cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia

The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)


Eligibility Criteria:
Inclusion Criteria:

* Patients with iron deficiency anemia

Exclusion Criteria:

* Patients with anemia caused by conditions other than iron deficiency
* Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase
* Patients with liver, kidney or circulatory system disease
* Patients with a history or present illness that is a malignant tumor or autoimmune disease
* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening
* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening
The Role of Small Bowel Ultrasound in Initiation of Infliximab in Crohn's Disease Patients

Goal is to prospectively determine if stool calprotectin and change in bowel wall thickness and hyperemia, as seen on small bowel ultrasound, at week 0, 14, and 54 can be used to predict response at week 54 to infliximab in pediatric patients with small bowel Crohn's Disease.

We will examine whether non-invasive disease monitoring tools such as bowel wall thickness as measured by small bowel ultrasound (SBUS) and mucosal inflammation as measured by fecal calprotectin, are independently associated with infliximab durability.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-23 years
* Initiating Infliximab therapy
* Crohns disease involving the distal small bowel +/- proximal colon
* Willingness to undergo SBUS and fecal calprotectin collection prior to starting infliximab and again at week 14 and week 54
* Able to give consent by patient and/or legal guardian

Exclusion Criteria:

* Ulcerative colitis or non-Crohn's Disease patients
* Lack of small bowel disease
* Patients started on alternative therapy
* Unable or unwilling to provide consent
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).

This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to participation in the study.
* Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
* BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

* CNV secondary to other causes in the Study Eye.
* Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
* Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
* Active ocular or periocular infection or inflammation.
* Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
* Uncontrolled glaucoma in the Study Eye.
* Women who are pregnant or lactating or intending to become pregnant during the study.
* Stroke or myocardial infarction in the 6-month period prior to Day 1.
* Uncontrolled blood pressure defined as a systolic value \> 180 mmHg or diastolic value ≥100 mmHg while at rest.
* History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
* Other protocol-specified exclusion criteria may apply.
MUltiple Sclerosis and Extract of Cannabis (MUSEC) Study

Study Objectives: To determine the efficacy and safety of a standardised extract of Cannabis sativa given orally 2 times daily as compared to placebo for the relief of muscle stiffness and pain in multiple sclerosis for a period of 12 weeks.

Study Patients: 400 patients with multiple sclerosis (age 18-64, stable disease during previous 6 months, ambulatory or not, antispasticity medication and physiotherapy stabilised ≥ 30 days) with experiencing muscle stiffness ≥ 4 on a 11-point numerical Likert scale at baseline.

Study treatment:

Group 1: Cannabis extract (delta-9-THC 2.5mg, CBD 1.25 mg per capsule), flexible dosing between 5 mg and 25 mg THC/d, administered twice daily, additionally to previous antispasticity and analgesic medication.

Group 2: Matched placebo, twice daily, additionally to previous antispasticity and analgesic medication.

Treatment Schedule: Start dose 5 mg THC/d, individual dose titration with increase of 5 mg THC every 3 days, maximal total daily dose 25 mg THC, administered as 2 equal doses based on tolerability. Treatment duration: 12 weeks.

Study sites: 20 neurological clinics in the United Kingdom.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Diagnosis of MS according to McDonald criteria.
* Current muscle stiffness ≥ 4 on a 11-point categorical rating scale.
* On-going troublesome muscle stiffness for at least 3 months.
* Stable disease for the previous 6 months.
* Antispasticity medication and physiotherapy stabilised for the last 30 days.
* Patients may be ambulatory or not.
* Age 18-64.

Exclusion Criteria:

* Immunosuppressants which may affect spasticity (including corticosteroids and interferon but ex-cluding azathioprine) taken currently or in previous 30 days
* Past or present history of psychotic illness.
* Open/infected pressure sores or other source of chronic infection.
* Significant fixed tendon contractures.
* Severe cognitive impairment such that the patient is unable to provide informed consent.
* History of clinically important renal, cardiovascular or neurol. diseases (apart from MS).
* Malignancy within the past 2 years.
* Cannabinoids taken currently or in previous 30 days.
* Positive qualitative urinary test on cannabinoids at screening visit. (In this case a patient will be allowed to repeat the test at a second screening visit later.)
* Known hypersensitivity to cannabinoids.
* Current drug abuse, including alcohol abuse.
* Laboratory parameters outside the following limits:

Creatinine \> 3x upper limit of normal Bilirubine \> 3x upper limit of normal Transaminases \> 5 x upper limit of normal

* Anticipated immunisations within the 12 weeks of trial participation.
* Other problems likely to make participation difficult at the discretion of the neurologist.
* Women who are pregnant, lactating or not using adequate contraception.
* Participation in other treatment studies currently or within the previous month.
Impact of Consuming a Plant-based Enriched Meal on the Adult Gut Microbiome

The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years,
* Healthy participants, both male and female,
* BMI in the normal and overweight range 18.5 ≤ BMI ≤ 29.9 kg/m2,
* Able to understand and to sign a written informed consent prior to study enrolment.

Exclusion Criteria:

* Known chronic diseases or conditions for which the investigators/investigation team deem as not suitable for study participation,
* Known food allergy and intolerance e.g. lactose intolerance, nuts allergy,
* Habitually, have \< 5 spontaneous bowel movements on average per week,
* Chronic or recurrent diarrhoea with spontaneous bowel movements \> 2 per day
* Prior gastrointestinal surgery (apart from appendectomy or herniotomy),
* Received systemic antiviral/antibacterial/antifungal therapy during the 3 months prior to study enrolment,
* Medications or supplements that are known to alter gut function or microflora i.e. acid antisecretory drugs, pre-/probiotics, laxative during the 4 weeks prior to study enrolment,
* Anti-hyperlipidaemic, antihypertensive medications and/or anticoagulant agents,
* Currently participating in another interventional clinical trial or research project,
* Alcohol intake \> 2 servings per day; specifically, a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. Or other chronic substance abuse,
* Changing diet patterns due to travelling and staying abroad for more than two weeks (Asia, Africa, or Latin America) during the two months prior to study enrolment,
* Food restrictions such as vegan, vegetarian, ketogenic, low carb, paleo, raw diets, caloric restrictive diets,
* Artificially sweetened beverage intake \>1000 ml/ per day,
* Female participants will be excluded if they are pregnant, have given birth in the last 6 months, or are lactating,
* Subject having a hierarchical or family link with the research team members,
* Occurrence of fever episodes, infection, or vaccination during 14 days before the start of the study.
Effectiveness of Basic Life Support Training for Rural Community Dwelling Elderly

The goal of this pre-post study is to test the effectiveness of basic life support (BLS) training for rural community-dwelling Elderly. The main question it aims to answer are can the training program tailored for rural elderly improve basic life support knowledge, attitude, and skills? Participants will receive an innovative BLS training program.


Eligibility Criteria:
Inclusion Criteria:

age older than 65-year-old, intact cognition, coordinated activities, and no history of severe cardiovascular disease, asthma, or lower extremity impairment.

Exclusion Criteria:

severe visual and hearing impairment, impractical to move, and mental illness.
Efficacy and Effectiveness of a Self-applied Online Program to Promote Resilience and Coping Skills in College Students

This study aims to evaluate the effectiveness and efficiency of this intervention protocol applied to three populations of Spanish-speaking university students (Spain, Argentina and Mexico). The purpose of this paper is to present the protocol designed to carry out the randomised controlled study (RCT).

This study is a multi-country randomized controlled trial (RCT) with three groups comparing efficacy of unguided Internet-based intervention for students low on resilience with three conditions: a) unguided web-based resilience intervention (CORE); 2) Healthy lifestyle psychoeducationalprogram (HLP); and 3) Care as usual condition (CAU). Online- and telephone assessments will be conducted at pre- and post-intervention, and at 6- and 12-month follow-up (see Figure 1). Participants will be randomized in a 1:1 ratio. Randomization will be stratified according to trial site.

The aim of this trial is to evaluate the efficiency and effectiveness of an Internet-based programme developed to promote resilience and coping skills among at-risk university students in Spain, Argentina and Mexico. The specific aims are:

1. To provide a preventative online intervention for enhancing resilience for decreasing symptoms of depression and anxiety and for increasing wellbeing
2. To evaluate the effectiveness and acceptability of CORE program in a randomized controlled trial compared with two conditions, Healthy lifestyle (HTP) and care as usual (CAU).
3. To analyze feasible strategies to implement CORE and to identify possible implementation barriers from final users, professionals of University counseling services and the University authorities in three Spanish-speaking countries.

Eligibility Criteria:
Inclusion Criteria:

* University students with a standard deviation score below the sample mean on the Connor-Davidson Resilience Scale (CDRISC-25).
* Adequate knowledge to understand and read Spanish and/or be Spanish-speaking.
* Internet access and computer skills.

Exclusion Criteria:

* University students who are on a waiting list for psychotherapy or who are or have been undergoing psychotherapy in the last 12 months.
* Individuals with a current or past psychotic or bipolar disorder.
* Individuals at risk of suicide.
Study of Sleep and Delirium in the Intensive Care Unit (ICU)

The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.

Delirium and sleep disruption are both common in the intensive care unit (ICU). Delirium is a state of acute confusion, experienced especially by older adults admitted to the hospital, with the potential to adversely impact patients' outcome. Of hospitalized patients, the highest rate of delirium occurs in elderly patients in the ICU. Development of ICU delirium is associated with longer ICU and hospital length of stay, significantly higher risk of functional decline, loss of independent living, and increased mortality. Previous studies have focused on describing the clinical manifestations, risk factors and outcomes of ICU delirium; yet, the contribution of sleep timing, as well as its quality and quantity, to the development of delirium, has not previously been rigorously investigated. Sleep disturbance, including changes in sleep patterns and architecture, and decreased quality of sleep are commonly observed in older subjects. In the ICU, environmental factors (such as noise levels and continuous ambient light) and health care practices (such as frequent performance of medical procedures and tests) further contribute to sleep disruption in the critically ill older patients. Additionally, many sedative and analgesic agents potently suppress slow wave sleep. In preliminary data acquired from ICU patients, the investigators have observed that fragmented sleep is prevalent due to frequent arousals and awakenings, and that sleep architecture is altered with an increase in light sleep, and a decrease in restorative slow wave sleep. Despite the common occurrence of both ICU delirium and sleep disruption, it is not known whether sleep disruption increases the risk of developing delirium in the critically ill older patients. In this exploratory study, the investigators propose to test the hypothesis that the severity and duration of sleep disruption is an independent predictor of the onset and duration of ICU delirium in a cohort of older ICU patients. The investigators will measure sleep disruption using continuous processed electroencephalography and measure ICU delirium using a well-validated and reliable standardized instrument. Results from this study will inform the contribution of sleep disruption in the development of ICU delirium in the older critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 45 years of age admitted to the ICU, and remain for at least 24 hours.

Exclusion Criteria:

* status post craniotomy,
* moribund state with planned withdrawal of life support,
* severe dementia,
* substantial hearing impairment or inability to understand English.
Clinical Evaluation of ACUVUE® OASYS® 1-Day and ACUVUE® OASYS®

The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.

After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent form;
* Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months;
* Prescription within power range of both study contact lenses, as stated in the protocol;
* Cylinder equal or lower than -0.75 diopter (D) in both eyes;
* Willing to wear lenses every day or at least a minimum of 5 days per week, 6 hours per day;
* Willing to discontinue artificial tears and rewetting drops on the days of study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Current AO1D or AO lens wearer;
* Other protocol-specified exclusion criteria may apply.
Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome

The aim of this study was to determine the level of salivary estradiol, progesterone and dehydroepiandrosterone in female postmenopausal women with and without burning mouth syndrome. In all participants the quantity of unstimulated and stimulated saliva would be determined and they would fulfill self-perceived quality of life questionnaire Oral Health Impact Profile-14 (OHIP-14). Intensity of burning symptoms would be determined on visual-analogue scale grading 0-10. All data would be compared between study and control group.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women with burning mouth syndrome

Exclusion Criteria:

* women with burning mouth syndrome who are not in menopause
Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery

Erector spinae plane block (ESPB) is a novel regional block technique that was proven to have superior outcomes in relieving postoperative pain in colorectal surgeries.Ketamine enhances the impact of local anaesthetics by reducing the duration and extent of motor block while shortening the onset of sensory and motor block.Transdermal Fentanyl Patch (TFP) was better than transdermal buprenorphine in postoperative analgesia following abdominal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing laparoscopic colorectal surgery.
* American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

* Known allergy to one of the study medications.
* Skin infections at the site of the needle puncture.
* Hepatic, renal or cardiac dysfunction.
* Patients diagnosed with obstructive sleep apnoea
Study of Sexuality in Parkinson Disease

The aim of this study is to evaluate the different aspects of sexual function among adults with Parkinson Disease to develop a treatment and address sexual problems as a routine part of diagnostic workup and therapeutic planning.

Because there is limited literature on sexual function in Parkinson disease, in this study, we examined sexual functioning in a large groups of patients with idiopathic Parkinson Disease compared with healthy subjects in the Italian community. To assess sexual function in PD we used the Brief Index of Sexual Functioning \[(BISF-M for man; BISF-W for woman), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI). Participants were also assessed by the Beck Depression Inventory (BDI).

This study aimed to provide a thorough epidemiological description of sexual dysfunction in Parkinson's disease. The knowledge of sexual function in PD might help to plan effective interventionist measures and ultimately to optimize patient's and the partner's quality of life.

Parkinson patients (aged 40-80) and 123 healthy controls (aged 40-80) will be recruited from four Italian Movement Disorders Clinics.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic PD
* marital status
* age 40-80

Exclusion Criteria:

* patients taking PDE
Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.

There is a complex pathobiology behind OM; chemo and radiotherapy affects the mucosa and submucosa causing DNA-strand brakes and generation of reactive oxygen species (ROS). This initiates a cascade of events, among others activation of transcription factors, up-regulation of pro-inflammatory cytokines, and activation of macrophages and proteases leading to tissue injury causing symptoms such as erythema, edema, ulceration, taste perception alterations, and mouth dryness. OM often causes local and systemic infections, fatigue, pain, and difficulties in basal functions such as swallowing (and hence drinking and eating) and talking and reduces patients' psychological well-being. Nearly 90 % of pediatric patients undergoing HSCT are afflicted with OM. In pediatric patients mucositis is reported as one of the most painful and debilitating side effects during cancer treatment.Beyond a significant suffering for the patient it is hence associated with higher costs for health care and increased mortality.

The current scientific situation regarding prevention and treatment of OM has been summarized in Cochrane reports showing limited data on adults and practically missing data on children and adolescents. Concluding guidelines from these reports emphasize the need for well conducted randomized controlled trials (RCT's) to evaluate and refine treatments in order to establish evidence based interventions.

The use of cryotherapy to prevent oral mucositis in patients who are receiving high-dose chemotherapy as a conditioning agent prior to HSCT continue to show evidence in the adult population.

The aim of this study is to compare treatment with cryotherapy (Arm 1)with a standard oral care protocal (Arm 2)

ARM 1 Children are instructed to use chew on ice-chips, ingest ice-cream or ice-water during infusion of chemotherapy as part of the conditioning treatment prior to HSCT. Melted ice should be replaced by new as soon as possible. Children receiving a 24-hour infusion are instructed to use cryotherapy for one hour 4 times a day.

ARM 2 Standard care for prevention and management of oral mucositis

Primary outcome

* Degree and duration of Oral mucositis

Secondary outcomes

* Oral pain
* Opioid use
* Duration of parenteral nutrition
* Weight loss
* Duration of neutropenic fever
* Duration of antibiotic treatment
* Duration of hospitalization
* Emotional and psychological status
* C reactive protein (CRP) and s-albumin correlation to grade of Oral Mucositis

Eligibility Criteria:
Inclusion Criteria:

Age between 4-18 Undergoing Hematopoietic Stem Cell Transplantation in Sweden sufficient knowledge in swedish to understand the protocols -

Exclusion Criteria:

-