cyrilzakka/clinical-trials huggingface dataset:
Effects of Gaseous Cryotherapy on Knee ROM After TKA: A Feasibility Study

A pilot study was performed to investigate the feasibility of a large randomized controlled trial (RCT) to assess the effects of hyperbaric gaseous cryotherapy (HGC) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.

Background: After total knee arthroplasty (TKA), patients can be discharged from hospital as early as two days after surgery. However, patients often do not achieve functional knee flexion range of motion (ROM) in the first postoperative days. Early application of hyperbaric gaseous cryotherapy (HGC) at the operated knee within an hour after surgery and the next postoperative days might increase ROM by reducing inflammation, edema and pain. However, it is unclear whether such early application of HGC is feasible. Moreover, there is no data to allow calculation of the sample size required to conduct a randomized controlled trial to compare the effects of HGC to those of conventional cryotherapy on the increase of knee flexion in the first two days after TKA.

Objectives: To investigate the feasibility of applying HGC within an hour after TKA and twice a day the next postoperative days. To collect data on changes in knee flexion ROM in the first two postoperative days to calculate the sample size required for a large randomized controlled trial. To compare the effects of HGC to those of conventional cryotherapy on changes in knee flexion ROM in the first two postoperative days.

Design: A prospective, single-blinded, randomized, controlled pilot trial.

Setting: Orthopedic postoperative unit in an acute care hospital.

Interventions: Patients were randomly allocated to either hyperbaric gaseous cryotherapy (intervention group) or the ice bag cryotherapy (control group). In each group, participants received the specific cryotherapy intervention at the operated knee within an hour after the surgery (day 0) and twice the next two postoperative days (day 1 and day 2).

Outcome measures: Feasibility measures included the rate of eligible patients who were willing to participate, attrition, adherence to interventions and presence of adverse effects. Active and passive knee flexion range of motion (ROM) and knee pain intensity at rest were evaluated on postoperative days 1 and 2. Change in active and passive knee flexion ROM and in knee pain intensity at rest from postoperative day 1 to day 2 were assessed. Length of hospital stay was collected.

Eligibility Criteria:
Inclusion Criteria:

* Planned unilateral TKA done at Verdun Hospital.
* Capacity to communicate in French or English.

Exclusion Criteria:

* Complications during or after the surgery.
* Inability to perform the tests due to other diseases.
* Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.
Examining the Longitudinal Relationship Between Sleep and Weight Gain in College Students

This two-year prospective, observational study examines the relationship between habitual short sleep and weight gain, as well as the association between habitual short sleep and behaviors that put people at risk of weight gain. Habitual short sleep is defined as sleeping \<6 hours per night on average. Participants will be healthy freshmen college students who are normal weight or overweight. Exclusion criteria include pregnancy, an inability to be ambulatory, currently taking a medication that could influence or interfere with sleep, or reporting a past/current neurological problem, past/current head injury, past/current sleep disorder, current mood, anxiety, or substance use disorder, current psychosis, or current suicidal ideation/plans. Recruitment will be during new student orientations that occur prior to fall semester. Eligibility will be determined using a screening interview, the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult, and DSM-5 Self-Rated Level 2 measures. Eligible participants will be assessed at baseline (time 1), and 8, 16, and 24 months after Time 1. Sleep, physical activity, food/beverages, substance use, and technology use will be collected daily during each eight day recording period. Sleep will be measured with a sleep monitor, activity will be assessed using an accelerometer, food/beverages will be obtained using the National Cancer Institute's Automated Self-Administered 24-hour Dietary Assessment Tool, and substance use and technology use will be measured via self-report. Participants will attend a session after each recording period to have weight and height measured, be scanned via Dual-energy x-ray absorptiometry (DXA), and complete a packet of questionnaires about demographics, health, sleep quality and beliefs, life events, food cravings, and physical development. It is hypothesized that participants will have different habitual sleep trajectories over time. It is also hypothesized that two particular sleep trajectories (stable habitual short sleep and increasingly shorter habitual sleep across time) will be significantly related to weight gain, increased body fat percent, and weight gain risk behaviors (i.e., increased caloric intake and decreased physical activity). Finally, it is hypothesized that the two sleep trajectories will be significantly associated with higher rates of media and technology use and higher rates of problematic sleep-related beliefs/behaviors.


Eligibility Criteria:
Inclusion Criteria:

* College freshmen
* Traditional college age
* BMI from 18.5-29.9.

Exclusion Criteria:

* Neurological problem
* Head injury
* Sleep disorder
* Mood disorder
* Anxiety disorder
* Substance use disorder
* Psychosis
* Suicidal ideation/plan
* Lacking the ability to be ambulatory
* Pregnancy
Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel

The aim of this study was to investigate if using lasers instead of scalpel for flap advancement in bone augmentation procedures would reduce post-operative swelling and pain.

Guided bone regeneration (GBR) is a well established method to augment excessive alveolar bone loss before and at the time of implant placement. Primary closure of soft tissue is a prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key factor for tension free primary wound closure. The tension free flap is usually attained by incising the buccal flap using scalpels. However, this procedure, especially in cases with major flap advancement, results in increased patient morbidity after surgery. Swelling and hemorrhage during the first week after surgery have a negative effect on patient's quality of life.

Currently, lasers are widely used as a tool for soft tissue management and diode laser appears to be an effective tool for incision and excision of the soft tissue. The major advantageous property of lasers is ablation of tissue together with effective hemostasis, minimal swelling and virtually no pain.

Eligibility Criteria:
Inclusion Criteria:

* patients with the need for a single-tooth replacement in the maxilla by implant and simultaneous GBR

Exclusion Criteria:

* general contraindication for bone augmentation or implant surgeries,
* existence of swelling or pain at the time of surgery,
* smoking habits, pregnancy, and lactation.
Safety Education in the Emergency Department: A Pilot Study

The purpose of this pilot study is to assess the feasibility and acceptability of video-based safe firearm storage education in the Pediatric Emergency Department.


Eligibility Criteria:
Inclusion criteria:

* Children \> 30 days and \< 18 years old presenting to the CHCO ED
* Parent/guardian who is ≥ 18 and ≤ 85 years old
* Arms 1 \& 2 will include a subset of patients ≥10 years and \< 18 years old with a firearm in the home.

Exclusion criteria:

* Child is in an emergent/acute medical condition
* Patient seen in our fast track area or other room without a television
* Parent/guardian is non-English speaking.
Exercise Induced Asthma and Airway Reactivity in Athletes

The overall aim is to explore pathophysiological factors related to airway hyperresponsiveness to direct and indirect provocation stimuli in athletes with different sport activities, with special focus on epithelial reaction linked to CC16 and to eicosanoid related inflammatory response. The investigators also wish to compare indirect testing done as hyper osmotic challenge with Mannitol compared to a defined sport specific exercise challenge.

By non-invasive tools the investigators wish to characterize type of airway reaction to various provocative stimuli in athletes doing two different sort activities, Tennis or swimming. As controls are being used sedentary age-matched controls from the same region, exposed to the same school environment. Thus we wish to:

* explore the prevalence of positive mannitol reactivity among swimmers and tennis player and how this relates to symptoms, disease history and to a sport specific exercise provocation test.
* compare the results from sport specific testing with a standardized eucapnic hyperventilation test (EHV)
* compare the overall reactivity to mannitol or EHV among swimmers and tennis players compared to aged matched controls.
* explore the role by CC16 in airway reactivity to different provocative stimuli and to see whether there is a difference between different sport activities, different test protocols and between athletes and controls.
* explore evidence of eicosanoid related inflammatory reaction in athletes and controls in relation to different provocative stimuli

The study population consists of 100 elite swimmers, 100 elite tennis players and 100 non-elite, eged matched controls. In the latter group, 30 are aged matched non-atopic non-asthmatic controls.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 16-19 from Skåne.
* All should approve attendance in the study by signing an informed consent. Igf they are aged under 18, parents should also sign.
* Three groups are included
* Elite aspiring swimmers with an average training intensity of at least hours per week the last year.

Exclusion Criteria:
Study of the ICG Distribution in Breast Tumours or in Axillary Lymph Nodes of Patients After Neoadjuvant Therapy

We will verify if IV injected ICG may colour breast tumors and axillary lymph nodes after neoadjuvant therapy (chemo- or hormonotherapy)

In the operating room:

ICG 0.25 mg/kg will be given as an iv injection at least 20 minutes before the beginning of the operation.

Optionally, dynamic NIR imaging centered on the tumor bearing breast will be acquired during the 15 minutes after injection (in comparison with standards of known fluorescence intensity).

Optionally and in case of tumorectomy, peroperative "in vivo" imaging of the surgical dissection will be acquired. The tumour and/or the mammary piece (and the axillary piece) of dissection will be directly imaged "ex vivo" using the PDE camera (in comparison with standards of known fluorescence intensity).

In the Laboratory of Pathology:

The fresh mammary piece will be processed as usual, but the "gross-thick" sections will be imaged using the PDE and the fluorescent areas will be defined (and later analyzed in comparison with standards of known fluorescence intensity).

After fixation, the tumoral tissues as well as - if identified - non tumoral fluorescent foci will be thereafter processed "as usual".

All the slides obtained will be analyzed using the NIR fluorescent microscope for the presence or not of detectable ICG and the ICG-positive tissues or compartments (vascular spaces, interstitial spaces, normal and/or tumoral cells, macrophages...) will be determined.

If fluorescent foci are identified at the level of the axillary piece, they will be isolated and analyzed like the other lymph nodes. Using the NIR fluorescent microscope, these isolated macroscopically fluorescent structures will be analyzed (lymph node? Other?).

Additionally, metastatic lymph nodes will also be controlled for their microscopic fluorescence or not.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathological diagnosis of mammary cancer who have received neoadjuvant therapy and are candidate, either for tumorectomy, or for mastectomy with complete axillary node dissection,
* Informed consent form signed.

Exclusion Criteria:

* Diagnosis of mammary cancer established, either by tumorectomy, or by "gross" biopsy,
* Age less than18 years old.
* Inability to give informed consent.
* History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
* Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
* Documented coronary disease.
* Advanced renal impairment (creatinine \> 1,5mg/dl).
* During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
* Pregnancy, breastfeeding
Intramuscular Lipid and Insulin Action:Ethnic Aspects

High levels of the hormone insulin are associated with risk for heart disease and diabetes, and may make it hard to lose weight. The types of food eaten may affect insulin levels. The purpose of this study is to determine if manipulation of dietary carbohydrate content improves insulin sensitivity (Si), augments weight loss, and promotes weight loss maintenance in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

Overweight, age 21-50 years,Women must be premenopausal, Normal glucose tolerance, weight stable for at least 6 months with a weight change no greater than 5 lbs.

Exclusion Criteria:

Exclusion criteria were type 1 or type 2 diabetes, polycystic ovarian disease, BMI \<26.5 or weight \>300 pounds, weight change \>5 pounds in last 6 months, regular exercise \>2 hours per week, pregnancy, currently breastfeeding, cholesterol medications, any disorders of glucose or lipid metabolism, use of medication that could affect body composition or glucose metabolism (including oral contraceptives and blood pressure medications), current use of tobacco, use of illegal drugs in last 6 months, history of hypoglycemic episodes, major food allergies or food dislikes, women with inconsistent or absence of monthly menstrual cycles, and a medical history that counter-indicated inclusion in the study.
Physiotherapy vs Telerehabilitation After Volar Plating of Distal Radius Fracture

Trial purpose is to research the outcome comparing traditional physiotherapy vs telerehabilitation after volar plating of distal radius fracture.

Patients with distal radius fracture that meet the operative criteria set by the Finnish Current Care guidelines are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo operative treatment and traditional physiotherapy vs telerehabilitation.

Baseline data is collected preoperatively and patients are followed at 1, 3 and 12 months after enrollment. The primary end-point is 3 months and the primary outcome is the Patient-Rated Wrist Evaluation (PRWE).


Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture, which applies the surgical requirements
* age between 18 to 65 years
* Non concomitant injuries including ligament injuries and distal ulna fractures, however ulnar styloid avulsion is accepted
* No significant comorbidities
* No previous problems with the examined hand
* Ability to understand Finnish fluently

Exclusion Criteria:

* High energy or multiple injuries
* Open fractures
* Injury of both upper extremities
* Other operative injury on the same side
* Rheumatoid arthritis of other inflammatory joint disease
* Heavy smoker (over 20 cigarettes per day)
* Disease of medication slowing ossification
* Alcohol or drug abuse
* Psychiatric disorder with poor treatment balance
* Neurological disorder which affects the function of the injured extremity
* Fixation material other than a volar locking plate
* Fracture fixation is not stable enough to start rehabilitation after 14 days
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients

The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic GIST patients suitable for TKI treatment
* GIST patients pursuing preoperative neoadjuvant TKI treatment

Exclusion Criteria:

* Patients with contraindications to MRI and/or TKI treatment. For patients with renal failure, CT without intravenous contrast will be performed according to clinical practice.
* Patients who do not sign the consent paper for any reason or do not accept the study premises or patients who wish to withdraw for any reason during the study
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis

To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.

The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.

Eligibility Criteria:
Inclusion Criteria:

* A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.
* Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:

I History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)

II Signs: 1) presence of follicles, 2) presence of a preauricular node

III Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation

Exclusion Criteria:

* Patients with allergy to corn starch, talcum powder, or dacron will be excluded.
* Patients with a corneal ulcer or history of recent trauma will also be excluded.
* Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.
* Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.
Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose

Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.

This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.

Eligibility Criteria:
Inclusion Criteria:

* Same Wrinkle Severity Rating Scale score at both Nasolabial Folds (either both Moderate \[3\] or both Severe \[4\])

Exclusion Criteria:

* Active or chronic skin disease, inflammation or related conditions, near or on the Nasolabial Folds
* Subjects who had undergone procedures based on active dermal response (e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the Nasolabial Fold area
Supporting Treatment Adherence for Resilience and Thriving (START)

This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.


Eligibility Criteria:
1. Assigned male at birth;
2. Identifies as male;
3. Age 18 or older;
4. Reads and speaks English;
5. Continental US residency;
6. Reports ever having had anal sex with a man;
7. Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
8. Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports \< 90% adherence to ART;
9. Screens positive for a moderate or severe stimulant use disorder in the past 3 months with an abbreviated version of the National Institute on Drug Abuse (NIDA)-modified Alcohol, Smoking and Substance. Involvement Screening Test (ASSIST);
10. Has an iPhone or Android smartphone;
11. Is willing to participate in an mHealth intervention

Exclusion Criteria:

1. HIV-negative or never tested for HIV;
2. HIV-positive men without a current ART prescription;
3. Does not return a viable DBS specimen at baseline for viral load testing
4. Not a sexual minority man
Study to Determine If the Volume Used to Dilute BOTOX Cosmetic™ for Injection Affects Its Overall Effect and Duration.

It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.

The study was designed to test this thinking, using the crow's feet wrinkles as the treatment area.

It is thought that the amount of fluid used to dilute Botox for injection has an effect on the quality of the result and the duration of effect on the treatment of upper face rhytides, even though the dose remains the same.

20 female subjects (10 per site), who fit the inclusion/exclusion criteria for study participation were injected with 5 units of Botox (one injection each side) into the crow's feet area. The injections were prepared with one side randomly receiving a five fold difference in volume for dilution.

Response to treatment was evaluated at 14 days, 30 days, 60 days and 90 days after the injection visit. Standardized photography was taken at each visit.

Analysis of the photographs of the lateral orbital (crow's feet rhytides) at maximum attempted contraction (maximum smile) was done by Canfield Scientific, Inc., using a specialized software program created to detect and measure changes.

Eligibility Criteria:
Inclusion Criteria:

* Female outpatients; at least 18 years of age
* Subjects of childbearing potential must have a negative urine pregnancy test result at the Baseline/Screening Visit and practice a reliable method of contraception throughout the study.
* Bilaterally symmetric moderate (score 2 on Allergan Photonumeric Guide for Crow's Feet) Lateral Orbital Rhytides at maximum smile

Exclusion Criteria:

* Subjects who are pregnant, are planning a pregnancy during the study period, have an infant they are breast feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
* Subjects with a history of injection to the lateral orbital area with botulinum toxin type A within one year of baseline visit.
* Subjects with a history of adverse reaction to botulinum toxin type A.
* Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert syndrome, Amyotrophic Lateral Sclerosis, or any other disease which might interfere with neuromuscular transmission.
* Subjects with a history of facial nerve palsy.
* Subjects with profound atrophy or excessive weakness of muscles in the target areas for injections.
* Subjects with a systemic infection or an infection at the injection site.