cyrilzakka/clinical-trials huggingface dataset:
Follow-up Study of GSK Biologicals' Human Papilloma Virus (HPV) Vaccine to Prevent Cervical Infection in Young Adults

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This is an observer blind follow up study of the study HPV-001, which evaluated the ability of the HPV vaccine to prevent HPV infection. The current study invites all of the 1113 subjects in the HPV-001 study that received all three doses of vaccine/placebo to be enrolled and followed-up for several additional years to see if the HPV vaccine prevents HPV-16 and HPV-18 infections and to evaluate the safety of the vaccine. Subjects will remain in the same study group as in the primary study. No vaccine or placebo will be administered in this study.

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


Eligibility Criteria:
Inclusion Criteria:

* Participated in study 580299/001 and received all three doses of vaccine/placebo.
* Written informed consent obtained from the subject prior to enrollment

Exclusion Criteria:

* Decoding of the subject's treatment allocation to either the subject or the investigator in study 580299/001.
Newborns in Level III Services in Alsace From Mothers With COVID-19

Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection.

Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries.

Assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up.

Importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.


Eligibility Criteria:
Inclusion criteria:

* Newborns born between March 1 and June 30, 2020 to COVID 19
* From positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
* Parents' non-opposition to the analysis of hospitalization data for children contained in the medical file

Exclusion criteria:

- Parents' opposition to the analysis of hospitalization data for children contained in the medical file
Pulmonary and Systemic Hepatocyte Growth Factors in Patients With COPD

The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of KGF) than controls, and Bonay et al found a direct relationship between the severity of airflow obstruction and HGF mRNA content in lung samples of smokers. These two studies suggest, therefore, that the pulmonary regulation of HGF may be abnormal in patients with COPD. However, both HGF and KGF can also be released by extra-pulmonary organs, thus having the potential to act systemically. Given the current clinical relevance attributed to the systemic effects of COPD, in this study we compared the levels of HGF and KGF in the pulmonary (bronchoalveolar lavage (BAL) fluid) and systemic compartment (circulating blood) of smokers with and without COPD and never smokers.

Background: The potential role of growth factors in COPD has begun to be addressed only recently and is still poorly understood. In this study we investigate potential abnormalities of hepatocyte growth factor (HGF) and keratinocyte growth factor (KGF) in patients with COPD.

Methods: To this end, we compared the levels of HGF and KGF, measured by ELISA, in bronchoalveolar lavage (BAL) fluid and in serum in 18 patients with COPD (62 ± 2 yrs, FEV1 57 ± 4% ref, X ± SEM), 18 smokers with normal lung function (58 ± 2 yrs., FEV1 90 ± 4% ref) and 8 never smokers (67 ± 7 yrs, 94 ± 4% ref).

Results: We found that, in BAL, HGF levels were higher in patients with COPD than in the other two groups whereas, in serum, HGF concentration was highest in smokers with normal lung function (p\<0.01). KGF levels were not significantly different between groups, neither in blood nor in BAL, (most values were below the detection limit).

Conclusions: These results highlight a different response of HGF in BAL and serum in smokers with and without COPD that may be relevant for tissue repair in COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD (GOLD II-III) 1, smokers without chronic bronchitis or dyspnea and with normal lung function, and never smokers who required bronchoscopy for clinical purposes.

Exclusion Criteria:

* Acute exacerbation last three months
* Chronic lung diseases (asthma, bronchiectasis and interstitial lung diseases) and cardiac, hepatic or renal failure.
* Systemic steroid treatment
Effects of Blood Letting in Metabolic Syndrome

Metabolic syndrome (MS) has an increasing prevalence worldwide and there is an urgent need for improvement of medical treatment. In traditional medicine phlebotomy (blood letting) is a recommended treatment for subjects with obesity and vascular disease. Recent studies showed that blood letting with iron depletion may improve insulin sensitivity in patients with diabetes mellitus. The investigators aimed to test if traditional blood letting has beneficial effects in patients with MS. A randomized trial with a sample size of 64 self-referred MS patients was conducted. Patients in the blood letting group were allocated to blood letting intervention and the control group was offered a later treatment (waiting list). In the intervention group 300-400 ml of venous blood were withdrawn at day 1 and after 4 weeks. Primary outcomes were the change of systolic blood pressure and of insulin sensitivity as measured by HOMA-Index.


Eligibility Criteria:
Inclusion Criteria:

* 25-70 years of age
* given diagnosis of metabolic syndrome

Exclusion Criteria:

* clinically significant hepatic, neurological, endocrinologic, or other major systemic or inflammatory disease, including malignancy
* known history of hemochromatosis, or presence of the Cys282Tyr mutation
* history of drug or alcohol abuse
* manifest cardiac disease
* history of disturbances in iron balance (e.g., hemosiderosis from any cause, atransferrinemia)
* preexisting anemia
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.


Eligibility Criteria:
Inclusion Criteria:

i) Administrative - The subject is able to understand the study, is willing to give voluntary, written, informed consent, will co-operate with assessment procedures and is geographically able to comply with the post-operative follow-up regime.

ii) Age - The subject's age is between 18 and 75 years inclusive.

iii) Sex - Male or female subjects may be recruited to the study.

iv) Diagnosis -Subjects must be undergoing primary THR surgery for non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, post-traumatic arthritis, fractured neck of femur and non-union of fractured neck of femur, SUFE or Perthes disease.

v) Suitability - Subjects who in the opinion of the Investigator are considered to be suitable for treatment with the devices involved in the study.

Exclusion Criteria:

i) Subjects undergoing revision procedure to the operative hip.

ii) Subjects who have had a previous femoral osteotomy to the operative hip.

iii) Subjects who have a history of active sepsis in the joint.

iv) Subjects who have been diagnosed with primary or secondary carcinomas in the last five years (excluding basal cell carcinoma or cervical carcinoma).

v) Subjects with any condition which may, in the opinion of the Investigator, interfere with the total hip replacement's survival or outcome, e.g. Paget's disease, Charcot's disease.

vi) Subjects with psycho-social disorders which, in the opinion of the Investigator would limit rehabilitation.

vii) Subject's whose weight is \> 100kg.

viii) Subjects with femoral head necrosis on the non-operated side (RSA and DEXA subjects only).

ix) Subjects who have a fracture of the femur \> 6 months old (RSA and DEXA subjects only).

x) Subjects diagnosed as having ankylosing spondylitis (RSA and DEXA subjects only)

xi) Subjects with a known history of poor compliance to medical treatment.
Manikin To Patient Intubation: Does It Translate?

This study evaluates a new approach to the instruction of pediatric residents in the skill of neonatal intubation. Half of the participants will receive focused simulation training and cognitive instruction while the other half will not. The collected data from both groups will be compared.

Current findings suggest that the training of pediatric residents is not sufficient prior to "live" tracheal intubations in the critical care setting. The current one to two days of airway management training as a part of resuscitation training (such as Pediatric Advanced Life Support (PALS) or Neonatal Resuscitation Program (NRP) is not sufficient to provide safe intubation skills.

This study will develop and implement tracheal intubation training using concepts of deliberate practice modeled after Ericsson. The concepts include focused training on a specific task, immediate feedback, time for problem solving and evaluation, and opportunities for repeated performance using a manikin. This proposal is an attempt to develop such a training model. Video recordings of live intubations will be reviewed and evaluated. The data between the two groups will be compared to see if there is improved intubation skills of live patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female residents from 18-89 years of age who have been assigned to the Neonatal Intensive Care Unit (NICU) for a monthly rotation are eligible to participate. At the beginning of all NICU rotations, all pediatric residents will be invited to participate in this research.

Exclusion Criteria:

* Any pediatric resident who does not wish to participate
Women's Knowledge About Endometriosis

In the world, 10% of women of childbearing age have endometriosis with diagnostic mostly between 25 and 30 years old.

Endometriosis is the leading cause of infertility in our country. A diagnosis delay of approximately 6.7 years is observed for endometriosis.

The aim of the study will be to describe knowledge of women about endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* women older than 18
* women of childbearing age
* with or without gynecological history
* agreed to participate in the study

Exclusion Criteria:

None
AM-101 in the Treatment of Post-Acute Tinnitus 1

The purpose of this research study is to test the safety and local tolerance of repeated treatment cycles of AM-101.

This open-label extension study is assessing the safety and local tolerance of repeated treatment cycles of AM-101 in subjects previously treated in the scope of the TACTT2 study (NCT01803646).

Eligibility Criteria:
Inclusion Criteria:

* Completion of TACTT2 study;
* Negative pregnancy test (woman of childbearing potential);
* Willing and able to attend the study visits during at least one treatment cycle.

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Adverse event leading to treatment discontinuation in TACTT2;
* Meniere's Disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane;
* Ongoing drug-based therapy for otitis media or otitis externa;
* Drug-based therapy known as potentially tinnitus-inducing;
* Other treatment of tinnitus;
* Drug abuse or alcoholism;
* Subjects with psychiatric diseases requiring drug treatment;
* Use of antidepressant or anti-anxiety medication;
* Any clinically relevant disorder or abnormality in physical examination;
* Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
* Women of childbearing potential who are unwilling or unable to practice contraception.

Other protocol-defined exclusion criteria may apply.
Aerobic Training Versus Cognitive Behavioral Therapy in Management of Anxiety

Anxiety and depression disorders (ADD) have the highest overall prevalence rate among psychiatric disorders in young females. Its manifestations are disabling, distressing a substantial negative impact on the quality of life. The purpose of this study was to compare the effect of cognitive-behavioral therapy and physical therapy on female students with mild to moderate anxiety and depression.

Female students of Taif University will be invited to participate in this study. 40 students will be assigned according to sample size calculation into the study as having mild to moderate anxiety and depression according to Depression, Anxiety and Stress Scale (DASS 21) most days of the week for at least six months. All study participants will sign an informed consent form. Screening for the physical activities in the last 7 days of all participants will be performed one day before starting the study protocol using The International Physical Activity Questionnaires (IPAQ) short form. The exclusion will be performed to severe psychological conditions such as schizophrenia and severe depression and any physical condition that limit physical activities. Also, participants who are taking any medications for the treatment of anxiety and depression will be excluded. Also, participants who had any abnormalities of the cardiovascular status that prevent them to perform the physical activities or reaching the target heart rate without risk as recommended by their primary care physician. The age range will be 18 to 25 years with a mean age of 21±0.75 years. Participants will be assigned into two groups: group A (GA) consists of 20 students and they will be instructed to increase their physical activities one hour daily, 5 days per week for 8 weeks of moderate to vigorous activities such as running, jumping, swimming, aerobics or dancing; and group B (GB) consists of 20 students and they will receive cognitive behavioral therapy for 8 sessions (once per week for 8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* mild to moderate anxiety and depression according to Depression, Anxiety and Stress Scale (DASS 21) most days of the week for at least six months
* Females Age 18-25 years

Exclusion Criteria:

* severe psychological conditions such as schizophrenia
* severe depression
* any physical condition that limit physical activities
A Two-day Education Program for Metabolic Syndrome Patients

This study was to evaluate the temporal change of metabolic indicators and quality of life by a two-day patient education program.

This study aimed to evaluate whether a two-day multidisciplinary education camp comprising doctors, nurses, exercise instructors, dietitians, social workers, and health administrators could initiate healthy lifestyle habits, improve health markers though lifestyle modification, increase knowledge and understanding of the disease, and have a profitable effect on mental health in relation to depression and quality of life for patients with metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* people satisfied with metabolic syndrome criteria

Exclusion Criteria:

* None
Intrapleural Cryotherapy for Malignant Pleural Mesothelioma

Can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory changes, resulting in the induction of anti-tumor immunity?

Patients that have been diagnosed, or are suspected of having malignant pleural mesothelioma, a cancer of the pleura, surgery may be considered as an attempt to treat the cancer. As part of the testing needed before surgery, a pleuroscopy or video camera examination of the pleura is necessary to establish the diagnosis and/or to evaluate the extent of the cancer. This study evaluates the effects of cryotherapy (freezing spray) on the ability of a patient's immune system to attack the cancer, as has been reported in other types of cancers. The purpose of this research is to gather information on the safety and effectiveness of cryotherapy in patients with malignant pleural mesothelioma. If successful, this study could provide support for future studies evaluating this new treatment for mesothelioma.

Eligibility Criteria:
Inclusion Criteria

* Subject provides informed consent
* Subject is \>18 years of age
* Subject is deemed competent for making medical decisions
* Subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma
* A negative pregnancy test is required in women of child-bearing potential, as standard of care.
* Subject is mentally capable of understanding study procedures.

Exclusion Criteria

Study subject has any disease or condition that interferes with safe completion of the study including:

* Platelet count \< 50K, coagulopathy defined as an International Normalized Ratio (INR) \> 1.5
* Anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published
* Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians.
* Hypoxemia with pulse oximetry values \<88% or partial pressure of oxygen in arterial blood (PaO2) \< 60 on baseline oxygen requirements.
* Concurrent participation in another study involving investigational drugs or investigational medical devices
* Absence of or limited access to the pleural space during medical pleuroscopy.
* Inability to read and understand the necessary study documents.
Individualized Discharge Planning in Patients With Rib Fracture

Patients with rib fractures may develop pneumonia and even respiratory failure requiring critical care, ventilator management, and hospitalization. Discharge planning is a broad range of time-limited services designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patients care.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were to be patients hospitalized due to fractures ribs due to falls, traffic accidents, and aggression.

Exclusion Criteria:

* Exclusion criteria were an inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, or inability to cooperate. Patients who had experienced hospitalization in the Intense Care Unit were also excluded.
Pain Associated With Neonatal Frenotomy

The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.


Eligibility Criteria:
Inclusion Criteria:

infants diagnosed with ankyloglossia at the nursery of the RHCC, who will be referred by a qualified neonatologist to the OCAD for a routine tongue-tie frenotomy procedure because of breast feeding difficulties.

* Ankyloglossia type 1 or 2 Exclusion criteria
* Abnormal oral or nasopharyngeal anatomy
* Any known congenital malformations
* Ankyloglossia type 3 or 4

Exclusion Criteria:

-
Different Dialysis Modalities and Diet on Gastrointestinal Biome and Azotaemic Toxins

. This is a prospective observational pilot study to analyse gastrointestinal tract bacterial populations in peritoneal dialysis and haemodialysis patients under the care of the Royal Free Hospital with chronic kidney disease who have been established on regular haemodialysis and peritoneal dialysis treatments in a Royal Free Hospital kidney care centre.

Patients, attending for outpatient haemodialysis and peritoneal dialysis to be tested for gastrointestinal tract bacterial population by taking a single mouth swab, and a stool sample. Additional blood sampling, when patients are having blood tests for routine clinical assessment.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 years and older up to 80 years
* Under the care of the Royal Free Hospital with chronic kidney disease and established on regular haemodialysis or peritoneal dialysis.
* Able to provide written informed consent obtained

Exclusion Criteria:

* Patients unable to provide written informed consent
* Patients not fulfilling inclusion criteria
Study to Assess Outcomes in Women Undergoing Either Hysteroscopic Sterilization (Essure®) or Laparoscopic Tubal Sterilization

This study is designed to assess post-procedural outcomes for women who chose to undergo either hysteroscopic sterilization (Essure®) or laparoscopic tubal sterilization, including:

* Pelvic and/or lower abdominal pain
* Abnormal uterine bleeding
* Surgical intervention (including "insert removal" and hysterectomy)
* Allergic, hypersensitivity, or autoimmune-like reactions


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 21 years of age;
* Subjects of all weights will be included;
* Subjects who are scheduled to undergo an Essure insert placement procedure for permanent birth control or laparoscopic tubal sterilization. Decision for either treatment based upon clinical practice and physician/patient counseling.
* For the Essure group only:

  • Subjects selecting hysteroscopic sterilization who are not contraindicated for the Essure procedure according to the most current approved version of the Essure IFU;
* For the laparoscopic tubal sterilization group only:

  * Subjects selecting laparoscopic sterilization who are not contraindicated for laparoscopic tubal sterilization according to common clinical practice standard of care.

Exclusion Criteria:

* Subjects who are post-menopausal;
* Subjects suspected of being or confirmed pregnant;
* Subjects post-partum or undergone pregnancy termination ≤6 weeks prior to scheduled procedure;
* Subjects uncertain about ending fertility;
* Subjects with an active upper or lower genital tract infection;
* Subjects with gynecologic malignancy (suspected or known);
* Subjects who have had an attempted prior sterilization procedure (either laparoscopic or hysteroscopic);
* Subjects scheduled to undergo concomitant intrauterine or laparoscopic procedures at the time of insert placement (intrauterine device removal is not considered a concomitant procedure) or laparoscopic sterilization;
* Subjects with unexplained vaginal bleeding.