cyrilzakka/clinical-trials huggingface dataset:
Association Between 4-Month Isokinetic Testing Measures and Second Knee Injuries After Primary Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament (ACL) is a frequent and disabling injury in athletes. Most of the time, ACL reconstruction (ACLR) is consider for regaining function and returning to preinjury sports while reducing the risk of secondary injuries. However, the risk of secondary severe knee injury is increased after ACLR, especially in athletes returning to strenuous activities. If strength symmetry is considered as an important factor in the Return-to-sport (RTS) decision, there is conflicting data about the association between strength symmetry and the risk of second knee injury after ACLR. The main objective of this study was to test if knee muscles strength symmetry at 4 months was associated with the psychological readiness and incidence of subsequent severe injury of both knees at a minimum 2 years follow-up after ACL-R.


Eligibility Criteria:
Inclusion Criteria:

Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) Patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 3-4 months Patient who received the information form Patients with access to the Internet

Exclusion Criteria:

Patient who did not participate in all follow-up consultations and isokinetic muscular assessments Patients who had a previous knee surgery before the ACLR Cognitive or sensory impairment making it impossible to understand the information form Neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery
Food Reward Processing in the Human Brain

The aim of this study is to investigate the influence of different metabolic states and hormonal satiety signalling on responses in neural reward networks.

Given the rapid development of obesity world-wide, a better understanding of the interaction between the encoding of food reward in mesocorticolimbic reward pathways and homeostatic energy regulation is of paramount importance for the development of new treatment strategies. Healthy participants will undergo functional magnetic resonance imaging while performing a task distinguishing between the anticipation and the receipt of either food or monetary reward. Every participant will be scanned twice in a counterbalanced fashion, both during a state of hunger (after 24-hours fasting) and satiety. Blood samples will be collected to assess hormonal satiety signalling. We hope to provide new insights into the neurobiological underpinnings of motivational processing and hedonic evaluation of food reward.

Eligibility Criteria:
Inclusion Criteria:

* BMI \<25 kg/m² and \>18.5 kg/m²
* no lifetime or current medical illness that could potentially affect appetite or body weight
* right-handedness
* normal or corrected-to-normal vision

Exclusion Criteria:

* history of head injury or surgery
* history of neurological disorder
* severe psychiatric disorder (psychosis, bipolar disorder, substance abuse)
* smoking
* borderline personality disorder
* current psychotropic medication
* inability to undergo fMRI scanning (e.g. metallic implants, claustrophobia, Pacemakers)
* pregnancy
Radial Artery Stenosis Following PiCCO Catheter Implementation

Cardiac output monitoring devices are commonly used in ICU patients. The most precise use direct measurement, which require artery cannulation. The gold standard is Swan-Ganz catheter, but it is a very invasive technique. PiCCO (Pulse index Continuous Cardiac Output) is the alternative way of haemodynamic monitoring. This technology is the easy, less invasive and cost-efficient tool for determining the main hemodynamic parameters of critically ill patients. It is based on two physical principles - transpulmonary thermodilution and pulse contour analysis. Both principles allow the calculation of haemodynamic parameters in critically ill patients. PiCCO method requires peripheral artery cannulation.

Cannulation may be followed by artery stenosis.

Aims of the study are:

1. to verify the occurrence of radial artery stenosis after 3 days of having a PiCCO cannula in place.
2. whether 5 days cannulation of radial artery with PiCCO catheter is related to more frequent stenosis rate.

An additional assessment:

1. to check whether the eventual stenosis is still present after 3, 14 and 30 days after decannulation - assessment depending on patients availability

Barbeau test and Doppler - ultrasonography preceded radial artery cannulation. Catheter removal (after 3 or 5 days of cannulation) is followed by Doppler - usg. Usg -Doppler is performed also 3, 14 and 30 days after decannulation - depending on patient being available

Eligibility Criteria:
Inclusion Criteria:

* critically ill patients with haemodynamic monitoring required

Exclusion Criteria:

* Barbeau test type D in radial artery
* artery inaccessible for cannulation - based on doppler ultrasonography
Endoscopy Quality Study

This study seeks to establish factors that influence the view at endoscopy. To achieve this patients, who have been already booked for endoscopy, will complete a questionnaire prior to their procedure. Demographic and endoscopist factors will also be ascertained.

The view at endoscopy will then be reviewed and scored against a rating scale, which will be validated as a first phase of the study. Factors can then be sought that are associated with a good endoscopic view.


Eligibility Criteria:
Inclusion Criteria:

* Any patient booked for routine OGD

Exclusion Criteria:

* Inpatient endoscopy
* Barretts surveillance endoscopy
Diltiazem in Jervell and Lange-Nielsen Syndrome

This study will test the effect of diltiazem, a calcium channel blocking drug, on the QT interval in patients with Jervell and Lange-Nielsen syndrome. This will be a single IV dose and acute effects (within minutes) will be observed.

Subjects will be recruited by study personnel and will be scheduled for a single outpatient visit. If an implanted cardiac device (pacemaker or ICD) is in place, it will be interrogated to ensure no recent rhythm abnormalities. Just prior to administering diltiazem, an ECG and BP will be obtained. If baseline SBP is \< 100 mm Hg or DBP \< 60 mm Hg, the study will be terminated. A single dose of I.V. diltiazem (0.25 mg/kg over 2 minutes) will be administered with 12-lead ECG and BP obtained at 2, 5, 7, 10, 15 and 20 minutes. If at 10 minutes there has been no QT shortening, and the SBP is stable (\<20% drop from baseline and \> 100 mm Hg) a repeat dose (0.35 mg/kg) will be given at 15 minutes, with 12-lead ECG and BP obtained at 17, 20, 22, 25, 30 and 35 minutes. After 20 minutes (single dose) or 35 minutes (2 doses), the test will end and the subject will remain on continuous telemetry for 2 hours. Prior to discharge the IV will be removed. The primary analysis will be a repeated measures (paired) comparison of the QTc at baseline and following diltiazem.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Genetically confirmed diagnosis of Jervell and Lange-Nielsen syndrome
* Able to provide written informed consent

Exclusion Criteria:

* Known hypersensitivity to diltiazem
* Pregnancy
* Congestive heart failure, angina, preexcitation, or chronic obstructive pulmonary disease
* Sick sinus syndrome or atrioventricular block in the absence of a pacemaker/defibrillator
* Any clinically significant ongoing medical or surgical condition that might jeopardize the subject's safety or interfere with the conduct of the study in the judgement of the investigator
* Baseline systolic blood pressure less than 100 Hg or diastolic blood pressure less than 60 Hg
Percutaneous Tibial Nerve Stimulation (PTNS) for the Treatment of Chronic Anal Fissure

Chronic anal fissure rarely heals spontaneously. About 50% heal on administration om topical muscle relaxants (e.g. diltiazem) and/or injection of Botulinum toxin, but for the remainder of patients surgery (with lateral internal sphincterotomy or fissurectomy) with subsequent risks of anal incontinence has been the golden standard. Treatment with PTNS (percutaneous tibial nerve stimulation) has been showed to produce healing of chronic anal fissures not responding to topical treatment, thus avoiding the risk for debilitating anal incontinence.

This study will prospectively include 52 patients with chronic anal fissure that have received topical treatment and stool softeners and have all been evaluated by experienced proctological surgeons. The treatment will be given for 10 consecutive work days and then evaluated at 3 and 12 months. If the patients symptoms are unimproved at 3 months alternative treatments will be offered.

Eligibility Criteria:
Inclusion Criteria:

* Verified anal fissure (Clinical assessement by experienced proctological surgeon)
* Full conservative treatment has been given

Exclusion Criteria:

* Inflammatory bowel disease
* Fistula and/or anal abscess
* Patients with compromised immunity
* Pregnancy
* Treatment with anti-coagulants (not aspirin)
* Previous irradiation towards pelvic floor
* Pacemaker or implanted defibrillator
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients

This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression to severe or life-threatening condition related to rejection of an abdominal solid organ transplant, at risk of worsening allograft function, or at risk of complications from current immunosuppressive therapeutic regimens.

Objectives:

The primary objective of this expanded access program is to evaluate safety and tolerability of ExoFlo in patients with graft inflammation, or worsening graft function, or evidence of rejection of an abdominal solid organ transplant despite conventional therapies. The secondary objective is to characterize the improvement seen in serum inflammatory markers and inflammation of solid abdominal organ.

Endpoints:

Primary Endpoint:

Incidence of AEs or SAEs.

Secondary Endpoint:

Improvement seen in serum inflammatory markers and inflammation of solid abdominal organ. This could include improvements seen in the following transplant types:

* Liver transplant: overall improved liver function, as seen by reduction in liver function test and improved albumin.
* Small bowel transplant: decreased inflammation on biopsy
* Pancreas: decreased amylase and lipase
* Multivisceral: any of the above criteria

Number of subjects: 20

Phase: Expanded Access Protocol

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Male or female, ages 18 to 75.
4. Previous abdominal solid organ transplant, including intestinal transplant.
5. Diagnosis of acute or chronic rejection / inflammation based on clinical observations, laboratory analysis, histological evaluation.
6. Diagnosis of worsening allograft function based on clinical observations, laboratory analysis, histological evaluation.
7. Failed primary and alternate standard of care therapies.
8. Serious or life-threatening condition or progressing to serious or life-threatening condition if not treated as evaluated by the treating physician.
9. In otherwise good general health as evidenced by medical history.
10. Male or female of reproductive potential must utilize a medically effective birth control method during from time of enrollment to 6 months after last dose of IMP.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Treatment with another investigational drug or other intervention within 30 days of enrollment.
The Effect of Yoga Training on Menopausal Symptoms on Menopausal Women

Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.

Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the adoption of yoga practice without health risks by women and its implementation as a lifestyle may be effective in reducing the symptoms of menopause experienced by women. In line with this information, it is aimed to determine the effect of yoga training on menopausal symptoms. The research will be carried out with menopausal women between the ages of 40-60 in Famagusta region. Women will be divided into two groups as intervention and control. Personal information form and menopause rating scale will be used in the research. The intervention group will be given yoga practice two days a week for 10 weeks. Menopause rating scale will be applied to the intervention and control group before and after the research.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in research,
* Can read and write in Turkish,
* Open to communication,
* Those who are between the ages of 40-60 and do not experience menstruation for at least one year, Do not use medication to treat menopausal symptoms,
* No diagnosed musculoskeletal disease, no severe heart disease,
* Not doing regular exercise and yoga,
* Not surgically menopausal,
* Women without psychiatric problems

Exclusion Criteria:

* Refusing to participate in research,
* Can't read and write Turkish,
* Communication is not possible,
* Those who are younger than 40 or older than 60 have experienced menstruation for at least one year
* Using medication for the treatment of menopausal symptoms,
* Those with a diagnosed musculoskeletal disease, severe heart disease,
* Doing regular exercise and yoga,
* Surgically menopausal, Women with psychiatric problems
Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients

This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

The study involves 6 clinic visits.

Eligibility Criteria:
Inclusion criteria:

* Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study
* Body weight ≥ 25kg/55 lbs
* Negative urine pregnancy test
* Patients who in the opinion of the investigator are able to comply with the requirements of this study

Exclusion criteria:

* Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone
* Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
* Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month
* Parallel participation in another clinical drug trial
* Past or present history of abuse of drugs or alcohol
* Pregnancy or breast-feeding
Comparison of Epidural, Combined and Dural Puncture Labor Epidural on Pain, and Course of Vaginal Delivery

The three standard techniques used for labor analgesia, thus epidural, combined spinal-epidural and dural puncture epidural will be compared regarding their impact on pain intensity, analgesic and local anesthetic consumption and course of vaginal delivery in a prospective, randomised, double blind manner


Eligibility Criteria:
Inclusion Criteria:

* parturients requiring regional labor analgesia
* dilation less than 5cm

Exclusion Criteria:

* contraindication for regional technique
* refuse to participate
* language barriers
* obesity
* no pain
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula

To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.

Hypothesize there will be no difference between formula groups.


Eligibility Criteria:
Inclusion Criteria:

* Singleton birth
* Term infant at birth
* Birth weight of 2500 g (5 lbs 8 oz) or more
* 4 - 18 days of age at Study Visit 1

Exclusion Criteria:

* History of underlying metabolic or chronic disease or congenital malformation
* Infant switched formulas more than one time between birth and Study Visit 1
* Known feeding problems at Study Visit 1
Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control

In this retrospective study, the investigators examined incidence and risk factors of postoperative nausea and vomiting (PONV) in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA).


Eligibility Criteria:
Inclusion Criteria:

1. Adults between 20 to 60 years old
2. Date from 1st, May 2011 to 31st, October 2011
3. Patients with fentanyl based intravenous patient-controlled analgesia for postoperative pain control

Exclusion Criteria:

1. Reoperation within 48 hours
2. Patients who cannot express numerical rating scale for pain due to sedation
Using Mother's Raw Milk Could Improve Breastfeeding in Hospitalized Neonates

Despite the importance of breast milk for sick or preterm neonates, there is currently no consensus regarding the use of raw mother's own milk (MOM) in neonatal units. The aims of this study are to: (a) describe factors associated with the use of raw MOM; (b) investigate the association between early use of raw MOM and breastfeeding continuation at discharge and up to 6 months later.


Eligibility Criteria:
Inclusion Criteria:

* Admitted neonates between April 2012 and June 2013 are eligible if they are intended to be breastfeed and hospitalized ≥7 days

Exclusion Criteria:

- Neonates with parents not fluent in French.
A Technology-Based Intervention for the Reduction of Overweight and Obesity Among College Students

The purpose of this study is to determine the feasibility and acceptability and efficacy of a two month technology-based weight loss program for overweight and obese college students.

A randomized controlled trial design will be employed to investigate the effectiveness, feasibility, and acceptability of a technology-based weight loss pilot intervention for the reduction of overweight and obesity in college students. Participants will be randomly assigned to one of two conditions: (1) 8-week intervention group, or (2) 8-week attention control group. Both conditions include 8 weekly lessons over 8 weeks. Undergraduate students (n=100) age 18-22 years who are overweight or obese (BMI ≥ 25 kg/m2) will be recruited from the University of Tennessee Knoxville. Measurements will be taken at baseline and 8 weeks. Since the study is a technology-based intervention, research staff will collect height and weight measures for BMI through a novel approach, utilizing Skype video conferencing.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility will include UTK undergraduate students who are overweight or obese (BMI ≥ 25 kg/m2) and between 18-22 years of age, with access to the Internet, a personal computer (laptop, tablet, or desktop computer), and a smartphone.

Exclusion Criteria:

* Any individual who does not meet all the inclusion criteria will be excluded from participation in the study.
* Students who have a medical condition that precludes adherence to dietary recommendations
* Who are currently prescribed medications that may impact weight, or who are currently participating in or planning to participate in another weight loss programs in the next six months
* Who have been diagnosed with a major psychiatric illness (e.g., bipolar disorder, schizophrenia, or depression) within the last 12 months
* Who are pregnant or plan to become pregnant in the next six months
* Who have given birth within the last six months
* Who have been diagnosed with any type of eating disorder within the past 12 months will be ineligible.
Multi-Site, Post-Market Study of the ICONACY I-Hip System

The purpose of this study is to evaluate the use and efficacy of the I-Hip for primary total hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* A candidate for primary hip replacement on this operative hip.
* Is 30 to 80 years of age.
* Has hip joint disease related to one or more of the following:

  * Degenerative joint disease, (including osteoarthritis or post-traumatic arthritis)
  * Avascular Necrosis (AVN).
* Will be available for evaluation for the duration of the study.
* Is able and willing to speak and read English, read and sign the informed consent, fill out the WOMAC and Patient Satisfaction questionnaires, and follow all study procedures.

Exclusion Criteria:

* Is younger than 30 years of age or older than 80 years of age.
* Has undergone partial hip replacement or previous ORIF (open reduction internal fixation of femur or acetabulum).
* Has undergone total hip replacement on this hip in the past (no revisions allowed in study).
* Infection, or history of infection, acute or chronic, in the hip joint, or acute or chronic unresolved systemic infection.
* Is currently experiencing radicular pain from the spine down operative leg.
* Has participated in an IDE/IND clinical investigation with an investigational product in the last three months, or is involved in any personal injury litigation, medical-legal or worker's compensation claim.
* Is a known drug or alcohol abuser or has a psychological disorder that could affect the ability to complete patient reported questionnaires.
* Has been diagnosed with fibromyalgia or has a significant neurological or musculoskeletal disorder or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
* Has been diagnosed with Paget's disease or Congenital hip deformity (dysplasia and/or dislocation).
* Is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)
* Is Obese: (Defined for this study as having a BMI\>45).
* Has insufficient bone quality.
* Has loss of ligamentous structures.
* Has materials sensitivity.
* Is currently a prisoner.
* Is pregnant or lactating.
* Has a contralateral amputation.
* Has a medical condition with less than 2 years of life expectancy.
Bioequivalency Study of Clarithromycin Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a potential generic 500 mg clarithromycin tablet formulation compared with Abbott Laboratories 500 mg clarithromycin tablet, Biaxin® following a single 500 mg dose, administered with food.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to clarithromycin or any other macrolide antibiotic.