cyrilzakka/clinical-trials huggingface dataset:
Influence of Neck Design on Peri-implant Hard and Soft Tissues

The goal of this clinical trial is to test two different implant neck designs in 36 patients. The main question\[s\] it aims to answer are:

* do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at one year?
* do triangular neck designed implants placed immediately after dental extraction have the same influence on peri-implant hard and soft tissues than regular neck designed implants at three years?

Participants that present an unrepairable tooth on the anterior upper maxilla will be asked to take a CBCT scan in order to verify the presence of the buccal bone. Once this is verified the patients will enter in the study and the day of the surgery they will be assigned to either control or test group.

* Control group: C1 round-neck implant
* Test groups: V3 triangular-implant neck

Researchers will compare test and control groups to see if they have the same effects on hard and soft tissues at 4 months, 1 year and 3 years.

Immediate implant placement is considered to be a technique-sensitive protocol with a variety of potential risks. The interface area between the neck of the implant and the abutment is critical; it can affect the treatment outcome, particularly mar-ginal bone loss (MBL) and soft tissue behavior. Traditionally, the implant neck is circu-lar in shape; however, a new triangular neck design has recently been introduced on the market, though advanced indications of this innovative design are still lacking.

The objective of this randomized clinical trial was to compare the clinical and radiographic outcomes obtained after immediate placement of implants and temporization of two different neck geometries: a traditional round neck (RN) and an innovative neck with a triangular shape (TN).

Eligibility Criteria:
Inclusion Criteria:

* healthy non-smokers or light smokers (\< 10 cigarettes/day)
* adults (\> 18 years of age),
* need for single tooth extraction of a maxillary incisor, canine or premolar
* adequate oral hygiene
* ability to follow instructions and attend the required appointments
* presence of a length of at least 3 mm of buccal bone measuring ≥ 0.5 mm in thickness, apical to the extraction socket
* stable and intact socket walls

Exclusion Criteria:

* patients with acute infections in the area of interest
* individuals with large occlusal discrepancies and/or occlusal overload para-functions
* smokers of more than 10 cigarettes/day
* patients with any medical condition or medication contraindicating dental implant treatment
Biodistribution Study With 186 Re-labelled Humanised Monoclonal Antibody BIWA 4 in Patients With Non-small Cell Lung Cancer

The primary objectives of this study is to assess the safety and tolerability of intravenously (i.v.) administered 186 Rhenium-isotope (186Re)-labelled bivatuzumab and to investigate the biodistribution and pharmacokinetics of 186 Re-labelled bivatuzumab in patients with non-small cell lung cancer (NSCLC)


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histological or cytological confirmation of Non small cell lung cancer (NSCLC) stage I, II or IIIa according to the staging system of the American Joint Committee on Cancer (AJCC)
* Patients destined for resection of the tumour
* Patients over 18 years of age
* Patients younger than 80 years of age
* Patients who had given 'written informed consent'
* Patients with a life expectancy of at least 3 months
* Patients with a good performance status: Karnofsky \> 60

Exclusion Criteria:

* Life-threatening infection, allergic diathesis, organ failure (bilirubin \> 30µmol/l and/or creatinine \> 150 µmol/l) or evidence of a recent myocardial infarction on Electrocardiogram (ECG) or unstable angina pectoris
* Pre-menopausal women (last menstruation \<= 1 year prior to study start)

  * Not surgically sterile (hysterectomy, tubal ligation) and
  * Not practicing acceptable means of birth control, (or not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
* Women with a positive serum pregnancy test at baseline
* White blood cell count \< 3000/mm³, granulocyte count \< 1500/mm³ or platelet count \< 100000/mm³. Details of prior chemotherapy and radiotherapy had to be known.
* Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy
Safety and Effectiveness of tPA in Intra-abdominal Abscesses

To determine if instillation of tissue plasminogen activator into a percutaneously drained intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.

On day 0 Subjects will have Tissue Plasminogen Activator injected into a drainage tube and allowed to dwell in the intra-abdominal abscess for one hour before allowing it to drain by gravity. This will be repeated on day 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

* Intrabdominal abscess

Exclusion Criteria:

* Hypersensitivity to tPA
* Recent stroke
* Uncontrolled htn
* Recent major hemorrhage
* Pregnancy
High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy

The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy

Exclusion Criteria:

* Variceal esophageal bleeding
* Concurrent PPI use
* Moribund patients
The Relationship Between Upper Extremity Explosive Power and Trunk Muscles in Volleyball Players

Volleyball is an interval sport involving consecutive aerobic and anaerobic loads. Strength training based on explosive movements can improve performance in the upper extremities. Strength performance has an important place in this sport. Trunk stabilization is defined as 'proximal stability for distal mobility'. Disorder in any segment of the kinetic chain model will affect the quality of movement in the lower and upper segments.The aim of this study is to examine the relationship between the morphological features of the transversus abdominis, lumbal multifidus (L4-5), internal external oblique muscles, and the anaerobic power of the upper extremity and shoulder girdle functionThis study was designed as a cross-sectional. They will consist of 30 volleyball players between 14-30 years of age. Muscle morphological features of the participants by ultrasound; explosive strength will be evaluated by Medicine Ball Throw test, functional evaluation will be evaluated by Closed Kinetic Chain Upper Extremity Endurance test.


Eligibility Criteria:
Inclusion Criteria:

* Training for an hour at least 3 days a week for at least 1 year
* Body Mass Index (BMI) below 30 kg/m2
* No concomitant neurological, rheumatological or systemic disease
* Volunteer to participate in the study.

Exclusion Criteria:

* Having any surgery / serious pathology of the spinal column
* Having had an upper extremity injury in the last 6 months that would affect his ability to play volleyball
* Having an injury that requires at least 2 weeks of discontinuation
* Severe musculoskeletal/systemic discomfort during the measurements.
MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.

This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years or greater
* Cytologic / histologic diagnosis ovarian cancer
* Stage of disease at diagnosis IC -IV
* Performance status (ECOG) \< 3
* Indication for chemotherapy treatment
* Written informed consent

Exclusion Criteria:

* Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
* Cerebral metastases
* Neutrophils \< 1000/mm3, platelets \< 100000/mm3, hemoglobin \< 8g/dl
* Creatinine \> o = 1.25 times the upper normal limit
* GOT or GPT \> o = 1.25 times the upper normal limit, except in case of liver metastases)
* Patient's inability to comply with followup
Psychosocial Training for Pediatric Health Care Providers

This study will provide psychosocial training to general health care providers to help them provide better care to children with mental health problems.

Up to 20% of school-age children have one or more mental health conditions that require treatment. These conditions are often treated by generalists. However, a significant proportion of children who seek treatment from generalists do not receive effective treatment. Studies indicate that generalists who treat adults can improve the administration of treatment after taking part in training programs, but these studies have yet to be translated into pediatric settings. This study will conduct a training program to help generalists provide effective treatments to children with mental health problems.

This study will evaluate a two-session, highly interactive training program in which general clinicians receive psychosocial training. The training program includes skills related to engaging parents and children, problem identification, solution-focused cognitive therapy, and making effective mental health referrals.

The child's mental health symptoms, functioning, changes in utilization of pediatric services, and utilization of community services will be measured along with the mother's emotional well-being and family functioning.

Eligibility Criteria:
Inclusion Criteria for Health Care Providers:

* Generalist clinician in primary care practice seeing children 6 to 16 years of age

Inclusion Criteria for Patients:

* 6 to 16 years of age
* Seeing a study-enrolled provider
* English or Spanish speaking
* Not in acute pain
Palliative Stereotactic Radiation for Pancreatic or Periampullary Adenocarcinoma

The investigators are looking to see if a certain dose of stereotactic body radiation therapy (SBRT) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

No standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). Linac based stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. We hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using Linac based SBRT delivered as 5 Gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. The toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Karnofsky Performance Status greater than or equal to 70%
* confirmed pancreatic or periampullary adenocarcinoma
* pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension
* Either:

  * standard of care treatment for pancreatic cancer that included radiation therapy

    \* patients may be receiving continued chemotherapy post initial CRT. or
  * standard of care treatment for pancreatic cancer that did not include radiation therapy \* patients must have attempted chemotherapy upon initial diagnosis
* acceptable organ and marrow function as determined by blood tests
* ability to understand and give consent
* must be a patient to be treated with SBRT only at Johns Hopkins Hospital
* life expectancy of greater than 3 months

Exclusion Criteria:

* extensive metastatic disease
* performance status of less than 70
* children are excluded form the study
* no uncontrolled intercurrent illness
* no concurrent malignancy other than melanoma
* pregnant or breast feeding women are excluded
* women who are not post-menopausal and have a positive pregnancy test
* life expectancy of less than 3 months
Minimal Extracorporeal Circuits (MECC) in Cardiac Surgery Procedures

The standard heart-lung machine is a major trigger of systemic inflammatory reactions, hemodilution, coagulopathy or organ failure. The strict reduction of blood-artificial surface and blood-air contact might represent meaningful improvements of the extracorporeal technology with respect to organ preservation.

The aim of this study is the evaluation of potential differences between a minimal extracorporeal circuit (MECC) and a conventional cardiopulmonary bypass (MOPS) system.


Eligibility Criteria:
Inclusion Criteria:

* extracorporeal circulation
* age \> 18 years old
Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is called gestational diabetes, and it places both mom and baby at risk for complications. Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have described a difference in the way and how well the drug works compared to when used outside of pregnancy.

Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth) blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in pregnancy.

This research study will help us learn more about the variations in blood sugar levels in women with diabetes in pregnancy who are taking glyburide and how changes in the timing of when the glyburide is taken would affect blood glucose levels. The goals of this study are:

* To find the how glucose changes throughout the day in women with diabetes in pregnancy receiving glyburide
* To learn the effect of changing the time of taking glyburide on glucose levels
* To learn the effect of changing the time between glyburide doses on glucose levels
* To see if insulin is secreted the same throughout the day in response to a morning dose of glyburide.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with gestational diabetes
* Singleton gestation
* Receiving glyburide for the treatment gestational diabetes
* Able to give consent

Exclusion Criteria:

* Women who require insulin for the treatment of gestational diabetes
* Diagnosis of pregestational diabetes
* Poor glycemic control, \> 50% of blood glucose values over 200mg/dl prior to start of the study
* Women receiving medications that affect glycemic control e.g. steroids, within a week of enrollment.
Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy

Cardiac resynchronization therapy reduces mortality in patients with systolic heart failure and left bundle branch block. Reduced biventricular pacing can lead to therapy failure. Most effective mortality reduction was seen with a BiV pacing above 98%.

Reduced BiV pacing is a common phenomenon with potential impact on CRT-response and pts' prognosis. Frequent ventricular ectopy may be associated with attenuated benefit from CRT. The investigators sought to systematically assess the effect of ventricular arrhythmia treatment on BiV pacing.


Eligibility Criteria:
Inclusion Criteria:

* reduced biventricular pacing \<98% due to ventricular arrhythmia

Exclusion Criteria:

* reduced biventricular pacing \<98% due to other cause
* age \<18
* pregnancy
Long-term Follow-up of the Helsinki Businessmen Study

The Helsinki Businessmen Study (HBS) is a clinico-epidemiological longitudinal study started in 1964. It also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. The cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. Latest in 2015. Also clinical and laboratory studies have been performed in random subcohorts. Follow-up is ongoing with new hypothesis-generating research questions.

The Helsinki Businessmen Study (HBS) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. Primary focus was on the prevention of cardiovascular diseases (CVD), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) HBS can be seen as a "life-course" study. Traditional CVD risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and CVD risk. Two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). The whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. Random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. The latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. Follow-up of the cohort is ongoing and new research questions formulated..

Eligibility Criteria:
Inclusion Criteria:

* Participants of director studies at the Institute of Occupational Health in Helsinki, Finland, between 1964-1973

Exclusion Criteria:

* Non-participants
NAVIGATE GRX Study

The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.

This multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted PCI with technIQ automated movements disabled. A secondary objective is to describe the learning curve associated with using technIQ.

Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female aged ≥ 20 years.
* Patients with coronary artery disease with clinical indication for Percutaneous Coronary Intervention (PCI).
* The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

* Failure/inability/unwillingness to provide informed consent.
* In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status or anatomic characteristics.
* Acute STEMI within 72 hours pre-procedure.
Effect of ARNI in Patients With Persistent AF and Enlarged Left Atrium After Catheter Ablation

The purpose of this clinical randomized trial is to evaluate the efficacy and safety of Sacubitril/Valsartan compared with ARB in improving cardiac remodeling in patients With Enlarged Left Atrium Diameter and Persistent AF.

Atrial fibrillation is one of the most common arrhythmia around the word. Prolonged atrial fibrillation may lead to structural changes in the heart such as atrial enlargement, which is an important risk factor for heart failure. Sacubitril/Valsartan is a new drug for the treatment of heart failure, previous studies have shown that it has a good effect in improving cardiac function. For patients with persistent atrial fibrillation and enlarged left atrial, the effect of reversing cardiac remodeling after catheter ablation is unclear. Some studies have described its positive effects in improving cardiac remodeling, but there is still no large-scale randomized controlled trial to further confirm. The investigators hypothesized that Sacubitril/Valsartan can reverse cardiac remodeling in patients with persistent atrial fibrillation and enlarged left atrium compared with ARB after catheter ablation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with persistent atrial fibrillation undergoing catheter ablation within 2 weeks.
2. ≥18 and ≤75 years of age.
3. Left atrium diameter（LAD）≥35mm, With or without right atrium diameter（RAD）≥40mm，diagnosed by Echocardiographic.
4. patient who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
5. Patients receiving ACE inhibitors (ACEI), angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications stable for the 1 month period prior to Visit.
6. Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mmHg are eligible for enrollment if they are on three or more medications to control BP at randomization.
7. Patients must have an eGFR ≥ 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
8. Patients with a potassium ≤5.2 mmol/l at Visit 1.

Exclusion Criteria:

1. Patients with prosthetic valves.
2. Any previous LA suigery.
3. Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
4. Presence of hemodynamically significant mitral and /or aortic valve disease.
5. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
6. Current acute decompensated HF requiring therapy.
7. Allergic to drugs or active ingredients (shakuba, valsartan) or any excipients。
8. Patients with previous history of angioedema associated with ACEI or ARB treatment.
9. Patient with hereditary or idiopathic angioedema.
10. patient with severe liver damage, biliary cirrhosis and cholestasis.
11. Patient with Renal artery stenosis.