cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate

The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years.
* RBC folate \> 317 nmol/L and \< 906 nmol/L.
* At least 1 menstruation during the last 3 months before screening with the exception of women using progestin-only methods (injection, implant) or progestin-releasing intrauterine system (IUS).
* Negative pregnancy test at screening and at admission into the study.
* Healthy as confirmed by medical history and physical examination.
* Body mass index (BMI) of 18.5-30.0 kg/m2 .
* Volunteers that smoke less than 10 cigarettes per day can be included up to the age of 30 years.
* Adequate vitamin B12 status defined as plasma B12 concentrations ≥ 110 pmol/L.

Exclusion Criteria:

* Regular intake of folic acid defined as \> 100 μg folic acid/day in vitamin supplements or fortified food during the last 4 months.
* Treatment with the following medications, which has the potential of interfering with folate metabolism: cholestyramine, methotrexate, trimethoprim, sulfasalazine, salicylic acid, cotrimoxazol, antacids or antiepileptic drugs.
* Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or lactation before start of treatment)
* Vascular or metabolic disease including existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), and any condition which could increase the risk to suffer any of the above mentioned disorders
* Any disease or condition that could compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication.
* Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results (e.g., herpes gestationis or idiopathic icterus pregnancy; middle-ear deafness ; Sydenham's chorea, porphyria, disturbances in the bile flow.
* Liver diseases: Presence or history of severe hepatic diseases including benign or malignant tumors
A Randomized Study Evaluating the Feasibility and Activity of Three Different Combination With Gemcitabine as First Line Therapy for Non Small Cell Lung Cancer

Phase II study that will evaluate the activity of gemcitabine as intravesical therapy on the marker lesion in superficial bladder carcinoma at intermediate risk. Primary objective is the evaluation of the pathological complete response after 8 instillation of gemcitabine. 46 patients are requested.


Eligibility Criteria:
Inclusion criteria

* Histologically or cytologically confirmed diagnosis of NSCLC
* Patients must have a locoregionally advanced unresectable non metastatic NSCLC Stage IIIB (only N3 supraclavicular or T4 for pleural effusion) or Stage IV according to the revised International Staging System
* Patients must have at least one measurable lesion
* WHO Performance Status 0 or 1
* Adequate Organ Function

Exclusion criteria:

* Prior systemic chemotherapy or immunotherapy including neoadjuvant or adjuvant treatments
* Prior radiotherapy for NSCLC
* Patients with symptomatic brain metastases or with leptomeningeal disease. However, patients with symptomatic brain metastases who become asymptomatic under corticosteroids treatment can enter the study
* Current peripheral neuropathy NCI grade 2
A Trial to Evaluate DR-2021 in Women With Secondary Amenorrhea

This is a multicenter trial to compare the effectiveness of 4 doses of DR-2021 with placebo and oral micronized progesterone in inducing withdrawal bleeding in women with secondary amenorrhea.

In this multicenter trial patients will be randomized to receive DR-2021, oral micronized progesterone, and placebo to evaluate the effects on withdrawal bleeding in women with secondary amenorrhea. Patients will be treated for 10 days and study participation will be approximately 24 days. Patients will undergo a physical exam including a pelvic and breast exam. Patients will be required to complete bleeding and spotting information daily in a diary.

Eligibility Criteria:
Inclusion Criteria:

* Not pregnant
* Secondary amenorrhea or oligomenorrhea of at least 50 days duration
* Not currently on any hormonal medication
* Not at risk of pregnancy or willing to use a non-hormonal method of birth control during the study (ie, condom)

Exclusion Criteria:

* Use an injectable or implantable estrogens, progestins, or androgens within the last 6 months
* Use of any hormonal birth control within the last 3 months
* Any contraindication to the use of progestins
Performance of Toric Silicone Hydrogel Contact Lenses

The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.

This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Is not a habitual wearer of either study lens
* Has a contact lens spherical prescription between +4.00 to - 10.00 (inclusive). Best corrected visual acuity of 20/30 or better in either eye
* Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* A person was excluded from the study if he/she:
* Has a CL prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:
* Pathological dry eye or associated findings
* Pterygium, pinguecula, or corneal scars within the visual axis
* Neovascularization \> 0.75 mm in from of the limbus
* Giant papillary conjunctivitis (GCP) worse than grade 1
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, Seborrheic conjunctivitis
* History of corneal ulcers or fungal infections
* Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)

To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis

Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg. At the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The patient is a postmenopausal osteoporotic female
* The patient is willing to limit direct sunlight exposure during the course of the study
* The patient must be ambulatory
* The patient has serum 25-hydroxyvitamin D =25 ng/mL

Exclusion Criteria:

* The patient is contraindicated to bisphosphonate therapy
* The patient has a vitamin D deficiency
* Patient will be excluded if their weight is above 85 kg
* The patient has a history of prior osteoporotic fracture
* The patient is currently or has received in the past treatment with effects on bone or calcium metabolism
* The patient has malabsorption syndrome
* The patient has active thyroid disease
* The patient has metabolic bone disease
* The patient had a myocardial infarction within 6 months of screening visit
* The patient has impaired renal function
* The patient is currently or has been a smoker in the last year
The Effect of Muscular Endurance on Disability Level and Participation in Life

Non-specific neck pain (NSBA), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. NSBA causes an increase in superficial cervical muscle activity, and a decrease in deep cervical muscle activity, which contains a large amount of muscle spindles. Patients with chronic neck pain face functional limitations in many ways. Evaluation of disability as a result of loss of functions related to neck pain is necessary to cope with neck pain. In the ICF activity and participation section due to neck pain, it is stated that the daily life activities of the person are limited due to neck pain, both at work and at home, and with this, the level of disability of the person increases. Loss of endurance, on the other hand, appears as a physical marker in the development of chronic neck pain due to the effect of muscle functions in patients who have problems in the neck region, according to ICF.

Patients with non-specific neck pain who volunteered to participate in the study and who met the inclusion criteria of the study will be included in the study after signing the voluntary consent form. First of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. The personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, muscle endurance measurements) will be recorded by the physiotherapist in the evaluation form. In addition to the evaluation form, the Northwick Park Neck Pain Questionnaire will evaluate the patients' neck disability, while the Keele Participation Evaluation will evaluate their level of participation in life.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary consent to participate in the study
* Clinical diagnosis of non spesific neck pain

Exclusion Criteria:

* There is physical/mental problem that may prevent exercise
Biomarkers for Bipolar Disorder: Chaperones and Reticulum Endoplasmatic Stress Response CHAP´s Study

The purpose of this study is to determine expression of chaperones proteins from the endoplasmatic reticulum stress response system in bipolar I patients (manic phase) compared to healthy controls.

Hypothesis: There is no difference in chaperones proteins expression between bipolar I manic patients and healthy controls


Eligibility Criteria:
Inclusion Criteria:

* Bipolar Disease type I manic phase
* YMRS \> 14
* HDRS \< 9

Exclusion Criteria:

* Use of lithium, divalproate, or carbamazepine in therapeutic levels over the past 30 days
Study in Children Who Have Switched to Isosource Junior Mix Formula

A Retrospective study In Children who have switched to Isosource Junior Mix formula (RICIMIX study) will review paediatric children \> 12 months of age who require Isosource Junior Mix as an enteral tube feeding formula and have consumed the formula for at least 1 month. The purpose of this study is to understand If there has been an improvement in outcomes/ experiences

* The current usage of ISJMIX formula in children who require blended diets
* Improved feeding intolerances
* Improved patient outcomes/ experiences

Retrospective data will be collected using questionnaire by the dietitians at the nutrition and dietetic department. All completed questionnaires will be sent back to Nestle Health Science/ CRO company.

The primary objectives:

The following measures will be collected retrospectively after 1 month use of ISJMIX

* Feeding tolerance \[no change, tolerance improved, tolerance worsened\]: gastric residuals, gagging/retching, vomiting, abdominal distention/ gas, stool consistency issues (too hard, too loose)
* Volume of formula consumed in a day

The secondary objective is to collect restropective data on:

* Any improved patient outcomes noted
* Calculate the potential cost savings made when using ISJMIX to help manage the feeding intolerances
* Calculate the potential costs benefit of using ISJMIX over other standard formulas

Eligibility Criteria:
Inclusion Criteria:

* All children who are using Isosource Junior Mix as tube feed formula

Exclusion Criteria:

* All children who did not switch to Isosource Junior Mix feed formula
Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

The objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.


Eligibility Criteria:
Inclusion Criteria:

* First-time patients, without prior antidepressant treatment that meet the diagnostic criteria of DSM 5 for major depressive disorder.
* Patients who meet the current major depressive disorder criteria in the MINI interview.
* Patients who signed the informed consent for the investigation.

Exclusion Criteria:

* Patients presenting insufficient data in the MINI interview for current major depression.
* Patients diagnosed with intellectual development disorder, by clinic.
* Patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by clinic and / or by the MINI interview.
* Patients with contraindications for MRI.
* Patients with serious or unstable medical problems.
* Patients undergoing some legal procedure.
* Patients with difficulties in understanding the interview or completing the assessment instruments.
A Study Of New Medicine (GSK 372475) For The Treatment Of Depression

To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder

Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
* Duration of current episode is at least 12 weeks duration and less than 2 years
* Symptoms of decreased energy, pleasure, and interest
* Female subjects who agree to use acceptable methods of birth control throughout the study

Exclusion criteria:

* Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
* Symptoms of MDE better accounted for by another diagnosis
* Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia.
* Started psychotherapy within 3 months prior to the Screening
* Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
* Received psychoactive drugs within 4 weeks of randomization
* Positive urine drug screen or positive blood alcohol
* Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
* Positive pregnancy test
* History of seizure disorder, myocardial infarction (\< 1yr), or unstable medical condition
* Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Falls Prevention in Older Home Care Recipients

The aim of this study is to investigate the effect of a falls-prevention exercise programme on health-related quality of life, fear of falling, falls and physical function in older people receiving home care. Participants in the intervention group perform the Otago exercise programme. Participants in the control group continue their usual activities.

Falls and falls-related injuries are considered a serious public health issue in the older population. Strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. This randomized controlled trial investigates the effect of a falls prevention program on health-related quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home care.

Eligibility Criteria:
Inclusion Criteria:

* has fallen at least one time in the last 12 months
* receives home-help services
* able to walk independently indoors with or without walking aid

Exclusion Criteria:

* medical contraindication to exercise
* life expectancy \<1 year
* scores under 23 points on Mini Mental Scale Examination
* participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group
Gut Microbiota in Patients With Moyamoya Disease

This study is to find out the association between gut microbiota and moyamoya disease.

Moyamoya disease (MMD) is a rare cerebrovascular disorder, it is a major cause of stroke in children and young adults in Japan, Korea, and China, but its pathogenesis is not yet clear. Dysbiosis of gut microbiota may play a role in the pathological change of MMD. In this research, the investigators would perform metagenomic sequencing to find the characteristics of gut microbiota of MMD and to explore the correlations with metabolic, immune, and clinical symptoms. This research will not only help the understanding of the pathophysiology of MMD, but also may provide a reference for the selection of clinical treatment options.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MMD by DSA according to the Japanese guidelines published in 2012,
2. Stenosis or occlusion of the terminal internal carotid and the proximal middle and anterior cerebral arteries and unilateral or bilateral involvement
3. Age: 2-60 years old.

Exclusion Criteria:

1. Moyamoya syndrome,
2. Pregnancy,
3. Evidence of gastrointestinal infection/ inflammation/ obstruction
4. History of partial or total resection of small or large bowel, as well as gut reanastomosis,
5. Use of antibiotics within 2 weeks prior to symptoms onset,
6. Gastrointestinal malignancy
7. Any hospitalization within 3 months before recruitment
Mom Power With High-Adversity Mothers and Children

This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.

Adverse childhood experiences (ACEs) are significant risk factors for psychopathology across the lifespan - risks that extend to the next generation, likely transmitted through both biological and behavioral pathways. Biobehavioral self-regulation and parenting are key candidates for transmission and potential points of intervention. However, nearly all intervention research takes a one-generation approach, measuring outcomes in the individual adult or child in treatment. Additionally, very little research has examined biomarkers of self-regulation in parents or children following treatment, and no known research has examined these processes in parents and young children simultaneously across treatment to explore bidirectional effects. There is a critical need to specify targets of two-generation interventions among high-adversity families to decrease intergenerational transmission of mental illness. The objective of this RCT is to determine whether Mom Power, an evidence-based two generation intervention for mothers with histories of trauma, enhances physiological and behavioral self-regulation in mothers and young children, testing mechanisms and examining bidirectional effects. The central hypothesis is that the intervention will shift behavioral and physiological (Respiratory Sinus Arrhythmia) self-regulation in mothers, children, and dyads to mitigate psychopathology risk. Three specific aims are proposed: 1) Examine intervention effects on children's biobehavioral self-regulation and psychopathology; 2) Examine intervention effects on mothers' biobehavioral self-regulation, psychopathology, and parenting behavior; and 3) Examine intergenerational change processes, including shifts in dyadic physiological and behavioral synchrony as well as bidirectional influences between mother and child self-regulation.

Eligibility Criteria:
Participants in this study must include a mother-child dyad. There is inclusion and exclusion criteria for both mother and child.

Inclusion Criteria:

* For moms: Mothers must be female, the biological mother, have an ACE score of 3 or more, speak English, and be 18 years or older.
* For children: Children must be between the ages of 2 and 5.

Exclusion Criteria:

* For mothers: No pacemaker or self-reported heart condition; no active maternal substance abuse or psychosis on screeners (Brown \& Rounds, 1995; Degenhardt, Hall, Korten, \& Jablensky, 2005).
* For children: No parent report of diagnosis of autism or global development delay, no parent report of pacemaker or heart condition
Management of Anxiety in Intensive Care Unit Including Olfactotherapy

The OCEAN observational study is a pilot study. The aim is to validate the interest of the intervention of essential oils, relaxing music and dim light on the anxiety of patient who are in the intensive care unit.

The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in one of the departments participating in the study
* Presenting moderate to high intensity anxiety (Digital scale ≥ 5);

Exclusion Criteria:

* Having already benefited from the "ZEN cart"
* Having taken an anxiolytic during the past 48 hours
* Patient (s) intubated and / or sedated
* Allergy or known intolerance to one of the essential oils used
* Respiratory allergies, asthma, or a history of seizures
* Unable to understand the information note (linguistic reason, or related to his medical condition)
* Pregnant or lactating woman.