cyrilzakka/clinical-trials huggingface dataset:
Cost Effectiveness Analysis of Cholecystectomy, Projected Long Term Outcomes and Complications Evaluation

Participation in this research study does not involve any procedures. Health preference will be ascertained through standard techniques including time-tradeoff, standard gamble, and rating scale to assess risks regarding potential complications specific to NOTES (Natural Orifice Translumenal Endoscopic Surgery)gallbladder removal.

The enticement of scarless surgery has created an unprecedented wave of enthusiasm and collaboration amongst surgeons, gastroenterologists, industry, and the lay public. However, major hurdles remain between current minimally invasive practices and the ultimate goal of safe, effective Natural Orifice Translumenal Endoscopic Surgery (NOTES). In an ideal world, these procedures should incur equivalent (or less) morbidity than current laparoscopic approaches and offer benefits of incisionless surgery. This idealism has been quickly tempered by the potential to create new and devastating complications with only minimal potential benefit to the patient. Several critical questions need to be answered. What probability of complication(s) are to be accepted? How will the potential benefits of NOTES be weighed against these new complications? What factors unique to NOTES will contribute to its cost effectiveness? The proposed study seeks to answer these questions before they occur. These results will give clinicians and investigators the necessary information with which to compare outcomes of NOTES and potentially alter techniques for safer, more effective interventions.

Eligibility Criteria:
Inclusion Criteria:

* Candidate of either sex
* 18 years old or above
* Have symptomatic cholelithiasis
* Wish to undergo laparoscopic cholecystectomy for treatment

Exclusion Criteria:

* Not Applicable
Group Versus Individual Care in Diabetes Clinic

In this prospective, randomized, non blinded, one center (University hospital) trial, 60 patients (28 with type 1 and 32 with type 2 diabetes) with a mean duration of diabetes of 22.5 ± 11.7 years were randomly assigned to group (6 patients per group) or individual usual care for one year. Primary end-point included change in Hba1c and visits to out-patients clinics, secondary endpoint included change in body mass index, blood pressure levels, waist circumference, non HDL Cholesterol, diabetes related and quality of life questionnaires and hospitalizations.

in the intervention arm patients attended 4 preplanned group visits in the study year and the empowerment model was used in the group care visits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes
* Fluency in Hebrew
* Attendance at least for the second time at the diabetes clinic
* Follow up of at least one year by a general practitioner
* Willingness to participate in the study and to give informed consent.

Exclusion Criteria:

* Uncontrolled psychiatric diseases
* Active cancer
* Pregnancy
Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease

We sought to determine whether the dual-source computed tomography assessment of aortic valve stenosis and coronary artery disease is equivalent to or even better than conventional invasive coronary angiography and transthoracic echocardiography.

Until now invasive coronary angiography has established itself for the assessment of symptomatic aortic valve stenosis. Literature shows a good correlation between MSCT, MRI, TTE and TEE for evaluating the severity of the aortic valve stenosis.

The dual-source computed tomography (DSCT) is capable of assessing coronary arteries with a high sensitivity and specificity in term of relevant stenosis (\>50%), due to its excellent spatial and temporal resolution. This study includes the assessment of patients with symptomatic valve stenosis. The severity of the aortic valve stenosis is being assessed by DSCT and TTE. Significant coronary artery stenosis and its localisation are assessed by DSCT and invasive coronary angiography. We examine the correlation between DSCT on one side and either TTE or invasive coronary angiography on the other.

Eligibility Criteria:
Inclusion Criteria:

* Patients with aortic valve disease who were scheduled to undergo cardiac surgery

Exclusion Criteria:

* Hemodynamic instability
* Renal insufficiency (serum creatinine level \> 133umol/L)
* Known allergy to iodinated contrast agents
* Non-treated hyperthyreosis
A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
* Male and female participants of childbearing potential who agree to use contraceptive methods

Exclusion Criteria:

* Have a history of diabetes or current diagnosis of diabetes
* History or presence of a of significant bleeding disorder
* Participants with significant comorbidity
* Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index
Real Life Use of Ravulizumab in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria

This study will collect clinical response data on participants who were already treated with eculizumab for at least 26 weeks and who started ravulizumab treatment as a specific therapeutic strategy as per ordinary clinical practice.

This study is an Italian multi-center, observational (non-interventional), cohort study composed of both retrospective and prospective observation periods on the same Paroxysmal Nocturnal Hemoglobinuria (PNH) participants. After the First Participant In from different Italian study centers, participants will be consecutively enrolled for 9 months and they will be observed for 52 weeks after the start of ravulizumab.

Eligibility Criteria:
Inclusion Criteria:

* Body weight of 10 kilogram or above
* Hemolysis with clinical symptom(s) indicative of high disease activity
* Documented diagnoses of PNH confirmed by high-sensitivity flow cytometry evaluation of red blood cells and white blood cells with granulocyte or monocyte clone size of ≥ 5%
* Clinically stable after having been treated with eculizumab for at least the past 6 months
* Participant already assigned to ravulizumab treatment as a specific therapeutic strategy within the current routine clinical practice (this decision has to be made independently and before the enrolment of the participant in the study)
* Vaccinated against Neisseria meningitidis (according to Summary of Product Characteristics) \< 3 years before dosing or at least 2 weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection
* Signed written informed and privacy consent prior to study participation

Exclusion Criteria:

* History of hematopoietic stem cell transplantation (evaluated at baseline)
* Known pregnant or breastfeeding participant (evaluated at baseline)
* Participant unable to read and write in Italian language and to autonomously fill in questionnaires and scales (evaluated at enrolment)
* Participants enrolled in any clinical study receiving experimental treatments for PNH (evaluated at baseline)
* Hypersensitivity to the active substance or to any of the excipient of the study drug.
* Participants with unresolved N. meningitidis infection at treatment initiation
* Participants who are not currently vaccinated against N. meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination
XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept

This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>18yo incarcerated in NYC jails with known release dates.
* DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
* Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.

Exclusion Criteria:

* Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.
* Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, \>99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant
* No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.
Posterior Tibial Artery Perforator-Pedicled Propeller Flaps in Reconstruction

Soft tissue defects in the lower leg remain a challenge for surgeons due to frequent bone exposure and paucity of soft tissues. The goal in this study was to evaluate the surgical technique and clinical significance of posterior tibial artery perforator-pedicled propeller flaps for reconstruction of defects in the lower leg.

The construction of the lower extremity defects with exposed bone and tendon is considered as the biggest challenge of all body regions in many plastic and reconstructive surgeons. The lower leg regions are in visible areas. Defects recovery and aesthetic consideration should be considered at the same time with the development of the economy and society. Although free flaps have been used to reconstruct these defects, some disadvantages still exist, such as needing microinstruments, long operation time and none like-with-like repair. In this article, a series of patients with soft tissue defects in the lower leg were transplanted with posterior tibial artery perforator-pedicled propeller flaps.

Eligibility Criteria:
Inclusion Criteria:

* 1.age range :10-80years. 2. in good overall heath without severe comorbidities. 3. posterior perforator tibial artery is no damage.

Exclusion Criteria:

1. age range \<10years or \>80years.
2. with severe comorbidities
3. Posterior perforator tibial artery of panticipants is damage
Exploratory Study of the Effects of Peptide PMS-001 on Long-Delay Recall in Patients With Moderate to Severe Dementia

This is a single-center, randomized, double-blind, placebo-controlled study. Patients will be randomly assigned to either the peptide intervention group (with dose escalation at 15mg, 30mg, 60mg, and 75mg) or the placebo control group. After learning and training, participants will receive an injection of PMS-001. The efficacy and safety of the intervention will be assessed at 1 hour, 1 day, 3 days, and 1 week post-intervention. This study aims to evaluate the effects of PMS-001 on improving long-delay recall in patients with moderate to severe dementia, as well as its safety profile.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be aged 60 to 80 years (inclusive) at the time of screening, regardless of gender.
2. Participants must have a Clinical Dementia Rating (CDR) total score \> 1, indicating moderate to severe dementia.
3. Participants must provide written informed consent to participate in the study.

Exclusion Criteria:

1. Presence of other neurological diseases that may cause cognitive decline, such as cerebrovascular disease, encephalitis, brain tumors, traumatic brain injury, epilepsy, Parkinson's disease, etc.
2. Presence of metabolic diseases that may cause cognitive decline, such as anemia, thyroid dysfunction, folate and vitamin B12 deficiency, etc.
3. Presence of severe psychiatric disorders, such as major depression.
4. History of carbon monoxide poisoning.
5. Presence of acute or severe life-threatening diseases.
6. Presence of severe visual, auditory, or language impairments that would prevent the completion of neuropsychological assessments.
7. Current use of psychotropic medications or a history of substance abuse.
8. Individuals with specific allergy histories, or those with a history of allergies to two or more medications, foods (such as milk), or pollen (excluding untreated, asymptomatic seasonal allergies), or known allergies to components of the study drug or similar agents.
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*0201 restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

URLC10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A\*0201 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2 peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

Disease characteristics

* Advanced or recurrent non small cell lung cancer
* Second line or later therapeutic status Patient characteristics
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*0201
* Laboratory values as follows

  * 2000/mm3\<WBC\<15000/mm3
  * Platelet count\>100000/mm3
  * Bilirubin \< 3.0mg/dl
  * Asparate transaminase \< 150IU/L
  * Alanine transaminase \< 150IU/L
  * Creatinine \< 3.0mg/dl
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Unhealed external wound
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal metastasis
* Decision of unsuitableness by principal investigator or physician-in-charge
Diagnostic Efficacy Of 3 EUS-FNB Techniques

Endoscopic ultrasound (EUS) is a widely recognized tool for over 30 years for diagnosing intra-abdominal lesions and gastrointestinal cancers, especially pancreatic neoplasia. In most hospitals, it is the preferred method for sampling using fine-needle aspiration (EUS-FNA) or histology needle aspiration biopsy (EUS-FNB) to obtain cytological and histological material for an anatomopathological diagnosis. It is also recognized by current oncology guidelines.

Numerous factors can affect the efficacy of this technique, such as the needle size, type (cytology or histology), number of passes made on the lesion, the presence or absence of a pathologist in the endoscopy room, the experience of the endoscopist, etc.

Currently, EUS-FNA or EUS-FNB are recommended interchangeably for diagnosis; however, it appears that histology needles (EUS-FNB) allow for greater diagnostic efficacy by obtaining a cellular block with fewer passes, which allows for more advanced anatomopathological analysis (such as immunohistochemistry or molecular analysis).

Regarding the technique for performing the puncture and acquiring the sample, current European guidelines recommend sampling using EUS-FNA or FNB by dry suction with a 10 mL syringe. However, other recognized techniques, such as using a stylet with the "slow-pull" technique (not positioning for or against) or liquid biopsy (which could obtain larger cellular blocks compared to dry puncture), are widely used and could obtain better samples, but there is no clear consensus currently.

Investigators' goal is to conduct a randomized clinical trial of three EUS-FNB techniques (dry puncture vs slow-pull vs wet puncture) used in daily clinical practice to evaluate which of the three techniques has greater efficacy in cytological and pathological diagnosis.


Eligibility Criteria:
Inclusion criteria

* Age ≥ 18 years
* Patients referred for EUS-FNB after imaging tests (CT, MRI, or abdominal ultrasound) of pancreatic, non-pancreatic intraabdominal, mediastinal, or pelvic lesions greater than 1 cm.
* Signed informed consent.

Exclusion criteria

* Coagulopathy (INR\> 1.5) or thrombocytopenia (\<50,000)
* Severe heart or respiratory failure that contraindicates sedation.
* Use of anticoagulants and antiplatelet agents that cannot be suspended.
* Use of a needle of a different gauge to 22G
* Refusal to sign informed consent.
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory chronic myelogenous leukemia.

OBJECTIVES: I. Determine the antileukemic efficacy of arsenic trioxide in patients with relapsed and/or refractory, chronic, accelerated, or blastic phase chronic myelogenous leukemia. II. Determine the pattern of clinical adverse experience in this patient population administered this drug.

OUTLINE: Patients are stratified according to disease stage (chronic phase vs accelerated phase or blastic phase). Patients receive arsenic trioxide IV over 1 hour on consecutive days or weekdays only for a total of 25 days followed by 3-5 weeks of rest. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with responding disease are followed at least monthly.

PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for the chronic phase stratum of this study within 2 years. A total of 17-37 patients will be accrued for the accelerated and blastic phases stratum of this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Chronic myelogenous leukemia (CML) confirmed by: Cytogenetic testing demonstrating presence of t(9:22) OR RT-PCR demonstrating presence of BCR/ABL rearrangement Chronic phase Blast count less than 15% OR Accelerated phase defined by 1 or more of the following: Blast count greater than 15% but less than 30% Blast count and promyelocytes greater than 30% Basophils greater than 20% Thrombocytopenia less than 100,000/mm3 not related to therapy Cytogenetic clonal evolution (13) OR Blastic phase Blast count greater than 30% OR Evidence of extramedullary blasts Relapse from or failure to achieve a major cytogenetic response to at least 1 course of standard anti-CML therapy including interferon alfa or cytotoxic chemotherapy Must have failed adequate trial of interferon alfa unless intolerance to or contraindication to interferon alfa Not eligible for allogeneic stem cell transplant

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 months after study No active serious infections that are not controlled by antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior interferon alfa Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (1 day for hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
Optimization of Sampling and Processing of Samples for Molecular Microbial Research on Ocular Surface Samples

The use of anesthetics and the processing of the retrieved samples are major confounding factors that influence the results of microbiome research.

The use of anesthetics is subject of discussion in ocular surface microbiome research. One publication showed a significant lower alpha diversity when using an anesthetic. However, the diluting effect of the anesthetic drop itself was not accounted for. On the other hand, using anesthetics will enable patients to tolerate sampling better and this might allow better sampling. To analyze the effect of anesthetic drops on the composition of the ocular surface microbiome, we sampled volunteers undergoing general anesthesia. By using artificial tears as a control, we aimed at accounting for the diluting effect of the anesthetic. By using volunteers under general anesthesia, we wanted to assure similar pressure with or without topical anesthesia since the executor was not influenced by the patient's reaction.

Furthermore, the effect of different extraction protocols on sequencing results will be assessed by sampling different volunteers in both eyes on non consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Willing to undergo sampling of the conjunctiva
* Fluent in written and verbal Dutch
* Capable of giving informed consent

Exclusion Criteria:

* Allergy to oxybuprocaine
* Medication usage in one eye only