cyrilzakka/clinical-trials huggingface dataset:
Development of a Test Battery for Measurement of Knee Function in Patients With Patellar Instability

About six months after patella stabilizing surgery postoperative restrictions are commonly lifted and patients may consider whether a return to activity/sports is feasible. Currently, there are no evidence-based criteria to determine a patients readiness for sports and/or activity (RTS) following stabilizing surgery. The purpose of this project was therefore to investigate the feasibility of a test battery to evaluate knee function in postoperative follow-up evaluation - and in RTS decisions - for patients with patellar instability. Banff Patellofemoral Instability Instrument 2.0 and Norwich Patellar Instability Score is being translated and validatend in a Norwegian population. Furter is patients experience of living with patellar instability explored.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone surgical treatment for recurrent patellar dislocation in Helse Vest. The investigators will include patients with reconstruction of the medial patella femoral ligament, trochleaplasty, tibial tubercle osteotomy, Insall or concomitant procedures.

Exclusion Criteria:

* Unable to give written informed consent.
* Medial patellar dislocation.
* unable to understand written or spoken Norwegian.
* patients with other knee injuries.
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)

The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of relapse without increasing the risk of graft-versus-host disease.

Transplant patients participating in this clinical trial will receive one of 3 standard pre-transplant chemotherapy preparative regimens as appropriate for their specific disease. They will then receive a standard non-manipulated donor stem cell infusion on transplant day (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor stem cell infusion on day +7.

Eligibility Criteria:
Inclusion Criteria:

* Neoplastic hematological disorder with indication of allogeneic transplant
* No available suitable HLA-matched donor
* Adequate cardiac, pulmonary, renal, and hepatic function
* Karnofsky performance status score greater than or equal to 70%

Exclusion Criteria:

* Medication non-compliance
* No appropriate caregiver identified
* Uncontrolled medical or psychiatric disorder
* Active central nervous system (CNS) neoplastic involvement
* Known allergy to Dimethyl Sulfoxide
* HIV1 or HIV2 positive
* Pregnant or breastfeeding
INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement.
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential.

Exclusion Criteria:

* Physical status of ASA III, IV, or V
* Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Subjects wearing acrylic nails or subjects refusing to remove nail polish
* Subjects who have a nail deformity on the measurement finger
* Subjects who do not have adequate skin integrity on the measurement finger
* Excluded at the Principal Investigator's discretion
Study of Wound Packing After Superficial Skin Abscess Drainage

Superficial skin and soft tissue abscess are frequently managed by opening them up with a procedure called "incision and drainage". It is routine practice in the United States to place packing material inside the abscess cavity after opening them up, in order to promote better wound healing and limit abscess recurrence. However, this practice has never been systematically studied or proven to decrease complications or improve healing. Patients with wound packing usually return to the emergency room or practice setting for multiple "wound checks" and dressing/packing changes which lead to missed days from work or school and utilization of healthcare resources. This procedure can often be painful and may even require conscious sedation (and the risks entailed) especially in children. With rates of superficial skin and soft tissue abscesses on the rise, and emergency room resources being stretched, it is important to determine whether packing wounds is necessary or even advantageous to patients.

This study is the first to systematically evaluate the efficacy of wound packing after superficial skin or soft tissue abscess incision and drainage in children. The investigators will be evaluating wound healing, complications, recurrence and pain associated with packing both short and long term. In addition, the investigators will also be evaluating the utility of bedside point-of-care ultrasound use in predicting the presence of pus inside the abscess cavity. This test may be useful to determine whether incision and drainage is necessary for an individual who has a skin infection that is suspicious for an abscess.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 - 24 years (i.e. any child seen in PED)
* Suspected abscess deemed to need incision \& drainage by attending physician or fellow
* Size of abscess is greater than or equal to 1cm
* Parent or patient consent, and child assent

Exclusion Criteria:

* Location of abscess on face, perianal, or genitals
* History of recurrent or chronic abscess
* Multiple abscesses requiring drainage at current visit
* Immunocompromised or unstable patient
* HIV, transplant recipient, immune deficiency syndrome
* immunosuppressive medications
* Wound already open/draining
* Previous participation in trial
* Patient will not be following up / managed by PES (e.g. surgical site)
Study Of Fluticasone Propionate/Salmeterol In Asthmatic Subjects

The aim of the present study is to investigate whether the effects of salmeterol in combination with fluticasone propionate on blood markers of airway inflammation are maintained after chronic dosing and whether the effect is influenced by the time of allergen challenge relative to the time of dosing.

A 12-week, randomised, double-blind, placebo-controlled, three-period, cross-over pilot study comparing the effect of salmeterol/fluticasone propionate, fluticasone propionate and placebo on perpheral blood eosinophils and serum IL-5 in response to allergen challenge in asthma subjects when allergen challenge is administered at 1 hour or 11-12 hours post-dose of the dosing interval

Eligibility Criteria:
Inclusion Criteria:

* Informed consent.
* Outpatient.
* Male or non-pregnant/non-lactating female.
* Aged 18-55.
* Diagnosis of asthma.
* Pre-bronchodilatory FEV1 \> 75% predicted.
* Using inhaled short-acting beta-2-agonists (SABA) with no inhaled corticosteroids.
* Judged capable of withholding SABA for at least 6 hours prior to visits.
* Reversibility of \>12% and 200mL or PC20 of \<8mg/mL.
* Demonstration of atopy

Exclusion Criteria:

* History of life-threatening asthma.
* Use of proscribed asthma medications.
* Use of anti-histamines or potent inhibitors of CYP3A4.
* Respiratory tract infection.
* Asthma exacerbation with 4 weeks of Visit 1.
* Subjects with exercise induced asthma only.
* Concurrent respiratory disease.
* Other clinically significant, uncontrolled condition or disease.
* Use of any investigational drug within 30 days.
* Allergic to beta-2-agonists, inhaled corticosteroids or excipients.
* Positive pregnancy test.
* Using immunosuppressive medications.
* Milk protein allergy.
* Factors likely to interfere with attendance.
* Current smokers or ex-smokers with a history of \>10 pack years.
* Affiliation wih Investigator site.
* Medications that may affect the course of asthma or interact with sympathomimetic amines.
Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test

Evaluate the effects of topical C-82 in a psoriasis plaque test.

The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate chronic stable plaque type psoriasis
* plaques thickness of at least 200 µm
* lesion(s) on the trunk or extremities (excluding palms/soles)
* skin must be without disease findings

Exclusion Criteria:

* other skin disease
* psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
* treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
* treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
* treatment with any biologics within 3 months preceding and during the trial
* known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol)
* drug or alcohol abuse
* symptoms of a clinically significant illness within 4 preceding and during the trial
* participation another clinical trial within 4 weeks of this clinical trial
Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes

This study will recruit subjects online and randomly assigned them to one of four arms. The arms vary by clinical decision (colorectal cancer screening or treatment of high cholesterol) by video order (poor shared decision making followed by good or good shared decision making followed by poor). Participants will view two videos and complete the Shared Decision Making process survey along with a few other measures after each video. Our main hypothesis is that respondents watching the good shared decision making videos will score higher on the Shared Decision Making Process survey compared to those watching the poor videos.

Study staff are working with a national sampling firm to recruit subjects and obtain 400 responses. Subjects were randomly assigned to one of four arms. (1) Colorectal cancer screening good shared decision making video then poor video second (2) Colorectal cancer screening poor shared decision making video then good video (3) Treatment of high cholesterol good video then poor video and (4) Treatment of high cholesterol poor shared decision making video first then good video. Participants completed measures of Shared Decision Making after each video.

The sample size was determined to ensure sufficient power to detect differences between the good and the poor shared decision making videos in this repeated measure design and analyses were planned to be separate for each arm (i.e. one analysis for the colorectal cancer screening videos and a separate parallel analysis of the statins for high cholesterol video). To detect an eta2 effect size of .04 with an alpha of 0.05 with 80% power would require 190 observations per clinical condition. Study staff rounded this to 200 observations per clinical condition, for a total required sample size of 400 patients.

The interventions were short Shared Decision Making Videos that were developed as part of two training courses on shared decision making by investigators at Massachusetts General Hospital.

For the analyses, study staff will examine the descriptives of the Shared Decision Making Process items for the two clinical conditions and orders. Study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. Then, study staff examine discriminant validity of the measure by examining whether scores for the good videos are higher then for the poor videos. Further, study staff will examine concurrent validity with the alternative shared decision making measure.

Eligibility Criteria:
Inclusion Criteria:

* Speak English
* No prior diagnosis of colorectal cancer
* No history of heart attack
* No history of stroke

Exclusion Criteria:

* None
Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions

Standard treatment for esophageal lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility Criteria:
Inclusion Criteria:

* symptomatic esophageal malignant lesions (primary solid tumors or metastases from solid tumor);
* age\>18 years;
* ECOG performance status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region
Clinical Trail to Evaluate the Efficacy and Safety of DWJ1451

* the change of sitSBP based on baseline between Treatment arm and control 1 arm \[ Time Frame: 8 weeks \]
* the change of LDL-C based on baseline between Treatment arm and control2 arm \[ Time Frame: 8 weeks \]


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 80 years
* patients with hypertension and hyperlipidemias

Exclusion Criteria:

* orthostatic hypotension
* History of ventricular tachycardia, atrial fibrillation
* uncontrolled diabetes mellitus
Dual-antiplatelet Therapy Strategies for Elective PCI in a Real-world Setting

To assess the safety and efficacy of in-laboratory clopidogrel loading dose administration before ad-hoc PCI versus clopidogrel preloading treatment in patients planned for diagnostic angiography with optional ad-hoc PCI.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women aged at least 18 years
* Scheduled for diagnostic CAG due to suspected obstructive coronary artery disease

Exclusion Criteria:

* Presence of contra-indications for the use of clopidogrel (hypersensitivity or known allergy to clopidogrel, severe liver insufficiency, resent or active pathological bleeding, patients known to be poor CYP2C19 metabolizers, patients using pharmacological CYP2C19 inhibitors and inducers)
* Patients using clopidogrel for other reasons than the scheduled diagnostic CAG (e.g. due to previous stroke)
* Patients using P2Y12 inhibitors other than clopidogrel (e.g. prasugrel, ticagrelor, cangrelor)
* Patients using VKA (e.g. acenocoumarol, fenprocoumon)
* Patients using DOAC/NOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)
* Inability to give informed consent (e.g., language barrier)
* Patients who have a documented mentioning of previous denial to any trial participation in the electronic patient dossier
Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension

This study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.

This will be a single centre, single arm, prospective cohort study. Patients with refractory hypertension will receive single fraction stereotactic radiotherapy for renal denervation. The study has been designed in a careful and stepwise dose escalation fashion in order to minimize the potential risks associated with this innovative technique. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as optimal dose of maximal effect. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies.

Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria associated with the procedure through 90 days. Efficacy will be evaluated by assessing mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 55 and ≤ 75 years. Systolic blood pressure of 160 mmHg or greater despite being treated with at least three hypertensive drugs for more than 3 months.

Exclusion Criteria:

GFR \< 45 ml/min/1.73 m2. Known causes of secondary hypertension. Hospitalized for hypertensive crisis within 1 year. History of acute coronary syndrome or cerebrovascular accident within the last 6 months.

Pregnancy or have a pregnancy plan. Contrast media or iodine allergy. History of abdominal radiotherapy or adhesive intestinal obstruction. Severe valvular heart disease. Stenosis \>50% or renal artery aneurysm in either renal artery. Others.
The CArdiovasCulAr Diabetes & Ethanol (CASCADE) Trial

Moderate alcohol may be beneficial for diabetics


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of type 2 diabetes
* Male or female alcohol abstainers (not more than 1 drink/week)
* Age between 40-75 yrs
* Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months

Exclusion Criteria:

* The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion
* Triglycerides \> 500 mg/dL
* HbA1c\<7 or \> 10%
* Serum creatinine \> 2 mg/dl
* Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST)
* Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy)
* Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness
* Patients with chronic hepatitis (C,B)
* Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants
* Presence of active cancer, or chemotherapy within the past 3 years
* Major illness that may require hospitalization
* A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse
* Pregnant or lactating woman
* Participation in another trial with active intervention
Animated Cartoons and Cooperation in Young Children Receiving Inhaled Medications

Up to 50% of infants and young children cry during the administration of their inhaled treatment for their asthma. This results in decreased lung deposition, and thus decreased effectiveness of their inhaled treatment.

The objective of this study is to evaluate whether animated cartoons can increase the cooperation of young children with asthma who are not cooperative during the delivery of their ICS therapy through a pMDI/spacer.


Eligibility Criteria:
Inclusion Criteria:

* Dyad parent-child.
* Parent must be 18 years or older and own a smartphone which can record videos and display animated cartoons.
* Child must be 6-47 months old, and require an inhaled corticosteroid therapy, and use a pressurized metered-dose inhaler and a spacer, and have difficulties in cooperation at least half of the time on the last week.

Exclusion Criteria:

* Children with a medical history of epilepsy, or visual or hearing impairment not corrected by an appropriate device/treatment.
* Parents not speaking French or English.
* Parents not able to run the mobile application used to record the videos of the child despite repeated explanations.
The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling

The number of smartphone users in Taiwan continues to increase exponentially. Smartphone addiction tends to not only disrupt the ability of social communication but cause physical and psychological problems as well. This study examined the relationship among skin conductance, electroencephalography, heart rate variability (HRV), social interaction anxiety and smartphone addiction among Line apps users, and we also tried to identify associated factors for further interventions.


Eligibility Criteria:
Inclusion Criteria:

(a) were older than 20 years of age and (b) used a smartphone with internet and Line app.

Exclusion Criteria:

the participants were those who (a) had alcoholism or drug dependence; (b) had any pre-existing major mental disorders; (c) had history of brain injury; and (d) had palmar hyperhidrosis.
Cardiac Monitoring of Post-Operative Cancer Patients Experiencing Atrial Fibrillation

The purpose of this study is to assess whether it is possible and acceptable to monitor patients at a distance who experience a condition called atrial fibrillation after their cancer surgery. Some patients have no other clinical reason for staying in the hospital after cancer surgery except in order to control their heart rhythm. Being able to send these patients home earlier and monitor them at a distance from their home can be good for their quick recovery. Studies have shown greater quality of life and patient satisfaction when patients are monitored at a distance for conditions like atrial fibrillation, however cancer patients have not been studied.


Eligibility Criteria:
Inclusion Criteria:

* Post-Operative cancer patients experiencing atrial fibrillation and otherwise clinically ready to be discharged.
* Must attend two outpatient visits at MSKCC's cardiology practice during the study period, as specified by the participant's Attending.
* Must be older than 21 years of age.

Exclusion Criteria:

* Non-English speaking patients