cyrilzakka/clinical-trials huggingface dataset:
Quality of Life of TEP vs Lichtenstein Hernioplasty

To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty

Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Both genders
* Unilateral inguinal hernias
* Reducible inguinal hernias
* Elective setting

Exclusion Criteria

* ASA Physical Status (American Society of Anaesthesiologists) Grade \> 2
* Recurrence
* Inguinal-scrotal hernias
* Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
* Pregnancy
* Refusal for general anaesthesia
Navigating the Clinical Trial Process for Hepatocellular Carcinoma

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in hepatocellular carcinoma clinical research, as well as the reasons for withdrawal or discontinuation.

Insights gained from this study will ultimately benefit those with hepatocellular carcinoma who may be invited to participate in clinical research in the years to come.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with hepatocellular carcinoma
* Willing to comply with all study related procedures and assessments
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

* No documented diagnosis of hepatocellular carcinoma
* Any serious and/or unstable pre-existing medical disorders
* Pregnant or lactating woman
The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer

The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer.

Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.

The goal of this observational study is to learn if the study protocol is feasible, if we can accrue participants easily, and to determine how well two tools (tissue dielectric constant and ultrasound) identify breast edema after breast conserving surgery for breast cancer.

Participants will be asked to attend one appointment in which all data will be collected. This will include questionnaires regarding symptoms, clinical examination, measurement of breast edema using two tools (ultrasound and tissue dielectric constant), measurement with the perometer and SOZO, and clinical photographs.

Eligibility Criteria:
All participants must meet the following inclusion criteria:

* Be a female between the ages of 18 and 85 years.
* Have undergone breast conserving surgery +/- LN removal (sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
* Have no residual cancer in the breast after definitive breast surgery
* Have been treated with radiation therapy and have completed breast cancer treatment (excluding Herceptin and hormonal treatments) at MGH greater than or equal to 3 months ago.
* Be able to read and understand English
* Understand the proposed study and be willing and fully able to comply with the study procedures
* Be a willing participant and be capable of giving and has given informed written consent for entry into the study

EXCLUSION CRITERIA

Participants will be excluded if they:

* Have bilateral BC
* Have metastatic or inflammatory BC
* Will be excluded from the SOZO measurement of the study if they have implanted cardiac devices or neurostimulators
* Have any medical condition that may result in breast swelling;

  * Uncontrolled congestive cardiac failure,
  * Arteriovenous haemodialysis,
  * Current infection or cellulitis of either breast.
* Be pregnant or currently breast feeding.
* Have a known over-active thyroid or known benign thyroid tumour
Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia.

Open-label pilot study in 20 older adults with insomnia (sleep onset latency\>30 minutes for at least 3 nights a week) with a two week intervention period.

Eligibility Criteria:
Inclusion Criteria:

1) Sleep onset latency \> 30 min for at least 3 nights per week

Exclusion Criteria:

1. Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages).
2. Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol).
3. History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder
4. Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).
Effect of Increasing Time Spent Outdoors on Myopia Prevention in School-Aged Children in Northeast China

The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors in northeast China.

The purpose of this study is to develop a school-based intervention aimed at prevent the onset and development of myopia among school aged children by increasing time spent outdoors among elementary and secondary school students in northeast China. It is expected that the results will provide evidences for policy-makers and school healthcare providers for their school children myopia prevention.

Eligibility Criteria:
Inclusion Criteria:

* Grade of 1 to 5 in elementary schools and grade of 7 to 8 in secondary schools.

Exclusion Criteria:

* Visual defect or other eye diseases; wearing orthokeratology; refractive surgery history.
The Role of Serum Adipokines in Predicting Response to Neoadjuvant Therapy in Patients With Rectal Cancer

It has been shown that adipokines (resistin, leptin, adiponectin) secreted from adipose tissue and proinflammatory cytokines such as IL-6, TNF-a are associated with the risk of developing colorectal cancer. However, the role of these factors in predicting clinical response to neoadjuvant therapy in rectal cancers is unknown. In this study, the role of serum adipokine levels before neoadjuvant therapy in predicting clinical response in patients with rectal cancer is investigated. For this purpose, blood will be drawn from patients with rectal cancer who will receive neoadjuvant therapy, serum adipokines will be studied and clinical response to neoadjuvant therapy will be compared.


Eligibility Criteria:
Inclusion Criteria:

* All patients with locally advanced rectal cancer

Exclusion Criteria:

* below 18 years old
* patients who did not received neoadjuvant therapyAll
Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)

The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of metastatic soft-tissue or bone sarcoma
* Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic disease
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate organ and bone marrow function
* Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization

Exclusion Criteria:

* Prior therapy with rapamycin or rapamycin analogs
* Ongoing toxicity associated with prior anticancer therapy
* Another primary malignancy within the past three years
* Concomitant medications that induce or inhibit CYP3A
* Significant, uncontrolled cardiovascular disease
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.

Eligibility Criteria:
Key inclusion criteria

* Female patients age 18 years or older
* Histologically and/or cytologically confirmed diagnosis of breast cancer
* Radiologic evidence of inoperable locally advanced or metastatic breast cancer
* Adequate tumor tissue for the analysis of PI3K-related biomarkers
* Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status
* Postmenopausal women
* Prior treatment with aromatase inhibitors
* Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
* Adequate bone marrow and organ function
* ECOG performance status ≤ 2

Key exclusion criteria

* Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant
* More than one chemotherapy line for metastatic disease
* Hypersensitivity to any of the excipients of buparlisib or fulvestrant
* Symptomatic central nervous system metastases
* Concurrent malignancy or malignancy within 3 years of study enrollment
* Certain drugs or radiation within 2-4 weeks of enrollment
* Increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent
* Certain scores on an anxiety and depression mood questionnaire given at screening
* Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus
* Active cardiac disease or a history of cardiac dysfunction
Molecular and Cellular Mechanisms of the In-stent-thrombosis

In-Stent-Thrombosis is a rare but serious complication after implantation of stents during PTCA.

In this prospective, open, not-randomized, controlled single-center pilot study 80 patients having had an in-stent-thrombosis (40 sub-acute thromboses (SAT), 40 late thromboses (LT)) and a control group of 80 patients having not developed a thrombosis will be compared.

The aim of this study is the establishment of diagnostic markers vor prediction of SAT (detection of CD39- and CD73-activity, respectively)and of LT (EPC-number and function, respectively) correspondingly aiming at the early identification of patients with high risk for developing an in-stent-thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* patients having developed an SAT or LT after stent implantation using PTCA

Exclusion Criteria:

* instabel coronary heart diseases,
* systemic autoimmune diseases,
* rheumatic diseases,
* tumors,
* impaired kidney or liver function,
* surgery within the last 3 months,
* pregnant or lactating women
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.

A Phase I, Randomised, Open-label, 3 way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.

Eligibility Criteria:
Inclusion Criteria:

* Female non-pregnant, non-lactating.
* Volunteers with suitable veins for cannulation or repeated venipuncture.
* Male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigational product.
* The female partner should use contraception during this period.

Exclusion Criteria:

* History of any clinically significant disease or disorder.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
* Volunteers who have smoked or used nicotine products within the previous 3 months from the date of screening.
* Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the Investigator .
Longitudinal Evaluation of a Fracture Liaison Service

The major objective of this study is to evaluated osteoporosis prevalence, both on computed tomography (CT) and dual x ray absorptiometry (DXA) in patients included in a fracture liaison service (FLS).

The secondary objectives are to evaluate the prevalence of antiosteoporotic treatments indication, of new fractures or mortality; to identify the risk factor for osteoporosis; the study the treatment's observance; to identify the screening threshold to diagnose osteoporosis on CT.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 50 years
* Bone fracture due to a fall

Exclusion Criteria:

* patient's opposition
The Effect of Different Lining Strategies on Amalgam Restorations

The aim of this research is to compare the clinical outcome of amalgam restorations placed in conjunction with three different lining protocols, each of which represents a different therapeutic concept.

Patients attending one of eight, United Kingdom general dental practitioners for a new restoration in a posterior tooth will be recruited and informed consent obtained. Each dentist will place 20 amalgam restorations either unlined (control), or lined with calcium hydroxide cement, rmgi cement, or sealed with a resin bonding agent (total - 640).

Pre-operative radiographs and pulp testing will be performed and measurement of cavity size to assess the remaining dental thickness. The pulp status and symptoms will be recorded at 6, 12, and 24 months. Post-operative sensitivity will be recorded by the patient at 1, 3, 7, 14 and 28 days using a visual analogue scale and diary. The dentists will be trained and calibrated to use United States Public Health Service criteria and the condition of the restoration will be assessed at 12 and 24 months.

For each lining option, one product and one admixed amalgam will be provided for use by all the dentists. Training and instruction will be given on the application of the liners and on amalgam condensation to increase standardisation.

The collected data will be assessed to identify any association between the outcome variables and the pre-treatment tooth condition or lining material used using logistic regression (α=0.05).

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over 18 years
* Presence of one or more carious cavities extending beyond the outer 1/3 of the dentine
* Able to give valid consent to participate in study
* Willing to receive an amalgam restoration in a target tooth
* Teeth free from pain
* Teeth with vital pulps

Exclusion Criteria:

* Replacement restorations
* Psychiatric conditions or medication which may affect pain perception.
* Cavities limited to the outer ⅓ of dentine.
* Teeth with existing symptoms or sensitivity
* Patients under 18 years
* Non-vital teeth
* Allergy or idiosyncratic reaction to the study materials
* Inability to return for review
* Fractured or cracked teeth
* Pregnancy or breast-feeding
Study Evaluating Isovorin in Colon Cancer

The purpose of the study is to verify superiority of 1-LV/5FU therapy to UFT Therapy of relapse-free survival time in patients with Dukes C and Cure A colon cancer. Secondary endpoints include disease-free survival time, survival time, and safety.


Eligibility Criteria:
Inclusion Criteria:

* Dukes C, Cure A colon cancer diagnosed histologically or cytologically
* Normal organ function of bone marrow, heart, liver and kidney
* Age 20-75

Other inclusion applies

Exclusion Criteria:

* Serious bone marrow suppression, infection, heart disease or complication
* Familial adenomatous polyposis or hereditary nonpolyposis
* Pregnant or breastfeeding women

Other exclusion applies
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea

This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.


Eligibility Criteria:
Inclusion Criteria:

* Male or female who is at least 18 years of age.
* Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
* CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
* PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
* Presence of 2 or fewer inflammatory facial lesions.

Exclusion Criteria:

* History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
* History of refractive surgery such as photorefractive keratectomy.
* The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
* The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
A Multi-Center Study Evaluating the Safety of AC-170 0.24%

The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).


Eligibility Criteria:
Inclusion Criteria:

* at least 2 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
* have ocular health within normal limits

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study
Characterization of Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma (MK-0000-215)

The purpose of this study is to characterize the baseline variability of a panel of tissue (tumor and adjacent) and blood-based biomarkers obtained from participants with hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80% Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one core needle biopsy (CNB) equivalent is =\< 0.65.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HCC.
* Candidate for surgical resection or has no contraindications to MRI procedures.

Exclusion Criteria:

* Prior loco-regional treatment of tumor, unless there is untreated tumor present representing a distinct untreated nodule.
* Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma or metastatic tumor.
* Had a liver transplant.
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes

The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT


Eligibility Criteria:
Inclusion Criteria

* All patients \>/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks.
* Non-anomalous singletons
* Ability to provide informed consent

Exclusion Criteria

* Patients with Type 1 diabetes
* Patients with fetal major congenital abnormalities
* Patients identified/referred after 30.6 weeks