cyrilzakka/clinical-trials huggingface dataset:
Calcium, Dairy, and Body Fat in Adolescents

Lifestyle choices,including diet,are conducive to healthy body weights in children. Dairy products and calcium supplementation have been associated with moderation of body weight and body fat. This study was designed to test the following hypotheses with overweight and obese adolescents consuming a controlled diet:

* Dietary calcium supplementation as calcium carbonate or dairy calcium modulates energy balance in adolescents.
* Increased calcium in the diet of adolescents will increase fecal fat excretion and thereby decrease fat absorption.
* Calcium and dairy product supplementation will increase lipid oxidation resulting in an increase in energy expenditure.

Subjects will consume a controlled diet containing 800 mg calcium for two three week periods. During one period they will also receive a frozen ice cream like product (smoothie) twice a day based on soy protein that contains no additional calcium. During the other period they will receive a similar product twice a day based on either dairy protein that contains 650 mg calcium or based on soy protein that contains 650 mg calcium as calcium carbonate

Eligibility Criteria:
Inclusion Criteria:

* Over weight (\>85th percentile BMI for age)

Exclusion Criteria:

* \> 180% of ideal body weight for height
* Malabsorptive disorders
* Bone disease
* Liver disease
* Kidney disease
* Anemia
* Smoking or illegal drugs
* Oral contraceptives
* Pregnancy
* Medications that influence calcium metabolism
Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy

The purpose of this study is to determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer with an LHRH-agonist.

This study will determine if methylphenidate improves fatigue in men undergoing hormonal therapy for prostate cancer. Fatigue is a common problem experienced by cancer patients. Those patients who are receiving chemotherapy or radiation are especially vulnerable to fatigue, as are men with prostate cancer who are receiving hormonal therapy with an LHRH-agonist (androgen deprivation therapy). Eligible men will be randomized to a daily dose of 10 mg methylphenidate or placebo for a total treatment period of 12 weeks. Subjects will be monitored for changes in fatigue and mood during this period. While the exact cause of fatigue in this setting is unknown, this study will hopefully lead to a better understanding of the process and provide patients with a much-needed remedy for fatigue

Eligibility Criteria:
Inclusion:

* Age \> 18 and ≤ 85 years
* Histologically confirmed prostate cancer
* Currently receiving LHRH-agonist therapy for greater than 6 months with measurable fatigue, defined as a score of \>1 on the Bruera global fatigue severity scale OR
* Deemed eligible to commence LHRH-agonist therapy, with confirmation of fatigue at Screening Visit 2
* Have a serum PSA which is stable or decreasing based on the PSA trend over the last 2 values taken at least 2 months apart, with the more recent value taken at least 2 months after initiation of LHRH-agonist therapy.
* Have adequate liver and renal function (Bilirubin ≤ 1.5 x ULN and AST, ALT and Serum Creatinine \< 2 x ULN)
* Able to swallow and retain oral medication
* Life expectancy of at least 1 year
* Able to read and write in English (and therefore accurately complete the required study questionnaires), understand instructions related to study procedures and give written informed consent.

Exclusion:

* Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (other exceptions are superficial bladder cancer or non-melanoma skin cancer)
* Previous chemotherapy within the last 5 years
* Anemia (Hemoglobin \< 100 g/L)
* Myocardial infarction within past 6 months
* Any unstable serious co-existing medical condition(s) including but not limited to ; unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, Severe bleeding diseases or immune disorders
* Severe depression as defined by CES-D score \>27
* History of motor tics, seizures or a family history of Tourette's syndrome
* Infection with HIV (Human Immunodeficiency Virus), HBV (Hepatitis B) or HCV (Hepatitis C)
* Evidence of drug or alcohol abuse
* Known hypersensitivity to methylphenidate
* Possess any other contraindications to methylphenidate use
Effect of Preload on Bladder Retention Volume During Spinal Anesthesia

The purpose of this study is to assess the influence of different fluid infusions on the quantity of bladder retention after spinal anesthesia. This study should determine if this increase in bladder retention is significant and relevant.

Background of the study:

Spinal anesthesia , through interruption of spinal nerve conduction, causes intense blockade of sensation, motor function as well as (para)sympathetic function. Loss of sympathetic tone causes vasodilation which may lead to arterial hypotension and bradycardia. To avoid these effects, in anesthetic practice, usually intravenouspreload is administered as cristalloids or colloids. The form and dosage of these plasma expanders will influence diuresis during spinal anesthesia-induced detrusor blockade. Excess diuresis may cause bladder distension and neccecitates bladder catheterization

Objective of the study:

To compare the quantitative effects of Ringer Lactate and HES 6% on diuresis during spinal anesthesia-induced detrusor blockade as well as prevention of hypotension and vasopressor use.

Study design:

Before spinal anesthesia is performed, patients are randomized into one of the 3 study groups (no preload, preload with Ringers' Lactate 14 ml/kg, preload with HES 6% 7 ml/kg). Spinal anesthesia is administerd with lidocaine 2% 70mg. Hypotension is treated with vasopressors, atropine or additional intravenous fluid. Bladder scans will be performed on the recovery unit and day-case unit. Total urinary volume is measured until sensory function at dermatome S2/3 is restored and spontanous voiding is possible.

Study population:

ASA 1-2 patients who present for spinal anesthesia for minor surgery on the lower extremitiy. Age 18-60 years.

Intervention (if applicable):

Prespinal administration of intravenous Ringers' Lactate 14 ml/kg or HES 6% 7 ml/kg.

Primary study parameters/outcome of the study:

Primary outcome is total urinary volume during spinal induced detrusor blockade, and number of subjects that have a bladdder volume over 500ml.

Secundary study parameters/outcome of the study (if applicable):

Secondary outcome parameters:

Periods of hypertension, and total dose of vasopressor en extra fluid administration.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness (if applicable):

Except for extra bladderscan and block height measurements, all actions are part of routine anesthesiologic care.

Ga naar boven

Eligibility Criteria:
Inclusion Criteria:

* ASA1-2
* undergoing minor procedure under spinal anesthesia

Exclusion Criteria:

* ASA3-4
* History or signs of heart failure / coronary artery disease.
* Bladder / urinary disease
* Neurologic disease that may affect bladder function
General Use-results Surveillance With Awiqli in Patients With Diabetes Mellitus

The purpose of the study is to investigate the safety and effectiveness of Awiqli in participants with diabetes mellitus under real world clinical practice in Japan. Participants will get Awiqli as prescribed by the study doctor. The study will last for about 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Awiqli has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
* Male or female with no age limitation.
* Diagnosis of diabetes mellitus. There is no limitation for type of diabetes mellitus and prior treatment for diabetes mellitus.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Contraindication described in Japanese package insert.
* Participants showing hypoglycaemic symptoms.
* Participants with a history of hypersensitivity to any ingredients of this drug.
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD

A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.

This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with stage 3b-4 CKD. The following biomarkers will be used as surrogate measures of protective activity: Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1. Additionally, the P21 biomarker will be monitored at various points of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
2. Body weight \<125 kg.
3. Able and willing to comply with all study procedures.
4. Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 28 days after study drug administration.

   Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
5. CKD as determined by estimated glomerular filtration rate (GFR) between 15-45 ml/min as estimated using the CKD-EPI equation (CKD class 3b-4). -

Exclusion Criteria:

1. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
3. Serum ferritin \> 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
5. Regular use of drugs of abuse and/or positive findings on urinary drug screening.
6. Current tobacco use and/or positive findings on urinary cotinine screening.
7. Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.
8. Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
9. Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -
Importance of Multidimensional Assessments in Accompanying Schooling of Children With Mild to Moderate Intellectual Disability.

The EVAL'ID study aims to demonstrate the value of a multidimensional assessment in accompanying schooling of children with Intellectual Disability. The study will be performed in the Rhône department (France) in children aged from 5 to 13 years with mild to moderate Intellectual Disability , and attending school either at ULIS (Unités Localisées pour l'Inclusion Scolaire, which enables disabled children to attend regular schools), or IME (Instituts Médico-Educatifs, which are special schools mandated to accommodate children and young people with Intellectual Disability at any level of disability). A multidimensional assessment encompasses the assessment of academic, cognitive, behavioral and adaptive skills of the children, with validated and reliable neuropsychological batteries, called ID Kit (Intellectual Deficiency assessment Kit), which includes the following scales : the Wechsler Intelligence Scale for Children 4th edition (WISC-IV), the Vineland Adaptive Behavioral Scale II, the GECEN rating form (Grille d'Evaluation Comportementale pour Enfants Nisonger, which is the French translation of the Nisonger Child Behavior Rating Form), and an academic skills rating form (GEVA-SCO). A comparison of the children neuropsychological profiles according to the type of school they attend, will be perform.

The project consists of three phases:

* Stage 1: Collection of information from each child records at MDPH (Departmental Administration for Disabled Persons), IME, ULIS schools, including the assessments that were performed, and from a survey of both caregivers and parents regarding their respective perception and knowledge of the child's disability
* Stage 2: All the children who were not previously assessed with the ID kit will be further evaluated using these tests. The results of these assessments will be shared with parents and caregivers.
* Stage 3: A survey regarding the perception and knowledge of the child's disability will be carried out again among caregivers and parents.


Eligibility Criteria:
Inclusion Criteria:

* Age : \> 5 and \<13 years
* With mild to moderate intellectual deficiency
* attending school either at ULIS or IME in the Rhône department.

Exclusion Criteria:

* No insurance coverage
* No parents agreement
Validation of the Chinese Version of Oxford Depression Questionnaire

Mood disorders are a group of psychiatric disorders that can affect a person's mood, energy, and motivation. Emotional blunting has been observed in clinical practice in patients with mood disorders. Emotional blunting has a negative impact on patients' overall treatment and leads to poorer adherence. The Oxford Depression Questionnaire (ODQ) is a measuring instrument of emotional blunting. The ODQ is expected to be a scientifically valid tool for detecting emotional blunting. The ODQ has high construct validity and internal reliability. However, no scientific validity studies have been conducted on ODQ in Chinese population. Therefore, this study is intended to investigate the reliability and validity of the ODQ in Chinese patients with mood disorders.


Eligibility Criteria:
Inclusion Criteria:

1) both biological parents were Han Chinese; 2) currently diagnosed with major depressive disorder or bipolar disorder according to the Mini International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 3) aged 13-65 years; 4) can complete the self-assessment questionnaires.

Exclusion Criteria:

1) currently diagnosed with neurological diseases or other major psychiatric disorders, e.g., schizophrenia, cognitive impairment, substance abuse; 2) diagnosed with severe somatic illnesses, such as diabetes and cardiovascular diseases;
Temozolomide in Treatment of Patients With Primary Central Nervous System Lymphoma

Consolidation treatment for Primary Central Nervous System Diffuse Large B cell Lymphoma(PCNSL)patients remains to be defined.Here we designed a tolerated treatment of HDMTX plus Temozolomide,followed by consolidation with Temozolomide in PCNSL patients.


Eligibility Criteria:
Inclusion Criteria:

- (1) histology confirmed to be PCNSL. (2) lymphoma invasion in brain, meninges, cerebrospinal fluid, eye organ. (3) ECOG score less than 3 points (4) at least 1 of the lesions can be evaluated with a double diameter. (5) the life expectancy of more than 6 months. (6) less or equal to 75 years,or more or equal to 18 years. (7) to be able to comply with the requirements of the study and follow-up procedures.

(8) to sign the consent form to participate in the study. (9) having adequate organ function, defined as follows: Liver function, serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) equal to or less than 2 times the upper limit of normal (ULN).

Bone marrow function: absolute neutrophil count more or equal to 1500/L, platelet count more than 100000/L,hemoglobin was greater than 9 g/dL.

Renal function, serum creatinine or creatinine clearance rate (less than 1.5ULN Cockcroft-Gault formula based on the improvement of more than 50ml/min).

(10) women with childbearing potential must start to get the test results of serum / urine pregnancy test negative within 48 hours prior to study. Postmenopausal women who have at least 12 months of menopause can be treated as non fertile.

Exclusion Criteria:

* (1) patients with a history of other malignancies within five years (except for the full treatment of cervical carcinoma in situ or basal cell carcinoma or squamous cell skin cancer).

  (2) had previously been treated with total cranial irradiation. (3) the upper digestive tract is lack of physical integrity, or suffering from malabsorption syndrome, or oral drug, or active gastric ulcer.

  (4) suffering from any unstable systemic diseases (including active infection, significant cardiovascular disease, any significant liver and kidney or metabolic disorders), metabolic disorders, physical examination results or laboratory examination results of contraindication to the use of drugs, or may affect the treatment results of interpretation or increase the risk of complications in treatment of risk (5) patients with human immunodeficiency virus (HIV) transmitted in the form of blood or other body fluids.

  (6) women in pregnancy and lactation. (7) women of childbearing age who do not want to use contraceptive measures during the study period and have sexual capacity of men.

  (8) patients who do not want to sign informed consent. (9) patients who were not willing to follow up. (10) for any drugs or excipients of allergy. Exit the case: no matter what reason patients withdrew from the study of cases in time will be postponed.
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye

Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is being developed by Allergan. It is desirable to understand the effect that this new emulsion has on tear film evaporation and tear lipid profile via interferometry, in patients with evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate the retention time of the lipid components of the new emulsion via tear collection and analysis in EDE and non-EDE patients


Eligibility Criteria:
Inclusion Criteria:

* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
* Over 18 years of age;
* Not wearing contact lenses in the past 3 months before enrolling
* Willing to use eye drops and comply with the study visit schedule as directed by the Investigator;
* Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye;
* At the Screening visit (Day -14), patients must have Ocular Surface Disease Index (OSDI) score \>18 (0 to 100 scale). At Baseline (Day 1) visits, patients must have OSDI score \> 12 to continue in the study.
* TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit
* Corneal sodium fluorescein staining score ≥ 1 and \<4 (Oxford scheme) at Screening and Baseline visit.

Exclusion Criteria:

* Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening
* Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the Screening visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use at the Screening visit;
* Any active anterior segment disease excluding blepharitis;
* Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus;
* History of epilepsy or migraines exacerbated by flashing, strobe-like lights;
* Rigid or soft contact lens wearer, including orthokeratology;
* History of eye surgery within 6 months prior to enrolment in the study;
* Previous corneal refractive surgery
Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases

Multicentric study, open label, uncontrolled phase IV in 140 patients with meibomian glands dysfunction .

Its objective is to Collect information from patients and ophthalmologists specialized in ocular surface and eyelids to anticipate how Blephasteam ® can be optimized.

This study involves 2 visits, visit of Inclusion, J0, then end of study visit, D21.

Between the two visits patients will be treated with Blephasteam ® for 21 days (up to two uses per day) and complete a questionnaire every two days during the first week and then once a week the next two weeks.


Eligibility Criteria:
* Signed and dated informed consent.
* Male or female up to 4 years old.
* Known and treated symptomatic Meibomian Gland Diseases, and/or Dry Eye related to MGDs stable since at least a month.
* Without any active pathology requiring a change in ocular treatments within the last month before inclusion.
* Best corrected far visual acuity (VA) \> 1/10
Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT

This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression.

While indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess stenosis. The current study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF) into one of two groups: direct decompression and indirect decompression. Enrolled participants will be evaluated before surgery, during their hospital course and post-operatively at 6 weeks, 3 months, 6 months, 1 and 2 years. Operative details, complications, reoperation rates, patient reported outcomes, clinical and radiographic outcome measures will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons:

  * Mobile degenerative spondylolisthesis
  * Severe vertical foraminal stenosis
  * Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain
* One-level central canal stenosis

  * WITH neurogenic claudication
  * As measured in preoperative MRI
* Oswestry Low Back Pain Disability Questionnaire score \> 35% (18/50)
* Failed 3 months of conservative treatment
* Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms

Exclusion Criteria:

* Multilevel central canal stenosis
* Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage
* Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum
* Prior surgery at index disc level (discectomy, decompression, or fusion)
* History of spinal or vertebral infection of the lumbar spine
* History of vertebral fracture of the lumbar spine
* Current pregnancy or interest in becoming pregnant over the next 1 year
* Active infection-systemic or local
* Non-English speakers