cyrilzakka/clinical-trials huggingface dataset:
Breath Analysis in Early Stage Lung Cancer Using Infrared Spectroscopy

The aim of this study is to sample and analyze volatile organic compounds (VOCs) from lung cancer patients and individuals without lung cancer ("healthy" controls). The breath sample analysis will help investigators describe and identify profiles of VOCs found in the breath of patients with lung cancer when compared to normal breath profiles using infrared spectroscopy. This work will help validate early proof of concept results conducted with prototype technology and later stage NSCLC breath samples, and inform future breath testing analysis.

Globally, lung cancer accounts for the most cancer deaths in both sexes combined. It is believed to develop slowly through progressive accumulation of genetic mutations, hence the disease allows time for diagnosis and curative surgical treatment. Five year survival rates for non-small-cell lung carcinoma (NSCLC) can range from 57-61% when detected in the early stages of disease. This is compared with a survival rate of approximately 6% once distant metastases are present. However, disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms. Therefore, technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality. Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds (VOCs) in exhaled breath. Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs. When coupled with machine learning techniques, this has the potential to be a novel approach for disease detection using exhaled breath.

Eligibility Criteria:
Inclusion Criteria

LC Group:

* ≥ 18 years;
* Able to give informed consent;
* Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
* Clinical evidence of lung cancer (metastatic or primary), inclusive of those receiving non-curative treatment, has not yet been treated or is not currently on treatment;
* No history of or any other active cancer;
* Able to provide a breath sample;

Control Group:

* ≥ 18 years;
* Able to give informed consent;
* Eligible for lung cancer screening or lung cancer follow-up testing (biopsy, surgery);
* No history of lung cancer or any other active cancer and is eligible for lung cancer screening;
* Able to provide a breath sample;

Exclusion Criteria

* Has received or is currently receiving curative treatment and may no longer have lung cancer;
* Cannot give informed consent;
The Effect of Case-Based Education on the Development of Nursing Students' Clinical Reasoning Skills

Aim: This study was conducted to determine the effect of case-based education on the development of clinical reasoning skills of nursing students in critical illnesses.

Methods: The study was conducted between January 20 and June 30, 2021 using a pilot randomized controlled trial design. In the study, 22 volunteer students were assigned to the experimental and control groups by simple randomization. The experimental group was given case-based education to improve their clinical reasoning skills, and the control group continued the standard education process. Data were collected using a Student Information Form, the Clinical Reasoning Case Form (CRCF), the Student Satisfaction with Education Questionnaire, and a Form for Views on the Education. In the evaluation of data, frequency values, Fisher exact test, Mann-Whitney U, and Wilcoxon tests, Cohen's d coefficient for effect size, ITT analysis, and covariance analysis were used.

Aim of the study This study was conducted to determine the effect of case-based education on the development of nursing students' clinical reasoning skills in critical illnesses.

Research hypotheses H01: There is no difference between the experimental group and the control group in terms of their CRCF scores.

H02: Case-based education on clinical reasoning has no positive effect on student satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Having completed the "Medical Nursing" and Surgical Nursing" courses,
* Volunteering to participate in the study,
* Participate in "Case-Based Education"

Exclusion Criteria:

* Not being willing to participate in the study,
* Abandoning the "Case-Based Education" practice
* Not taking one or two of the "Medical Nursing" and "Surgical Nursing" courses at all, or to have taken them but unsuccessfully
Best Incision in Cesarean Section of Obese Women

The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher transverse supra umbilical incision techniques during elective cesarean section in morbidly obese patients. The main questions it aims to answer are:

Is there a difference in operative time between the two incision techniques? Is there a difference in estimated blood loss between the two techniques? Is there a difference in post-operative pain scores between the two techniques? Is there a difference in wound complication rates between the two techniques? Participants will be randomly assigned to receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during their scheduled cesarean delivery.

Researchers will compare the Pfannenstiel incision group to the higher transverse supra umbilical incision group to see if there are differences in operative time, blood loss, post-operative pain, and wound complications.

This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined as pre-pregnancy body mass index ≥40 kg/m2.

Patients will be randomly allocated to one of two groups (30 patients per group):

Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision 2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus sheath in the same line as the skin incision, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.

Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, followed by transverse incision of the anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and transverse uterine incision in the lower segment.

The primary outcome measures will be operative time, estimated blood loss, post-operative pain scores, and wound complication rates. Secondary outcomes will include length of hospital stay, patient satisfaction scores, and cosmetic results.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 20 and 40 years.
* Singleton pregnancy.
* Gestational age ≥ 37 weeks.
* Scheduled for elective cesarean delivery.
* Morbid obesity, defined as pre-pregnancy body mass index (BMI) ≥ 40 kg/m2.
* Willing and able to provide informed consent.
* Able to adhere to study procedures and follow-up schedule.

Exclusion Criteria:

* Emergency cesarean delivery.
* Multiple gestation (twins, triplets, etc)
* Placenta previa or vasa previa.
* History of more than 1 previous cesarean delivery.
* HIV, hepatitis B/C infection.
* Current anticoagulation therapy.
* Immune-compromised conditions.
* Premature rupture of membranes.
* Pre-existing skin conditions affecting the abdomen.
* Inability to provide informed consent.
Syndrome Patterns for Chronic Atrophic Gastritis Malignant Transformation

Chronic atrophic gastritis (CAG) is acknowledged as the precancerous stage of gastric cancer (GC). The present study aims to explore Traditional Chinese Medicine (TCM) syndrome features in different stages of CAG malignant transformation respectively. The proposed study is a cross-sectional study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 study patients will be recruited on-site in hospitals.

CAG is acknowledged as the precancerous stage GC. Active treatment of CAG is vital in arresting malignant transformation. Traditional Chinese medicine (TCM) has been widely used in treating CAG and preventing GC in China. To date, few study has been conducted to assess the syndrome features of different stages of CAG malignant transformation combining TCM indicators.

The present study aims to explore TCM syndrome features in different stages of CAG malignant transformation. The proposed study is a registry study based participant survey conducted in 4 hospitals in Beijing, China. After obtaining informed consent, a total of 2000 eligible study patients will berecruited on-site in hospitals.

Comparative analysis of prevalence of presenting TCM features is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Exploratory factor analysis,correspondence analysis, association rule analysis, hierarchical clustering analysis, and complex system entropy clustering analysis will be performed respectively for validating features of syndrome in different stages of CAG malignant transformation.

Previous reports on TCM syndrome features for CAG exist, but no studies have been undertaken base on large-sampled study design and detailed analysis in different stages of CAG malignant transformation respectively.

The outcome of our study has the potential to clerify core TCM pathogenesis of CAG, facilitate early intervention, and promote optimization of treatment strategies of CAG malignant transformation by TCM.

Eligibility Criteria:
Inclusion Criteria:

* (1) 18-75 years of age; (2) Meeting diagnostic criteria of CAG after upper gastrointestinal endoscopy; (3) Willing to cooperate with data, tissue sample, and blood sample collection during recruitment; (4) Willing to respond truthfully and timely to researcher queries after recruitment, able to cooperate with data, tissue sample and blood sample collection during follow-ups; (5) Willing to sign informed consent.

Exclusion Criteria:

* (1) Meeting past history of previous stomach surgery; (2) Unable to participate in data, tissue sample or blood sample collection for any reason.
Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage

The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged 40 years of age and older with Fitzpatrick skin types I through III
* Clinically moderate to severe photodamage

Exclusion Criteria:

* Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel of the face
* Subjects with diagnosis of skin cancer within 3 months of study entry
* Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of the face within 3 months of study entry
* Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study entry and are unwilling to refrain from botulinum toxin treatments during the study
Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Acute pancreatitis (AP) is a common disease of the gastrointestinal tract that can result in emotional, physical, and financial burdens on the patient.

In the last 20 years, the incidence of AP and rate of hospitalization have steadily increased. Approximately, two-thirds of AP patients will have a mild and self-limiting course of the disease, leaving the remaining one-third experiencing moderately severe to severe disease that is associated with worse outcomes. Overall, the estimated mortality of pancreatitis is 1% however, mortality can be as high as 30% to 40% among patients with AP and organ failure or pancreatic necrosis. Despite numerous randomized clinical trials, there is no medication shown to be successful at treating AP.

AP is associated with fluid deficit secondary to low intake and vomiting. Early intravenous fluid (IVF) resuscitation has been long-established as the initial cornerstone treatment to prevent hypovolemia and subsequent organ failure within the first 48 to 72 hours. The rationale for such intervention is to provide adequate intravascular volume support to counteract fluid shift into the third space. However, available evidence for an effective fluid regimen is lacking with regard to the type of fluid, the optimal rate of administration, and how to assess appropriate goals/targets for adequate resuscitation. Furthermore, the literature has presented conflicting results on whether aggressive versus goal-directed fluid resuscitation will lead to a reduction in mortality and improve outcomes. Although early supportive care with IVF therapy is recommended by the major guidelines, there are potential, serious complications associated with aggressive resuscitation, including volume overload, respiratory failures, intra-abdominal compartments.

Eligibility Criteria:
Inclusion Criteria:

* ● Age \> 18 years

  * Diagnosis of AP based on International Statistical Classification of Diseases( ICD)-10 code

Exclusion Criteria:

* ● Diagnosis of chronic pancreatitis

  * Patients who did not follow the IVF infusion protocol
  * Received \< 24 hours of IVF therapy
  * Transferred from another institution
Human Gut Microbiota and microRNA Expression

In this study, stachyose was used as an intervention factor. We will evaluate changes in fecal gut microbiota and miRNA expression profiles in subjects under stachyose intervention

In the stachyose intervention group, each person in the stachyose intervention group took 5 g of stachyose daily before breakfast, and the administration method was 100 ml of drinking water dissolved and taken orally for two months. Each person in the placebo control group took the same amount of maltodextrin daily. Stool samples of the subjects were collected weekly.

Eligibility Criteria:
Inclusion Criteria:

* healthy human

Exclusion Criteria:

* people who need intake antibiotics，probiotics or its product
SMS Counseling on Gestational Diabetes

The use of technology-based education and counseling services in the self-management of gestational diabetes contributes to better control of blood sugar levels, motivation and increased self-efficacy in women. Therefore, this study was planned as interventional research to determine the effect of SMS counseling given to individuals with gestational diabetes on self-efficacy and knowledge levels. This study was conducted descriptively with 95 patients with gestational diabetes who were treated in the endocrine service of a university hospital between August 15, 2021 and April 24, 2022. Personal information form created by the researchers, The Self-Efficacy Scale in Gestational Diabetes, and Diabetes Knowledge Scale were used to collect data.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with gestational diabetes,
* being in the 30th week of pregnancy,
* having a smartphone,
* volunteering to participate in the study,
* having no communication problems,
* having no psychiatric problems

Exclusion Criteria:

* being non-literate,
* having communication problems (hearing or sight),
* not volunteering to participate in the research
Computer-Assisted Quantification of the Synovial Perfusion in Patients With Arthritis Using Two-Dimensional and Three-Dimensional Power Doppler Ultrasonography

The purpose of this study is to compare the data obtained by computer-aided quantification of the synovial perfusion in patients with arthritis using two-dimensional and three-dimensional power Doppler ultrasonography and the clinical data used to represent the degree of joint inflammation. Intra- and inter-observer reliability of this method will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* patients with at least one painful swollen peripheral joint observed by a rheumatologist, including:

  * shoulder joints
  * elbow joints
  * wrist joints
  * metacarpophalangeal (MCP) AND
  * proximal interphalangeal (PIP) joints of hands, ankle joints, subtalar joints, mid-tarsal joints, MTP and PIP joints of feet

Exclusion Criteria:

* patients with active infection
* patients with concurrent malignant disease
* patients with a history of traumatic, septic, or cystal arthritis
* previous joint surgery, or isotopic synovectomy within the past 12 months before the study
Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center

The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.

This is a prospective randomized controlled trial examining the efficacy of brief Prolonged Exposure Therapy (Brief PE) delivered to individuals admitted to a Level I Trauma Center to reduce PTSD symptoms. The overall goal of this project is to test a Brief PE (three 60-minute sessions) to reduce psychological distress after injury and to mitigate long-term post-injury distress including PTSD as well as secondary health outcomes (including depression, general anxiety, pain, and quality of life) at 1, 3, and 6 months from baseline. The intervention group (Brief PE) will be compared to standard clinical care with treatment as usual (TAU).

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 65 years old.
* Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott \& White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH/MCW) Level 1 Trauma Center

Exclusion Criteria:

* Patients in police custody
* Patients not fluent in English
* Patients with severe cognitive impairment
* Patients who are acutely suicidal
* Patients with active psychosis
Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions

The investigators believe that this simple, clear, and objective study may be a great help in understanding the accommodative response during various accommodative stimulation conditions.

The purpose in this study was to investigate physiological changes in accommodative power, pupil diameter, astigmatic value, and axis when visual stimuli were applied under binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions using the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan).

Eligibility Criteria:
Inclusion Criteria:

1. age between 20 and 40 years
2. spherical equivalent (SE) within ± 4.0 diopters (D)
3. correctable distant and near visual acuity by glasses to 20/20
4. normal ocular alignment.

Exclusion Criteria:

1. disturbance of accommodation (e.g., Adie's pupil, Parkinson's disease, accommodative esotropia, accommodative spasm, presbyopia)
2. disorders that can affect accommodation (e.g., history of ocular trauma, previous ocular surgery)
3. disorders that might limit testing accuracy (e.g., corneal pathological features, cataract, glaucoma, vitreous opacity, and retinal abnormalities).
Vaccine Therapy Plus QS21 in Treating Women With Breast Cancer Who Have No Evidence of Disease

RATIONALE: Vaccines made from GM2-KLH and given with QS21 may make the body build an immune response to and kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of GM2-KLH vaccine plus QS21 in treating patients with breast cancer who have no evidence of disease.

OBJECTIVES: I. Determine whether immunization with GM2-KLH vaccine plus the immunological adjuvant QS21 induces an antibody response against GM2 and cells expressing GM2 in disease free patients at high risk for recurrence of breast cancer.

OUTLINE: GM2-KLH vaccine plus QS21 is administered subcutaneously to sites on the upper arm and upper leg at weekly intervals for 4 weeks. Two additional vaccines are administered at weeks 12 and 24. Patients are followed every 3 months after the sixth vaccination.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Eligible patients must have no evidence of disease in addition to 1 of the following features: Stage I, II, or III breast cancer and have received adjuvant chemotherapy and remain clinically free of identifiable disease, but have rising CA15.3 (BR2729) or CEA levels Stage III breast cancer and have completed adjuvant therapy no more than 24 months ago Recurrence in the ipsilateral axilla following a lumpectomy/axillary dissection or modified radical mastectomy Recurrence in the ipsilateral breast following a lumpectomy/axillary dissection Stage II breast cancer with at least 4 positive axillary lymph nodes at 24 months following completion of adjuvant therapy Patients with isolated elevation of the CEA level must have a colonoscopy to rule out colon carcinoma A colonoscopy within the past 5 years is acceptable if there is no strong family history of colon carcinoma, colonic polyps, or inflammatory bowel disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Premenopausal or postmenopausal Performance status: Karnofsky 90-100% Life expectancy: Not specified Hematopoietic: Lymphocyte count at least 500/mm3 WBC count at least 3,000/mm3 Hepatic: Aspartate aminotransferase no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other concurrent active cancers except basal cell or squamous cell carcinomas of the skin No history of a seafood allergy No known history of immunodeficiency or autoimmune disease

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery
A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery.

With IRB approval and informed consent, 100 female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery were randomly allocated to either the current standard (control group) or to additional efforts to remove residual CO2 at the end of surgery (intervention group; power analysis yielded 45 patients necessary per group). In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. In the intervention group, CO2 was removed by means of Trendelenburg position (\> 30 degrees) with 5 manual pulmonary recruitment maneuvers. Postoperative shoulder pain was assessed prior to discharge and 12, 24, 36 and 48 hours later using a visual analog scale (VAS). In addition, positional characteristics of the shoulder pain and incidence of postdischarge nausea and vomiting (PDNV) were recorded 48 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* female
* age 15-65
* ASA I-II
* scheduled for outpatient gynaecological procedure

Exclusion Criteria:

* previous laparatomy
* patients requiring hospitalisation
* procedure required conversion to laparatomy
* 48h follow-up no feasible