cyrilzakka/clinical-trials huggingface dataset:
Relaxation-Response-based Mental Health Promotion - Open and Calm 2013

The purpose of the study is to investigate health-promoting and stress-reducing psychological, physiological and hormonal effects of a 9-week meditation-based course in personal health and to examine potential baseline factors for any such effects. Thus, the investigators will investigate the course format (individual course or group-based course) as a potential factor the course outcome, and also individual background factors such as demographics and genetic variations.


Eligibility Criteria:
Inclusion Criteria

* Experience of stress, defined as a Cohen's perceived stress scale score \> 12.
* Speaks and reads Danish fluently.
* Ability to use the internet to complete questionnaires.
* Participation in face-to-face study information meeting.
* Signed agreement to the study conditions and informed consent form

Exclusion Criteria

* Other current treatment (psychological, medical or other) for stress, depression, anxiety, phobias, traumas or other psychological problems.
* Other current treatment for bodily illnesses, such as pain, migraine, cancer.
* More than one diagnose with psychiatric disease (e.g. anxiety, depression) within the past 3 years.
* Body-Mass Index \> 30.
* Major Depression Inventory score \> 25 at inclusion interview.
* Physical handicaps affecting life stress or quality of life chronically.
* Drug use (\> 50 times hash during the past two years; max 20 times harder drugs, max 2 times per month since the 18th birthday on average; no periods \> 3 years where the use of drugs exceeded two times per month).
* Alcohol use \> 21 drinks/week for men, and \> 14 drinks/week for women and AUDIT-scores (a scale of alcohol-related problems) \>20.
* Serious head trauma.
Evaluation of Influenza-Specific Immune Responses in Children and Adults During the 2010-2011 Influenza Season in the U.S.

This is a specimen collection protocol designed with the purpose of understanding the immune responses to influenza in children and adult subjects through collection of blood specimens and influenza medical history data. This protocol will allow the investigators to evaluate influenza-specific immune responses to a variety of influenza strains in a broad age range of the U.S. population early and late in the 2010-2011 influenza season. Immune responses will be evaluated using blood samples. The underlying hypothesis for this protocol is that the detailed characterization of immune responses to influenza in subjects from different age groups will further the understanding of immune responses cross-reactivity and advance development of influenza vaccines that are cross-reactive against old, new and re-emerging influenza strains.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 6 through 17 years and adults 18 years of age or older
* Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
* Able and willing to complete the informed consent/assent process
* Willing to donate blood for storage and for research, at least at three study visits
* Willing to have genetic tests performed on stored blood for research purposes

Exclusion Criteria:

* Known to be pregnant.
* Medical, psychiatric, occupational or other condition that, in the judgment of the site investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent.
* Bleeding disorder diagnosis or any contraindications to blood drawing as assessed by the site investigator
* Immune system known to be compromised by HIV or other active infection, active cancer, or systemic immunosuppressive treatments.
* Seasonal influenza vaccine within the 12 weeks prior to enrollment.
* Another subject from the same household enrolled into the same age group.
Effect of Favipiravir on Mortality in Patients With COVID-19 at a Tertiary Center Intensive Care Unit

Effect of Favipiravir and Lopinavir-Ritonavir on Mortality in a Tertiary Center Intensive Care Unit: Single Center Experience

Many agents have been given for treatment of COVID-19 infection. "Covid-19 Diagnosis and Treatment Guideline" by Ministry of Health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat COVID-19 at the time of publication date of detailed guideline Favipiravir is a RNA dependent RNA polymerase inhibitor and approved for treatment of influenza in Japan at 2014 The aim of the study was to compare ICU and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older

Exclusion Criteria:

* patients younger than 18 years old
* patients who have received both lopinavir-ritonavir and favipiravir sepuentially
Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy

The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy.

The study included threefold: (1) It will employ kinematic analysis, along with clinical assessment tools to examine the effects of mCIT on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. The clinical tools will include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) It investigated the effects of forms (group vs. individual intervention) on upper extremity performance.

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of spastic CP
2. age between 4 and 10 years old
3. shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least
4. basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance
5. ability to follow simple oral commands
6. no related musculoskeletal surgery of the affected upper limb
7. not have injected the Botox into the affected upper extremity during the past 6 months
8. no visual or auditory disability
IBIS Megastudy- Pilot

In this pilot study, the investigators will determine the feasibility and acceptability of multiple low-cost behavioral interventions, designed with end-user input, to promote HIV retesting among adults in rural Kenya and Uganda who have higher risk of HIV exposure.

HIV re-testing is crucial in ensuring early identification of disease to promote well-being of an individual as well as preventing onward spread of infection by treating those identified to have disease promptly. The proposed study aims to identify approaches that would encourage individuals aged 15 years and above at high risk of HIV infection to retest. This IBIS Megastudy pilot trial will pilot 11 intervention prototypes for acceptability, feedback, and implementation outcomes prior to using the interventions in a larger-scale Megastudy trial (main trial to be submitted as a separate CT.gov record).

Eligibility Criteria:
Inclusion Criteria:

* at least 15 years of age
* At increased risk of HIV infection (defined by self-reported risk \[at least one of the following over the 3 months prior to enrollment: \>1 sexual partner, known HIV-positive sexual partner, diagnosed with a sexually transmitted infection, or paid or received gifts or money in exchange for sex\] or by Kenya or Uganda MoH criteria for priority group)
* Documented negative HIV antibody test within 7 days of enrollment
* No intent to migrate out of community in next 3 months
* Daily access to a mobile phone (required since some of the interventions will be delivered by phone)

Exclusion Criteria:

* HIV-positive
Combined Nortriptyline and Transdermal Nicotine for Smoking Cessation

Treatment of smokers with a tricyclic antidepressant, nortriptyline, can reduce tobacco withdrawal symptoms and increases long term cessation rates when combined with transdermal nicotine and a behavioral cessation programs. The study is a placebo-controlled, randomized, parallel group trial in which smokers aged 18-70 will be subject to the combination of oral and patch treatments.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70,
* smoking \> 10 cigarettes per day,
* no current major depression,
* no concurrent psychiatric medications

Exclusion Criteria:
Safety, Tolerance and Activity of HE3286 in Patients With Type 2 Diabetes Mellitus

This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks.

Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes. The investigational drug, HE3286, holds the potential to be the first in a new class of insulin sensitizers with a potentially novel mechanism of action that may improve the current therapeutic options available to a T2DM patient.

This is a phase II, double-blind, randomized, placebo-controlled study of the safety, tolerance and activity of HE3286 in patients with type 2 diabetes mellitus. Patients receiving stable metformin or who are drug-naive will receive study treatment (HE3286 or placebo) for a treatment period of 12-weeks. Changes in hemoglobin A1c (HbA1c) will be assessed over a treatment period of 12-weeks.

Eligibility Criteria:
Main Inclusion Criteria:

* Patient with a diagnosis of Type 2 Diabetes Mellitus (T2DM)
* Patient must be a) on a stable dose of metformin as monotherapy for at least 10 weeks prior to screening; or b) drug-naive, defined as never having received drug treatment for T2DM or not having received antidiabetic drug therapy during the 3 months prior to screening.
* Patient with a fasting blood glucose level of ≤ 225 mg/dL at screening (≤ 255 mg/dl for drug-naive patients);
* Patient with HbA1c levels \>7.5% (7.0 - 10.5% for drug-naive patients) at screening;
* Patient with BMI 28-37 kg/m2 for females 28-39 kg/m2 for males

Main Exclusion Criteria:

* Patient who has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities within 6 months prior to screening;
* Patient with unstable diabetic complications requiring treatment or ongoing active intervention;
* Patient with a history of long term insulin therapy within the past year;
* Patient who has had therapy with rosiglitazone, pioglitazone, exendin-4 or sitagliptin, alone or in combination within 6 months prior to screening;
* Patient who has any clinically significant abnormalities in laboratory results at screening;
DPBRN Longitudinal Study of Dental Restorations Placed on Previously Un-restored Surfaces

The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN "Reasons for placing the first restoration on permanent tooth surfaces" study, and the factors affecting how long the fillings last.

This study is an observational follow-up of previously placed dental restorations (fillings) and is conducted during routine dental care visits.

Eligibility Criteria:
Inclusion Criteria:

* participant in the DPBRN "Reasons for placing the first restoration on permanent tooth surfaces" study
Post-Market Clinical Investigation of NanoFUSE® Bioactive Matrix

This purpose of this study is to determine fusion rates and compare clinical outcomes of the NanoFUSE® Bioactive Matrix during post-market clinical use.

NanoFUSE® is indicated to be placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. This product provides a bone graft substitute that remodels into the recipient's skeletal system.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Medically suitable for surgical management and the use of NanoFUSE® Bioactive Matrix consistent with product labeling
* Psychosocially, mentally, and physically able to fully comply with the protocol, including the post-operative regimen, requires follow-up visits, filling out required forms, and the ability to understand and give written informed consent
* Retrospective data collection must be allowed by the IRB and all information deidentified

Exclusion Criteria:

* Previous fusion surgery of the proposed site
* Use of chronic medications known to affect the skeleton (e.g. glucocorticoid usage \> 10mg/day)
* Pregnant or female intending to become pregnant during this study period
* Obesity (BMI \>40kg/m2)
* Systemic infection or infection at the surgical site
* Current or past substance abuse
* Poor general healthy or any concurrent disease process that would place the patient in excessive risk to surgery (e.g. significant circulatory or pulmonary problems, cardiac disease
* Medical condition that would interfere with post-operative assessments and care
Partial Adenoidectomy in Cases of Velopharyngeal Dysfunction

The velopharyngeal valve is a tridimensional muscular valve that is located between the oral and nasal cavities. It consists of the lateral and posterior pharyngeal walls as well as the soft palate. The role of the velopharyngeal valve is to separate the oral and nasal cavities during speech and swallowing.

Velopharyngeal dysfunction is the inability to separate the oral and nasal cavities adequately during speech production through the actions of the velum and pharynx. Velopharyngeal dysfunction can be caused due to lack of tissue (velopharyngeal insufficiency) or lack of proper movement (velopharyngeal incompetence) of the walls. While Velopharyngeal dysfunction is commonly associated with cleft lip and palate, it can also be seen with submucous cleft and other noncleft conditions such as ablative palatal lesions, adenoidectomy, deafness or hearing loss, and cerebral palsy. In Velopharyngeal dysfunction, the incompletely closed velopharyngeal valve causes an inability to effectively manage the air stream for continuous speech causing hypernasal speech.

Adenoid hypertrophy may play a role in velopharyngeal closure especially in patients with palatal abnormality.

In 1958, Gibb indicated an incidence of hypernasality postadenoidectomy in approximately 1 of 2000 cases. Closure pattern of velopharyngeal valve in typical patients is velo-adenoidal rather than velopharyngeal closure. Adenoid mass is vital to velopharyngeal closure in such patients and removal necessitates a change in the pattern of velopharyngeal valving.

Trans-oral endoscopic partial (superior) adenoidectomy adenoidectomy enables the surgeon to inspect the velopharyngeal valve during the procedure; thus avoiding occurrence of velopharyngeal dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected).

Exclusion Criteria:

* Patients who had undergone any secondary corrective surgery for velopharyngeal insufficiency.
* Patients with craniofacial anomalies.
* Any associated medical comorbidity that contraindicates general anesthesia.
* Refusal of enrollment in the research by the patients or care givers.
Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease

The present protocol is a dose-finding and toxicity study in preparation of a randomised study comparing current standard treatment CSA/prednisolone with the new combination CSA/prednisolone/everolimus.

The primary objective of the present study is to evaluate the feasibility of treatment with everolimus in combination with CSA/prednisolone in patients with aGVHD after allogeneic HSCT. This evaluation takes into account the following parameters:

* Feasibility of oral application everolimus
* Daily dose needed to reach the targeted plasma level everolimus
* Time to reach the targeted plasma level of everolimusSecondary objectivesThe study will evaluate the toxicity and safety of the treatment with ever-olimus/CSA/prednisolone with regard to
* Incidence and severity of treatment induced toxic events
* Incidence, severity and seriousness of adverse events
* Treatment induced morbidity
* Treatment induced 1-year-mortality Furthermore the study will collect data about
* Efficacy of everolimus/CSA/prednisolone on aGVHD
* Drug interactions between everolimus and CSA

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to inclusion into the study
* Allogeneic HSCT from HLA-identical related or unrelated donors
* Clinically confirmed acute GVHD ≥ grade II
* Age \< 70 / \> 18 years, male or female
* Karnofsky performance status \> 60 %

Exclusion Criteria:

* Oral treatment is not feasible
* Severe hepatic impairment Child-Pugh C
* Active cerebral epilepsy
* Renal failure (Creatinine clearance \< 50 ml/min)
* Life expectancy \< 3 months
* Known hypersensitivity to everolimus, sirolimus or to any of the excipients
* Confirmed pregnancy (serum β-HCG)
* Non-effective contraception for both, male and female patients, if the risk of conception exists
* Patients with limited legal capacity
* Patients unwilling and unable to undergo study procedures
Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
* Capable of understanding provided information and complying with protocol requirements
* Provide written informed consent to participate in the study
Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy

This Observational study will explore the utility of the Biodesix, Inc. "PIR" (primary immune response) test to predict outcomes in treatment-naïve advanced stage NSCLC with PD-L1 tumor proportion score (TPS) \> 50% and ECOG performance status (PS) 0-2 NSCLC patients who are treated with PD-1/PD-L1 based therapy with or without the addition of platinum based chemotherapy.

This is an observational, multicenter study designed to assess biomarkers (serum and plasma) as predictive of early progression in 390 treatment-naive patients with advanced stage non-small cell lung cancer (NSCLC) and PD-L1 TPS ≥50% treated with two standard of care (SOC) regimens, platinum based PD-1/PD-L1 regimen with monotherapy (single agent PD-1/PD-L1 therapy).

Prior to enrollment, tumor specimens will be tested for PD-L1 expression according to participating centers' standard operating procedures. Patients will be treated, according to physician choice, with platinum-based PD-1/PD-L1 regimen versus single agent PD-1/PD-L1 regimen. For each treatment cohort of 195 patients, enrollment will proceed in sub-cohorts to ensure a population with 20% ECOG PS2 patients and a total of 40 squamous cell carcinoma patients per treatment arm.

Patients will receive one of the following standard-of-care (SOC) treatment regimens at the discretion of the treating investigator:

* PD-1/PD-L1 therapy
* Platinum doublet-based chemotherapy plus PD-1/PD-L1 combination

Tumor assessment will follow RECIST v1.1.

Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.

Remaining serum and plasma will be stored for subsequent exploratory studies and will be available to the investigators in the ALCMI network per ALCMI standard operating procedures.

Additionally, pathology reports including PD-L1 results and Next Generation Sequencing results, from any CLIA laboratory, will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Treatment naïve for their stage IIIC/IV AJCC 8 non-small cell lung cancer with a tumor biopsy PD-L1 TPS \> 50%
* Intent to treat with PD-1/PD-L1 or PD-1/PD-L1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin
* ECOG PS 0-2
* Ability to consent to participate in the study

Exclusion Criteria:

* Ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.

Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
* Patients with suspected cystic neoplasm of the pancreas
* Able to provide written informed consent

Exclusion Criteria:

* Pregnant and/or nursing
* Incarceration
* Imaging showing possible pancreatic cancer
* Prior history of pancreatic cancer or pancreatic surgery
* History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
* Previous therapy for a pancreatic cystic lesion
* History of pancreatic necrosis
* Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years
Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

In patients with a standard indication for pacing and no previous history of AF, detection of Atrial High Rate Episodes predicts an increased risk of stroke and systemic embolism.

Overdrive atrial pacing with the AF Suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.


Eligibility Criteria:
Inclusion Criteria

1. Age ≥ 65 years
2. History of hypertension requiring pharmacological therapy (≥ 4 weeks of therapy).
3. Recent (\< 8 weeks) St. Jude Medical Inc. pacemaker implant (IDENTITY® Adx DR (Model 5386/5380)), ICD implant (EPIC 2 or Atlas 2) or other St. Jude Medical Inc. pacemaker or ICD with the same capabilities.
4. In pacemaker patients only the primary indication for pacing is sinus or AV node disease.

Exclusion Criteria

1. Previous documented AF, atrial flutter (lasting greater than 5 minutes), or other sustained SVT (not including episodes detected by the device)
2. Geographic/social or psychiatric factor likely to interfere with follow-up
3. Requirement for oral anticoagulation (heart valve, deep vein thrombosis, etc.)