cyrilzakka/clinical-trials huggingface dataset:
Treatment of Bedsores With VIP Light

Difficulty healing wounds have a significant effect to the general fitness of the patient and his quality of life. On Account of the frequency of their appearing, constitute the serious health and social problem. In comprehensive dealing with such patients physiotherapy will matter greatly. The visible polychromatic polarized light is most often used physical factor assisting comprehensive treatment bedsores.

Purpose of the work: Analyze of using the visible polychromatic polarized light in the comprehensive process of healing bedsores at elderly people with the limited motor activity.

Material and methods: Participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. The study was conducted in people over 65 years old, with bedsores grade III and IV in Torrance scale. The therapy included radiation of bedsores with VIP light. Effectiveness of the method of treatment was examined using photographic images and to measure the extent of the wound.

18 people were examined. In all subjects, were assessed the risk of developing bedsores according to the scale Dutch Consensus Prevention of Bedsores CBO. All bedsores were irradiated with a Bioptron lamp (20 sessions, twice a day). Photo and measurement of bedsores size and Torrance score, were made:on the first, 9, 18 and 36 day of therapy.

Eligibility Criteria:
Inclusion Criteria:

* a high risk of bedsores development (Dutch Consensus Prevention of Bedsores CBO)
* having a bedsore(s)
* permanent stay in a nursing home
* recommended light therapy (VIP light)

Exclusion Criteria:

* ability to locomotion
* age under 65 years old
Erector Spinae Plane Block and Spinal Anesthesia for Supine Percutaneous Nephrolithotomy

This study aimed to compare the Effectiveness of Erector Spinae plane block to Spinal as a surgical anesthesia and analgesia in Percutaneous Nephrolithotomy patient

Thirty subjects (who meet all inclusion criteria and do not have exclusion criteria) are given informed consent before enrolling the study and randomized into two groups: erector spinae plane block and spinal. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry will be set on the subjects in the operation room. Peripheral venous blood samples will be taken for IL-6 examination. All patients will be sedated using Target Controlled Infusion with propofol (Schnider model, effect site) to obtain mild-moderate sedation prior to the block. On Erector Spinae Plane group, single-shot ultrasound guided block will be performed on the operated side with stimuplex 100 mm needle and 25 ml of isobaric bupivacaine 0.5% with epinephrine 1:200.000 will be administered at level Th 9. On the Spinal group, spinal anesthesia will be performed on lateral decubitus position at the level of L3-L4 or L4-L5 and hyperbaric bupivacaine 0.5% 16-18 mg will be given as regimen. Prior to urethral manipulation, all subjects will be given fentanyl iv 50 mcg and sedation with TCI Propofol will be maintained throughout the procedure. Sensory loss was evaluated by performing skin clamping with a scalpel at the level of the incision before the surgery. The ESP block was considered successful in providing surgical anaesthesia when there was no movement and significant changes in vital signs during skin clamping and throughout the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old and above
* ASA 1,2 and 3
* Patient who will undergo elective supine Percutaneous Nephrolithotomy

Exclusion Criteria:

* Patient who does not agree to be included in the study
* BMI \<18.5 kg/m2 or \> 40 kg/m2
* Patient with single functional kidney
* Patient who is contraindicated for local anesthetics
* Patient who has severe heart disorder
* Patient with communication disability and cognitive disorders
* Patient with chronic pain with history of high opioid consumption and or alcohol addiction
* Pregnant patient
Natural History of Netherton Syndrome

The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).


Eligibility Criteria:
Inclusion criteria \[for Part 1 and Part 2\]

1. Confirmed diagnosis of NS by at least one of the following:

   * Genetic testing of mutations in Serine Protease Inhibitor of Kazal Type 5 (SPINK5);
   * Absence or major deficiency of the protein Lympho-Epithelial Kazal-Type-Related Inhibitor (LEKTI) in skin biopsy;
   * Clinical assessment (signs and symptoms).
2. Provision of consent or assent (i.e., by parent or legal guardian) as required by local regulations:

   * \[Part 1\] to authorise access to existing medical records for study data collection;
   * \[Part 2\] to participate in the longitudinal 52-week evaluation of disease severity and clinical outcome assessments.

   \[for Part 2 only\]
3. Not participating in a clinical trial at the time of study enrolment for Part 2.

Exclusion criteria \[for Part 1 and Part 2\]

1. Patient who has died prior to 2002.
2. Patient whose last known survival status is dated prior to 2002 (i.e., patient has been lost to clinical follow-up since 2002).
Duloxetine Versus Paroxetine for Major Depression

To determine if duloxetine works just as well as paroxetine in the treatment of major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* You are male or female at least 18 years of age with nonpsychotic major depression. Females of child-bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

* You have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality.
* You have a history of hepatic dysfunction, current jaundice, or positive hepatitis B surface Antigen or positive hepatitis C surface Antibody regardless of ALT.
* You have an ALT greater than or equal to 2 times the upper limit of normal.
* You have abnormal thyroid-stimulating hormone concentrations.
PET/CT and Sentinel Node in Oral Cancer

In this study, the investigators want to pre-operatively scan patients who do not have any clinically suspicion of metastases with an 18F-FDG-PET/CT whole body scan , where after they go to lymphoscintigraphy incl. SPECT/CT and sentinel node biopsy. Material from the oral cancer and, after permission of each patient, also normal oral tissue will be analyzed molecular-biologically. Also a blood sample will be analyzed for molecular tumor markers.

The investigators want to see if PET/CT is able to detect any signs of sub-clinically metastases. Besides, the investigators want to fusion PET/CT with SPECT/CT data from the lymphoscintigraphy study and improve our PET/CT scanning with a dual-time PET scan of the head-and-neck region.

These patients are normally preoperatively sent to a CT scan of the thorax and abdomen; in this study, this CT is replaced by a wholebody PET/CT scan. Afterwards, the patients goes to sentinel node lymphoscintigraphy and then to operation.

By combining biomarkers and molecular imaging in patients with a clinically T1/T2N0M0 oral cancer, we want to characterize the tumor physiologically and correlate these physiological features to the clinical appearance of the cancer.

Aims of the study:

* can PET/CT in this patient group metastases with consequently change of treatment?
* can fusion of SPECT/CT and PET/CT with calculation of standardized uptake value (SUV) indicate, how much tumor tissue there should be in a positive sentinel node to be detected by PET?
* can dual-time PET scanning better determine lymph node metastases, than single-time PET scanning?
* correlation between SUV in PET with molecular-biological findings both in the primary tumor and in metastases

Eligibility Criteria:
Inclusion Criteria:

* biopsy-verified oral cancer
* over 18 years of age

Exclusion Criteria:

* under 18 years of age
* inable patients
* pregnancy
* known allergy to contrast agents
* kidney insufficiency
* other known cancer
* diabetes mellitus
* acute medical conditions such as acute infection, acute cardial or lung disease or other intercurrent diseases
Macroscopic and Molecular Changes in Knee Muscular-tendon Unit in Response to Acute Resistant Load

The aim of this study is to determine the influence of acute resistance exercises on anatomical and biological changes in the quadriceps muscle and tendons of the knee


Eligibility Criteria:
Inclusion Criteria:

* Non-professional athletes
* Pass heart/lung endurance tests
* Pass ergometrics testing

Exclusion Criteria:

* Have been injured
* Had physiotherapy for back or lower limbs in past 6 months
* Orthopedic surgery in lower limbs
Study of Breakthrough Cancer Pain: Assessment of Fentanyl Buccal Tablets Titration and Treatment in Opioid-Tolerant Patients

Breakthrough cancer pain (BTcP) is a common problem in patients with cancer. Fentanyl Buccal Tablet (FBT) is used for the treatment of BTP in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. FBT treatment should be individually titrated to an effective dose that provides adequate analgesia and minimizes undesirable effects. To reach the safest effective dose for the individual patient as soon as possible, the dose titration process is critical. The aim of this study, conducted under pragmatic conditions in a large-scale population of cancer patients is to compare the proportion of patients reaching an effective FBT dose after titration starting with either a 100 mcg dose or a 200 mcg dose.


Eligibility Criteria:
Inclusion Criteria:

* The patient is willing to provide written informed consent to participate in this study.
* The patient can be either an out-patient or an in-patient.
* The patient has a histologically documented diagnosis of cancer.
* The patient has stable background pain due to cancer.
* The patient experiences up to 4 BTcP episodes per 24 hours.
* As maintenance opioid therapy, the patient is currently taking 1 of the following: at least 60 mg of oral morphine/day, at least 25 mcg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of hydromorphone/day, of an equianalgesic dose of another opioid for a week or longer before administration of the first dose of study drug.
* Women of childbearing potential, using a medically accepted, highly effective method of birth control and agree to continued use of this method for the duration of the study.
* The patient must be willing and able to successfully self-administer the study drug and to fill in study documents.

Exclusion Criteria:

* The patient is without maintenance opioid therapy.
* The patient has uncontrolled or rapidly escalating pain as determined by the investigator.
* The patient has known or suspected hypersensitivities, allergies, or other contraindications to the active drug or to any of the excipients of the study drug.
* The patient has respiratory depression or chronic obstructive pulmonary disease, or any other medical condition predisposing to respiratory depression.
* The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
* The patient is expected to have surgery during the study.
* The patient is pregnant or lactating.
* The patient has participated in a study involving an investigational drug in the prior 30 days.
* The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
* The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that could, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED

This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.

This study is a randomized, multicenter, double-masked, vehicle-controlled study to evaluate the safety and efficacy of NEXAGON (lufepirsen ophthalmic gel) in subjects with persistent corneal epithelial defects (PCED). The study will enroll subjects who will complete a Screening Period, Treatment Period (up to 8 weeks) and Follow-up Period (4 weeks). Those subjects whose defect has not re-epithelialized by the completion of the Treatment Period or who achieved re-epithelialization but failed to maintain re-epithelialization for 28 days after treatment completion (durability) are eligible to enter the NEXAGON Open-label Treatment Period for an additional 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments
2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment
3. Subject must provide written informed consent (or assent)
4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test

Exclusion Criteria:

1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention
2. Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and/or protozoal) that has not fully resolved and/or treatment has not been completed
3. Present with evidence of corneal ulceration/melting involving the posterior third of the stroma and/or perforation in either eye
4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and/or active
5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time
6. Have any other ocular disease requiring topical ocular medication in the affected eye
7. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results
8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)
9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1
10. Use of the medications presented in the protocol that are prohibited in the study.
The Effect of Prostaglandin I2 on the Endothelial Cell Function Disorder in Type 2 Diabetes Mellitus Patients

This study attempts to examine the effect of oral prostaglandin I2 (Beraprost Na), administered for eight weeks, on the endothelial cell functional disorder among asymptomatic high risk diabetes mellitus patients.

This study plans to include those subjects who have complaint of peripheral microvascular symptoms but have evidences of having neither a coronary arterial disease nor a peripheral arterial disease and show normal findings in the vascular stiffness test (PWV and ABI)) and plethysmography of the legs (PVR)) ,among Type II diabetes mellitus patients of forty-five (45) years old or older, This study is conducted by using a randomized double blind method. These drugs are distributed through a pharmacy in the clinical study center and administered randomly for eight weeks while this study allots patients by using a double blind method. Beraprost Na is administered along with a placebo that was manufactured by the same manufacturer to have the identical exterior look and weight of Beraprost Na. After eight weeks of drug administration, this investigation attempts to verify symptomatic improvement and change in the endothelial function by using VENDYS® and ICG perfusion imaging.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus patient
* Patients with symptoms of a minute peripheral blood flow disorder

Exclusion Criteria:

* Cases with either an already-diagnosed coronary arterial disease or a peripheral vascular disease
* Cases with a history of stroke
* Cases with an abnormal finding of vascular stiffness test (PWV and ABI) and plethysmography of legs (PVR)
* Pregnant women or fertile women with an unclear pregnancy
Per-Oral Endoscopic Myotomy (P.O.E.M.) for Treatment of Esophageal Motility Disorders

Spastic esophageal motility disorders induced significant symptoms including dysphagia, retrosternal pain and regurgitation. Per oral endoscopic myotomy (P.O.E.M.) is a novel approach to perform myotomy through the esophagus with long submucosal tunnel. This study aimed to investigate the feasibility and safety of P.O.E.M. and translate the techniques from animal study to clinical practice in human.


Eligibility Criteria:
Inclusion Criteria:

* All patients with age ranged 18 to 80 who had primary esophageal motility disorders will be recruited. The primary motility disorders included: Achalasia, hypertensive LES, Nutcracker esophagus and Diffuse esophageal spasm.

Exclusion Criteria:

* Patients will be excluded from this study with the followings -

  1. Pregnancy
  2. Informed consent not available
  3. Previous history of esophagectomy or mediastinal surgery
  4. Previous history of endoscopic resection for early esophageal cancers, including endoscopic mucosal resection and endoscopic submucosal dissection
  5. End-stage Achalasia with dilated esophagus more than 6cm on Barium swallow
A Study To Evaluate The Safety And Pharmacokinetic Profile Of A P38 Inhibitor (PH-797804) In Subjects With Rheumatoid Arthritis Who Are Also Taking Methotrexate

The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Adult with RA for at least 6 months
* Stable weekly dosage of oral methotrexate 12.5- 25 mg/week

Exclusion Criteria:

* Severe, progressive and/or uncontrolled other disease
* Chronic or recent serious infection; current infection
* Concomitant use of RA therapy other than methotrexate with some exceptions
Patient Education at Dismissal After Surgical Procedure

Can improvements in patient dismissal education materials reduce incidence of wound non-healing and infection.

The investigators seek to address the specific educational needs of patients and caregivers with low-literacy, dyslexia and related learning disabilities in the context of properly performing wound care for patients with surgical wounds. Specific aims include both improving care by decreasing wound complications and improving patient satisfaction by using techniques designed for this population. Objectives include utilizing surveys to determine the incidence of dyslexia among the patients' and caregivers' within the general surgery service as well as the perception of our current educational offerings, to design a new dismissal package with enhanced educational offerings, to re-measure this effect on the patient experience with survey data, and to compare wound infection rates before and after implementing the new curriculum. Dyslexia and associated learning disabilities are common and likely impact the health literacy among this population due to the ubiquitous literacy-based documentation of hospital course and dismissal instructions. Adults with dyslexia may be reluctant to disclose any inability to understand written instructions. There is currently no mechanism within the dismissal system to specifically identify and address the unique needs of this population. The impact on clinical outcomes of proper wound packing is substantial, and if performed incorrectly can lead to slow wound healing and infections that often require readmission, multiple courses of antibiotics, and reoperation. In severe cases, improper wound care can lead to severe infection, sepsis, and death. By enhancing the educational offerings of proper wound care to this population, the investigators hope to reduce these complications.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients on the general surgery service with open wounds requiring packing

Exclusion Criteria:

* Patients with wound vacs
* Patients receiving exclusively professional wound care or home health services
Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer

This randomized phase II trial studies how well low-dose ibuprofen in improving cognitive impairment in patients with cancer. Anti-inflammatory agents, such as ibuprofen, may slow the decline of cognitive processes and diseases involving the brain.

PRIMARY OBJECTIVES:

I. To provide preliminary data on the effect of ibuprofen on alleviating chemotherapy-related cognitive impairment (CRCI) in cancer patients receiving chemotherapy or who have received chemotherapy within the last 6 months compared to a placebo control, as assessed by the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog).

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive ibuprofen orally (PO) twice daily (BID) for 6 weeks.

ARM II: Patients receive placebo PO BID for 6 weeks.

After completion of study, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy or who have received chemotherapy within the last 6 months; chemotherapy with concurrent radiation therapy (RT) is allowed
* Answer YES to the question: "Have you noticed any problems in your memory, attention, concentration, multi-tasking or other cognitive functions?" any time after initiation of chemotherapy cycle 1

  * NOTE: If a participant answers NO, they may be re-approached at a subsequent cycle
* Be able to swallow medication
* Be able to read English
* Have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist

Exclusion Criteria:

* Have a confirmed brain tumor or brain metastases
* Be taking a regular daily dose of an NSAID NOTE: Daily doses of 81 mg aspirin are permitted and higher doses of an NSAID on an 'as needed' basis are permitted
* Be diagnosed with dementia or severe neurodegenerative disease
* Have a contraindication to NSAIDs at the oncologist's discretion (i.e., allergy, worsening of ongoing medical problem due to NSAID, very low platelet count from chemotherapy, full-dose anti-coagulation/high risk of bleeding, and uncontrolled conditions such as hypertension, asthma, or peptic ulcer disease)
* Have been hospitalized for treatment of a major psychiatric illness within the last five years
* Have a serum creatinine above 1.5 upper limit of normal (ULN) (collected within the past 4 weeks); ULN is per institutional definition
* Concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or to interfere with antiplatelet activities
* Be colorblind
* Have active substance abuse (e.g. alcohol, drugs) per self-report or medical record