cyrilzakka/clinical-trials huggingface dataset:
Application of the ICE-T Postoperative Multimodal Pain Regimen to Laparoscopic Hysterectomy

This is a randomized controlled trial evaluating whether application of ice packs and scheduled ketorolac to the surgical site after laparoscopic hysterectomy reduces need for narcotic medications.

Patients who undergo laparoscopic hysterectomy and chose to participate in the study will be randomized to either receive the standard post-surgical analgesic protocol (control group) or the standard post-surgical analgesic protocol plus scheduled ketorolac and surgical site ice packs. Usage of narcotic analgesics for breakthrough pain will be monitored and compared between cohorts. All care received by test subjects will be standard of care, with the only difference being the use of ice packs and scheduled ketorolac.

Eligibility Criteria:
Inclusion Criteria:

Females, 18-65 years old at time of new patient evaluation, Planned laparoscopic hysterectomy only or hysterectomy with or without unilateral or bilateral oophorectomy or salpingo-oophorectomy by Dr. Corey Wagner, Uterus with expected size greater than 250 grams as determined by bimanual exam or standard of care ultrasound obtained prior to or as part of new patient evaluation

Exclusion Criteria:

Diagnosed or suspected endometriosis, Diagnosis of malignant carcinoma of the uterus, ovaries, or fallopian tubes, Diagnosis of severe renal disease (as determined by a GFR of less than 45), Known nonsteroidal anti-inflammatory drug (NSAID) intolerance, History of myocardial infarction, stroke or other cardiovascular disease, Known hypersensitivity or allergic reactions to Acetaminophen, Toradol, Ibuprofen, other NSAIDs, Aspirin or Roxicodone, Previous diagnosis of liver disease or hepatitis, Unable to take Tylenol (acetaminophen), Pre-existing narcotic drug regimens or opioid use disorders, Known diagnosis of or history of peptic ulcer disease, gastrointestinal bleeding or perforation, Known or suspected gastrointestinal obstruction including paralytic ileus, Diagnosis of severe bronchial asthma, Known diagnosis or history of cerebrovascular bleeding, Known bleeding disorder or coagulopathy based on patient history unless excluded by appropriate hematological examination, Daily prescription NSAID use, Adults unable to consent, Pregnancy as determined by urine or serum pregnancy test obtained in women of child-bearing age, Prisoners, Individuals who do not read and understand English
The Impact of Ureteral Stents on Peristalsis

The purpose of the study is to investigate the impact of ureteral stents on the functioning of ureteral peristalsis (normal contractions in the ureteral organ muscle).

Ureteral stents are commonly used in the field of urology to maintain urinary drainage and are inserted into ureters of patients who suffer from kidney stones, urinary tract infections or cancer. Usually the muscle cells of the ureter contract in a coordinated fashion (peristalsis) in order to provide urinary flow from the kidney into the bladder. By inserting a stent these contractions are disrupted, eventually resulting in a loss of peristalsis. This phenomena is accompanied by swelling of the kidney and pain, which are well-known negative side effects of stents. To avoid stent-related morbidity and improve patients care this issue needs to be investigated further. A first step is to analyse the impact of stents on peristalsis and to possibly bring these results into context with hypothesised molecular mechanisms involved in peristalsis.

Eligibility Criteria:
Inclusion Criteria:

1. stone disease
2. localized tumor disease
3. hydronephrosis of unknown ethiology
4. patients who receive a prophylactic stent before a planned operation.

Exclusion Criteria:

1. Patients being septic and in a life-threatening condition before or after stent-insertion
2. patients with tumors in a progressive state that affect the retroperitoneum (contralateral ureter might be affected and can not serve as a control for the stented side)
3. patients with Morbus Ormond (same reason as above)
4. patients requiring ureteral stents bilaterally (same reason as above)
5. long-term stented patients will be excluded as we are interested in evaluating the onset of changes in peristalsis rate which are expected to be most significant in an acute setting.
6. patients with preexisting abnormalities/pathologies of the urinary tract e.g. reflux disease, megaureter or bladder dysfunctions as these will likely affect our results
7. non English-speaking patients will be excluded as they will not be able to understand the letter of consents.

Exclusion criteria for control group:

1. known preexisting pathology in the urinary tract (see above)
2. volunteers who underwent previous surgical procedures on kidney, ureter or bladder within the past 5 years as this may change the starting position of our study
3. patients currently taking an α-blocker (alfuzosin, terazosin, doxazosin, tamsulosin, prazosin) because these medications are known to affect peristalsis
4. patients currently taking calcium channel blocker (verapamil, diltiazem, nifedipine, nicardipine, bepridil, mibefradil) because these medications are known to affect peristalsis
A Novel MSE Score to Predict rHCC Patients

Develop and validate a novel scoring system based on pathological factors to predict the postoperative survival of patients with rHCC.Patients with rHCC who underwent hepatectomy were recruited from two hospitals.Exploring whether this scoring system is related to prognosis


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of ruptured tumor confirmed by enhanced computed tomography (CT) and/or abdominal magnetic resonance imaging (MRI),
* a diagnosis of HCC made by two experienced pathologists

Exclusion Criteria:

* extrahepatic HCC metastasis
* death within 1 month after surgery
Circulating Myokine Levels and Bone Metabolism

Circulating levels of several myokines will be measured in serum samples obtained from women in various categories of bone density and according to the presence of fracture or not as well as before and after treatment with teriparatide and denosumab

Serum samples for the measurement of several myokines will be obtained from: 1) equal groups of premenopausal women with normal BMD, postmenopausal women with normal BMD, postmenopausal women with osteopenia, and postmenopausal women with osteoporosis; 2) women with hip fracture compared with controls (women subjected to surgery due to knee osteoathritis); 3) women with osteoporosis treated with teriparatide or denosumab for 12 months

Eligibility Criteria:
Inclusion Criteria:

Substudy 1:

• adult women

Substudy 2:

• postmenopausal women with an incident hip fracture

Substudy 3:

• postmenopausal women with osteoporosis

Exclusion Criteria:

* secondary osteoporosis
* any disease that could affect muscle and/or bone metabolism
* any medication that could affect muscle and/or bone metabolism
Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis

Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.

This study should allow:

* to assess the prevalence of psychiatric disorders co-morbid in PLCH patients
* a targeted and more effective management of patients
* a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 18 years of age or older with PLCH diagnosed at adulthood
* Patients affiliated to the French Health Care System
* Informed patients

Exclusion Criteria:

* Patient unable to understand the interview (language barrier)
* Patient under guardianship or curatorship
* Patient under AME (French medical help for foreigners)
Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

The objective of this study is to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients.

Type II DM is a highly prevalent and heterogeneous condition. New treatment modalities to complement existing interventions are therefore of great interest, including dietary interventions for primary prevention or as a possible therapeutic option that may confer beneﬁts beyond currently recommended conventional therapies. Hence, the present work aims to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients, as compare to standardized medication regimen.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for the clinical trial are:

* Clinical diagnosis with Type II DM for at least 6 months' duration without clinically manifest complications (retinopathy, diabetic nephropathy, vascular diseases, foot ulcer - as diagnosed by the physician/recorded in database)
* Male or female
* Pharmacological treatment with metformin or insulin, or a combination of metformin and glibenclamide.
* Chronological age: 18 years and above
* Metabolically stable (current laboratory results for A1C 6.0-8.5%; or fasting plasma glucose 6.4-8.5 mmol/l)
* Not taking antioxidant/anti-inflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba) (Example of anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)

Exclusion Criteria:

* Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders
* Active gastric/duodenal ulcer
* Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia)
* Cancer (all types), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
* Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
* Gestational Diabetes Mellitus
* Pregnancy/lactation
* Hormone replacement therapy (for at least 3 months prior to entering the study)
* Herbal remedies (any parts from the plants such as flowers, rhizome, seeds, roots, leaves, fruits, stems)
* Use of steroids, chemotherapy, immunosuppressant or radiotherapy.
* Vegetarian patient (pure vegan)
* Gluten intolerance
* Participations currently under another supplementary program
HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have elderly (9-59 ages) AML pathologically confirmed per WHO guidelines.
* Patients WITH intermediate-risk AML-CR1
* Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
* Patients must have a HLA mismatched donor who should be able to provide informed consent.
* All genders and races are eligible.
* ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
* By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
* Donors must be able to safely undergo leukapheresis.

Exclusion Criteria:

* received operation 4 weeks before randomization
* acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
* active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
* Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
* There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
* Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
* Any situation processed by the PI that will be damaged to the patients safety.
* Patients and / or authorized family member refuse to sign the consent. attend other clinical researchers in 3 months.
* Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

This research study is being done to see if combining the investigational chemotherapy drug, MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your myeloma cancer stem cells.

To explore the effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). Myeloma CSCs will be assessed by a clonogenic assay from the bone marrow and flow cytometry from peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 100 years at the time screening
* Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma
* Written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
* Patient must agree to take Lenalidomide with low dose dexamethasone as their initial therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
* Life expectancy of \>6 months
* Serum creatinine ≤ 2
* ANC≥1000
* Platelets ≥ 50,000
* Total bilirubin ≤ 2 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN
* Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results.
* Concurrent enrollment in another clinical study, except for non-interventional, observational studies.
* Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than Lenalidomide and dexamethasone.
* Previous monoclonal antibody (mAb) or other treatment specifically directed against cluster of differentiation antigen 19 (CD19).
* History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration.
* Previous systemic cancer therapy for myeloma.
* Any active secondary malignancy.
* Human immunodeficiency virus (HIV) positive serology or acquired immune deficiency syndrome.
* Active hepatitis B as defined by seropositivity for hepatitis B surface antigen. Or patients with positive hepatitis B core antibody titers.
* Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis.
* Documented current central nervous system involvement by multiple myeloma.
* Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study.
* Diagnosis of plasma cell leukemia
* Diagnosis of POEMS syndrome
* Diagnosis of Amyloidosis
* Diagnosis of non-secretory myeloma
Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study

The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of patients are not satisfied after TKA. This project will look to find out if the research team can identify patients who will not recover well at an earlier stage, so that these patients can be helped sooner.

The study will try to determine if doing intense physiotherapy with patients who are not doing well at the first review (6 weeks after their operation) can improve how well they have recovered at one year.

The study is a randomised controlled trial comparing the effect of intensive physiotherapy compared to current standard of care therapy, targeted to patients performing poorly at 6 weeks following total knee replacement.

All patients will be made aware of the study pre-operatively at the recruiting centres. Prior to surgery they will complete the routine pre-operative outcome assessment questionnaires (Oxford Knee Score and EQ-5D) as part of the national PROMS program and then undergo the local standard total knee replacement and immediate post-operative care pathway.

All patients will be routinely reviewed 6 weeks post-operatively by the usual clinical teams. At this review the Oxford Knee Score will again be assessed. Those patients who report a score of 26 or less (on the 0-48 OKS scoring system), which is defined as poor by the Kalairajah classification (Kalairajah, 2005), will be approached to consent. If consent is given and the patient is eligible to enter the trial, randomisation into one of the following groups will occur: to standard care (encompassing a one off physiotherapy review, 6 weeks of home exercise prescription and final review) or to an interventional arm, where 18 sessions of structured physiotherapy will be administered over a 6 week period, where 6 of these sessions will be 'contact sessions' performed under the supervision of the physiotherapist.

All trial participants will be reviewed immediately post intervention (i.e. at 14 weeks post operation) and then by postal questionnaire at 26 and 52 weeks post-operation.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary total knee arthroplasty for osteoarthritis.
* Defined poor outcome (Oxford Knee Score less than or equal to 26) at first post-op review (6 weeks).
* Patients are able to consent and willing to comply with the study protocol

Exclusion Criteria:

* Patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty
* Knee replacement for a diagnosis other than osteoarthritis
* Patients unable to attend the study physiotherapy intervention centre
* Procedures done purely for pain relief (such as for patients with no walking capacity)
* Patients already receiving ongoing structured post-operative exercise rehabilitation
Sensory Responses to Dorsal Root Stimulation

The goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. Patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. Investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. Invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.

For this study, investigators aim to determine whether DRG and spinal root stimulation might be viable techniques for restoring feedback. Investigators will focus on patients undergoing temporary percutaneous trials of DRG or lateral spinal cord stimulation with leads manufactured by either Boston Scientific (under PMA P030017) or St. Jude (under PMA P150004), which have FDA premarket approval for the management of chronic pain in the trunk and lower limbs. In this early experiment, investigators will not focus on individuals with limb loss, but rather will include patients already undergoing a percutaneous trial of DRG or spinal root stimulation to treat pain. Investigators will characterize the location, modality, and intensity of sensations evoked in the hands or feet with stimulation delivered by an external stimulator.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between the ages of 18 and 70 years old.
2. Subjects must be undergoing an epidural spinal cord implanted electrode array clinical trial with Dr. Helm for the management of pain.
3. Persons must understand the consent and the procedures.

Exclusion Criteria:

1. Persons with open wounds;
2. Persons with implanted metal rods in the spine or limbs;
3. Persons with defibrillator or pacemaker;
4. Persons with permanent skin metal tags or decorations.