cyrilzakka/clinical-trials huggingface dataset:
Comparison of Picosecond and Q-switched Laser for Benign Pigmented Lesions Treatment

The objective of this study is to evaluate the efficacy and safety of picosecond 532 and 1,064 nanometers laser in the treatment of benign pigmented lesions compared with q-switched 532 and 1,064 nanometers laser.

Benign pigmented lesions can be divided into epidermal lesions such as freckles, lentigines, solar lentigines or cafe au lait macules and dermal lesions such as Nevus of Ota or Hori's nevus.

Q-switched 532 and 1064 nm lasers were reported to be safe and effective in the treatment of these benign pigmented lesions. By using selective photothermolysis theory, both q-switched 532 and 1064 nm lasers target on melanin causes photomechanical destruction of the melanin. However, the occurrence of post inflammatory hyperpigmentation (PIH) were reported especially in patients with darker skin type.

Recently, picosecond 532, 755, 1064 nm laser was reported to treat benign pigmented lesions effectively. With their ultra short pulse duration (picosecond domain), it is ideally believed to be pure photomechanical effects without thermal injury to surrounding tissue. As a result, the incident of PIH should be reduced.

The investigators then aimed to compared the efficacy and efficacy of different pulse duration between nanosecond and picosecond laser in the treatment of benign pigmented lesions.

Eligibility Criteria:
Inclusion Criteria:

* age \>18
* having any benign pigmented lesions on both sides of the face or any tattoo on any part of body which would like to be removed
* Fitzpatrick skin phototype 3-5

Exclusion Criteria:

* Previously treated with any laser within 3 months before enrollment into the study
* Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind
* Patients who have photosensitive dermatoses
* Pregnancy and lactation woman
* Patients with wound infections (herpes, other) on the day of treatment
* Patients with moderate and severe inflammatory acne, Immunosuppressed patients, history of vitiligo
* Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care
Resistance Swallowing Training in Patients With Tracheotomy

The goal of this clinical trial is to learn investigate the effect of instrument-assisted early progressive resistance swallowing training on swallowing related muscle strength in critically ill patients. It will also learn about the safety of swallowing training. The main questions it aims to answer are:

* Does instrument-assisted early progressive resistance swallowing training increase the swallowing related muscle strength in critically ill patients?
* What medical problems do participants have when taking swallowing training?

Researchers will compare instrument-assisted early progressive resistance swallowing training to pure effortful swallowing to see if instrument-assisted early progressive resistance swallowing training works to increase muscle strength.

Participants will:

-Take instrument-assisted early progressive resistance swallowing training or pure effortful swallowing every day for 2 weeks and take muscle strength test every week.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Tracheotomy after intubation and ventilator ventilation
* Receiving treatment in ICU, and expected hospital stay \> 2 weeks after pneumonectomy
* Be able to cooperate to complete the maximum anterior tongue pressure test

Exclusion Criteria:

* Inability to cooperate with tongue pressure testing and swallowing training, including disturbance of consciousness, oropharyngeal neuromuscular or motor impairment
* Patients refuse to participate in this study
* Significant malocclusion and facial asymmetry
Cardiotoxic Effects of Chemotherapy in Patients With Sarcomas: A Two and Three-dimensional Echocardiographic Speckle Tracking Imaging Study

This study is being done to identify markers that will allow researchers to identify in advance patients with sarcomas who are at highest risk for developing heart failure related to chemotherapy.

PRIMARY OBJECTIVES:

I. To detect acute and subacute changes in myocardial function by two-dimensional (2D)-Speckle Tracking Echocardiography (STE) derived strain and strain rate in sarcoma patients undergoing chemotherapeutic treatment.

Ia. To compare 2D-STE and three-dimensional (3D)-STE derived strain and strain-rate; Ib. To compare 2D-STE and 2D- and 3D-left ventricle ejection fraction (LVEF); Ic. If feasible, to compare 2D-STE and cardiac biomarkers \[serum cardiac troponin T and N-terminal fragment of brain natriuretic peptide (NT-proBNP)\].

II. To predict chemotherapy-induced cardiotoxicity by using 2D-STE and/or other significant parameters for early detection of cardiac dysfunction.

OUTLINE: This is an observational study.

Patients receive anthracycline once a day or split between 2-3 days per standard of care (SOC). Patients undergo 2D-STE throughout the study and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed at Mayo Clinic and treated for sarcoma with doxorubicin as first-line treatment

Exclusion Criteria:

* First-line treatment not including doxorubicin

  * Treatment performed outside of Mayo Clinic with different protocols
  * Age \< 18 years
The Prognostic Significance of Premature Ventricular Complexes in Patients Without Structural Heart Disease

With this project the investigators aim to investigate whether premature ventricular complexes (PVC) have a prognostic significance in persons without structural heart disease. Further the investigators look at the possible connection between PVC-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in PVC-patients with normal findings at echocardiography.

The PULSE project consists of four different studies:

* in study one the investigators include patients who are evaluated because of PVCs and have no signs of structural heart disease at echocardiography and exercise test. The investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population
* in study two the investigators carry out a sub-group analysis of the population in study one to assess whether PVC:s different sites of origin (morphology) are related to the clinical outcome
* in study three the investigators include persons with a high PVC-burden (at least 10 000 PVC:s/day) and normal echocardiography. The included subjects undergo magnetic resonance (MR) to investigate whether it can identify signs of heart disease where standard echocardiography cannot

Eligibility Criteria:
Inclusion Criteria:

- Diagnosed with Premature Ventricular Complexes at Three major Hospitals in Stockholm, Sweden

Exclusion Criteria:

* History of Myocardial Infarction
* Undergone coronary arterty bypass grafting (CABG)
* Finding of Heart Failure at echocardiography
* Direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable kidney cancer.

OBJECTIVES:

* Evaluate the best response in patients with advanced or unresectable renal cell carcinoma (RCC) treated with lenalidomide.
* Evaluate the response duration, time to tumor progression, and survival of patients with advanced RCC treated with lenalidomide.
* Evaluate the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed renal cell carcinoma (RCC)

  * Advanced or unresectable RCC
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan
* No brain metastases

  * Brain metastases that have been treated with either radiotherapy or surgery and remain asymptomatic, with no active brain metastases, as shown by CT scan or MRI, for ≥ 6 months are allowed

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancies within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide or thalidomide
* No uncontrolled intercurrent illness including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatric illness or social situation that would limit study compliance
* No hepatitis A, B, or C positivity
* No HIV positivity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 1 prior systemic therapy for RCC (e.g., chemotherapy, hormonal therapy, immunotherapy)
* At least 4 weeks since prior surgery, radiotherapy, hormonal therapy, chemotherapy, or immunotherapy and recovered
* No prior lenalidomide
* No other concurrent anticancer agents or treatments
* No other concurrent investigational agents
* No concurrent sargramostim (GM-CSF), radiotherapy, or thalidomide
Efficacy and Safety of TD-1473 in Crohn's Disease

A Phase 2 study to evaluate the efficacy, safety and tolerability of TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 48 weeks of treatment.

A Phase 2 multi-center, randomized, double blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 12 weeks of induction therapy with TD˗1473 in subjects with moderately-to-severely active Crohn's Disease. This study includes 3 phases: Screening, Induction, and Active Treatment Extension (ATE). The Induction phase of the study is a randomized, double blind, placebo controlled, parallel group study evaluating 2 oral dose levels of TD-1473 compared to placebo for 12 weeks in subjects with moderately to-severely active CD. Subjects who complete Induction will continue to receive TD-1473 in the ATE, for up to 48 additional weeks.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age at screening
* Males and females with clinical evidence of Crohn's disease for at least 3 months duration at screening
* Moderately-to-severely active Crohn's Disease at baseline, as defined by a Crohn's Disease Activity Index (CDAI) score of 220-450 inclusive
* SES-CD score of ≥ 3 with ulceration (corresponding to a score of 1) in at least 1 of the 5 ileocolonic segments on the Ulcerated Surface subscore of the SES-CD\]
* Is corticosteroid-dependent or has demonstrated inadequate response, or intolerance to conventional therapy (aminosalicylates, corticosteroids and immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate) or biologics (e.g., anti-TNF therapy, anti-IL-12/23 (anti-interleukin), anti-integrin).
* Additional inclusion criteria apply

Exclusion Criteria:

* Is currently receiving biologic (anti-TNF, anti-integrin, or anti-IL12/23) therapy
* Has a current bacterial, parasitic, fungal, or viral infection
* Has clinically significant abnormalities in laboratory evaluations
* Prior exposure or potential exposure to a JAK inhibitor that was stopped due to intolerance or lack of efficacy
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening or 5x the half-life of the investigational drug, whichever is longer, or is currently participating in another trial of an investigational drug (or medical device)
* Subject has failed ≥ 3 biologic agents of 3 different mechanisms of action (i.e., anti-TNF, anti-integrin, and anti-IL12/23)
* Additional exclusion criteria apply
Rehabilitation of Patients After Subarachnoid Hemorrhage

The study's main objective will be to assess which effect early initiated rehabilitation has on the frequency of complications and the level of physical and cognitive functioning after aneurysmal subarachnoid hemorrhage (SAH).

To this end the following aspects will be investigated:

The frequency of complications (with special emphasis on pulmonary complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains and lines)

* Length of stay in hospitals and socio-economic impact
* Physical and cognitive function in the early and chronic phase after SAH
* Health-related quality of life and participation in society in the chronic phase

Oslo University Hospital (OUS) is the primary hospital for Health Region South-East regarding treatment of patients with SAH. Approximately 120 patients are referred annually. OUS,Rikshospitalet, Dept of Neurosurgery offers 24/7 service of surgical and vascular aneurysm repair performed by a dedicated vascular team.

Patients admitted in 2012 are treated in accordance to the standard institutional protocol plus an early rehabilitation model adapted to SAH, while patients admitted in 2011 who did not receive any early rehabilitation, but apart from that were treated identically, serve as a control group.

All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study. Examination of the patients from both 2011 and 2012 will be performed as part of routine, neurosurgical follow- up which is in the early phase at 3-6 months and in the chronic phase at least 12 months post SAH. Exclusion criteria for participation in the study: unsecured ruptured aneurysm, symptomatic aneurysm without rupture, previous SAH or brain injury, diagnosis of a neurodegenerative disorder, patients from other health regions or tourists, patients that were treated at the intensive care unit (ICU )only.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study.

Exclusion Criteria:

* Unsecured ruptured aneurysm,
* Symptomatic aneurysm without rupture
* Previous SAH or brain injury, diagnosis of a neurodegenerative disorder
* Patients from other health regions or tourists
* Patients that were treated at the intensive care unit (ICU )only.
ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

ABX Plus Cisplatin Versus Gemcitabine Plus Cisplatin in Triple Negative Breast Cancer (TNBC)

A Phase III, Multicenter, Randomized Study of ABX Plus Cisplatin (AP) Versus Gemcitabine Plus Cisplatin (GP) as First-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 70 years old
2. Histological proven unresectable recurrent or advanced breast cancer, including de novo stage IV disease.
3. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER \<1%, PR \<1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+). For those with Her2 (1+), FISH test might be considered by the investigator.
4. No prior chemotherapy for metastatic breast cancer is permitted. Prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
5. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)
6. Performance status no more than 1
7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function
8. Life expectancy longer than 12 weeks
9. No serious medical history of heart, lung, liver and kidney
10. Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
3. Treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
4. Treatment with an investigational product within 4 weeks before the first treatment
5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration
6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
7. Patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
8. Uncontrolled serious infection
The Reproducibility Of Diffusion Weighted Magnetic Resonance Imaging For Neuroendocrine Tumor Liver Metastases

Imaging with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) is normally used to see how tumors respond to treatment. If tumors shrink after therapy, doctors continue with the same treatment. On the other hand, growing tumors in a patient can bring about a change in therapy. Unfortunately, it often takes three to six months, or even longer before the investigators see tumors shrink or grow on scans. Doctors are looking for new imaging tools that can look at how tumors respond early on during treatment. This study will help us decide if such an MRI technology called DWI (Diffusion Weighted Imaging) can be used as a helpful imaging tool.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologic evidence of well differentiated neuroendocrine tumor of gastroenteropancreatic origin
* Evidence of metastatic disease of at least 2.0 cm in the liver by MRI or CT imaging.
* Patient ≥18 years of age on the day of signing informed consent.

Exclusion Criteria:

* Any contraindication to MRI based on departmental MR questionnaire
* Inability to cooperate for an MR exam
* Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy or one that would not interfere with the MRI results is allowed.
* Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
Active Intervention for Patients With Neck Pain

Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. More than 80 % of individuals experience neck pain and neck associated disorders. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

While neck pain can be severely disabling and costly, treatment options have shown moderate evidence of effectiveness. The optimal physiotherapy intervention is currently unclear. Consequently, more research in this area combining different techniques in patients with a specific clinical profile is needed. It has been previously shown that participants prefer self-care measures for the management of neck pain. The aim of this study was to investigate the effects of a 4-week active exercising program in patients with chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

* To suffer from chronic neck pain (at least 3 months' duration)
* Neck pain of at least 3 on a visual analogue scale.
* Participants' symptoms should be at least partly related to increased nerve mechanosensitivity in the neck and upper limb confirmed by the reproduction of participants' symptoms by median nerve upper-limb neurodynamic test.

Exclusion Criteria:

* Whiplash related neck pain.
* Previous cervical surgical intervention.
* Cognitive impairments which prevent them to follow instructions.
* Visual or acoustic limitations.