cyrilzakka/clinical-trials huggingface dataset:
The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia

For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.


Eligibility Criteria:
Inclusion Criteria:

* primary unilateral inguinal hernia

Exclusion Criteria:

* not willing to participate
* not capable to understand or fill in the questionnaires
The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty

Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck laxity following facialplasty


Eligibility Criteria:
Inclusion Criteria:

* Adult females and males between the ages of 40-80 inclusive, having premature jowl and/or neck laxity one to fifteen years following facialplasty, seeking skin tightening treatments.
* Lack lipodystrophy in the jowl or neck area or at least not amenable to liposuction improvement (not a candidate for liposuction).
* Lack of previous Face Lift complications (no nerve injury or hematoma history).
* The patients should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, (including thepermission to use photography).
* The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.

Exclusion Criteria:

* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* The Handpiece should be used at least 1cm away from cochlear implants in the ear.
* Superficial permanent implant in the treated area such as metal plates and screws, metal piercing, silicone implants or an injected chemical substance.
* Current or history of skin cancer (remission of 5 years), or current condition of any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* Pregnancy and nursing.
* History of bleeding coagulopathies or use of anticoagulants
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonalvirilization.
* Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
* Any surgery or treatment such as laser or chemicals in treated area within 3-6 months prior to treatment or before complete healing.
* Allergies, in particular to anesthesia.
* Mental disorders such as Body Dysmorphic Disorder (BDD).
* As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient.
3D Ultrasound of Abdominal Aortic Aneurysm Characteristics

AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.


Eligibility Criteria:
Inclusion Criteria:

* Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
* Scheduled for elective endovascular repair (EVAR);
* Preoperative CTA with iodine contrast available;
* Informed consent form understood and signed.

Exclusion Criteria:

* BMI\>40 kg/m2
* Symptomatic AAA;
* Implanted pacemaker or ICD;
* Unable to hold breath for ≤7 seconds;
* Pregnant;
* Hypersensitivity to the active substance(s) or any of the excipients in Sonovue;
* Known right-to-left cardiac shunt;
* Severe pulmonary hypertension (pulmonary artery pressure \> 90mmHg);
* Uncontrolled systemic hypertension;
* Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress syndrome);
* Clinically unstable cardiac disease (recent, \< 3 months, or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrhythmia's, endocarditis, etc.);
* Prosthetic valves;
* Loss of renal function (GFR \< 31 mL/min), end-stage renal disease;
* End-stage liver disease;
* Sepsis;
* Hypercoagulable status, recent (\< 3 months) thrombosis;
* Congestive heart failure (class III or IV);
* Psychiatric or other condition that may interfere with the study;
* Participating in another clinical study that interferes on the primary outcomes of this study;
* 3D US measurement of AAA is impossible because of bowel gasses or other causes.
The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors

A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016. This study used stratified randomized sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview was applied to all subjects.

A cross-sectional study of 350 medical student Universitas Indonesia from first grade until fifth grade was done during November-December 2016. This study used stratified randomized sampling. The Rome IV criteria was used for diagnosing IBS. Questionnaire-guided interview was applied to all subjects. A bivariate analysis was done to know the relationship between IBS and its related factors using chi-square, unpaired t-test, and their alternatives. Multivariate analysis was done using logistic regression test

Eligibility Criteria:
Inclusion Criteria:

* Age of participant \>= 15 years
* Volunteer to participate in study

Exclusion Criteria:

* Red flag symptoms: febrile, vomiting, rectal bleeding, weight lost
* Diagnosed as having Inflammatory bowel disease
* Peptic ulcer drug consumption
* History of gastrointestinal surgery
HER2 and LA/mUC: A Multi-country Chart Review Cohort Study

This study is being done to learn about urothelial cancers that make HER2 and how that affects treatment choices for participants with urothelial cancer. During this study, the medical and health records of participants will be reviewed to learn more about their health.

Participants will have urothelial cancer that has grown in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is the predominant cell type.
* Locally advanced unresectable or metastatic stage disease
* Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.
* At least 1 prior line of systemic therapy for locally advanced unresectable or metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing chemotherapy.
* Initiation of anticancer therapy for UC after prior progression on platinum-based therapy with or without maintenance avelumab between 01 January 2019 and 12 months before the end of data collection
* Radiographically documented and measurable disease progression immediately before index date

Exclusion Criteria:

* Any concurrent malignant neoplasm requiring systemic therapy during the study window
* Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count \< 400 cells/mm3 and to monitor adverse effects of AZT.

Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.

Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.

This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is ordered and prescribed by the patient's physician. The physician is responsible for obtaining informed consent, assuring that the patient meets the eligibility criteria, dispensing the medication to the patient, monitoring the patient's condition on treatment, and reporting required data to the project coordinating center.

Eligibility Criteria:
Inclusion Criteria

Concurrent Treatment:

Allowed:

* Blood transfusions for hematologic toxicity.

Criteria for children 3 months to less than 15 months of age:

* Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).

OR

* If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture.

Patients must meet two of the following criteria:

* Be HIV culture positive or p24 antigen positive.
* Have at least one of the Class P-2 symptoms (by CDC criteria).

Be immunosuppressed defined as having:

* CD4+(T4) lymphocytes = or \< 400 cells/mm3.
* Abnormal age adjusted immunoglobulin levels (IgG or IgA). Decreased helper/suppressor ratio \< 1.0.

Note:

* In general, abnormal values for any of the above lab tests should be confirmed in 2 measurements at least 1 week apart, and other clinical causes for these abnormalities should be ruled out.

Criteria for children 15 months to 12 years of age:

* Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).

OR

* If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture.

Patients must meet one of the following criteria:

* Have at least one of the class P-2 symptoms (by CDC criteria).
* Be immunosuppressed defined as having CD4+(T4) lymphocytes = or \< 400 cells/mm3, based on two measurements at least 1 week apart.

Exclusion Criteria

Co-existing Condition:

Patients with known hypersensitivity to AZT are excluded.

Patients with the following are excluded:

* Failure to meet inclusion criteria.
* Inability to obtain signed informed consent from a parent or legal guardian.
* Enrollment in another treatment protocol that expressly prohibits concomitant treatment with zidovudine (AZT).
* Enrollment in another clinical trial in which AZT is a treatment.
* Known hypersensitivity to AZT.
Functional Exercise Training in Cerebral Palsy: Follow Up

The goal of this cross-sectional study is to compare able-bodied peers to adolescents and young adults with cerebral palsy (CP) who have been regularly performing high-intensity functional training for almost two years.

The main research question is: is structured, long-term exercise training able to compensate strength and cardiovascular deficits in adolescents with CP compared to able-bodied peers?

The pilot study investigating the effects of a functional exercise training in adolescents and young adults with cerebral palsy (CP) showed increases in strength, power, daily function as well as cardiovascular health. In order to establish the origin of the improvements and its broader effects, we wish to conduct follow-up measurements to the pilot study. These follow-up measurements would establish whether the positive changes in physical performance are due to neural or muscular changes (or both), and shed more light on how therapy should be performed and prescribed in adolescents with CP. Additionally, we wish to measure their aerobic capacity as well as examine their microvascular health. For this cross-sectional analysis, the participants of the CP-FIT Pilot Study who continued to train on a regular basis will be compared to age-matched peers in order to establish whether their strength and fitness deficits compared to peers can be compensated through structured and progressive functional exercise training.

Eligibility Criteria:
Inclusion Criteria:

CP Individuals:

* Diagnosis of CP.
* Between 14 and 26 years of age.
* Gross Motor Functional Classification System (GMFCS): I-II.
* Cognitive abilities must include: Ability to verbally or non-verbally communicate pain or discomfort; Ability to attend testing and; ability to understand and follow instructions. All included participants are capable of making decisions on their own and no not show any signs of mental or cognitive limitations.

Healthy peers:

- Between 14 and 26 years of age.

Exclusion Criteria:

CP Individuals:

* Any surgery or botulinum toxin treatment within 6 months prior to the measurements or scheduled during study period. Other medications can be continued as prescribed by the participants' physician.
* Known cardiovascular or pulmonary diseases that have not received medical clearance to participate in physical exercise.
* Uncontrolled seizures or epilepsy.
* Inability to conform to the above mentioned cognitive and physical abilities.

Healthy peers:

* Diagnosis of congenital heart defects, pulmonary diseases or any neuromuscular disorders or diseases.
* Diagnosis of any acute diseases.
Comparison of Strength and Constant Score Pre- and Post-Subacromial Injection for Full Thickness Rotator Cuff Tears

Clinical manifestations of rotator cuff tear include shoulder pain, weakness, and stiffness. The level of pain is often a limiting factor when assessing shoulder range of motion and strength pre-operatively. Pain itself has even been a cause of weakness due to muscle atrophy.

The purpose of this study is to further understand the effect pain has by measuring constant shoulder scores in patients before and after ultrasound guided subacromial (the outer end of the shoulder blade) injection of lidocaine (a local anesthetic or numbing agent) compared to saline (salt solution), in patients indicated for arthroscopic rotator cuff repair. The saline and lidocaine has been approved for use by the U.S. Food and Drug Administration (FDA). The constant shoulder score includes your level of pain, activity level, range of motion and strength measures.


Eligibility Criteria:
Inclusion Criteria:

* Patient is determined to have a full thickness rotator cuff tear (1-3 cm), on the pre-operative MRI scan or found arthroscopically, and is scheduled to undergo arthroscopic surgical repair
* Written informed consent is obtained

Exclusion Criteria:

* Revision Surgery
* Irreparable tear or partial tear
* Subscapularis involvement
* Any patient lacking decisional capability
Comparative Efficacy of 20% Benzocaine Versus TAC Alternate Gel

The project is a study comparing the effectiveness of two topical anesthetics for control of pain associated with dental needle insertion in the palatal mucosa. A standard dental topical anesthetic (20% benzocaine) will serve as an "active" control and will be compared to a combination topical anesthetic, consisting of 20% lidocaine, 4% tetracaine and 2% phenylephrine (TAC Alternate Gel, Compounding Arts Pharmacy, Lafayette, LA).


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers 18 years or older
2. Ability to consent to participate in the research
3. Ability to communicate a VAS score
4. Generally healthy, ASA I and ASA II
5. No known drug allergies
6. Ability to tolerate pulse oximeter and blood pressure cuff without psychological, or physiological consequence

Exclusion Criteria:

1. Allergy or other contraindications to the topical anesthetics
2. Inability to consent to participation in the study
3. Use of analgesics prior to the procedure
4. Vulnerable populations
Long-Term Follow-Up in Patients With Prostate Cancer After Surgery

This clinical trial studies how well a long-term follow-up works in patients with prostate cancer after surgery. Long-term follow-up data may serve as a resource to help ask clinical questions, describe health-related quality of life and long-term complications related, and facilitate future studies focusing on interventions to improve health status and health-related quality of life in prostate cancer survivors.

PRIMARY OBJECTIVES:

I. To provide comprehensive long-term follow-up care to prostate cancer survivors at the City of Hope who underwent definitive surgical therapy.

II. To use the information obtained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to serve as a resource that will help answer clinical questions, generate and test hypotheses, describe the incidence of long-term complications, and facilitate future studies focusing on interventions for long-term complications of prostate cancer and its therapy.

III. To use the information gained from follow-up of prostate cancer survivors who underwent definitive surgical therapy to describe health-related quality of life (HRQL) concerns and to serve as a resource to facilitate future studies focusing on interventions to improve health status and HRQL in prostate cancer survivors.

OUTLINE:

Patients undergo long-term follow-up and receive a written survivorship care plan including comprehensive health evaluation and health education beginning 1 year post surgery.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer
* Treated with a definitive surgical procedure at City of Hope
* At least one year post surgical treatment for prostate cancer
* No history of recurrent, progressive, or metastatic disease
* Currently stable disease or no evidence of disease
* No prior treatment of prostate cancer with radiation or chemotherapy
* No history of other urologic cancer (e.g., bladder cancer, renal cell carcinoma) in addition to prostate cancer

  * Note: Patients who develop recurrence while participating in the Prostate Cancer Survivorship Clinic will be referred back to their urologist and may resume participation in the Survivorship Clinic when deemed appropriate by their treating physician

Exclusion Criteria:

* Current treatment with testosterone replacement or androgen deprivation therapy
* Treatment for another noncutaneous cancer within the past 2 years
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects

The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male 18-55
* Women not of child bearing potential, 18-55

Exclusion Criteria:

* History of or current treatment for psychiatric illnesses, substance abuse or dependence
* History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)
A Logical Framework for Tailor-made Paradigm Shift Hospital Foodservice to Prevent Malnutrition Among Geriatric Patients in Hospitals

Hospital Food service is important for patient recovery by providing necessary aid with adequate meal consumption. Overall, hospital experience can influence patients' satisfaction for the foodservice quality. Thus, it is important to evaluate patient satisfaction with food service to meet consumers' needs in order to prevent malnutrition. The aim of the studies is to develop the Malaysian geriatric patients' hospital foodservice protocol (My GERYFS). There are 3 Phases in this research which is phase 1 is a multicentre cohort study conducted among elderly and healthcare professionals involved in Klang Valley Hospitals. Phase 2 for To develop a tailor-made hospital foodservice protocol for Malaysian geriatric patients with healthcare professional input and phase 3 is to determine the feasibility and cost-effectiveness of MY GERYFS protocol in a Malaysian hospital. Effectiveness of this study protocol can bring benefits to elderly to prevent malnutrition in the hospitals via foodservice.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years and older
* Able to understand and speak Malay or English or both
* Patients who are on oral diet or on Oral Nutrition Support (ONS) or both
* Patients who are admitted for more than 48 hours

Exclusion Criteria:

* Patients who are mentally disturbed
* Critically ill patients
* Patients who are on full enteral or parenteral feeding