cyrilzakka/clinical-trials huggingface dataset:
A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)
3. Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)
4. Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
5. ECOG performance status: 0-2
6. age ≥18 years
7. measurable disease according to RECIST v1.1
8. adequate organ function defined as:

   1. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
   2. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
   3. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault \>60 ml/min
   4. Neutrophils ≥1 Gpt/l, Platelets \>50 Gpt/l unless caused by bone marrow carcinosis

Exclusion Criteria:

1. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
3. Severe uncontrolled infection
4. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
5. Any prior treatment for metastatic disease
Safety and Efficacy Study of Gevokizumab to Treat Non-infectious Uveitis Controlled With Systemic Treatment

The purpose of this study is to evaluate the efficacy of gevokizumab in reducing the risk of recurrent uveitic disease in subjects with non-infectious uveitis whose disease is currently controlled with systemic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-infectious intermediate, posterior, or pan- uveitis in at least one eye
* Controlled uveitic disease in both eyes
* Stable dose of oral corticosteroids in combination with selected stable immunosuppressive therapy
* Effective contraceptive measures

Exclusion Criteria:

* Infectious uveitis and masquerade syndromes
* Isolated anterior uveitis
* Contraindication to mydriatics
* Active tuberculosis disease
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent infection or predisposition to infection; active ocular infection
* Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply
Therapeutic Effects of Arch Support Insoles on Children

Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children

A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).

All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).

The control group were evaluated at baseline and up to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks

Exclusion Criteria:

* age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet
Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use

The purpose of the project is to improve adolescent behavioral counseling services in healthcare settings with a new Internet/Intranet-based Motivational Enhancement Therapy (iMET) intervention that targets the use of tobacco, alcohol, and other drugs.

We have previously developed and tested in a treatment population a promising MET program for alcohol and drug use. We will broaden the MET intervention to also target tobacco use and convert the new materials into a self-administered format.

Eligibility Criteria:
Inclusion Criteria:

* 12-21 years old
* Coming for routine care

Exclusion Criteria:

* Medically or emotionally unstable day of visit
* Already receiving behavioral health services
* Cannot read/understand English
* Will not be available for post-tests
Sensory Characteristics and Psychosocial Factors Related With Non-specific Neck Musculoskeletal Pain Chronification

Chronic pain is commonly defined as any pain which lasts more than 12 weeks. Chronic non-specific neck pain (CNSNP) has no specific underlying disease causing the pain. There are neurophysiological factors that may modulate pain response and perception in the central nervous system, producing sensory changes such as the presence of temporal summation (TS) and pressure, cold or heat hyperalgesia. TS describes the progressive increase in reported pain intensity as a function of repeated noxious stimulation (e.g. thermal, electrical or mechanical). TS and hyperalgesia are measured through quantitative sensory tests (QST) where pain pressure thresholds (PPT) are measured with an algometer. The current evidence show that PPTs are significantly lower compared to healthy subjects and the association between PPTs, pain intensity and disability are inconsistent. Further, there are psychosocial factors (catastrophizing, kinesiophobia, stress...) that may influence the pain experience. This psychosocial factors associated with chronic pain are not systematically collected in the QST literature complicating the interpretation of data. The objectives of this study are 1) to determine disability, sensory (TS and PPTs) and psychosocial changes (kinesiophobia, catastrophizing, sleep quality, life quality, stress and anxiety) in the natural evolution or in the result of physiotherapy treatment in CNSNP individuals, 2) to study the correlations between disability, psychosocial and sensory factors and 3) to observe if there is a homogeneity between the subjects.


Eligibility Criteria:
Inclusion criteria for individuals with CNSNP were:

1. age between 18 and 65 years;
2. capable to understand, write, and speak in Spanish;
3. having suffered neck pain during the last 12 weeks at least;
4. pain localized in the neck region with or without pain radiation;
5. Negative Spurling test;
6. Negative Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS);
7. Negative Upper Limb Tension Test for the median nerve;
8. PainDetect test with non-neuropathic pain result. .

Exclusion Criteria:

1. Presence of red flag as reported in the medical history (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis);
2. Neck pain with cervical radiculopathy;
3. fibromyalgia syndrome,
4. previous neck surgery;
5. currently undergoing any type of pain treatment or having received physical therapy in the previous 3 months.
Real-time Interactive Digital Healthcare System in Post Operation Patients With Breast Cancer; Pilot Study

This study aims to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer. This is prospective pilot study. 20 breast cancer patients who underwent wide local excision-axillary lymph node diessection or modified radical mastectomy will be examined, and those with limited range of motion (ROM) of affected shoulder will be enrolled in the study. Shoulder ROM, Quick-DASH, pain evaluation with NRS, quality of life evaluation with FACT-B and EQ-5D will be evaluated on enrollment, 4-week, 8-week, and 12-weeks after enrollment.

The limited range of motion (ROM) of the shoulder occur often after receiving breast cancer surgery, which may be due to post-operative pain, stiffness of shoulder girdle muscle, and etc. Due to this limited ROM, the patients may suffer difficulty in activities of daily life and quality of life may be reduced.

Uincare Homeplus is software manufactured in Korea, which uses infrared, kinect camera and motion capture technology to track 3D motion of the patients' articulation. Using this technology, the patients can receive feedback of their motion immediately.

The objective of the study is to examine the effect of hospital-home linkage short-term rehabilitation therapy using real-time interactive digital healthcare system (Uincare Homeplus) in post-operative patients with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent breast cancer surgery (wide local excision-axillary lymph node dissection or modified radical mastectomy)
* Limited active/passive range of motion of the affected shoulder (Flexion \<160' or Abduction \<160')
* post-operative day not exceeding 8 week
* Patients who agreed informed consent

Exclusion Criteria:

* Bilateral breast cancer surgery
* Patients with shoulder pain of limited ROM before breast cancer surgery
* Those unable to perform exercise due to general deconditioning
* Those with communication difficulty
The Effect of Renastart Formula Supplementation in Children With Acute Kidney Injury in Maintaining Normal Serum Electrolytes Levels

This clinical trial will evaluate Renastart formula effectiveness in children with acute kidney injury (AKI) and acute on top of chronic kidney disease (CKD), in maintaining normal serum electrolytes levels without using electrolyte binders,24 patients will be recruited from Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University, they will be assigned randomly in to two arms, arm 1 including patients who will be treated by electrolytes binders, arm 2 including patients who will be treated by Renastart formula, after initial assessment serum electrolyte evaluation will be followed up monthly for 3 months.


Eligibility Criteria:
Inclusion Criteria:

•Infants and Children with AKI and acute on top of CKD Suffering from hyperkalemia and/or hyperphosphatemia at Pediatric Nephrology Unit (PNU), Children's Hospital, Ain Shams University Hospitals.

Exclusion Criteria:

* Patients are on dialysis.
* Pediatric patients with coexisting another medical problems and different risk factors which can affect serum electrolytes such as: Constipation, high volume blood transfusion and Diabetes medications disrupt potassium balance e.g., ACEI, ARBS and Diuretics.
Mechanistic Study of ISIS ISIS-APOCIIIRX in Type 2 Diabetes

The purpose of this study is to evaluate the effects of ISIS ISIS-APOCIIIRX on Triglyceride Levels and Insulin Sensitivity in Subjects with Type 2 Diabetes on stable treatment with metformin.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>/= 25 to \</= 40 kg/m2
* Type 2 Diabetes Mellitus and on a stable dose of metformin
* Hypertriglyceridemia

Exclusion Criteria:

* Significant abnormalities in medical history, clinical examination or clinical testing
* Use of oral anti-diabetic medication other than metformin within 3 months prior to dosing
* History of outpatient insulin use for more than 2 weeks in the last year
Switch to Darunavir/r + Maraviroc Quaque Die in Patients With R5 Tropism by Viral DNA Genotyping (GUSTA)

Objectives of the study:

1. To verify the safety and the efficacy of the study treatment, defined as the persistent control of the virus' replication at 48 weeks after the simplification to maraviroc + darunavir with ritonavir in patients with R5 tropism by viral DNA genotyping.
2. To collect relevant information about the safety, the immunologic and the economic impact of this strategy.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with the same regimen including 3 HAART from at least 4 months
* Aged 18 years or older
* Who gave informed consent to the participation to the study
* With at least two viral load \< 50 copies/mL in two consecutive determinations at least 6 months apart (tolerance of two weeks)
* With CD4 cell count \> 200 cells/μL and absence of any opportunistic infection or AIDS-related disease for at least one year prior to the screening.
* With R5 tropism by viral DNA genotyping (geno2pheno "clonal")
* With CD4 cell count nadir\>50 cell/mmc or 100 cell/mmc if previous enfuvirtide or integrase inhibitors use

Exclusion Criteria:

* With at least one major or two minor mutation conferring resistance to darunavir reported in the update list of International AIDS Society - USA , in previous resistance test
* Previous D/M or X4 viral tropism
* Previous major clinical toxicities (grade \>=3) to the proposed drugs of the study
* Pregnancy or breast feeding, desire of pregnancy in the short term
* Past exposure to Chemokine Receptor 5 antagonist
* HBsAg serostatus
* Liver cirrhosis of class C (Child-Pugh)
* Sulpha drug hypersensitivity
* The presence of major non AIDS-defining diseases that, in the opinion of the investigator, may compromise the retention of the patient in the study for the necessary follow-up period.
* Estimated glomerular filtration \< 30 ml/min (cockroft-Gaut; MDRD formula if black-African or african-american) at screening visit
* Hypertransaminasemia of grade IV (more than 10 times the upper normal limit) at screening visit
Strategies to Help Adult ED Patients Quit Smoking

The purpose of this study is to determine whether a brief, focused intervention in the hospital emergency department is effective in helping adults quit smoking.

In urban communities, the prevalence of tobacco use among adults visiting a hospital emergency department (ED) nears 40%, well in excess of the 25% smoking prevalence rate of the general population. Many of these patients lack easy access to primary care, suggesting the ED may be an attractive locus to initiate tobacco cessation efforts. With over 100 million annual visits to U.S. EDs, it may be possible to engage millions of smokers in tobacco cessation efforts. The major purpose of this study is to examine whether a multicomponent intervention delivered in the ED by a Lay Educator to adult smokers interested in quitting is more likely to result in cessation than usual care. A secondary goal is to test whether patients who present to the ED with a tobacco-related illness (as indicated by ICD9 code) are more likely to quit than ED smokers with a non-tobacco-related condition. This will allow us to test the validity of the "teachable moment" as an opportune time to engage patients in considering a behavioral change. The proposed study is a randomized trial of a motivational interview, provision of six weeks' worth of nicotine patches, literature, and post-visit follow-up (Enhanced Care) vs. referral to a cessation clinic (Minimal Care) for ED patients who smoke. Eligibility criteria: age \> 21 years, contemplation or preparation stage of change, not admitted to hospital. All patients will undergo a standardized stage of change assessment, and measurements of nicotine dependence and exhaled carbon monoxide. All will receive a cessation fact sheet and referral card to the smoking cessation clinic; the cards of those in the Enhanced Care group will have a specific appointment date and time. The Enhanced Care group will receive a language-appropriate pamphlet discussing smoking cessation. We will record the ICD9 codes associated with each visit. Major outcome measure: cessation within 3 months of the ED visit, stratified by treatment group. Secondary outcome measure: cessation within 3 months of the ED visit, stratified by whether the visit was smoking-related. If smokers receiving Enhanced Care are more likely to quit, then the ED could be considered a new, effective locus for tobacco control, potentially reaching several million smokers. If patients with a smoking-related diagnosis for the ED visit are more likely to quit than those with non-smoking-related ICD9, then this supports the construct of the teachable moment.

Eligibility Criteria:
Inclusion Criteria:

* \>= 10 cigarettes smoked daily
* being discharged from the ED
* contemplation or preparation stage of change
* speaks English or Spanish

Exclusion Criteria:

* being admitted to hospital
* too ill to consent
Access to Genetic Information Leveraging Innovative Technology (AGILITY)

AGILITY is a type 1 hybrid trial that will test the effectiveness of a chatbot to provide pre-test information about genetic screening for tier 1 conditions. A randomized control trial of 2400 adult participants from diverse primary care clinics at the University of Florida Gainesville to receive virtual information about tier 1 condition genetic testing from a chatbot or traditional genetic counseling. The assessment of the outcome of the trial is to determine whether the chatbot is inferior to genetic counseling. Non-inferiority will be determined based on informed choice to undergo testing (or not). Implementation outcomes of acceptability, feasibility, and appropriateness will be evaluated to inform future potential through interviews with patients, primary care providers and GCs.

AGILITY is a type 1 hybrid trial that will test the effectiveness of a chatbot to provide pre-test information about genetic screening for tier 1 conditions. A randomized control trial of 2400 adult participants from diverse primary care clinics at the University of Florida Gainesville to receive virtual information about tier 1 condition genetic testing from a chatbot or traditional genetic counseling. The assessment of the outcome of the trial is to determine whether the chatbot is inferior to genetic counseling. Non-inferiority will be determined based on informed choice to undergo testing (or not). Implementation outcomes of acceptability, feasibility, and appropriateness will be evaluated to inform future potential through interviews with patients, primary care providers and GCs. This trial will provide evidence of whether chatbots can serve to address a shortage of genetic counselors by extending pre-test education in a population screening environment to alternate sources such as chatbots. Inclusion of an observation arm for individuals with positive family history who then are offered traditional clinical genetic service is a strength of the design that will allow for contrast between populations and service models as well. Inclusion of assessments of feasibility, acceptability, and appropriateness from multiple stakeholders is critical to future study design and implementation potential.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Male or Female
* University of Florida Gainesville primary care patients
* Negative family history for hereditary breast and ovarian cancer, and Lynch syndrome and familial hypercholesterolemia

Exclusion Criteria:

* Positive family history of hereditary breast and ovarian cancer, and Lynch syndrome, and familial hypercholesterolemia
A Clinical Study for Magnetic Stimulation of the Posterior Tibial Nerve in Overactive Bladder

To evaluate the safety and feasibility of non-invasive magnetic stimulation of the posterior tibial nerve using the EMKinetics LoFIT Pulse System for treating patients with documented overactive bladder.


Eligibility Criteria:
Inclusion Criteria:

* Women \>18 years of age
* A score of \> 4 on the OAB-q short form for urgency (question 1)
* Average urinary frequency \> 10 times in one 24 hour day based on a 3-day voiding diary
* Self-reported bladder symptoms present \> 3 months
* Self-reported failed conservative care (e.g., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) or use of antimuscarinics.
* Off all anti-muscarinics for at least 2 weeks prior to enrollment
* Capable of giving informed consent
* Ambulatory and able to use a toilet independently, without difficulty
* Capable and willing to follow all study-related procedures

Exclusion Criteria:

* The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.)
* The patient has an active urinary tract infection.
* Neurogenic bladder
* Botox use in bladder or pelvic floor muscles in the past year
* Pacemakers or implantable defibrillators
* Primary complaint of stress urinary incontinence
* Current vaginal infection
* Current use of InterStim
* Current use of Bion
* Current use of TENS in the pelvic region, back or leg
* Previously been treated with PTNS
* Use of investigational drug/device therapy within the past 4 weeks
* Participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function
* Deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination
* The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee (or permanent metallic tattoo \<30cm from left ankle).
* The patient has chronic constipation (less than two (2) bowel movements per week)
* The patient has history of gastric or urinary retention
* The patient has uncontrolled diabetes
* Subjects with nerve damage, injury or surgery that would impact either tibial nerve or pelvic floor function
* The patient is unable or unwilling to sign informed consent
* The patient is currently on pharmacologic treatment that could affect bladder function
* Known Cystocele \>/= to Grade 3 that has not been reduced by treatment (surgery or pessary)
Driveline Silicone Skin Interface Registry

The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI)


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed the INTERMACS informed consent form
* Subject has signed the SSI registry informed consent form
* Subject age ≥ 18 years
* Subject implanted with a HeartMate II LVAD
* Subject in whom the full length of the velour portion of the percutaneous lead is fully kept under the skin resulting in a silicone skin interface at the skin exit site
* In the prospective study cohort, Subject is planned to be supported with the HeartMate II LVAD for at least 12 months
* In the retrospective study cohort, at the time of enrollment, Subject has been supported with a HeartMate II for at least 10 months

Exclusion Criteria:

* In the retrospective study cohort, Subject is ongoing with long-term right heart mechanical circulatory support (RVAD)
* In the retrospective study cohort, Subject had a post-implant sternal re-entry (for bleeding, etc.) or delayed sternal closure
* In the retrospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results
* In the prospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results