cyrilzakka/clinical-trials huggingface dataset:
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™

Primary Objective - Stage I:

To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

Primary Objective - Stage II:

To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.

Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

Eligibility Criteria:
Inclusion Criteria :

* Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
* Infants with at least 36 weeks of gestation at delivery.
* Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
* Able to attend the scheduled visits and to comply with the study procedures.
* Parent or legal guardian willing to take rectal temperatures during the infant series.
* Parent or legal guardian has access to a telephone.
* Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
* Able to obtain at least 1.5 mL of blood sample prior to Dose 1.

Exclusion Criteria :

* Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
* Known or suspected hypersensitivity to any component of the study vaccine to be administered.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Known Human Immunodeficiency Virus (HIV)-positive mother or child.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay or neurologic disorder.
* Chronic medical, congenital, or developmental disease.
* Participation in any other clinical trial.
* Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
* Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.
Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients

The primary aim is to describe platelet function in adult patients treated with extracorporeal membrane oxygenation (ECMO). A clarification of the platelet function in these critically ill patients contributes to an understanding of the mechanisms underlying their coagulopathy.

The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).

The knowledge of platelet function during extracorporeal membrane oxygenation (ECMO) remains sparse. In the present study, the aim is to investigate platelet function in adult patients treated with ECMO using flow cytometry. The investigators hypothesize that platelet function increases from day 1 to day 3 in patients treated with ECMO. The secondary aim is to investigate the association between platelet function and the incidence of bleeding episodes and thrombosis during ECMO treatment.

The present study is a substudy to the study entitled; "Coagulopathy During Extracorporeal Membrane Oxygenation" (pending Clinical Trial ID number).

Eligibility Criteria:
Inclusion Criteria:

* Treatment with veno-venous or veno-arterial ECMO
* Age ≥18 years

Exclusion Criteria:

* ECMO treatment initiated post-operatively
Tetralogy of Fallot Seed Grant

Patients with pulmonary regurgitation after surgical correction of ToF over 13 years old will be recruited from the UCSF adult congenital heart disease clinic. Since there is no data in the literature describing the prevalence of abnormal MRI volumetric and functional parameters in asymptomatic patients with PR after ToF repair, a pilot study with 30 patients will be conducted. Increase in sample size may be necessary in the future to accurately interpret the data. After informed consent is obtained, clinical history and physical examination as well as review of old charts will be performed to characterize these patient's clinical status. All patients will undertake a graduated supine bicycle exercise test with MVO2 measurement to assess exercise capacity.

MRI studies will be performed in a 1.5 tesla unit. SSFP cine images will be obtained in the short-axis plane encompassing the entire heart. Velocity-encoded cine MR images will be obtained perpendicular to the direction of blood flow in the main pulmonary artery. Volumetric and flow analysis will be performed in a separate dedicated workstation by a radiologist. End-diastolic volume, end-systolic volume, ejection fraction, total ejection fraction and pulmonary regurgitant fraction will be calculated.


Eligibility Criteria:
Inclusion Criteria:

Patients over 13 years of age with pulmonary regurgitation after surgical correction of tetralogy of Fallot.

1. Adult patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are under follow-up at the adult congenital heart disease clinic at UCSF or
2. Pediatric patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are under follow-up at the pediatric congenital heart disease clinic at UCSF and are referred for a clinically indicated cardiac MRI studies or
3. Adult and pediatric patients with pulmonary regurgitation after surgical repair of tetralogy of Fallot who are referred for clinically indicated MRI studies at UCSF.

Exclusion Criteria:

Contraindication for MRI study. Claustrophobia.
Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients.

Systematic screening for cervical cancer stops in France at 65 years old. The incidence of certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer.

The aim of our study is to understand help-seeking behavior and its delay for this type of cancer among patients older than 65.

Our study assess the reasons for which the patient took time to go to the doctor despite of their symptoms. We use a qualitative methodology. Our study categorizes lived experiences, recorded in semistructured interview transcripts. We use psychodynamic and semiopragmatic analyses of the discourse to obtain hypotheses about possible reasons of the delay in the help-seeking process."

Eligibility Criteria:
Inclusion Criteria:

* Women of 65 years or more treated or followed at Lorraine Institute of Oncology
* Diagnosed after 65 years or later of a low gynecological cancer
* Without diagnosis of dementia
* Retained ability to express by herself without assistance
* Affiliated to public health system
* Informed and having expressed her non-opposition

Exclusion Criteria:

* Women under 65 or diagnosed before being 65 of a low gynecological cancer
* Diagnosed of dementia
* No longer to express herself
* Patient deprived of freedom
Improving Health Status in COVID-19 Long-Hauler

This randomized clinical trial investigates the effects of a distance physical activity coaching program on the health of COVID-19 long-hauler. The study evaluates the impact of individualized coaching interventions to improve participants' physical activity and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes.
* Agreed to participate.
* Post COVID-19 condition patients meeting the WHO definition for this disease.
* Sedentary patients according to the cut-off point of the International Physical Activity Questionnaire (IPAQ).

Exclusion Criteria:

* Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
* Cognitive impairment that prevented them from understanding and answering the questionnaires.
* Patients suffering from a reinfection with SARS-CoV-2.
* Patients with a history of severe or critical COVID-19 disease severity.
* Patients participating in other studies.
Multi-center Study to Evaluate the Safety and Efficacy of Aesculap MonoMax® for Abdominal Wall Closure

MonoMax will be used for a continuous all-layer (except skin) suture to close abdominal wall after midline incision. The primary objective of this trial is to demonstrate that the frequency of wound infection and the frequency of reoperation due to burst-abdomen after primary median laparotomy for elective surgical intervention are equal or lower than in the INSECT trial. The secondary objectives are to demonstrate that the length of postoperative hospital stay and the frequency of abdominal hernias 12 months after the surgery are equal or lower than in the INSECT trial. \[Knaebel HP et al., 2005\]


Eligibility Criteria:
Inclusion Criteria:

* Age equal or greater than 18 years
* Expected survival time \> 12 months
* Patient undergoing elective and primary median laparotomy
* BMI \< 35
* Expected length of skin incision \> 15 cm

Exclusion Criteria:

* Peritonitis
* Emergency surgery
* Coagulopathy
* Current immunosuppressive therapy (\> 40 mg of a Corticoid per day or Azathioprin)
* Chemotherapy within 2 weeks before operation
* Radiotherapy of the abdomen completed less than 8 weeks before operation
Effect of Progressive Neck Motor Control Exercises on Temporomandibular Joint Dysfunction

The primary aim of this study was to investigate the effects of progressive neck motor control exercises on craniocervical pain, posture, function and kinesiophobia in different types of temporomandibular dysfunction. The secondary aim of the study was to examine the differences between the effects of progressive neck motor control exercises on different types of temporomandibular dysfunction.

In this randomised controlled study, the effects of progressive neck motor control exercise therapy on craniocervical pain, posture, function and kinesiophobia in individuals with different types of temporomandibular dysfunction (myofascial, disc displacement with reduction, disc displacement without reduction) and their differences with the control group will be compared. Participants diagnosed by a dentist according to three different types of temporomandibular dysfunction will be included in the study. Participants will be divided into groups by block randomisation method. A total of 6 groups will be included in the study, including participants with three different types of temporomandibular dysfunction who voluntarily agree to participate in the study and meet the inclusion criteria, and the control group of each group. The study groups will receive the same treatment and patient education for 6 weeks, while the control groups will receive only patient education.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 55 years old,
* Temporomandibular joint-related complaints for at least 3 months,
* Temporomandibular dysfunction is diagnosed as a result of clinical and radiological evaluation by the dentist,
* Neck pain of 3 or more according to the numeric pain scale

Exclusion Criteria:

* Cognitive problems,
* The one with the splint,
* Those who have used painkillers or muscle relaxants for temporomandibular dysfunction complaints in the last 1 week,
* With any systematic joint or muscle disease (e.g. fibromyalgia, rheumatoid arthritis),
* Those with serious systemic diseases,
* Any neurological disorder (e.g. trigeminal neuralgia),
* Pregnancy or breastfeeding,
* Treated for Temporomandibular joint or orofacial muscle pain in the last 3 months,
* Has undergone an operation/trauma to the cervical region and/or temporomandibular joint,
* Positive vertebrobasilar artery test
An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

This study will provide treatment with erlotinib to participants with advanced NSCLC who have received at least one course of standard chemotherapy or radiation therapy, or who are not medically suitable for either. Efficacy and safety will be monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to (≥) 18 years of age
* Histologically or cytologically documented inoperable, locally advanced, metastatic, or recurrent NSCLC
* Previous treatment with no more than 2 prior chemotherapy regimens

Exclusion Criteria:

* Previous systemic anti-cancer therapy with human epidermal growth factor receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitors
* Inability to take oral medication
* Any other malignancies within 5 years
A Long-term (12 Months) Safety, Tolerability and Efficacy Study of LCZ696 in Patients With Essential Hypertension

The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have successfully completed protocol No. CLCZ696A2219 and who, as judged by the study investigator, are able to continue in the current study.
* Ability to communicate and comply with all study requirements and demonstrate good medication compliance during CLCZ696A2219.

Exclusion Criteria:

* Patients who did not complete CLCZ696A2219.
* Presence of significant protocol violation in CLCZ696A2219.
* Patients who are deemed to be unable to comply with the protocol by the investigator.
* Other protocol-defined inclusion/exclusion criteria may apply
IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer

RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation therapy and may help patients live more comfortably.

PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer.

OBJECTIVES:

* Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to time since prior radiotherapy. Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months.
* Arm II: Patients receive an oral placebo three times daily for 6 months. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* History of early breast cancer

  * T1-T3, N0-N1, M0
* No evidence of cancer recurrence
* Palpable breast induration due to prior radiotherapy
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 2 years since prior radiotherapy

Surgery:

* Not specified

Other:

* At least 3 months since prior dietary supplementation containing IH636 grape seed proanthocyanidin extract over 50 mg per day
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Weight ≥ 20 kg (44 lbs.)
2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
4. The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days
3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
4. Inappropriate anatomy for femoral introduction and delivery of the study valve
5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
7. Interventional/surgical procedures within 30 days prior to the TPVI procedure.
8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
9. History of or current intravenous drug use
10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
13. Participating in another investigational drug or device study that has not reached its primary endpoint.
14. Female who is lactating or pregnant
Auditory Neuropathy and Cochlear Implants

The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural synchrony and hence contribute to the development of auditory skills in patients with Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to evaluate the auditory performance and the characteristics of the electrically evoked compound action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory perception was evaluated by sound field thresholds and speech perception tests. To evaluate ECAP's characteristics, the threshold and amplitude of neural response together with the amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research. The auditory perception benefits as well as the possibility to measure the ECAP showed that the electrical stimulation could compensate the neural dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at this point. Therefore, a careful and complete evaluation of each AN/AD patient before recommending the Cochlear Implant is advised


Eligibility Criteria:
Inclusion Criteria:

* All children with AN/AD who had received the cochlear implant during the research´s period.
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a

The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown. This study seeks to address this public health issue. Breastmilk will be collected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding breastfeeding to protect the health of infants.


Eligibility Criteria:
Inclusion Criteria:

* Current COVID-19 positive status or COVID-19 positive status during pregnancy
* Intent to breastfeed or currently breastfeeding

Exclusion Criteria:

- None
COVID-19 and Cancer Consortium Registry

In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals.

The COVID-19 and Cancer Consortium (CCC19) registry prospectively collects anonymized data about patients diagnosed with COVID-19 and cancer. The goal of the registry is to generate hypothesis-generating and hypothesis-supporting findings that are generalizable to the population at large. Specifically:

I. Characterize patient factors, such as pre-existing comorbidities, baseline medication exposures, cancer type, status, and treatment, and demographic factors that are associated with short- and long-term outcomes of COVID-19 (laboratory-confirmed or presumptive), including severity and fatality, in patients with cancer.

II. Describe cancer treatment modifications made in response to COVID-19, including dose adjustments, changes in symptom management, or temporary or permanent cessation.

III. Evaluate the association of COVID-19 with cancer outcomes.

Eligibility Criteria:
Inclusion criteria:

• Healthcare providers or their proxies who would like to report a patient with ALL of the following criteria:

* Suspected (presumptive positive based on clinical presentation) or lab-confirmed COVID-19.
* Current or past medical history of invasive malignancy (any type)

Exclusion criteria:

* Participants at international sites not explicitly listed below
* Non-healthcare providers (or their proxies)