cyrilzakka/clinical-trials huggingface dataset:
Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study

In this study the investigators want to measure the impact or effects of adding cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in skin temperature above the injured tissues is presume to have a positive effect in the healing process. The combination of conservative care and cryostimulation could then be appreciated. The investigators chose to measure these effects with 3 elements: visual analog pain scale, validated elbow questionnaire and pain free grip strength. This pilot study consist in a two arm design, each arm including 15 patients.

Lateral epicondylitis is one of the most prevalent upper limb conditions that can affect up to 1-3% of the active population. Invalidity and health care costs incurred by this condition are posing a real challenge to our societies knowing that the natural history of the lateral epicondylitis can last from 1 to 2 years. Many therapies have been tested and so far none has proven conclusive when used alone so far (Blanchette and Normand 2011). The use of cryostimulation is widespread in the sport scene without strong literature supporting its evidence. The aim of this study is to quantify the effects of cryostimulation when added to conservative care in the treatment of chronic lateral epicondylitis.

Thirty (30) patients will be divided randomly in two groups:

* The control group (n=15) will receive conservative care including myofascial trigger points (involved forearm) and radial head mobilisations (Bergmann \& Peterson, 2010).
* The experimental group (n=15) will receive the cryostimulation and the conservative treatment as mentioned above.

A total of eight treatments will be given to each patient; the whole protocol lasting four to six weeks. The treatments will be delivered by experienced and trained clinicians in cryostimulation and myofascial treatment protocols.

The effects of the two treatment protocols will be monitored by a validated elbow questionnaire (PRTEE, (Rompe, Overend et al. 2007)), a visual analog pain scale and the pain free grip strength at three moments: at inclusion, at the ninth visit and 3 months after the last treatment.

Eligibility Criteria:
Inclusion Criteria:

* Must have pain at lateral elbow (lateral epicondylitis) for at least six months
* Pain must not come from trauma
* Painful palpation of the lateral epicondyle
* At least one out of two positive test: Cozen's, Mill's

Exclusion Criteria:

* Fibromyalgia
* Diabetes
* Patient taking more than three medications at the time of inclusion
* Cervical radiculopathy
* Painful shoulder
* Cold intolerance / allergies
* Smoking
* Cortisone infiltration at the painful lateral epicondyle in the month previous to the inclusion
Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME

To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.

In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME.

To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.

Eligibility Criteria:
Inclusion Criteria:

* Age: above 40 years old.

  * Patients with type two diabetes mellitus of more than 5 years duration.
  * Patients with Best corrected visual acuity better than 3/60.
  * Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit.
  * No evidence of vitreomacular traction.
  * Lens status: Pseudophakia or clear crystalline lens.

Exclusion Criteria:

Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).

* Ischemic maculopathy by FFA.
* Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally.
* Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula.
* Presence of proliferative diabetic fibrovascular membranes threatening or at the macula.
* Presence of diabetic optic atrophy or neuropathy.
* Presence of neovascular glaucoma.
* Cataractous lens either preoperatively or as intra or postoperative complication.
* Vitrectomized Eyes.
* A prior intraocular surgery within the past six-months.
* Lost follow up
Acceptance and Efficacy of Live Supervision

In order to meet an existing lack of empirical studies in the field of cognitive behavioral therapy supervision, the present randomized controlled trial is aimed at comparing two different types of supervision. This study compares computer-assisted live supervision and delayed video-based supervision regarding efficacy and acceptance among therapists, patients and supervisors. The efficacy of supervision is defined on different levels such as change of psychotherapeutic competence, nondisclosure, self-efficacy, self-awareness of the supervisee as well as therapeutic alliance, supervisory alliance and therapy outcome.


Eligibility Criteria:
Supervisees

Inclusion Criteria:

* Having successfully completed the interim audit
* Having started to treat ambulant patients under supervision

Exclusion Criteria:

-

Patients

Inclusion Criteria:

* Meeting ICD 10 criteria for a mental disorder
* Informed consent

Exclusion Criteria:

* Currently in psychotherapy
* Suicidal tendency
* Clinical diagnosis of alcohol or drug addiction, acute schizophrenia, schizoaffective disorder or bipolar disorder
Effect of Positive-word Stimuli on the Limits of Stability During Multi-direction Reach Operation in Standing Position

The purpose of the study was to examine the immediate effect of positive-word stimuli on the limits of stability during multi-direction reach operation in standing position in healthy young adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 24 years of age
* Males and Females

Exclusion Criteria:

* Person with physical disability that is enough to interfere with daily life
Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)(TERMINATED)

The purpose of this study is to determine the overall survival of patients diagnosed with Stage 3b or 4 non-small cell lung cancer (NSCLC) treated with an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 66336) in combination with paclitaxel and carboplatin with that of patients treated with placebo in combination with paclitaxel and carboplatin.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
* Age greater than or equal to 18 years old
* ECOG performance status of 0 to 1
* Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
* Meets protocol requirements for specified laboratory values
* Written informed consent
* Appropriate use of effective contraception if of childbearing potential
* Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease

Exclusion Criteria:

* Prior chemotherapy for any stage of NSCLC
* Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
* Concurrent treatment or treatment within the last 2 years for any other malignancy
* Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
* Medical conditions that would interfere with taking oral medications
* Patients with bone metastases as the only site of disease
* Pregnant or nursing women
* Known HIV positivity or AIDS-related illness
* Patients with significant QTc prolongation at baseline
Effectiveness of Auxiliary Segmental Lingual Appliances in Leveling the Curve of Wilson at Second Molars

This study aims to evaluate the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar) will be recruited.. Using a split-mouth design, one side will receive the intervention (auxiliary segmental lingual appliances), while the other side will serve as the control. The variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. Measurements will be taken on digital impressions at baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after applying the auxiliary segmental lingual appliances. The effectiveness will be assessed by comparing the two groups.

This study focuses on evaluating the effectiveness of auxiliary segmental lingual appliances in leveling the Curve of Wilson at the second molars in patients undergoing labial fixed orthodontic treatment. The study will recruit patients who exhibit an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar). A split-mouth design will be employed, where one side of the mouth will receive the intervention (auxiliary segmental lingual appliances), and the other side will serve as the control.

The primary variables measured include the Curve of Wilson at the second and first molars, and the distance from the mesiolingual and distolingual cusps of the second molar to the occlusal plane of the first molar. These measurements will be taken using digital impressions at three different time points: baseline (T0), after leveling with a stainless steel labial archwire (T1), and three months after the application of the auxiliary segmental lingual appliances.

The study aims to compare the effectiveness of the auxiliary segmental lingual appliances by analyzing the differences between the intervention and control sides. This comparison will help determine the impact of the appliances on achieving a more balanced and functional occlusal plane, potentially improving orthodontic treatment outcomes for patients with malocclusion issues.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing labial fixed orthodontic treatment.
* Patients exhibiting an excessive (deep) Curve of Wilson at the second molar bilaterally (meaning lingually inclined mandibular second molar).
* Patients willing to participate and provide informed consent.

Exclusion Criteria:

* Patients with limited mouth opening and gagging reflex preventing placement of auxiliary segmental lingual appliances.
Nellix® Registry Study: EVAS-Global

This registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System.

Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.

1. Baseline: medical history, physical exams, CT image, bloodwork,
2. Procedure: implantation information
3. Discharge: Physical exam, bloodwork and adverse events, if any
4. Follow-up according to institutional standard through to 5 years including Physical exam, CT image or standard of care imaging eg Doppler Ultrasound, bloodwork and adverse events, if any

Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 18 years old
2. Subject has signed informed consent for data release
3. Subjects with AAA and eligible for endovascular repair

Exclusion Criteria:

1. Currently participating in another study where primary endpoint has not been reached yet
2. Known allergy to any of the device components
3. Pregnant (females of childbearing potential only)
Use of Standing Frame and "Innowalk Pro" in Patients With TBI

This study will explore physical and physiological responses to mobilization of patients with acquired brain injuries in subacute phase using a classic standing frame and a standing device with simultaneous passive movement of legs, "Innowalk Pro".

Several studies underline the importance of early mobilization of patients with brain injuries, leading to shorter hospital stays, less contractures, and improved general function.

The routine mobilization treatment in the rehabilitation of patients with severe brain injuries in Sunnaas Rehabilitation Hospital is initial use of a tilt table where tilt angle is gradually increased, and when tolerated, standing in a classic standing frame where the patient's lower body is fixed to the device in an upright standing position.

"Innowalk Pro" is a robotic standing device where legs are fixed, but passively moved by electric motors in an upright standing position. An assumption is that standing in "Innowalk Pro" might be better tolerated at an earlier stage of rehabilitation than standing in a classic standing frame.

Eligibility Criteria:
Inclusion Criteria:

* Severe brain injury / stroke \<1 year post injury.
* Medically stable
* Paresis in lower extremities, minimal walking function (even with personal assistance) (FIM movement (walk), score 1-2)
* Planned stay in Sunnaas RH for a minimum of 2 weeks from time of inclusion
* Tolerate 5 minutes in 40 degrees 'upright' position in tilt table (custom orthostasis test)
* Body weight ≤95 kg
* Body height ≤190 cm

Exclusion Criteria:

* Fractures in the lower extremities or in the columna with movement or strain restrictions or with pain.
* Aggressive and provocative behavior that affects the ability to collaborate.
* Other conditions where upright position is contraindicated
Pain Assessment by Pupil Dilation Reflex (PDR) and Pupillary Pain Index (PPI) in Response to Noxious Stimulation in Anesthetized Adults

After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively.

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled abdominal or gynecological surgery
* ASA I-II

Exclusion Criteria:

* History of eye deformity, invasive ophthalmologic surgery
* Known cranial nerve(s) deficit
* Infection of the eye
* Predicted difficult airway management (DAF Guidelines)
* Chronic opioid use (\>3 months)
* Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
* Preoperatively administrated benzodiazepins or antiemetics
Clinical Performance Evaluation of AQT90 FLEX TnI and TnT

The AQT90 FLEX Troponin I (TnI) and Troponin T (TnT) Tests are in vitro diagnostic assays intended as an aid in the diagnosis of myocardial infarction (MI) in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX TnI and TnT assays for both whole blood and plasma in the intended use population.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 21 years of age or older.
* Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
* Subject is presenting to the ED with acute chest pain or equivalent ischemic symptoms suggestive of ACS or MI (e.g., acute chest pain/pressure, shortness of breath, discomfort in upper extremity, jaw or epigastrium, diaphoresis, nausea, vomiting, lightheadedness, dizziness, weakness, and/or syncope).

Exclusion Criteria:

* Subject is pregnant or may be pregnant.
* Subject has an invalid written informed consent or has withdrawn consent.
Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.

Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.

Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Scheduled for elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

* Emergency procedures
* Scheduled for heart or lung transplantation
* Scheduled for ventricular assist device implantation
* Use of the Medtronic Elongated Once-Piece Arterial Cannula
* Diagnosed with sepsis
* Diagnosed with delirium
* Experiencing hemodynamic instability (heart rate \> 100 and systolic blood pressure \< 90)
* Requiring mechanical circulatory support
* Requiring vasoactive medications
Comparison of Rice Based-meal on Functional Constipation in Young Korean Women

This study was conducted to investigate the effects of rice based-meal on functional constipation in young Korean women.

Studies comparing and evaluating the effects of a rice-based diet and a wheat-based diet on bowel movements are insufficient. In summary, efficient measures are needed to help individuals consume enough dietary fiber from natural sources in daily life to improve their bowel movements, rather than to consume a fiber supplements separated or synthesized from a particular natural food. In this study, investigators compare and evaluate the effects and safety of eating rice-based diets (brown rice-based and white rice-based) and a wheat-based diet in terms of bowel health and bowel movements among young women with functional constipation.

Eligibility Criteria:
Inclusion Criteria:

* Age of 19 to 30 years females
* Meet of Rome Ⅲ diagnostic criteria of functional constipation
* Ability to give informed consent

Exclusion Criteria:

* Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, cardiovascular disease
* Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
* Known history of moderate to severe hepatic impairment (i.e., serum ALT\>1.5×ULN, AST\>1.5×ULN)
* Subjects with significant hypersensitivity about brown rice, polished rice, wheat, milk
* Regular ingestion of probiotic products
* Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
* Subjects who participated in other clinical investigation within 2 months prior to first administration
* Subject who drink constantly (21 units/week over)
* Subject who are pregnant or breast feeding
* Subject who have irritable bowel syndrome by ROME Ⅲ criteria
* Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study(i.e., laboratory test and others)
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
* Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m²
* Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
* Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)

Exclusion Criteria:

* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
* Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
* Are treated with a CSII (insulin pump)