cyrilzakka/clinical-trials huggingface dataset:
An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction

This research study is looking into the effects of clavulanic on smoking behavior in adult cigarette smokers. The primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.


Eligibility Criteria:
Entry criteria:

Inclusion Criteria all subjects:

1. Age 18-65 years
2. English fluency
3. Functional vision (with corrective lenses as needed) to complete assigned assessments and tasks
4. Smoke \> 10 cigarettes/day for a minimum of 2 yrs. and have an expired carbon monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation at screening and scanning)
5. If female, provide a negative urine pregnancy test.
6. Agrees to refrain from all other tobacco (i.e., dip/chew, cigars, cigarillos) and/or nicotine products (i.e., e-cigs, patches, gum/lozenges, inhalers/sprays) for the duration of study participation

Exclusion Criteria all subjects:

1. Sensitivity or allergy to clavulanic acid/antibiotics
2. Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
3. Any physical or intellectual disability affecting completion of assessments
4. Any contraindication to MRI
5. Use of antidepressants medications with smoking cessation efficacy
6. Presence of an untreated illness or serious medical condition
7. Current or past psychosis
8. Electroconvulsive therapy in last 6 months
9. Positive pregnancy test (Urine pregnancy testing at screening and prior to fMRI scan) or currently breast feeding or BAC greater than 0.0
10. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with CLAV) within 14 days of study participation
11. Abnormal liver function determined by Complete Metabolic Panel - liver enzymes outside normal ranges of AST (SGOT) 5-40 unites/L and ALT( SGPT) 7-56units/L
12. Abnormal renal function determined by Complete Metabolic Panel - outside normal ranges of BUN 6-24 mg /dl and Creatinine level 0.6 -1.2 mg /dl male, 0.5-1.1mg /dl female
13. Any other condition or concern that in the investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results
Pilot Evaluation of a New Computerized Test for Pragmatic Inferences in Children with ASD

This study aims to evaluate the relevance of a new computerized test for pragmatic inferences (TIPi) in children aged 8 to 12 YO, presenting a typical development, autism spectrum disorders, another neurodevelopmental condition and attention-deficit/hyperactivity disorder.

By virtue of pragmatic inference-making, a listener can go above and beyond the linguistic meaning of the speaker's utterance in order to understand what the speaker intended to communicate. Such inferences allow the listener to understand inter alia irony, metaphor, indirect requests, scalar and ad-hoc implicatures. Autistic individuals have typically been described, by clinicians and language specialists, as tending towards having a literal understanding of language and as being deficient with respect to understanding a speaker's intended meaning, and these difficulties have a major impact on quality of life and social participation. Therefore, assessing these abilities seems essential, both for diagnosis purpose and to draw a clear description of an individual's functioning profile. Yet, no tool is available for children aged 8 to 12 in French. A new test named TIPi has been developed to resolve this issue. This new test is computerized and runs in a touch pad. The main goal of the present study is to evaluate the ability of the TIPi to discriminate autism spectrum disorders (ASD), attention-deficit/hyperactivity disorder (ADHD) children from typically developing (TD) children. Secondary goals are (i) to measure the typical development of these abilities in TD children in this age range, (ii) to assess the developmental link these skills might have with other cognitive of language abilities (mentalizing, cognitive flexibility, core language skills, central coherence), and (iii) to compare the pragmatic profile of ASD children with another neurodevelopmental condition: developmental language disorder, in order to test the relevance of this test for differential diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 8 and 12 years old
2. Native French speaker
3. Informed consent of the parents and children
4. \[For ASD group\] Diagnosis of ASD provided by a trained and entitled clinician
5. \[For DLD group\] Diagnosis of DLD provided by a trained and entitled clinician
6. \[For ASD and DLD groups\] IQ above 70
7. Intellectual efficiency within the norm (ITQ \> 70), confirmed by objective results (psychometrics) in the participant's file, or collected if necessary within the framework of this study (using the WISC V);
8. Medical diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) by a competent professional, confirmed by a parental assessment (ADHD-RS-IV)

Exclusion Criteria:

1. Uncorrected visual impairment
2. Uncorrected auditory impairment
3. Motor disability preventing the use of a touch pad
4. \[For the TD group\] Diagnosis of any neurodevelopmental or psychiatric condition
5. \[For ASD group\] Diagnosis of language disorder of attention disorder (ADHD)
6. \[For DLD group\] Diagnosis of ASD or ADHD
7. \[For ADHD group\] Diagnosis of ASD or DLD
A Person-centred and Thriving Promoting Care Model for Residential Aged Care

The overall aim of this study is to evaluate the effects, meaning and significance of a person-centred and thriving promoting model for residential aged care in Australia, Norway and Sweden. More specifically, the following research questions will be explored:

1. Can a person-centred and thriving promoting care model increase residents' thriving, and have a positive impact on residents' perception of the caring environment?
2. Can a person-centred and thriving promoting care model increase relatives' satisfaction with care, and have a positive impact on their experience of visiting their relative, and perception of the caring environment?
3. Can a person-centred and thriving promoting care model increase staff's job satisfaction, decrease stress of conscience, and have a positive impact on their perception of the caring environment and person-centred care?
4. What meaning and significance do relatives and staff ascribe to the intervention? The study is designed as a multi-centre, controlled group before-after design with participating sites in Victoria (Australia), Oslo (Norway) and Västerbotten (Sweden). Two residential aged care facilities at each site will be allocated to either intervention or control, in total three intervention and three control facilities divided over the three sites.

Care staff at the intervention facilities will participate in a 12-month education on how to integrate aspects of person-centredness, thriving and a caring environment into daily care practice. Participating staff will work together with their colleagues and members from the research group to create a reflective and creative learning environment that builds on and develops the staff members' clinical experience and skills, and combines it with theoretical and research-based knowledge.

At the control facilities, care staff will participate in a 2-hour lecture on the theoretical and philosophical foundations of person-centredness, thriving and a caring environment, and then continue with practice without further involvement from the research team.

Evaluation data will be collected by study specific questionnaires before the education starts, immediately after the education and at a 6-month follow-up. In addition, focus group interviews and individual interviews will be conducted with a selection of staff members and relatives at the intervention facilities to explore meaning and significance of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years of age
* living in the facility for \>1 month by the time of data collection
* visiting the residential aged care facility on a regular basis (\>1/month)
* working in the residential aged care facility on a temporary and or permanent basis (\>1month contract)
* have been working \>1 month in the residential aged care facility by the time of data collection.

Exclusion Criteria:

* newly moved in to the facility
* visiting the facility more seldom than once a month
* working on a short-term contract
Gamma-Glutamyl Transpeptidase (GGT): A Potential Diagnostic Marker for Helicobacter Pylori Infections

The investigators hypothesis:

Presence of anti-GGT (antibody against GGT) indicates H. pylori infection.

Subjects will be requested to provide 1-5g of their solid/semi-solid stool sample, to be collected within 24 hours prior to their scheduled visit for urea breath test. Patients should not have been treated for H. pylori prior to stool collection. Stool samples will be tested using ELISA for the presence of the H. pylori GGT antigen using monoclonal antibodies against GGT. Stool samples will also be tested for the presence of H. pylori DNA using PCR and Western blot analysis respectively.

Presence of the GGT antigen in stool will be compared between H. pylori-positive and H. pylori-negative patients. Rapid urease test results will be used as the gold standard of H. pylori diagnosis. The sensitivity and specificity of the stool antigen test will be established.

Eligibility Criteria:
Inclusion Criteria:

* The subject is greater than 21 years of age.
* The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
* The subject must be willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:

* Subjects who have been taking antibiotics over the past 1 month will be excluded from study.
Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors

The treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the presence of residual tumor that can be removed.

This study aims to compare the extent of glioblastoma resection between the standard treatment and intraoperative MRI.


Eligibility Criteria:
Inclusion Criteria:

* supratentorial brain tumor, on contrast enhanced dMRI suspected to be GBM
* indication for gross total resection (GTR) of the tumor
* age ≥18 years
* WHO Performance Scale ≤ 2
* ASA class ≤ 3
* adequate knowledge of the Dutch or French language
* informed consent

Exclusion Criteria:

* recurrent brain tumor
* multiple brain tumor localizations
* earlier skull radiotherapy
* earlier chemotherapy for GBM
* Chronic Kidney Disease or other renal function disorder
* known MR-contrast allergy
Role of Slowly Digesible Starch on Diabetes Risk Factors

The purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.

In a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. The investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.

Eligibility Criteria:
Inclusion Criteria

* Have a body mass index between 30 and 44.9 kg/m2
* Are 35-65 years of age
* Have pre-diabetes, which means impaired fasting glucose (IFG)
* Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing
* Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study
* Are willing to maintain weight throughout the study

Exclusion Criteria

* Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer
* Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL
* Have an average screening blood pressure \> 150/100 mm Hg
* Are a pre-menopausal woman but do not have a regular menstrual cycle
* Are pregnant or breastfeeding
* Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents
* Have emotional problems such as clinical depression or other diagnosed psychological conditions
* Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study
* Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study
* Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal)
* Chronically consume alcohol (\> 4 servings per day) or actively smoke cigarettes (\> 1/4 pack per day)
* Are on any chronic medication that has not had a stable dose for 1 month or longer
* Are required to perform of any kind of heavy physical activity
* Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.
Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results

The purpose of this study is to evaluate the clinical results and MRI imaging of autologous cartilage reconstructions or collagen matrix of the knee.

There is currently little data in the literature on clinical outcomes and imaging of this type of lesion.


Eligibility Criteria:
Inclusion Criteria:

* cartilaginous reconstruction by autologous transplant or collagenous chondro-inducing knee matrix
* \> 18 years

Exclusion Criteria:

* Other cartilaginous reconstruction techniques,
* other than knee joint
Use of Mobile Technology to Promote Sustained Lifestyle Changes to Prevent Type 2 Diabetes in India and the UK

Primary prevention of diabetes is of paramount importance in both developed and in developing countries. Several studies including the Indian Diabetes Prevention Programmes have shown that Lifestyle modification in people with prediabetes can reduce the progression to diabetes by 58%. However, there are two main problems in applying diabetes prevention strategies to the population as a whole. (1) Trial based interventions are unrealistic on a population level in any country. (2) The oral glucose tolerance test applied so far to identify those at high risk is a poorly reproducible and time consuming test both for the participant and for health care workers. Hence more practical means of defining individuals who would benefit from lifestyle intervention are required.

The current study proposes a prevention strategy that will employ a lifestyle modification programme delivered by text messaging in both India and the UK.Subjects will be identified based on the HbA1c measurement instead of the oral glucose tolerance test. The study will also assess the efficacy, acceptability and cost effectiveness of mobile phone based intervention both in India and the UK.

Messages will be based to deliver education, treatment targets, advice, support and motivation. Subjects will be invited to participate and, once recruited, will be randomised to usual care or the SMS intervention group.

Usual care will consist of a one-to-one 30 minute interview, conducted by the research team, delivering personalised diet and exercise advice.

The intervention group will undergo the same initial interview and, in addition, will receive 3 times weekly text messaging with education, advice, support and motivation. These messages will be personalised to individual targets set at the initial interview.

Primary Outcome:Progression to Diabetes Secondary Outcomes will be based on Physical activity / Cardiovascular risk factors/and quality of life.

The study programme is compatible with major initiatives in both the UK and India for the prevention of diabetes and cardiovascular disease (CVD).


Eligibility Criteria:
Inclusion Criteria:

* Men and women with no history of diabetes
* Persons with 2 or more risk factors including

  1. Age 35-55 years
  2. Positive family history of diabetes
  3. Body mass index ≥23kg/m2
  4. Waist circumference \>90cm for men and \>80cm for women
  5. Hypertension
  6. Sedentary habits
* HbA1c 6.0% - \<6.5%

Exclusion Criteria:

* Known diabetes
* Any other illness
* Unwilling to participate
Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial

Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption.

Patients ASA 18-65 who will undergo laparoscopic nephrectomy are included in this prospective randomized clinical trial. Patients will be divided into two groups; erector spina and transversus abdominis plane block. Anesthesia will. induced with propofol, fentanyl, and rocuronium will be administered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of the depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient-controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 age
* patients undergoing laparoscopic nephrectomy
* ASA 1-3

Exclusion Criteria:

* \<18- \>65 \< age
* patients undergoing open nephrectomy
* ASA 4-5
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.


Eligibility Criteria:
Inclusion Criteria:

* Treated with thiazolidinedione (TZD) alone or in combination with metformin. TZD dose stable for at least 120 days prior to screening, and those patients on metformin must have been on a stable dose for at least 30 days prior to screening.
* HbA1c between 7.1% and 10.0%, inclusive.
* Body mass index (BMI) between 25 kg/m\^2 and 45 kg/m\^2.

Exclusion Criteria:

* Patient previously in a study using exenatide or GLP-1 analogs.
* Treated with oral anti-diabetic medications other than TZD and metformin within 3 months of screening.
* Treated with oral insulin within 3 months of screening.
Entry Into Comprehensive Methadone Treatment Via Interim Maintenance

The purpose of the study is to determine whether one of three levels of counseling intensity will be associated with better treatment outcomes when combined with methadone maintenance treatment for heroin-addicted adults drawn from a methadone treatment program waiting list.

Waiting lists for methadone treatment programs persist, and new and more effective approaches for expanding treatment access and improving outcomes for heroin dependent individuals are needed. Recently completed research demonstrated that so-called "Interim Methadone Maintenance" (i.e., methadone with crisis counseling only, for individuals on waiting lists) was associated with greater entry into methadone treatment, less self-reported heroin and cocaine use, lower rates of opioid-positive drug tests, and lower rates of self-reported crime. The present study will build on this work by comparing three levels of counseling provided with methadone treatment: 1)"Interim" Methadone Treatment; 2) "Comprehensive" Methadone Treatment (which is the name for the usual amount of counseling provided, i.e., about once per week) and; 3)"Restored" Methadone Treatment in which the counselors will have a lower case load and will be able to provide more attention to their patients.

Eligibility Criteria:
Inclusion Criteria:

* adult
* meets criteria for methadone maintenance
* unable to gain admission to methadone program within 14 days

Exclusion Criteria:

* pregnant
* acute medical or psychiatric illness
A Study Comparing Two Methods of Placing an Interscalene Nerve Catheter for Postoperative Pain Control in Patients Who Undergo Open Shoulder Surgery.

This is a randomized, double-blinded, prospective study designed to compare two approaches (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing an interscalene nerve block and catheter for pain control after open shoulder surgery. Both approaches have been used successfully but neither has been proven to be superior. Our endpoints are pain scores, time for block placement, and catheter dislodgements. We hypothesized that patients with the out-of-plane approach would have decreased pain and fewer catheter dislodgements.

Interscalene nerve block is an effective method of analgesia for surgery of the upper extremity. Perineural interscalene catheters offer the advantage of extended pain relief up to 48 hours after shoulder surgery. This is a prospective, randomized trial designed to compare two approaches (posterior and anterolateral) to interscalene continuous nerve catheter placement for analgesia after open shoulder surgery (open rotator cuff repair, total shoulder arthroplasty or revision, hemi-arthroplasty, or proximal humerus open reduction internal fixation). Specifically, the objectives of this study are to compare measured pain scores, opioid consumption, and catheter dislodgements. We hypothesize that the anterolateral approach will produce lower pain scores, less opioid consumption, and fewer catheter dislodgements.

All patients undergoing open shoulder surgery will be recruited and enrollment in the study will not deviate from the current standard of care at Thomas Jefferson University Hospital. All nerve blocks will be placed by a regional anesthesiologist or a fellow in regional anesthesia. Patient medical history will be obtained and blocks will be placed per usual protocol. Block efficacy will be assessed by physical exam immediately after placement by the anesthesiologist and another member of the research team. Operative details, including medications given, will be recorded.

Patient pain scores and medications given in the PACU will be recorded. Supplementary analgesics will be available. Pain scores, medications given, and sensory examinations will be recorded for 48 hours postoperatively. Data will be analyzed both at the conclusion of the study and at several interims before that.

Eligibility Criteria:
Inclusion Criteria:

* speaks English

Exclusion Criteria:

* children,
* neuropathy in operative arm