cyrilzakka/clinical-trials huggingface dataset:
Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility Criteria:
Inclusion Criteria:

* A female who enrolled in the study 102115 and received three doses of vaccine.
* Written informed consent obtained from the subject prior to enrolment.

Exclusion Criteria:

* Use (or planned use during the study period) of any investigational or non-registered product or off-label use of licensed product (drug or vaccine).
* Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling.
* Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
* Planned administration of any HPV vaccine, other than that foreseen by the study protocol, during the study period.
A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding.

The goal of this randomized clinical trial is to compare the influence of casein phosphopeptide amorphous calcium phosphate (CPP-ACP), CPP-ACP in combination with fluoride (CPP-ACPF), high fluoride concentration, and conventional fluoride toothpaste on the color and size of white spot lesions (WSLs) in orthodontic patients following bracket removal.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with fixed orthodontic appliances at the Ghent University Hospital who developed at least three WSLs at debonding were included. Informed consent had to be obtained from the patient, both verbally and written.

Exclusion Criteria:

* Patients were excluded from the study if enamel demineralization was already present before orthodontic treatment.
Early Identification of Mental Disorders: Application of a Multi-modal & Domains System

This study aims to build a multi-modal collection template and establish a multi-modal database of seven mental disorders including depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders by collecting voice information, facial micro-expression, eye tracking, EEG physiology data respectively. This study will contribute to the multi-modal diagnosis of major mental disorders such as depression in the future and realize clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of ICD-11 or DSM-5 for depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders, and do not limit subtypes and current disease state;
2. Age 15-60;
3. Han nationality;
4. gender is not limited;
5. have enough audition level to complete the necessary inspection of the research;
6. Understand the research content and sign the informed consent form. If the patient is unable to sign the informed consent form in person due to low education level or other reasons, he or she can be entrusted to sign it by his relatives or his guardian.

Exclusion Criteria:

1. Mental retardation that significantly affects the patient's current mental state;
2. Patients who have serious physical diseases, and it is difficult to complete the necessary examination, including the history of brain trauma or cerebrovascular disease, severe liver cirrhosis, acute and chronic real failure, severe diabetes, aplastic anemia, moderate and severe malnutrition, other serious physical diseases such as nervous system, heart, liver, kidney, endocrine system and blood system, or diseases that may interfere with the test evaluation (abnormal indexes are more than 2 times higher than normal).
Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy

The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.

Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.


Eligibility Criteria:
Inclusion Criteria:

ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs

Exclusion Criteria:

Patients unable tor unwilling to consent BMI \>40
Comparison of Nonposterior- and Posterior-Stabilized Mobile-Bearing Total Knee Arthroplasty

The purpose of this study is to determine if there are any clinical or radiographic differences in non-posterior stabilized rotating mobile bearing design versus a posterior stabilized rotating mobile bearing designs.

Out comes measures were to determine

1. whether the knee and function scores and the radiographic results of the knees with a PFC Sigma RP knee prosthesis would be better than those with an LCS RP prosthesis.
2. whether the patients with a PFC RP knee prosthesis would have a better range of knee motion than those with an LCS RP prosthesis.
3. whether patient satisfaction and preference would be better in the patients having a PFC Sigma RP knee prosthesis than those of patients having an LCS RP knee prosthesis
4. whether complication rate would be less in the knees with a PFC sigma RP knee prosthesis than in the knees with an LCS RP prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
* Screening pain criteria sufficient as assessed by WOMAC and VAS scores
* Ability to read and understand the informed consent

Exclusion Criteria:

* Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
* Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
* Body mass index \>40
* Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
* History of malignancy within the last 5 years
* Participation in a clinical research trial within 12 weeks prior
* Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months
* Effusion of the target knee requiring aspiration within 3 months
* Use of electrotherapy or acupuncture for OA within 4 weeks
* Significant and clinically evident misalignment of the target knee
* Any known active infections
* Any chronic condition that has not been well controlled for a minimum of 3 months
Multi-Centre, Open-Label, Two Segment, Study Comparing Plasma Pharmacokinetics of Ketoprofen in Diractin® Alone to Diractin® Applied Concomitant With Heat or Moderate Exercise

* Comparison of the plasma PK after single use of 100 mg ketoprofen from Diractin®. 50 mg applied on 2 major joints to
* 400 mg ketoprofen from Diractin® (100 mg applied to 4 joints - overexposure)
* 100 mg and 400 mg ketoprofen from Diractin® used concomitant with heat application
* 100 mg and 400 mg ketoprofen from Diractin® used concomitant with moderate exercise


Eligibility Criteria:
Inclusion Criteria:

* All of the following criteria have to be met to include a subject in the study:

  * Understands nature and provision of the study
  * Have been informed about the study by the investigator and gave signed and dated informed consent prior to participation
  * Male and female subjects
  * Age 18-55 years
  * Subjects in good health as determined by the Investigator
  * Woman of childbearing potential using reliable methods of contraception with a low failure rate (i.e. less than 1% per year), e.g. implants, injectables, combined oral contraceptives, reliable intrauterine-devices, vasectomised/ infertile partner or surgically sterile (uterus removed or both tubes tied) or postmenopausal (at least 2 years without periods)

Exclusion Criteria:

* 4.2.1 General Exclusion Criteria

  * Investigator or any other team member involved directly or indirectly in the conduct of the clinical trial
  * Subjects who are inmates of psychiatric wards, prisons, or other state institutions
  * Participation in another clinical trial within the last 30 days
  * Not willing to refrain from exposing target areas after treatment to excessive ultraviolet light (solar radiation or solarium)
  * Pregnancy or lactation

4.2.2 Medical History Related Exclusion Criteria

* Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, and ingredients used in pharmaceutical products
* Alcohol or drug abuse
* Malignancy within the past 2 years
* Skin lesions, dermatological diseases or tattoo in the treatment area
* Major surgery 3 months before enrolment
* Impaired haematopoesis and coagulation
* Gastric and duodenal ulcer and gastrointestinal bleedings
* Systemic lupus erythematodes, mixed connective tissue disease
* Major heart disease / uncontrolled hypertension
* Hepatic failure with ALT and/or AST \> 2.0 ULN
* Renal failure with serum creatinine levels \> 1.5 milligrams/deciliter (mg/dL)
* Varicosis, thrombophlebitis and other vascular disorders of the lower extremities
* Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-sceletal system of the lower limbs
* HIV - Infection
* Blood donation one (1) month before screening and during study
* Hepatitis B and C
* Asthma bronchiale
One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.


Eligibility Criteria:
Inclusion Criteria:

* SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL
* VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion Criteria:

* PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE
* Other protocol-defined exclusion criteria may apply
Benefit of a Flash Dose of Corticosteroids in Digestive Surgical Oncology: a Randomized, Double Blind, Placebo-controlled Trial

Perioperative inflammation is harmful in cancer patients, namely in those undergoing surgery: it increases the risk of recurrence, decreases cancer survival, increases post-operative complications, and prolongs the time of recovery and the duration of hospital stay. Severe postoperative complications are also a risk factor of poor survival in cancer patients. Seemingly, some effective therapies currently used to improve the surgical outcome (e.g. immunonutrition, enhanced-recovery protocols) have an inflammatory effect. The modulation of perioperative inflammation therefore seems crucial to improve outcomes in patients undergoing surgery for digestive cancer.

A short perioperative treatment with high doses of corticosteroids has already been tested in several randomized trials. A recent meta-analysis showed that perioperative corticosteroids decreased inflammatory markers and might be associated with fewer complications in esophageal, liver, pancreatic and colorectal surgery: the decrease in the risk of postoperative complications was around 50% without adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Age \>_18 years
* Elective surgery for any digestive cancer (except purely hepatic surgery)
* Patients operated in a curative intent
* Patients who had given their written informed consent
* Patients affiliated to a National health insurance scheme

Exclusion Criteria:

* Emergency surgery
* Pregnant or breastfeeding women
* Patients with an ongoing oral treatment by steroids
* Palliative surgery
* Exclusive liver surgery
* Concomitant hyperthermic intraperitoneal chemotherapy
* Patient with at least one contra-indication to methylprednisolone treatment :
* active infection
* progressive/symptomatic viral infection (particularly hepatitis, herpes, chickenpox, herpes zoster)
* uncontrolled psychotic state
* hypersensitivity to methylprednisolone or to one of its excipients
* ASA grade \>3
* Persons subject to a measure of legal protection (guardianship, tutorship)
* Persons subject to a court order
* Impossibility to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
A Social Emotion Regulation Intervention in MS

The current project will examine effectiveness of an intervention based on the concept of the social regulation of emotion. The intervention is designed to improve well-being in individuals with MS by leveraging participants' existing social support. Effectiveness will be tested on a sample of 42 individuals with MS, half of whom will receive the intervention and half of which will receive an inactive control. Investigators will document changes resulting from treatment on self-reported levels of stress, depression, and quality of life. Intervention evaluation will expand scientific knowledge of emotion regulation disruption in MS, and potentially identify a novel and highly efficient means of treatment.

Multiple sclerosis (MS) is a progressive and debilitating neurological disease which not only affects a patient's physical health, but also adversely affects their mental health. Depressed mood is common in MS, and poor mental health in individuals with MS has wide-ranging consequences on social relationships and community integration. The preponderance of negative emotions and sparsity of positive emotions in MS are attributable in part to ineffective emotion regulation strategies. Thus, the clinical trial seeks to evaluate the effectiveness of an intervention which instructs individuals on using the social regulation of emotion.

The social regulation of emotion occurs when a one's emotional state benefits from an interaction with another person, such as when seeking comfort from a trusted friend. The current intervention was designed to leverage existing social relationships for emotional support in a manner which should strengthen the perception of social support and also reinforce existing relationships. The primary goal of this trial is to examine changes in mental well-being after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis diagnosis
* English language fluency

Exclusion Criteria:

* currently taking steroids or benzodiazepines
* within 30 days of an exacerbation
* history of substance abuse
* diagnosis of bipolar, schizophrenia, epilepsy, stroke
ToleroMune House Dust Mite Follow on Study

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune HDM is currently being developed for the treatment of HDM allergy.

The Purpose of this optional observational follow-on study is to evaluate the continued efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline approximately two years after the completion of the baseline EEC visit in TH002 following challenge with HDM allergen in an EEC.

Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Eligibility Criteria:
Inclusion Criteria:

* previously randomised in study TH002, completed all dosing visits and the PTC

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to House Dust Mite allergen
* FEV1 \<80% of predicted.
* Symptoms of a clinically relevant illness
* Subjects who cannot tolerate allergen challenge in the EEC
Effects of tDCS and tUS on Pain Perception in OA of the Knee

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and functional limitations in people with osteoarthritis of the knee. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.


Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent to participate in the study.
2. Subjects between 18-85 years old.
3. Diagnosis of chronic osteoarthritis with pain of either the knee as self-reported.

   Prior to beginning baseline procedures this must be confirmed by medical records or a letter from the subject's physician. This document may either be brought in by the subject or retrieved by study staff after a medical release form is signed by the subject. After consent, if the subject fails to provide the necessary documentation or it cannot be retrieved by study staff the subject will be considered a screen fail.
4. Existing knee pain in the past 6 months of at least 3 on a 0-10 VAS scale on average.
5. Pain resistant to common analgesics and medications for chronic pain used as initial pain management such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
6. Having the ability to feel pain as self-reported

Exclusion Criteria:

1. Pregnancy or trying to become pregnant in the next 6 months.
2. History of alcohol or drug abuse within the past 6 months as self-reported.
3. Contraindications to transcranial brain stimulation or TUS, i.e. implanted brain medical devices or implanted brain metallic devices.
4. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
5. Epilepsy.
6. Use of carbamazepine within the past 6 months as self-reported.
7. Suffering from severe depression (with a score of \>30 in the Beck Depression Inventory)
8. History of unexplained fainting spells as self-reported.
9. Head injury resulting in more than a momentary loss of consciousness
10. History of neurosurgery as self-reported.
Treprostinil Iontophoresis : a Pharmacodynamic and Pharmacokinetic Study

The purpose of the study is to assess skin blood flow after non-invasive local administration of treprostinil by using a low-intensity current (i.e. iontophoresis) on the forearm and the fingers of healthy volunteers and patients with systemic sclerosis. The investigators also aim at assessing the systemic bioavailability and dermal diffusion of treprostinil iontophoresis.

Digital ulcerations are a complication of systemic sclerosis (SSc). Available treatments (i.e. IV iloprost) induce major adverse effects, limiting the use of such therapies. Iontophoresis is a non invasive route of administration of drugs. In experimental and clinical preliminary studies, the investigators have shown that iontophoresis of treprostinil on the forearm of healthy subjects induces a sustained increase in skin blood flux and that it is well tolerated (clinicaltrials.gov NCT01082484, manuscript in press). The investigators therefore aim at validating this proof of concept on the digits of SSc patients.

Eligibility Criteria:
Inclusion Criteria:

* Cutaneous systemic scleroderma with sclerosed fingers

Exclusion Criteria:

* pregnant or breast-feeding women
* any chronic disease (in the control group)
* smoking
Chlorhexidine Cloths to Reduce Surgical Site Infection in Cesarean Deliveries

Pregnancy-associated infection represents a major cause of maternal morbidity and mortality. Cesarean delivery is the most common major surgical procedure and is associated with a rate of surgical site infection (SSI) that is approximately 5-10 times the rate for vaginal delivery. Efforts to reduce the risk of SSIs in this patient population include the use of preoperative antibiotic prophylaxis in addition to skin and vaginal antiseptic preparations.Nevertheless, the rate of SSI in women undergoing non-scheduled cesarean delivery is up to 18%, a significant number that contributes to prolonged hospital stays and increased health care costs.

Every effort should be made to reduce this major cause of pregnancy-associated morbidity and mortality to aid in the care of patients and reduce the associated prolonged hospital stays, readmission rates and health care costs. Studies have shown that preoperative application of chlorhexidine cloths reduces the risk of SSI, however this is based on literature in the orthopedic and intensive care patients. The efficacy of this intervention has not been studied in obstetric patients undergoing cesarean delivery. Furthermore, obstetric patients undergoing non-scheduled cesarean delivery represent a target population as it is thought that infectious morbidity is higher in this patient population. Therefore, there is a need for this trial to determine if this intervention is effective in reducing the rate of postoperative SSIs.

This randomized clinical trial will be investigating the use of preoperative chlorhexidine cloths, a chemical skin antiseptic agent effective on gram positive and gram negative bacteria, as an intervention to reduce the rate of surgical site infections (SSIs). The intervention group will be women undergoing non-scheduled cesarean delivery randomized to receive preoperative abdominal application of 2% chlorhexidine cloths. The control group will be women undergoing non-scheduled cesarean delivery randomized to receive standard preoperative care. The impact on women's health is significant, as a reduction in SSIs in this prevalent patient population can reduce the number of prolonged hospital stays, outpatient follow-ups for infection, hospital readmissions and health care costs.

Eligibility Criteria:
Inclusion Criteria:

* undergoing non-scheduled cesarean delivery \> 23 weeks gestation

Exclusion Criteria:

* allergy to chlorhexidine, emergency cesarean delivery, evidence of infection at operative site