cyrilzakka/clinical-trials huggingface dataset:
Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing

A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.

Patients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.

The study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)
* Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines
* Signed informed consent for usage of data

Exclusion Criteria:

* Pre-existing coagulation disorders with increased risk of bleeding
* Defects involving the bronchial system (bronchus/trachea/pulmo)
* Any foreseeable deviation from IFU of Suprasorb® CNP endo
* Known intolerance or allergy to one or more components of Suprasorb® CNPendo
Working Memory Training for Substance Dependent Individuals

Background: Substance abusers show impaired working memory (WM) functioning. Promising findings show training WM results in an improved working memory capacity (WMC) and a decrease of clinical symptoms in a range of disorders, including alcohol addiction.

Aim: To test the effect of a WM training in addition to treatment as usual (TAU) on substance use, craving, WMC, impulsivity, attention bias and psychopathology.

Design: A randomized double-blind placebo-controlled trial with a parallel group design. The WM training adapted to participants' WMC whereas the placebo training consisted of non-adaptive easy versions of these tasks.

Setting: Two departments of an addiction treatment clinic in Rotterdam, the Netherlands.

Participants: 120 inpatients diagnosed with an alcohol, cannabis or cocaine dependency who were in treatment as usual .

Measurements: Primary outcome measures: Substance use and craving. Secondary outcome measures: WMC, impulsivity, attention bias and psychopathology. Participants were assessed before and after 24 sessions of WM training as well as two months after the training.


Eligibility Criteria:
Inclusion Criteria:

* Substance dependency: cocaine, cannabis or alcohol

Exclusion Criteria:

* Age below 16 or above 67
* Current psychosis
* Neurological complaints
Ketoprofen Gel vs Placebo in Children With Ankle Sprain

The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

Ankle sprains may be associated with soft tissue injuries and fractures. Although diagnostic modalities are important, alleviation of pain is also a part of emergency department management. The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ankle sprain
* Patients over 8 and lower than 18 years old

Exclusion Criteria:

* Ankle sprain more than 24 hours
* visual analogue scale score lower than 40mm
* Allergy to the study drug
Use of Cyclobenzaprine After Vaginal Surgery

The management of post-operative pain in patients after vaginal surgery provides many unforeseen challenges. Although vaginal surgery is considered a minimally invasive approach for the repair of pelvic floor prolapse and urinary incontinence, patients may still experience varying degrees of discomfort and post-operative pain. Narcotics, however, can introduce a host of problems in addition to the potential addictive properties of the medication. A vicious cycle ensues as patients seek better pain control at the expense of worsening constipation, but without adequate control of pain after surgery, voiding dysfunctions are often exaggerated.

Cyclobenzaprine (Flexeril®) in conjunction with NSAIDs has long been the basis for management of acute musculoskeletal injuries, but the practice of prescribing this centrally acting muscle relaxant for post-operative patients has also been successful in the management of pain.

An online search of medical databases revealed that there are currently no published retrospective or prospective studies determining the efficacy of cyclobenzaprine in post surgical patients in conjunction with traditional pain management. The investigators hypothesize among healthy patients undergoing elective vaginal surgery for pelvic organ prolapse, the short-term use of a muscle relaxant could reduce the spasticity of the pelvic floor muscle attributable to surgery and thereby reduce the use of narcotics. Consequently, the reduction of narcotics and the control of post-surgical pain may also hasten the return of normal urinary and defecatory function.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 years old
* Undergoing vaginal surgery with apical or posterior repair requiring hospitalization
* Willingness to participate in the study
* Normal neurological exam
* English speaking

Exclusion Criteria:

* Contraindication to NSAIDs
* Allergy to hydrocodone, hydromorphone, or cyclobenzaprine
* Renal disease
* Use of any antidepressants including SSRI, SNRI, MAOI in the last 3 months
* Glaucoma
* Diabetes
* Hyperthyroidism
* Uncontrolled hypertension (\>160/100 mm Hg)
* History of chronic narcotic use in the last 3 months
* History of pelvic pain
Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation

The aim of our study is to add to the literature the effect of the effectiveness of the physiotherapy and rehabilitation in the clinic, which will be applied to the patients after the osteochondral allograft transplantation operation, which is a current treatment approach applied after knee cartilage tissue damage, on the range of motion, functionality, pain and muscle strength of the patients during the recovery process. The clinical importance of our aim is that it will have the potential to guide health professionals in determining the appropriate treatment approach in order to reveal the best results that can be obtained due to the lack of many studies in the literature on the treatment of patients after osteochondral allograft surgery.


Eligibility Criteria:
Inclusion criteria:

Patients who underwent osteochondral allograft transplantation surgery Participant's acceptance/desire to participate in the study

Exclusion criteria:

Patient participant's refusal/desire to participate in the study Inability to perform exercises due to infection etc.
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.


Eligibility Criteria:
Inclusion Criteria:

* Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
* Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
* History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion Criteria:

* History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
* Moderate to severe scoliosis
* Back pain due to major trauma or visceral disorder
* Unwilling to refrain from commencing concomitant physiotherapy
* Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
* Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
* Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception
Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test Validation Study

This is a cross-sectional validation study, designed to evaluate the discriminative validity of the Chronic Obstructive Pulmonary Disease Assessment Test translated in a local language in patients with Chronic Obstructive Pulmonary Disease.

The Chronic obstructive pulmonary disease Assessment Test is a new questionnaire that has been developed recently to improve communication between doctors and patients. It is known to have good relationship with other measures of quality of life. For the wider application to practice, it has been translated into a local language in many countries.

Eligibility Criteria:
Inclusion Criteria:

Subjects eligible for enrolment in the study must meet all of the following criteria:

1. Type of subject: Outpatients
2. Informed consent: Subjects must give their signed and dated written informed consent to participate.
3. Gender: Male or Female
4. Age: 40 years of age or older at a clinic visit
5. COPD diagnosis: Subjects with an established diagnosis of COPD in the past 6 months or before.
6. Tobacco use: Smokers or ex-smokers with a smoking history of more than 10 pack years.

Exclusion Criteria:

1. Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if COPD is the current diagnosis.
2. Lung diseases: Subjects with current active respiratory disorders other than COPD, e.g. lung cancer, tuberculosis.
3. Non-compliance: Unable to complete questionnaires
Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches

This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.

For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University.

Inclusion criteria:

* Age range from 2-3 weeks after birth.
* Only the Non-syndromic unilateral cleft lip and palate neonates.
* Newborn infants without any surgical intervention.

Exclusion criteria:

* Patients with the life threatening syndromes.
* Respiratory difficulties are not considered for presurgical treatment.
* Uncooperative guardians.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 2-3 weeks after birth.
* Only the Non-syndromic unilateral cleft lip and palate neonates.
* Newborn infants without any surgical intervention.

Exclusion Criteria:

* Patients with the life threatening syndromes.
* Respiratory difficulties are not considered for presurgical treatment.
* Uncooperative guardians.
Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin

Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes management. Most patients with type 1 diabetes and patients with type 2 using insulin, frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate the insulin treatment and get information about how to change the insulin regimen, if necessary. Without SMBG it is almost impossible to achieve this goal.

The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes not using insulin results in better glycemic control.

Study Objectives:

Primary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on Glycemic control (as measured with glycosylated hemoglobin (HbA1c)?

Secondary: What is the effect of SMBG in patients with type 2 diabetes who are not using insulin on the following parameters:

* Health status
* Diabetes related complaints
* Patient satisfaction
* Cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral blood glucose lowering drugs
* Dosage of oral blood glucose lowering drugs
* Bodyweight (BMI)

Two treatment protocols are proposed. Treatment A consists of self-monitoring of blood glucose and treatment B consists of usual care. Patients in the A-group are instructed to measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and 3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day (no more, no less). Patients should record these glucose values in a diary. Patient will get one page with information in Dutch. No further education than for handling the device and interpreting the values is given, so that besides this intervention, there will be no differences compared with the control group like other forms of education.

The duration fo the trial will be 12 months.

Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes
* HbA1c 7 - 8,5% at previous and present annual check-up
* Use of 1 or 2 different oral blood glucose lowering drugs
* In case of two oral blood glucose lowering drugs, they should not both have a maximum dosage
* Sufficient knowledge of the Dutch language to understand the requirements for the study

Exclusion criteria:

* Change in oral blood glucose lowering drugs in the past three months
* Use of insulin
* Use of device for self-monitoring of blood glucose at the start of the study, or in the preceding 6 months
Association Between Fractional Exhaled Nitric Oxide and Asthma Control

The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma control according to the global initiative for asthma guideline.

From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.

In Thailand, this field of study is less extend, especially in children population. We hypothesized that in uncontrolled or partly controlled group may have high level of fractional exhaled nitric oxide (FeNO) than controlled group.

It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and level of asthma control among atopic asthmatic Thai children and will be the main objective of this research.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of atopic bronchial asthma
* follow up in clinic of allergy and clinical immunology, Siriraj hospital

Exclusion Criteria:

* smoker or past history of smoking
* has chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
* drink ethanol within 48 hours before enrollment
* history of upper or lower respiratory tract infection within 6 weeks before enrollment
* drink caffeine within day before enrollment
* during pregnancy
* history of systemic steroid use within 8 weeks before enrollment
Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients

The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy
* Have undergone mastectomy

Exclusion Criteria:

* Patients who are unwilling to participate
Clinical Trial to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Multiple Myeloma

This is a open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MM with relapsed or refractory disease and have had at least 3 different prior lines of therapy including proteasome inhibitor .
* Evidence of cell membrane BCMA expression.
* Subjects must have measurable disease,including 1) Serum M-protein greater or equal to10 g/L. 2) Urine M-protein greater or equal to 200 mg/24 h. 3)Serum free light chain (FLC) assay: involved FLC level greater or equal to 100 mg/L provided serum FLC ratio is abnormal.
* ≥ 18 years of age at the time of signing informed consent.
* Estimated life expectancy \>3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
* Adequate organ function.
* Voluntarily sign informed consent form(s).

Exclusion Criteria:

* Subjects with graft versus host disease and need to use immunosuppressive agents.
* Subjects who had received chemotherapy or radiotherapy within 3 days prior to the blood collection period.
* Use of systemic steroids in combination within 5 days prior to the blood collection period (except for recent or current use of inhaled steroids)
* Subjects who had previously used any gene therapy product.
* Subjects with known central nervous system disease.
* Subjects with plasmacytic leukemia, Wallenian macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
* Subjects had the following cardiac conditions, including but not limited to unstable angina pectoris, myocardial infarction or coronary artery bypass graft in the 6 months prior to enrollment, severe arrhythmias with poor drug control;
* Subjects infected with active HBV or HCV, HIV, syphilis or other untreated active infections;
* Pregnant or lactating women.
* Subjects who have other uncontrolled diseases and are considered by the researchers to be unsuitable to participate in the study.
* Any situation that the researcher believes may increase the risk of subjects or interfere with the results of clinical trials.
Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage

In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.

In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.

The goal of this study is to determine cerebrospinal fluid and serum markers which will be predictive of vasospasm. This in turn may lead to improved outcomes in this population of patients.

The data will be compared to excess cerebrospinal fluid collected from patients who are undergoing lumbar puncture in the Neurology Clinic or excess cerebrospinal fluid from patients undergoing cranial surgery for other causes like tumor excision.

For patients enrolled in the study, cerebrospinal fluid will be collected by either lumbar puncture or external ventricular catheter. Specimens will be collected immediately pre-operatively if an external ventricular drain is in place or intraoperatively if an external ventricular drain is not present. We will also collect cerebrospinal fluid post operatively after placement of an external ventricular drain regularly from the excess cerebrospinal fluid that has been collected in the drainage bag. CSF will be collected in a serial fashion at multiple time points: immediately post operatively, during vasospasm and before the external ventricular drain is removed.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible to participate in this study are those that have a documented subarachnoid hemorrhage from a ruptured cerebral aneurysm or patients who have excess cerebrospinal fluid after a Lumbar Puncture or surgery for tumor resection.
* 18 years of age or older

Exclusion Criteria:

* Patients or family who are unable to understand the informed consent process will be excluded.
Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder

The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is characteristic of people with social anxiety disorder.

The purpose of this pilot study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based intervention for SAD (MIND-SAD) that incorporates the following components: training in classical mindfulness, including concentration and insight (vipassana) meditation; training in self-compassion; and mindful exposure. An exploratory aim of the study is to evaluate the effects of the mindfulness intervention on biological markers of stress reactivity, including salivary cortisoland salivary alpha-amylase. The study is a two-arm, parallel design, prospective study comparing 12 weekly sessions of MIND-SAD delivered in a group format versus a wait-list control (WLC).

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Social Anxiety Disorder; Baseline score of 30 or higher on the Liebowitz Social Anxiety Scale; Baseline score of 4 or higher on the Clinical Global Impression of Severity

Exclusion Criteria:

* Lifetime history of psychosis or bipolar disorder; substance abuse in the past 12 months; diagnosis of borderline or antisocial personality disorder; serious suicide risk; currently in psychotherapy; regular meditation or yoga practice in the past 12 months