cyrilzakka/clinical-trials huggingface dataset:
Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis

Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for Morningness (CSM) respectively

Cirrhosis of the liver is a chronic, diffuse, degenerative disease in which the parenchyma deteriorates, the lobules are infiltrated with fat and structurally altered, dense perilobular connective tissue forms and often areas of regeneration develop. These regeneration nodules have a reduced blood supply resulting in impaired liver function \[1\] and \[2\]. Factors that are taken into account to determine the severity of cirrhosis include serum albumin, prothrombin concentration, serum bilirubin, ascites and encephalopathy. A point system known as the Child's-pough-Turcotte score has been designed to determine the severity of cirrhosis. Depending on the total score, patients are classified as class A (early cirrhosis) through class C (advanced cirrhosis) \[3\].

A disturbance of sleep is recognized as one of the early signs of hepatic encephalopathy. Reversal of sleep rhythm, drowziness and lethargy are classic signs of this disease. Sleep disturbance and excessive daytime somnolence are common in patients with cirrhosis. It was estimated that up to 70% of individuals with cirrhosis (regardless of etiology) experience sleep disturbances \[4\]. Difficulty falling asleep and a shift in sleep schedule toward the latter part of the night, which might be result in daytime sleepiness, are commonly reported findings in patients with hepatic cirrhosis without encephalopathy \[4\].

Individuals with hepatic cirrhosis (n=50) and healthy controls (n=30) were recruited. Sleep quality, sleep timing parameters and circadian preference were evaluated using the Pittsburgh Sleep Quality Index (PSQI), Sleep Timing Questionnaire (STQ) and The Composite Scale for Morningness (CSM) respectively

Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis
* controls

Exclusion Criteria:

* HCC
Exergaming for Better Physical Fitness

The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g. exergame) can lead to increased physical activity, aerobic fitness and health benefits in sedentary adults. The project will include 28 sedentary adults, 18 years and above, who are not sufficiently active according to current guidelines defined as doing (\<150 minutes/week of moderate intensity physical activity or \<75 minutes/week of vigorous physical activity and/or do not do any regular endurance training ). The physical fitness (maximal oxygen consumption), blood pressure, body composition and objectively measured physical activity will be tested before and after the intervention period.

Also, the participants gaming frequency will be registered throughout the 8 week period. Aim of this study is to investigate if access to this game can provide health benefits for adults who are not motivated to take part in regular physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary (\<150 mins of moderate intensity physical activity/week) and/or do not regularly take part in endurance training.
* Able to ride a bike for up to 60 minutes

Exclusion Criteria:

* Known cardiovascular disease
* Taking beta-blockers or anti-arrhythmic drugs
Effect of 12-week Probiotic Supplementation on Bacterial and Viral Infections in Infants Aged 6 to 12 Months.

The purpose of this clinical trial is to evaluate the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months.

Probiotics are live bacteria that offer a health benefit to the host when administered via the diet in adequate amounts. Probiotic supplementation is safe for use in infants to the elderly and has demonstrated beneficial effects for a wide variety of health conditions such as acute diarrhea, antibiotic-associated diarrhea, allergies, and inflammatory bowel disease. The immune-enhancing benefits of probiotics are attractive, particularly for infants, a group that is particularly prone to a variety of infections, e.g. respiratory tract infection, strep throat, and diarrhea. Probiotic supplementation has been utilized in previous studies of childhood infections with promising results.

In this study, the safety and effectiveness of 12-week probiotic supplementation on the incidence and duration of infectious episodes in infants aged 6 to 12 months will be determined. The subjects will receive follow-on formula containing 1 million CFU/g Lactobacillus rhamnosus HN001 (trademarked DR20), 1 million CFU/g Bifidobacterium animalis subsp. lactis HN019 (trademarked DR10), or placebo formula for at least three feeds per day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 12 months.
* Known vaccination history.
* Ability of the participant's parent or legal guardian to comprehend the full nature and purpose of the study including possible risks and side effects.
* Parental or legal guardian's consent to the study and willing to comply with study procedures.

Exclusion Criteria:

* Symptoms of any infection at screening.
* History of ≥5 infections in the previous 2 months.
* Lactose intolerance or unable to drink milk.
* Leukopenia or leukocytosis.
* Immunodeficient or use of immunosuppressive drugs.
* Use of antibiotic and anti-inflammatory medications within the last 2 weeks.
* Use of products containing prebiotics or probiotics within the last 2 weeks.
* Use of low-lactose or lactose-free infant or follow-on formula within the last 2 weeks.
* Hepatitis B or C.
* Medications or supplements that may affect subject safety or confound study outcomes in the opinion of the investigator.
* Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator.
* Participation in another study with any investigational product within 3 months of screening.
* Any other condition that, in the investigator's opinion, may preclude the subject's ability to safely complete the trial.
Survey of Dysmorphic Uterus Knowledge Among Gynecologists.

Uterine malformations were initially described by Cruveilhier and Von Rokitansky in the 1800s. Many proposed classifications had been presented over the years, although only two are mostly used worldwide: the first proposed by the American Fertility Society (AFS) and the one recently published by European Society on Gynecologic Endoscopy / European Society of Human Reproductive Endocrinology (ESGE/ESHRE). Both classifications describe a special type of uterus, with an abnormally shaped narrow uterine cavity. This type of uterus was initially defined, before the use of ultrasound, as "hypoplasic uterus" by K. Menge and K.V. Oettingen in 1930. Subsequently, the AFS in its classification defined it as type VII as Diethylstilbestrol-related and the ESGE/ESHRE classification defined it as class U1a or T-shaped uterus.

At present there are no clear diagnostic criteria for this type of uterus and the only parameter widely accepted is that of "narrow uterine cavity due to thickened lateral walls". The purpose of this study is to conduct a survey of gynecologists in active clinical practice and resident (in training) gynecologists to establish the degree of concordance when cataloging 3D ultrasound images of normal or dysmorphic uteri, with the aim to identify common parameters that allow to identify the dysmorphic uterus with narrowing of the side walls.

The study will be carried out in two stages: in an initial step, participants will complete a survey evaluating their knowledge of uterine malformations and their involvement in assisted reproduction in their current clinical practice.

In the second step, participants will then watch a video of hysteroscopies and 3D ultrasound images of different cases highlighting the hysteroscopic/ultrasound correlation of the different variants of the uterus with narrowing of the side walls. Each participant will be shown 40 (forty) 3D ultrasound images of uterus of normal women without infertility and 40 (forty) infertile women with uterus with narrowing in the middle third diagnosed by hysteroscopy + 3D ultrasound and associated infertility (in T, Y or I shape). Once the survey is finished, the degree of concordance will be evaluated, with the aim to identify common parameters of diagnosis of dysmorphic uterus by 3D ultrasound.


Eligibility Criteria:
Inclusion Criteria:

* Practicing gynecologist specialist or fellow/resident (in training);
* Knowledge of the ESGE/AFS and T-Y-I uterine anomalies classification.

Exclusion Criteria:

• None.
Paclitaxel in Treating Patients With Early-Stage Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel in treating patients with early-stage bladder cancer.

OBJECTIVES: I. Evaluate toxicity and safety of intravesical paclitaxel in patients with superficial bladder cancer. II. Evaluate the efficacy of paclitaxel against transitional cell carcinoma in situ (CIS) and/or unresectable papillary superficial bladder cancer. III. Evaluate a dose-response effect and choose an appropriate dose for further clinical study.

OUTLINE: Cohorts of patients receive intravesical paclitaxel in escalating doses, administered twice weekly for 6 weeks, then once every 2 weeks for another 6 weeks, for a maximum of 2 courses at a dose level. Patients must complete 8 of the first 15 instillations and a 3 month cystoscopic exam with biopsy and cytology to be deemed evaluable. Participants are followed by quarterly cytoscopy and cytology for an additional 21 month period. Biopsies are performed at 3 and/or 6 months, and thereafter if clinically applicable.

PROJECTED ACCRUAL: 19 evaluable patients will be enrolled.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven CIS and/or unresectable/residual superficial bladder tumor (pTa G1-G3 to pT1 G1-G3) -confirmed by biopsy, bladder mapping, or positive cytology Cystoscopic examination and bladder mapping must be performed within 6 weeks of study

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky of 60 to 100% Life Expectancy: Not specified Hematopoietic: Hemoglobin greater than 11 g/dL WBC greater than 4500/mm3 Neutrophils greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin, AST, and ALT no greater than 2.5 x normal Renal: Creatinine no greater than 2.5 x normal Cardiovascular: No concurrent cardiovascular disease Other: No active infection requiring concurrent therapy Not pregnant or nursing No upper renal tract disease No concurrent malignancy except for basal or squamous cell skin cancer or noninvasive cancer of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: No intravesical BCG within 3 months prior to study entry Prior BCG therapy is required for CIS patients (if not contraindicated) Chemotherapy: No prior intravesical chemotherapy within 4 weeks prior to study No prior systemic anticancer therapy within 4 months prior to study No prior paclitaxel therapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy within 4 months prior to study Surgery: Not specified Other: No hypersensitivity reactions to products containing cremophor
Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients

The aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.


Eligibility Criteria:
Inclusion Criteria:

* Geriatric patients aged above 55 years
* Patients with untreated carious lesions
* Patients who have at least 20 teeth under occlusion
* Patients with normal occlusion
* Vital teeth with carious cervical lesion with asymptomatic vital pulp.
* Teeth with no or minimum mobility.
* Teeth with normal occlusion.
* Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion Criteria:

* Patients who are unable to return for recall appointments
* Presence of abnormal oral, medical or mental conditions.
* Patients with severe medical diseases.
* Patients with xerostomia
* Patients with parafunctional habits.
* Non vital teeth.
* Teeth with signs or symptoms of pulpitis.
* Teeth with non carious lesions.
ValoRization of Dairy Sidestreams to Fight Calcium dEficits iN Postmenopausal Women

The primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (BMD) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.

The study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. Besides, two visits at month 6 and 9 for dispensing of trial products. Outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. Outcome parameters will moreover be analyzed based on DXA scan obtained at the randomization visit and at the final visit at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 45 years and 65 years of age by the time of inclusion.
* Subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years.
* Subject is Caucasian.
* Has a BMI below 35.0.
* Holder of a computer.
* Has a sufficient vitamin D status (plasma 25OHD concentration \> 50 nmol/L).
* Subject is willing and able to provide written informed consent prior to participation.

Exclusion Criteria:

* Subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy evaluated by the investigator.
* Intake of antibiotics in the last 3 months before enrollment.
* Subject with an osteoporosis diagnosis or history of osteoporotic fractures.
* Presence of renal, gastrointestinal, hepatic or endocrinological diseases.
* Subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer).
* Known or suspected abuse of alcohol or recreational drugs.
* Known milk allergy.
* Known or suspected hypersensitivity to trial products or related products.
* Blood donation except from the donation in this study.
* Subject where it is not possible to obtain sufficient data.
Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).

Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for prostate MRI for possible prostate cancer
* Safe to undergo an MRI scan
* Able to give informed consent

Exclusion Criteria:

* MRI referrals where prostate cancer is not the question
* Patients who are not safe to undergo an MRI scan
* Patients who have undergone prostate biopsy in the previous 10 weeks
* Patients unable to give informed consent
Dose-finding Study of MCI-196

The Primary Objective of this study is to determine the initial starting doses of colestilan (MCI-196) in paediatric subjects with Chronic Kidney Disease Stage 5 on Dialysis and with Hyperphosphataemia.

This study has been terminated because of insufficient patient recruitment. There were no safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 years to \<18 years with CKD stage 5 on dialysis (haemodialysis or peritoneal dialysis) for at least one month
* The subject has a documented diagnosis of hyperphosphataemia, as demonstrated by serum phosphorus(P) levels above the age-related upper limit of normal KDOQI Clinical Practice Guidelines for Nutrition in Children with CKD updated 2008)
* The subject has been taking CBPB prior to enrolment into the study (i.e., prior to the screening visit)
* The subject must have demonstrated serum P levels \>1.5 standard deviation (SD) above the KDOQI 2008 age-related mean value at any time during the wash-out period (this must be demonstrated after stopping treatment with CBPB)
* At the time of randomisation, the subject must have demonstrated an increase in serum P levels from his/her most recent P central laboratory measurement by at least 10% above the pre-wash-out level

Exclusion Criteria:

* The subject has been diagnosed with hypocholesterolaemia (i.e., cholesterol levels below age-related normal ranges, per local practices)
* The subject has current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose him/her to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, make the subject unsuitable for inclusion in the study (e.g., the subject currently has or has had a history of seizure disorders, dysphagia, swallowing disorders, predisposition to or current bowel obstruction, ileus or severe gastrointestinal \[GI\] disorders such as chronic or severe constipation \[as judged by the Investigator\], intestinal stenosis, intestinal diverticulum, sigmoid colitis, GI ulcers, current or a history of GI bleeding, or major GI tract surgery)
* The subject was treated with a combination of two or more phosphate binders within one month prior to screening
* The subject cannot stop treatment (prescription or over-the counter) of any of the following orally taken medications during the wash-out period: any product containing calcium (Ca), magnesium (Mg), aluminium compounds, sevelamer, lanthanum, ketosteril
* The subject is receiving immunosuppressant treatment for any medical condition at the time of randomisation or is expected to receive such treatment during the course of the study
* The subject is considered unstable on his/her current treatment for CKD within one month prior to screening (e.g., subjects starting treatment with vitamin D or its analogues, or other agents/procedures that may influence bone mineral metabolism \[i.e., serum P and Ca levels\])
Effect of Core Stability Training on Segmental Trunk Control and Quality of Life in Children with Cerebral Palsy

Spastic diplegia is a common shape of cerebral palsy that significantly affects trunk control and quality of life in children. Core stability training (CST) has been utilized as a potential intervention to improve the trunk function. This study investigated the effects of CST on segmental trunk control and quality of life in children with spastic diplegia.

Forty children with spastic diplegia (age: 3 - 6 years) were randomly assigned to either a control group (n=20) receiving a selected physical therapy program or an experimental group (n=20) receiving the same program plus a 30-minute CST program three times weekly for 12 weeks. Segmental trunk control was assessed using the Segmental Assessment of Trunk Control (SATCO) scale, and quality of life was measured using the Pediatric Quality of Life Inventory (PedsQL). Both outcome measures were evaluated pre- and post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* 3-6 years
* 1 to 1+ spasticity according to modified Ashworth scale
* level II and III according to GMFCs
* able to follow instructions and understand commands

Exclusion Criteria:

* significant visual or auditory problems
* fixed deformities
* Botox injection
* orthopedic surgery
Intraoperative Nociception Monitoring with Medstorm, Medasense and Anspec-pro During Total Intravenous Anesthesia

The randomized controlled trial study aims to validate a new pain monitor during general anesthesia by comparing the new ANSPEC-PRO monitor (non-CE marked) with already CE-marked pain monitors (Medstorm and Medasense). One hundred and eighty patients will be randomized into six groups, wherein each group has 30 patients. Patients preparing for a surgical operation under general anesthesia will be included to be monitored for pain during surgery procedure, while the standard monitoring, medication, and standard care will not be disturbed.

Pain monitoring is done with the ANSPEC-PRO, MEDASENSE, or MEDSTORM in the operation room, before and during general anesthesia: the pain monitor will record data continuously, while the following will be recorded in parallel: blood pressure, heart rate, saturation, CO2, O2 end-tidal concentrations, electromyogram, signal quality, the given amount of analgesics and hypnotics, and TOF (train-of-four).

Primary Objective: Validation of ANSPEC-PRO as pain monitor during general anesthesia.

Secondary Objectives

* Evaluation of quality of monitoring ANSPEC-PRO compared with other pain monitors (Medasense and Medstorm);
* Evaluation of the correlation between measurements of pain monitors (ANSPEC-PRO, Medstorm and Medasense) and the level of analgesia represented as TCI infusion of Remifentanil;
* To determine the most suitable device for the development of a MIMO pharmacodynamic interaction model of Propofol and Remifentanil for use in closed- loop drug-delivery systems for anesthesia;
* Evaluation of the interaction between analgesics and hypnotics measured by ANSPEC-PRO and BIS/Neurowave.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 years and younger than 80 years
2. Patients able to comprehend, sign, and date the written informed consent document to participate in the clinical trial.
3. ASA Class I, II, III classified by the anesthesiologist.
4. Patients planned for a surgical procedure under general anesthesia.

Exclusion Criteria:

1. Patients having epidural analgesia infused by a pain pump during the operation.
2. Patients with chronic pain or getting medication used for chronic pain, like anti-epileptics, antidepressants, opioids.
3. Pregnant women (asked at the patient before the operation)
4. Patients with electrically sensitive life support systems (e.g. implanted pacemaker, defibrillator)
Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors

Phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at the time of informed consent
* Relapsed or refractory solid tumors following standard therapy.
* ECOG Performance Status 0 or 1.

Exclusion Criteria:

* History of insulin-dependent diabetes, type 2 diabetes, or hemoglobin A1c \>6% at screening.
* History of myocardial infarction within 12 months prior to Day 1 or chronic heart failure.
* Known central nervous system or brain metastases.
* Prior anti-IGF-1R therapy of any kind.

Other protocol-defined inclusion/exclusion criteria may apply.