cyrilzakka/clinical-trials huggingface dataset:
Safety of a Sheath Cryoprobe Bronchoscopic Transbronchial Biopsy Technique

The purpose of this study is to evaluate the safety and collect data on the initial effectiveness of a 1.1mm flexible single-use cryoprobe with oversheath used for transbronchial lung biopsy via a bronchoscopic approach.

A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe.

This study does not involve randomization or assigning different patients to different procedures to compare. Everyone who enrolls in this study will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe. The only difference from the standard of care approach is that the physician performing the transbronchial biopsy will use the 1.1mm sheath cryoprobe rather than forceps or another currently available larger cryoprobe.

Patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, ≥ 18-years-old
* Scheduled to undergo bronchoscopy with transbronchial biopsy as the standard medical care determined by their treating pulmonologist

Exclusion Criteria:

* Pregnant or nursing females, or females of child bearing potential who refuse to take a pregnancy test prior to enrollment
* Individuals with current or recent systematic conditions, such as uncontrolled hypertension (systolic \> 200 mmHg or diastolic \> 110 mmHg), type 1 diabetes, severe pulmonary hypertension, acute kidney injury, stroke (within the last 6 months) or myocardial infarction (within the last 3 months)
* Presence of bleeding disorder
* Platelet count \<50,000
* Current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is acceptable)
* International Normalized Ratio (INR) \<1.5
* Robotic Bronchoscopy
A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy

The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be on current HIV treatment regimen at least 3 to 6 months prior to study (this must be one protease inhibitor, or ritonavir-boosted protease inhibitor, and two nucleoside reverse transcriptase inhibitors) must be subject's first PI ever received
* Plasma HIV-1 RNA level \< 50 c/mL within 3 to 6 months prior to study start
* Fasting LDL cholesterol \> 130 mg/dL

Key Exclusion Criteria:

* WOCBP who do not use effective barrier contraception for any reason
* Women who are pregnant or breast feeding
* A life expectancy \< 12 months
* Presence of a newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
* Cushing's Syndrome
* Uncontrolled diabetes mellitus, history of diabetic ketoacidosis or hyperosmolar syndrome
* Untreated hypothyroidism or hyperthyroidism
* Nephrotic syndrome or significant proteinuria
* Obstructive liver disease
* Active alcohol or substance abuse
* Proven or suspected acute hepatitis in the 30 days prior to study entry
* Intractable diarrhea (greater than or equal to 6 loose stools/day for at least 7 consecutive days) within 30 days prior to study start
* History of acute or chronic pancreatitis
* Inability to swallow capsules
* Presence of cardiomyopathy
* Known history of prolonged QTc interval
* Any of the following:

  1. clinical symptoms potentially related to heart block
  2. heart rate \< 40 bpm
  3. any of the following EKG abnormalities:

  i) pause length \> 3 seconds ii) second or third degree AV heart block iii) QTc interval \> 450 msec for males iv) QTc interval \> 470 msec for females
* Fasting serum triglyceride level \> 750 mg/dL
* Any of the following lab values within 2 weeks of starting study drug:

  1. serum creatinine greater to or equal to 1.5 times the upper limit of normal
  2. total serum lipase greater than or equal to 1.4 times the upper limit of normal
  3. liver transaminases greater than or equal to 3 times the upper limit of normal
  4. total serum bilirubin greater than or equal to 1.5 times the upper limit of normal
* Hypersensitivity to any component of the formulation of study drug
* Use of any lipid-lowering agent within 4 weeks prior or during study
* Use of a PI-containing ARV regimen prior to entry which is comprised of more than one PI
* Inclusion of an NNRTI in the PI-containing regimen
* Prisoners or subjects involuntary incarcerated for treatment of psychiatric or physical illness
Trauma Intervention for Affect Regulation, AIDS, and Substances

The Purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in HIV care with HIV-positive women.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* woman or trans woman
* substance use
* elevated PTSD symptoms
* HIV care difficulties

Exclusion Criteria:

* not HIV positive
* no substance use
* men
* no HIV care difficulties
* no history of trauma
Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy

The purpose of the study is to investigate differences in perioperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.

The purpose of the proposed study is to investigate differences in intraoperative and postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized surgical trial.

Objectives:

1. To evaluate differences in total operating time between subjects undergoing AM compared to VM.
2. To evaluate differences in morcellation time between AM and VM.
3. To evaluate differences in the amount of total narcotic use during hospital admission between AM and VM through morphine milligram equivalents (MME).
4. To evaluate differences in the patient's subjective pain assessment via Visual Analogue Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM and VM groups.
5. To evaluate differences in the patient's pain medication usage as reported by the patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM groups.
6. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
7. To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week postoperative visit between the AM group compared to VM group.
8. To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at 24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.

Eligibility Criteria:
Inclusion Criteria:

* All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
* Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
* Age \>18 years old
* Uterus \>12 weeks, or \>250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
* English and Spanish speaking

Exclusion Criteria:

* Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
* Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
* Appendectomy for endometriosis is not excluded
* No chronic pain disorders requiring medical management (endometriosis can be included)
* Planned abdominal hysterectomy or vaginal hysterectomy candidates
* Conversion to laparotomy or inability to complete morcellation
* Contraindications to laparoscopy
An Open Trial to Assess the Tolerability of AVANZ® Salsola Immunotherapy

This trial is an open, national, multi-centre trial. The trial will be initiated in December 2013 and subjects will receive treatment for 6 weeks.

Safety monitoring will be performed in an ongoing basis through a Clinical Safety Group with immediate access to Adverse Events registered in the clinical database. The composition, procedures and deliverables of the Clinical Safety Group will be detailed in a Safety Agreement prior to trial start.


Eligibility Criteria:
Inclusion Criteria:

* A clinical history of Salsola kali pollen induced allergic rhinoconjunctivitis with or without asthma at least one year prior to trial entry.
* Positive Skin Prick Test to Salsola kali pollen (wheal diameter ≥ 3 mm).
* Documenting in the last 5 years a positive specific Immunoglobulin E against Salsola kali pollen (≥ Class 2; ≥0.70 KU/L).

Exclusion Criteria:

* Forced expiratory volume at one second 1 \< 70% of predicted value at screening after adequate pharmacologic treatment.
* Uncontrolled or severe asthma.
* History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months.
* At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infection (serous otitis media is not an exclusion criterion).
* Treatment with parenteral corticosteroids, oral corticosteroids or anti-IgE in the previous 3 months or during the study (except for steroids if needed as rescue medication).
* Currently treated with angiotensin converting enzyme (ACE) inhibitors, tricyclic antidepressants, β-blockers, mono amine oxidase inhibitors (MAOIs) and any other drug containing alum (e.g. antacids) taken on a daily basis.
* Immunotherapy with Cupressus arizonica or Salsola kali pollen extracts within the previous 5 years (initiation of subcutaneous immunotherapy is acceptable if treatment has been discontinued before reaching maintenance dose; for SLIT 3 months in the last 5 years is accepted) or concomitant immunotherapy with any other allergen.
* History of anaphylactic shock due to e.g. food, insect venom, exercise or drug.
* History of severe and recurrent angioedema.
The Follow-up Study for the Patients of Illicit Substance Use Disorder

The patients will be diagnosed according to DSM-5, the severity of individual substance use disorder will be assessed, and the plan of treatment will be provided. The treatment will be determined by the diagnosis and severity of addiction, the mood or psychiatric comorbidities, the hyperactivity or attention deficit, alcohol addiction, and etc. The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members. In order to evaluate the efficacy of the different therapy, we will evaluate the psychological and social status of the patients and follow up every 3 months. The efficacy of different treatment will be evaluated according to our study instruments.

The patients will be diagnosed according to DSM-5, the severity of individual addiction will be assessed, and the plan of treatment will be provided. The treatment will be determined by the diagnosis and severity of addiction, the mood or psychiatric comorbidities, the hyperactivity or attention deficit, alcohol addiction, and etc. The motivational enhancement interview, the individual psychotherapy, the group psychotherapy, the family therapy will be provided by our team members. In order to evaluate the efficacy of the different therapy, we will evaluate the psychological and social status of the patients and follow up every 3 months.

The patients will be received the basic physiological assessment, the chest X-ray, electrocardiogram, liver and renal function, hematology test, urine screening for addictive substances, screening for blood infectious diseases (including hepatitis B, C and HIV infection) will be included.

Besides, the Drug Abuse Screen Test (DAST), the Severity of Dependence Scale (SDS), the Reliability of Readiness to Change Questionnaire, the Opiate Treatment Index (OTI), drug Avoidance Self-Efficacy Scale (DASES), the Family APGAR score, The brief version of the World Health Organization Quality of Life instrument (WHOQOL-BREF Taiwan version), Chinese health questionnaire (CHQ), parental bonding instrument (PBI), Toronto Alexithymia Scale (TAS), Brief Symptom Rating Scale (BSRS-5), Chinese version of Adult ADHD Self-Report Scale (ASRS-V1. 1), Becker Depression Scale (BDI) and Becker Anxiety Scale (BAI) will be evaluated every 3 months after receiving our treatment.

Eligibility Criteria:
Inclusion Criteria:

Patients with illicit substance use disorder diagnosed by DSM-5

Exclusion Criteria:

The age of the patient is below 20 years old or above 65 years old, the patients cannot cooperate with the tools of investigation
Sutureless Closure for Primary Total Anomalous Pulmonary Venous Connection

The purpose of this study is to assess the percentage of pulmonary venous stenosis after TAPVC repair with sutureless closure.

Parents of patients with TAPVC after repairing by sutureless technique will be informed about the study. If parents agree to participant in the study and sign the informed consent, the investigators will collect information of patients and echocardiography results at 1 month, 6 month, 12 month and 18 month after the operation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with TAPVC operated with sutureless closure and be agreed to join this study by parents from 01/2019 to 06/2024.

Exclusion Criteria:

* TAPVC operated with sutureless closure have single ventricle, isomerism or heterotaxy, congenital pulmonary venous stenosis.
* TAPVC enrolled to study but cannot the obtain the echocardiography at the time of 1 month, 6 month, 12 month and 18 month.
Hyperpronation and Foot Pain

Effects of training and pellots


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Comparative Analgesic Effect After Total Knee Arthroplasty Between Intraosseous and Peri-articular Injection

The goal of this RCT is to compare analgesic effect after total knee arthroplasty between intraosseous multimodal analgesic agent injection versus periarticular injection. The main question\[s\] it aims to answer are: Does Intraosseous multimodal analgesic cocktail injection have more post-operative analgesic effect than Peri-articular injection in patients who have done TKA (P)? Participants will randomized to intraosseous injection group or peri-articular injection group and will record the 100-mm VAS pain scores for 2 weeks after TKA. Researchers will compare to peri-articular injection group to see pain and functional outcomes after TKA.

Intra-operatively, you will be randomly assigned to receive intraosseous multimodal analgesic agent injection or peri-articular multimodal analgesic agent injection along with other standard medications. In the intraosseous injection group: Participants received combinations of 0.5% bupivacaine 100 mg + 0.1% adrenaline 0.6 mg + Morphine 5mg + Ketorolac 30 mg (totally 22 ml) which divided by 12 ml inject into intramedullary canal before bone plug impaction to close the canal and 10 ml inject into metaphysis of tibia before cementation and implantation. In the peri-articualr injection group: Participants received combinations of the same drug and mix with normal saline solution for totally 75 ml which divided by 25 ml inject into medial gutter and 25 ml inject into lateral gutter before cementation and implantation. And the last 25 ml of multimodal analgesic drugs were injected into quadriceps.

Eligibility Criteria:
Inclusion Criteria:

* 50 - 80 yrs of age ASA classification: 1-3 Unilateral TKA

Exclusion Criteria:

* Secondary OA knee Previous knee surgery Can't undertaken spinal block and adductor canal block Renal insuf. (Crcl \< 30 ml/min) History of convulsive disorder Abnormal liver function BMI \> 35 Kg/M2 Allergy to study drugs History of coronary disease Hb \< 10 (g/dl) Can't understand 100mm-VAS assessment Refuse to recruit in the study, or refuse follow up Using opioid in 5 days before surgery Unstable vital sign History current VTE Using anti-platelet or anti-coagulation medicine Severe deformity
Evaluation of the PI-RADS v2.1 Score Using Multiple Readers

The interpretation of prostate multiparametric MRI (mpMRI) is difficult and requires expertise. As a result, it suffers from substantial inter-reader variability. The so-called Prostate Imaging Reporting and Data System (PI-RADS) scoring system has been launched in 2012 to try and standardise prostate mpMRI interpretation. It is a 5-level score that assesses the likelihood that suspicious focal prostatic lesions seen on mpMRI are clinically significant prostate cancers. Despite the use of semi-objective criteria for each category of the score, the inter-reader reproducibility of the first two versions (PI-RADS v1 launched in 2012 and PI-RADS v2 launched in 2015) was moderate at best, even for experienced readers. The last version (PI-RADS v2.1) has been launched in March 2019 in an effort to improve the inter-reader reproducibility. This version has not been evaluated yet.

The purpose of our study is to evaluate the accuracy and inter-reader reproducibility of the PI-RADS v2.1 score on a large set of 171 prostate MRIs using 21 readers of varying experience.

Twenty-one readers (14 seniors and 7 juniors) from 9 different institutions and with varying experience in prostate mpMRI accepted to participate to the study.

Reader will assess the dataset independently and will be blinded to the other readers' results. They also be blinded to clinical and biochemical data.


Eligibility Criteria:
Inclusion Criteria:

* Prostate mpMRI and biopsy performed at our institution
* Performed between September 2015 and July 2016
* No history of prostate cancer at the time of the mpMRI

Exclusion Criteria:

* Patients who already had treatment for prostate cancer
* Patients under Active Surveillance
Effect of Dietary Fiber on Metabolism, Inflammation and Nutritional Status in Patients With Chronic Diseases

The prevalence of chronic disease is increasing rapidly in China. Medical nutritional therapy (MNT) is essential for the prevention and control of chronic diseases. For example, dietary fiber plays an important role in chronic disease management. Evidence suggests that increasing fiber intake can decrease the risk of chronic diseases, such as overweight/obesity, hyperlipidemia, hyperglycemia, GI diseases, etc. However, according to the nation-wide survey, the dietary fiber intake of Chinese people shows a downward trend in recent years, and the relationship between dietary fiber and metabolism of chronic patients is still controversial. So, this study aims to explore the effects of dietary fiber on metabolism, inflammatory factors and nutritional status among patients with chronic diseases, so as to provide reference for proper nutrition intervention towards chronic disease.

Investigators plan to recruit potential participants in hospital clinics using posters. An anticipated total of 120 patients with chronic diseases (including overweight, obesity, hyperlipemia, hyperglycemia, etc) will be randomized to receive oat beta-glucans (study group) or routine nutrition management (control group) respectively. The outcome parameters, including weight, blood glucose level, blood fat level, etc, will be measured and compared over a 12-week intervention period. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70y
* Be diagnosed with obesity, hyperlipemia or hyperglycemia
* Fully understood and voluntarily signed the informed consent

Exclusion Criteria:

* Secondary hyperlipidemia or hyperglycemia
* Multiple organ failure
* Allergic or intolerant to dietary fiber(dietary supplement)
* Have gastrointestinal diseases
* Have a history of abdominal diseases
* Experienced intra-abdominal surgery
* Pregnant and lactating women
Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients

This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）.


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide written informed consent/assent for the trial;
2. Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III\~IV;
3. Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses;

Exclusion Criteria:

1. Patients who do not have pathological diagnosis;
2. Patients who can't finish the follow-up;
3. The anti-PD-1, anti-PD-L1 therapy was less than two courses;
4. Patients whose cancer diagnosed with small cell lung cancer.