cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Etoposide/Cisplatin With Irinotecan/Cisplatin to Treat Extensive Disease Small Lung Cancer

This study is a randomized, multi-center clinical trial. Patients are stratified according to performance status (ECOG 0, 1 vs 2) and institution. Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients receive etoposide IV on days 1, 2, 3 and cisplatin IV on day 1. Courses repeat every 3 weeks Arm B: Patients receive irinotecan IV on days 1, 8 and cisplatin IV on day 1. Coursed repeated every 3 weeks

Treatment in both arms continues for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1.5 years


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed small cell lung cancer
* Extensive disease (distant metastasis, contralateral hilar lymph node involvement, or cytologically confirmed malignant pleural effusion)
* If patients have brain metastasis with neurological symptom, they should be stabilized neurologically with prior radiotherapy or surgery for the brain metastasis (no neurologic symptom in progress and without further steroid treatment)
* No prior chemotherapy, immunotherapy, surgery or radiotherapy for small cell lung cancer (Local radiotherapy for brain or bone metastasis with symptom is permitted, in which case patients can be enrolled in this study when they have recovered from toxicity of radiotherapy)
* One or more measurable disease by RECIST criteria
* at least 18 years of age
* Performance status of 0, 1 and 2 on the Eastern Cooperative Oncology Group (ECOG) criteria
* Adequate hematologic (neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL), hepatic (transaminase =\< upper normal limit(UNL)x2.5, bilirubin level =\< UNLx1.5), and renal (creatinine =\< UNL) function
* Informed consent from patient which conforms to Institutional Review Board

Exclusion Criteria:

* History of cured basal cell carcinoma or cured uterine cervical malignancy except for carcinoma in situ within 5 years
* Medically uncontrolled serious heart, lung, neurological, psychological, metabolic disease
* Uncontrolled serious infection
* Enrollment in other study within 30 days
Evaluation of Emergency Triage Using a Computerized Simulator

A four-level triage scale (the Geneva Emergency Triage Scale, GETS) has been used since 1997 in our emergency department (ED). A recent evaluation of this scale showed that our instrument had an excellent intra-rater reliability but insufficient inter-rater reliability. We also observed a wide variability in the way triage nurses perform (J Clin Epidemiology, 2006 in press). These variations in the triage process are mainly explained by a poor standardization of vital signs measurement. Therefore, we have recently modified our triage instrument and introduced explicit criteria for vital signs evaluation during the triage process.

The objectives of this study are:

* To evaluate the inter- and intra-rater reliability of our modified triage scale using a computer simulator
* To measure the impact of visual clues on the triage decisions when using the triage simulator
* To evaluate the performance of triage nurses and chief physicians in their triage decisions.

We expect to observe:

* an improvement of the inter-rater reliability of our instrument compared to the previous version
* a better standardization and more systematic use of vital signs measurement
* a higher reliability when visual clues are given to the evaluator
* lower rates of under- and over-estimation of emergency levels.

A four-level triage scale (the Geneva Emergency Triage Scale, GETS) has been used since 1997 in our emergency department (ED). A recent evaluation of this scale showed that our instrument had an excellent intra-rater reliability but insufficient inter-rater reliability. We also observed a wide variability in the way triage nurses perform (J Clin Epidemiology, 2006 in press). These variations in the triage process are mainly explained by a poor standardization of vital signs measurement. Therefore, we have recently modified our triage instrument and introduced explicit criteria for vital signs evaluation during the triage process.

The objectives of this study are:

* To evaluate the inter- and intra-rater reliability of our modified triage scale using a computer simulator
* To measure the impact of visual clues on the triage decisions when using the triage simulator
* To evaluate the performance of triage nurses and chief physicians in their triage decisions.

We expect to observe:

* an improvement of the inter-rater reliability of our instrument compared to the previous version
* a better standardization and more systematic use of vital signs measurement
* a higher reliability when visual clues are given to the evaluator
* lower rates of under- and over-estimation of emergency levels.

Eligibility Criteria:
Inclusion Criteria:

* Triage nurses
* Emergency physicians
Comparative Analysis of the Effectiveness of the Use of Nimesulide and CBD Oil in Patients With Pain in the Preauricular Region Due to the Pain-dysfunctional Syndrome of the Temporomandibular Joint.

During the study, the effectiveness of analgesic therapy with nimmsulide and cannabidiol oil will be compared.

Two study groups will be formed. The study will be conducted on patients reporting to the Dental Prosthetics Clinic of PUM in Szczecin. Patients aged 18-65 years with pain located in the area of the temporomandibular joint and the preauricular area, resulting from a dysfunction of the temporomandibular joint, will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Patients (female and male) aged 18-65 years, able to swallow tablets
2. Patients with pain located in the temporomandibular and preauricular regions resulting from temporomandibular joint dysfunction
3. Patients with clinical diagnosis of Temporomandibular Joint Dysfunction

Exclusion Criteria:

1. patients with clinically diagnosed acute inflammation of the outer ear, middle ear, sinuses of the nose
2. patients allergic to nimesulide or cannabidiol oil
3. patients with contraindications to include therapy with nimesulide or cannabidiol oil such as:

   * gastric or duodenal ulcer disease,
   * severe blood clotting disorders,
   * severe liver dysfunction,
   * severe renal impairment,
   * severe heart failure, pregnancy,
   * breastfeeding,
   * concomitant intake of citrochrome blockers CYP3A4 or CYPP2D6 (warfarin, macrolides, calcium channel blockers, benzodiazepines, cyclosporine, sildenafil, SSRI, tricyclic antidepressants, opioids)
Markers of Airway Inflammation in BAL Fluid From Children With Asthma

The study compares the biochemical markers in bronchoalveolar lavage samples from asthmatic children to those markers found in non-asthmatic children with other respiratory diseases. The investigators hypothesize that certain markers will be associated specifically with asthma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or younger
* Scheduled for bronchoscopy at National Jewish Health for persistent asthma, persistent, poorly controlled wheezing, chronic cough, GERD, atelectasis, bronchopulmonary dysplasia, infection.
* Consent and assent from parent and patient \[if appropriate\].

Exclusion Criteria:

* Unwillingness to consent/assent to retrieval of BAL fluid for research analysis.
Management and Coaching in Atrial Fibrillation

The purpose of this study is to evaluate the effect of a cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives.

A randomized controlled design with pre- and 12 month posttest including persons living with atrial fibrillation and their relatives.

The distress management program (cognitive behavioral therapy) delivered in groups by a specialistnurse, a pedagogue and a cardiologist all trained in the distress management program. The program delivered to participants into three group- sessions extensive two hours each during a five weeks period 2011-2013.

Eligible participants were all consecutive identified when discharge after hospital care due to atrial fibrillation. The random process were managed by an open-label computer as block - randomization. Participants were enrolled and randomized during 2011-2013 into two arms; either to an experiment group to the distress management program or the control group. The trial, run alongside the standard care all of the participants received at a cardiology unit in a county hospital. The standard care was required to following actual guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with atrial fibrillation.
* Relative to patient with atrial fibrillation.
* To be over 18 years old .

Exclusion Criteria:

* Unwillingness to participate in the study.
* Other complicating illness'.
* Language difficulties that prevent answering surveys.
* Participation in another study.
* Accommodation outside the hospital's catchment area.
A Clinical Study of BRCA and DNA Damage Repair Genes in Blood Samples of Chinese Pancreatic Cancer Patients

This study aims to know the status of BRCA and DDR genes in PDAC patients in China. Peripheral venous blood samples of the patients will be collected for next-generation sequencing of BRCA and DNA damage repair related genes. At the same time, it is necessary to record clinical information such as age, gender, tumor pathological type, tumor stage and grade, whether surgery is performed, the size of postoperative residual lesions, and treatment methods. Prognostic indicators include the association of factors such as PFS, ORR, and DCR are also recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pancreatic cancer
* PS score ≤ 2
* no severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder

Exclusion Criteria:

* PS score \> 2
* with severe heart, cerebrovascular disease, severe coagulation dysfunction or severe mental disorder
Very Intensive Variable Repetitive AmbulatioN Training

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the independent and combined (paired) contributions of intensity and variability of stepping training on locomotor function, with secondary measures of health and community mobility. For Aim 2, we will evaluate the independent and combined effects of intensity and variability of stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness of providing these interventions to accelerate motor recovery and health. Our central hypothesis is that results of this study will provide a theoretical foundation for implementation of physical therapy interventions which can facilitate short-term gains in locomotor function, and contribute to long-term improvements in health, function and participation through increased community mobility.

Eligibility Criteria:
Inclusion Criteria:

* history unilateral stroke \> 6 months duration
* walks without physical assistance at speeds \< 1.0 m/s

Exclusion Criteria:

* no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes
Healthy Lifestyles: A Home Based Physical Activity Intervention in Persons Living With HIV

This study is being done to understand how a physical activity walking intervention affects metabolic parameters (i.e., blood sugar, cholesterol, certain body measurements) in people with and without HIV. This study involves a physical activity intervention where participants will progressively increase activity as tolerated over a six month period.

This study is being done to understand how a physical activity walking intervention affects metabolic parameters (i.e., blood sugar, cholesterol, certain body measurements) in people with and without HIV. This study involves a physical activity intervention where participants will progressively increase the total number of daily steps to approximately 10,000 steps/day as tolerated. We will monitor participant steps and physical activity using a physical activity monitor. The study will consist of 5 in-person study visits where participants will complete body measurements, laboratory testing (for metabolic parameters e.g. blood sugar and cholesterol), and a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Persons living with or without HIV
* Metabolic Syndrome or risk factors for metabolic syndrome with BMI \>=30
* Able to provide informed consent
* No physical limitations that prevent walking for more than 10 minutes
* Can provide evidence of medical clearance by healthcare provider, if required before or during the study

Exclusion Criteria:

* Currently exercising regularly (at least 2x weekly of at least 20minutes of moderate or vigorous activity)
* Current enrollment in another physician activity and/or dietary clinical trial or on diet/weight-loss program
* Active plans for bariatric surgery
* Inability to commit to the intervention schedule
* Not eligible as per screening form
* Currently pregnant or planning to become pregnant
The Effect of Clear Masks in Improving Patient Relationships

To evaluate the effect of wearing masks that hide a surgeon's facial features versus one that shows them. New patients with no prior relationship with the surgeon will be asked questions regarding communication and trust with the surgeon.

Surgeons within the University of North Carolina Department of Surgery will be recruited via an email list-serve. This recruitment email will describe the study and have the consent attached. If the surgeons are interested in participating they will respond to the email and sign the consent form.

The project personnel will arrange to attend their clinic that has new patients scheduled. A random group generator will be used to randomize the patients. The surgeons will be provided either a transparent mask that demonstrates their full facial features or their typical mask that covers their mouth, for each new patient visit. Following each visit, the surgeon will tell the project personnel that they are complete and the project personnel will enter the room, introduce the project, obtain verbal consent (enroll the patient) and if agreeable, provide a brief verbal survey to the patient. The survey will entail confidential questions regarding basic demographics, surgeon communication and trust, as well as an impression of the masks. Survey answers will be Likert scale and open ended. Patients will also be given a debriefing form at the completion of their participation. Surgeons will be asked their impression of the mask at the completion of their participation. All data will be kept confidential on password protected devices.

If patients do not agree to the study they will not be included. If surgeons feel uncomfortable at any point they may withdraw from the study. Any patient demonstrating concerning symptoms of an infection will not be included in the study.

The investigators expect to recruit 10 surgeons, with 10 patients each, totally 100 patients (50 in each arm, clear vs. covered mask). Using Mann-Whitney U test, data will be analyzed for differences in responses between the two groups. Demographic data for both the patient and surgeon will also be analyzed. Patient comments will be qualitatively analyzed for themes by trained researchers.

Eligibility Criteria:
Inclusion Criteria Surgeon:

* Faculty within Department of Surgery at the University of North Carolina at Chapel Hill
* Must be English speaking
* Plans to see new in person visits in clinic

Exclusion Criteria Surgeon:

* None

Inclusion Criteria Patient:

* At least 18 years old
* Can understand and speak English without the use of an interpreter
* Has capacity to make independent medical decisions

Exclusion Criteria Surgeon:

* Has a prior relationship with the surgeon
* Has symptoms of a respiratory infection (cough, shortness of breath, fever)
Rivastigmine Patch Effect on the Post-operative Delirium in Patients at Risk of Dementia.

Delirium is a common and serious condition and is associated with adverse outcome. The elderly who have cognitive dysfunction are expected to show delirium more frequently. It is most likely that delirium represents a response to impaired cholinergic neurotransmission. Investigators aimed to establish the preventive effect of the cholinesterase inhibitor, rivastigmine patch, on the post-operative delirium limited to femur neck fracture operation in patients at risk of dementia.

Investigators evaluated the delirium prevention effect of rivastigmine patch in patients with femur neck fracture and cognitive impairment. Investigators measured the frequency and severity of post-operation delirium in the patch applied and non-applied subjects.

Eligibility Criteria:
Inclusion Criteria:

* Consecutively enrolled the patients who is going to operation after femur neck fracture.
* Patients agree to the informed consent.

Exclusion Criteria:

* depressive mood and their geriatric depression scale is over 6 / 15.
* Their Korean version MMSE(minimental status examination) are over 25, or global dementia scale (GDS) are under 3 or over 5.
* any delirious state at pre-operation period by DSM IV and CAM (Confusion Assessment Method)
Use of Intrathecal Analgesia in Appendectomy

Acute appendicitis which is the most common cause of acute abdominal pain, is an acute inflammation of appendix vermiformis. Appendectomy operations can be performed as laparoscopic and open surgery. Addition of opioids to intrathecal local anesthetics to improve the quality of preoperative analgesia is an increasingly used method in recent years. The aim of this study is to compare bupivacaine-fentanyl and bupivacaine-alfentanil which are used intrathecally to create motor and sensory block. 50 volunteer patients who were diagnosed as appendicitis by laboratory tests and clinical diagnostic methods in general surgery clinic and classified as American Society of Anesthesiologists Classification I-II (ASA Class I-II) aged between 20-60 years scheduled for laparoscopic appendectomy operation, were included in this study. The patients were randomly assigned into two groups, Group I and Group II. Patients received spinal anesthesia with either 10 mg heavy bupivacaine (2 cc)+25 mcg fentanyl (0.5 cc) intrathecally (Group I, n=25) or 10 mg heavy bupivacaine (2 cc)+250 mcg alfentanil (0.5 cc) intrathecally (Group II, n=25).


Eligibility Criteria:
Inclusion Criteria:

* Individuals who will undergo laparoscopic appendectomy operation and volunteer to participate in the study were included.

Exclusion Criteria:

* Individuals who meet the criteria but are not volunteers
* Previously underwent appendectomy
The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions

Iodine 131 (131I） treatment on Graves disease and Graves ophthalmopathy relationship has always been the focus of debate. Majority view is that the current treatment does not increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is not a contraindication of 131I treatment. While treatment with corticosteroids, a timely corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But the merger with severe proptosis in patients with Graves , especially infiltrative exophthalmos , the application of 131I treatment will induce or aggravate not yet reached consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective study and visual assessment is not lack of uniform standards, and a variety of factors (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment or not, how to dose adjustments, and the use of which required treatment with systemic issues such as research, explore treatment exophthalmos reduction and mitigation of increased proptosis reasonable treatment of symptoms. To further promote the standardization of 131I treatment of Graves disease on basis.

no more description

Eligibility Criteria:
Inclusion Criteria:

* a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed.

Exclusion Criteria:

* 131I treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy
Tenofovir Combination or Mono-therapy for MDR CHB

Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.

Inclusion criteria were CHB patients with resistance to more than two classes of nucleos(t)ide analogues (NA) and hepatitis B virus (HBV) DNA level ≥200 IU/mL.

Patients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (\<20 IU/mL) at month 36.

Eligibility Criteria:
Inclusion Criteria:

* CHB patients with:

  1. documented HBsAg positivity at least 6 months before enrollment
  2. age \>18 years old,
  3. confirmed genotypic resistance to more than two classes of NAs
  4. HBV DNA level ≥ 200 IU/mL
  5. compensated liver diseases (defined by Child-Pugh-Turcotte score \<7; prothrombin time \<3 seconds above upper limit of normal or international normalized ratio \<1.5; serum albumin \>3 g/dL; total bilirubin \<2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy)
  6. willingness to give an informed consent.

Exclusion Criteria:

1. laboratory abnormalities of low serum phosphorous level \<2.0 mEq/dL, elevated serum creatinine \>1.5 mg/dL, decreased creatinine clearance rate \<50 mL/min, absolute neutrophil count \<1000 cell/mL, or low hemoglobin level \<10 g/dL (if female, \<9 g/dL)
2. no definite evidence of genotypic resistance
3. positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
4. HCC
5. a proof of pregnant or lactating women
6. evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)
7. any untreated malignancy.
Jinghua Weikang Capsule Containing Quadruple Therapy for IgAN With Helicobacter Pylori Infection

This study is to evaluate the efficacy and safety of the Jinghua Weikang Capsule (a Chinese patent medicine for peptic ulcer and gastritis) containing quadruple therapy (Jinghua Weikang Caplsule plus triple therpy) for eradicating Helicobacter pylori in IgA nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* IgA nephropathy diagnosed by renal biopsy;
* Current Helicobacter pylori infection;
* Age 18-65.

Exclusion Criteria:

* ①eGFR\<90ml/（min·1.73m2）-
* History of Helicobacter pylori treatment
* Present taking hormones or immunosuppressants
* Malignant tumor and high-grade intraepithelial neoplasia and severe dysplasia of gastric mucosa
* Allergy history to medicines used in the study
* History of gastric surgery
* Uncontrolled chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, respiratory diseases, mental disorders and other researchers are considered to affect treatment and assessment
* Combined with other primary or secondary nephropathy except for IgAN
* Combined with acute renal injury
* Female patients with pregnancy, lactation and planned pregnancy.