cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Efficacy Study of CLS003 ICVT in Subjects With Cutaneous Warts.

A phase 2, randomized, vehicle-controlled, double-blind study to assess the efficacy, safety and pharmacodynamics (PD) of topically applied CLS003 in otherwise healthy patients with cutaneous warts.


Eligibility Criteria:
Inclusion Criteria:

* absence of evidence of any active or chronic disease;
* Free of clinical significant systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of Adverse Events;
* Have at least 2 (non-subungual) common warts or at least 2 plantar warts on non-genital, nonfacial skin

Exclusion Criteria:

* Any clinically significant abnormality that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
* For women: a positive pregnancy test and/or nursing at screening or women who plan to become pregnant or are breastfeeding;
* A positive test for drugs of abuse at screening;
* History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption \> 28 units/week);
* Positive test results for Hepatitis B, Hepatitis C or HIV;
* Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to starting the study or cryotherapy within 60 days of starting the study;
* Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrollment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
* Have a known sensitivity to any of the investigational product ingredients
* Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening;
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year;
Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery

This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia

This randomized, controlled, double blind study will be conducted on women with preeclampsia with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Immediately, after spinal anesthesia administration, patients will receive either 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded at 1 and 5 minutes post-delivery.

Eligibility Criteria:
Inclusion Criteria:

* Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
* Singleton pregnancy
* Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Height \<150 cm
* Weight \<60 kg
* Body mass index ≥45 kg/m2
* Women presenting in labor
* Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection)
* Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
* Preoperative administration of intravenous hydralazine or magnesium sulphate
* Hemoglobin \<10 gm/dL
* International Normalized Ratio \>1.3
* Platelet count \<100,000 /mm3
* Preoperative serum creatinine \>1.1 mg/dL
Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following

1. Patients who are refractory to the treatment.
2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
3. Patients without a history of or concurrent malignant tumors.

Exclusion Criteria:
Dexamethasone for Palliation - Brain Metastases

Brain metastases occur when cancer cells from the initial tumour site (for example, lung or breast) spread to the brain. This develops in approximately 10% - 30% of adults with cancer. They can produce different complaints related to their effect on brain functioning, decrease in a person's ability to carry on with their usual activities, a reduction in the quality of life and shortened life expectancy.

The standard treatment particularly for people with more than one brain metastasis consists of palliative radiation therapy to the brain and steroids. Steroids (such as Decadron or Dexamethasone) are medication used to reduce swelling around the tumour, and thus symptoms improve. Steroids could be very helpful but have a number of potential side effects, particularly if used for longer periods of time. There is no standard dose of Decadron used in treating brain metastases patients. The most commonly dose used is 4 mg four times/day.

This study will assess if lower doses of Decadron - 8 mg every morning for symptomatic patients and 4 mg every morning for asymptomatic patients - are effective in maintaining symptom control in patients with brain metastases, without neurological deterioration that necessitates the patient to go back or to a higher dose at any time. This information will help also in understanding how to decrease the side effects associated with higher doses of steroids in people with your condition.


Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of cancer (even if primary unknown)
* Brain metastases (single or multiple) confirmed by imaging (CT, MRI)
* No contraindication for RT/steroids
* Patient will be treated with Whole Brain Radiation Therapy
* Informed consent

Exclusion Criteria:

* Primary cancer is lymphoma or leukemia
* Complete surgical excision of brain metastases
* Patient was on steroids for more then 2 weeks prior to entering the study
* Confusion or other factors that would impair ability to assess symptoms
Safety and Immunogenicity of Pentavalent Meningococcal Conjugate Vaccine (EuNmCV-5) in Healthy Adults Aged 19 to 55 Years Old

Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, X, and Y)-CRM197 Conjugate vaccine


Eligibility Criteria:
Inclusion Criteria:

* Subjects 19 to 55 years of age
* Written informed consent
* Available for all visits and telephone calls scheduled for the study

Exclusion Criteria:

* Previous or suspected disease caused by N. meningitides
* Household and/or intimate exposure to an individual with culture-proven N. meningitides infection within 60 days prior to screening
* Serious acute, chronic or progressive disease as determined by investigator
* History of alcohol or substance abuse
Effects of SGLT2i on the Cognitive Function in T2DM Patient (ESCDP)

Type 2 diabetes is associated with diabetic cognopathy, the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population. Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied.

Sodium-glucose transporter-2 (SGLT-2) inhibitors, which lower serum glucose by inhibiting SGLT2-mediated glucose reabsorption in renal proximal tubules, could be neuroprotective. It was recently reported that the SGLT-2 inhibitor improved cognitive function and ameliorated oxidative stress via attenuating mitochondrial dysfunction, insulin resistance, inflammation, and apoptosis in mice or HFD-induced obese rats, that means SGLT-2 inhibitor may provide neuroprotection in the diabetic brain. Hence, Invokana (Canagliflozin) might act as a potent dual inhibitor of AChE and SGLT2. Since the development of diabetes is associated with AD, the design of new AChE inhibitors based on antidiabetic drug scaffolds would be particularly beneficial. Moreover, the present computational study reveals that Invokana (Canagliflozin) is expected to form the basis of a future dual therapy against diabetes associated neurological disorders.

The overall goal of this study is to explore the effects of SGLT2 inhibitor on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.


Eligibility Criteria:
Inclusion Criteria:

* Newly onset type 2 diabetes within 3 months
* 7%\<HbA1c\<10%

Exclusion Criteria:

* Type 2 diabetes with acute diabetic complications.
* Type1 diabetes.
* Thyroid dysfuncition.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
* History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
* Hepatic insufficiency (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
* Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
* Acute infections, tumor, severe arrhythmia.
* Alcohol or medicine addiction, psychoactive substance abuse.
* Other diseases affecting cognitive function (congenital dementia, brain trauma, parkinson's diseases, toxicencephacopathy,epilepsy, mental disorders, severe lungdy sfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.)
* Fertile woman without contraceptives.
* Allergic to or have contraindication to the intervention drugs.
Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes

Determine the incidence of hypoglycemia during / after sexual intercourse among young adults with type 1 diabetes using continuous -type sugar meter IPRO for a week.

Determine the incidence of hypoglycemia during / after sexual intercourse among young adults with type 1 diabetes using continuous -type sugar meter IPRO for a week.

Eligibility Criteria:
Inclusion Criteria:

type 1 diabetes

Exclusion Criteria:

type 2 diabetes other concomitant disease
A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion

A study which participants with mild to moderate dry eye disease will have a punctum of one eye injected with Restyalne Defyne and the other eye injected with saline solution. Participants will be evaluated over four visits.


Eligibility Criteria:
Inclusion Criteria:

* Twenty-one (21) to 80 years of age
* Baseline Ocular Surface Disease Index score of at least 13 with no more than 3 responses of "not applicable" for each eye individually
* In the study eye, a baseline Schirmer test with anesthetic of ≤ 10 mm/5 minute
* Literate, able to speak English and able to complete the questionnaire independently
* Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.

Exclusion Criteria:

* Use of ophthalmic cyclosporine or lifitegrast within 30 days prior to Day 0.
* History of surgical punctal occlusion (e.g., cautery), canalicular infection or canalicular surgery.
* Corneal transplant in either eye
* Ocular surgery (such as cataract surgery or LASIK) in either eye within six months of the Baseline Visit.
* A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease).
* The history or presence of any ocular disorder or condition in either eye that, in the opinion of the investigator, would interfere with the interpretation of the study results (e.g., significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection (except mild blepharitis), conjunctivitis or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; history of ocular herpetic infection; evidence of keratoconus; lid or lacrimal cancer.
* Active severe systemic allergy, seasonal allergies, rhinitis or sinusitis requiring treatment (i.e. antihistamines, decongestants, oral or aerosol steroids).
* Use of steroids, including administration by systemic, inhaled or topical ocular routes (dermatologic steroids not applied to the eyelids are allowed).
* Participation in a clinical trial during the past 30 days
* Women who are pregnant, planning a pregnancy, or nursing at study entry
First Event of Infection by HIV-1 of Uterine Vaginal Tissue

This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose age ≤50 years and ≥18 years
* Patients for which surgery like laparoscopy or hysterectomy is necessary as part of a benign pathology.

Exclusion Criteria:

* Patients under 18 years
A Study on the Verification of Kidney CT Non-inferiority Using Low Concentration Contrast Agent

This prospective study aims to evaluate clinical usefulness of low-voltage renal CT using low-concentration contrast agent and to compare with existing imaging techniques.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with no abnormalities in renal function (Serum creatinine \< 1.4 mg/dl , GFR \> 45mL/min/1.73 m2) in blood tests performed within one month
* Those who understand the contents of the research subject explanation and voluntarily sign the consent form

Exclusion Criteria:

* Body mass index \> 30
* Subjects whose renal function abnormality was confirmed in a blood test (Serum creatinine \> 1.4 mg/dl , GFR \< 45mL/min/1.73 m2) conducted within one month
* Diabetic patients taking metformin
* Those with a history of urinary tract obstruction
* Those with a history of bladder, urinary tract, or kidney surgery that may affect the evaluation of the contrast agent in the renal parenchyma
* Those whose anatomical deformities have been identified in previous images that may interfere with image analysis
* Those who know or have been reported to have a history of contrast agent side effects in previous CT scans
* Those with a history of hypersensitivity or adverse reactions to iobrix (intravascular CT contrast) or iodine based agent
* Those with severe thyroid disease
* Pregnancy
* Those who are judged unsuitable for clinical trials by the researcher for reasons such as having other severe diseases or being judged to have a high risk of adverse reactions to intravascular contrast agents
Multidimensional Treatment Foster Care for Adolescents

The purpose of the study is to examine the effects of Multidimensional Treatment Foster Care compared to treatment as usual (TAU) for adolescents in Denmark in need of out-of-home placement.

It is difficult to treat adolescents with serious behaviour problems. Although the number of adolescents displaying serious behaviour problems is limited, they are a serious concern to the society e.g. because of their frequent violent behaviour, criminal activities and lack of school adherence.

Multidimensional Treatment Foster Care (MTFC)is a community-based treatment program developed in USA. The goal of the MTFC program is to decrease problem behaviour and to increase developmentally appropriate normative and prosocial behavior in adolescents who are in need of out-of-home placement.

This study will evaluate the effect of MTFC on adolescents in out-of-home placement.

Participants will be recruited by caseworkers in the municipalities and randomly assigned to either MTFC or TAU. TAU will consist of other kinds of out-of-home placements. Outcomes will be assessed for all participants at baseline, post-treatment (12 months), and 12 months post-treatment. Parents and youth will be asked to fill out questionnaires on e.g. behaviour, parental stress, sense of cohesion, general health.

Eligibility Criteria:
Inclusion Criteria:

* 12-17 years old
* In need of out of home placement
* serious behaviour problems

Exclusion Criteria:

* severe psychiatric illness in youth or parent
* risk of suicide in youth
* acute psychosis in youth
* sexual offence by youth
* severe substance abuse in youth or parent
Sequential and Hybrid Therapies for H Pylori Infection

Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.

The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.

A total of 240 subjects will be asked to participate in this study.

H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.

Eligibility Criteria:
Inclusion Criteria:

* consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H. pylori-eradication therapy
* ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women.
Keratometric Tear Breakup Time and Fluorescein Tear Breakup Time

The purpose of the research is to determine if putting fluorescein onto the eye (most common test done for dry eye syndrome) is an accurate way to measure dry eye symptoms. The investigators can avoid placing any foreign substance into the eye by using a manual keratometer. Therefore, the investigators want to compare the measurements of tear breakup time using fluorescein with using a novel method, a manual keratometer and then compare these measurements to a validated dry eye symptoms questionnaire. All qualifying patients who were scheduled in the Jones Eye Institute Clinics for a complete eye exam were offered information about the study and invited to participate. Participants were recruited from February 29, 2009 to April 14, 2009.Participants who did not meet the study protocol's inclusion and exclusion criteria were not included the study or study data analysis. All subjects eyes were measured for KTBUT and FTBUT.

This is an observational study to measure the difference between Keratometric Tear Break Up Time (KTBUT) and Fluorescein Tear Break Up Time (FTBUT). All qualified study participants had their eyes measured for tear break up time measured with a keratometer and with fluorescein dye. In this study, we compare the use of the most common method, fluorescein dye, to measure tear break up time to a novel method, a keratometer, to measure tear break up time. Using the keratometer avoids instilling fluorescein dye into the tear film and not altering the tear film's physiologic environment.

Eligibility Criteria:
Inclusion Criteria:

* An adult, between ages 18-99
* An adult who is able to understand study instructions

Exclusion Criteria:

* An adult with corneal pathology that prevents accurate assessment of keratometric or fluorescein tear break up time.
* An adult with an allergy to fluorescein, a very common eye dye that detects defects in the cornea.
* The inability to answer questions on your own.
A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer

This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
* Participant who in the Investigator's opinion requires combination therapy for their disease
* Life expectancy of greater than or equal to (\>/=)12 weeks

Exclusion Criteria:

* Previous chemotherapy for metastatic breast cancer
* Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
* Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment