cyrilzakka/clinical-trials huggingface dataset:
Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?

To see if infant outcomes will improve when mothers are helped to hold their preterm infants skin-to-skin as soon as possible after birth and as often as possible and for as long as possible each time during the next five days.

A similar intervention was studied in a RCT with fullterm infants but this was done with emphasis on close contact rather than skin-to-skin contact and lasted only the first 6 hours postbirth. This study was conducted by the same PI and funded by the National Center for Nursing Research, NIH 1990-1994. This research yielded numerous significant and beneficial differences.

Two pilot studies were done with healthy late preterm infants and mothers who planned to breastfeed. Skin-to-skin contact began in the delivery room. The first pilot was a descriptive exploratory study with 10 mother-infant dyads done in Cali, Colombia; skin-to-skin began at birth and lasted through hour 6 when all dyads went to the postpartum ward. Follow-up was through hospital discharge on the second day. All outcomes were positive.

The second pilot was an RCT done in the United States with a well balanced sample of 8 dyads, 4 in each group. Mean observation time lasted 47 hours (Medicaid required discharge time for the mothers) with skin-to-skin contact occurring 84% of the time. All outcomes favored the skin-to-skin group, for example 3.8 days to discharge home compared to 14.5 for the controls. Follow-up was at one year and similarly positive.

Similar differences were hypothesized for the RCT reported here in which the intervention was extended to the care of somewhat smaller and sicker preterm infants and lasted five days unless the infant was discharged sooner. The consent form was in layman terms, four pages long, and fulfilled all the requirements of the Institutional Review Boards of the Bolton School of Nursing at Case Western Reserve University, University Hospitals Case Medical Center and its General Clinical Research Center, and Kadlec Medical Center, Richmond, WA.

Eligibility Criteria:
Inclusion Criteria:

Mother and Infant Dyads

Infants:

* singleton birth
* 32 to 36 completed weeks
* 5-minute Apgar score of 6 or more
* weighed 1300 to 3000 grams
* no birth defects that would interfere with feeding
* healthy enough to experience skin-to-skin contact with their mothers.

Mothers:

* 18 or more years of age
* spoke English
* free of serious drug abuse
* well enough to experience skin-to-skin contact with their infants with assistance if needed.

Exclusion Criteria:

Infants:

* too ill to be with their mothers
* who have a condition that interferes with feeding.

Mothers:

* who are too ill to care for their infant
* are serious drug abusers.
Red Blood Cell Lifespan

Background:

A low amount of red blood cells in the blood of patients with limited kidney function is a well known problem. Besides the lack of substances in the blood like iron or erythropoietin the shortened survival of red blood cells leads to the low red blood cell count. Red blood cells of patients on kidney replacement therapy (dialysis) die earlier than those of healthy persons. They live only about 70 days compared to 120 days in healthy humans. Today little is known about the causes for the shorter survival of the red blood cells in patients on dialysis. Because inflammation leads to a shorter life of the red blood cells in people suffering from several diseases leading to inflammation we would like to learn about the role of inflammation in the shortened life of red blood cells of dialysis patients.

When red blood cells are dying the content is broken down to several substances. One of these substances is the gas carbon monoxide (CO). The carbon monoxide is exhaled with the breath. The more red blood cells die the more CO is exhaled. That's why we can calculate the lifespan of the red blood cells when we measure the amount of CO in breath at the same time as the red blood cell count in the blood.

Aim of the study:

We aim to learn about the influence of inflammation of on red blood cell survival in dialysis patients. To look for factors with effect on inflammation or red blood cell survival, for example type of dialysis access, medication or kind of dialysis treatment.

Study procedures:

Over the course of the 18 month study, 6 observational assessments will take place. If the patient experiences a situation with increased inflammation during the study period (for example any kind of infection or intervention) up to two more study visits will take place. Each study visit will include blood sampling, performed without the need for an extra needle stick, and a breath sampling in order to calculate the red blood survival and to measure markers for inflammation in the blood. The breath sample will be taken using the easy to use GaSampler device developed by a company called Quintron especially for medical breath sampling.

In order to get a sample of air at the patient's home for calculation of carbon monoxide produced in the body we will ask the patients to take home an open empty plastic bottle before each study visit. The bottle should be kept overnight on a table or sideboard in the apartment. Before leaving home for hemodialysis or in clinic visit the patient will seal the plastic bottle with the top, take it to the dialysis center and hand it to the research staff.

Risks:

The amount of the additional blood drawn is 30 ml; this is the amount 2 tablespoons, at each study visit. This does not harm the patient. The breath sampling does not imply any risk.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Chronic hemo- or peritoneal dialysis treatment greater than 3 months

Exclusion Criteria:

* Inability to understand the English language and give informed consent for participation in the study
An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Inadequate glucose control while using metformin monotherapy (MET) for at least 8 weeks at stable daily doses of at least 1500 milligram (mg) before screening visit (Visit 1)

  a. Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 10.5% at Visit 1
* Adequate qualifying continuous glucose monitoring (CGM) reading during the pre-randomization (selection) phase
* Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute (mL/min)/1.73 meter square (m\^2) at Visit 1
* Body mass index of 22 through 45 kilogram per meter square (kg/m\^2) at Visit 1

Exclusion Criteria:

* History of any of the following (at Visit 1):

  1. Diabetic ketoacidosis (DKA)
  2. Type 1 diabetes mellitus (T1DM)
  3. Pancreatic (for example, Beta-islet cell) transplantation
  4. Diabetes secondary to pancreatitis or pancreatectomy
  5. Personal history of, or ongoing, pancreatitis
  6. One or more episodes of severe hypoglycemia (requiring assistance from others), as documented in the history obtained at Visit 1
  7. Hereditary glucose-galactose malabsorption or primary renal glucosuria
* Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG) greater than (\>) 270 milligram per deciliter (mg/dL) during the pre-treatment phase
* Treatment with any other oral or parenteral antidiabetic medications different from metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1 receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and investigational agents
* Received an investigational drug or vaccine or used an invasive investigational medical device within 30 days before the planned first dose of study drug
* Current use of "natural medicines" or natural medicinal products for diabetes (for example, cactus-derived nutrients, celery)
A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)

This will be a multicenter, open-label study enrolling a total of up to 23 patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease and measurable tumor lesions
* Life expectancy \> 3 months
* For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial and for 6 months following their final exposure to study treatment
* Willingness and capability to be accessible for study follow-up

Exclusion Criteria:

* Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred \> 6 months from concluding adjuvant therapy
* Peripheral neuropathy Grade ≥ 2
* Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
* Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
* Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
* Evidence of clinically detectable ascites
* Other invasive malignancies within 5 years prior to Cycle 1, Day 1
* History or evidence upon physical examination of active central nervous system (CNS) disease
* Current or recent participation in another experimental drug study
* Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease
* Active infection requiring parenteral antibiotics
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study
* Known or suspected to be positive for the human immunodeficiency virus (HIV)
* Known to be positive for hepatitis C or hepatitis B surface antigen
* Inadequately controlled hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1
* History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1
* Bleeding diathesis or coagulopathy
* Pregnancy (positive pregnancy test) or breast feeding
* Serious, non-healing wound, ulcer, or bone fracture
Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of hidradenitis suppurativa. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≤50 kg/m2, inclusive
* Diagnosis of clinically active moderate-to-severe HS (Hurley Stage 2 or 3)
* Total abscess or inflammatory nodule (AN) count of ≥5, affecting at least 2 distinct anatomic regions, with at least 1 accessible AN of adequate size for biopsy (diameter \> 1 cm)
* Total draining tunnel (dT) count of ≤20
* Documented history of inadequate response or intolerance to at least a 3-month course of 1 conventional systemic therapy (e.g., antibiotic) and 1 biologic drug (e.g., adalimumab or secukinumab)
* Doses of medications for HS must be stable for at least 5 weeks prior to study drug administration
* Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration

Exclusion Criteria:

* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
* History of or current inflammatory or other autoimmune disease
* Complex presentations of HS
* Skin disease other than HS that may confound clinical assessments or increase subject risk in the study
* Uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
* Active current infection or history of recurrent infections
* Active or untreated latent tuberculosis
* Primary or secondary immunodeficiency
Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment

Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. We believe that in patients, who have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating System for bridge therapy will suffer from the injury of reactive oxidative species, too. It will damage the kidney, lung, cerebral cortex, and other organs. It may result in death before the recovery of liver function or undergoing liver transplantation.

Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 2. Investigate the microcirculation status and risk factors in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 3. Study the relationship between oxidative stress and microcirculation status. 4. Study the correlation between oxidative stress and prognosis. 5. Study the correlation between microcirculation status and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Patients with acute deterioration on Chronic liver failure, who required liver support treamtment
3. Patients with acute liver failure due to acute hepatitis, who reauired liver support treatment
4. Patients with acute liver dysfunction within 7 days after liver transplantation, who required liver support treatment

Exclusion Criteria:

1. Age \> 70 years old
2. Cancer, not curable
3. Patients who had used of antioxidant therapy within 24 hours before study
4. Patients who had received hyperbaric oxygen therapy within 24 hours before study
5. Patients who had received peroxide treatment within 24 hours before study
Immunohistology in USDD and Correlation Between Bacterial Flora and Phlogosis

Diverticulosis of the colon is a frequent condition in adults in western countries and a significant number of patients experience clinical symptoms even when the diverticulosis is not complicated by diverticulitis.

Both central and mucosal immunity are altered in Uncomplicated Symptomatic Diverticular Disease (USDD) and Rifaximin ameliorate clinical symptoms and normalize the immunological abnormalities.

The Study Protocol is verify the modifications in the immunological pattern induced by reducing bacteria related activation of immunity by Rifaximin treatment.


Eligibility Criteria:
Inclusion Criteria:

* male and female
* age 18 or more
* radiologic or endoscopic diagnosis of diverticular disease located in sigma or colon descendent
* Informed consent
* patients willing to participate in to the study

Exclusion Criteria:

* other colon diseases
* Inflammatory Bowel Diseases
* signs or symptoms of inflammation
* consumption of : antibiotics, anti-inflammatory drugs ( FANS and 5-ASA), prebiotics, Proton Pump Inhibitors, corticosteroids, fiber within three months
* pregnancy and breast feeding
* acute diverticulitis characterized by:
* moderate/sever pain in left iliac fossa
* fever \> 38°C
* abdominal pain
* haematochezia
* leukocytosis (20% more than the normal range)
* remote acute diverticulitis
* rifaximin hypersensitivity
* neoplastic diseases
* immunodeficiencies
* poor physical conditions
* leaver deficiencies (Child C), kidney (Creatinine\>2,2 mg/dl), heart (NYHA 3-4)
* major psychiatric illness
* drugs abuses and alcoholism
* participations in other clinical trials within 4 weeks
* patients unwillingness certificate
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer

The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative metastatic breast cancer

Study design and setting We will conduct an international, multicentre, open-label, randomised controlled trial. All oncological departments who treat patients with metastatic breast cancer can participate. The EU Clinical Trial Regulation will be applied.

Interventions Trial participants will be randomised to trastuzumab deruxtecan or standard treatment.

Trastuzumab deruxtecan

Patients randomised to trastuzumab deruxtecan will be treated as:

Trastuzumab deruxtecan until progression or intolerable toxicity, Trastuzumab deruxtecan: 5.4 mg/kg intravenous on day 1 of a 21 days cycle.

Standard

Patients randomised to standard will be treated as:

CDK4/6 inhibitor with an endocrine therapy until progression or intolerable toxicity CDK4/6 inhibitor: Physician's choice of ribociclib (600mg daily for 21 days in a 28 days cycle) or abemaciclib (150mg twice daily).

Endocrine therapy: letrozole (2.5mg daily), anastrozole (1mg daily), exemestane (25mg daily), tamoxifen (20mg daily) or fulvestrant (intramuscular 500mg every 4 weeks)

Other treatment Prophylactic antiemetics are allowed, including corticosteroids. Prophylactic antibiotics are allowed if deemed necessary for the patient. G-CSF is allowed when needed.

All other symptomatic treatment to perform best of care is allowed as long as name, administration and length is documented in the chart. Bone targeted agents are allowed. No other antineoplastic treatment is allowed.

Radiological evaluation Patients will initially be scanned every 9-12 weeks as per investigator's or co-investigator's discretion with minimum a CT of the thorax and abdomen or a FDG-PET/CT. Patients with response can have this interval extended. Upon progression treatment/control is to be done according to department preferences, but subsequent treatment and day of death must be registered.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 or above.
* Radiologically/pathologically verified metastatic breast cancer.
* ER-positive (1% or more) and HER2-low (HER2 1+ or HER2 2+/ISH-neg)10,11.
* PAM50 Luminal B, HER2-enriched or Basal-like.
* Performance status 0-1.
* Evaluable disease

Exclusion Criteria:

* Patients who are incapable of understanding the written material received
* Patients with inaccessible tumour tissue
* Other malignant disease within 5 years (in situ cervix and non-melanoma skin cancer excluded)
Position of Children During Urine Collection: Evaluation Study

Urinary tract infection (UTI) is a frequently suspected cause of fever in young children, justifying urine cultures. Sampling procedures are decisive for the reliability of UTI diagnosis. Even though official guidelines recommend clean catch method, catheterization or suprapubic aspiration, urine bag collection remains widely used. In our experience, the rate of contaminated bag-obtained cultures reaches 30.2 %. In a recent study, the investigators have noticed that the rate of contaminated urine cultures was lower when children were kept in an upright position at the time of urine collection. The upright position could explain this decrease, perineum being less in contact with urine. These results are borderline significant, the investigators would like to confirm them with a specific study.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 - 36 months
* Non-toilet-trained children
* Indication to bag urine collection with the following criteria :
* fever ≥ 38.5 °C
* unexplained fever
* and at least 1 of the following criteria for girls and uncircumcised boys, at least 2 criteria for circumcised boys :
* age ≤ 12 months
* fever ≥ 48 hours
* poorly tolerated fever (chills ± cyanosis ± pronounced weakness...)
* preceding episode of tract urine infection

Exclusion Criteria:

* Parents opposed to the participation of their children in the study
* Diarrhea
* Current antibiotic treatment or during the 8 preceding days of the urine collection
* Genitals / perineal anomaly
Radial Artery Access With Ultrasound Trial

Radial artery access for cardiac catheterization can require multiple attempts. Multiple attempts increase the time required, patient discomfort, and the risk of arterial spasm. Ultrasound guidance has been shown in other studies to reduce the number of attempts and complications in central venous and femoral artery access. This study will test if the addition of ultrasound guidance reduces the number of attempts and time required to access the radial artery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting for cardiac or peripheral catheterization with planned radial approach.
* Barbeau's or Allen's test indicating at least some degree of collateral circulation in palmar vessels
* Functional ultrasound equipment with ultrasound trained attending operator

Exclusion Criteria:

* Inability to provide informed consent
* Femoral access
* Emergency procedure (Shock, STEMI)
* End-stage renal disease on hemodialysis
* Previous ipsilateral puncture within 1 week
RISE FOR HEALTH Study

The RISE FOR HEALTH study (RISE) is an initiative of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium, which was formed by the NIDDK in 2015 to develop the science to improve bladder health in women and girls. RISE is designed to identify risk and protective factors for bladder health and lower urinary tract symptoms (LUTS) and to estimate the distributions of bladder health and bladder health knowledge, attitudes, and beliefs in women of all ages across the life course.

This will be accomplished by conducting a population-based prospective cohort study. A sample of individuals who live within the study base, i.e., the county containing each PLUS clinical research center and each adjacent county, will be invited to complete two baseline surveys and then two follow-up surveys one year later. A subset of participants will be invited to attend an in-person evaluation to collect additional clinical information and biologic specimens.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling
* Age ≥18 years
* Identify or born as female (includes cis- and trans-women, and trans-men)
* Able to read and understand English or Spanish
* Able to read and provide informed consent

Exclusion Criteria:

* Physical or mental health conditions that would prohibit self-administration of questionnaires either electronically or using paper and pencil (e.g., dementia/cognitive impairment/blindness/severe arthritis).
* Residence in a nursing home or other institutionalized living facility.