doses of remestemcel-L as outlined in that protocol will be evaluated at baseline (Day 100) and at Days 120, 140, 160 and 180 after initial remestemcel-L infusion for evidence of duration of response over time.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have participated in MSB-GVHD001 and have received at least one infusion of remestemcel-L.
* Participant or participant's authorized representative must be capable of providing written informed consent. Assent, if applicable, must also be collected when required by the Institutional Review Board (IRB)/Ethics Committee (EC).
* Female participants of childbearing potential (≥ 10 years of age) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for the follow-up time period. Acceptable methods of contraception include abstinence, barrier method with spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
* The participant must be willing and able to comply with study procedures, remain at the clinic as required during the study period, and return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

* The investigator believes it to be in the best interest of the participant not to participate in the safety follow-up study.
* Participant has participated or is currently participating in any autologous or allogeneic stem cell or gene therapy study for the treatment of aGVHD. Participants participating in investigative protocols aimed at modification of the transplant graft (such as T cell depletion) or aimed at modification of the conditioning regimen will be allowed in the study.
Feasibility of a Yoga Program for Veterans With PTSD

This study is designed to examine the feasibility of a 12-week yoga program on physiological and psychological health and its neurobiological mechanisms in N=15 veterans with posttraumatic stress disorder (PTSD). The investigators will be examining specific parameters of health and mechanisms before and after the yoga program.


Eligibility Criteria:
Inclusion Criteria:

* U.S. Military Veteran
* 18 years of age or older
* Diagnosis of PTSD as assessed by a score of \>30 on the PTSD-Checklist Version 5 (PCL-5)
* Willing and able to attend testing and yoga sessions at the Athletic and Human Research Performance Center (AHPRC) on the campus of Marquette University
* Clear to participate in physical activity based on the Physical Activity Readiness Questionnaire (PARQ+)

Exclusion Criteria:

* Currently pregnant or trying to become pregnant
* Positive score to one or more items on the PAR-Q+ without physician approval
* Already established regular use of yoga (i.e., more than one day per week)
Laparoscopic or Conventional Mesh Repair of Incisional and Umbilical Hernia

The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.

The aim of this study is to compare immediate and long-term (24 months) results of laparoscopic and open mesh repair of incisional and umbilical hernia.

Five hundred patients will be included in this randomized, multicentric trial.

Hypotheses are that laparoscopic approach: 1- reduces immediate parietal complications without increasing intra abdominal septic complications 2- is less invasive and also reduces patients' hospital stay and recovery time; 3- has the same efficacy, than open approach.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter

Exclusion Criteria:

* Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication
* Patients with a recurrence of incisional hernia
* Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible
* Pregnant women
* Patients with HIV therapy
* Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin\> 35 micromol / l; TP \< 55%) or significant thrombocytopenia (\< 60 000 platelets)
* Patients with a contra indication for laparoscopy
* Patients with a life expectancy \< one year, or whose mobility within two years of treatment will damage proper monitoring
* Patients unable to understand information about the protocol
NSAIDs and PGE2 Levels in Vitrectomy Patients

The purpose of this study is to assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before vitrectomy.

A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. Samples were immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. The minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (R \& D Systems, Minneapolis, MN).


Eligibility Criteria:
Inclusion Criteria:

* patients with pucker scheduled for vitrectomy

Exclusion Criteria:

* diabetes
* active inflammation
Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.

This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood.

G6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin concentration must be measured.

Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples.

Another venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified laboratory for reference testing by the gold standard assays:

* G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay
* hemoglobin measurement by a hematology analyzer

Individuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

Eligibility Criteria:
Inclusion Criteria:

-Willingness to provide consent

Exclusion Criteria:

-Blood transfusion in the past 90 days by self-report
Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women

This is a randomized, double-blind, multicentre, parallel pilot clinical trial to study the efficacy of a treatment of lactulose 15 ml + vitamin D 400 U + calcium 0.5 g compared to lactulose placebo 15 ml + vitamin D 400 U + calcium 1 g in bone mass preservation among postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

Women aged between 55 and 65 years old; postmenopausal who have amenorrhea for 5 or more years; women with the diagnosis of osteopenia defined DMO -1,5 to -2,5

Exclusion Criteria:

Any disease causing osteopenia (hyperthyroidism, hyperparathyroidism, hypercortisolism, osteogenesis imperfecta, rheumatoid arthritis, homocystinuria, etc.)
The Effect of Online Transtheoretic Model Based Health Education on Overweight University Students

Aim: In this study, it was aimed to determine the effect of health education given to overweight university students based on the Transtheoretic Model (TTM) on nutrition and physical activity behaviors.

Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 54 students, 27 of which were in the experimental group and 27 in the control group, who met the inclusion criteria between October 2021 and November 2021. Students were divided into nutrition and exercise change stages groups according to TTM. The students in the experimental group were given one-on-one health education in accordance with the TTM change stages, using the online method. In the study, data were collected using the Sociodemographic Form, Nutrition and Exercise Stage Determination Form according to TTM, Nutrition Change Processes Scale (NCPS) and Exercise Change Processes Scale (ECPS). Chi-square test and t test for dependent and independent groups were used in the analysis of the data obtained. Statistical significance level was accepted as p\<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,
* University students without chronic diseases
* BMI level between 24.9 and 30,
* Open to communication and cooperation,
* Internet and smartphone/tablet/computer etc. owner.

Exclusion Criteria:

* BMI level of 24.9 and below,
* Using any drug,
* Who left the research voluntarily.
* Under the age of 18