cyrilzakka/clinical-trials huggingface dataset:
Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)

32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting of three consecutive treatment periods: two 1-week periods followed by one 2-week period, evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days follow-up period.

During the course of the study, subjects will be examined for any side effects that may occur (safety and tolerability).

Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837 present in the blood (pharmacokinetics) will also be determined.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis
* Subjects with gating G551D CFTR mutation on at least one allele in the CFTR gene
* Subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen with ivacaftor, for at least 2 weeks prior to screening
* Weight ≥ 40.0 kg
* Subjects on stable concomitant treatment regimen for at least 4 weeks prior to baseline (excluding ivacaftor)
* Pre- or post-bronchodilator FEV1 ≥ 40% of predicted normal
* Subject will have to use highly effective contraceptive methods

Exclusion Criteria:

* On an ivacaftor-containing treatment regimen and unable or unwilling to discontinue ivacaftor for the washout and treatment periods of the study
* Concomitant use of antifungal drugs within 4 weeks of baseline
* A history of a clinically meaningful unstable or uncontrolled chronic disease
* Liver cirrhosis and portal hypertension
* Any significant change in the medical regimen for pulmonary health within 4 weeks of baseline
* Unstable pulmonary status or respiratory tract infection or changes in therapy for pulmonary disease within 4 weeks of baseline
* Abnormal liver function
* Clinically significant abnormalities on ECG
* History of malignancy, solid organ/haematological transplantation
* Abnormal renal function
* Participation in another experimental therapy study within 30 days or 5 times halflife
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®

This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* As per currently approved Reclast® Package Insert:

Exclusion Criteria:

- As per currently approved Reclast® Package Insert:
Virtual Histology Intravascular Ultrasound to Evaluate Prognostic Risks of Saphenous Vein Graft Disease Before Percutaneous Coronary Intervention.

The study is a prospective cohort study conducted in Tianjin Chest Hospital, China. Patients with saphenous vein graft disease after coronary artery bypass graft, and planning for receiving percutaneous coronary intervention after virtual histology intravascular ultrasound will be enrolled between May 2017 and April 2019. These subjects will be followed up at 1, 6 and 12 months post-operation of PCI to assess the short-term and long-term effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients with SVGD after CABG
* Planning to receive PCI using drug-eluting stents
* 18 to 80 years old
* Finishing VH-IVUS examination
* Willing to participate in the study and sign informed consent

Exclusion Criteria:

* Patients with liver disfunction and renal failure
* Aspirin and clopidogrel allergy
* Acute myocardial infarction after CABG
* History of stroke in the past 3 months
* Gastrointestinal bleeding and hemoptysis recently
* Vasculitis and non-atherosclerotic coronary artery disease
* Coagulation disorders
* History of malignancy
* Women during pregnancy
The Immune Landscape of Epithelial Ovarian Cancer

This is a single center prospective observational study to characterize the immune landscape of newly diagnosed epithelial ovarian cancer (OC).

Patients with newly diagnosed epithelial OC will be enrolled in 4 different cohorts: A) Newly diagnosed high grade serous or endometroid OC undergoing primary debulking surgery; B) Newly diagnosed high grade serous or endometroid OC undergoing neoadjuvant chemotherapy (NACT) followed by interval debulking surgery; C) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing primary debulking surgery; D) Rare subtypes of epithelial OC (low grade serous, low grade endometrioid, clear cell, mucinous or carcinosarcoma) undergoing NACT followed by interval debulking surgery. A cohort of women undergoing adnexectomy for benign pathology will be enrolled (cohort E) for comparative analysis.

Enrolled patients will be asked to provide the following biological samples at specified time points: archival and fresh tumor tissue, peripheral blood samples, rectal and vaginal swabs, ascites (when present).

The main aim of the study is to characterize the immune landscape of epithelial OC in tumor tissue and peripheral blood and correlate the presence of myeloid-derived suppressive cells (MDSCs) and other immune infiltrates and of the systemic immune response with progression free interval (PFI) in epithelial OC.


Eligibility Criteria:
Inclusion criteria cohort A-D:

* Suspicious diagnosis of epithelial ovarian cancer (subsequent histologically confirmation required)
* Plan to undergo a surgical procedure for the management of epithelial ovarian cancer or recurrent ovarian cancer previously treated with conventional treatment and involved in the trial as group A-D
* ≥18 years old
* ECOG Performance Status ≤ 2
* Written informed consent

Inclusion criteria cohort E:

* Indication for adnexectomy for a benign gynecological condition
* ≥18 years old
* ECOG Performance Status ≤ 2
* Written informed consent

Exclusion criteria cohort A-E:

* Other active concomitant neoplasms that might confound the results of the planned analysis.
* Ongoing active autoimmune disease requiring treatment or condition of immune deficiency
* Ongoing chronic treatment with steroids or other immune suppressive agents at the time of study entry
The Effect of Supplementation of Vitamin D3 on Inflammation Induced by 100 km Running, Iron Metabolism and Erythropoiesis

A group of runners received vitamin D (10,000 IU - international unit per day) for two weeks. The aim of the intervention was to check the effect of vitamin D supplementation on selected parameters of inflammation and iron metabolism in comparison with the placebo group. Blood was collected before and after supplementation. Next: before, after 25, 50, 75,100 km running and 12 hours after the run. The data were subjected to statistical analysis.

Subjects were randomized to two groups: the experimental one, n = 20 and the placebo one, n = 20 with the same age, experience in running and 25(OH)D level. The experimental group received vitamin D3 supplementation (around 10,000 UI/day, i.e., 20 droplets -Vigantol medicament, Merck) and the control group received a placebo (20 droplets of sunflower oil, placed in an identical bottle as vitamin D3) for two weeks before a run. The last vitamin D dose was taken 24 h before the 100 km ultra-marathon. 40 male athletes took part in the 100 km ultra-marathon. Blood was collected before (day 0) and after supplementation (day 14). Next (day 15): before, after 25, 50, 75,100 km running and 12 hours after the run (day 16). The data were subjected to statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* male
* athletes running ultra-marathons

Exclusion Criteria:

* vitamin D3 supplementation
* multivitamin and iron supplementation
* serum 25(OH)D low \< 10 ng/mL
* serum 25(OH)D high \> 100 ng/mL
* haemoglobin \< 10 g/dL
* other (sports injury, tournament)
Assessing the Effects of Robotic Pets on Patients With Dementia in the Acute Care Hospital Setting

Robotic pets can provide a source of affection and companionship for patients. This is especially important as individuals with dementia may receive infrequent visitation from family members if their families struggle with how to cope and communicate with their loved one. Several options such as the "Joy for All™" and "Paro" robotic pets offer a source of companionship that is both interactive and comforting.

Sarasota Memorial Health Care System (SMHCS) researchers are seeking to make companion pets available to patients with dementia to provide them with a supplemental enrichment experience that enhances their overall care and lowers their risk for superimposed delirium. The intervention will consist of providing a robotic pet to the patient within 48 hours of admission, which the patient will keep with them throughout their hospital stay and upon discharge. SMHCS researchers will evaluate the effects of the robotic pet interaction on patient delirium scores, as measured by the Nursing Delirium Screening Scale (Nu-DESC), length of stay, and the use of intravenous psychotropic medications, code greys, falls occurrence, restraint use, and IV dislodgement in patients with mild-to-moderate dementia. The Nu-DESC scale is a short assessment tool, estimated to take approximately 3-5 minutes to complete and is already part of standard care at SMHCS. This tool is used by nursing staff with minimal additional training and shows consistent sensitivity (85.7%) and specificity (86.8%) in detecting delirium. The NuDESC score may be positive in a patient with dementia, since some characteristics of dementia can be similar to delirium. However, patients with dementia are at higher risk for developing delirium, so the NuDESC is a helpful tool for the nurse. A score of 2 or higher is considered screening positive for delirium. For this study, the NuDESC tool will be used as a guideline to assist in the screening of delirium. The patients will have to score a 4 or less to be included in the study. Patients that are scoring \>4 will be excluded. Theoretic Framework of Acceptability (TFA) is a questionnaire which will be used to assess health care provider acceptability of the companion animal. This tool is currently not in use at SMHCS, but it will be used as part of this study to assess whether health care providers accept (or reject) the robotic pets as companion animals.


Eligibility Criteria:
Inclusion Criteria:

* Patients with:

  * Dementia indicated in the patient's chart
  * Admitted to the designated medical-surgical units at Sarasota Memorial Health Care System
  * Ages 65 and older
  * NuDESC score will be 0-4 during study enrollment.

Exclusion Criteria:

* Patients who are:

  * \<65 years old
  * NuDESC score \>4 during study enrollment
  * Patients at risk for alcohol withdrawal or substance abuse withdrawal
  * Enhanced isolation precautions (c.diff)
  * Presenting with paranoia, hallucinations, or severe agitation
A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder

The purpose of study is to compare bladder intact-event free survival (BI-EFS) in participants receiving TAR-200 in combination with intravenous (IV) cetrelimab versus concurrent chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Ineligible for or have elected not to undergo radical cystectomy
* All adverse events associated with any prior surgery and/or intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade less than (\<) 2 prior to randomization
* Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
* Thyroid function tests are within the normal range per investigator assessment (or stable on hormone supplementation). Investigators may consult an endocrinologist for participant eligibility assessment in the case of equivocal or marginal test results
* Adequate bone marrow, liver, and renal function: Bone marrow function (without the support of cytokines or erythropoiesis-stimulating agent in preceding two weeks): Absolute neutrophil count (ANC) greater than or equal to (\>=) 1,500/cubic millimeters (mm\^3); Platelet count \>=80,000/mm\^3; Hemoglobin \>=9.0 grams per deciliter (g/dL); Liver function: (Total bilirubin less than or equal to (\<=) 1.5 \* upper limit of normal (ULN) or direct bilirubin \<= ULN for participants with total bilirubin levels greater than (\>)1.5\*ULN (except participants with Gilbert's Syndrome, who must have a total bilirubin \< 3.0 mg/dL), and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to (\<=) 2.5\* institutional ULN); Renal function: Creatinine clearance \>=30 mL/min using the Cockcroft-Gault formula. 24-hour creatinine clearance test will also be accepted for estimating renal function in situations where Cockcroft-Gault formula is not a good predictor of estimating adequate renal function

Exclusion Criteria:

* Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study
* Must not have diffuse CIS based on cystoscopy and biopsy. Diffuse, or multi-focal, CIS is defined as the presence of at least 4 distinct CIS lesions in the bladder at the time of the Screening re-TURBT
* Participants must not have evidence of cT4b, or N1-3, or M1 disease based on local radiology staging (chest, abdomen, and pelvis must be performed using Computed tomography \[CT\] or Magnetic resonance imaging \[MRI\]) within 42 days prior to randomization
* Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 200
* Evidence of bladder perforation during diagnostic cystoscopy. Participant is eligible if perforation has healed prior to randomization
Acute Physiological Effects of Greek Traditional Dancing

In Greece, people of different age groups, including young children to older adults, are involved in traditional dance. To date, the well-know benefits of dancing include entertainment, socialization and increased physical activity. However, the acute effects of Greek traditional dancing on health, physical performance and muscle damage indices remain largely unknown. Therefore, the aim of this project is to evaluate the acute effect of Greek traditional dancing on health-, physical performance-, and muscle damage-related parameters by considering the impact of dancing tempo (slow vs moderate vs fast). In a crossover repeated measures design 10 pre- and 10 post-menopausal women will participate in the three dancing sessions of different tempo in a random order.

This study aims at determining the acute effect of Greek traditional dancing on health- and physical performance-related parameters by considering the impact of dancing tempo. Ten pre- and ten postmenopausal women meeting the inclusion criteria will be assigned to a crossover trial. Initially, participants will undergo baseline testing including (i) anthropometrics, (ii) body composition, (iii) physical performance, (iv) physical activity level and (v) dietary intake. After baseline measurements, a 7-day familiarization period will take place, during which participants will practice daily on the three experimental dances. Each dance will be characterized by a different tempo (beats per minute) so that there will be one dance from each tempo category (i.e. slow, moderate and fast). After familiarization, participants will execute in a random order the three dancing sessions, on separate days. Each dancing session will consist of one dance (of either slow or moderate or fast tempo) lasting \~ 3- 4 minutes. During each dance heart rate, oxygen consumption and activity intensity will be continuously monitored. Before and immediately after the dance systolic and diastolic blood pressure, perceived exertion and blood lactate will be measure. In addition, before each dance and at 24 and 48 hours post-dance muscle soreness, muscle strength and resting metabolic rate will be measured and a resting blood sample will be drawn for the assessment of inflammatory and oxidative stress markers.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal and postmenopausal women.
* Abstain from vigorous physical activity and/or exercise during the last (at least) 6 months prior to the study.
* Free of musculoskeletal diseases and injuries.
* Free of cardiometabolic diseases.
* Free of mental health disorders
* No body weight loss \>10% over the last 6 months prior to the study
* Non-smokers

Exclusion Criteria:

* Perimenopause and menopause women
* Participation vigorous physical activity and/or exercise during the last (at least) 6 months prior to the study
* Presence of musculoskeletal diseases and injuries.
* Presence of cardiometabolic diseases.
* Presence of mental health disorders
* Body weight loss \>10% over the last 6 months prior to the study
* Smokers
Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.


Eligibility Criteria:
Inclusion Criteria:

* Has luminal Crohn's disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater than or equal to (\>=)220 but \<=450 and either: a. Mean daily stool frequency (SF) count \>=4, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>=2, based on the unweighted CDAI component of abdominal pain (AP)
* Active transmural activity in at least one segment (segmental magnetic resonance index of activity \[MaRIA\] \>= 11)
* a. Has demonstrated inadequate response/intolerance to conventional therapy; b. Has previously demonstrated lack of initial response (that is, primary non-responders), responded initially but then lost response with continued therapy (that is, secondary non-responders), or was intolerant to a maximum of 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (that is, janus kinase \[JAK\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents)

Exclusion Criteria:

* Has complications of Crohn's disease, such as symptomatic strictures or stenoses (unless less than \[\<\]3 centimeter (cm) dilatation and not symptomatic or displaying associated fistula/fistulae and/or or abscess), fibrotic stenosis, internal fistulas, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab
* Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active perianal fistulas may be included if there are no associated stenoses, no anticipated surgery and no abscesses currently identified
* Has had any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline
* Has a draining (that is, functioning) stoma or ostomy
* Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, in the previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
Clinical Evaluation of the OrthoPAT Advance System

This study is intended to provide additional performance data of the OrthoPAT Advance in routine orthopedic surgery.

The OrthoPAT Advance system is being developed by Haemonetics to change the user interface, especially for adding calculations for Estimating Blood Loss- (EBL). The OrthoPAT® serves as the predicate device. The following items will be changed in the OrthoPAT Advance system compared to OrthoPAT:

* Software \& User Interface - ability to enter irrigant and anti-coagulant volumes and allow Estimated Blood Loss (EBL) calculation to be made by OrthoPAT Advance.
* Hardware -

  * Redesign of reservoir and filter to process blood earlier by reducing hold-up volume and improve fluid visualization in reservoir.
  * Extended battery life.

It is not intended to validate the major changes in the OrthoPAT Advance device (reservoir / filter and EBL), which will be conducted as lab based tests. The correct functioning of the reservoir / filter and EBL changes will be confirmed in the clinical setting in this study. However the most rigorous challenge to the filter will be by presenting the worst case media and this can only be controlled in the laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 18 years
* Subject is scheduled for a total knee/hip replacement/ revision or a hysterectomy.
* Subjects determined eligible per site standard of care for use of intra- and post-operative use of cell salvage device

Exclusion Criteria:

For subjects where product is transfused

* Subject is undergoing a trauma procedure where there is a possibility of contamination from an open wound.
* Patient is diagnosed with sepsis.
* Patient is diagnosed with sickle-cell anemia.
* Malignant cells may be mixed with blood salvaged from the surgical field.
* Prostatic or amniotic fluid is mixed with blood salvaged from the surgical field.
* Blood salvaged from the surgical field may be contaminated from an active infection at wound/drain site.
* Blood salvaged from the surgical field contains topical hemostatic agents, anti-bacterial agents, or wound irrigants not intended for parenteral use.

For all subjects:

* Subject is undergoing a procedure which involves high, rapid blood loss such as liver transplants, certain cardiovascular procedures, and trauma procedures where blood loss is high (per Investigators judgment).
* Any procedure terminated prior to completion by subject request, operator decision or error, or device error.
* Any subject with which at least 200mL of filtered blood or 1 full disc is not available for processing and data collection within the study.