cyrilzakka/clinical-trials huggingface dataset:
Oxytocin and the Social Brain

It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on oxytocin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with increased trust, generosity, empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of oxytocin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal oxytocin on several tasks involving social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Understanding how oxytocin influences these aspects of social functioning will help to inform research that has begun to establish the potential for use of this neuropeptide in education as well as psychiatric disorders such as autism spectrum disorders and schizophrenia that are characterized by social deficits.

The investigators hypothesize that compared to placebo, oxytocin will improve deception detection, increase empathy and altruism, and enhance responses to photo stimuli of primary caregivers. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for oxytocin, but rather, analyses of relevant moderators will elucidate these findings.


Eligibility Criteria:
Inclusion Criteria:

* 18-30 years of age
* Healthy (see below)
* Fluent in English
* Right-handed

Exclusion Criteria:

* Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
* Symptoms of runny nose due to allergies/cold or other reason
* Current restricted fluid intake for any reason
* Heart disease
* Hypertension
* History of myocardial infarction
* History of cardiac arrhythmia
* Kidney or liver disease
* Vascular disease
* Epilepsy
* Migraine
* Asthma
* Nephritis
* Diabetes and other endocrine diseases
* Frequent or unexplained fainting
* History of stroke
* Aneurysm or brain hemorrhage
* Active psychiatric diagnosis
* Current psychopharmacologic treatment
* Drug or alcohol abuse
* Medical or neurological illness
* Regular use of medication (e.g., vasoconstrictive medications)
* Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs
* Smoking more than 15 cigarettes a day
* Consumption of any alcoholic beverages in the past 24 hours will be excluded
* Elevated blood pressure (\>135/90)
* Low blood pressure (\<90/55)
* Body temperature \>100.1 F
* Left-handed
* Claustrophobia
* Presence of metal in their body
Assessment of Safety, Pharmacokinetics and the Effect of BIBR 1048 MS on Coagulation Parameters in Healthy Volunteer Subjects

To assess safety, pharmacokinetics and the effect of BIBR 1048 MS on coagulation parameters in healthy volunteer subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with GCP and local legislation
* Age ≥ 18 and ≤ 50 years
* Broca ≥ - 20% and ≤ + 20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders
* History of orthostatic hypotension, fainting spells and blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* History of any bleeding disorder including prolonged or habitual bleeding
* History of other hematologic disease
* History of cerebral bleeding (e.g. after a car accident)
* History of commotio cerebri
* Intake of drugs with a long-life (\> 24 hours) within 1 month prior to administration
* Use of any drug which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with investigational drug within 2 months prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familiar bleeding disorder
* Thrombocytes \< 150000/µl
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe Crow's Feet Lines and Frown Lines
* Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)

Exclusion Criteria:

* Current or previous botulinum toxin treatment of any serotype
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
* Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
* Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
* Oral retinoid therapy within one year
Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births

Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.

A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.

Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.


Eligibility Criteria:
Inclusion Criteria:

* Women must be pregnant
* Must be able to provide informed consent
* Must agree to have a community health worker present at the time of delivery
* Must agree to participate in a follow up interview by the study midwife
* Must agree to have pre and postpartum haemoglobin taken

Exclusion Criteria:

* Women who do not meet the inclusion criteria
High-Dose Therapy Treatment in Patients With Follicular Lymphoma

Follicular lymphomas are a subgroup of B-cell non-Hodgkin lymphomas, accounting for 15% to 30% of newly diagnosed lymphomas.1-3 Median survival varies from 5 to 10 years depending on the prognostic factors at diagnosis and response to first-line therapy.4-6 Whatever the treatment, no plateau appears on survival curves, and virtually all patients relapse; follicular lymphomas are ultimately progressive, and fatal.2,3,5 No reference first-line treatment is clearly defined. One of the most active therapies is still doxorubicin-based chemotherapy with or without interferon.7-9 New therapeutic approaches including purine analogs and anti-CD20 monoclonal antibody are promising and are progressively included in the management of these lymphomas.2,3,10-13 The role of high-dose therapy (HDT) as a salvage treatment for patients with relapsing follicular lymphoma is demonstrated by some authors; several reports have shown the superiority of HDT followed by autologous stem-cell transplantation, purged or unpurged, compared with conventional chemotherapy in terms of no relapse and overall survival.14-18 Only a few reports have been published showing HDT results as a first-line treatment for poor-risk patients with follicular lymphoma, and the results remain controversial.19-26 These data prompted the French Groupe Ouest-Est des Leucémies et Autres Maladies du Sang (GOELAMS) to conduct a prospective randomized trial using patients with newly diagnosed follicular lymphoma with a high tumor burden. A combined doxorubicin-based chemotherapy associated with interferon was compared to front-line HDT followed by purged autologous stem-cell transplantation.

Age 8-60 years old follicular lymphoma Not previously treated Stage II bulky, III or IV An Arbor classification high tumor burden

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years old
* Follicular Lymphoma B, C or D (Working Formulation)
* No previous treatment
* Seronegativity HIV
* ECOG performance status less than or 2
* eligible for autologous stem-cell transplantation
* Stage II , III or IV Ann Arbor Classification
* criterias of high tumor burden
* Patient's written informed consent

Exclusion Criteria:

* Age less than 18 years old or more than 60 years old
* Other type of lymphoma
* Stage less than 3 or III-IV (faible masse)
* Seropositivity HIV
* Patients with a history of another malignancy except basal cell skin cancer or in situ uterus cancer
Food Effect Study of D-0502 Tablet in Healthy Volunteers

This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be medically documented as healthy and acceptable at physical examination.
2. Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or higher.
3. Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
4. Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
5. Subjects must be female with postmenopausal status defined as meeting at least one of the following criteria:

   1. Have undergone a bilateral oophorectomy any time in life;
   2. Age ≥60 years, or
   3. Age \<60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value \>40 milli-international units per milliliter (mIU/mL) and an estradiol value \<40 picograms per milliliter (pg/mL) (140 picomoles per liter \[pmol/L\]).
6. Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

Exclusion Criteria:

1. Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological or psychiatric disorders, as determined by the investigator.
2. Subjects who have any history or suspicion of kidney stones.
3. Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C.
4. Subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days before Day 1 of study medication dosing.
5. Subjects had undergone major surgery within 3 months prior to Day 1.
6. Subjects who is participating in a clinical research study involving the administration of an investigational or marketed drug or device, or who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
7. Subjects with positive urine drug screen test at screening.
8. Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Bariatric Surgery and Pharmacokinetics of Enalapril

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on enalapril are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age.

Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).


Eligibility Criteria:
Inclusion Criteria:

* Male or female between, and including, 46-50 months of age at the time of vaccination.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™.
* Written informed consent obtained from both parents/guardians of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period.
* Administration of any pneumococcal vaccine since the end of study NCT00333450.
* Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical
* History of any neurologic disorders or seizures
* Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
* History of hypotonic-hyporesponsive episode after any previous vaccination.
* Major congenital defects or serious chronic illness.
* History of invasive pneumococcal diseases.
* Acute disease at the time of vaccination
* Rectal temperature \>= 38.0°C or oral/axillary/tympanic temperature \>= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic Pancreatitis

Primary objective: To describe and compare the safety and efficacy of treatment with AAT in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT).

The goal of this study is to assess whether infusion of Prolastin-C during peri-transplant period can enhance islet autograft survival and function in chronic pancreatitis patients who have total pancreatectomy and islet autotransplantation. This is a prospective, controlled, double-blind study. The primary endpoint will be area under the curve for the serum C-peptide level during the first 4 hours of an mixed meal tolerance test (MMTT), normalized by the number of islet equivalents (IEQ)/kg at day 365±14 after the transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total pancreatectomy and islet auto-transplantation
* Age \> 18 years
* Diabetes free before surgery

Exclusion Criteria:

* Patients who are under immunosuppression
* Patients who have had Puestow or Frey pancreatic surgery
* Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)
Efficacy of Antibiotic Therapy in Severe Alcoholic Hepatitis Treated With Prednisolone

Treatment of reference of severe alcoholic hepatitis is based on corticosteroids, given for 28 days. However, about 25-35% of patients do not take benefit from this treatment and die within the 6 months following the diagnosis. Numerous trials have evaluated the impact of several strategies in association with corticosteroids. None of them has shown an improvement in survival (primary endpoint) as compared to corticosteroids alone.

The project is based on an approach never tested in a randomized controlled trial in severe alcoholic hepatitis, targeting the group of patients at high risk of death (25-35% at 2 months). This approach is based on animal and human studies.Antibiotics are effective in animal models and in other circumstances characterized by liver failure such as gastrointestinal bleeding related to portal hypertension. The interest of studying this population is emphasized by the frequency of infections in these critically ill patients. Antibiotics will be administered before the development of any infection, as it is likely that these patients present with mesenteric bacterial adenitis without systemic signs of infection. Primary endpoint will be 2-month survival as most deaths occur within 60 days and treatment is given for 30 days.

This is a multicenter double-blind randomized controlled study on two parallel groups.

Once inclusion and exclusion criteria verified and after having obtained patient written consent, participative centers will process to inclusion in the trial.

Corticosteroids as well as antibiotics or their placebo will be started orally. Patients will be managed in the hospital unit until day 7, which corresponds to the evaluation of response to treatment using the Lille model. After this 7-day period, patients will be followed-up at day 14, day 21, day 30, day 60 (primary endpoint).

During each visit, biological and clinical features including efficacy and tolerance will be assessed as well as presence of infection and hepatorenal syndrome (secondary endpoints).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-75
* Recent onset of jaundice (\<3 months)
* Biopsy proven alcoholic hepatitis (transjugular liver biopsy)
* Maddrey's discriminant function ≥ 32, defining severe alcoholic hepatitis
* MELD score ≥21
* Alcohol consumption ≥ 40g/day (women) and ≥ 50g/day (men)
* Written informed consent

Exclusion Criteria:

* Previous severe allergy or hypersensitivity to amoxicillin or clavulanic acid (anaphylactic shock, Quincke edema, severe urticaria)
* Hypersensitivity to any component of the medication
* History of liver injury to amoxicillin and/or clavulanic acid
* Phenylketonuria, because of the presence of aspartame in the powder for the oral suspension
* Type 1 hepatorenal syndrome before the initiation of treatment
* Severe extrahepatic disease
* Any malignant tumor \< 2 years
* Uncontrolled gastrointestinal bleeding
* Ongoing viral or parasitic infection
* Untreated bacterial infection.
Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

This study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. A total of 204 patients are planned to be included. The primary endpoint is the incidence of success aneurysm occlusion at 6-month post procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years to 80 years.
2. Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm.
3. Modified Rankin Scale (mRS) ≤ 2.
4. Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation.
5. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.

Exclusion Criteria:

1. Target aneurysm is an aneurysm requiring staged procedure.
2. Target aneurysm that has been previously treated with vascular embolization or surgery.
3. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
4. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
5. Acutely ruptured aneurysm within 14 days of enrollment.
6. Hunt and Hess (H\&H) scale ≥3.
7. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
8. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.
9. Platelet count \<50\*103/mm3 (50\*109/L) or any known coagulation deficiency, or International normalized ratio (INR)\>3.0.
10. Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants.
11. Life expectancy \< 1 year, and unable to complete the required follow-ups;
12. Female who was pregnant or breastfeeding, women/men planning to havve children in the next year.
13. Currently enrolled in another investigational device or drug study.