cyrilzakka/clinical-trials huggingface dataset:
Oxytocin's Effect on Attention Training

This study aims to investigate oxytocin's effect on attentional bias training. Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral). Effects of the training will be assessed using an eye-tracking anti-saccade task.

In this study, a dot-probe task will be used to examine if subjects show an attentional bias towards negative stimuli and whether the bias can be modified using a subsequent attentional bias training. During this training participants learn to direct their attention away from threatening stimuli. In a between-subject placebo controlled design participants will receive either intranasal oxytocin or placebo before the training to examine whether oxytocin could facilitate the effects of the attention training. Effects of the training and of oxytocin on the training will be assessed by means of an eye-tracking anti-saccade task. Based on previous studies showing the strongest effects of threat-attentional bias training in high anxious subjects, the study will recruit participants with an elevated trait anxiety.

Eligibility Criteria:
Inclusion Criteria:

* male participants with elevated trait anxiety (\> 45 scores as assessed with the State and Trait Anxiety Inventory, Spielberger, 1983)
* without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* smoking or drinking 24 hours before the experiment
Brain Activity During Complex Walking in People With Atypical Parkinsonian Syndromes

Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as atypical Parkinson's disease (APD) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions.

The challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecologically valid state. The investigators aim therefore to explore brain function during complex walking in healthy and APD by investigating the effects of age and neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in older healthy adults and people with APD.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of PSP according to Movement Disorder Society (MDS) (2017) or
* MSA according to MDS criteria (2022)
* the ability to walk with or without a mobility device for ≤5 minutes continuously

Exclusion Criteria:

* cognitive difficulties affecting the ability to understand and/or follow verbal/written - instructions
* severe freezing of gait
* Severe hearing or visual impairments that affect participation in the assessments
* Other neurological diseases
* Other diseases that can affect gait or balance.
Pulse and Constitution of Pregnant Women

The present project plans to detect pregnant pulses using this portable ANS (autonomic nervous system) Watch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited.

ANS(autonomic nervous system) Watch has been developed as to detect pulse waves using a pressure detector. It is used to measured cardiovascular indices, including cardiac output, and vessel stiffness. ANSWatch is developed to apply to the prediction of traditional Chinese medicine (TCM) pulses, such as the wiry pulse. There are 28 types of pulses in TCM. Among them, the slippery pulse is the most commonly seen pulse in pregnant women. The present project plans to detect pregnant pulses using this portable ANSWatch connected to a laptop. One hundred pregnant women and 100 non-pregnant women will be recruited. After taking the indices of the subjects, a neural network is designed to provide the prediction for pregnancy constitution, pregnancy pulse and slippery pulse in pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* nonpregnant females and singleton pregnant females aged 20 - 45 years;
* no estrogen, progesterone, or ovulation inducing medications were in the past six months

Exclusion Criteria:

* active heart disease, liver disease, kidney disease, or thyroid disease;
* any chronic disease which needs medication
* smoking, drug abuse, or alcohol abuse;
* psychiatric disorders or impaired cognitive function;
* taking Chinese medicine or western medicine in three months;
* Acute conditions currently, such as gastroenteritis, upper airway infection, acute attach of asthma, etc.
Long-term Follow-up of Anal Fistulae in Crohn's Disease Treated With Anti-TNFalpha and Interest of New MRI Sequences

Main purposes of this study are :

* Analysis of relapse risk of anal fistulae with prospective follow-up of patients undergoing pelvic MRI every 6 months for one year. This monitoring also determines if the presence of path of fistulae visible on MRI during inclusion visit is associated to increased risk of perianal abscess under infliximab or adalimumab treatment.
* Evaluation of interest of new magnetic resonance imaging sequences for detection of persistent anal fistulae under infliximab or adalimumab treatment.

Secondary purposes are:

* Description of patients with one or more paths of fistulae visible with MRI after at least one year of treatment with infliximab or adalimumab administered for anal fistulae and showing a complete healing of fistulae at clinical examination of inclusion visit.
* Identification of predictive factors (included the presence of paths of fistulae visible with MRI during inclusion visit) of relapse of anal fistulae during the 1-year-follow-up after inclusion visit.


Eligibility Criteria:
Inclusion Criteria:

* Aware and cooperative, giving written consent
* Crohn's disease diagnosed with clinical, biological, endoscopic and/or radiologic criteria
* Patient treated with infliximab or adalimumab for perianal fistulizing Crohn's disease since at least one year
* Absence of drainage seton at inclusion
* Absence of active perianal lesions at inclusion: absence of suggestive symptoms and normal proctologic clinical examination without general anesthesia
* Patient with MRI monitoring for perianal fistulizing Crohn's disease

Exclusion Criteria:

* Patient under juridical protection or without affiliation to social security
* Refusal or impossibility of giving informed consent
* Patient not followed-up by MRI or having a contraindication for MRI, especially the presence of cardiac stimulators or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or encephalic metallic foreign bodies, endo-prostheses placed since at least 4 weeks or osteosynthesis material placed since less than 6 weeks or gadolinium intolerance history
* Surgery for Crohn's disease already planned at inclusion visit, individual participating to another study evaluating efficacy and/or tolerance of medical or surgical treatment for perianal fistulae of Crohn's disease
* Patient treated with anti-TNF for luminal Crohn's disease
* Patient having active perineal lesions
Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II

Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.


Eligibility Criteria:
Inclusion criteria:

1. Age \>= 40 years;
2. IPF diagnosed, according to most recent American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), Latin American Thoracic Association (ALAT) IPF guideline for diagnosis and management, within 5 years;
3. Combination of High Resolution Computerized Tomography (HRCT) pattern, and if available surgical lung biopsy pattern, as assessed by central reviewers, are consistent with diagnosis of IPF
4. Dlco (corrected for Hb): 30%-79% predicted of normal; 5.FVC\>= 50% predicted of normal

Exclusion criteria:

1. Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \> 1.5 x Upper Limit of Normal (ULN)
2. Bilirubin \> 1.5 x ULN;
3. Relevant airways obstruction (i.e. pre-bronchodilator FEV1/FVC \< 0.7);
4. Patient likely to have lung transplantation during study (being on transplantation list is acceptable for participation);
5. Myocardial infarction within 6 months;
6. Unstable angina within 1 month;
7. Bleeding risk (genetic predisposition; fibrinolysis or full-dose therapeutic anticoagulation or high dose antiplatelet therapy; history of hemorrhagic CNS event within 12 months; haemoptysis or haematuria or active gastro-intestinal bleeding or ulcers or major injury or surgery within 3 months);
8. Thrombotic risk (inherited predisposition; history of thrombotic event (including stroke and transient ischemic attacks) within 12 months;
9. International normalised ratio (INR) \> 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \> 50% of institutional ULN);
10. N-ACetyl Cystein, prednisone \> 15mg/day or equivalent received within 2 weeks of visit 1;
11. Pirfenidone, azathioprine, cyclophosphamide, cyclosporine A received within 8 weeks of visit 1;
Regulatory B Cells in Inflammatory Rheumatisms and Biomarkers of Response to Biologic Treatments

B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans.

B cells are known to play an important role in auto-immune diseases by activating T cells, secreting inflammatory cytokines and autoreactive antibodies. However, a sub-type of B cells named regulatory B cells or Bregs has recently shown capacities to prevent or cure arthritis in mouse models. Bregs have also been identified in humans. Main objective: To study Bregs abnormalities in patients with rheumatoid arthritis (RA) at different stages of the disease compared to subjects with mechanical pathologies.Secondary objectives:- To evaluate the specificity of any abnormalities identified in RA by studying Bregs in patients with other autoimmune or other inflammatory joint diseases.- To evaluate the effect of biological and synthetic treatments on Bregs in patients with RA. - To assess whether the rate of Bregs before treatment is predictive of response to biological and synthetic treatments.

Eligibility Criteria:
Inclusion Criteria:

For RA patients and control patients:

* Age over 18 year old
* Blood sample taken as part of the usual management
* Steroid less than or equal to 15 mg/day and stable for at least a week

For RA patients:

* Patient with RA meeting the ACR / EULAR 2010

For control patients:

* Patients with systemic autoimmune disease (lupus, Sjogren's syndrome, scleroderma) or other inflammatory arthritis (spondylitis, crystals) or a mechanical pathology (limb osteoarthritis or spinal pathology) .

Exclusion Criteria:

* steroids over 15 mg/day
* rituximab infusion in less than 12 months
Topical 5% Imiquimod Cream for Vulvar Paget's Disease

The purpose of this study is to evaluate the efficacy, safety and immunological response of topical 5% imiquimod cream for non-invasive vulvar Paget's disease.

Vulvar Paget's disease is a rare skin tumour and generally seen in postmenopausal, Caucasian women as an erythematous, eczematous, scaling or ulcerating plaque. Initial symptoms are irritation, burning, pain and a skin lesion. The origin of vulvar Paget's disease is not yet entirely understood. The treatment of choice is surgical excision, despite high recurrence rates. The mutilating consequences of surgery can lead to impressive morbidity to address this, several series report the use of topical 5% imiquimod cream for vulvar Paget's disease.

The objective of this study is to assess the efficacy, evaluate the safety, immunological effect of topical 5% imiquimod cream for vulvar Paget's disease and the quality of life during treatment.

Eligibility Criteria:
Inclusion Criteria:

* Non-invasive vulvar Paget's disease, primary or recurrence after earlier surgery;
* Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines.

Exclusion Criteria:

* Invasive vulvar Paget's disease;
* Underlying adenocarcinoma;
* Treatment of the vulva with topical 5% imiquimod cream during the last 6 months;
* Participation in a study with another investigational product within 30 days prior to enrolment in this study;
* Hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetylalcohol, atearylalcohol);
* Patients with autoimmune disorders;
* Immune compromised patients (e.g. HIV patients, patients with a history of transplantation);
* Insufficient understanding of the Dutch or English language;
* Pregnant women;
* Lactating women.
Nutritional Status in Orthognathic Surgery Patients

The aim of this study is to determine the effect of orthognathic surgery on nutritional status, anthropometric measurements, food consumption levels, physical activity levels, biochemical parameters, chewing ability and oral-health impact profile.

Sub-objectives of the study;

* Determining nutritional status changes after orthognathic surgery
* Determining changes in anthropometric measurements (body weight, BMI, fat mass, muscle mass, total body water, waist circumference, hip circumference, mid-upper arm circumference) after orthognathic surgery
* Determining food consumption changes after orthognathic surgery
* Determining changes is physical activity levels after orthognathic surgery
* Determining changes in biochemical parameters 3 months after orthognathic surgery
* Determining changes in chewing ability after orthognathic surgery
* Determining changes in oral-health impact profile after orthognathic surgery
* Determining changes in pain intensity

The aim of this study is to compare these parameters preoperative to postoperative timeline of orthognathic surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old,
* Volunteer to participate in the study,
* Dysgnatic patients with malocclusion who applied to Marmara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery will be included in the study.
* Type of surgery (only patients with genioplasty operation will not be accepted)

Exclusion Criteria:

* Patients with a history of acute facial trauma,
* Patients with previous facial surgeries,
* Pregnant or lactating women
* Those who have diseases that may cause systemic neuropathy such as diabetes, hypertension, kidney disease,
* Those who do not want to sign the consent form,
* Orthognathic surgery patients treated with genioplasty only,
* Patients with a history of eating disorders (anorexia nervosa, bulimia nervosa, etc.).
* Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.
A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants

The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4 inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.

The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants in order to evaluate the effect of the potent CYP3A4 inhibitor itraconazole on the single-dose PK of TAK-906 maleate.

The study enrolled 12 participants. Participants received the following treatment sequence:

• TAK-906 maleate 25 mg; Itraconazole 200 mg + TAK-906 maleate 25 mg

Participants were given an oral dose of TAK-906 in the First Intervention Period which was followed by a washout period, after which participants were given Itraconazole solution along with TAK-906 orally in the Second Intervention Period.

This single center trial was conducted in the United States. The overall duration to participate in this study was 7 weeks. Participants remained confined in the clinic from Day 1 up to Day 2 (First Intervention Period) and Day 4 up Day 6 (Second Intervention Period). Participants returned for a Follow-up Visit, 10 to 14 days after last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.
2. Has a body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) and a body weight greater than (\>) 50 kilogram (kg) at the Screening Visit.
3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months before administration of the initial dose of trial drug/invasive procedure.

Exclusion Criteria:

1. Has a positive alcohol or drug screen.
2. Has had a major surgery, donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 8 weeks of the first dose of study drug.
3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \[354 mL/12 ounces\], wine \[118 mL/4 ounces\], or distilled spirits \[29.5 mL/1 ounce\] per day).
4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
5. Has a substance abuse disorder.
Computer-Based Balance Training for People With Parkinson's Disease

This study will be carried out to determine the effectiveness of in-home computer games played by a person with Parkinson's disease for 50 minutes 3 times a week on measures of standing and walking balance.


Eligibility Criteria:
Inclusion Criteria:

1. presence of bradykinesia along with at least one of the following: muscular rigidity, 4-6 Hz rest tremor, and postural instability (Gelb, Oliver, \& Gilman, 1999; Hughes, Ben-Shlomo, Daniel, \& Lees, 1992).
2. Hoehn \& Yahr disease Stage 1 (unilateral disease) to 3 (mild to moderate bilateral disease, physically independent) (Fahn and Elton, 1987).

Exclusion Criteria:

1. history of strokes, repeated head injury, encephalitis, oculogyric crises, neuroleptic treatment, MPTP exposure, more than one affected relative, sustained remission, strictly unilateral features after 3 years, supranuclear gaze palsy, early severe autonomic involvement or dementia, Babinski sign, tumor, or a negative response to L-DOPA (Hughes et al., 1992).
2. other neurologic, orthopedic or cardiac problems, cognitive impairment as evidenced by 5 or more errors on the Mini Mental State Examination (MMSE) (Folstein, Folstein, \& McHugh, 1975)
3. visual or hearing impairments serious enough to interfere with their ability to interact with the computer-based training program.
Changes in Functional Performance in Individuals With Parkinson's Disease Following 2-month Physiotherapy Intervention

Aim of current study was to evaluate the effect of a 2-month comprehensive physiotherapy intervention on different aspects of functional performance. In addition, progression of PD motor symptoms (using standardized clinical tests for the assesment) was of interest

The aim of current study was to enroll 50 patients with Parkinson's disease (PD) and randomly assign them into intervention and control group. Patients were randomly contacted through the epidemiological database of patients with Parkinson' disease of South-Estonia. 44 participants agreed to come to the baseline assessment including:

* Timed-Up-And-Go Test Battery
* Four square step test
* Physical performance test
* Short Physical Performance
* 10-m walk test
* Grooved Purdue Pegboard test
* Assessment of range of motion In addition, current disease status was assessed using Unified Parkinson Disease Rating Scale, Mini Mental Sate Examination. Further, quality of life was assessed using PDQ-39, hand-writing was recorded using white, squared and striped paper and freezing of gait questionaire (FOG-Q) was administered. Within a week from baseline assessment participants randomly assigned to intervention group, started physiotherapy intervention. The intervention was carried out in small groups (3 people in a group) and was carried out as out-patient physiotherapy during 8 week period. During each week 2 sessions with a length of an hour were scheduled. Within a week of the last therapy session, second assessment was conducted (for control group the second assessment was carried out ten weeks post-baseline assessment.

Third assessment was assigned one year after (then the same assessment was performed, in addition body composition was analysed using DXA), forth assessment an other year later.

During forth assessment 15 members starting in the intervention group and 10 starting in the control group participated.

Eligibility Criteria:
Inclusion Criteria:

1. confirmed diagnosis of idiopathic Parkinson Disease
2. age within the age limits
3. no other untreated medical conditions that might affect gait or postural stability
4. able to walk without assistive device
5. score of Mini Mental State Examination above 24
6. no other neurological conditions in medical anamnesis

Exclusion Criteria:

Not meeting the inclusion criteria