cyrilzakka/clinical-trials huggingface dataset:
PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries

Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.

Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.

Eligibility Criteria:
Lumbar Fusion Patient Group

Inclusion Criteria:

* Skeletally mature adults between 18 and 70 years old
* Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
* Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
* Willing and able to comply with the requirements of the protocol including followup requirements
* Willing and able to sign a study specific informed consent.

Exclusion Criteria:

* More than 3 intervertebral levels to be fused
* Posterior fixation used at more than 1 level for 1-level intervertebral fusion
* Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
* Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
* Any additional approaches, e.g. anterior, XLIF
* Active local or systemic infection
* Prior interbody fusion surgery at the index level
* Prior fusion at the adjacent levels
* Previous known allergy to polyetheretherketone (PEEK) or titanium alloy

Cervical Fusion Patient Group

Inclusion Criteria:

* Skeletally mature adults between 18 and 70 years old
* Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels
* Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
* Willing and able to comply with the requirements of the protocol including followup requirements
* Willing and able to sign a study specific informed consent

Exclusion Criteria:

* More than 3 vertebral levels to be fused
* Any additional approaches, e.g. posterior cervical fusion
* Active local or systemic infection
* Prior interbody fusion surgery at the index level
* Prior fusion at the adjacent level
* Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.

The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy.

The hypothesis is that clinical characterization by measurement of nocturnal urine production and maximal voided volumes in children with MNE and subsequent treatment tailoring improves the response to first-line treatment approach.

This is a randomized, controlled study.

This study will be performed at Aarhus University Hospital (Denmark), Ghent University Hospital (Belgium) and Hospital of Zhengzhou University (China) following the same protocol.

According to the initial randomization, children will be allocated to treatment without (group A) or with (group B) prior clinical characterization based on home recordings.

Group A: The children will be randomized to either an enuresis alarm or desmopressin without evaluating the home recordings.

Group B: The home recordings will be evaluated and treatment will be based on the recordings. Desmopressin will be administered to the children with nocturnal polyuria and the conditional alarm to the children with reduced bladder capacity. Children with nocturnal polyuria and reduced bladder capacity will be treated with both desmopressin and conditional alarm. Children with neither nocturnal polyuria nor reduced bladder capacity will again be randomized to either desmopressin or alarm treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-14 years.
* Three or more wet nights per week regarding the home registrations.

Exclusion Criteria:

* Ongoing constipation and/or faecal incontinence.
* Daytime symptoms such as urgency, frequency or incontinence.
* Recurrent urinary tract infections.
* Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated.
* Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
* Former operations in the urinary tract.
* Prior or ongoing treatment with alarm, desmopressin or anticholinergics.
* Ongoing medication that may interfere with the parameters tested.
* Pregnant or lactating girl.
* Contra-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatremia or SIADH.
* Hypersensitivity / allergy to substances in the tablets.
Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

The purpose of this study is to collect data on the incidence, complications and impact on quality of life of herpes zoster (HZ) disease in adults \>=50 years of age in Spain. This study will also collect data on costs related to the HZ disease, especially postherpetic neuralgia (PHN)


Eligibility Criteria:
Inclusion Criteria:

* A male or female \>=50 years of age at the time of study enrolment presenting with acute HZ;
* HZ diagnosis for this HZ episode;

  * is the subject's first outpatient diagnosis; OR
  * took place at another site/ centre up to seven days before the initial visit for the present study;
* Ability to comply with study procedures\*;
* Written informed consent obtained from the subject\*. Note: \* will be applicable to secondary objectives only and not for the primary objective to calculate incidence.

Exclusion Criteria:

• Subject participating in another research study. Note: This exclusion criteria is applicable to secondary objectives only and not for the primary objectives to calculate incidence.
Lung Injury Prediction Study

The purpose of the study is to externally validate the acute lung injury/acute respiratory distress syndrome (ALI/ARDS) prediction model (Lung Injury Prediction Score - LIPS) in a multicenter sample of patients at risk presented to the acute care hospitals: United States Critical Illness and Injury Trials Group (USCIITG).


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patients with one of the known risk factors for acute lung injury at the time of hospital admission

Exclusion Criteria:

* ALI/ARDS already present at the time of hospital admission, denied use of medical records for research, children, hospital readmission, transfer from another hospital
The Predictability of Intraoperative Rotational Thromboelastometry on Postoperative Bleeding and Transfusion Requirements

Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.

Viscoelastic hemostatic assay has been reported to be superior to predict perioperative bleeding in cardiac surgical patients compared with conventional blood coagulation test. However, the role of rotational thromboelastometry (ROTEM) in predicting perioperative bleeding and transfusion requirements in pediatric patients who undergoing surgery for congenital heart disease. Therefore, the investigators attempt to evaluate the predictability of intraoperative rotational thromboelastometry for perioperative bleeding and transfusion requirements in pediatric cardiac surgical patients by comparing with conventional coagulation test. The investigators also attempt to evaluate the correlation between ROTEM parameters, platelet count, and results of conventional coagulation test results.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients (\< 10 years) who underwent surgery for congenital heart disease with cardiopulmonary bypass in 2013 at Samsung Medical Center

Exclusion Criteria:

* incomplete data about blood loss count or transfusion requirements during seven days after surgery
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients?

Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in the world and the most effective drugs available to reduce gastric acid secretion. However, studies have shown that PPIs are not always prescribed with a clear indication. Indeed, between 25% and 86% of older individuals taking a PPI have been overprescribed these medications. In older patients, overprescribing of a PPI is associated with increases in morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that overprescription of PPIs is associated with the individual multimorbidities in older patients evaluated using the multimorbidities group criteria included in the CIRS. The aim of the present study was to establish a relationship between overprescribing of PPIs and multimorbidities in older patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 75 years or more
* Patients hospitalized in geriatric short stay
* Patients with an inhibitor therapy proton pump short geriatric entry
* Patients who have given their written consent

Exclusion Criteria:

* Patients who have expressed their inability or refusal to sign an informed consent
Drug Utilisation of Mysimba/Contrave

This study will assess a retrospective cohort of users of Mysimba/Contrave with up to 548 days (\~18 months) after initiation with treatment with Mysimba/Contrave. This study will describe Mysimba/Contrave utilisation and incidence of AESIs for users compliant and non-compliant with the SmPC.


Eligibility Criteria:
Inclusion Criteria:

* At least one prescription of Mysimba/Contrave in his/her medical records any time during the study period (US) OR at least one dispensing of Mysimba/Contrave in his/her registry any time during the study period (Nordic);
* At least 365 days of computerized records prior to first Mysimba/Contrave prescription or dispensing date; and3Patient is active (i.e., alive and registered/accruing data) at the time of the first Mysimba/Contrave prescription or dispensing date.

Exclusion Criteria:

- All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
Massage Impact on Sleep in Pediatric Oncology

This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).

Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments.

This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication
2. Expected to be an inpatient for at least 21 days
3. Aged 12 to 21 years at enrollment.
4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).

Exclusion Criteria:

1. Cognitive impairment sufficient to preclude completing questionnaires appropriately
2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
3. Previous enrollment
Transforming Outcomes for Patients Through Medical Home Evaluation & reDesign

The purpose of this study is to support enhancement, implementation, and evaluation of an improved model for delivering improved primary care to high-risk older adults through the use of health IT tools, focusing on issues related to the patient-centered primary care home (PCPCH) and other similar high-value elements that are proposed to improve patient outcomes. During this study, participating clinics will utilize the already-implemented Integrated Care Coordination Information System (ICCIS). Clinic staff will meet with a practice facilitator (monthly and as needed), and will track study activities and submit invoices via ICCIS reporting. These invoices will be used to simulate a shared savings model where clinics will be reimbursed based on their progress and effort towards their goals.

Clinics will set and work towards goals that they have chosen. Goals for the control arm are self-selected by the clinics themselves; goals for the invention arm are related to high-value elements (HVE) that have been identified as areas that can improve patient outcomes. These HVE are:

1. Evidence-based Care Management Based on Need
2. Identification of At-Risk Populations
3. Patient Engagement and Alerts Based on Goals
4. Integrated Information for Care Management, especially around Utilization
5. Population Management Tools


Eligibility Criteria:
Inclusion Criteria:

* clinics must be from the Oregon Rural Practice-based Research Network (ORPRN)
* Primary care clinic meeting one of the following health care setting descriptions: 1) small clinics in rural area, 2) medium-sized clinics in rural area, 3) clinics in moderate-sized health system, or 4) clinic within an academic medical center;
* Clinic will or has attested for PCPCH, achieving Tier 2 or 3 (of 3 tiers);
* Clinic is willing to contract to be a PCPCH with payers;
* Clinic has stable electronic health record (EHR) system with no plans to change systems during study duration;
* Clinic has willingness to receive practice facilitation and participate in study activities, including completion of assessments;
* Clinic has willingness to engage with research team members as defined in the study.

Exclusion Criteria:

* patients less then 18
Mindfulness App for Reducing Food Cravings

More than half of Canadian are overweight or obese and over fifty percent of individuals who are obese are emotional eaters. Emotional eating is defined as the tendency to eat in response to negative emotions and can be understood as reward-based eating behavior that is reinforced by modern obesogenic environments. Over time, food-related cues can interfere with reward-based learning processes such that an individual develops a conditioned response to eat for reasons that are not associated with physiological hunger. Mindfulness has the potential to act on the reward-base habit loop of emotional eating. One potential target is cravings or the urges to eat. This can be targeted using the mindfulness exercise called "RAIN" which calls for individuals to (1) Recognize and name their craving, to (2) Acknowledge its presence and to give it space to "be"; (3) then Investigate and bring an attitude of curiosity to their experience - Where did these feelings comes from? Have I felt this way before? then (4) Not-identify with your experience- that is, remind yourself that although your craving or urge to eat is very powerful, it only makes up a small part of who you are. The aim of the study is to therefore test a pilot intervention that implements a targeted mindfulness-based exercise (RAIN), using a mobile app, to attenuate the relationship between feeling a negative internal state (affect) and eating.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (age \> 18 years) who meet criteria for emotional eating
2. Demonstrate a lack of control over eating
3. High levels of preoccupation with food

Exclusion Criteria:

1. Having been pregnant in the past six months or planning on becoming pregnant in the next year
2. currently undergoing treatment for cancer
3. using medication that affects body weight or appetite
4. being diagnosed with Bulimia Nervosa, Binge Eating Disorder, currently active Major Depression, or other psychiatric illnesses that may affect appetite.
5. Participants must also be proficient in English
6. Own a smartphone
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers

The purpose of this study is to determine whether nitric oxide (NO)gas is effective in the treatment of venous ulcers of the lower leg.

SUbjects were divided into two Groups - one receiving 200ppm NO gas delivered topically to the wound area for 8 hours a day for 6 weeks. The other Group (control arm) received Standard of Care (compression) for 22 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and HIPAA authorization
* Must be ≥ 18 years of age
* Must have a venous ulcer for 60 days or greater
* ABPI \> 0.8 and ≤ 1.2
* Must have ulcer between 3cm2 and 25cm2 in size

Exclusion Criteria:

* Has an ulcer that is deemed by the Investigator to be caused primarily by a medical condition other than venous insufficiency
* BMI ≥ 35
* Has evidence of clinical infection
* Suffers from diabetes mellitus with HbA1c ≥ 8%
* Suffers from clinically significant arterial disease
* Has a known allergy to any of the compounds / drugs that are part of this protocol
* Has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone
* Has used any investigational drug(s) within 30 days preceding randomization
* Is unable to manage self-treatment
* Is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
* Suffers from a condition which in the opinion of the Investigator would compromise the safety of the subject and / or the quality of the data
* Is using any of the prohibited concomitant medications or treatments
* Has previously participated in this study
Study of Safety and Efficiency of the Use of Neutral Argon Plasma in Cyto-reduction of Miliary Implants in the Peritoneal Surface.

Neutral argon plasma vaporization shows little damage to normal tissue and allows a complete removal of tumor tissue, that is, without leaving any cell debris viable tumor.

Our primary objective is to evaluate the effectiveness and safety of neutral argon plasma on peritoneal implants with different dosimetry in vivo and ex vivo.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with peritoneal carcinomatosis (an attempt will be made to cover all histological types of carcinomatosis in similar distribution as 2 patients with carcinomatosis of colonic origin, 2 patients with carcinomatosis of ovarian origin, 2 patients with peritoneal pseudomyxoma, 2 patients with peritoneal mesothelioma and 2 patients with carcinomatosis of gastric origin) with PCI greater than 0 in regions 10-13, and that have been selected as candidates for cytoreductive surgery + HIPEC or for laparoscopy-laparotomy explorer (selection criteria established according to clinical practice usual), and that present peritoneal miliary dissemination consistent with the characteristics of this study for the tissue under examination (implants smaller than 0.25 cm, CC1).
* Signature of specific informed consent for participation in this study and to obtain biological samples.

Exclusion Criteria:

* Patients not suitable for CRS and HIPEC, according to the clinical criteria of the Surgery Unit Oncology and multidisciplinary committee.
* Refusal of the patient to participate in the study.
Reducing Sedentary Behaviour With Technology

Cancer-related fatigue (CRF) can be experienced by individuals with Prostate Cancer (PC), which can have profound effects on their well-being. Although physical activity has been shown to improve CRF, the recommended levels are generally not met. Step count and distance traveled information can help individuals to increase their physical activity. Wearable technology (WEAR) provides the user with feedback of their physical activity which can motivate behaviour change. Similarly, education workshops (EDU) on the effects of sedentary behaviour and physical activity may also reduce sedentary behaviour.

The objectives of this study are to evaluate the effects of WEAR and EDU on sedentary behaviour and CRF, and to explore the feasibility of WEAR in this population. Participants in this study will be randomly assigned into WEAR, EDU, WEAR+EDU, or control over a three-month intervention. Assessments at baseline, post-intervention and a 3-month follow up will evaluate CRF, quality of life and level of sedentary behaviour, and use of WEAR devices.

The results from this study will provide evidence-based knowledge on the impact of WEAR and EDU on sedentary behaviour and CRF, and an understanding on the use of technology within the PC population. These results can shape the development of programming for CRF and the use of scale-able technology-based interventions/approaches in this population.


Eligibility Criteria:
Inclusion Criteria:

* PC survivors aged 18 years or older
* Currently sedentary, defined as \<90 minutes per week of activity
* Fluent in English
* Access to a computer with internet connectivity

Exclusion Criteria:

• Men who are or have received chemotherapy
Treatment of Social Phobia With Combined Cognitive Bias Modification and iCBT

The purpose of this study is to determine whether an internet-based treatment program, consisting of combined cognitive bias modification and cognitive behavioral therapy, reduces symptoms of social phobia among a population diagnosed with this disorder.

Previous studies have shown that individuals with social phobia have attention biases, often focusing on or avoiding aversive stimuli (such as judging facial expressions) and thereby reinforcing the bias. Computerized training programs have been developed to implicitly direct the users attention. In this study, such a program -- combined with an established, well-researched and proven effective form of internet-based cognitive behavioral therapy (iCBT) -- will be provided to 128 participants that meet the diagnostic criteria for social phobia, and the pre/post-measurements will be compared. Participants will be randomized to one of two groups, receiving one of two variants of the cognitive bias modification program (both receive iCBT).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided
* Diagnosed social phobia (according to DSM-IV criteria)
* Access to computer with internet connection

Exclusion Criteria:

* Severe depression (and/or suicidal behavior)
* Suffer from other severe psychiatric condition (e.g. psychosis)
* Non-stable use of medication (3 months stable dosage)
* Undergoing other, parallel psychological treatment