cyrilzakka/clinical-trials huggingface dataset:
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine

The main objective of this trail is to investigate if and to what extent BI 409306, BI 425809 and lamotrigine attenuate ketamine induced cognitive deficits.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
2. Age of 18 to 55 years (inclusive)
3. BMI of 18.5 to 32 kg/m2 (inclusive)
4. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
5. Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

   * Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide)
   * Sexually abstinent
   * Vasectomised (vasectomy at least 1 year prior to enrolment)
   * Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy)
   * Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea

Exclusion Criteria:

1. Any finding in the medical examination (including ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
7. History of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
8. History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply
Postoperative Cognitive Dysfunction in Geriatric Patients

Geriatric patients have a high risk of developing postoperative cognitive deficits. Hypothetical causes are insufficient intraoperative cerebral perfusion or drugs that are administered in the perioperative setting. This study will investigate the role of these two factors in patients aged 65 or older undergoing elective surgical procedures under general aesthesia. Non-invasive techniques will be used to monitor intraoperative cerebral perfusion and anticholinergic activity in the patient's blood is determined. Data will be compared to those of a young (20-40 year old) group of patients undergoing elective surgical procedures using an identical anesthetic technique. A second control group of healthy volunteers older than 65 will be investigated to quantify practice effects with repeated testing of cognitive functions.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgical procedure under general anaesthesia

Exclusion Criteria:

* History of cerebrovascular disease
* Mini Mental status \<23
* Cardiac surgery
* Neurosurgery
Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater Saphenous Vein

The aim of this study is to perform a randomized, prospective trial comparing the two current methods of treatment for chronic venous insufficiency, in an effort to evaluate complications and outcomes for each method, and ultimately, to see if one is superior to the other.

Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in the lower extremities. The most common cause is a refluxing or incompetent Greater Saphenous Vein (GSV). This condition results in pooling of deoxygenated blood in the lower extremities rather than successful transport of the blood back to the heart and lungs. The historical treatment has been to surgically remove or 'strip' the GSV so that blood is rerouted through the healthier deep veins. A less invasive treatment option, Endovenous Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This involves advancing a catheter under ultrasound guidance through the GSV and then advancing a laser fiber or radiofrequency probe through the catheter. These devices then produce the energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency ablation and laser ablation are accepted treatments, neither technology has been definitively proved to have fewer complications or superior results. This is in part because very few practices have the ability to make a head to head comparison between the two technologies and must choose one or the other secondary to financial constraints. The aim of this study is to perform a randomized prospective trial comparing the two modalities so that more definitive information to evaluate complications and outcome can be obtained and then recommendations on which, if either, technology is superior can be made.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic chronic venous insufficiency.
* Patients in whom endovenous thermal ablation is clinically indicate.
* Have previously undergone at least 6 weeks of conservative treatment with compression stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).
* Have venous disease that meets CEAP clinical class 2 through 6.
* Have symptoms secondary to Greater Saphenous Vein insufficiency defined as reverse flow in the saphenous vein \>0.5 seconds after calf compression or while standing.

Exclusion Criteria:

* Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive of spider vein injections or other cosmetic surface procedures).
* Have a history of DVT.
* Have a history of hypercoaguability disorder.
* Are pregnant or breastfeeding.
* Are nonambulatory.
Assessment of Coronary Artery Disease in Stroke Patients

This study is to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of coronary atherosclerosis in stroke patients with coronary CT angiography.

Stroke and coronary artery disease (CAD) share common risk factors and pathological mechanisms. CAD is an important cause of death in patients with stroke.

Currently, coronary CT angiography (CCTA) is very useful non-invasive tool for detection of CAD and plaque analysis.

Therefore, the investigators aimed to evaluate the prevalence, plaque characteristics (plaque types, stenosis degree, remodeling) and predictors of CAD in stroke patients through follow-up (more than 5 years) using CCTA.

Eligibility Criteria:
Inclusion Criteria:

* Acute stroke patients who diagnosed by clinical and brain MR imaging
* Who performed coronary CT angiography within 3 months after acute stroke

Exclusion Criteria:

* intracranial hemorrhage including intracerebral, subdural or subarachnoid hemorrhage
* brain tumor
* Previous myocardial infarction
* Previously performed percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or other cardiac surgery
* Insufficient medical record
* Poor image quality of CCTA scan
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 65-75 years of age without evidence of memory impairment
* Subject has overactive bladder symptoms but otherwise healthy
* Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
* Weight within normal range
* Ability to follow study instructions and likely to complete all required visits

Exclusion Criteria:

* Residual urine within bladder greater than 4 ounces
* Moderate or severe memory impairment
* Bleeding disorder
* Blood-thinning agents
* Concurrent overactive bladder medication
* Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
* Chronic kidney failure
* Abdominal bypass surgery for obesity
Young Adult Cardiovascular Health sTudy

The purpose of this study is to understand more about why young people who were born prematurely may have increased risk of high blood pressure and lower cardiovascular exercise capacity.

Young adults with a history of preterm birth are identified as having a unique risk profile for developing hypertension and having reduced exercise capacity. Globally, there are 15 million annual preterm births. In Europe, incidence is 6-15% of all births, with up to 6 million adults in the United Kingdom having a preterm birth history. Understanding the associations between early life exposures and this early cardiovascular risk is extremely important to be able to target primary prevention strategies.

As yet there are no clear explanations for the reduced exercise capacity and elevated risk of hypertension reported in preterm born young adults. Magnetic resonance imaging studies of young adult born premature demonstrated altered heart shape, with increased left ventricular mass, reduced cavity sizes and reduced stroke volumes. The changes in cardiac size identified from these studies is similar to those seen in other disease groups and has been equated to greater than 50% increased risk of cardiovascular clinical events in these groups. These structural changes may account for the reduced exercise capacity observed in preterm born young adults

This study aims to understand the physiological determinants of limited exercise capacity and associated cardiovascular risk profile of adult preterm born populations.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 to 40 years.
* History of preterm birth, diagnosis of hypertension or full term birth normotensive control
* Able (in the investigator's opinion) and willing to comply with all study requirements.
* Participant is freely able to access John Radcliffe Hospital for study visits

Exclusion Criteria:

* Aged \<18 years \>40 years
* Unwilling or unable to give informed consent for participation in the study.
* Pregnant or lactating during the course of the study.
* Planning to donate blood during the study duration.
* Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
* Contraindication to Magnetic Resonance Imaging
The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

A randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.

A randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. Statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* patients ages 18-50 years;
* medically competent (no proxies or prisoners); and
* multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age.

Exclusion Criteria:

* Inability to obtain informed consent;
* fetal death;
* immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.
Prognostic Outcome Score in Functional Neurological Disorders

Monocentric retrospective observational cohort study, using a consecutive series of patients hospitalized for FND from 2012 to 2015 in the neurology department A of the Grenoble Alpes University Hospital. During the discharge staff, an estimation of different prognostic factors had been performed in a consensual way by the medical team for all subjects. It is possible to calculate a score (POS) retrospectively from the data collected during the staff. The following items were evaluated on a Likert scale from 1 to 5: quality of adherence to the diagnosis, presence of a current medical treatment, presence of a similar history, duration of evolution of the disorders presented, ability to verbalize, presence of a social adaptation to the disorders, access to psychiatric care.

The aim of the study will be to study the properties of the calculated score according to the evolution of the patients. The investigators will retrospectively collect information from the medical records. In addition, the evolution of the disorder since the initial hospitalization will be analyzed via a self-evaluation by the subjects and the study of the current medical records.

The investigators will also collect information on the quality of life of the patients in the cohort and their perception of the disease at present.

Using a Clinical Global Impression (CGI-I) scale on FNDstatus, subjects will be classified into two groups by the two principal investigators (Dr. Vercueil, M. Bratanov): the first with a favorable evolution (disappearance of symptoms at the last follow-up, low health care consumption, favorable self-assessment of health status, persistence of symptoms at a low level of disability, satisfactory social and professional integration), and the second with an unfavorable evolution (persistence of symptoms at a disabling level, high health care consumption, unfavorable self-assessment of health status, lack of social and professional integration, multiple medical consultations). The prognostic properties of the POS score will be then studied in order to establish an ROC curve that will allow to classify patients in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Male or female gender
* Hospitalization in Neurology Department A from 2012 to 2015 with a final retained diagnosis of NFT
* POS score at time of hospitalization available

Exclusion Criteria:

* Patient under legal protection
* Inability to complete a self-questionnaire
* Minor subjects
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.

Exclusion Criteria:

* Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.

Patients who have:

* Serum creatinine levels \>212 µmol/L (2.4 mg/dL).
* Creatinine clearance \<50 ml/min.
* WBC \<4.0x109/L, Hgb \<10 g/dL, platelets \<140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
FAMily Factors INvolved in Eating Disorders

This observational study compares parental age and birth order in patients diagnosed with anorexia nervosa and bulimia nervosa.

Study participants are recruited (300 patients for each entity). Healthy subjects without evidence of an eating disorder serve as a control group. Psychometric assessment will include data on pathological eating behavior and general psychological and interpersonal problems.

Outcome measures The SCL-90-R questionnaire is a self-report inventory for adolescents and adults that assesses a wide range of psychological problems and symptoms of psychopathology. The questionnaire consists of 90 items, each of which contributes to one of nine primary symptom dimensions.

The short form of the Inventory of Interpersonal Problems (IIP-C) is used to measure interpersonal problems. This self-report questionnaire contains 64 items assigned to eight subscales.

Eligible candidates are stratified as cases or matched controls as follows:

1. Cases are eligible patients diagnosed with anorexia nervosa or bulimia nervosa (n=300 for each entity) at the time of study inclusion.
2. Controls (100) are healthy subjects of a similar age distribution and from the same study site without the diagnosis of an eating disorder.

Inclusion criteria:

- Age \> 12 and \< 59 years (adolescents and adults).

Exclusion criteria:

* Diagnosed with a malignant disease
* Not fluent in the German language
* Severe mental disorder

Eligibility Criteria:
Inclusion Criteria:

- Age \> 12 and \< 59 years (adolescents and adults) with either anorexia nervosa or bulimia nervosa.

Exclusion Criteria:

* Diagnosed with a malignant disease
* Not fluent in the German language
* Severe mental disorder
Angiotensin II and Chronic Inflammation in Persistent Microvascular Dysfunction Following Preeclampsia

Women who develop preeclampsia during pregnancy are more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. The purpose of this investigation is to 1) determine the mechanisms contributing to this lasting blood vessel damage and chronic inflammation, and to 2) identify factors (both physiological and pharmacological) that mitigate these negative effects in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Post-partum women who have delivered within two years and who have had a preeclamptic pregnancy diagnosed by their obstetrician before 34 weeks of gestation and confirmed according to the American College of Obstetricians and Gynecologists criteria for severe preeclampsia. \[This information will be self-reported by the subjects.\]
* Post-partum women who have delivered within two years and who have had a normal pregnancy.
* 18 years and older.

Exclusion Criteria:

* skin diseases
* current tobacco use
* diagnosed or suspected hepatic or metabolic disease
* statin or other cholesterol-lowering medication
* history of hypertension prior to pregnancy
* history of gestational diabetes
* current pregnancy
* allergy to aspirin or NSAIDs or known allergy to materials used during the experiment (e.g. latex)
* renal disease, bleeding disorders and history of gastrointestinal bleeding.
* Known allergies to study drugs
* Taking blood thinners, aspirin or NSAIDS.
* Women who choose to breastfeed will not participate in any parts of the project that include salsalate.
A Trial of Paclitaxel (Genexol®) and Cisplatin Versus Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) and Cisplatin in Advanced Non Small Cell Lung Cancer

This is a randomized clinical trial of Paclitaxel (Genexol®) and Cisplatin versus Paclitaxel loaded polymeric micelle (Genexol-PM®) and Cisplatin in advanced non small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological evidence of locally advanced, metastatic or recurrent NSCLC (stage IIIB or Iv)
* At least one measurable lesion(s) by RECIST criteria
* No previous palliative chemotherapy
* Age 18 or higher.
* ECOG PS 0-2
* Life expectancy of at least 3 months.
* Adequate hematologic, hepatic, renal function
* Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul)
* Adequate liver function (≤ Total bilirubin ≤ 1.5 upper normal limit, ≤ AST/ALT x 2.5 upper normal limit, Alkaline phosphatase ≤ 2.5 upper normal limit)
* Adequate renal function (≤ serum creatinine 1.5 mg/dl)
* Written informed consent

Exclusion Criteria:

* No prior chemotherapy for NSCLC
* Patients with malignancies (other than NSCLC), except for adequately treated nonmelanoma skin cancer or in situ carcinoma of the cervix.
* Peripheral neuropathy ≥ grade 2 (NCI CTC, version 3.0)
* Clinically significant cardiac disease (medically uncontrollable heart disease)
* Active infection or other serious medical illness
* Contraindication to any drug contained in the chemotherapy regimen
* Pregnant or lactating women were excluded.