cyrilzakka/clinical-trials huggingface dataset:
Effects of Myofascial Massage and Patient-therapist Communication Levels on Shoulder Muscle Properties in Breast Cancer Survivors with Myofascial Pain

The objective of the proposed study is to assess how myofascial massage alters stiffness and microvascular perfusion of shoulder muscles and how these changes are influenced by patient-therapist interactions.

The primary hypothesis is that stiffness of shoulder muscles will be decreased, and microvascular perfusion will be increased after a 30-minute myofascial massage, and that the addition of patient-therapist communication levels will result in greater changes with certain levels.

Please note that there are certain details left off of this registration in order to collect information regarding certain aspects of the trial. These details (approved by the IRB) will be updated at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Previous unilateral breast cancer diagnosis
* Treatment for primary breast cancer was completed 3 months to 2 years prior to enrollment (defined as completion of all treatments except oral maintenance therapies)
* Myofascial pain in upper quadrant of the chest
* Ability to understand and willingness to sign a written informed consent.

Exclusion Criteria:

* Chronic neuromuscular or orthopedic injury currently affecting upper extremity function that is unrelated to their cancer diagnosis
* Currently undergoing physical therapy, occupational therapy or other treatment for side effects related to their cancer diagnosis or other injury to the upper extremity
* History of fibromyalgia
* Broken or bruised skin in the chest/shoulder area
* Diagnosed with metastatic breast cancer
* Currently receiving treatment for other forms of cancer
Feasibility of Telemedicine Medical Abortion

This pilot study is designed to obtain data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail.


Eligibility Criteria:
Inclusion Criteria:

* desires abortion

Exclusion Criteria:

* medically ineligible for procedure
Splenic Artery Ligation and Portocaval Shunt in Small-for-size Syndrome

Our study aimed at assessing the changes of portal vein pressure, portal vein flow and hepatic arterial flow (HAF) in liver remnants ≤ 30% of the standard liver volume by reducing portal vein overflow via ligation of the splenic artery.

It has been reported that prevention of acute portal overpressure in small-for-size liver grafts leads to better postoperative outcomes. Accordingly, we aimed to investigate the feasibility of the technique of splenic artery ligation in a case series of patients subjected to major liver resections with evidence of small-for-size syndrome and whether the maneuver results in reduction of portal venous pressure and flow.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* American Society of Anesthesiologists (ASA) distribution I to III
* Patients scheduled for major liver resection (≥4 segments)

Exclusion Criteria:

* patients with extrahepatic disease
* patients with metastatic liver tumors
What is the Impact of Frozen Embryo Transfer Protocol, on Endometrial Compaction

This study aims to evaluate endometrial thickness on the day of the frozen embryo transfer, compared to endometrial thickness on the last day of assessment of the endometrium before exposure to progesterone in respect to the protocols used for endometrial preparation

247 FET cycles were included in the study. Records of all patients and their cryopreservation embryos were analyzed. Data collection included baseline parameters of age, BMI (kg/m2), type of infertility, parity, lifestyles, and cause of infertility, as well as treatment parameters, including number of embryos transferred, embryo quality and pregnancy outcomes.

To reflect the broad range of patients typically encountered in clinical practice, no inclusion/exclusion criteria were applied regarding baseline characteristics.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Pregnancy
StUdy oN Burst Fractures (SunBurst)

Thoracolumbar (TL) burst fractures are seen in all ages and usually associated with high-energy trauma. Treatment include both surgical and non-surgical options. In cases without neurological deficit or definite rupture of the posterior ligament complex (PLC) both surgical treatment and non-surgical treatment are considered standard of care. This study aims to compare outcome between surgical and non-surgical in patients with a single level TL burst fracture (AO A3/4) in a randomized controlled trial (RCT).

The study is an international, multicenter, randomized controlled trial. 202 patients with a single level TL burst fracture will be enrolled in the study. They will be randomized 1:1 to either surgery with posterior fixation or non-surgical treatment. The study is pragmatical in its approach, i.e., the treating physician can decide on details of the surgical treatment as well as details of the non-surgical treatment. In non-surgically treated patients brace treatment is not required, but a hyperextension brace may be offered. The subjects will be followed with patient reported outcomes, clinical assessments, and radiological assessments. Data will be collected from questionnaires, patient files or national registers to compare sick leave, medical complications, pharmaceutical prescriptions and overall costs for each treatment.

Eligibility Criteria:
Inclusion Criteria:

* A single level thoracolumbar (Th10-L3) burst fracture, A3 or A4, according to the AO Spine classification
* Aged 18-66 years
* Informed consent
* Acute injury with diagnosis and treatment within 2 weeks
* May have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment
* May have a single nerve root injury

Exclusion Criteria:

* Unable to consent, no consent given or not informed
* Neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury
* Definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on MRI
* Patients with ankylosing spinal disorders spanning the fracture area
* Prior spinal surgeries within the fractured area
* Open vertebral fracture
* Additional injury which would impair early ambulation, e.g., long bone fractures, severe head injury, long-lasting intensive care
* Patients not deemed suitable due to severe co-morbidities. (E.g., established osteoporosis that would impair the possibility to maintain integrity of spinal implants, pathological fractures, severe cardiac or pulmonary compromise, or other systemic disease that would result in such high anesthesiologic risk that surgery would not be attempted.)
* Patients already included in the study cannot be randomized again if they get an additional spine fracture
Influence of the Immunosystem in Non-celiac Glutensensitivity

Patients with non-celiac gluten sensitivity (NCGS) complain about gastrointestinal and extraintestinal symptoms while consuming gluten-containing cereals. The symptoms strictly correlate with ingestion of gluten-containing cereals and disappear quickly under elimination diets. Till now, there are no specific markers to diagnose NCGS. This study aims to determine the effect of a low FODMAP diet (fermentable oligo-, di- and monosaccharides and polyols) and a glutenfree diet on the mucosal immunity, clinical symptoms, and psychological well-being. Furthermore, the influence of the diets on the microbiome will be analyzed.

Patients with gluten-sensitivity are rigourously checked for wheat allergy and celiac disease. Genotyping for DQ2/8, serological detection of celiac specific antibodies, and gastroduodenoscopy are performed. Furthermore, a skin prick test and detection of wheat specific IgE are done.

After exclusion of celiac disease and wheat allergy patients are considered as patients with NCGS.

Patients and healthy controls are asked to consume a low FODMAP diet for two weeks, followed by a 5 day washout and subsequent two week gluten-free diet.

At the beginning and the end of each diet the participants fill in questionnaires concerning Nutrition (Freiburger Nutrition protocol), psychological well-being index (PGWB), gastrointestinal symptom Rating score (GSRS), and stool consistency (Bristol stool Chart). Furthermore, stool samples are selected at each time point to determine the microbial pattern.

NCGS patients with ongoing complaints will have a second gastroduodenoscopy at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* healthy controls
* patients with glutensensitivity

Exclusion Criteria:

* patients with glutensensitivity but without celiac disease or wheat allergy
11C-PIB PET Study in MESA at Columbia University

The investigators will conduct a study of brain positron emission tomography (PET) using 11C-PIB for the imaging of brain amyloid in 250 participants in the Multiethnic study of atherosclerosis (MESA) at Columbia University Irving Medical Center in New York City. Participants will be imaged only once with Pittsburgh Compound B (PIB) PET.

This is a single center PET study of 11C-PIB. Eligible participants are current participants in the MESA study in New York City, without contraindications to MRI or PET procedures. Those eligible will have one brain PET scan with 11C-PIB within 12 months of a brain MRI. Vital signs will be checked prior to injection of 11C-PIB, 10 minutes after the injection, and again at the completion of the PET scan. The primary outcome measure for amyloid will be whole brain 11C-PIB SUVR. The relation between exposure groups and amyloid in the brain will be analyzed using linear regression.

Eligibility Criteria:
Inclusion Criteria:

* Current participants in MESA study at Columbia University
* 60 years or older
* Fluent in English and/or Spanish.
* Able to participate in all scheduled evaluations and to complete all required tests and procedures.

Exclusion Criteria:

* Active treatment for cancer
* Any serious medical condition which would prevent long-term participation
* Pregnancy
* Weight \>300 pounds
* Participants previously diagnosed or adjudicated to have dementia
* Participants unwilling to undergo cognitive testing
* Plans to leave the community within five years
* Language barrier (speaks other than English, Spanish, Chinese)
* Inability to give informed consent or to obtain consent from a Legally Authorized Representative (LAR)
Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil

This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transplant treatment protocol.

MMF will be omitted from the transplant regimen in 60 eligible patients with hematologic malignancies. Participants will be followed for up to 2 years post standard of care transplant at Cedars-Sinai.


Eligibility Criteria:
Inclusion Criteria:

* Patient age 18-75 years
* Patient has a related donor who is at least Human Leukocyte Antigen (HLA) haploidentical, or an unrelated donor who is a most a single HLA antigen mismatch.
* Patient signs the Informed Consent Form for the study
* Patient has a hematologic malignancy other than myelofibrosis and meets standard criteria for allogeneic stem cell transplant.
* Patient is deemed suitable to receive Fludarabine and Total Body Irradiation (Flu/TBI) 1125 or Flu/TBI 800 conditioning regimen as standard of care transplant
* Donor is willing to donate peripheral blood stem cells

Exclusion Criteria:

* Patient has a diagnosis of myelofibrosis
* Patient has high titer antibodies against one or more donor HLA antigens
* Patient has undergone prior autologous or allogeneic stem cell transplant.
* Inability to collect sufficient peripheral blood stem cells from the donor
GW679769 In Fibromyalgia

The purpose of the study is to investigate safety, tolerability and efficacy of oral GW679769 up to 120 mg dose compared to placebo in patients with ACR(American College of Rheumatology)-defined fibromyalgia, co-morbid with depression.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of fibromyalgia (ACR criteria).
* Non-severe depression (HAM-D score \>14 \<24).
* Women must commit to consistent use of an acceptable method of birth control.

Exclusion criteria:

* Severe depression (HAM-D score \> 24).
* Unable to discontinue medications for pain or depression.
* Laboratory and ECG value at screening outside sponsor defined ranges.
* Positive to stool occult blood test.
The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity

Obesity is highly prevalent in older adults and is a major cause of sarcopenia and disability in older adults. Although exercise can counteract the effects of obesity and sarcopenia, many have difficulty adhering to an exercise program and the benefits of exercise are variable. Therefore, there is an urgent need to test novel pharmacologic interventions to prevent disability and loss of independence. Oxytocin is a pituitary hormone released during parturition and lactation that is also known to suppress appetite in rodents and humans; and, recent small studies have found that intranasal oxytocin reduces body weight in adults. We propose a pilot study of intranasal oxytocin as a novel approach to promote weight loss and increase muscle mass in older subjects with sarcopenic obesity.

The pilot study will be conducted at 3 sites in 9 visits over a period of 12+ weeks. Older sedentary subjects will be screened for sarcopenic obesity using a modified consensus definition and evaluated at baseline for safety labs, glucose tolerance, body composition, cognition and physical performance, as well as systemic inflammatory markers in blood and muscle tissue.

Eligible subjects self-administer 24 IU intranasal oxytocin four times a day for 8 weeks.

The study will examine whether the intervention will promote weight loss and preserve muscle mass, thereby preserving and/or improving physical function in older subjects with sarcopenic obesity.

Generalized linear mixed effects model will be used to evaluate the effect of oxytocin on the change of each continuous measure. The effect of oxytocin will be assessed by whether the time by oxytocin interaction is significantly different from 0 with a 2-sided p-value\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* BMI 30-40 kg/m2
* Sedentary (\< 2 strenuous exercise/week)
* Gait speed \< 1 meter/second

Exclusion Criteria:

* Diabetes (ADA criteria)
* Heart disease (MI or New York Heart Classification grade III-IV)
* Poorly controlled hypertension (SBP \> 170 or DBP \>95 mm/Hg)
* Anemia (Hematocrit \<34%)
* Renal Disease (Serum Creatinine \>1.4, abnormal serum sodium levels, abnormal urinalysis, or physical exam findings indicative of fluid imbalance; individuals with underlying disorder of sodium/water balance, such as SIADH, diabetes insipidus, or psychogenic polydipsia)
* Liver Disease (AST/ALT/AlkPhos \> 2x upper limit of normal)
* Use of systemic steroid, androgens, or anti-coagulants
* Active/unstable conditions: inflammatory, thyroid, autoimmune, gastrointestinal (GI), hematologic, or neoplastic disorders
* Individuals with underlying seizure disorder or underlying neurologic disorder that increases seizure risk
* Cognitive impairment (MiniCog \<3), unstable mental illness, substance abuse, or history of eating disorder
Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

Magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements.

Spinal anesthesia is commonly used for the major abdominal cancer surgery because of decreasing the risks of general anesthesia.The quality and duration of sensory and motor block and decrease post operative pain is important in the major abdominal cancer surgery and patient's content satisfaction. Opioids in high doses and other drug such as clonidine and neostigmine added to local anesthetics to this purpose, but significant side effects.

Magnesium sulfate block the N- methyle -D- aspartate (NMDA) channels in a voltage-dependent way to be improve the quality and duration of spinal block. However, the use of magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. Systemic delivery of magnesium sulfate decrease postoperative opioid requirements. In experimental studies, spinal injection of magnesium sulfate reduces the respond to painful stimulus in rats.

Eligibility Criteria:
Inclusion Criteria:

* patients with ASA physical status II or III, 21-year-old or older with major abdominal cancer surgery

Exclusion Criteria:

* significant coexisting, hepatorenal, or other end organ disease, obesity (BMI \> 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs
Use of Predictive Model to Assist Patients Having an Embryo Transfer After IVF

To determine in women undergoing IVF who are at high risk of multiple births (\>35%), as calculated by the application of a predictive model - IVFsingleTM, if single embryo transfer will lead to both comparable clinical pregnancy rate (CPR) and other secondary outcomes such as live birth rate (LBR) and cumulative live birth rate (cLBR) in comparison to DET while reducing the incidence of multiple births (a secondary outcome measure).


Eligibility Criteria:
Inclusion Criteria:

Under 38 1st or second IVF attempt

-

Exclusion Criteria:

Over 37 years old donor egg third or greater IVF attempt cancellation in previous cycle for poor response successful pregnancy with IVF -
Detection of Tumor DNA Through Cervical Smear and Liquid Biopsy in Endometrial Cancer Patients and Evaluation of Prognostic and Predictive Values of Tumor DNA Assay

Circulating tumor DNA (ctDNA) may help detect and prognosis-stratify patients with endometrial cancer. Both cervical swab-based genomic DNA (gDNA) and whole blood-based ctDNA can be utilized for this goal. Our objective is to utilize cervical swab and whole blood samples to analyze tumor-derived ctDNA from patients with endometrial cancer. These samples will be collected prospectively, and prior to staging operation. Samples from patients without cancer, who undergo hysterectomy for benign gynecological cause, will be utilized as controls. Variants called by next generation sequencing were classified into four-tiers based on ASCO/AMP system. These initially captured samples will be used to compare performance in terms of detection rate and to stratify patients based on the mutational profile. Additionally, in patients with advanced disease, we plan to collect whole blood samples every 3 months to assess any changes in mutational landscape. Clinical data including age, cormorbidities, treatment methods, date of diagnosis and recurrence, response evaluation for chemotherapy or radiotherapy, survival data will be used to contextualize our findings.


Eligibility Criteria:
Inclusion Criteria:

1. Female, over 19 years of age
2. Patients with endometrial cancer or benign gynecological diseases

Exclusion Criteria:

1. Patients in pregnancy
2. Patients being treated for cancer of other organs, including gynecological cancer.
3. Patients who has difficulty reading and understanding Korean.
4. The tester's determination that the patient will not be able to comply with the clinical trial procedures.
5. Patients with severe infections or other serious medical problems that have resulted in impairment of the patient's function, making it difficult to the trial.
Temozolomide in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

OBJECTIVES: I. Determine the objective response rate to temozolomide in previously treated (closed to accrual 8/01) and chemotherapy-naive patients with advanced non-small cell lung cancer. II. Determine the freedom from progression median, and 1-year and 2-year survival rates in these patients on this regimen.

OUTLINE: Patients are stratified by prior chemotherapy (yes (closed to accrual 8/01) vs no). Patients receive oral temozolomide daily for 42 days. Treatment repeats every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months.

PROJECTED ACCRUAL: Up to 66 patients (33 per stratum (previously treated stratum closed to accrual 8/01)) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Stage IIIB, IV, or recurrent non-small cell lung cancer for which no curative therapy with surgery, radiation, or combination chemoradiotherapy exists Chemotherapy-naive patients: No prior chemotherapy OR At least 6 months since prior adjuvant, induction, or radiosensitizing chemotherapy OR Previously treated patients (closed to accrual 8/01): No more than one prior chemotherapy regimen for relapsed or metastatic disease AND/OR No more than one prior adjuvant, induction, or radiosensitizing chemotherapy within the past 6 months Measurable or evaluable disease CNS metastases allowed (previously treated metastases cannot be only site of measurable disease) No brain metastases with prior whole body irradiation

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other active invasive malignancies

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biologic therapy allowed Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy Surgery: See Disease Characteristics
Improving Clinical PET/CT Image Quality in Retrospectively Reconstructed Breath-Hold Images

The patient has been referred for an FDG PET/CT scan. FDG is a form of sugar that contains a small amount of radioactivity; it is used to see the size and possible spread of cancer in the body.

Pictures of the body are taken on a machine called a PET/CT scanner. The purpose of this current study is to see if we, the investigators, can take clearer pictures of the tumor than we could with our routine scan method. This would allow us to better see how FDG is picked up by the tumor. PET/CT is presently one of the best tools for detecting cancer and determining its spread in the body. However, due to breathing motion, PET and CT images may become blurred and the location of the tumor on CT and PET images may not match. We have developed a new method that enables us to reduce image blurring and to measure the tumor more accurately on PET images. In this study we want to compare two kinds of images: those from the standard PET/CT scan, and the PET/CT scan pictures taken with our new method.

If successful, we may use this new method for clinical routine in the future.


Eligibility Criteria:
Inclusion Criteria:

* Participant is capable of providing written consent.
* 18 years of age or older.
* Patient with a known or suspected FDG-avid malignancy in the torso

Exclusion Criteria:

* none