cyrilzakka/clinical-trials huggingface dataset:
Outcomes Database to prospectivelY aSSEss the Changing TherapY Landscape in Renal Cell Carcinoma

ODYSSEY RCC is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings.

This trial is a prospective, observational Phase IV study is to understand the cancer management and health-related quality of life in patients with mRCC in routine real-world clinical practice in the United States, including both community and academic treatment settings. Primarily, the study will evaluate patient experience through collection of patient reported outcomes (PROs). The study will also collect and assess information on the therapies used such as first-line treatment selection, treatment sequence and duration, the drivers of physician selection of particular agents, and discontinuation of therapies.

The primary objective is to determine distinct patterns of change in the quality of life and symptom burden in mRCC patients receiving therapy.

Patients will be identified and undergo consent and baseline assessments, including research blood collection and processing, by the study site team, this baseline visit will be their only clinic visits per protocol. All other visits are standard of care visits and outside the scope of the study.

Subsequent follow up with be coordinated centrally by DCRI. Additional clinic data will be obtained via PCORnet data pull and Medicare claims. Patient reported outcomes, quality of life and medications data will be obtained via the DCRI Call Center through follow-up phone interviews.

Eligibility Criteria:
Inclusion Criteria:

* Age 19 or over at time of informed consent.
* Diagnosis of metastatic renal cell cancer (mRCC) with less than or equal to (≤) 3 months of first-line systemic therapy or less than or equal to (≤) 3 months of second-line systemic therapy for mRCC.

  1. Prior surgery and radiation therapy are permitted.
  2. Prior neoadjuvant and adjuvant therapy for non-metastatic renal cell carcinoma are permitted.
  3. Patients currently not on therapy and being observed are permitted.
* Evidence of signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
* Ability to comply with completion of PROs

Exclusion Criteria:

* Patients being treated for metastatic solid tumors other than mRCC are excluded. Non-cytotoxic oral agents for adjuvant or maintenance therapy of other cancers are permitted.
* Patients who are not intending to undergo follow up care at a study site within PCORnet
The Contribution of Parent-infant Interaction While Singing During Kangaroo Care, on Preterm-infants' Autonomic Stability and Parental Anxiety Reduction

The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects

Premature infants and their parents are prone to high anxiety levels and a risk of experiencing trauma due to the preterm birth and its implications. Facing various emotional physical and neural high-risk factors may lead to continuous stress reactions in both the infant and parents, affecting their well being, the parent-infant relationship and the infant's medical state outcome. Attending to both infants' emotional and physiological needs of stability and comfort, as well as parents' support, can lead to an improvement in the premature infants' medical state and the parent-infant bonding process. Furthermore, reducing stress reaction facilitates perceptual memory and learning in premature infants. Two well established interventions in the neonatal care aiming to address the varied premature-family needs are Kangaroo care (KC) and Music Therapy (MT). Various research and clinical reports over the last three decades, regarding each modality, has shown beneficial effects in improvement and stabilization of infants' medical state, inclusion of parents in their infants' treatment and in facilitation of meaningful parent-infant interactions to promoting bonding patterns. However, a major lack of rigorous Randomized control studies presenting the clinical applications of MT techniques and methods in the NICU care exists, as well as only few research have positioned the parents in center of investigation, and/or presented their outcome and perspective. Accordingly, only few research have investigated the combination of MT and KC through an RCT. The current study will investigate the combination of the two modalities in a mixed-methods design, in order to provide comprehensive knowledge regarding the effects of family-centered MT during KC, on premature-infants' autonomic nervous system stability (measured by parasympathetic tone, physiological vital signs and behavioral states); Parents' anxiety levels; And parents' unique experiences of the intervention. Additionally, the study will analyze separately mothers and fathers to elucidate similar and different effects

Eligibility Criteria:
Inclusion criteria:

1. Preterm infants ≤ 37 weeks' gestation
2. Clinically stable preterm
3. Hearing confirmed by distortion product oto- acoustic emissions

Exclusion criteria:

1. Preterm infants treated with Central Nervous System (CNS) related medication (Luminal, Oxygen)
2. Infants with Intraventricular hemorrhage stage ≥ 3, Peri ventricular Leukomalacia
3. Parents refusal to participate
Cast Vs Splint in Distal Radius Fractures

This study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) Fiberglass cast, and (2) Thermoplastic splint. Both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. Casts and splints are both established devices in routine clinical use.

Casts and splints are both established methods of treating DRF. Casts have been traditionally the gold standard for non-operative care of fractures, but there are distinct disadvantages such as skin rash and pruritus, malodour, skin maceration and loosening as the initial swelling subsides. Casts require specialized tools for removal and they have to be reapplied by specialized staff if the casts become loose or wet. Splints have the advantage of being removable and therefore facilitate hygiene and provide a better fit because of the adjustable straps. Splints are theoretically less rigid and patient non-compliance because of the ease of removal may result in a greater likelihood of fracture displacement. However, it is known that fractures displace even in casts and the efficacy of casts at maintaining reduction over splints has not been established. Moreover, it has been clearly shown that the elderly patients have good functional outcomes that do not correlate with the position in which the fracture heals i.e. they tolerated a large degree of fracture malunion (Arora; Egol).

The primary goal of this study is to show that there is no difference in the final functional outcome between distal radius fractures treated non-operatively with splints and casts. The secondary goals are to demonstrate: (1) splinting results in greater patient comfort and acceptance; (2) there is no significant difference in final radiographic outcomes between DRF treated with casts and splints; and (3) there is no difference in clinical outcome at the 6-month and 12-month follow-up points.

This study is clinically important for several reasons. First, patients may be encouraged to use splints instead of casts if there is no difference in functional outcome and the former provide better comfort. Second, patients may not be required to present for long (\>6-month) follow-ups if it can be shown that the clinical improvement plateaus at 6 months after injury. This is consistent with our aim to improve patients' overall quality of life after musculoskeletal injuries and forms a core component of functional ageing.

Eligibility Criteria:
Inclusion Criteria:

* Closed DRF in patients \> 60 years
* Presenting to HRMC within 10 days of injury
* Isolated injury
* With or without M\&R performed in EMD
* Declined surgical fixation after appropriate discussion

Exclusion Criteria:

* Wounds - skin tears, bad abrasions, open fracture
* Ulnar fracture \> styloid
* Other MSK / non-MSK injuries
* Bilateral fractures
* Prior wrist fractures / wrist surgery
* Other upper limb conditions affecting function (e.g. CVA)
* Cognitive impairment
* Allergy to plaster or fiberglass
Single-Dose Administration Trial of TLC599 in Osteoarthritis of the Knee

This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Protocol No: TLC599A1001

Name of Finished Product: TLC599

Title of Study:

A Randomized, Open-label, Parallel, Phase I/II Single-Dose Administration trial of TLC599 in Subjects with Osteoarthritis (OA) of the Knee

Methodology This trial is a multi-site, randomized, open-label, parallel, and single-dose administration study to investigate the safety and efficacy of TLC599 in subjects with osteoarthritis of the knee.

Study duration:

The trial will last 14 weeks including a 14-day screening period and a 12-week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, at least 20 years of age
2. Documented diagnosis of OA of the knee for at least 6 months
3. At least a grade 2 severity based on the Kellgren and Lawrence Grading Scale
4. VAS score of ≥ 4 at baseline

Exclusion Criteria:

1. Subjects who received systemic corticosteroids for the last 30 days prior to baseline
2. Subjects who received non-steroidal anti-inflammatory drug (NSAID), analgesics, or rehabilitations therapy within 7 days prior to baseline
3. History of rheumatoid arthritis or other autoimmune disease
4. Clinical signs and symptoms of acute infection or infection related inflammation in the other knee before dosing
5. History of infective arthritis, suspected or concurrent infection, or suspected or confirmed crystal diseases (gout or pseudogout) of the study knee
6. Concurrent systemic active or uncontrolled infectious disease
7. A history of treated malignancy which is disease free for ≤ 5 years. (The malignancy does not include non-basal-cell carcinoma of skin or carcinoma-insitu of the uterine cervix)
8. History of acquired or congenital immunodeficiency diseases
9. Platelet count \< 80,000/μl, or blood coagulation disorders, including subjects with hemophilia, decompensated liver cirrhosis or uremia
10. Stroke or myocardial infarction within 3 months prior to the screening visit
11. Use of intra-articular corticosteroid, hyaluronic acid, or other intra-articular injection in the study knee joint within 3 months prior to the screening visit
12. Unstable study knee joint, including anterior cruciate ligament, any surgery to the study knee within the 12 months prior to the screening visit, and any prior arthroscopic or open surgery of the study knee or any planned/anticipated surgery during the study period
13. Any skin lesion/breakdown at the anticipated injection site or any condition that impairs penetration of the study knee joint space
14. Female subjects who are pregnant, nursing, planning pregnancy, or who are of childbearing potential and not using reliable means of contraception 15.Known allergy or hypersensitivity to the study drug or its components
Practice of the Short Wave Diathermy (SWD) Application

Various national \& international bodies like FDA, CSP has laid down the guidelines for the reasonable use of SWD electro therapeutic agent (EPA) ensuring safety \& effectiveness.

However, it remains uncertain, whether the practicing physiotherapists are aware of the very existence of this guidelines and implementing them in daily practice. Any lack of knowledge about this background can endanger the patient safety leading to serious health hazards.

In the present survey, 49 physiotherapy practitioners were interviewed with a self-report measure to investigate their knowledge base, mode of application of SWD (6 items) \& the awareness about recommended guidelines (5 items) etc.

Study design: cross sectional survey design with the use of a self-report form to record the participant's views was used. Sampling frame consisted of physiotherapists working in private clinics in sub-urban area of Mumbai, Maharashtra, India.

Institutional ethic committee of Terna Physiotherapy College granted permission to conduct this survey. The self-report forms were coded in order to conceal the identity of the therapist.

In this survey 49 physiotherapists were interviewed with a self-report form consisting of total 23 item. In the initial section of this survey form a general information was collected regarding years of experience (1 item), Types of condition treated (1 item), No of patients treated (item 1) Duration of onset (item 1) \& the type of modality used (item 1). Specific items interrogating therapist's knowledge about the EMF generating modality were designed to retrieve the information about dosage prescription (7 item), acquaintance with recommended guidelines \& indications (item 5), years of experience with that particular modality (item1), Any kind of side effects observed (item 1), any action taken for the same (item 2), referring personnel for recommending this modality (item 1), overall therapist's experience with the effectiveness of this modality (item1).

Eligibility Criteria:
Inclusion Criteria:

* Private physical therapists practitioners

Exclusion Criteria:

* Who were volunteering to participate
3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding

Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.

Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.

Group (B): Patients will be treated with clear aligner therapy in lower anterior crowding.

Eligibility Criteria:
Inclusion Criteria:

Adult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .

Exclusion Criteria:

Previous orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.
Determinants of Time Required by Medical Information Technicians for Quality Control of Hospital Activity Coding

Since 2008, in France, hospital funding is determined by the nature of activities provided (activity-based funding). Quality control of hospital activity coding is essential to optimize hospital remuneration. There is a need for reliable tools to allocate human resources wisely in order to improve these controls.

The main objective of this study was to identify the determinants of time needed by medical information technicians to control hospital activity coding in a Regional Hospital Center.

From March 2016 to the beginning of January 2017, medical information technicians reported the time they spent on each quality control, and the time they needed when they had to code the entire stay. Multiple linear regressions were performed to identify the determinants of quality control or coding duration. A split sample validation was used: model was created on one half of the sample and validated on the remaining half.

Eligibility Criteria:
Inclusion Criteria:

* To be admitted to a medical unit of the CHR Metz Thionville

Exclusion Criteria:

* Any exclusion criteria
Implantable Antenna Sensors for Continuous Glucose Monitoring

The researchers' long-term goal is to develop a small implantable device that can continually monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect the antenna signals and those can be used to predict the patient's glucose levels.

Our goal is to develop a small size implantable device that can continually monitor glucose levels. The scientific objective of this application is to examine the efficacy of using implantable antennas to measure the glucose levels. The central hypothesis of this application is that the changes in the glucose levels in the medium surrounding the antenna will affect the antenna parameters such as input impedance and resonance frequency, and these changes can be used to predict the patient's glucose levels. We have formulated this hypothesis on the basis of our preliminary data, which will be detailed later, in the Preliminary Studies section. The rationale for the proposed research is that, once the correlation between the glucose levels and antenna parameters are determined, the design of a miniaturized long term glucose monitoring device will become a reality.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult able to give a blood sample

Exclusion Criteria:

* Adults with diabetes or other glycemic or hematologic disorders.
* Sick adults
Use of Ramipril and Felodipine Combination Therapy in Hypertension: An Effectiveness Study With Local Patients in Argentina

Primary:

* To assess effectiveness of Ramipril-Felodipine in hypertensive Argentinean patients

Secondary:

* To assess tolerability of Ramipril-Felodipine in hypertensive Argentinean patients.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* Patients who couldn´t control their hypertension after 6 weeks of treatment with monotherapy (calcium blockers, beta blockers, diuretics, ACE inhibitors, AT2 blockers)(uncontrolled hypertension).

Exclusion Criteria:

* Already on fixed-dose combination treatment for hypertension
* Contraindication to angiotensin converting enzyme (ACE) inhibitors or CCB therapy
* Known hypersensitivity to felodipine (or other dihydropyridines), ramipril, other ACE or any of the excipients of ramipril felodipine.
* History of angioedema
* Unstable haemodynamic conditions: cardiovascular shock, untreated heart failure, acute myocardial infarction, unstable angina pectoris, stroke.
* Patients with AV block II or III
* Severely impaired hepatic function.
* Pre-existing bilateral renal artery stenosis or stenosis of the artery to a solitary kidney
* Pregnant and lactating mothers
* Patients on dialysis or haemofiltration.
* Patients with creatinine clearance \< 20ml/min
* Use of potassium sparing diuretics
* Severe hypertension (SBP ≥ 180 mmhg or DBP ≥ 110 mmhg)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Cell-Surface Plectin in the Diagnosis of Cholangiocarcinoma from ERCP-directed Biliary Samples

Cholangiocarcinoma is a malignancy that is most-often diagnosed with ERCP-directed cytology brushings of the biliary tree, but the yield on this cytology has been previously shown to only be 5%-40%. Additionally, the vast majority (approximately 80%) of patients are not diagnosed until they are surgically unresectable (due to late stage at time of diagnosis), at which point there is no chance for cure and their only options are palliative. Therefore, better diagnostic modalities are needed. Plectin is a structural protein located inside of most cells, but it has been shown to be expressed on the cell surface of malignant cells in the pancreaticobiliary tract. The investigators hypothesize that ERCP-guided biliary samples can provide cells and immunohistochemical staining can detect cell surface plectin in patients with cholangiocarcinoma. This would be a novel diagnostic tool which could greatly reduce the time to diagnosis. A previously performed study pilot study at the University of Virginia (unpublished) showed that ERCP-directed biliary biopsies in patients with known cholangiocarcinoma had positive plectin immunohistochemistry, thus showing this is possible. In this current study, patients with a biliary stricture or tumor who are already undergoing ERCP as part of their routine clinical care (i.e. no procedures will be done exclusively for this research study) will undergo an additional biopsy and/or brushing to be assessed for cell-surface plectin expression via immunohistochemistry. The investigators hypothesize that plectin immunohistochemistry will have a higher sensitivity for cholangiocarcinoma than biopsies and/or brushings (cytology) alone.


Eligibility Criteria:
Inclusion Criteria:

* Biliary stricture or mass seen on imaging; already undergoing ERCP as part of their routine clinical care

Exclusion Criteria:

* Age \< 18 years old; inability to consent
Cerebral Haemodynamic Changes by Red Blood Cell Transfusion in Neonates

The timing and the indications for red blood cell (RBC) transfusions remain one of the most controversial topic in Neonatology. Indeed, biomarkers routinely used to discriminate between patients that will benefit from RBC transfusion appear insufficient. Tissue oxygenation could be useful to determine the need for transfusion.

This study aims to assess the effects of RBC transfusion on cerebral haemodynamics and oxygenation in neonates with a new hybrid optical device (BabyLux) integrating time-resolved spectroscopy (NIRS-TRS) and diffuse correlation spectroscopy (DCS).

It is hypothesized that cerebral blood flow decreases after RBC transfusion, whereas cerebral oxygenation and oxygen metabolism are unchanged.

The BabyLux hybrid setup can determine the following parameters in the same tissue sample non-invasively and continuously with a high temporal resolution (0.1-0.2 Hz):

* Cerebral blood flow index (CBFi), i.e. an index that is proportional with CBF
* Concentration of oxyhaemoglobin (O2Hb)
* Concentration of deoxyhaemoglobin (dHb)
* Total haemoglobin concentration (tHb)
* Tissue oxygen saturation (rStO2)
* Cerebral metabolic rate of oxygen index (CMRO2i), i.e. an index that is proportional with CMRO2 Hence, the BabyLux device allows assessment of key parameters of cerebral haemodynamics and, in particular, to examine if the percentage change of cerebral metabolic rate for oxygen is close to the expected zero, as an external quality control of the separate NIRS parameters.

There are no studies on RBC transfusion in neonates evaluating cerebral haemodynamic utilizing DCS and TRS combined.

Hence, primary aim of this study is:

- to assess the effect of RBC transfusion on cerebral haemodynamics and oxygenation as measured by the Babylux device.

Secondary aims are:

* to quantify the effect of estimated ∆\[Hb\] on the differential path length factor (DPF);
* to compare two different NIRS devices and techniques. BabyLux measurement will be performed before and after RBC transfusion, whereas during RBC transfusion cerebral oxygenation will be monitored with a spatially resolved continuous wave (CW) NIRS.

Eligibility Criteria:
Inclusion Criteria:

* RBC transfusion prescribed according to local NICU guidelines
* Corrected age \< 4 weeks corrected age
* Signed informed consent

Exclusion Criteria:

None