cyrilzakka/clinical-trials huggingface dataset:
Nanoscope Cost Analysis Study

The study is a pilot study designed to generate preliminary data regarding the cost of partial meniscectomy using NanoScope versus conventional arthroscopy in a traditional operating room (OR) setting


Eligibility Criteria:
Inclusion Criteria:

1. Subject requires simple partial posterior or mid-body meniscectomy.
2. Subject is 18 - 60 years of age.
3. Subject body mass index (BMI) is 35 or lower (BMI ≤ 35).
4. Subject signed informed consent and is willing and able to comply with all study requirements and follow-up visits.
5. Confirmed meniscal injury by physical exam as per standard of care.
6. Normal mechanical alignment; \< 5° varus and \< 7° valgus, of the affected knee by clinical assessment or X-Rays as per standard of care

Exclusion Criteria:

1. Subject requires complex repair or anterior meniscectomy.
2. Subject has a concomitant chondral lesion of the ipsilateral knee in addition to meniscal tear.
3. Current bilateral knee injury.
4. Insufficient quantity or quality of bone.
5. Blood supply limitations and previous infections which may retard healing.
6. Congenital ligamentous hypermobility defined by Beighton score 4 or 5.
7. Locked knee or haemarthrosis.
8. Subjects that are skeletally immature.
9. Advanced Osteoarthritis; Kellgren Lawrence ≥ 2
10. Fracture of the lower extremities within 6 months prior to screening.
11. Previous surgery on the affected knee within 12 months prior to screening.
12. Sensitivity to silicone, polyester, nylon, FD\&C Blue No. 2 dye and beeswax.
13. Other concomitant disease that would interfere with study outcomes.
14. Subject is included in a vulnerable population (child, prisoner, etc).
15. Conditions that tend to limit the patient's ability or willingness to restrict activities, follow directions, or perform online subject assessments during the healing period.
16. Subject is requesting or receiving Worker's compensation related to the knee injury. -
Supporting Patient Provider Communication in Paediatric Care

Children with Cancer or congenital heart disease (CHD) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. To help children cope with their problems and prevent psychological distress, the investigators developed SiSom, a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer.

This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses: When children use SiSom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations:

* Children and parents will experience less anxiety.
* Children and parents will be more satisfied with the outpatient visit.
* There will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.

To better understand the mechanisms by which these effects may occur, the investigators will also explore:

* Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed;
* The relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions.

Finally, the investigators will investigate time requirements, ease of use and usefulness of SiSom by children and clinicians.

For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. This study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.


Eligibility Criteria:
Inclusion Criteria:

* Between 7 and 12 years.
* Ethnic norwegian.
* Undergoing treatment for cancer or diagnosed with a congenital heart disease.

Exclusion Criteria:

* Receiving or have received radiation the brain as this may affect their abilities to use SiSom and communicate during consultations.
* Syndromes, mental retardation, developmental disorders, language disorders, or cognitive disorders that affect their ability to report symptoms or communicate during consultations.
* Other ethnic origin.
Effect of Flavored, Carbonated Drinks on Salivary Flow, Salivary Composition, and Taste Perceptions

To determine the effect of flavored, carbonated drinks on salivary flow rate, saliva composition, and taste perceptions compared with control drinks (water, carbonated water, non-carbonated)

Previous studies have shown that drinking a beverage can stimulate the production of saliva and alter its composition. These effects could impact oral processing and taste perceptions. Various ingredients in beverages such as carbonation may affect saliva and oral processing. The objective of this study is to determine the effect of flavored carbonated beverages on salivary flow rate, saliva composition (pH, mucins, carbonic anhydrase, and total protein), and taste perceptions compared with unflavored and non-carbonated control drinks.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female
* If female, subject is not pregnant or nursing (based on self-report)
* Subject is 18-45 years of age, inclusive
* Subject is a regular consumer of carbonated drinks (questionnaire)
* Subject is willing to avoid alcohol consumption 24 hours prior to visits
* Subject is willing to fast (no food or gum) for 2 hours prior to study sessions
* Able to speak, write, and read English
* Provision of written consent to participate

Exclusion Criteria:

* Subject smokes, vapes, or uses any nicotine/tobacco products (or has quit for less than 6 months)
* Subject currently has or recently had an illness (cold, flu, COVID) within the past month
* Subject has a condition affecting the oral cavity such as Xerostomia (dry mouth), Sores/lesions, Untreated dental caries, Major dental implants/appliances (including dentures)
* Subject has a reduced sense of taste (dysgeusia) or smell (parosmia)
* Subject has a health condition that would interfere with the study as indicated on the general health questionnaire (GHQ) (including cardiovascular, renal, or metabolic diseases)
* Subject has participated in a clinical trial within the past 30 days
* Subject has participated in any PepsiCo trial within past 6 months
* Subject has a condition or is taking medication that the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the person at undue risk
* Subject is employed by, or has a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any PepsiCo product. If subject is unsure if a company would be considered a competitor to PepsiCo, they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Effect of Non-surgical Periodontal Treatment

Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling.

Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place. Women were divided into two groups, the group 1 received supra and subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received only supragingival scaling with OHO too.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place.

Exclusion Criteria:

* Patients with systemic disease or who used medications that interfere in the etiological factors of periodontal disease in the last six months, who wore braces and / or prosthetic devices, and women smokers who did not complete treatment.
Zephyr Etude Post-Inscription (French Registry)

The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.

This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure.

Patients prescribed the Zephyr Valve treatment will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3-years post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction procedure by the physician.
* Subjects who signed an Informed Consent Form to allow data collection.

Exclusion Criteria:

* Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
Efficacy/ Safety of Product CM9241GRU in Patients With Perennial Allergic Rhinitis

To evaluate the efficacy and safety of CM9241GRU versus placebo in the treatment of perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes aged 18 and over
* Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF)
* Participants with a diagnosis of perennial allergic rhinitis, as determined by a history of symptoms related to non-seasonal allergen exposure for at least 9 months in the 12 months prior to the screening visit.

Exclusion Criteria:

* Participants who have had nasal surgery in the six (6) months prior to the screening visit, or who have obvious external structural abnormalities that interfere with nasal airflow and are considered clinically relevant by the investigator;
* Participants with non-allergic rhinitis (e.g. vasomotor, infectious, medication or drug-induced rhinitis) or seasonal allergic rhinitis;
* Participants with a current diagnosis or history of chronic rhinosinusitis, chronic purulent postnasal drip in the two (2) years prior to the screening visit;
* Participants diagnosed with asthma requiring regular use of systemic or inhaled corticosteroids; uncontrolled asthma (ACT: 5-15); partially controlled asthma (ACT: 16-19);
* Participants with a history of immunotherapy treatment in the 2 years prior to the screening visit;
* Participants with an upper respiratory tract infection or rhinosinusitis requiring antibiotic treatment in the 14 days prior to the screening visit and the randomization visit;
* Participants with an upper respiratory tract viral infection in the 7 days prior to the screening and randomization visits;
* Participants with severe hypertension, severe coronary artery disease, arrhythmias, glaucoma, hyperthyroidism, prostatic hypertrophy.
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with another antibiotic, ciprofloxacin, in the treatment of adults with uncomplicated infections of the skin and the supportive layers beneath the skin.

Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. This is a randomized, double-blind, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (500 mg once daily for 7 days) compared with ciprofloxacin (500 mg once every 12 hours for 10 days) in adults with uncomplicated infections of the skin and the supportive layers beneath the skin. The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit on Days 3 - 5 of the study and one visit \[post-therapy\] 2 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. The primary assessments of effectiveness include the clinical response to treatment (categorized at post-therapy as cured, improved, or failed) and the microbiological response at post-therapy (the elimination of the disease-causing bacteria, categorized as eradicated, partially eradication, or persisted, determined by patient and by type of bacteria). Safety evaluations (incidence of adverse events, physical examination, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with ciprofloxacin in patients with uncomplicated infections of the skin and the supportive layers beneath the skin. One levofloxacin 500 mg tablet by mouth, once daily (and a placebo tablet once daily, 12 hours later) for 7 days, followed by one placebo tablet every 12 hours for 3 days; or one ciprofloxacin 500 mg tablet by mouth once every 12 hours for 10 days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, swelling, drainage, or other relevant clinical signs
* able to provide a sample of tissue from the affected area of the skin
* able to receive oral medications.

Exclusion Criteria:

* Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin
* having a severe infection
* previous allergic or serious adverse reaction to similar antibiotics, or have severe lactose intolerance
* taken antibiotics internally within 48 hours of the start of the study with resulting improvement
* requirement of a second antibiotic taken internally or requirement of an antibiotic applied directly to the site of the infection in addition to the study drug
Post-Marketing Study to Assess Complication Rates of Oncology Patients With Ports and Peripheral IVs

This study is to collect current information on complications rates of subjects undergoing chemotherapy administration through Ports and peripheral IVs.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 21 years
* Subject is currently undergoing or has had infusional cancer therapy (solid tumor or hematologic) through a Bard PORT with a distally-valved catheter/open-ended catheter or infusion through a PIV
* Subject had a chemotherapy regimen consisting of a vesicant and/or irritant
* Subject has signed an Informed Consent Form (ICF) or has had an ICF signed by the subject's legally authorized representative

Exclusion Criteria:

* Subject has/had an implanted non Bard PORT
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery

LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and lung blood clots occur commonly after patients have surgery to replace a hip or knee joint. These clots often occur while patients are in bed in the hospital after hip or knee joint surgery. The purpose of this study is to test if different dose strengths (amount of drug in the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717 is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is one of the standard medications given after hip or knee joint surgery.


Eligibility Criteria:
Inclusion Criteria:

* Are scheduled for total knee or hip replacement surgery (only one side, first time joint replacement)
* Are at least 18 years of age and no more than 75 years of age.
* Have a body weight more than 50 kg and less than 120 kg.
* Sign an approved Eli Lilly and Company informed consent document.

Exclusion Criteria:

* Have had hip or knee replacement surgery in the non-surgical leg or any surgical procedure in the surgical leg within 6 months prior to enrollment.
* Other surgeries (brain, spinal cord, eye within 12 months; chest or abdominal surgery within 1 month).
* Have taken drugs that might increase possibility of bleeding.
* Other risk factors for bleeding (bleeding disorders, abnormal results on blood tests, ulcers)
* Increased risk for blood clots.
Treatment of Acute Pancreatitis With Ketorolac

Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.

Patients with acute pancreatitis will be randomly assigned in either study group or control group.

* The study group will receive injection or oral Ketorolac.
* The control group will receive standard medical treatment.

Ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours).

Hs-CRP will be measured in admission in addition to standard laboratory tests.It will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.

Eligibility Criteria:
Inclusion Criteria:

1. Predicted Severe Acute Pancreatitis
2. Enrollment within 72 hours of diagnosis
3. Obtaining informed consent
4. Age \>18 years

Exclusion Criteria:

1. Heart disease, Hypertension
2. Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
3. Lactating women
4. Pregnancy
5. Advanced renal disease
6. Hypersensitivity to ketorolac, aspirin, other NSAIDs
7. Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
8. Active or history of peptic ulcer disease
9. Recent or history of GI bleeding or perforation
10. Inflammatory bowel disease
11. Severe hepatic impairment or active hepatic disease
Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life

We are interested in studying whether and how medical problems other than primary cancer before hematopoietic cell transplantation would impact the profiles of quality of life and toxicities post-transplantation for patients with blood cancers. We want to see if by assessing comorbidities (such as diabetes) early on, we can identify those patients who will have more toxicities or limitations in their quality of life after transplant. The generated information could set the stage for future intervention studies aiming to improve quality of life for patients with blood cancers after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Allogeneic HCT candidates who are \>18 years of age
* Able to speak and read English
* Able to provide informed consent
* Access to a telephone for study-related communications
* Diagnosed with a hematological malignant disease
* Willing to complete survey packets at 5 time-points, spanning two years

Exclusion Criteria:

* HCT candidates who are 18 years or younger at the time of study enrollment
* HCT candidates who cannot read, write, or speak English
* Patients with diagnoses of non-malignant diseases, or solid tumors are primary disease
Clinical Experimental Study to Investigate Specific Features of ClampArt®

A single centre, clinical experimental study. Every subject will undergo clamp experiments, where a clamp device (ClampArt®) measures and controls the blood glucose concentration after administration of marketed insulin products.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, TD1, TD2

Exclusion Criteria:

* Participation in a Trial within the last weeks
The TOGETHER Project - Kidney

Researchers are trying to develop a way to customize immunosuppression treatment, based on the results of a blood test that measures the risk of rejection.


Eligibility Criteria:
Inclusion Criteria:

* Conventional solitary kidney transplant (ABO compatible, crossmatch negative, not a kidney transplant simultaneously transplanted with another non-renal organ including heart, liver, lung or pancreas)
* Patients who have given informed consent and are willing to comply with the protocol, including the use of their specimens and data for subsequent research.

Exclusion Criteria:

* EBV -seronegative recipient
* ABO incompatible kidney transplants.
* Simultaneous kidney and extra-renal organ transplants including pancreas, liver, heart, lung, bone marrow transplantation, etc or prior recipient of non-renal transplant. Subjects who had previous extra renal transplants may be included in the study.
* Positive crossmatch kidney transplants (T cell crossmatch \>100, B flow cytometric crossmatch \>150).
* Participating in other clinical trials
* Any kidney transplant recipient \< 18 years of age.
Sacral Erector Spinae Plane Blocks in Pediatric Patients

Patients who were operated by Department of Pediatric Surgery and who received sacral erector spinae plane blocks as a part of postoperative analgesia management will be scanned.

Erector spinae plane block (ESPB) is a safe and effective regional anesthesia technique in pediatric patients and can be performed at any level of the thoracic and lumbar vertebrae. In addition, ESPB can be performed at the sacral region in the midline. In pediatric patients, sacral ESPB provides effective analgesia and this method can replace caudal blocks.

This study aims to investigate the efficacy of sacral ESPB retrospectively. Demographical data of the patient, indication/surgery type, total volume applied, additional analgesic use, type of the analgesic if used will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were operated by Department of Pediatric Surgery

Exclusion Criteria:

* Incomplete patient forms
Effect of Combined Fatty Acid Supplementation and Eccentric Exercise Training on Exercise Performance

The aim of the study is to determine whether fish oil (specifically omega-3 long chain polyunsaturated fatty acids \[EPA-DHA\]) supplementation can enhance eccentric resistance exercise performance when combined with a resistance exercise training study. The investigators aim to establish the potential mechanisms that might mediate performance changes at a cellular level.


Eligibility Criteria:
Inclusion Criteria:

* Males
* Healthy

Exclusion Criteria:

* Resistance exercise training within the past 6 months
* Vitamin or fish oil supplementation over the past 6 months
* Habitual use of anti-inflammatory drugs
* History of heart disease
* History of coagulation/bleeding disorder
* History of metabolic disease
* Serious allergy
* Known to have blood-borne virus
* Females (Due to differences in cell membrane incorporation of Omega-3 between the sexes and the testing schedule being unable to fit in with menstrual cycle, altering the blood markers that are being measured)
* Currently no symptoms of general illness