cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms

To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast.
* Must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted).
* Women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen.

Exclusion Criteria:

* Patients having known central nervous system (CNS) metastases.
* Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
* Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1 week prior to day 1 of treatment on study.
Adaptive Portable Essential Tremor Monitor

The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Clinical diagnosis of essential tremor
* Able to provide informed consent

Exclusion Criteria:

* Significant medical or psychiatric illness
* Not capable of following the required clinical instructions
* Serious medical conditions that compromise safety
Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway

This is a register-based, epidemiological study of HPV type distribution in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive carcinomas. This study will involve data collection from different databases in the Cancer Registry of Norway.

This protocol posting has been updated following Protocol Amendment 1 (02 April 2010). The sections impacted are: enrolment, outcome measures and eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

All subjects must meet the following criteria at study entry:

* Women aged 18 years and above at the time of the collection of the primary cone specimen;
* Who have undergone for the first time a conization due to high grade lesions or microinvasive cervical carcinomas, histologically diagnosed in 2003, with possible extension backwards in time;
* Availability of recurrent cone specimen with high grade lesions/ microinvasive cervical carcinomas or invasive cervical cancer;
* Availability in designated local laboratories of the primary and recurrent cone specimens;
* The cone specimen was adequately preserved;
* Written informed consent obtained from the subject. If the subject is deceased, the cone and biopsy specimens will be used according to prior approval from the Ethics Committee.

Exclusion Criteria:

None.
Pain Perception With a Comfort-ın Jet Injection and Conventional Dental Injection

The investigators aimed to compare the effectiveness of the Comfort-in system, which is a jet injection type, and infiltrative anesthesia with a traditional injector, and to measure the effect of children's anxiety on the severity of pain.

Among the children between the ages of 4 and 10 who were admitted to clinic between 2018-2020, whose clinical and radiographic examinations were completed; Patients with deciduous teeth that needed the same dental treatment (filling or amputation) with symmetrical local anesthesia application and positive (3) or definitely positive (4) according to the Frankl Behavior Evaluation Scale were included in the study. In study with a split-mouth design, infiltration anesthesia was applied with a conventional dental injector to one of the symmetrical teeth requiring the same treatment, while the Comfort-in jet injection system was applied to the other by the same physician. Patients were randomized into two grups according to the injection technique.

Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain intensity was assessed during anesthesia(Pain 1), during treatment(Pain 2), at the end of the treatment(Pain 3) and on the postoperative 1st day (Pain 4)by the specially 7 colors (white, yellow, green, blue, magenta, red, black) using the Wong-Baker facial expressions and pain grading scale.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version.

The data were analyzed by IBM SPSS Statistics 19, the significance level was taken as p \<0.05.The datas were analyzed with a three-way variance method in repeated.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 4-10 years
* Having no developmental or systemic disorder or no history of allergy
* Having "positive" or "definitely positive" cooperation level according to the Frankl Behavior Scale
* Having sufficient mouth opening
* Operation only on primary teeth
* Having decayed teeth that require anesthesia

Exclusion Criteria:

* Patients younger than four years, older than 10 years,
* Patients with systemic or developmental disorders
* Children with an allergy history
* 'Negative' or 'definitly negative' behavior rating according to the Frankl scale
* Patients whose mouth opening is not sufficient for dental treatment
* Operating only on permanent teeth
* Teeth that are beyond the treatment stage
* When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.
Effect of Genetic Polymorphism on the Occurrence of Post-Operative Atrial Fibrillation After CABG

Postoperative Atrial Fibrillation (POAF) is one of the most common complications following coronary artery bypass grafting (CABG) occurring to 20% - 40% of patients. It is associated with prolonged hospitalization, increased hospital costs, increased complications and mortality rate.

Despite the use of Beta Blockers, approximately 20% of patients develop atrial fibrillation following CABG surgery, suggesting a role for polymorphism in the genes The aim of the present study is to determine the minor allele frequency of some of the genes that affect the beta blockers' response and to determine the association between polymorphism in these genes and the occurrence of postoperative atrial fibrillation after coronary artery bypass grafting in Egyptian patients receiving perioperative beta blockers.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Candidates for CABG surgery without a concurrent valve surgery.
3. Patients receiving perioperative beta blockers before new onset of postoperative AF.

Exclusion Criteria:

1. Patients who have either persistent or permanent AF, atrial flutter or atrial tachycardia on ECG obtained on the day of the operation.
2. Serum creatinine \>2 mg/dL before the surgery.
3. Uncontrolled thyroid disease.
4. Recent treatment with amiodarone before the occurrence of POAF
Using CHWs and HPV Home Tests to Increase Cervical Cancer Screening in Minority Populations

Caribbean immigrants (both Hispanics and Blacks from Haiti) are less likely to be screened for cervical cancer than the general population. One promising approach is outreach strategies that employ Community Health Workers (CHWs). Yet even in well structured CHW programs, many women remain unscreened. In our NCI Community Networks sponsored project, we are testing an approach that combines CHWs with self sampling for the human papilloma virus (HPV) as a screening strategy among such hard to reach populations.

Building on our existing community partnerships, we propose a randomized CBPR study among 600 women in three underserved communities in Miami-Dade County to determine optimal approaches to increase cervical cancer screening among Caribbean and other underserved women. The study is a three arm study with 200 women randomized at each site over 3 years. Women in the control group would be exposed to NCI approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. Our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the CHW group, women randomized to a CHW intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the CHW group without HPV sampling. Secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.

Eligibility Criteria:
Inclusion Criteria:

* Haitian, Hispanic or African American women
* ages 30-65 years
* not having had a pap smear in the last three years
* live in Miami-Dade County

Exclusion Criteria:

* having had a hysterectomy
* history of cervical cancer
* plan to move out of the neighborhood during the next six months
* are enrolled in any other cancer prevention/outreach related study
Safety and Efficacy Study of Adjunctive Rosiglitazone in the Treatment of Uncomplicated Falciparum Malaria

The purpose of this study is to examine the safety, tolerability, and efficacy of adjunctive rosiglitazone in the treatment of uncomplicated P.falciparum malaria.

Study Rationale: Evidence suggests that if PPAR-RXR agonists (such as rosiglitazone) are used as adjunctive therapy in P. falciparum malaria infections they may increase phagocytic clearance of P. falciparum malaria, modulate deleterious inflammatory responses and decrease sequestration of malaria parasites in vital organs. They may therefore represent a novel immunomodulatory treatment approach for P. falciparum malaria.

Study Objectives: 1) To examine the in vivo effect of rosiglitazone on the rapidity of clearance of P. falciparum parasitemia and fever in patients with non-severe P. falciparum infections 2) To assess the safety and tolerability of adjunctive rosiglitazone treatment in non-severe cases of P. falciparum infection.

Primary Outcomes: Time to clearance of P. falciparum parasitemia

Study Design: Randomized double blind placebo-controlled trial.

Intervention: Standard antimalarial treatment (atovaquone/proguanil) to all patients combined with adjuvant rosiglitazone treatment (8mg per day) or placebo.

Setting: Hospital for Tropical Diseases at Mahidol University, Thailand.

Participants: 140 patients with non-severe P. falciparum infection.

Follow-up: 28 days

Eligibility Criteria:
Inclusion Criteria:

* Microscopically confirmed P.falciparum infection
* Age \>18 years
* Able to tolerate oral therapy
* Able to give informed consent

Exclusion Criteria:

* Fulfillment of WHO criteria for severe/cerebral malaria
* Prior treatment with any thiazolidinedione
* Allergy to rosiglitazone
* History of diabetes mellitus
* History of severe/decompensated liver disease
* ALT level \>2.5 times normal
* Current treatment for congestive heart failure
* Pregnancy or breastfeeding
The Effect of Different Focusing Methods on Muscle Activity

The aim of this study is to compare the effects of different focusing methods on muscular activity

After the first data collecting ( Demographic data, Inclusion criteria) surface electromyography EMG evaluations will be taken from 6 muscles( Vastus Medialis, Rectus Femoris, Vastus Lateralis, Biceps Femoris, Semitendinosus, Gluteus Medius). These recordings will be taken in 3 different circumstances: 1- Without a focusing method 2- With an external focus and 3- With an internal focus

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Having a Body Mass Index between 18.5-24.9

Exclusion Criteria:

* Having trauma/surgery involving the lower extremity in the last 6 months or having any disorder affecting hip and knee muscle function
* Foot Posture Index score not being between 0 and +5
* Hamstring Flexibility- Sit and Reach Test score greater than +5 cm
* Restricted ankle dorsiflexion angle (It will be expected to be at least 5 degrees more than neutral)
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis

Ursodeoxycholic acid is the mainstay treatment medicine for primary biliary cholangitis(PBC). About 1/3 of the patients do not respond to UDCA, which is defined as refractory PBC. Mesenchymal stem cells (MSC) has been reported to improve the outcomes of PBC patients. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for refractory PBC. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in PBC patients that do not respond to UDCA treatment. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with refractory PBC will be randomly assigned to receive MSC treatment plus UDCA or UDCA alone (control). Three times of MSC infusion (0.1-1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in alkaline phosphatase. Secondary outcomes are changes of other liver function indices such as ALT TBIL AST GGT, improve of symptoms and liver histology.


Eligibility Criteria:
Inclusion Criteria:

1. informed consent
2. Age between 18-70 years old
3. BMI between 17-28
4. Meeting at least 2 of the 3 criteria: (1) positive for anti-mitochondial antibody (AMA)；(2) Elevated ALP or GGT；(3) PBC diagnosis confirmed by liver biopsy
5. Serum ALP \>/=1.67 ULN after at leat 6 months treatment with UDCA 1(3-17mg/kg/day) -

Exclusion Criteria:

1. Pregnancy, breast-feeding females
2. Use of liver-toxic drugs over 2 week within 6 months prior to recruitment；
3. refractory variceal bleeding, uncontrolled hepatoencephalopathy or uncontrolled ascites.
4. Acute of chronic kidney failure.
5. Commodities with other liver diseases such as viral hepatitis, alcoholic liver disease, auto-immune hepatitis or liver cancer
6. Severe cardiovascular disease；
7. liver transplantation listed patients；
8. ALT/AST over 5xULN，or total bilirubin \>85umol/l
9. anticipated need for liver transplantation within 1 year according to mayo risk score
10. Other candidates who are judged to be not applicable to this study by doctors
Volume Restoration of the Aging Midface With Sculptra Aesthetic

The purpose of this study is to examine the effect of Sculptra Aesthetic on the cosmetic rejuvenation of the midface complex. The investigators plan to both qualitatively determine the restoration of midface architecture as well as quantitatively document the change in midface volume by employing three-dimensional (3D) surface imaging which critically analyzes volumetric tissue changes. Our hypothesis is that patients who receive Sculptra Aesthetic injections will experience significant improvement in facial midface volume restoration.

* Measure the midfacial volumetric correction from Sculptra Aesthetic treatment, using three-dimensional digital surface imaging
* Determine the mean change from baseline in facial contour via quantitative volumetric measurements
* Correlate volumetric correction with clinical improvement as measured by the Facial Lipoatrophy Panel grading system
* Correlate the mean volumetric change in midfacial treatment area with the amount of product used
* Obtain photographs pre- and post-treatment for the purpose of providing a subject visual aid during the course of treatment
* Collect safety data


Eligibility Criteria:
Inclusion Criteria:

* Age 40-60 years old
* BMI greater than 18.5 and less than 24.9

Exclusion Criteria:

* Age less than 40 years or greater than 60 years
* Prior surgical or non-surgical treatment to the midface within the past 2 years
* Interested in seeking other treatments to the midface during the study period
* Pregnant, lactating, or breast feeding
* Hypersensitivity to poly-L-lactic acid, carboxymethylcellulose, or mannitol
* Allergy to lidocaine or epinephrine
* History of atopy, anaphylaxis, or multiple severe allergies
* Current immunotherapy or history of autoimmune disease
* History of or active stroke or myocardial infarction
* History of or active connective tissue disease
* History of or active bleeding disorders
* History of or active cancer
* Serious abnormalities in laboratory findings
* Active hepatitis
* Active infection or inflammatory process of skin
* History of or risk factors for hypertrophic scarring or keloid formation
The Effect of Ablation Depth on Dry Eye After LASIK Treatment of Myopia

The study tried to find the relation between ablation depth and degree of dryness after LASIK treatment of myopic patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with age ≥ 21 years
* Normal Pentacam maps
* Myopia with spherical equation less than 12 D
* Corneal thickness ≥ 500 Microns
* Calculated residual stromal bed ≥ 280 microns
* No signs or symptoms of dry eye.

Exclusion Criteria :

* Keratoconus and forme fruste keratoconus
* Auto-immune diseases
* History of dry eye or previous use of tear substitutes
* Previous ocular surgery
* Pregnant or lactating women.
A Study of LY3009104 in Healthy Participants

This will be a 2-part, randomized, participant- and investigator-blind study in healthy males and females.

Part A of this study is to determine a safe and tolerable single oral dose of LY3009104 that yields drug exposures slightly exceeding typical exposures anticipated from repeated administration of an efficacious dose to participants. The concentration of the drug in the blood stream will be measured and information about any side effects that may occur will also be collected.

Part B of this study is to evaluate the effect of LY3009104 on the electrical activity of the heart as measured by electrocardiogram (ECG) in relation to placebo following a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females as determined by medical history and physical examination. Are drug free, disease free, and no cardiac abnormalities.
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
* Have a clinically normal screening ECG with a measurable QT interval as judged by the investigator, and which in Part B allows accurate measurements of QT interval.

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
* Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study or affects or confounds the corrected QT (QTc) analysis or have QTc greater than 450 milliseconds (msec).
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
Comparing Strategies for Translating Self-management Support Into Primary Care

This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.

The specific aims of the proposed study are:

* Primary Specific Aims

  1. To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol.
  2. To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices.
* Secondary Specific Aims

  1. To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention.
  2. To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years old or over
* Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months
* Able to read in English or Spanish
* Plan to remain in the practice during the study period

Exclusion Criteria:

* Developmentally disabled
* Decisionally challenged
* Pregnant women