cyrilzakka/clinical-trials huggingface dataset:
Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic autoimmune and inflammatory disease. The pathogenesis of SLE results from interactions between genes, hormones, and the environment; however, the exact etiology is unknown. SLE can affect many organs and systems, including the musculoskeletal, hematological, renal, neuropsychiatric, cardiovascular and pulmonary systems, and skin. Non-specific general complaints such as malaise, fatigue, arthralgia, anxiety, depression, fever, and weight loss are evident at the onset of the disease and during the activation periods. Patients experience hopelessness due to the complexity of the symptoms and the chronic and progressive nature of the disease, and they experience deterioration in their quality of life due to the interaction of anxiety and depression findings with other symptoms. SLE is a difficult disease to manage because of the different organ and system involvement processes.

In addition, these symptoms of the disease and the nature of chronic pain, including central sensitization, cause it to accompany a process that is affected by the mood of the person. Some patients present to a rheumatologist with mild symptoms, while others may present with severe, life-threatening symptoms. The onset of the disease before the age of 18 is defined as childhood onset (juvenile). Childhood-onset SLE accounts for approximately 1/5 of SLE patients. It is known that the main mechanism in the formation of the disease is the production of more than one autoantibody.

Although childhood SLE (jSLE) appears to be basically the same disease with similar etiology, pathogenesis, and laboratory findings as in adults, there are differences in the frequency and severity of clinical manifestations. In this respect, the clearest finding is that children with SLE have greater disease severity and earlier disease-related organ damage than adults with SLE. Studies on the disease show that patients with jSLE have not only physical but also cognitive effects.

The aim of our study is to examine the effects of exercises applied with a dual-task approach on patients' physical and cognitive status in jSLE cases.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 6-16 years diagnosed with jSLE by a pediatric rheumatologist
2. Those who have had the disease for at least one year
3. Those whose medical treatments are in a stable period
4. Patients willing to be rehabilitated and able to adapt to the study

Exclusion Criteria:

1. Cases older than 16 years old diagnosed with jSLE
2. Patients with initiation of multi-organ failure
3. Those whose medical treatments are in flux
4. Wanting to leave the study
5. Not participating in assessments
6. Not attending treatment programs regularly
7. Not being able to adapt to treatment programs at the cognitive level
Effects of Regulatory Tools on Work Environment and Employee Health

This study evaluates the effects of the Labour Inspection Authority's regulatory tools on workplace exposures to prevent employee ill health. Norwegian municipal enterprises with employees in the home care sector have been randomized to three different experimental groups and to one control group. We hypothesize a significant lower level of work environmental exposures and health complaints, after adjusting for pre-intervention measures, in the experimental groups compared to the control group.

A variety of work environmental exposures are shown to cause ill health. Compliance with occupational health and safety legislation and regulation is assumed to prevent work-related ill health. The Norwegian Labour Inspection Authority oversees that enterprises comply with the requirements of the working environment laws and regulations. The agency possesses two key regulatory tools to ensure compliance, i.e. inspections and guidance.

Inspections are used to check whether enterprises meet legal requirements. If inspectors reveal violations to legal requirements, the Labour Inspection Authority may respond with orders, coercive fines, and shutdown of operations and in worst-case report enterprises to the police.

Guidance are used to notify the enterprises of the legal requirements pertaining to work environmental standards, and to advice the employers and employee representatives concerning the most effective means of realizing compliance with the legal requirements.

Enterprises randomized to the experimental groups will receive one of three different intervention activities from the Labour Inspection Authority, i.e. targeted inspection visits, participation on a one-day workshop led by two inspectors on how to reach compliance with occupational health and safety (OHS) standards, or participation in an online risk assessment course for conducting written objectives in relation to health, environment and safety activities.

The interventions will be carried out at the organizational level (enterprise), whereas the effects of the interventions on working environment and health complaints will be measured at the individual level (employee). Two months before the Labour Inspection Authority perform their interventions, a baseline questionnaire assessing self-reported organizational, psychosocial and mechanical work factors and health complaints will be sent to all home-care workers employed in the included municipal enterprises. The effects of the different interventions on work environment and employee health will be evaluated through questionnaire measurements 6, 12 and 20 months post interventions.

Eligibility Criteria:
Inclusion Criteria:

* All employees in municipal enterprises that provide home care services with a minimum of 20 employees and a maximum of 100 employees.

Exclusion Criteria:

* Employees in municipal enterprises that have received an inspection from the Labour Inspectorate in the years 2017 and 2018.
Use of the Quantra QPlus Sytem in Cardiac Surgery

Single center retrospective study evaluating the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.

Yavapai Regional Medical Center (YRMC) implemented the Quantra QPlus System to aid in their efforts to effectively reduce the transfusion rate of allogenic blood products and improve outcomes in patients undergoing cardiac surgery. Use of the Quantra to guide decisions related to the use of blood products in cardiac surgery patients began in 2019. In this retrospective study, YRMC evaluated the impact of using the Quantra QPlus System to guide transfusion decisions on postoperative outcomes in patients undergoing cardiac surgery.

Eligibility Criteria:
* Pre-Quantra Group: All consecutive patients undergoing cardiac surgical procedures during the period from January 2019 to September 2019 (n=64)
* Post-Quantra Group: All consecutive patients undergoing cardiac surgical procedures during the period from May 2020 to April 2021 (n=64)
Topical 0.5% Ivermectin Cream for Treatment of Demodicidosis

The purpose of this study is to determine whether 0.5% ivermectin cream is effective in the treatment of demodicidosis (including papulopustular rosacea)


Eligibility Criteria:
Inclusion Criteria:

* subjects with clinical and laboratory diagnosis of demodicidosis with symmetrical facial eruption who are willing to comply with study requirements

Exclusion Criteria:

* known hypersensitivity to ivermectin.
* pregnancy
* immunodeficiency such as HIV or immunosuppressive therapy
* concomitant use of systemic antibiotics or steroids
Post Operative Cognitive Dysfunction and Delirium After Spinal Surgery

Aim of this trial is to define if Post-Operative Cognitive Dysfunction and Delirium, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values.

Post-Operative Cognitive Dysfunction and Emergence Delirium has not been yet investigated after general anaesthesia with Targeted-Controlled-Infusion (TCI), daily used in the investigator's Hospital to anesthetize patients undergoing spinal surgery. Aim of this trial is to define if neurocognitive tests (Pfeiffer test, Montreal Cognitive Assessment, Trail Making Test A and B, Digit Span Test, Confusion Assessment Method) before and after surgery relate to concentrations at effector's site (Ec) of propofol and remifentanil TCI, the values of Bispectral Index, blood pressure values and usage of drugs to increase arterial blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* General Anaesthesia delivered with Propofol and Remifentanil with Targeted Controlled Infusion
* Surgical duration \> 60 minutes

Exclusion Criteria:

* Neurological pathologies
D2 vs D3 Lymph Node Dissection for Left Colon Cancer

The efficiency of the D3 lymph node dissection is still controversial for left colon cancer patients. This study will try find difference in 5-year overall survival between D2 and D3 lymph node dissection. Investigation of the functional and short-term outcomes will clarify safety of the D3 lymph node dissection.

Discussion about optimal type of lymph node dissection in colorectal cancer continues during last 15 years, when in Europe was presented concept of complete mesocolic excision. However, this concepts is very close to Japanese D3 lymph node dissection and in the first view it seems the same but principal differences were found. Japanese concept is partial resection of the bowel according feeding artery (short bowel specimen, long lymphovascular pedicle), opposite European concept is wide resection of the bowel like hemicolectomy or extended hemicolectomy, sigmoidectomy. In complete mesocolic excision anatomical landmarks are still unclear but in Japanese guidelines it has anatomical margins which can standardize this procedure. Also nerve sparing technique around root of inferior mesenteric artery was described. One more difference is in histological examination of the specimen. European concept is to pay more attention to the quality of complete mesocolic excision and less - to the number of investigated lymph nodes. In Japan lymph node extraction is performed by surgical team from the fresh specimen and send to pathologist separately (each group of lymph nodes). Considering the absence of randomized control trials for patients with left colon cancer DILEMMA trial was started using Japanese approach

Eligibility Criteria:
Inclusion Criteria:

1. Agreement of the patient to participate in trial
2. Colon cancer (only adenocarcinoma )
3. The tumor located between the splenic flexure and rectosigmoid junction
4. cT3-Т4а,b
5. cN0-2
6. cM0
7. Tolerance of chemotherapy
8. ASA 1-3

Exclusion Criteria:

1. сТis - Т2, сТ4b (tail of the pancreas, stomach, small bowel, ureter, urinary bladder)
2. Preoperative complications of the tumor (perforation and full bowel 3. obstruction)
3. Previous radiotherapy or chemotherapy
4. Synchronous or metachronous tumors
5. Women during Pregnancy or breast feeding period
Safety Analysis and Oncological Outcomes in HoLERT vs TURBT

Bladder urothelial cancer is the second most common urologic tumor and represents a worldwide public health problem. Most cases are diagnosed as non-muscle invasive tumors, and can be treated with transurethral resection of bladder tumor (TURBT). However, the electrical energy-based TURBT fragments the tumor, burning it to its own muscular layer leading to artifacts that may spoil the histopathological analysis, resulting in understaging after the first TURBT ranging from 30-64%, depending on the presence of detrusor muscle. Modern laser technologies have been emerging as an alternative to classical TURB using en bloc tumor resection technique (ERBT). Therefore, the laser is applied on tumor's pedicle to resect the whole and intact tumor without fragmentation or fulguration as occurs in TURBT. The purpose of using laser if to improve the resection quality, decrease intra and perioperative complications, avoid re-TURBT and reduce recurrence rates at the resection site and in distant sites. Thus, the purpose of this study is to evaluate Laser Holmium use for large tumors resection (\>3cm), reducing complications, costs, and the need for new approaches, and improving the muscle layers samples.

This is a single-institution, randomized, single-blinded, prospective, controlled study, with 2 groups - 50 patients in Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) arm and 50 patients in TURBT arm. All the patients will undergo a new procedure between 30-60 days after the first one (monopolar re-TURBT). The laser group will be operated by an experienced surgeon with more than 50 cases of prostate resection. The monopolar TURBT group will be operated by institutions´s surgeons assistants, urologists with more than 2 years of experience in the area and more than 50 surgeries performed. Pathological samples will be analyzed in the FMUSP Urology Laboratory by a pathologist with huge experience in analysis of bladder tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 80 years old;
* Presence of bladder tumor \> 3cm without signals of MIBC or advanced disease (US, CT scan or MRI 3 months before surgery)
* Able to understand and willing to sign a written informed consent document
* Satisfactory clinical pre operatory conditions for surgery with regional or general anesthesia.

Exclusion Criteria:

* Previous diagnosis of muscle-invasive bladder cancer;
* Tumor's Invasive aspect (T2 or more) on image (US, TC or RNM);
* Previous TURBT in the last 5 years;
* Urethral stenosis;
* Previous intra-vesical os systemic chemotherapy or radiotherapy;
* Previous treatment with intravesical BCG
* No clinical conditions for regional or general anesthesia;
* Any other significant disease or disorder which, in the opinion of the investigator may either put the participant at risk because of trial participation or may influence the trial result, or the participant's ability ti participate in the trial.
Functional Training for the Prevention of Deep Venous Thrombosis

This study aims to analyze the post-operative functional training on the prevention of deep venous thrombosis (DVT) in the patients who have accepted major surgeries for the gynecological malignancies. The functional training consists of: (1) active and passive ankle pump motions including flexion and extension, circumduction; (2) abdominal breathing training. The primary end is the incidence of DVT happened 30 days from surgery. The secondary ends include the patients satisfaction about functional training.


Eligibility Criteria:
Inclusion Criteria:

* Having received major surgeries for gynecologic malignancies
* Good performance status
* Aged 18 years or older
* Signed an approved informed consents
* No injuries to the skin, musculoskeletal system
* No venous thromboembolic disease before surgeries

Exclusion Criteria:

* Not meeting all of the inclusion criteria
* Delayed extubation
Effects of a Digital Patient Platform (CMyLife) for Patients With Chronic Myeloid Leukemia (CML) on Information Provision, Patient Empowerment, Medication Compliance, Guideline Adherence and Quality of Life

A controlled before-after study is performed in order to gain insights into the effectiveness of the CMyLife platform in terms of medication compliance, guideline adherence, quality of life, information provision and patient empowerment. Participants who agreed to use the CMyLife platform for at least 6 months, were enrolled in the treatment group and participants who did not agree to use the platform were enrolled in the control group. After signing informed consent, participants received a baseline questionnaire by mail. Upon completion of the baseline questionnaire, participants used (intervention group) or did not use (control group) the CMyLife platform for at least 6 months, after which they were asked to complete the post-intervention questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed CML patients in chronic phase CML
* Participants were treated with first or second line TKI's at the haematology department of the participating hospitals. Patients treated with second line TKI's were only allowed to participate if they switched TKI's as a result of side effects and not if they did not respond to the first line TKI

Exclusion Criteria:

* Participants in acceleration phase
* Participants in blastcrise
* Participants with planned pregnancy in the study period
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer

This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research phase (Part 1) of the study will assess the disposition of a single oral dose of \[14C\]-pamiparib. In the treatment phase (Part 2) participants will be allowed to have continued access to pamiparib.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available
2. A total body weight between 50 and 100 kg, inclusive at Screening
3. Measurable disease by CT/MRI
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
5. Adequate organ function

Key Exclusion Criteria:

1. Clinically significant cardiovascular disease
2. Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome.
3. Poor peripheral venous access
4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
5. Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Vaginal Progesterone in Twins With Short Cervix

A Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial of Vaginal Progesterone to Prevent Early Preterm Birth In Twin Pregnancy with Short Cervix.

This is a placebo-controlled, double-blind, randomized clinical trial of asymptomatic women with twin pregnancy and a cervix length 10 mm to 25 mm discovered on a routine screening transvaginal sonogram between 20w0d to 24w0d gestational age. Women will be randomized in either the in-patient or out-patient setting (1:1) to a daily vaginal application of micronized progesterone cream(200 mg)vs. placebo to determine if daily vaginal progesterone administration reduces the risk of preterm birth prior to 34w0d of gestation.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 20w0d and 24w0d
* Twin pregnancy, diamniotic-dichorionic, both twins living
* Cervical length 10 mm to 25 mm discovered by a screening transvaginal ultrasound exam

Exclusion Criteria:

* Mother less than 18 years of age
* Uterine contractions of 40 seconds duration or more, 10 or more per hour
* Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)
* Ongoing vaginal bleeding
* Any condition likely to cause serious neonatal morbidity independent of gestational age, including:

  1. fetal malformation likely to require surgery
  2. fetal malformation involving vital organs
  3. fetal viral infection
  4. hydrops fetalis
  5. discordance in estimated fetal weight more than 10%
  6. velamentous insertion of umbilical cord of either twin
  7. placenta previa of either placenta
* Any contraindication to continuing the pregnancy
* Cervical cerclage in place or planned
* Any contraindication to vaginal micronized progesterone, including:

  1. Known sensitivity to progesterone or any of the other ingredients
  2. Liver dysfunction or disease
  3. Known or suspected malignancy of breast or genital organs
  4. Active thromboembolic disorder, or history of hormone-associated thromboembolic disorder
Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer

Clinical Efficacy and Safety of EGFR-TKI Combined With Nimotuzumab in the Treatment of Leptomeningeal Metastases From Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older, gender not limited;
* A definite diagnosis of Leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging;
* Have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis
* Patients who received any of EGFR inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage
* Detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed EGFR mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive EGFR expression
* Bone marrow, liver, kidneys and blood clotting function are relatively stable

Exclusion Criteria:

* Eastern Cooperative Oncology Group scored \> 2 points
* Patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study
Plasma miRNAs Predict Radiosensitivity of Different Fractionation Regimes in Palliative Radiotherapy for Advanced Non-small Cell Lung Cancer：Multicenter Controlled Study.(RadmiR-01)

Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the main pathological type is non-small cell lung cancer (NSCLC). Most of them present with advanced stage at diagnosis. Radiotherapy is an important treatment strategy for advanced non-small cell lung cancer. However patients have different responses to radiotherapy due to individual differences, thus there is still lacking of sensitive markers to predict treatment response at present. Using bioinformatics to process the data and small sample clinical trial, our previous study found 5 plasma miRNAs were related to radiosensitivity. The design is controlled clinical trial. According to the size of lung lesions, the investigators divided the patients into hyperfractionated radiotherapy group（50Gy/11F/2W) with lesion ≤5cm in diameter and conventional fractionated radiotherapy group（60Gy/30F/6W）with lesion \>5cm in diameter.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological histology and/or cytology confirmed NSCLC;
2. Based on AJCC Cancer Staging, IIIA, IIIB, IV lung cancer patients with NSCLC;
3. PS 0-2;
4. Expected survival \> 3 months;
5. Age 18\~75 years old;
6. The function of lung, liver, kidney, bone marrow was normal;
7. The patients had not received radiotherapy for previous primary tumor and metastases;
8. At least accept 2-4 cycles of chemotherapy,not disease progression after chemotherapy,start radiotherapy in two weeks after the last cycle of chemotherapy;
9. Wild-type EGFR;
10. Sensitive mutant EGFR, but refused to targeted therapy;
11. In line with the indications of radiotherapy and accept it;
12. Voluntarily enrolled to participate in,better compliance, cooperate with experimental observations, and sign informed consent.

Exclusion Criteria:

1. Vital organs (e.g., heart, liver, kidney) have serious dysfunction;
2. Patients with other malignancies;
3. Patients with a history of autoimmune disease;
4. The patients are pregnant and lactating (Women of childbearing age need to check the pregnancy test);
5. In the activity of acute or chronic infectious diseases;
6. Patients with a clear history of drug allergy or allergic genus;
7. Patients with participating in other clinical trials at the same time;
8. Other cases that researchers believe that patients should not participate in the present trial.