cyrilzakka/clinical-trials huggingface dataset:
First-In-Human Study Evaluating a Novel Catheter Device in Subjects With Treatment-Resistant Hypertension

The carotid body is located at the bifurcation of the internal and external carotid arteries. It is a chemoreceptor that plays a role in the sympathetic nervous system and in the development and maintenance of hypertension. Hypertension is a major cardiovascular risk factor and is associated with coronary artery disease, stroke, chronic kidney disease, and heart failure.

The objective of this study is to assess the effectiveness and safety of a catheter-based system to ablate the carotid body and reduce blood pressure (BP) in patients with resistant hypertension and to confirm sustainability of the treatment benefits long-term as seen following surgical CB removal.


Eligibility Criteria:
Inclusion Criteria:

* Mean office SBP ≥160 mmHg and DBP ≥90 mmHg during screen-in period
* Mean daytime systolic ABPM ≥135 mmHg during screen-in period
* Adherent to a stable drug regimen of three (3) or more anti-hypertensive medications of different classes (including one (1) diuretic), with no medication changes expected for at least six (6) months post-procedure
* No change in anti-hypertensive drug prescription (dose, number of medications, or class of medication) for at least six (6) weeks prior to enrollment
* Negative pregnancy test for women of child-bearing age
* Willingness and able to comply with follow-up requirements
* Signed informed consent

Exclusion Criteria:

* Secondary causes of hypertension
* Calculated eGFR \<30mL/min/1.73m2
* History of repeated episodes of hypoglycemic unawareness
* Morbid obesity, defined as Body Mass Index \>40 kg/m2
* Severe obstructive sleep apnea (AHI \> 35/hr.)
* Pacemaker and/or implantable defibrillators
* History of transient ischemic accident or cerebrovascular accident during six (6) months prior to screening
* History of acute heart failure, congestive heart failure (NYHA class III-IV), myocardial infarction, unstable angina, coronary bypass or coronary angioplasty during six (6) months prior to screening
* History of ipsilateral carotid endarterectomy treatment or ipsilateral carotid artery stenting
Development, Field Testing and Evaluation of the Efficacy of a Hand-held, Portable and Affordable Thermo-coagulator to Prevent Cervical Cancer in Low- and Middle-income Countries

This project develops, tests and produces a lightweight, cordless, battery driven and rechargeable hand-held device for treating cervical precancer (Liger Thermal Coagulator). The study evaluates its effectiveness compared to the current standard treatment (cryocautery) when used as part of a screen and treat programme using Visual Inspection with Acetic acid (VIA) in Sub Saharan Africa.

This project aims to improve screen and treat programmes for cervical cancers by discovering the best method of treatment. The specific aims are

1. To develop, test and produce 20 novel lightweight hand-held cordless, portable battery driven and rechargeable Thermal Coagulators (Liger Medical, Utah).
2. To evaluate the success / failure rate of Thermal Coagulation in a randomised controlled trial comparing thermal coagulation to the existing current standard cryocautery and to Large Loop Excision of the Transformation Zone (LLETZ aka LEEP) as part of a screen and treat programme in Zambia.
3. To evaluate the user satisfaction scores of the Liger Thermal Coagulator cryocautery as part of a screen and treat programme in Zambia.
4. To determine the rate of over treatment of VIA positive women as revealed by histopathological examination of the randomly assigned excised treatment cases.
5. To determine the value of Z scan to predict normality and abnormality in VIA positive women randomly assigned to excisional therapy

In collaboration with a medical devices company in Utah, the engineering performance of the Liger Thermal Coagulator has been developed and tested in vitro and in vivo. 200+ Liger units have been produced and a randomised controlled trial of the device has been undertaken, compared to cryocautery and LLETZ using efficacy and user friendliness as endpoints. The inclusion of a study arm of excisional therapy allows to quantify the rate of overtreatment in VIA programmes and using the Z scan may allow for a non invasive method of accurately predicting normality and abnormality in VIA positive women.

Eligibility Criteria:
Inclusion Criteria:

* Positive on VIA test for cervical cancer screening
* Eligible for ablative treatment

Exclusion Criteria:

* Pregnancy
* Not voluntarily willing to participate
Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?

Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.

Eligibility Criteria:
Inclusion Criteria:

* Male
* age between 18-50 yrs
* signed informed consent

Exclusion Criteria:

* Cardiovascular disease
* Hypertension (systole \> 140 mmHg, diastole \> 90 mmHg)
* Hypercholesterolemia (fasting total cholesterol \> 6,0 mmol/l)
* Drug abuse
* Concomitant medication use
* Inability to perform the ischemic isometric muscle contraction
* Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* Alanine-Amino-Transferase (ALAT) \>90U/L (more than twice the upper level of the normal range)
* Creatinine Kinase (CK) \>340U/L (more than twice the upper level of the normal range)
* Participation in any trial concerning medicinal products during the last 60 days prior to this study.
* Participation in clinical trial involving
Effects of a Program of Physical Exercise and Electrotherapy on Muscle Strength in Subjects of the Fourth Age

The purpose of this study is to determine whether neuromuscular electrical stimulation, strengthening exercises, or combination of both over lower limbs are effective in the improvement of the stability fundamentally against falls, greater independence and, therefore, better quality of life in elderly over 75 years.


Eligibility Criteria:
Inclusion Criteria:

* Age above 75

Exclusion Criteria:

* Mental disorder
* Previous electrotherapy treatments
* Pacemakers
* Lower limbs prosthetics
* Major coronary diseases
Evaluation of a Low-fluoride Anticaries Toothpaste

The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.


Eligibility Criteria:
Inclusion Criteria:

* 30 adult subjects (between 18-50 years of age)
Enable I Long-term Follow-up Study

This was a prospective, non-randomized, multi-center, non-interventional post-market study. The study was a post-market long-term follow-up study based on the same cohort of patients (148 patients) enrolled in a previous investigational study from March 2007 to December 2009 (ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005) involving 10 European sites. Patient follow-up took place on a yearly basis up to 10 years after the implant/enrollment. The primary objective of this study was to evaluate the safety and effectiveness of the Medtronic ATS Enable Aortic Bioprosthesis during long-term follow-up.

As this was an observational study, safety and efficacy data were summarized and described. There was no statistically powered study hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were enrolled and implanted for the ATS 3f Enable™ Aortic Bioprosthesis Model 6000, number S2005
* Patient willing to sign the new Data Release form (DRF) or Patient Informed Consent (PIC) for the post-market study (what is applicable for the study due to local requirements and regulations)

Exclusion Criteria:

* ATS 3f Enable™ Aortic Bioprosthesis Model 6000 was explanted
* Patient died
* Patient lost to follow-up
* Patient withdrew consent
ABC Science Collaborative Registry Study

The ABC Registry is associated with Pro00107943 and provides a resource for collecting information on members of school communities both regionally in North and South Carolina, as well as nationally in the United States (U.S.) through the National Program, including children, parents, teachers, superintendents, and other staff; and children identified through clinical practice. The overall goals of the Registry are to collect data relevant to public health during the coronavirus 2019 (COVID-19) pandemic and to establish and engage school communities that may be eligible for participation in future research studies, including observational studies, as well as prospective COVID-19 trials.


Eligibility Criteria:
Inclusion Criteria:

* Participant currently attends, is the parent of a student, works in, or works with a school that is participating in the ABC Science Collaborative, or participant is an adult or child who learned of the registry through clinical practice and is interested in participating in COVID-19 related research,
* Participant or their parent/guardian has provided informed consent or assent, as applicable
* Participant or their parent/guardian has downloaded the "ABC Science" App from the App store as a part of the ABC Science Collaborative and has agreed to the App's Terms of Use
* Participant or their parent/guardian is able to speak and read English or Spanish

Exclusion Criteria:

* There are no specific exclusion criteria for this registry. Participants must meet inclusion criteria.
Intravesical BCG Administration to Patients With Invasive Bladder Cancer

Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.

Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.

After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Have suspected or known invasive (≥T1) bladder cancer
2. Be able to give informed consent
3. Be age 18 or older
4. Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)

Exclusion Criteria:

1. Have non-invasive (\<T1) bladder cancer
2. Unable to give informed consent
3. \< 18 or older
4. Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids \>1 month)
A Prospective Cohort Study to Evaluate the Oncotype DX® Test in Early Stage Breast Cancer

A prospective population-based cohort study is being conducted in Ontario to evaluate whether the performance of Oncotype DX® changes the treatment recommended and the treatment received in women or men with node negative, ER positive breast cancer who are receiving (or will receive) endocrine therapy and who are candidates for chemotherapy. One thousand eligible consenting women and men will have their tumor tissue specimen sent to Genomic Health where the Oncotype DX® assay will be performed.

The evidence supporting the adoption of Oncotype DX® is relatively weak by the criteria used by the Ontario Health Technology Advisory Committee (OHTAC). There is only one small published prospective study that reports on Oncotype DX® changing clinical management. The economic models that estimated the potential advantages of using an Oncotype DX® guided treatment strategy may have overestimated the benefits because they assumed that all patients with tumors \>1cm in the absence of Oncotype DX® testing would receive chemotherapy in addition to tamoxifen, and that the magnitude of benefit with chemotherapy over tamoxifen is relatively large, i.e. reduces recurrence risk by 74% and associated with an absolute benefit of 28%. (The benefit comes from one trial and is applied to all patients). It is estimated that there are about 3,300 incident cases with node negative, ER positive, HER2 neu negative tumors annually in Ontario, it is important to evaluate the adoption of this test for decision making in Ontario.

Eligibility Criteria:
Inclusion Criteria:

* Women or men with histologic evidence of invasive breast cancer (ductal, lobular or mixed disease).
* Surgical resection including breast conserving surgery or modified radical mastectomy or simple mastectomy, within the last four months.
* Axillary lymph nodes assessed for tumor by:

  (i) sentinel node biopsy, or (ii) axillary node dissection, or (iii) both
* Axillary lymph node assessment negative for cancer, or positive only for micrometastases (i.e., cancer \<2mm by H\&E stain).
* Tumor is estrogen receptor (ER) positive.
* Receiving or to receive adjuvant endocrine therapy (i.e., tamoxifen or aromatase inhibitor).
* Being considered for adjuvant chemotherapy.

Exclusion Criteria:

* Axillary lymph node positive for cancer.
* Patients with inoperable locally advanced breast cancer.
* Metastatic breast cancer, including local ipsilateral recurrence.
* HER2 neu positive.
* Physician/Patient unwilling to comply with study protocol.
* Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring

Internet plays a more and more important role in many applications of healthcare. Many researches on the integrations of internet and mental health care have been proposed in recent years. This project aims at the development of an online treatment system which combines the biofeedback therapy and the web technologies to treat the patients suffering from panic disorder with partial response to medications. This project also evaluates the efficacy of a new- designed wireless temperature biofeedback ring.

The participants should be chronic panic patients. They login an web-based server and practice muscle relaxation on-line every day. There will be two two parallel groups: one group practicing muscle relaxation only and the other practicing muscle relaxation with finger surface temperature monitor through a wireless biofeedback ring.

Eligibility Criteria:
Inclusion Criteria:

1. The participant must fulfill DSM-IV criteria for panic disorder.
2. The participant must be between 18 and 60 years of age.
3. The participant must have panic disorder as the primary problem.
4. If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 2 months before starting treatment, and b) the participant have to agree to keep the dosage constant for 1 month after starting treatment.
5. If the participant was already in therapy, the contact must have lasted at least 6 months and not be based on cognitive behavior therapy.
6. All participants have access to a computer with an Internet connection.

Exclusion Criteria:

1. The participant suffers from any other psychiatric disorder in immediate need of treatment.
2. The participant fulfills DSM-IV criteria for major depression.
3. The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. The participant has alcoholism.
A Clinical Study to Evaluate the Safety and Efficacy of ETX101, an AAV9-Delivered Gene Therapy in Children With SCN1A-positive Dravet Syndrome

EXPEDITION is a Phase 1/2 study in the UK to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet Syndrome aged 6 to \< 48 months. The study follows and open-label, dose-escalation design.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a predicted loss of function pathogenic or likely pathogenic SCN1A variant
* Participant must have experienced their first seizure between the age of 3 and 15 months
* Participant must have a clinical diagnosis of Dravet syndrome or the treating clinician must have high clinical suspicion of a diagnosis of Dravet syndrome
* Participant is receiving at least one prophylactic antiseizure medication

Exclusion Criteria:

* Participant has another genetic mutation or clinical comorbidity which could potentially confound the typical Dravet phenotype
* Participant has a known central nervous system structural and/or vascular abnormality (indicated by an MRI or CT scan of the brain).
* Participant has an abnormality that may interfere with CSF distribution and/or has an existing ventriculoperitoneal shunt.
* Participant is currently taking or has taken antiseizure medications (ASMs) at a therapeutic dose that are contraindicated in Dravet syndrome, including sodium channel blockers.
* Participant has experienced seizure freedom for a period of 4 consecutive weeks within the 90-day period prior to informed consent.
* Participant has previously received gene or cell therapy.
* Participant is currently enrolled in a clinical trial or receiving an investigational therapy.
* Participant has clinically significant underlying liver disease.
Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS

This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.

Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.

Eligibility Criteria:
Inclusion Criteria:

* OA of one or both knees as diagnosed by the treating physician
* At least 18 years of age
* Willing and able to comply with the study procedures
* Signed informed consent form

Exclusion Criteria:

* Any systemic inflammatory condition ( e.g., rheumatoid arthritis)
* Active malignancy at time of injection
* Pregnant at time of injection
* Lactating at the time of injection
* Knee joint infections or skin diseases or infections in the area of the injection site.
* Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment
* Participating in another device or drug study
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers

To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose \[14C\] selumetinib in volunteers


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.
* Regular bowel movements (ie, on average production of at least 1 stool per day).

Exclusion Criteria:

* Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.
* Exposure to radiation levels above background exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
* History or presence of any clinically significant disease or disorder in the opinion of the investigator
* Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, vital signs or ECG at baseline in the opinion of the Investigator.
Evaluating the Impact of Limited Compared With Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Stage II-III Soft Tissue Sarcoma of the Trunk and Extremities

This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.

PRIMARY OBJECTIVE:

I. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance.

SECONDARY OBJECTIVE:

I. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients.

OUTLINE: Patients are assigned to 1 of 2 groups based on risk status.

GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site.

ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site.

GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I.

Eligibility Criteria:
IInclusion Criteria:

* ≥18 years old
* Completion of sarcoma therapy (chemotherapy, radiation therapy and/or surgery) within 8-14 weeks of study enrollment
* Willingness to complete surveys x 2 years

Exclusion Criteria:

* Documented metastatic disease at the time of enrollment
* Non-English-speaking patients

Pregnant women will be included in this clinical trial.