cyrilzakka/clinical-trials huggingface dataset:
A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine Reward

GSK598809 is being developed as an innovative treatment for substance dependence and potentially other compulsive behavioral disorders. This study will asses the effects of a single dose of GSK598809 in modulating nicotine reward in 2 cohorts of otherwise healthy male volunteers who smoke. Each cohort of subjects will receive a single dose of placebo or GSK598809 in two dosing sessions binded crossover fashine. There will be a washout period of at least seven days between each session.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male smokers aged 18-65 with a desire to quit smoking.
* Body weight greater than 50kg and BMI within range 19 - 29.9 kg/m2
* Healthy with no significant medical, psychiatric or laboratory evaluation abnormality.

Exclusion Criteria:

* Positive pre-study urine drug/breath alcohol screen: positive HIV 1/2, Hepatitis B or Hepatitis C test at screening.
* History of alcohol/drug abuse or dependence (other than nicotine) within 12 months of the study.
* History of psychiatric disorder or sensitivity to any of the study medications or components thereof or a history of drug or allergy that in the opinion of the physician responsible contraindicates their participation.
* History of cardiac or pulmonary disease/abnormalities.
Exploring Patient and Staff Experience of Using iPads for PPI Activity

Patients' and healthcare professionals' experience of using Apple iPads to conduct patient and public involvement activity

There is a long overdue push to get patients engaged at the earliest stage possible of the research cycle so there is earlier collaboration between the public/patients and the researcher rather than much later on in the research process. For this reason there are successful patient and public meetings that occur in various specialities within the NHS. However, attending these meetings can be difficult as timings for multiple people to attend at the same physical location can be logistically difficult. It can be further compounded if potential members are unable to attend due to their illness. For example, patients may be on home oxygen and therefore may not be selected by the facilitator or perhaps they themselves may decide to exclude themselves.

Previous research has had an online forum to engage the public/patients with the research process. However, the findings were that there was room to improve from an engagement perspective and furthermore, the real-time communication was limited due to how forums functions.

For this reason, the investigators have suggested using iPads so the investigators can have virtual meetings which negates the need to attend meetings physically. The investigators have used iPads instead of other tablets due to their higher encryption standards and because the in-built FaceTime is easier to use than other systems that install a separate application. Virtual meetings where a group of people are not in the same physical location and are communicating via telephone or the internet. Many patients who may not have been considered/been approached about being part of PPI can now participate virtually. In addition, the time commitment is significantly reduced as it would only involve the time the meeting would be held and not the travel time, which can be extensive.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over
* Part of a respiratory medicine PPI group or a PPI group that will be started prior to consent into the study at Nottingham University Hospital Trust

Exclusion Criteria:

* Adults lacking mental capacity
A Drug-Drug Interaction Study of GK Activator (2) and Glyburide in Patients With Type 2 Diabetes.

This study will assess the potential pharmacodynamic and potential pharmacokinetic interaction between GK Activator (2) and glyburide, in type 2 diabetes patients not adequately controlled with glyburide as standard prescribed therapy. Patients will enter the study taking a dose of glyburide (10-20mg po daily) as prescribed prior to study start. GK Activator (2) 100mg bid will be added for 5 days. From days 6-12 patients will receive GK Activator (2) monotherapy, and from day 13 GK Activator (2) will be discontinued and glyburide treatment re-started. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, aged 18-75 years;
* type 2 diabetes mellitus; currently on glyburide 10-20 mg/day for \>=3 months;
* untreated, or taken off anti-diabetic or statin therapy \>=2 weeks before study start.

Exclusion Criteria:

* type 1 diabetes mellitus, or latent autoimmune diabetes in adults;
* diabetic neuropathy, retinopathy or nephropathy;
* patients treated with insulin or PPAR gamma agonist with 6 weeks of screening.
Anatomical and Perioperative Predisposing Factor for Limb Occlusion of Incraft Infrarenal Endograft (LIMIT Study)

The aim was to determine, within the patient enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company) studies which are preoperative and postoperative anatomical risk factors associated to limb occlusion. In the three studies the total number of enrolled patients was 400, of whom 134 enrolled in the US


Eligibility Criteria:
Inclusion Criteria:

* Patients with abdominal aortic aneurysm, who have been treated with the INCRAFT® Grafting System (AAA Stent-Graft System).
* All cases treated with Incraft who were enrolled in three controlled prospective studies, INNOVATION, INSPIRATION and INSIGHT (Sponsor: Cordis, A Cardinal Health Company)

Exclusion Criteria:

* no exclusion criteria
Paracetamol Oral Paediatric Suspension at 4.8% : Study of Acceptability and Safety.

Evaluate the acceptability over 24 hours of a new paracetamol formulation 4.8% paediatric oral suspension in children weighing between 3 and 26 kg including limits


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter :

Inclusion Criteria:

* Children of both sexes weighing between 3 and 26 kg including limits.
* With a fever and/or painful episode justifying a paracetamol treatment for a minimum duration of 24 hours.
* Likely to be followed throughout the entire study period in out-patient.
* For whom the informed consent has been signed by the parents or legal guardian and by the child if old enough (see chapter 12.3).

Exclusion Criteria:

* Presenting digestive disorders, vomiting.
* Presenting a hypersensitivity to paracetamol or one of the ingredients of the study product
* Presenting a hepatocellular failure.
* Presenting a fructose intolerance.
* Presenting a serious concomitant disease, such as cancer, immune deficiency or a serious renal, hepatic cardiac, neurological, psychiatric or metabolic disease.
* Presenting a history of significant biological anomalies.
* Treated with Kayexalate® (sodium polystyrene sulphonate)
* Not covered by a social security regime.
* Whose parents are incapable of understanding
* Who cannot come back to the consultation for the final evaluation and/or submit to the study constraints.
* Who participated in another clinical study in the 30 days prior to inclusion.
* Is a relation of the investigator.
Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites

The purpose of this single-center, randomized, prospective cohort study is to evaluate the clinical outcome and negative-pressure wound therapy (NPWT) mediated modulation of the biologic milieu of a modified NPWT dressing on split-thickness skin graft (STSG) donor sites.

The investigators have designed a prospective randomized trial in which subjects will be assigned to a modified negative-pressure wound therapy (NPWT) dressing or standard moist dressing. The investigators will measure the percentage of re-epithelization at set postoperative time intervals using digital photography, pain using the visual analog scale (VAS), and healing quality using the Vancouver Scar Scale (VSS). The investigators hypothesize that the NPWT will lead to less pain and increased re-epithelization in a shorter postoperative time course. This specific aim seeks to prove/disprove that patients who receive a modified NPWT dressing perceive the advantage with improved healing, pain, shorter length of stay, and other wound symptoms related to delayed donor site wound healing.

The donor site for STSGs provides a consistent model of superficial wounds that offers the opportunity to study both mechanisms of wound healing and potential mechanisms of action of NPWT. In patients undergoing both standard dressings and NPWT, the investigators will sample the wound exudate and perform microbiopsies of the healing wound at fixed intervals and perform histologic and molecular analysis in order to quantify the degree of re-epithelization and the trophic and inflammatory profile of the healing wound.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Both genders are eligible for study
* Written consent obtained from the subject or agent
* Donor site wounds must not exceed 5% total body surface area (TBSA)
* Subject must be receiving a split-thickness skin graft (STSG)
* Donor site is amenable to either NPWT or standard of care (occlusive dressing)
* Ability to comply with necessary wound care/follow up

Exclusion Criteria:

* Age \<18 years
* Subject has been diagnosed with Diabetes
* Subject is a smoker
* Subject takes steroids
* Subject takes immunosuppressive medications
* Subject with immunosuppressive disorders
* Donor site wounds that exceed 5% total body surface area (TBSA)
* Subject has sensitivity to silver or acrylic adhesives
* Inability to comply with necessary wound care/follow up.
Effect of Phonophoresis on Trigger Points

purpose of this study was to investigate the effects of phonophoresis with fastum gel versus reparil gel on pain intensity, pain threshold, and cervical ROM of participant with trigger point of upper trapezius.

participants will be divided into 3 groups, 2 study groups and 1 control group.

Eligibility Criteria:
Inclusion Criteria:

* upper trapezius trigger point

Exclusion Criteria:

* cervical disc
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.

This post-market study will assess the performance of and user satisfaction with the PureWick™ Male External Catheter in a home setting. The study will also observe safety of the study device and collect information from participants about their experience using the device.

Approximately 15 men requiring the use of diapers or pads at night for urine management will take part in this prospective, open-label, crossover trial. Participants will be 1:1 randomized to a treatment sequence using two devices: the PureWick™ System (PureWick™ Male External Catheter \& PureWick™ Urine Collection System) and the UltraFlex™ Self-Adhering Male External Catheter. Participants will use each urine management device overnight while sleeping for a period of 7 days with a 2-day washout period in between. Total duration of participation is approximately 16 days. The primary efficacy endpoint is the mean capture rate. The primary safety endpoint is the number of device-related AEs requiring medical intervention. Capture rates and Adverse Events are assessed daily throughout each 7-day treatment phase. Sleep disturbance is assessed at baseline and every 7 days during treatment. End of study preference questionnaire is completed at the end of treatment. Device adherence is assessed by the proportion of device wear nights that the study device became dislodged. Tolerability is assessed by number of nights of actual device use.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male participants ≥ 65 years of age at the time of signing the informed consent
2. Male anatomy at the time of enrollment
3. Currently use diapers, pads, or equivalent at night for urine output management
4. Willing to comply with all study procedures in this protocol
5. Provision of signed and dated informed consent form

Exclusion Criteria:

1. Has frequent episodes of bowel incontinence; or
2. Has chronic urinogenital infections, active genital herpes; or
3. Has Urinary retention; or
4. Has experience using study devices in the home setting within the last year; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study; or
8. Is considered a vulnerable population.
Study Assessing Efficacy of ZARNESTRA™ Combined With Tamoxifen in Patients With Advanced or Metastatic Breast Cancer

The purpose of this study is to evaluate the objective response rate when ZARNESTRA is added to treatment with tamoxifen


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, metastatic or locally advanced inoperable breast cancer
* Tumor considered potentially hormone-sensitive, i.e. presence by IHC of hormone receptors for estrogens (ER+ for more than 10% of cells) and/or progesterone (Pg+ for more than 10% of cells) or both. This expression may have been detected on the primary tumor or at a metastatic site. The method used will be reassessed by IHC if it involves a radioligand technique whenever it is possible to obtain histological material.
* Progressing on treatment with tamoxifen, given either as adjuvant treatment or for advanced/metastatic breast cancer. Any previous treatment with a steroidal or nonsteroidal antiaromatase in a neo-adjuvant, adjuvant or metastatic situation is permitted. Likewise, any previous treatment with chemotherapy and/or herceptin in a nonmetastatic situation is permitted.
* Post-menopausal patients
* Age \> 18 years
* At least one measurable lesion according to the Response Evaluation Criteria for Solid Tumors (RECIST) criteria; for patients who only have bone metastases, an evaluable non-irradiated lytic lesion is required
* Performance Status (WHO): PS ≤ 2 (Appendix 1).
* Laboratory tests in accordance with the following criteria:

Neutrophils ≥ 2x109/l,Platelets ≥ 100x109/l,Hemoglobin ≥ 10 g/dl, ASAT, ALAT ≤ 2.5 N , or \< 5 N when liver metastasis,bilirubin ≤ 1.5 N creatinin ≤ 1.5 N

* Signed, written consent before any study-related procedure

Exclusion Criteria:

* Men
* Pre-menopausal patients who are not receiving concurrent LHRH agonist therapy
* ER- and PR-negative patients
* Contraindication to antiestrogens (thromboembolic risk) or ZARNESTRA
* Non metastatic tumor susceptible to management by radiotherapeutic and/or surgical means
* T4d inflammatory tumor (PEV 2 or 3).
* Short-term, life-threatening lesions: hepatic invasion \> 1/3 of liver volume, pulmonary lymphangitis, uncontrolled cerebral metastases, carcinomatous meningitis
* Sensory neuropathy \> or = grade 1 (WHO)
* Previous history of uncontrolled cancers or controlled for less than 5 years, except basal cell skin cancers and in situ cancers of the cervix.
* Chronic diseases (somatic or psychiatric) with a poor prognosis
* subjects with enzyme-inducing anti-convulsants (e.g., phenytoin, phenobarbital, carbamazepine) : this treatment is not permitted while taking ZARNESTRA
* Patients who, for family, social, geographic or psychological reasons, could not be followed up correctly.
Effect of Acetazolamide on Exercise Performance in Patients With Respiratory Disease at Altitude

In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance at altitude in patients with COPD.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Exercise performance will be evaluated by maximal cycling spiroergometry and constant load ergometry.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides
Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.

Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.

Eligibility Criteria:
Inclusion Criteria:

* abdominal surgery by laparotomy

Exclusion Criteria:

* laparoscopy
* history of chronic pain
* opioid self-administration
* psychiatric disorders
* difficulties with communication
* renal or hepatic dysfunction
* ASA physical status \> 3
A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)

This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.


Eligibility Criteria:
Inclusion criteria:

* Participant has an LDL-C ranging from ≥100 mg/dL to \<160 mg/dL.
* Patient has a triglyceride (TG) level of ≤500 mg/dL.

Exclusion Criteria:

* Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).
* Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal \[ULN\])
* Participant has increased creatine kinase (CK) (≥2 x ULN).
* Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.
* Participant has a history of alcohol and/or drug abuse.
Remote EEG Device for Identification of Risk for Neonatal Seizures

The purpose of this study is to see if the use of wireless brain wave monitoring can be helpful for newborns and help their medical providers identify seizures earlier and to monitor for the risk for seizures.

Our goals are to evaluate the effectiveness of the Epilog device in identification of neonates who are at risk for seizures and need formal EEG monitoring or cooling. The current process for these patients would be transfer from Rochester Methodist Hospital to the St. Mary's level 3 NICU for EEG monitoring. Given that in case of neonatal encephalopathy, there is 6-hour window in which to make the critical decision of whether to initiate therapeutic hypothermia or not, rapid access to EEG data is crucial. We would like to perform a pilot study on use of wireless EEG technology in neonates with mild neonatal encephalopathy and neonates with spells to see if this device can be used to determine the risk for neonatal seizure and need for escalation of care and full scalp EEG.

Eligibility Criteria:
Inclusion Criteria:

* Age 28 days old or less (postnatal age)
* Neonatal encephalopathy as judged by clinical team or symptoms concerning for subtle seizures
* Patient currently in level 1 newborn nursery or level 2 or 3 NICU

Exclusion Criteria:

* Medical comorbidity which would result in prolonged need for sedation
* Prolonged EEG monitoring is medically indicated
Outcome of Patients With Congenital Heart Disease

Advanced surgical and medical healthcare systems have resulted in an increased prevalence of children and adults with congenital heart disease in Western countries. These patients often necessitate non-cardiac interventions. Previous studies have demonstrated that these patients are at increased risk of morbidity and mortality when presenting for non-cardiac interventions. The aim of this study is to know the prevalence of patients with congenital heart disease presenting for non-cardiac interventions in a tertiary hospital and to determine their outcome.

Previous studies have shown that children and adults presenting with congenital heart disease are at increased risk of morbidity and mortality after non-cardiac interventions. This risk depends on the type of pathology, the age of the patient and the experience of the physicians in charge of these patients.

We sought to determine the prevalence of children and adults with congenital heart disease presenting for non-cardiac interventions and to investigate their outcome.

Eligibility Criteria:
Inclusion Criteria:

* All children and adults with congenital heart disease

Exclusion Criteria:

* Parental or patient refusal
* Patients presenting for cardiac interventions
Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial

In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.


Eligibility Criteria:
Inclusion Criteria:

board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation

Exclusion Criteria:

* non