cyrilzakka/clinical-trials huggingface dataset:
Blue Light for Treating Eczema

Monocenter, randomized, intraindividual, open label, exploratory study comparing 4 weeks of treatment with 453nm blue light with no treatment in patients with Eczema. Patients will be screened up to 28 days before start of treatment. During the screening visit, the purpose and procedures of the study will be explained to potential patients and informed consent will be obtained. In addition, fungal superinfection of the target area will be examined using direct preparations and mycology cultures. At the baseline visit, patients with Eczema will be determined and all inclusion and exclusion criteria will be assessed. For eligible patients, two comparable treatment areas will be randomized to treatment with blue light (target area) or to serve as untreated control area. After randomization, patients will receive treatment of the target area with 3 applications per week at the investigational site for a total treatment period of 4 weeks. During those 4 weeks, safety and effectiveness assessments will be performed at weekly intervals. After end of treatment, the patients will be followed-up for another 2 weeks. In case no full resolution of adverse events occurred at the 2 week follow-up visit, a follow-up call will be performed after another 2 weeks. Treatment responses will be photo documented


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent prior to any study-mandated procedure
2. Good health as determined by the Investigator according to physical examination
3. Willing and able to comply with study requirements
4. Skin type I-IV according to Fitzpatrick
5. Eczema, severity defined by an Eczema Area Severity Index (EASI)smaller/equal 20
6. Comparable clinical symptomatology of both intended treatment Areas

8. Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intrauterine device \[IUD\] or transdermal contraceptive patch) 9. Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study

Exclusion Criteria:

1. Inmates of psychiatric wards, prisons, or other state institutions
2. Investigator or any other team member involved in the conduct of the clinical study
3. Participation in another clinical trial within the last 30 days
4. Pregnant and lactating women
5. Photodermatosis and/or Photosensitivity
6. Porphyria and/or hypersensitivity to porphyrins
7. Congenital or acquired immunodeficiency
8. Patients with any of the following conditions present on the study areas; Malignoma of the skin or severe actinic damage of the skin, atypical naevi or signs of hyperpigmentation, precancerosis viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic skin
9. Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome)
10. Current diagnosis of exfoliative or toxic dermatitis.
11. Evidence of superinfection of the intended treatment areas
The Effect of Different I:E Ratio on Gas Exchange of Patients Undergoing One-lung Ventilation for Lung Surgery

Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. We tried to evaluate the effect of IRV during OLV with lung protective strategy.

Pulmonary gas exchange disturbance is a common anesthetic problem during one-lung ventilation (OLV) for thoracic surgery. Continuous positive airway pressure or positive end-expiratory pressure are usually applied to improve this disorder including hypoxia, but these methods are not enough. The inverse-ratio ventilation (IRV), which prolongs the inspiratory time greater than expiratory time, can be applied for adult respiratory distress syndrome. The effect of IRV is to improve gas-exchange status by increasing mean airway pressure and alveolar recruitment. The application of IRV during OLV has not been performed to our knowledge, and there is a possibility of IRV to improve oxygenation during OLV. There is a possibility of increase of auto-PEEP, or air trapping in subjects with chronic obstructive pulmonary disease, but this kind of auto-PEEP can be overcome by external PEEP. Therefore, we tried to evaluate the effect of IRV during OLV with lung protective strategy.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective lung lobectomy surgery.
* the duration of one-lung ventilation is more than one hour.
* subjects with more than twenty years old.

Exclusion Criteria:

* subjects with past history of pneumothorax, asthma
* Age under 20, more than 70 years.
* Patients with ischemic heart disease, valvular heart disease
* patients with hemodynamic unstability
Effect of Light Emitting Diode Therapy on Muscle Fatigue

The purpose of this study is to determine the optimal time interval between light emitting diode application and exercise to improve fatigue resistance.The results of this study could be useful in planning a rehabilitation program in musculature disorders and also in athletic training.

1. To determine the effect of light emitting diode applied 5 minutes before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
2. To determine the effect of light emitting diode applied 1 hour before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
3. To determine the effect of light emitting diode applied 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.
4. To determine the difference between light emitting diode applied 5 minutes,1 hour or 5 hours before exercise on pain, rate of perceived exertion and maximum voluntary contraction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non athletics subjects.
* Age ranges from 20-40 years.
* Body mass index is less than 25 kg/m 2

Exclusion Criteria:

* Neurological deficit and recent injury to either upper extremity
* non diagnosed pain .
* Contraindications to LED irradiation (such as light hypersensitivity, fluctuating blood pressure, insufficient blood circulation, fever and inflammation of the skin)
* Conditions in which physical exertion is contraindicated (such as cardiovascular deficits, hypertension and respiratory problems)
* Restriction in shoulder or elbow range of motion;
* Neoplasm,
* Rheumatoid,
* Strength training in the past 6 months;
* Previous surgery in the spine or upper extremity;
* Complaints of pain in the shoulder, elbow,wrist, and trunk musculature system;
* Use of dietary supplements; and not in any other exercise program for at least the past 3 months.
Sham Device, Pill Placebo or Treatment For Arm Pain

This study investigates the role of two active interventions and their placebo effects in randomized control trials. The study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. The active interventions are amitriptyline and acupuncture. The placebo are sham acupuncture device and placebo pill.

There is evidence that the magnitude of the placebo effect produced by a device is greater than that produced by a pill. If this is the case, it has significant ramifications for all trials involving devices and for our understanding of the role of the placebo effect in randomized controlled trials (RCT). This two phase study 1)investigates the role of the placebo effect in RCT's and 2)conducts two trials of treatments for persistent upper extremity pain secondary to repetitive strain injury (RSI), including carpel tunnel syndrome. In Phase I. 240 patients with RSI are randomly assigned to receive a placebo device (a recently validated sham acupuncture device) or a placebo pill (dummy amitriptyline). Our primary hypothesis is that patients will respond better to the sham device than the placebo pill. A finding that sham acupuncture produces a greater placebo response than a placebo pill has important implications for the interpretation of results in trials that compare devices to sham devices, devices to pills, and medical management to surgery. Phase II randomly assigns patients from the sham acupuncture arm of Phase I to receive either TCA or continue to receive the sham version. Patients in the placebo pill arm of Phase I will be randomly assigned to receive either AMI or continue receiving the placebo pill. From the patients'perspective, the shift in treatment assignment from Phase I to II should not be noticeable. Phase II will allow us to test whether the active treatments outperform their respective placebos. Both of these treatments have shown promise in small studies, but neither has been prospectively studied in a large trial with appropriate controls. Because Phase I also functions as a run-in period for Phase II, analysis combining both phases will allow us to examine whether a run-in has methodological advantages in a device trial. Moreover, combined analyses permit testing whether patients level of response to placebo in Phase I affects their response to active treatment Phase II. A positive finding here would contribute importantly to our understanding of the role of the placebo in RCTs.

Eligibility Criteria:
Inclusion Criteria:

* Treated for repetitive strain injury for at least 3 months at a clinical site in the Greater Boston Area
Development of Machine Learning Models for the Prediction of Complications After Colonic, Colorectal and Small Intestine Anastomosis in Psychiatric and Non-psychiatric Patient Collectives (P-Study)

Our study aims to lay the basis for a predictive modeling service for postoperative complications and prolonged hospital stay in patients suffering from psychiatric diseases undergoing colorectal surgery.

Furthermore, we aim to investigate the impact of preoperative Risk factors, psychiatric and psychosomatic diseases on the outcomes of colorectal surgery and the complications after colorectal surgeries like anastomosis insufficiency via predictive modeling techniques

The service mentioned above will be publicly available as a web-based application


Eligibility Criteria:
Inclusion Criteria:

* Colocolic, colorectal and small intestine anastomosis
* Neoplasia,
* Diverticulitis
* Mesenteric ischemia
* Iatrogenic or traumatic perforation
* Inflammatory bowel disease

Exclusion Criteria:

* Patients \<18 years
* Patients suffering from recurrent colorectal cancer bearing
* Peritoneal carcinomatosis or unresectable metastatic disease at the time of bowel resection and anastomosis will be excluded.
* Patients who cannot be followed up on for more than six weeks after surgery
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
* Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Subjects with a history of TB or latent TB infection
* Subjects with a history of cancer
The Healthy Baby Bottoms Study

Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several factors including: excessive moisture, topical irritants, reduced pH, friction, maceration and bacterial infection. When infants soil their diaper, diaper contents saturate the area raising the pH of the skin above the normal level of 5 or less, and leaving the area highly vulnerable to maceration from friction. Irritants in urine and feces are then able to penetrate the macerated skin, causing inflammation and greater skin friability. An elevation in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such, Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper rash wounds, as well as for assisting with wound healing and reducing any associated pain. The purpose of this study is to determine caregivers' perceptions of the benefits of using Theraworx Foam on their infant's diaper area as part of their hygienic routine, including whether they feel the product is pleasant and easy to use, and whether they feel it helps prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.


Eligibility Criteria:
Inclusion Criteria:

* Read English at the 8th grade level
* Have reliable access to email for 7 weeks
* Complete the first online survey within 24 hours of the request
* Custodial guardian of an infant between the ages of 1-12 months old living with him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding recruitment

Exclusion Criteria:

* Does not have a stable address at which to receive a package of Theraworx and is unable/unwilling to pick it up at Children's National Health System
* Infant is immunocompromised, has a congenital disorder, or on the day of recruitment, has a diaper rash, has a moderate to severe illness requiring hospitalization or transfer to the emergency room, or was circumcised \<10 days prior.
"Diagnostic Yield and Safety of Transbronchial Lung Biopsy Using Cryoprobes Versus Conventional Forceps.

Transbronchial lung biopsy (TBLB) is a bronchoscopic procedure used to obtain peripheral lung tissue. Small size and artefacts cause variable, and usually poor, diagnostic yield. The use of cryoprobes may allow for larger size and better quality biopsy samples.

Objectives:To analyze the histological quality and immunohistochemical findings of samples obtained by cryoprobe compared with TBLB obtained by conventional forceps and to assess the safety and complications of TBLB with cryoprobe versus the conventional method.

Methodology:

Prospective randomized study of 80 patients. The transbronchial lung biopsy was indicated for diagnoses of a interstitial lung disease. In both procedures the videobroncoscopy used will be a Olympus 260-T.

The transbronchial lung biopsy will be carried out with conventional forceps (Boston ® Biopsy Forceps, Ref 1556 and Olympus ® FB-19E) and cryoprobe (Erbokryo AC ®). TBLB will be performed by fluoroscopy guided and the cryoprobe or forceps will place in an area of the peripheral lung previously selected according to CT findings. Lung biopsies will be processed: The samples submitted for histological analysis will be fixed in formalin and embedded in paraffin. Staining will perform with hematoxylin-eosin and Masson's trichrome and the samples will be analyzed by a pathologist according to a protocol. The samples submitted to immunohistochemical study will be frozen (liquid nitrogen) for later transport.The specifical monoclonal antibodies will be used for immunohistochemical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Interstitial Lung disease.

Exclusion Criteria:

* Respiratory failure,haemodynamic instability, haemoptysis.
Functionality of the Pulse Oximeter and Accelerometer Portions of a Novel Wearable Device

The purpose of this study is to asses the function of an oxygen sensor and the movement sensor in a novel device prototype.

After informing the patient about the study and the potential risk. The patient is asked to wear a prototype of a novel device to sense oxygen levels and movement for the duration of the visit. The day of the enrolment is when the visit will be completed. The patient is required to complete an overnight sleep test (no more than 15 hrs) with the prototype device worn on their index finger and wrist.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* 21 years of age or older
* Suspected to suffer from hypoxic events
* Able to provide informed consent

Exclusion Criteria:

* Pregnant
A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-60 years.
* Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
* Chronic HBV infection for ≥ 6 months.
* On NRTI therapy with HBV DNA \< LLOQ for ≥ 6 months.
* Serum ALT and AST ≤ ULN at screening visit.

Exclusion Criteria:

* Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
* Significant liver fibrosis or cirrhosis.
* History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
* History of hepatic decompensation.
* Diagnosed or suspected hepatocellular carcinoma.
* Current or past history of infection with HIV, HCV or HDV.
* Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
* Known history of immunological function impairment.
* History of intolerance to intramuscular or subcutaneous injection.
Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.

The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
* Heart transplantation above 3 years dated back
* Serum creatinine \< 3,5 mg/dl (310 µmol/l) and BUN \< 150 mg/dl
* Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month

Exclusion Criteria:

* Carcinoma within the last 3 years
* Acute rejection episodes during the last 6 month
* Infection requiring therapeutic intervention
* Hepatitis B, Hepatitis C or HIV infection
* WBC \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl
* Florid gastrointestinal ulcer
* Haemodialysis within the last 4 weeks before study entry
* Pregnancy / lactation
* Administration of other immunosuppressive agents than prescribed
* Mycophenolatmofetile incompatibility
Bleeding Ulcer and Erosions Study "BLUE Study"

A prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal tract - risk-medication, presence of Helicobacter pylori, treatment and outcome.

Patients admitted to hospital due to hematemesis and/or melena with endoscopic finding of ulcer and/or erosion in the ventricle and/or duodenum are eligible for inclusion in the BLUE study after an informed consent has been obtained. The gastroscopy must be performed within 72 hours after admission. Epidemiological data, comorbidity and past clinical history are recorded in addition to the consumption of defined risk medication and proton-pump inhibitors (PPI) during the last 4 weeks.

The Forrest classification is used to describe an ulcer if present at endoscopy and endoscopic modalities for treatment are used according to established recommendations. Surgery or radiological intervention will be applied if needed.

An infection with H. Pylori is diagnosed by different methods including a rapid urease test, culture and serology. If one of these tests is positive, the patient will receive triple therapy. To secure successful eradication patients are tested with 13C UBT (breath test) or HP antigen stool test after 3 months and HP IgG serology after 6 months.

Registration of lowest haemoglobin (Hb) level during hospitalization and an algorithm to treatment with blood transfusion and/or high dose IV iron will be performed to evaluate alternative treatments to blood transfusions alone. Effect of treatment is evaluated at 8 weeks and 6 months. A follow-up gastroscopy and blood test is performed after 2-3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years who consent to be enrolled in the study
* Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum.
* Gastroscopy must be performed within 24 hours of the findings above.

Exclusion Criteria:

* Patients who do not wish to participate or are not competent to give consent.
* Patients that due to language problems or other reasons do not understand the content of the information about the study.
* Patients with erosions without hematemesis, in whom one diagnose possible bleeding source on colonoscopy.
* Patients with malignant ulcer, ulcer simplex or cameron lesions.