cyrilzakka/clinical-trials huggingface dataset:
Seeking Informed Consent to Phase I Cancer Clinical Trials: Identifying Oncologists'Communication Styles

The purpose of this study is to examine doctor-patient communication about treatment options which may include an experimental, new treatment for cancer. What we learn from this study may help us to teach doctors better ways to talk to their patients.

Subjects will be cancer patients attending one of three outpatient clinics at Memorial Sloan-Kettering Cancer Center. Subjects will be recruited from the Melanoma/Sarcoma, GI and Genitourinary Oncology services. The patients of six oncologists across the three services will be approached. All patients of these six oncologists who are invited to participate in a Phase I clinical trial will be approached to participate in the study. Patients who consent to participate in this study will be included in the sample regardless of their trial decision.

Design and Analysis:

To gather information about the communication strategies used by oncologists to discuss trials, a qualitative analysis of audio recordings of consultations containing discussions of Phase I trials will be conducted. These consultations will be audio recorded and transcribed in full; analysis will proceed using the constant comparative method. Initially (and as is consistent with the qualitative method employed for this study), a small sample of 15 patients will be recruited. Once an exhaustive analysis of this original data set is complete a further set of 15 patients will be recruited and transcripts of these consultations analyzed. In order to identify any new themes, the themes that emerged from the new data set will be compared with those identified in the original data set. We anticipate that the study will be completed within one year of commencement.

Significance: Oncologists report that one of their most significant communication challenges is communicating effectively and ethically with their patients about joining a clinical trial. Communication skills training has demonstrated efficacy in assisting doctors in this difficult task, however, there is a paucity of research in this area and studies have been limited to the Phase II and III trial setting. There is some research evidence that suggests that different communication issues and challenges emerge in the Phase I versus the Phase II and III trial setting. The pilot research proposed in this protocol will: a) explore the types of communication currently used by oncologists when recruiting patients to clinical trials and b) develop a set of communication strategies that can be used to address gaps in doctor- patient communication in this difficult area.

Eligibility Criteria:
Inclusion Criteria:

* Patients at the outpatient oncology clinics of the six participating physicians (Drs Schwartz, Scher, Slovin, Tse, Shah \& Carvajal)
* Diagnosed with cancer
* Eligible for a Phase I trial
* Discussing participation in such a trial with their physician during their visit

Exclusion Criteria:

* Fewer than 18 years of age
* Not proficient in English
* Cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study
Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population

"This is a prospective, single-center specimen collection study. Subjects 18 years of age or older who do not have symptoms of COVID-19 will be enrolled. Two nasal swab samples and one saliva sample will be collected from each subject. The saliva sample will be tested with the COVIDSeq Test and one nasal swab will be tested with an EUA approved COVID test. The other nasal swab sample will be stored and a subset (approximately 250 specimens) will be tested with the COVIDSeq Test. Results of all testing will be provided to the sponsor for statistical analysis.

Results from the comparator EUA test will be provided to the collection site investigator or designated collection site study staff. No medical treatment, guidance on treatment decisions, nor medical care will be provided. "


Eligibility Criteria:
Subject Inclusion Criteria:

An individual must meet the criteria below to be eligible.

* Individual is attending or invited to visit a participating collection site.
* Individual is 18 years or older at the time of consent.
* Individual is feeling well at the time of consent or specimen collection and does not have any of the following symptoms of COVID-19 per the current CDC guidance such as cough, shortness of breath or difficulty breathing, fatigue, fever or chills, muscle or body aches, headache, sore throat, new loss of taste or smell, congestion or runny nose, nausea or vomiting, or diarrhea.
* Individual is willing to participate in study procedures and able to provide written informed consent in the English language.

Subject Exclusion Criteria:

An individual cannot meet the below criteria.

* Individual is confirmed to have COVID-19 and continues to require isolation in accordance with current CDC guidelines at the time of consent or specimen collection.
* Individual is asymptomatic but suspected to have COVID-19 due to recent close contact (as currently defined by the CDC) with a person with COVID-19 and continues to require quarantine in accordance with current CDC guidelines at the time of consent or specimen collection. \[5\]
* Individual had symptoms of COVID-19 less than 10 days before time of consent or specimen collection."
A Randomized Clinical Trail of The Effect of Postoperative Uric Acid Control on Stone Recurrence and Renal Function in Patients With Hyperuricemia of Urolithiasis.

The purpose of this study was to explore the effects of uric acid control on stone recurrence and renal function in patients with calculi of hyperuricemia through a prospective controlled study.

2020.1 -2020.12 patients with urolithiasis and hyperuricemia were enrolled in the urology department of our hospital (100 cases). The patients were informed of this study before operation and randomly divided into uric acid drug control group (n = 50) and non-drug control group (n = 50). The patients were followed up for 3 months, 6 months, 12 months and 18 months after operation.

Informations as age, sex, height, weight, calculation BMI, past medical history, history of gout, diabetes, hyperthyroidism, calcium supplements will be recorded.

Rapid blood glucose, serum total cholesterol, high density cholesterol, thyroid hormone detection, androgen, estrogen detection, serum sodium, potassium, chlorine, calcium, magnesium, phosphorus, serum uric acid will be tested.

Renogram test to evaluate the change of single renal function. The stones burden will be followed-up with ultrasound or kub or CT plain scan.

Eligibility Criteria:
Inclusion Criteria:

* .Over 18 years old, under 70 years old, regardless of sex .The subjects had no mental illness or language dysfunction, could understand the situation of this study and had signed an informed consent form.

.No clinical manifestations of urinary tract infection, urinary routine examination showed urinary tract infection, but urinary etiology test was negative (urinary routine leukocytosis), treated with broad-spectrum antibiotics for more than 3 days.

.Clinical manifestations of urinary tract infection, urine routine examination showed urinary tract infection, and patients with positive urinary etiology were treated with sensitive antibiotics for more than 7 days.

* Serum uric acid value ≥480 µmol / L
* urinary stones

Exclusion Criteria:

* Transplanted kidney
* Fever or urinary tract infection is not treated according to the inclusion criteria
* Pregnant women and female menstruation
* Unable to tolerate anesthesia or surgery due to severe systemic disease, heart disease, pulmonary insufficiency and important organ failure
* Patients with renal insufficiency Clcr \<30 mL/min
* Those who take side effects of febuxostat，Patients with side effects of febuxostat, patients with a previous history of coronary heart disease
Identification of Correlations Between Reaction to Biotine and Autoimmune Diseases

Working hypothesis and aims: Biotin is conjugated covalently to several proteins and use as a co-factor. Conjugation of biotin to non-targeted, unspecific proteins (e.g. immunoglobulins) leads to the breakage of the immune tolerance and to the formation of anti-biotin antibodies. Anti-biotin antibodies will be found in correlation with the progression and the present of autoimmune disease. In this research the correlation between immune response against biotin and the formations of autoimmune disease, will be studied:

A. Assessment of the possibility that biotin elicit immune response involved in the developmental stage of the autoimmune disease.

B. Assessment of the possibility that anti-biotin antibodies indicate the developmental stage of the autoimmune disease and therefore can serve as an disease early stage marker.

Methods: A. Patient recruitment. Gathering participant's medical record and blood samples. B. Records of clinical and biochemical measures. C. Serum of all patient will be tested for the correlation between biotin level, biotin bound to antibodies and anti-biotin antibodies to liver functions tests. D. Controlled test for repeatedly injected mice with biotinilated self-antibodies. Level of anti-biotin will be tested and their influence on the mouse. E. Determination of the correlation between biotinilated antibodies or anti-biotin antibodies to disease eruption or severance and autoimmune disease.

Expected results :Serum biotin-protein levels and Anti biotin antibodies levels are increased in patients with active autoimmune liver diseases.

Importance: The proof of connection between biotin-carrying immunoglobulins, anti biotin antibodies and autoimmune diseases will open new research direction of possible factors that cause to autoimmune disease.

Probable implications to Medicine: Identification of correlations between reaction to biotine and autoimmune diseases will enable their usage as biomarkers for autoimmune diseases, severity of the disease and personalization of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Freely given informed consent
* Autoimmune disease

Exclusion Criteria:
Comparison of Passive and Active Joint Mobilization for Chronic Ankle Instability

The features of CAI were confirmed through studies that 64% to 77% had extra-articular conditions mainly related to calf tendon disorder. In addition, joints are laxity, sensory motors are deficient, and the range of dorsi flexion is decreased. this study is to investigate the effects of active joint mobilization(AJM) under weight-bearing conditions to stimulate various proprioceptors for CAI with deficiency in sensorimotor and postural control.


Eligibility Criteria:
Inclusion Criteria:

* First ankle sprain one year before clinical trial
* A score of less than 24 on the Cumberland Ankle Instability Tool (CAIT)
* No ankle sprains occurred within 4 weeks of starting the test
* Two or more more ankle sprains in the past month

Exclusion Criteria:

* If you have a history of lower extremity surgery
* In case of receiving treatment for the affected ankle within 1 month
* If you have a psychological problem
Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

The purpose of this study is to determine how reducing the level of nicotine in cigarettes may affect adolescent smoking behavior. In this study, the researchers will randomize adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline period. Participants will be instructed to smoke only those cigarettes. The researchers will conduct daily assessments of total cigarette use (both study cigarette and non-compliant use of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect real-world smoking behavior in adolescents, and illuminate the potential mechanisms through which these products may effect such changes. Such knowledge will contribute to the science base that may inform future policy decisions.


Eligibility Criteria:
Inclusion Criteria:

* current daily smoking (1 or more cigarettes per day for the past 6 months or longer). Participants must meet a breath carbon monoxide criterion of 6 ppm or higher; if this is not met, urine cotinine levels, detected by a NicAlert cotinine screening device, must indicate recent smoking (level 3 or higher).
* Participants must speak and comprehend English well enough to complete study procedures.

Exclusion Criteria:

* Current pregnancy
* Self-reported daily use of alcohol or other non-prescribed drugs (excluding marijuana).
* Participants who are seeking treatment for their smoking or who report that they intend to quit smoking within the next 30 days and have made a 24-hour quit attempt in the past year
* Participants who report current suicidal ideation on the MINI suicide subscale questions 4 \& 5 ("In the past month did you have a suicide plan?" and "In the past month did you attempt suicide?"), as well as participants who indicate that they have made a suicide attempt in their lifetime
* Participants who report use of other non-cigarette tobacco products more than 9 out of the last 30 days
Duration of Urinary Catheterization Following Cesarean Deliveries Under Neuraxial Anesthesia

In cesarean deliveries, urinary catheters are often used to help empty the bladder while patients have limited mobility. These catheters typically stay in during early recovery because certain pain medications can make it hard for patients to urinate. Recently, the Society of Obstetric Anesthesia and Perinatology (SOAP) recommended removing catheters within 6-12 hours after delivery to aid recovery. However, at BC Women's Hospital, a review found that catheters stayed in for an average of 19 to 19.4 hours, even when patients were mobile.

Leaving catheters in too long can increase the risk of urinary tract infections (UTIs), pain, and urination issues, which can delay recovery and extend hospital stays. An internal review showed that factors like patient anxiety may affect when catheters are removed. Postpartum anxiety affects around 9.9% to 20.7% of new mothers in the first year and is an important factor in recovery after a cesarean delivery.

The main goal of this study is to look at how long urinary catheters stay in patients who had a cesarean delivery under spinal or epidural anesthesia, and what the score is from a questionnaire used to measure anxiety called the State Trait Anxiety Inventory (STAI-S), to see if there is a link between them.

This study aims to analyze how long foley catheters stay in the patient after their cesarean delivery under neuraxial anesthesia and what barriers there are in taking them out earlier.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥19 years of age.
* Undergoing cesarean delivery (elective or emergent) at BC Women's Hospital.
* Neuraxial anesthesia as their primary mode of anesthesia (spinal, epidural, combined spinal-epidural, dural-puncture epidural).
* In-patient status at 24 (+/- 8) hours.
* Self-reported proficiency in speaking and reading English.

Exclusion Criteria:

* Refusal to participate.
* Inability to provide informed consent.
* Other surgery (i.e. cervical cerclage) or delivery modes (i.e. operative vaginal delivery).
* De novo general anesthetic, or patients who had a conversion from neuraxial to a general anesthetic.
* Communication from patient's nurse indicating that it is not appropriate to approach due to distressing birth experience and/or outcome.
Acupuncture in Depression: From the Clinical Trial, Biomarkers to Molecular Biology

Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime prevalence rate and causes major clinical, social and economic burden to patients and their family. Despite more than 40 antidepressants with various mechanisms are available on the market, half of patients fail to achieve remission with optimized medication treatment. Due to unsatisfactory efficacy, frequent intolerability and poor compliance of psychopharmacotherapies, novel and safe alternative therapies are critically in need to improve the treatment of depression.

Traditional Chinese medicine (TCM) theory describes a state of health maintained by a balance of energy in the body. If imbalanced, it can be corrected by acupuncture, the insertion of fine needles into different parts of the body. Although there are several clinical trials to demonstrate the antidepressant effects of acupuncture, its biological and physiological mechanisms are still unknown. In addition, clinical depression is frequently accompanied with somatic presentations, which are related to autonomic nervous dysfunction. It would be of interest to know if acupuncture could regulate autonomic nervous system (ANS) and improve the somatic symptoms in depression. The purpose of this study is to assess the effectiveness of acupuncture in the treatment of depression and to determine the influence of acupuncture on the molecular and ANS systems.

In this study,the investigators will test the antidepressant effect of acupuncture versus sham intervention on major depression, in an eight-week, double-blind, randomized-controlled trial in 40 MDD patients who still have significant depressive symptoms without changing at their treatment modality for the last 4 weeks. During the visits at weeks 0 (baseline), 1, 2, 4, 6, 8 (intervention), and 12 (4 weeks after intervention), subjects will be assessed depressive symptoms with the 21-item Hamilton Rating Scale for Depression (HAM-D). Before and after the intervention (Weeks 0 and 8),Computerized TCM constitution diagnosis will be measured and the blood samples will be collected for biomarker analyses, including neurotransmitter, inflammatory molecules and immunologic function. All parts of this research will start after being approved by the Institution Review Board in study sites.

The outcomes of this study could provide the evidence of applying acupuncture as an alternative effective treatment for depression and to improve the understanding of biological mechanisms for its antidepressant effects.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of major depressive disorder (MDD)
* Over 18 on the 21-item Hamilton Rating Scale for Depression

Exclusion Criteria:

* Schizophrenia
* Ubstance dependence disorders
Effect of Different Subcutaneous Injection Methods on Pain and Satisfaction

This study; In patients treated with subcutaneous heparin A randomized controlled trial was planned to determine the effect of the injection time and the device called "Palm Stimulator" to reduce the pain felt during injection.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* The one who is literate,
* No physical, mental disabilities or communication difficulties,
* Low Molecular Weight Heparin in the treatment plan,
* No history of allergy,
* Agreeing to participate in the research,
* There is no scar tissue, incision or infection in the area to be injected,
* Patients who will receive a 1-day injection and whose pain score is between 1-10 according to VAS will be admitted.

Exclusion Criteria:

* Who gave up participating in the research while continuing the research,
* Using subcutaneous insulin therapy,
* There is an amputation in the right/left arm area where the study will be performed,
* There is scar tissue, incision or signs of infection in the area to be injected,
* Patients who received injections for 1 day and whose pain score is 0 (zero) according to VAS will not be admitted.
Covid-19 Patients With Hypertension and/or Kidney Diseases

1. correlation between COVID-19 and Hypertension and/or kidney diseases.
2. Assess Assess the effect of COVID-19 on patients with Hypertension and/or kidney diseases.
3. Assess the effect of hypertension and/or kidney diseases on COVID-19 presentation.
4. Assess the outcome of COVID-19 in patients with hypertension and/or kidney diseases

The pandemic situation with the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from China has endangered human lives. Coronavirus disease 2019 (COVID-19) is presented with asymptomatic, mild, or severe pneumonia-like symptoms¹.SARS-CoV-2 has infected humans in all age groups, of all ethnicities, both males and females while spreading through communities at an alarming rate². COVID-19 patients with hypertension, chronic kidney disease, Diabetes, malignancies, HIV, and other comorbidities could develop a life-threatening situation. From the data have reported the characteristics of comorbidities in patients with COVID-19, hypertension was present in nearly 21%, followed by diabetes in nearly 11%, and established cardiovascular disease (CVD) in approximately 7% of patients³.

Hypertension posed an increased risk of severe morbidity (approx. 4-fold) and death (approx. 7-fold) from COVID-19 in the presence of multiple comorbidities⁴.

The patients with underlying kidney problems are vulnerable to developing COVID-19 infection.The disease also has had consequences on longitudinal management of patients with chronic kidney disease and end stage kidney disease.

Eligibility Criteria:
Inclusion Criteria:

Patients above 18 years old. Patients who diagnosed as COVID-19 PCR positive with hypertension and/or kidney diseases.

Exclusion Criteria:

Young patients below 18 years old. Patients who refused to participate in reseach
Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders

This trial investigates the behavioral effects of manualized social skills training (KONTAKT) in children´s and adolescents with high-functioning autism spectrum disorder with psychiatric comorbidity in a RCT, multicenter study. N = 288 are recruited from 10 child and adolescent psychiatric clinics in Stockholm County. The examination of genetic variants as predictors for outcome and a qualitative study of KONTAKT complete the trial.

There are few randomized controlled trials of social skills group training for the Children's and adolescents with high functioning autism spectrum disorders (HFA)(1). The Objective of this trial is to investigate the behavioral effects of the manualized social skills group training KONTAKT (2,3) and the role of genetic variants for training effects.

Eligibility Criteria:
Inclusion criteria:

* Children and adolescent with High-functioning autism (F84.5, F 84.9 according to International Classification of Diseases (ICD-10). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).
* Normal psychometric range of intelligence, intelligence quotient (IQ)\> 70 according to Wechsler Intelligence Scale for Children- Fourth Edition (WISC-IV).
* Comorbid diagnosis: ADHD (F90.0 and F98.8), Anxiety Syndrome (F41.1) and depression (F32.9) according to a best estimate clinical assessment.

Exclusion criteria:

Any behavioral disorder not currently allowing meaningful participation in group-based training for ASD, e.g. presence of clinically diagnosed self-injury, conduct disorder (F91), hyperkinetic conduct disorder (F90.1), antisocial personality disorder (F60.2), borderline personality disorder (F60.3) or any form of schizophrenia or related psychotic disorder (F20-F29).