cyrilzakka/clinical-trials huggingface dataset:
Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study

The PLAN-V Study is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals, who have received the COVID-19 vaccine during their pregnancy, and their infants across the antenatal, delivery and postpartum periods.

There is a pressing need for research to answer critical questions about the role of maternal vaccination for protection of the mother-infant dyad, to inform public health recommendations and to support evidence-based decision-making by Canadian families and their care providers.

The investigators' goal is to generate rapid, reliable evidence specific to the immunogenicity and safety of COVID-19 vaccines in the pregnant population. The specific PLAN-V Study objectives are:

1. To evaluate immunogenicity of COVID-19 vaccines in pregnant women/individuals and the fetal/newborn immune response to maternal vaccination.
2. To evaluate safety of COVID-19 vaccination in pregnant women/individuals based on obstetrical, fetal and newborn health outcomes.
3. To compare immune responses to COVID-19 vaccination and natural COVID-19 disease among pregnant women/individuals and their infants exposed in utero
4. To compare the immune responses to COVID-19 vaccination between pregnant and non-pregnant women/individuals.

PLAN-V is an Ontario-based prospective, longitudinal study that will consist of extensive biosampling and detailed data collection from pregnant women/individuals and their infants across the prenatal, delivery and postpartum periods. With this approach, detailed participant profiles will be generated that will enable us to explore vaccine reactogenicity; vaccine-associated adverse events; frequency of obstetrical and fetal/newborn outcomes; and measures of infant health and well-being. The study will build on existing resources and expertise available through the COVID-19 Ontario Pregnancy Event (COPE) Network to establish a prospective, longitudinal cohort study of pregnant women/individuals, and their infants.

The PLAN-V Study will consist of pregnant women/individuals who are planning to receive a COVID-19 vaccine(s) at any stage in pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women/Individuals ≥ 16 years of age who are ≥7 0/7 weeks' gestation on the day of enrollment
* Capacity to provide informed consent and to comprehend and comply with the study requirements
* Planning to deliver at a participating site hospital
* Planning to receive or have previously received one-dose of a Health Canada approved COVID-19 vaccine (any product, any number of doses) during the current pregnancy

Exclusion Criteria:

* Cases with known major fetal concerns
* Women/Individuals who are fully vaccinated against COVID-19
* Women/Individuals who are pregnant due to surrogacy, or planning to give their child up for adoption
* Women/Individuals with a non-viable pregnancy (e.g., ectopic)
An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.

Estimation of the concordance of Tc 99m localization in liver metastases from colorectal carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.

This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m Tilmanocept in the localization and detection of liver metastases in subjects with confirmed colorectal carcinoma (CRC). The study will be divided into two cohorts.

If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data.

This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be reviewed to establish concordance with FDG PET imaging.

Eligibility Criteria:
Inclusion Criteria:

* The subject has provided written informed consent with Health Information Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
* Subjects must be ≥18 years old;
* The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with FDG PET/CT confirmed metastases to the liver;
* The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
* The subject must be at least 4 weeks past any major intraabdominal surgery, including surgery to the liver;
* Subjects with prior malignancies other than colon and/or rectum cancer are allowed, provided they have been treated with curative intent, and have no evidence of recurrence of that malignancy;
* Each subject must have no more than 10 qualifying liver lesions that have been clinically confirmed metastatic adenocarcinoma of the colon by FDG PET/CT imaging.
* If of childbearing potential, the subject has a negative urine pregnancy test within 48 hours before administration of Tc 99m Tilmanocept, has been surgically sterilized, or has been postmenopausal for at least 1 year

Exclusion Criteria:

* The subject is pregnant or lactating.
* The subject has undergone any liver surgery, exclusive of a biopsy.
* The subject has known sensitivity to dextran.
* The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 10 days prior to Tc 99m Tilmanocept administration
* Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
* Has received an investigational product within the 30 days prior to Tc 99m Tilmanocept administration
Rigid Versus Semirigid Thoracoscopy in Diagnosing Pleural Diseases: a Randomized Study

The purpose of our study was to compare the size and the quality of biopsy samples together with the diagnostic adequacy of semirigid thoracoscopy with that of rigid instrument in prospective, randomized fashion. The second aim was to compare safety and tolerability of both types of procedure, performed in local anesthesia with addition of intravenous sedation and analgesia.


Eligibility Criteria:
Inclusion Criteria:

* 18 or more years old
* unilateral pleural effusion of unknown origin
* pleural irregularities suspicious for pleural malignancy
* referral for thoracoscopy after less invasive means of diagnosis had failed

Exclusion Criteria:

* uncontrolled bleeding tendency
* unstable cardiovascular status
* severe heart failure
* ECOG performance status 4
* persistent hypoxemia after evacuation of pleural fluid
A Hybrid Effectiveness-implementation Evaluation on Programs Promoting Healthy Aging With Sport Exercise (PHASE Program)

The goal of this clinical trial is to provide scientific evaluation on the effects of Promoting Healthy Aging with Sport Exercise (PHASE) Programs on the functional capacity of older. Based on the participants' mental well-being and physical health status, they will be provided with several tailored exercise intervention, including 1) football training; 2) gero-technology enhanced multi-component exercise; 3) slow sports and exercise; 4) walking exercise; 5) home-based exercise. A control group is also recruited and provided with no exercise intervention.

This clinical trial is aimed to match a range of sport exercise to older adults who are in the different phase of transition along the continuum of intrinsic capacity, and to explore effective measures to promote healthy aging. The effectiveness of the tailored interventions will be tested among the six study arms of older adults with different intrinsic capacities, with five intervention arms and one control. Exercise intensity will be measured for each participant. The outcomes are overall health status, physical function, psychological function, and cognitive function. The outcomes are measured at baseline (pre-intervention), 3 months (post-intervention), and 6 months (post-intervention) to explore the program benefits.

Eligibility Criteria:
Inclusion Criteria:

* Age above 60 years

Exclusion Criteria:

* Any contraindication to exercise training
A Study to Assess the Safety and Efficacy of a Microneedle Device for Local Anesthesia

The purpose of this study is to determine whether the MicronJet microneedle device is effective for inducing rapid and painless local anesthesia prior to insertions of intravenous catheters.

Local anesthesia is routinely administered to reduce patient discomfort and improve the outcome of a wide variety of painful medical procedures. However, injection of a local anesthetic agent into the skin using a regular needle is in itself painful. Therefore, common procedures involving needle pricks (e.g. venipuncture) which may be quite painful are usually performed without local anesthesia.

NanoPass has developed a microneedle injection device (MicronJet) which enables painless delivery of drugs directly into the superficial layers of the skin.

The objective of the study is to assess the safety and efficacy of this device for intradermal injection of a local anesthetic agent before insertion of an intravenous catheter to healthy adults.

Each subject will receive an injection of a local anesthetic to one arm, and a control placebo injection of physiological water to the other arm. Both injections will be administered intradermally using the MicronJet. Following the injections, an intravenous catheter will be inserted into the injection site in each arm, and the subject will rate the pain caused by the insertion. Safety parameters will be recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females. a signed informed consent.
* No significant abnormalities in screening physical exam.
* No significant abnormalities in clinical laboratory parameters.
* No significant abnormalities in ECG within 21 days of the start of the study.
* Intact skin at the sites of injection.
* Accessible veins in the antecubital area.

Exclusion Criteria:

* Hypersensitivity to local anaesthetics.
* History of previous vasovagal events.
* Presence of tattoos, discoloration, acne, scars, keloids or any other marks, bruises cuts or abrasions at the injection sites.
* Subjects with active or chronic skin disease or systemic disease with significant skin involvement.
* History of skin allergy or hypersensitivity.
* History of easy bruising.
* Current or previous history of neurological disorders (particularly neuropathies).
* A history of drug or alcohol abuse.
* Acute infection within 7 days prior to study day.
* Subjects who participated in a clinical study within 4 weeks prior to study day, or who plan to participate in another clinical trial during the time of the trial.
* Subjects suffering from Behçet's disease.
* Pregnant or lactating women.
* Any contraindication (relative or absolute) to study drug.
A Phase I Study of Subcutaneously Administered Proleukin (Aldesleukin) in HIV-Infected Patients

To determine the MTD and dose-limiting toxicities of recombinant interleukin-2 (aldesleukin; Proleukin) administered subcutaneously in HIV-seropositive patients. To identify a tolerable subcutaneous regimen that will replicate the immunologic improvement demonstrated in the outpatient polyethylene glycolated IL-2 and high-dose continuous infusion IL-2 studies. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Patients will receive subcutaneous Proleukin, and the MTD will be determined.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection by ELISA and Western blot.
* CD4 count \> 200 cells/mm3.

Required:

* FDA-approved antiretroviral therapy for at least 2 months prior to study entry.
Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation

Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a certain volume of fluid into the epidural space for cauda anesthesia may push some cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the head. Such mild changes are compensated well by healthy individuals and no clinical sequel is seen, however at-risk populations may be affected. We aim to see how different amounts of fluid injected into the epidural space may change two clinical parameters affected by intracranial pressure to determine if a lower volume is safer than a higher one.

Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus allows for easy and safe access into the epidural space. Anatomically, injection of a certain volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal fluid cranially. This push may lead to increased intracranial pressure. We will measure two findings affected by intracranial pressure (optic nerve sheath diameter and cerebral oxygenation) and compare the effects of two different volumes of caudal injections on these measures.

Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal anesthesia is an effective method for peri-operative analgesia, will be recruited for this study. Injection volume will be determined depending on the level of analgesia required for the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after caudal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA class 1 or 2
* Scheduled for elective surgery suitable for caudal anesthesia
* Parental/guardian consent for caudal anesthesia and measurements obtained
* Closed fontanelles

Exclusion Criteria:

* Open fontanelle
* Parental/guardian refusal
* Previous intracranial or ocular pathology
* Coagulapathies
* Variations in gross and ultrasonographic sacral anatomy
* Block performence to end of surgery expected to last less than 30 minutes
* Block volumes more than 30ml needed
* Laparoscopic surgery
* Need for long term analgesia with epidural catheter
Efficacy and Safety of Spinal Cord Stimulation in Patients With Chronic Intractable Pain

The purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (SCS) using the PINS spinal cord stimulator device for chronic and intractable pain.

Adult patients with chronic intractable pain of the trunk and/or limbs who are candidates for a treatment with spinal cord stimulation will be prospectively randomized into 2 arms. Spinal cord stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Have been diagnosed with chronic, intractable pain of the trunk and/or limbs which has been refractory to conservative therapy for a minimum of 3 months.
2. VAS ≥ 5
3. Be 18 years of age or older at the time of enrollment
4. Be willing and able to comply with study-related requirements, procedures, and visits
5. Be willing and capable of giving informed consent

Exclusion Criteria:

1. Pregnancy or potential for with unwillingness to use contraception
2. Have a current diagnosis of a coagulation disorder, bleeding diathesis
3. Have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control
4. Have a life expectancy of less than 1 year
5. Have a condition currently requiring or likely to require the use of diathermy
6. Other inappropriate situations determined by the researcher
Study of the Role of Soluble Inhibitor of Interleukin 22, Interleukin 22 Binding Protein (IL-22BP), in Chronic Inflammatory Bowel Disease

IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial barrier function and regeneration during experimental colitis. IL-22 binding protein is a small, soluble, and secreted protein potently inhibiting IL-22 actions through preventing the binding with IL-22 Recepteur. This study aims at characterizing how IL-22 binding protein is regulated in Inflammatory bowel disease to better understand the way IL-22 acts on epithelial cells during flares of the disease.


Eligibility Criteria:
Inclusion criteria

1. Crohn's disease or Ulcerative colitis
2. Healthy controls paired for age and sex
3. Samples availability in the biobank
4. Signed consent
5. No (Immune Mediated Inflammatory Disorders other than Inflammatory bowel disease
6. No other conditions predicted or known to affect IL-22/IL-22 recepteur /IL-22 binding protein regulation
7. Availability of clinical data
8. Age \>18 y.o.
9. No pregnancy
Comprehensive Reverse Shoulder Data Collection

This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse Shoulder. The secondary objective is collection of long term clinical outcomes.

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder function while reducing pain.

This is a multi-center study. Having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. All potential study subjects will be required to participate in the Informed Consent Process.

Eligibility Criteria:
Inclusion Criteria:

* Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
* The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
* The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Exclusion Criteria:

* Absolute contraindications include infection, sepsis, and osteomyelitis.
* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Osteoporosis.
* Metabolic disorders which may impair bone formation.
* Osteomalacia.
* Distant foci of infections which may spread to the implant site.
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma

The primary objective of this Phase 3 study is to definitively confirm the safety and efficacy of BiovaxId, an autologous tumor derived immunoglobulin idiotype vaccine, as measured by a significant prolongation of the period of disease free survival when administered to patients with indolent follicular Non-Hodgkin's Lymphoma (NHL) during their first complete remission.

Patients with Stage III-IV follicular lymphoma and tumor \> 2cm (Stage II allowed if tumor \> 5cm), previously untreated by other than local radiation, provide tumor material by tissue biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a complete remission, followed by a waiting period to reconstitute the immune system, patients who remain in remission randomized to the active treatment arm receive a series of 5 idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the control arm receive a time-matched series of KLH injections also accompanied by GM-CSF. Patients are subsequently studied to observe their immune responses both to the non-specific immune stimulating agents and for the specific immune response to the vaccine. Patients are followed for a minimum of 4 years post-randomization or until relapse.

Eligibility Criteria:
Inclusion/Exclusion Criteria:

* Diagnosis of indolent follicular lymphoma(follicular small-cleaved cell, follicular mixed or follicular large cell with centrocytes) with surface IgM or IgG phenotype.
* Stage III-IV with lymph node \> 2cm or Stage II with lymph node \> 5 cm
* No prior chemotherapy other than local radiation (not greater than 2 sites)
* ECOG \< 2
* Survival \> 1 yr
* Serum creatinine \< 1.5 mg/dl
* Bilirubin \<1.5 mg/dl
* SGOT/SGPT \< 3.5 ULN
* No HIV antibodies or HBV antigen
* Negative pregnancy screen (females)
* No unrelated neoplasm in the previous 10 years
* No evidence of primary or secondary CNS lymphoma
BagEL - Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management

There is a growing number of patients undergoing bariatric surgery requiring lifelong follow-up. BagEL (Bariatric Patients in Primary Care: Post-operative Nutrition and Lifestyle Management) is a survey to evaluate a newly developed structured disease management program including nutrition and lifestyle management in primary care.

During last decades the prevalence of obesity is growing. Therefore, the number of bariatric procedures are also increasing. Frequent complications after surgery are nutritional deficiencies (e.g. vitamins, minerals, protein) which require mandatory long-term follow-up. So far adequate follow-up programs are only provided in specialized bariatric centers like in the outpatient clinic for obesity at the General Hospital of Vienna. These programs are focusing on prevention and premature identification of deficiencies.

Rising numbers of bariatric-surgical procedures pose a challenge for bariatric centres because of the accumulating numbers of bariatric patients requesting follow-up at least once a year.

To provide full coverage an appropriate possibility would be to transfer follow up to non-specialised facilities including general practitioners and family doctors using a so called "pass" providing practical treatment recommendations (necessary follow-up appointments, laboratory blood tests, questions regarding nutrition and lifestyle behavior).

To our best knowledge such a structured post-bariatric care management program in primary care does not exist by now. The aim of this study is therefore the evaluation of such a pass.

Eligibility Criteria:
Inclusion criteria:

* older than 18 years and each sex,
* bariatric-surgical treatment - in particular omega loop gastric bypass, Roux-en-Y-gastric bypass - and sleeve gastrectomy at the department of surgery General Hospital Vienna,
* Operation date maximum 21 months before study beginning,

Exclusion criteria:

* Pregnancy (a possible existing pregnancy is excluded by questioning)
* Nursing mothers
* Not German speaking patients
Precision Orthodontics: A Comparison of Custom vs Traditional Bracket Treatment Efficiency

This investigational testing aims to target multiple investigations sites to examine treatment efficiency metrics using a completely digital and patient-specific bracket treatment system for the correction of malocclusions.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be healthy and between the ages of 10 and 65.
* Eruption of all permanent teeth excluding second and third molars
* Sufficient labial tooth surface for bonding
* No more than one tooth missing from a single arch quadrant
* No existing molar tubes or bands

Exclusion Criteria:

* Presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), and tumors of the parathyroid gland
* Presence of bridges or implants
* Cases requiring orthognathic surgery
* Significant periodontal disease
* Intake of drugs affecting tooth movement or bone formation (chronic use of Non-Steroidal Anti-Inflammatory Drugs, bisphosphonates, levothyroxine, or teriparatide drug class)
* Pregnancy