cyrilzakka/clinical-trials huggingface dataset:
Depo-Medrol on Psoas After LLIF

The goal of this study is to determine the effects of a corticosteroid administered to the psoas muscle following a transpsoas lateral lumbar interbody fusion (LLIF) on postoperative hip flexor weakness and thigh pain and numbness.

Primary Objective and Outcome Measure:

* Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.

Secondary Objectives and Outcome Measures:

* Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.
* Quantity patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically:

  * EQ5D: Eur-Quality of Life 5 dimension questionnaire
  * ODI: Oswestry Disability Index
* Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.

Ancillary Objectives and Outcome Measures:

* To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain.

Groups:

* Control group (standard care) - 1cc gel foam powder mixed with thrombin
* Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol

Eligibility Criteria:
Inclusion Criteria:

* Patients from the practices of Drs. Singh, Mallozzi, Moss
* Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
* Patients who agree to be a part of the study
* Patients with lumbar disc degeneration
* Patients between ages of 18 and 75

Exclusion Criteria:

* Scoliosis \>10°
* Spondylolisthesis \>Grade 1
* Flatback deformity
* Patients with insulin dependent diabetes
* Patients with \>3 levels of fusion
* Alternative interbodies
* Chronic oral steroid users
* Patients with allergy/intolerance to depo-medrol or other steroids
* Patients requiring bilateral transpsoas approaches
* Patients with ipsilateral symptomatic hip pathology
* Revision fusion procedures
* Cases involving trauma, tumor, or infection
* Patient's not capable of providing consent themselves
* Non-fluent English speakers (for consenting reasons)
* Patients who are lost to follow-up before the two year follow up period
Growth and Tolerance of Young Infants

To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.


Eligibility Criteria:
Inclusion Criteria:

* Subject is judged to be in good health.
* Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
* Birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
* Subject is between 0 and 8 days of age at enrollment.
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
* Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
* Subject participates in another study that has not been approved as a concomitant study.
Can 3D Ultrasound be Used as an Alternative to MRI to Assess Myometrial Invasion in Endometrial Cancer?

Aim: Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer.

This study will assess whether 3D ultrasound is accurate at predicting myometrial invasion aqnd lymph node metastasis of endometrial cancer. All patients will receive routine standard of care (MRI). The results of the 3D ultrasound will be compared to the MRI report and final histology.

Aim:

Assess the diagnostic accuracy of 3D Ultrasound, compared to MRI and final histology with respect to myometrial invasion of endometrial cancer.

Background:

When a diagnosis of endometrial cancer is confirmed on biopsy, women get staged to assess the level of spread. Current gold standard is an MRI. A proportion of women, are unable to undergo or complete an MRI scan due to their morbid obesity or claustrophobia. To this end, many have assessed the role of ultrasound in staging endometrial cancer as a cheaper and easier alternative to an MRI. In the last 20 years there has been a rise in the use of 3D ultrasound as it has become commercially available. There is, however a paucity of data on the role of 3D ultrasound in the assessment of myometrial invasion and lymph node metastasis. This research project will assess whether 3D ultrasound is a safe, effective alternative to MRI to assess the depth of spread of womb cancer.

The study:

All women with suspected endometrial cancer will receive a pelvic (internal) ultrasound as per routine care. In addition to the normal 2D ultrasound, women will receive a 3D ultasound and images will be saved. This adds an additional 1-2 minutes scan time.

In those women with confirmed cancer on histology an MRI is performed to assess stage of cancer (current routine standard of care). This will include T1, T2, DWI and contrast enhanced sequences. Patients referred to Hammersmith Hospital from other trusts will also be able to undergo a 3D ultrasound if this was not already performed. Definitive management of endometrial cancer includes a hysterectomy and the surgical specimen will be examined for depth of myometrial invasion and lymph node involved (if removed). In the meantime, the saved 3D ultrasound images will be analysed and rendered to predict the stage of the endometrial cancer and lymph node involvement. The results of 3D ultrasound, and MRI will be compared against the stage found on the gold standard test (on histological examination).

Eligibility Criteria:
Inclusion Criteria:

All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.

Exclusion criteria:

Anyone lacking capacity. \<18years old. Pregnant.
Safety And Efficacy Of Rifabutin In HIV Patients

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Mycobutin®.
Gefitinib in the Treatment of the First Relapse of Prostate Cancer Beyond Prostatectomy or Radiotherapy

To evaluate activity of gefitinib in subjects with relapsed prostate cancer by estimating PSA response rate at study closure


Eligibility Criteria:
Inclusion Criteria:

* Relapsed prostate cancer after prostatectomy or radiotherapy
* PSA levels below 10 ng/mL
* Lymph node negative
* Metastasis negative
* Withdrawal of hormone therapy at least 6 months before entry into the study
* Written informed consent

Exclusion Criteria:

* Metastatic disease
* Hormonal treatment 6 months before study entry
* Concomitant radiotherapy, surgery and/or chemotherapy
* ILD
Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain

Clinical experiences have shown that significant pain regression during a menstrual cycle has been often achieved by the use of spinal manipulative therapy (SMT) indicated in women with primary dysmenorrhea with coexisting functional disorders of lumbosacral (LS) spine. Namely, by activation of the nociceptive and vegetative system, LS spine disorders, before all segmental dysfunction and degenerative changes, can induce referred pain and reflex disturbances of pelvic organs (somatovisceral reflexes). Since significant improvement or disappearance of pain during a menstrual cycle is often achieved with adequate therapy of coexisting vertebral disorders in women with primary dysmenorrhea, it is important to recognise latent or manifest vertebral disorders in dysmenorrheic women using clinical examination (Grgić, 2009).


Eligibility Criteria:
Inclusion criteria:

* The age of the participants will be ranged from 25 to 35 years.
* Their body mass index will be ranged from 20 to 25 kg/m2.
* They will have regular menstrual cycle.
* They will not receive any hormonal therapy or taking any regular drugs.

Exclusion criteria:

The potential participants will be excluded if they meet one of the following criteria:

* Pelvic inflammatory diseases.
* Any pelvic pathological condition
A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse

This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 40 to 60 years.
2. POP Q stage III \& IV
3. Uterovaginal prolapse.
4. Vaginal vault prolapse.
5. BMI \>35.

Exclusion Criteria:

1. Age \> 40 years or \< 60 years.
2. POP Q stage I or II.
3. BMI \< 35.
4. Previous repair of uterovaginal or vaginal vault prolapse.
5. Comorbidity with Stress Urinary Incontinence.
6. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
7. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.
Predicting Peripheral Neuropathy of Paclitaxel for Gastric Cancer

Although advances in chemotherapy have improved the prognosis of gastric cancer patients, many patients still suffer from adverse events. Therefore, it is necessary to establish personalized treatment by identifying patients at high risk for side effects. Although paclitaxel-based therapy is the standard second-line treatment, peripheral neuropathy is a troublesome adverse event. The purpose of this study is to establish a liquid biopsy assay to predict paclitaxel-induced peripheral neuropathy in gastric cancer patients.

Paclitaxel-based therapy is the standard second-line treatment for gastric cancer patients, but approximately 30-40% of patients develop peripheral neuropathy that interferes with daily life, and about 10% develop severe grade 3 peripheral neuropathy. Particularly severe side effects can cause patients to lose strength, forcing them to discontinue treatment, and thus losing the opportunity to receive other treatments that were originally expected to have a therapeutic effect. This study aims to predict peripheral neuropathy in the side effects of second-line treatment (paclitaxel plus ramucirumab) in patients with gastric cancer using liquid biopsies (small RNA). If patients at high risk for side effects can be predicted prior to treatment, high-risk patients can be offered drug reductions or other chemotherapy options. The aim of this study is to predict peripheral neuropathy of paclitaxel in second-line chemotherapy for gastric cancer by liquid biopsy.

Eligibility Criteria:
Inclusion Criteria:

1. unresectable or recurrent Gastric cancer (GC) histologically confirmed to be primary adenocarcinoma of the stomach.
2. age over 20 years.
3. Eastern Cooperative Oncology Group performance status score of 0-2.
4. written informed consent following full study information is provided to the patient.
5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC.
6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging.

Exclusion Criteria:

1. Patients with a life expectancy of shorter than 3 months
2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency.
3. Patients with a history of serious allergic reactions or serious drug allergy.
4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires.
5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.
A Post-Marketing Study for On Label Evaluation of the GE Vscan Ultrasound Imaging System

This study is to collect data and learn more about the Vscan Ultrasound Imaging System. It is an "observational" study with no additional procedures or intervention prescribed other than using the Vscan along with a routine medical physical exam.

The study requires 2 visits to OHSU.

At the first visit a cardiac physical exam will be done by a cardiologist.

At a second visit, a different cardiologist will perform an ultrasound scan (as part of your standard of care) using a Vscan Ultrasound System. The first and the second visit may be done on the same day depending upon your schedule and if it's convenient for you to stay. The total exam time for both the visits, including standard exam and the study device exam will be about 45 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* provided signed and dated informed consent and is willing to provide GE Healthcare with demographic data, cardiac medical history, information collected as part of the study
* New patients who have an echocardiogram less than 6 months and patients who will be undergoing an echocardiogram as part of their routine clinical care

Exclusion Criteria:

* Pregnant
* less than 18 years of age.
* unwilling to provide informed Consent
Robotic-Assisted Surgery in Treating Patients With Spine Tumors

This pilot clinical trial studies robotic-assisted surgery in treating patients with spine tumors. Robotic-assisted surgery is a less invasive type of surgery for spine tumors and may have fewer side effects and improve recovery

PRIMARY OBJECTIVES:

I. To perform a small pilot study that will demonstrate the feasibility of neurosurgical spinal procedures using the da Vinci surgical robot.

SECONDARY OBJECTIVES:

I. To compare complication rates, operative time and estimated blood loss with historical controls.

II. To observe wound healing, cerebrospinal fluid (CSF) leaks, neurological injury and hardware failure.

II. Routine imaging of the spinal segment.

OUTLINE:

Patients undergo robotic-assisted surgery using the da Vinci robot.

After completion of study treatment, patients are followed up for 100 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient has primary or secondary spine tumor based on computed tomography (CT) or magnetic resonance imaging (MRI)
* Karnofsky performance status (PS) of \>= 80 or Eastern Cooperative Oncology Group (ECOG) PS 0-1
* Expected survival greater than 3 months
* Patient must be able to understand and sign a study-specific informed consent form

Exclusion Criteria:

* Previous surgery at that specific segment
* Radiation at that specific spinal segment within the last 2 months
* Karnofsky PS \< 80 or ECOG PS \> 1
* Pregnancy (due to risk of anesthesia)
* The presence of medical conditions which contraindicate general anesthesia
* Unexplained fever or untreated, active infection
* Inability to obtain exposure to allow performance of the planned spine surgical procedure
* History of psychiatric condition or diminished capacity that could compromise the giving of informed consent, or interfere with study compliance
Effects of Family Status of Osteopathic Medical Students on Their Perceived Level of Stress.

The investigators are interested in studying the effects of familial obligations, including marriage, parenthood, familial caregiving, on stress levels in Osteopathic Medical Students (OMS). The investigators expect to find that having a family may increase the stress level of OMS in comparison with OMS who don't have familial obligations.


Eligibility Criteria:
Inclusion Criteria:

* Medical Students

Exclusion Criteria:

* Not current Medical Students
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Body mass index (BMI) of 17.5 to 35.4 kg/m2, inclusive; and a total body weight \>50 kg (110 lb), at the Screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.
* Capable of giving signed informed consent.

Exclusion Criteria

* Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection).
* At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed.
* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
* Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06865571.
* A positive urine drug test, for illicit drugs on Day -1,
* At Screening or Day -1, a positive breath alcohol test.
* Male participants with partners who are currently pregnant.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact.
* Unwilling or unable to comply with the criteria in the Lifestyle Considerations.
* Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Effects of Instrument Assisted Soft Tissue Mobilization and Bowen Technique in Fibromyalgia

To compare the effects of Bowen's and Graston Technique in patients of chronic low back pain for reducing pain, enhancing lumbar range of motion and physical functioning and reducing depression.

Fibromyalgia is a chronic disease of idiopathic etiology, which is estimated to affect 2-4% of the population. It causes pain, stiffness, and tenderness in muscles, tendons, and joints, as well as sleep disturbances, fatigue, anxiety, depression, and alterations in intestinal functions. Chronic low back pain is a pain of more than 12 weeks limited to the lower area of the back .The chief complaint of a patient with fibromyalgia is widespread musculoskeletal pain which is bilateral and involves both upper and lower parts of the body. The pain may be localized initially, commonly in the neck and shoulders. The predominant description of the pain is muscle pain, but the patients may complain of joint pain as well .

Grastοn technique is an instrument assisted soft tissue treatment method (ІASTM) derived from the Cyriax1 cross-friction massage. Physіοtherapist strikes stainless steel instrument in a longitudinal dіrectіοn and in circular patterns at the treatment site. Many IASTM instruments including ASTYM, Fascial Abrasion Technique and Graston Technique etc. facilitates the healing process through increased fibroblast proliferation and increased collagen synthesis, maturation, and alignment.

Bowen Therapy is a dynamic fascial and muscle release approach, consisting of gentle cross-fiber movements applied to the fascia, muscles, tendons, muscle insertions, muscle septa, ligaments and viscera. It is named after Tom Bowen, who created a form of bodywork in Geelong, Australia and addresses the body as a whole unit rather than just the presenting symptoms.

The rationale for the use of these techniques is to identify the effects of IASTM and Bowen therapy in chronic low back pain of fibromyalgia and to analyze the additional effects of these techniques by reducing the hyperalgesia and excitability in central nervous system by working on the descending pain modulation system and to identify the most time effective treatment for chronic low back pain in fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 65 years
* Both Genders
* Patients with fibromyalgia were included in the study if they fulfilled criteria of the American college of rheumatology for fibromyalgia.
* Patients having chronic mechanical low back pain of more than three months

Exclusion Criteria:

* Patients with tumor, infection and major trauma to the spine causing fracture or disruption of spine.
* Patients with cauda equina syndrome
* Any neurological disorder
* Any previous spinal fusion surgery or spinal cord stimulation.
* Pregnant females