cyrilzakka/clinical-trials huggingface dataset:
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma

Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.

The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.

Eligibility Criteria:
Inclusion Criteria:

* papillary carcinoma of thyroid (less than 4cm)
* no evidence of lymph node metastasis in preoperative work-up result
* the patients who accept this study

Exclusion Criteria:

* large thyroid cancer( \> 4cm)
* morbid
* anticoagulation agent usage
* endoscopic or robotic thyroid operation
* evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan
Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL

This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.


Eligibility Criteria:
Inclusion Criteria:

1. Participants currently entered on Alopexx Oncology Study AO-101
2. Participants who received 6 cycles of DI-Leu16-IL2 on Study AO-101.
3. Documented clinical benefit following 6th cycle of DI-Leu16-IL2
4. Able to begin extension study within 8 weeks of receiving 6th cycle of DI-Leu16-IL2
5. Participants must have received prior Rituximab-containing therapy.
6. Participants in this extension study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months.
7. Provide written informed consent prior to any study procedures.

Exclusion Criteria:

1. Pregnant or lactating female
2. An immediate need for palliative radiotherapy or systemic corticosteroid therapy.
3. Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcAb) or hepatitis B surface antigen (HbsAg). Participants who are sero-positive only, that is, surface antibody positive \[HbsAb\], are permitted.
4. Other significant active infection
5. Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
6. Uncontrolled hypertension (diastolic ≥ 100 millimeters of mercury \[mmHg\]) or hypotension (systolic ≤ 90 mmHg)
7. History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.
The Process of Blood Collection With a Vascular Imaging Device

The study was planned to determine the effect of using a blood vessel imaging device (VID) and venous blood collection procedure on the pain and satisfaction level of the individual during phlebotomy. The randomized controlled experimental design study was carried out in a blood collection unit in a training and research hospital between 1-15 April 2022. The study sample was calculated as 100 people by power analysis and the method of drawing lots was applied to the groups. Data were collected using the patient identification form, visual analogue scale (VAS), and pain and satisfaction scales.

The population of the study consisted of adult individuals who benefited from polyclinic services and applied to the blood collection unit between the specified dates in a single center.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65,
* Who wanted peripheral vascular access,
* Volunteered to participate in the study,
* Did not have any pain complaints,
* Did not take analgesics in the last 12 hours,
* Could be contacted,
* Did not have obesity, dehydration, peripheral oedema, or a cancer diagnosis and did not need emergency intervention.

Exclusion Criteria:

* Those who do not meet the criteria for admission
The Role of Naive T-Cells in HIV Pathogenesis

While HIV mainly infects mature T-cells it can also infect newly produced (or naïve) T-cells. These infected naïve T cells may then act a viral reservoir even in patients with undetectable viral loads. Understanding when and how these cells are infected is important because it could help us to understand why patients fail therapy even if they have a persistently undetectable viral load.

The overall goal of this project is to provide a comprehensive analysis of the role of naïve T-cells in the pathogenesis of T-cell decline and long-term persistence of HIV infection.

The study is divided into two parts.

Part 1 aims to determine the origin of HIV infected naïve T-cells in vivo by assessing the viral relatedness between HIV strains from naïve and memory CD4 T-cells. To do this we will be studying ten chronically infected individuals. Naïve and memory CD4 T-cells from these individuals will be purified using a magnetic bead sorting (MACS) strategy. Envelope sequences will then be isolated and subjected to diversity calculation

Part 2 seeks to answer whether infection of naïve T-cells is established early in infection and what the effect of antiretroviral therapy is on this subset of T-cells. We will initially examine the relative proportion of CD31+ (recent thymic emigrants) and CD31- naive CD4+ T-cells in infected acute (n=15) and chronic (n=15) infection and uninfected (n=15) individuals compared with healthy controls. We will then prospectively test individuals prior to and at 3, 6, 12, 18 and 24 months following intiation of HAART (Highly Active Antiretroviral Therapy) in individuals with acute (n=10) and chronic (n=10) HIV infection. Immunophenotyping will detemine the proportion of naïve T-cells that are CD31+ and those that are CD31-. Naïve and memory T-cell subsets will again be purified and total and integrated HIV DNA will be quantified using real-time PCR.

Eligibility Criteria:
Inclusion Criteria:

-

Part 1:

- HIV positive by ELISA and Western Blot VL \>2,000, CD4 \>350

Part 2:

* HIV positive by ELISA and Western Blot
* Established Chronic infection (15 individuals)
* Acute infection (15 individuals).
* Any viral load or CD4 count.
* No therapy.
* Any individual who initiates HAART as determined by the treating physician

Exclusion Criteria:

* none
Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac Catheterization

All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.

Renal Artery Stenosis (RAS) is a common finding in patients with generalized atherosclerosis. It is the cause of 15-20% of end stage renal disease in elderly patients. The prevalence of asymptomatic RAS in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. It is critical to find and manage the RAS before it's symptoms appear. The Gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. In this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of July-September in one of the most referral heart center in Iran, "The Tehran heart center" which is doing more than 50 coronary angiography daily.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years

Exclusion Criteria:

* contraindication to contrast use
* not signing consent
Creatine Supplementation on Kidney Function in Resistance-trained Individuals

There is a claim that creatine supplementation might affect kidney function, especially in those consuming a high-protein diet. The aim of this study was to investigate the effects of creatine supplementation on kidney function in resistance-trained individuals ingesting a high-protein diet.


Eligibility Criteria:
Inclusion Criteria:

* participation in recreational resistance training
* consumption of a high-protein diet (≥ 1.2 g/Kg/d)

Exclusion Criteria:

* vegetarian diet
* use of creatine supplements in the past 6 months
* chronic kidney disease
* use of anabolic steroids.
Pancreatic Cancer Recurrence in the Netherlands

The aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a pancreatic resection (PPPD, Whipple, distal pancreatectomy or total pancreatectomy) for histologically proven PDAC in one of the 16 Dutch centers for pancreatic surgery

Exclusion Criteria:

* Patients with 30-day postoperative mortality
A Comparison of the Therapeutic Effect Between Head-point Acupuncture and Conventional Body Acupuncture on Insomnia

The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled. The aim of the study is to compare the therapeutic effect between head-acupoints acupuncture and body-acupoints acupuncture on Insomnia.

The investigators will conduct a single-center, and randomized controlled cases study. A total of 120 participants with insomnia will be enrolled, and randomly assigned into two groups, 60 of them are the head-acupoints acupuncture group, who will receive GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and bilateral GB13 head-acupoints acupuncture treatment, and 60 of them are the body-acupoints acupuncture group, who will receive bilateral HT7, PC6, SP6, ST36, KI3, LR3 body-acupoints acupuncture treatment for 4 weeks.

The primary outcomes of therapeutic effect on insomnia are changes of the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS).The time frame of the three primary outcomes are: baseline week 0, week 2, week 4 and week 6.

The secondary outcomes of therapeutic effect on insomnia are sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the actigraphy (time frame: baseline week 0, week 2, week 4 and week 6), as well as the heart rate viability(HRV) recorded by the ECG monitor (time frame: baseline week 0, week1, week 2, week 3, week 4 and week 6; and 30 minutes before and 60 minutes after acupuncture through study completion).

Eligibility Criteria:
Inclusion Criteria:

1. aged 20\~70 years,
2. met the diagnostic criteria of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition, DSM-V)
3. experienced insomnia at least three times a week for more than a month
4. voluntarily agreed with the investigation and signed a written informed con- sent form before the clinical trial started.

Exclusion Criteria:

1. a pregnant or lactating woman
2. the patient's insomnia is caused by mental disorders other than mild anxiety,
3. the patient has serious cardiovascular, liver, kidney or hematopoietic system disease
4. the patient's insomnia is caused by nervous system disease (eg, stroke, Parkinson's Disease)
5. the patient has taken Chinese herbs and herbal formulas for insomnia two weeks before the trial
6. the patient with cardiac pacemaker
7. the patient does not want to wear portable physiological signal recording device (SOMNOwatchTM) and handheld ECG monitor
8. the patient has a history of sleep apnea
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.

The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 year old
* Healthy adult volunteers

Exclusion Criteria:

* with a history of mental disorder
* For female volunteers, those who are suspected of being pregnant or lactating
Terazosin for Dementia with Lewy Bodies

The TZ-DLB trial will be a 3:2 (active:placebo) randomized, double-blind, placebo-controlled Pilot trial to evaluate the tolerability of terazosin for the treatment of dementia with Lewy bodies.

This will be a single center, randomized, double-blind, placebo-controlled, pilot study to assess the tolerability of terazosin (TZ) at 1 and 5 milligrams (MG) daily for patients with DLB. The primary goal of this study is to assess the tolerability of TZ in patients with DLB. This is a pilot study and is not powered to assess efficacy of this medication. Our hope is that this study will guide future studies of this (and similar) medications for the disease modification of DLB. This study is also aimed to learn more about how patients with produce and use energy and if TZ can help to reverse energy deficits that appear in DLB.

Eligibility Criteria:
Inclusion Criteria:

* Men or women with the diagnosis of dementia with Lewy Bodies per 2017 DLB Consortium criteria.
* Baseline MOCA 18 or above. On stable AChEI and/or memantine treatment regimen for ≥4 weeks prior to baseline.

Exclusion Criteria:

* Subjects unwilling or unable to give informed consent
* No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age-related illness will be included if their disease under control with stable treatment regimen for at least 30 days.
* Orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic on supine to sitting or standing, or a sitting blood pressure of ≤90/60.
* Clinically significant traumatic brain injury or post-traumatic stress disorder
* Presence of other known medical comorbidities that in the investigator's opinion would compromise participation in the study
* Psychiatric comorbidities including major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neurology assessment in the opinion of the responsible site principal investigator. Subjects with clinically significant depression as determined by a Beck Depression Inventory score greater than 21 at the screening visit. Current suicidal ideation within one year prior to the baseline visit as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) If the participant has a Beck Anxiety Score greater than 22 at the initial screening visit.
* Use of investigational drugs within 30 days before screening
* Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit
* Use of doxazosin, alfuzosin, prazosin, or tamsulosin
* For female participant, pregnancy, or plans for child-bearing during study period
* Participant is restricted from traveling to and from the study site
EVIS - Ex-vivo Assessment of T-lymphocyte Homing in Primary Pancreatic Cancer

This is a single-centre, prospective, non-randomised research study. The research team will investigate the feasibility of assessing primary human pancreatic tissue for changes to T lymphocyte function and localisation in the presence and absence of AMD3100.

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Western countries. It is a lethal disease that typically presents late, metastasises early and is resistant to conventional treatments such as radiation and chemotherapy. In 2012 there were 8700 deaths in the UK from pancreatic cancer, making it the fifth most common cause of cancer-related death.

Current therapeutic strategies are aimed at extending survival as well as improving symptoms and quality of life, but although conventional chemotherapeutic agents have achieved modest clinical benefit, the need for novel therapies is great.

This study proposes to extend our pre-clinical studies to develop an ex-vivo assay for the assessment of AMD3100 effectiveness in human samples.

The research team will investigate the feasibility of assessing primary human pancreatic tissue for changes to T lymphocyte function and localisation in the presence and absence of AMD3100 through obtaining a blood sample and fresh pancreatic tissue intra-operatively from pancreatic tumours located in the head of the pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary pancreatic adenocarcinoma who are undergoing pancreaticoduodenectomy (Whipple's) resection.
* Patients who are over 18 years of age at the time of signing the informed consent form and who are physically and mentally capable of consenting.
* Willing and able to comply with study procedures.

Exclusion Criteria:

• Any condition or abnormalities that in the judgment of the investigator/surgeon/ histopathologist would place the patient at undue risk.
Change of Circulating Tumor Cells During Laparoscopic or Transanal Endoscopic Surgery for Rectal Cancer.

The primary purpose of this study is to compare the changes of circulating tumor cells (CTCs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. Our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.

Mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. At present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. Traditional laparoscopic surgery and emerging transanal total mesorectal excision (TaTME) are the main methods. More than one-third of rectal cancer patients will eventually occur local recurrence and distant metastasis, which are the most important factors affecting prognosis. Circulating tumor cells may lead to distant metastasis, so the detection of CTCs in blood has important clinical significance in predicting the recurrence and metastasis of rectal cancer and monitoring treatment response. Due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of CTCs in the blood, which may affect the prognosis of patients. Therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of CTCs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. To explore the effect of two surgical methods on the risk of micrometastasis, and to provide evidence for the selection and improvement of rectal cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Mid-low rectal cancer.
2. Single lesion.
3. No metastasis.
4. Clinical Stage T2-3, N0-1.

Exclusion Criteria:

1. History of malignant tumors.
2. Acute bowel obstruction, bleeding or perforation.
3. Received neoadjuvant treatment.
4. Tumor over 6cm in diameter or in severe adhesion with surrounded tissues.
5. Severe other contradictions of surgery.
6. Pregnant women will be excluded.

Exit Criteria:

1. The patient suffered from massive hemorrhage.
2. The operation mode needs to be changed according to the patient's condition.
The Phase III Clinical Study of Herombopag for the Treatment of Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery

This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged 18 years or older withc a Child-Pugh score of Class A or Class B;
2. Platelet count less than 50×10\^9/L on baseline;
3. Elective invasive procedures or surgeries that are planned.

Exclusion Criteria:

1. Any history of arterial or venous thrombosis, including partial or complete thrombosis;
2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening;
3. Portal vein blood flow velocity rate \<10 centimeters/second at Screening;
4. There are other diseases that may cause thrombocytopenia.
Magnesium Effect on Embryonal PR Interval

Magnesium is a known treatment for neuroprotection in preterm labor before 32 week of gestation. High concentration of Magnesium in the blood stream known as cause of conduction abnormalities and ECG changes such us prolonged QT, QRS and PR in about. The goal of our work is to evaluate the PR intervals in embryos after maternal treatment with magnesium during preterm labor.

We will recruit 25 woman with threaten preterm labor, magnesium blood level and PR interval will be evaluated before magnesium loading dose (4gr) and 20 minutes after the loading dose.

PR interval will be evaluated by Mitral-Aorta Doppler.

Eligibility Criteria:
Inclusion Criteria:

* Women at risk for preterm labor before 32 week of gestation

Exclusion Criteria:

* Fetal malformations
* Maternal Lupus
* Fetal conduction abnormalities
Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l).

The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.


Eligibility Criteria:
Inclusion:

* Intensive care patients who require blood glucose control by intravenous application of insulin

Exclusion:

* All contraindication of intravenous insulin therapy