cyrilzakka/clinical-trials huggingface dataset:
Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.

Eligibility Criteria:
Inclusion Criteria:

* subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
* Adult age (25 plus) male or female
* Stable medical health
* Ability to participate in the study for at least 3-4 years
* Able to understand and respond to surveys used in the study
* Adequate amount of bone in the mandible to receive 3 implants.

Exclusion Criteria:

history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)

* surgical limitations:
* uncontrolled systemic disease: diabetes, etc.. that may compromised healing
* irradiated surgical site
* inadequate bone height and width (re: implant size)
* inability to undergo minor oral surgery because of health or personal reasons
* psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions)
* Severe TMDs related to joint pathology
Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi

Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.

This is a prospective, observational study to evaluate the utility of removing Dysplastic Nevi (DN) with a defined 2 mm margin. This is a non-interventional study that will observe the pathology results following a standard of care biopsy. Principal Investigator (PI) hypothesize that the majority of lesions removed with this technique will have margins free of nevus cells on examination of histopathological sections. Hence, pathologists will not suggest that an additional excision be performed to remove any residual nevus. PI also hypothesize that if biopsy sites are followed over time, the rate of nevus recurrence will be low, because investigators would have removed the majority, if not all of the lesion at the time of initial biopsy.

Eligibility Criteria:
Inclusion Criteria:

* All patents seen in the practices of the study physicians are eligible to participate in the study.
* Patients must be over 18 years of age.
* Patients who are able to provide informed consent.
* Patient must have a lesion in which the differential diagnosis includes a DN and for which the study dermatologist deems it is appropriate to perform a saucerization biopsy.

Exclusion Criteria:

* Patients who are less than 18 years of age.
* Patients who are unable to provide informed consent.
* Lesions for which a saucerization biopsy is impractical in the judgment of the study dermatologist based on certain clinical factors (e.g. patient on anticoagulation therapy, lesion size and/or anatomic location).
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* History of intolerance or an unsatisfactory response to oral iron
* Screening Visit central laboratory Hgb ≤11 g/dL
* Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM or iron dextran
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery during the 30 day period prior to screening or during the study period
* AST or ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Women who are breastfeeding
* Pregnant or sexually-active females who are not willing to use an effective form of birth control
Omphalitis Community Based Algorithm Validation Study

The objective of this study is to develop and test a simple community-based diagnostic algorithm for omphalitis in sub-Saharan Africa. To date, there has been no validated community-based algorithms developed and tested in the sub-Saharan context where the manifestations of omphalitis presentation may vary and diagnosis could be potentially more challenging in infants with darker skin color. Given the current attention to cord care at the global and national policy level, validated community-based algorithms will be needed to allow primary health workers to identify cord infections and reduce associated morbidity.

After obtaining guardian informed consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits will undergo two independent, parallel evaluations; first, by a community level worker and second, by a Zambian medical doctor (gold standard). A third independent assessment of a photo of the cord will be performed remotely by a board-certified pediatrician. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.


Eligibility Criteria:
Inclusion Criteria:

* Neonate between day 1-10 of life presenting to Livingstone and Mazabuka district hospitals and community health centers in Southern Province, Zambia
* No prior diagnosis of omphalitis
* Guardian willing to allow their newborn to participate in the study
* Guardian aged 15 and above
Sensor Optimization of Cardiac Resynchronization Therapy Response

The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.
* Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)
* Subject (or subject's legally authorized representative) must be willing to give informed consent
* Subjects must be at least 18 years of age

Exclusion Criteria:

* Subject has congenital heart disease
* Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure
* Subject has unstable coronary artery disease
* Subject cannot undergo transvenous catheterization
* Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease
* Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control
* Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus
* Subject is pregnant
* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager
The Effect of an Escape Room Simulation on Post-mortem Care Training

Simulated escape room games create an active learning environment to increase students' motivation and participation and encourage learning while developing skills. Therefore, this study examines the effectiveness of simulated escape room games in nursing students' post-mortem care education.

To meet the emotional and physical needs of the individual living in the last days of life, the nurse must have the necessary knowledge, skills, and understanding. For this reason, post-mortem care has an important place in the nursing education curriculum. To increase student motivation and include them in the learning process in clinical skills laboratory environments, game strategies have been frequently used in education in recent years. The "escape room" game has emerged as a new pedagogical method to provide interactive teaching. The use of interactive teaching and games in health education has a positive effect on the learning process.

Eligibility Criteria:
Inclusion Criteria:

* Being 4th grade nursing student

Exclusion Criteria:

* Not willing to participate the study
HER2-positive Breast Cancer Registry

The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-IV HER2-positive breast cancer

Exclusion Criteria:

* None
Interleukin-2, Vinblastine, and GM-CSF in Treating Patients With Metastatic Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy with interleukin-2 and GM-CSF may be a more effective treatment for kidney cancer.

PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2, vinblastine, and GM-CSF in treating patients with metastatic kidney cancer.

OBJECTIVES: I. Determine the effect of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) in combination with interleukin-2 and vinblastine on the response rate of patients with metastatic renal cell carcinoma. II. Assess the potential toxicities of this treatment combination in these patients.

OUTLINE: This is a single arm, nonrandomized study. Patients receive vinblastine as an IV bolus once every 2 weeks. Interleukin-2 is administered by subcutaneous injection on days 1-5 each week for 9 weeks. Sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) is administered by subcutaneous injection on days 1-5 each week for 9 weeks. Each 9 week cycle is followed by 3 weeks of rest. Patient may continue treatment for a maximum of 5 cycles in the absence of disease progression. Patients are assessed every 12 weeks for the duration of treatment.

PROJECTED ACCRUAL: 20-35 patients will be accrued into this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven inoperable, metastatic, or recurrent renal cell carcinoma Measurable or evaluable disease No brain metastases

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: At least 3 months Hematopoietic: Neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Liver enzymes less than 3 (5 if known liver metastases) times institutional normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Adequate cardiac function No unstable angina No significant coronary artery disease No heart failure with New York Heart Association classification III or IV Pulmonary: No evidence of pulmonary disease (documented normal DLCO and PFT) Other: No prior malignancy except: Nonmelanoma skin cancer Carcinoma in situ of any kind No pregnant or lactating Fertile patients must use adequate contraception Normal thyroid functions as evidenced by normal T4 and TSH

PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic therapy At least 4 weeks since prior biologic therapy Chemotherapy: No more than 1 prior chemotherapy At least 4 weeks since prior chemotherapy Endocrine therapy: No more than 1 prior hormonal therapy At least 4 weeks since prior hormonal therapy Radiotherapy: At least 4 weeks since prior radiation therapy No prior radiation therapy if entire tumor was within radiation field Surgery: Not specified
Low Birth Weight Follow-up

The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.


Eligibility Criteria:
Inclusion Criteria:

* Participation during the low birth weight BCG trial between 2008 and 2013.

Exclusion Criteria:

* Not living in the Bandim Health Project's study area.
Interchangeability of Arterial Coagulation and Venous Coagulation, in the Context of Cardiac Surgeries Under Cardiopulmonary Bypass, Using the DMDiv Hemochron Signature Elite

Adequate coagulation measured using activated clotting (ACT) is important during vascular and cardiac surgeries. Unfractionated heparin is the most common anticoagulant used. For point of care testing, under supervision of biology department, the investigators use Hemochron Signature Elite®(HSE) (Werfen®-Barcelona Spain) to determine coagulation during cardiac surgery under Cardiopulmonary Bypass (CPB), with arterial or venous blood. The dosage of heparin varies according to this result, throughout the CPB. On the Connect Manager® software (Livanova®, Italy) which records all the data of a CPB, it is mandatory to inform, during an ACT, the sampling site in arterial or venous. The chemical compositions of arterial blood and venous blood are different (O2, Co2...) Even if the qualities of coagulation in vivo are identical, what happens when they are chemically analyzed using the medical device HSE ? Can we trust the results of this device to secure anticoagulation under CPB? Are the results affected by the sampling site? The objective of this study is to compare the reliability of hemostasis control , during cardiac surgery under cardiopulmonary bypass, for both venous and arterial blood. Effective and controllable anticoagulation is mandatory during cardiac surgeries under extracorporeal circulation. The monitoring of the effectiveness of heparin is carried out, in our center, using the Hemochron Signature Elite® (HSE) medical device, which measures the ACT (Activated Clotting Time). There is no comparative study between hemostasis of venous blood, versus arterial blood, with this point of care device.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over,
* undergoing conventional heart surgery under normothermic Cardiopulmonary Bypass (nadir 34°) (Aortic valve replacement, coronary artery bypass graft surgery, valve plasty, atrial septal defect, ventricular septal defect, intracardiac tumours, heart surgery, ascending aorta, combined surgery...)
* They must be affiliated with Social Security in France, and have given their written consent.

Exclusion Criteria:

* Minor Patients,
* Emergency Cardiac Surgeries, Extracorporeal circulation in hypothermia, Cardiac surgery without CEC
* Patients already included in a research protocol,
* Patient under guardianship or curators or deprived of public law,
* Patient with proven Heparin Induced Thrombopenia (HIT) not receiving heparin
* Pregnant woman, breastfeeding or parturient
Erectile Rating During the Treatment of Rectal Cancers Localized

Erectile dysfunction will be explored by recording R / P and self-administered questionnaire IIEF-5.

Erectile dysfunction will be explored by recording R / P and self-administered questionnaire IIEF-5. This dual evaluation will be made before the beginning of the therapeutic treatment and 3 months and 12 months after surgery. Assessed by IIEF-5 will be made only 6, 18 and 24 months after surgery. There will be no changes made to support oncology patients.

Eligibility Criteria:
Inclusion Criteria:

1. Male patient.
2. Age greater than 18 years.
3. Neoplastic rectal stage ≤ T3.
4. Patient sexually active before diagnosis.
5. Laparoscopic surgery.
6. Medico-surgical institute Bergonié.
7. Patient information and consent for participation in the study.

Exclusion Criteria:

1. Patients already treated for erectile dysfunction.
2. Absence of sexual activity before diagnosis.
3. Presence of secondary lesions at diagnosis (M +).
4. Classified T4 tumor preoperatively.
5. Surgery by laparotomy.
6. History of pelvic cancer surgery prostate or bladder.
7. History of pelvic radiotherapy (outside of the current process).
8. History of prostate or bladder neoplasia known.
9. Other neoplastic known.
10. Patient for psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patient deprived of liberty or under guardianship.
Nerve Block of the Proximal Interphalangeal Joints PIPs in Rheumatoid Arthritis (RA) Patients: a Prospective Pilot Study

Researchers will include 83 rheumatoid arthritis patients (either early or established) diagnosed after 2010 ACR/EULAR criteria with bilateral hand arthritis aged 18 or above. Nerve block to the neural bundle of the 2nd and 3rd PIPs will be done to one hand (the dominant in half of the participants and the non-dominant in the remaining). The other hand will be used as a control and injected subcutaneously with saline. Half ml of Bupivacaine will be injected through a 27G needle at the level of the volar proximal digital crease of the 2nd and 3rd PIP. The needle will be directed alternatively toward the two pedicles on both sides.

PIPs of the 2nd and 3rd fingers in both hands will be examined EULAR-OMERACT scoring system at 0, 2 weeks, and 2 months intervals. Visual analog scale (VAS) for each hand will be used at the same intervals. There are no certain conditions for medications and all the patients were using sDMARDS.

PIPs of the 2nd and 3rd fingers at the control group will be injected with .5 mL of saline on each joint through a 27G needle.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis patient according to ACR/EULAR criteria
* age \>18
* bilateral hand affection

Exclusion Criteria:

* peripheral neuropathy
* other chronic arthritis
* patient who did mastectomy or any other hand operation
Effectiveness of Internet Delivered Cognitive Behavior Therapy (CBT) for Irritable Bowel Syndrome (IBS)

The study will recruit 80 out-patients diagnosed with Irritable Bowel Syndrome from a gastroenterological clinic. The recruitment will be consecutive with all patients receiving the diagnosis being offered to participate. After recruitment and 3 week baseline measure of IBS symptoms they will be randomised to either 10 weeks of internet delivered CBT or waiting list. After treatment IBS-symptoms are measured again to assess treatment effectiveness. All patients on waiting list are offered the same treatment as patients randomised to treatment.

All patients are assessed 12 months after completion of treatment.

Patients in treatment condition are hypothesized to experience significant reduction IBS symptoms and quality of life compared to patients on waiting list.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Irritable Bowel Syndrome according to Rome III criteria

Exclusion Criteria:

* History of inflammatory bowel disease (IBD)
* Symptom debut after age of 50
* Ongoing severe mental illness (psychosis, severe depression, suicidal ideation, bipolar disease)
* Inability to participate in internet delivered treatment
The Effect of Transcranial Direct Current Stimulation of the Primary Motor and Somatosensory Cortex on Pain Thresholds.

The purpose of this study is to investigate the modulatory effect of a novel tDCS configuration on the pain sensitivity in healthy subjects.

The purpose of this study is to investigate the modulatory effect of a single session 20 min anodal primary motor cortex (M1) and cathodal primary somatosensory cortex (S1) transcranial direct current stimulation (tDCS) on the pain sensitivity on the descending part of musculus trapezius in healthy young adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age between 18-30 years
* Living in Denmark

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Current use of opioids, antipsychotics, benzodiazepines
* Previous or current neurological, musculoskeletal, rheumatic, malignant, inflammatory or mental illnesses
* Current or prior chronic pain conditions
* Lack of ability to cooperate
Pharmacokinetics of Dactinomycin in Young Patients With Cancer

RATIONALE: Studying samples of blood in the laboratory from patients with cancer receiving dactinomycin may help doctors learn how dactinomycin works in the body and how patients will respond to treatment.

PURPOSE: This laboratory study is evaluating the pharmacokinetics of dactinomycin in young patients with cancer.

OBJECTIVES:

* Determine the pharmacokinetics (PKs) of dactinomycin in pediatric patients with cancer.
* Determine the degree of interpatient variation in the PKs of this drug.
* Determine the influence of characteristics such as age, tumor type, and concurrent therapy on drug PKs in these patients.
* Correlate drug PKs with clinical response and toxicity observed in these patients, focusing particularly on the incidence of severe liver toxicity or veno-occlusive disease.
* Correlate pharmacogenetic variability with clinical and PK data.

OUTLINE: This is a multicenter study.

Patients undergo blood collection for pharmacokinetic sampling of dactinomycin at baseline (prior to the initiation of dactinomycin) and periodically during course 1 of chemotherapy. An additional blood sample is obtained before or after treatment for the collection of peripheral blood lymphocytes. DNA from these cells is isolated and investigated for genetic variation in genes relevant to the pharmacology of dactinomycin. Plasma concentrations of dactinomycin are determined by liquid chromatography mass spectrometry analysis.

Patients are followed for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Currently being treated with dactinomycin on a clinical trial at a United Kingdom Children's Cancer Study Group center

PATIENT CHARACTERISTICS:

* Single- or double-lumen central venous catheter or portacath in place

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics