cyrilzakka/clinical-trials huggingface dataset:
A Study on Efficacy of Feeding N1115 Probiotic Supplement to Young Children

The aim of the study is to examine the intervening effects of N1115 Probiotic Supplement (containing Junlebao Lp. N1115) on gut development in young children at the age of 6 month to 3 years by the way of a randomised, double-blinded, parallel, placebo-controlled clinical trial, and to explore the change of intestinal microbiota composition and healthy condition after intervention.

N1115 Probiotic Supplement contains Lactobacillus paracasei N1115 \[Junlebao Lp. N1115\], a lactobacillus bacteria strain isolated from traditional homemade yogurt in North China. In recent studys feeding Junlebao Lp. N1115 to C57BL/6 mice, the data suggest that Lp. N1115 enhances intestinal development in neonatal mice, and may confer benefits on the growth at early stage of life.

This study is to investigate if a N1115 Probiotic Supplement product containing Lp. N1115 will improve intestinal health in young children. This randomised, double-blinded, placebo-controlled trial includes two treatment groups which respectively need to recruit 30 volunteers born by cesarean section and aged from 6 months to 3 years. The study group receives N1115 Probiotic Supplement, while the control group receives placebo. The trial lasts for 8 weeks and include four time points of data collection. The stool consistency of children will be recorded everyday, the saliva and stool samples will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 6 months and ≤ 3 years,
2. Child was born by caesarean section,
3. Parent/Guardian has given written informed consent,
4. Be in generally good health as determined by the investigator.

Exclusion Criteria:

1. Are currently taking probiotics or prebiotics, or have taken them in the past 2 weeks,
2. Unwilling to avoid probiotics/prebiotics for the duration of the study,
3. Has any food allergies or an allergy or hypersensitivity to any component of the study products, including, milk proteins allergy or cow's milk allergy,
4. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgement, entry to the study),
5. Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results,
6. Subjects have taken antibiotics within the past 3 months (history of antibiotic use in previous 6 months recorded),
7. Subjects may not be receiving treatment involving experimental drugs,
8. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
9. Subjects may not be receiving treatment involving experimental drugs,
10. Exposure to any non-registered drug product within 30 days prior to screening visit.
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* History of at least 4 recurrences of genital herpes in the preceding 12 months
* Lesions located on the external genitalia or anogenital region
* Willing to discontinue suppressive treatment
* Documented positive herpes simplex virus (HSV)
* General good health, and history of normal renal function

Exclusion Criteria:

* Women of childbearing potential not using approved form of contraceptive
* Pregnant or nursing women
* History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
* Known to be immunosuppressed
* Known to have renal dysfunction
* Receiving anti-herpes therapy
* Known to have other genital tract disorders
* Known to have condition which could interfere with drug absorption

Additional protocol-defined inclusion/exclusion criteria may apply.
Gait Training For Reducing Risk Of Fall in the Elderly

Falling is considered one of the major problems that may affect the elderly, which may lead to bad consequences. Safe walking needs the older adult to anticipate and respond quickly to external demands and sudden environmental changes.Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is an innovative device that recently used for the training of impaired gait and balance.Therefore, this study will aim to evaluate the efficacy of gait training with a virtual reality treadmill on the risk of fall in the elderly.

Fall injuries produce serious threats to elderly people. Fall hazards are many, they include physical, psychological, social, and economic consequences. Many studies have shown that walking and balance exercises effectively contribute to enhancing walking performance, improving obstacle avoidance, and reducing the incidence of falls in the elderly. Therefore, the practice of complex and challenging situations of the usual daily walking is very important to prevent falls. Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is recently used for the training of impaired gait and balance. C-Mill applies a virtual reality environment, obstacle avoidance games, and a variety of balance challenges in a safe and controlled environment to increase walking adaptability and improve performance in everyday life.Fall injuries produce serious consequences. The management of these injuries is costly and has a negative impact on healthcare entities. Therefore, prevention programs for preventing and reducing falls among the elderly are very important for reducing these serious consequences. Therefore, this study will compare the efficacy of gait training with a virtual reality treadmill and the conventional physical therapy training program on the risk of fall in the elderly.

Eligibility Criteria:
Inclusion Criteria:

60 healthy older adults, both sexes, will participate in this study. Their ages will be between 60 to 70 years. They should have stable medical status based on a confirmed written medical report signed by their physicians. All participants should not receive other training to improve their balance and gait during the duration of the study application except through this study training program.

Exclusion Criteria:

The exclusion criteria will include any participant with:

* a cognitive reduction (\< 23 points based on the Mini-Mental State Examination scale;
* muscle paralysis,
* ﬁxed lower limb bony deformities,
* balance deficits,
* visual problems,
* diabetes mellitus,
* polyneuropathy,
* gait disorders,
* using assistive walking devices during walking,
* vertigo, anti-seizures drug use and hypertension,
* vestibular and cerebellar problems; and
* auditory and perceptual diseases/impairments
The Effects of Weight Loss on Tinnitus Symptoms

Subjective tinnitus is the perception of irregular sound at different frequencies. Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. This study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms. Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical 8 activity (P.A.), diet, P.A., and control groups. Dietary and anthropometric records, Tinnitus Handicap 9Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were compared at the baseline and at the end of the study.

Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. The present study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms.

Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical activity (P.A.) (n = 15), diet (n = 16), P.A. (n = 15), and control (n = 17) groups. Dietary records, anthropometric measurements, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were recorded and compared at the baseline and at study completion.

Eligibility Criteria:
Inclusion Criteria:

* obese

Exclusion Criteria:

* diagnosed with tinnitus
Bacterial Sexually Transmitted Infections (STIs) Viability by Polymerase Chain Reaction (PCR)

It is a cross-sectional, without risk or constraint, monocentric study on the viability of the main bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM).

The main objective is to evaluate the proportion of pharyngeal, urogenital and anal specimens detected positive by nucleic acid amplification test (NAAT) for Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium that contain viable bacteria in MSM.

Screening for C. trachomatis and N. gonorrhoeae STIs at 3 anatomical sites, i.e. pharyngeal, urogenital and anal, is recommended every three to six months in MSM with high-risk sexual behaviors, using NAAT. A positive NAAT result defines the patient as infected, and the patient will receive antibiotic treatment. However, repeated use of antibiotics has led to the emergence of multi-drug resistant strains of M. genitalium, another STI agent, and N. gonorrhoeae, and to changes in the gut microbiota. One disadvantage of NAATs is that they amplify the nucleic acids of viable and dead bacteria. Thus, it is not possible to affirm that the patient has an "active" infection, defined by the presence of viable bacteria. Bacterial viability can be studied by real-time PCR (called V-PCR). This method combines the high sensitivity and specificity of PCR with the ability to exclude detection of nucleic acid remnants from non-viable bacteria. It does so by incorporating a sample pretreatment step with a membrane impermeable DNA intercalating dye prior to molecular analysis by blocking amplification of remnant DNA from non-viable bacteria. This allows the V-PCR analysis to detect DNA originating from intact (i.e. viable) bacteria. Using V-PCR, studies in women have shown that only half of the anorectal samples and one quarter of the pharyngeal samples positive for C. trachomatis contain viable bacteria.

The team proposes to investigate the presence of viable C. trachomatis, N. gonorrhoeae and M. genitalium bacteria by V-PCR in pharyngeal, urogenital and anal specimens from MSM detected as positive by NAAT for these bacteria.

The results of this work will allow us to assess whether all types of specimens tested in these patients contain viable bacteria, and if so, in what proportions.

Eligibility Criteria:
Inclusion Criteria:

* Males \> 18 years
* Men who have sex with men
* Participant consulting at the Bordeaux University Hospital
* Oral consent to participate in the study
* Member or beneficiary of a social security system

Exclusion Criteria:

* Participant \< 18 years
* Participant subject to a legal protection measure (protection of the court, guardianship or curator).
* Participant deprived of liberty by judicial or administrative decision.
Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

It has been shown that individuals with type 2 diabetes have higher blood sugar throughout the night than individuals without type 2 diabetes. However, it is still unknown if this rise in blood sugar can be controlled using medications.

This study will examine the effects of three different diabetes treatments to determine if they improve night time blood sugars. Participants will be randomly assigned for 8 weeks to one of the following three groups:

GROUP 1: Insulin. Participants will be instructed on self-injecting insulin glargine once-daily in the morning. The dose will be increased by the study team to avoid episodes of low blood sugar and to maintain fasting blood sugar concentrations between 70 to 180 mg/dl.

GROUP 2: Metformin. Participants will start the drug (500 mg twice daily) with meals. After 72 hours and in the absence of side effects, they will increase the dose to 500 mg with breakfast and 1,000 mg with supper. After a further 72 hours and in the absence of side effects, they will increase the dose to 1,000 mg twice daily with meals and continue until the end of the trial. The dose will be adjusted by the study team to maintain fasting blood sugar concentrations between 70 to 180 mg/dl.

GROUP 3: Dorzagliatin. This medication dose will be 75 mg twice daily. The investigators anticipate fasting glucose concentrations will be between 70 to 180 mg/dl since the dose of this medication cannot be titrated.


Eligibility Criteria:
Inclusion Criteria:

* BMI:25-40 kg/m2.
* HbA1C ≤ 9% on lifestyle therapy with or without monotherapy with metformin or sulphonylureas (SU); or combination therapies (metformin and SU, DPPIV inhibitors, only short acting GLP-1 analogues exenatide (Byeta) and liraglutide (Victoza).

Exclusion Criteria:

* Insulin therapy
* SGLT2 inhibitors
* Long acting GLP-1 analogues
* TZDs
* Medications affecting GI motility (e.g., erythromycin, pramlintide).
* Medications that may affect glucose metabolism such as corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, and anticoagulants.
* Unstable diabetic retinopathy, microalbuminuria, macrovascular disease.
* Upper GI disorder/surgery, debilitating chronic disease, anemia, and symptoms of undiagnosed illnesses.
* History of alcoholism or substance abuse.
* Pregnancy or breast feeding, or other comorbidities precluding participation.
Anterior Chamber Illumination in Cataract Surgery for Eyes With Poor Red Reflex

With a poor red reflex, it is difficult to see the anterior capsule and continuous curvilinear capsulorhexis (CCC) margin, sometimes resulting in decentered CCC or radial tearing of the anterior capsule. In addition, other complications, such as rupture of the posterior capsule, dropping of the lens nucleus, or zonular dialysis, can occur during phacoemulsification because of poor visualization of the posterior capsule. These complications also increase the time of surgery and may affect the results of the vitrectomy.

Several surgical techniques have been used to alleviate the problem of poor lens visibility. fixed a chandelier illuminator on the sclera, turned off the microscope light source, and visualized the lens by illuminating the vitreous cavity. Furino improved anterior lens capsule visibility by staining it with triamcinolone acetonide. Although both techniques were effective, both had limitations. Vitreous chamber illumination reduces the visibility of the cornea and iris because of the need to turn off the microscope light. Staining the anterior lens capsule with triamcinolone acetonide allows for better anterior chamber visualization but the lenticular nucleus and cortex remain difficult to see.

This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.

Eligibility Criteria:
Inclusion Criteria:

* cataract with poor red reflex

Exclusion Criteria:

* Eyes that had previous intraocular surgery or trauma were excluded.
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
* Patients had to be capable of taking study medication as outpatients and recording the effects.

Exclusion Criteria:

* Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
* Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.
Effects of Different Treatment Modalities for Obstructive Sleep Apnea on Temporomandibular Joint

this study aims to evaluate the subjective symptoms, clinical and radiographic signs of temporomandibular disorders related to the use of CPAP, MAD and physical therapy in the treatment of patients with obstructive sleep apnea.

The study will be conducted on thirty-nine patients with OSA attending to sleep disorders breathing Unit, Chest Department at Mansoura University Hospital confirmed by polysomnography in the period between July and September 2022. The patients will be divided equally into three therapy groups each compromise 13 patients:

Group I: patients will be treated with CPAP. Group II: patients will be treated with digitally fabricated MAD. Group II: patients will be treated with physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* • All adult patients, diagnosed as having OSA after full night polysomnography.

Exclusion Criteria:

* • Pregnant patients
Effectiveness of Acupuncture for Depressed Patients Not Taking Antidepressant Medications

Acupuncture is a popular complementary/alternative therapy that has been in use for thousands of years for the treatment of various medical and psychiatric conditions, including Major Depressive Disorder (MDD). In this study, the investigators applied the investigators acupuncture-treatment-for-depression protocol, based on Traditional Chinese Medicine (TCM) principles for treating MDD, to depressed patients not taking any antidepressant medications (a protocol that the investigators previously piloted as a medication augmentation therapy for partial responders with MDD).

The investigators specifically investigated the efficacy, safety, and tolerability of this TCM-based protocol for such patients, as well as potential differences in outcomes between weekly vs. twice-weekly treatment. The investigators hypothesized that acupuncture monotherapy would be associated with a response rate of at least 50%, which the investigators defined as a decrease in depressive symptoms from the beginning to the end of the study of 50% or more, and that the response would be greater among patients who received acupuncture 2 times per week (vs. 1 time per week). The investigators also hypothesized that acupuncture would be associated with minimal side effects.


Eligibility Criteria:
Inclusion Criteria:

* Has current or past DSM-IV MDD diagnosis based on SCID; AND current 17-Hamilton Rating Scale for Depression (BRSD) score of 14 or above
* Age between 18-65
* No treatment with antidepressant(s) in the past 3 months
* If patient has received psychotherapy, no initiation or termination of therapy in the past 3 months.

Exclusion Criteria:

* Patients with primary diagnosis other than Major Depressive Disorder, or any history of psychosis or mania.
* Conditions that could make it difficult to conclusively determine that depressive symptoms were the result of MDD and not some other condition, including substance abuse or dependence within the last 6 months, medical conditions that could produce depression, including epilepsy, history of an abnormal EEG, severe head trauma, or stroke.
* Serious uncontrolled medical conditions \[e.g. poorly controlled diabetes, severe congestive heart failure\], or other medical conditions that have not been stable for at least 3 months.
* Electroconvulsive therapy (ECT) during the last year.
* Current active suicidal or self-injurious potential necessitating immediate treatment.
* Currently receiving concomitant Acupuncture Treatment, or any Acupuncture treatment in the past three months.
Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime


Eligibility Criteria:
Inclusion Criteria:

* newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio \>200mg/mmol on early morning urine sample, hypoalbuminemia (\<25g/L)

Exclusion Criteria:

* prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
The Effect of DNS Therapy on Asymmetry in Children After Surgery of Congenital Heart Disease

This thesis will examine the consequences of congenital heart disease (CHD) surgery in children. The main goal of this work is to point out the possible development of late consequences after cardiac surgery in childhood (e.g. asymmetry, scoliosis, hypomobility of the spine) and to assess the effect of DNS therapy on the resolution of the consequences. For patients, after an intensive three-week rehabilitation intervention, an improvement in the monitored initial parameters is expected, which would lead to an improvement in the quality of life.

As part of the diploma thesis, a study will be conducted in patients after cardiac surgery performed at the Motol Hospital within the Children's Cardiology Center. The intervention will be performed in Rehabilitation Clinic Teplice nad Bečvou. The study group will include children aged 6-18 years after VSV surgery without other serious health complications. The subjects will undergo therapy according to DNS for 3 weeks. Therapy according to DNS will take place twice a day (1x individual physiotherapy 40 minutes, 1x group 40 minutes) and will be supplemented with conventional therapy (e.g. scar care).

The initial examination will be performed by a doctor and a trained physiotherapist in a blinded mode (information about which patients are undergoing the intervention will not be known). The initial examination will include imaging of the spine, ideally EOS (low radiation exposure). During the initial and final examination, a trunk stabilization examination will be performed according to the DNS protocol with photo documentation, the values of MIP and MEP oral pressures (cm H₂O) will be measured, the symmetry index will be measured using the SCODIAC software, the mobility of the spine will be examined (Schober distance, Stibor distance, Otto inclination distance, Thomayer distance, in cm) and the respiratory amplitudes on the chest will be measured (mesosternal and xiphosternal, in cm). The subjects will complete the SF-36 quality of life questionnaire before the start of therapy and after its completion. The parameters will be compared during the initial and final examination.

Eligibility Criteria:
Inclusion Criteria:

* children 6-18 years, surgery of congenital heart disease

Exclusion Criteria:

* any other disease