cyrilzakka/clinical-trials huggingface dataset:
Axial Alignment in Patients Operated Using the Visionaire Patient Matched Cutting Blocks

- Title: PATIENT-MATCHED INSTRUMENTATION VS. STANDARD INSTRUMENTATION: A RANDOMIZED CLINICAL TRIAL COMPARING POSTOPERATIVE AXIAL ALIGNMENT and COMPONENT POSITION

* Short Title: Visionaire Alignment
* Methodology: Monocentric, Single Blinded, Randomized Controlled Trial
* Study Duration: November 2010 to July 2014
* Study Centres: Leicester General Hospital, United Kingdom (UK)

Malalignment is one of the main reasons for knee arthroplasty revision. With the use of patient matched cutting block we expect better axial alignment of the components.

Research Objectives:

* The primary research objective is to evaluate the axial alignment and component position in TKA with use of Smith \& Nephew's VISIONAIRE Patient Matched Technology and to compare with the alignment when standard instrumentation.
* Secondary research objectives include assessing the safety and effectiveness of the VISIONAIRE patient matched technology as compared to commonly accepted standard instrumentation in patients suffering from symptomatic osteoarthritis of the knee joint.

  - Outcome Measures:
* Implant alignment and Component position by means of CT-scans
* Knee Society Score
* EuroQol-5 Dimensions (EQ-5D)
* Knee injury and Osteoarthritis Outcome Score (KOOS)
* Oxford Knee Score
* Knee-related adverse events
* Standard and full leg x-ray

  * Number of Subjects: 70 (2\*35)
  * Enrollment time: 18 months
  * Diagnosis and Main Inclusion Criteria: Patients with osteoarthritis of the knee requiring total knee arthroplasty
  * Study Product, Dose, Route, Regimen:

VISIONAIRE patient matched technology versus the commonly accepted standard instrumentation for the Genesis II total knee arthroplasty implant

Eligibility Criteria:
Inclusion Criteria:

* Indication for TKA, Axial alignment between 10 degrees valgus and 20 degrees varus, BMI \<36, patient must be amendable for both Genesis II total knee and Visioniare cutting blocks

Exclusion Criteria:

* Insufficient femoral or tibia bone stock, inflammatory arthritis (e.g. rheumatoid arthritis), patient is immunosuppressed, has an active infection (local or systemic), patient has physical, emotional or neurological conditions that would compromise the patients compliance with rehabilitation and follow up.
Playing Cognitive Games For Older Adults With Insomnia

The purpose of this research is to look at the effects of computerized cognitive training on sleep, mental abilities (cognition), and other aspects of daytime functioning, such as mood, and arousal


Eligibility Criteria:
Inclusion Criteria:

* 60+ yrs of age.
* No neurological or psychiatric illness, dementia, or loss of consciousness \> 5 mins.
* Nongamers (i.e. \<1 hour of video/cognitive training games per week over last 2 years)
* Proficient in English (reading and writing).
* Meet clinical diagnosis for Insomnia.

Insomnia:

* Insomnia complaints for 6+ months.
* Complaints occur despite adequate opportunity and circumstances for sleep.
* Consist of 1+ of the following: difficulty falling asleep, staying asleep, or waking up too early
* Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia.

Exclusion Criteria:.

* Unable to provide informed consent.
* Unable to undergo randomization.
* Cognitive impairments (i.e. mild cognitive impairment, dementia)
* Other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder)
* Severe untreated psychiatric comorbidity that renders randomization unethical
* Using psychotropic or other medications (e.g., beta-blockers) that alter sleep
* Uncorrected visual/auditory impairments
* Participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.
Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.

Human subjects will participate in this cross-sectional study by attending a single visit where their mouth will be examined and saliva will be collected to help determine the accuracy of a POC salivary diagnostic device. The study population will consist of 174 persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis; and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2) discriminant analysis that examines whether the concentration would correctly identify the subject as health or disease using a defined threshold for MMP-8 levels.

Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.

Eligibility Criteria:
Inclusion Criteria:

* Males or females of all racial and ethnic groups over 18 years of age;
* At least 20 erupted teeth and the ability to provide expectorated saliva;
* Able and willing to comply with study requirements; and
* Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures

Exclusion Criteria:

* Prisoners or institutionalized individuals;
* Persons with acute illness or infectious disease (as evidenced by fever, malaise, sore throat, recurrent cough, lymphadenopathy, swelling and/or a physician consultation);
* Evidence of oral mucosal lesion or ulceration; or
* Use of glucocorticoids or cyclooxygenase inhibitors (i.e. such as ibuprofen, Naprosyn(Aleve) or non-steroidal anti-inflammatory drug) daily for the past two weeks.
The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing

To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.

To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.

PICO:

Population (P): Children with full permanent dentition. Intervention (I): Pomegranates peel extract. Comparator (C): Chlorhexidine.

Outcome(O):

Primary outcome: Bleeding on brushing, criteria:Asking patient, unit:Binary. Secondary outcome:Counting streptococcus mutans, criteria: Agar plate, unit: CFUs/mL

Eligibility Criteria:
Inclusion Criteria:

* children aged 12-15 years old.
* Cooperative children.
* Both genders.
* Medically free.

Exclusion Criteria:

* Children undergoing orthodontic treatment.
* Children using any other oral hygiene aid other than routine teeth brushing.
* Children with known history of allergy to any mouth rinse or drug.
* Parents unable to give informed consent.
A Trial of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of Chemotherapy-related Moderate to Severe Neutropenia of Patients With Nonmyeloid Malignancies

The study is being conducted to evaluate the preference, and safety of HHPG-19K Injection and Auto-HHPG-19K Injection in Prevention of chemotherapy-related moderate to severe neutropenia of Patients with nonmyeloid malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. The patient signs the informed consent form and voluntarily participate in this study;
2. Age ≥18 years;
3. Have the ability to read and understand Chinese;
4. Pathologically or histologically confirmed diagnosis of non-myeloid malignant tumor diseases (including solid tumors and malignant hematologic tumors);
5. Patients who plan to receive at least two consecutive cycles of anti-tumor trerapy based on a moderate to high FN risk chemotherapy regimen (see Appendix 4 for details of the chemotherapy regimen);
6. The investigator determines that the patient are eligible to receive administration of HHPG-19K injection and Auto-HHPG-19K injection (delivered through an adhesive patch automatic drug delivery device);
7. ECOG (Eastern Cooperative Oncology Group score) score 0-1 points;
8. Expected survival ≥3 months;
9. Good function of major organs, meeting the following criteria:

   1. Neutrophil count ≥1.5 ×109/L;
   2. Platelet count≥75 ×109/L;
   3. Hemoglobin level≥80 g/L.
10. Women of childbearing age must take a blood pregnancy test within 3 days before randomization, and the result is negative, and they should not be lactating. Female subjects of childbearing age and male subjects whose partners are women of childbearing age must agree to approach highly effective contraceptive methods from the day of signing the informed consent form until at least 6 months after the last administration (for female subjects) or 3 months after the last administration (for male subjects).

Exclusion Criteria:

1. Women who are planning to become pregnant or breastfeeding;
2. Allergic to polyacrylate adhesives, HHPG-19K, polyethylene glycol recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor and other preparations expressed in Escherichia coli;
3. Having a history of bone marrow transplantation and/or stem cell transplantation;
4. Other situations deemed unsuitable for inclusion in the study as determined by the investigator
Fasting Mimicking Diet (FMD) in Conjunction With Chemotherapy in Advanced Ovarian Cancer

Rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. Interventions to reduce toxicity are needed.

Short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. In a prospective clinical trial of breast cancer patients randomized to FMD or regular diet during chemotherapy, less antiemetic was required in the FMD group; radiographic and pathologic responses were better in this group.

This trial tests whether platinum-taxane chemotherapy combined with a FMD in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and/ or improved tumor response to therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. All patients with advanced ovarian, fallopian tube and primary peritoneal carcinomas deemed appropriate candidates for neoadjuvant chemotherapy and patients with recurrent, platinum-sensitive disease (as defined by an interval of at least 6 months following completion of last platinum-based chemotherapy prior to disease relapse or progression)
3. ECOG Performance Status of 0, 1 or 2.
4. Adequate bone marrow reserve (absolute neutrophil count (ANC) ≥1.5 x 109/L and platelet count ≥100 x 109/L).
5. Adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (ULN).
6. Adequate hepatic function defined as:

   Bilirubin ≤1.5 x ULN ALT and AST ≤3 x ULN
7. BMI ≥19 kg/m2

Exclusion Criteria:

1. Patients with malnutrition and/ or BMI \<19
2. Patients with active eating disorders (as identified by history of pre-enrollment nutrition screen)
3. Diabetes mellitus requiring medication management (both insulin and non-insulin requiring). Patients with diabetes mellitus controlled by diet alone (i.e. patients not requiring anti-glycemic medications) are NOT excluded and are eligible for participation.
4. Allergy to component of fasting mimicking diet (FMD)
5. Patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas with relapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients

Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.


Eligibility Criteria:
Inclusion Criteria:

* Functional MR 2+ - 4+
* Symptomatic heart failure, NYHA Class II to IV
* LVEF \> 25% or \< 50% OR dilated mitral annulus \> 30mm

Exclusion Criteria:

* MR of organic origin
* Severe mitral leaflet tethering
* History of MI or PCI within 60 days of study procedure
* Inability to walk a minimum of 100 meters in 6 minutes
* Significant left main stenosis or proximal circumflex stent
* Indication of non-patent CSO or discontinuous CS-GCV-AIV
* Bi-ventricular with leads in CS or other devices impeding device placement
* Severe aortic valvular disease
* Chronic corticosteroid use other than \< 20mg prednisone for arthritis
* Significant co-morbidities
Comparison of Different Intermittent Pneumatic Compression Devices for Deep Vein Thrombosis

Various kinds of intermittent pneumatic compression devices (IPC) with particular ways of compression have been developed and used for prevention of deep vein thrombosis.

There are still some controversies about the physiologic properties and clinical impact of numerous issues including the variety of the cuff length, inflation rate, compression sequence, compression-relaxation cycle rate, and pressure generation characteristics.

This study is designed to compare clinical efficacies as well as venous hemodynamic improvements between Simultaneous bilateral compression with fixed venous refill time versus alternate compression with adjusted refill time


Eligibility Criteria:
Inclusion Criteria:

* the patients who undergo total knee replacement arthroplasty

Exclusion Criteria:

* (1) chronic superficial or deep venous insufficiency, (2) venous anomalies like duplication of the superficial femoral vein, (3) previous venous thromboembolism history, (4) being under anticoagulation therapy, (5) severe arteriosclerosis obliterans without palpable dorsalis pedis pulse, (6) open fracture, hemorrhagic condition, or extensive dermatitis at lower legs, (7) congestive heart failure. Additional exclusion criteria included a documented malignant tumor, because pharmacologic prophylaxis with anticoagulants would be more reasonable in this case.
High Volume Lactated Ringer's Solution and Pancreatitis

The purpose of this study is to examine whether giving large amounts of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious complication of ERCP. Typically, a small amount of IV fluids are given during this procedure (\~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will reduce the risk of PEP.

This trial is designed as a phase II/III study. The phase II portion of the trial will be completed to establish safety and efficacy data prior to proceeding with a phase III study. The phase II trial will enroll 110 patients that are undergoing elective ERCP as outpatients. Following the phase II portion, if the data suggests that the intervention arm (high volume group) is safe, the investigators will begin enrolling patients who are undergoing ERCP in a more urgent setting as inpatients.

We plan on enrolling 1,400 consecutive high risk patients undergoing ERCP. We are assuming a baseline PEP risk of 9.2%. Fluid administration will be based on Ideal Body Weight (IBW) in order to standardize the aggressive fluid administration across all body weights and reduce the potential for adverse cardiopulmonary outcomes.

All participants will be monitored for 90 minutes following their procedure to assess the development of any adverse symptoms. Analysis by a data safety monitoring board (DSMB) will take place throughout the study. The DSMB is comprised of a panel of experts independent of NorthShore University HealthSystem.

Eligibility Criteria:
Inclusion Criteria:

Patients to be included in the study are those undergoing ERCP with the following:

* Clinical suspicion of sphincter of Oddi dysfunction
* History of post-ERCP pancreatitis (at least one episode)
* Pancreatic sphincterotomy
* Pre-cut (access) sphincterotomy
* Ampullectomy

Exclusion Criteria:

* Age \< 18 years old
* Intrauterine pregnancy or breastfeeding mother
* Congestive heart failure
* Advanced/symptomatic coronary artery disease
* Known ascites
* Renal failure
* Active or recent gastrointestinal hemorrhage
* Acute pancreatitis within 72 hours prior to ERCP
4-Day Primary Irritation Patch Test of MIS Solution

This is a 7 day primary irritation patch test. This study investigates the irritation potential of Next Science MIS Wound Irrigation Solution under standardized conditions compared with an inert control (normal saline) and a known irritant, 20% sodium dodecyl sulfate (also known as sodium lauryl sulfate \[SLS\]) solution in deionized water \[DI\] water) on intact skin of healthy human subjects.

In accordance with ISO 10993-10:2010(E), study products will be delivered via dermal patch at 15 and 30 minutes (min) and up to 1-hour (h), 2-h, 3-h, 4-h and then, pending results, 24-h (evaluated up to at least 48-h) continuous exposure. Response rate will be evaluated immediately after application then 1 h, 2 h, 24 h, 48 h, and then 72 h post-exposure.

Eligibility Criteria:
Inclusion Criteria:

* Individuals eligible for inclusion in the study were those who:

  1. Were male or female, 18 - 75 years of age, in general good health (confirmed by medical history);
  2. If females of childbearing potential, were using an acceptable form of birth control (i.e., oral contraceptive, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who had a vasectomy);
  3. In the case of females of childbearing potential, had a negative urine pregnancy test (UPT) at Screening (a woman was considered to be of non-childbearing potential if she was postmenopausal for at least 12 months or was surgically sterile \[hysterectomy, bilateral oophorectomy\]);
  4. Agreed not to use systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
  5. Agreed not to use systemic/topical analgesics such as aspirin (81 mg daily aspirin were allowed at the discretion of the Investigator), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen was permitted);
  6. Were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, interfered with the study results or increased the risk of adverse events (AEs);
  7. Were of any skin type or race providing the skin pigmentation allowed for discernment of erythema;
  8. Completed a medical screening procedure; and
  9. Read, understood, and signed an informed consent agreement

Exclusion Criteria:

* Had any visible skin disease at the study site which, in the opinion of the investigative personnel, would have interfered with the evaluation; 2. Were receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, would have interfered with the study results; 3. Had psoriasis and/or active atopic dermatitis/eczema; and/or 4. Had a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated. 5. Had a history of allergies or sensitivity to study material being tested. 6. Were pregnant women. 7. Were women who were breast-feeding.
DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc

Lumbar disc herniation is the most important and frequent affection in rheumatology. The first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is used.But when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis.

Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no studies evaluating the benefit and the efficiency of this technic. Since a few years, the rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* age\> 18
* lumbar radiculalgy
* lumbar disc herniation described by MRI
* more than 6 weeks
* prescription of DISCOGEL

Exclusion Criteria:

* medical history of surgery at the same stage
* patient under Clopidogrel or prasugrel
Implementing a Healthcare Provider Education Intervention in Rural Communities to Reduce Asthma Morbidity

The aim of the study is to pilot test the implementation of healthcare provider education interventions to improve asthma outcomes in rural youth residing in Bradford County, Florida. The investigators propose to assess the feasibility and acceptability of implementing the Easy Breathing program a rural, medically underserved county and evaluate changes in healthcare provider practices and asthma-related outcomes of rural youth diagnosed with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Any child between 6 months and 18 years of age at one of the primary care clinics in Braford county.

Exclusion Criteria:

* Unable to meet inclusion criteria.