cyrilzakka/clinical-trials huggingface dataset:
Transcranial Direct Current Stimulation (tDCS) on Working Memory in College Going Students

Working memory deficiencies, might make it difficult for students to recall instructions, complete complex activities, and grasp and follow directions solving a math problem or writing a sentence. The functions of working memory are critical for effective human activity. Transcranial direct current stimulation (tDCS) has grown in popularity and academic interest in recent years as a way to improve cognitive abilities. so there is need to determine the effect of tdcs on working memory in college going students.


Eligibility Criteria:
Inclusion Criteria:

1. College going students
2. Both male and female
3. Able to follow verbal commands

Exclusion Criteria:

1. Chronic skin problems.
2. Seizure and any neurological disorder
3. Any recent trauma or surgery
4. Any cardiovascular or pulmonary disease
5. Psychosomatic disorders
Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus

To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* volunteer to participate and be able to sign informed consent prior to the trial.
* patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
* No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
* Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

* Patients with insulin allergy.
* Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
* Drug abuse and alcohol dependence in the past 5 years.
* Systemic hormone therapy was used in the last three months.
* Patients with poor compliance and irregular diet and exercise.
* Patients with pregnancy, lactation or pregnancy intention.
* Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy

This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is female
* Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS
* Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \& reconstruction)
* Patient utilized a textured expander only
* Patient utilized a smooth gel permanent implant only
* Patient has agreed and is able to comply with the study follow-up requirements
* Patient or guardian has provided consent for participation

Exclusion Criteria:

* Patient is undergoing single-stage breast reconstruction
* Patient is undergoing a delayed reconstruction
* Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.
* Patient is undergoing planned reconstruction using autologous tissue
* Patient has a known hypersensitivity to collagen or bovine derived materials
* Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study
* Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)
Comparison of Joint Mobility Levels and Performance in Young Male Basketball Players and Sedentary Peers

The aim of our study was to determine the joint mobility levels and its effects on performance in male basketball players and their sedentary peers aged 16-22 years.

According to the studies on the effect of hypermobility on the performance; The young athletes who played tennis had lower equilibrium results than those without hypermobility. Although there is not any study that investigate its effects in basketball, there are studies for tennis and volleyball in literature.


Eligibility Criteria:
Inclusion Criteria:

For Players:

* Being a healthy male between the ages of 16-22,
* Playing basketball for at least 1 year,
* Body Mass Index \<30,
* Volunteer to participate in research.

For Sedentary Peers:

* Being a healthy male between the ages of 16-22,
* International Physical Activity Questionnaire Short Form score \<600 MET-min/week,
* Body Mass Index \<30,
* Volunteer to participate in research.

Exclusion Criteria:

* To have a musculoskeletal problem which prevents the person from exercising,
* Having a cardiovascular system disorder that limits exercise capacity
* Neurological disorder or cognitive dysfunction
* Smoking
Nurse Perspectives Regarding Use of the Labor Mirror

The objective of the study is to examine the views of Labor \& Delivery nurses regarding use of the labor mirror during the active phase of the second stage of labor.

A survey link will be sent to Labor \& delivery nurses via hospital group email. The nurses will be asked to share their experiences regarding the following: if use of the labor mirror helps patients push more effectively, how often patients accept the labor mirror, why they feel patients may decline use of the labor mirror, how often they offer the labor mirror to eligible patients, and a range of how long they have been a labor \& delivery nurse at this facility. The survey is voluntary and the results are anonymous.

Eligibility Criteria:
Inclusion Criteria:

* Labor \& Delivery Nurses at Mount Carmel East Hospital

Exclusion Criteria:

* All others
A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Patients With Unstable Angina Not Responding to Standard Medical Therapy Who Are Eligible for Coronary Angioplasty

The purpose of this study is to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, versus placebo in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty.

This is a randomized, placebo-controlled study to evaluate the safety and efficacy of abciximab, an anti-platelet therapy, in patients with unstable angina who are not responding to standard medical therapy and who are eligible for coronary angioplasty. The primary outcomes of the study include any of the following within 30 days: the number of deaths from any cause, myocardial infarctions or the number of recurrent ischemic events requiring urgent intervention (such as a coronary artery bypass surgery, repeat coronary angioplasty, coronary stent placement, or intra-aortic balloon pump). Please see attached results.

Patients will be treated with abciximab or matching placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory angina as evidenced by at least one episode of ischemia (chest pain and/or ST-T changes) despite bed rest and at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin, or persistent newly developed negative T-waves occurring or continuing after at least 2 hours of treatment with oral or intravenous nitrates and intravenous heparin
* Having clinical signs and symptoms of angina at rest or minimal exertion with dynamic ST-segment and/or T-wave changes
* Having an episode of chest pain within 48 hours prior to the start of study agent administration
* Having a culprit lesion in a single native coronary vessel suitable for angioplasty on the qualifying angiogram

Exclusion Criteria:

* Patients who have had a recent myocardial infarction, unless CK has returned to less than twice the upper limit of normal
* Having features of ongoing ischemia that would require immediate intervention, or had a percutaneous transluminal coronary angioplasty (PTCA) within the past 24 hours
* Having an unprotected occlusion of the main left coronary artery \> 50%, a culprit lesion located in a venous or arterial bypass graft, or recent bleeding or a condition associated with increased bleeding risk
* Receiving concurrent administration of oral anticoagulants at the time of study entry, administration of intravenous dextran (prior to or planned for use during angioplasty), or planned administration of thrombolytic agent prior to or during angioplasty
* Having persistent hypertension at admission despite treatment, or a platelet count less than 100,000 per millimeter cubed
" Comparative Evaluation of Aggressive Gap Arthroplasty With Minimal Gap Arthroplasty in the Management of TMJ Ankylosis "

the most commonly used protocol in the management of TMJ ankylosis is Kabans protocol in which 1.5 to 2 cm aggressive resection of bone is recommended which may lead to gap between cranial base and condyle of mandible.1 However, there are certain disadvantages associated with aggressive gap arthroplasty such as pseudo articulation with shortening of the mandibular ramus, premature occlusion on the affected side with a contralateral open bite in unilateral cases,2 in bilateral cases gagging of the posterior teeth and anterior open bite.3 Few studies in the literature available agreed that minimum gap arthroplasty i.e. 5 to 8 mm of gap is sufficient for TMJ movements in all planes and recurrence of ankylosis is likely to be prevented by interposed material (graft)4 .So, a randomized control study to compare outcomes of minimal gap arthroplasty with aggressive gap arthroplasty for management of TMJ ankylosis is planned.

A standardize protocol for each patient will be followed that comprises of case selection, clinincal evaluation, radiographic assessment,treatment planning and measurement of varius parameters.

* Medical and Dental history of the patient will be obtained.
* A written consent form signed by the patient, will be obtained.
* Case evaluation will be done which will include clinical and radiographic evaluation Based on the case evaluation, surgical treatment of ankylosis will be performed . patient will be randomized into the following two groups. Group A -minimal gap arthroplasty for management of Tmj ankylosis Group B -aggressive gap arthroplasty for management of TMJ ankylosis A minimum of 6 subjects per group completing the study would be giving a good external validity to the present study.

  1. All the patients were evaluated with history, clinical and radiological examinations (panoramic and CT scans). Informed consent will be obtaine from all the patients.
  2. In both groups, all the patients will be operated by an experienced surgeon.The data acquisition will be done by a resident who will be kept blind for group allocation.

  3. In group 1 cases treatment of TMJ ankylosis will be done by minimal gap arthroplasty and in group 2 cases treatment of TMJ ankylosis will be done by aggressive gap arthroplasty 4. both groups cases will be evaluated preoperatively ,intraoperatively and postoperatively Follow-up visits will be at 1, 3, and 6 months 5. preoperative and postoperative evaluation will be done clinically ( mouth opening ,protrusive movement, laterotrusive movement ) , radiologically (OPG, CTscan) .

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy adult(ASA Classification I-II)
* Any age group
* Sawhneys classification type IV
* Unilateral ankylosis
* Written informed consent

Exclusion Criteria:

* Any syndromic patient
* Recurrence cases
* Sawhneys classification type I,II,III
Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Advanced biopsy-proven metastatic non-small cell lung cancer
* Somatic activating mutation in EGFR in a tumor biopsy
* No prior EGFR inhibitor treatment (gefitinib, afatinib, erlotinib, dacomitinib, osimertinib) however, prior treatment with other chemotherapies are allowed
* Archival tissue available from a pre-treatment tumor biopsy or willing to undergo a tumor biopsy prior to study initiation.
* Measurable (RECIST 1.1) indicator lesion not previously irradiated
* Karnofsky performance status (KPS) ≥ 70%
* Age \>18 years old
* Ability to swallow oral medication
* Agree to use effective methods of contraception from the time of screening until 3 months after treatment discontinuation (for males and females of child-bearing potential)
* Adequate organ function

  * AST, ALT ≤ 3 x ULN
  * Total bilirubin ≤1.5x ULN
  * Creatinine ≤ 1.5x ULN OR calculated creatinine clearance ≥ 60ml/min
  * Absolute neutrophil count (ANC) ≥ 1000 cells/mm\^3
  * Hemoglobin≥9.0 g/dL
  * Platelets ≥100,000/mm\^3

Exclusion Criteria:

* Pregnant or lactating women
* Any radiotherapy within 1 week of starting treatment on protocol.
* Any major surgery within 1 weeks of starting treatment on protocol.
* Any evidence of active clinically significant interstitial lung disease
* A mean QTc \>470ms (Fridericia"s correction), clinically important arrhythmia, conduction or morphology of resting ECG (eg complete LBBB, 1st -3rd degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmia)
* Cardiovascular disease or cerebrovascular disease, CVA or MI \< 6 months prior to study enrollment, unstable angina, NYHA \>Grade II CHF, or serious cardiac arrhythmia uncontrolled by medication or with the potential to interfere with protocol treatment
* History of pneumonitis or interstitial lung disease (ILD), drug induced ILD, radiation pneumonitits that required steroid treatment, and any evidence of clinically active ILD
* Serious chronic GI conditions associated with diarrhea
* Symptomatic, unstable brain metastases requiring escalating doses of steroids
* Continue to have unresolved \> CTCAE grade 1 toxicity from any previous treatment
Evaluating Materials to Educate Patients About Cervical Dysplasia

Primary Objective:

To pilot test high and low literacy patient education materials for colposcopy clinic patients, assessing impact on patient knowledge and patient feedback about the materials.

Women with an abnormal Papanicolaou (Pap) smear are typically referred for a colposcopy and biopsy. However, data collected by research groups and others shows that women with abnormal Pap smear results have limited understanding of the meaning of the results, the causes of cervical dysplasia, and the procedures used to evaluate and treat it. This situation is further complicated by the fact that many patients, particularly those with less education, have low health literacy in general. This means that much of the existing patient education materials will likely be inappropriate or ineffective for this group. One approach is to develop materials at low literacy levels; however, it is not known whether such materials will be provide sufficient information and be effective for patients with high health literacy.

The long term goal is to study the importance of tailoring patient education materials to colposcopy patients' level of health literacy. To this end, researchers have developed two educational brochures with approximately the same information, but which vary in their health literacy (readability) level. As a first step in this research, researchers propose to present these materials to colposcopy patients returning for colposcopy visits to assess changes in knowledge and obtain patient feedback on the brochures.

The proposed pilot study represents the first step at evaluating the patient education materials and determining the patient's level of understanding of what they receive.

Eligibility Criteria:
Inclusion Criteria:

1. Over 18 years old;
2. Follow up colposcopy clinic patients who completed a colposcopy and treatment (if indicated) at an earlier date;
3. Able to communicate in English

Exclusion Criteria: None
Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult Italian Population.

Diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease.

Self-monitoring of blood glucose (SMBG) in type 1 diabetes (T1D) is mandatory to implement safe and effective adjustments in insulin therapy in order to reduce glucose levels and prevent hypoglycemic episodes. It is known that a higher rate of glucose testing (up to 8 times/day) is associated with improved glucose control, however, long-term repeated daily glucose tests are painful, inconvenient and difficult to pursue.

Continuous glucose monitoring (CGM) is an alternative to SMBG, but the use of conventional CGM has been limited by the need of repeated calibration using capillary glucose testing, relatively short sensor lifespan and high costs. The recently introduced CGM FreeStyle Libre™ (Abbott Diabetes Care, Witney, UK) flash glucose monitoring (FGM), a new generation of glucose testing device, has the advantage to be user friendly by just scanning the reader over the sensor.

The FGM system does not require calibration, has a long sensor lifetime of 14 days and it's relatively affordable, explaining the widespread use of the device.

The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" as it is not equipped with alarms capable of alerting the patient to cut-off value for the hypo- or hyperglycemia, but allows the glycemic trend to be viewed at request.

Patients will be identified and enrolled in the Diabetes Departments of different hospitals/clinics in the Emilia Romagna region, Italy. Patients will be divided in two groups A (naive patients,) and B (patients already using the device at enrollment) and followed for 12 months.

Study design is observational prospective and includes 3-months follow up visits until the 12-month final evaluation.

At each visit, patient clinical data, adherence and side effects will be recorded and data download from the device will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diabetes Mellitus type 1 for at least 12 months
* Multi-injection insulin therapy
* C-peptide \<0.2 nmol/L
* At least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement).

Exclusion Criteria:

* Diabetes Mellitus type 2
* Other types of diabetes
* Other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system.
Cohort Study on A Following-up System of Native Arteriovenous Fistulae

A cohort including more than 100 maintenance hemodialysis patients will be followed up according to a certain Following-up System of Native Arteriovenous Fistulae (AVF) prospectively. The assessment results of the Following-up System of AVF help the physicians make decisions of AVF surgery and puncture methods. The results of this study would identify the effect of the system on survival of AVF. Other 100 hemodialysis patients from other centers will be treated by routine protocol and compared to the experiment goup.

The Following-up System of AVF includes 3 stages. In the 1st stage, before AVF surgery operation, the contents of Following-up System of AVF include history, physical exam, ultrasonography detection. The assesment results will guide the methods of the AVF surgery operation. In the 2nd stage, before AVF puncture firstly and 3 months after AVF operation, the contents of Following-up System of AVF include physical exam and ultrasonography detection. The results will help the nurses and doctors make a decision of the method of AVF puncture. In the 3rd stage, during the following 2 years after AVF puncture successfully, the contents include physical exam and ultrasonography detection regularly. The adequacy of hemodialysis by using AVF will be assessed by urea clearance index (Kt/V).

The data of patients in other hemodialysis centers will be recorded and compared to the patients in experiment group.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis patients using AVF;
* Ages 18-70 years old;
* Agreement with frequent following-up.

Exclusion Criteria:

* Younger than 18 years or elder than 70 years;
* Cachexia;
* Acute renal failure;
* Exceptive life time less than 6 months;
* Pregnant or planning pregnant;
* Waiting for renal transplantation or transferring to peritoneal dialysis.
Multi-Center Study on Performance of the Ponto Implant System Using Minimally Invasive Ponto Surgery (in Adult Patients)

This prospective, multi-center study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS).

This prospective, multi-centre study funded by Oticon Medical AB will be conducted at six clinical sites in North America. Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. The total number of participants included in the study will be 64. Patients who are withdrawn from the study prior to completion will not be replaced.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Implant system using the surgical technique Minimally Invasive Ponto Surgery (MIPS). The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patient indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines.
* Normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected.
* Skin thickness of 12mm or less at the implant site

Exclusion Criteria:

* Patients undergoing re-implantation
* Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus
* Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator.
* Any other known condition that the investigator determines could interfere with compliance or study assessments.