cyrilzakka/clinical-trials huggingface dataset:
Treatment of Tendon Disease Using Autologous Adipose-derived Mesenchymal Stem Cells

This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1\*10\^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1\*10\^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.

All injection will be done under ultrasound guidance.

Eligibility Criteria:
Inclusion Criteria:

1. clinically diagnosed as rotator cuff tear or lateral epicondylitis (tennis elbow);
2. symptom duration is over 3 months, non-steroidal drug treatment , rehabilitation treatment and other conservative treatment is invalid;
3. patient that can understand the clinical trials and signed the informed consent.

Exclusion Criteria:

1. patient that underwent other injection treatment within 6 weeks
2. some associated diseases (such as arthritis, synovitis, entrapment of related nerve, radiculopathy to the target lesion, generalized pain syndrome, rheumatoid arthritis, pregnancy, impaired sensibility, paralysis, history of allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue)
3. patient that enrolled other clinical trials within 3 months
4. history of drug/alcohol addiction, habitual smoker
Light Therapy for Internet Gaming Disorder

This project aims to investigate (1) the efficacy of light therapy on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy


Eligibility Criteria:
Inclusion Criteria:

1. the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder;
2. the scores of the Young-Internet addiction Test ≥ 50;
3. playing internet games ≥15 h/week for ≥1 year

Exclusion Criteria:

1. current or history of psychiatric or neurological illness;
2. current or history of use of illegal substances and other addictions;
3. current use of psychotropic medications ;
4. any history of head trauma, presence of metal in the body or other contraindication to functional MRI scanning;
5. photosensitivity disorders, such as systemic lupus erythematosus and chronic actinic dermatitis.
Measuring and Modulating Changes in EEG Resting State Functional Connectivity During Short-term and Long-term Pain

Background and aims: Experimental prolonged pain models can shed more light on the cortical mechanisms involved in the transition from acute to chronic pain including changes in resting state functional connectivity (rsFC). This experiment aimed at examining the effect of 24-hour-capsaicin application on the rsFC of the default mode network (DMN), a prominent network in the dynamic pain connectome.

Methods: Electroencephalographic (EEG) rsFC measured by Granger causality was acquired at baseline, 1-hour, and 24-hour following the initial patch application (placebo or capsaicin). After 24 hours, the patch was cooled down then heated up to assess rsFC changes in response to pain relief and facilitation. Pain was induced using a topical capsaicin patch (or placebo as control) on the right forearm and assessed on a 0-10 numerical rating scale (NRS).


Eligibility Criteria:
Inclusion Criteria:

Healthy men and women, age 19-44, right-handed (assessed using the Edinburgh Handedness Inventory, speak and understand English.

Exclusion Criteria:

1. Chili allergies
2. History of chronic pain or current acute pain
3. Present or previous neurologic such as epilepsy, Alzheimer disease, dementia, stroke, migraine and other headache disorders, multiple sclerosis, Parkinson's disease, neuroinfections, brain tumours and head trauma.
4. Present or previous musculoskeletal disorders such muscle/tendon strain, ligament sprain tension,tendonitis, degenerative disc disease, mechanical back syndrome, and ruptured/herniated disc.
5. Present or previous mental illnesses such as depression, bipolar disorder, and schizophrenia.
6. Pregnancy
7. Current use of medications that may affect the trial (e.g. pain relieving medication and anti-inflammatory medication)
8. Using hair products that may interfere with EEG conductance such as gel, except for shampoo, prior to the trial.
9. Drug addiction defined as the use of cannabis, opioids or other drugs
10. Consumption of alcohol, caffeine, or tobacco 6 hours before the experimental onset
11. Lack of ability to cooperate -
Crossmodal Learning in Therapeutic Processes (Task 2-1)

Interventional study of the effects of vibro-tactile feedback on behavioral deficits and learning during motor training in patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke according to ICD 10 I61-I69
* Deficit still existing (Rankin score of at least 1 at inclusion)
* Age \>= 18, \<=80
* Existing declaration of consent

Exclusion Criteria:

* Pregnancy
* Lacking capacity for consent
Different Strategies for Preventing Severe Acute Malnutrition in Niger

Options for large-scale preventive distributions include fortified blended flours, ready-to-use foods and direct cash transfer either alone or in combination with family protective rations. Finding the most appropriate strategy is essential to prevent child malnutrition in countries like Niger with annual hunger gaps. Here, the investigators compare different preventive strategies on the incidence of acute malnutrition among children 6 to 23 months.


Eligibility Criteria:
Inclusion Criteria:

* resident in selected villages
* height between 60 and 80 cm.

Exclusion Criteria:

* refusal to participate
A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament

This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy.

The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55
* MRI confirmed primary and total ACL injury of traumatic origin
* Indication for ACL reconstruction in arthroscopy
* Written informed consent
* Active and non-sedentary lifestyle

Exclusion Criteria:

* Complex meniscal injuries
* Cartilage lesions of sizes\> 2 cm2
* Other ligamentous lesions
* Axis deviations greater than 10°
* Rheumatic, neuromuscular or general systemic diseases
* Prevention of injured knee traumas treated surgically
* Difficulties in compliance in following the rehabilitation programs
* Obesity (BMI ≥ 30)
* Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients
Unlock the Cell: Castleman's Disease Flow Cytometry Study

Castleman disease, a rare lymphoproliferative disorder, is characterized by inflammatory cytokine production and multiple organ system dysfunction. In this study, we will investigate inflammatory markers, cells, and signaling pathways in prospectively collected blood samples and/or buccal swabs or saliva using biochemical and RT-PCR techniques, proteomics, genomics, immunohistochemistry, storage for future use, cell culture treated with external stimuli, flow cytometry, and other molecular tests

This is a University of Pennsylvania-sponsored project that is supported by the Castleman Disease Collaborative Network and the patients/loved one's group Castleman's Warriors (Castleman's Awareness and Research Effort).

Castleman Disease (CD) is a rare and poorly understood lymphoproliferative disease. The multicentric CD subtype (MCD) involves enlarged lymph nodes in multiple regions of the body and can be fatal if untreated. MCD patients demonstrate acute inflammatory crisis due to upregulation of inflammatory agents most notably IL-6 and VEGF followed by multiple organ failure and death.

Unlock the Cell aims to identify the pathways the disease takes through flow cytometry studies. The purpose of the CD Research study is to collect blood samples and/or buccal swabs or saliva samples and medical information of MCD patients and compare them to control samples so researchers can understand the causes of MCD, and design treatments based on our findings.

In this study, the investigators will analyze inflammatory markers, cells, and signaling pathways in prospectively collected blood samples using biochemical and RT-PCR techniques, proteomics, genomics, immunohistochemistry, storage for future use, cell culture treated with external stimuli, flow cytometry, and other molecular tests. A secondary aim is to collect excess stored tissue samples (e.g., lymph node, bone marrow) from previous procedures and store these samples along with unused blood samples for future research purposes to be performed at the University of Pennsylvania or shared with other Castleman disease researchers and biobanks.

Eligibility Criteria:
Inclusion Criteria:

* CD patients: Individuals of any age who are diagnosed with or suspected by a physician to have CD, including those who do have the ability to consent and those who lack the ability to consent
* Related Disease: Individuals who state that they have a disease that is a "Related Disease". "Related Disease" means autoimmune, oncology, inflammatory/lymphoproliferative disorders and infectious diseases that are similar to Castleman
* Healthy Individuals: Individuals without a history of auto-immune, inflammatory, infectious disease or oncologic disorders.

Exclusion Criteria:

• All individuals whose medical or psychological conditions (such as a mental handicap) would, in the opinion of the Principal Investigator, compromise the subject's safety or successful participation in the study.
Evaluation of Mild TBI in Collegiate Athletes

The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.


Eligibility Criteria:
Inclusion Criteria:

1. University of Florida student athlete involved in Men's Football, Men and Women's Basketball, Men and Women's Swimming, Men and Women's Diving, Women's Soccer, or Women's Lacrosse or University of Florida student athlete not participating in those sports who is being treated for a sports-related head injury.
2. Age greater than or equal to 18 years of age.
3. Willing to undergo the Informed Consent Process and provide Informed Consent prior to enrollment into the study.

Exclusion Criteria:

* Subject is otherwise determined by the Investigator to be medically unsuitable for participation in the study
Effective Postoperative Pain Relief After Laparoscopic Cholecystectomy With TENS

The study evaluates the effect of TENS (transcutaneous electrical nerve stimulation) treatment for first line of treatment compared with conventional treatment with opioids on pain relief and time spent time in the post-anesthesia care unit after laparoscopic cholecystectomy. Half of the patients are randomized to TENS as first line of treatment and the second half is randomized to conventional opioid treatment. Patients who does not report postoperative pain which requires treatment are used as controls.

Postoperative pain is often a problem after laparoscopic cholecystectomy. Conventional treatment with intravenous (iv) opioids often offers satisfactory pain relief. However, opioids have negative side effects, such as sedation, nausea, and respiratory depression. Some of these side effects require monitoring of the patient, resulting in longer duration of stay in the post-anesthesia care unit (PACU) after surgery. Transcutaneous electrical nerve stimulation (TENS) has been used to provide pain relief in various postoperative pain conditions. Previous studies from the investigator's center indicate that TENS treatment for postoperative pain after gynecological surgery results in shorter time in the PACU.

Previous studies indicate that patients reporting pain intensity associated with venous cannulation to \> 2 VAS (visual analog scale) units have higher risk of postoperative pain in the PACU. The aim of the study is to compare time spent in the PACU and to compare the postoperative pain relieving effect of high frequency, high intensity TENS as first line of treatment with conventional treatment with iv opioids in patients undergoing laparoscopic cholecystectomy. Furthermore, the study evaluates if postoperative opioid consumption can be reduced by using TENS as first line of treatment. In addition, the study tests if pain intensity associated with venous cannulation can be used to predict occurrence of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

For randomized patients:

• Patients who reports postoperative pain intensity ≥ 3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy.

For controls:

• Patients who reports postoperative pain intensity \<3 according to numeric rating scale during the stay in the post-anesthesia care unit after laparoscopic cholecystectomy

Exclusion Criteria:

(for all patients)

* Patients who do not want to participate in the study
* Patients younger than 18 years
* Inadequate knowledge of the Swedish language
* Patients with pacemaker or internal cardioverter defibrillator
* Patients who preoperatively report continuous opioid consumption
* Patients with chronic pain conditions
* Patients with impaired sensibility over the dermatomes that are to be treated with TENS
* Alcohol or substance abuse
Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C Acetabular Components

MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.


Eligibility Criteria:
Inclusion Criteria:

To be included in the study, subjects must meet all of the following criteria:

* Has previously undergone primary Total Hip Arthroscopy for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis;
* Correction of functional deformity
* Subject was implanted with the specified combination of components, namely, any MicroPort Orthopedics or Wright Medical Technology femoral stem and PROCOTYL C Acetabular Components
* Subject is willing and able to complete required study visits or assessments

Previously implanted bilateral subjects can have both THAs (Total Hip Arthroscopy) enrolled in the study provided:

1. the specified combination of components were implanted in both,
2. all other aspects of the Inclusion/Exclusion Criteria are satisfied,
3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
4. the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrolment of a previously unimplanted hip is not permitted in this study.

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

* Subject was skeletally immature (less than 21 years of age) at time of implantation
* Subject has a non-MicroPort or non-Wright Medical Technology component implanted (femoral heads, acetabular shells, acetabular liners) in the enrolled Total Hip Arthroscopy
* Subject is currently enrolled in another clinical investigation which could affect the endpoints of this protocol
* Subject is unwilling or unable to sign the Informed Consent document
* Subject has documented substance abuse issues
* Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
* Subject is currently incarcerated or has impending incarceration
Bilevel Versus Servoventilation in Complex Sleep Apnea

Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with complex sleep apnea during continuous positive airway pressure (CPAP) treatment.

Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.

Eligibility Criteria:
Inclusion Criteria:

Predominant obstructive apnea without treatment Predominant central apnea with CPAP treatment

Exclusion Criteria:

primary central sleep apnea non-compliance to CPAP therapy
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)

Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.

The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of either DLE or SLE
* Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)
* Is prepared to grant authorised persons access to the medical records
* Has signed informed consent

Exclusion Criteria:

* Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome
* Has scarring at the target lesion
* Systemic treatment of SLE
A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)

The EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle tip has entered the epidural space. The objective of this First In Human study is to evaluate the safety and performance of using the EpiFinder to identify the epidural space in subjects with a clinical indication to receive a lumbar Epidural Steroid Injections.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject with clinical indication for lumbar ESI based on subject's clinical problem (e.g. DDD hernia disc, spinal stenosis)
* Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed

Exclusion Criteria:

* Subject with marked spinal deformities
* Previous back surgery
* Contraindication for epidural injections (e.g. continuous use of anticoagulants, infection, allergic reactions to the injected substances)
* Subject has known hypersensitivity to contrast media that cannot be pre-medicated
* Subject with severe obesity (body mass index \>35 kg/m2)
* Subject observed seizure within 7 days prior to study enrollment
* Subject presenting for emergency
* Subject has a skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) in their lumbar region
* Subject is pregnant (to be determined by urine pregnancy test)
* Subject who is currently participating or has participated in an investigational study, within the past 30 days
Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

This study is being conducted to collect data on the management of major bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

Purpose:

Eligibility Criteria:
Inclusion criteria:

* Greater than or equal to 18 years of age;
* Confirmed diagnosis of non valvular atrial fibrillation (NVAF) (Diagnosis of AF is considered confirmed if there is medical chart documentation that the patient has atrial fibrillation or AF or the ICD-9 or ICD-10 code for AF is documented);
* NVAF is defined as follows: nonvalvular atrial fibrillation is restricted to cases in which the rhythm disturbance occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
* Documentation that the patient presented to an emergency department/emergency room (ED/ER) for a major bleeding event (index event);
* Major bleeding is defined by International Society on Thrombosis and Haemostasis (ISTH) as:
* fatal bleeding and/or
* symptomatic bleeding in a critical area/organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
* bleeding causing a fall in hemoglobin of 20g per liter or more, or leading to transfusion of 2 or more units of whole blood or red blood cells
* Documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event.

Exclusion criteria:

* Confirmed diagnosis of valvular AF (Diagnosis of valvular AF is considered confirmed if there is medical chart documentation that the patient has valvular AF or VAF. In the absence of documentation to indicate whether the patient has non-valvular or valvular AF,);
* Documentation that the patient was taking dabigatran with a concomitant anticoagulant (contemporaneous parenteral anticoagulant or another oral anticoagulant) within 72 hours of the index event;
* The concomitant administration of antiplatelet medications prior to the onset of the index event is not exclusionary;
* Documentation of the patient receiving thrombolytic therapy within 48 hours of the onset of the index event;
* Documentation that the patient was enrolled in an interventional investigational or other BI observational clinical trial at the time of the onset of the index event;
* Medical record was not retrievable, was missing or empty.
Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3
* Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam

Exclusion Criteria:

* Patients who refuse to participate in this study
* Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
* Patients with an allergy to propofol, fentanyl, or bupivacaine
* Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
* Patients judged to be inappropriate for this study