cyrilzakka/clinical-trials huggingface dataset:
Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand

The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment of early stage osteoarthritis. The hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer.

As standard of care, routine strength, pain scale scores (VAS) and range of motion will be recorded, a baseline disability survey (DASH score) will also be administered. After these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure.

The subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.

The investigators central hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options. The overall aim of the project is to validate the clinical use of AAM for the treatment of early-stage osteoarthritis of the hand in adult patients (\>18 years of age). The specific aims for this project are:

1. To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand

   a. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points
2. To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength

   a. To determine efficacy, the investigators will measure visual analogue pain scale scores as measures by visual analogue scale, disability scores as measured with DASH scores, and standardized range of motion and strengths scores as measured by the same study administrator at each of the follow up time points
3. To determine patient satisfaction with the procedure a. To determine patient satisfaction, the investigators will administer a survey at each of the follow up time points

Eligibility Criteria:
Inclusion Criteria:

* Patients greater than 18 years, with presentation to the Cedars Sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (CMC, IP, PIP or DIP joints).
* Radiographic evidence of osteoarthritis.

Exclusion Criteria:

* Prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery).
* Rheumatoid or other inflammatory arthritis condition
* Collagen vascular disease
* Pregnancy or breast-feeding
* Congestive heart failure
* Chronic obstructive pulmonary disease
* Chronic renal failure
* Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix).
Factor XIII and Pulmonary Embolism in Neurosurgical Patients

Two studies (Gerlach et al. 2000; Gerlach et al. 2002) described the impact of factor XIII on the risk of prospective hemorrhage for patients undergoing craniotomy. Since then, factor XIII is measured and substituted in various centers. Few reports support the idea of factor XIII being involved in the formation of deep venous thrombosis and pulmonary embolism. In this prospective observational study, patients undergoing craniotomy for brain tumors or vascular lesions are investigated concerning the incidence of postoperative pulmonary embolism in respect of possible risk factors (factor XIII activity levels, standard coagulation parameters, tumor entity, blood loss).


Eligibility Criteria:
Inclusion Criteria:

* preoperatively low Factor XIII activity
* neurosurgical procedure (craniotomy)
* substitution of Factor XIII
* postoperative occurence of pulmonary embolism

Exclusion Criteria:
Radicle Energy: A Study of Cannabinoids on Energy and Other Health Outcomes

A randomized, blinded, placebo-controlled study of cannabinoid formulations and their effects on energy levels, focus, appetite and other health outcomes

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm (3000 total), age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for more energy (less fatigue and/or better concentration/focus during screening); (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) indicate an interest in taking a plant derived cannabinoid product to help with their energy and/or focus.

Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded. People with a calculated BMI of 18.5 or less will be excluded.

Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age and older
* Resides in the United States
* Endorses: a desire for more energy (less fatigue) and/or a desire for better concentration (focus/attention)
* Selects more energy and/or better concentration as a primary reason for taking a cannabinoid product
* Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e.

CBD, THC) for the duration of participant engagement

* Expresses a willingness to take a study product and not knowing the product identity until the end of the study

Exclusion Criteria:

Pregnant, trying to become pregnant, or breastfeeding Reports a diagnosis of liver disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Lack of reliable daily access to the internet Reports taking any medication that warns against grapefruit consumption Calculated BMI 18.5 or less
Sorafenib Plus S-1 in Advanced Solid Tumors

Primary Objective:

1. To define the recommended dose for phase II study of S-1 combined with sorafenib
2. To evaluate the dose-limiting toxicities of the combination therapy

Secondary Objectives:

1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy
2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.
3. To determine the changes of biomarkers between pre- and post-treatments.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment.
* Have measurable lesion.
* 20-75 y/o.
* ECOG performance score no more than 2.
* Life expectancy \> 12 weeks.
* Adequate hematopoietic, hepatic and renal functions.

  1. Hemoglobin \> 9.0 g/dl
  2. Absolute neutrophil count \> 1,500/mm3
  3. Platelet count 100,000/ mm3
  4. Total bilirubin \< 1.5 times the upper limit of normal (ULN)
  5. ALT and AST \< 2.5 x ULN
  6. Serum creatinine \< 1.0 x ULN
* Recovery from prior therapy that given \> 4 weeks before enrolment.
* No pregnancy and breast-feeding.
* Signed informed consent.

Exclusion Criteria:

* Severe cardiovascular disorders.
* Pulmonary fibrosis or interstitial pneumonia.
* HIV infection.
* Active infection.
* Major anti-cancer treatment within 4 weeks of study entry.
* Exposure to the current investigational agent before.
* Known or suspected allergy to the current investigational agent.
* Unable to swallow oral medications.
* Substance abuse, medical, psychological or social conditions interfering with the patient's participation or evaluation of the study results.
* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
* Symptoms of bowel obstruction, malnutrition, splenomegaly.
* Receiving active anti-coagulant therapy.
* Patients with concurrent CYP 2A6 and/or CYP 3A4 or 3A5 inducers or inhibitors; a minimal of 2 weeks wash-out period required.
Effect of Weight on Hip Excursion During Gait

Background: Children with diplegia had considerably larger hip and knee excursion during gait cycle than did normal developing children.

Objective: To investigate the effect of using weight around the ankle on hip excursion in children with diplegia.

Fifty children with spastic diplegic cerebral palsy were assigned into two groups at random (A, B). Both groups had received the same prescribed exercise program with classical gait training for group A and gait training while using weight around ankle for group B. Treatment was conducted for one hour three sessions per week for successive 3 months. Two-dimensional (2D) gait analysis was used to evaluate hip excursion throughout the gait cycle before and after three months of therapy.

Eligibility Criteria:
Inclusion Criteria:

* able to follow simple basic commands,
* identified with gait abnormalities described as level II on Gross Motor Function Classification System (GMFCS).
* diagnosed as spastic diplegia.

Exclusion Criteria:

* severe visual or auditory problems,
* lower limb surgical orthopaedic surgery or
* BOTOX injection in the six months preceding the start of the study,
* and uncontrolled seizures.
Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Acute-On-Chronic Liver Failure.

All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016.ACLF (Acute on chronic Liver Failure). ACLF will be randomize into

Group 1: MVP (Modest Volume Paracentesis) OF Less than 5 liters with IV albumin at a dose 8 gms/L of ascitic fluid

Group 2: MVP (Modest Volume Paracentesis) of Less than 5 liters without albumin


Eligibility Criteria:
Inclusion Criteria:

1. All patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥ 5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease (ACLF) admitted in the hospital.
2. All Cirrhotics decompensated with ascites admitted in the hospital.
3. Grade II/III ascites
4. Need for paracentesis.

Exclusion Criteria:

1. Age \<12 or \> 75 years
2. Hepatocellular carcinoma
3. Non cirrhotic ascites such as malignancy or tubercular peritonitis
4. Serum Cr \>1.5mg%
5. Refractory septic shock
6. Grade III/IV hepatic encephalopathy
7. Abdominal wall cellulitis
8. Active variceal bleed
9. Respiratory, cardiac and renal failure
10. Refusal to participate in the study
Efficacy Study of a Sensory Feedback Knee Orthosis in Patients Suffering From Unoperated Severe Knee Sprain

Ortheses are commonly used for the repair of damage to the musculoskeletal system. However, immobility, by itself, causes serious side effects that require long and costly rehabilitation. The Sensory Feedback Ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. The clinical study Orthosens will evaluate the efficacy and safety of the Sensory Feedback Ortheses.


Eligibility Criteria:
Inclusion Criteria:

* Patients agreeing to participate in the study and who signed informed consent.
* Indication of bracing immobilization for 6 weeks following a unoperated severe sprain of the knee with partial or total rupture of the anterior cruciate ligament and a peripheral injury, medial or lateral collateral ligament, with or without meniscal lesion.
* MRI scan confirming the nature of the lesion to be provided

during the inclusion visit.

* Patients whose knee is immobilized for 7 to 15 days in Zimmer-like splint.
* Patients aged from 18 to 65.
* Patients agreeing to choose their physiotherapist from a list provided by the investigators.
* Patient (s) with insurance coverage.

Exclusion Criteria:

* Patients with a bucket handle meniscus tear.
* Patients with a pentad injury.
* Patients with osteochondral fragments.
* Patients with a knee fracture apart from "Segond fracture" and "bone bruise".
* Patients who underwent ligament surgery for the concerned knee.
* Patients with a bone lesion which may interfere with the knee joint(distal femur, proximal tibia, patella).
* Patients with any history of rupture of the central pivot (anterior cruciate ligament and posterior cruciate ligament), of lateral ligament planes rupture (medial collateral ligament and lateral collateral) or lateral planes ligament injury without rupture, dating from less than 1 year.
* Patients whose sprain results from an accident at work.
* Patients with an inability / unwillingness to follow protocol requirements.
* Patients for whom there would be no suitable brace size in the Thuasne range.
* Patients participating in another clinical study or who have tested an experimental drug within 30 days prior to study entry. - Patients with another disease which, according to the investigator, may interfere with the results or the conduct of the trial and thus justify their non-inclusion in the study.
A Random Controlled Test (RCT): Acupuncture Treatment on Nonspecific Low Back Pain (NLBP)

Hypothesis: Acupuncture procedure of He's Santong Methods could be an option to treat nonspecific low back pain.

He's Santong Methods is a combined manipulated needling methods, including filiform needling, fire needling and bloodletting needling, which was created by Dr. He Puren who is one of the most famous TCM doctors in China.

Eligibility Criteria:
Inclusion Criteria:

* The patient who is suffering the Non-specific Low Back Pain which meets the diagnostic criterion of posterior ramus of lumbar spinal nerve syndrome.
* The patient who is from 18 to 79 years old.
* The patient who can comprehensively understand and fill in the questionnaires about the disease.
* The patient who suffered problems no less than 12 weeks.
* The patient who have not the other diseases which can result in back pain.
* The patient who received the clear examinations of X-ray, CT scan or MRI.
* The patient who wrote the informed consents.

Exclusion Criteria:

* The patient whose low back pain is the consequences of spondyloschisis, Spondylolysis, osteoarthritis, osteoporosis, internal disease, metastatic tumor.
* The patient who have the hemorrhagic disease such as hemophilia.
* The patient who have the spinal diseases which have not been diagnosed clearly.
Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis

The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician

The main questions aims to answer:

* Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?
* Does educational program improve mothers knowledge and practice regarding chest physiotherapy?

Researcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days


Eligibility Criteria:
Inclusion Criteria:

* 1. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.

Exclusion Criteria:

1. Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)
2. Children who intubated and admitted to Intensive Care Unit (ICU).
Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema

This study is a double-blind randomized clinical trial in Diabetic patients (type 2) over 18 years of age who have diabetic macular edema with involvement of the central 1 millimeter (central macular thickness is more than 300 μm) and BCVA 20/30 or less who visit the retina clinic of Labbafinejad Hospital Are studied. (In patients with bilateral macular edema, only one eye is included in the study.) Complete ocular examinations (including best corrected visual acuity - anterior segment - intraocular pressure - dilated pupil funduscopy with severity of diabetic retinopathy), optical coherence tomography (OCT), EDI-OCT( Enhanced Depth Imaging Optical Coherence Tomography ) - as well as Optical coherence tomography angiography (OCTA ) are performed for all patients at baseline. Blood tests are also taken from patients for fasting blood sugar and HbA1C. Patients are then randomly divided into two groups. The first group is treated with injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day. For the second group (control group), 3 injections of 1.25 mg of intravitreal bevacizumab monthly with artificial tears (twice a day as a placebo) are prescribed. Patients in both groups are visited 1 month after the third basic intravitreal bevacizumab (IVB) injection and complete ophthalmology examinations are performed and central thickness of macula is recorded based on the patient's OCT as well as the need for IVB re-injection. EDI (Enhanced Depth Imaging)-OCT and OCTA are performed again for all patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Diabetic Melitus type 2
* Patients with center-involving diabetic macular edema (central macular edema \> 300 micrometer)
* Patients have diabetic retinopathy at the stage of nonproliferative diabetic retinopathy (NPDR) or early PDR (proliferative diabetic retinopathy) or regressed PDR
* In patients with bilateral macular edema, only one eye is included in the study.

Exclusion Criteria:

* uncomplicated cataract surgery
* history of cataract surgery during last 4 months
* history of Panretinal Photocoagulation (PRP) during last 4 months
* any retinochoroidal disease except Diabetic retinopathy
* optic disc pathology
* patient with high-risk PDR or advanced PDR
* one-eye patients
* patient with glaucoma or uveitis
* pregnant or lactating patients
* patients whom topical Timolol or Dorzolamide are prohibited for any reason
Monocyte Chemoattractant Protein-1 2518A/G Polymorphism

The pathogenesis of proliferative diabetic retinopathy (PDR) remains poorly understood. Recent studies have implicated that monocyte chemoattractant protein-1 (MCP-1) is associated with diabetic microvascular or macrovascular complications. However, the relationship between SNP polymorphism c.2518A/G in the MCP-1 gene with diabetic retinopathy remains controversial. In the present study, we evaluated the association of a single nucleotide polymorphism (SNP) in the MCP-1 gene with diabetic retinopathy (DR) and diabetic macular edema (DME) in Chinese population from Southern China with type 2 diabetes.

The association between polymorphism of MCP-1 c.2518A/G and DR had been reported in Japan and Korea, but their opinion were inconsistent. However there is no report in China so far. This study was designed to clarify the relationship of polymorphism of MCP-1 c.2518A/G with type 2 diabetes with or without DR. The relationship between MCP-1 c.2518A/G and different stage of DR has also been studied.This article proved that the MCP-1 c.2518G/G genotype is a susceptibility gene for DR in Chinese type 2 diabetic patients, especially the High-risk PDR. There is no association with DME and c.2518G/G.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic retinopathy
* age at diagnosis ≥30 years and a known duration of diabetes of ≥5 years.

Exclusion Criteria:

* eyeball atrophy
* epimacular membrane
* age-related macular degeneration (ARMD)
* intravitreal injection medicine
* vitreous hemorrhage
Lung Stereotactic Body Radiotherapy (SBRT) Delivered Over 4 Days Versus 11 Days

Stereotactic Body Radiotherapy (SBRT) has emerged as a new treatment option for peripherally located lung tumours, offering very high rates of tumour eradication, with minimal side effects. Even though this treatment option is being adopted in more and more cancer centres, there is still no consensus about the optimal schedule for the radiation treatment. Generally speaking, most lung SBRT schedules involve delivering 3-4 days of radiation. At the Sunnybrook Odette Cancer Centre, the lung SBRT policy is to deliver 4 days of radiation over 11 days (each treatment given once very 3rd day). However, some centres deliver the same treatment over 4 days in a row (each treatment given once daily over 4 days). There is no evidence from the published literature to suggest that there is any difference in side effects between delivering the SBRT over 4 days versus 11 days. To confirm this, the investigators propose to conduct a comparative (randomized) study to compare these 2 approaches.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of malignancy in the lung (either NSCLC or metastasis)
* If pathologic diagnosis is not available, there must be evidence of FDG uptake on PET-CT suggestive of malignancy and/or evidence of tumour growth over serial CT scans
* Clinical stage I lung cancer or solitary lung metastasis located in the periphery away from central mediastinal structures and \<=5cm in size
* Patient deemed suitable for lung SBRT (reasonable performance status, acceptable pulmonary function) by the attending Radiation Oncologist
Effects of Treatment of Ascites by the ALFApump System on Renal and Circulatory Function

This is a single centre, prospective, uncontrolled study to include 12 consecutive patients with cirrhosis of the liver and recurrent or refractory ascites. The main aim (primary objective) of the study is to investigate the effect of treatment of ascites by the Sequana medical pump on the renal and circulatory function in patients with cirrhosis and recurrent or refractory ascites. The secondary objectives are the following:

* To evaluate the efficacy of treatment for handling ascites, associated with changes in the body weight of patients and their requirements for evacuation paracentesis during follow-up.
* To investigate the effects of treatment on bacterial translocation, by means of determining bacterial DNA.
* To determine the incidence of complications associated with treatment in the course of follow-up.
* To evaluate the effect of treatment on quality of life of the patients treated, evaluated in questionnaires entitled Short Form-36 and CLDQ (chronic liver disease questionnaire).


Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years of age
2. Cirrhosis of the liver defined by histological and/or clinical, analytical and radiological criteria.
3. Presenting refractory or recurrent ascites, requiring 2 or more evacuation paracentesis procedures over the last 3 months.
4. Written informed consent
5. Ability to comply with study procedures and ability to operate the device
6. Women of childbearing age should use adequate contraceptives

Exclusion Criteria:

1. Digestive haemorrhage over the last 7 days (these patients can be included once the 7-day period has gone by).
2. Kidney failure defined as serum creatinine higher than or equal to 2 mg/dl.
3. Serum bilirubin greater than 5 mg/dl.
4. Severe coagulopathy defined as platelet count of less than 40,000 or prothrombin time of less than 40%.
5. Recurring bacterial peritonitis, defined as 2 or more episodes over the last 6 months.
6. Recurring urinary infections, defined as 2 or more episodes over the last 6 months.
7. Clinical evidence of loculated ascites.
8. Advanced hepatocarcinoma, defined as one which exceeds Milan criteria.
9. Previous liver transplant.
10. Obstructive uropathy or any bladder anomaly which might contraindicate implantation of the device.
11. Pregnancy
12. Patients being in another clinical study that did not reach primary endpoint yet