cyrilzakka/clinical-trials huggingface dataset:
Randomised Controlled Trial on Pre-peritoneal Drainage After Totally Extra-peritoneal Hernioplasty for Inguinal Hernia

This is a RCT on drain versus no drain after laparoscopic totally extra-peritoneal hernioplasty. We will assess the difference in seroma formation after surgery in 2 two groups by an independent assessor clinically and radiologist to document the size of seroma after surgery. Other secondary outcomes will be measured including post-operative pain, discomfort, analgesic used, patient satisfaction, recurrence of hernia, wound infection, etc.

Inguinal hernia is a common disease and causes significant morbidity if left untreated. With the advances of laparoscopic approach of extra-peritoneal hernioplasty, it significantly reduces the post-operative pain and lead to a better quality of life with higher acceptance to patients.However, similar to traditional Litchenstein approach, post operative seroma formation is still a common problem encountered after surgery. Numerous method has been described to reduce chance of seroma formation, however, none was proven to be effective except pre-peritoneal drainage. There are currently 2 large retrospective non-randomized cohort study to evaluate the effectiveness of preperitoneal drainage available for reference. We therefore study the feasibility and efficacy of preperitoneal drainage with large scale randomized trial.

Patient fulfill inclusion criteria and consent to surgery and study will be recruited. A standardized pre-peritoneal dissection and mesh placement will be adopted. Immediately before deflation of pre-peritoneal space, randomization will be performed by calling research assistant for study group using computer generated code. Drain will be placed for 23 hours after operation and ultrasonography will be performed immediately after removal of drain. USG will be repeated at post-operative 1 week, 1 month, 3 months, 6 months and 1 year after surgery. For non-drain group, a fake drain will be attach to the skin of the wound to achieve double blinding to patients and assessors. In addition to seroma, patient demographics and secondary outcome including post-operative pain score, discomfort, foreign body sensation, patient satisfaction, infection, recurrence, etc will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 and below 80
* Male or female patients
* Unilateral inguinal hernia
* First occurrence hernia
* Consent to laparoscopic hernioplasty for inguinal hernia

Exclusion Criteria:

* Inguino-scrotal hernia
* Recurrent inguinal hernia
* Incarcerated hernia
* Bilateral inguinal hernia
* Bleeding tendency
* On anti-platelet agent or anti-coagulant
* Co-morbidies
* Decline or not consent to surgery
Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma

To evaluate the effects of intravitreal ranibizumab (IVR) as adjunctive treatment for trabeculectomy with mitomycin C (TMC) in neovascular glaucoma (NVG).

This is a prospective study of 15 consecutive eyes from 14 patients (One patients had NVG in both eyes at presentation.) with NVG presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand between December 2008 and December 2009. Each eye received IVR (0.5 mg/0.05 ml) 1 week before TMC. Trabeculectomy was performed with fornix-based conjunctival flap method.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with neovascular glaucoma
* Age more than 80 year old
* Provide written informed consent

Exclusion Criteria:

* Un-cooperated patients
Effect of Cervical Paraesophageal Lymph Node Metastasis Versus Supraclavicular Lymph Node Metastasis on the Overall Survival of Patients With Thoracic Esophageal Squamous Cell Carcinoma: An Observational Study

The goal of this observational study is to learn about in health conditions of ESCC. The main question\[s\] it aims to answer are:

•Lymph node metastasis(LNM) in cervical paraesophageal or supraclavicular which influence OS more.

Participants will describe the main status quo after surgery

Researchers will compare Lymph node metastasis(LNM) in cervical paraesophageal and supraclavicular to see if dead.

Demographic and pathologic data, including gender, age, pathological T stage, pathological N stage, 8th tumor-node-metastasis (TNM) stage, tumor location, tumor grade, lymphovascular invasion, perineural invasion, LNM, cervical paraesophageal LNM, supraclavicular LNM, and radical resection, were collected from the Sichuan Cancer Hospital and Institute Esophageal Cancer Case Management (SCH-ECCM) database.

Eligibility Criteria:
The inclusion criteria were as follows:

* patients who had undergone esophagectomy and
* patients who exhibited LNM in the supraclavicular region.

The exclusion criteria:

* tumor location outside the thoracic region,
* pathological examination results confirming the presence of non-squamous cell carcinoma, - patients with both cervical paraesophageal LNM and supraclavicular LNM, or
* those with missing required data
Sharing and Talking About my Preferences

The purpose of this study is to figure out the best way to help veterans do advance care planning. This study will examine the effects of two theory based behavior interventions by randomizing veteran into 4 groups to see which veterans will complete the 4 step process of advance care planning.

Purpose: The purpose of this study is to examine the effects of two theory-based behavior interventions on engagement of Veterans in advance care planning (ACP) by means of the following specific aim:

Primary Aim: To conduct a randomized controlled trial examining the effects of: a) usual care; b) computer-tailored intervention (CTI); c) motivational enhancement therapy (MET); d) CTI + MET on the proportion of middle-age and older Veterans receiving primary care at the VA who complete the process of ACP, defined as completing a total of 4 key ACP behaviors, including selecting a health care proxy, communicating with the proxy about goals of care, communicating with the clinician about goals of care, and documenting proxy selection and goals.

Primary Hypothesis: The proportion of Veterans completing ACP will be higher among those in each of the intervention groups compared to Veterans receiving usual care.

All of 4 groups will receive their assessments and, if, their interventions, by telephone and/or mail. The veterans will from the VA Connecticut Healthcare System. Participants will be identified through a data query of the Regional Data Warehouse who have had a primary care visit in the past 12 months. We will then be able to oversample female and minority Veterans.

Eligibility Criteria:
Inclusion Criteria:

* Veteran

  ---Must have seen primary care provider in the past 12 months
* Primary language is English

Exclusion Criteria:

* Severe hearing or vision loss

  * moderate-to-severe cognitive impairment
* active psychiatric illness
* No regular phone or permanent address
The Role of Transpapillary Stenting in the Treatment of Bile Leakage After Liver Transection.

Bile leakage after liver transection is treated by external drainage. The question addressed is whether downstream control by transpapillary stent insertion into distal bile duct can enhance healing.

All patients who present with clinically significant bile leakage after liver resection at postoperative day two or longer are offered the opportunity to become randomized to either continuous external drainage or the addition of transpapillary stent.

Eligibility Criteria:
Inclusion Criteria:

* Liver resection including at least two liver segments.

Exclusion Criteria:

* Hepatobiliary digestive anastomosis.
Prevention of Chronic Lung Disease (CLD) in Preterm Infants

Pulmonary inflammation plays an important role in the early development of CLD. Postnatal glucocorticoids have been shown effective in the prevention or treatment of CLD with various success. However, systemic glucocorticoid therapy often associated with various short term and long term complications. Therefore, modification of the therapeutic regimen is needed. Inhaled steroid, including inhaled budesonide,have been tried but the results are essentially unsuccessful, most likely due to small airways that the inhaled steroid reaching to the peripheral lungs are limited and unpredictable. Direct instillation of budesonide into the airway has also shown to be ineffective, possibly due to poor distribution of steroid in the lungs.

The investigators hypothesize that intratracheal instillation of budesonide, a strong tropical steroid, using surfactant as vehicle would facilitate the delivery of budesonide to the lung periphery and would inhibit lung inflammation and improve the pulmonary outcome. The result of our pilot study (Pediatrics, 2008) indicated this high possibility.

After informed consent is obtained, infant will be randomly assigned to two groups based on a double-blind design. Group I will receive surfactant and budesonide and GII will receive surfactant and air as control through endotracheal route. Therapy will be given every 8 hours until the infant require FIO2 \< 30% or is extubated. The end point of assessment is the combined incidence of CLD and death judged at 36 weeks postconceptional age and the long term neurological and cognitive function at 2-3 years.

The incidence of CLD and death in the selective group of infant is about 60%. Using this 60% incidence in the placebo group and expected 40% (33% improvement) in the treated group, 130 infants in each group is needed to detected a difference, permitting a 5% chance of type I error and 10% chance of type II error. The total safe target number will be 300; 150 in each group. A collaborative study is therefore proposed. The primary outcome to be assessed is the combined incidence of CLD and death. The secondary outcome to be assessed is short term and long term side effects.

Eligibility Criteria:
Inclusion Criteria:

* Infant with birth weight between 500-1500 gram
* Severe respiratory distress syndrome and requires mechanical ventilation with FIO2 \> 60% shortly after birth

Exclusion Criteria:

* Severe congenital anomalities
* Lethal cardiopulmonary status at birth
Gabapentin to Reduce Postoperative Nausea and Vomiting

The intrathecal administration of morphine is gaining popularity. It is easy to do and can reduce the pain after surgery up to 24 hours. However, it causes postoperative nausea and vomiting more than other methods providing postoperative analgesia. Patients suffering from these side effects have to spend a longer period of time recovering in the hospital with high cost of medical treatment.

Objective: to study the efficacy of oral administrating of gabapentin 600 mg before surgery to reduce the postoperative nausea and vomiting in patients receiving intrathecal morphine.

Methods: Eighty patients undergoing orthopedic surgery and receiving intrathecal morphine will be randomized into 2 groups. The first group will receive oral gabapentin 600 mg and the second group will receive a placebo tablet. Both groups will receive a standard prophylactic medication for postoperative nausea and vomiting. The degrees of nausea and vomiting in both groups will be assessed over 24 hours postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general or regional anesthesia receiving spinal morphine
* ASA physical status I-III

Exclusion Criteria:

* Patients with allergy to morphine or gabapentin
* Chronic use of narcotics
* Psychotic
* Bleeding disorder
* Cardiovascular disorder
* Liver or renal failure
* Pregnancy or breast feeding
* Neurologic disorder
Remote Myocardial Ischemic Preconditioning in Humans

Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI.

Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI. We will also test the hypotheses that IP diminishes the inflammatory response to PCI, and that higher baseline blood endothelial progenitor cell counts are predictive of a favorable response to IP.

Aim 1: To evaluate whether remote ischemic preconditioning reduces the frequency of myonecrosis (troponin T≥0.03 ng/ml following PCI).

Aim 2: To evaluate whether remote ischemic preconditioning reduces the inflammatory response to PCI (post PCI hsCRP level).

Aim 3: To evaluate whether pre-procedure circulating endothelial progenitor cell counts correlate with the effect of remote ischemic preconditioning on myonecrosis.

Background: Percutaneous coronary intervention (PCI) frequently results in ischemic myonecrosis. Ischemic preconditioning (IP) has been shown in animal studies to increase the myocardial tolerance to subsequent ischemia. Our primary hypothesis is that remote IP reduces myocardial ischemic injury during PCI.

Aims: The aims of the study are to assess in patients with coronary artery disease requiring PCI, whether remote IP reduces: 1) the frequency of myonecrosis; and 2) the inflammatory response to PCI; and 3) whether the effect of IP correlates with pre-procedure circulating endothelial progenitor cell counts.

Methods: The study is a prospective, randomized trial to assess the efficacy of remote IP as adjunctive non-pharmacological therapy for PCI in patients with stable or unstable angina. Remote IP will be performed by 3 cycles of 3-minutes of arm ischemia alternating with 3- minutes of reperfusion of the arm immediately before PCI. Myonecrosis and inflammation will be detected by measuring serum troponin T and high sensitivity C-reactive protein, respectively. Blood EPC counts will also be measured before the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible for randomization if they meet the following criteria:

  1. Age ≥ 18 years
  2. Clinically indicated elective or urgent PCI

Exclusion Criteria:

* Patients will be ineligible for the study if one or more of the following conditions exist:

  1. Pre-PCI Troponin T ≥ 0.03
  2. Systemic hypotension (systolic \<90 mmHg) or cardiogenic shock
  3. Presence of an arteriovenous fistula or lymphedema of either arm
  4. Currently enrolled in other active cardiovascular investigational studies
  5. Severe endocrine, hepatic, renal, disorders
  6. Pregnancy or lactation
  7. Inability to provide consent
  8. Federal Medical Center inmates
  9. Inability or unwillingness to provide informed consent
Internet-based Exposure Therapy for Excessive Worry

The purpose of this study is to examine if an internet-based exposure therapy is effective in reducing excessive worry amongst patients who suffer from this problem.

Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of excessive worry. The secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression.

Trial Design: Randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished.

Duration: Ten weeks

Primary Endpoint: Change in worry symptoms from baseline to Week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).

Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)

Safety Parameters: Adverse Events is assessed weekly via the internet.

Description of Trial Subjects: Patients \> 18 years old with a PSWQ score more than 56 points

Number of Subjects: 140

Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* ≥ 18 years
* Situated in Sweden
* Informed consent
* Penn State Worry Questionnaire score more than 56 points

Exclusion Criteria:

* Substance dependence during the last six months
* Post traumatic stress disorder, bipolar disorder or psychosis
* Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
* MADRS-S score above 25 points
* Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
* Received exposure based Cognitive behavior therapy (CBT) for pathological worry the last 2 years
Diamel in the Treatment of Metabolic Syndrome

The purpose of this study is to assess the efficacy of Diamel administration in the treatment of Metabolic Syndrome. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome diagnosis according to WHO definition, with or without glucose intolerance.
* Signed informed consent

Exclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes treated with oral hypoglycemic drugs and/or insulin
* Other diseases associated with insulin resistance (eg. Acromegalia, endogenous hypercortisolism, etc)
* Neuropathies or hepatic conditions diagnosed biochemically or by clinical exam.
* Mild or severe heart conditions (eg. heart failure, ischemic cardiopathy)
* Sepsis or any other condition that could potentially interfere with treatment
* Any other treatment that could potentially interfere with treatment
* Pregnancy
Comparison of Insulin Degludec With Insulin Glargine in Subjects With Type 1 Diabetes Mellitus

This trial was conducted in Europe. The aim of this trial was to compare the pharmacodynamic (the effect of the investigated drug on the body) response of insulin degludec (insulin 454) with insulin glargine at steady-state conditions in subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) and treated with insulin for at least 12 months
* Subject is considered to be generally healthy, except for the underlying diabetes mellitus and related morbidity (such as well controlled hypertension and dyslipidaemia) based on an assessment of medical history, physical examination and clinical laboratory data, as judged by the Investigator
* Body Mass Index (BMI) between 18.0 and 28.0 kg/m\^2 (both inclusive)
* Glycosylated haemoglobin (HbA1c) below or equal to 10.0 % based on central laboratory results
* Subject with a daily basal insulin requirement of between 0.2 IU/kg/day and 0.6 IU/kg/day will be allowed to participate in the trial. Current total daily treatment with insulin must be less than 1.2 U/kg/day

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Subject who has participated in any other trials involving investigational products within 3 months preceding the start of dosing
* Subject who has donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
Compression Garments on Hypermobility Type of Ehlers-Danlos Syndrome (CGhEDS)

This study evaluates the effects of wearing a compression garment on the postural balance of patients with hypermobility type of Ehlers-Danlos syndrome, in randomised controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years
* hEDS with the 2017 diagnostic criteria .
* A normal neurological examination with no sensory disorders, no cerebellar syndrome or vestibular syndrome.
* An optimal balanced analgesic treatment before inclusion
* Patients who have not modified their physical treatment (physiotherapy) since 6 months.

Exclusion Criteria:

* Surgery of the lower limb (hip, knee or ankle)
* Patient having already wear compression garments in the year preceding.
* Neurological history of sensory , vestibular or cerebellar disorders.
Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study

The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.

This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.

A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.

Eligibility Criteria:
Inclusion Criteria:

Subjects enrolled in this study must meet the following inclusion criteria:

1. Subject has signed an informed consent.
2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
3. Subject is a candidate for surgery.
4. Subject is 18 to 80 years of age.
5. Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
6. Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

1. Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
2. Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
3. Subject has any condition requiring repeated MRI scans;
4. Subject has any condition requiring diathermy;
5. Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
6. Subject has a history of cranial surgery.
7. Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator.
8. Subject abuses drugs or alcohol.
9. Subject has a history of seizure
10. Subject has confirmation of diagnosis of a terminal illness associated with survival \<12 months.
11. Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control.
12. Subject has participated in a drug, device or biological trial within the preceding 30 days.