cyrilzakka/clinical-trials huggingface dataset:
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction

The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.

Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.

The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* 1.\> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal

Exclusion Criteria:

* 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR\>1.5, Platelet\<50000) 4.expected survival \> 3 months based on Karnofsky performance score 5.duodenal stricture
Sublingual Microcirculation Data of Patients With Systemic Diseases

This is an observational clinical study, patients with systemic diseases will be enrolled according to the inclusion and exclusion criteria. 360 patients will received the examination of sublingual microcirculation by using sidestream dark filed video microscope. The microcirculation data includes total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The patients will be divided into right groups according to their systemic diseases as follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis (60), group 5 peripheral arterial occlusive disease (30), group 6 coronary artery disease (30), group 7 liver cirrhosis (30), and group 8 anemia (30).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 20 to 79 years old
* BMI ranged from 18.5 to 27 kg/m2
* Presence of one of the condition

  1. Diagnosed hypertenison \> 6 months, without other systemic diseases
  2. Diagnosed diabetes mellitus \> 6 monthes, without other systemic diseases
  3. Diagnosed with both hypertension and diabetes mellitus \> 6 months, without other systemic diseases
  4. Diagnosed with end stage renal disease and recevied renal replacement therapy \> 6 months
  5. Diagnosed with peripheral arterial occlusive diseases \> 6 months
  6. Diagnosed with coronary artery disease \> 6 months
  7. Diagnosed with liver cirrhosis \> 6 months
  8. Diagnosed with anemia \> 6 months, hemoglobin level \< 10 g/dL

Exclusion Criteria:

* Diagnosed with sepsis, major tauma, or admission to ICU within one month
* Body temperature higher than 37.5 ℃ or lower than 35.5 ℃
* Any on of the following condition

  1. Asthma
  2. Chronic obstructive pulmonary disease
  3. Endocrine diseases
  4. Hematological disorders
  5. Uncured cancer
  6. Chronic uncured infection
  7. Other major disease with limited daily activity
* Non-native speakers
Evaluation of the Effects of Diosmin/Hespiridin Combination on the Clinical Outcomes in Patients With Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is one of the most prevalent disorders worldwide. Insulin resistance, inflammation and disturbance in sex hormone levels are the main contributing factors of this disease.The majority of studies addressing the status of chronic low-grade inflammation in PCOS have focused on the measurement of C-reactive protein (CRP) followed by stimulation of interleukin 6 (IL-6) and tumor necrosis factor (TNF-alpha).

Daflon 500 mg tablets (containing 90% of diosmin and 10% of hesperidin) is used in patients to treat varicose veins, venous ulcers, hemorrhoids and lymphatic insufficiency. It has anti-diabetic, anti-inflammatory, microcirculatory, and antioxidant effects. So the aim of the work is to investigate the effect of Diosmin/Hesperidin in the management of PCOS through evaluation of Oxidative stress and inflammation, improvement of signs and symptoms through patients' follow-up, improvement of PCOS status by sonography and hormonal levels, measuring of anti-diabetic effect by measuring, fasting insulin, HOMA-IR and measuring the improvement of patient's quality of life by using the women health questionnaire (WHQ).


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of PCOS aged in the range from18-40 (premenopausal adults) diagnosed with PCOS according to Rotterdam criteria by an expert gynecologist; (1) oligo-ovulation and/or anovulation (2) Clinical and biochemical hyperandrogenism and (3) polycystic ovaries on ultrasonography

Exclusion Criteria:

* 1-Pregnant and nursing women 2-Menopause women 3-Diabetic patients 4-Adrenal hyperplasia 5-Adrenal Tumor 6-Thyroid dysfunction 7-Women on confounding medications which affect ovarian function
A Study to Test the Effectiveness of Different Interventions to Improve Physical Activity in Adults.

During the initial months of the COVID-19 pandemic, physical activity (PA) engagement levels declined worldwide. Despite the overwhelming adoption of wearable fitness tracker (WFT) devices, it continues to be unclear as to their effect on PA engagement or PA motivation. Building on past research, we hypothesized that combining a WFT with a known impactful intervention, motivational interviewing (MI) would positively influence both self-determination theory (SDT) motivation and PA during an unprecedented global emergency.

A four-group randomized controlled study was conducted amongst 40 inactive adults over a 12-week period during the COVID-19 pandemic. One group (WFT, n = 10) received a wearable fitness tracker, a second (MI, n=10) received bi-weekly MI sessions, a third (WFT+, n=10) received both, and a fourth (Education, n=10) received basic PA education. Outcome measures for motivation and PA were measured though an online survey before and after the 12-week period.


Eligibility Criteria:
Inclusion Criteria:

* Females or males, aged 18 or older,
* does not currently engage in 150 minutes of moderate to vigorous PA per week,
* owns an Android, or iPhone smartphone device,
* is willing to download a mobile app to be used on the smartphone device, 5) is willing to wear a small, wrist worn fitness tracker for the duration of the study, and 6) is be willing to attend 6 biweekly MI sessions over 12 weeks.

Exclusion Criteria:

* a history of myocardial infarction, angina, coronary artery bypass surgery, congestive heart failure, or diabetes,
* limiting conditions such as concurrent cancer treatment, peripheral artery disease, orthopedic injury, or pain limiting arthritis,
* seeking to participate in other structured PA programs during the duration of the study,
* pregnant at the initiation of the study or plans to become pregnant during the study, and
* alcohol or other substance abuse within the previous 12 months.
SocknLeg - a User Friendly Medical Compression Study of a Modified Application of a Medical Device

The study intends to investigate a novel compression system termed Socknleg composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking.

The investigator tests a novel compression system termed Socknleg in 20 healthy individuals and 20 patients with chronic venous disease. Socknleg is composed of an understocking covering the foot with three added stockings extending from the ankle to the knee without covering the foot. The novel Socknleg system is compared to a standard class III compression stocking. Outcome measures are successful donning and the comparison of interface pressure measured on the level of the ankle.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers: age \> 18 years, proband information read, consent form signed
* Patients: age \> 18 years, chronic venous insufficiency CEAP C5 (healed venous ulcer).Age \> 18 year, patient information read, consent signed.

Exclusion Criteria:

* Active venous ulcer
* Peripheral arterial disease
* Peripheral neuropathy
Comparison of Two Volar Plating Systems for Distal Radius Fractures

We plan to compare 2 types of plating systems for volar plating of distal radius fractures (Aptus 2.5® Medartis AG, Basel, Switzerland vs. INTEOS 2.5® - Hofer Medical GmbH and Co KG, Austria) in a prospective single-blinded controlled clinical trial.

This study represents a prospective randomized clinical trial comparing two different systems of volar plate osteosynthesis in patients with distal radius fractures.

Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Envelopes will be prepared containing equal number of cards representing either the conventional or the novel plating syste. On the morning of the surgery a randomly picked envelope decides allocation one of the study groups. Patients will be blinded to treatment until completion of the study. Patients allocated to the control group receive Aptus 2.5® volar plate for distal radius fractures (Medartis AG, Basel, Switzerland), while patients in the study group will receive the plating system INTEOS 2.5® (Hofer GmbH and Co KG, Austria). In the control group, the pronator quadratus muscle will be cut prior mounting of the plate, while in the treatment group the plate will be inserted underneath the pronator quadratus leaving the muscle intact.

Eligibility Criteria:
Inclusion Criteria:

* " Distal radius fracture, Type A2, A3, B1, B2, B3, C1, C2 (according to AO Müller classification3) " Patient age between 18 and 75 years " Closed fracture or I° open fractures (according to Gustilo-Anderson classification6) " Agreement of patient to participate and written informed consent

Exclusion Criteria:

* " Polytraumatized patients " Severe systemic disorder (ASA 3) " New and/or preexisting fracture/Injury of contralateral forearm " II° and III° open fractures (according to Gustilo-Anderson classification6) " Associated injuries of the ipsilateral wrist (e.g. scapholunate dissociation, concomitant fractures) " Non-compliance to postoperative protocol (e.g. physiotherapy) " Delayed definitive surgical treatment of more than 14 days after injury " Change from temporary procedure (e.g. Fixateur externe) " Complex regional pain syndrome (CRPS, M.Sudeck) " Loss to follow-up
Long-Term Efficacy in AMD of Rheopheresis in North America

The purpose of these studies are to evaluate the effect on vision in subjects with AMD who received active and placebo treatment in the MIRA-1 study.


Eligibility Criteria:
Inclusion Criteria:

* Must have participated in treatment arm of MIRA-1 trial and completed 4 treatments and 6 and 9 month follow up visits.
* Dry AMD in at least one eye.
* Available for study duration of 12 months.
* Weigh \>110 lbs.
* If on lipid-lowering medication must remain on for duration of trial. If not, must agree to not initate during trial.
* Normal Pt/ PTT. If on coumadin, at the discretion of the investigator.
* Must be highly motivated, alert and oriented, and able to provide consent.
* Agree to discontinue current ocular vitamin regimen and take uniform supplement provided by the sponsor.

Exclusion Criteria:

* Both eyes wet AMD.
* Condition limiting view of the fundus.
* Poor general health or unstable diseases.
* HCT \< 35%, evidence of active bleeding, platelet count \<100000 K/uL, prolonged Pt/ PTT, or significant coagupapathies.
* significant cardiac problems.
* Uncontrolled hypertension.
* History of CVA of TIA within a year.
* Significant hepatic, renal, or pulmonary disease, or insulin dependent diabetes.
* Allergy to fluorescein sodium and indocyanine green (ICG), heparin, ACDA, local anesthetics, or adhesive tape.
* Pregnant or breastfeeding women, or women of childbearing potential not using chemical or mechanical contraception.
* Investigation trial within 30 days.
* Major surgery within 30 days.
* Unwilling to adhere to visit schedule.
* Unstable medical of psychological condition.
Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)

4L split dose PEG is the gold standard for bowel preparation, however it comes with poor tolerability and poor compliance. Combination of PEG with different agent is useful in reducing total volume, improving compliance and tolerance of patient.

The objective of this study is to demonstrate that combination bowel preparation, PEG plus SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when compared to large volume PEG.

This is a prospective, randomized, single-center, single-blinded, non-inferiority trial.

Participants with out patient colonoscopy arranged will be included and randomized in a 1:1 ratio to receive either a split dose of 4L PEG + Electrolyte (Klean-prep® ) or 1L Klean-prep® plus 2 sachets SPMC (Picoprep®).

Trained endoscopists will be using the Boston Bowel Preparation Scale (BBPS) to assess the quality of bowel preparation. Patient would also rate the tolerance, compliance and adverse effect by filling the questionnaire before the colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Patient who mentally capable to consent for participating the trial
2. 18 - 65 years old
3. Scheduled for 1st colonoscopy
4. Elective outpatient colonoscopy

Exclusion Criteria:

1. Prior colorectal or abdominal-pelvic surgery
2. Inflammatory bowel disease
3. Active bowel condition eg intestinal obstruction
4. Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis and hypomotility syndrome
5. Recent myocardial infarction, congestive heart failure, uncontrolled hypertension
6. Renal dysfunction, hepatic disease
7. Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or antidiarrhoeal agents
8. Hypersensitivity to PEG or SPMC solution
9. Pregnant or breastfeeding women
10. Inability to give informed consent
Adolescent Acts of Kindness Intervention With Reflection

Adolescents will complete a 4-week intervention, during which they will either complete a kind act for others, complete a kind act for others with a reflection component, or report their daily activities three days per week. Psychological measures will be indexed before and after the intervention.

There is growing policy and scientific interest in promoting the positive benefits of kindness and prosociality. This is particularly true for adolescents, whose psychological and social maturation offers fertile ground in which kindness can be seeded early in life with potentially positive effects on their psychological health. Much of the existing efforts have focused on large-scale community engagement and service-learning programs. Investigating less costly and time-intensive alternatives is necessary to broaden engagement and access. This project aims to implement one such effort with an enhanced acts of kindness intervention for adolescents. The enhancement incorporates existing evidence that requiring adolescents to reflect upon and savor their experience of helping others promotes the positive impact of such interventions. 120 high-school-aged youth will be recruited and assigned to one of three groups (40/group). Participants will either conduct a kind act for others, complete a kind act for others with a reflection component (enhanced condition), or report their daily activities three days per week for 4 weeks. During this intervention, they will receive text messages 3 days per week instructing them to complete their respective act. Participants will provide a brief description of this act that evening, as well as complete brief surveys at the end of the week for each week of the intervention. Participants will also complete a pre- and post-intervention questionnaire and participants' parents will complete a brief survey at the start of the study to provide demographic information and an idea of what prosocial behaviors participants witnessed in their home. The investigators will use these data to assess the effects of prosocial behavior on psychological health. Conceptual frameworks from developmental psychology guide the hypothesis that prosocial behavior will influence adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 14-17

Exclusion Criteria:

* None
Novel Diagnostics and Probiotics to Improve Management of Paediatric Acute Gastroenteritis

Many children admitted to hospital in Botswana without bloody diarrhoea are presumed to have viral gastroenteritis and so not treated with antibiotics - but they may indeed have a treatable cause for their illness. We will conduct a randomized trial to see if rapid testing using novel methods to identify potentially treatable causes of diarrhoea leads to improved outcomes. We will also be randomizing children to probiotic therapy versus placebo (the standard of care) to see if this treatment decreases the duration of diarrhoea. The proposed study is a pilot trial, necessary before embarking on a large multi-centre trial.


Eligibility Criteria:
Inclusion Criteria:

* acute non-bloody gastroenteritis

Exclusion Criteria:

* diarrhoea \> 14 days
* sepsis, pneumonia, UTI, meningitis requiring empiric antibiotic therapy
* malignancy, IBD
* known link to another patient with diarrhoea of defined aetiology
* transferred in already on antimicrobials
* live outside study area
* children with severe acute malnutrition will be eligible for diagnostic arm but not probiotic arm
Comparison Endotracheal Cardiac Output Monitor (ECOM) to a Standard Device in Measuring Heart Blood Volume

The purpose of this study is to evaluate a new monitor that measures cardiac output (amount of blood pumped by the heart). The system that is being tested in this study, called Endotracheal Cardiac Output Monitor (ECOM), uses electricity (impedance cardiography) to measure cardiac output and is not harmful to the patient.

This study will test the accuracy and efficacy of the ECOM system in anesthetized and sedated patients who, in the normal course of clinical care in the OR or ICU, are having cardiac output measured. The investigators propose that unlike the standard system for cardiac output measurement, the ConMed ECOM System should result in a simplified, inexpensive, continuous, less-invasive, and accurate method of measuring cardiac output. Such a technique could allow the rapid diagnosis of instability in the cardiovascular system for critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Patients requiring all of the following:

  * an oral ET tube
  * an arterial catheter
  * measurement of CO

Exclusion Criteria:

* Patients not competent to give informed consent
Radiosurgery for Drug Resistant Invalidating Tremor

Stereotactic lesioning of thalamus and basal ganglia for treatment of tremor is a well-known procedure which, prior to the introduction of deep brain stimulation, or DBS, was usually achieved using stereotactic surgical procedures.

Radiosurgery of invisible targets to treat movement disorders and intractable pain are still the domain of frame-based procedures, due to the need of a solid reference system registered to the anterior commissure-posterior commissure (AC-PC) line, which allows the use of stereotactic atlases.

In this study we want to utilize a mathematical method that uses atlas-derived stereotactic coordinates to perform frameless images-guided radiosurgery of such functional targets Particularly the aim of the present study is to investigate both the efficacy and the safety of the methodology to treat upper limb and hand tremor in elderly or in patients which are not ot susceptible of surgical procedures. For these reasons a dose escalation prospective trial have been designed.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by severe upper limb tremor refractory to medical therapy and who are candidate for a deep brain stimulation (DBS) procedure.
* Age: ≥ 18 years old
* Refusal of DBS procedure
* Written consent

Exclusion Criteria:

* Pregnancy
* Allergy to contrast medium
* DBS procedure susceptibility, if not refused
Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study

The purpose of this study is to determine if telecare using modern telecommunication devices can improve the metabolic control and the quality of life of type 1 diabetic patients.

We aim at comparing conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion (CSII) (face-to-face visits) with an intensive coaching using the Web and the cellular phone network for data transmission and Short Message Service (SMS). This telecommunication device is called GlucoNet. The specific objectives are to measure the efficiency of GlucoNet in improving metabolic control, reducing health care costs and improving the quality of life of patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* Age ≥ 18
* HbA1c between 7.5 and 10%
* Treated with continuous subcutaneous insulin infusion for a minimum of 3 months

Exclusion Criteria:

* Unstabilized diabetic microangiopathy
* Ongoing pregnancy or planned pregnancy
* Unwilling to perform a minimum of 4 capillary blood tests per day
* Unable to use the GlucoNet device
Effects of Systematic Patient Feedback on Therapy Outcome

The aim of this study is to evaluate the effects of a feedback-system in psychotherapy on adult out-patients at a community mental health centre. It is hypothesized that the intervention will lead to more effective treatment, decreasing treatment dropout as well as improving patient-therapist relationship and patient activation in treatment.


Eligibility Criteria:
The aim is to include a total of 128 patients.

Inclusion Criteria:

* Referred for treatment of mental disorder(s)

Exclusion Criteria:

* Psychiatric emergency
* Poor/no understanding of Norwegian language
* Lack of ability to execute the practical procedures required for the project