cyrilzakka/clinical-trials huggingface dataset:
Microbiome Sampling During Endurance Exercise

The small intestine and feces of subjects undergoing endurance exercise will be sampled to examine their microbiome composition

The close relationship between humans and the commensal microbes of their gut microbiota represents vast potential for health maintenance, but most efforts have been focused on disease. Gastrointestinal (GI) problems are very common especially in endurance athletes, and are known to impair performance or subsequent recovery. Moreover, GI symptoms among athletes vary enormously, and some athletes are more prone than others; the links between this variation and the differences in microbiome composition across individuals have not been elucidated. The investigators propose to use a novel, non-invasive sampling technology to quantify the effects of exercise on the GI environment including the small intestines, and aim to establish the potential for dietary interventions to improve recovery from exercise.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study:

* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
* ASA Classifications 1 and 2.
* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. Non-English speakers will not be included in the study because consent forms are in English, and any instructions during exercise will need to be provided in English.

Exclusion Criteria:

Subjects with any of the following conditions or characteristics must be excluded from the study:

* History of any of the following:
* Prior gastric or esophageal surgery, including lap banding or bariatric surgery
* Bowel obstruction
* Gastric outlet obstruction
* Diverticulitis
* Inflammatory bowel disease
* Ileostomy or colostomy
* Gastric or esophageal cancer
* Achalasia
* Esophageal diverticulum
* Active Dysphagia or Odynophagia
* Active medication use for any gastrointestinal conditions
* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
* A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Active Thoracic Compromised Distal LANding in TEvar

Thoracic endovascular aortic repair (TEVAR) has become the mainstay of aortic intervention for descending thoracic aortic pathology. Its durability hinges on achieving adequate seal in the endograft landing zones (LZs), with the distal LZ largely understudied. Only recently are suboptimal distal LZs receiving attention for their role in major complications including stent graft migration, type 1B endoleaks, and distal stent graft-induced new entry tears, all of which can contribute to further aortic degeneration. The thoracic distal LZ. When a short distal LZ was reported, the distal endoleak rate ranged from 3.5% to 33%. This led to reintervention in 19%, along with coverage of the celiac trunk in more than half of short LZ cases.

The objective of this study was to evaluate the outcomes of TEVAR patients with compromised distal landing zone (CDLZs) treated with distal active fixation stent-grafts (DAFs), distal scallop stent-grafts, distal Aptus Heli-FX EndoAnchors, and standard stent-grafts.


Eligibility Criteria:
Inclusion Criteria:

* Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter \> 55mm or rapid growth (\>10mm / year).
* Patients presenting with at least 2 cognizable features related to an adverse aortic morphology will be considered for inclusion. The following features will be evaluated for the inclusion: distal LZ length ≤25-mm, distal LZ diameter ≥38-mm, LZ conical morphology, distal descending thoracic aorta angulation ≤116° or tortuosity index ≥1.4

Exclusion Criteria:

* Emergency setting, including hemodynamic instability at time of enrollment
* Patients with aortic dissection pathology
Hormone Profiles in Adults With Newly Diagnosed Epilepsy

Both sodium valproate and lamotrigine are currently used in the treatment of newly diagnosed epilepsy. Although they appear to have similar efficacy, they have different side effects, which have not been well studied. This study aims to compare one particular aspect of their possible side effects, namely whether they affect certain hormonal functions.

Sodium valproate is an established antiepileptic drug used against a broad range of seizure types. Lamotrigine, a newer antiepileptic drug available since late 1980s, has a similar range of action and is approved as first-line treatment for epilepsy in the United States and many European countries as well as in Hong Kong. Recently, concern has been raised over the association between valproate treatment and polycystic ovarian syndrome, a condition characterised by multiple cysts in the ovaries in women and a range of hormonal and metabolic disturbances. Cross-sectional studies from Finland suggest that up to 40% of women treated with valproate have polycystic ovaries. Lamotrigine substitution for valproate has been reported to normalise these parameters in some patients. Elevated serum insulin and androgen levels have also been reported in over 50% of male patients taking valproate for epilepsy. However, such high incidence of hormonal abnormalities associated with valproate treatment has not been reproduced in studies conducted in other western populations. No similar studies in Chinese patients have been reported. In addition, these cross-sectional studies suffer from many potential confounding factors, such as previous treatment with other antiepileptic drugs, variation in duration of treatment, thus limiting the ability to establish a causal relationship.

This phase IV study aims to examine whether valproate treatment is associated with hormonal abnormalities in Chinese epilepsy patients. Newly diagnosed patients will be randomised to receive valproate or lamotrigine and their hormonal profiles measured prospectively for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 15 and 55
* Ethnically Chinese
* Newly diagnosed epilepsy requiring antiepileptic drug treatment; or patients previously treated with antiepileptic drugs but have withdrawn from medication for at least 1 year, and now require resumption of antiepileptic drug therapy due to seizure relapse.

Exclusion Criteria:

* Post-menopausal women.
* Pregnant women.
* Women who have undergone oophorectomy.
* Women taking or have taken oral contraceptive pills in the previous 3 months.
* Women diagnosed with or suspected to have polycystic ovarian syndrome.
* Subjects with diabetes mellitus.
* Subjects receiving hormone replacement or glucocorticoids.
* Subjects receiving long-term warfarin.
* Subjects suffering from significant systemic diseases, or illnesses that interfere with pituitary-gonadal functions.
* Subjects with a progressive or degenerative neurological disorder.
* Subjects who are unable to take their medication reliably.
Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight

Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS.

In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml.

So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.


Eligibility Criteria:
Inclusion Criteria:

* 8-18 years old
* overweight or obesity
* basal insulin ≥ 20 uU/ml

Exclusion Criteria:

* pubertal delay
* hypogonadism
* hypothyroidism or hyperthyroidism
* obesity-related genetic diseases
Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)

The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of the mother-child initiated oral health care program, termed BASIS, in preventing early childhood caries (ECC).

The main questions it aims to answer are:

* To compare mean knowledge and attitudes scores in the prevention of ECC among mothers of toddlers in the study group before and after receiving the BASIS program.
* To compare mean knowledge and attitude scores in the prevention of ECC between mothers of toddlers in the study group after receiving the BASIS program and mothers of toddlers in the control group after receiving the current Ministry of Health (MOH) programs.
* To compare oral health care practices in the prevention of ECC between mothers in the study group after receiving the BASIS program and mothers in the control group after receiving the current MOH program.
* To compare caries incidence between toddlers in the study group and toddlers in the control group after mothers' exposure to the BASIS program and the current MOH program, respectively.

Researchers will compare the BASIS program to the MOH program to see if the BASIS is effective to prevent ECC.

Participants of the BASIS program:

* Received anticipatory guidance delivered during pregnancy and after given birth at 6 months and 12 months
* Complete self-administered questionnaires measuring the knowledge, attitudes and practices related to the prevention of ECC during pregnancy and after given birth at 6 months, 12 months and 18 months
* Have their child oral cavity clinically examined at 6 months, 12 months and 18 months


Eligibility Criteria:
Inclusion Criteria:

* First-time pregnant women
* Aged 18 years and above
* In their third trimester
* Singleton pregnancy
* Able to read and write in Malay language
* Own a mobile phone with WhatsApp
* Will be the primary caretaker of their newborn

Exclusion Criteria:

• Diagnosed with cognitive disorders
Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses

The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at least 18 years of age.
* Patients who have bilateral NanoFlex implantation at least 3 months previously.
* No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss.
* DCVA of 20/25 or better in both eyes.
* Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.87.
* Uncorrected VA in dominant eye 20/25 or better.

Exclusion Criteria:

* History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity.
* Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation.
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).
Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea

Nocturnal reduction in blood oxygen is expected independently associated with the development of worsened glycemic control in individuals with type 2 diabetes mellitus.

The aim of the present study is to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.

Introduction:

Obstructive sleep apnea syndrome (OSAS) is a prevalent illness showing a heterogeneous symptom presentation, which ranges from low clinical suspicion to evident limitations in the quality of life. The main reasons for this variability relate to its potential association with major concomitant diseases, which include diabetes and a variety of cardiovascular pathologies. (1).

Also, OSA is a known risk factor for many comorbid disorders, causing resistance to conventional treatments and increasing the risk of mortality, which multiplies health care expenditures and even though the distribution of comorbidities differs between men and women, their effect progressively increases with OSA severity (2,3) Occurrence of apneic events and Reduction in blood oxygen and elevations in blood carbon dioxide are sensed by chemoreceptors in the brain and carotid bodies, which trigger brief microarousals and result in sleep fragmentation (4).

Nocturnal reduction in blood oxygen has also been independently associated with the development of worsened glycemic control in individuals with type 2 diabetes (4).

Aim of the work:

to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.

Material and Methods:

This study will be conducted on all patients referred for evaluation of sleep related breathing disorders. All Medical files were reviewed. Data collected included .full medical history, demographics, measurements of weight and height, body mass index in kg/m2, neck circumference (NC), Epworth Sleepiness Scale (ESS) scores, measurements of overnight pulse oximetryglyceminc control (measurement of glycated HB, fasting and 2h postprandial blood sugar)The diagnosis that was concluded after a polysomnography study.

Eligibility Criteria:
Inclusion Criteria:

* All patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder

Exclusion Criteria:

* Patients less than 18 years old and Patients receiving treatment for sleep related breathing disorders were excluded
Infant Aquatics Neurodevelopment Premature Infants

The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development.

Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.


Eligibility Criteria:
Inclusion Criteria:

Major inclusion criteria: Infants who are hemodynamic stable, no seizures or apnea attacks, IVH/PVH grade \< 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. These criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development.

Exclusion Criteria:

infants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, IVH/PVH grade \>or =3, with diagnoses of chromosomal abnormalities.
Preventing Postpartum Depression in African American Home Visiting Clients

The goal of this study is to determine whether a 6 week intervention is effective in preventing the worsening of depressive symptoms and development of clinical depression in low-income African American pregnant and recently delivered women who are enrolled in home visiting programs.

This study will conduct a randomized controlled trial (RCT) with women from four Baltimore City home visiting programs. We will screen 200 women who are pregnant or have a child \< 6 months for study inclusion; 91 women at elevated risk for developing postpartum depression (PPD) will be randomized to an intervention (MB Course) or usual home visiting control group. Women in the intervention group will receive the 6-week MB Course delivered in a group setting by the Study Clinician with reinforcing messages provided by home visitors during 1-on-1 home visits, while women in the attention control will receive usual home visiting services and information on postpartum depression. Primary outcomes include depressive symptoms and depressive episodes.

Eligibility Criteria:
Inclusion Criteria:

* pregnant or has child \< 6 months of age
* enrolled in home visiting program
* exhibiting elevated depressive symptoms and/or personal history of clinical depression

Exclusion Criteria:

* no current clinical depression at time of enrollment
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .


Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
* Males or females, 22 years of age or older
* Subjects seeking augmentation therapy for the lips.

Exclusion Criteria:

* History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
* History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
* Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
Primary Care-Based Follow-up of Cancer Survivors of the Prostate and Kidney

In France, the second cancer plan of 2009-2013 aimed to strengthen the role of MT by putting it back at the center of patient monitoring, in particular by asking "regional health agencies to encourage and support local experiments" which aim for better coordination between the city and the hospital. The third cancer plan for 2014-2019 insists on this measure because it had proven to be unproductive, and recommends, in addition to the creation of a nurse dedicated to the coordination of care between community medicine and the hospital, the creation of a direct telephone line to reach the hospital medical team. This measure is mainly aimed at the follow-up of certain cancers that do not require the technical support of the hospital, as is the case in the post-operative follow-up of RCC and CaP, where the additional examinations carried out during follow-up are carried out in the city.

The research hypothesis is that this new method of monitoring had a positive impact on care in terms of quality, accessibility, organization and costs.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (≥18 years old)
* Patient operated on for localized prostate or kidney cancer
* Patient followed at the HUS during the period from 01/01/2015 to 12/31/2021
* Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Patient under active therapy (hormonotherapy, systemic treatment) for the pathology studied
* Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)
* Subject under judicial protection
* Subjects under guardianship or curatorship
Low-Dose Endotoxemia and the Acute Phase Response

The purpuse of this study is to examine the acute phase respons when different doses of E. Coli Endotoxin is injected in healty volunters.


Eligibility Criteria:
Inclusion Criteria: Healty volunteers -

Exclusion Criteria:

Infection 14 days prior to the trial Regular medication Present and /or former heart disease -
Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet

flexible flatfoot is a common foot misalignment in children. various treatment procedures are used to correct or to avoid future complain among adults and pediatric population.

Ethics Statement This study was approved by the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, Egypt (no. P.T.REC/012/0016370) and strictly adhered to the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics. Children's participation was commissioned by asking their legal guardian to sign a consent form prior to data collection.

Study design A prospective double-masked randomized controlled trial was carried out from September 1, 2018 to December 31, 2019 at the Out-patient Physical Therapy Clinic of Faculty of Physical Therapy, Cairo University.

Sample size estimation Sample size calculation was performed prior to the study using G\*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) \[F tests- MANOVA. Estimates of means of SAI were calculated from a preliminary study included 10 children who were assigned to the two treatment groups (5 children for each). Repeated measures, within-between interaction, α=0.05, β=0.2, Pillai V = 0.1, and large effect size\] and revealed that the appropriate sample size for this study was not less than 65 children. ¬then, 70 children were recruited to account for the possible dropout rates.

Randomization Seventy-two volunteer children who were recruited from governmental schools at Cairo and Giza Provinces. The online Graph Pad software was used to allocate study participants to either intervention group (corrective exercise and NMES) control group (corrective exercise and placebo NMES). All children/legal and examiners were unaware of group allocation.

Eligibility Criteria:
Inclusion Criteria:

The criteria for inclusion were

* Di¬agnosed (by an orthopedist) with asymptomatic FFF,
* Navicular height more than 9-millimeter (mm),
* Grade III flatfoot grade (midfoot width exceeding forefoot width)
* Normal body weight (BMI from 5th to 85th percentile),
* Presented with no neuromuscular or osseous anomalies.

Exclusion Criteria:

The authors excluded all children who had a history of

* Symptomatic flatfeet
* Congenital deformities of the lower extremities (e.g. genu valgum, femoral anteversion, leg length discrepancy, hypermobile joint)
* Scar/irri¬tated skin at the electrode placement
* Neurological/ neuromuscular disorders.