cyrilzakka/clinical-trials huggingface dataset:
PREterM FOrmula Or Donor Breast Milk for Premature Babies

In order to address this crucial question, central to preterm newborn care, a multicentre United Kingdom (UK) -wide study randomising 4000 preterm babies would be necessary to achieve sufficient power to evaluate the impact on the short-term outcomes necrotising enterocolitis and bloodstream infection, and establish cohorts large enough to address long-term metabolic (such as obesity, type 2 diabetes), cardiovascular (such as blood pressure) and developmental outcomes. This pilot trial will evaluate the practicability and feasibility of such a large multicentre UK randomised controlled trial. In addition to evaluating feasibility and to ensure maximal use of resources allocated, this study will also assess outcomes that are indicative of long term metabolic health.

Mother's Own Milk (MOM) is recommended for preterm babies. However, on average, mothers giving birth preterm are able to provide less than half their baby's milk requirements. Standard clinical practice is to make up any shortfall in MOM with either pasteurised Human Donor Milk (HDM) or Preterm Formula (PTF). Which option is more beneficial to clinical outcomes is unknown.

Pasteurisation reduces or destroys many biologically active components and HDM, unlike PTF, is very variable in composition. Clinicians who use HDM do so primarily in the hope that despite pasteurisation it will reduce bloodstream infection and necrotising enterocolitis, a serious, devastating inflammatory disease characterised by bowel death and multisystem failure. These are two of the most feared conditions in newborn medicine as described above. Landmark nutritional trials in the early 1980's suggest positive effects of human milk on insulin sensitivity, and other metabolic outcomes. Clinicians who prefer PTF believe it benefits growth, including brain growth, and improves neurodevelopmental outcome.

Neonates born below 32 weeks gestational age will be randomised to receive fortified HDM, unfortified HDM, or PTF to make up any shortfall in MOM until 35 weeks postmenstrual age with a sample size of 22 in each group. The trial is designed to reflect current preterm feeding practice. The trial will take place in neonatal units in London and parent consent obtained within 48hr of birth. Permission will be sought for long term follow up, initially from parents (later from children themselves). Outcomes will be body composition using magnetic resonance imaging and other imaging techniques. This pilot study will specifically assess feasibility by testing 1) provision of HDM by Human Milk Banks in London 2) acceptability to parents and clinicians using feedback on trial design 3) recruitment to target and 4) retrieval of clinical data for all recruited babies form the National Neonatal Database.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born between 25+0 to 31+6 weeks gestational age
* Written informed consent from parents

Exclusion Criteria:

* Major congenital or life threatening abnormalities or congenital abnormalities that preclude early milk feeding
* Inability to randomise infant within 48 hours
Treatment of Grammatical Time Marking in Post-Stroke Aphasia

The study aims to assess an individual or self-administered computer therapy's effectiveness in grammatical time marking. The main objective is to examine whether the therapy improves grammatical time marking of inflected verbs treated on the sessions. We also explore whether the observed progress can be transferred to untrained items, more ecological contexts and if is maintained two and four weeks after the end of treatment.

This therapy will be administered to six individuals with brain lesions after stroke. Four individuals will take part of the individual therapy and two individuals will take part of the self-administered computer therapy. The therapy will last one month, at the rate of three weekly sessions of approximately one hour.


Eligibility Criteria:
Inclusion Criteria:

* Have had an imaging-objectified stroke in adulthood that resulted in aphasia (fluent or non-fluent). The time between the stroke and participation in this study must be greater than 6 months.
* Be a native French speaker or have excellent mastery of French.
* Be between 18 and 75 years old.
* Present grammatical tense marking disorders objectified by language evaluation (deficit scores on the "Batterie d'Évaluation de la Production Syntaxique" (BEPS) verb flexion task, Monetta et al., 2018; and/or on the "Test d'expression morpho-syntaxique fine" (T.E.M.F.) active sentence production subtask, Bernaert-Paul and Simonin, 2011).

Exclusion Criteria:

* Present chronic symptoms of a substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
* Have significant uncorrected vision and/or hearing impairment.
* Have significant impairments in oral/written comprehension.
* Present apraxia of speech or a severe arthritic disorder
* Present hemineglect
* Present impaired judgment and discernment, objectified by a neuropsychological evaluation
Auriculotherapy in Tension-type Headache Due to Temporomandibular Dysfunction

Objectives: Verify the effect of auriculotherapy in patients with tension-type headache resulting from temporomandibular dysfunction.

Design: Randomized clinical study Setting: Randomized Study Participants: The study consist of 38 participants randomized into two groups: an intervention group (n = 18, sample loss = 1) and placebo group (n = 20, sample loss = 6) Interventions: The intervention group will receive treatment with auricular acupuncture in the Shen Men, Kidney, Sympathetic, Subcortex, Adrenal and Cerebral points. The placebo group will receive auriculotherapy in the trachea point.

Main outcome measures: visual analog scale for pain pain (VAS) and surface electromyography (EMG).

This is an experimental clinical trial in which will be selected at the University, 40 students with tension-type headache due to temporomandibular dysfunction. Among the selected subjects will be randomized by blind draw into two groups: intervention group (IG) and placebo group (GII).

The instruments that will be used for the evaluation are the visual analog pain scale, the Survey questionnaire for Temporomandibular Disorders (RDC) 3, and surface electromyography (EMG System of Brazil).

The EMG signals will be collected in the rest position (3 samples) and maximum voluntary isometric contraction (3 collections). The masseter and temporalis muscles bilaterally will be evaluated according to the protocol of Rodrigues.

For treatment of Ear, initially cleaning the pinna is made to be manipulated with 70% alcohol and later will be inserted mustard seed with a tape in the following points: Shenmen, Sympathetic, Kidney, subcortex, Adrenal and Brain second Souza in GI and GII point of the trachea. Such treatment will last 15 minutes each session, being held 2 times a week, alternating the ear to be manipulated over a period of 5 weeks.

For comparison between groups the Mann-Whitney test statistic with Software BioStat 4.0 software will be used. With a significance level (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Individuals with tension-type headache due to temporomandibular dysfunction, aged 20 to 30 years, of both sexes

Exclusion Criteria:

* Individuals with migraine type headache, secondary headaches
* Use of medicines more than 10 days per month and any type of acupuncture treatment in the last 12 months
Decreased EEG Complexity in Schizophrenia

Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized that chronic residual schizophrenia is characterized by decreased complexity in EEG.

Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte, NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to the international 10-20 system

Eligibility Criteria:
Inclusion Criteria:

diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S)

Exclusion Criteria:

-
To Evaluate the Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures

To evaluate the long-term safety and efficacy of pregabalin in patients with partial seizures.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for the preceding double-blind study
* Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

* Cannot have absence seizures.
New Device to Maintain the Embryo Temperature During Transfer

The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.

The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.

With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.


Eligibility Criteria:
Inclusion Criteria:

* Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.

Exclusion Criteria:

* Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.
Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker

About one to two million women in Taiwan suffers from overactive bladder (OAB). The most commonly used anti-muscarinic drugs have a high rate of side effects. While beta-3 adrenoceptor agonist, Mirabegron, has far fewer side effects, there are no consensus on whether it can be used as first-line treatment. The investigator's preliminary study showed that the concentration of beta-3 adrenoceptor in the urine of OAB patients is higher than that in the normal control group, so comparing urinary beta-3 adrenoceptor concentration of OAB patients before and after treatment may be used as a biomarker of therapeutic effectiveness. The results of this study will be of great help in understanding the effectiveness of Mirabegron and formulating OAB treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis compatible with 2002 ICS for overactive bladder syndrome
* Symptoms persisted for more than 3 months
* Completed pre-treatment urodynamic study
* Has plans for treatment with Mirabegron or Solifenacin due to clinical symptoms
* Patient is willing to cooperate with study including follow up and complete questionnaire surveys

Exclusion Criteria:

* Has stress urinary incontinence
* Pelvic organ prolapse
* Interstitial cystitis
* Constipation
* Gastroesophageal reflux disease
* Prior failed medical treatment for overactive bladder syndrome
* Uncontrolled hypertension
* Glaucoma
* Currently pregnant
* Using other medications for overactive bladder syndrome
The Role of Osteopathic Treatment in the Axial Variations of the Lumbar Spine: RCT

The aim of the present study is to determine whether there is a relationship between osteopathic treatment and the change of physiological axes of the lumbar spine, through the use of Dynamic Magnetic Resonance Imaging.


Eligibility Criteria:
Inclusion Criteria:

* will be admitted patients of both genders
* patients with chronic low back pain at baseline
* patients aged between 18 and 35 years

Exclusion Criteria:

* patients diagnosed with the disease of the musculoskeletal system or congenital malformation of the column
* patients with disorders of the pelvic floor, or who have undergone surgery of the reproductive system
* patients with neurological disorders that can cause painful symptoms of lumbar segment
Verification of Saliva MMP-1 as a Diagnostic Marker of Oral Cavity Cancer

The study is designed to measure salivary matrix metalloproteinase-1 (MMP-1) using the enzyme-linked immunosorbent assay (ELISA) we developed previously in patients with oral potentially malignant disorders (OPMD), oral squamous cell carcinoma (OSCC), and healthy participants. The purpose of this study is to evaluate the potential of the newly developed salivary MMP-1 ELISA as an adjunctive tool to aid in diagnosis of OSCC.


Eligibility Criteria:
Inclusion Criteria:

* Group OSCC: patients with lesions of OSCC
* Group OPMD: patients with lesions of OPMD
* Group HC: healthy subjects who are not suffering from any oral lesions and having behaviors of smoking, and/or betel nut chewing

Exclusion Criteria:

* Subjects having personal history of other cancers or severe diseases
Feasibility of a Sensor-less Sleep Monitor (Somnofy®) in Diagnosis and Follow-up in Obstructive Sleep Apnea.

To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.

A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.

Eligibility Criteria:
Inclusion Criteria:

* referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
* able to sign an informed consent

Exclusion Criteria:

* Pregnancy
* Serious disease which could affect ability to complete the study
* Complicated sleep disorders
Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri

This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy menstrual bleeding and Dysmenorrhea caused by Adenomyosis.

Levonorgestrel releasing intrauterine device will be MetraPlant-E, which is used in this study in group A, is a modified Levonorgestrel -releasing intrauterine system from the old IUD - Intrauterine Device "Metraplant", MetraPlant-E design has a T-shaped frame containing Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque, All the "T" frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate, Levonorgestrel and Barium Sulphate, which ensures more exposure of the endometrial surface to the system and hence expected more endometrial suppression.

It consists of Levonorgestrel Hormone (60 mg), Ethylene Vinyl Acetate (120 mg) \& Barium Sulphate (20 mg) Metraplant-E is designed without any coat membrane, which will help in more rise in Levonorgestrel level (higher initial release). The high initial release of Levonorgestrel (reached more than 28µg/24hrs in Metraplant-E in this study of in-vitro release) may help in early stoppage of bleeding in patients who suffer from irregular bleeding.

Women in group A will receive IUD - Intrauterine Device- during menstruation .It will be inserted into uterus in similar procedure to non-hormonal IUD .Pelvic exam will be done, the vagina will hold open with speculum, grasping the cervix, measuring uterine length and proper insertion of IUD - Intrauterine Device by non-touch technic. Women will receive proper antibiotics after insertion.

Group B will receive combined oral contraceptive pills (Yasmin) which will be Monophasic pills have a constant dose of both estrogen and progestin in each of the hormonal active pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets, it provides an oral contraceptive regimen, it will be used continuously for 6 months with stoppage after 3 months for withdrawal bleeding.

Both treatment arms (Metraplant E and Yasmin) will be followed up after 3 months and 6 month of patients' recruitment. Assessment of pain related symptoms will be done using visual analogue scale pain score, while assessment of menstrual improvement will be done using menstrual diary.

Eligibility Criteria:
Inclusion Criteria:

* Women patient aged 30-45 years
* Diagnosed adenomyosis by transvaginal ultrasound or MRI or 3D ultrasound
* Patient complains of heavy menstrual bleeding or dysmenorrhea or both
* Living in a nearby area to make follow-up reasonably possible
* Planning for birth spacing for at least 2 years.

Exclusion Criteria:

* Pregnancy or seeking fertility
* Severe underlying comorbidities (hepatic, oncological)
* Pelvic inflammatory disease
* Other cervical or uterine pathologies
* Deep venous thromboembolism
* Hormonal therapy contraindications
* Endometriosis or fibroid
Metabolic Dysfunction Associated Fatty Liver Disease in Long-Term Cholecystectomy Patients

The aim of this study was to examine the association between metabolic associated fatty liver disease (MAFLD) in participants who had undergone cholecystectomy and those who had not undergone cholecystectomy. MAFLD is defined as hepatic steatosis(with ultrasonography) entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.

In this way, the long-term effects of cholecystectomy surgeries, which are commonly performed in the society and thought to be harmless, will be evaluated.

Cholecystectomy is known to be a harmless operation with low perioperative mortality and morbidity. However, the unexplained increase in metabolic disorders in cholecystectomy patients has led to the need for further investigation of cholecystectomy patients. Non-alcoholic fatty liver disease is an important health problem with an average prevalence of 25% worldwide and serious hepatic and systemic complications. The aim of this study was to examine the association of cholecystectomy with metabolic dysfunction associated fatty liver disease (MAFLD), which is an important public health problem in the long-term.

This case-controlled cross-sectional study was planned to evaluate the relationship between patients who had undergone cholecystectomy with MAFLD. MAFLD is defined as hepatic steatosis entity in addition to the presence of overweight or obesity, diabetes mellitus, or evidence of metabolic dysfunction.

The study included 86 participants with cholecystectomy and 63 participants without cholecystectomy. It was planned to compare the participants according to the diagnostic criteria for MAFLD (with or without MAFLD).

Eligibility Criteria:
Inclusion Criteria:

* who were found to have undergone cholecystectomy at least five years ago,
* who could feed orally and perform activities of daily living
* participants who had not undergone cholecystectomy with similar characteristics were included in the study

Exclusion Criteria:

* those with chronic liver disease
* malignancy or history of malignancy
* in a chemotherapy program
* with active infection
* any organ failure
* pregnancy
* use of drugs that cause steatosis in the liver
Floating for Chronic Pain

In recent years there has been a novel approach for the treatment of chronic pain: Floatation REST (restricted environmental stimulation therapy). Floating is a therapeutic approach, in which patients float in a specialized pool or tank on water that contains high concentrations of Epsom salt (Magnesium sulfate). Water is kept at skin temperature (35-36°C) and the pool or tank is shielded to provide almost complete darkness and silence. This therapeutic approach has proven to be effective in alleviating chronic pain.

Due to the difficulties associated with designing a credible placebo control there have been no randomized controlled trials (RCTs) with patients blinding so far. Such blinding, however, is crucial, to assess the true therapeutic effect of the intervention.

The investigators will conduct the first patient blinded RCT of Floatation REST for chronic pain with a credible placebo control for floating and a no-treatment group.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of chronic pain disorder with somatic and psychological factors (German ICD F45.41)
* Able and willing to give written informed consent

Exclusion Criteria:

* Pregnant or nursing women (self report)
* Previous experience with floating
* Acute illnesses that may exacerbate or shadow the chronic pain condition (acute inflammation, major depression, active neoplasm, etc.)
* History of alcohol and drug abuse
* Any clinically relevant abnormal findings in the clinical history, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study or the subject's ability to participate in the study.
* Any clinical condition that may prevent the subject from floating, such as: open injuries, contagious diseases (influenza, GI infections, athlete's foot), GERD, epilepsy, claustrophobia, schizophrenia, incontinence or acute skin disorders.
* Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems

During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition.

In this study we want to establish the prevalence of cobalamin deficiency in infants with gastrointestinal symptoms and/or feeding problems. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status.

Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.


Eligibility Criteria:
Inclusion Criteria:

* Children below 8 months of age
* Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms

Exclusion Criteria:

* Children with syndromic disease