cyrilzakka/clinical-trials huggingface dataset:
Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?

Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.

Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.

Eligibility Criteria:
Inclusion Criteria:

* solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
* formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.

Exclusion Criteria:

* a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
* lesions previously punctured on past EUS-FNA procedures
* American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
* cases of surveillance of solid pancreatic lesions
* severe coagulation disorder (platelet count \< 50000 or International Normalized Ratio \> 2,0)
* impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all)
* patient unwillingness to participate
Investigation of Pain and Symptom Burden in Patients With Newly Diagnosed Head and Neck Cancer

RATIONALE: Collecting information by questionnaire about the quality of life of patients with head and neck cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is testing a questionnaire for assessing pain control, head and neck symptoms, and general symptoms of illness, demographics, moods, alcohol and tobacco history, and quality of life related to cancer in patients with newly diagnosed head and neck cancer.

OBJECTIVES:

* To pilot test a questionnaire measuring the collection of the following data from patients with newly diagnosed head and neck cancer: head and neck cancer-related symptoms, general demographics, pain control, general symptoms, mood, smoking and drinking history, and quality of life.
* To identify questions that may be unclear or difficult for patients to understand.
* To determine the time required for each patient to complete the questionnaire and assess the feasibility and burden to the patient.
* To determine the baseline incidence of symptoms and psychosocial issues in these patients.

OUTLINE: Patients complete a timed questionnaire comprising questions of head and neck symptoms, demographic information, pain control, symptom control, mood, smoking and drinking history, and anxiety and depression under the supervision of the investigator.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of head or neck carcinoma

  * Newly diagnosed disease
* Able to speak English
* Able to give informed consent

Exclusion Criteria:

Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms

The primary objective for the 12-week Titration-/Maintenance Period is:

To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.

A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA).

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe idiopathic RLS with daytime symptoms

Exclusion Criteria:

* Females who are pregnant or lactating.
* Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
* Subjects with evidence of impaired liver/kidney function upon entry into the study
Effect of Anthocyanins Extracted From Purple Potatoes on Healthy Study Subjects' Postprandial Glycemia and Insulinemia

A randomized, single-blind cross-over clinical nutrition trial will be conducted. The effects of yellow-fleshed potatoes and yellow-fleshed potatoes supplemented with anthocyanins extracted from purple-fleshed potatoes on healthy men's postprandial glycemia and insulinemia will be compared. Additionally, the postprandial metabolism and metabolites, and the appearance and metabolism of the flavonoids and their metabolites is studied in plasma, urine and feces.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* Male
* No regular medication
* No participation in a drug trial or blood donation within 2 months
* Non-smoker
* Signs informed consent
* Body mass index 18.5-27 kg/m2
* Fasting plasma cholesterol \< 5.5 mmol/l
* Fasting plasma triacylglycerols \< 2.6 mmol/l
* Fasting plasma glucose 4-6 mmol/l
* blood pressure \<140/80 mmHg
* hemoglobin\>130 g/l
* Fasting plasma alanine amino transferase (ALAT) \<60 U/l (normal liver function)
* Fasting plasma thyroid-stimulating hormone (TSH) 0.4 - 4.5 mU/l (normal thyroid function)
* Fasting plasma creatinine \<118 µmol/l (normal kidney function)

Exclusion Criteria:

* Regular smoking
* Alcohol abuse
* Regular medication
Clinical Effects of Radiofrequency in Fibromyalgia

The aim of this study is to analyze the effects of a single-session of Radiofrequency in patients with Fibromyalgia in comparison to a placebo group.

The aim of this study is to analyze the effects of a single-session of Radiofrequency on peripheral vascular blood flow of the skin of the hands and core body temperature in patients with Fibromyalgia in comparison to a placebo group. Also, to study the clinical effects of the intervention on subjective pain perception, pain threshold to pressure and electrical pain threshold and intensity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Fibromyalgia in accordance with the American College of Rheumatology criteria for classifying Fibromyalgia (2016 revision) by a rheumatologist of the Public Health System of Andalusia (Spain)
* Age from 18 to 70 years
* No other rheumatic diseases
* Absence of regular physical activity
* Limitation of usual activities due to pain on at least 1 day out of the previous 30

Exclusion Criteria:

* Male sex
* Presence of cardiac, renal or hepatic insufficiency;
* Severe physical disability
* Pregnancy or lactation
* Active infections
* Psychiatric illness
* Active tumor.
* Treatment with vasoactive drugs or anticoagulants or a history of drug use
* Skin disorders
* Any other non-pharmacological therapy
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion Criteria:

* FEV1 between 30 and 80% of predicted normal value post-bronchodilator (GOLD stages 2 and 3)
* Clinical diagnosis of COPD

Exclusion Criteria:

* Other clinically relevant disease or disorders
* Exacerbation of COPD within 30 days
Girl2Girl: A Web-based Trial

This is a pilot effectiveness study of Girl2Girl, a text messaging-based pregnancy prevention program for cisgender sexual minority adolescents.

An estimated one in four teen women will become pregnant by the time she is 20 years of age. That said, significant disparity in rates exist for lesbian, gay, bisexual and other sexual minority women (LGB) versus non-LGB teen women: Research suggests that lesbian and bisexual teen women are between two and four times more likely to report having been pregnant than teen women who identified as exclusively heterosexual. Despite this compelling evidence that lesbian and bisexual adolescent women are at risk for teen pregnancy, programs tailored to the unique needs of adolescent LGB women are nonexistent. Evidence-based teen pregnancy prevention (TPP) programs targeting LGB teen women are urgently needed.

The Girl2Girl intervention text messaging-based TPP program designed specifically for LGB women ages 14-18 years, nation-wide. This is an extension of a previous randomized controlled trial. Here, the cohort was recruited using an effectiveness strategy: Girls were allowed to register and enroll themselves without needing to talk to research staff. All eligible and interested youth were allowed to enroll; no diversity targets were applied.

Eligibility Criteria:
Inclusion Criteria:

* Endorse a non-heterosexual sexual identity (i.e., lesbian/gay, bisexual, queer, questioning, unsure) on the screener;
* Be cisgender (i.e., be assigned a female sex at birth and endorse a female gender identity) on the screener;
* Be aged 14-18;
* Be English speaking;
* Be able to provide informed assent, including the self-directed self-safety assessment.

Exclusion Criteria:

* Not passing the self-directed self-safety assessment
* Knowing someone who is already enrolled in the program (added part-way through the recruitment period)
* Non-cisgender identity in the screener
Study of Obeldesivir in Children and Adolescents With COVID-19

The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).

The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.

Pediatric participants will be enrolled as follows:

* Cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg
* Cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg
* Cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg
* Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg
* Cohort 5: ≥ 14 days to \< 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kg
* Cohort 6: 0 days to \< 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
* Cohort 7: 0 days to \< 56 days of age, GA \< 37 weeks and birth weight ≥ 1.5 kg

Eligibility Criteria:
Key Inclusion Criteria:

* Individual or legal guardian willing and able to provide written informed consent prior to performing study procedures. Individuals will provide assent, if possible, in accordance with local requirements and investigator's discretion.
* Aged \< 18 years who meet one of the following weight criteria and gestational age (GA) criteria where applicable:

  * Cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg
  * Cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg
  * Cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg
  * Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg
  * Cohort 5: ≥ 14 days to \< 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg
  * Cohort 6: 0 days to \< 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
  * Cohort 7: 0 days to \< 56 days of age, GA \< 37 weeks and birth weight ≥ 1.5 kg
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days before screening.
* Initial onset of coronavirus disease 2019 (COVID-19) signs/symptoms ≤ 5 days before screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath, sore throat, headache, myalgia/arthralgia present at screening.
* Presence of ≥ 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness due to COVID-19 per protocol.

Key Exclusion Criteria:

* Anticipated access to and use of authorized or approved COVID-19 therapies during the current COVID-19 illness \< 5 days after screening (therapies including but not limited to nirmatrelvir/ritonavir, molnupiravir, intravenous remdesivir (RDV), monoclonal antibodies).
* Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection \< 4 months prior to screening.
* Received any approved, authorized, or investigational direct acting antiviral drug against SARS-CoV-2 for the treatment of COVID-19 \< 28 days or \< 5 half-lives, whichever is longer, before enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Watchful Waiting. An Observational Study of Patients With Rectal Cancer After Concomitant Radiation and Chemotherapy

The purpose of this study is to investigate if operation and permanent stoma can be omitted in patients with cancer in the lower part of the rectum.

Patients entering this study are offered the possibility of avoiding an extensive operation and a permanent stoma.

Over the past 2 years Vejle Hospital examined patients with rectal cancer during their course of treatment and we have developed a method to predict complete response.

Patients in this study are treated with chemotherapy and external irradiation supplemented with an endorectal boost (2 fractions). At the start of treatment and weeks 2, 4, and 6 of the treatment course an endoscopy is performed to evaluate the response. The final evaluation is performed 6 weeks after end of treatment. Patients with complete remission are offered observation. Patients with residual tumor are advised to be operated.

Follow-up is performed every 2 months the first year and every 3 months the second year. 2 follow-up visits are planned for the third year. A yearly follow-up is scheduled for the fourth and fifth year.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologically verified adenocarcinoma in the rectum
* Planned APR or ultra low resection
* Primary resectable T2 or T3 tumor
* Distance from anus to lower edge of tumor ≤ 6 cm
* Suited for curative intended radiation and chemotherapy
* Accept taking of biopsy and blood samples for translational research
* Age ≥ 18 years
* Normal function of bone marrow

  * leukocytes ≥ 3 x 10\^9/l
  * thrombocytes ≥ 100
* Normal liver function

  * ALAT \< 2.5 x upper normal value
  * bilirubin \< 2.5 x upper normal value
* Renal function

  * Serum creatinin \< 1.5 x upper normal value
* Written and orally informed consent

Exclusion Criteria:

* Other malignant disease within the last 5 years apart from basocellular skin cancer and carcinoma in situ cervicis uteri
* Distant metastases
* Pregnant or breast feeding patients
Virtual Reality for Pain Control During Extracorporeal Shock Wave Lithotripsy: a Prospective, Comparative, Randomized Study at a Single Institution

The aim of this study is to prospectively analyze patient satisfaction, pain, delivered energy and clinical effectiveness of using VR as a complimentary treatment modality during SWL.

The patients were randomized in two groups SWL with VR and SWL without VR. When a patient was randomized for a VR session we put on the monitor after adequate patient positioning. We used the Oncomfort Sedakit.

The size and location of stone pre-treatment was measured based on the best available imaging tool (CT\>RX/ultrasonography) using the maximal stone diameter. The locations of the stones were described as upper pole stones, midpolar stones, lower pole stones, renal pelvis stones and proximal ureteric stones. Each SWL treatment was standardized using diclofenac 100 mg suppository as analgesic and local lidocain/prilocain cream (EMLA 5g, Aspen) to numb the skin. Visualization of the stone was done by fluoroscopy of ultrasonography, as these proved to be equivalent (Van Besien et al. 2017).

A specific and standardized ramping protocol was applied. After finishing this protocol, the energy level could be raised further depending on the level of discomfort of the patient.

Directly after the procedure, the patients were asked to complete a questionnaire where they were asked to write down the experienced amount of pain during the procedure on a VAS of 10 cm and the satisfaction level using a Likert-scale. The total delivered energy was noted.

Two weeks after every SWL session, follow-up imaging (ultrasound and plain abdominal radiography) was performed by a radiologist. Residual stone size was estimated on plain abdominal radiography or ultrasonography. The radiologist was blinded for the randomization process. Practitioner and patient were not. After each SWL the clinical outcome was noted.

Eligibility Criteria:
Inclusion Criteria:

- Patients with renal or ureteric stones in need of a shock-wave lithotripsy. The indication was based on the European association of urology guidelines

Exclusion Criteria:

* none
Determinants of Depression and Its Impact on Quality of Life in Patients With Chronic Pancreatitis

Chronic pancreatitis (CP) is associated with recurrent intractable abdominal pain, pancreatic exocrine insufficiency and endocrine dysfunction. Very few studies had evaluated the quality of life in CP, and even a fewer have assessed the mental status in these patients.

In the current study, we proposed to evaluate the the relationship between pain, quality of life and depression status in two large independent cohorts of patients with CP. We also proposed to evaluate the brain metabolites in the right and left anterior cingulate cortex, basal ganglia, hippocampus and prefrontal cortex using magnetic resonance spectroscopy. We further proposed to evaluate the pasta metabolites and look for associations with the mental state. Finally, we proposed to evaluate how CP related education of the patients could impact on their mental status and response to interventions on pain.


Eligibility Criteria:
A. Inclusion Criteria:

* Age 18-60yrs
* Both genders
* Documented CP for at least 3 years
* Capable and willing to provide informed consent

B. Exclusion Criteria:

* Acute exacerbation of pancreatitis
* Pancreatic malignancy
* On anti-depressant and antipsychotic medications
* Concomitant psychiatric illness (other than depression)
* Pancreatic malignancy
* Major co-morbidities
* Pregnancy and lactation
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus

This will be a randomized, cross-over design. Subjects will be randomized to one of two interventions on two separate study days, 1 week apart.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 yrs
* Type 2 diabetes controlled with diet or diet and oral agent, with the exception of sulfonylureas such as glimepiride (Amaryl), glipizide, Glucotrol/GlucotrolXL) and glyburide (DiaBeta, Micronase, (Glynase Prestabs); meglitinides such as reaglinide (Prandin) and nateglinide (Starlix); and alphaglucosidase inhibitors such as acarbose (Precose) and miglitol (Glyset)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dL
* Potassium \<3.5 mEq/L
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* History of bypass surgery, midface trauma, esophageal varices, coagulation abnormalities
* Patients currently on any anti-coagulant medication
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Unable to give informed consent or follow instructions
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, fish oil or any component of the test product
* Patient who in the Investigators assessment cannot be expected to comply with treatment
* Currently participating or having participated in another clinical trial.
AMG 701 Expanded Access Program

Expanded access requests for AMG 701 may be considered for adult patients with relapsed and/or refractory multiple myeloma whose disease is in partial response or better after AMG 420 therapy. To request access, use Responsible Party contact information provided in this record.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex

This is a multi-center, randomized, placebo-controlled, flexible-dose, parallel-group study designed to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and /or psychotic features.

This study is to evaluate the efficacy and safety of lurasidone (in combination with lithium or divalproex) for the maintenance treatment of bipolar I disorder in subjects with or without rapid cycling and/or psychotic features.

Eligibility Criteria:
Inclusion Criteria:

Open-label Phase

* 18 years of age or older
* Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) diagnosis of bipolar I disorder

  •≥ 1 manic, mixed manic, or depressed episode in past 2 years
* YMRS or MADRS total score ≥ 14 if on lithium or divalproex; ≥ 18 if not on lithium or divalproex

Double-blind Phase

Inclusion Criteria:

* Subjects must achieve consistent clinical stability, defined as total scores ≤ 12 on the YMRS and MADRS over at least 12 weeks, with the allowance of two excursions (YMRS and/or MADRS total scores up to 13 or 14, respectively) except during the last 4 weeks before randomization

Exclusion Criteria:

Open Label Phase

* Diagnosis of an Axis I or Axis II disorder, other than bipolar I disorder, that is the primary focus of treatment within 3 months of screening
* Subjects for whom diagnostic agreement between the Investigator and United BioSource Corporation (Boston) (UBC) cannot be reached
* Ultra-fast rapid cycling (defined as ≥ 8 mood episodes over the previous 12-month period)
* Subjects who test positive for drugs of abuse at screening. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study
* Unstable/inadequately treated medical illness
* The subjects answers "yes" to "Suicidal Ideation" items 4 or 5 on the C-SSRS (at time of evaluation)

Double Blind Phase

* Subjects who in the Investigator's judgment have not been compliant with study medication during the stabilization phase
* Subjects who have not stabilized during the open-label phase (within 20 weeks)
* Subjects who test positive for drugs of abuse at double-blind phase baseline. In the event a subject tests positive for cannabinoids (tetrahydrocannabinol), the Investigator will evaluate the subject's ability to abstain from cannabis during the study