cyrilzakka/clinical-trials huggingface dataset:
Transvaginal Versus Transperineal Repair of Rectocele

Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients with anterior rectocele

Exclusion Criteria:

* Male patients.
* Combined rectocele with internal rectal prolapse.
* Anismus.
* Associated anorectal condition such as hemorrhoids and anal fissure.
* Pregnancy.
* Unwilling to participate in the trial
Scheduled Awakenings for the Treatment of Nocturnal Enuresis

This study is a simple effectiveness trial to determine if the Lully Sleep Guardian has any effect on benign nocturnal enuresis.

Primary monosymptomatic nocturnal enuresis (PMNE) is defined by the Diagnostic \& Statistical Manual of Mental Disorders (DSM- IV) as an involuntary voiding of urine during sleep, with a severity of at least twice a week, in children aged \>5 years in the absence of congenital or acquired defects of the central nervous system(1-3).

PMNE affects 10-20% kids at 5 years old (1, 4, 5). It does resolve spontaneously so that 5% of 10 year olds and 1% of 15 year olds are still affected (2-4). Is more common in boys. While the disease its self is benign, and improves without intervention, it does pose a significant social and emotional burden on the child and their family. These include parental disapproval, sibling teasing, and inability to attend sleep overs with peers, all of which lead to families seeking treatment options (3, 4).

Current treatments start with conservative management. This includes appropriate fluid intake, scheduled toileting during the day, avoidance of bladder irritants and constipation (4, 5). If these fail to improve symptoms or families are looking for a more active form of treatment, first line therapy is either a bed wetting alarms or desmopressin (1, 4, 5).

The Lully Sleep Guardian was initially developed for use in night terrors. The device works by programing a vibrating disk that is placed under the child's bed to alter sleep patterns and prevent the onset of sleep terrors. The child is not woken up for the treatment of sleep terrors. The device has also been shown to anecdotally improve users' nocturnal enuresis. There have been no reports of safety concerns or hazards with the device (7, 8).

The aim of this study is to determine the effectiveness of scheduled awakenings, with the Lully Sleep Guardian, in patients with PMNE, at reducing the frequency of bed-wetting.

Eligibility Criteria:
Inclusion Criteria:

* Benign nocturnal enuresis
* Age: 5 - 17
* Must have or have access to an Apple iPhone, iPad, or iPod Touch

Exclusion Criteria:

* Diurnal Enuresis
* Constipation
* Neurogenic Bladder
* Any serious underlying cardiopulmonary problems that require diuretics or antihypertensive medications to manage
* Any bladder active medications
* Age: \< 5 years of age; \> 17 years of age
* Cerebral Palsy
* Mental disorders, mood disorders, or autism-spectrum disorder
* Epilepsy or seizure history
* Restless leg syndrome
* Use of benzodiazepine/clonidine
The Effectiveness of Oral Corticosteroids in the Treatment of Lumbar Stenosis

The aim of this study is to evaluate the effectiveness of the use of systemic corticosteroids administered orally in narrow lumbar canal syndrome.

60 patients are being randomized, plank by randomization, the patient and the examiner will be blinded. Will be placed in opaque brown envelopes in order to maintain the secrecy of allocation.

Included patients aged between 50 and 75 years of both sexes participate in the work to accept and sign the Informed Consent The patient will be screened in advance after the acceptance of it will be an anthropometric assessment, with assessment of height, weight and presence of associated comorbidities.

After clinical evaluation they headed for the initial evaluation, after this evaluation, patients are randomized and and delivered to the patient the medication with corticosteroids or placebo for an unrelated medical research. It is also given a bottle of paracetamol 750 mg and a sheet dated, in which the patient is instructed to register the day this sheet and number of capsules taken, which is also an evaluation factor.

evaluation VAS SF 36 Roland Morris questionnaire Test 6-minute walk Likert scale ELegibility Criteria

Clinical diagnosis:

Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.

Radiological diagnosis:

Presence of lumbar canal stenosis with an area less than 100mm2 Hamanishi based on criteria measured at lumbar spine MRI in the follow-up from L1 to S1.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain and at least two of the following complaints in lower limbs: pain, weakness, burning or numbness that worsens with walking and improves with the cessation of walking.

Exclusion Criteria:

* decompensated diabetes mellitus.
* Systemic hypertension and decompensated heart
* systemic disease affecting the lower limbs
* Neuromuscular Disease
* Use of steroids in the past 3 months.
* Patients with previous surgery of the thoracic or lumbar spine.
* cognitive disorder that interferes with the ability to understand or interpret the questionnaires
* Spondylolisthesis except degenerative
* degenerative scoliosis with Cobb angle of 10 °
Metabolic Response to the Acute Consumption of Fiber-enriched Pasta

Cardio-metabolic diseases are a leading cause of mortality worldwide. Over the years, therefore, there have been considerable efforts to identify strategies for prevention and management of risk factors. The diet, with its pleiotropic effects, is one of the most effective approaches to reduce the cardio-metabolic risk. In this context, the dietary fibers have been extensively studied and the available evidence supports the beneficial effects of its consumption. However, worldwide the average fiber consumption is still less than the recommended daily dose. For this reason, the availability of functional foods, such as additional sources of fiber in the diet, may facilitate the attainment of fiber recommended.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-29 kg / m2
* Good Health status

Exclusion Criteria:

* Diabetes
* Cardiovascular events (IMA or stroke) severe heart disease
* Kidney or liver failure
* Anemia and any other chronic disease
Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis

The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic pathways and use of pathways that increase risk of inflammation . The investigators have postulated that manipulation of colonic bacterial metabolism with this diet will induce remission in UC without involving additional immune suppression.

Ulcerative colitis is a chronic inflammatory disease primarily involving the colon. It has long been considered to be due to a dysregulated immune response targeting the colon, and involves unknown environmental factors . Recent studies have highlighted several characteristics which may suggest that UC is associated with alterations of the microbiota, defective production of short chain fatty acids and an impaired mucous layer. However at present, no effective therapy targets the microbiota or its interaction with the colonic epithelium. UC in humans is characterized by increased mucosal sulfides and increased sulfate and sulfide reducing bacteria and activation of amino acid metabolism pathways which impair butyrate production, whereas certain dietary patterns in humans and rodent models may induce dysbiosis and favor sulphide reducing bacteria. Further support for targeting the microbiota includes several studies demonstrating that antibiotics might be helpful for severe refractory colitis. Development of treatment strategies that target the microbiota could reduce exposure to immune suppression, and add new therapeutic strategies that do not exist at present.

Though diet has a significant impact on the composition of the microbiota no dietary intervention to date has proven effective for induction of remission. The investigators hypothesized that ulcerative colitis is caused by a series of events involving dysbiosis with sulfate or sulfide reducing bacteria combined with defective production of short chain fatty acids, coupled with a defective mucous layer.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent
2. Established diagnosis of UC.
3. Age: 8 - 19 years ( inclusive)
4. Mild to moderate active disease, 10 ≤ PUCAI ≤45.
5. Stable medication (IMM/ 5ASA) use for the past 6 weeks. Patients who have received topical 5ASA therapy for \<7 days and are active may be included if topical therapy is stopped at enrolment

Exclusion Criteria:

Exclusion criteria:

1. Any proven current infection such as positive stool culture, parasite or C. difficile.
2. Antibiotic or Steroids use in the past 2 weeks.
3. PUCAI \>45
4. Acute severe UC in the previous 12 months.
5. Current Extra intestinal manifestation of UC.
6. PSC or Liver disease
7. Pregnancy.
8. Allergy to one of the antibiotics or age \<11 will exclude patients from entering the antibiotic arm
Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China

To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir \[ADV\] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study

Sampling Method: Consecutive patient sampling

Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study

Eligibility Criteria:
Inclusion Criteria:

* CHB patients, or CHB patients with compensated cirrhosis, as defined by the current Chinese guidelines
* Male or female
* ≥ 18 years of age
* Either Hepatitis B e antigen (HBeAg) positive or negative
* Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient self-report)
* Has compensated liver disease
* Patients with compensated cirrhosis
* Patients who consent to participate in this study
* Local residents with medical reimbursement coverage preferred

Exclusion Criteria:

* Co-infected with hepatitis C virus (HCV)
* CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase
* CHB patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study
* CHB patients with a confirmed pregnancy
Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation

Recently, a new prolonged-release tablet version of tacrolimus (Envarsus®) using the so-called MeltDose™ (US Patent No. 7,217,431) drug-delivery technology has been approved as immunosuppressive medication for patients after kidney and liver transplantation in adults but not yet in children. Studies in adults proved that Envarsus® provides the same therapeutic effectiveness as the conventional immediate-release tacrolimus formulation (Prograf®) with improved bioavailability, a more consistent pharmacokinetic profile and reduced peak to trough which might result in reduced tacrolimus dosing and subsequently reduced CNI related toxicity. Furthermore, the once daily formulation might result in improved drug adherence.

The aim of this study is to assess pharmacokinetic profiles of Envarsus® as well as effectiveness and tolerability of this drug in children and adolescents ≥ 8 and ≤ 18 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. caucasian paediatric kidney transplant recipients (single-organ recipients)
2. aged ≥ 8 years but ≤ 18 years who are under tacrolimus (Prograf®) therapy and who are able to swallow tablets with a minimum dose of 0.75 mg / day Envarsus®
3. not less than 6 months after transplantation
4. stable kidney function (delta eGFR \< 10 ml/min/1.73 m2 (CKID formula) over the last 3 months)
5. women of childbearing potential and women without childbearing potential
6. patient/parents/legal guardian(s) must be capable of understanding purpose and risks of the study
7. signed informed consent obtained by patient and parents/legal guardians

Exclusion Criteria:

1. coefficient of variation of tacrolimus trough levels \> 0.35 over the previous 6 months
2. pregnancy/breast feeding
3. instable kidney function
4. hypersensitivity to any of the components of the medications used
5. not eligible for any reason according to the investigator's valuation
6. known positive HIV-1 or HCV test
7. participation in another clinical trial (other investigational drugs or devices at the time of enrolment or within 30 days prior to enrolment)
Post-Marketing Drug Intensive Monitoring Surveillance of EDIROL in Patients With Postmenopausal Osteoporosis

This is a post-marketing drug intensive monitoring surveillance with an observational, non-interventional design. The objectives are to compare the incidence of hypercalcemia in patients with and without calcium intake (including dietary supplements, excepting calcium from meals), and to monitor the type, incidence, severity, and relevance of other adverse drug reactions,including urolithiasis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal osteoporosis patients who signed the informed consent form and are expected to receive Edirol during the intensive monitoring period.

  * Patients with postmenopausal osteoporosis
  * Patients who signed the informed consent form
  * Patients who are expected to receive Edirol during planned enrollment period

Exclusion Criteria:

* Exclude if any of the following:

  * Men
  * No osteoporosis
  * Other osteoporosis (not postmenopausal)
* Started Edirol before ICF signature
* Did not sign ICF
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD

To evaluate the effects of HPIPC for the treatment of symptoms of PAD


Eligibility Criteria:
Inclusion Criteria:

* Intermittent claudication \>6mo
* Ischemic ulceration or ulcer of mixed (venous) etiology
* ABI \< 0.7
* Ambulatory
* Able to comply

Exclusion Criteria:

* Gangrene
* M.I. within 6mo
* Inability to walk
* Wound infection
* Systemic corticosteroids
* HBO, Apligraf, Dermagraft within 6mo
* Falsely elevated ankle to brachial index (ABI)
* Inflammatory condition affecting healing
An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer

The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and \[18F\] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. \[18F\] FDG PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689 for the same schedule.


Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving written informed consent
2. Females of non-childbearing potential, 18 years or older with ovarian cancer
3. Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer
4. Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent uterine or gastro-oesophageal tumors (these tumor types will only be included if there is poor enrollment of patients with ovarian cancer)
5. Disease at least 2 cm suitable for assessment by imaging
6. Performance Status score of 0, 1 or 2 according to the Eastern Cooperative Oncology Group scale
7. Adequate organ systems function

Exclusion Criteria:

1. Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose of GSK2141795
2. Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK2141795
3. Current use of a prohibited medication
4. Anticoagulants at therapeutic doses are permitted only after consultation with the GSK Medical Monitor
5. Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption
6. Any major surgery within the last four weeks of screening
7. Unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy
8. Previously diagnosed diabetes mellitus
9. Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids
10. Any serious or unstable pre-existing medical, psychiatric, or other condition
11. Symptomatic or untreated CNS metastases or leptomeningeal involvement
12. Evidence of severe or uncontrolled systemic diseases
13. QTc interval ≥ 470 msecs
14. Other clinically significant ECG abnormalities
15. History of myocardial infarction, acute coronary syndromes
16. Class III or IV heart failure
17. Pregnant or Lactating patients
18. History of hepatitis B or C or HIV
Affective and Physiological Outcomes of Virtual and Mixed Reality Workplace Exergames

The aim of this study was to compare the acute effects of virtual reality (VR) and mixed reality (MR) based exergame practices on physical and psychological health indicators during micro-breaks among university administrative staff. The main research questions aimed to be answered are:

1. How does VR exergame and MR exergame affect physical health indicators such as heart rate and perceived exertion in university administrative staff?
2. How does MR exergame with VR exergame affect the mood of university administrative staff?
3. How does MR exergame with VR exergame affect the enjoyment of exercise and gaming experience of university administrative staff?

Researchers will compare passive rest with VR Exergame and MR exergame to see if VR and MR sessions improve physical and psychological outcomes compared to passive rest.

Participants will: Sit quietly in a designated room for 5 minutes without engaging in any physical activity. Avoid talking, using mobile devices, or interacting with others during the rest session to ensure consistent conditions for all participants.

Using a randomized crossover design, participants will experience three different conditions: VR-based exergames, MR-based exergames, and passive rest. Each condition will be performed on separate days, with a minimum of 48 hours between sessions to prevent carryover effects.

The primary outcomes will include mood states, heart rate, and perceived exertion. These measures will help assess the immediate physical and psychological responses to the interventions.

The secondary outcomes will focus on exercise enjoyment and overall gaming experience, evaluating the subjective experience and engagement levels during VR and MR exergaming sessions.

The intervention will be delivered through PowerBeatsVR, a rhythm-based exergame that requires physical movements such as dodging obstacles and throwing punches. VR and MR modes will be compared to determine their effectiveness in promoting physical activity and improving mood during short breaks in a workplace setting. The passive rest condition will serve as a baseline for comparison.

This study addresses the growing interest in workplace wellness strategies by exploring the potential of VR and MR exergames in reducing sedentary behavior and enhancing mental well-being in work environments.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and over
* Being suitable for physical activity according to PAR-Q test
* Not exercising for 30 minutes 3 days a week
* Not having used VR/MR technologies before

Exclusion Criteria:

* People with epilepsy, vertigo or neurological diseases
* Use of antidepressants or similar medication
* Individuals with high Physical Activity Level (IPAQ)
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life

The study will compare two different dental materials on dental lesions near the gum line that cause chronic pain on oral health related quality of life.

The study will compare two different dental materials on dental lesions near the gum line. One of the materials is tooth colored and the other material is white but both materials use different mechanisms to attach to the teeth and may have different outcomes. The study will determine if one material is more effective in relieving chronic pain. In addition, we will evaluate changes in oral health related quality of life after the placement of the two different dental materials.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-64
* Chief complaint associated with pain from cold or hot
* Chronic sensitivity associated with supragingival lesions
* Pain not associated with decay
* Fluent in English and able to read English at a 6th grade level
* Pulpal response \<40 via pulp tester
* Active salivary flow from palpation of parotid and submandibular glands
* Patients self reporting pain over 6/10 in the past week and/or the past 2 months

Exclusion Criteria:

* Pregnant women
* Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
* Unexplained dry mouth
* Patients taking two or more medications associated with dry mouth
* Pulpal response \>40 via pulp tester
* Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
* Complicated medical history (\>4 concurrent treatment for systemic diseases)
* Lesion \>1mm below the gum line
VR-based Intervention for Cognitive Restoration

The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women treated for breast cancer.

Cognitive dysfunction is a kind of cluster of commonly reported neurotoxic symptoms following cancer diagnosis and treatment, especially chemotherapy. Our previous studies found that breast cancer patients and survivors had greater difficulties in performing attention, working memory, and executive function tasks and had persistent neural inefficiency of an executive network of the brain than disease and treatment counterparts.

The aim of this study is to test the efficacy of a nature-based cognitive intervention to restore cognitive function among women with cognitive complaints after breast cancer treatment. All participants will receive the initial screening to verify their cognitive status and then will be randomly assigned to the experimental or control group. The experimental group will receive a 4-week cognitive intervention by using a VR headset. Each VR content includes 10-12 video scenes with visual and auditory stimuli that were generated from nature.

Eligibility Criteria:
Inclusion Criteria:

* Being treated with chemotherapy for breast cancer
* Having affirmative responses to three questions about cognitive problems and their impact on daily performance
* Having FACT-Cog scores of 58 or less
* Having Mini-Cog scores of 3 and higher
* Having the ability to read, understand or respond to questionnaires and cognitive assessment
* Being willing to participate and able to provide written informed consent

Exclusion Criteria:

* Having metastatic breast cancer
* Having Patient Health Questionnaire-2 score of 3 and higher
* Being diagnosed with neurological disorders such as dementia, multiple sclerosis, or traumatic brain injury
* Having epilepsy or seizure
* Having 'quite a bit' or 'extremely' severe level of nausea and vomiting
* Having visual or hearing impairments
* Having other problems that prevent them from wearing the VR headset