cyrilzakka/clinical-trials huggingface dataset:
Measure of Engagement of Epilepsy Patients in Messaging Groups

This study will measure the engagement of people with epilepsy in a mobile phone based messaging platform as well as understand if there is an impact on their self-management

The primary purpose of this study is to assess a person with epilepsy's level of usage of a mobile messaging application for peer support. The secondary purpose is to understand what characteristics of their group drive different levels of usage and improvements in self-management.

Participants can participate as much or little as they want for a minimum of six weeks. Participants will complete an initial and a final questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application

Exclusion Criteria:

* A diagnosis of learning disability/difficulty, significant mental health conditions; those in care, bereaved, or prisoners. Any other vulnerable individuals (individuals unable to protect themselves against significant harm or exploitation)
Rotating Frame Relaxation and Diffusion Weighted Imaging of Human Gliomas

Grading of gliomas is of significant clinical importance since the prognosis as well as the treatment of choice are distinct in low-grade and high-grade gliomas. With standard MRI modalities, however, a reliable distinction is often impossible. Moreover, the gold standard for glioma grading by histopathology may also have limitations due to unrepresentative tumor samples. Therefore, more advanced MRI techniques are urgently needed that would have higher sensitivity and specificity in the definition of tumor type, grade and extent.

Assessment of radiologic response for high-grade gliomas utilizes the updated RANO criteria 12 weeks after completion of chemoradiotherapy. However, there is an urgent need to identify nonresponding patients earlier, preferentially midtreatment in order to consider alternative treatment strategies. Imaging biomarkers, such as diffusion weighted MR imaging (DWI), have provided promising results in assessing early treatment response. Furthermore, a serum biomarker with diagnostic value could improve tumor follow-up and clinical management of gliomas.

The aim of our study is to develop novel imaging protocols suitable for the magnetic resonance imaging (MRI) of glioma using advanced MRI techniques such as rotating frame imaging, novel DWI acquisition and post-processing methods We also study the correlation between advanced MRI parameters and histopathology of the tumor specimen. In addition, early treatment response is assessed with advanced MRI parameters at 3 week and 10 week after initiation of radiotherapy. Finally, our objective is to study the association between serum biomarkers and corresponding MRI with potential tumor progression.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 80 years old
* Language spoken: Finnish or Swedish
* Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
* Supratentorial primary malignant glioma (the diagnosis is based on radiological and clinical grounds)
* Supratentorial recurrent glioma based on MRI and/or \[11C\]methionine PET imaging
* Patient is scheduled to either surgery or stereotactic biopsy
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
* Any psychiatric condition that compromises the subject's ability to participate in the study
* Infections: Patient must not have an uncontrolled serious infection
* No contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* Patient must not have claustrophobia with serious symptoms
* Pregnant or lactating women
Effect of Whole Body Electromyostimulation and/or Protein Supplementation on Sarcopenic Obesity in 70+

The aim of the study is to determine the effect of 16 weeks of Whole Body-Electromyostimulation (WB-EMS) and/or protein supplementation on Sarcopenic Obesity (SO) in community dwelling male subjects 70+ with SO .

108 eligible men will be randomly assigned to either a (1) WB-EMS and Protein (2) Protein (3) sedentary control group.

WB-EMS will be applied 1,5 x 20 min per week (i.e. 3 sessions in two weeks) with bipolar current, 85 Hz in an intermitted mode (4 s - 4 s of rest). Protein supplementation will be adjusted to dietary intake in order to reach a total protein intake between 1,5 - 1,7g/kg body-mass/d . Primary study endpoint will be the Sarcopenia Z-Score

The aim of the study is to evaluate the effects of Whole-Body Electromyostimulation (WB-EMS) with additional protein supplementation on Sarcopenic Obesity parameters in independently living men 70 years and older with sarcopenic obesity. The randomized controlled study compares three groups with 36 subjects each: (1) WB-EMS with additional protein supplementation, (2) protein-only and (3) passive control group, over a period of 16 weeks of WB-EMS -training. Group (1) conducts 1.5-times/week a 20 minute-sessions of WB-EMS with additional protein, group (2) is limited to protein supplementation (only) and group (3) is constrained to maintain their habitual living behavior and physical activity. Based on an individual nutrition analysis the protein intake will be adjusted to 1.5-1.7 g/kg/ bodymass/d. All groups will be supplemented with a maximum of 800 IE Vitamin D.

Primary study endpoint will be changes of the Sarcopenia Z-Score with skeletal muscle mass assessed via bio-impedance analysis (BIA). Secondary study endpoints are changes of Obesity (i.e. body-fat as assessed via BIA), cardiometabolic risk (i.e. Metabolic Syndrome Z-Score), strength parameters evaluated via Dr. Wolff BackCheck and Physiomed LegPress, quality of life (SF-12) and functional disability (late life physical disability index).

Eligibility Criteria:
Inclusion Criteria:

* community dwelling, independent living men
* Sarcopenia
* Obesity (body fat \>=25%)

Exclusion Criteria:

* exclusion criteria for WB-EMS-application (e.g. cardiac pacemaker)
* diseases/medication that affect the study endpoints (e.g. Glucocorticoids \>5mg/d)
* absence of more than 2 weeks during the study period
Strategy of Transfusion in Trauma Patients - STATA Trial

The purpose of this study is to compare two already validated methods for massive transfusion in trauma patients admitted to the emergency room of a large reference hospital.

In this randomized trial trauma patients in need of massive transfusion will be assigned to one of the following transfusion strategies:

1. - Fresh Frozen Plasma, Platelets Concentrate and Packed red blood cells in 1:1:1 ratio.
2. - These patients will receive Red blood cells based on Haemoglobin measurements and will receive either Beriplex® P/N (CSL Behring GmbH, Marburg, Germany) or Haemocomplettan® P (CSL Behring, Marburg, Germany), or Platelets based on thromboelastometry.

To be included patients must meet the following inclusion criteria:

1. - Trauma victims
2. - Adults between 18 - 80 years old
3. - Injury Severity Score (ISS) between 15 and 45
4. - Assessment of Blood Consumption (ABC) Score ≥ 3 points
5. - Shock Index ≥ 1,2
6. - Acute hemorrhage of more than 50% estimated blood volume in 3 hours or more than 1,5 ml/kg/min of blood during 20 minutes.

Exclusion Criteria:

1. - Early cardiac arrest
2. - Pregnancy
3. - Injury Severity Score (ISS) \> 45
4. - Patient transferred from another hospital
5. - Drug abuse history
6. - Known coagulation impairment
7. - Known use of anticoagulants, or platelet antiaggregants.

The group of health-care providers recruiting the patients based on eligibility criteria, is different than the group that evaluates the clinical outcomes of the included patients, in such a way that no researcher is tasked with post-randomisation care of the subjects. This is done to prevent observational bias.

Two informed consent forms are signed for each patient. The first one is signed by an independent physician. Another consent form is signed by the patient's family or the own patient within 24 hours of hospital admission.

The randomisation is performed by sealed envelopes assigned to the eligible patients anytime they reach the protocol criteria. The envelopes were created using a computer generated randomisation table specifically designed to this study.

An interim analysis was performed in October 2015 and it showed that there was no increased mortality or morbidity within the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* Trauma victims
* Adults between 18 - 80 years old
* Injury Severity Score (ISS) between 15 and 45
* Assessment of Blood Consumption (ABC) Score ≥ 3 points
* Shock Index ≥ 1,2

Exclusion Criteria:

* Early cardiac arrest
* Pregnancy
* ISS \> 45
* Patient transferred from another hospital
* Drug abuse history
* Known coagulation impairment
* Known use of anticoagulants, or platelet anti-aggregants. -
Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

The purpose of this study is to determine if autologous nonmyeloablative hematopoietic stem cell transplantation is able to induce prolonged and significant increases of C-peptide levels associated with absence of or reduction of daily insulin.

Patients with type 1 DM depend on exogenous insulin administration for survival and for control of long-term complications. The best-established treatment is tight control of blood glucose achieved by frequent daily injections or continuous subcutaneous infusion of insulin, ie, intensive insulin therapy. Although insulin therapy has developed enormously, even the most modern technologies do not allow the maintenance of normoglycemia.

Since the establishment of the autoimmune etiology of type 1 DM in the late 1970s, many clinical trials analyzing the effects of different types of immune interventions demonstrated that beta-cell preservation is an achievable target in different degrees.

Controlled trials and further biological studies are necessary to confirm the role of this treatment in changing the natural history of type 1 DM.

This is a prospective pilot study which will enroll patients with type 1 diabetes mellitus within the first months of diagnosis, with clinical and laboratory findings. The donor stimulation will be with cyclophosphamide, filgrastim, and mesna. The cells will be recollected from peripheral blood by apheresis and refrigerated. The patients will receive a nonmyeloablative conditioning regimen with cyclophosphamide and fludarabine, and after this, the cells will be injected intravenously. They will receive a standard regimen of post-transplant prophylaxis. The duration of use of this prophylactic drugs scheme depends on the patient's recovery time. The reinfusion of stem cells will be completed after the last dose of cyclophosphamide, through a peripheral vein.

Lately, every three months, the C-Peptide levels, glucose and insulin serum levels will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed in type 1 diabetes mellitus

Exclusion Criteria:

* Patients with HIV
* Patients with Hepatitis
* Patients with hematologic disease
* Patients with hearth failure
* Renal, Hepatic or psychiatric disease
* Pregnant patients
Leeches for the Treatment of Knee Osteoarthritis

Previous studies have not addressed the question, whether or not a repeated leeching can supply symptomatic relief of osteoarthritic pain for extended periods of time. We present a randomized study to the effectiveness of single and repeated leech therapy in cases with advanced osteoarthritis of the knee using a large patient group compared to a control group, who were both blinded to the actual treatment modality.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee
* Persistent osteoarthritic symptoms for at least 6 months
* Radiographic evidence of late stage osteoarthritis of the knee (stage III-IV)
* History of conservative management including pain medication and physical therapy

Exclusion Criteria:

* Anticoagulant treatment or history of hemophilia
* History or presence of rheumatic diseases leading to secondary osteoarthritis
* Presence of hematological, hepatic, renal or immunological disease
* Insulin-dependant diabetes mellitus
* Intraarticular injections or systemic application of corticosteroids during the 3 preceding months
* History of surgery of the affected knee during the last 3 months or joint replacement
* History of previous leech therapy
* Lack of informed consent
Effects of Dietary Supplement Tauroursodeoxycholic Acid on Vascular Function

The purpose of the present study is to determine if use of dietary supplement tauroursodeoxycholic acid enhances insulin-stimulated leg blood flow and glucose disposal.

The notion that cellular stress lowers insulin-induced vasodilation is largely founded on ex vivo studies and experiments in rodents. However, it remains unknown if maintenance of cellular function with the use of dietary supplement tauroursodeoxycholic acid enhances vascular function in humans. The investigators test the hypothesis that daily administration of this dietary supplement enhances vascular function, particularly, insulin-stimulated leg blood flow and glucose disposal.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosed by primary physician
* Body mass index less then 43 kg/m2

Exclusion Criteria:

* Recent weight gain or loss (\>5% body weight in the last 3 months)
* Pregnancy
* Consumption of \>14 alcoholic beverages per week
* Changes in the medication use or dose within the last 3 months
* Known cardiovascular or pulmonary disease
* Taking medication for advanced retinopathy or neuropathy
* Taking prescription anticoagulants
* Nicotine use
A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease

The primary objectives of this exploratory study are to evaluate the effects of bosentan on hemodynamics (via cardiac catheterization) during exercise in patients with Pulmonary Arterial Hypertension (PAH) who have abnormal hemodynamics during exercise but normal hemodynamics at rest. The authors hypothesize that early treatment may change the course of disease progression by improving hemodynamics during exercise, thus delaying disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years of age
* For female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception:

  * Barrier-type devices (e.g., condom, diaphragm) used ONLY in combination with a spermicide. A double-barrier method is recommended.
  * Intrauterine devices (IUDs)
  * Oral contraceptives, if used in combination with a barrier method
* Body weight of 40 kg or higher
* Patients diagnosed with connective tissue disease
* Hemodynamics at rest, based on cardiac catheterization, should be as follows:

  * Mean pulmonary arterial pressure (mPAP) : 18 - 25 mmHg
  * PCWP ≤ 15 mmHg
* Hemodynamics during exercise, based on cardiac catheterization, should be as follows: mPAP \> 30 mmHg
* Provide written informed consent

Exclusion Criteria:

* PAH associated with any other condition
* Severe obstructive lung disease : FEV1∕ FVC \<0.5
* Total lung capacity \<60% of normal predicted value
* Unable or unwilling have a cardiac catheterization procedure
* Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (6-MWT)
* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
* Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
* AST and ∕or ALT \> 3 times uln
* Hemoglobin concentration \> 25% below the lower limit of normal
* Systolic blood pressure \< 85 mm Hg
* Pregnancy or breast-feeding
* Treatment or planned treatment with another investigational drug
* Treatment with an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion
* Treatment with calcineurin-inhibitors (i.e., cyclosporine A and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of study start;
* Known hypersensitivity to bosentan or any of the excipients
Treatment Outcome of Short Implant Assisted Mandibular Overdenture

This study evaluates the use of short dental implants to support mandibular overdenture together with the use of laser therapy for treatment of patients with atrophic ridges. All participants will receive laser therapy; half of participants will receive two short implants and the other half will receive four short implants.

The conventional solution to complete edentulism is the use of complete removable dentures. One negative effect of edentulism is resorption of the edentulous ridge over time. Construction of a successful mandibular complete denture for patients with advanced mandibular ridge resorption is often difficult and on some occasions virtually impossible. It has been proved that when implants are placed, bone gets stimulated resulting in minimal bone loss. But anatomic limitations to implant placement have been observed in atrophic ridges, so short implants introduced as a recent alternative to aggressive surgical procedures proposed to compensate for tissue deficiency. Also, Low Level Laser Therapy (LLLT) has proven success in improving implant stability which is very crucial in short implants. Thus, the purpose of this study is to evaluate and compare the treatment outcome of mandibular overdenture assisted by two short implants versus that assisted by four short implants in combination with LLLT.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous patients.
* Patients with mandibular resorbed edentulous ridge.
* Medically fit patients with no systemic conditions.
* Class I ridge relation.
* Adequate zone of keratinized mucosa.

Exclusion Criteria:

* Metabolic bone disease or unstable systemic condition.
* Heavy smokers.
* A history of radiotherapy in the head and neck region.
* Physical or mental disability.
* Temporomandibular and neuromuscular disorders.
A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.


Eligibility Criteria:
INCLUSION CRITERIA: Patients will be eligible for inclusion in the study if they meet the following criteria:

1. Provide signed and dated informed consent and are willing to receive the study medication
2. Age ≥ 18 years of age
3. If a female of childbearing potential is willing to practice at least one method of birth control during treatment and for at least 28 days after treatment with study medication:

   1. barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or
   2. surgical sterilization, approved hormonal contraceptives (such as birth control pills, depo-Provera, or Lupron Depot), or IUD are all acceptable.

      * Rhythm, temperature, and verbal promise of abstinence are not acceptable methods of birth control.
4. If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery.
5. Planned cardiac surgery procedures meeting current Duke criteria to receive anti-microbial prophylaxis active against MRSA:

   a. Patients will meet at least one of the following criteria which are the same as for prophylaxis with vancomycin: i. preoperative hospitalization \> 48 hours ii. transfer to Duke from outside facility iii. previous history of MRSA iv. any patient deemed to be high risk for MRSA by the attending surgeon, due to a complicated past medical and/or surgical history

EXCLUSION CRITERIA: Patients who satisfy any of the following are not eligible for study enrollment.

1. Hypersensitivity to daptomycin
2. Inability to receive standard prophylaxis agents (cefuroxime and rifampin) for any reason
3. Staphylococcal bacteremia at the time of enrollment
4. Diagnosis of S. aureus or coagulase negative staphylococcus pacemaker/defibrillator infection within the preceding 18 months
5. Patient is undergoing emergency CABG
6. Weight \>150 kg or \<50kg
7. Patients considered unlikely to survive at least 7 days due to underlying illness.
8. Patients with creatinine clearance (CLcr) \< 30mL/min (calculated using the Cockcroft-Gault equation using actual body weight)
9. Severe neutropenia (absolute neutrophil count \<0.500x103 /µL)
10. Pregnant, nursing or lactating women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed)
11. Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation
12. Any other condition that in the opinion of an investigator, would confound or interfere with evaluation of safety or efficacy of the investigational medication, or prevent compliance with the study protocol
The Impact of Baby-friendly Hospital Initiative to Breastfeeding, Breastfeeding Counselling and Breastfeeding Attitudes

The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital, Finland. The baseline measurement will be conducted before the implementation of BFHI in 2017 and second measurement will be conducted in 2019 after the certification process. Both staff members and breastfeeding mothers will be recruited in the study. The main outcomes are the duration of breastfeeding and breastfeeding attitudes.


Eligibility Criteria:
Inclusion Criteria:

* Staff: All staff members taking care of mothers and/or infants in the hospital.
* Mothers: Mothers who have given birth in the study hospital during the data collection period.

Exclusion Criteria:

* Mothers:

  * who have given birth outside the hospital,
  * whose infant's condition is critical,
  * whose infants are transferred to another unit.