cyrilzakka/clinical-trials huggingface dataset:
Antibiotic Concentration After Delivery to Middle Ear for Chronic Suppurative Otitis Media

The study team aims to elucidate the potential role of ototopical antibiotic concentration on outcomes in patients diagnosed with chronic suppurative otitis media (CSOM). Chronic suppurative otitis media (CSOM) is characterized by chronic inflammation of the middle ear with persistent discharge from a non-intact tympanic membrane. CSOM is notably associated with a significant burden of disease worldwide. Topical fluoroquinolones are first line therapy for CSOM and are advantageous as compared to oral or intravenous therapy in that these antibiotics avoid systemic side effects and have the potential to locally deliver high antibiotic concentrations, which were thought to be sufficient to overcome all bactericidal resistance to fluoroquinolones.

The investigators will measure antibiotic concentration in aspirates via liquid chromatography with tandem mass spectrometry (LC-MS/MS) from the middle ear of selected subjects with CSOM who are prescribed and instructed to self-administer ototopical ciprofloxacin. Enrolled subjects will be asked to return 3 to 10 days after initial visit to aspirate the middle ear and receive a follow-up evaluation. Furthermore, the subjects will be asked to keep logs of their medication use and to administer the ototopical medication one hour prior to their appointments. The measured ciprofloxacin concentrations will be correlated with clinical outcomes, primarily the time to symptom resolution. The guiding hypothesis is that patient self-administration of ciprofloxacin drops vary in antibiotic delivery with diluted concentrations significantly below the in vitro concentration of the prescribed solution and that these concentrations are below the bactericidal concentration of ciprofloxacin-resistant bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than or equal to 18 years of age
* Diagnosis of Chronic Suppurative Otitis Media (CSOM)

Exclusion Criteria:

* Atypical presentation of CSOM or atypical anatomy of the ear
* Presence of additional ear pathophysiology beyond CSOM
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Non-English speaking
Job-Site Diet Education on Metabolic Syndrome

This study conducted an 8-week workplace nutrition education intervention to examine the effects of the intervention on metabolic syndrome factors associated with employees. A historical intervention was designed to recruit adults with a body mass index level of \>22 and without any endocrine disorder from a community in Yilan, Taiwan. The intervention group was recruited between 2010 and 2012 and received an 8-week intervention, during which dietitians delivered a nutrition education session and a one-on-one dietary guidance session on a weekly basis. The age- and sex-matched control group (n = 34) was recruited between 2014 and 2015 to analyze the metabolic syndrome variables. The metabolic syndrome variables included blood pressure, blood sugar, serum lipid profile, and waist circumference.

Content of classes Week1 Things that you must know during the weight reduction study period Week2 Daily individual calorie requirement: what are the main food groups? Week3 How to record the daily diet after the weight reduction program Week4 Food serving size and replacement Week5 The principles of eating out Week6 Physical activity advice (delivered with health education flyers to the participants)

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* BMI of ≥ 22

Exclusion Criteria:

* History of critical illness
* Having been diagnosed with at least one endocrine disorder
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast Cancer

The study is being conducted to evaluate the efficacy and safety of anlotinib combined with chemotherapy treatment for patients with HER2 negative advanced breast cancer previously received anthracyclines and taxanes

Breast cancer is the most frequent malignancy in women worldwide. Treatments on HER2 negative breast cancer are still under exploration. Therefore, it is imperative to find a novel therapy to treat these patients.

Anlotinib is an anti-angiogenic small-molecule butyrate kinase inhibitor, and preliminary phase II study results show that anlotinib has good efficacy and tolerability in the treatment of HER-2-negative advanced breast cancer.

This study is a prospective, multicenter, observational clinical study that will collect and report anlotinib in combination with anlotinib in patients with HER2-negative advanced breast cancer treated with anthracyclines and taxanes in a real-world clinical setting Efficacy and safety data for chemotherapy treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old (calculated on the day of signing informed consent);
2. Histologically diagnosed advanced breast cancer, including inoperable locally advanced breast cancer or recurrent/metastatic breast cancer;
3. Immunohistochemical detection of HER-2 (-) or (1+), of which HER-2 (2+) must be tested by FISH and the result is negative;
4. All patients have previously underwent chemotherapy containing anthracyclines and taxanes (adjuvant, neoadjuvant or rescue therapy) , and treatment failure or disease progression received at most two chemotherapy regimens after recurrence/metastasis. HR+/HER2- breast cancer patients need to complete endocrine drug therapy;
5. Physical condition ECOG PS: 0-1;
6. There is at least 1 measurable lesion of metastasis according to RECIST 1.1;
7. The patients voluntarily joined the project and signed the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Patients with a previous history of breast cancer were excluded, except for ipsilateral DCIS who received only local therapy ≥5 years ago; patients with a history of any other cancer (except non-melanoma skin cancer or cervical carcinoma in situ) were excluded;
3. allergic to Anlotinib;
4. Received eribulin, capecitabine treatment or anti-angiogenic drug treatment in the past;
5. Uncontrolled brain metastases (except asymptomatic, or patients with stable brain metastases receiving local treatment);
6. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* history of positive diagnostic test for ragweed within the past 2 years;
* positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion Criteria:

* ocular infection;
* history of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
* moderate to severe asthma;
* dry eye syndrome;
* history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease;
* pregnancy or lactation
Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction

The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.

The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury. The data from this exploratory study can be used to help develop estimates of the proportions of patients who experience significant venous/nerve/tissue compromise in the lower extremity as a result of the application of traction forces necessary to achieve hip joint distraction, and may serve as a basis for sample size planning in future studies comparing the effects of various methods of hip distraction techniques during hip arthroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 years of age inclusively
* Has elected to undergo a standard hip arthroscopic procedure that is expected to require access to the central compartment of the hip joint (bilateral hip enrollment is allowed)
* Is able to give voluntary, written informed consent to participate in this clinical investigation and has signed an informed consent document

Exclusion Criteria:

* Any major systemic or lower extremity trauma, or any preexisting medical condition/illness that represents a contraindication for hip arthroscopy surgery
* Significant peripheral vascular disease characterized by diminished dorsalis pedis or tibial pulse
* Significant peripheral neuropathy demonstrated by nerve conduction velocity test
* Preoperative use of statins or other medications known to elevate serum CPK-MM levels within one week of surgery
* Total hip replacement of the indicated hip(s)
* History of substance abuse within past 12 months (this includes any chronic narcotic use)
* Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the informed consent process
Biomarkers and Knee Osteoarthritis

High joint load during walking has been linked to cartilage degradation. Biomarkers, found in the blood and urine, are protein fragments released after cartilage degradation characteristic of OA. They have the potential to enable direct and immediate disease state monitoring and identification of early cartilage changes. Little is known about the association of biomarkers with joint load or if exercise aimed at reducing joint load changes biomarker levels, thus reducing the risk of OA progression. This study will provide novel information on these relationships and will guide future intervention studies. The investigators hypothesize that certain biomarkers will be highly correlated with joint loading during walking and that the levels of these biomarkers in the blood and urine will decrease following an exercise intervention aimed at cartilage unloading.

Participants will be tested twice (baseline and 11 weeks later) where they will undergo gait and strength analyses by the same blinded assessor, complete self-report questionnaires, and have blood and urine samples drawn. Participants will then be randomized into either: (i) exercise; or (ii) usual care (no additional treatment). Those in the exercise group will complete 10-weeks of strengthening targeting lower limb muscles. Once weekly, they will consult with the study physiotherapist (MAH) at UBC to ensure proper performance and safe progression of exercises. Participants will be given cuff weights and resistance bands to complete exercises at home five times per week. Exercise compliance will be monitored using log books. All participants will be encouraged to maintain their usual treatment regimen (except for exercises completed by the exercise group), but will document any unexpected alterations such as medication changes or physician visits.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 50 years (to meet the American College of Rheumatology clinical definition of OA)
* radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
* knee pain during walking greater than 3/10 (based on an 11-point scale; 0 = "no pain", 10 = "maximal pain") on most days of the previous month
* predominance of pain/tenderness over the medial (inside) region of the knee

Exclusion Criteria:

* articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial (medial compartment OA is more common than lateral and the KAM is a validated measure of medial compartment loading only)
* currently in a structured exercise program
* medical condition precluding exercise
* inflammatory arthritic condition
* history of knee replacement surgery
* recent use of corticosteroids (oral or via injection)
* unable to attend exercise training sessions at UBC
* pain originating predominantly from the patellofemoral joint
* inability to ambulate without a gait aid
* non-English speaking (questionnaires are in English and must be completed by the study participant only)
* recent (within 6 months) arthroscopic knee surgery
* significant hip or back pain (limits the ability to perform the testing and exercises)
Double Blind, Placebo-controlled Study of Raloxifene for Negative Symptoms of Schizophrenia in Postmenopausal Women

Primary objective: To assess the efficacy of adding raloxifene as an adjunct to antipsychotic treatment to improve negative symptoms of schizophrenia in postmenopausal women.

This is a double-blind, randomized, placebo-controlled study of raloxifene as adjuvant treatment to antipsychotic treatment. Treatment period of 12 weeks.

The primary result obtained is that women treated with 60 mg of raloxifene compared to those treated with a placebo show greater improvement in psychotic symptoms. The investigators also found improved response in some aspects of social functioning and neuropsychological functioning.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia (DSM-IV criteria)
* Postmenopausal patients. Postmenopause is defined as after a period of one year of spontaneous amenorrhea and a serum follicle stimulating hormone (FSH) level \> 20IU/L.
* Stable doses of their current antipsychotic medication for at least a month prior to study initiation.
* Presence of significant negative symptoms (defined as one or more negative symptom score greater than 4 in the PANSS scale) (Kay 1987)
* Patients have to give written informed consent to participate in the study.

Exclusion Criteria:

* Patients with a substance abuse/dependence diagnosis in the previous six months.
* Mental retardation.
* Endocrine abnormalities, acute or chronic liver disease, impaired kidney function.
* History of thromboembolism, breast cancer, abnormal uterine bleeding, history of cerebrovascular accident.
* Patients taking hormone replacement therapy.
* Patients taking mood stabilizer medication that cannot be discontinued.
Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section

The development of regular sleep-wake cycle is an important factor of the newborn maturation and it has influence on behavior .Factor that may influence the process of the maturation of the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected and measured with actigraphy, using a wrist-watch like device that continuously measures and records the subject's movements.The present study aims to compare vacuum delivery with regular, elective and not elective caesarean sections. We hypothesize that the sleep of vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn, born either by regular delivery, vacuum extraction or cesarean section

Exclusion Criteria:

* Preterms, newborns that need special medical treatment and/or repeated blood sampling as glucose.
Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).

This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Males and non-pregnant, non-lactating females
2. Age \> 18 years
3. On thrice weekly hemodialysis for at least the previous three months prior to screening
4. Serum phosphorus levels ≥ 2.5 mg/dL and \< 8.5 mg/dL at Screening Visit (Visit 0)
5. Serum phosphorus levels \> 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
6. Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening
7. Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50%
8. Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
9. Willing and able to give informed consent

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening Visit (Visit 0)
2. Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
3. Serum phosphorus levels \>10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
4. History of multiple drug allergies
5. History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
6. Previous intolerance to oral ferric citrate
7. Absolute requirement for oral iron therapy
8. Absolute requirement for Vitamin C (multivitamins \[Centrum, Nephrocaps, Renaphro, etc.\] allowed)
9. Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
10. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
11. Inability to tolerate oral drug intake
12. Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
13. Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
14. Receipt of any investigational drug within 30 days of randomization
15. Inability to cooperate with study personnel or history of noncompliance
16. Prior exposure to ferric citrate
17. Patients with hemochromatosis or Thalassemia
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence

This study is an explorative, open, single-arm clinical investigation to collect real-life measurement data in order to assess the mathematical algorithms involved in TENA SmartCare Change Indicator.

The purpose of this exploratory clinical investigation is to evaluate safety and to collect real-life measurement data using the TENA SmartCare Change Indicator. The collected data will be used to assess the device related algorithms. These algorithms have been established and verified in a laboratory environment. However, due to possible differences in parameters, real-life measurement data are to be collected to aid in further product development.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is willing and able to provide informed consent and to participate in the clinical investigation.
2. The subject is ≥18 years of age.
3. The subject is diagnosed with urinary incontinence.
4. The subject is being cared for at Tre Stiftelser.

Exclusion Criteria:

1. The subject has ≥ 4 fecal "incidences" per week.
2. The subject has severe absorbent product related skin problems, as judged by the investigator.
3. The subject is hyper sensitive related to allergic reaction to any of the included materials, as judged by the investigator.
4. The subject has ≥ 2 intermittent urinary catheters per day.
5. The subject has a pacemaker or an implantable cardioverter-defibrillator.
6. The subject removes the incontinence product.
7. The subject demonstrates responsive behavior towards sensors.
8. The subject has any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
9. The subject is not cared for at Tre Stiftelser.
10. The subject is pregnant or lactating.
Optimal Timing of BR55 CEUS of the Ovaries

This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 contrast-enhanced ultrasonography (CEUS) of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.


Eligibility Criteria:
Inclusion Criteria: Enroll a subject in this study if the subject meets the following inclusion criteria:

* Is a female subject of at least 18 years of age;
* Is premenopausal;
* Is scheduled to undergo preventative salpingo-oophorectomy for high risk of ovarian cancer not earlier than 24 hours and not later than 5 days following the second BR55 CEUS examination;
* Provides written Informed Consent and is willing to comply with protocol requirements.

Exclusion Criteria: Exclude a subject from this study if the subject does not fulfill the inclusion criteria, or if any of the following conditions are observed:

* Is a pregnant or lactating female. Exclude the possibility of pregnancy:

  * by testing on site at the institution (serum βHCG) within 24 hours prior to the start of investigational product administration,
  * by surgical history (e.g., tubal ligation or hysterectomy),
* Has undergone prior systemic therapy for ovarian cancer;
* Has history of concurrent malignancy;
* Has history of any clinically unstable cardiac condition including class III/IV congestive heart failure;
* Has had any severe cardiac rhythm disorders within 7 days prior to enrolment;
* Has severe pulmonary hypertension (pulmonary artery pressure \>90mmHg) or uncontrolled systemic hypertension and/or respiratory distress syndrome;
* Has open and/or non-healing wounds in the chest, abdomen and pelvis;
* Has other systemic vascular abnormalities associated with neovascularization that in the opinion of the investigator could significantly affect the ability to evaluate the effects of BR55;
* Is participating in a clinical trial or has participated in another trial with an investigational compound within the past 30 days prior to enrolment;
* Has previously been enrolled in and completed this study;
* Has any known allergy to one or more of the ingredients of the Investigational Product or to any other contrast media;
* Is determined by the Investigator that the subject is clinically unsuitable for the study;
* Has had major surgery, including laparoscopic surgery, within 3 months prior to enrolment;
* Has history of surgery to the ovaries or pelvic inflammatory disease.