cyrilzakka/clinical-trials huggingface dataset:
Anti-craving Efficacy of Right and Left Prefrontal High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependence

Null hypothesis: There will be no significant difference in the change in craving parameters between right and left prefrontal high frequency rTMS in patients with alcohol dependence.

The patients clinically diagnosed as Alcohol dependence syndrome (F 10.24) according to ICD-10 DCR, fulfilling the inclusion and exclusion criteria will be taken up for the study. A detailed physical examination will be done to rule out any major medical or neurological disease. Written informed consent will be taken after explaining the objectives and procedure of the study in detail. To ensure that the patients selected are right handed, Handedness Preference Schedule will be applied. Socio-demographic data will be collected. Baseline SADQ-C and CIWA-Ar will be administered to determine the severity of alcohol dependence and the intensity of withdrawal symptoms respectively. When the CIWA-Ar score becomes ≤ 10, then they will be taken up for rTMS application. For these patients baseline ACQ-NOW will be administered to measure the baseline craving. Patients will be randomly allocated into two groups using randomization table. The first group will receive active rTMS of the right pre-frontal cortex; the second group will be administered active rTMS of the left pre-frontal cortex. Each patient will receive rTMS sessions 5 days a week for 2 weeks. ACQ-NOW score will again be documented in both the groups after the last rTMS session to observe the changes in craving parameters. The rating will be done by one of the authors who will be blind to the nature of rTMS stimulation being administered to the patients.

The motor threshold (MT) for the left abductor pollicis brevis will be determined by a figure of 8 shaped coil, using the Rossini-Rothwell method. MT will be defined as the lowest intensity, which produces 5 motor evoked potential (MEP) responses of at least 50 µV in 10 trials. The prefrontal cortex rTMS stimulation site will be determined by measuring 5 cm anterior and in a parasagittal line from the point of maximum stimulation of left abductor pollicis muscle. Ten active rTMS treatments will be administered at 10 Hz frequency, over right or left prefrontal cortex at 110% of MT for duration of 5 seconds and 20 trains per session, with the coil-angled tangentially to the head.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Alcohol dependence syndrome according to ICD-10 DCR,
2. Male patients aged between 18-60 years,
3. Patients with CIWA-Ar scores ≤10,
4. Right handed, normotensive patients,
5. Patients giving written informed consent.

Exclusion Criteria:

1. Comorbid psychiatric, major medical or neurological disorders,
2. History of withdrawal seizures, delirium tremens or significant head injury,
3. Subjects with pacemaker or metal in any part of the body excluding the mouth.
The Sense of Agency

The ability to recognize of being the actors of the behaviour and its consequences, the so-called "Sense of Agency" (SoA), is a crucial component of self-awareness. One key aspect is the distinction from a mere inference about the causality between an act and its consequences and the sense of being the agent of it. Despite a large number of behavioural studies, there is unsatisfactory evidence on the functional anatomical underpinnings of the SoA and the distinction between causality and the SoA proper. Here, the investigators use an implicit measurement of the SoA and its modulations during fMRI: the intentional binding phenomenon (IB). The ivestigators also study how the SoA and the ensuing neurophysiological correlates are modulated by the presence of a movement disorders, such as Gilles de la Tourette Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age included between 18 and 65 years
* Right handed
* No contraindication to the fMRI exam

Exclusion Criteria:

* Contraindication to the fMRI exam
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission

This is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months.

Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months).

Number of Subjects (Planned and Analysed):

* 360 patients for demonstration of non-inferiority between once daily and twice daily;
* 326 to be analysed in per-protocol (PP) analyses; and
* 360 in intention-to-treat (ITT) analyses.


Eligibility Criteria:
Inclusion Criteria:

1. Patients have an established diagnosis of ulcerative colitis and are in clinical remission with an UC-DAI \< 2 at enrollment
2. Extension of the disease \> 15 cm distance from anal verge
3. Patients who have had a clinical relapse within the past year. Clinical relapse is defined as activity of the disease for which maintenance therapy had to be adjusted.
4. Patients on oral mesalazine maintenance therapy ≤ 2.5 grams per day
5. 18 years or older
6. Signed informed consent

Exclusion Criteria:

1. Patients with evidence of other forms of inflammatory bowel disease, idiopathic proctitis or infectious disease
2. Patients allergic to acetylsalicylic acid and other salicylate derivates aspirin or salicylates derivatives
3. Patients who used mesalazine \> 2.5 grams orally in the previous month,
4. Patients who used rectal mesalazine \> 3 grams per week in the previous month
5. Use of corticosteroids (oral and/or rectal routes) within the last month
6. Intake of immunosuppressants within the last 3 months
7. Patients with (known) significant hepatic (up to 2 x upper limit of normal) or (known) renal function abnormalities, to 1.5 x upper limit of normal values
8. Patients with history or physical examination findings indicative of active alcohol or drug abuse
9. Patients with a history of disease, including mental/emotional disorders, that would interfere with their participation in the study
10. Women who are pregnant or nursing (non-menopausal women who are sexually active and do not use effective contraceptives, as judged by the investigator, must have a negative pregnancy test)
11. Patients who participated in another clinical study in the last 3 months
12. Patients who were previously participating in this study
13. Patients with any other disease that may influence the study assessment, such as malignant disease, etc.
14. Patients who are unable to comply with any requirements of the protocol
15. Patients who are unable to write or read local language.
Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section

Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder tip pain and improve discomfort during Caesarean section.

Cesarean section (CS) is the most frequent major abdominal surgery among women worldwide . Shoulder pain, is a common but mostly neglected consequence of caesarean section and little is known about this entity. The pain is described as sharp, deep and referred, usually begins intraoperatively and continue for 2-3 days after surgery.

Although infant and maternal death rates have been decreased after CS, this procedure is not free of risks for mother and child. Compared with normal vaginal delivery (NVD), some CS complications include: more haemorrhage; increased postoperative pain; atelectasia; nausea; vomiting; risks for wound infection or wound opening and shoulder pain.

Although spinal anaesthesia (SA) is a common technique for CS in the past decade, and there are many studies about CS complications, there are few studies about shoulder pain as one of CS complications. Kikuchi et al. reported that women undergoing cesarean section under compined spinal epidural anaethesia experience shoulder-tip pain with great frequency. Our study was planned and performed to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder pain and improve discomfort during CS.

Sharp pain observed in these patients was experienced in the shoulder area or under the diaphragm. The pain was described as coming from deep within the shoulder, and in some, would seem to radiate from the right chest. The pain spread down the upper right arm and up the right neck in some, resulting in muscular tension and pain. The cause of this pain is postulated to sub-diaphragmatic air trapping, subdiaphragmatic clot or peritoneal irritation. This type of shoulder pain is reported commonly after laparoscopic surgery and it is reported that heat, massage and drinking hot water or hot tea with fresh lemon relieves this pain.

Eligibility Criteria:
Inclusion Criteria:

* nulligravida healthy women who delivered single term baby, with American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

previous caesarean section; pre-eclampsia; gestational diabetes; trauma; fractures or chronic pain in shoulder joints, forearms, upper limbs; cardiovascular or biliary system disorders; women undergoing emergency caesarean; previous history of abdominal surgery; conditions preventing spinal block, including local infection; coagulopathies; haemodynamic instability
Study of ENMD-2076 in Patients With Multiple Myeloma

Safety, tolerability, maximum tolerated dose and clinical benefit of ENMD-2076 administered over a range of doses in patients with relapsed or refractory multiple myeloma.

The study is designed to assess the safety, tolerability, maximum tolerated dose, and clinical benefit of treatment with ENMD-2076 administered orally once daily over a range of doses in patients with relapsed or refractory multiple myeloma.

Eligibility Criteria:
Major Inclusion Criteria:

1. Histological evidence of MM and evidence of relapse or refractory disease. Patients with non secretory myeloma or plasmacytoma only will be excluded.
2. Patients must have failed thalidomide, lenalidomide, or velcade or be intolerant or ineligible to receive these agents.
3. Age ≥18 years.
4. ECOG performance status 0-2.
5. Patients must have adequate organ and marrow function

Major Exclusion Criteria:

1. Prior cytotoxic chemotherapy or investigational agent within 28 days or autologous stem cell transplant within 6 months of receiving study drug ENMD-2076.
2. Prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis).
3. Concomitant corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
4. Have unstable angina pectoris or recent myocardial infarction (within 6 months.
5. Have uncontrolled hypertension or congestive heart failure.
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-318 in Subjects With MPS I

The purpose of the study is to evaluate the safety, tolerability of ascending doses of SB-318. SB-318 is an intravenously delivered Zinc Finger Nuclease (ZFN) Therapeutic for genome editing. It inserts a correct copy of the α-L-iduronidase (IDUA) gene into the Albumin locus in hepatocytes with the goal of lifelong therapeutic production of the IDUA enzyme.

The objectives of the study are to provide long term expression of IDUA and improve the current clinical outcome of enzyme replacement therapy (ERT) or hematopoietic stem cell transplantation (HSCT) therapy in subjects with attenuated MPS I, a recessive lysosomal storage disorder that results from mutations in the gene encoding IDUA. SB-318 is a therapeutic for ZFN-mediated genome editing which will be delivered by adeno-associated virus (AAV)-derived vectors. SB-318 is intended to function by placement of the corrective copy of the IDUA transgene into the genome of the subject's own hepatocytes, under the control of the highly expressed endogenous albumin locus, and is expected to provide permanent, liver-specific expression of iduronidase for the lifetime of an MPS I patient.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 5 years of age
* Clinical diagnosis of attenuated MPS I deficiency (Hurler-Scheie, Scheie, or Hurlers status post-HSCT)

Exclusion Criteria:

* Known to be unresponsive to ERT
* Neutralizing antibodies to AAV 2/6
* Serious intercurrent illness or clinically significant organic disease (unless secondary to MPS I)
* Receiving antiviral therapy for hepatitis B or C, or with active hepatitis B or hepatitis C or HIV 1/2
* Lack of tolerance to laronidase treatment with significant IARs or occurrence of anaphylaxis
* Markers of hepatic dysfunction
* Creatinine ≥ 1.5 mg/dL
* Contraindication to the use of corticosteroids for immunosuppression
* Current treatment with systemic (IV or oral) immunomodulatory agent or steroid use (topical treatment allowed)
* Participation in prior investigational drug or medical device study within the previous 3 months
* Prior treatment with a gene therapy product
* Elevated or abnormal circulating α-fetoprotein (AFP)
* Weight \<20 kg at Screening Visit
The Effect of Nebulized Epinephrine in Asthma Exacerbation in Pediatric Age Group With the Standard Treatment Compared to Standard Treatment Using Improvement PRAM Score as a Primary Outcome

Our study aiming to look in improvement of Pediatric Respiratory Assessment Measure (PRAM) score as a primary outcome. The secondary outcomes involving the need for second step management, need for admission and possible side effects.

It's double blinded randomized control study comparing Nebulized Epinephrine with standard treatment (salbutamol + Ipratropium) versus the standard treatment only in pediatric patient.

A pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.

Because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size.

Patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization.

PRAM score with calculated before and at 60, 80, 100 min after the treatment.

Eligibility Criteria:
* Inclusion Criteria:

  * Pediatric age group 3 - 12 years
  * known to have asthma
  * Initial PRAM Score showed moderate to severe asthma exacerbation
* Exclusion Criteria:

  * History of lung or upper airway disease other than asthma:

    * bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreign body aspiration, bronchopulmonary dysplasia, cystic fibrosis and lower airway mass effects
  * History of congenital heart disease or cardiac arrhythmia or heart failure.
  * Known hypertension
  * Impending respiratory failure (Decreasing mental status, Respiratory fatigue, Impending respiratory arrest, Hypoxemia (pO2 \< 60 mmHg), pCO2 could be normal or high)
  * Allergy or hypersensitivity to epinephrine
  * Patient/Parents refusal to participate in the study
Transpulmonary Thermodilution Using an Implented Central Venous Access Port

Perioperative hemodynamic optimization requires monitoring adapted to the risks of the surgery and the patient. The investigators currently use a local hemodynamic protocol based on the data of the literature. According to this protocol, specific patients may require cardiac index and central venous oxygen saturation monitoring. the investigators chose to monitor the cardiac index (CI) with the transpulmonary thermodilution technique (TPTD) (PiCCO, Pulsion Medical System, Munich, Allemagne). The technique is based on the injection of a cooled bolus of saline into a central vein with a central venous catheter (CVC). The variation of temperature is measured with an arterial femoral catheter and allows the assessment of the cardiac output according to Stewart-Hamilton's theory. Many studies showed the reliability of this technique (Bein J Cardio Thorac Vasc Anesth 2004, Buhre Cardio thorac vasc anesth 1999, Felbinger J Clin ANesth 2005, Felbinger TW J Clin Anetsh 2002, Godie O Ann Thorac Surg 1999).

In our institute, most of the patients are fitted with a port for chemotherapy or parenteral nutrition. When PiCCO monitoring is necessary, a central venous catheter is inserted on the opposite side of the permanent implantable venous port. Indeed, insertion of the CVC can be more difficult because of the port. It may be interesting to use the port for TPTD in order to avoid the insertion of a new CVC. This would be possible only if the measurement of CI by the port was as reliable as the classical measurement with a CVC.

The aim of this study was to assess whether measurement of the CI by TPTD was possible and reliable via the port. The investigators conducted a prospective study comparing the measurement of the CI by TPTD before and after fluid challenge via the port versus the CVC.


Eligibility Criteria:
Inclusion Criteria:

* presence of port
* scheduled surgery with perioperative optimization requirement according to the local hemodynamic protocol
* oral consent of the patient after oral and written information

Exclusion Criteria:

* age inferior to 18
* Contraindication or failure to the insertion of the CVC
* Contraindication to the use of the port : local or general infection suspected or proved, absence of blood backflow
Study of the Inhibition of [11C]R-rolipram Binding to Brain Phosphodiesterase - 4 (PDE-4) by HT-0712

This Positron Emission Tomography (PET) imaging study is designed to explore the relationship between HT-0712 dose level and inhibition of brain phosphodiesterase-4 activity, in order to optimize the dosage regimens utilized in subsequent trials.

The objective of this project is to demonstrate the inhibition of human brain PDE4 by HT-0712, by measuring the inhibition of \[11C\]R-rolipram binding, a radiotracer which also binds to and inhibits PDE4. Plasma samples will be drawn to determine if there is a relationship between plasma pharmacokinetics of HT-0712 and its pharmacodynamic effect, as determined through the inhibition of \[11C\]R-rolipram binding in the brain.

Eligibility Criteria:
Main Inclusion Criteria:

* Healthy, elderly, non-smoking men and post-menopausal women
* Ability to give informed consent

Main Exclusion Criteria:

* Current or history of uncontrolled hypertension, major depression, Parkinson's disease, stroke and diabetes.
* Physical or behavioral conditions that may alter brain function
Comparison of CE-DBT and MRI in Patients With Known Breast Lesions

The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.

This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI. Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study. Participants will be scanned with the DBT system after the administration of iodinated contrast agent. Images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years old
* Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
* Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
* Able to provide written informed consent

Exclusion Criteria:

* Severe untreatable claustrophobia
* Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)
* Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis
* Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female above 18 years;
2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

1. Subject with clinical diagnosis of at least one severe AK on TAs
2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
3. Subject with pigmented AK on the TAs