cyrilzakka/clinical-trials huggingface dataset:
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)

This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease. The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction in hepatic fat with respect to placebo is expected).


Eligibility Criteria:
Inclusion Criteria:

* Females must be of non-childbearing potential
* Body mass index (BMI) ≥32.0 kg/m\^2
* In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests
* No clinically significant abnormality on electrocardiogram
* Has documented hepatic fat content ≥10% within 6 months of enrollment
* Maintained stable weight (by history) for at least 4 weeks
* Agrees not to initiate a weight loss program and agrees to maintain consistent dietary habits and exercise routines for the duration of the study
* Has a rating of 'moderate' or 'severe' steatosis on ultrasound at the prestudy (screening) visit

Exclusion Criteria:

* Change in weight greater than 4% between prestudy visit and randomization into the study
* History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant
* Liver disease other than fatty liver or non-alcoholic steatohepatitis (NASH)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x the upper limit of normal range
* Serum triglyceride level \>600 mg/dL
* History of stroke, chronic seizures, or major neurological disorder
* History of clinically significant endocrine, gastrointestinal, cardiovascular (including congestive heart failure), hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Had abdominal surgery, gastric bypass, bowel resection, recent liver biopsy, or any other procedure within a minimum of 4 weeks
* History of neoplastic disease
* Claustrophobia or other contraindication to magnetic resonance imaging (MRI)
* Have not washed off agents associated with changes in hepatic fat or used for treatment of Non-alcoholic fatty liver disease (NAFLD) or NASH for a minimum of 3 months prior
* Consumes excessive amounts of alcohol, coffee, tea, cola, or other caffeinated beverages
* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks
* Significant multiple and/or severe allergies
* Intolerance or hypersensitivity to pioglitazone hydrochloride or any inactive ingredients
* Regular user of any illicit drugs or has a history of drug (including alcohol) abuse.
Diagnosis of Cervical Lesions in Women With Unhealthy Looking Cervix

Endocervix (cervical canal) is the cavity of the cervix and connects the external os with the internal os. It is fusiform in shape and has posterior and anterior oblique longitudinal ridges, the plicae palmatae. These are not exactly apposed but inter-lock like a zipper so that the canal is kept closed.

The original squamous epithelium is clearly identified as a smooth, usually featureless covering of the cervix; its uniform pink color contrasts with the redness of the original columnar epithelium. It joins the latter at the original squamocolumnar junction.

Many clinicians encounter cervical lesions that may or may not be associated with cytologic abnormalities. Such abnormalities as ectropion, Nabothian cysts, and small cervical polyps are quite benign and need not generate concern for patient or clinician, whereas others, including those associated with a history of exposure to diethylstilbestrol, cervical inflammation, abnormal cervical cytology, and postcoital bleeding, should prompt additional evaluation. Further, in some patients, the cervix may be difficult to visualize. Several useful clinical suggestions for the optimal examination of the cervix are presented.


Eligibility Criteria:
Inclusion Criteria:

1. Suspicious cervix
2. Age between 20 to 60 years

Exclusion Criteria:

1. Previously diagnosed cervical lesions.
2. Pregnant women.
Study of PYX-201 in Combination With Pembrolizumab in Advanced Solid Tumors

The primary objective of this study is to determine the recommended Phase 2 doses (RP2D(s)) and maximum tolerated dose (MTD) of PYX-201 in combination with pembrolizumab for participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria

1. Histologically or cytologically confirmed advanced solid tumors, including first-line (1L) head and neck squamous cell carcinoma (HNSCC), advanced or metastatic triple negative breast cancer (TNBC), hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative breast cancer (HER2- BC), gastric cancer (GC), cervical cancer, and second-line and higher (2L+) HNSCC.
2. Male or non-pregnant, non-lactating female participants age ≥18 years.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
4. Participant must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria.
5. Life expectancy of \>3 months, in the opinion of the Investigator.
6. Adequate hematologic function.
7. Adequate hepatic function.
8. Adequate renal function.
9. Adequate coagulation profile.
10. Clinical sites must conduct fresh tumor biopsy or provide participant's archived tumor tissue sample.

Exclusion Criteria

1. Known additional malignancy that is progressing or has required active treatment within the past 2 years.
2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Significant cardiovascular disease within 6 months prior to start of study drug.
4. Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment at the start of study drug.
5. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
6. Failure to recover to Baseline severity or National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 Grade ≤1 from acute non-hematologic toxicity due to previous therapy, prior to Screening.
7. Participants with active neuropathy of any grade per CTCAE v5.0 at Screening.
8. History of uncontrolled diabetes mellitus.
9. Participants with immunodeficiency or active autoimmune disease that is contraindicated for pembrolizumab.
10. Participants with a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
11. Prior solid organ or bone marrow progenitor cell transplantation.
12. Prior high-dose chemotherapy requiring stem cell rescue.
13. Previously received treatment with a programmed death-1 (PD-1)/L1 inhibitor any prior treatment with an agent directed to another stimulatory or co inhibitory T-cell receptor.
14. Severe hypersensitivity (Grade ≥3) to pembrolizumab and/or any of its excipients and/or PYX-201 and/or any of its excipients.
Recycling of Chronic Smokers to Sustained Abstinence

To develop and to test a brief telephone intervention following clinic treatment for smoking cessation.

DESIGN NARRATIVE:

A total of 1,083 chronic smokers were randomly assigned either to a traditional state-of-the-art smoking cessation clinic or to the clinic supplemented by telephone support for recycling. Telephone outreach consisted of three separate rounds of intervention three months, nine months, and 21 months after the targeted date for quitting in the smoking cessation clinics.

Telephone calls to abstinent subjects reinforced success and offered advice and support in coping with difficult situations. Calls to relapsers and nonabstainers debriefed concerning the relapse episode (as appropriate) and encouraged subjects to initiate concrete action toward quitting including setting a quit date. Subjects were offered self-help materials as well as referrals to more intensive programs.

Follow-up data collection was separate from recycling contacts and occured six, 12, 24, and 34 months after the initial smoking cessation clinics. Projected longterm sustained abstinence rates were 35 percent for recycling and 25 percent for the clinic only comparison. If results were as predicted, an effective low-cost telephone outreach protocol was made available that could dramatically assist in smoking cessation and thereby substantially reduce cardiovascular disease.

Eligibility Criteria:
No eligibility criteria
Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC

To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.

The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically proven non-small cell lung cancer
* no prior chemotherapy or only adjuvant chemotherapy which had been completed \>6 months before registration
* ECOG performance status 0 to 2
* measurable lesion(s)
* normal marrow, hepatic and renal functions
* provision of written informed consent

Exclusion Criteria:

* active infection or severe comorbidities
* history of anaphylaxis of any origin
Electroacupuncture for the Treatment of Functional Constipation

The purpose of this study is to investigate the effect of electroacupuncture on functional constipation.

This study will supply significant evidence for using acupuncture to treat functional constipation(FC), and will help us to identify whether it is a therapeutic effect rather than a placebo effect.

Eligibility Criteria:
Inclusion criteria:

* functional constipation according to the Roman Ⅲ standard;
* aged between 18 and 65 years old

Exclusion criteria:

* unconsciousness, psychosis or can't express subjective symptoms;
* pregnant women or women in lactation period;
* serious diseases of the heart, liver, kidney, and others;
* bleeding disorders.
Immediate Effect of Energy Alignment and Mantra on Stress Related Pain in Adolescents

Psychiatrists have expressed concern at the emergence of education as a serious source of stress for school-going children - causing high incidence of deaths by suicide. Many adolescents in India are referred to hospital psychiatric units for school-related distress - exhibiting symptoms of depression, high anxiety, frequent school refusal, phobia, physical complaints, irritability, weeping spells, and decreased interest in school work. Previous studies have found significant anxiety, distress, depression, worn outs and severe impact of psychological factors on the performances of dental, engineering and medical student. But students preparing for competitive exams have not been studied yet.

Current study reports the scientific evidence of immediate effect of yoga based techniques combined with music and Vedic chants on adolescents preparing for competitive exams.


Eligibility Criteria:
Inclusion Criteria:

* All adolescents enrolled at the participating centers and that agree to sign informed consent.

Exclusion Criteria:

* not agreement to sign the informed consent
Pilot Study for Evaluating the Role of F-18 FLT PET/CT in Therapeutic Decision Making in Non-small Cell Lung Cancer

The objective of this pilot study is to determine whether 18F-FLT PET/CT can predict which patients will have poorer progression free survival and overall survival in advanced Non-small Cell Lung Cancer (NSCLC) after first-line therapy and, therefore, need more aggressive treatment.

Standard therapy for patients with advanced NSCLC is platinum based doublet chemotherapy. Current first-line chemotherapy is usually limited to 4-6 cycles, as prolonging treatment does not result in additional benefit and may often cause further toxicity. Until recently, treatment guidelines recommended withholding administration of later-line systemic anti-cancer treatment until disease progression.

There are several reports suggesting that maintenance therapy following first-line chemotherapy offers improved survival in advance stage patients. This approach involves the administration of an active treatment immediately after first-line chemotherapy, thus maintaining the clinical benefit initially obtained. However, drug related toxicity and costs are of great concern. There may also be patients with less aggressive disease where an immediate transition to maintenance therapy after first-line results in overtreatment.

Therefore, selecting patients who require more aggressive treatment or earlier intervention is necessary.

If FLT PET/CT can discriminate the patients with shorter progression free survival and overall survival in this pilot study, patients could be selected for more aggressive or earlier treatment such as maintenance therapy, and the investigators could expect to prolong survival while reducing the adverse events and costs that will accompany inconsequential therapy with FLT PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* advanced non-small cell lung cancer (stage IIIB, IV)
* at least one measurable lesion
* performance status (ECOG) 0-2
* 1st-line platinum chemotherapy and no progression

Exclusion Criteria:

* mixed small cell and non-small cell
* uncontrolled brain metastasis
* previous malignancy within 5 years (except basal cell carcinoma of skin, carcinoma in situ of uterine cervix)
* pregnant or breast feeding
* pemetrexed chemotherapy
Sport Cord Test Following ACL Reconstruction

The primary purpose of this study is to determine the interrater reliability and validity of the Sportcord Test as a measure of physical performance following anterior cruciate ligament (ACL) reconstruction. A secondary purpose is to systematically track subjective and objective outcomes on patients following ACL reconstruction to help identify differences between those who have subsequent knee problems and those who do not. The study hypotheses are the following:

1) The Sportcord Test will provide a valid and reliable measure of functional performance following ACL reconstruction. 2) Patients who have subsequent knee problems in the 12 month study period will exhibit different scores on clinical special tests compared to those who do not.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing surgical reconstruction for a torn ACL.
* Returning to participation in a sport(s).
* Will receive physical therapy/rehabilitation after surgical reconstruction for a torn ACL.
* Between ages of 10 and 50.

Exclusion Criteria:

* Non-weight bearing.
* At least 12 weeks removed from surgery.
* Unable to walk, squat, or jump/land without pain in the surgically repaired knee.
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups:

1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy.
2. Standard arthroscopic treatment (above) without cell transplant.

Adipose-derived stem cells (ADSC) may be beneficial to patients with OA because they may differentiate into chondrocytes, promote endogenous tissue repair, and have potent anti-inflammatory properties.

Early studies show promising clinical results using ADSCs to treat patients with osteoarthritis, but no clinical trials have been completed comparing cellular therapy to standard arthroscopic treatment.

The investigators aim to determine whether ADSC transplantation as adjuvant therapy in patients with arthroscopic findings of mild to moderate arthritis will result in improved clinical outcomes scores at one and two-year follow-up compared to standard arthroscopic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 35 and 70 years-old
* Patient is scheduled to undergo one or a combination of the following procedures:

  * Meniscal debridement or partial menisectomy
  * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
  * Removal of loose bodies
  * Chondroplasty
  * Synovectomy
  * Soft tissue releases for flexion or extension contracture.
* Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral femoral condyle (Kellgren-Lawrence Grade 2 or 3)
* \< 6 months of knee pain or \< 6 months of a significant exacerbation of existing knee pain
* Physical examination findings consistent with the proposed surgical procedure.
* Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications, with or without concomitant bracing and/or injections

Exclusion Criteria:

* Age \< 35 or \> 70 years old
* Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 or 4)
* Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)
* Patient scheduled to undergo any concomitant surgical procedures with the exception of:

  * Meniscal debridement or partial menisectomy
  * Meniscal repair that does not necessitate a different postoperative protocol from meniscal debridement or partial menisectomy
  * Removal of loose bodies
  * Chondroplasty
  * Synovectomy
  * Soft tissue releases for flexion or extension contracture
* Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture, Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant
* Previous arthroscopy within 1 year
* Subchondral edema
A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders

The purpose of this study is assessing the efficacy of swallowed Flovent® vs. placebo for the treatment of eosinophilic esophagitis (EE).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent for study by parent or guardian. Assent will be obtained from all minors 11 years of age and older.
* Age older than or equal to 3 years and younger than or equal to 30 years
* Endoscopic findings consistent with EE (edema, furrowing, exudates, rings)
* Histological findings to include proliferation of basal layer and peak eosinophil density ≥24 per high power field (400x). This degree of tissue eosinophilia has been shown to correlate well with poor-responsiveness to acid suppression therapy, suggesting it is a primary eosinophilic disease and not secondary to GERD\[11\].
* Allergy evaluation including skin-prick testing with multiple food antigens to insure elimination diet is not indicated.
* If allergic to specific foods, option to be on a minimum 3 months of elimination diet without detectable resolution by repeat endoscopy with biopsies demonstrating no improvement to disease.
* Patients enrolled at CCHMC will be under the direct care of Dr. Putnam or any of the other staff gastroenterologists at this institution who will supervise endoscopic procedures. Patients may also be enrolled at institutions other than CCHMC, but the diagnosis of EE must be validated by an expert pathologist in EE at CCHMC (Margaret Collins, MD).
* 20 additional patients without EE will be enrolled as unaffected controls for purposes of comparison with patients with EE. Enrollment pool will comprise patients undergoing routine upper endoscopy and having no identifiable pathology.

Exclusion Criteria:

* Patients with history of poor tolerance to FP, patients unable to cooperate with use of MDI, pregnant females, patients inhaling any corticosteroid for asthma, and patients with concurrent or recent (within 3 months) use of systemic steroids.
IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssion

This study invastigates the effect of icosapent ethyl in patients with aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 50 years
2. Mild to moderate AVS

Exclusion Criteria:

1. Bicuspid aortic valve
2. History of chest radiotherapy
3. History of rheumatic fever
4. Moderate to severe renal failure, defined as eGFR \< 30 ml/min
5. Hyperparathyroidism
6. Paget's disease
7. Diagnosis of (active) malignancy in last 5 years
8. Anticipated or planned aortic valve surgery in the next 6 months
9. Life expectancy \<2 years
10. Chronic atrial fibrillation
11. Use of anticoagulant medication or dual antiplatelet therapy
12. Known hypersensitivity to fish and/or shellfish
13. Known hypersensitivity to soya
14. Malabsorption syndrome and/or chronic diarrhea
15. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control \[such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)\] to avoid pregnancy for the entire study.
16. Women who are pregnant or breastfeeding
17. Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
18. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study