cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea.

This study is Single arm, Single Centre trial to check the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cell {MNC} (100 Million per dose).trial to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.

This study is Single arm, Single Centre trial study the Safety and Efficacy of Bone Marrow Derived Autologous mononuclear cells (MNCs) ,to be conducted for 36 months in patients with diabetes Mellitus in India,Primary outcome measure are Improvement in cognitive and Psychiatric Symptoms and Improvement in Jerky,random, and Uncontrollable Movements called Chorea.

Eligibility Criteria:
Inclusion Criteria:

* Patient should suffer from Hunting tons Chorea,
* Hunting tons chorea commonly become noticeable between the ages of 35 -44
* Willingness to undergo Bone Marrow derived Autologous cell Therapy.
* Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
* Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion Criteria:

* Patient with History of Immunodeficiency HIV+,Hepatitis B virus ( HBV) and History of Life threatening allergic or immune -Mediated Reaction. the site of bone marrow aspiration potentially limiting Procedure.
* alcohol and drug abuse / dependence.
* Severe skin infection.
* Haemodynamically unstable.

  =subject with primary and secondary diabetes , Insulin dependence.
* Neurological disease caused by autoimmune or genetic cause.
* patients suffering from peripheral muscular dystrophy.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate

This study assessed the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18.5 - 65/75 years (depending on the dose group).
* Diagnosis of rheumatoid arthritis (ACR 1987 revised classification for criteria for RA) with a disease duration of at least 6 months prior to randomization.
* Active disease at screening and baseline evaluation (same evaluator) ) with more than 6 tender and 6 swollen joints of 28 examined (including any effused joint) and either a) Westergren erythrocyte sedimentation (ESR) ≥ 28 mm/hour, or b) CRP ≥ 6 mg/L.
* Patients should have failed at least 1 DMARD in the past, but should not be deemed "refractory to all therapies"
* Patients should have a current treatment regimen of ≥ 15 mg methotrexate/week and with the current dose stable for approximately 3 months.
* Patients were required to have an otherwise stable RA therapeutic regimen, consisting of either a stable dose of NSAIDs and/or a stable dose of oral corticosteroids (prednisone or equivalent \< 10 mg daily) for at least 4 weeks prior to randomization.

Exclusion Criteria:

* Previous treatment with anti-TNF-α antibody therapy (or other biological therapy) within appropriate timeframe (considering the half life of the compound)
* Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within four weeks prior to randomization OR require narcotic analgesics other than those accepted by the investigator for analgesia (e.g., codeine, tramadol, dextropropoxyphene)

Other protocol-defined inclusion/exclusion criteria may apply.
Exacerbating Factors in Inflammatory Bowel Disease

Cross-sectional study of potential triggers for flares of Crohn's disease or ulcerative colitis.

Detailed questionnaires with patient in regards to potential triggers for flares of IBD. Includes both patients with flares and those in remission as a control group.

Eligibility Criteria:
Inclusion Criteria:

* History of verified Crohn's disease or ulcerative colitis

Exclusion Criteria:

* unwilling to participate
Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients

Cervical cancer is a major health problem for Chinese women. It is estimated that nearly 100,000 new cervical cancer cases occur in China every year, which accounts for about 20 percent of global new cases. Surgery and radiotherapy are two major radical treatment methods for IB-IIB cervical cancer. Unlike the United States and some other countries, most of operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN guidelines. However, in China a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors .

In our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor\>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. The objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the patients with intermediate risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed Ib\~IIa （FIGO）cervical carcinoma without previous treatments
* Age between 18-70
* With the presence of these three pathological risk factors after radical surgery:(1) positive lymphatic vascular space,(2)outer one-third invasion of the cervical stroma, (3) bulky tumor≥4cm
* At least 3 months of disease-free survival

Exclusion Criteria:

* The presence of other uncontrolled life-threatening disease (Suffering from myocardial infarction or stroke, or unstable angina, decompensated heart failure, or a history of deep vein thrombosis)
* Receiving other anti-cancer therapy, such as traditional Chinese drug
* Don't be able to finish the whole treatment(chemotherapy or radiotherapy)
* liver dysfunction (ALT、AST\>2.5×ULN)
* renal dysfunction (Creatinine\>1.5×ULN)
* WBC\<4,000/mm3 or PLT\<100,000/mm3
* Received preoperative radiotherapy
The STop UNhealthy Substance Use Now Trial

The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices

The STop UNhealthy (STUN) Substance Use Now Trial (STUN II) is a multisite trial aiming to evaluate the comparative effectiveness of the following strategies for improving the implementation of screening and interventions for substance use disorders in primary care: practice facilitation (PF), PF plus a learning collaborative (LC), PF plus performance incentives (PI), and PF+LC+PI. We plan to enroll 144 clinic staff participants from 48 primary care practices

Specific aim 1 (primary aim) will compare the effect of learning collaborative (LC) participation, performance incentives (PI), or their combination, with practice facilitation (PF) only, on implementation of evidence-based screening for SUDs.

Specific aim 2 (secondary aim) will compare the effect of LC participation, PI, or their combination, with PF only, on implementation of evidence-based interventions for SUDs, including (a) brief counseling, (b) medications (e.g., buprenorphine, naltrexone) and adherence to them, and (c) referral to specialty care.

Specific aims 1 and 2 will produce fundamentally important evidence about the comparative effectiveness of PF, PF+LC, PF+PI, and PF+LC+PI strategies on uptake of evidence-based screening and interventions for SUD when delivered to primary care practices.

Specific aim 3 (exploratory aim) will use a longitudinal mixed-methods evaluation to assess the association between implementation effectiveness and putative moderators (e.g., organizational readiness for change) and mediators (e.g., implementation climate). Aim 3 will generate scientific knowledge about mechanisms of change (why and how the various strategies work) in primary care settings.

Eligibility Criteria:
Inclusion Criteria:

* Clinic staff members from primary care practices who provide care for adult patients and have a leadership role within the practice (e.g. lead physician, practice manager, lead medical assistant/nurse, clinical champion)

Exclusion Criteria:

* Clinic staff members who already have ongoing involvement in programs that would conflict with or preclude this study
Fast-Track vs Conventional for UKA

The purpose of this study is to see if it is possible to discharge patient undergoing a UKA 1 day postoperatively


Eligibility Criteria:
Inclusion Criteria:

* UKA, ASA I-II

Exclusion Criteria:

* medical history of abdominal bleeding
Optical Head-Mounted Display Technology for Low Vision Rehabilitation

The goal of this study is to examine the ability of optical head-mounted display technology to enlarge the visual field of patients with severe visual field loss due to retinal dystrophy and to improve mobility and patient-reported outcomes.

Worldwide it is estimated that 191 million people have moderate to severe visual impairment (MSVI) and an additional 32.4 million are blind. Patients with uncorrectable MSVI may undergo low vision rehabilitation (LVR), which has been shown to improve functional abilities, such as mobility. However, existing LVR strategies do not adequately address severe visual field constriction.

In this pilot study, the investigators will test the hypothesis that optical head-mounted display (HMD) technology expands constricted visual fields and improves mobility outcomes for patients with retinal dystrophy. We will use the Moverio HMD platform which is considered a non-significant risk device. Outcomes for patients with retinal dystrophy will be compared to normal age-matched controls.

Eligibility Criteria:
Inclusion criteria for subjects with retinal dystrophy:

* diagnosis of retinal dystrophy
* severe vision loss that constitutes legal blindness
* able to perform a reliable Goldmann visual field test
* constricted visual field less than or equal to 20 degrees by Goldmann perimetry using the III4e stimulus in at least one eye with best-corrected visual acuity ≥ 20/60

Inclusion criteria for control subjects:

* healthy controls
* visit history with the Comprehensive and Pediatric Ophthalmology Services at the University of Michigan
* able to perform a reliable Goldmann visual field test

Exclusion criteria for subjects with retinal dystrophy:

* movement disorder that precludes evaluation of mobility
* functional vision loss
* pregnant women

Exclusion criteria for control subjects:

* visually significant ocular condition other than correctable refractive error
* movement disorder that precludes evaluation of mobility
* functional vision loss
* pregnant women
Alzheimer's Prevention Registry: A Program to Accelerate Enrollment Into Studies

The Alzheimer's Prevention Registry (www.endALZnow.org) will collect contact and demographic information on individuals. The objective is to provide information the latest news and advances in Alzheimer's prevention research, and to inform enrollees about research studies in their community. Enrolled individuals will receive regular email communications. As research studies become available, individuals will be notified via email with information as to how proceed should they be interested. Registry enrollees are under no obligation to participate in a research study. Study opportunities may include surveys, healthy lifestyle interventions (e.g., diet, exercise), memory \& thinking tests, brain scans, and investigational drug trials. To join the Registry, please visit www.endALZnow.org


Eligibility Criteria:
Inclusion Criteria:

* Must be able to accept the Alzheimer's Prevention Registry website terms and conditions

Exclusion Criteria:

* None
Activities to Change Your Mood: A Test of the Acceptability and Initial Efficacy in Clinical Samples and Healthy Controls

This is a study investigating how brief online activities can influence mood and attitudes.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-65
* schizophrenia group - have a psychotic disorder diagnosis
* healthy control group - Do not have a current DSM-5 diagnosis via the SCID-5
Biocontainment Device for Aerosol Generating Procedures

The primary goal of this study is to assess use of a biocontainment device for planned airway procedures under general anesthesia. This will serve as a platform for using this device as a novel biocontainment and aerosol evacuation system as part of rapid sequence intubation protocols for COVID-19 patients. We hypothesize that airway procedures with the aerosol biocontainment device will be safe and effective with airway procedure times approaching times for airway procedures without the device.

This is a multi-site (two sites), unblinded, randomized, observational study performed in a controlled environment in the operating room. The hypothesis is that rapid sequence intubation or other urgent airway procedures performed with the biocontainment device will be safe and can be performed in an equivalent manner to urgent airway procedures without the biocontainment device. Methods to minimize bias include randomizing patients to intubation with or without the biocontainment device.

Eligibility Criteria:
Inclusion Criteria:

A) User (healthcare worker):

• Anesthesiologist, anesthesia resident, or CRNA at the Hospital of the University of Pennsylvania or PPMC who has signed and dated informed consent.

B) Patient:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* ASA I, II, III
* Undergoing planned procedure involving an airway procedure under general anesthesia

Exclusion Criteria:

A) User (healthcare worker):

• Pregnancy due to potential risks from lifting the device.

B) Patient:

* Known history of difficult airway
* Anticipated difficult airway management for any reason
* COVID-19 positive status
* Pregnancy
* Planned prolonged intubation post-surgery or anticipated inability to answer patient questionnaire within 1 week of intubation.
Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching

Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The necessity for anticoagulant therapy after orthopedic surgeries is widely understood, but treatment administration patterns in the prevention of venous thromboembolism (VTE) after orthopedic surgeries during the hospital stay have yet to be examined.

The main objective of this study is to perform a comparative effectiveness review examining the benefits and harms associated with venous thromboembolism prophylaxis in patients undergoing orthopedic surgeries.

It is around efficacy and safety evaluation of using anticoagulant for thromboprophylaxis in patients undergoing orthopedic surgeries taking into the account the reliable selection of patients most benefit.

The aims of this study is to analyze patient records in teaching hospitals database of our country (including: Hanoi Medical University, Bach Mai Hospital, Cho Ray Hospital, Viet Duc University Hospital) and compare the outcomes and costs between different types of anticoagulant medications that were prescribed for the prevention of VTE following orthopedic surgeries. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving rivaroxaban or enoxaparin. The outcomes of interest include the occurence of DVT and PE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).


Eligibility Criteria:
Inclusion Criteria:

* Undergo Orthopedic Surgery
* Thromboprophylaxis Decision Taken
* At least 18 years of age

Exclusion Criteria:

* Planned intermittent pneumatic compression
* A requirement for anticoagulant therapy that could not be stopped
* Severe hypersensitivity reaction (eg, anaphylaxis) to rivaroxaban or enoxaparin.
* Received another anticoagulant for more than 24 hours
* Active bleeding or a high risk of bleeding
* Thrombocytopenia associated with a positive test for antiplatelet antibody.
* Warfarin associated international normalized ratio (INR) more than 1.5 on the day of the surgery
* Conditions preventing bilateral venography
* Intensive care unit (ICU) stay after surgery
* Pregnant or breast-feeding
* Creatinine clearance less than 30 ml per minute or acute renal failure before the surgery or at any point during the study period.
* Moderate or Severe (Child Pugh B or C) hepatic Impairment or in patients with any hepatic disease associated with coagulopathy.
* Concomitant use of drugs that are both P--glycoprotein inhibitors and moderate to strong cyp3a4 (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir \& conivaptan)
* Creatinine clearance (CrCl) 15 to 80 mL/min and concurrent use of P-glycoprotein inhibitors or moderate CYP3A4 inhibitors (eg, abiraterone acetate, diltiazem, dronedarone, erythromycin, verapamil)
POEM for Spastic Esophageal Disorders

This study evaluates the efficacy and safety of the Per-Oral Endoscopic Myotomy (POEM) technique for lower esophageal sphincter myotomy in patients suffering from spastic esophageal disorders such as achalasia at a Canadian institution.

The investigators hypothesize that POEM is a safe and effective technique for the surgical management of such disorders at our institution.

Standard surgical care for spastic esophageal disorders such as achalasia includes a procedure called Heller myotomy.

The treatment in our study, called endoscopic myotomy (also known as peroral endoscopic myotomy - POEM) is different from standard surgery (Heller myotomy) because it is less invasive, is less likely to cause reflux, and usually requires shorter operative times with less loss of blood during the surgery. Although POEM has been adopted worldwide and has proven to be successful, the experience in Canada is very limited to date.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic achalasia or similar spastic esophageal disorder and pre-op barium swallow, manometry, and esophagogastroduodenoscopy being consistent with the diagnosis
* Ability to undergo general anesthesia
* Age \> 18 yrs and \< 85 yrs. of age
* Ability to give informed consent
* Candidate for elective Heller myotomy

Exclusion Criteria:

* Contraindications for esophagogastroduodenoscopy
* Contraindications for elective Heller myotomy
* BMI \> 45
* Currently pregnant
* Refusing to participate in the study or without informed consent
* Concomitant participation in other clinical trial
Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant

The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies. The rotator cuff must be functional.

The aim of this study is to prospectively collect data from consecutive series to implement a Post Marketing Surveillance plan.

Degenerative shoulder pathologies associated with a functional rotator cuff are currently treated by hemi-arthroplasty or total prosthesis replacement. The choice of surgery process is mainly made according to the status of the glenoid.

Concerning hemi-arthroplasty, two types of humeral prosthesis are usually used: anatomical stems or resurfacing head implants. Both provide good results. Nevertheless with these prostheses, patient can present with post-operative pains due to glenoid erosion, linked to the metallic compounds used in such a prostheses. To face this issue, it was decided to modify the metallic compounds, and in order to mimic the tribological properties of the cartilage, Pyrocarbon (PyC) was found to be the best material.

First application of PyC in a medical device was for cardiac valves in 1969. Currently more than 2 million people live with PyC cardiac valves. Mechanical and physical properties of PyC are in favor of its use in orthopedic surgery; furthermore, its biocompatibility plays an important role in its good acceptability.

As very good results were observed when used in hand and wrist, interposition PyC implant was suggested for shoulder. Another advantage was that such interposition device allowed performing less invasive surgery, a particularly important criteria for young patients.

INSPYRE shoulder prosthesis was then designed as a shoulder interposition implant intended for partial replacement of the gleno-humeral joint. This implant is inserted between the glenoid cartilage and the humeral metaphyseal cavity. It is indicated in primary surgery to relieve severe pain or significant disability caused by degenerative pathologies, e.g., osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head. The rotator cuff must be functional.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring a Humeral Head Replacement (HHR) with INSPYRE as per indication of the Instruction For Use:
* with degenerative indication such as primary Gleno Humeral (GH) osteoarthritis, post-traumatic arthritis, primary and secondary avascular osteonecrosis of the humeral head,
* presenting a functional rotator cuff,
* able to return for all scheduled and required study visit;
* having provided informed Consent about scientific study participation if applicable.

Exclusion Criteria:

* Acute proximal humeral fracture,
* Systemic or local infection,
* Rotator cuff tear,
* Instability of the humeral head,
* Axillary nerve palsy,
* Revision arthroplasty.