cyrilzakka/clinical-trials huggingface dataset:
Folate Supplementation in Schizophrenia

This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.

This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:

* To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
* To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
* To examine the efficacy of folate supplementation for reducing negative symptoms

Eligibility Criteria:
Inclusion Criteria:

1. Schizophrenia, any subtype
2. Ages 18-68
3. Male or female
4. A score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale
5. Stable antipsychotic dose for \> 6 weeks
6. Capable of providing informed consent

Exclusion Criteria:

1. Unstable medical illness
2. Substance abuse
3. Megaloblastic anemia
4. Non-english speaking
Guidelines for Post-exercise Dietary Intake in T1DM

The investigators hypothesise that manipulating the glycaemic index of the meal after exercise and before sleep will help prevent Type 1 diabetes individuals experiencing hypoglycaemia.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-50 years old (male or female).
* Free from any diabetes related complications (apart from mild background diabetic retinopathy).
* HbA1c \<8.5%.
* Not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study.
* Demonstrate normal cardiac function in response to exercise.

Exclusion Criteria:

* Aged younger than 18, or older than 50 years.
* Suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy).
* HbA1c \>8.5%.
* Currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study.
* Failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.
A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections

RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs

The main goal of this study was to assess to what degree disease activity assessment is influenced and supported by the enrichment of OCT images with segmentation information (i.e. by identification, highlighting and quantification of pathological fluid compartments associated with neovascular activity).

The study comprised a prospective data collection phase and a retrospective analysis of OCT images phase. The prospective observation period per patient was up to 12 months.

The study included patients (naïve patients and patients who had been pre-treated with licensed anti-VEGFs not more than 3 years) being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nAMD
* Male and Female patients with ≥18 years of age at index
* Receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during the recruitment period
* Signed written informed consent
* Patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically indicated according to the respective label
* Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening

Exclusion Criteria:

* Patients treated for any other retinal disease than nAMD within 6 months prior to the index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema, myopic CNV, and have diagnoses of diabetes-related macular degeneration)
* Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at screening
* Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
* Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
* Patients who have any contraindication and are not eligible for treatment with the chosen anti-VEGF treatment as according to the respective label.
* Any medical or psychological condition, in the treating physician's opinion, which may hinder the patient from participating in this study for the expected 12 months
* Patients participating, in parallel, in an interventional clinical trial
* Patients participating, in parallel, in any other Novartis sponsored NIS generating primary data for an anti-VEGF drug
A Study of AK130 in Patients With Advanced Malignant Tumors

A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
3. Life expectancy ≥3 months.
4. Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
5. Subject must have at least one measurable lesion according to RECIST Version1.1.
6. Adequate organ function.

Exclusion Criteria:

1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
2. Receipt of any anti-TIGIT, anti-TGF-β treatment.
3. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.
4. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
5. Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.
6. History of organ transplant.
7. Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.
The Effect of Therapeutic Play on Pain, Fear and Emotional Indicator

This study was planned to determine the effect of therapeutic play and preparation for hydrotherapy treatment on pain, fear and emotional indicator levels in children with burn injuries.

It is an experimental randomized controlled study. The population of the research will be children between the ages of 3-6 who are hospitalized in the Pediatric Burn Intensive Care Unit. As a result of the power analysis using the G\*Power 3.0.10 program, at least 52 children in total (control group 26, therapeutic play group 26) with 50% power, 0.05 alpha margin of error, 0.80 beta margin of error and 20% effect size. was determined to be included in the study. However, considering the case losses, the number of children to be included in the study was determined as 64 by increasing the sample size by 20%. The data will be collected between the dates to be determined by the researcher after obtaining the ethics committee approval and written permission from the institution where the research will be conducted. Introductory information form, FLACC Pain Scale, Child Fear Scale and Child Emotional Indicators Scale will be used to collect research data.

The research will be conducted with the children of parents who agreed to participate in the study. There are two groups, the control group and the experimental group. While the routine practice of the clinic will be applied to the control group, creative therapeutic games will be played to the experimental group together with the routine practice. Children will be stratified according to their pain scores, fear scores and burn depth (degree) and will be assigned to an equal number of children in each group using the blocking method. Before the procedure, the introductory information form will be filled in by the researcher in line with the patient file and parent information. After parents are informed about which group the child is in, their written consent will be obtained.


Eligibility Criteria:
Inclusion Criteria:

* The child is between 3-6 years old
* The child is receiving the first hydrotherapy treatment in the clinic.
* Presence of second and/or third degree superficial and/or deep burns
* Volunteering of the child and family to participate in the research
* The child was given analgesics half an hour before the procedure.
* No simultaneous debridement during hydrotherapy
* Burn width between 20%-70%

Exclusion Criteria:

* The child is younger than 3 years old, over 6 years old
* Presence of any other chronic disease other than burns
* The child is receiving mechanical ventilator support.
* Having a trecheostomy done to the child
* The child has been given sedative medication in the last 8 hours.
* Having a companion other than mother or father
* Hydrotherapy treatment takes less than 30 minutes, more than 45 minutes
* The child does not want to play
Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD

A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD).

This will be a phase II, multi-centre, randomized, double-blind, placebo-controlled study designed to assess preliminary efficacy, safety and pharmacokinetics (PK) of 2-7 days continuous IV administration of sevuparin for the management of acute VOC in subjects with SCD.

Adults and adolescents ≥ 12 years of age will be randomized to treatment with sevuparin or placebo (ratio 1:1).

Eligibility Criteria:
Inclusion Criteria:

* Sign a written informed consent (adults, parents) and assent (adolescents)
* Male or female, age 12-50 years.
* Diagnosis of Sickle cell disease
* Subjects admitted for an acute, painful VOC to be treated/or treated with parenteral opioid analgesia.
* Expectancy of need for hospitalization during at least 48 hours.
* Be at least 1 year postmenopausal, surgically sterile, or if Women of Child Bearing Potential (WOCBP), e.g. following menarche practicing an effective method of birth control

Exclusion Criteria:

* Severe hepatic failure/disease, abnormal liver enzyme tests or history of hepatitis B virus (HBV), hepatitis C virus (HCV)
* Abnormal conjugated (direct) bilirubin 3 fold above ULN
* History of clinically significant bleeding in vital organs
* Current clinically significant bleeding, as judged by the investigator
* Current use of acetylsalicylic acid (ASA), anti-platelet therapy, anticoagulant therapy
* Abnormal coagulation laboratory values
* A platelet count \<75,000/µL.
* BMI \>35
* Subjects with more than 5 hospitalizations for VOC during the last 6 months
* Evidence of acute SCD complications other than VOC at screening
* The use of strong opioids for \> 3 consecutive days during the last 15 days before presenting to the hospital
* History of chronic drug abuse.
* Renal dysfunction
* Known infection (positivity) with human immunodeficiency virus (HIV), HBV or HCV.
* Significant ECG abnormality
* History of a clinically significant drug allergy to heparin, LMWH's, sevuparin, or morphine.
* Use of any investigational agent during the 30 days prior to the first dose.
* For females: pregnancy, lactating or intention of becoming pregnant
* Evidence of clinically significant disorders that might interfere with the study aim or safety of the subject
* Any condition that, in the view of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.
Postoperative Remote Monitoring of Vital Signs in Older Cardiac Surgery Patients

A significant number of elderly patients experience a complication after cardiac surgery. This study aims to determine if postoperative remote monitoring of vital signs can be used to identify medicatie risk factors for vital sign deterioration in older cardiac surgery patients.

* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs after ICU discharge
* Main study endpoint is vital sign deterioration.

Cardiac surgery in elderly patients aims to improve functional capacity and overall survival but may also precipitate major morbidity and mortality. Despite major improvements in the safety of anesthesia and surgery a significant number of elderly patients experience a complication after cardiac surgery.

To determine if postoperative remote monitoring of vital signs can be used to identify medication risk factors for vital sign deterioration in older cardiac surgery patients..

* Single center pilot study.
* 100 older patients undergoing cardiac surgery.
* Continuous remote monitoring of vital signs starts after ICU discharge
* PR, RR and SpO2 will be continuously monitored in all patients.
* Patients and healthcare personnel are blinded for monitoring results.
* Main study endpoint is vital sign deterioration.

The study population includes 100 patients ≥70 years undergoing elective cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* ≥70 years undergoing elective cardiac surgery.

Exclusion Criteria:

-
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in subjects with acne vulgaris following 28 days of dosing.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acne vulgaris
* Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) throughout the study
* If male, the subject must agree to shave the facial treatment area and agree to maintain his routine shaving regimen for the duration of the study
* willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip makeup), and chemical peels throughout the study

Exclusion Criteria:

* Oral acne treatments within 6 months
Flap Sparing in Postoperative Radiotherapy of Oral Cavity Cancers

Patients with oral cavity cancer treated by reconstructive surgery with a flap.

Patients will be treated in the study for :

* Experimental arm: Post-operative radiotherapy with flap sparing
* Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT)

Patients with oral cavity cancer treated by reconstructive surgery with a flap.

Patients will be treated in the study for :

* Experimental arm: Post-operative radiotherapy with flap sparing
* Control arm: Standard post-operative radiotherapy without flap sparing (current practice) Radiotherapy by IMRT using photons or proton therapy (IMPT) Our purpose is to demonstrate the feasibility of sparing surgical flaps from radiotherapy, in order to reduce toxicity while maintaining local disease control.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Performance Status 0-2
* Patient with oral cavity cancer (soft tissue or soft tissue-bone flap), treated by reconstructive surgery with a flap. Oropharynx cancer whose flap extends significantly into the oral cavity may be included in the study
* Quality of resection with margins \> 1 mm
* Patient candidate to post-operative radiotherapy (Intensity-Modulated Radiation Therapy (IMRT) or proton therapy)
* Concomitant chemotherapy is allowed (stratification parameter)
* Patient must have signed a written informed consent form prior to any trial specific procedures
* Patient affiliated to the social security system

Exclusion Criteria:

* Local flap (small size limiting IMRT modulation potential)
* History of radiotherapy of head and neck area
* Metastatic disease
* History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
* Simultaneous participation in another clinical study may compromise the conduct of this study.
* Pregnant or lactating women
* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
* Patient deprived of freedom or under guardianship
Efficacy & Safety of Nasal Influenza Immunisation in Children

The UK Departments of Health now recommend annual influenza vaccination for all children 2-7 years of age, with children over 7 years eligible for vaccination if in certain higher risk clinical categories. Though data are available documenting the safety and immunogenicity of LAIV in this age group, there are little data to assess efficacy and immune correlates in UK children, and in particular atopic children. This study will enrol 200 children (and at least 200 unvaccinated household sibling controls), many with a history of asthma or recurrent wheezing, and allow an assessment of efficacy, safety and immune correlates in these children, and how this varies with prior administration of pandemic influenza vaccine and/or LAIV.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 - 18 years old
* Written informed consent from parent/guardian (or patient themselves from age 16 years), with assent from children aged 8 years and above wherever possible.

Exclusion Criteria:

* Hypersensitivity to the active ingredients, gelatin or gentamicin (a possible trace residue) \[notwithstanding allergy to egg protein\]
* Previous systemic allergic reaction to LAIV
* Previous allergic reaction to an influenza vaccine (not LAIV) is a relative contra-indication, which must be discussed with the site PI to confirm patient suitability
* Children/adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids\*\*.

  \*\*High-dose steroids is defined as a treatment course for at least one month, equivalent to a dose of prednisolone at 20mg or more per day (any age); or for children under 20kg, a dose of 1mg/kg/day or more.
* Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
* pregnancy
* Febrile ≥ 38.0 'C in last 72 hours
* Acute wheeze in last 72 hours requiring treatment beyond that normally prescribed for regular use by the child's treating healthcare professional
* Recent admission to hospital in last 2 weeks for acute asthma
* Current oral steroid for asthma exacerbation or course completed within last 2 weeks
* Received any blood or blood products within the past 12 weeks
* Any other significant condition or circumstance which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Positron Emission Tomography/Computed Tomography (PET/CT) Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Tolerability and Diagnostic Performance of BAY86-4367 in Patients With Prostate Cancer and Healthy Volunteers

Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-4367 in patients with cancer


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers:

  * males, \>/=50 and \<= 65 years of age
* Cancer patients:

  * males \>/= 45 years of age
  * patients with recurrent prostate cancer had a positive choline PET/CT for detection, or staging, or restaging of cancer, evaluation of the primary prostate cancer detection rate with BAY 86-4367 in comparison to histology as standard of truth (choline PET/CT is optional).

Exclusion Criteria:

* Exclusion criteria for all healthy volunteers and patients:

  * Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY 86-4367, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
  * Known sensitivity to the study drug or components of the preparation.
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)

Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-37
* Female
* Less than two previous unsuccessful IVF cycles

Exclusion Criteria:

* Day 3 FSH \>9.9
* Fewer than 8 mature oocytes retrieved
* Fewer than 8 normally fertilized embryos on day 2 after fertilization