cyrilzakka/clinical-trials huggingface dataset:
Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)

* Prospective, single-arm, multi-center registry study
* A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included.
* Patients will be followed clinically for 12 months after the procedure.
* Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
* Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
* Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)


Eligibility Criteria:
Inclusion Criteria:

1. Age 19 years of older
2. Symptomatic peripheral artery disease:

   * Moderate or severe claudication (Rutherford category 2 or 3)
   * Critical limb ischemia (Rutherford category 4-5)
3. Femoropopliteal artery lesions with stenosis \> 50%
4. ABI \< 0.9
5. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age \> 85 years
7. Severe hepatic dysfunction (\> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF \< 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy \<1 year due to comorbidity
12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
The Mollie Study, a Study to Evaluate the Safety and Efficacy of the Mollie Medical Device

Study to evaluate the use of a medical device in relieving collision dyspareunia


Eligibility Criteria:
Inclusion Criteria: Females 18 years of age and older with a diagnosis of collision dyspareunia -

Exclusion Criteria:

-
The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients

To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous history of candidiasis.


Eligibility Criteria:
Inclusion Criteria

Prior Medication:

Allowed within 6 months of study entry:

* Treatment for oral candidiasis.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Either history of esophageal candidiasis or current mucocutaneous candidiasis (angular cheilitis).
* Allergies to chlorhexidine.
* Gross periodontal neglect or need for periodontal treatment within the past two weeks.

Concurrent Medication:

Excluded:

* Systemic or oral topical mucocutaneous antifungal therapy.
* Systemic or oral topical corticosteroids.
* Antibiotics.
* Mouth rinses other than the study drug.

Concurrent Treatment:

Excluded:

* Dental prophylaxis.

Patients with the following are excluded:

* Complete dentures, full partial dentures, removable dentures which fit poorly, or any prosthetic appliances which cannot be cleaned with sodium hypochlorite.
* Allergies to chlorhexidine.
* Sensitivity/intolerance to alcohol.
* Anterior composite/acrylic restorations with poor marginal adaption.
* Gross periodontal neglect or periodontal treatment within the past two weeks.
* Inability to comply with the study protocol based on the investigator's discretion.

Prior Medication:

Excluded within 7 days of study entry:

* Systemic or oral topical mucocutaneous antifungal therapy.
* Antibiotics.
* Daily use of mouth rinses.
* Excluded within 1 month of study entry:
* Systemic or oral topical corticosteroids.

Prior Treatment:

Excluded within 2 weeks of starting study drug:

* Dental prophylaxis or periodontal treatment.

Patients must be:

* HIV positive.
* Previously experienced at least one episode of clinically diagnosed oral candidiasis but currently free of clinical signs of oral candidiasis.
* Willing to sign informed consent.
* Willing to complete a medical history.
Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

To study the diagnostic performance of infrared spectroscopy on fresh synovial fluids in early septic arthritis diagnosis in patients with acute joint effusion

Diagnosis of a joint effusion is frequently a medical emergency, especially when septic arthritis is suspected. Septic arthritis diagnosis relies on microscopic and bacteriological analysis of synovial fluid obtained by arthrocentesis. Direct microscopic examination can be made within 2 to 12 hours but it is negative in about 50 % of the cases. It is necessary to wait 72 hours to obtain the result of the culture and reasonably rule out the diagnosis of septic arthritis. A method of establishing an immediate etiological diagnosis could improve the care of patients with joint effusion that is a therapeutic emergency and justify a hospitalization and a parenteral antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 year old
* patients with an acute arthritis defined by an evolution of less than 6 weeks
* patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study
* patients who received information about the protocol and have not expressed opposition to participate

Exclusion Criteria:

* patients opposing the study
* protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
ParKinWalk: Physical Activity and Long Group-walking for Parkinson's Disease

The study will evaluate the impact of exercise training program followed by long-walking onon supervised and unsupervised gait assessment in Parkinson´s disease and control subjects.

Background: Several studies suggest an impact of physical exercise on walking parameters in Parkinson´s disease (PD) patients.

Objective: the present study will evaluate the impact of three months physical exercise training program followed by a group-long walking on motor impairment in PD.

Methods:

PD patients will be randomized in two arms: one group will be assessed to a training exercise program of three months followed by long-walking in group under the support of physician/physiotherapist and caregivers. A complete motor, cognitive and general assessment will be performed at baseline. The patients will be evaluated under supervised an unsupervised conditions at baseline, before the long-walking, during the walking and after 2 months after the walk.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson´s disease diagnosis
* stable dopaminergic treatment ( stable dose in the last three months before baseline evaluation)

Exclusion Criteria:

* gait impairment due to other medical conditions
* dementia
* impulsive compulsive disorder
* severe depression
A Comparison of pCLE Based Targeted Biopsy and WLE Based Standard Biopsy in Staging the Operative Link on Gastric Intestinal Metaplasia (OLGIM): A Randomized，Cross-over Study

Gastric intestinal metaplasia (GIM) is an important premalignant lesion for gastric cancer. Precisely surveillance of patients with GIM may result in early detection and improved prognosis. Though important, it is not necessary to recommend surveillance endoscopy for all patients with GIM, since the progression rate to gastric cancer within 10 years is only 1.8% in those patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years or older with Helicobacter pylori infection;
* Histologically verified GIM, atrophic gastritis or dysplasia.

Exclusion Criteria:

* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
* Conditions unsuitable for performance of pCLE, such as coagulopathy, impaired renal function or allergy to fluorescein sodium;
* Pregnancy or breastfeeding;
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Study of RPT193 in Healthy Adult Male Subjects

Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.

A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces

Eligibility Criteria:
Inclusion Criteria:

* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening

Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
* History or presence of clinically significant medical or psychiatric condition or disease
* History or presence of alcohol or drug abuse within the past 2 years prior to dosing
* History or presence of:

  * Gastrointestinal ulcers, or history of other significant GI diseases
  * Malignancy within the last 5 years, with the exception of successfully treated basal cell carcinoma.
  * Clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality
  * Ongoing or recent (within 30 days prior to RPT193 administration) bacterial, fungal, or viral infection requiring therapy
  * Known family history of sudden death.
* Positive for human immunodeficiency virus, hepatitis B, hepatitis C
* Unwilling to abstain from alcohol, xanthane-containing beverages or food or foods containing grapefruit/Seville orange prior to admission
* Received radiolabeled substances or exposed to radiation sources over past 12 months
Prospective Evaluation of Topical Almond Oil vs Hydroquinone

The purpose of this study is to analyze facial pigmentation and skin microbiome changes after topical almond oil application, compared to the use of topical hydroquinone.

The purpose of this experiment is to analyze facial pigmentation and skin microbiome changes after topical almond oil application, compared to the use of topical hydroquinone.

There will be a total of 50 subjects:

* 25 randomized to receive almond oil nightly
* 25 randomized to receive 2% hydroquinone nightly

Study Timelines:

* The duration of an individual subject's participation will last from the day of the consent/screening (visit 1) until visit 5 where they will have images taken and measurements collected to assess skin pigment, skin hydration, sebum excretion rate.
* The duration of participation is 4 months.
* The estimated time for the investigators to complete primary analysis is 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women of Fitzpatrick skin types 3 to 6

Exclusion Criteria:

* Those with a nut allergy
* Smoking is an independent risk factor and serves as a confounder for the development of facial aging \[18\]. Therefore current smokers, those that have smoked within the past year, and former smokers with greater than a 20 pack year history of smoking will be excluded.
* Those with an autoimmune photosensitive condition or a known genetic condition with a deficiency in collagen production (such as Ehlers-Danlos syndrome) will be excluded as this can be a confounder for facial photoaging.
* Hormonal medications or therapies will not be allowed unless they have been stable on their medications for at least 2 months. Examples include oral contraceptives, progesterone-based injections, and estrogen based hormonal replacement therapy.
* Those who have undergone any cosmetic procedures to the face in the 4 months prior to enrollment in the opinion of the investigator. People that have undergone deeper chemical peels (TCA based peels) within 1 year prior to enrollment will also not be eligible.
* Individuals who are unwilling to discontinue vitamin E containing supplements and food sources during the washout and intervention.
* Individual who are unwilling to discontinue topical cosmetic products during the duration of the study.
* Individuals who are not willing to engage in a two-week washout on topical treatments known to affect facial pigmentation and these agents will be restricted during the study period as well. These include topicals that contain:

  * Retinoids such as tretinoin, adapalene, retinol.
  * Antioxidant ingredients such as vitamin C or vitamin E.
  * Pigment-reducing agents such as hydroquinone, azelaic acid, kojic acid per the discretion of the investigator except for the hydroquinone that is provided in this study.
  * Topicals that contain a nut oil or nut extract as part of their ingredient list.
* Furthermore, subjects will be asked to refrain from use of any other topical products for one week prior to each visit apart from the study agents supplied from this study.
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads

Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. Quality of life and experience of use questionnaires will be completed. Scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.

AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy and for 2 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment. Patients will be asked to complete the following questionnaires: training evaluation after training is complete; and symptoms from device use, experience with device use and self-assessment of hair loss after each chemotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female age 21 years or older at the time of signing informed consent.
* Documented pathologic diagnosis of invasive breast or gynecologic cancer, any stage, requiring treatment with a taxane-containing chemotherapy regimen
* Planned start of treatment with taxane-based chemotherapy in the adjuvant, neoadjuvant or advanced setting
* Plan to complete chemotherapy within 6 months of treatment start
* If received prior chemotherapy causing hair loss, \>/= 2 years since last chemotherapy dose and complete recovery of hair
* ECOG performance status 0-1
* Willing and able to sign informed consent for study procedures
* Willing and able to participate in all study procedures

Exclusion Criteria:

* Plan to use chemotherapy regimen other than that listed in inclusion criteria, including any anthracycline-based regimen
* Plan to initiate bone marrow ablation chemotherapy
* History of or plan to initiate whole or partial brain or skull irradiation
* Hormone therapy concurrent with current chemotherapy regimen
* Existing or suspected scalp metastases
* History of concomitant diagnosis of: autoimmune disease affecting hair; cryoglobulinemia; untreated iron deficiency with or without anemia; cold agglutination disease; post-traumatic cold dystrophy; untreated or poorly controlled hyper- or hypothyroidism
* Female pattern baldness
* History of persistent chemotherapy-induced alopecia from prior chemotherapy
* Concomitant exposure to investigational agents, drugs, devices or procedures that cause hair loss
* Concomitant other solid tumor or hematologic malignancy in addition to the current diagnosis
Dyslipidemia Treatment in Thailand and Cardiovascular Outcomes

The purpose of this study is to establish the proportion of patients on lipid-lowering pharmacological treatment (statin or combination) reaching the LDL-C goals according to the updated 2004 National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines.

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Provision of subject informed consent, Female or male aged = 18 years
* Patients eligible for treatment of dyslipidemia with statins, according to the current guidelines NCEP ATPIII about Dyslipidemias and Atherosclerosis Prevention Receiving lipid-lowering drug treatment for at least 15 days.

Exclusion Criteria:

* Involvement in the planning and conduct of the study (applies to either AstraZeneca staff or staff at the study site).
* Previous enrolment or randomisation of treatment in the present study
* Participation in a clinical study during the last 90 days
Muscle Metabolism and Oxygenation During Localized Fatigue-exercise in COPD

The purpose of this study is to investigate whether a localized exercise, in which cardiorespiratory demand is reduced, will result in greater limb muscle fatigue in patients with COPD as a consequence of muscle oxygenation and muscle metabolism disturbances.


Eligibility Criteria:
Inclusion Criteria:

* COPD (FEV1/FVC \< 0.70 and FEV1 \< 0.80 predicted
* Healthy subjects: no evidence of airways obstruction (FEV1/FVC \> 0.70 and FEV1 \> 0.80 predicted)
* Smoking history \> 15 pack-years

Exclusion Criteria:

* Chronic hypoxemia and/or hypercapnia (PaO2 \< 60 mmHg or SpO2 \< 88% at rest and/or PaCO2 \> 45 mmHg)
* Recent exacerbation (\< 3 months)
* Recent cancer (\< 3 years)
* Diabetes
* Myopathy, neuromuscular or articular disease
* Unstable cardiac disease
* Absolute contraindications to exercise testing
* Regular physical activity or exercise training program in the last 2 months
* Physical activity score \> 9 in the Voorips questionnaire
* Thigh skinfold thickness \> 15 mm
* BMI \> 30
Population Pharmacokinetics of Cephalosporins and Macrolides in Chinese Children With Community Acquired Pneumonia

This study is based on the hypothesis that the pharmacokinetics of antibiotics in children is different from adults. Cephalosporins and macrolide antibiotics are the common drugs for children with community acquired pneumonia, the investigators aim to study the population pharmacokinetics of cephalosporins and macrolide antibiotics in children receiving the drug for treatment of community acquired pneumonia, and to correlate it with treatment effectiveness and incidence of adverse effects.

Potential Impact: This novel knowledge will allow better and more rational approaches to the treatment of community acquired pneumonia. It will also set the foundation for further studies that will be able to test improved therapies that may increase treatment response in vulnerable children.


Eligibility Criteria:
Inclusion Criteria:

* Children 1-18 years old of both sexes, with a diagnosis of community acquired pneumonia and eligible for treatment with cephalosporins and macrolide antibiotics, as per current treatment protocols.
* Community acquired pneumonia diagnostic criteria: meet any one of the 1-4 following items plus the fifth item:

  * 1. With cough, expectoration, or pre-existing respiratory disease getting worse, and with purulent sputum with or without chest pain;
  * 2. Fever;
  * 3. With pulmonary consolidation and crackles;
  * 4. White blood cells\>10×10\^9/L or \<4×10\^9/L;
  * 5. X-ray on chest shows flake, patchy infiltrate shadows or interstitial changes, with or without pleural effusion.
* Informed consent signed by the parents, and consent or assent of the patients (according to age and consenting capacity).

Exclusion Criteria:

* It is unable to provide complete medical records or the current condition can not accept the diagnosis process.
* It does not agree to participate in this study.
Evaluation of the Development of an Advanced, Conformable Prosthetic Socket, Study I

The purpose of this study is obtain prosthetist's feedback on the novel conformable socket material developed by Infoscitex, and determine if it is a viable alternative to current prosthetic socket liners. During this task, the research team will travel to the prosthetists locations to have them evaluate the socket system by examining the material and providing their professional opinions and feedback with regard to comfort and fit for the amputee, its ease of use, and breathability.

Modern prosthetics have improved significantly with regards to control and functionality, but the fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. The volume of the residual limb of an amputee changes throughout the course of a day and throughout the year. Volume fluctuation within the socket can lead to issues for the amputee, including decreased comfort, increased shear forces, increased pressure on bony prominences, as well as a poor gait pattern. An uncomfortable or non-performing socket/residual limb interface decreases user compliance with the prosthetic and therefore decreases the activity level of amputees who want to remain active in their civilian and military lives.

The investigators are developing a multilayered socket that takes advantage of a novel braided material for strength and passive conformability with thin layers dedicated to wearer comfort. This new socket provides ultimate fit for improvement in the performance of the prosthesis. The socket adapts itself to the changing physical shape of the residual limb as the prosthesis is worn. The adaptation is a natural result of the material properties, so is done passively and in real time. The materials are lightweight, breathable, and ultrasound transparent, allowing the prosthetic to function in a variety of environments.

This study will be undertaken to have six prosthetists evaluate the material, where they will be asked to complete a questionnaire and give their opinions regarding the material. This will inform design changes for the material.

Eligibility Criteria:
Inclusion Criteria:

* prosthetists who are active professionals and have clients (or have had clients in the past 6 months)

Exclusion Criteria:

* prosthetists who are not American Board for Certification of Orthotics and Prosthetics certified
Hand Massage on Fatigue With Cancer Receiving Brachytherapy

This randomized controlled trial was designed to examine the effect of hand massage on the level of fatigue in patients receiving BT therapy. Randomized controlled trial was conducted in the radioterapi outpatient clinic of university hospital located in a large city in Turkey. When 12 patients were included in each group, it was determined that the power was 90% at the 5% Type I error level, and a total of 24 women with gynecological cancer were included in the study. The primary outcome of this study was the mean difference in fatigue scores between the groups following the three brachtherapy cycles hand intervention. Patient Information Form and Brief Fatigue Inventory (BFI) used. This study predicted that hand massage applied in each session, starting from the first session of brachytherapy application, would reduce the level of fatigue in women.

Therefore, this study aimed to compare the effects of hand massage intervention the level of fatigue in patients receiving BT therapy. . This randomized clinical trial was conducted.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over,
* underwent BT regularly
* Patients who volunteered to participate in the study

Exclusion Criteria:

* Having skin problems
* with metastases,
* have bleeding or coagulation disorders,
* using complementary integrated therapy during the study,
* Having edema or wound in the hand area,
* not wanting to get a massage
* Patients receiving general anesthesia during the procedure