cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Mechano-Analgesia and Cold Application on Ecchymosis, Pain and Satisfaction at Subcutaneous Heparin Injection

Fifty-five patients received three subcutaneous heparin injections (165 injections) by the same investigator using additional techniques such as mechano-analgesia and cold application, and without any additional techniques.

The abdomen was divided into four quarters. The first, second, and third SC heparin injections were applied from the right abdominal region using ShotBlocker®, left abdominal region with an ice pack, and lower abdominal region without any additional application, respectively. All the injection sites were circled using a skin marking pen (r = 5 cm).

All the injections were administered following a standard procedure. Pain and satisfaction were assessed immediately after the injection by using the VAS score. Ecchymosis was assessed with an ecchymosis measurement tool at 48 and 60 hours after the injection (Figure 3).

Eligibility Criteria:
Inclusion Criteria:

* Must be older than 18 years
* Open to communication
* No complications during the operation
* Normal body mass index (BMI; reference range, 18.5-29.9 kg/m2) (d) and
* Platelet count (150.000-300.000)
* Give consent to participate in the study

Exclusion Criteria:

* Oral and parenteral anticoagulant treatment for at least 5 days
* Infection, scar tissue or incision, and parenteral treatment in their abdominal area
* Hematological and allergic disease
Agreement Among Expert Radiologists in Diagnosing Primary Liver Tumors by Magnetic Resonance Imaging (MRI)

The purpose of this multicenter study is to evaluate the agreement among expert radiologists in interpreting magnetic resonance images (MRI) assessing common primary liver tumours in non-cirrhotic patients.

Magnetic Resonance Imaging (MRI) is currently the method of choice for non-invasive diagnosis of primary liver tumors. However, differentiation of hepatocellular carcinoma (HCC) from adenoma and focal nodular hyperplasia (FNH) remains challenging, particularly in non-cirrhotic patients.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological diagnosis of Hepatocellular Cancer (HCC), Adenoma and/or Focular nodular hyperplasia (FNH).
* Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
* Patients that underwent liver resection with an intention to cure.
* Patient over 18 years of age

Exclusion Criteria:

* Other histopathological diagnosis such as cysts and hemangiomas.
* Patient age less than 18 years of age.
Acute Intermittent Hypoxia in Persons With Multiple Sclerosis

The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.


Eligibility Criteria:
Inclusion Criteria:

* Have relapsing-remitting MS
* Volitional ankle plantar flexion strength in at least one leg
* Are relapse free for 30 days
* Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)

Exclusion Criteria:

* Currently taking antispasticity medications,
* Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
* Pregnant or nursing women (safety for developing fetus or infant is unknown)
* Cognitive concerns (must be able to consent to study, follow steps)
Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns

This study aims to understand patient profiles, treatment patterns, and clinical outcomes among ALK-positive NSCLC patients treated with alectinib, and post-alectinib treatment patterns and outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a documented diagnosis of NSCLC.
2. Patients ≥ 18 years of age at initial recorded diagnosis of NSCLC.
3. Patients who received treatment with alectinib during the study identification period, including those who initiated alectinib prior (index date-1) to the start of the study identification period.
4. During the study observation period, patients observed with at least 2 visits after the index date-1.

Exclusion Criteria:

1. Receipt of treatment indicated for another primary cancer or diagnosis of another primary cancer (with the exception of non-melanotic skin cancer), within 5 years of index date-1 will be excluded.
2. Patients enrolled in clinical trials prior to receiving alectinib during the study ID period (index date-1), will be included and flagged in the analysis.
Occlusal Outcomes by OGS After a Finishing Protocol

Evaluation of the effects of the implementation of a new finishing protocol in orthodontics patients

Patients who are being treated in the postgraduate orthodontic clinics and who meet the inclusion and exclusion criteria, will be subject to a detailed evaluation according to the OGS criteria and upon meeting the treatment completion criteria they will be placed an aligner with setup for 3 weeks. The scores obtained before and after the aligner will be compared with a historical control group The OGS score obtained for each group, will be compared and the impact of the protocol and the aligner will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the active phase of the bimaxillary orthodontic treatment in the Orthodontics Postgraduate Program of the UdeA by criteria of the treating clinician, during 2014 - 2018 period were included. Patients treated by using the UDEA1 finishing protocol (GC) and the UDEA 2 (GE) finishing protocol, which included aligners. All patients must have standardized diagnostic records at the end of the finishing phase (cast models and panoramic X-Rays) and must accepted to participate in the study voluntarily

Exclusion Criteria:

* Patients that require prosthetic, periodontal and / or surgical treatments or with systemic compromise that may influence the outcome of orthodontic treatment
CT Lucia 601 IOL Implantation in the Sulcus

To perform a retrospective investigation of the CT Lucia 601 IOL implantation in the sulcus

The purpose of the study is to collect data that are parameters of post-IOL implantation safety:

* Questionnaire on subjective quality of vision
* Centration and anteroposterior position of the IOL (using biometry)
* Presence and quantification of any inflammation or pigment present in the anterior chamber (flare meter)
* Refractive outcome, with calculation of customized A-constant of the CT Lucia 601 IOL in-the-sulcus and quantification of higher-order aberrations (HOA)
* General safety-parameters:

  * Visual acuity
  * Intra-ocular pressure
  * Presence of macular edema or retinal nerve fiber layer (RNFL) thinning (SD-OCT)
  * Any adverse ophthalmic events

Eligibility Criteria:
Inclusion Criteria:

* Patients with an implantation of a CT Lucia 601 lens for different reasons:

  * During vitrectomy to treat a complicated cataract surgery and had the implantation of a CT Lucia 601 IOL in the sulcus or patients
  * During phaco surgery with a posterior capsule tear that necessitated the implantation of the implant lens in the sulcus
  * Explantation of an in-the-bag lens and implantation of a CT Lucia 601 as replacement lens (e.g. to treat opacification of the implant lens or intolerance of the implant lens).
* Age : \> 18 years
* Signed informed consent
* Preoperative myopia less than 10 diopters
* Implantation of the CT Lucia IOL at least six months earlier

Exclusion Criteria:

* History of uveitis
* Ocular pathology or history that could influence the biometry of the effective lens position, such as ocular trauma with zonulolysis, congenital iris- or lens defects etc.
* Any eye condition influencing the lens position (to be specified) according to the investigator
Sirolimus Use in Angioplasty for Vascular Access Extension

Dialysis patients presenting for angioplasty intervention for graft failure will be randomized to receive either Sirolimus or not receive Sirolimus (standard of care) to assess the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure.

This is a randomized control study to determine the feasibility of using sirolimus peri-angioplasty to compare the time from primary failure or angioplasty intervention to second or next angioplasty intervention or graft failure to a control group who would not have received Sirolimus

Eligibility Criteria:
Inclusion

1. hemodialysis patients referred for angioplasty for hemodialysis access stenosis through either access flow or clinical monitoring in either an AVF or AVG
2. \> 18 years of age.
3. Total white blood cell count \> 3 x 109 /L and platelet count \> 100.0 x 103/uL
4. Fasting triglycerides \< 4.0 mmol/L, fasting cholesterol \< 7.8 mmol/L while on optimal lipid lowering therapy.

Exclusion Criteria:

1. A woman who is pregnant or breastfeeding
2. Active malignancy
3. Concomitant treatment with immunosuppressant medications
4. Active infection or treated for infection within the last 30 days
5. Pre-existing interstitial lung disease
6. Thrombocytopenia with platelets less than 100 109/L
7. Previous renal or other solid organ transplant
8. Preexisting liver failure
9. Life expectancy less than 6 months
10. Planned major surgery or major surgery within the last 6 months
11. History of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
12. Known history of any coronary intervention within the 6 months prior to current screening
13. Prior or current use of Sirolimus or any of its derivatives within 3 months prior to angioplasty
14. Active gastrointestinal disorder that may interfere with drug absorption
15. Known to be HIV positive or known active hepatitis B or C infection
16. Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (known to interact with Sirolimus) that is not discontinued before starting Sirolimus treatment.
D Vitamin Intervention in VA

This study will supplement African American male (AAM) veterans at risk for diabetes and newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps to improve early markers of diabetes. The study will be done at Veteran Administration Medical Center in Chicago.

The goal of this randomized clinical trial (RCT) is to determine vitamin D efficacy and safety for improving early markers of T2DM in African American male (AAM) veterans at risk for T2DM (n=205, duration 12 months).

The primary outcome will be change in oral glucose insulin sensitivity (OGIS). The secondary outcomes will include various parameters of glucose metabolism and other biomarkers.

Analysis based on primary and secondary goal as well as predetermined levels of A1C, OGTT and 25OHD at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

Veterans at Jesse Brown VA Medical Center (JBVAMC) only

* Male
* African American race
* Age 35-85 years
* BMI 28-39.9 kg/m2
* Stable weight (+/- 10%) for at least 3 months prior to study entry
* FPG 95 - 125 mg/dl
* A1C 5.7 - 6.4%
* Circulating 25OHD 5.0 - 29.9 ng/ml
* Subjects who take ergocalciferol are allowed in the study after a washout period 1 3 month.
* Subjects who take vitamin D supplements other than ergocalciferol are allowed in the study as long as total dose is no more than 600 IU/day (including MVI and calcium plus D supplements).
* Non-diabetic subjects who are diagnosed with T2DM during screening (A1C 6.5-7%) or after randomization are allowed to continue if they follow lifestyle intervention and do not need to take anti-diabetic medications.

Exclusion Criteria:

* Subjects with T2DM
* Weight gain or loss of more than 10% within 3 months prior to the study entry
* History of kidney stones, hyperparathyroidism, sarcoidosis or hypercalcemia
* A1C \>7%.
* Very low 25OHD levels (\<5 ng/ml) and/or the presence of a physical consequence of very low vitamin D levels (hypocalcemia, hypophosphatemia, proximal muscle weakness)
* Chronic kidney disease (CKD) stage 4 and 5
* Problems that in the judgment of PI may be associated with the risk to the subject or non-compliance
* Subjects who take vitamin D supplements and not willing to go through washout period for ergocalciferol or to take no more than 600 IU/day of total vitamin D supplements
* History, clinical manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject
* Non-diabetic subjects who are diagnosed with T2DM after randomization and need to take anti-diabetic medications are brought for the final visit
Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults

Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore, these dietary non-digestible carbohydrates might relieve functional constipation.

Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.

Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4 weeks.

Study population: Human subjects with functional constipation according to ROMEIII criteria (total n=120; male and female; 18-75 yr).

Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides, (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral chews.

Main study parameters: The primary parameter is the number of complete bowel movements per day in subjects with functional constipation according to Rome III criteria. Secondary outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 yr
* Agree to study design (signed informed consent)
* At least two of the following symptoms ≥25% of the time with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to inclusion (ROME III criteria for functional constipation):

  * straining, lumpy or hard stool
  * sensation of incomplete evacuation
  * sensation of anorectal obstruction ⁄ blockage
  * use of manual manoeuvres
  * \<3 bowel movements per week
* Availability of internet connection
* BMI 20-30
* Male or female
* Willingness to abstain from functional ingredients and such as probiotics, prebiotics and foods containing high amounts of fermentable fibers and laxatives starting 1 month prior to start of the study as well as during the washout period.

Exclusion Criteria:

* Currently participating in another clinical trial
* Drug usage
* Excessive alcohol usage (\>4 consumptions/day or \>20 consumptions/week)
* Pregnancy or lactating
* Underlying disease of the GI-tract or previous laparotomy, except cholecystectomy and appendectomy
* Use of antibiotics within 1 month prior to inclusion
* Vegetarians
* Weight loss \> 5 kg within 1 month prior to inclusion
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia

The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy. The secondary aims are to determine the therapeutic plasma levels, plasma half-life and pharmacokinetics of Exendin (9-39) during a 9-hour intravenous infusion.

This study will enroll infants with congenital hyperinsulinism owing to KATP channel mutations who are unresponsive to medical therapy and will require a pancreatectomy to control hypoglycemia from a single academic medical center in the United States.

An open-label, two-period, two-treatment crossover study design with a dose-escalation component will be implemented. Successive cohorts of patients (up to 5 participants/cohort) will each receive a fixed dose of Exendin (9-39) infusion and normal saline vehicle on two separate days in random order. The protocol specifies 0.02 mg/kg/hr, via continuous intravenous infusion, administered over 9-hours for the first cohort. The volume of saline to be infused will be calculated to match the volume of Exendin (9-39). Successive cohorts will be given doses that are increased in up to 1/2 log increments. Overall, the investigators hypothesize that antagonism of the GLP-1 receptor by Exendin (9-39) will increase fasting blood glucose levels, prevent protein-induced hypoglycemia and decrease glucose requirement to maintain euglycemia in infants with CHI.

Aim 1. To examine the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in infants with congenital hyperinsulinism unresponsive to medical therapy.

Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of Exendin-(9-39) during an intravenous infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed clinical diagnosis of congenital hyperinsulinism
2. Infants less than 12 months of age at study enrollment
3. Failure to respond to treatment with diazoxide

Exclusion Criteria:

1. Evidence of a medical condition that might alter results, including kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
2. Treatment with medications that may affect glucose metabolism at the time of initiation of study procedures, including:

   1. Treatment with glucagon 4 hours prior to infusion (T=0)
   2. Treatment with octreotide 24 hours prior to infusion (T=0)
   3. Treatment with diazoxide 72 hours prior to infusion (T=0)
3. Suspected Beckwith-Wiedemann syndrome or other syndromic forms of congenital hyperinsulinism.
Effects of LRYGB on Pharmacokinetics of Nine CYP Probe Drugs

Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required.

The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs.

The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4).

The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 kg/m2 or BMI 35-40 kg/m2 and a comorbidity or its risk factor, such as type 2 diabetes, hypertension, sleep apnea, osteoarthritis of weight bearing joints or polycystic ovarian syndrome;
* previous conservative treatment for obesity had been proven to be ineffective;
* patients were assigned to undergo LRYGB surgery
* patients are able to give a written inform consent.

Exclusion Criteria:

* smokers
* consuming alcohol more than 20 g per day were included in the study
* taking drugs which alter CYPs activity
* history of hypersensitivity to the drugs used in the cocktail
Evaluation and Comparison Between General Anesthesia VS Two Types of Combined Anesthesia for Opioid Consumption in Laparoscopic Hysterectomy

The aim of the study is to evaluate and compare general anesthesia VS two types of combined anesthesia in opioid consumption after laparoscopic hysterectomy

Managing post-operative pain is essential to reduce length of stay, complications, mortality, healthcare costs and the risk of readmission to hospital. At the same time, pain treatment, especially with opiod drugs, could cause side effects and worsen the quality of post-operative hospitalization. Furthermore, intrathecal fentanyl may cause an acute tolerance to opioids, and may worsen postoperative analgesia. In literature, some studies underline how the use of regional anesthesia represents an effective solution in pain control. The goal of this study would be to determine whether post-operative analgesic needs and pain levels are increased by mixing intrathecal fentanyl with spinal anesthesia and intrathecal morphine.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 year of age,
* ASA physical status I to III scheduled for laparoscopic hysterectomy (with or without adnexectomy)

Exclusion Criteria:

* patients with inability to consent,
* patient refusal,
* contraindication to spinal anesthesia (e.g., hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis, coagulopathies or ongoing anticoagulant therapy),
* known chronic pain syndrome, known
* suspected non- compliance,
* drug, or alcohol abuse ,
* major oncological surgeries,
* allergy to drugs used in the protocol,
* previous chronic use of analgesics
* history of opioid abuse
Semi-personalized IM Smoking Cessation Interventions

Text messaging can provide smokers with quitting methods, information on available smoking cessation (SC) services and social support. This kind of intervention was proven to be effective for smoking cessation. Instant messaging (IM), by sending text and pictures, could provide users with better instantaneous and inexpensive support in their time of need. However, IM intervention is understudied in smoking cessation or other health-related areas to our knowledge, its approaches and efficacy warrant further investigation. This study aims to assess the effect of the combined intervention (nicotine replacement therapy sampling, active referral, and brief advice plus a supportive semi-personalized instant messaging advice) on smoking cessation and to assess the effect of the above interventions on secondary outcomes, including quit intention and attempts, smoking reduction, level of nicotine dependence, use of nicotine replacement therapy (NRT) and SC services.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or above and smoked at least 1 cigarette daily;
2. Hong Kong residents able to read and speak Cantonese;
3. Exhaled carbon monoxide of 4 ppm or above, assessed by a Smokerlyzer;
4. Using a cell phone with instant messaging tool (e.g. WhatsApp, WeChat);
5. Able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication;

Exclusion Criteria:

1. Have psychiatric/ psychological diseases or regular psychotropic medications; and
2. Using SC medication, NRT, other SC services or projects.
Telerehabilitation Exercise in Older Adults

The aim of this study was to investigate the effectiveness of chair-based exercises and cognitive exercises through synchronous telerehabilitation in older adults.

Older adults will be divided into two groups (intervention group n=16; control group n=11) .


Eligibility Criteria:
Inclusion Criteria:

* Getting a score of 6 or above on the Hodkinson Mental Test

Exclusion Criteria:

* -Having another chronic disease that can cause pain Having a neurological disease Being blind Having an orthopedic, neurological or mental disability