cyrilzakka/clinical-trials huggingface dataset:
Side Effects of Autologous Mesenchymal Stem Cell Transplantation in Ankle Joint Osteoartritis

Ankle osteoarthritis is a joint condition which results from damage and loss of the cartilage in a joint. Treatment options for ankle osteoarthritis are usually aimed at controlling pain and limiting motion that provokes the pain. Nonsurgical treatment approaches are tried first. If unsuccessful, surgical options are considered. Stem cell therapy is one of the therapeutic options that can repair the damaged cartilage. Bone marrow derived mesenchymal stem cells have showed the capacity of bone and cartilage regeneration.

In this clinical study the investigators aim to investigate the safety of intra-articular injection of cultured autologous bone marrow derived mesenchymal stem cells (BM-MSCs) to the ankle joint in patients with severe ankle osteoarthritis. Patients will undergo bone marrow aspiration and will receive cultured BM-MSCs one month later. Patients will be assessed clinically with scoring system (FAO, VAS, WOMAC) preoperatively as well as 2 and 6 months postoperative to measure pain reduction and joint function improvement. Paraclinical studies (X-Ray and MRI) will be performed before and 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis diagnosed by MRI
* End stage osteoarthritis candidate for total ankle replacement

Exclusion Criteria:

* Pregnancy or lactating
* Positive tests for HIV, HCV, HBV
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder
L-Carnitine Administration in Early Sepsis

Sepsis is a severe and overwhelming response to an infection in the body. Over 750,000 patients in the United States develop sepsis every year. As sepsis becomes progressively more severe, a patient's blood pressure drops to dangerous levels and the body cannot pump oxygen to the rest of the body, which is necessary for normal cell function. This is called septic shock. When someone develops septic shock, it is very common for the smallest blood vessels in the body called the microcirculation to clog, like a highway during rush hour. Even with the best medical care, more than one in three patients with septic shock will die.

The major goal of this study is to test if intravenous replacement of a naturally occurring nutrient that is lost by the body during sepsis called L-carnitine can reduce how sick a patient with sepsis becomes. In our study, some patients will receive L-carnitine and others will receive saline. We will measure markers determining severity of illness in both groups and compare them to see if L-carnitine helps patients get better faster. Based on research already conducted, we believe L-carnitine will improve blood flow in the microcirculation, delivering more oxygen to cells, and help the body get better. To test if this is true, we will directly look at the microcirculation under the tongue with a special magnifying camera that looks at red blood cells, and compare both groups.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed infection
* Any two of four criteria of systemic inflammatory response
* Requirement for vasopressors to treat shock
* Enrollment within 12 hours of vasopressor initiation
* SOFA score of greater than or equal to 5 at the time of enrollment

Exclusion Criteria:

* Age \<18 years
* Pregnancy or breastfeeding
* Any primary diagnosis other than sepsis
* Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable
* Any history of seizures or a known seizure disorder
* Any known inborn error of metabolism
* Anticipated requirement for surgery that would interfere with the 12 hour infusion time
* Active participation in another interventional study
* Inability to obtain informed consent
* Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment
* Known systemic allergy to carnitine
Antecedent Picky Eating Behaviour in Young Children

Picky eating behaviour in young children is a very common concern for parents. The aim of the study is to investigate factors during early life which are associated with a child becoming a picky eater.

Singleton children from the Avon Longitudinal Study of Parents and Children will be studied prospectively (n=5758-6608). Parental-completion questionnaires will be used to define 'picky eating' status at age 3 years, and child and parental feeding behaviours and practices throughout the first 2 years of the child's life. Multinomial logistic regression models with 3 levels of picky eating status (not, somewhat and very picky) as the dependant variables will be used to test associations with antecedent variables, first assessing variables from pregnancy, and the first and second year of life, separately, then combining all significant variables in a final model.

Eligibility Criteria:
Inclusion Criteria:

* Child enrolled in ALSPAC, singleton, parent answered question on picky eating behaviour in questionnaire

Exclusion Criteria:

* Child not enrolled in ALSPAC, multiple, parent did not answer question on picky eating behaviour in questionnaire
The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.

The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* age 20-40 years;
* Moderate to severe intrauterine adhesion (AFS score ≥5）;
* complains of menstruation disorder and reproductive dysfunction
* Agreement to have second-look hysteroscopy
* informed consent

Exclusion Criteria:

* ovarian failure
* patients who did not proceed to second-look hysteroscopy within the specified time frame
* Contraindication of hormone
REMS Retigabine Study

As part of a post-marketing commitment, GSK will conduct a survey of prescribers' and pharmacists' understanding of the risk of urinary retention with retigabine products. This is to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as outlined in the REMS approved by the FDA on 10th June 2011. The objectives of this survey are to assess prescribers' and pharmacists' understanding of the risk of urinary retention and the symptoms of acute urinary retention potentially associated with retigabine use as evaluated by a survey instrument.

This is a cross-sectional study of approximately 200 physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months. The primary outcome of the survey is the proportion of physicians and pharmacists providing correct responses to a series of questions concerning the risk of urinary retention and the symptoms of acute urinary retention that may be associated with retigabine. The risks captured will be those described in the retigabine Dear Healthcare Provider (DHCP) letters, specifically risks of urinary retention.

POTIGA is a trademark of Valeant Pharmaceuticals North America, used by GlaxoSmithKline under license.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, speak, and understand English.
* Willing to take the online survey or have the survey administered via a telephone interview, including electronically signing a Confidentiality \& Consent agreement and completing all study protocol-specified procedures.
* Prescribed retigabine within the past 12 months (prescribing physicians)
* Filled a prescription for at least one AED within the previous three months (pharmacists).

Exclusion Criteria:

* Physicians or pharmacists meeting any of the following criteria will not be eligible to take the survey:
* The physician or pharmacist is currently employed by, or is a representative of any of the following:
* A pharmaceutical company or manufacturer of medicines or healthcare products.
* Contributor/editor to published guideline committees for epilepsy or UR.
* The physician or pharmacist has a visual impairment that would prevent him or her from being able to read independently.
* The physician or pharmacist participated in the Pilot REMS study for retigabine.
* The physician or pharmacist is an employee of GSK or Concentrics Research.
Melatonin on Coronary Artery Calcification

We planned to evaluate the effects of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis.

CAC is prevalent in coronary artery disease (CHD), and the extent of CAC predicts cardiovascular risk. The causes of CAC include dysregulated matrix metabolism, epitaxial mineral deposition, inflammation, oxidative stress, and apoptosis. Melatonin is the main indoleamine produced by the pineal gland; it is known recently to have anti-inflammatory, anti-cancer and antioxidant activities. Several studies have shown that melatonin protects against inflammation and apoptosis in vascular calcification. Melatonin also inhibits oxidative stress-induced apoptosis and calcification in endplate chondrocytes. The investigators planned to determine the efficacy of melatonin on progression of coronary artery calcification (CAC) in patients with moderate calcified coronary atherosclerosis. This study may shed light as to whether oral melatonin supplementation can be an adjunct therapy in CAC patients.

Eligibility Criteria:
Inclusion Criteria:

Patients with a documented Agatston score≥30 and moderate calcified coronary atherosclerosis (\<50% diameter lumen narrowing) were eligible for the study.

Exclusion Criteria:

1. unstable angina pectoris
2. symptomatic chronic heart failure and/or left ventricular ejection fraction (EF) \<40%
3. atrial fibrillation or other arrhythmias
4. type I diabetes mellitus or uncontrolled type II diabetes mellitus
5. renal failure
6. liver disease
7. gastrointestinal disease that affected absorption
Exploratory Study to Evaluate the Efficacy of an Occlusion Based Dentifrice in Relief of Dentinal Hypersensitivity

The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arms, parallel design study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at baseline, four and eight weeks to monitor clinical efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study.
* Participants will be required to have at least four teeth with facial/cervical erosion, abrasion and/or gingival recession which respond to qualifying evaporative (air) assessment at the Screening visit and have at least two teeth (incisors, canines or pre-molars) demonstrating signs of sensitivity, measured by qualifying tactile threshold (Yeaple ≤ 20 gram (g)) and evaporative (air) (Schiff Sensitivity Score ≥ 2) assessments at the Baseline visit.

Exclusion Criteria:

* Specific Dentition Exclusions for Test teeth

  1. Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of Screening.
  2. Tooth with exposed dentin but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing etiologies other than erosion, abrasion or recession of exposed dentin.
  3. Sensitive tooth not expected to respond to treatment with an over-the-counter dentifrice in the opinion of the investigator
* Use of a sensitivity dentifrice within 8 weeks of screening
* Individuals who require antibiotic prophylaxis for dental procedures
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients with Locally Advanced Pancreatic Adenocarcinoma (LAPC)

The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.

Single center, open label, escalating dosage of PCX12 with standard of care practice for subjects who are diagnosed with adenocarcinoma of the head of the pancreas. Subjects with undergo standard of care radiation therapy and then start on PCX12 therapy starting at 200 ng/kg of PCX12 escalating to a potential maximum dosage of 800 ng/kg of PCX12 with adjacent tolerability and safety guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patient with pathologically proven diagnosis of adenocarcinoma of the pancreas
* Initially staged as locally advanced by National Comprehensive Cancer Network (NCCN) criteria of solid tumor contact with aorta, superior mesenteric artery (SMA) or celiac axis \>180 degrees and/or unreconstructable superior mesenteric vein/portal vein (SMV/PV) due to portal involvement or occlusion, tumor contact with most proximal draining jejunal branch into SMV
* Have completed first line chemotherapy without progression or non-regional metastases
* Tumor is radiographically evident on CT scan after chemotherapy
* Tumor is anatomically amenable to SBRT, e.g. does not directly invade the stomach or bowel
* Tumor is amenable to intra-tumor injection under endoscopic ultrasound guidance
* ECOG performance status 0-2
* Patients with childbearing potential must demonstrate a negative urine or serum pregnancy test
* Male or female subjects, aged at least 18 years; Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year
* Patient must be able to understand and willingly sign study specific informed consent prior to study entry
* Anticipated life expectancy ≥ 12 weeks
* Patients aged at least 18 years of age

Exclusion Criteria:

* Progression of disease or metastatic disease after first line systemic therapy
* Prior radiation treatment or surgical resection of any pancreatic malignancy
* Inability to tolerate SBRT, Endoscopic ultrasound or IL-12 Injection procedure
* Lack of radiographically evident disease after first line chemotherapy
* Severe, active comorbidity that shortens the patient's life expectancy to less than 12 weeks
* History of past malignancy
* Patient who is pregnant and/or breastfeeding
* Inability to comply with other required protocol procedures including required biopsies
A Prospective Clinical Study On A Total Hip Resurfacing System

This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.


Eligibility Criteria:
Inclusion Criteria:

* intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:

  * Osteoarthritis
  * Avascular necrosis
  * Traumatic arthritis
  * Legg Perthes
  * Rheumatoid arthritis
Phase II Study of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer

The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have measurable disease
* Patients must have experienced on pervious chemotherapy regime
* Men and Women, with the age 20 years or older
* ECOG PS: 0-1

Exclusion Criteria:

* Patients with previous therapy with Taxanes
Fecal Microbiota Transplantation by Oral Capsules for Hepatic Encephalopathy Treatment

This interventional study aims to evaluate the safety and efficacy of oral capsule fecal microbiota transplantation (FMT) for treating hepatic encephalopathy refractory to conventional rifaximin and lactulose therapy in patients with liver cirrhosis. Patients diagnosed with hepatic encephalopathy refractory to rifaximin and lactulose therapy will be randomized into three groups. While continuing conventional therapy, the first group receives FMT via colonoscopy and oral capsule administration, the second group receives only oral capsule administration, and the third group serves as a control, receiving only conventional therapy.

The aims of the study are:

To evaluate the efficacy and safety of FMT by oral capsules in cirrhotic patients with hepatic encephalopathy refractory to standard therapy.

To evaluate changes in the gut microbiota composition and in the intestinal and systemic inflammatory condition occurring after FMT and if they can be associated with clinical improvement.

To evaluate metabolic modifications occurring after FMT and if they can be associated with clinical improvement.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of liver cirrhosis
* Hepatic encephalopathy of grade \>1 or higher according to West Haven classification, persistent or recurrent despite treatment with lactulose/lactitol and rifaximin at adequate doses started at least 30 days before the Hepatic encephalopathy episode

Exclusion Criteria:

* Na \<130 meq /l
* Creatinine \> 1.3 mg / dl
* Presence of grade 3 ascites
* Presence of esophagogastric varices at risk of haemorrhage in the absence of adequate prophylaxis
* Presence of other possible causes of encephalopathy (cerebral vascular disease, known neurodegenerative or cognitive disorders)
* Known psychiatric disorders or other causes of brain dysfunction (e.g. hypoglycemia, hyponatremia)
* Alcohol consumption
* Diagnosis of hepatocellular carcinoma
* Contraindication to fecal microbiota transplantation (e.g. pregnancy or breastfeeding)
* Presence of known intestinal diseases
* Any clinical condition that, in the opinion of the investigators, may contraindicate the enrollment in the study
Fish Oil Supplementation, Resting Energy Expenditure, Skeletal Muscle Membrane Composition and Metabolism in Elderly Subjects.

Resting metabolic rate (RMR) declines by 1-2% per decade after 20 years of age. This reduction is linked to a decrease in fat free mass (FFM) (10-20%) and the rate of energy expenditure of tissues (Manini 2010).

It has also been shown that as we age there is a:

* Concomitant reduction in basal fat and carbohydrate oxidation, most likely due to the decrease in RMR than to a change in respiratory exchange ratio (RER) (St-Onge and Gallagher 2010).
* A change towards a more saturated membrane of different tissues (Rabini et al 2002).

Incorporation of omega-3s, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), into cell membranes may alter energy metabolism by:

* Increasing the rate at which proteins operate (Hulbert 2007).
* Promoting the release of EPA and DHA into the cytosol which will act as ligands for peroxisome proliferator-activated receptors (PPARs) (Calder 2011). PPARs play an important role in energy homeostasis by regulating genes involved in lipid metabolism (Kota et al 2005).
* Augmenting protein synthesis through activation of the mTOR-p70s6k pathway (Di Girolamo et al 2014).

Supplementation with fish oil in older males and females:

* Increases whole muscle phospholipid profile of EPA and DHA (Smith et al 2011).
* Increases lean body mass (LBM), RMR, and fatty acid oxidation (Logan et al unpublished)
* Decreases carbohydrate oxidation (Logan et al unplubished). Skeletal muscle (SM) accounts for 20-30% of RMR (Zurlo et al 1990, Manini 2010), therefore it is tempting to speculate that these changes may occur by some of the mechanisms described earlier, with skeletal muscle being an important contributor.

To date there are no studies that have examined the effect of n-3 supplementation (3g/day)\* on plasma membrane fatty acid composition, RMR and substrate oxidation, and the possible mechanisms behind it.

Therefore the purpose of this study is to determine whether in older adults (female and male), supplementation with n-3 alters:

1. RMR and fatty acid oxidation.
2. Membrane composition of whole muscle and sarcolemma.
3. Content of skeletal muscle membrane fatty acid transport proteins.
4. Dose response of NaKATPase and SERCA efficiency
5. Content of mitochondrial proteins
6. Expression and content of PPARs and proteins involved in translocation of FA transporters (AMPK, ERK1/2, CamKII).
7. Phosphorylation of AMPKα(THR172), ERK1/2(THR202 TYR204) and CaMKII(THR286).
8. Proteomic profile of skeletal muscle.
9. Body composition


Eligibility Criteria:
Inclusion Criteria:

* Between 60 and 75 years old
* Must currently practice a consistent diet and exercise regimen, and maintain this throughout the duration of the study

Exclusion Criteria:

* Have any medical condition (no evidence of significant cardiovascular disease or organ dysfunction, including hypertension, dyslipidemia, and diabetes mellitus), and hospitalization or surgeries
* Consume more than two meals of fish/wk and/or have taken an omega-3 supplement during the prior three months.
* Have a BMI \> 30 kg/m2