cyrilzakka/clinical-trials huggingface dataset:
Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to 4 weeks in a daily wear modality.


Eligibility Criteria:
Inclusion Criteria:

* Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
* Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
* Willing and able to wear spherical contact lenses within the available range of powers.
* Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Currently enrolled in any clinical trial.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Astigmatism of 1.00D or more.
* Currently wearing contact lenses in a daily disposable modality.
* Currently wearing AIR OPTIX AQUA or PureVision 2 contact lenses
* Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
* Other protocol-defined exclusion criteria may apply.
Study of Carbon Dioxide Exchange Patterns During Robotic Prostatectomies

The AirSeal® System will allow for lower carbon dioxide (CO2) absorption rates than the standard Endopath System.

The primary observation to be made is the level of carbon dioxide in the arterial blood, specifically when the patient is insufflated and deflated during the surgery. As a result of the consistent pressure that the AirSeal® system maintains, carbon dioxide will be absorbed in lower levels when compared to the standard of care systems in which fluctuations in intra-peritoneum pressure are seen.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Eligible and elect to undergo robotic prostatectomy surgery @ OhioHealth Dublin Methodist Hospital

Exclusion Criteria:

* Age \< 18
* Emergency surgery
* Ascites
* BMI\>44 or \<18
Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus

This will be a randomized, open-label, active-controlled, 6-period crossover study. Target population will be subjects with Type 2 Diabetes Mellitus (T2DM)

To assess the dose-response and dose-exposure of Dance 501 (Human Insulin Inhalation Solution) administered with the Dance 501 Inhaler.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with T2DM.
* BMI between 25.0 and 40.0 kg/m2.
* Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months.
* Non-smoker for at least 5 years.
* Forced vital capacity and forced expiratory volume in one second is at least 75% normal.

Exclusion Criteria:

* Any condition affecting pulmonary drug absorption.
* History or presence of cancer except basal cell skin cancer or squamous cell skin cancer.
* Serious systemic infectious disease during four weeks prior to dosing.
* Clinically significant abnormal lab values.
* Proliferative retinopathy and/or severe neuropathy.
* Recurrent severe hypoglycemia.
* Current treatment with oral anti-diabetic drugs except metformin, glucagon-like peptide receptor agonists.
* Current treatment with MAO inhibitors.
* Unstable Thyroid hormones for at least 3 months.
* Insufficient glycemic control with significant fluctuations of blood glucose.
Effect of a Specific Hand Intervention in Women With Arthralgia Secondary to Hormone Therapy Following Breast Cancer.

This study aims to evaluate the impact of a 12-week hand exercise program on pain, manual dexterity, and hand function in women experiencing hand joint pain (arthralgia) due to hormone therapy after breast cancer. Participants will be randomly assigned to either an intervention group, where they will perform specific hand exercises, or a control group, which will not receive any exercise program. Pain levels, hand function, and manual dexterity will be assessed before and after the intervention using questionnaires and functional tests. The goal is to determine whether targeted hand exercises can improve pain and daily hand use in this population.

This is a randomized, evaluator-blinded clinical trial that aims to determine the effects of a 12-week hand exercise program on pain, manual dexterity, and functional performance in women experiencing hand arthralgia due to hormone therapy following breast cancer. Participants will be randomly assigned to one of two groups: an intervention group performing specific hand exercises or a control group with no exercise intervention.

The primary outcome will be changes in hand pain levels assessed using the Brief Pain Inventory (BPI) and McCaffrey's Initial Pain Assessment Tool. Secondary outcomes will include functional performance measured with the DASH and ABILHAND questionnaires, as well as manual dexterity, speed, and coordination assessed through standardized tests (Purdue Pegboard Test, Box and Block Test, and Minnesota Rate of Manipulation Test).

The study will evaluate the potential benefits of targeted hand exercises for improving pain, dexterity, and quality of life in breast cancer survivors experiencing treatment-related hand symptoms.

Detailed Description

Study Design:

Type: Interventional (Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single-Blind (Evaluator) Primary Purpose: Treatment Duration: 12 weeks

Eligibility Criteria:
Inclusion Criteria

Experiencing hand arthralgia as a result of hormone therapy (aromatase inhibitors or tamoxifen) following breast cancer.

Ability to communicate pain levels effectively. Ability to follow simple instructions to participate in the intervention and assessments.

Exclusion Criteria Participants requiring any medication changes during the study period that could influence pain levels (increase or decrease).

Concurrent physiotherapy or occupational therapy specifically targeting the hand during the study.

Pre-existing diagnosis of arthritis or osteoarthritis in the hand before starting hormone therapy.

Presence of systemic diseases associated with hand arthralgia. Neurological conditions affecting hand movement.
Study to Determine the Antibody Response to 500µg G17DT in Treatment of Patients With Gastric Cancer

This study was designed to investigate the antibody response generated by a 500µg dose of G17DT in patients with gastric cancer.

Another study, GC2, initiated prior to the start of this study investigated the appropriate dose and dosing schedule for G17DT in patients with Stage I-III gastric cancer. The highest dose tested in the GC2 study was 250µg. This dose was well tolerated but was not considered sufficiently immunogenic. Since tolerability had not constrained dosing up to 250µg, the GC5 study was designed to investigate a 500µg dose administered as a regimen of 0, 2, and 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed UICC Stage I, II or III gastric adenocarcinoma.
* Patients must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial.
* Male or Female patients aged 18 years or older.
* Life expectancy of at least 3 months.
* WHO Performance Status of 0 to 1.
* Written informed consent

Exclusion Criteria:

* Gastric surgery within four weeks of baseline (Week 0, visit 2) or gastric surgery anticipated during the period of the study.
* History of other malignant disease within the previous five years, except nonmelanomatous skin cancer or in situ carcinoma of the uterine cervix.
* Previous use within the last four weeks, concomitant use of anticipated use in the period of study, of any anti-cancer therapies.
* Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids.
* Females who were pregnant, planning to become pregnant or lactating.
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study.
* Previous G17DT treatment.
* Haematologicial indicators:

Haemoglobin (Hb) \< 10g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L
Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

This study evaluates the effect of the medical device "Excilor® Forte" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.

Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software.

Eligibility Criteria:
Inclusion Criteria:

* Subject having given her/his informed, written consent.

  * Subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
  * Subject being psychologically able to understand information and to give their/his/her consent.
  * Age: more than 18 years.
  * Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet).
  * Subject with positive KOH staining.
  * Subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
  * Female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.

Exclusion Criteria:

* Subject considered by the Investigator likely to be non-compliant with the protocol.
* Patient enrolled in another clinical trial during the test period.

  · Woman being pregnant, nursing or planning a pregnancy during the course of this study.
* Subject having a known allergy to one of the constituents of the tested products.
* Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology...
* Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).

This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Eligibility Criteria:
Key Inclusion Criteria:

* Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
* Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer \[AJCC\] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality
* At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
* Concurrent chemotherapy regimen of Cisplatin 100mg/m\^2 on days 1, 22, and 43
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal to 2
* Adequate hematologic, renal and hepatic function
* Negative pregnancy test by serum or urine
* Signed informed consent

Key Exclusion Criteria:

- Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for greater than 3 years)
fNIRS in Pediatric Hearing Aids

Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants.

Hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS.

The use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Group A: Infants and toddlers 3-18 months of age who are normal hearing.
* Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional.
* Socially insured subject
* Parents or guardians who have given their consent to participate in the study

Exclusion Criteria:

* Medical condition that does not allow for research compliance.
Effect of Chewing Gum in Hemodialysis Patients

The aim of this prospective randomized controlled study was to investigate the effects of chewing gum on interdialytic weight gain, thirst, dry mouth and intradialytic symptoms in hemodialysis patients.

The prevalence of xerostomia varies high in patients with chronic hemodialysis (HD), and the decreased saliva flow rate due to various mechanisms is the main factor in its development. The significant decrease in saliva flow due to the atrophy and fibrosis of the salivary glands in HD patients is further affected by the restriction in fluid intake. The use of drugs such as antidepressants, antipsychotics, antihistamines, antihypertensives, aspirin, benzodiazepines, opioids and proton pump inhibitors also leads to hyposalivation and xerostomia. Thirst is common in chronic HD patients due to both volumetric and osmometric causes but the primary mechanism is osmometric. The osmolarity of the extracellular fluid increases with the dietary salt and the hypothalamus is stimulated by the shrinkage of the osmoreceptor cells, leading to the desire to ingest liquids. Volumetric thirst develops secondary to water and salt loss and the resultant stimulation of cardiac baroreceptors, with the cardiac return volume decreasing gradually towards the end of the HD session. Increased interdialytic weight in HD patients causes increased risk of death due to cerebrovascular events and cardiovascular diseases and leads to an increase in morbidity and mortality together with a deterioration of the patient's quality of life. Interdialytic weight gain (IWG) causes incompliance with fluid control as a result of the secondary excessive consumption of liquid and food and is an important condition.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* On maintenance hemodialysis three times per week for four hours per session
* Receiving hemodialysis therapy for a least six moths at the time of the study
* Able to communicate in Turkish
* Willing to participate to the study

Exclusion Criteria:

* 18 years of age younger
* Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis.
* The patient who took chemotherapy and radiotherapy
* Have salivary gland infection and dementia
* Oral and / or dental diseases to prevent chewing gum
* Unwilling to to participate to the study
Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV

The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.

The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease. Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults, even in the absence of antiretroviral treatments. In studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. This study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in HIV infected children in the Dominican Republic.

Children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Parent/caregiver signature on consent form

Exclusion criteria:

* Unknown HIV status
* Fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry
* Massage therapy within 30 days prior to study entry
* Unable to have massage (e.g., extensive skin lesions)
* Symptoms of child abuse
* Child born drug-addicted
Experience and Health Impact of University Students Accessing a Digital Nutrition, Fitness and Mindfulness Platform

Dietary choices, quality of life and stress will be evaluated in a sample of 100 undergraduate students who are in their first year of university. Students will be randomized into the following two groups; intervention arm (students who will use a preventative self-care program for 12 weeks) vs. control arm (students who will not use a preventative self-care program for 12 weeks).

When individuals look after their own health using online applications they can expect similar or even better health outcomes compared to those obtained by using conventional methods. These kind of tools are popular among University students. Due to the many changes and challenges that students face in the first year of University, this sector of our population is at higher risk of presenting nutritional problems, anxiety, depression and suicidal thoughts.

Recently, a Canadian online application called My Viva Plan® became available. This program is based on preventive self-care and it includes three key pillars of health: nutrition, fitness, and mindfulness. Changes in dietary choices, quality of life and stress will be evaluated in a sample of 100 undergraduate students who are in their first year of university. Students will be randomized into the following two groups; students who will use the program vs. students who will not use the program. Questionnaires regarding physical activity, mindfulness and mental well-being will be evaluated at baseline, week 6 and week 12. Body composition characteristics using bioelectrical impedance analysis will be collected at the start and end of the study (baseline and week 12).

The objective is to determine if the use of an online application based on preventive self-care will result in better food choices, better quality of life, and reduced stress in first year university students.

Eligibility Criteria:
Inclusion Criteria:

* First-year undergraduate university students attending the University of Alberta's North Campus
* Students who are able to complete study assessments in their first year of university
* 17-30 years of age

Exclusion Criteria:

* Students with self-reported eating disorders
* Students with self-reported untreated depression, anxiety or other mood disorders
* Students who do not own a device to access the internet (i.e. tablet, computer, laptop, smart phone)
* Students who are not able to communicate in English
* Pregnant or lactating women
* Individuals with pace-makers or electronic implantable devices
LASER Trial. LAparoscopic Elective Sigmoid Resection Following divERticulitis - a Multicenter, Prospective, Randomized Clinical Trial

The purpose of this study is to find out whether elective sigmoid resection will improve quality of life compared to conservative treatment with lifestyle guidance and fiber supplement in patients with a recurrent or complicated diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent left colon diverticulitis (minimum 3 within 2 years, at least 1 confirmed with CT)

OR

* Earlier complicated left colon diverticulitis

OR

* Prolonged (over 3 months) pain or disturbance in bowel habits after a CT-confirmed left colon diverticulitis

Exclusion Criteria:

* Multimorbidity that prevents elective surgery
* Contraindication to laparoscopy
* Colonic stricture
* Fistula (e.g. colocutaneous, colovaginal, colovesical)
* Active malignancy
* Earlier resection of sigmoid colon or rectum
* Acute diverticulitis that has not settled
* Colonoscopy/sigmoidoscopy/virtual colonoscopy not performed within 2 years
* Age \< 18 or \> 75 years
* Pregnancy
* Inability to answer health surveys (e.g. dementia, psychiatric condition)