cyrilzakka/clinical-trials huggingface dataset:
Fractional Laser Therapy and Dermabrasion for Scar Revision

The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.

Post traumatic and post surgical scar resurfacing is a common reason for patient visits to dermatologists and plastic surgeons. The Fraxel Laser is a new FDA cleared treatment for textural irregularities of the skin. There have been no studies examining the efficacy of Fraxel specifically for scar resurfacing though it is being used in clinical practice as its clearance was given under hte umbrella of "coagulation of soft tissue." Dermabrasion is the gold standard for scar resurfacing and provides the criterion against which Fraxel therapy should be measured.

Eligibility Criteria:
Inclusion Criteria:

* post surgical or post traumatic scar on face or scalp
* age 18 or older
* able to read and comprehend English
* Willing to follow treatment schedule and post treatment care requirements
* signed informed consent form
* Fitzpatrick skin type I-III

Exclusion Criteria:

* known photosensitivity
* taken any medications known to induce photosensitivity in previous three months
* taken accutane within past 12 months
* pregnant or nursing
* currently on topical or oral antibiotics
* immunocompromised status
* skin type IV or greater
The Effect of Abdominal Massage and Warm Application on Excretory Activity in Patients Undergoing Total Knee Replacement With Spinal Anesthesia

The aim of this study was to determine the effect of abdominal massage and warm application on the excretory activity (time of first bowel sounds, defecation time and the amount of laxative used until discharge) after total knee replacement surgery performed with spinal anesthesia.

Abdominal massage and hot application will be applied to the patients at least 30 minutes after the morning and evening meals (08:30 am, 20:30 pm) for 15 minutes each, similar to the literature. The hot application will be applied to the abdominal area with a hot water thermophore for 15 minutes before the abdominal massage. After the hot application, abdominal massage will be started. In the abdominal massage, which will be applied clockwise to stimulate bowel movements, four basic movements will be used: superficial exertion, deep exertion, petrisage and vibration. Abdominal massage will be applied to the patients in accordance with the Abdominal Massage Application Checklist created by the researcher in line with the literature.

Warm application and abdominal massage will be applied to the study group from the first evening of the total knee replacement procedure, and the application will continue in the morning and evening hours until the first defecation. After the application, bowel sounds will be listened to in accordance with the application steps. In the control group, bowel sounds will be listened to at times corresponding to the hours of hot application and abdominal massage, daily laxative use will be determined and recorded in the Excretory Activity Form.

Eligibility Criteria:
Inclusion Criteria:

* Written and verbal permission was obtained to participate in the study,
* 18 years of age or older,
* Conscious, oriented and cooperative,
* Speaks and understands Turkish,
* Total knee replacement with spinal anesthesia planned,
* No condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumors, surgical intervention or radiotherapy to the abdominal area, presence or suspicion of ileus, and pregnancy),
* No physician-diagnosed chronic constipation,
* Mobilized,
* Patients who do not have problems with transition to oral feeding and can be fed orally will be included.

Exclusion Criteria:

* Written and verbal permission to participate in the research could not be obtained,
* Under 18 years of age,
* Unconscious, disoriented and uncooperative,
* Can speak Turkish but cannot understand it,
* Total knee replacement with general anesthesia planned,
* Any condition in which abdominal massage is contraindicated (inflammatory bowel disease, presence of abdominal tumors, surgical intervention or radiotherapy to the abdominal area, presence or suspicion of ileus, and pregnancy),
* Physician-diagnosed chronic constipation,
* Non-mobilized,
* Patients who have problems with transition to oral feeding and who cannot be fed orally will not be included.
Chemical Analysis of Limb Microfluidics

Compartment syndrome (CS) is a condition where an increase in pressure in an anatomical compartment (e.g. the lower leg) affects the blood supply of the tissues, leading to tissue damage. The condition is difficult to diagnose, and more difficult to determine when and how to manage it.

Treatment aims to reduce the pressure in the compartment by whatever means possible. Surgical management by of CS is highly invasive and has associated risks including infection, damage to local structures (i.e. nerves), and possibly the inability to close the wound leading to the need for further reconstructive procedures.

The clinical challenge in suspected CS is knowing if and when to intervene. Some cases of mild CS may resolve without an operation, and therefore intervening too soon causes unnecessary harm to the patient. However, waiting too long to operate with high compartmental pressures may lead to irreversible damage to the tissues, resulting in either a useless limb or necrotic tissue needing amputation.

Current strategies for determining limb health include interrogation of symptoms, signs on examination, and serial measurements of compartmental pressures, but no absolute measurement of tissue health. As such, there is an element of clinical judgment in management and no evidence base with which to develop clear treatment guidelines. There is a need for a minimally invasive method of continuously monitoring tissue health to improve the understanding of CS and its management before significant improvement in patient outcomes can be delivered.

It is proposed the application of leg "microfluidics" - analysis of samples of leg fluid - in a series of predictable clinical scenarios which simulate the threatened and unsalvageable limb. This is with an ultimate aim of developing a method of limb fluid sampling that can predict if CS is present and requires intervention.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (aged greater than or equal to 18 years) who are either:

i. Undergoing an intervention where there is a controlled reduction in blood flow to the limb that is reversible (e.g. using a tourniquet or clamp) or irreversible (e.g. during limb amputation).

ii. At risk of developing compartment syndrome following trauma or surgical intervention as determined by the clinical care team.

Exclusion Criteria:

Age \<18 years old Unable to provide informed consent
To Pace or Not to Pace in Sinus Node Disease

Optimal pacing strategy for patients with SND is still unknown, although several publications in the past years demonstrated a deleterious effect of ventricular pacing. However, pacing has always been apical in these trials, and to which extent this absence of pacing is beneficial for patients with very long PR intervals is still to be found.

The aim of this study is to compare ventricular septal pacing to no pacing in patients with SND.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sinus node disease

Exclusion Criteria:

* Complete or high degree AV block
* Permanent atrial fibrillation
Nerve Stimulation to Modify a Spinal Reflex

This study will determine whether stimulating the nerves or the brain can modify the spinal reflex that controls the muscles that flex and extend the ankle. Training spinal nerve networks with sensory input may provide a way of re-establishing movements, such as walking, in patients with spinal injury.

Healthy normal volunteers with no history of peripheral neuropathy or radiculopathy, ankle contractures or tendon surgery may be eligible for this study. Participants will undergo three stimulation procedures, each in a different session, to measure leg muscle reflexes. The procedures are:

* Reflex testing - Metal electrodes are taped to the skin over the leg muscles. A small electrical pulse is delivered through the electrodes to stimulate two nerves to the muscles. This evokes a reflex between the ankle flexor and extensor muscles. The responses to several dozen stimuli are averaged.
* Nerve stimulation - The nerve to the muscle that flexes the leg is electrically stimulated near the knee through electrodes taped to the skin. The strength of the stimulus is adjusted to produce little or no muscle movement. The stimulation is repeated every few seconds for 45 minutes.
* Transcranial magnetic stimulation - An insulated wire coil is placed on the subject's scalp. A brief electrical current passes through the coil, creating a magnetic pulse that travels through the scalp and skull and causes small electrical currents in the outer part of the brain. There may be twitching in the muscles of the arm or leg. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions to help determine the best position for the coil over the part of the brain that controls the leg. The leg is then stimulated once every 10 seconds, combined with nerve stimulation every 1 to 2 seconds.

Training of spinal interneuronal networks may offer a means for re-establishing movements such as locomotion in patients with spinal injury. Sensory feedback in the pattern which results from the leg movement is hypothesized to be the critical component for training spinal networks. This protocol will address the basic assumption underlying such training: can a specific pattern of sensory input modify the strength of a spinal cord circuit? We will test whether peripheral nerve stimulation can modify the strength of the spinal reflex mediating reciprocal inhibition between ankle flexor and extensor muscles in normal subjects, comparing patterned and unpatterned stimulation.

Eligibility Criteria:
INCLUSION CRITERIA:

Healthy adult volunteers willing to participate

EXCLUSION CRITERIA:

History of peripheral neuropathy or radiculopathy

Implanted devices, including pacemakers, pumps, and defibrillators

Ankle contractures or tendon surgery
Evaluation of the Integrated Home Dialysis Model

The purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis \[HHD\], peritoneal dialysis \[PD\] or a combination of both, e.g. PD and then HHD) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. The investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with PD or HHD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with PD/HHD 90 days after RRT initiation between January 1, 2000 and December 31, 2012 reported in ANZDATA
* ≥ 18 years

Exclusion Criteria:

* Less than 90 days of dialysis
* \< 18 years
* Patients transferred to Australia/New Zealand after initiation of dialysis in another country
Lifestyle Intervention for Rheumatoid Arthritis

The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.

The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.

Eligibility Criteria:
Inclusion Criteria:

1. BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).
2. BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).
3. Age 18 or older
4. Medical diagnosis of RA

Exclusion Criteria:

1. Pregnancy
2. Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)
3. Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.
4. Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)
StrataXRT Versus Aquaphor for the Prevention and Management of Radiation Dermatitis

The aim of this study is to assess the efficacy and safety of StrataXRT® in comparison to standard of care (defined using the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) by assessing the severity of inguinal RD in patients receiving elective radiation therapy +/- systemic therapy to the bilateral inguinal nodes.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Life expectancy of at least 6 months
* Biopsy-confirmed malignancy without gross nodal involvement of the right or left inguinal regions
* Patients will receive elective radiation therapy to bilateral inguinal nodal regions prescribed to 45-50 Gy in 1.8-2 Gy fractions using photon or proton therapy
* No known allergy to studied products
* Able to give written informed consent, or have written consent given on their behalf
* Patients who are able and willing to attend the post-radiation weekly skin assessment appointments
* Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if preferred by patient. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Exclusion Criteria:

* Patients with gross cancer involvement of either or both inguinal regions.
* Patients who have received prior pelvic and/or inguinal radiation therapy.
* Patients who cannot apply the studied products to the inguinal region or have it administered to them as required by this study.
* Patients with any medical condition such as active connective tissue disorder that predisposes them to an increased risk of potentially severe radiation dermatitis.
* Patients with existing rashes or wounds in either inguinal region at baseline.
* Planned inguinal dissection within 90 days after completion of radiation therapy on this study.
* Female patients who are pregnant or breast feeding.
* Patients who are unable to give written informed consent, or are unable to have written consent given on their behalf.
PD1 Antibody and Lenalidomide as a Treatment for EBV-HLH or CAEBV

The present study was a prospective one-arm clinical study, in which EBV-HLH/chronic active EBV infection patients were selected as the main subjects to evaluate the effect of PD-1 antibody and lenalidomide regimens on ebv-dna and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with CAEBV confirmed by 2016 Revised World Health Organization classification.
2. If the patient has previously suffered CAEBV-HLH, the HLH should be in remission.
3. A woman of childbearing age must be determined not to be pregnant by a pregnancy test and is willing to take effective measures to prevent pregnancy during the trial period and ≥12 months after the last administration of the drug; All male subjects used contraceptive methods during the study period and ≥6 months after the last administration;
4. Ages Eligible for Study: 1 Year to 65 Years.
5. Sign the informed consent.

Exclusion Criteria:

1. Heart function above grade II (NYHA).
2. Pregnancy or lactating Women.
3. Allergic to PD-1 antibody or lenalidomide.
4. Active bleeding of the internal organs.
5. uncontrollable infection.
6. Participate in other clinical research at the same time.
Pathologic Assessment of Rectal Prolapse in the Young

Patients aging less than 45 years with rectal prolapse will undergo full pathologic and functional assessment to determine the underlying etiology.

Full clinical assessment of the patients will be conducted by history taking querying the type and duration of symptoms, associated medical conditions, history of previous surgery for rectal prolapse, and presence of fecal incontinence which will be graded by Wexner continence score. In addition, patients will undergo thorough general and local examination to determine the type of rectal prolapse (internal or external) and the condition of the anal sphincters and pelvic floor muscles.

Functional assessment of the anorectal region will be done by anal manometry to measure the resting and squeeze anal pressures, rectal sensation and compliance; endorectal ultrasonography to assess the integrity of the anal sphincters; and pudendal nerve terminal motor latency (PNTML) to exclude pudendal neuropathy.

Random biopsies (2-4 in number) will be taken from the pelvic floor muscles, external anal sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be preserved in formalin solution and will be sent for histopathological examination. Tissue samples will be subjected to immunohistochemistry to calculate the ratio between collagen type I and type III, and to reveal any myopathic or degenerative changes. Additionally, schistosomal affection of the pelvic floor muscles will be detected by immunohistochemistry examination for the ova of schistosomal mansoni.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders aging below 45 years with primary or recurrent rectal prolapse, whether internal or external prolapse

Exclusion Criteria:

* Patients above 45 years, patients with associated anorectal pathology as anal fissure, hemorrhoids or neoplasm, and patients with documented psychiatric or mental disorders.
Insufficient Cellular Oxygen in ICU Patients With Anaemia

The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the ICU.

Evidence is increasing that in some cases a Hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is an early indicator of oxygen disturbance in the cell and therefore a physiological trigger for red cell transfusion. The goals are: 1. Determining the feasibility of using mitoPO2 and the variability of mitoPO2 measurements in critically ill intensive care unit (ICU) patients before and after receiving a red cell transfusion 2. Describing the effects of red cell transfusion and the associated change in \[Hb\] on mitoPO2 and on other physiologic measures of tissue oxygenation and oxygen balance 3. Describing the association between mitoPO2 and vital organ functions. Included patients will undergo red cell transfusion as planned. However, red cell transfusion will be delayed by 2 hours. At multiple predefined moments data collection including blood samples and measurements of mitoPO2 will take place.

The results of this study cannot be immediately translated to clinical practice. Using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. Application will be in ICU patients with anaemia who might or might not profit from red cell transfusions. It will lead to a reduction of both over- and under- transfusion.

Eligibility Criteria:
Inclusion Criteria:

* adult patient admitted to the ICU
* Hb below 6.3 mmol/l (10 g/dl)
* central venous catheter in situ
* red cell transfusion planned

Exclusion Criteria:

* adults without a legal representative to ask for informed consent
* patients less than 18 years old
* pregnant or breast feeding women
* patients in need of emergency red cell transfusion e.g. bleeding
* not having a central venous catheter in situ
* porphyria and or known photodermatosis
* patients with an expected ICU stay \<24 hours
* patients with hypersensitivity to the active substance or to the plaster material of ALA
Genetic Autopsy and Sudden Death

The purpose of the study is to better identify hereditary cardiac causes of sudden unexpected death in young subjects through Next-Generation Sequencing of autopsy tissue

Monitoring :

For index cases group, all the data will be monitored. For the relatives group, only the informed consent will be monitored

Statistical analysis :

* Evaluate the additional elucidation rate of unexpected sudden death
* Evaluate causes obtained by Next Generation Sequencing (NGS) ( in comparison with conventional autopsy (macroscopic and / or microscopic)
* Descriptive study of the causes of sudden unexpected death, identified hereditary cardiac causes percentages compared via various diagnostic approaches
* Cost-effectiveness analysis

Data Management :

A database is created for the AGEMOS study with control of the discrepancies. All the index cases' data entered in the data base will be double checked

Eligibility Criteria:
Index cases :

Inclusion Criteria:

* Subjects of more than 2 years old and less than 41 years old
* Sudden unexpected death from natural and nontraumatic causes
* Macroscopic autopsy performed within 72 hours after death and without signs of body decomposition
* No extracardiac obvious causes, including toxicological analysis when available
* No significant coronary cause after autopsy (such as tight coronary stenosis, congenital abnormality of the arteries, coronary vasculitis)
* Informed consent of the close relation (family/reliable person) and / or legal representative

Relatives :

Inclusion Criteria:

* To be a first degree relative (parents, sister, brother, child) of a deceased subject included in the AGEMOS study and accept to perform medical examination and transmit results of examination