Kornimate/medical-research-clean huggingface dataset:
relation between maternal iodine status and prenatal foetal thyroid dimension

Conditions: Deficiency Disease

Summary: mother with severe iodine deficiency are more likely to have neonates with further poor mental development . in order to select population which could benefit from iodine supplementation, ioduria has been tested but cannot be routinely practised. strong background data suggest that iodine status could be antenatally correlated with foetal thyroid volume. the aim of that study is to examine correlation between these two parameter in a population of 130 healthy pregnant women.

iodine is an essential element in thyroid homeostasis, particularly in pregnant woman and her fetus. various studies have clearly shown that antenatal thyroid disorders at both the mother and the fetus could cause in extreme situations of neurological consequences. at a broader scale, subtle alterations of thyroid hormone balance has been implicated in developmental delays and deviations of the iq bell curve in newborn infants of mothers with elevated tsh. the clinical implications of these basic data and public health are yet to confirm. it has been clearly established that there is a moderate iodine deficiency in france with a decreasing gradient from west to east. in the ile de france, there is a moderate iodine deficiency, this has led some teams to propose a systematic supplementation of all women in iodine. one way to target women who really need supplements systematic determination of urinary iodine tongue; this assay is reliable but is difficult to implement in an ad hoc practice at the individual level. our team has expertise in the field of fetal thyroid, particularly in its sonographic and reference curves of the perimeter and diameter of the thyroid are now clearly established reliably. knowing that iodine deficiency is causing a decline in maternal urine iodine with a phenomenon goitrigénèse and biological hypothyroidism and that some studies have shown that neonatal thyroid volumes were higher in iodine deficient mothers . we postulate that the measurement of fetal thyroid by our criteria can be correlated with maternal urinary iodine. if this were the case, we will have a simple test to identify iodine supplementation in pregnant women.

Eligibility criteria:
inclusion criteria: * normal single pregnancy in a healthy volunteer exclusion criteria: * any associated disease * pertubation of thyroid status at 12 ga

Keywords: foetal thyroid mensuration
safety and efficacy of the irreversible electroporation (ire) system for adenotonsillar hypertrophy in children

Conditions: Tonsillar Hypertrophy; Upper Airway Obstruction

Summary: this is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. the study is designed to evaluate the safety and efficacy of an irreversible electroporation (ire) system for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in children.

the purpose of the ire system is to address the clinical need for reducing the volume of hypertrophic tonsil(s) and adenoid while minimizing side effects and complications. procedure time will also be reduced. the ire system is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of the tonsils and adenoid volume. on basis of these finding and in view of the known safety profile and efficacy of current adeno-tonsillar reduction technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the ire system in adeno-tonsillar reduction.

Eligibility criteria:
inclusion criteria: * age 3 - 18 years. * tonsillar hypertrophy (more than 2 in brodsky grading system for tonsils (bgst)). * symptomatic upper airway obstruction. exclusion criteria: * age below 3 years, or above 18 years. * patients which underwent prior tonsillectomy or tonsillotomy. * body mass index (bmi) above the 95th percentile for patient's age and sex, as per the centers for disease control and prevention (cdc) growth charts. * patients with a pacemaker or similar electro stimulator implants. * patients for whom the anesthesia involves high risk. * epilepsy or other condition involving convulsions. * significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease). * bleeding diathesis. * known or suspected complications for any general or local anesthetic agents.
treatment patterns and outcomes in participants with advanced melanoma in germany using a german database

Conditions: Advanced Melanoma

Summary: this study is a non-interventional retrospective observational study performed on secondary data from a german multi-site cohort registry, the german national registry of skin cancer (adoreg).


Eligibility criteria:
inclusion criteria: * signed informed consent for inclusion in adoreg registry must be documented at study site * diagnosis of advanced (nonresectable or metastatic) melanoma in stage iii or stage iv * participants received any systemic therapy to treat the advanced melanoma * first-line systemic treatment was initiated within the index window (19-jun-2015 to 30-jun-2018) exclusion criteria: * age \<18 years at index date * receipt of clinical trial study drug at any time
tick-borne encephalitis (tbe) seropersistence after first booster and response to a second booster in children, adolescents and young adults (follow-up to study 700401)

Conditions: Encephalitis, Tick-Borne

Summary: the main purpose of this study is to assess the seropersistence of tbe virus antibodies in children, adolescents and young adults who received the first booster vaccination with either fsme-immun 0.25 ml junior or fsme-immun 0.5 ml in precursor study 700401.


Eligibility criteria:
inclusion criteria: subjects who participated in precursor study 700401 and meet all of the following criteria are eligible for participation in this study: * subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law); * subject provides written assent to the study according to age and capacity of understanding; * subject received the first booster vaccination with either fsme-immun 0.25 ml junior or fsme-immun 0.5 ml during the course of precursor study 700401; * blood was drawn after the first booster vaccination in precursor study 700401; * subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the subject diary). exclusion criteria: subjects who participated in precursor study 700401 and meet any of the following criteria are not eligible for participation in this study: * subject received any tbe vaccination since his / her first booster vaccination in precursor study 700401; * subject has a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, japanese b encephalitis) since his / her first booster vaccination in precursor study 700401; * subject is known to be hiv positive since his / her first booster vaccination in precursor study 700401 (a special hiv test is not required for the purpose of the study); * subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable); * subject has a known or suspected problem with drug or alcohol abuse (\> 4 liters of wine/week or equivalent level of other alcoholic beverages); * subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.
the use of clear aligners with movement enhancement techniques

Conditions: Malocclusion

Summary: the purpose of this study is to use clear aligners to measure tooth movement and length of treatment.

orthodontic tooth movement is the result of a force applied to the crown of a tooth and the biological remodeling of the gum and bony tissues.

Eligibility criteria:
inclusion criteria: * require orthodontic treatment * have a permanent dentition * no craniofacial anomaly present * no past and present signs and symptoms of periodontal disease * no significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement * no previous orthodontic or orthopaedic relapse * no history of trauma, bruxism or parafunction * 16- 46 years old, inclusive * no skeletal jaw discrepancy * angle class i or class ii molar and canine relationship * crowding of at least 4mm per arch * no osteoporosis drugs exclusion criteria: * subjects who do not fulfill all inclusion criteria requirements
home treatment for individuals suffering from severe addictive disorders

Conditions: Substance Use Disorders

Summary: home treatment (ht) has been successfully implemented in adult psychiatry in several countries including switzerland. patients with addiction problems were generally excluded even if the latter was not the main diagnosis. on the other hand, community treatments have successfully been established for these individuals. the investigators have recently offered ht to persons with severe addictive disorders which was well accepted. the investigators intend to conduct a pilot study to prepare a large-scale study if successful. the investigators intend to compare ht to treatment as usual (regular inpatient treatment) on a specialized ward with respect to readmission rates during 6 months after discharge. the data show that 70.8% of all readmissions occur during the first 6 months. therefore, a period of 6 months is considered an adequate time interval to sufficiently answer this pilot study's question.


Eligibility criteria:
inclusion criteria: * substance use disorder * age 18 or above * sufficient french language skills * competent subjects * consent to randomization progress exclusion criteria: * organic brain disease or developmental disorder * non voluntary admission * severe somatic comorbidity * history of complicated substance withdrawal * acute suicidal ideation * aggressive behavior * acute psychiatric disease such as mania or psychosis * distance to center (must be reachable within 60 minutes)
serial night time position splint on systemic sclerosis

Conditions: Diffuse Systemic Sclerosis

Summary: this is a randomized controlled trial with blinded evaluator and follow-up of one year. seventy six patients with diffuse systemic sclerosis, will be randomized into two groups.the patients can not change their medication during the study. patients will be evaluated at baseline and at 3, 6, 9 and 12 months. the experimental group will use a serial night time position splint who will be adjusted monthly, while the control group will remain the drug treatment. the outcomes assessed will be: pain, hand range of motion, quality of life, functional capacity, upper limb function and dexterity. our hypothesis is that the serial night time position splint will improve the hand range of motion in diffuse systemic sclerosis patients.


Eligibility criteria:
inclusion criteria: * diffuse systemic scleroses diagnosed following the acr criteria * older than 18 years old * sclerodactyly exclusion criteria: * neurological, psychiatric diseases and other rheumatic disease (including overlapping) * previous use of splints or allergy to splint material * surgery schedule to the next 12 months

Keywords: diffuse systemic sclerosis hand range of motion splint
helsinki ultra-acute stroke biomarker study

Conditions: Acute Stroke

Summary: the aim of this study is to establish diagnostic and predictive biomarkers for patients with suspected acute stroke, that are transported by ems as candidates for thrombolytic treatment. the study focuses on the ultra acute phase, \<4.5 hours from symptom onset, including the prehospital setting. analyses will include known biomarkers (e.g. gfap, nr2 peptide) and a discovery phase for novel markers. patient outcome will be evaluated at 3 month using the modified rankin scale (mrs).


Eligibility criteria:
inclusion criteria: * acute stroke suspected by ems personnel * transport to tertiary hospital as possible candidate for thrombolytic treatment of ischemic stroke * age ≥18 * successful prehospital blood sampling by ems personnel exclusion criteria: * unsuccessful prehospital blood sampling by ems personnel
clinical study on the safety of cnt-02 for tgcv and nlsd-m

Conditions: Primary Triglyceride Deposit Cardiomyovasculopathy (TGCV); Neutral Lipid Storage Disease With Myopathy (NLSD-M)

Summary: this study is planning to evaluate the safety and clinical efficacy of medium-chain fatty acid capsules (food-grade cnt-02) in subjects with primary triglyceride deposit cardiomyovasculopathy (tgcv) and neutral lipid storage disease with myopathy (nlsd-m) associated with adipose triglyceride lipase (atgl) genetic defects.


Eligibility criteria:
inclusion criteria: 1. patients for whom atgl gene deletion has been previously confirmed. 2. patients who can take the investigational product orally. 3. male and female who are at least 20 years old at the time of consent. 4. patients who gave written informed consent. exclusion criteria: 1. patients with diabetic ketoacidosis. 2. patients with the possibility of diabetic ketoacidosis (patients with poorly controlled diabetes mellitus \[hba1c\>8.4%, ngsp\]) 3. patients with terminal malignancy. 4. pregnant or lactating women. 5. patients who do not consent to using contraception while participating in this study. 6. patients allergic to mct oil. 7. patients participating in other clinical trial. 8. otherwise, patients determined to be ineligible for this study by the investigator or sub-investigator.

Keywords: neutral lipid storage disease cnt-02 primary triglyceride deposit cardiomyovasculopathy (tgcv) neutral lipid storage disease with myopathy (nlsd-m)
evaluate the depth and duration of anesthesia

Conditions: Pain

Summary: the purpose of the study is to determine the depth (mm) of anesthesia provided by the synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.


Eligibility criteria:
inclusion criteria: * had no known significant diseases * normal 12-lead electrocardiogram * willing to refrain from using any local topical preparations exclusion criteria: * taken over-the-counter (otc) or prescription analgesics in any form within 24 hours * known allergy or sensitivity to any component of the synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components * had an active dermatological disease of any origin that may have interfered with their ability to participate

Keywords: topical anesthesia analgesia
a study to investigate biomarkers of skin androgenization following testosterone administration (0000-015)(completed).

Conditions: Skin Androgenization

Summary: postmenopausal women will receive testosterone gel or matching placebo gel daily. sebum excretion rates will be measured before and after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * subject is at least 3 years postmenopausal * subject is in good general health * subject is willing to avoid excess alcohol or strenuous physical activity during the study exclusion criteria: * subject has donated a unit of blood or has taken an investigational drug in another clinical trial in the last 4 weeks * subject is a regular user of any illicit drugs * subject drinks excessive amounts of coffee, tea or cola * subject has used an estrogen or progestogens hormone replacement therapy in the past 6 months * subject has a history of cancer * subject has acne

Keywords: biomarkers of skin androgenization
cognitive behavioral treatment of pediatric trichotillomania

Conditions: Trichotillomania

Summary: this study will compare the effectiveness of cognitive-behavior therapy (cbt) to a minimal attention control (ac) condition for treatment of pediatric trichotillomania (ttm).

ttm is a persistent impulse control disorder in which the individual acts on urges to pull out his or her own hair. onset typically occurs by adolescence, and ttm is often associated with significant functional impairment and distress. cbt is a type of psychotherapy designed to change problematic behaviors and thinking. it includes self-monitoring of hair-pulling urges and homework assignments to practice the use of cognitive and behavioral strategies. participants are assigned randomly to receive either cbt or ac for 8 weeks. participants assigned to cbt receive weekly 1-hour sessions of cbt for 8 weeks; participants assigned to ac receive 6 telephone contacts and 2 in-person sessions for 8 weeks. after 8 weeks, cbt participants who respond to treatment enter phase ii, which lasts an additional 8 weeks and includes 4 in-person maintenance sessions. ac participants who are still symptomatic after 8 weeks are offered cbt.

Eligibility criteria:
inclusion criteria: * primary diagnosis of trichotillomania * minimum symptom duration of 6 months * presence of a stable parent or guardian exclusion criteria: * other primary psychiatric diagnosis * bipolar illness, pervasive developmental disorder, thought disorder, current major depression, add/adhd * concurrent psychotherapy * currently receiving psychotropic medications

Keywords: cognitive-behavior therapy minimal attention control
randomized safety study of cvt-301 compared to an observational control group

Conditions: Idiopathic Parkinson's Disease

Summary: this study is a 12-month, open-label, randomized, multicenter study which will evaluate the safety and efficacy of cvt-301 for the treatment of up to 5 off episodes per day in parkinson's disease (pd) patients experiencing motor fluctuations (off episodes) and will include a concurrent observational cohort of pd patients managed using the usual standards of care.

a randomized, double-blind, placebo-controlled, phase 2b study in patients with pd (cvt-301-003) demonstrated clinically important, and statistically significant cvt-301-associated improvements in motor function at doses of 35 and 50 mg ld fpd, compared with placebo, as measured by the unified parkinson's disease rating scale (updrs) motor assessment (part 3); furthermore, cvt-301 was generally safe and well tolerated. a phase 3, randomized, placebo-controlled study designed to assess the efficacy and safety of 35 mg and 50 mg fpd as an adjunct to a cd/ld regimen in the treatment of off symptoms over 12 weeks (cvt-301-004) was conducted in parallel with this study.

Eligibility criteria:
inclusion criteria: * has signed and dated an internal review board/independent ethics committee (irb/iec)-approved informed consent form before any protocol-specific screening procedures are performed. * women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative serum human chorionic gonadotropin (hcg) test at screening. these patients must be willing to remain on their current form of contraception for the duration of the study. * patients who have idiopathic pd (i.e., not induced by drugs or other diseases) as defined by fulfilling steps 1 and 2 of the united kingdom (uk) brain bank criteria, diagnosed after the age of 30 years. * patients who are classified as stage 1 to 3 (in the on state) on the modified hoehn and yahr scale for staging of pd severity. * patients who have experienced motor fluctuations for a minimum of 2 hours of average daily off time per waking day (excluding early morning off time) by self-report and confirmed by the pd diary (on 3 consecutive days) during the screening period. exclusion criteria: * patients who have dyskinesia of a severity that would significantly interfere with their ability to participate or perform study procedures. * pregnant or lactating females or females wishing to become pregnant. * patients who have any known contraindication to the use of levodopa (ld), including a history of malignant melanoma or a history of narrow-angle glaucoma. * patients who have had previous surgery for pd (including but not limited to deep brain stimulation \[dbs\] or cell transplantation). * patients with a history of psychotic symptoms requiring treatment, or suicide ideation or attempt within the prior 12 months.

Keywords: parkinson's disease motor fluctuations levodopa inhaled drugs off episodes
association between hypermobility and chronic musculoskeletal pain

Conditions: Hypermobility, Joint; Arthralgia; Myofascial Pain Syndromes; Fibromyalgia; Pain Disorder

Summary: study hypothesis:- benign joint hyper mobility syndrome which persists into adulthood is a special type of benign joint hyper mobility which is more likely to predispose to chronic musculoskeletal pain. young indian adults aged between 25 and 40 years who are blood donors or relatives of patients admitted as inpatient or presenting to the out patient department, in amrita institute of medical sciences will be enrolled, after excluding the exclusionary criteria. they will be assessed for the presence of chronic musculoskeletal pain using a validated self filled questionnaire. the primary investigator who will be blinded to their response will examine them for the presence of benign joint hyper mobility syndrome and for tender points suggestive of fibromyalgia. primary objective:- to determine whether chronic musculoskeletal pain is associated with hypermobility among indian adults. study design:- cross sectional survey


Eligibility criteria:
inclusion criteria: 1. completed their 25th birthday 2. not yet celebrated their 40th birthday 3. are relatives of patients being treated in amrita institute of medical sciences or voluntary blood donors in the same institute exclusion criteria: 1. subjects who have been diagnosed previously with a inflammatory musculoskeletal disease. 2. subjects detected to have signs or symptoms of inflammatory arthritis on a detailed clinical examination and history taking. 3. subjects who have symptoms suggestive of diabetes mellitus or hypothyroidism or have been previously diagnosed with the same. 4. subjects who are not willing to participate. 5. subjects who have been diagnosed as having a connective tissue disorder or have a family history of the same.

Keywords: chronic musculoskeletal pain benign joint hypermobility syndrome fibromyalgia