cyrilzakka/clinical-trials huggingface dataset:
Self-Management of Chronic Low Back Pain: Targeting Patient Activation

Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.

In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years of age)
* Seen in primary or specialty care practice for non-specific low back pain
* Chronic low back pain per the NIH Task Force on Research Standards for cLBP
* Worst back pain of at least 4/10 points
* Oswestry disability index of at least 24%
* English speaking

Exclusion Criteria:

* History of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months
* Possible non-musculoskeletal cause for LBP symptoms diagnosis at baseline
* "Red flag" LBP diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm)
* Neurological disorder resulting in moderate to severe movement dysfunction
* Presence of any psychotic disorder
To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.

All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.


Eligibility Criteria:
Inclusion Criteria:

1. Documented cirrhosis with any underlying etiology
2. Hepatic encephalopathy of grade II and above
3. 18 to 65 years of age

Exclusion Criteria:

1. Acute change in mental status due to a diagnosis other than hepatic encephalopathy
2. Patients who have received lactulose as an anticoma measure before enrollment
3. Patient who have developed encephalopathy post bleed
4. Patients with gut paralysis
5. Patients with tense ascites
6. Patients with altered sensorium due to organic brain disease.
7. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
8. Hemodynamic instability obviating vasopressors for resuscitation
9. Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease
10. Refusal of consent
Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy

To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.

To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:

* Age at diagnosis
* Number of children
* Will of having children
* Marital status
* Scholarity
* Period of time from the diagnosis
* Time of the last menstruation period
* Chemotherapy administration
* Clinical staging at the diagnosis
* Pathological evaluation
* Documentation of the cancer therapy

Eligibility Criteria:
Inclusion Criteria:

* Women with age ≥ 18 and ≤ 40
* Indication of (neo) adjuvant chemotherapy
* Prior chemotherapy treatment
* Patients with menstrual periods in the last 6 months
* In use of contraceptive methods
* Without breast cancer recurrence
* Capacity to read and understand the informed consent

Exclusion Criteria:

* Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
* Patients whom initiated chemotherapy treatment before entering the study
* Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
* Previous diagnosis of infertility
Study on the Relationship Between Mobile Phone Addiction and Functional Gastrointestinal Disorders

A cross-sectional study was conducted to collect the relevant data of college students' mobile phone addiction and FGIDs (IBS, FD) in the form of questionnaire, so as to understand the situation of college students' mobile phone addiction and the incidence of FGIDs (IBS and FD), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of FGIDs among college students.

This study adopts the method of cross-sectional survey to collect the relevant data of Chinese college students' mobile phone addiction and FGIDs (IBS, FD) in the form of online and face-to-face questionnaire, so as to understand the situation of Chinese college students' mobile phone addiction and the incidence of FGIDs (IBS, FD), and explore the correlation, so as to provide new ideas and scientific basis for the prevention, diagnosis and treatment of FGIDs.

Eligibility Criteria:
Inclusion Criteria:

* College students from all over the country, over 17 years old, have a physical examination before entering school
* Sign the informed consent form, voluntarily participate and fill in the questionnaire

Exclusion Criteria:

* People with diabetes, hyperthyroidism or hypothyroidism, peptic ulcer, inflammatory bowel disease, digestive tract tumor or severe medical and surgical disease
* History of abdominal surgery (such as esophagus, stomach, small intestine, colon, rectum, appendix, gallbladder, hysterectomy, cesarean section)
* Recently, there are some alarm symptoms, such as relieving black stool, bloody stool, hematemesis, abnormal anemia, fever, abnormal weight loss (no intention to lose weight, weight loss 5 kg in 3 months), change of defecation habits, dysphagia and so on
* In the past 4 weeks, he has taken drugs that affect the judgment of gastrointestinal symptoms, such as anti-inflammatory painkillers, diazepam drugs, anti-anxiety drugs, depressants and so on
Periodontal Disease and P. Gingivalis in Rheumatoid Arthritis

Periodontitis (PD) has been postulated to be a risk factor for the onset and progression of rheumatoid arthritis (RA). Recent reports suggest that infection with Porphyromonas gingivalis (P. gingivalis), a major oral pathogen in PD, could play a pivotal role in the development RA. The objective of this study is to examine the relationship of PD and P. gingivalis infection with the risk and severity of RA.

In this study, we will examine whether periodontitis (PD) and P. gingivalis impact rheumatoid arthritis (RA) risk by enrolling 300 patients with RA and 300 comparator patients with osteoarthritis and comparing results from comprehensive dental examinations and antibody responses to P. gingivalis. We will examine whether these associations are modified by the presence of certain genetic risk factors previously implicated in RA and whether evidence of infection with P. gingivalis precedes RA onset by examining banked sera from the Department of Defense Serum Repository (DoDSR) and the Studies of the Etiology of RA (SERA). We also plan to explore whether there are novel proteins expressed by P. gingivalis that drive autoimmunity in RA and whether immune responses to these bacterial proteins predict the future development of RA.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 years or older
* Diagnosis of rheumatoid arthritis, or osteoarthritis
* Have 9 or more evaluable posterior teeth (out of a total of 28 teeth, excluding third molars)
* Willing and able to provide informed consent

Exclusion Criteria:

* Received tetracyclines within the last 6 months.
* Need for antibiotic premedication for dental probing.
* Pregnant or breast feeding
Post-marketing Safety Evaluation of Pneumococcal Vaccines Among Children and Elderly Adults.

The purpose of this observational study is to examine the risk of adverse events following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age \<59 months and 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older.

The purpose of this observational study is to examine 1) the risk of adverse events (AEs) following vaccination with 10 or 13-valent pneumococcal conjugate vaccine (PCV10 or PCV13) among infants or children age \<59 months using a self-controlled risk interval design and 2) the risk of AEs following vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) among adults age 65 years and older compared with influenza vaccine recipients using a cohort design. We will use the national health insurance database from the National Health Insurance Service (NHIS) linked with the national immunization program registry data from the Korea Centers for Diseases Control \& Prevention (KCDC).

Eligibility Criteria:
Inclusion Criteria:

* Children \< 5 years who had received PCV10 or PCV13 from May, 2014 to December, 2018.
* Persons 65 years or older who had received at least one dose of PPSV23 or influenza vaccine (as a comparator) between January, 2014 and December, 2018.

Exclusion Criteria:

* Persons who experienced outcomes of interest within 1 year before the date of vaccination.
Phenotypic Spectrum of CTCs in Tumors of the Female Reproductive System

The study evaluates the level and molecular profiles of different CTC populations as markers for predicting the risk of developing hematogenous metastases and the effectiveness of treatment in patients with tumors of the female reproductive system (breast cancer, endometrial cancer, and ovarian cancer).

The primary objective are:

1. To assess the presence and number of different populations of CTCs at different time points (before biopsy, before surgery, and after surgery).
2. To assess the relationships of different CTCs populations prior to treatment initiation with the effects of neoadjuvant chemotherapy and the risks of recurrence and metastases.
3. To assess the molecular profiles of different CTCs populations in the blood and in ascitic fluid.

The secondary objective is to compare the multicolor flow cytometry results with data of ultrasound, CT and/or MRI, serum tumor markers, and immunohistochemical studies in patients with breast cancer, endometrial cancer and ovarian cancer

The overall goal is to study the diagnostic and prognostic efficacy of various CTC populations as liquid biopsy markers in tumors of the female reproductive system (breast cancer, endometrial cancer, and ovarian cancer).

Phase I study:

Determination of different populations of CTCs in blood and ascitic fluid (if any) prior to treatment.

The main objectives of the study:

1. To assess the presence and number of different CTC populations at different time points (before biopsy and before surgery) using multicolor flow cytometry.
2. To assess the relationships between different CTCs populations prior to treatment initiation with the effects of neoadjuvant chemotherapy and the risks of recurrence and metastases.
3. To assess the molecular profiles of different CTCs populations in the blood and in ascitic fluid.

Additional research tasks:

To compare the multicolor flow cytometry results with the data of ultrasound, CT and/or MRI, serum tumor markers, and immunohistochemical studies in patients with breast cancer, endometrial cancer, and ovarian cancer Methodology: Open-label, exploratory, single centre study. Blood and ascitic fluid collected from subjects (if available)

Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential.
* Clinical and radiological diagnosis of breast cancer or Ovarian cancer or Endometrial Cancer General satisfactory condition (according to the ECOG scale ≤2) Subject is capable to undergo the diagnostic investigations to be performed in the study
* Informed consent

Exclusion Criteria:

* Active current autoimmune disease or history of autoimmune disease

  * Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
  * Known HIV positive or chronically active hepatitis B or C The subject has multiple primary malignant tumors
Physical Activity, Meal Composition, and RMR Among Children Adolescent and Adults

Resting metabolic rate (RMR) is the amount of energy the body uses at rest, and accounts for 60%-70% of daily energy expenditure. Although measured at rest, RMR is strongly influenced by physical activity because the increased metabolic rate during exercise is partially carried over even when exercise stops. Therefore, persons who are physically active maintain higher RMR and less body fat than do sedentary controls. It is well known that high energy intake stimulates whereas caloric restriction reduces RMR. Food thermogenesis corresponds to approximately 10% of daily energy expenditure. Diet-induced thermogenesis is greater on a high protein and carbohydrate diet than on a fat diet. Other factors the affect RMR are age (RMR tends to decline progressively over the life span) and body composition (lean body mass is regarded as the main determinant of RMR). However, the research regarding the effect of a specific combination of macronutrients and exercise on RMR is scarce.

Therefore, the aim of the current study is to assess the combined effect of a meal composition and physical activity on RMR in normal weight and overweight children, adolescents and adults.

One hundred (100) healthy volunteers, 50 normal weight (NW) and 50 overweight (OW), age 6-30 will be recruited for the current study. All participants and/or their parents will sign informed consent prior to their participation. Participants will visit the clinic 4 times, with a week's difference between them. Participants will arrive at the clinic after 12 hours of fasting and avoiding physical activity for 14 hours. During the first visit, their RMR will be measured, and 15min later they will perform 60 min of aerobic training, and 15 minutes later they will be asked to drink 300ml of water, followed by a second RMR test. In the consecutive visits they will follow the same routine without the first RMR test, and drink either carbohydrate enriched shake, protein enriched shake or fat enriched shake; in a random order.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6-30 years.
* Normal weight and over weight participants

Exclusion Criteria:

* Elite athletes
* Participants with physical limitations concerning strenuous physical activity.
ASC Therapy for Patients With Severe Respiratory COVID-19

The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system.

This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death.

We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function.

The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-80 years
* Confirmed HCoV-19 infection
* Temperature above 38.0o C
* Pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment:

  1. Respiratory distress, RR ≥ 30/min;
  2. Oxygen saturation ≤ 93% at rest state;
  3. Arterial partial pressure of oxygen (PaO2) / Fraction of inspiration O2 (FiO2) ≤ 300mmHg, 1mmHg=0.133kPa
* Pneumonia that is judged by chest radiograph or computed tomography
* In respirator and possible for treatment within the first 24 hours

Exclusion Criteria:

* Patients that have need for additional immunosuppressive treatment
* Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
* Co-Infection with other infectious agent.
* Females capable of becoming pregnant must have a negative pregnancy test prior to treatment. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
* Patients who are participating in other clinical trials.
Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion

One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)

This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.

Eligibility Criteria:
Inclusion Criteria:

* Requesting abortion 19-23 weeks
* No contraindication to induction abortion

Exclusion Criteria:

* Fetal demise
* Ruptured membranes
* Evidence of pelvic infection
* Inability to give informed consent
Progressive Resistance Training Versus Relaxation for Breast Cancer Patients During Chemotherapy: Biological Mechanisms and Effects on Fatigue and Quality of Life

The purpose of this randomized intervention study is to investigate the effects and biological mechanisms of a supervised 12-week progressive resistance training on fatigue and quality of life in breast cancer patients during chemotherapy. To determine the effect of the exercise itself beyond potential psychosocial effects due to attention by trainers or the group support, patients in the control group have a comparable training schedule (i.e. 60 min, twice a week, for 12 weeks) but with relaxation training (Jacobsen method).


Eligibility Criteria:
Inclusion Criteria:

* breast cancer patient after lumpectomy or mastectomy, stage I-III
* adjuvant chemotherapy
* BMI at least 18

Exclusion Criteria:

* contraindication for exercise
* radiotherapy during intervention period
Retrospective Analysis of Chest X-ray Severity Scoring System of COVID-19 Pneumonia

The research will be retrospective, and will include all patients who were admitted during 2020 and 2021 in the COVID-19 ICU of University Hospital Center Osijek due to pneumonia caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The association of chest x-ray infiltrate evolution with changes in laboratory inflammatory parameters and respiratory function parameters will be examined.

The research will be retrospective, and will include a review of medical history of all patients admitted in the COVID-19 ICU of the University hospital Osijek during 2020 and 2021. Associated comorbidity, hospital admission date, intubation date, mechanical ventilation, extubation, discharge, and patient final outcome will be recorded for each patient. By analyzing X-rays of the lungs by radiology specialists, inflammatory infiltrates in the lungs will be quantified via the Brixia system, during hospital admission, admission to the Respiratory Center, and during treatment at the Respiratory Center. All patients will have their Sequential Organ Failure Assessment (SOFA) and/or Acute Physiology and Chronic Health Evaluation (APACHE II) values calculated upon admission. Inflammatory parameters (c-reactive protein (CRP), procalcitonin (PCT), interleukine-6 (IL-6), ferritin), red blood cell count, leukocytes, blood urea nitrogen (BUN), arterial blood gases and ventilation parameters on admission to the hospital, admission to the ICU, and on several occasions during treatment in the ICU will be analysed. Also, empirical use of antibiotics, the occurrence of bacterial superinfections, sepsis and organic failure will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Pneumonia caused by SARS-CoV-2 virus
* Admission to the ICU COVID-19 unit

Exclusion Criteria:

- Patients with lung tumors or history of lung resection