cyrilzakka/clinical-trials huggingface dataset:
Short Term Effectiveness Study of Juxta-Fit Versus Trico Bandages in the Treatment of Leg Lymphedema

Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device which can be easily adjusted to the circumference of the limb and is usually used during the maintenance phase of lymphedema treatment. The aim of the study is to assess the effectiveness of Juxta-Fit in the initial treatment phase of leg lymphedema compared to the traditional treatment with Trico bandages in relation to interface pressure and to explore if self-management by Juxta fit is efficient after a short demonstration. Data are collected at 0-2-24 hours

Application of marketed compression systems (Juxta-Fit or Trico bandages) used for treatment by trained specialists with assessment of the interface pressure and volume reduction. For the first two hours, bandages and Juxta fit will be applied by experienced medical staff and the use of the juxta-fit device will be explained to the patient. Thereafter the devices will be removed and patients in the Juxta fit group will apply the device themselves in the treatment. In this second phase after 2 hours, patients may adjust the Juxta-Fit according to their needs and comfort when they feel the device is getting too loose as activity of self-management during 24 hours. The patient will document this in a diary.

Detailed measuring data:

Volumetry:

Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.

Pressure:

Measurements after 0h, 2h (pre and post system change) and 24 h at the B1 region:

* Supine and standing to calculate the Static Stiffness Index (SSI);
* Supine with and without dorsal flexion to calculate the Dynamic Stiffness index (DSI).

Circumference measurement as safety parameter At 5 cm above the upper part of the patella the circumference is measured at 0-2-24 hours to monitor eventual fluids shift.

Questionnaire

- The Visual Analog Scale (VAS) is used at 0 (pre-treatment), 2 and 24 hours to register the comfort of the materials used.

Eligibility Criteria:
Inclusion criteria:

* Gender: male or female
* More than 18 years of age
* Patients with distal lymphedema of the leg requiring multilayer lymphedema bandaging of the leg stage 2/3 (pitting component)
* The patient is able to understand the study and is willing to give written informed consent to the study.

Exclusion criteria:

* Allergy to one of the used materials
* Proximal lymphedema (involvement of thigh, genitalia)
* Severe systemic diseases causing peripheral edema
* Acute superficial or deep vein thrombosis
* Arterial occlusive disease (stadium II, III or IV) Ankle Brachial Pulse Index (ABPI) \<0,8
* Local infection in the therapy area
* Auto-immunological disorders or vasculitis
* Use of systemic corticosteroids
* Inability to don, doff, and adjust the Juxta-Fit
* If the ankle circumference around the malleoli is greater than 38cm or if the difference between the arch circumference and the circumference around the base of the toes is greater than 7cm.
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies.

Safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. Local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Eligibility Criteria:
Inclusion Criteria:

* Completed Day 28 of either the DRM04-HH04 or DRM04-HH05 study with at least 80% treatment compliance
* Male or females

Exclusion Criteria:

* Subject has a clinically significant abnormality on physical exam, vital signs or ECG at the Week 4 visit of DRM04-HH04 or DRM04-HH05 study that would make further treatment with glycopyrronium contraindicated
* Male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy
* Any other condition which, in the judgement of the Investigator, would put the subject at unacceptable risk for participation in the study
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma

The primary objective is to determine the safety, tolerability, and preliminary efficacy of belzupacap sarotalocan for the treatment of primary indeterminate lesions and small choroidal melanoma (IL/CM).

This is an open-label, ascending single and repeat dose escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of up to 4 dose levels and repeat dose regimens of belzupacap sarotalocan via suprachoroidal administration with 1 or 2 laser applications per treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
* Have no evidence of metastatic disease confirmed by imaging
* Be treatment naïve for IL/CM

Exclusion Criteria:

* Have known contraindications or sensitivities to the study drug or laser
* Active ocular disease
Hydroxyurea in Young Children With Sickle Cell Anemia

The purpose of this study is to asses prospectively the safety and efficacy of hydroxyurea therapy in children with Sickle cell Anemia between ages 18 months and 5 years, with special emphasis on the ability of hydroxyurea to prevent or reverse chronic organ damage.

Previous studies have shown that hydroxyurea therapy in adults and older children with SCA improves laboratory parameters and ameliorates the clinical severity of disease. Little is known, however, about the effects of hydroxyurea on the chronic organ damage that occurs in patients with SCA and leads to significant morbidity and mortality in young adults. The objectives of this study are to assess the safety and efficacy of HU in young children with SCA and to determine whether HU preserves renal function, reduces transcranial doppler ultrasound (TCD) values, and prevents development of brain ischemia as evidenced by MRI/MRA imaging. In addition, we will evaluate the effects of hydroxyurea on quality of life

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Sickle Cell Anemia (Hb SS or Hb S beta zero-thalassemia)
Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome

The purpose of this research study is to learn how cancer care providers can help their patients communicate the need for genetic testing in families with inherited cancer syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Documentation of HBOC or Lynch-associated "pathogenic/ likely pathogenic" mutation per American College of Medical Genetics and Genomics criteria (1)
* Diagnosis of one or more invasive cancers: epithelial ovarian, fallopian tube, primary peritoneal, breast, colorectal, endometrial
* Mutation listed in NCCN guidelines with at least Category 2A evidence for intervention
* Over the age of 18
* Psychological ability and general health that permits completion of study requirements and follow-up
* Willingness to complete follow-up surveys in person, electronically, or by telephone for up to 6 months

Exclusion Criteria:

-"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria
Bovine Atelocollagen Skin Sensitization Test

Bovine atelocollagen skin testing of healthy adult volunteers to investigate the potential of allergy to atelocollagen medical device implants

Day 01: Receive 0.1 mL intradermal injection of atelocollagen skin test into left volar forearm.

Day 15: Receive 2nd intradermal injection of 0.1 mL atelocollagen skin test into right volar forearm (14 days after 1st injection).

Day 45: Final assessment of both injection sites (30 days after 2nd injection)

Note: ALL injection sites will be assessed clinically at 30 minutes (for observational purposes) and at 72 hours (to determine response) after each injection. Visit windows for 72 hour assessments, and Day 15 and Day 45 visits can occur up to 96 hours (4 days) after target time.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, of either sex, aged at least 18 years.
* Volunteers must be capable of understanding and following directions in English.
* Subjects who are healthy and have normal skin on the volar surface of the forearm.
* Subjects willing and able to comply with the requirements of the study.
* Subjects willing and able to comply with the follow-up requirements.
* Subjects willing and able to give written and verbal informed consent.

Exclusion Criteria:

* Subjects who are pregnant, nursing or intend to become pregnant.
* Current treatment by a physician for allergy, unless physician consulted by Investigator and participation was approved.
* Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month.
* Recent immunization, including COVID-19 (less than 14 days prior to skin test).
* Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
* Subjects with medical history indicating atopy or dermatographia ('skin writing').
* Subject has a current skin disease of any type apart from mild facial acne (e.g., eczema, psoriasis).
* Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
* Subjects who were or are currently being treated with any systemic immuno-suppressive therapy, including but not limited to chemotherapy agents or cortico-steroids (including inhaled or insufflated) within the past 3 months.
* Subjects who were or are currently being treated with any topical OTC drug or prescription therapy on their arms (below the elbow) within the past 3 months.
* Subjects with a history indicative of abnormal immune function (e.g., auto- immune diseases, HIV, cancer, etc.).
* Subjects with known lidocaine hypersensitivity.
* Subjects with known sensitivity to bovine collagen.
* Subjects who have a history of dietary beef allergy, undergoing desensitization to beef products or planning to undergo desensitization within the study evaluation period.
* Subjects with severe allergies manifested by a history of anaphylaxis.
* Subject is currently enrolled in an investigational drug or device study.
Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics

Progression of T2DM is widely accepted to be contributed by two main components: beta cell function deterioration where insulin secretion is impaired and insulin resistance where insulin physiological response is reduced. Insulin resistance and beta cell function will be estimated through a mathematical model, homeostasis model assessment. Fasting insulin and C-peptide will be measured using liquid chromatography tandem mass spectrometry. Insulin resistance and beta cell function is then compared with the glycaemic control, HbA1C.

Primary objective

• To investigate the association between the estimation of insulin resistance and beta cell function through homeostasis model assessment with HbA1C among oral anti-diabetics treatment non-responder.

Secondary Objectives

* To compare the insulin resistance and beta cell function between the OAD treatment responders (negative control) and non-responders
* To investigate the relationship between plasma level of metformin and gliclazide with the estimation of beta cell function and insulin resistance
* To identify the proportion of patients with high insulin resistance and proportion of patients with low beta cell function
* To identify difference in insulin resistance and beta cell function of different ethnic groups in Sarawak
* To compare insulin resistance with cardiovascular disease risk using Framingham Risk Score and ASCVD risk estimation

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed to have T2DM, currently treated with oral anti-diabetics agents (either on maximum dose of Metformin only or with maximum dose of Gliclazide) for at least 3 months with no change in medications and dosage during the period of 3 months

Exclusion Criteria:

* Patient that is on exogenous insulin, is on hormone replacement therapy or any steroids medications, with renal impairment with creatinine clearance less than 30ml/min and unable to provide informed consent
New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.

Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance.

The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.

This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for prostate biopsy
* Signed informed written consent

Exclusion Criteria:

* None (other than general contra indications for prostate biopsy or patient not willing to participate)
Safety and Tolerability of Topically Applied Bovine Lung Surfactant on Intact Skin

Bovine Lung Surfactant is used as standard therapy for reducing alveolar surface tension in preterm infants. Here the drug is administered via airways.

The use on skin to stimulate the wound healing has not yet been tested in humans, i.e. it is not yet approved for the treatment of wound healing disorders. In the planned clinical trial Lung Surfactant is used the first time for the local treatment of skin lesions in humans. No substance related side effects were observed during the application via airways in neonates.

The innovative idea to use lung surfactant for skin wound healing derived from two observations. First, when the skin is injured, the barrier protecting the moist body surface from the dry environment is discontinued and in part lost.

Lung surfactant has several characteristics that might be beneficial for treatment of chronic cutaneous wounds.


Eligibility Criteria:
Inclusion Criteria:

* Two healthy forearms,
* No known chronical skin diseases,
* Dermatoses or allergies,
* Signed form of consent,
* Caucasian

Exclusion Criteria:

* Pregnancy or nursing period,
* Diabetes (Type I or II),
* Systemic or infectious diseases,
* Skin disease,
* Known allergies against bovine products or wound dressings,
* Mental diseases, missing ability to consent,
* Addictive disorders (e.g. alcohol, drugs),
* Peripheral circulatory disorder, Morbus Raynaud,
* Current (or \< 4 weeks ago) participation in clinical trials
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.

A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers

E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged 18 to 60 years of age inclusive.
2. BMI between 18 to 35 kg / m2 inclusive.
3. Healthy based on medical history and screening assessments, in the opinion of the Investigator.
4. Current smoker of at least 8 cigarettes per day on average.
5. Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
6. Able to participate, and willing to give written informed consent and comply with study restrictions.

Exclusion Criteria:

1. Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
2. Clinically significant abnormality on screening ECG.
3. Sustained blood pressure recordings at screening of \< 90 mmHg or \> 150 mmHg for systolic blood pressure, or \< 50 mmHg or \> 90 mmHg for diastolic blood pressure.
4. Sustained resting heart rate of \> 100 or \< 40 beats per minute at screening.
5. Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
6. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
7. Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
8. Blood or plasma donation of \> 500 mL within 1 month prior to Assessment Day 1.
9. Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
10. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE

The Departments of Neurology and Neurosurgery are conducting this research study to evaluate the safety and effectiveness of intravascular angioplasty for the treatment of venous narrowing in the treatment of Multiple Sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* EDSS 0-6.5 (0-5.5 in the phase II of the study)
* Diagnosis of relapsing MS according to the McDonald criteria (Polman et al., 2005)
* 1 relapse within the past 12 months or GAD positive lesion on an MRI within the past 3 months (only for phase II of the study)
* Be on treatment with currently FDA approved disease-modifying treatments (excluding Tysabri or steroids (within the last 30 days prior to enrollment)
* Evidence of ≥2 sonographic parameters of suspicious abnormal extracranial cerebral venous outflow (see Table 1 background and 1.5 section)
* Normal renal function: creatinine clearance level of \>60

Exclusion Criteria:

* Relapse, disease progression and Tysabri and steroid treatment in the 30 days preceding study entry
* Pre-existing medical conditions known to be associated with brain pathology (e.g., neurodegenerative disorder, cerebrovascular disease, positive history of alcohol abuse, etc.)
* Severe peripheral chronic venous insufficiency
* Abnormal renal function
* Contrast allergy (anaphylaxis)
* Not accepting to undergo the endovascular treatment
* Peripheral Vascular Disease
The Correlation Between Maternal Infant Bonding, Pain and Postpartum Depression

The delivery process can be associated with significant maternal pain. which has many long and short term affects.

The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.

Delivery is a process that is correlated with maternal pain. The maternal pain can have signifcant long term and short term maternal and neontal impact.

The most common method for pain reilef during delivery is epidural analgesia. Few studies have examined the assocaition between use of epidural analgesia and postpartum depression, with some studies showing a postive correlation and other condricting so.

Maternal bonding is defined as her's emotional state, including maternal feelings towards the infant, it has proven to be the basis for the child's later attachment and sense of self.

A stable and strong bond between mother and child is associated with positive parental behavior and of the child's cognitive and behavioral development, while a unstable maternal infant bond can may lead to long term matenal and infant complications.

The aim of our study is to assess whether pain during and after childbirth negatively impacts a mother's attachment to her baby (maternal bonding) and the increases the incidence of postpartum depression.

In this study women the day after labor will be approched , following obtaining consent will be requested to fill out a the PBO vailadited maternal bonding questtionanire , the valadited EPDS (endinbough postpartum depression questionnaire) and a general questionnaire detailing their demographic , obstetric history and pain levels.

At six weeks postpartum a member of the research team will call the study participant and ask the PBO and EPDS questionnaires to asses the correlation between delivery pain , maternal bonding and postpartum depression,

Eligibility Criteria:
Inclusion Criteria:

\*Women whom have given birth at rabin medical center with the ability to follow study requirements.

Exclusion Criteria:

* Women given birth to twins
* Women who's baby was hospitalized
* Women who were treated with magnesium
* Women who's babies were born with congenital malformations