cyrilzakka/clinical-trials huggingface dataset:
A Study Called VICTORIA to Learn More About How Well Larotrectinib Works in Adults With TRK Fusion-positive Cancer by Comparing Larotrectinib Data From Clinical Studies With Data of Other Treatments From Actual Practice

This is an observational study in which patient data from the past of adult people with solid tumors harboring NTRK gene fusion are studied. This study will focus on 5 tumor types which have been at the late stage or have spread to other parts of the body. These 5 tumor types are:

* Non-small-cell-lung cancer
* Colorectal cancer (located in the intestine)
* Thyroid cancer
* Sarcomas (located in the connective tissue like bones or body fat)
* Salivary gland carcinoma

In some people with cancer, the cancer cells have specific changes in their building plans (genes) called NTRK gene fusion. NTRK stands for neurotrophic tyrosine receptor kinase, the specific gene that is changed. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive. While NTRK is the gene, TRK (tropomyosin receptor kinase) is the name of the protein. The specific cancer is therefore also called TRK fusion-positive cancer.

The study drug, larotrectinib works by blocking the altered TRK fusion protein. Larotrectinib is already available in the US, Europe, and in other countries and is approved for doctors to prescribe to patients with TRK fusion cancer.

The main purpose of this study is to learn more about how well larotrectinib works in adults with TRK fusion-positive cancer compared to other treatments. Researchers will compare how long participants who received larotrectninib lived to how long participants who received other treatments lived. To do this, larotrectinib data from past clinical studies will be compared with data on other treatments gathered from different health data sources. The data will cover the time between January 2013 and end of August 2022.

Besides this data collection, no further tests or examinations are planned and no visits are required in this study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced stage of disease or metastatic disease.

Exclusion Criteria:

* Patients involved in TRK inhibitor clinical trials will be excluded from RW control cohort.
Perilunate Management

Perilunate injuries can be debilitating injuries that involve the carpus. These can limit patients' functionality both acutely and long-term. Not only do their potential for nerve injury increase risk of lasting weakness and chronic pain, but their complex surrounding involving the carpus also leads to potential for misalignment when healing. The approach for treating perilunate injuries often relies on internal fixation, prompting the need for surgery. However, there is no clear recommendation for whether to pursue open or arthroscopic surgery as both offer benefits and pose risks.

The aim of this study is to determine the similarities and differences in outcomes for management of perilunate injuries.

Perilunate injuries are those that affect the wrist, which can be debilitating to patients. Often, these injuries require surgical treatment, which can either be performed open or arthroscopic. There is currently no consensus for which approach offers better outcomes. Therefore, this study will allocate patients who require surgical treatment of perilunate injuries to either open or arthroscopic surgical intervention to compare their outcomes. The results will offer insight into the compromises made with each surgical approach and create a foundation orthopedic surgeons can leverage to decide how to manage a patient to ensure best possible outcomes.

This study will involve 12 patients who were identified as having perilunate injuries requiring orthopedic surgical treatment. Their participation will involve consenting to be randomly allocated to the surgical approach, and they will be asked to complete commonly used orthopedic surveys (eg DASH score) that are used to evaluate the functional healing of their injury. They will be followed for up to 1 year after their surgery. A chart review will be conducted to follow their progress and surgical outcomes.

Patients will be recruited from Grady Memorial Hospital. No specimens will be collected or banked for this study.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (18 years old and older).
* Patients requiring surgical intervention for a perilunate injury will be consented and then randomly allocated to either open or arthroscopic surgery.

Exclusion Criteria:

* Prisoners will not be included in this study.
* Patients younger than 18 years old and pregnant patients will be excluded from this review.
* Patients who require specific surgical approach for their treatment, cannot be randomly allocated to one of the study arms, so will be excluded from this study.
* The study will not include data from minors, cognitively impaired individuals, or individuals who are vulnerable to coercion or under influence.
Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss

Results are inconsistent and further studies are needed to better understand the impact of bariatric surgery on the bone-BMA relationship depending on the type of bariatric surgery: RYGB vs. SG. Future studies are also needed to define the molecular mediators of bone loss and BMA changes. Several molecular mediators have been considered including gut hormones, adipokines, gonadal hormones and more recently G-CSF. However, the evidence to support any of these alone or in combination as primary mechanisms of bone loss is scant.

The study will be to explore potential changes in BMA after bariatric surgery and search for possible associated factors. Specifically, we want to investigate if such changes in BMFF differed in participants among different surgical types (RYGB vs. SG) and diabetic status. Secondly, we want to explore factors associated with BMFF changes including metabolic homeostasis (glycemic control and blood lipid levels), adipokines (leptin and adiponectin), calciotropic hormones (Ca++, PTH...), body composition parameters and bone markers (cross-laps, P1NP and sclerostin). We hypothesize that the BMFF would particularly decrease after RYGB compared to SG and that participants with T2D would have a larger decrease in BMFF than participants without T2D.


Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women (defined as last menses \>12 months)

* Obesity with a BMI ≥ 35 kg/m²,
* Patients with an indication for bariatric surgery with two surgical techniques, RYGB and SG, but who have never had a bariatric surgery procedure previously,
* Enrollment will be stratified for each surgical techniques, RYGB and SG, by preoperative diabetes status, defined by having HbA1c \>6.5% or a prior physician's diagnosis of diabetes plus use of an antidiabetic medication.
* Patients who have signed the informed consent.

Exclusion Criteria:

* women who were pre- and perimenopausal and men in order to minimize sex hormone and BMA changes unrelated to the surgical procedure.
* women who used medications known to impact bone metabolism or BMA, including bisphosphonates, teriparatide, denosumab, hormone replacement therapy (HRT) and oral glucocorticoids (\>5mg prednisone equivalent daily for\>10 days in the last 3 months.
* Other exclusion criteria included prior bariatric surgery, estimated glomerular filtration rate \<30 mL/min,
* any contraindication to magnetic resonance imagery (MRI).
Ablation Index Guided High Power Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation

The investigators will compare the ablation time during pulmonary vein isolation of Ablation Index-guided high power ablation with those with conventional ablation.

Ablation time of conventional group will be used from OPTIMUM study. For secondary outcomes, acute outcomes of pulmonary vein isolation using two different strategies will be compared. During 1 year of follow-up in both groups, atrial fibrillation recurrence will be evaluated. The atrial fibrillation recurrence rate at 1 year after pulmonary vein isolation will be compared between the two groups. In addition, fluoroscopic time, procedure time, and complication rates for the high power ablation group will be compared with those with conventional power.

Ablation Index guided high power ablation will be performed in 70 patients with atrial fibrillation with prospectively and consecutively. A contact force-sensing catheter will be used. Ablation will be performed with point-by-point technique using Visitag automated annotation criteria as below;

Ablation Index(AI) target:

* Anterior/roof : 450 AI
* Anterior near carina area : 500 AI
* Posterior/inferior/carina : 350 AI
* Posterior near carina area : 400 AI
* Area near esophagus :25W, 15sec or 300 AI (no further ablation if esophageal temperature increase more than 39°C)
* Interlesion distance ≤ 4.5mm

VISITAGTM settings

* 2.5mm stability range
* 7 sec stability time
* FOT 25%, 3g force
* Tag size 2mm

Ablation parameters are preset as below;

* RF power range: 40W at anterior/roof, 30W at posterior/inferior, 25W at near esophagus area (decrease power 5W by operator decision)
* Target contact force range: 10-20 g
* Flow rate:
* 8 ml/min for STSF \< 30W
* 15 ml/min for STSF ≥ 30W

Acute reconnection will be analysed according to predefined segments.

Subgroup analysis will be performed according to type of AF. Data of patients with paroxysmal atrial fibrillation and persistent atrial fibrillation will be analysed separately, and investigate whether this new ablation strategy is effective in both group of patients. To compare outcomes with OPITMUM phase 2 study, the proportion of patients with paroxysmal and persistent atrial fibrillation would be 75% and 25%. Therefore, 53 patients with paroxysmal atrial fibrillation and 17 patients with persistent atrial fibrillation will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic paroxysmal or persistent AF who failed anti-arrhythmic agents

Exclusion Criteria:

* Patients who had previous ablation for AF
* Patients with left atrial diameter more than 50 mm
* Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist (VKA) or non-VKA (NOAC) agent
* Known severe left ventricular systolic dysfunction (ejection fraction \<35%)
* Pregnancy
Outcome of Discharged HFmrEF Patients

This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who discharged from the Xiangtan Central Hospital. Through the long-term follow-up the cardiovascular outcome of patients being discharged from the hospital, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.

This study aimed to define the independent risk factors related cardiac events (cardiac death or heart failure-related hospitalization) among heart failure with mildly reduced ejection fraction (HFmrEF) patients who hospitalized in Xiangtan Central Hospital from January 1, 2015 to August 31, 2020. The patients would be clinically followed-up until August 31, 2021 per clinical visit or telephone call, the risk factors related to cardiovascular outcome (cardiac death or heart failure-related hospitalization) will be explored to provide clinical evidence to intervene the discharged HFmrEF patients aiming to improve patients outcome in the future clinical practice.

The clinical features of hospitalized heart failure with mildly reduced ejection fraction (HFmrEF, EF 41-49%) will be analyzed by retrospectively by reviewing patients medical records, laboratory and clinical imaging examination results during initial hospitalization, clinical outcome of enrolled patients will be obtained through clinical visit and telephone call. The primary endpoint is the composite cardiac events (cardiac death or heart failure related rehospitalization). The secondary endpoint is the all-cause death.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: Heart failure with mildly reduced ejection fraction (HFmrEF) Presence of symptoms and/or signs of HF, and a mildly reduced LVEF (41- 49%); Elevated natriuretic peptides (BNP \>35 pg/mL or NT-proBNP \>125 pg/mL); Other evidence of structural heart disease.

Exclusion Criteria:

* none
Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger

In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.

Exclusion Criteria:

* Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
* Patients with multiple trigger fingers
AM-111 in the Treatment of Acute Inner Ear Hearing Loss

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);\*
3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;
4. Age ≥ 18 and ≤ 65 years on the day of screening;

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Bilateral ISSNHL;
2. Acute hearing loss from noise trauma, barotrauma or head trauma;
3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;
4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
5. History of acoustic neuroma or other retrocochlear damage in the affected ear;
6. History of otosclerosis in the affected ear;
7. Suspected perilymph fistula or membrane rupture in the affected ear;
8. Congenital hearing loss;
9. History of ISSNHL in the past 2 years;
10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;

Other protocol-defined exclusion criteria may apply.
Respiratory Training in Friedreich's Ataxia

This is a prospective interventional study of patients with Friedreich's Ataxia that receive respiratory strength training for a period of 12 weeks with two research visits at the beginning and at the end of the study period. Visits include swallowing evaluation with fiberoptic endoscopic evaluation of swallowing, pulmonary function testing, surface electromyography and patient surveys.


Eligibility Criteria:
Inclusion Criteria:

* confirmed genetic testing of Friedreich's Ataxia
* have an overall DIGEST score of 1 or higher based on FEES screening
* are able to perform pulmonary function testing

Exclusion Criteria:

* have been on antibiotics within 15 days prior to baseline screening.
* have been prescribed systemic corticosteroids or neuromuscular blocking agents within 15 days of the baseline screening
* have an allergy or contraindication to topical lidocaine or oxymetazoline
* have any other concurrent medical condition which, in the opinion of the investigators, would make the subject inappropriate to participate in testing or respiratory exercise
A Study of Baricitinib (LY3009104) in Healthy Chinese Participants

The main purpose of this study is to investigate the safety and tolerability of the study drug known as baricitinib in healthy Chinese participants. The study will measure how the body absorbs, breaks down and gets rid of baricitinib. The study will last about 20 days, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy Chinese males agreed to use methods of birth control or are postmenopausal Chinese females, as determined by medical history and physical examination
* Have a body mass index of 19.0 to 24.0 kilograms per meter squared (kg/m²), inclusive, at screening.
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
* Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.

Exclusion Criteria:

* Have a history of adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications.
* Have an abnormality in the 12-lead electrocardiogram (ECG).
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
* Have a history of stomach or intestinal surgery.
* Current or recent history (\<30 days prior to screening of a clinically significant bacterial, fungal, parasitic, viral (not including rhinopharyngitis), or mycobacterial infection.
* Have an absolute neutrophil count (ANC) less than 2000 cell/microliter (μL) (2 x 109/liter \[L\]).
* Have current herpes zoster or simplex within 90 days prior to the first dose,
* Have evidence of active or latent tuberculosis (TB)
* Have used or intend to use over-the-counter, prescription medication, or Chinese herbal preparation within 14 days prior to dosing and during the study.
* Have consumed grapefruit, grapefruit juice, or grapefruit products within 7 days prior to the first dose or are unwilling to abide by the grapefruit restrictions during the study.
Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Has participated in a prior study with AXS-07 for the treatment of migraine

Exclusion Criteria:

* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Impact of Photobiomodulation on Pain Associated With Orthodontic Treatment

Orthodontic treatment can cause pain. Research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment. In this study, data was collected from the medical charts of patients who had orthodontic treatment and recorded their pain levels for 1 week at the beginning of orthodontic treatment while they used a light therapy device or did not use at device. This collected information was used to see if the light therapy device could lessen orthodontic pain.

Orthodontic treatment can cause pain. This type of pain is the most common reason why patients stop orthodontic treatment or don't follow the instructions from the orthodontist. A company called PBM Healing has made a dental device called PBM Ortho that is used inside the mouth like a mouthguard. This device uses light therapy called photobiomodulation (PBM) to help with healing, move teeth faster, and lessen inflammation and pain. Other research studies have shown that light therapy can help reduce pain that is caused by orthodontic treatment.

In this research study, information from patients' medical charts was collected from 7 dental clinics located in Japan. Some patients at these clinics were asked to use the PBM Ortho device every day for 1 week and to record how much pain they were having. Other patients that did not use this device were simply asked to record their pain level every day for 1 week. This collected information was used to see if the light therapy device could lessen this pain from orthodontic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy male and female patients (age 18 - 65), i.e., did not suffer from systemic illness nor require medication during the study period.
* Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
* Orthodontic treatment using clear aligners or fixed appliances via non-extraction therapy.
* Non-smoker with no use of chewing tobacco.
* Good oral hygiene.
* Caries free.
* No sign of periodontal disease.

Exclusion Criteria:

* Systemic diseases
* Medication use for the past 6 months; especially use of anti-inflammatory (e.g., NSAIDs)
* Smoking.
* Active dental caries.
* Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
* Sleep apnea and other airway pathologies
* Photosensitivity or use of drugs that may cause photosensitivity
* Use of osteoporosis drugs
* Epilepsy
* Patients who had an implanted cardiac device unless the device is known to not be affected by magnetic fields