cyrilzakka/clinical-trials huggingface dataset:
Upper Airway Ultrasound in the Assessment of Difficult Visualization of the Larynx

failed and Difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. There are several conventional clinical airway assessment parameters such as the modified Mallampati classification,thyromental and hyomental distance, interincisor distance, neck movementsand neck circumference, which are usually used to predict a difficult airwayand are components of multivariate risk indices. Despite the use of these parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. Ultrasound has been evolving as a useful device for airway assessment,and sublingual ultrasound has been used for this purpose.

By an anesthesiologist who is experienced in airway ultrasound, patients will preoperative sonographic assessment . the patient will lie in the ramped up position , with head in the neutral position.The linear probe of the ultrasound machine will be used. Under the patient's chin, The probe of ultrasond will be placed , at different levels, to get the of the submandibular area in transverse view and the upper part of the neck. The transverse view will be used for measuring the the skin to hyoid, tongue volume,and the skin to epiglottis distance. The mid-sagittal view will be used for measuring the distance between epiglottis ,pre-epiglottic space , vocal cords, and the neck fat volume .

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients above 18 years of age.
2. Both genders
3. Patients scheduled for elective surgery under general anesthesia
4. Obese patients with BMI \> 30 kg/m2

Exclusion Criteria:

1. Patients with psychological disorders or those lacking co-operation.
2. Patients with maxillofacial anomalies, restricted neck movements and limited mouth opening.
3. American Society of Anesthesiologists (ASA) physical status class IV
4. Emergency operations
Effect of Lactobacillus Paracasei PS23 on Improving Aging and Muscle Loss in the Elderly

This study refers to the supplementation of PS23 in human experiments to help the elderly maintain muscle mass, delay muscle loss, promote physical activity, and delay the occurrence of disability and debilitation in elderly people.

Taiwan has become an aging society in recent years. There are important issues to attenuate aging and activate the potential capacity of elderly population. The physical function of middle-aged and older people will degenerate with age and produce age-related diseases. Common symptoms are organ function deterioration, and old age disability caused by malnutrition and muscle loss is also a common care problem. Therefore, how to prevent the complications of muscle loss is one of the important ten years of geriatric research. Although past research has been confirmed, it can improve the debilitating condition of the elderly through nutrition counseling and exercise intervention. However, there is not much in-depth discussion on how probiotics can improve muscle loss and delay symptoms in elderly people. Therefore, this study refers to the supplementation of PS23 in human experiments to help the elderly maintain muscle mass, delay muscle loss, promote physical activity, and delay the occurrence of disability and debilitation in elderly people. One hundred and twenty elderly people will be recruited and then divided into three groups with 40 people in each group: (A) placebo group, (B) PS23 probiotic group, (C) PS23-HT prebiotic group, supplemented for 12 weeks. The diet record, functional test and muscle mass will be carried out every six weeks after the start, to understand whether PS23 is effective in improving muscle loss and weakness in elderly people.

Eligibility Criteria:
Inclusion Criteria:

* age between 65 and 85 years old

Exclusion Criteria:

* Have taken antibiotics within one month or are receiving antibiotic treatment
* Have used probiotic products in powder, capsule or tablet form within two weeks (except for yogurt, yogurt, Yakut and other related foods)
* People allergic to lactic acid bacteria products
* Patients diagnosed with stroke or hypertension (systolic blood pressure greater than 139, diastolic blood pressure greater than 89)
* Exclusion of limbs and hips that have been replaced with artificial joints
* Persons with incapacity/insufficient decision-making ability
* Who has been determines that it is not suitable to participate in the research.
Evaluation of the Role of Connected Scales in the Therapeutic Care of Hematology Patients

In this research, we will evaluate the feasibility of following by remote monitoring, using a connected scale, in hematology patients suffering from myeloma or lymphoma and requiring treatment with chemotherapy. 30 patients will be included in the research and will all use a connected scale for the duration of their participation (7 weeks +/- 1 week). During their participation, patients will be asked to weigh themselves once a day, ideally at a set time. Patient data will be accessible by the medical team via a remote monitoring platform.

Alerts will be generated in the event of abnormal development of certain clinical parameters (weight, heart rate, etc.) allowing early treatment to be implemented by the medical team.

At the end of their participation, we will evaluate patients' support and perception of this tool, as well as the healthcare consequences of the alerts generated by the remote monitoring platform.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over (male or female)
* Patient suffering from aggressive non-Hodgkin's lymphoma or multiple myeloma with a plan for systemic chemotherapy or having started two cycles or less or patient with the need for therapeutic intensification under the cover of autograft in the context of myeloma or lymphoma
* Patient who can be contacted by telephone during their participation in the research
* Patient able to return home at the end of their initial hospitalization
* Patient affiliated to social security
* Patient able to read and speak French
* Patient having signed free, informed and written consent

Exclusion Criteria:

* Patient with an estimated life expectancy \< 3 months
* Patient with moderate to severe cognitive impairment (assessed by MMSE \< 20)
* Patient with a psychiatric or physical disability that does not allow the use of the device
* Patient with a pacemaker
* Patient participating in another intervention research project
* Pregnant patient
* Patient deprived of liberty
* Patient under legal protection (guardianship or curatorship)
Nonoperative Treatment of Acute Achilles Tendor Rupture

A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.


Eligibility Criteria:
Inclusion Criteria:

* acute achilles tendon rupture with clear onset of symptoms
* closed rupture
* resides in the catchment area of our hospital district

Exclusion Criteria:

* avulsion fractures in the calcaneus
* unwillingness to participate
* inability to communicate using Finnish language
Fecal Microbiota Transplantation in Cirrhosis

Patients with cirrhosis were recruitted and divided into cintrol group and FMT group. Patients in FMT group were carried by fecal microbiota transplantation, and biochemical indexes, intestinal flora and intestinal HIF expression were observed before and after FMT respectively.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cirrhotic
* aged 18-80 years.
* must be able to cooperate with treatment

Exclusion Criteria:

* Patients with severe cardiac, pulmonary and renal dysfunction;
* Patients with severe hypertension and cerebrovascular accidents;
* Patients with liver cancer or active infection are in the active stage of hepatic encephalopathy or gastrointestinal bleeding;
* Prothrombin activity ≤40%, platelet count \< 50\*10\^9/L;
* Patients with intellectual and language disorders and mental disorders;
* Probiotics with antibiotic and drug grade were used within 3 months prior to sampling;
* There are prehepatic or posthepatic portal hypertension reasons;
* Drug history: anticoagulant therapy, use of antiplatelet drugs, and current use of beta blockers, statins or interferon (IFN) treatment;
* Peptic colon examination contraindications, such as intestinal perforation, intestinal obstruction, etc.
* Other researchers believe that patients should not be included in the group.
Topical Treatments for Ankle Sprains

Our aim was to evaluate the effects of topical analgesic drugs on rapid recovery of joint functions and pain relief in acute ankle injuries.

A total of 100 patients were included in the study and divided into 2 groups as Diclofenac and Etofenamate. The pain scores of the patients were evaluated with the Numeric Rating scale and Wong-Baker scale before and after treatment. Dorsiflexion and plantarflexion active joint movements were measured with a hand-held goniometer for joint function before and after treatment.

We found that ankle sprains were more common in men. In our study, we found that both topical analgesics were effective in improving joint movements and reducing pain.


Eligibility Criteria:
Inclusion Criteria:Those over the age of 18, who applied to the emergency room within the first 48 hours after an ankle sprain, who have grade 1/mild and grade 2/moderate ankle sprains, who have excluded fractures and dislocations, who have no muscle-tendon ruptures, no vascular or nerve injuries, no open wounds or burns, whose vital signs are stable, and who give written and verbal consent.

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Exclusion Criteria:Those who did not present within the first 48 hours of ankle sprain, grade 3/severe ankle sprain, multiple trauma, pregnancy, suspected pregnancy, foot and ankle fractures and dislocations, those who had a previous ankle operation or fracture, and cases who did not accept to participate in the study

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Treatment With hOKT3gamma1(Ala-Ala) in T1DM

This is a phase II study to examine the clinical and immunological effects of humanized FcR non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop this therapy to prevent the immune destruction leading to β cell loss.

This is a 2-arm, open-label phase II trial involving 0 or 3 cycles of treatment 6 months apart with hOKT3γ1 (Ala-Ala), over the first year of disease in participants with new onset T1DM. Each cycle consists of 12 daily doses of hOKT3γ1 (Ala-Ala).

Participants will be randomized in a ratio of 2:1 to either the experimental arm or the control arm and will be stratified by study site.

To be eligible, participants must be: male or female between 7-30 years of age, diagnosed with T1DM within the past 6 weeks, have a body weight ≥26 kg at the time of enrollment and have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days).

Participants randomized to the experimental group will start the first cycle of hOKT3γ1 (Ala-Ala) within 4-8 weeks of T1DM diagnosis. Each participant randomized to the experimental group will receive 3 cycles of drug treatment, separated by 6 months each. Each cycle consists of 12 days of drug treatment.

Both groups will undergo the Mixed Meal Stimulated C-Peptide Test and receive blood draws for mechanistic studies on the same schedule.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with T1DM within the past 6 weeks
* have a body weight ≥26 kg at the time of enrollment
* have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days).

Exclusion Criteria:

* Pregnant or lactating females;
* Prior OKT3 treatment;
* Known hypersensitivity to murine products;
* Uncompensated heart failure or fluid overload, recent myocardial infarction;
* History of epilepsy, cancer, active infection, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease, any concurrent autoimmune diseases, asthma;
* Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial;
* Inability to give informed consent;
* Prior participation in a clinical trial that could potentially affect diabetes or immunologic status;
* Participation in a clinical trial within the last 6 weeks;
* HIV positive;
* Positive for Hepatitis B surface antigen or Anti-Hepatitis C antibody;
* Seropositivity for Toxoplasmosis (IgG);
* Lymphopenia (\<1000 lymphocytes/microliter);
* Thrombocytopenia (\<150,000/mm3 platelets);
* Anemia (Hgb \< 10g/dL);
* Vaccination with a live virus within the past 6 weeks;
* Positive PPD skin test;
* Any infectious mononucleosis-like illness within the 3 months prior to enrollment;
* Serologic evidence of acute infection with EBV or CMV based on tests listed and as defined by the protocol.
Prospective and Comparative Analysis of Arthroscopic and Open Surgery for Hallux Rigidus

Comparison between arthroscopic and open surgery for hallux rigidus.


Eligibility Criteria:
Inclusion Criteria:

* Hallux rigidus

Exclusion Criteria:

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Role of Circulating Tumour DNA Testing in Assessing for Alterations of Primary Anti-EGFR Resistance in RAS/RAF Wild-type Metastatic Colorectal Cancer Patients

The study aims to explore the clinical utility of circulating tumour DNA (ctDNA) in assessing for alterations of anti-epidermal growth factor receptor (EGFR) primary resistance in RAS and BRAF wild-type metastatic colorectal cancer (CRC) patients treated with anti-EGFR monoclonal antibodies (cetuximab / panitumumab) in combination with fluorouracil (FU)-doublet chemotherapy.

A single blood sample (20mL) will be collected after the patient has given informed consent. The blood sample will be collected within 4 weeks prior to the patient starting chemotherapy. Blood samples collected will be processed in accordance with the Guardant360 Clinical Blood Collection Kit instructions (Guardant Health, Inc.).

Patient outcomes with respect to response rate, progression-free survival, overall survival, toxicities and other co-morbid conditions will be ascertained by medical record review conducted by the study personnel. Prospective clinical data that will be collected include: patient demographics, tumor stage and pathological tumor characteristics at diagnosis, laboratory data at diagnosis and serial pre-specified time points, imaging outcomes, chemotherapy information, date of recurrence, and date and cause of death.

Although the data will be censored at the study end-points, the patient's medical record will be reviewed indefinitely to follow the health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed stage IV colon or rectal cancer who are RAS/BRAF wild-type by routine tumor profiling and who are beginning standard-of-care treatment with fluorouracil-based doublet chemotherapy in combination with anti-EGFR monoclonal antibodies. Prior treatment with adjuvant therapy is allowed if completed more than 6 months prior to relapse of disease.

Exclusion Criteria:

* Pregnant women will be excluded from the study.
* Patient unable to give informed consent will be excluded from the study.
* Patients who have previously received chemotherapy in the metastatic setting.
* Patients who have previously received adjuvant chemotherapy less than 6 months prior to relapse of metastatic disease.
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).

Deficits in general emotion regulation skills have been shown to be associated with various mental disorders. Thus, general affect-regulation training has been proposed as promising transdiagnostic approach to the treatment of psychopathology. In the present study, we aimed to evaluate the efficacy of a general affect-regulation as a stand-alone, group-based treatment for depression. For this purpose, we randomly assigned 218 individuals who met criteria for major depressive disorder (MDD) to the Affect Regulation Training (ART), to a waitlist control condition (WLC), or to a condition controlling for common factors (CFC). The primary outcome was the course of depressive symptom severity as assessed with the Hamilton Rating Scale for Depression and the Beck Depression Inventory. Differences between groups will be analyzed with the help of multi-level analyses. To clarify mechanisms of change we will test whether changes in emotion regulation skills will mediate potential differences between conditions regarding change of depressive symptoms. As secondary goal, the study will try and clarify whether participating in ART might augment the efficacy of subsequent individual cognitive-behavioral therapy.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MDD according to DSM-IV criteria as the primary diagnosis
* age 18 and above
* sufficient German language skills

Exclusion Criteria:

* high risk of suicide
* indication of substantial secondary gain
* currently in psychotherapeutic treatment with an institution/professional other than those involved in the study
* co-occurring psychotic, bi-polar, and/or substance disorders
* organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment
Dose Proportionality Study About Amaryl M Slow Release (SR) 1/500 mg

The pharmacokinetics of glimepiride and metformin will be compared after single dose intake of both combinations in order to answer to the following questions:

* Is there a dose proportionality effect between Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?
* What is the safety profile of Amaryl M SR 1/500 mg and Amaryl M SR 2/500 mg?


Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 to 45 years of age, inclusive (Age based on the date to give the informed consent)
* Ideal body weight (Broca index): between 50 to 90 kg, inclusive, and within ±20 % of Ideal Body Weight, \[(Height in cm-100)×0.9\]
* Subjects who are appropriate to participate in this study judged from clinical laboratory and physical examinations taken within 4weeks prior to the start of study
* Subjects who are able to abstain from caffein or caffein-containing products (e.g., coffee, cola, tea, chocolate), grapefruit and grapefruit containing products, alcohol and smoking within 72 hours before dosing and during the hospitalization
* Subjects who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

* History of allergies including drug allergy, except untreated, asymptomatic, seasonal allergies at the time of dosing
* Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 10 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included)
* History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
* History of a significant surgical resection of gastrointestinal tract except appendectomy
* Abnormal clinical laboratory findings, especially for AST or ALT\> 1.25 fold of upper normal limit
* Evidence of alcohol abuse (defined as regular alcohol intake that exceeds 24 oz \[675 ml\] of beer, 12 oz \[340 ml\] of wine or 160 ml of soju or 3 oz \[85 ml\] hard liquor \[e.g., brandy, whiskey, gin\] per day) or drug abuse
* Heavy smokers (\> 10 cigarettes per day), or can't quit smoking during hospitalization
* Participation in clinical trials of any drug within 3 months prior to the participation of the study
* Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study \[Day 1\].
* Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or HIV antibody
* Judged to be inappropriate for the study by the investigator
Brain Metastasis in Breast Cancer Patients

The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.

A retrospective cohort study will be conducted in the Henry Ford Health System (HFHS). Using medical record review, we will identify all women diagnosed with advanced stage (stage III and IV) breast cancer between January 1, 1995- December 31, 2007. For each case included in the study, we will obtain data on demographics, tumor information, treatment related medical encounters and procedures, and occurrence and timing of brain and/or other distant metastases. The main outcome for this study is the development of distant metastases. Each patient in the cohort will be classified as to the occurrence and date of distant metastases. Metastases will be classified as Brain, Distant lymph node, Lung/pleural effusion, Liver, Bone, Other visceral, Other non-visceral.

Other secondary outcomes to be explored include:

* Survival after advanced breast cancer-time in months from the date of advanced stage breast cancer diagnosis until death or end of study period
* Time to brain metastases-time in month from the date of advanced stage breast cancer diagnosis until brain metastases diagnosis
* Survival after brain metastases-time in months from the date of diagnosis of brain metastases until death or end of study period

Eligibility Criteria:
Inclusion Criteria:

* Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 2007;
* At least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
* Age 30 years or older at diagnosis.

Exclusion Criteria:

* Does not have at least one year of follow-up after initial diagnosis (among patients who did not die before one year of follow-up); and
* Age less than 30 years or older at diagnosis.