cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Chinese origin
* Known or suspected blood vessel diseases

Exclusion Criteria:

* Pregnancy
* Lactation
* Conditions interfering with MRI
* Allergy to any contrast agent or any drugs
* Participation in other trial
* Require emergency treatment
* Severely impaired liver and kidney functions
In-vivo Behavior of Asqelio Monofocal Biaspheric Intraocular Lens

This is a study to evaluate the 24 month postoperative incidence and intensity of posterior capsular opacity in patients submitted to cataract surgery and implanted with a hydrophobic monofocal IOL.

This study is a two-arm masked clinical evaluation study of incidence of PCO after successful bilateral cataract surgery with implantation of a monofocal IOL. Subjects will be assessed 24 months after IOL implantation. Clinical evaluations will include incidence of adverse events, patient satisfaction questionnaire, as well as measurements of visual performance, optical quality, presence and intensity of PCO, presence and intensity of IOL glistening.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 22 years or older submitted to cataract surgery in at least 1 eye and implanted with Asqelio monofocal or Clareon monofocal IOL

Exclusion Criteria:

* Any pathology reducing potential best-corrected visual acuity beyond 0.30 LogMAR, including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely shallow anterior chamber, microphthalmos, retinal detachment, severe recurrent anterior or posterior segment inflammation of unknown ethiology, iris neovascularization, uncontrolled glaucoma, clinically significant macular degeneration, or pseudoexfoliation diagnosis.
* Previous ocular surgery
* Rubella
* Surgery motivated by traumatic cataract
* Ocular trauma or refractive surgery
* Any other systemic or ocular condition that, in the investigator's opinion, should exclude the subject from study
* Requiring additional procedures due to intraoperatory complications, mechanical or surgical interventions for manipulating the pupil, excessive iris movility, significant vitreous loss, significant, anterior chamber hyphema, capsular annular breakage, or any other unrecognized ocular conditions that might compromise IOL positioning, as well as impossibility of locate the IOL in the capsular bag due to surgical complications.
Energy Homeostasis in Anorexia Nervosa

The purpose of this study is to investigate the potential biological predispositions that contribute to the difficulty patients with anorexia nervosa have in maintaining normal weight.

Anorexia Nervosa (AN) is a psychiatric illness that is characterized by extreme weight loss and severe body image distortions. In this study, we are examining changes in body composition, metabolic rate, and reproductive function before and after treatment for AN. More specifically, we are testing the hypotheses that 1)Weight-restored patients with AN have elevated resting energy expenditure (REE) compared to controls, 2) Weight-restored patients with AN have a central disposition of body fat compared to controls, 3) Weight-restored patients with AN who gain the most fat centrally will have the least improvement on psychological measures, 4) Weight-restored patients with AN will have leptin levels out of proportion to body fat mass. It will also investigate the relationship between REE and leptin with respect to the return of menses.

Eligibility Criteria:
Patients:

Inclusion Criteria:

* DSM-IV diagnosis of Anorexia Nervosa
* BMI ≤ 17.5kg/m2 (equivalent to 80% of ideal body weight)
* Medically stable
* Participation in in-patient treatment sufficient to restore patient to a BMI of at least 19kg/m2

Exclusion Criteria:

* On medication\*
* Current substance abuse or dependence
* History of suicide attempt or other self-injurious behavior within the previous 6 months
* Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos)

Controls:

Inclusion criteria:

* No current psychiatric disorder (including eating disorder, depression, bipolar disorder, schizophrenia, substance abuse/dependence)
* No history of an eating disorder
* BMI greater than 19kg/m2 and less than 21kg/m2
* Weight stable (+/- 2kg) for the previous 6 months
* No history of excessive or repeated dieting
* No history of excessive exercise (defined as greater than 6 hours/week)
* Regular menstrual cycles

Exclusion criteria:

* On medication\*
* Pregnant or lactating
* Significant medical problem
* Non-removable metal on/in their body (e.g. metal pacemaker, surgical clips, metallic-ink tattoos)

  * At the time of testing, subjects will be free of fluoxetine for 6 weeks, and free of all other medications for a minimum of 2 weeks
To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations

Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and others have previously reported, a portion of OA might be caused primarily by bone alterations. In this study, we prospectively and retrospectively show that the bone altertations may affect OA primarily in all of the joints.

In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone, instead of cartilage. Here we prospectively and retrospectively show that the bone altertations may affect RA primarily in all of the joints.


Eligibility Criteria:
Inclusion Criteria:

* RA and/or OA

Exclusion Criteria:

* N/A
Autologous Mesenchymal Stem Cell Transplantation in Cirrhosis Patients With Refractory Ascites

Liver cirrhosis (LC) is the final destiny in chronic liver disease.The quality of life in liver cirrhosis patients with refractory ascites are very wretched. The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via liver artery in Child-Pugh B and C stage of liver cirrhosis patients with refractory ascites. The immunomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect and influence of MSCs in the patients,include assay of liver function,variation of ascites,Child-Pugh score etc.


Eligibility Criteria:
Inclusion Criteria:Inclusion Criteria:

Aged 18\~65 years. Ultrasonographic evidences of cirrhosis. hepatic cirrhosis patients with refractory ascite.

Exclusion Criteria:

history of moderate to severe hepatic encephalopathy or variceal bleeding during the last two months before enrolment.

Prothrombin time is less than 30s. Severe problems in other vital organs(e.g.the heart,renal or lungs). Liver tumor on ultrasonography, CT or MRI examination. Pregnant or lactating women. Imaging evidences of vascular thromboses.

-

Exclusion Criteria:

-
A Post Market Surveillance on INFUSE Bone Graft

This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.

This study is a prospective, observational, multi-center, post-market surveillance to collect patient data regarding on-label use of INFUSE™ Bone Graft for lumbar fusion via ALIF or OLIF. Commercially available device will be used within its intended use.

This study is supposed to be conducted during a period of 4 years with 600 or more cases after the product approval in Korea. According to the standard of care in Korea, the patients will be followed at least 12 months post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Has degenerative disc disease and is indicated for lumbar interbody spine fusion from L2-S1 with INFUSE™ Bone Graft via ALIF or OLIF technique
* Agrees to participate in the study and is able to understand and sign the Informed Consent
* The procedure planned for the patient complies with the labeling of the devices that may be used in the surgical procedure
* Has at least six months of nonoperative treatment prior to the study treatment
* Is at least 18 years old at the time of informed consent

Exclusion Criteria:

* Has a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation
* Has any active malignancy or undergoes treatment for a malignancy, or operative site is in the vicinity of a resected or extant tumor
* Is skeletally immature (\<18 years of age or no radiographic evidence of epiphyseal closure)
* Is pregnant or lactating
* Has an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone
* The use of the Infuse™ Bone Graft component implanted at locations other than the lower lumbar spine (e.g., cervical spine)
* Repeat applications of the Infuse™ Bone Graft component
* Has up to Grade 1 retrolisthesis
* Has hepatic or renal impairment
* Has metabolic bone disease
* Has autoimmune disease
* Has immunosuppressive disease or suppressed immune systems resulting from radiation therapy, chemotherapy, steroid therapy, or other treatments
* Is illiterate or vulnerable (e.g., the participant is incapable of judgment or is under tutelage) as per the investigator's assessment
* Concurrent participation in another clinical study that may confound study results
* Has a considerable risk for surgery
* Has a condition that could compromise study (e.g., mentally incompetent, alcohol or drug abuse) as per the investigator's assessment
Performance of Toric Silicone Hydrogel Contact Lenses Following One Month of Daily Wear

The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.

Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)
* Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients

The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2.

Exclusion Criteria:

* Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy
Effects of WBV Associated With IMT on Functionality

The pre-frail elderly are a population more vulnerable to diminished functionality and future disabilities. Thus, interventions focused on the prevention of sarcopenia are indicated to prevent dysfunction in this population. This study aims to evaluate the effects of whole body vibration training associated with inspiratory muscle training on functional outcomes, balance and muscle metabolism in pre-frail elderly women.


Eligibility Criteria:
Inclusion Criteria:

* To able to walk without assistance
* Good understanding to carry out the proposed tests, evaluated through the Mini Mental State Examination (MMSE).

Exclusion Criteria:

* Contraindication or difficulty to perform evaluation procedures
* Users of medications that interfere with the cardiovascular and / or muscular system
* Smokers
* Neuromuscular or degenerative diseases
* Pulmonary comorbidities
* Heart diseases and labyrinthitis
The Effect of Preoperative Inflammation-based Scores on Postoperative Morbidity and Mortality for Laparoscopic Gastrectomy

The purpose of this study is to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.

A prospective cohort study will be performed to explore the effect of preoperative inflammation-based scores on postoperative morbidity and mortality for laparoscopic gastrectomy.The evaluation parameters are perioperative clinical efficacy, postoperative complications and 3-year survival and recurrence rates.

Eligibility Criteria:
Inclusion Criteria:Age from 18 to 75 years

* Primary lower third gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:• Women during pregnancy or breast-feeding

* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* Enlarged or bulky regional lymph node envelop important vessels
* History of other malignant disease within past five years
* History of previous neoadjuvant chemotherapy or radiotherapy
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values
Omega-3 Supplementation in Cervix Cancer Patients Undergoing Chemoradiotherapy

Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Recently, omega-3 fatty acids have gained interest for their beneficial effects in cancer cachexia. Moreover, nutritional supplementation enriched with omega-3 could potentially maintain body weight in cancer patients undergoing intensive treatment.

The investigators aims in this study is to evaluate the effect of omega-3 supplementation on body composition, functional capacity, inflammatory profile and quality of life in cervix cancer patients undergoing chemoradiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Cervix cancer at FIGO stage II and III
* Chemoradiotherapy treatment proposal (cisplatin + radiotherapy)
* Nutritional diagnosis of pre-cachexia ou cachexia

Exclusion Criteria:

* metastasis (FIGO stage IV)
* Nutritional diagnosis of refractary cachexia
Role of Metabolomics in the Diagnosis of Endometriosis

Endometriosis is one of the most common benign gynecological, affecting about 10% of premenopausal women. The pathophysiology of this disease is still not completely clear. Despite its prevalence, there is no blood test available for the diagnosis of endometriosis and the average delay time to diagnosis is 9.4 years.

Metabolomics is a scientific discipline that studies changes in metabolites related to the pathophysiology of the disease.

Aim of the study is to identify an alteration in the expression of the metabolites in women with endometriosis


Eligibility Criteria:
Inclusion Criteria:

* women of childbearing age ;
* written consent to laparoscopic surgery;
* written consent to the study .

Exclusion Criteria:

* Suspicion or diagnosis of malignant disease
* Inability or unwillingness to provide written consent
The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age

This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs).

At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the completion of questionnaires

This research study is a complex, long term investigation of the relationships between children's eating behaviors, and parent-child interaction during eating and their associations with BMI and dietary intake. It builds on earlier observational research which, like this research, had small experimental components used to classify children into different phenotypic groups based on different responses to the experimental conditions. The small activities and experiments of this follow up study constitute a trial as defined by NIH, registered here. The exploratory outcomes measured from these activities are not listed in this registration for reasons of scientific integrity. To be clear, the bigger structure of this research is essentially an observational follow up study with the same children who were previously studied as infants. The goal of the project is to identify potential future intervention targets.

Eligibility Criteria:
Inclusion Criteria for Children (ages 5-7.99) and their parents (18 and older):

* Prior participation in "The Development of Eating Behavior in Infancy" project
* Family lives within reasonable driving distance of the University of Michigan

Exclusion Criteria:

* Significant developmental delays that would impede child's ability to participate
* Foster child
* Child has developed significant health problems that affect appetite, eating, or growth.
Fecal Microbiota Transplant National Registry

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

This registry will prospectively enroll 4,000 patients who undergo FMT at 75 sites throughout North America. Information on FMT methodology employed (e.g., screening of donor and recipient, preparation, FMT delivery) will be collected from each site. The indication for FMT as well as baseline information on recipient will also be collected. Following FMT, patients will be followed at regular intervals up to 10 years post FMT. This will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after FMT as well as direct communication with patients at least annually up to 10 years after FMT. Follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Recipient Inclusion Criteria

  * Ability to give informed consent
  * Receiving FMT or other gut-related microbiota product within 90 days after providing consent
  * Access to internet and/or telephone
* Donor Inclusion

  * Ability to give informed consent
  * Providing stool sample for FMT

Exclusion Criteria:

* Incarceration
Behavior Therapy Prior to Bariatric Surgery

Obesity is an ever increasing public health problem in this country. Bariatric surgery is currently the most effective treatment for morbid obesity and two hundred thousand surgeries are performed in the United States each year. Unfortunately, despite anatomically successful surgery, it is estimated that at most surgical centers about 30 percent of patients will not achieve significant weight loss following surgery. It has been proposed that participation in preoperative behavior therapy can enhance postoperative outcomes, although empirical evidence for this premise is lacking. The current study is a pilot project designed to conduct a prospective randomized trial to examine the impact of participation in a 12-week standardized preoperative behavioral weight management program on percentage of excess weight loss and psychosocial and medical outcomes at six months after roux-en-Y gastric bypass surgery. The cost of bariatric surgery is not covered by this study and only patients local to the Rochester, Minnesota area are eligible to participate.

It is hypothesized that patients who complete the 12-week behavioral program will experience greater weight loss and improved psychosocial and medical outcomes compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 40 and 60
* age 25 to 65
* ability to participate in weekly LEARN groups for 3 months at Mayo Clinic (local to the Rochester, MN area)
* seeking RYGB procedure

Exclusion Criteria:

* patients seeking surgical revision of a previous bariatric procedure
* diagnosis of schizophrenia
* diagnosis of bipolar disorder
* diagnosis of borderline personality disorder
* non-local patients