cyrilzakka/clinical-trials huggingface dataset:
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks

This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits.

Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat thickness reduction will be documented by ultrasound.

At the baseline visits health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.

The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart.

At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-899 device.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

Follow-ups visits at 1 month and 3 months after the final treatment will be held.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) of 20 to 35 kg/m2.
* Visible excess of adipose tissue confirmed with pinch test at the flanks ("love handles") area.
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
* Successful initial determination of the flanks' fat thickness by means of ultrasound.
* No procedure for fat reduction at the treated area in the last six months.
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
* Age between 18 and 70 years.

Exclusion Criteria:

* Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
* Metal implants
* Drug pumps
* Malignant tumor
* Pulmonary insufficiency
* Injured or otherwise impaired muscles in the treatment area
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy, postpartum period, nursing
* Graves' disease
* Scars, open lesions, and wounds at the treatment area
* Abdominal hernia
* Gynecological disease incl. inflammation in the pelvis
* Hip and rib cage trauma or recent surgery of those
* Previous liposuction in the treatment area in the last six months
* Unstable weight within the last 6 months (change in weight ± 3%)
* Previous body contouring or cellulite treatments in the flanks area in the last six months
* Any other disease or condition at the investigator's discretion
SGO Society of Gynecologic Oncologists Data Outcomes Project

SGO Society of Gynecologic Oncologists Data Outcomes Project.

Examines data over period of time

Eligibility Criteria:
Inclusion Criteria:

1. Must have a pelvic mass with surgery taking place.
Effectiveness of Slow Back Stroke Massage and Murrotal Quran on Fatigue and Quality of Life of Patients Undergoing Haemodialysis

The study aimed to investigate the effectiveness of slow back stroke massage and murrotal Quran on fatigue and quality of life on patients undergoing hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing hemodialysis minimal 6 months

Exclusion Criteria:

* patients with hear impairment
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS

The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 to 80 years old
* Clinically diagnosed to have lower urinary tract symptoms secondary to BPH:

  1. Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) \>=8
  2. Detectable prostatic enlargement determined by Digital Rectum Examination (DRE)
  3. Urinary flow between 5 to 15ml/second in a total void volume \>=150mL
* Currently on regular doxazosin GITS once-daily for at least 4 weeks without clinically significant side effects
* Complaints of erectile dysfunction with Erectile Function domain (EF) of the International Index of Erectile Function (IIEF) score \<= 21

Exclusion Criteria:

* Congestive heart failure, unstable angina, arrhythmia, myocardial infraction
* Hypertension or on any antihypertensive agents
* Take nitrate and medication contradicted to vardenafil
* Uncontrolled or poorly controlled diabetes mellitus
* Intolerance or contra-indicated for the use of vardenafil
* Hepatic disorder
A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)

This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of macular edema following retinal vein occlusion
* Prescribed OZURDEX®

Exclusion Criteria:

* Previous treatment with OZURDEX®
Emergency Department Acupuncture for Acute Musculoskeletal Pain Management

The purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the Emergency Department (ED) for treating acute musculoskeletal pain. The overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. This full-scale randomized controlled trial (RCT) has been statistically powered to test the effectiveness of ED-based acupuncture for both one-hour (Stage 1) and one-month (Stage 2) pain reduction outcomes. The feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews.

Stage 1 is a 2-phase study design. Phase (1): Enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. Subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ED visit. Subjects may also have a blood draw for biomarker analysis during their ED visit. A planned interim analysis of the first 60 patients (2/3 of the Phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for Phase 2. At interim analysis, it was determined by the DSMB that neither arm was superior, so the recommendation was to continue Stage 1 Phase 2 unchanged with 3 arms. Stage 1 is complete, and we will proceed with Stage 2 powered to the 4-week pain score outcome. Stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or older
* Clinical diagnosis of acute (≤7 days) musculoskeletal pain as determined by an ED provider
* Able to read and understand the consent form in English

Exclusion Criteria:

* Unable to receive acupuncture due to injury or infection of acupuncture sites
* Unwilling or unable to attend the follow-up outpatient acupuncture clinic
* Severe hearing or speech impairment
* Cognitive impairment, including evidence of drug, medication or alcohol intoxication, that would prevent comprehension of consent procedures or study measures and procedures
* Critical illness
* Deformity
* Medical condition that would contraindicate safe participation as determine by an ED provider
Primary Mediastinal Large B-cell Lymphoma With CNS Involvement

retrospective study focused on patients with a known diagnosis of PMLBCL which experienced a CNS relapse during the course of their disease to obtain information about the clinical characteristics, the management at diagnosis and at each relapses , and the outcome of these cases. The aim of the study is to put together the large International series on CNS+ PMLBCL data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy administered alone or concomitant with CNS prophylaxis , the information about the site of re biopsy when available , the dose intensity of lymphoma therapy received at relapse and the outcome of patients.

Both patients treated in routine practice or within clinical trials will be considered. Moreover to better characterized the pathological features of this rare entity a central pathological review of the initial diagnosis and when available of for histological confirmed relapse will be considered.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma (PMLBCL) according WHO Classification
* Had a recurrence/progression with Central Nervous System (CNS) involvement
* Availability of details on clinical presentation, treatment details and outcome
* Availability of details on pathological data for central review
* Age ≥18 years

Exclusion Criteria

* Patients with CNS lymphoma other than PMLBCL subtype
The Effects of Autologous Platelet-rich Plasma Supplement During Sperm Cryopreservation on Post-cryopreserved Sperm Quality

Sperm cryopreservation is an essential procedure for male fertility in certain situations, like cancer, vasectomy or other obstructive surgeries, autoimmunity diseases, immunosuppressive therapeutic strategies, or when the male partner is incapable of providing sufficient spermatozoa on the day of egg retrieval. Semen cryopreservation is mainly associated with decreased viability, motility, and DNA damage of spermatozoa due to the osmotic and mechanical stresses attributed to the freezing-thaw- ing process. Sperm cryodamage mainly originates from osmotic changes, cold shock, intracellular ice crystal formation, and oxidative stress. Based on this, some protective strategies have been proposed and developed, even the addition of cryoprotectants. Recently, Platelet-rich plasma (PRP) is becoming very popular in medicine. The therapeutic effect of platelets is related to alpha granule contents. A study showed that PRP modulates ROS toxicity through a different mechanism. VEGF detoxify oxidative damage via activation of the nuclear factor (erythroid- derived 2)-like2 (Nrf2) pathway. Oxidative stress modulation and apoptosis inhibition both have an essential role during the cryopreservation process. In this case, it raises the question of whether PRP can improve the sperm quality against freeze-thawing-induced damage. Therefore, the present study aimed to examine different concentrations of PRP on frozen-thawed sperm parameters of vitality, morphology, motility and DNA fragmentation

* Each participant will be collected a semen and PRP.
* Each semen will be separated into two specimens as the additional autologous platelet-rich plasma supplement group and control group (no adding autologous platelet-rich plasma). Both groups will undergo cryopreservation by Sperm vitrification for 14 days.
* The additional autologous platelet-rich plasma supplement group: the semen will be added by 5% PRP and mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
* The control group (no adding autologous platelet-rich plasma): the semen will be mixed with Sperm Freezing Medium and undergo cryopreservation by Sperm vitrification for 14 days.
* After 14 days, the vitrified semen was transferred to a water bath of 37 °C for thawing. And analyzed Semen analysis via Computer Assisted Sperm Analysis: CASA and analyzed DNA fragmentation

Eligibility Criteria:
Inclusion Criteria:

1. A man who be a Rajavithi hospital clients or staff.
2. Aged 20-40 years old.
3. Has normal semen analysis.
4. Can communicate and understand Thai language very well.
5. Voluntarily participated in the research.
6. Sexual abstinence for 2-7 days.

Exclusion Criteria:

1. A man who ever diagnosed with infertile patient.
2. A wan who diagnosed with any hematological disease such as Coagulation disorders, Hypertension, Thrombocytopenia, Platelet dysfunction.
The Role of Pulsed Dye Laser Therapy in the Management of Burn Scars

The purpose of this study is to determine the effects (good or bad) of pulsed dye laser treatment in burn scar height, texture, redness and pliability in acute burn injury.

While the literature tends to support the use of laser therapy in the management of burn scars, there is a definite lack of appropriately powered, randomized controlled trials. Laser therapy can be quite expensive when compared to other treatment modalities for burn scars, and while promising, its true usefulness has yet to be conclusively demonstrated. For this reason, our research group is proposing the commencement of two randomized controlled trial pilot studies assessing the effects of pulsed dye laser (PDL) on burn scars. The objectives of this project will be to determine the effectiveness of pulsed dye laser therapy on burn scar vascularity, pliability, height and texture. It has been hypothesized that the PDL works on acute injury to decrease scar formation, and the fractional laser works on scar that is quiescent to promote remodelling. Therefore the investigators are proposing to study both acute injury and late burn scars. This project will compare the effects of each laser type, and will either help support or refute the assertion that laser therapy can be used to improve burn scars.

Objectives:

To determine the benefit of pulsed dye laser treatment in improving burn scar height, texture, vascularity and pliability in acute burn injury.

Eligibility Criteria:
Inclusion Criteria:

* burn scar
* living in Winnipeg
* scar age one to 6 months
* Fitzpatrick I-III skin type

Exclusion Criteria:

* open wound
* active infection
* previous scar treatment with steroid injection or interferon
* established disposition towards keloid scarring
Novel Biophotonics Methodology for Colon Cancer Screening

This is a proposal to establish a Bioengineering Research Partnership (BRP). The major objective of the BRP is to refine and provide comprehensive, definitive multi-center validation of these novel methodologies for colorectal cancer (CRC) screening, thus providing a quantum leap in population screening.

Background and Significance highlights the impracticality to provide total colonic evaluation for the entire population. Risk-stratification via exploitation of the "field effect" is an attractive approach. However, all existing methodologies (e.g FOBT, fecal DNA, flexible sigmoidoscopy) are clearly suboptimal underscoring the need for novel tools for identifying the field effect.

1) We have developed ELF/LEBS for depth-selective (from \~30 to hundreds of microns) spectroscopic assessment of living tissue. 2) We tested these novel techniques in two animal models of CRC (the AOM-treated rat and MIN-mouse) and in human subjects (n=190). We demonstrated that ELF/LEBS has the potential to detect precancerous changes in the colon at a time point that precedes the formation of adenomas and other histological/molecular markers of CRC. 3) We demonstrated that rectal ELF/LEBS can detect field effect alterations in histologically normal rectal tissue changes due to the presence of adenomas anywhere in the colon. In our pilot studies, the diagnostic accuracy of rectal ELF/LEBS far exceeded any other currently known markers of CRC. Therefore, assaying ELF/LEBS in the rectum has the potential to provide accurate risk-stratification for colon carcinogenesis without the need for bowel preparation and colonoscopy. 4) We have developed prototypes of ELF and LEBS fiber-optics probes for in vivo use.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years old or older and is having a colonoscopy procedure.

Exclusion Criteria:

* Concurrent usage of anticoagulation or blood thinner medication within the last 7 days that would preclude Hx of Inflammatory Bowel Disease/Colitis/Chemotherapy.
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation

The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension.

The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* A diagnosis of open angle glaucoma or ocular hypertension
* Prior use of prostaglandin(s)
* Intra ocular pressure of 22-34 mmHg in at least one eye

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
* Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
* Presence of any abnormality or significant illness that could be expected to interfere with the study
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)

The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

The duration of treatment is 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery).
* Patient is scheduled to receive general anesthesia.
* Patient is scheduled to receive postoperative opioids.
Dose-Response of Exercise on Long-Term Weight Loss

The purpose is to examine varying durations and intensities of exercise on long-term weight loss.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. 21-45 years of age
3. BMI = 27-40 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 24 months. (Pregnancy will be based on self-report and will be included on the detailed medical history that is completed by subjects.)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
Effectiveness of Dental Trauma Educational Poster to Secondary Students

to investigate the effectiveness of the educational poster regarding knowledge of dental trauma for the secondary school students

To investigate the effectiveness of the educational poster about dental trauma to increase the knowledge of secondary students.

Schools will be randomly divided into two groups, baseline score of knowledge in questionnaire will be collected for all subjects. Poster will be sent to intervention group, the school will place it at the notice broad or area of similar function in the classroom. For the control group, nothing will be given, then after 2 weeks, the score of knowledge by the second questionnaire of both groups will be collected again.

To compare the difference in knowledge before and after in both groups, statistical test will be performed.

Investigators conduct a cluster randomized controlled trial. A list of secondary schools was requested from the Education Bureau. Secondary schools will be invited to join the study and then randomized to the intervention group and the control group in the unit of school using computer generated numbers. All students will fill in the first questionnaire and send it back to the investigator in 1 week. Then copies of the same poster will be given to the intervention schools, these schools will be requested to place them in the classrooms of the participating students. No poster will be given to the control group. After 2 weeks, the poster will be removed. The same questionnaire will be filled out by all the students in both groups and sent back in 1 week. Then the data will be processed to show whether the poster is effective to improve the knowledge of the students.

Eligibility Criteria:
Inclusion Criteria

- All secondary schools in Hong Kong that the students can read Chinese or English

Exclusion Criteria

- no school consent or individual guardian consent
Comparison of Perennial and Preseasonal Subcutaneous Immunotherapy

Specific immunotherapy, which involves the administration of allergic extracts to patients with symptoms of allergic disorder, is the leading therapeutical tool of modern allergology. According to the latest studies immunotherapy not only reduces symptoms' severity but also may modify the course of allergic disease by reducing the risk of new sensitisations and development of more advanced stages of the disease.It has been hypothesized basing on clinical observation that perennial immunotherapy is more effective and safer in comparison to preseasonal immunotherapy. The aim of the study was to compare the effect of perennial and preseasonal immunotherapy on rhinoconjunctivitis symptoms and safety of both treatments.


Eligibility Criteria:
Inclusion Criteria:

1. IgE-mediated seasonal allergic rhinitis with symptoms during the grass and rye pollens season (May, June, July);
2. Symptoms of allergic rhinoconjunctivitis requiring medication during the last season
3. Positive skin prick test to grass and rye pollens only with wheal at least as large as histamine control reaction and diameter \> 5mm;
4. For female patients effective contraception and negative pregnancy test results were necessary.

Exclusion Criteria:

1. Previous course of immunotherapy with grass and rye pollens extracts or allergens which are unknown during the last 5 years
2. FEV1 \< 80% of predicted
3. Uncontrolled bronchial asthma according to GINA
4. Non-allergic rhinoconjunctivitis
5. Severe acute or chronic diseases, severe inflammatory diseases
6. Autoimmune diseases, immunosuppression, neoplastic diseases
7. Severe psychiatric and psychological disorders including alcohol or drug abuse
8. Contraindication for application of adrenaline;
9. Treatment with beta-blockers
10. Pregnancy or lactation period
11. Females patients seeking to become pregnant
12. Low compliance.