cyrilzakka/clinical-trials huggingface dataset:
Role of 3D Tomography in Breast Cancer

The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.


Eligibility Criteria:
Inclusion Criteria:

* All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
* Able to provide informed consent.

Exclusion Criteria:

* Males
* Women less than 40 years old
* Pregnant women
* Lactating women
* Woman who have had bilateral mastectomies
* Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
* Women who are unable to tolerate study constraints, frail or unable to cooperate
* Women with large breasts that cannot be accommodated within the field of view of the CT system
* Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  * Treatment for enlarged thymus gland as an infant
  * Irradiation for benign breast conditions, including breast inflammation after giving birth
  * Treatment for Hodgkin's disease
* Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  * Tuberculosis
  * Severe scoliosis
Oblimersen in Treating Patients With Merkel Cell Carcinoma

This phase II trial is studying how well oblimersen works in treating patients with Merkel cell cancer. Biological therapies, such as oblimersen, may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma (skin cancer).

PRIMARY OBJECTIVES:

I. Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen.

SECONDARY OBJECTIVES:

I. Determine the time to progression in patients treated with this drug. II. Determine the response duration in patients treated with this drug. III. Determine the safety and tolerability of this drug in these patients. IV. Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oblimersen IV continuously on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Merkel cell carcinoma

  * Metastatic OR regionally recurrent disease
  * Localized disease not amenable to curative therapy (surgery or radiotherapy) also allowed
* Measurable disease

  * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* No known brain metastases

  * Previously resected or irradiated brain metastases allowed if stable for at least the past 3 months and no evidence of neurological compromise exists
* Performance status - Karnofsky 60-100%
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* WBC \>= 3,000/mm\^3
* AST/ALT =\< 2.5 times upper limit of normal
* Bilirubin normal
* INR =\< 1.5
* Creatinine normal
* Creatinine clearance \>= 60 mL/min
* No atrial fibrillation unless stable for at least the past 6 months
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Adequate venous access
* No peripheral neuropathy \> grade 1
* No active or ongoing infection
* No other concurrent uncontrolled illness
* No prior grade 3 or 4 anaphylactic reaction to phosphorothioate oligonucleotide
* No psychiatric illness or social situation that would preclude study compliance
* More than 3 weeks since prior chemotherapy and recovered
* More than 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to 25% or more of bone marrow
* More than 3 weeks since prior investigational therapy and recovered
* No prior oblimersen
* No other concurrent investigational agents
* No concurrent anticoagulation except 1 mg of warfarin for mediport patency
* No concurrent combination antiretroviral therapy for HIV-positive patients
Short-term Sugary Beverage Consumption on Glucose Control and Cardiovascular Disease Risk Factors

Our goal is to determine how the addition of sugar-sweetened beverages to the diet affects glucose control, cardiovascular disease risk factors, and pulmonary function in healthy, young adults.

In a 3-arm randomized controlled trial, 36 participants consumed one of three beverages for three weeks: water (W), caffeine-free soda (S), or 100% fruit juice (FJ). Participants consumed two servings/day (\~710mL) of their randomized beverage for three weeks, along with their habitual diets. At baseline and following the 3-week intervention, participants completed glucose control, cardiovascular disease risk factor, and pulmonary function assessments.

Eligibility Criteria:
Inclusion Criteria:

* Free from diagnosis of diabetes and pulmonary illness
* Have no intake of glucose or lipid lowering medication.

Exclusion Criteria:

* Smoke
* Currently pregnant
* Have bronchitis
* Have more than 2 risk factors for cardiovascular disease, as defined by the American College of Sports Medicine (ACSM).
Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization

Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH.

Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.

Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated one week, one month, three months and six months after the treatments.

Discussion: This study will enable the determination of differences in the effectiveness of the proposed treatments as well as differences among the evaluation times for each proposed treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years;
* Good overall health;
* At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS.

Exclusion Criteria:

* Active caries or defective restorations on the tooth to be analyzed;
* Sufficient dentin loss that requires restorative treatment or periodontal surgery;
* Having undergone any professional desensitizing treatment in the previous six months;
* Having used a desensitizing paste in the previous three months;
* Use of anti-inflammatory drugs or analgesics at the time of recruitment;
* Currently pregnant or nursing.
Magseed and Magtrace Localization for Breast Cancer

The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.

The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. It also aims to follow skin discoloration after Magtrace injection and describe when and how it resolves. The Magtrace will be injected preoperatively. Sentinel node biopsy will be performed and detection rates will be recorded for both methods.

The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Intraoperative localization of the seed is achieved with the use of the Sentimag probe.

Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy. To accurately assess the response in the breast and the axilla, it is important that both the positive lymph node/s are marked before neoadjuvant systemic therapy to be able to locate them later on. Systemic therapy can negatively impact lymphatic drainage and hence reduce the accuracy of the sentinel lymph node biopsy (SLNB). However, when SLNB is paired with the removal of the previously positive target lymph node, a technique called Targeted Axillary Dissection, the operation becomes a lot more accurate, with lower morbidity of the patients.

A part of the study is also the verification of the time stability of breast tumor labeling with Magseed in the period from the onset of neoadjuvance to the subsequent operation following the oncological pretreatment of the patient.

All patients will undergo sentinel lymph node detection also by the classic detection system with Tc99.

Patients receive the Magseed marker via ultrasound-guided injection into a lymph node or to non-palpable breast cancer lesion.

After completion of the study, patients are followed up within 6-30 days post-surgery at our surgical clinic.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cT0-4 breast cancer
* Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy
* With/ without received neoadjuvant chemotherapy prior to surgical resection

Exclusion Criteria:

* Distant metastases
* The subject is known to be pregnant
* Pacemaker of another implantable device in the chest wall
* Allergy to dextran or other iron-containing particles
Safety, Tolerability, and Pharmacodynamic Profile of Oral 2101 in Secondary Raynaud's Disease

To investigate the severity of secondary Raynaud's disease-related attacks during the 14 days 2101 dosing period.

1. Number and cumulative duration of Raynaud's attacks.
2. Adverse events and changes in vital signs.
3. SLx-2101 pharmacokinetic parameters derived after dosing on Day 1 and Day maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC0-4), time to Cmax (tmax), and accumulation ratio

Eligibility Criteria:
Inclusion Criteria:

* male and female ages 18 and 65 y.o.
* BMI Body weight within a body mass index range of 17 - 30 kg/m2 (inclusive).

Exclusion Criteria:

* Hypersensitivity to the active substance of SLx-2101or to any of the excipients.
* Past or present disease that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations
Antipruritic Effect of Topical Ketamine, Amitriptyline, and Lidocaine

The purpose of this study is to examine the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as "KeAmLi") using non-histaminergic itch provocations in healthy volunteers. The primary outcome is itch reduction (AUC) between the vehicle and active treatment (KeAmLi-combo). Secondary outcomes include modality-specific analgesic properties of the topically applied ketamine, amitriptyline, lidocaine, and KeAmLi-combo to controlled quantitative thermal and mechanical stimuli, which can improve our understanding of the mechanism of action of these substances in the context of topical therapy.

This is a double-blind, vehicle-controlled study to evaluate the antipruritic efficacy of topical ketamine, amitriptyline, lidocaine, and a tri-combination of ketamine, amitriptyline and lidocaine (hereafter referred to as "KeAmLi") using non-histaminergic itch provocations in healthy volunteers. Each participant will be pre-treated with the vehicle and 4 active topical creams, over two study visits (3 treatments on the 1st visit and 2 treatment on the 2nd visit). Each treatment will be applied to the randomized forearm test area for 30 minute, and then sensory testing will be performed. Sensory testing includes thermal and mechanical stimuli, and itch induction using the plant cowhage. These tests will reveal mechanistic information and potential cellular and molecular targets for improved antipruritic and analgesic therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects (absence of disease) between 18 and 50 years of age.
2. Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
3. No history of chronic itch or pain.
4. Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications 48 hours prior to the study visits.
5. Must abstain from the use of moisturizers on the arms the day of study visit.

Exclusion Criteria:

1. Individuals under 18 or over 50 years of age.
2. Inability to complete the required measures.
3. The presence of an itchy skin disease or a painful condition.
4. Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
5. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
6. Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception 48 hours prior to the study visits (e.g. antihistamines, anesthetics, anti-inflammatories, opioids, neuroleptics, etc.).
7. Use of emollients on the volar aspects of the forearms arms on the day of the study visit.
8. Use of anti-depressants, anti-psychotics, and illicit drugs.
9. Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
10. Known history of anaphylactic shock, or allergy to cowhage and/or known adverse reactions to lidocaine (or other local anesthetics of the amide type), ketamine or amitriptyline.
Combined Locoregional Treatment With Immunotherapy for Unresectable HCC.

Efficacy and Safety of Locoregional treatments Combined With PD-1 Inhibitor in Patients With Unresectable Hepatocellular Carcinoma.

Hepatocellular carcinoma is the most frequent primary and ranked as the sixth most common neoplasm and the third leading cause of cancer death.

Percutaneous ablation and TACE are the effective locoregional treatments for the patient with HCC. Moreover, some studies suggested that TACE combined with ablation could further improve the survival rate and reduce the post-operation complication.

Although PD-1 inhibitor was approved by FDA for HCC, the latest RCT indicated that no significant difference was found in the ORR and PFS between the groups of PD-1 inhibitor and Sorafenib.

Therefore, this study aims to assess the efficacy and safety of microwave ablation combined with simultaneous TACE plus PD-1 inhibitor for the non-resectable HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 - 80 years old and life expectancy of at least 12 weeks.;
2. Clinically or histologically diagnosed as HCC and the diameter of target tumor lesion ≥ 5 cm;
3. Child-pugh classification A or B (score \< 7);
4. BCLC Staging as B or C;
5. ECOG 0-1;
6. Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion Criteria:

1. History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy;
2. The surgeon assessed that the tumor lesion was not unsuitable for microwave ablation;
3. Any contraindications for hepatic embolization procedures:

   1. Known hepatofugal blood flow;
   2. Total thrombosis of main portal vein.
4. The tumor thrombus of main portal vein, IVC or right atrium;
5. Tumor burden ≥ 70% of liver volume; and no measurable site of disease as defined by modified RECIST (mRECIST) criteria with spiral CT scan or MRI;
6. Subjects with chronic HBV infection have HBV DNA viral load \> 100 IU/mL at screening, and have not received antiviral therapy prior to initiation of study therapy; In addition, coinfection of HBV and HCV;
7. The alcoholic or pregnant women;
8. Patients with second primary cancer or history of other cancer within 3 years;
9. Diagnosis of active autoimmune disease, immunodeficiency, or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Sintilimab-monotherapy treatment;
10. Blood count, liver function: Haemoglobin \< 9.0 g/dL, white cell count \< 1.0 x10\^9/L; Total bilirubin \> 3 mg/dL; Aspartate Aminotransferase (SGOT) or Alanine aminotransferase (SGPT) \> 5 x upper normal limit (ULN), Albumin \< 2.8g/dL; International normalized ratio (INR) \>2.3;
11. Renal function dysfunction: Serum Creatinine \>2 mg/dL or creatinine clearance (CrCl) \< 30 mL/min (if using the Cockcroft-Gault formula ); and severe heart, lung, brain or other organ disease;
12. Non-compliance with TACE or ablation procedure.
Study Of Denagliptin In Subjects With Type 2 Diabetes Mellitus (T2DM)

GW823093 is a selective DPP-IV Inhibitor and is being investigated as a once a day oral therapy. The purpose of the Study is to evaluate the effectiveness, safety, and tolerability of 2 doses of GW823093, compared to placebo, taken once daily in patients with Type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes mellitus treated with diet and exercise or oral anti-diabetic treatment
* Body mass index between 20 and 40
* Females of childbearing potential must use adequate birth control.

Exclusion criteria:

* Subjects with previous use of insulin
* Type 1 diabetes
* Uncontrolled thyroid disease
* History of drug or alcohol abuse in the past year
* Any other clinically significant disease.
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.

Purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.

Eligibility Criteria:
Inclusion Criteria:

* Children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same.

Exclusion Criteria:

* Psychotic at study entry
* Diagnosis of bipolar disorder
* Diagnosis of schizoaffective or schizophrenia
* Anorexia
* Bulimia or eating disorder not otherwise specified (NOS)
* Autism
* Pervasive developmental disorder
* High risk of suicide within 2 weeks of initiating study treatment
* Significant mental retardation
* Taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant
A Randomized Controlled Trial of Best Approach to Care Compared to Diversified Chiropractic Adjustive Technique

There are a variety of treatment approaches used by the chiropractic profession. Some of these require forceful joint manipulation and some do not. This study is designed to compare outcomes of two such techniques that are common to chiropractic practice. The hypothesis is that there is no difference between forceful and non-forceful approaches to treatment.

The comparison will permit a one month treatment period for both techniques and a three week follow-up. Patients will be assessed at baseline (intake), and at specified intervals and at three weeks following the termination of care.

Eligibility Criteria:
Inclusion Criteria:

chronic musculoskeletal pain ability to communicate in English

Exclusion Criteria:

pregnancy contraindications to manipulation pending litigation chiropractic care within the last month
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.

Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of gastric acid. The clinical significance of this phenomenon is however unclear. This study aims to examine whether or not healthy volunteers, who over a relatively short period of time treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms will be measured subjectively using a validated questionnaire, which is filled out each day. Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin and chromogranin-A).

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* 18-70 years of age
* Informed consent
* No prior history of any GI disorder

Exclusion Criteria:

* Dyspeptic complaints
* H. pylori infection
* Ongoing treatment with pain-relieving medications (i.e., NSAID)
* Pregnancy or breast feeding