cyrilzakka/clinical-trials huggingface dataset:
DA-EDOCH14-R in Poor-prognosis Diffuse Large B-cell Lymphoma

Poor prognosis dufuse large B-cell lymphoma (DLBCL) represents 50% of all DLBCL with overall cure rates ranging from 50-60% with modern dose-dense immunochemotherapy regimens such as R-CHOP14. Using an alternative strategy, as infusional and dose-adjusted R-EPOCH, the investigators have shown an 83% of complete responses (CR), with an estimated 5-year overall survival (OS) rate of 75% (García-Suárez et al. British Journal of Haematology 2007, 136:276). Despite this improvement in outcome, the search for new treatment strategies should continue. Therefore, compared with prior R-EPOCH the investigators decided to investigate whether the introduction of dexamethasone (40 mg IV on days 1-5) in place of prednisone (based upon data which demonstrated that the former was associated with enhanced Central Nervious System penetration) and the reduction of treatment intervals from 3 to 2 weeks would be feasible and might improve the outcome in this group of patients.

Medication, Dose and Method for Administration:

* Rituximab: 375 mg/m2, endovenous, according to the protocol of the service, day 1 (except in the first cycle, in which it will be on day 5).
* Etoposide: 50 mg/m2/day, in continuous 24-hour infusion, days 1 to 4.
* Adriamycin: 10 mg/m2/day, in continuous 24-hour infusion of, days 1 to 4.
* Vincristine: 0.4 mg/m2/day, in continuous 24-hour infusion, days 1 to 4
* Dexamethasone: 40 mg, endovenous, days 1 to 5. Followed by prednisone 30 mg (day +6), 20 mg (day +7), and 10 mg (day +8).
* Cyclophosphamide: 750 mg/m2, endovenous, in 30 minutes, day 5, after ending the continuous infusion of adriamycin, etoposide and vincristine.
* MESNA (If the dose of Cyclophosphamide is \> 1 g/m2

Eligibility Criteria:
Inclusion Criteria:

* Signing the Informed Consent.
* Histology: diffuse large B-cell lymphoma de novo (primary mediastinal B-cell lymphomas will be included provided that they have a mass greater than 7 cm in larger diameter) and follicular NHL grade 3b.
* aaIPI: 2-3.
* Age: Between 18 and 70 years.
* General Condition (ECOG/WHO): Proper organic function, defined by: FEVI ≥ 40%, serum creatinine \< 150 µmol/L, serum bilirubin \< 30 µmol/L, control of other medical conditions such as: infection, leukocytes ≥ 3.5 x 109/l and platelets ≥ 100 x 109/l (except if they are caused by lymphomatous infiltration of bone marrow or of the spleen).

Exclusion Criteria:

* HIV-positive.
* Pregnancy or breastfeeding.
* Serious disease compromising the performance of the therapeutic regimen.
* Recent history of another malignant disease (except skin cancer different from melanoma or carcinoma in-situ of the cervix), prior radiotherapy or chemotherapy, history of indolent lymphoma.
* CNS infiltration at diagnosis.
Step-reduction in Older Men and Women

This study investigates the effects of two weeks of reduced daily ambulation and a subsequent return to normal physical activity on metabolic health of older adults.

Aging results in a progressive loss of muscle mass that is accelerated by periods of muscular disuse, common for older adults during hospitalization or convalescence from illness. Transient physical inactivity has been shown to cause muscular atrophy and impairments in insulin sensitivity in both younger and older adults. However, the recovery capacity of older adults after such physical inactivity remains unknown. This study aims to determine the impact of two weeks of daily step reduction to ≤1000 steps per day, an experimental model mimicking short-term physical inactivity, on glycemic control in older adults and further investigate whether older adults are able to recover from the consequences of this inactivity simply by returning to their habitual activity for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker

Exclusion Criteria:

* Use of assistive walking devices
* Chronic use of analgesic or anti-inflammatory drugs
* History of neuromuscular problems or muscle and/or bone wasting disease
* Acute or chronic illness including cardiac, pulmonary, liver or kidney abnormalities, uncontrolled hypertension, insulin or non-insulin dependent diabetes or other metabolic disorders
* Daily use of statins, particularly simvastatin and atorvastatin
* Use of medications known to affect protein metabolism
* Normally complete fewer than 3000 steps per day
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)

Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.

Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Infrarenal AAA ≥50 mm maximum diameter
* Indication for EVAR within IFU of company
* Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or \<40% thrombus at largest AAA diameter

Exclusion Criteria:

* Ruptured AAA
* Fenestrated or branched EVAR
* Concomitant iliac artery aneurysm
* Non-ability to adhere to the FU protocol
* Lack of consent
* Pregnancy
Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.


Eligibility Criteria:
Inclusion

1. Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.
3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram (ECG).
4. Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
5. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
3. Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the test article.
4. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
5. Any history of clinically important cardiac arrhythmias.
6. Familial history of long QT syndrome or unexpected cardiac death.
7. History of drug abuse within 1 year before study day 1.
8. History of alcoholism within 1 year before study day 1.
Time-Effect of Montelukast Protection

The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration.

Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day.

Eligibility Criteria:
Inclusion Criteria:

* children with exercise-induced asthma

Exclusion Criteria:

* viral infections
* montelukast treatment
An Investigational Agent for the Treatment of Complicated Intra-Abdominal Infections or Acute Pelvic Infections (0826-038)

The purpose of this study is to determine the effect of an approved medication for adults for an investigational use in pediatric patients 3 months to 17 years for the treatment of complicated intra-abdominal infections or acute pelvic infections.

The duration of treatment is 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 3 months to 17 years with intra-abdominal infection or acute pelvic infection

Exclusion Criteria:

* Immune problems
* Kidney problems
A Study of Tadalafil After Radical Prostatectomy

The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer
* have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))
* develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery
* have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study
* agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
* does not require the initiation of adjuvant therapy for prostate cancer

Exclusion Criteria:

* history of ED
* have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor
* have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer
* have a history of prostatic surgery or prostatic physical treatments
* have a history of diabetes mellitus
* have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
* have clinically significant renal insufficiency as determined by the investigator
Perioperative Glucocorticoid Administration in the Treatment of Adult Distal Radius Fractures

The purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (GC) injections versus those not receiving GCs for the treatment of distal radius fractures. The investigators hypothesize that patients who receive GC will have improved ROM and functional outcome measures compared to patients who do not receive GC. In addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the GC and non-GC groups. In order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age and older.
* Patients undergoing ORIF with VP fixation of an acute, isolated DRF with or without associated distal ulna fracture and with or without associated carpal tunnel release

Exclusion Criteria:

* Worker's compensation patient
* Non-operatively treated fractures
* Open fractures
* Preoperative neurovascular injury
* Coexisting fractures or injuries
* Diabetes mellitus
* Allergy or contraindication to GCs
* Associated non-orthopedic injury that would prohibit the administration of GCs
* Patients currently incarcerated
* Pregnant patients
Indirect Bonding Accuracy of 3D Printed Digital Transfer Trays

The goal of this study is to compare the bracket transfer accuracy of two frequently used 3D printed indirect bonding trays.

This is an interventional study. Participants have 3-6mm crowding without tooth loss and deformity. It is planned to be 2 groups in the study. Each group will include 15 participants. Indirect bonding will be applied with shell and bar designs that are frequently used. Brackets will be bonded from second premolar to other side's second premolar of upper and lower jaw. Bracket transfer accuracy of two different trays will be compared with planned position and each other.

There are planned to be 2 groups in the study. Each group will include 15 participants. The patients who apply for orthodontic treatment will be included in this study. inclusion criteria: patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health. The exclusion criteria were patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth. Informed and written consent forms will be obtained from each patient for experimentation.

Intraoral scans with the 3Shape device (3Shape TRIOS, Copenhagen, Denmark) are routinely recorded from the patients whose treatment will begin before treatment. Bracket positions will be adjusted on the scan images using 3Shape OrthoAnalyzer 2015 software. Then, the bracket model will be transferred to the Appliance Designer software program, 2 types of transfer trays will be designed and produced with the 3D printer in the clinic. Patients will be indirectly bracketed with the produced transfer trays and intraoral scan recordings will be taken again after bracketing. This image and the images where the brackets are placed in the software will be overlaid with the GOM Inspect software (GOM GmbH, Braunschweig, Germany) and the deviations will be calculated for both transfer trays and the differences will be compared.

The measurements to be performed are: linear: mesiodistal, buccolingual, incisogingival; angular: torque, angulation, rotation. Measurements will be calculated separately for all teeth.

None of these steps deviate from the routine treatment protocol and none of the procedures are harmful or invasive for the patient.

Eligibility Criteria:
Inclusion Criteria:

Patients between age of 17-30, in complete permanent dentition, have mild to moderate (3-6mm) crowding according to Little's irregularity index, good oral hygiene and periodontal health.

Exclusion Criteria:

Patients needing treatment with extraction, having shape anomaly, deficiency, fractures, crowns or abrasions in their teeth.
RENOVATE Palliative: HFNC vs. Standard Respiratory Support in Patients With Do-Not-Intubate Order and ARF

Randomized clinical trial in which the main objective is to compare High Flow Nasal Cannula (HFNC) versus the standard respiratory care in the alleviation of dyspnea perception in patients with do-not-intubate (DNI) order. This is a pragmatic study that will take place in 10 Brazilians ICU facilities which are already participating in the main study RENOVATE NCT03643939.

Do-not-intubate (DNI) is usually established in cases where endotracheal intubation (ETI) is considered disproportionate to prognosis and/or incompatible with the expression of wishes and values of the patient. Regardless of the profile of this care plan offered to patients with DNI, the control of dyspnea is one of its central objectives. The approach to dyspnea includes pharmacological measures such as opioids and non-pharmacological measures, such as oxygen therapy and Non-Invasive Ventilation, and more recently, the high flow nasal catheter (HFNC). HFNC provides high flow of heated and humidified mixed gas through a nasal cannula. In addition to the ability to generate high flows and supplemental oxygen, HFNC may generate a low level of positive airway pressure, may decrease dead space ventilation and may contribute to better patient comfort, such as the possibility of oral feeding while undergoing treatment, performing oral hygiene and allowing conversation and interaction with family members. This pilot study aims to evaluate the efficacy of HFNC in reducing dyspnea and improving comfort in patients with Acute Respiratory Failure (ARF) and DNI order.

Eligibility Criteria:
Inclusion Criteria:

Participants must be 18 years of age or older, with ARF of any cause on admission or post-extubation with prior DNI directives or DNI order determined in the current hospitalization.

Patients must meet the following criteria below:

1. Dyspnea (defined on the Borg scale ≥4);
2. SpO2 \<90% or paO2 \<60 mmHg in room air;
3. Absence of delirium;
4. One of the following:

A. Signs of respiratory distress and use of accessory muscles; B. Respiratory rate greater than 25 incursions per min .

Exclusion Criteria:

1. Refusal of treatment;
2. Agitation or non-cooperation;
3. Presence of delirium at the time of randomization;
4. Anatomical abnormalities that may interfere with the adjustment of the non-invasive positive pressure ventilation mask
5. Glasgow \<12;
6. Psychomotor agitation that prevents adequate medical / nursing assistance requiring sedation;
7. Contraindications to NIV: uncontrollable vomiting, hypersecretion of the airways, facial deformities, trauma or extensive facial burn;
8. Presence of pneumothorax or extensive pleural effusion;
9. Expected imminent death, defined as an estimated death of less than 24 hours.
Making Connections Thru Music

Healthcare systems around the world, including within the United States, have long-established shortages of trained caregivers. The American Health Care Association states that "the health care system has experienced a shortage of trained caregivers for critical roles for some time." This scarcity directly impacts the 45,800 Long-Term Care (LTC) communities throughout the U.S.

Concurrent with this staff shortage, more than half of LTC residents have some form of dementia. These two issues create a serious public health concern, since dementia is associated with a variety of behavioral expressions, such as aggression, anxiety, and agitation. Behavioral expressions of dementia can be successfully managed with the use of tailored, psychosocial interventions and communication support. Unfortunately, existing staff shortages make the facilitation of such interventions challenging.

One powerful and often-overlooked approach to ameliorating staffing shortages involves the utilization of retired volunteers to facilitate interventions for persons with dementia (PWD). Based on the nearly universal love of music and a promising pilot study, the product to be developed and tested in this STTR will build upon the combined prior work of the Principal Investigators. Making Connections Thru Music (MCTM), an urgently needed product, will enable retired volunteers to facilitate an evidence-based music and discussion intervention with PWD. MCTM aims to improve engagement, enhance quality of life, and reduce behavioral expressions in PWD. The intervention will consist of two main components: (1) a comprehensive online training course for volunteers, which will provide a general overview of dementia, demonstrate effective communication strategies to use with PWD, and instruct volunteers to effectively facilitate MCTM sessions, and (2) an app containing a structured MCTM intervention protocol and toolkit, which will be the means by which volunteers facilitate MCTM. MCTM will be marketed to LTC communities.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers must be aged 55+ and speak/read conversational English.
* Staff participants must be at least 18 years old, work within a residential care facility participating in the study, and speak and read English.

Exclusion Criteria:

* Volunteers will be excluded if they are diagnosed with dementia based on self-report and/or if they score 23 or lower on theMini Mental State Exam (MMSE; Folstein et al., 1975). Such a score would be indicative of possible cognitive impairment.
* Staff members will be excluded if they work third shift only. PWD Residents with dementia must be diagnosed with dementia (any type), score 10 or above on the MMSE, be aged 65+, and speak/read conversational English.
* PWD will be excluded if they show signs of rapid physical or cognitive decline (based upon staff report or as evidenced by information gained during screening).
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of wet age-related macular degeneration in at least 1 eye
* Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye

Exclusion Criteria:

* Hypersensitivity, allergy, or anaphylactic reaction to iodine
* Cataract or refractive surgery within the last 3 months
* History of vitrectomy
Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension

The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility Criteria:
* Subjects 18 years of age or older
* of either sex
* of any race
* diagnosed with ocular hypertension or open angle glaucoma