cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study to Assess the DynaSense System

The study is designed to test the DynaSense system, which is a patient movement and orientation monitoring system. The study is intended to determine that:

* the DynaSense system identifies patients that are not turning adequately on their own and therefore require caregiver-assisted turns.
* the DynaSense system identifies patients that are turning adequately on their own and therefore do not require a caregiver-assisted turn.
* the DynaSense system helps ensure compliance with an institution's established patient turning protocol.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female 18 to 110 years of age;
* Inpatient currently on the unit and expected to remain for at least 12 hours;
* Able and willing to comply with the study procedures;
* Subject (or his/her agent) is able to read, understand, and provide Informed Consent in the English language.

Exclusion Criteria:

* Subject is a female subject under the age of 60 who is pregnant, planning on becoming pregnant, or is currently breastfeeding.

  1. Any woman under the age of 60, must have a negative urine pregnancy test prior to being enrolled in the study; OR
  2. Be postmenopausal for at least 2 years, OR
  3. have had a bilateral tubal ligations, OR
  4. have had a bilateral oophorectomy, OR
  5. have had a hysterectomy.
* Subjects with a known tape allergy or sensitivity to EKG leads or similar types of adhesives used in common medical products.
* Subjects who cannot have the patient sensor applied on the surface of the patient's anterior torso.
* Subjects who have a pacemaker or implantable cardiovascular-defibrillator (ICD).
* Subjects with dementia, Alzheimer's disease or other mental disabilities and incapacitation that would prevent the subject from providing written informed consent. If the subject is unable to provide informed consent due to mental incapacity, then the subject's Durable Power of Attorney may provide informed consent and sign the informed consent on behalf of the subject.
* Subjects who refuse to have an area of hair on their chest be clipped or shaved, if needed for patient sensor adhesion.
* Subjects, who in the opinion of the Principal Investigator, are at increased risk by participating in the clinical study.
* Subjects who have participated in another clinical study within the past 30 days or are currently participating in another clinical study at the time of screening.
The Occurrence of Post Dural Puncture Headache After Epidural Blood Patch

Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice.

The investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.

Currently, spinal anesthesia is commonly used for cesarean section in many institutes, since it is a safe technique for both mother and child, with high satisfaction of obstetricians and their colleagues. Bloom, et al. claimed that there was 37,142 women underwent cesarean section in 2002 where 94% was under regional anesthesia, as 40% spinal, 42% epidural and 12% combined spinal and epidural anesthesia.

However, the procedure is inevitable to have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH) . The PDPH is caused by accidental dura puncture resulting in continuous cerebrospinal fluid (CSF) leakage and gradual intracranial pressure reduction. This is a potential complication of neuraxial anesthesia in clinical practice. The needle characteristics as bevel orientation, stylet reinsertion, an approach, multiple insertion, and operator experience, patient age, history of previous PDPH, body mass index (BMI) \> 35 are some responsible factors for the incidence. Chan et al. revealed that amongst 65,348 parturients, the occurence of PDPH was 1.1-1.9%, while Bloom et al. proposed his number as 0.4%. Interestingly, an obstetric meta-analysis showed an incidence of 1.5-11%, caused by spinal needle.

The PDPH is defined as a symptom of severe headache that appears within 7 days following a lumbar puncture. It may be accompanied by other manifestations such as tinnitus, hypoacusis, photophobia, nausea, or neck stiffness. Actually, it can resolve within 1 week or 48 hour after a treatment of blood patch. Other additional treatments include bed rest, analgesics, increase fluid intake, or caffeine containing beverages. In a severe case, a retractable pain might have a good response to intravenous caffeine and epidural blood patch (EBP). Though treatments of PDPH include both pharmacologic and non-pharmacologic regimens, Cochrane review concluded that the EBP was more effective than any other conservative treatments. As a result, the investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.

Eligibility Criteria:
Inclusion Criteria:

* parturient after received spinal block for cesarean section who have post Dural puncture headache and received epidural blood patch in Siriraj hospital during 1 January 2006 to 30 December 2015

Exclusion Criteria:

* patient who diagnosed post Dural puncture headache from accidental Dural puncture from epidural needle or received combine spinal epidural anesthesia
Dissecting De-automatization

The proposed study will assess the effects of mindfulness meditation training on an eye blink conditioning (EBC) task in a sample of novice meditators. This methodology will allow investigation of whether mindfulness interrupts classical conditioning through the process of de-automatization. Implicit learning rates, as reflective of unconscious habit formation and measured by the frequency of conditioned responses during the EBC, will be a main outcome of interest. The proposed study will also assess the effects of mindfulness meditation training on an emotion regulation (ER) task, with a specific focus on reappraisal of negative images and savoring of positive images.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60,
2. willingness to participate in study interventions and assessments.

Exclusion Criteria:

1. Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention, or a history of meditation practice,
2. Learning disability, significant memory problems or significant attentional disruptions as determined by self-report,
3. History of head injury resulting in loss of consciousness.
A Long-term Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With OAG or OH: RENGE Study

The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons
Blood Flow Restriction Therapy Combined With Neuromuscular Electrostimulation in Amateur Female Soccer Players

The objective is to know the effects of Neuromuscular Electrical Stimulation (NMES) and its combination with Blood Flow Restriction (BFR) Therapy in healthy amateur female soccer players.

The objective is to know the effects of Neuromuscular Electrical Stimulation (NMES) and its combination with Blood Flow Restriction (BFR) Therapy in healthy amateur female soccer players.

For this purpose, a randomized clinical trial will be performed: 20 amateur female soccer players were distributed in two groups (control group n=10; experimental group n=10). In the control group, NMES (symmetrical biphasic rectangular pulse, 350 μs and 80Hz) combined simultaneously with active exercise in knee extension (75 repetitions in 4 sets, 20% 1RM, 30 seconds rest between sets) was applied. The experimental group performed the same intervention combined with blood flow restriction (BFR) therapy (80% of arterial occlusion pressure). The variables measured were muscle strength, muscle volume and static proprioception.

Eligibility Criteria:
Inclusion Criteria:

* Be federated in a sports club playing 11-a-side soccer for at least the last two seasons.
* Be between 16 and 28 years of age.
* Be physically active players at the time of the study with a regular practice of at least 5 hours per week during the last 2 months,
* Have been playing soccer for at least 5 hours per week during the last 2 months.
* Have been playing soccer for at least 2 years

Exclusion Criteria:

* Those who presented at the time of the study any lesion classified according to the Munich consensus and diagnosed by a doctor.
* Those with systemic lupus erythematosus.
* Hemophilia.
* Unregulated hypertension.
* History of pulmonary thromboembolism or stroke.
* Impaired blood coagulation.
* Contraceptive intake.
* Spinal radicular lesions.
* Previous surgeries related to the circulatory system.
Retrospective Review of Anterior and Posterior Cervical, Thoracic, and Lumbar Instrumented Arthrodesis Surgeries

Retrospective review will allow for an evaluation of potential patient- or procedure-related factors that are associated with the development of either radiologic or clinical adjacent-segment pathology.

Spinal arthrodesis can be performed through either anterior, posterior, or lateral approaches for a variety of traumatic, degenerative, or deformity conditions. In recent years, the development of more sophisticated segmental instrumentation techniques and hardware has allowed for incorporation of multiple spinal levels in single settings. The long-term consequences for spinal motion segments adjacent to such fusions remain unknown.

The investigators propose to undertake a retrospective case study analysis evaluating both radiologic and clinical parameters indicative of adjacent-segment pathology in patients who have undergone instrumented arthrodesis procedures at Ohio State University, performed by either Dr. Francis Farhadi, James B. Elder, or Gary Rea.

Eligibility Criteria:
Inclusion Criteria:

* Must have had a Spinal arthrodesis procedure at Ohio State University

Exclusion Criteria:

* NA
Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS

Phase 1, open-label study of BHV-0223 in ALS.

This is a phase 1, open-label, single arm study to evaluate the safety, tolerability and pharmacokinetics of multiple doses of BHV-0223 in subjects with ALS.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with diagnosed ALS by the revised El Escorial diagnostic criteria, including laboratory supported probable, probable, or definite ALS;
2. Subjects who have never taken riluzole tablets, OR Subjects who previously took riluzole tablets but discontinued at least 1 month prior to the screening visit. Subjects must not have had ALT or AST \> 5 x ULN while taking riluzole tablets, or any other clinically significant tolerability issues (e.g., hypersensitivity reactions) in the judgement of the investigator;
3. Subjects determined by the investigator to be medically stable;
4. Subjects determined by the investigator to be willing and physically able to complete the study as designed, with or without caregiver assistance.

Exclusion Criteria:

1. Target Disease Exceptions
2. Medical History Exceptions

   1. Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
   2. Subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment;
   3. Subject has a history of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results in the investigator's judgment;
   4. Any other sound medical, psychiatric and/or social reason in the investigator's judgment;
3. Physical and Laboratory Test Findings

   1. Positive urine pregnancy test in WOCBP at screening;
   2. Subject has evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or other determinations beyond what is consistent with the target population, in the investigator's judgment;
   3. Subject has liver function testing abnormalities (ALT, AST , or total bilirubin) that are \> 1 x ULN;
4. Other Exclusions a. Subjects who are unable to be compliant with the visit schedule or protocol procedures.
Efficacy Trial Comparing ZD6474 With Erlotinib in NSCLC After Failure of at Least One Prior Chemotherapy

To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib


Eligibility Criteria:
Inclusion Criteria:

* Confirmed locally advanced or metastatic NSCLC
* Failure of at least one but not more than two prior chemotherapy regimens

Exclusion Criteria:

* Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar)
* Chemotherapy or other type of anti cancer therapy within 4 weeks of study start
Effect of Aspirin at the Acute Phase of Cerebral Ischemic Event.

Aspirin is the only anti-platelet medication used at the acute phase of ischemic stroke. The investigators would like to study laboratory effect of the first oral 300 mg dose of aspirin, given at hospital, after an ischemic event.

The principal hypothesis is that platelet activity would be able to recover during this day and could lead to ischemic recurrences.

Two blood samples are accomplished. The first 2 hours after aspirin intake and the second 23 hours after. Photometric aggregometry are performed with arachidonic acid and collagen induced platelet aggregation, measure of thromboxan B2 levels and reticular platelets count.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women
* Ischemic stroke less than 48 hours
* Signed consent

Exclusion Criteria:

* Danger to prescription of aspirin (haemorrhagic risk...)
* Prescription of heparin or VKA
Oocyte Retrieval Progesterone Levels and IVF

Objective: To assess whether basal hormonal level can predict the elevation of P4 on the day of oocyte retrieval, as well as to examine the impact of P4 elevation on the day of oocyte retrieval on the outcome of assisted reproduction.

Design: Prospective cohort study Setting: Department of In Vitro Fertilization, Gynecology and Obstetrics Institute, Clinical Center of Serbia Patient(s): One hundred sixty four patients enrolled in the ART procedure Main Outcome Measure(s): Pregnancies, miscarriages, biochemical pregnancies and deliveries

A prospective clinical trial was conducted at the Clinic for Gynecology and Obstetrics Clinical Center of Serbia from January 1st to December 31st 2015. The study included 164 patients enrolled in the ART procedure at the Clinic.

Basal hormonal status - serum levels of estradiol (E2 - pg/ml), progesterone (P4 - ng/ml), follicle-stimulating hormone (FSH - mIU/ml), luteinizing hormone (LH - mIU/ml) and anti-Mullerian hormone (AMH - ng/l) were measured on the 2ndor 3rd cycle day before stimulation commencement. During COS levels of estradiol were determined, while levels of progesterone were determined on the day of oocyte retrieval i.e. aspiration. Blood samples were taken by Vacutainer tubes (BD Vacutainer Systems) and centrifuged according to the manufacturer's instructions for the preparation of the serum samples. AMH value (Gen II ELISA ref. No. A79765; Beckman Coulter) in serum was measured by ELISA (enzyme-linked immunosorbent assay), 1 ng / ml). FSH, LH, estradiol, and progesterone were analyzed by chemiluminescent immunoassay (Access 2 immunoassay system, Beckman Coulter).

The main outcome measures were the procedure success as well as the pregnancy outcome. Pregnancy was confirmed by a positive finding of serum β-hCG (\>25 MIU/ml) 14 days after embryo transfer. Clinical pregnancies were confirmed by transvaginal ultrasound findings of a gestational sac with a vital embryo at the 6th gestational week.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years of age
* BMI of 18 to 30 kg/m2
* regular menstrual cycles from 25 to 32 days
* established diagnosis of infertility.

Exclusion Criteria:

* Less then 18 or more then 40 years old
* BMI less then 18 or more then 30 kg/m2
* irregular menstrual cycles
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY

A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale.

Primary Study Objective(s) Primary study objective The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study).

1. Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
2. Evaluation of actual patient adherence to OACs

Secondary Study Objective(s)

1. Evaluation of potential patient adherence to OACs
2. Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
3. Validation of new original 5-item Questionnaire
4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)

AF patients from ongoing PROFILE registry will be invited to visit the scientific center.

2 visits with a 6-month interval are expected for each patient as part of routine clinical practice and phone contact is scheduled for each patient 1 year from the first visit to the scientific center (follow-up period).

Eligibility Criteria:
Inclusion Criteria:

* Men and women above 18 years of age who were included in the PROFILE registry by the start of the observational study
* Presence of written informed consent to participate in the study, fill in the study questionnaires and have personal data analyzed
* Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK

Exclusion Criteria:

* Patients with high bleeding risk, including patients with:

  * Congenital or acquired bleeding disorders
  * Uncontrolled resistant hypertension
  * Exacerbation of gastric and duodenal ulcer
  * Vascular retinopathy
  * Recent history of intracranial or intracerebral hemorrhage
  * Pathology of the brain and spinal cord vessels
  * Recent history of brain, spinal cord or eye surgery
  * History of bronchiectasis or pulmonary hemorrhage
  * A CHA2DS2-VASc score of 0 (OACs are not indicated)
  * Pregnancy, lactation
  * Planned surgery
  * Known hypersensitivity to ingredients of medications used in the study
Real-Time Accurate Pathology Inspection and Decompression Study

The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. Secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes.

Objectives The primary objective is changes in spine and lower limb pain following a laser-assisted neural decompression (LAND) procedure for the treatment of lumbar, thoracic, or cervical spine and/or extremity pain. Secondary objectives will be changes in quality of life, prescription pain medication use, and patient satisfaction with procedure outcomes.

Design and Outcomes This is a prospective observational study to determine the degree to which a laser-assisted neural decompression (LAND) procedure relieves spine and extremity pain. Subjects will have elected to have the procedure are part of their standard of care in treating their spine and/or leg pain. Subjects will complete a baseline survey and two follow-up surveys at 3-months and 12-months after their procedure date.

Interventions and Duration There will be no study intervention. Subjects will only be monitored and evaluated for pre- and post-operative pain, quality of life, satisfaction, and medication use. Subjects will be followed for 12 months following their LAND procedure.

Sample Size and Population This study will last for 4 years starting February 10, 2020. There will be no maximum subject population size. We aim for a minimum population size of 1,500 in order to give statistical significance with results.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed spinal decompression procedure by their healthcare provider.
* Previous conservative care such as physical therapy or chiropractic care that failed to provide adequate pain relief.
* Willing and able to adhere to the protocol of the study including the survey timeline.
* Between the ages of 18-85 years.

Exclusion Criteria:

* Inability or unwillingness to give written informed consent.
* Not a candidate for the LAND procedure
Music Interventions for Dementia and Depression in Elderly Care

This study evaluates the effectiveness of two music-based approaches - group music therapy and recreational choir singing - for reducing depression symptoms in people living with dementia. It also examines mechanisms and heterogeneity of treatment effects.

Dementia and depression are highly prevalent and comorbid conditions in older adults and are associated with individual distress, substantial carer burden, and high societal costs.

Music interventions represent a highly promising type of non-pharmacological interventions for both dementia and depression in older adults. They are widely used, but have yet to be rigorously tested in large trials.

The MIDDEL trial is the largest trial of music interventions to date, and the first to compare different music-based interventions - group music therapy (GMT), and recreational choir singing (RCS) - alone and in combination across countries.

MIDDEL is designed as a large, pragmatic, international cluster-randomised controlled trial with a 2x2 factorial design that will compare the effects of GMT, RCS, both, or neither, for care home residents aged 65 years or older with dementia and depressive symptoms.

Study sites will be located in Australia and in five European countries, and a total of 100 care home units will be randomised to one of the four study conditions.

Eligibility Criteria:
Inclusion Criteria:

* resident (full-time, 24h/day) at a participating care home;
* dementia as indicated by a Clinical Dementia Rating score of 0.5 or more and a Mini-Mental State Examination (MMSE) score of 26 or less;
* at least mild depressive symptoms, as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 8;
* a clinical diagnosis of dementia according to ICD-10 research criteria;
* have given written informed consent (may be assent by proxy for those unable to provide consent themselves).

Exclusion Criteria:

* diagnosis of schizophrenia or Parkinson's disease;
* severe hearing-impairment;
* in short-term care;
* unable to tolerate sitting in a chair for the duration of the sessions.