cyrilzakka/clinical-trials huggingface dataset:
Evaluation Protocols for Isolation of Analytes From Urine for Future Oncology Applications

The aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). The following factors will be evaluated (1) volumetric collection with Colli-Pee®, a collection device developed by Novosanis for standardized collection of urine, and (2) stabilization methods.

This is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. The participants will be asked to provide a urine sample collected with the Colli-Pee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. For the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different Colli-Pee® variants and fill out questionnaires accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Being able to understand and read Dutch
* For cancer patients specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer)

Exclusion Criteria:

* For cancer patients specifically: patients suffering from a blood cancer
FUTURE 3 Study Extension

The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

1. Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH-progression, if bosentan was not permanently discontinued
2. Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of the FUTURE 3 core study (AC-052-373)
3. Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.

Exclusion Criteria:

1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet
2. Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy
3. Pregnancy
4. AST and/or ALT values \> 3 times the upper limit of normal range (ULN)
5. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
6. Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373)
7. Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
Phase II Trial of ZD1839 (Iressa) in Patients With Nonresectable Adrenocortical Carcinoma (ACC)

The use of Iressa will result in a greater than 20% response rate in patients with nonresectable adrenocortical cancer who have previously been treated with one other form of systemic therapy (either Mitotane or chemotherapy).

Adrenocortical carcinoma is a rare cancer with an incidence of 1.5 to 2 per million people in the United States. Surgery is the only potentially curative option. Current systemic therapy, either Mitotane or chemotherapy, typically gives response rates of 20% or less. This study is designed to see if the newer targeted therapy, Iressa, may be of benefit for patients with this fatal disease.

Patients with nonresectable adrenocortical cancer who have progressed on at least one other form of systemic therapy (Mitotane or chemotherapy) will be given Iressa 250 mg by mouth daily until disease progression. This is a standard two-stage Phase II clinical trial. Eighteen patients with measurable disease will be enrolled in the first stage. If there is at least one responder, then an additional nine patients with measurable disease will be enrolled for a total of 27 patients with measurable disease. Up to six patients without measurable disease may be enrolled at any point in this study. Iressa will be provided free for all study participants.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be able to provide informed consent
* Subject must be 18 years of age or older
* Subject must have histologically confirmed ACC by Department of Pathology at Dartmouth Hitchcock Medical Center
* Subject must have inoperable disease
* Subject must have received some form of systemic therapy prior to enrolling in the study

Exclusion Criteria:

* known severe hypersensitivity to Iressa
* other co-existing malignancies diagnosed within the last five years except basal cell cancer or cervical cancer in situ
* any unresolved CTC grade 2 toxicity from previous anticancer therapy (except alopecia)
* absolute neutrophil count less than 1.5 x 1,000,000,000 per liter
* platelets less than 20 x 1,000,000,000 per liter
* severe uncontrolled systemic disease
* pregnancy\\breastfeeding
* women who are fertile and not willing to practice abstinence or contraception
* use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's Wort
* treatment with a non-approved or investigational drug within 28 days before Day 1 of study treatment
* prior use of ZD1839 (Iressa) or any other anti-EGFR therapies
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Community Acquired Bacterial Pneumonia (CABP)

This is a study of safety and effectiveness of ceftaroline fosamil in children with Community Acquired Bacterial Pneumonia receiving antibiotic therapy in the hospital.

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in children who are initially hospitalized with Community Acquired Bacterial Pneumonia (CABP)

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 2 months to \< 18 years old.
* Presence of CABP requiring hospitalization and IV antibacterial therapy

Exclusion Criteria:

* Documented history of any hypersensitivity of allergic reaction to any β-lactam antimicrobial.
* Confirmed or suspected infection with a pathogen known to be resistant to ceftriaxone.
* Confirmed or suspected respiratory tract infection attributed to sources other than CABP pathogens.
* Non-infectious causes of pulmonary infiltrates.
Group Training for Parents Whose Children Suffer From ADHD and Comorbidity Using a Behavioral-Dynamic Approach

The purpose of this study is to determine whether a new parent training protocol for children with Attention Deficit Hyperactivity Disorder (ADHD) can over perform the state of the art Parent Training protocol (PBT) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Parents to children 6-12 with ADHD symptoms according to the criteria of Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V)
* The child was diagnosed in the past as ADHD by MD

Exclusion Criteria:

* Parents with psychotic symptoms or suicidality
* Parents with active manic episode
* Parents with substance dependence
* Parents with autism spectrum disorder
Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes

To compare the efficacy of two dosages (600mg/day and 1200mg/day) of bicifadine SR with placebo for 14 weeks in reduction of chronic neuropathic patin (measured by a daily rating of pain intensity) associated with diabetic periperal neuropathy in adult outpatients.

To compare the tolerability of two dosages of bicifadine SR with placebo in adult outpaitens treated for chronic neuropathic pain for 14 weeks associated with diabetic peripheral neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older
* Diagnosis of type-1 or type 2 non-insulin dependent diabetes mellitus
* Chronic bilateral pain due to diabetic neuropathy
* Pain for at least six months
* Primary pain is located in the feet
* Others-contact site for information

Exclusion Criteria:

* Symptoms of other painful conditions
* Presence of amputations other than toes
* Clinically significant psychiatric or other neurological disorder
* Use of certain medications
* Clinically important other diseases
* Pregnancy
* History of alcohol or narcotic abuse within two years
* Others-contact site for information
Safety and Efficacy of the CarboFix Pedicle Screw System

The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years old or older.
2. Confirmation that the physical examination of radiopathy, myelopathy or combination is in correlation with the affected level.
3. Lumbar CT, MRI, or myelography confirms the level of involvement is consistent with the subject's examination.
4. Informed consent given by the subject.

Exclusion Criteria:

1. Subject is not eligible for fixation with market-available fixation means.
2. Familial history NF2.
3. Acute traumatic spinal injury with or without neurological signs.
4. Metabolic bone disease.
5. History of Paget's disease or other osteodystrophies whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism hyperparathyroidism, Ehrlers-Danlos-syndrome, osteogenesis imperfecta, achondroplasia, tuberculosis.
6. History of mental disorder or current psychiatric treatment.
7. Pregnancy and/or female subjects intending to become pregnant within the expected time frame of the study and/or female subjects of child bearing age who do not use conventional contraceptive methods.
8. Immune deficiency disease.
9. Infection in the location of the operative site, discitis, osteomyelitis, fever and/or leukocytosis (as diagnosed based on the results of CBC and ESR tests).
10. Scoliosis.
11. Treatment with drugs that may interfere with bone metabolism such as:

    1. Cumulative dose of 150 mg. of Prednisone or equivalent within the last 6 months.
    2. Calcitonin within the past 6 months.
    3. Bisphosphonates for 30 days or more within the last 12 months.
    4. Bone therapeutic doses of fluoride for 30 days or more within the last 12 months.
    5. Bone therapeutic doses of vitamin D or Vitamin D metabolites for 30 days or more within the last 6 months.
    6. Treatment by chemotherapy within the last 12 months.
12. Lack of willingness to make a commitment to return for required follow up visits.
13. Drug and/or alcohol abuse.
14. Morbid obesity.
15. Metal allergies.
16. Recent use of other investigational drugs or devices (within the past 30 days).
GANfort® in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Are Insufficiently Responsive to Monotherapy

This is an observational study of patients diagnosed with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) who are insufficiently responsive to monotherapy and who are prescribed GANfort® (fixed combination of 0.3 mg bimatoprost and 5 mg timolol) by their physician.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open angle glaucoma or ocular hypertension
* Prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol)

Exclusion Criteria:

* None
Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients

Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.


Eligibility Criteria:
Inclusion Criteria:

* Blood samples sent for ANCA lab test

Exclusion Criteria:

* Patients with ANCA vasculitis
* Patients with known malignancy
Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes

This study aims to understand the heart and blood sugar health benefits of using an adjunctive therapy to lower high insulin levels in people with type 1 diabetes. The investigators will also look at people with a specific type of diabetes called Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY) and those without diabetes to help interpret the results. The investigators will use a medication that helps the body get rid of sugar, called and SGLT2 inhibitor, with the goal to reduce the body's insulin requirements. The investigators believe this could lead to better heart and blood sugar health, including a better response to insulin and more available nitric oxide, a gas that helps blood vessels function well. The investigators will compare heart and blood sugar health risk factors in participants with type 1 diabetes, participants with Glucokinase-Maturity Onset Diabetes of the Young (GCK-MODY), and non-diabetic healthy volunteers under two conditions: high insulin levels typical of type 1 diabetes and normal insulin levels typical of the other two groups.


Eligibility Criteria:
Inclusion Criteria:

Age: 18-60 years BMI: 18-28 kg/m² Weight: ≥ 50 kg

T1DM Participants:

Duration of T1DM: 1-30 years HbA1c: 5.7-7.5% Insulin Therapy: Using automated insulin delivery

GCK-MODY Participants:

HbA1c: 5.7-7.5% Genetic Confirmation: Positive GCK sequencing

Control Participants:

HbA1c: less than 5.5%

\*\* Exclusion Criteria: Severe Hypoglycemia: ≥1 episode in the past 3 months

Comorbidities:

* Any hospital admissions for diabetic ketoacidosis in the past 6 months
* SBP greater than 140 mmHg and DBP greater than 100 mmHg
* eGFR by MDRD equation of less than 60 mL/min/1.73 m²
* AST or ALT greater than 2.5 times ULN
* Hct less than 35%

Medications:

* Any antioxidant vitamin supplement within 2 weeks before the study
* Any systemic glucocorticoid
* Antipsychotics
* Atenolol, Metoprolol, Propranolol
* Niacin
* Any thiazide diuretic
* Any oral contraceptive pill with greater than 35 mcg ethinyl estradiol
* Growth hormone
* Any immunosuppressant
* Antihypertensive
* Any antihyperlipidemic

Other:

* Pregnancy
* Tanner stage less than 5
* Peri- or post-menopausal women
* Active smoker

T1DM Participants:

Medications: Any diabetes medication except insulin C-peptide: greater than 0.7 ng/mL (fasting)

GCK-MODY Participants:

None specific
Uterine Filling Pressure in Hysteroscopy

The aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a Myosure device with a pressure of 60 mmHg to those using the standard of 80 mmHg.

An a priori sample size calculation was completed. To achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.The study will be a double-blind randomized control trial. Patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. The consent process will happen in the pre-operative appointment. Participants will then be randomized to either the standard of care of 80mmHg or the experimental pressure of 60 mmHg for uterine filling pressure via an automated randomization program. The physician performing the surgery and the patient will not know what group they are assigned to. The procedure involved in the study will be hysteroscopy. Hysteroscopy is a procedure that is used to diagnose and sometimes treat intrauterine pathologies. In order to visualize the uterus, pressurized saline is used to distend the uterus.

In this study, the specific hysteroscopic procedure will involve the removal of uterine fibroids with a MyoSure Hysteroscopic Morcellator device. These tissue samples will be collected and sent to Pathology to be weighed. During the surgery, the surgeon will be able to request an adjustment pressure if visualization is not adequate. Physicians will start with a pressure of 80mmHg. Once physician is ready to introduce the myosure hysteroscopy device, the pressure level will then be randomized. During the procedure, monitoring will be done by anesthesia through the use of pulse oximetry and measurement of vitals during the Monitored Anesthesia Care. There is also real-time monitoring of hysteroscopic fluid deficit via the fluid management system that is attached to the hysteroscopic pump. Fluid deficit can also be confirmed by the nurse who manually counts the amount of fluid used during theprocedure. Per policy, once a 2500mL deficit is reached, the procedure is terminated. After the surgery, the surgeon will fill out a questionnaire that measures the outcomes of surgeon satisfaction and visualization during the procedure. The other end points of procedure time, specimen weight, volume of normal saline used, any changes in pressure needed during the surgery, and whether the patient required Lasix post-operatively will also be collected at this time.

Eligibility Criteria:
Inclusion Criteria:

* Patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids
* Age equal to or greater than 18
* Ability to understand and willingness to sign consent form. We will include non-English speaking patients in this study

Exclusion Criteria:

* Patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids
* Patients under the age of 18
Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus

People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to 80% of the patients will develop chronic pain called "central pain" and describe the pain as: burning, stabbing, or "like electricity." Central pain mechanism is unknown and therefore treatment is currently not effective.

It is hypothesized that chronic pain is associated with impaired function of the systems regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury patients. Presence of such a connection, between the regulating system dysfunction and central pain, will help both predicting the risk of central pain and develop a treatment.

The current research objective is to make several sensory measurements which will measure the functioning mechanisms of regulation and control of the pain. These measurements are accepted throughout the world and are based on psychophysical assessment of patients. these Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients demonstrate impairment in the regulation of pain. Finding such a link between central pain and impaired regulation could shed light on the mechanism of central pain. In addition, these measurements are designed to assess whether fresh spinal cord injury patients that have not yet developed central pain demonstrate impairment in the regulation of pain immediately after the injury. By repeated assessments of pain regulation capabilities, which will be made to fresh Spinal Cord Injury patients during the first months of injury, and comparing the results of these measurements between those who will develop center pain and those who will not, we could identify indicators for predicting the risk of central pain. Another goal of the study is to investigate the efficacy of central pain treatment, using a TENS, when the parameters of the TENS treatment will be built according to the level of functioning of the regulating systems of the individual.


Eligibility Criteria:
Inclusion Criteria:

* for all subjects:

  * age - 18-70
  * Cognitive status that allows voluntary cooperation understanding of instruction
* for chronic Spinal Cord Injury subjects:

  * spinal cord injury (complete and incomplete)
  * height of injury - under 7th cervical vertebra
  * time since injury - one year or more.
* for chronic Spinal Cord Injury subjects:

  * spinal cord injury (complete and incomplete)
  * height of injury - under under 7th cervical vertebra
  * time since injury - three weeks or less

Exclusion Criteria:

* subjects suffering from the following conditions: pacemaker,pregnancy,cancer, tuberculosis, thrombosis, metallic implants
* systemic diseases that affect the sensory perception (such as diabetes)
* patients with other neurological pathologies (such as head injury-TBI)
* Pregnancy
GyneFix-Viz*: A Study of Serosal-Anchor (SA) Distance

The GyneFix-Viz is a frameless copper intrauterine device (IUD) used for contraception. The GyneFix IUD has been marketed in Europe and Asia for about 10 years. The new anchor in the GyneFix IUD was designed to be more visible on ultrasound and this could improve safety by reducing failed insertions and perforations. We now need to know how easy it is for doctors to see and measure the distance of the anchor to the outside of the uterus. The purpose of this open, prospective, observational study is to assess the feasibility of measuring the distance from the serosa of the uterus to the anchor following insertion of the GyneFix-Viz and at follow-up 6-8 weeks later. Secondary objectives are to assess the ease and pain of insertion, the acceptability of the device to Canadian women and any complications. We will also compare expulsion rates in post-abortion and other women.


Eligibility Criteria:
Inclusion Criteria:

1. healthy women requesting intrauterine contraception
2. willing to have a GyneFix IUD for pregnancy prevention
3. able to return for a follow-up ultrasound
4. able to read and understand consent form

Exclusion Criteria:

1. Any contraindications precluding insertion of an IUD (e.g., infection, cancer of the uterus, malformation etc.)
2. Immediately after a pregnancy interruption \> 10 weeks gestation
Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Is in good health (any underlying chronic illness must be documented to be in stable condition)
* Has documented proof of receipt of 23-valent pneumococcal polysaccharide vaccine ≥1 year prior to study entry
* Is a male or postmenopausal female

Exclusion Criteria:

* Has received prior administration of any pneumococcal vaccine other than 23-valent pneumococcal polysaccharide vaccine
* Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
* Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
* Is known or suspected impairment of immune function
* Has received systemic corticosteroids for \>=14 consecutive days and has not completed treatment \<=30 days prior to study entry, or received systemic corticosteroids exceeding physiologic replacement doses within 14 days prior to study vaccination
* Has a coagulation disorder contraindicating intramuscular vaccination
* Receives immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease
* Has received a blood transfusion or blood products, including immunoglobulins within the 6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine. Autologous blood transfusions are not considered an exclusion criterion
* Has participated in another clinical study of an investigational product within 2 months before the beginning of or any time during the duration of the current clinical study
* Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.