cyrilzakka/clinical-trials huggingface dataset:
A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
* Have positive antinuclear antibodies (ANA)
* Agree not to become pregnant throughout the course of the trial
* Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)

Exclusion Criteria:

* Have active severe Lupus kidney disease
* Have active Central Nervous System or peripheral neurologic disease
* Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
* Have active or recent infection within 30 days of screening
* Have had a serious infection within 90 days of randomization
* Have evidence or test positive for Hepatitis B
* Have Hepatitis C
* Are human immunodeficiency virus (HIV) positive
* Have evidence of active or latent tuberculosis (TB)
* Presence of significant laboratory abnormalities at screening
* Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
* Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
* Have changed your dose of antimalarial drug in the past 30 days
* Have changed your dose of immunosuppressive drug in the past 90 days
* Have previously received rituximab
Evaluation of the Human Rotavirus Vaccine at Varying Schedules and Doses in Rural Ghana

The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Between 42 and 55 days of age at the time of enrollment.
* Healthy infant free of chronic or serious medical condition as determined by history and physical examination at the time of study enrollment.
* Parents/guardians of each subject are able to understand and follow study procedures and agree to participate in the study by providing parental/guardian permission.

Exclusion Criteria:

* If child has previously had intussusception or abdominal surgery.
* Use of any immunosuppressive drugs or immunoglobulin and/or blood product use since birth or anticipated during study period.
* Current enrollment in any other intervention trial or use of any investigational drug or vaccine throughout the study period.
* Birthweight less than 2000 grams or gestation \< 36 weeks, if this information is available.
* Any subject who reports plan to leave the study area before the completion of the study (i.e., relocation, migration, etc.).
* Another child living in the same compound is already enrolled in the trial (i.e., only one participant can be enrolled per compound).
* After the rotavirus vaccine is introduced into the routine EPI system in Navrongo: Another child in the compound is less than 16 weeks of age.
* The child has received rotavirus vaccine outside of this study.
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise.

Canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (T2DM). This is a randomized (study drug assigned by chance), double blind (neither the patient or the study doctor will know the name of the assigned treatment), parallel-group, 3 arm (patients will be assigned to 1 of 3 treatment groups) multicenter study to determine the efficacy, safety, and tolerability of canagliflozin (100 mg and 300 mg) compared to placebo (a capsule that looks like all the other treatments but has no real medicine) in patients diagnosed with T2DM who are not achieving an adequate response from diet and exercise to control their diabetes. Approximately 450 patients with inadequate glycemic control with diet and exercise will receive once-daily treatment with canagliflozin 100 mg or 300 mg once daily for 52 weeks or 26 weeks of double-blind treatment with placebo followed by 26 weeks of sitagliptin 100 mg (sitagliptin is an antihyperglycemic agent that will allow patients randomized to the placebo group to improve glycemic control and remain in the study). Patients will participate in the study for approximately 60 to 68 weeks (referred to as the Main Study). The study will also include a High Glycemic Substudy in 50 to 100 patients with T2DM who have poorer glycemic control with diet and exercise. Patients in the substudy will be assigned to receive double-blind canagliflozin 100 mg or 300 mg for 26 weeks and the total duration of patient participatation in the substudy will be approximately 34 to 42 weeks. During treatment, if a patient's fasting blood sugar remains high despite treatment with study drug and reinforcement with diet and exercise, the patient will receive treatment with metformin (rescue therapy) consistent with local prescribing information. Study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. Patients will take single blind placebo for 1 or 2 weeks (wks) before randomization to the Main Study or the High Glycemic Substudy.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have a diagnosis of T2DM
* Patients in the main study must have a Hemoglobin A1c (HbA1c) between \>=7% and \<=10% and a fasting plasma glucose (FPG) \<270 mg/dL (15 mmol/L)
* Patients in the High Glycemic Cohort Substudy must have an HbA1c between \>10% and \<=12% and a FPG \<=350 mg/dL (19.44 mmol/L)

Exclusion Criteria:

* History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening
Evaluation of a Minimally Invasive Image-Guided Surgery System for Hepatic Ablation Procedures

This study was designed in two phases: Phase I is designed to confirm that the surgeon is able to perform accurate liver surface registration including standard liver features used as landmarks during a scheduled laparoscopic liver ablation procedure and acquires a level of comfort with the procedure.

The surface of the liver will be manually swabbed with the study tracked laparoscopic probe with landmarks noted during data collection. After registration of the liver is obtained, the registration points obtained during this procedure will be evaluated by the surgeon by moving the tracked laparoscopic probe over the liver surface and evaluating the location of the tracked laparoscopic probe displayed on the guidance system three dimensional (3D) image. The surgeon will accept or reject the registration accuracy.

The hypothesis is that the surgeon will be able to successfully acquire liver surface registrations with a small learning curve for technique and will be able to proceed to Phase II of the study.

Phase II contains the registration process included above but adds the additional process of tracking the ablation probe used to perform tumor ablation by attaching the Pathfinder Multi-Tool adaptor and collecting data showing the location of the ablation probe as tracked and displayed on the Pathfinder three dimensional (3D) image.

The surgeon will use ultrasound (US) guidance to locate tumor location during the laparoscopic procedure. The images collected during this process will be recorded by Pathfinder.

The Pathfinder System used during this study is used for data collection purposes only and is not used during the surgical procedure as an image guided system.

Preoperative computed tomography (CT) scans, obtained as standard of care, will be used to generate the image guided liver system 3D liver surface images used during the study.

During the laparoscopic procedure, the Pathfinder device will be inserted through the standard laparoscopic ports (5mm or 10mm) being used for the staging procedure.

A total study population will include 30 subjects: 10 in Phase I and 20 in Phase II that complete the laparoscopic procedure scheduled.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for laparoscopic liver ablation procedure
* Had a preoperative CT image that includes the liver

Exclusion Criteria:

* Severe cirrhosis of the liver
* Kidney failure or dialysis
* Unable to consent
Mobile Health-Health Action Process Approach Based Intervention on Sedentary Behaviour and Stress in Office Workers

This study will explore the effectiveness of a Health Action Process Approach (HAPA) mobile health (mHealth) intervention on reducing sedentary behaviour and perceived stress in desk-based office workers. Half of participants will receive a mHealth HAPA intervention consisting of a theory-driven behavioural counselling session and weekly HAPA based worksheets delivered through a mobile application. The other half of participants will act as a control group and will receive no intervention or information past the letter of information. The study will take place over eight weeks, with the first four weeks acting as the intervention period and a follow-up at the end of week eight.

This two-arm, repeated measure randomized control trial will randomize participants into two groups, an intervention group and a no-contact control group in an attempt to reduce sedentary behaviour in desk-based office workers. The study will last for eight weeks, comprising of a four week intervention period and a follow-up at week eight.

Participants will be full time desk-based office workers primarily recruited from large businesses and corporations. The primary objective of the study is to reduce sedentary behaviour, while the secondary objective is to determine if a theory-based behaviour change intervention tailored to workplace sedentary would affect general stress levels of desk-based office workers over the course of the intervention.

The intervention group will receive an initial theory-based behaviour change counselling session through video chat and then continued through a mobile application where weekly worksheets will be delivered to a participant's mobile phone and encourage the participant to create their own personal and specific action plans and coping strategies. The control group will receive no intervention or further instruction past the letter of information.

Sedentary behaviour will be collected in the form of duration of time spent sitting, frequency of sedentary behaviour breaks, and duration of sedentary behaviour breaks. These variables will be measured through a sedentary behaviour and perceived stress questionnaires that will be delivered through a downloadable mobile phone application.

Outcome measures will be compared within and between groups to detect differences. Participants will be recruited through emails to relevant liaisons and senior executives as well as through emails directly to office working employees in the London area.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* full-time employee in a desk-based office job (work from home accepted)
* have access to a smartphone with internet connection
* can read and write in English

Exclusion Criteria:

* any medical or physical limitation that would prevent standing, stretching, and/or light physical activity
EBUS Guided Cryobiopsies With Ultrathin Cryoprobe in Patients With Peripheral Pulmonary Nodules - a Feasibility Study

The standard procedure in the diagnosis of peripheral round foci is bronchoscopy with transbronchial forceps biopsy (TBB). Despite the simultaneous application of X-ray fluoroscopy, the diagnostic value of this method depends strongly on the size, location and relationship of the foci to the airways as well as their radiological representability. By inserting radial 20 MHz ultrasound probes through the working channel of a flexible bronchoscope into the periphery of the lung, the detection of peripheral foci can be improved. By simultaneously using a virtual bronchoscopy with an ultra-thin bronchoscope, even smaller round foci in the periphery of the lung can be detected. For some years now, tension-resistant cryoprobes have been used for transbronchial biopsy. Here, especially in lesions that can only be reached endoscopically tangentially, advantages have been shown over forceps biopsy. Much larger tissue samples can be obtained without increasing the complication rate. Studies showed that the combination of the EBUS navigation technique with the cryobiopsy procedure is feasible and safe in the endoscopic diagnosis of peripheral lung tumors. This study investigates to what extent the combination of an ultra-thin cryoprobe with an ultra-thin bronchoscope together with the radial EBUS can further improve the diagnosis. This study is a non-randomized pilot study to prove the feasibility of this procedure. The EBUS probe and the bronchoscope are CE certified for this application. The study will be conducted as a monocentric study at the Thorax Clinic at Heidelberg University Hospital.

A total of 30 patients with an indication for transbronchial biopsy will be prospectively included. All patients will be examined according to the clinical standard. After a freezing time of 3-7 seconds, the probe together with the bronchoscope will be extracted and the sample will be defrosted in a water-filled sample vial. Up to 4 biopsies will be taken depending on the investigator's assessment. The samples will be collected separately and the order of the biopsies will be recorded. The primary endpoint is the feasibility of the procedure. Secondary endpoints are safety, diagnostic hit rate, biopsy size and quality and success rate depending on the position of the EBUS probe (tangential or central).


Eligibility Criteria:
Inclusion Criteria:

* Single or multiple peripheral pulmonary round foci in CT
* signed patient information

Exclusion Criteria:

* severe co-mornidity
* no signed patien information
* contraindication for intervention
Position of Teamleader and Leadership Performance

Investigation in simulated cardiac arrests. Team leaders are randomly designated. Designated teamleaders are instructed to lead their team from the position of the patient's head or remote from the patient.

participants: physicians taking part in voluntary simulator-based workshops. Teams of 3-4 are formed. One teammember is randomly allocated as teamleader design: prospective, randomized, single-blind, cross-over intervention: teamleaders are randomized and instructed to lead their team from the conventional position at the patient's head or from a remote hands-off position data analysis: will be performed from videorecordings

Eligibility Criteria:
Inclusion Criteria:

* Physicians taking part in voluntary workshops

Exclusion Criteria:

* refusal to participate and/or being videorecorded
Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

The purpose of this study is to assess the safety, tolerability, and immunogenicity of a single dose of different formulations of V114 (V114-A and V114-B) and Prevnar 13® (pneumococcal 13-valent conjugate vaccine) in adult participants

≥50 years of age in good health.


Eligibility Criteria:
Inclusion Criteria:

* Good health; any underlying chronic illness must be documented to be in stable condition
* Highly unlikely to conceive through 6 weeks after administration of the study vaccine

Exclusion Criteria:

* Prior administration of any pneumococcal vaccine
* History of invasive pneumococcal disease (IPD) \[positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture-positive pneumococcal disease
* Known hypersensitivity to any vaccine component
* Known or suspected impairment of immune function
* Received systemic corticosteroids for \>=14 consecutive days and has not completed treatment \<=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
* Coagulation disorder contraindicating intramuscular vaccination
* Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
* Received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion.
* Participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
* Breast feeding
* User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
CentriMag Ventricular Assist System in Treating Failure-to-Wean From Cardiopulmonary Bypass for Pediatric Patients

The purpose of the study is to evaluate the safety and effectiveness of the CentriMag ventricular assist system to help pediatric patients who have experienced heart failure during surgery and cannot be removed from cardiac bypass.


Eligibility Criteria:
Inclusion Criteria:

1. Age 5 years to 16 years, inclusive
2. Inability to wean from cardiopulmonary bypass (CPB)

Exclusion Criteria:

1. Body weight \< 20 kg
2. Severe aortic insufficiency
3. Unrestricted intra-cardiac communications (i.e. large VSD)
4. Pulmonary vascular resistance index (PVRI) \> 10 IU
5. Presence of DIC
6. On hemodialysis (excluding hemofiltration)
7. Contraindications to systemic anticoagulation
8. Active systemic infection unresponsive to antibiotics
9. Unresolved malignancy
10. On other investigational VAS
Love Group for Geriatric Psychiatry Outpatients

Loneliness is a key predictor of mortality in older adults, and is a prominent risk factor for mental and physical illness in older adulthood. The goal of this study is to determine the feasibility and acceptability of a group loneliness intervention in geriatric psychiatry outpatients. This type of group loneliness intervention is based on functional analytic psychotherapy (FAP), called Awareness, Courage, and Love (ACL) Groups. The objective of this clinical trial is to adapt, implement, and evaluate the ACL group for outpatients.

The objective of this clinical trial is to adapt, implement, and evaluate a type of loneliness group intervention called Awareness, Courage, and Love Groups for older adult outpatients diagnosed with a psychiatric disorder. The following research questions will be answered: (a) Are ACL groups with geriatric psychiatry outpatients feasible and acceptable? (b) Do such ACL groups demonstrate preliminary efficacy?

Eligibility Criteria:
Inclusion Criteria:

* Older adults with psychiatric disorder(s)

Exclusion Criteria:

* Individuals who are disoriented to person, delirious, unable to tolerate or participate meaningfully in the group, or otherwise unable to provide consent to research and psychotherapy
* Unable to speak English
Evaluation of the Efficacy of Aromatherapy on the Well-being of Healthcare Professionals

The main objective is to evaluate the efficacy of aromatherapy (inhaler sticks) on the well-being of healthcare professionals practicing in medical and surgical intensive care unit, operating room/anesthesia and emergency departments

The secondary objectives of this study are :

1. To evaluate the efficacy of aromatherapy on anxiety of healthcare professionals;
2. To evaluate the efficacy of aromatherapy on stress symptoms of healthcate professionals;
3. To assess compliance with aromatherapy.

Conduct of research:

All participants included in the study will receive the study treatment (essential oils mixtures in inhaler sticks for 2 months) and the control (no intervention for 2 months), in random order. At inclusion and at the end of each period, questionnaires of well-being, anxiety and stress will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare professional ;
* Working in a medical or surgical intensive care unit or in a operating room/anesthesia unit or in the emergency department;
* Agrees not to use any topical, oral or inhaled essential oils during the two study periods, other than those specified in the study protocol;
* Written informed consent;

Exclusion Criteria:

* Pregnant or breastfeeding woman;
* Known allergies to essential oils;
* Asthma;
* Scheduled departure from the unit;
* Antidepressant treatment or anxiolytic treatment;
* Taking topical, oral or inhaled essential oils durink the week prior to inclusion.
Evaluation of Satisfaction and Effect on Daily Living Activities With the Use of Myoelectric Controlled Prosthesis

Myoelectrically controlled arm prostheses are often offered to individuals with upper extremity limb loss in order to restore body balance and compensate for the lack of grasping ability during the rehabilitation process. Myoelectrically controlled prostheses utilize the presence of two independent signals from a set of agonist and antagonist muscles. However, individuals with upper extremity amputation may not want to use their prosthesis. One of the reasons for not wanting to use the prosthesis is prosthesis dissatisfaction. This study aims to evaluate prosthesis satisfaction and the effect of prosthesis use on daily living activities of upper extremity amputees using myoelectric controlled prosthesis.

The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. Patients' satisfaction with using their prosthesis will be evaluated with TAPES (Trinity Amputation and Prosthesis Experience Scale) and daily living activities using their prosthesis with SF-36 (Short Form-36).

Eligibility Criteria:
Inclusion Criteria:

1. Being between the ages of 18-65
2. Having an upper extremity amputation
3. Using myoelectric controlled arm prosthesis for at least 3 months

Exclusion Criteria:

1. Being under the age of 18
2. Having significant cognitive or hearing impairment that would preclude participation in research