cyrilzakka/clinical-trials huggingface dataset:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation followed by combination chemotherapy in treating patients with metastatic prostate cancer that has not responded to hormone therapy.

OBJECTIVES: I. Evaluate the complete and partial remission rates and event free and overall survival of patients with metastatic hormone refractory prostate cancer treated with high dose chemotherapy plus peripheral stem cell transplantation followed by consolidation chemotherapy. II. Evaluate the toxic effects associated with this treatment in these patients. III. Evaluate the quality of life, and need for analgesics, in these patients.

OUTLINE: Patients are stratified by stage of disease and extent of metastatic disease. Patients receive daily filgrastim (G-CSF) subcutaneously for 4 days until peripheral blood stem cells are collected. Patients then receive carmustine IV over 2 hours on day -2 and melphalan IV over 20 minutes on day -1. Stem cell infusion will be on day 0. At 3, 6, 9, and 12 months after transplant, patients receive vinorelbine IV over 10 minutes and cisplatin IV over 24 hours. Quality of life and pain are assessed before the transplantation, just before discharge after transplantation, prior to each consolidation course, and then at 3, 6, and 12 months after the final course of chemotherapy. Patients are followed at least every 3 months for the first 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic hormone refractory adenocarcinoma of the prostate that is progressive on hormone based therapy, as demonstrated by: New metastatic lesion Consecutive series of increasing PSA levels following hormonal therapy No CNS disease

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: SWOG 0-2 (unless due to bone pain) Life expectancy: Not specified Hematopoietic: CD34+ at least 4 million/kg Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal No active chronic hepatitis or liver cirrhosis Renal: Creatinine no greater than 3 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% Pulmonary: FVC, FEV1, and corrected DLCO at least 50% of predicted (high resolution CT scan of chest and P02 at least 70 if unable to complete PFTs) Other: No active infection requiring intravenous antibiotics Not HIV positive

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than one course of cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: Not specified
Anti-Inflammatory Lifestyle Intervention for Emerging Adult Cancer Survivors

To test the feasibility and acceptability of AILI and associated research procedures among emerging adult cancer survivors (EACS, N=16) age 18-29.

This is a single-arm pilot trial designed to assess the feasibility and acceptability of an anti-inflammatory lifestyle intervention (AILI) for emerging adults (EA) adapted for emerging adult cancer survivors (EACS).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-29
* Cancer diagnosis of any type
* Body fat percentage \>16.2% for women; \>10.6% for men

Exclusion Criteria:

* Individuals receiving active chemotherapy/radiation or those having completed active chemotherapy/radiation within the past 6 months
* Individuals who are currently pregnant or lactating
* Current involvement in a weight loss program or current use of weight loss medication
* Individuals who report any other uncontrolled medical conditions that may pose a safety issue given the recommendations for the diet and unsupervised physical activity (e.g., uncontrolled hypertension)
* Individuals with rheumatologic and gastrointestinal conditions associated with severe systemic inflammation (e.g., rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease)
* Individuals with medical conditions resulting in known perturbations in the hypothalamic-pituitary-adrenal axis (e.g., endogenous hypercortisolemia \[Cushing's syndrome\] or adrenal insufficiency)
* Individuals who report a heart condition, chest pain during periods of activity or rest, or loss of consciousness as assessed by the Physical Activity Readiness Questionnaire (PAR-Q)
* Report of lifetime diagnosis of Anorexia Nervosa or Bulimia Nervosa, or any compensatory behaviors (vomiting, laxative abuse) within the previous 3 months
* Hospitalization for depression or other psychiatric disorder within the past 12 months
* Report of lifetime diagnosis of bipolar disorder or psychotic disorder
* Indication of current suicidal intent
* Inability to speak and read English
Effects of WB-EMS and High Protein Diet in IBD Patients

Patients with inflammatory bowel disease (IBD) often suffer from muscle weakness and a low bone mineral density as a consequence of systemic Inflammation and disease treatment limiting Quality of life in a considerable way. Exercise interventions to build up muscle mass and increasing physical function are promising Tools to improve the whole muscular Status of those patients. However, in the acute Phase of IBDs conventional Training methods may be too strenous, also because patients are suffering from acute gastrointestinal symptoms and feel fatigued. Due to those symptoms, patients present low Food intake and great loss of nutrients and energy especially by diarrhea. Individualized nutritional Support may be helpful to avoid malnutrition. The aim of this pilot study is to investigate the effect of a combined exercise and Nutrition Intervention using the gentle Training method of whole-body electromyostimulation (WB-EMS) combined with a individual high Protein nutritional Support on muscle mass, Body composition, physical function, Quality of life and gastrointestinal symptoms in outpatients with IBD.


Eligibility Criteria:
Inclusion Criteria:

* outpatients with inflammatory bowel disease (Crohn's disease, ulcerative Colitis)
* adults (18 years and older)

Exclusion Criteria:

* simultaneous participation in other nutritional or exercise intervention Trials
* acute cardiovascular events
* use of anabolic medications
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis
Structural Modification In Supraglottic Airway Device

The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA without the need of using an exchange catheter, thus enabling an ETT to move in the body of the SGA and convert a supraglottic to endotracheal ventilation. In its original form an adaptor made from same material currently used in the endotracheal tubes can make ventilation through the proposed airway device possible in exactly the same manner of a conventional SGA currently used. This adapter also known as the R-piece can be replaced with an ETT. The modification also allows placement of SGA over an existing ETT to convert and endotracheal (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.

The special design allows conversion of a telescopic coaxial portion (R piece), replacing with an ETT which can act coaxially to provide both supraglottic (up position) and endotracheal (down position) of ETT. See this modification in https://www.youtube.com/watch?v=iy84lALU1aI

Currently the proposed change to the conventional SGA has been made and feasibility tested on Manikins. The A/Z airway modification is also demonstrated in the attached link video https://www.youtube.com/watch?v=ukLOAC55iG8

In this study, we are trialing the A/Z concept on an original A/Z modification by a manufacturer on their currently used SGA. Thus instead of investigators making the changes by cutting a channel in a conventional SGA immediately before use in the Operating Room, they have asked a manufacturer to do so professionally.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. scheduled for a general anesthesia procedure with ETT \& muscle relaxation

Exclusion Criteria:

1. Patients who are not able to consent
2. Non English Speaking
3. History of difficult airway
4. Physical exam of airway which suggests difficulty in airway management or need to use special equipment
5. BMI \>35
6. Gastroesophageal reflux disease
7. Anesthetic plan other than general anesthesia
8. Emergency procedures
Acute Care for Elders (ACE) Program at OHSU Hospital

The purpose of this investigation is to assess the effectiveness of a multi-disciplinary Acute Care for Elders (ACE) program dedicated to the care of patients age 70 and older admitted to Oregon Health \& Science University's hospital medicine service. The ACE program will aim to improve the quality of care of older patients in the investigators hospital by implementing focused interventions and recommendations specific to geriatric needs and syndromes, including: reduced fall rate, decreased incidence and duration of delirium, early recognition and treatment of impaired mobility and function, careful minimization of medication use, prevention of unnecessary catheter and restraint use, decreased hospital readmission rates, improved transitional care following hospital discharge, and high levels of patient and referring physician satisfaction. Additionally, the ACE program aims to improve resident and student competence in treating geriatric syndromes, and to improve staff and learner satisfaction with caring for older adults. ACE programs have been well studied at other institutions, so the investigators will be implementing a program that is already standard of care, and studying the elements that are unique to OHSU.

This will be a quality improvement project. Study participants will be a convenience sample of OHSU faculty, staff, residents and students who are employed by or on rotation with General Medicine Team 1 of the Medicine Teaching Service. Faculty, staff, and learners (ACE team members) will receive the ACE training. Study personnel will conduct prospective and retrospective chart review of patients admitted to the ACE service to determine outcomes as noted above.


Eligibility Criteria:
Inclusion Criteria (ACE faculty, health care providers and students):

* employed by OHSU or enrolled in one of OHSU's schools (medicine, nursing, pharmacy)
* share in the care of older adults on the General Medicine Team 1 service.

Inclusion Criteria (patients):

* admitted to the internal medicine service during the time frame of the study
* age 70 or older at time of hospital admission

Exclusion Criteria (ACE faculty, health care providers and students):

* non-English-speaking

Exclusion Criteria (patients):

* none
"Using a Multisite TENS SysteM to Improve Fibromyalgia-related Symptoms.

Fibromyalgia is a debilitating pain condition that is characterized by the chronic occurrence of pain affecting the musculoskeletal system, a sensitivity to pressure stimuli, and a low threshold to noxious stimuli. The topography of pain is widespread, although it could be more pronounced in some bodily regions. Besides pain, patients suffer from a wide range of symptoms, including fatigue, anxiety and depression manifestations, and altered quality of life. Facing these debilitating symptoms, the available therapeutic strategies for treating pain and associated manifestations are usually faced with limited efficacy and numerous side effects. A previous pilot trial on fibromyalgia (EXOFIB-1 study) was conducted to evaluate the effects of Exopulse Mollii suit on fibromyalgia has showed beneficial and promising results. The intervention significantly alleviated pain, reduced fatigue, decreased physical and psychosocial impact of the disease, and improved the quality of life of patients with fibromyalgia. However, the observed effect sizes were small to medium. The investigators believe that a stimulation duration extended to six months would yield more positive outcomes and higher effect magnitude.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75 years, with a definite diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) 2010 criteria, set for at least three months
* Patients should be French speakers, able to understand verbal instructions, and affiliated with the National Health insurance

Exclusion Criteria:

* Patient included in another research protocol during the study period
* Patient unable to undergo medical monitoring for the study purposes due to geographical or social reasons
* Patient with contraindication to wearing Exopulse Mollii suit (e.g., cardiac stimulator, a ventriculoperitoneal shunt, intrathecal baclofen pump, pregnancy, and/or body mass index above 35 kg/m2)
* Patient with somatic or psychiatric diagnoses other than anxiety and depression (e.g., arrhythmias, uncontrolled epilepsy, other diseases causing osteoarticular and muscular pain)
* Any change in the pharmacological therapy in the last three months
* Introduction of a medical device other than Exopulse Mollii suit during the study period
* Patient under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
Restoring Normal Sagittal Thoracic Posture Improves Management Outcomes in Patients With Chronic Nonspecific Neck Pain

Because changes in sagittal thoracic alignment have been reported to alter the mechanical loading of the cervical spine and decreased thoracic mobility has been identified as one of the predictors for neck and shoulder pain , it makes sense that thoracic articular treatment improves local kinematics and simultaneously neck pain improves. The purpose of this study is to investigate the effects of a multimodal program, with thoracic hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis , applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.

Interventions directed at improving hyper-kyphosis of the thoracic spine may have therapeutic effects on the cervical spine; however, there is a lack of controlled studies evaluating this. The purpose of this study is to investigate the effect effects of a multimodal program, with thoracic hyper kyphosis rehabilitation using the Denneroll™ thoracic traction orthosis , applied to participants with chronic non-specific neck pain and thoracic hyper-kyphosis.

In this study, 80 participants, with chronic non-specific neck pain and thoracic hyper-kyphosis will be included. Participants will be randomly assigned to the control or an intervention group. Both groups will receive the multimodal program; additionally, the intervention group received the Denneroll™ thoracic traction orthosis. Outcome measures will include kyphotic angle (max.), neck pain and disability , sensorimotor control outcomes; head repositioning accuracy , smooth pursuit neck torsion test and overall stability index . Measures will be assessed at three intervals: baseline, 10 weeks, and 6 months after cessation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* neck pain for more than 3 months
* thoracic angle measured more 55 degrees

Exclusion Criteria:

* Any signs or symptoms of medical "red flags",
* a history of previous spine surgery.
* signs or symptoms of upper motor neuron disease.
* vestibulobasilar insufficiency.
* amyotrophic lateral sclerosis.
* bilateral upper extremity radicular symptoms.
The Effect of the Nature And Frequency of a Stimulation on the Amplitude of the Temporal Summation of Pain

Temporal summation is a mechanism that enhances pain perception. It is a natural mechanism present in most individuals. Generally, temporal summation is measured by the application of a moderately painful stimulation for several seconds.However, there is still no official recommendation in the literature. There is therefore a great disparity in the protocols. Some studies apply thermal stimulation (heating the skin) while others apply mechanical stimulation (applying pressure). Another point of contention is that some studies apply continuous stimulation for 2 minutes while others apply a series of several small stimulation of 1 second). Between these studies, the amplitude of temporal summation varies according to the stimulation performed. Note also that the study population is also very different between studies. In these conditions, it remains difficult to know the impact of the nature of the stimulation on the measured amplitude of the temporal summation.

Objective: To determine the effect of the nature and frequency of the stimulation used to measure one of the physiological mechanisms of pain

Methods: In order to meet the objective, 34 pain-free participants will be recruited (17 females and 17 males) between the ages of 18 and 30 years. A single visit will be proposed (approximately 1 h). Each participant will be stimulated with 4 stimulation conditions:

* continuous thermal (1 stimulation of two minutes)
* repetitive thermal (30 stimulations of 1 second)
* continuous mechanical (1 stimulation of two minutes)
* repetitive mechanical (30 stimulation of 1 second) In order to control certain psychological parameters, questionnaires measuring anxiety, depression and fear of pain will be administered. This will allow the investigation team to perform subgroup analyses if necessary. A repeated measures analysis of variance will be performed to meet the objective.

Anticipated Results: The objective of this project is to determine the impact of different stimuli on the measurement of a pain mechanism. In this sense, the results will be important since they will allow to develop recommendations to optimize the measurement of this mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 30 years, able to consent (understand English or French)
* No chronic pain
* No primary sensory disorders

Exclusion Criteria:

* Presence of upper extremity injuries
* Absence of anxiety symptoms (HADs Score \< 6) (Appendix 1)
* Presence of cardiovascular disease / neurocognitive disorders / mental illness
* Pregnant or postpartum women less than one year old
Evaluating Risk Factors of Post-LASIK Ectasia

Ectasia after refractive surgery is a relatively rare complication which can lead to sight-threatening complications if not detected and treated in time. It is important to continue our quest to improve our methods of identifying absolute and relative risk factors of ectasia following various keratorefractive surgical procedures.

Surgical correction of refractive errors is becoming increasingly popular. In the 1990s, the excimer laser revolutionized the field of corneal refractive surgery with PRK and LASIK, refractive lenticule extraction (ReLEx) of intracorneal tissue using only a femtosecond laser, and lately ReLEx smile (SMILE). The term LASIK (Laser in situ keratomileusis) was first used in 1990 by Pallikaris, in which a microkeratome was used to cut a hinged corneal flap, followed by excimer ablation of the stromal bed and flap repositioning . LASIK is known to be a safe refractive surgical procedure, with good refractive efficacy and predictability and is associated with rapid visual recovery with minimal risk of complications.

Most of complications are flap related and include a free cap, a button hole, an incomplete cut, flap striae, interface debris, diffuse lamellar keratitis (DLK), and epithelial ingrowth. Other complications include undercorrection, overcorrection, decentered ablation, irregular ablation, and ectasia.

Corneal ectasia is a sight-threatening complication of laser refractive surgery characterized by progressive steepening and thinning of the cornea.It is defined as progressive stromal thinning and steepening of the cornea, resulting in refractive aberrations and visual deterioration. The incidence of post- LASIK ectasia is estimated to be between 0.04% and 0.6%.Corneal ectasia has been observed to occur as early as 1 week and as late as several years after LASIK.

The main purpose of assessing risk is to determine what group or groups of people present a higher chance to develop post-LASIK ectasia. The development of postoperative ectasia varies between LASIK centers and depends on the screening tools used to screen candidates, the experience and technical skill of the surgeon, and the tools used during the surgery. Risk factors for the development of post-LASIK ectasia include young age, a personal or family history of keratoconus, forme fruste keratoconus (FFKC), high myopia, low-residual stromal bed (RSB), and deep primary keratotomy resulting in a thick flap.

Although several risk factors have been identified for the likelihood of ectasia development after keratorefractive surgeries, some cases have been reported to develop in an enigmatic way, without the prescence of any of these risk factors.

Eligibility Criteria:
Inclusion Criteria:

* All subjects presented with ectasia following LASIK

Exclusion Criteria:

* Any associated ocular pathology.
* Any previous ocular surgeries other than LASIK.
* Corneal opacities.
* Ocular trauma.
Research Study Examining Nerve Block for Migraine

Migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve block, which is a procedure involving an injection of a small amount of a local anesthetic next to a nerve to the skin, causing an area of skin to become numb. We have also noticed that light sensitivity goes away quickly after a nerve block. We would like to see how quickly this happens and how long the benefit of nerve block lasts. We are interested to see if these effects are due to the injection itself or due to the lidocaine.

A subject may be asked to participate in this study if a subjects physician has planned for a subject to receive an injection of BOTOX® in the area of the Greater Occipital Nerve (a spinal nerve located at the back of the head) as part of a subjects routine preventive treatment for migraine today.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with episodic or transformed migraine age 18to 80 years old.
* Subjects must have unilateral migraine headache and trigeminal distribution brush allodynia at the time of injection.
* Subjects must be able to consent or assent to the study.

Exclusion Criteria:

* Subjects who in their own or in the investigator's opinion are unable to report the severity of four symptoms (pin sharpness to determine efficacy of nerve block, headache severity, photophobia severity and allodynia severity), every 30 seconds for 5 minutes post injection;
* Subjects with skull defect, or history of injury to the area of the GON.
* Subjects with prior adverse reaction to GON block, lidocaine or marcaine.
* Subjects who are pregnant or lactating
Opportunistic Salpingectomy in Non-gynecological Surgeries

The goal of this study is to evaluate patient's compliance for opportunistic salpingectomy (OS) and procedure feasibility in non gynecological abdominal surgeries

Patients who are candidate for non-gynecological abdominal surgery, are offered OS. If agree, a general surgeon perform the procedure during the planned abdominal surgery

Eligibility Criteria:
Inclusion Criteria:

* Women who were candidates for non-gynecological abdominal surgery
* Aged 45 or older, or aged 40 or older with a desire for bilateral salpingectomy

Exclusion Criteria:

* Pregnant women
* Candidates for urgent surgery