cyrilzakka/clinical-trials huggingface dataset:
A Mobile App for Medication Adherence in Persons With Hypertension: a Pilot Study

A development and pilot test of an app targeting persons with hypertension. Content in the app was based on persons with hypertensions experiences and a literature review. The participants experience of using the app as well as testing a instrument for medication adherence.


Eligibility Criteria:
Inclusion Criteria:

* 40-70 years of age,
* have hypertension (i.e., ICD 10 codes I10-I15 in the person's medical history) for ≥1 year
* have been prescribed medications to treat said hypertension
* speak and understand Swedish
* have a smartphone

Exclusion Criteria:

* having received medication with unit-dose packages (Apodos)
* previous stroke
* previous myocardial infarction
* psychological disorder or cognitive impairment (i.e. ICD 10 codes F01-F99)
* pregnancy-induced hypertension´
* insulin treatment
* kidney disease, defined as glomerulus filtration rate (GFR) \<60 ml/min.
Deep Brain Stimulation Lead Localization After Implantation

Deep brain stimulation (DBS) is an effective treatment for a variety of neurological and psychiatric disorders, with more than 200,000 patients implanted with DBS devices worldwide. Parkinson's disease is one of the typical indications.The clinical outcomes of DBS depends on the accurate implantation of the lead, and the identification of the lead locations is the basis for evaluating the effectiveness of the treatment. The aim of this study is to localize the implantation position of the lead based on postoperative MRI images and to reconstruct the relative spatial relationship between the lead and the stimulation target. By comparing with the lead position identified based on postoperative CT, this study will evaluate the accuracy of identifying the DBS lead position directly from MRI. This study may help to optimise the stimulation parameters and investigate the best stimulation targets for DBS patients.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease patients with DBS devices, DBS implanted for at least 1 month.
* Ability to tolerate DBS turn-off for at least 30 minutes.
* DBS devices do not contain the ferromagnetic material.
* The patients can fully understand the content of the trial and sign the informed consent form.
* Able to comply to the requirements of this study.

Exclusion Criteria:

* Presence of other concomitant diseases that have or require implantation of pacemakers, defibrillators, cochlear implants, or other neurostimulation devices.
* Patients who are abnormally sensitive to temperature or allergic to heat.
* Patients with severe psychiatric disorders or cognitive impairment.
Microbiota Intervention to Change the Response of Parkinson's Disease

The clinical phenotype of Parkinson's disease (PD) is quite variable, as is the response to and side effects from medications. While many patients respond to carbidopa/levodopa early on, motor fluctuations and dyskinesias can become a problem as the condition progresses, causing significant impairment in function and quality of life. The gut microbiome is of increasing interest in PD, potentially contributing to pathophysiology and clinical phenotype. Furthermore, gut bacteria are capable of metabolizing levodopa, which may decrease its ability to reach the central nervous system and could explain the variable effect seen clinically. Altering the population of drug-metabolizing bacteria could improve the clinical symptoms of PD and the benefit seen with medications. The investigators hypothesize that the gut microbiome in people with PD correlates with their phenotypic characteristics, which can be improved with targeting the microbiome through dietary or therapeutic interventions. The investigators propose a two-part clinical trial. First, a cross-sectional analysis will correlate the microbiome profile with (a) the clinical phenotype of PD and (b) medication response. Second, a randomized, controlled trial, will evaluate the effect of microbiome manipulation on clinical phenotype and medication response. The investigators plan to reduce the level of bacteria through antibiotic use, resetting the potentially disadvantageous microbiome population. Outcomes will include changes in clinical symptoms, alterations in the the microbiome, and changes in serum markers of inflammation. This thorough characterization will broaden our understanding of the gut-brain axis significantly in PD in clinically relevant ways that have yet to be explored.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* Stable on levodopa therapy with fluctuations

Exclusion Criteria:

* Chronic gastrointestinal disease
* Recent antibiotic or probiotic therapy
* Pregnant
* Immunocompromised
Effects of Abnormal Respiratory Mechanics and Assisted Mechanical Ventilation on Neuro-regulation of Respiration

Due to recent technological improvements, it is now possible to record the electrical activity of the diaphragm (Eadi), a direct expression of the central nervous system respiratory center activity. By providing a relatively easy-to-use technique to record Eadi the NAVA (Neurally Adjusted Ventilatory Assist) technology offers a new opportunity to explore the effects of various interventions on neural inspiratory activity in human subjects during spontaneous and assisted ventilation both for normal and simulated abnormal respiratory mechanics.

The main aim of this project is to measure and compare the components of Eadi signal, the direct reflect of the respiratory centers activity, under various conditions of normal and simulated altered respiratory mechanics (either obstructive or restrictive respiratory mechanics° in order to better understand the neuroregulation of breathing. The second aim of the present project is to perform a similar analysis regarding the effects of various modes (Pressure Support and NAVA) and various levels of assisted ventilation both in case of normal and abnormal respiratory mechanics. Based on the information recorded on Eadi and flow and pressure signals, the last aim of this project is to correlate Eadi and pneumatic derived parameters both during spontaneous breathing and assisted ventilation.

Practically, by using the NAVA recording technology, the investigators will perform a physiological study on normal volunteers to explore the effects of normal and simulated abnormal respiratory mechanics on Eadi, flow and pressure signals (airway, oesophageal and transdiaphragmatic pressures) in order to better understand the neuroregulation of breathing. Thirty healthy volunteers with documented normal lung function tests will be included in the study (obstructive respiratory mechanics will be simulated in 15 healthy volunteers and respiratory mechanics will be simulated in 15 healthy volunteers).


Eligibility Criteria:
Inclusion Criteria:

* Man ;
* Less than 35 years old ;
* Non obese (BMI \<30 kg/m2) ;
* Normal pulmonary function tests (vital capacity and forced expiratory volume in one second in the normal range for the age and size)
* No history of respiratory disease (asthma, pneumothorax) ;
* No contraindication for nasogastric tube placement

Exclusion Criteria:

* Active or past respiratory disease ;
* Contraindication to nasogastric tube placement ;
* Less than 18 years old;
* Subject protected by the law (eg subject incapable of discernment, wardship subject, ...) ;
* Subject not covered by a social security system ;
* Subject with a subordination relationship with a member of the research team.
Cardiovascular Effects of Adderall in Healthy Adults.

This study is designed to investigate the cardiovascular response (blood pressure, heart rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years of age and older
2. Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness
3. Subjects who are on no medications
4. Subjects with no prior history of regular amphetamine use, and non-prescription stimulants
5. Nonsmokers

Exclusion Criteria

1. Subjects with known cardiovascular disease, thyroid disease
2. Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence
3. Subjects currently taking medications
4. Prior history of regular amphetamine use, or non-prescription stimulants
5. Smokers
6. Pregnant subjects
7. Known lactose intolerance (due to presence of lactose in the prepared medication)
8. Family history of sudden cardiac death
Mood Change After General Anesthesia in Children

Most drugs used in general anesthesia work on various receptors in the human brain, causing unconsciousness, loss of memory, and loss of reflection of the autonomic nervous system. After the anesthesia, baseline physiological function will be attained by administration of some reversal drugs or as the time goes by. In this process, various side effects may occur.

Emergence delirium (ED) is a representative behavioral disturbance after general anesthesia in children and that can cause several problems during the recovery period. Previous studies found that ED and postoperative behavioral problems might be connected. Preschoolers are the most vulnerable group in developing ED after general anesthesia, however, it is difficult to evaluate the psychiatric problems at this age.

The Child Behavior Checklist (CBCL) 1.5-5 is an internationally well-known standardized tool for assessment of developmental psychopathology, consisted of 99 problem items. Items are categorized as following syndrome scales: Emotionally reactive, Anxious/Depressed, Somatic complaints, Withdrawn, Attention problems, Aggressive behavior, and sleep problems.

In this study, the investigators would observe the behavioral and emotional changes of the child using the CBCL 1.5-5 between before and after the general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 and 7 years of American Society of Anesthesiologists physical status (ASA PS) I or II who are planned to receive surgery under general anesthesia

Exclusion Criteria:

* If the guardian and the subject are difficult to evaluate normally due to language barriers/language disorders/delay or autistic disorder
* with developmental delay, neurological disorders or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances, etc
* refusal of consent
* Any visual or auditory problems of the primary responder of CBCL
* recently received psychiatric medication or sleep supplements
* Recent history (within a month) of received general anesthesia or surgery
Non-Powered Negative Pressure Wound Therapy vs Open Technique for Pilonidal Disease

Pilonidal Disease is disease of young patients with significant morbidity and is difficult to treat. Currently multiple methods are practiced for the treatment of the disease, two of them are preferred over others and practice extensively. First one involves excision of pilonidal sinus and dressings while the second one is excision of the pilonidal sinus with application of negative pressure wound therapy. None of these approaches is considered superior to the other, as not enough comparison studies of the two procedures have been done. In order to clarify this and find the best option for our patients, investigators are taking opportunity to compare these two modalities. If participants choose to participate in this study they will be randomly selected to one of these groups and the progress of wound healing will be monitored after surgery with the measurement of wound weekly and photographs. Investigators are hoping to find out which procedure is superior. This will allow investigators to provide the best treatment option for their patients in future.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient suffering from Pilonidal Disease willing to participate in study.

Exclusion Criteria:

* Patients below the age of 16 years (not able to consent).
* Not consenting to participate in study.
* Patient with less than 3 cm between inferior opening of sinus and anus.
ZipLine Incision Approximation Verses Suture:ZIPS3 Physician Preference Study

Zipline incision approximation vs. Suture -- zips 3 study. A prospective, multi-site, non-blinded, randomized controlled, study designed to evaluate user preferences associated with use of the zipline 3 system versus conventional suturing for incision closure.

The objective of this study is to evaluate user preferences associated with the ZipLine 3 system versus conventional suture placement.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18 and 75 years of age

   * In generally good health
   * Willing to be evaluated in 5-14 days and 3-months post op
2. Patient requiring a non-emergent skin incision or biopsy

   * Maximum excision size 1.5x3.0 cm
   * Requiring 4-0 or smaller suture for closure
   * In area of body trunk or extremities with low mobility and tension

Exclusion Criteria:

1. Facial Incisions or incisions in high stress or tension areas
2. Previously diagnosed peripheral vascular disease
3. Insulin-dependent diabetes mellitus
4. Known bleeding diathesis
5. Known personal or family history of keloid formation or scar hypertrophy
6. Known allergy or hypersensitivity to adhesives
7. Presently taking steroids, immune stimulants, beta blockers, or anticoagulants
8. Atrophic skin deemed clinically prone to blistering
9. Any skin disorder affecting wound healing
10. Incisions requiring dermal sutures
11. Any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study
Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/or Scalp Psoriasis

The purpose of this study is to evaluate the efficacy of guselkumab treatment versus placebo in skin of color participants with predominant moderate-to-severe body psoriasis or predominant moderate-to-severe scalp psoriasis by assessing improvements in the signs and symptoms of psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of plaque psoriasis (with or without psoriatic arthritis \[PsA\]) for at least 6 months before the first administration of study drug
* Self-identify as non-white or non-caucasian
* Be a candidate for phototherapy or systemic treatment for psoriasis
* Have an involved body surface area (BSA) greater than or equal to (\>=) 10 percent (%), psoriasis area and severity index (PASI) \>=12, investigator global assessment (IGA) \>=3 at screening and at baseline (Cohort A), or have a scalp surface area \>=30%, psoriasis scalp severity index (PSSI) \>=12, scalp specific investigator global assessment (ss-IGA) \>=3, and one plaque outside of the scalp at screening and at baseline (Cohort B)
* Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
* Agree not to receive a Bacillus Calmette-Guérin (BCG) vaccination during the study, and within 12 weeks after the last administration of study intervention

Exclusion Criteria:

* Has a nonplaque form of psoriasis (example: erythrodermic, guttate, or pustular)
* Has received ustekinumab, ixekizumab, secukinumab, or brodalumab within 12 weeks of first dose of study drug
* Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has or has had a serious infection (example: sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous antibiotics for an infection during the 2 months before screening
Percutaneous Transluminal Forceps Biopsy

To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture

Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy

Eligibility Criteria:
Inclusion Criteria:

* Patients with biliary strictures without histology available

Exclusion Criteria:

* Pregnant patients
* Children
Hyperoxia Before and After Cardiac Arrest and Myocardial Damage

Several studies show how patients with hyperoxia after cardiac arrest has increased mortality, but the association of hyperoxia before cardiac arrest and myocardial damage has never been investigated. Neither has the association between hyperoxia after cardiac arrest and myocardial injury.

Our research hypothesis is that hyperoxia before cardiac arrest aggravates myocardial damage, secondly we wish to analyze the association between hyperoxia after cardiac arrest and myocardial injury.

The exposure variables is oxygenation within 48 hours before and 48 hours after cardiac arrest, our primary outcome is myocardial damage and will be measured as peak troponin within 30 days after cardiac arrest.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* With a record of ICD-10 diagnosis of cardiac arrest in 2014, admitted to a hospital in the Capital Region of Denmark.
* First recorded cardiac arrest in 2014
* Admitted to ICU
* Serum troponin measured within 7 days after cardiac arrest

Exclusion Criteria:

* Out of hospital cardiac arrest, OHCA
* In of hospital cardiac arrest, IHCA, but with no registered saturation before cardiac arrest.
Study of an Expandable Interbody Device for the Lumbar Spine

The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from patients in this 2 year follow-up clinical study.

Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work status

Eligibility Criteria:
Inclusion Criteria:

* DDD at 1 or 2 levels between L2 and S1
* Between 18 and 80 years of age
* Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months
* Ability to provide a signed Informed Consent

Exclusion Criteria:

* Trauma at level(s) to be fused
* Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated
* Immunosuppressive disorder
* History of substance abuse
* Any known allergy to a metal alloy
Mirena® IUD's Effect on Fallopian Tube Fimbriae and Ovarian Cortical Inclusion Cyst Cell Proliferation

Combination-type oral contraceptives (COCs) have been shown to significantly reduce the risk of invasive epithelial ovarian cancer (IEOC); this protective effect may be achieved to a large extent through COCs ability to reduce cell proliferation in the fallopian tube fimbriae (FTF). The progestin-releasing Mirena® intra-uterine device (IUD) is an increasingly popular method of contraception, but it is not known if its use will reduce a woman's risk of IEOC. Mirena® use does not block ovulation in most women but it may release sufficient progestin to also reduce cell proliferation in the FTF. This study aims to evaluate the effects of the Mirena® IUD on cell proliferation in the FTF as a possible biomarker of protection against IEOC.


Eligibility Criteria:
Inclusion Criteria:

* Women between 35 and 50 years of age (inclusive)
* Women who will be scheduled to undergo an RRSO or RRs
* Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar(ies))
* Women who are willing to have a Mirena® IUD inserted at least prior to risk-reducing surgery or who already have the Mirena® in place
* Women using non-hormonal forms of contraception (Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion.)

Exclusion Criteria:

* Any medical contraindication to use of a Mirena® IUD, including:

  * Pregnancy (a pregnancy test is required prior to study entry)
  * Known uterine anomaly that distorts the shape of the uterine cavity
  * Acute pelvic inflammatory disease
  * Postpartum endometritis or endometrial infection
  * Known or suspected uterine or cervical neoplasia
  * Known history or suspected breast cancer or other progestin-sensitive cancer
  * Uterine bleeding of unknown etiology.
  * Untreated acute cervicitis, vaginitis, or other lower genital tract infections
  * Acute liver disease or liver tumor (benign or malignant)
* Use of tamoxifen, raloxifene, or chemotherapy within the previous 6 months
* Positive pregnancy test
* Breastfeeding
* Use of a copper IUD if the patient is not willing to have it removed prior to surgery and replaced with a Mirena® IUD
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents

This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.

This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese youth (male and female), age 11-17 years with BMI \>95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* 11-17 years of age
* BMI \>95%tile for age and sex
* Being seen for an initial clinic visit at the UW Pediatric Fitness Clinic
* Parent willing to participate in study

Exclusion Criteria:

* History of chronic disease that effects hepatic or renal function including: Type 1 or Type 2 diabetes mellitus, known liver disease or other chronic illness.