cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

This trial is conducted in Asia, Europe and North America. The purpose of the trial is to evaluate the safety and efficacy of turoctocog alfa in prevention and treatment of bleeds in previously untreated children with haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Age below 6 years
* Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
* Male patients diagnosed with congenital severe haemophilia A (FVIII level equal to or below 1%)
* No prior use of purified clotting factor products (previous exposure, equal to or less than 5 ED to blood components, e.g. cryoprecipitate, fresh frozen plasma, is accepted) including commercially available NovoEight® /Novoeight®

Exclusion Criteria:

* Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
* Previous participation in this trial defined as withdrawal after administration of trial product
* Congenital or acquired coagulation disorders other than haemophilia A
* Any history of Factor VIII inhibitor
* Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG), routine systemic corticosteroids)
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.

1. To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus ribavirin combination therapy) and patients with other forms of liver diseases undergoing liver biopsy as controls.
2. To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls.
3. To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.

Eligibility Criteria:
Inclusion Criteria:

BLVRA expression study

* Therapeutically naïve HCV patients undergoing antiviral treatment with peg-interferon plus ribavirin combination therapy

BLVRA genetic polymorphisms study

* HCV infected patients prior, during, after or without antiviral therapy

Exclusion Criteria:

* Co-infection with HAV, HBV and HIV
* Disorders of heme metabolism
The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease

The objective of this experiment is:

* Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD.
* Secondary: To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise stress.

Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it can drastically reduce quality of life. It has been hypothesized that tyrosine may impact upon individuals suffering from PD. There is ample evidence in animal models that supports our theory; however there is no clinical evidence of the impact tyrosine supplementation may have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses. Positive findings that supplemental tyrosine increases BP and HR in people with PD during daily activities such as standing up from a chair and walking can lead to new therapies to improve Parkinsonian orthostatic hypotension.

Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve after tyrosine supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD according to the UK Brain Bank Diagnostic criteria
* Diagnosis of orthostatic hypotension according to EFNS guidelines
* Able to walk on a treadmill comfortably for 6-10 minutes
* Currently taking levodopa
* Subjects between the age of 50-80 years old

Exclusion Criteria:

* Currently taking an amino acid supplement
* Currently taking medication that affects BP
* Normal BP response to testing
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a primary diagnosis of ADHD
* Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

* Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms
* History of seizure during the last 2 years
* Subject has any specific cardiac condition or family history of significant cardiac condition
* Subject is pregnant or lactating
Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.

Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

Eligibility Criteria:
Inclusion Criteria:

* BMI\<40 kg.m-2;
* Age over 18 years;
* American Society of Anesthesiologists' physical status status I-III
* who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent

Exclusion Criteria:

* Pregnancy
* Recent upper gastrointestinal bleed (\< 1 month)
* Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors)
* Previous surgical procedures on the esophagus, stomach, or upper abdomen
* Gastroesophageal reflux disease
* Previous use of prokinetics or high doses of opiates.
Multi Cervical Unit Measures of Cervical Isometric Strength and Range of Motion: A Pilot Study

This study is designed to collect normative data on cervical isometric strength and range of motion to supplement an existing normative data base.


Eligibility Criteria:
Inclusion Criteria:

* Logan students, faculty and staff

Exclusion Criteria:

* recent surgery,or unstable or fused joints of the cervical spine
* using medications, prescription or herbal muscle stimulants, relaxants, etc
* previous cervical spine injury, surgery or condition that would affect your range of motion in the cervical spine
* currently have any local infection, injury or other malignancy affecting the cervical spine
* congenital conditions affecting the cervical spine, i.e. block vertebrae
* systemic illness with an adverse effect on the cervical spine
* a history of dizziness, light headedness or passing out, or any seizure disorder
* had a neck, shoulder or back injury
* ever been in an automobile accident
* exercise regularly
* pregnant
* spinal manipulation mobilization or other therapy in the last 48 hours
Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide \<0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.

Eligibility Criteria:
Inclusion Criteria:

1. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).

Exclusion Criteria:

1. Inability to provide written informed consent.
2. Mentally unstable and/or unable to comply with the procedures of the study protocol.
3. History of any solid organ transplant.
Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment

This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.

After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.

After signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.

1. Treatment group: The r-hFSH starting dose will be based on the patient's profile and physician's experience. r-hLH will be added at a ratio of 2:1 starting from day 1 of r-hFSH administration; the dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patient's ovarian response, and the r-hFSH: r-hLH dose will be 2:1, continuing to 24\~48 hours prior to trigger drug injection.
2. Control group: r-hFSH alone will be administrated for ovarian stimulation. The r-hFSH starting dose will be based on the patient's profile and physician's experience. The dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patient's ovarian response, continuing to 24\~48 hours prior to trigger drug injection.

The estimated treatment duration is 11 days from the first day of COS until 24\~48 h prior to trigger drug injection, and this may vary depending on individual circumstances.

Follicular development, serum E2 and P levels will be monitored during COS according to the investigator site's ART practice until the criteria to administer trigger drug are met to induce final oocyte maturation. Trigger drug administration is to be performed according to the site's routine clinical practice.

Oocyte pick-up (OPU), IVF/ICSI, ET, and luteal phase support (LPS) will be performed according to the site's routine practice. LPS will be started after oocyte retrieval in fresh embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* Age 35 to 40 (including 40)
* 18.5\<BMI\<28 kg/m2
* AFC up to 14
* First or second ART cycle
* Planned for ovarian stimulation with GnRH-antagonist for down-regulation
* Ejaculated sperm

Exclusion Criteria:

* Contraindications to ART treatment
* History of two or more spontaneous miscarriages
* History of two or more implantation failures after fresh or frozen-warmed embryo transfers
* Diagnosis of severe endometriosis
* Patients with endocrine and metabolic diseases (diabetes mellitus, hypogonadotropic amenorrhea, genital system tumors, hyperprolactinemia, etc.)
* Confirmed chromosomal abnormalities
Clinical Trial of Two Techniques for Gingival Displacement

Regardless of the selected technique for dental impression, gingival displacement is an essential procedure specially when making impressions of subgingival finishing lines, because a moisture-free sulcus is a requirement for an effective impression.

The objective of this randomized clinical study is to evaluate the efficacy of the conventional and cordless gingival displacement (GD) techniques.

On conventional technique we normally use a cord for gingival displacement. On the other hand, on cordless technique do not require this need.

Eligibility Criteria:
Inclusion Criteria:

* good general and dental health
* at least two anterior teeth with an indication of prosthetic dental crown

Exclusion Criteria:

* smoking habits
* systemic diseases
* pregnant
* had not consumed antibiotics or anti-inflammatory drugs in the last 60 days
* the selected teeth must have good periodontal health characterized by regular gingival margin with at least 2 mm of attached gingiva, non-fibrotic gingival tissue, no marginal recession, probing depth ≤ 3 mm, no evidence of significant loss of bone insertion and present no visible plaque and gingival bleeding
Parental Representations of the Impact of the Use of Screens on Their Preschool Children Health and Development.

The main objective of this study was to evaluate the distribution of parental representations concerning the use of screens by preschool children, expressed in qualitative surveys: perceptions of screens as a source of learning, a source of appeasement, a source of behavioral difficulties and a source of reduction in the social interactions of young children.

The hypothesis of this study was the representations expressed in the qualitative studies were the reflection of the opinion of a majority of parents of young children.


Eligibility Criteria:
Inclusion Criteria:

* parents of 2-6-years-old preschool children

Exclusion Criteria:

* Minor parents
A Six-Month Prospective Follow-Up Study of WB001

This study is a 6-month follow-up study to WB001-001 conducted to assess and evaluate the durability of the effect of {WB001+TAU} beyond the 8-week treatment period.

This study is a 6-month prospective, observational follow-up study to the WB001-001 trial. Participants will be a convenience sample of those enrolled in the WB001-001 parent trial who consent to participate in a follow-up study at baseline for WB001-001. After completion of WB001-001's EOT assessment, those consenting to participate in the current study will be screened to confirm eligibility. Eligible participants will complete six assessment batteries (patient-reported outcomes \[PROs\]) on a monthly basis for a 6-month observation period.

Eligibility Criteria:
Inclusion Criteria:

1. Must have prior enrollment in the WB001-001 trial and completion of Week 8/EOT
2. Must be willing and able to comply with all study procedures

Exclusion Criteria:

1. Documented AE or SAE at WB001-001 Week 8 related to participant safety, by Investigator judgement
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat FTR

evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tricuspid regurgitation

evaluation of safety and efficacy of 'Pivot Bridge' to short-term treat Functional Tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t study

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females aged 20 years or above
* Patients with clinical symptoms (Symptomatic) whose degree of tricuspid regurgitation using echocardiography meets the criteria of Severe or higher presented in the TR grade classification table
* Short-term treatment using a catheter is required (expected to be effective) by a local site heart team including at least one cardiothoracic (cardiovascular) specialist and at least one thoracic surgeon each, and clinical symptoms of NYHA Class Ⅱ or higher person who falls under
* In the screening test, A person who can confirm the possibility of reducing tricuspid valve regurgitation by inserting that 'Pivot Balloon' (Clinical Trial Approval No. 1327), etc.) through the same access path as the 'Pivot Bridge', a clinical trial medical device
* An individual who voluntarily agreed to the participation in the clinical trial and signed the written consent
* An individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial

Exclusion Criteria:

* Uncontrolled hyperthyroidism
* A recent formation of soft blood clot or embolic material
* Uncorrected coagulopathy
* Prohibition of anticoagulant agents
* Those who had experience with anticoagulant use prior to participation in this clinical trial and who were treated with major bleeding (minor bleeding such as nosebleeds that can be hemostasis not applicable) due to anticoagulant use at this time or accompanied by severe anemia requiring hospitalization one with experience
* Previous insertion of a device such as an Implantable Cardioverter Defibrillator (ICD) or a pacemaker
* Those who is judged to have little possibility of reducing tricuspid valve regurgitation by inserting a balloon-type device (e.g. ASD sizing balloon, pivot balloon, etc.) through the same access route as the clinical trial medical device 'Pivot Bridge'
* Persons with an anatomical structure that cannot be inserted through the corresponding route
Hemostatic Textile to Control Bleeding at Donor Graft Sites

The rationale underlying the study is that donor site bleeding is common and often problematic when presenting to the burn surgeon or staff. Frequently, gauze wound dressings are not sufficiently hemostatic to control a donor site bleed thereby leading to administration of vasoconstrictive agents and repeated application of wound dressing/pressure. The hemostatic textile Stasilon™ has proven superior to gauze in reducing bleeding from anesthetized pigs undergoing standardized surgically-induced trauma. Also, observational case reports have noted cessation of bleeding in a limited number of human patients with difficult to control bleeds.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years old
* burn injury requiring allografting from donor site

Exclusion Criteria:

* \< 18 years
* unable to give consent due to mental or emotional instability
Pharmacovigilance in Gerontopsychiatric Patients

The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment.

The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises.

To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites.

At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed.

Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system.

In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually.

2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.


Eligibility Criteria:
Inclusion Criteria:

* Age 65+ years old
* Inpatients treated at one of the geriatric psychiatry study sites.
* Signed consent form ( Patient and/or legally authorized custodian)

Exclusion Criteria:

* Patients that are incapable to give their informed consent and are not under legally authorized custodianship.
* Parallel participation in another clinical trial.
Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.

Primary objective

- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.

Secondary objectives:

* To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.
* To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.
* To investigate safety and tolerability of Jalosome®.
* To investigate patient's compliance to Jalosome® treatment.
* To investigate patient's global satisfaction with Jalosome® treatment.

Primary endpoint:

* Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.

  • Secondary endpoints:
* Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.
* Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.
* Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.
* RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.
* Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.
* Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.
* Patient's compliance to Jalosome® treatment.
* Patient's global satisfaction with Jalosome® treatment.
* Jalosome® overall safety and tolerability.

Study design:

Monocentric, randomized, double-blind, placebo controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subject aged ≥18 years old.
* Performance status 0-1.
* Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
* Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
* Willingness and ability to give informed consent and comply with study procedures.

Exclusion Criteria:

* Pregnant or lactating women.
* Previous RT on the head and neck area.
* Planned to receive concurrent cetuximab.
* Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
* Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
* Use of a tissue-equivalent bolus.
* Use of over-the-counter topical medications containing steroids.
* Presence of rashes or unhealed wounds in the radiation field.
* Recent sun exposure (\<1 month).
* Mental conditions that could adversely affect subject's adherence to the study.