cyrilzakka/clinical-trials huggingface dataset:
The Effect of Alternative Keyboards on Discomfort and Typing Kinematics

Awkward postures during computer keyboard use have been hypothesized to be one cause of musculoskeletal pain/discomfort as well as musculoskeletal disorders of the upper extremity (MSD-UE). Alternative computer keyboards purport to reduce musculoskeletal pain/discomfort and have been shown to change aspects of keyboard users' kinematics under laboratory conditions. However, research that has examined the effectiveness of alternative keyboards in reducing musculoskeletal pain/discomfort in the workplace is equivocal, and no study has examined the association between postures and musculoskeletal pain. The Aims of this 3-year prospective double cross-over trial are: 1) To examine the effectiveness of an alternative keyboard in reducing reports of pain over 6-months; 2) To examine the neutrality and stability of postures during keyboard use; and 3) To identify which postures are associated with lower levels of musculoskeletal pain. Seventy-five computer users will be randomly assigned to one of two keyboard use orders: Group 1 - AB (standard keyboard, alternative keyboard); Group 2 - BA (alternative keyboard, standard keyboard). All subjects will use their assigned keyboards for 6-months before switching to the next keyboard. Every week, subjects will report their musculoskeletal pain levels. Just prior to and just after each 6-month intervention subjects' kinematics performances on the keyboards will be recorded at the worksite using the Keyboard - Personal Computing Style (K-PeCS) instrument and in a laboratory setting using 3-dimensional motion capture technology.

Aim 1: To examine the effectiveness of an alternative keyboard in reducing pain over 6-months.

Hypothesis 1 (H-1) - At six months subjects using an alternative keyboard will have significantly lower musculoskeletal pain levels than when using a standard keyboard.

Aim 2: To examine the neutrality and stability of postures during keyboard use.

Hypothesis 3 (H-2) - Subjects using an alternative keyboard will have significantly more neutral postures than when using a standard keyboard at baseline and at 6 months Hypothesis 3 (H-3) - Subjects 6-months keyboarding postures will remain equivalent to the keyboarding postures documented at baseline.


Eligibility Criteria:
Inclusion Criteria:

* Use a computer at least 20 hrs per week
* Aged 18-65
* Experiencing some pain during computer use

Exclusion Criteria:

* Currently use an alternative keyboard
* Serious trauma injury to the upper extremity
* Rheumatic disorder
The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial

The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.


Eligibility Criteria:
Inclusion Criteria:

* periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy.

Exclusion Criteria:

* smokers, pregnant female, other systematic disease
Evaluate Safety and Efficacy of 25 mg Hydrocortisone Acetate Suppositories in Treatment of Internal Hemorrhoids

A randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of Hydrocortisone Acetate Suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic internal hemorrhoids.

STUDY DESIGN:

25 mg hydrocortisone suppositories administered twice daily compared to a vehicle placebo in approximately 100 subjects with symptomatic internal hemorrhoids. Subjects will be randomized in a 1:1 ratio (Test product: placebo).

The study will consist of 2 periods:

1. Treatment Period (2 weeks/ Days 1-14)
2. Follow-up Period (2 weeks/ Days 15-28)

The visits are as follows:

Visit 1 (Day 1 Baseline/Randomization) Visit 2 (Day 8±1, Interim Visit) Visit 3 (Day 15±2, End of Treatment Visit) Visit 4 (Day 29±3, End of Study Visit)

ENDPOINTS:

1. Clinician Reported Outcome (ClinRO) - Anoscopy (Visits 1, 3). Anoscopy - Visual assessment of hemorrhoids. Video of the procedure will be recorded for blinded central reading and assessment
2. Patient Reported Outcome: Subjects will use Daily Diaries to record the time and date of each medication application, concomitant medication and adverse events. The subjects will complete the Subject Questionnaire at Visits 1, 2, 3 and 4 (or early termination) and daily between visits.

Eligibility Criteria:
Inclusion Criteria:

* internal hemorrhoids.
* hemorrhoidal bleeding.
* male or female aged 18 years and older.
* willing to forego the use of non-prescription (OTC) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study.
* agree to not change their diet during the study.

Exclusion Criteria:

* external hemorrhoids.
* using other OTC or prescription medications for treatment of hemorrhoidal disease and/or pain.
* pregnant or nursing female.
* received systemic glucocorticoids within the last 2 months prior to starting study.
* participated in an investigational drug study within 30 days prior to baseline.
PrehabPal: A Digital Tool to Help Older Adults Prepare for Cancer Surgery

This is a multi-center, randomized trial investigating the use of PrehabPal web app versus a written surgery prehabilitation instructions among individuals aged 65 years and older preparing for colon cancer surgery. PrehabPal is a web app designed with, and for, older adults preparing for surgery at University of California, San Francisco (UCSF). This app has the potential to fill a crucial clinical gap for older cancer patients by designing an individualized prehabilitation program and providing prehabilitation coaching.

PRIMARY OBJECTIVE:

I. Determine the effectiveness of PrehabPal in delivering prehabilitation and improving outcomes for elders who undergo colorectal cancer surgery.

SECONDARY OBJECTIVES:

I. Determine the impact of PrehabPal on surgical outcomes and functional recovery compared to standard written surgery prehabilitation materials.

OUTLINE:

Participants will be randomly assigned to 1 of 2 conditions. Study participation will continue for up to 12 weeks, with intervention 7-21 days before surgery and a follow-up visit 8 weeks after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female \>=65 years of age at time of evaluation for colorectal cancer resection.
2. Documentation of a colorectal diagnosis as evidenced by the following criteria:

   a. Biopsy proven colorectal cancer or unresectable neoplastic polyp.
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
4. Self-reported access to the Internet.
5. Participant has at least seven days prior to surgery date to optimize for surgery.
6. English language proficient.

Exclusion Criteria:

1. No English language proficiency.
2. No Internet access.
3. Documented diagnosis of dementia or Alzheimer's disease.
4. Surgery scheduled within 7-days.
5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Quantitative GLP-1 Receptor Imaging Correlated to ex Vivo Distribution of In-111-exendin

The main goal is to study the correlation of pancreatic uptake of In-111-DTPA-exendin-4 (measured by ex vivo counting) with the beta cell mass determined in the pancreatic specimens obtained after surgery.

In order to fully characterize the highly promising tracer In-111-DTPA-exendin-4 in humans, quantitative SPECT imaging will be correlated to the ex vivo tracer distribution in patients undergoing pancreatectomy or a Whipple procedure. In vivo imaging will be combined with post-pancreatectomy (micro)autoradiography, measurement of In-111-DTPA-exendin-4 concentrations in the pancreas using a gamma counter and morphometric determination of the actual beta cell mass. By this means, the relation between tracer uptake and beta cell mass in non-diabetic patients and T2D patients will be established. These highly relevant data will allow the improvement of the interpretation of clinical quantitative SPECT data in subsequent studies in patients with T1D and T2D. In addition, high uptake has been observed in the duodenum/pyloric area in patients in an ongoing study. At this point in time, it remains unclear which cells are responsible for this uptake. It would be of great interest to identify the GLP-1R positive cells in order to better understand the physiological actions of GLP-1 agonists.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for partial or complete pancreatectomy or Whipple procedure at Radboudumc

Exclusion Criteria:

* Resection that provides insufficient amount of tissue
* Previous treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl- Peptidase IV inhibitors
* Breast feeding
* Pregnancy or the wish to become pregnant within 6 months
* Renal disease
* Liver disease
* Age \< 18 years
Omegaven Protocol:Intermediate Size Patient Population

Children requiring prolonged courses of PN are at risk for developing PN associated liver disease. We hypothesize that although omega-6 fatty acid emulsions prevent fatty acid deficiency, they are not cleared in a manner similar to enteral chylomicrons and therefore accumulate in the liver and resulting in steatotic liver injury. We further hypothesize that a fat emulsion comprised of omega-3 fatty acids (i.e., fish oil) such as Omegaven® would be beneficial in the management of steatotic liver injury by its inhibition of de novo lipogenesis, the reduction of arachidonic acid-derived inflammatory mediators, prevention of essential fatty acid deficiency through the presence of small amounts of arachidonic acid, and improved clearance of lipids from the serum.


Eligibility Criteria:
Inclusion Criteria:

- 1. Inborn and transferred newborns born between the gestational age of 22-40 weeks who develop chronic liver failure, secondary to parenteral nutrition.

2. Patients will be PN dependent (unable to meet nutritional needs soley by enteral nutrition) and are expected to require PN for at least another 30 days 3. Patients must have diagnosis of parenteral nutrition associated liver disease (PNALD) as defined by serum direct bilirubin greater than 2mg/dL on 2 consecutive occasions 4. have had PNALD for at least four weeks prior to planned Omegaven initiation 5. Direct bilirubin \> 2.0 mg/dl 6. Signed patient informed consent. 7. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).

Exclusion Criteria:

- 2. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,) 3. severe and/or unstable concomitant systemic disease such as complex congenital cardiac disease, renal failure, autoimmune disease, sepsis, inborn error of metabolism, genetic liver disease, 4. bleeding disorder; 5. biochemical disturbance with potential of worsening with proposed treatment, e.g. persistent hyperglycemia, hypertriglyceridemia, hypercalcemia.

6. The parent or guardian or child unwilling to provide consent or assent In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study.
HFLVV for Hypoxemia in Robot-assisted Cardiac Surgery

These robot-assisted cardiac surgeries usually require single-lung ventilation (SLV) to facilitate surgical exposure. SLV creates ventilation/perfusion mismatch and shunt (Qs:Qt) through the collapsed lung and leads to hypoxemia. Pulmonary gas exchange often deteriorates after cardiopulmonary bypass (CPB) because of ischemic tissue damage. In some cases, severe hypoxemia may require the cessation of surgical procedures and the initiation of double-lung ventilation to improve oxygenation. In this study, the investigator applied the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to the non-dependent lung (differential ventilation) during the weaning from CPB. The investigator hypothesized that the differential ventilation would produce the least interference with the surgeon's exposure and better oxygenation. The investigators evaluate the airway pressure, shunt fraction, PaO2/FiO2, cerebral oximetry, surgical field condition and the length of stay in intensive care unit of patients underwent the robot-assisted cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for robot-assisted cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* age \<18 or \> 70 years
* PaO2/FiO2 ratio \< 300 mmHg before anesthesia induction
* American Society of Anesthesiologist (ASA) Grade \> 3
* Patients who were converted to conventional open-chest procedure
CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL

The aim of this study is to compare the clinical performances of high-viscosity glass ionomer (GI), glass carbomer (GC), zirconia-reinforced GI (ZIR), and bulk-fill (BF) composite resin restorations.For this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. The restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified US Public Health Service criteria. The data will statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

* patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments.

Exclusion Criteria:

* patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.
Effects of Aging and Gender-Affirming Hormone Therapy on Vascular Endothelial Function and Metabolic Profiles in Transgender Women

This study will examine markers of vascular endothelial function (vascular health) and metabolic profiles in younger versus older transgender women (people who were assigned male at birth but whose gender identity is female). Data will also be compared to those from cisgender women and men.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years old or 50-75 years old
* Identify as a transgender woman
* Have taken estradiol and spironolactone for at least one year
* Currently taking oral or transdermal estradiol

Exclusion Criteria:

* Don't identify as a transgender woman
* Not currently taking estradiol or spironolactone
* Have been on estradiol and spironolactone for less than one year
* History of orchiectomy
* Current tobacco smoker
* Current illicit drug use
* History of prior or active estrogen-dependent neoplasms
* Acute liver or gallbladder disease
* Venous thromboembolism
* Hypertriglyceridemia \>500 mg/dL
* Fasted plasma glucose \>7.0 mmol/L or previously treated diabetes
* Resting blood pressure \>140/90 mmHg
Impact of Operation on Fertility for Women with Severe Endometriosis

The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.


Eligibility Criteria:
Inclusion Criteria:

* Rectosigmoid endometriosis and wish for surgery
* Pregnancy intention for at least 6 months
* AMH above 5 pmol/ml
* Maximum of 2 previous IVF treatments
* Male partner

Exclusion Criteria:

* Endometriosis involving the ureter unilaterally or bilaterally (randomization unethical)
* BMI above 32
* Contraindication for IVF (untreated uterine factor infertility, untreated/maltreated systemic or malignant disease, oocyte aspiration severely riskful (e.g. severe abdominal adhesions)
* No wish for randomization
Evaluation of Preoperative Biliary Drainage Before Pancreatoduodenectomy

The purpose of this study is to evaluate the efficacy of preoperative biliary drainage (PBD) which is performed prior to pancreatoduodenectomy candidates with obstructive jaundice by observing the prevalence of drainage and surgery related complications, hospital stay, medical cost and life quality compared to surgery alone. It is anticipated that PBD can reduce the prevalence of complications and improve the outcome of pancreatoduodenectomy.

Obstructive jaundice is a common symptom in patients with pancreatic head cancer or peri-ampullary cancer. It is regarded that proper surgical resection is the only possible way of radical cure for those patients without evidence of metastasis. Since high preoperative bilirubin level is suggested to be a risk factor for pancreatoduodenectomy, preoperative biliary drainage has been applied to clinical practice to improve the outcome of surgery. However, results from previous studies have inconsistent results showing that PBD may have adverse effect on patients by elevating the prevalence of complications. Since PBD is widely performed worldwide, its value needs to be clarified. Thus the present study is designed to systematically evaluate the value of PBD via recruiting participants who may most likely benefit from PBD. It is anticipated that results from this study can present an instructive conclusion on whether PBD should be performed prior to pancreatoduodenectomy as well as reveal the preferable type of PBD.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 70 years old
* CT (Computed Tomography), CTA (Computed Tomographic Angiography), MRI (Magnetic Resonance Imaging) or ultrasonic test suggested pancreatic head carcinoma or periampullary carcinoma with obstructive jaundice
* First routine test of serum bilirubin above 250μmol per liter

Exclusion Criteria:

* Distant metastasis in liver, lung or other sites
* Invasion of local blood vessels (e.g. aorta, portal vein, postcava)
* Poor physical condition, unable to tolerate anesthesia and surgery (e.g. severe cardio-pulmonary diseases, blood coagulation disorders)
* With cholangitis, active hepatitis or other diseases which should be excluded from study according to the investigators
Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants

The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or enoxaparin.

Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture. The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin (baseline, saline control and 6 specified concentrations of anticoagulant).

Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care activated partial thromboplastin time (aPTT) and prothrombin time (PT).

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form
2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture -

Exclusion Criteria:

1. Subjects who cannot communicate reliably with the Investigator
2. History of major bleeding or major trauma within the 6 months prior to signing informed consent
3. Propensity to bleeding (i.e. due to recent trauma, surgery, peptic ulcer, gastrointestinal bleeding or hemorrhoids)
4. Significant infection or known inflammatory process in the 2 weeks prior to screening
5. Active smoker or current use of any tobacco products or use within 3 months prior to signing informed consent
6. Treatment with any investigation product or therapy within 30 days prior to screening
7. Received non-steroidal antiinflammatory drugs or medications (including anticoagulants or aspirin) with a direct effect on hemostasis within 7 days of blood sampling
8. Unwilling to comply with the procedures in the protocol
9. Currently enrolled in any other study -