cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.

This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
2. CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
3. CT chest or PET/CT within 6 weeks prior to registration
4. Clinically determined to be resectable based on NCCN Criteria:
5. No radiographic evidence of superior mesenteric vein or portal vein distortion
6. No evidence of distant metastasis
7. Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
8. No enlarged lymph nodes per CT criteria or PET avid lymph nodes
9. No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
10. Adequate cardiopulmonary reserves to tolerate surgery
11. Karnofsky performance status \> 70
12. Age \>18
13. Adequate bone marrow function defined as follows:
14. Absolute neutrophil count (ANC) \> 1800 cells/mm3
15. Platelets ≥ 100,000 cells/mm3
16. Hemoglobin \> 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb \> 8 g/dl is acceptable.)
17. Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
18. Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

1. Prior surgical resection of any pancreatic malignancy
2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
3. Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
5. Severe, active comorbidity, defined as follows:

   1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
   2. Transmural myocardial infarction within the last 6 months
   3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
   4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
7. Any evidence of distant metastases (M1)
8. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
The Correlation Between Iodine and Selenium Status in Pregnancy and Risk of Thyroid Disease

Two hundred and ninety pregnant women with gestational age less than 20 weeks will be recruited in this study. Selenium and iodine conditions, and risk of thyroid disease will be monitored until termination of pregnancy, with pregnancy outcomes recorded.

The study will recruit 290 pregnant women with gestational age less than 20 weeks. Iodine and selenium condition will be evaluated through dietary recall (on base of Chinese food ingredient information) and biochemical examinations (serum iodine concentrations, urinary iodine concentrations, serum selenium concentrations, etc). The nutritional status of iodine and selenium will be monitored and followed up for all the included subjects throughout the pregnancy. The information of thyroid function and level of anti-TPO and anti-TG will be collected. And all the complications (especially thyroid disease) in pregnancy will also be recorded. All pregnant women will be followed up until the termination of pregnancy, with pregnancy outcomes recorded.

Eligibility Criteria:
Inclusion Criteria:

* Clinical confirmation of being pregnant.
* Being within less than 20 weeks of gestationa.

Exclusion Criteria:

* Being pregnant but over 20 weeks of gestationa.
* Mentally or psychologically unstable.
HIP Fracture REhabilitation Programme

Objectives: To evaluate the effect of a HIP-REP on the quality and independence in ADL ability (performance), measured with the Assessment of Motor and Process Skills (AMPS) and health-related Quality of Life (QoL).

Hypothesis: The HIP-REP will increase the quality and independence in ADL performance, measured with AMPS and health-related QoL measure.

Little is known about the effect of an intersectoral rehabilitation intervention aiming at reducing the decrease in Activities of Daily Living (ADL) ability for elderly with hip fractures. Despite positive surgical outcomes, one-quarter dies within a year after surgery, around eight percent are readmitted to hospital, and just one-third regain their pre-fracture level of physical functioning and ADL ability. After hip fracture, the loss of independence, and further decrease in ADL ability often persists beyond three months after surgery. This increases the risk of social isolation, depression and thus a decrease in QoL. Therefore, the investigators want to evaluate whether an activity-based rehabilitation intervention across sectors is effective and influences this fragile group of patients. The investigators hope to increase the ability to safely and independently perform ADL in elderly with hip fractures, and thereby enhance their health-related QoL.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Recent proximal hip fracture (S 72.0 medial femur fracture, S 72.1, pertrochanteric femur fracture, S 72.2 subtrochanteric femur fracture)
* Living at home prior to hip fracture in Herlev, Gentofte, Furesoe, Rudersdal or Lyngby-Taarbæk municipalities
* Ability to give informed consent

Exclusion Criteria:

* Not expected to be discharged to home or rehabilitation centers in the municipality
* Not able to speak and/or understand Danish
* Have prior severe physical and /or mental disabilities
The Effect of PD01 on Cardiovascular Health and Microbial Environment

This randomized, placebo-controlled trial aims to determine the effects of daily administration of a carotenoid-producing Bacillus strain PD01 over a 6-week period on cardiovascular health biomarkers, microbiota composition and functioning and intestinal barrier function in overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

* Overweight men/women (BMI 25-35 kg/m2)
* Healthy individuals
* Age between 18 and 70 years
* Fasting glucose \< 7.0 mmol/L
* Normal HbA1c (4.4 to 6.2%)

Exclusion Criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L);
* History of (severe) cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
* Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
* Use of medication interfering with endpoints
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Use of antibiotics in the 90 days prior to the start of study
* Known pregnancy, lactation
* Abuse of products; alcohol (\> 20 alcoholic consumptions per week) and drugs
* Smoking
* Blood donation within 3 months before study period
* Plans to lose weight or following a hypocaloric diet during the study period;
* Weight gain or loss \> 3 kg in previous 3 months
* High physical activity (\>4.5 hours of running/week)
* Hormone replacement therapy (women)
* History of any side effects towards intake of pro- or prebiotic supplements of any kind
* History of any side effects towards intake of carotenoids
* Prohibited use of pro-, pre- or synbiotics during study period and from one month prior to start of study.
* High intake of fruits and vegetables (more than the 75th percentile of dietary intake of fruits and vegetables)
* Vegetarians/vegans
Pathophysiology of Perioperative Fluid Management in Emergency Laparotomy

Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

In critically ill patients and patients undergoing major surgery, the combination of internal fluid shifts and fluid retention resulting in extravascular fluid accumulation and postoperative organ dysfunctions, complicates perioperative fluid management and influences patient outcome.

Changes in extravascular volume after surgery have been much debated, studies in major surgery suggest that extracellular volume expansion may correlate with intraoperative fluid administration, while other studies show the intravascular volume to be decreased after surgery.

Difficulty in obtaining accurate measurements of the fluid phases is recognized and despite years of research, perioperative extravascular volume changes have not been clarified in acute high-risk abdominal (AHA) surgery. It is essential to be able to identify and characterize the transition from necessary fluid resuscitation to harmful fluid volume accumulation, intra- as well as extravascular.

The present study seeks to investigate the perioperative fluid status and fluid shifts in patients undergoing AHA surgery, specifically focusing on intra- versus extra-vascular fluid status in patients with intestinal obstruction versus intestinal perforation.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology:

   1. Perforated small intestine
   2. Perforated large intestine
   3. Perforated ulcer
   4. Intestinal obstruction
   5. Anastomotic leakage following elective surgery
2. Provided verbal and written informed consent
3. Must speak and understand the Danish language

Exclusion Criteria:

1. Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
2. Primary surgery for intestinal ischemia, abdominal bleed
3. Emergency re-operations after elective surgery owing to intraabdominal bleeding, paralytic/obstructive ileus, intestinal ischemia
4. Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery were excluded from the cohort. Sub-acute surgery was defined as surgery planned within 48 hours.
5. Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.
6. Dementia and/or cognitive dysfunction (diagnosed).
Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma

RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.

OBJECTIVES:

* Determine immunologic responses in patients who have completed first-line therapy for Hodgkin's lymphoma treated with Hodgkin's antigens-GM-CSF-expressing cell vaccine.
* Determine the durability of these immunologic responses in these patients.
* Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses.
* Determine the safety and tolerability of this vaccine in these patients.

OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to 4 courses.

Immunologic responses are serially monitored along with disease status.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of classic Hodgkin's lymphoma
* Must have completed first-line therapy without evidence of disease progression

PATIENT CHARACTERISTICS:

* HIV negative

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 6 months since prior chemotherapy or radiotherapy
A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair

This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making small perforations either in the torn tendon near its edge, or in the bone that the tendon is repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the shoulder. Trephination is a new technique that is used in addition to the standard method of repairing the rotator cuff tendon.

This study will help to determine whether this technique improves the speed of healing, the strength and the re-tear rate of the repair. You are being asked to take part in this study because you have a tear of the rotator cuff that requires surgical treatment. A total of 90 participants will participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
* Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for 6 months.

Medical management will be defined as:

* The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
* Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc)
* Activity modification
* Imaging, and intra-operative findings confirming a full thickness tear of the rotator cuff.

Exclusion Criteria:

1. Characteristics of the cuff tear that render the cuff irrepairable: fatty infiltration in the muscles grade III (50%) or greater; superior subluxation of the humeral head; retraction of the cuff to the level of the glenoid rim.
2. Partial thickness cuff tears.
3. Significant shoulder comorbidities e.g. Bankart lesion, osteoarthritis
4. Previous surgery on affected shoulder e.g. Previous rotator cuff repair.
5. Patients with active worker's compensation claims
6. Active joint or systemic infection
7. Significant muscle paralysis
8. Rotator cuff tear arthropathy
9. Charcot's arthropathy
10. Significant medical comorbidity that could alter the effectiveness of the surgical intervention (eg. Cervical radiculopathy, polymyalgia rheumatica)
11. Major medical illness (life expectancy less then 1 year or unacceptably high operative risk)
12. Unable to speak or read English/French
13. Psychiatric illness that precludes informed consent
14. Unwilling to be followed for 1 year
15. Advanced physiologic age
Biomechanical and Viscoelastic Properties of Plantar Fascia in Pregnant Women-Pilot Study

The feet, which are support surfaces, are adapted to the physiological relaxation and biomechanical changes that occur during pregnancy. In this adaptation, it has not been objectively clarified how the plantar fascia, which plays a very important role in maintaining the height of the plantar arch, undergoes a change. Therefore, the aim of this pilot study is to investigate the normative values of trimester-specific biomechanical and viscoelastic properties of the plantar fascia, which adapts to changes in foot structure during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* First-time pregnancy
* They are between the ages of 18-40
* Pre-pregnancy Body-Mass-Index (BMI) \< 30 kg/m2

Exclusion Criteria:

* Presence of any connective tissue disease that would affect the biomechanical or viscoelastic properties of the fascia
* Deterioration of skin integrity in measurement areas
* Presence of orthopedic, neurological, rheumatic problems that may cause musculoskeletal disorders and deviations from normal in biomechanical alignment
* History of surgery or fracture in the lower extremity and foot-ankle region in the last 6 months
* Defining metabolic disorders such as type I, II diabetes, gestational diabetes mellitus (GDM), preeclampsia
Duration of Analgesia in Bier Block for Patients Undergoing Hand Surgery

Intravenous regional anesthesia (Bier block) is widely used as an anesthetic technique for operations of short duration of the distal upper or lower extremities Today, IVRA is still popular in many countries being used in the emergency room, for outpatients and for high-risk patients with contraindications for general anesthesia.

IVRA offers a favorable risk-benefit ratio, cost-effectiveness, sufficient muscle relaxation and a fast on- and offset. New upcoming methods for monitoring, specialized personnel and improved emergency equipment made IVRA even safer. Moreover, IVRA may be applied to treat complex regional pain syndromes. Prilocaine and lidocaine are considered as first-choice local anesthetics for IVRA. Also, various adjuvant drugs have been tested to augment the effect of IVRA, and to reduce post-deflation tourniquet pain. Since major adverse events are rare in IVRA, it is regarded as a very safe technique. Nevertheless, systemic neuro- and cardiotoxic side effects may be linked to an uncontrolled systemic flush-in of local anesthetics and must be avoided.

Dexamethasone decreases postoperative pain and prolongs the duration of local anaesthetic peripheral nerve blocks in studies including a limited number of patients .

Fentanyl is a powerful synthetic opioid that is similar to morphine but is 50 to 100 times more potent.fentanyl acts on opioid receptors. These receptors are G-protein-coupled receptors, which contain seven transmembrane portions, intracellular loops, extracellular loops, intracellular C-terminus, and extracellular N-terminus. The extracellular N-terminus is important in differentiating different types of binding substrates. When fentanyl binds, downstream signaling leads to the inhibitory effects, such as decreased cAMP production, decreased calcium ion influx, and increased potassium efflux. This inhibits the ascending pathways in the central nervous system to increase pain threshold by changing the perception of pain; this is mediated by decreasing propagation of nociceptive signals, resulting in analgesic effects

Eligibility Criteria:
Inclusion Criteria:

* ASA Grade 1 \& 2

Exclusion Criteria:

Patient refusal ASA Grade 3 \& 4 patients SEVERLY HYPOVOLEMIC STATE History of neurological. Reynauds disease, scleroderma, sickle cell anemia, myasthenia gravis, decompensated cardiac disease, diabetes mellitus, peptic ulcer, gastritis, and those with liver or renal insufficiency were excluded
Clinical Evaluation of Posterior Indirect Adhesive Restorations

Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.

Indirect adhesive restorations are indicated in large Class II defects, replacement of large compromised existing restorations or endodontically treated teeth where cuspal protection is required. The need to perform adhesive restorations of posterior teeth is not only linked to esthetic purposes, but also have possibility of strengthening the remaining tooth structure. Indirect technique decreases polymerization shrinkage, reduces microleakage and also improves the marginal seal when comparing direct resin composites. Furthermore, it provides improved physical and mechanical properties, ideal occlusal morphology, more precise control of proximal contours and contacts. Indirect adhesive restorations are classically delivered with an adhesive procedure including dual-cure cement. Updated approaches now include the use of composite resins as luting agent.

This study will be carried out as a prospective study, with assessment of the restorations after three years. PASS 11 Software was used to calculate the sample size. At least 77 indirect adhesive restorations will be included for this study. Patients referred to Istanbul Okan University Faculty of Dentistry between 2016-2017 who had returned for the baseline recall and at least one year recall after the treatment will be invited for eligibility to participate in the study. 83 indirect adhesive restorations in at least 60 patients will be included. The patients who will not meet all the inclusion criteria will be excluded from the study. A signed informed consent form will be obtained from all patients before beginning the study.

Restorations will be evaluated clinically and radiographically according to FDI World Dental Federation criteria over 3-year period. Three main groups- esthetic, functional, biological properties- and their sub-categorizes of FDI World Dental Federation criteria will be scored on a scale of 1 to 5. Statistical analysis will be performed using R (v.3.5.3) Software and the SIGN.test function in the BSDA package (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Significant loss of dental hard tissue
* Endodontically treated teeth in posterior region
* Replacement of large compromised existing restoration
* Large Class II restoration
* Age of 18-60 years
* Good oral hygiene
* Presence of interproximal contact to at least one neighboring teeth
* In occlusion with antagonist teeth
* Cavity preparation with at least one cuspal coverage

Exclusion Criteria:

* Serious medical problems or allergies to substances and/or products to be used
* Severe periodontal problems
* Poor oral hygiene
* Direct pulp capping
* Presence of parafunctional behaviors
* Pregnant or breast feeding
A Clinical Investigation Evaluating Three New 1-piece Ostomy Products

This investigation evaluates three new ostomy appliances and their impact on the peristomal skin.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Have an ileostomy with a diameter between 10 and 55 mm
5. Be able to handle the Clinical App. and product themselves
6. Must be able to use custom cut product
7. Minimum change of product every second day
8. If current product is SenSura Mio - Be willing to use Maxi bag during investigation
9. Subject using Sensura or Sensura Mio flat 1 pc. open for at least two weeks before inclusion in the study.
10. Negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding\*\*
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation