cyrilzakka/clinical-trials huggingface dataset:
LMA® Gastro Airway Versus Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography

Comparison of second generation supraglottic airway devices about anesthesiologist, endoscopist and patient, which used for gastrointestinal procedures. The investigators believe that the endoscope will be easier to reach by the part of GLT extending to the esophagus, but the structural stiffness of this part may damage the esophageal mucosa. On the other hand, since the endoscopic canal of the LMA® Gastro ends at the upper end of the esophagus, it may be more difficult to orient the endoscope to the esophagus, but it may be superior in terms of ventilation efficiency. Therefore these two device worth for comparing.

Supraglottic airway (SGA) devices are produced for avoiding endotracheal intubation for anesthesic interventions. Second generation SGA's like GLT and LMA® Gastro airway are using for endoscopic biliopancreatic procedures. Both of them have an airway canal and endoscopic canal. Although they can use for same reason, their designs are different. So, their airway securities, endoscopic manipulations and complications, would be different.

This study planned as single blind. American Society of Anesthesiologists (ASA) Physical status 1-2 100 patients which will be take endoscopic retrograde cholangiopancreatography (ERCP) included. The study starts after randomization and ends after discharge from the recovery room. All patients will be monitorised for hemodynamic parameters. Depth of anesthesia will be provided by bispectral index (BIS) monitoring. After anesthesia induction SGA will placed by an experienced anesthesiologist. Bilateral chest movements and auscultation, capnogram graphy and oropharyngeal leak pressure test will be used for confirmation of placement. After procedure endoscopist will take pictures of esophagus and hypopharynx. After extubation and sufficient consciousness and breathing of patient, patients will be transferred to post-anaesthesia care unit (PACU). Vital parameters will continue to monitoring in PACU. Patients will be discharge as usual with an Aldrete score ≥ 9.

Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1-2
* Elective Procedures
* Weight 50-100 Kg

Exclusion Criteria:

* Laryngeal mask airway contraindications.
* Anesthesic drug allergies
* Height \<155 cm
* Body Mass index \> 35 kg/m2
* Alcohol or narcotic drug usage
* Restrictive or obstructive pulmonary diseases
* Hepatic cardiac or renal failure
* Psychotic problems
* Neurologic or cognitive deficiencies.
* Pregnancy
* Difficult airway or facial deformities
* Previous cervical surgery or cervical radiotherapy
* Previous esophagus surgery
* High risk of pulmonary aspiration
Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia

The purpose of this study is to demonstrate the superior efficacy of NK-104-CR 8 mg daily compared to Livalo® IR 4 mg daily on fasting serum low-density lipoprotein cholesterol (LDL-C) reduction and to evaluate the comparative safety of NK-104-CR 8 mg daily to Livalo® IR 4 mg daily after long-term treatment


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with primary hyperlipidemia or mixed dyslipidemia
* Patients for whom lipid-lowering therapy is indicated according to NCEP ATPIII
* Patients who are naïve to statin or who are able to safely discontinue the use of all lipid-lowering agents for 4 weeks before randomization and throughout study participation

Exclusion Criteria:

* Homozygous familial hypercholesterolemia;
* Any conditions which may cause secondary dyslipidemia.
* Newly diagnosed or poorly controlled diabetes mellitus as defined by HbA1c \>9%
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older
* Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
* Planned postoperative admission to the intensive care unit (ICU)

Exclusion Criteria:

* Allergy or hypersensitivity to dexmedetomidine or the placebo study medication
* Preexisting diagnosis of Alzheimer's Disease or Related Dementia, severe cognitive impairment or delirium at baseline
* Severe liver failure (Child-Pugh score \> 5)
* History of obstructive sleep apnea
* Severe deficit(s) due to structural or anoxic brain damage
* Undergoing a surgical procedure requiring total circulatory arrest
* SARS-CoV-2 positive or symptomatic (e.g., fever, cough, loss of taste/smell)
* Blind, deaf, or unable to communicate in English
* Patients experiencing circumstances for which long-term follow-up might be difficult (e.g., homelessness, active psychotic disorder, or substance abuse)
* Co-enrollment in other interventional studies that, in the opinion of the site investigator and/or PI, might interfere with study participation, collection, or interpretation of the study data
Familial Aggregation and Biomarkers in REM Sleep Behaviour Disorder.

In this cohort study, the investigators aim to study the familial aggregation of REM sleep behavior disorder (RBD) and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.

REM sleep behavior disorder (RBD) is a parasomnia characterized by abnormal behavioral manifestations during REM sleep. Previous case-control studies and prospective studies have documented the progression of α-synucleinopathy neurodegeneration in relation to RBD and have identified some biomarkers of predicting neurodegeneration in patients with iRBD, such as olfactory dysfunction, color vision deficit, autonomic dysfunction, tonic EMG activity during REM sleep, and psychiatric disorder. However, these biomarkers might precede the onset of RBD, as a result, searching for biomarkers for the neurodegeneration before RBD onset is helpful to map the progression of neurodegeneration. In this regard, the investigators aim to study the familial aggregation of RBD and its core features, and compare the differences in major biomarkers of neurodegeneration, including percentage of EMG activity during REM sleep, cognitive functions, autonomic dysfunction, and psychiatric disorders, between unaffected first degree relatives of RBD cases and non-RBD controls.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese aged 40 or above;
2. Being capable of giving informed consent for participation of the study;
3. Sex matched between relatives from probands and controls.

Exclusion Criteria:

1. Aged 39 or below;
2. Not capable of giving informed consent for participation of the study
A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease.
* Study treatment must be first-line therapy for Stage IV or recurrent disease.
* Participants in all parts of the study must have:
* measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v1.1)
* an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* a life expectancy of at least 3 months at the time of first dose

Exclusion Criteria:

* Untreated symptomatic central nervous system metastases
* Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies
* Participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results

Note: Other protocol-defined inclusion/exclusion criteria apply.
A Study of MEDI9253 in Combination With Durvalumab in Select Solid Tumors

Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced/metastatic solid tumors.

Up to approximately 192 participants may be assigned to study intervention in the study across approximately 30 sites globally.

Eligibility Criteria:
Inclusion Criteria:

1. Participant must be at least 18 years old at signing of informed consent.
2. Body weight \> 35 kg at screening

Exclusion Criteria:

1 Primary central nervous system (CNS) disease is excluded, as well as untreated or uncontrolled metastatic CNS involvement, leptomeningeal disease, or cord compression.

NOTE: CNS disease that has been treated and stable/controlled for at least 3 months is permitted. Participants with CNS disease controlled via systemic steroids are not permitted.
Hair Regeneration in Androgenetic Alopecia

This clinical trial study aims to compare the effectiveness and safety of secretome from ADSCs with minoxidil in AGA cases, to provide future reference or standard in the application of cell-based therapy and its derivatives in AGA cases. The subject of this study is androgenetic alopecia population. The main questions it aims to answer are:

* Is the secretome of ADSC's effective compared to minoxidil?
* Is the secretome of ADSC's safe compared to minoxidil?
* Is the combination of the secretome of ADSC's and minoxidil better in safety and effectiveness compared to secretome or minoxidil alone?

This study was a single-blind clinical trial using an experimental research design on subjects with androgenetic alopecia. Variables tested in this study were the method of "treatment of AGA by administering secretome concentrate alone, compared to using minoxidil alone and with a combination of both."

Subjects were divided into 3 groups:

* 20 subjects received secretome
* 20 subjects received minoxidil
* 20 subjects received both treatments Participants will undergo history taking, and a physical examination (including vital signs, body weight, and hair pull test). Pictures of patients' head were then taken and the hair loss degree was graded using Hamilton-Norwood. Hair growth was evaluated every month starting from months 0, 1, 2, and 3. Clinical assessment of hair growth was examined through physical and supporting examinations including photography, trichoscan, and trichoscopy.

The sample size for this study was calculated with the help of G\*Power version 3.1 software (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany).

The inclusion and exclusion criteria are applied. Statistical data were analyzed using SPSS® version 21 software. On numerical data, normality analysis was carried out using the Kolmogorov-Smirnov test.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18-59 years
* Clinical presentation of AGA with Hamilton-Norwood Grade III-VI
* Willing to be a research subject, sign a consent form, and commit to regular follow-up visits

Exclusion Criteria:

* Hair loss other than AGA, including telogen effluvium, alopecia areata, trichotillomania, secondary syphilis, systemic lupus erythematosus hair loss due to chemotherapy, autoimmune conditions, or malignancies.
* Patients taking oral medications or vitamins aimed at increasing hair growth in the last month
* Patients applying topical medications aimed at increasing hair growth in the last 2 weeks
* Patients with active bacterial, viral, or fungal infections on the scalp
* Patients undergoing AGA therapy cosmetic procedures in the form of PRP injections, laser procedures, or micro-needling in the last 3 months
Targeted Decision Making In Renal Cell Carcinoma Relying on a Radiogenomics Translational Platform

This project aims to provide an accurate strategy to guide the decision making relying on tumor biopsies using standard histology, immunohistochemistry (IHC), spatial transcriptomics, genomics combined with Magnetic Resonance Imaging (MRI) and radiomics. Moreover, the investigators will explore potential markers indicative of response to systemic agents or ablative therapy.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a renal mass up to 4 cm
* Adult \> 18 years
* Candidate to renal surgery
* Informed consent signed

Exclusion Criteria:

* Contraindication for MRI
Healthy Immigrant Families: Working Together To Move More and To Eat Well

This project will broadly explore the efficacy of community participation in the design and implementation of an intervention to improve physical activity and nutrition among immigrant and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 11 years old
* Reside in a household with at least one adult and one child (11-18)
* Not planning to move from the area over the next two years
* Willing and able to participate in all aspects of the study
* Willingness to provide oral informed consent
* Hispanic, Sudanese, Somali
* Residing in Rochester, MN

Exclusion Criteria:

* Self-reported pregnancy
* Self-reported insulin-dependent diabetes
* Self-reported diagnosis of cancer within the past 3 years
* Answer of "yes" to the following question: "Do you know of any reason why you should not do physical activity? For example, would it be unsafe for you to do increased physical activity because of a health problem?"
Open-Label Extension Study of Kuvan for Autism

This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism.

This is an open-label extension study available only to subjects who completed an earlier double-blind, placebo-controlled study of sapropterin in children with autism. During this protocol, all subjects will be receiving brand-name Kuvan 20 mg/kg/day for 16 weeks; subject who complete the first 16 weeks will have the option of continuing on Kuvan at the same dose for up to 90 days after the last subject has completed the first 16 weeks of this protocol. The purpose of the study primarily is to gather additional information on safety and efficacy in this population.

Eligibility Criteria:
Inclusion Criteria:

* All subjects must have completed earlier trial, CHC 0901 (NCT00850070)
* Parents must be willing and able to sign informed consent

Exclusion Criteria:

* Child failed to complete CHC 0901 (NCT00850070)
Improving Treatment of Inflammatory Bowel Diseases Through Better Understanding Infliximab Drug and Antibody Levels

The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients

The use of pharmacokinetic analyses incorporating relevant determinants of the infliximab serum concentration can be used to develop a predictive model that will allow optimized dosing for individual patients.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of CD or UC by usual criteria,
* moderate to severely active CD defined by a CDAI ≥ 220, with confirmed endoscopic activity (CDEIS ≥ 6) or moderate to severely active UC, defined by a Mayo Score ≥ 6, with a Mayo endoscopic subscore ≥ 2,
* a need for treatment with IFX for induction of remission as clinically indicated
* patients previously exposed to adalimumab and/or certolizumab who are naïve to infliximab will be allowed to participate.

Exclusion Criteria:

* perianal CD exclusively
* disease limited to the rectum in patients with UC (i.e., disease must extend ≥ 15 cm from the anal verge)
* patients with known antibodies to IFX (ADAs) at baseline
* a contraindication to infliximab therapy
* a contraindication to endoscopy
* an ostomy
* planned surgery
* evidence of severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease at the discretion of the investigator,
* Pregnancy or breastfeeding,
* treatment with any investigational drug in the past 30 days, or 5 half lives (whichever is longer).
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.


Eligibility Criteria:
Inclusion Criteria:

* Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
* Children who have minimal to moderate inadequate eyelashes due to alopecia areata
* Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion Criteria:

* Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
* Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
* Use of over the counter eyelash growth products within 6 months.
* Use of prescription eyelash growth products (eg, Latisse®)
* Any eye condition that would prevent required ophthalmology exams
Development and Clinical Application of Invalid Foods Using Mealworms

Malnutrition in cancer patients continues after surgery and worsens the patient's overall health and quality of life. Previous studies reported edible insects in patients' diets increased postoperative muscle mass and weight gain. Therefore, by using nutritionally excellent mealworms for a long time, it is proved that nutritional status and survival rate are improved, leading to development of various products of edible insects.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery with pancreaticobiliary disease and liver cancer (metastatic liver cancer)
* Karnofsky performance status ≥ 70
* Patients who can communicate without difficulty in obtaining a consent form for the test

Exclusion Criteria: Patients with any of the following criteria are excluded.

* Patients who underwent palliative surgery
* Patients with uncontrolled pre-operative disease
* Previous history of surgery affecting nutritional status
* Pregnant and lactating women
* Patients with allergy to mealworms
A Registry for Patients With Multifocal Ground Glass Opacities (GGOs)

The purpose of this registry study is to actively monitor people with GGOs and collect information about them, so that investigators can learn more about these lesions and about the risk of developing lung cancer in study participants whose GGOs are being monitored in the active surveillance program.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Have two or more GGOs on initial CT imaging
* GGOs must be measure ≤3.0 cm and ≥0.6 cm in the greatest dimension
* GGOs must be greater than half ground glass

A biopsy is not necessary for inclusion in the trial. Biopsy of a GGO, even with a diagnosis of adenocarcinoma, does not necessarily preclude enrollment in this surveillance protocol. In other words, patients with a diagnosis of adenocarcinoma are still eligible, at the discretion of the clinician and/or investigator, if they meet the above criteria.

Exclusion Criteria:

* Patients who are actively undergoing lung cancer treatment or have a history of lung cancer, except for cases of completely resected pathologic stage IA nonsmall cell lung cancer (NSCLC). Patients with stage IA NSCLC and multiple GGOs can enroll in this active surveillance protocol after complete resection of the NSCLC and confirmation of stage on final pathologic assessment.
* The presence of any solid lesion ≥0.6 cm suspicious for malignancy.
* Patients who are actively undergoing treatment for other malignancies
The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD

Data collection and observation of changes within AMD patients performing visual training on mobile devices

In the presented study a training-therapy in patients with dry AMD war evaluated. The main focus was on remote visibility and thus better handling of daily activities.

Therapy with high-contrast administration is used for amblyopia in childhood. Furthermore, simulation therapy is used in hemianopsia in the adult age, in which case the lesion is usually not located in the eye.

This stimulating therapy for children and adult patients led to the hypothesis that this treatment could also improve AMD's situation. The entire visual procedure also shows the possibility of change even in adult patients.

The presented study investigates if regular training with a device that provides a moving grating-stimulus, the "Medical Eye Trainer" (MET), can improve the subjective perception of visual performance during typical activities of daily living. The aims of the study were not to show improvement of reading vision nor to show changes in the retinal structure.

Eligibility Criteria:
Inclusion Criteria:

* All eyes had been affected by dry AMD for 3.5 years or more

Exclusion Criteria:

None
A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data

Bloom Technologies is developing a wearable device for monitoring pregnancy.

In this study, Bloom Technologies wants to investigate the reliability of this new technology.

For this reason, a device that records very high-quality data (g,Hlamp) was chosen. The study device is attached to the body by means of electrodes (up to 32) that can be safely attached to the skin. Most of the electrodes are placed on the abdomen, and a few on the chest and back.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age ≥ 30 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand English or Spanish
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* History of allergies to skin adhesives
* Irritated or lesioned skin at the electrodes locations