cyrilzakka/clinical-trials huggingface dataset:
Umblical Pilonidal Sinus Evaluation

Purpose: Pilonidal sinus disease (PSD) is a chronic inflammatory condition of skin due to implanted loose hair. PSD is commonly seen in sacrococcygeal region, but can also be seen in axilla, perineum, suprapubic regions, on hands and umbilicus. The aim of this project was to find factors influencing the development and treatment of umbilical pilonidal sinus.

Material and methods: In this cross-sectional prospective study, the investigators evaulated 82 (19 female, 63 male) patients with a history of umbilical pilonidal disease (e.g. predisposing factors, treatment modalities) between 2012 and 2020.

In this study, participants were volunteer patients admitted to Erzincan University Medical Faculty to the General Surgery Outpatient Clinic between March of 2012 and December of 2020 with umbilical symptoms such as umbilical discharge and umbilical pain. All patients were diagnosed by physical examination confirmed with ultrasonography . Patients with diseases other than umbilical sinus were excluded from the study. Examined patients' characteristics include age, gender, intergluteal sinus disease history, family history, belly shaving histoy, daily shower, treatment modality and healing status. There were 3 treatment modalities: conservative approach (daily shower, shaving, antibitics if infected); topical silver nitrate treatment; surgical operation for umbilical sinus as excracting the hairs from the sinus ± excising the sinus. To determine if "healed" the investigators followed up our patients ensuring no symptoms for a minimum 2 years.

Chi-square tests were conducted to compare the distribution of categorical variables. Age was analyzed as a continuous variable with a t-test. Univariable and multivariable logistic regression models were used to calculate odds ratios and 95% confidence intervals. P-values of less than 0.05 were considered statistically significant. Statistical analyses were conducted with R version of 3.6.1 (R Foundation for Statistical Computing, Vienna, Austria, https://www.r-project.org) software packages.

Eligibility Criteria:
Inclusion Criteria:

* all patients with umblical pilonidal sinus

Exclusion Criteria:

* no disease
MicroRNAs as Biomarkers in Patients With Chagas Disease

The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.

The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:

* Collection of Blood samples for biochemical analysis;
* Electrocardiogram;
* Holter Electrocardiogram;
* Echocardiogram;
* Treadmill Test;
* X-Ray Imaging;
* Magnetic Resonance Imaging;
* Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* Chagas disease diagnosis confirmed by 2 different serologies
* Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

Exclusion Criteria:

* Significant valve disease defined as aortic stenosis with a gradient of VE/Ao \> 50 mmHg
* Mitral stenosis with a valve area inferior than 1,5 cm2
* Severe or moderate aortic and/or mitral regurgitation
* Chronic use of immunosuppressive agents
* Dialysis treatment of terminal renal failure
* Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
* Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
* Any other comorbidities that impact patient's survival within the next 2 years
* Liver disease in activity
* Continuous use of steroids as treatment for COPD
* Hematologic, neoplastic or bone diseases
* Homeostasis disturbances
* Inflammatory diseases or chronic infectious diseases
Effects of Two Techniques of Mobilization in the Dorsiflexion on Patients With Chronic Ankle Instability

Restrictions on ankle dorsiflexion are common in subjects with chronic ankle instability (CAI). In fact, this is one factor that can contribute to the recurrence of such injuries. Passive mobilization techniques to improve ankle dorsiflexion are commonly used in physiotherapy treatments. However, no studies have compared manipulative techniques of mobilization techniques in subjects with chronic ankle instability.

The aim of this study is to compare the effects of two mobilization techniques on ankle dorsiflexion in patients with chronic ankle instability.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic ankle instability

Exclusion Criteria:

* Acute or subacute ankle sprain.
* Recent lesions in lower extremities.
Mobile Health Application for Family and Behavioral Health Provider Communication

The purpose of this study is to examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.

Purpose: we will examine feasibility, tolerability, utilization, and effectiveness of using the SupportTeam mobile application in the context of Cognitive Behavioral Therapy (CBT) for veterans with PTSD.

Participants: (N=100) 50 veterans who have served in the military since October 2001 and have PTSD with anger problems; and 50 collateral family members/close friends above the age of 18.

Procedures (methods): All Veterans with PTSD will receive a 12 session standard CBT for anger. Veterans in the intervention group will additionally receive instructions for using SupportTeam with a family member or friend that will provide data for the CBT clinician. Veterans in the control group will receive the CBT sessions, but will not receive the SupportTeam mobile application.

Eligibility Criteria:
Inclusion Criteria:

For Veteran:

* Age 18 or older
* Served in a branch of the US military since October, 2001
* Meets DSM-5 criteria for current PTSD as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);
* Reports at least one episode of anger or irritability in the past week;
* Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
* Has a family member or friend who also has and uses a smartphone with a data plan and agrees to participate in the study.
* Is able and willing to attend 12 weekly sessions at Duke Psychiatry offices within normal business hours (M-F 8:00-5:00)

For Collateral:

* 18 years old or older
* Has and regularly uses an iOS (iPhone 5s or higher with iOS 8 or higher) or Android (with 4G network and Android 4.1 or higher) smartphone with a data plan;
* Has a family member or friend who meets the veteran inclusion criteria and agrees to participate in the study.

Exclusion Criteria, Veteran:

- Is currently participating in, or is scheduled to participate in a manualized psychosocial treatment.
Prognosis of Bronchiectasis in Children--A Multicenter Prospective Cohort Study

This prospective cohort study is designed to observe of the effect of intervention therapy on the long-term prognosis of children with bronchiectasis. The main purpose of the study was to evaluate the degree of deterioration of lung function, to observe and compare the quality of life, the time of pulmonary exacerbation, and the changes of lung image.

All enrolled patients are followed up for half a year, 1 years, 2 years, 3 years, 4 years, 5 years, while observation of pulmonary function, symptoms, signs, quality of life, the times of acute pulmonary exacerbation, and the changes of lung image are performed.

Eligibility Criteria:
Inclusion Criteria:A included patient must be coincident at least one point of the four items of high-resolution computed tomography (HRCT) manifestations.

* Internal bronchial diameter greater than the accompanying pulmonary artery.
* lack of bronchial tapering
* bronchi visible in the peripheral 1cm of lung
* bronchial diameter greater than adjacent segmental bronchi

Exclusion Criteria:Subject will be excluded if she or he has one of the following

* It is unable or doesn't agree to accept the follow-up process
* undergoing trial for other medications or instruments.
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions.

InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments:

A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND).

After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either:

P. prophylactic PLND Q. no prophylactic PLND


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Measurable disease as determined by RECIST (version 1.1) criteria;
3. Histologically-proven squamous cell carcinoma of the penis,
4. Stage:

   * any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0 or;
   * any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 or;
   * any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0
5. Performance Status ECOG 0, 1 or 2.

Exclusion Criteria:

1. Pure verrucous carcinoma of the penis,
2. Nonsquamous malignancy of the penis,
3. Squamous carcinoma of the urethra,
4. Stage M1,
5. Previous chemotherapy or chemoradiotherapy,
6. Concurrent malignancy (other than SCC or Basal Cell Carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 years.
Safety, Tolerability,Pharmacokinetics(PK)and Pharmacodynamics(PD)Assessment of LCQ908 in Patients With Severe Hypertriglyceridemia

This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
* Non breast feeding women.
* Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.

Exclusion Criteria:

Patients with:

* uncontrolled type 1 or type 2 diabetes mellitus,
* active pancreatitis (the month prior to study start),
* history of drug or alcohol abuse within the 12 months prior to dosing,
* or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply
Intraoperative Non-invasive Eye Movement Monitoring

For procedures involving proximity to the nerves responsible for eye movement, the need to monitor eye movement exists. The current solution is to place needles in the muscles surrounding the eye. The Investigators have invented a non-invasive electrode and software designed to monitor eye movements non-invasively. The electrode is placed on the skin on the corner of the eye and using the natural dipole of the eye, detects the horizontal and vertical movements of the eye. The Investigators would like to prove efficacy compared to the standard monitoring.


Eligibility Criteria:
Inclusion Criteria:

- Subject will be undergoing surgery involved of the nerves controlling the eye

Exclusion Criteria:

- None
Topical 0.4% Ketorolac and Vitreoretinal Surgery

To determine whether use of topical 0.4% ketorolac has any effect on pupil size during vitreoretinal surgery.

Other outcomes will be to assess postoperative pain and inflammation and visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18, routine elective vitrectomy

Exclusion Criteria:

* history of trauma, uveitis, prior intraocular surgery within 3 months, requirement of mechanical pupil dilation, prior inclusion of other eye
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes

The primary objective of this study is to show that a prandial insulin regimen, consisting of premeal insulin lispro "mid mixture" (or a combined regimen of insulin lispro "mid mixture" and insulin lispro "low mixture") plus metformin will result in significantly better overall glycemic control (lower HbA1c) at endpoint than once-daily insulin glargine plus metformin. Insulin lispro "mid mixture" consists of 50% insulin lispro and 50% NPL. Insulin lispro "low mixture" consists of 25% insulin lispro and 75% NPL.

In a substudy of approximately 60 patients, additional data will be collected on markers associated with risk of atherosclerosis or cardiovascular disease in the context of a controlled, outpatient, high-fat test meal.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes (World Health Organization \[WHO\] classification
* Have used one or more of the following oral anti-hyperglycemic medications-metformin or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide, gliclazide, glimepiride) alone or in combination with one or two insulin injections per day for at least 3 months immediately prior to entering the study. Patients using more than 2 insulin injections per day or subcutaneous insulin infusion prior to the study will not be eligible to participate.
* Have a hemoglobin A1c between 6.5% and 11%, inclusive, according to the central laboratory at Visit 1.
* Have clinically acceptable LDL-C, in the investigator's opinion, at Visit 1.
* As determined by the investigator, are capable and willing to learn how to use the insulin injection pens; comply with their prescribed diet, exercise, and medication regimen; perform self-monitoring of blood glucose; and use the patient diary as required for this protocol.

Exclusion Criteria:

* Have hypersensitivity to metformin or a known allergy to metformin hydrochloride, insulin lispro MM, insulin lispro LM, or insulin glargine, or excipients contained in these products.
* Have known metabolic or lactic acidosis.
* Have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 micromol/L (1.5 mg/dL) for males and greater than or equal to 110 micromol/L (1.2 mg/dL) for females.
* Have cardiac disease with functional status that is Class III or IV
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (ALT) greater than three times the upper limit of the reference range as defined by the central laboratory.
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question\[s\] it aims to answer are:

* How safe is ISA104?
* Does ISA104 induce immunity against hepatitis B virus?

Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs.

Researchers will compare the ISA104 vaccine to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* cHBV
* Active treatment with NUCs and HBV DNA \< limit of quantification

Exclusion Criteria:

* Immune-compromised
* Evidence of liver cirrhosis
Personalized Nutrition to Improve Recovery in Trauma

The purpose of this study is to determine if a particular method of providing nutrition improves the outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery following trauma and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method being tested is a structured nutrition delivery plan, called the SeND Home pathway, that involves TPN, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. Participants will be randomly assigned (like the flip of a coin) to the SeND Home program or standard of care nutrition. In the SeND Home program, participants will receive TPN, followed by oral nutrition supplements (shakes) for 4 weeks after discharge. The control group will follow standard of care nutrition delivery that begins during ICU stay and concludes at hospital discharge. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass and complete walking and strength tests, and surveys about quality of life.

Severe abdominal trauma can impact patients in a variety of ways. Current data shows that trauma patients can experience problems with physical function, muscle weakness, and poor quality of life after they are released from the hospital. There is a critical need to improve nutrition in trauma patients with severe abdominal injuries to optimize the recovery process. The purpose of this study is to evaluate if the use of a planned nutrition delivery plan with early intravenous (IV) nutrition will improve outcomes. Participants will be randomly assigned 1:1, like flipping a coin, to the SeND Home program or routine care.

Participants in the standard of care program will receive standard nutrition delivery as determined by clinical care providers. This may include TPN.

Participants in the SeND Home program will receive TPN within 72 hours of abdominal surgery. Indirect calorimetry will be used to determine nutrition needs.Once participants are able to have a liquid diet they will receive nutrition shakes up to 3 times a day while in the hospital and for 4 weeks after discharge.

Participants will undergo tests to measure muscle mass, have blood draws, complete walking and strength tests, and surveys about quality of life. These tests will be done at several times throughout hospitalization and participants will be asked to return for a 3 month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* Penetrating abdominal trauma requiring emergent major abdominal surgery
* Admitted to the surgical ICU
* Not expected to receive oral nutrition for 72 hours or more

Exclusion Criteria:

* Patients who are unable to ambulate at baseline
* Expected withdrawal of life-sustaining treatment within 48 hours
* Prisoners
* Positive pregnancy test for women of child bearing potential.
Bupivacaine Versus Lidocaine Infiltration for Postoperative Pain in Thyroid Surgery

The purpose of this study is to compare the efficacy of Bupivicaine and Lidocaine for postoperative pain control in thyroid surgery.

Patients planned for total thyroidectomy will be recruited for participation. After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. Patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with Bupivacaine (0.5% with 1:200 000 epinephrine) or Lidocaine (2% with 1:100 000 epinephrine).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of thyroid disease (malignant tumors T1-T3/NX-N1a, benign tumors)
* Planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection)
* Will be admitted for at least 12h postoperatively

Exclusion Criteria:

* Thyroid cancer staged as T4 (invasion, anaplastic) or requiring sternotomy
* Thyroid cancer staged as N1b (cervical, retropharyngeal, superior mediastinal nodal involvement)
* Previous ipsilateral thyroid surgery to operation side
* Previous total thyroidectomy or completion thyroidectomy
* History of neck radiation therapy
* Neck dissection beyond central neck (levels 1-5)
* Goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy
* Surgery requiring extension of incision beyond 8 cm
* History of diabetes mellitus
* History of renal or liver disease
* History of narcotic abuse
* History of chronic pain medications use in past 6 months for any condition
* History of coagulation defect
* Allergy to Bupivacaine or Lidocaine
Evaluation of the Effects of Bicarbonate-calcium Water in Premenopausal and Postmenopausal Women as a Prevention of Osteoporosis

The goal of this clinical trial is to evaluate the effect of bicarbonate-calcium water for the prevention of osteoporosis. Participants are women in pre- or post- menopausal state. The intervention group must drink bicarbonate-calcium water while the control group low mineral water


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women aged ≥40 years
* Menopausal women, period of early menopause 1-10 years

Exclusion Criteria:

* Inclusion in other study protocols
* estrogen-replacement hormone therapy
* osteoporosis therapy
* corticosteroid therapy
* insulin therapy.
* calcium supplementation
* kidney diseases of medium-severe level
* liver diseases of medium-severe level
* severe osteoporosis