cyrilzakka/clinical-trials huggingface dataset:
Open-label, Uncontrolled Postmarketing Study of Cell-derived A/H1N1 Influenza HA Vaccine in Japanese Elderly Subjects

This is to evaluate immunogenicity based on EMEA/CHMP criteria, and safety \& tolerability of cell-derived A/H1N1 influenza HA vaccine in healthy Japanese elderly subjects.

This is an open-label, uncontrolled post-marketing study of the cell-derived A/H1N1 influenza HA vaccine. Subjects received 3.75μg of cell-derived H1N1sw vaccine formulated in half (i.e., half the content of the European-licensed adjuvanted seasonal influenza vaccine) MF59 adjuvant (3.75_halfMF59). All vaccination were administered IM in the deltoid muscle, preferably of the non-dominant arm at the first vaccination and of the opposite arm to the first vaccination, as a rule, at the second vaccination. Blood samples were collected at baseline (day1), 3 weeks after the first vaccination (day 22) and three weeks after the second vaccination (day 43). Sera were tested by Hemagglutination Inhibition (HI) assay. Local and systemic reactions were collected for the first week following each injection using Diary Card (i.e. Day 1 to Day 7 and Day 22 to Day 28). All AEs, SAEs, and AEs that led to withdrawal from the study and related prescription medications were collected for the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese aged over 60 years

Exclusion Criteria:

* Any serious chronic or progressive disease according to judgment of the investigator (including, but not limited to neoplasm, insulin dependent diabetes, cardiac, renal, hepatic or respiratory disease)
* History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients
* Administration of swine influenza (A/H1N1) vaccine prior to Day 1 or documented confirmed or suspected swine influenza disease
* History of progressive or sever neurological disorders
* Known or suspected impairment/alteration of immune function
Changes to Function and Quality of Life and Patient Experience for Patients Undergoing Treatments for Recurrent Oropharyngeal Cancer

The purpose of this research project is to measure changes in communication, swallowing and quality of life and individual patient priorities which may happen over time in patients with a diagnosis of recurrent head and neck cancer, specifically recurrent cancer (cancer which has returned after previous treatment) of the back of the throat, the tonsils and/or the base of tongue (recurrent oropharyngeal cancer) and what it is like for patients and their significant others to experience these changes over time.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 years or over) competent to provide consent
* Have a diagnosis of recurrent OPC
* Have adequate linguistic and cognitive function to participate in interview
* English speaking

Exclusion Criteria:

* Any previous medical condition, other than HNC, which has a known impact on communication/ swallowing (Parkinson's Disease, Multiple Sclerosis, cerebral vascular accident (CVA)
Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.

Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,...


Eligibility Criteria:
Inclusion Criteria:

* Endovenous ablation of the great saphenous vein (GSV) planned
* Patient signed informed consent
* Patient must complete the 1 year follow-up
* CEAP between 2 and 6
* BMI=\<35
* Diameter of the GSV in upward position less than 20 mm diameter
* No problems in deep venous system

Exclusion Criteria:

* No informed consent is signed
* Latex allergy
* Arterial insufficiency
* Deep vein thrombosis or deep vein insufficiency
* Klippel Trenaunay
* Diameter fo GSV \> 20 mm
* Cross dilation with 2 or more insufficient side branches
* Previous GSV operation
* Redo-operation
* Carcinoma less than 1 year ago
* BMI \> 35
* Liver-insufficiency with contraindication for local tumescence
* Intake of warfarins
* Pregnancy, breastfeeding, \< 3 months after pregnancy
* Bilateral GSV insufficiency that has to be treated
* Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV
Clarithromycin Triple Therapy Plus Bismuth for Helicobacter Pylori First-line Treatment

Standard triple therapy including a proton pump inhibitor (PPI) and clarithromycin with either amoxicillin or metronidazole are no longer recommended as empirical ﬁrst-line therapy to treat Helicobacter pylori infection because of high antibiotic resistance. It is unknown whether the addition of bismuth overcome antibiotic resistance. This study is designed to evaluate the efficacy and safety of the addition of bismuth to standard triple therapy for H. pylori first-line eradication.


Eligibility Criteria:
Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria:

* Previous H. pylori eradication therapy
* Less than 18 years old
* With history of H. pylori infection treatment
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Impact of Sub-anesthetic Dose of Ketamine on Post Spinal Hypotension in Caesarean Delivery

The purpose of this study is to evaluate the effect of sub anesthetic dose of ketamine on vasopressor (Ephedrine) requirement to prevent maternal hypotension after spinal anesthesia in caesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Physical status American Society of Anesthesiologist(ASA) I or II. Full term pregnancy

Exclusion Criteria:

* ,Pre-eclampsia.
* Chronic hypertension.
* Cardiovascular troubles.
* any contraindications to spinal anesthesia as back infection , coaguolopathy , patient refusal
Effect of Capacitive and Resistive Radiofrequency on Postpartum Diastasis Recti

To evaluate the effect of capacitive and resistive radiofrequency on postpartum rectus abdominis diastasis.

Eighty females postpartum with rectus diastasis will be included in this study; they will be recruited the outpatient clinic at El Mahalla Al Kobra (The first author's pervious workplace) and will be referred by obstetric and genecology physicians. Patients will be assigned into two groups.

Group A: It will include 40 patients participating in abdominal belt. Group B: It will include 40 patients participating in abdominal belt plus TECAR therapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Postpartum women (7 days after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus).

  2. Multiparous women (2-3) times delivered vaginally with or without episiotomy.

  3. Their age will be ranged from 20 -35 years old. 4. Their BMI will be less than 30 kg/cm2.

Exclusion Criteria:

* Any participant will be excluded if she meets one or more of the following criteria:

Postpartum women will be excluded from the study if they have:

1. Abdominal or back surgery.
2. Abdominal hernia.
3. History of abnormal pregnancy, uterine fibroid or polyhydramnios during pregnancy.
4. Neurological disorders as multiple sclerosis, stroke and spinal lesion.
5. Musculoskeletal diseases such as fractures muscle strains, severe knee osteoarthritis which may affect their physical activity.
Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation

tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.

tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.

Eligibility Criteria:
Inclusion Criteria:

* stroke with at least slight deficit in upper limb

Exclusion Criteria:

* epilepsy
* contraindication to tDCS
* presence of metal in the head
* inability to understand/complete behavioural tasks
* chronic intake of alcohol or recreative drugs
* major health condition (e.g. terminal renal failure, instable heart failure etc ...)
* pregnancy
IVIG Treatment in Systemic Sclerosis

The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin) on the skin in patients with scleroderma. Approximately 24 subjects will take part in this investigator-initiated study at Georgetown University Hospital and Johns Hopkins Hospital. This study will last for one year (12 months). This research is being done because systemic sclerosis can cause severe, progressive organ involvement. The investigators hope this study treatment will improve the outcomes in this disease, including skin, muscle, joint, gastrointestinal, and lung involvement.

The investigators propose a double-blind controlled trial of 24 patients with Privigen® (Immune Globulin Intravenous (Human), 10% liquid treatment) with 3:1 randomization. Subjects with scleroderma will be given 2 g/kg/mo of Privigen® or placebo (Albuminar®-5) for 6 months. Scleroderma is generally a progressive disease, and while the skin does improve with time in some patients, others have progressive disease in spite of aggressive treatment. Also, spontaneous improvement in other organ systems is even less likely. Patients entered into the trial will have failed to respond to standard of care treatment over the past 4 months. Thus, the investigators feel that any actual improvement observed can be attributed to the IVIG treatment. Since this is a pilot study, future larger controlled trials will be necessary to clearly demonstrate the effectiveness, but the investigators are hoping that this study will give us signals that will guide the future clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Diffuse systemic sclerosis with active skin involvement as defined as a mRSS \>12, with no improvement or worsening in the previous 4 months in spite of treatment with methotrexate, cellcept, imuran, or anti-TNF agent;
* 18 years of age or older;
* Disease duration of less than 5 years from the first non-Raynaud's symptom of scleroderma.

Exclusion Criteria:

* Use of more than 10 mg of prednisone, or any dose of cytoxan, d-penicillamine, or rituximab in the last 3 months;
* History of deep vein thrombosis (DVT), stroke, or other thromboembolic phenomenon;
* History of anaphylaxis or other serious reaction to human blood or blood products.
* Absolute IgA deficiency
* A prior receipt of IVIg treatment
Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation

The aim of this study was to characterize pharmacokinetics of fentanyl during and after Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non linear mixed effects modeling.

Patients received an initial intravenous bolus of fentanyl 100 μg and infused at variable rates ranging from 250 to 400 μg/hr.

Arterial blood samples (3ml) were taken immediately before the start of infusion (baseline), and at scheduled time which were coincident with laboratory tests during surgery as follows. In pre-anhepatic phase, blood were taken at 10min, 30min, 1hr, 3hr, 5hr until clamping of the hepatic blood supply and venous drainage, after the star of anhepatic phase, blood were taken at 5 min, 10 min, 30 min, 60 min, 90 min, 2hr until the vessels were reconnected to new liver. In neo-hepatic phase, blood were taken at 5min, 10min, 30min, 60min, 90min, 2hr, 3hr, 5hr until fentanyl-infusion stop, and at 0hr, 1hr, 3hr, 5hr, 8hr, 12hr, 24hr immediately after the stop of infusion. Samples were collected into tubes containing heparin as an anticoagulant and immediately placed on ice. After centrifugation for 8 min at 1800 g, the plasma was transferred to a cryovial and stored at -70°C until assay.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 19 - 65 years of age
* Over 45kg of weight
* Written Informed consent
* Patients receiving a liver graft from living donor (ASA PS III or IV)

Exclusion Criteria:

* Patients with renal dysfunction
* Patients with Fulminant hepatic failure
* Patients participated other clinical trials within 2 months
* Unable or Unwilling to give informed consent
* Abnormal test results with clinical significance
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
* Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
* Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Age 4 to 24 years
* Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
* Has used a handheld game system to play video games within a year of enrollment
* If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
* Is willing to complete all study procedures, with appropriate parent/guardian supervision

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
* Infection with a blood borne pathogen (e.g., HIV, hepatitis)
* Subject or parent/guardian is employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
DE-eSCALation of Opioids Post-surgical dischargE

The Descale Study aims to:

1. Look at the prescribing trends of opioids and the scale of long-term use following surgery within East Kent (United Kingdom)
2. Carry out a feasibility study to:

   * see if clinical pharmacists can support patients following surgery to manage their post-surgical pain safely and prevent long-term opioid use
   * calculate how much it costs the National Health Service (NHS)
   * see how the patients experienced the intervention

For Aim 1, historic records of patients who have had surgery and were discharged on opioids will be reviewed. Data collected will include type and strength of pain-relieving medication prescribed; type of surgery; number of additional opioid prescriptions following discharge; use of medical services (e.g., General Practice appointments, physiotherapy); and patient demographics.

For Aim 2, clinical pharmacists will carry out early high-risk medication safety reviews to ensure that patients have their pain managed safely. Investigators will collect key data from patients receiving the clinical pharmacist intervention to see how it affected opioid use, costs and healthcare use. Patients who took part in the study will be invited to participate in an interview and will be asked what they know about opioids and the health risks, and their experiences of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or above.
* Undergone surgery and discharged with opioid medication\* less than 120mg MME/day from a participating hospital and taking it for the treatment of acute non-malignant post-surgical pain.

  * Investigators have used the British National Formulary (BNF) definition of opioids and will recruit participants who have been prescribed one or more of the following drugs: Codeine, Dihydrocodeine, Buprenorphine transdermal patches, Fentanyl transdermal patches, Morphine, Oxycodone, Tramadol, Diamorphine, Dipipanone, Tapentadol, Pentazocine.

Exclusion Criteria:

* Aged under 18 years of age.
* Unable to provide written informed consent.
* More than 90 days opioid use pre-surgery.
* On \> 120 mg MME/day.
* Additional surgical procedures planned during the 3-month intervention.
* A history of methadone treatment.
* Regularly inject opioids.
* Using opioids for malignant pain.
* Undergone a caesarean section.
* Is pregnant\*.
* Classified as vulnerable (e.g., severe dementia, severe co-existing or terminal medical condition).

  * Risk of miscarriage or stillbirth from opioid withdrawal
A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens

RATIONALE

* Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma.
* Radiotherapy may cause adverse effect such as xerostomia and mucositis.
* Amifostine has the ability of protecting the normal tissue but also has some side effects.

PURPOSE

* This phase II trial is to study the protecting effect and safety of different Amifostine regimens in patients with nasopharyngeal carcinoma.

RATIONALE: Nasopharyngeal carcinoma is a kind of malignant tumor which is treated primarily by radiation therapy. This therapeutic strategy often causes adverse effects such as dysfunction of salivary gland and lesion of oral mucosa. With concurrent chemotherapy, it may also cause toxicity to kidney, bone marrow, and other organs or tissues. When administered prior to chemoradiotherapy, Amifostine has been proved to has the ability of protecting the normal from these adverse effects so as to improve the patient tolerance. However, there are also some side effects of Amifostine itself, such as nausea, vomiting and hypotension, especially when high dose is applied.

PURPOSE: This phase II randomized controlled trial is to study the protecting effect and its safety of Amifostine every-other-day regimen compared with standard everyday regimen on adverse effects such as myelosuppression, xerostomia and mucositis, in patients with nasopharyngeal carcinoma Stage T1-T4, N0-N3, M0 and undergoing concurrent chemoradiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Nasopharyngeal cancer patients diagnosed by pathology or cytology
* UICC/AJCC 2010 Stage T1-4 N0-3 M0
* Male or female patients with age between 18 and 75 years old
* Karnofsky Performance Scores ≥ 60
* Expected survival ≥ 3 months
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis
* No previous allergic reaction to the drug

Exclusion Criteria:

* History of alcohol or drug abuse within 3 months
* Pregnant or lactating women
* Currently under treatment with other similar drugs
* Anti-hypertension drugs applied in less than 24 hours
* Severe hypocalcemia
* Dysfunction of heart, lung, liver, kidney or hematopoiesis
* Severe neurological, mental or endocrine diseases
* Previous allergic reaction to the drug
* Patients participated in clinical trials of other drugs within last 3 months
* Other unsuitable reason
The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial

The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection.

The names of the groups in this research study are:

* Group A: Prehabilitation program
* Group B: Usual Care

This is a non-blinded, randomized control trial to determine the feasibility of a hybrid-model, prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant therapy (chemotherapy and/or radiation) before surgical resection. Investigators hope that prehabilitation will result in improved outcomes after surgery.

Participants will be randomized into one of the study groups: Group A: prehabilitation program, or Group B: usual care. Randomization means that a participant is placed into a group by chance.

The research study procedures include screening for eligibility, in-clinic visits, physical exams, exercise training, blood tests, and questionnaires.

It is expected that about 40 participants will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years at time of enrollment.
* English-Speaking.
* Diagnosis of clinical stage II-III rectal cancer.
* Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
* Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.

Exclusion Criteria:

* Distant metastatic disease known at the time of diagnosis.
* Functional incapacity (i.e., incapable of performing exercise testing).
* Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
* Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
* Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
* Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.
A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma

To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC


Eligibility Criteria:
Inclusion Criteria:

* suspected to have pancreatic cancer by radiological imaging
* planned systemic treatment
* possibility of conversion surgery
* willingness to participate the study

Exclusion Criteria:

* without pathologically confirmed pancreatic cancer
* poor performance status or organ functions that cannot meet the systemic treatment requirements
* metastatic disease
* pregnant patients