cyrilzakka/clinical-trials huggingface dataset:
Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term effects are not known. The objective was to to evaluate long term effects of laparoscopic adhesiolysis for treating chronic abdominal pain.

Therefore one hundred patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 3, 6 and 12 months and 12-year follow-up.

This multi-center randomized controlled trial, included patients with chronic abdominal pain likely to be caused by adhesions from previous abdominal surgery. Chronic abdominal pain was defined as continues or intermittent abdominal pain of at least six months' duration. After excluding other pathology (see exclusion criteria) included patients underwent a diagnostic laparoscopy to confirm the adhesions and to exclude serious morbidity not visible with other diagnostics. If during laparoscopy adhesions were the only pathology present, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. For the randomization and surgical procedures the investigators refer to the original article. Patients were unaware of their treatment assignment and the outcome assessment was blinded. Abdominal pain and quality of life (QOL) were assessed pre-operatively and at 3, 6 and 12 months of follow-using a visual analog scale (VAS), verbal rating pain change score (VRCS) and the short form 36 (SF-36). After twelve months randomization was disclosed and placebo group patients with persisting abdominal pain could request laparoscopic adhesiolysis. After twelve year follow-up pain, QOL, medical history and analgesic intake were analyzed to assess the long term effects of laparoscopic adhesiolysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and above with chronic abdominal pain that was likely to be caused by adhesions due to previous abdominal surgery were recruited. Before attributing abdominal pain to the existence of adhesions all patients had an extensional diagnostic work-up to exclude other pathology.

Exclusion Criteria:

* Current treatment by psychologist or psychiatrist
* Use of laxatives, sedatives, morphine, antipsychotics, antidepressants, or drugs that stimulate the central nervous system
* Abnormal outcome of standardized non-invasive diagnostics:

  * Biochemical investigation
  * Lactose tolerance tests or H2 respiration test
  * Feces analysis of worms and worm eggs
  * Ultrasound or CT scan of the abdomen
  * Radiographic studies of small and large bowel (or colonoscopy)
Comparative Evaluation of Osseodensification Versus Conventional Implant Site

The present study is a human, prospective, randomised controlled clinical trial conducted to explore and compare the clinical and radiological outcome of Osseodensification protocol with conventional implant site preparation protocol. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Twenty two dental implants were placed in twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.

All the patients received Norris implant. the implant site preparation technique being Osseodensification protocol for the test group and conventional implant site preparation protocol for the control group, eleven in each group. The clinical and radiographic parameters were recorded at baseline, immediate post implant placement, six months and twelve months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Single/multiple missing teeth in the maxillary anterior/posterior region.
2. Bone density of D2 or D3 (Carl E.Misch).
3. Patients between 18-75 years.
4. Patients who demonstrate good plaque control (PI\<10%) and showing good compliance.
5. Patients willing to participate in the study.

Exclusion Criteria:-

1. Insufficient density or height of residual ridge.
2. Patients with bleeding disorder or on anticoagulant therapy.
3. Pregnant and lactating females.
4. Patients with history of smoking.
5. Use of systemic antibiotics in the past 3 months.
6. Patients treated with any medication known to cause periodontal changes.
7. Drug and alcohol abuse.
8. Occlusal interferences.
9. Patients with history of titanium allergy.
10. Immunocompromised state and debilitating disease.
11. Malignancy or radiotherapy/chemotherapy for malignancy.
12. Systemic diseases that would negatively influence wound healing.
Coronary Covered Stents Implantation for the Treatment of Coronary Artery Perforation

A clinical trial of Coronary Covered Stents System for the treatment of coronary artery perforation.

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Coronary Covered Stents System for the treatment of coronary artery perforation.

Eligibility Criteria:
General Inclusion Criteria

1. Subjects aged ≥ 18 years.
2. Subjects with perforated coronary or aortic-coronary bypass graft vessels.
3. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.

Angiography Inclusion Criteria

1. The lesion is a perforated coronary artery or aortic coronary bypass graft vessel of Ellis type I, type II or type III.
2. Reference vessel diameter from 2.5 mm to 4.0 mm.
3. According to the judgment of the investigator, the perforations require covered stent coverage and for which the covered stent can be delivered.
4. Up to one perforated lesion will be treated and up to one covered stent expected to be implanted.

General Exclusion Criteria

1. Subjects who are unable to receive anticoagulation or antiplatelet therapy.
2. Subjects who are unable to tolerate 6 months of DAPT treatment.
3. Subjects who are allergic to aspirin, heparin, contrast agents, cobalt-based alloys (including metallic elements such as cobalt, chromium, nickel, and tungsten), or polytetrafluoroethylene.
4. According to the judgment of the investigator, subjects who are poorly compliant and unable to complete the study as required; or subjects who are otherwise deemed unsuitable for the enrollment.
5. Primary or secondary cryptogenic coronary perforation or bleeding.
6. Patients who are expected to require treatment with an adjunctive device such as IABP/ECMO.

Angiographic Exclusion Criteria

1. anatomical structures proximal to the target lesion or within the lesion (e.g., severe tortuosity, etc.) that would obstruct delivery of the coronary covered stent.
2. implantation of the covered stent may result in occlusion of a significant coronary branch relevant to the treatment.
3. left or right coronary opening area or coronary sinus entrapment.
4. balloon dilation can not relieve bleeding symptoms
5. Subjects who need to implant two or more covered stents
6. primary or secondary unexplained coronary perforation, or ≥ 2 perforation sites.
7. Other conditions that are not suitable for covered stents treatment.
An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.

This study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

This study will be conducted in multiple countries, all outside of the United States. The study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden, Denmark, Norway, France, and Italy

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent.
2. Male or female aged 18 years or older.
3. Patient with previously confirmed chronic spinal cord injury, either:

   1. Traumatic; at any level and any completeness of injury and ASIA grade classification, or
   2. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.
4. At least 3 months post spinal cord injury at time of consent.
5. NBD score ≥10, confirmed at Baseline .
6. Only TAI treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. Peristeen®).
7. Confirmed NBD refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18.
8. Able to handle smartphone/tablet.

Exclusion Criteria:

1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.
2. Untreated rectal impaction.
3. Any radiotherapy to the pelvis.
4. Any current treatment with anticoagulants (not including aspirin or clopidogrel).
5. Any current treatment with long-term systemic steroid medication (not including inhalation agents and/or local topical treatment).
6. Current use of prokinetics.
7. Any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision).
8. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.
9. Overt or planned pregnancy.
10. Ongoing symptomatic UTI as judged by investigator.
11. Diagnosed psychiatric illness, considered as unstable by the investigator.
12. Diagnosed with MS.
13. Involvement in the planning and conduct of the study (applies to both WHC staff and staff at the study site).
14. Previous enrolment in the present study.
15. Simultaneous participation in another clinical study that may interfere with the present study.
Single Nucleotide Polymorphisms (SNPs) Associated With Postherpetic Neuralgia

Postherpetic neuralgia (PHN) is a common condition and affecting 5 to 30% of the herpes zoster patients. In some cases, the pain remained refractory after first and second line treatment for herpes zoster. This suggests that there may be genetic variants that make some patients susceptible to PHN. Using saliva samples from herpes zoster patients the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in pain and PHN.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 50 years
* Clinically defined herpes zoster patients

Exclusion Criteria:

* Patients not able to provide informed consent
The Clinical Efficacy of the Video Laryngeal Mask (SaCoVLM™) in Geriatric Patients: A Comparison With a Conventional Supraglottic Airway Device (Ambu®Auragain™)

This study aims to investigate whether the use of a video LMA device (SacoVLM™) will facilitate successful supraglottic airway device (SAD) insertion compared to the use of a conventional 2nd generation SAD (Ambu®Auragain™) in elderly patients. This study is a randomized trail with a 50% probability of being assigned to either group. Randomization will be done by an anesthesiologist not involved in anesthesia or postoperative outcome assessment. Patients and the investigator in charge of postoperative outcomes assessment will be blinded to group allocation.


Eligibility Criteria:
Inclusion Criteria:

Adult patients 65 years of age or older, ASA class I\~III, scheduled for elective surgery under general anesthesia under 2 hours, and eligible for SAD use for airway maintenance.

Exclusion Criteria:

Refusal to participate, patients unable to read consent form, anticipated difficulty in face mask ventilation or airway management based on past history or anatomical structure, upper respiratory tract infection, airway-related diseases such as asthma or pneumonia, risk of gastroesophageal reflux
Probing the Role of Feature Dimension Maps in Visual Cognition: Manipulations of Relevant Locations on Salience Processing? (Expt 3.1 Pilot)

How do we know what's important to look at in the environment? Sometimes, we need to look at objects because they are 'salient' (for example, bright flashing lights of a police car, or the stripes of a venomous animal), while other times, we need to ignore irrelevant salient locations and focus only on locations we know to be 'relevant'. These behaviors are often explained by the use of 'priority maps' which index the relative importance of different locations in the visual environment based on both their salience and relevance. In this research, we aim to understand how these factors interact when determining what's important to look at. Specifically, we are evaluating the extent to which the visual system considers locations that are known to be irrelevant when considering the salience of objects. We're testing the hypothesis that the visual system always computes maps of salient locations within 'feature maps', but that activity from these maps is not read out to guide behavior for task-irrelevant locations. We'll have people look at displays containing colored shapes and/or moving dots and report aspects of the visual stimulus (e.g., orientation of a line within a particular stimulus). We'll measure response times across conditions in which we manipulate the presence/absence of salient distracting stimuli and provide various kinds of cues about the potential relevance of different locations on the screen.

The rationale is that by measuring changes in visual search behavior (and thus inferring computations performed on brain representations), we will determine how these aspects of simplified visual environments impact the brain's representation of important object locations. This will support future studies using brain imaging techniques aimed at identifying the neural mechanisms supporting the extraction of salient and relevant locations from visual scenes, which can inform future diagnosis/treatment of disorders which can impact our ability to perform visual search (e.g., schizophrenia, Alzheimer's disease).


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 55 years of age
* normal or corrected-to-normal vision

Exclusion Criteria:

• N/A
Role of Vitamin D in Secondary Prevention of Cardiovascular Events

The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

The purpose of this study is to determine if Vitamin D supplementation helps prevent recurrent cardiovascular events, such as heart attack or stroke, in patients who have already experienced at least one cardiovascular event. This study will investigate if the addition of 150,000 international units of cholecalciferol (vitamin D3) by mouth every 2 months to a subject's medication regimen will prevent further cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of age \> 19 years at the time informed consent is signed.
* Subject with a diagnosis of unstable angina (with Thrombolysis in Myocardial Infarction (TIMI) score of greater than or equal to 3) / NSTEMI or STEMI,or documented coronary artery disease defined as at least one coronary artery with \> 50% occlusion
* Subject who is able to come back to our clinic for follow up visits for at least 1 year after enrollment.

Exclusion Criteria:

* Subject is on treatment with either phenytoin or phenobarbitol or orlistat (since these medications may cause vitamin D deficiency).
* Subject who needs two or more steroid bursts per year for other co-morbid conditions (since steroids may impair vitamin D metabolism).
* Subject is on an investigational drug, which is a new drug class and not part of standard ACS protocol.
* Subject is taking supplements of vitamin D with doses \>400 IU/day.
* Subject has hypersensitivity to vitamin D products.
* Subject has history of systemic lupus erythematosus (since vitamin D deficiency is common in this group27).
* Subject has history of sarcoidosis (since they have hypercalcemia and high levels of vitamin D28)
* Subject has history of renal stones.
* Subject has hypercalcemia, which is defined as serum calcium levels \>10.6 mg/dl, at the time of screening.
* Subject has end stage renal disease, defined as either chronic kidney disease stage V or requiring dialysis (since these patients have altered vitamin D and calcium metabolism).
* Subject has systemic disease (including terminal cancer, cirrhosis, end stage COPD etc.,) with reduced (\<12 months) life expectancy.
* Subject has a history of psychiatric illness/condition that would interfere with his/her ability to understand or complete the requirements of the study.
* Subject has any condition that in the opinion of the investigator places the subject at an unacceptable risk as a participant in this study.
* Subject is pregnant.
Selected Aspects of Mental Health of Athletes

The study will assess the prevalence of mental health problems among different athletes. The study is based on the application of the battery of psychodiagnostic questionnaires, which were chosen aiming at investigating the prevalence of different symptoms related to problems in mental health or disorders.

This descriptive cross-sectional study will undertake sample with athletes categorized by the quality of their achievement.

In the field of sports, there is a lot of knowledge about sports injuries, nutrition and regeneration. Much less is known about mental health among athletes. The investigators often think that the incidence of mental problems is low among top athletes. As the main cause of this misconception, the authors attribute the idealization of sports and athletes. Both the professional and the lay public are often of the opinion that only mentally strong individuals can be successful, which of course means that there is no place in the highest level for individuals with mental problems and disorders.

The clinical study will be performed with 400-500 athletes of both genders aged 18 to 40, from Slovenia. The investigators will invite all athletes who have been categorized in the current year and classified into the membership category, i.e. national, international, world or Olympic class (there were 500 at the last categorization) and they compete in various sports disciplines. The study will be designed as a cross-sectional study. For the purpose of the research, the investigators will use a battery of psychodiagnostic questionnaires consisting of five parts: demographics and sport characteristic, depression symptomatic, anxiety symptomatic, eating problems, alcohol use and abuse and resilience characteristics of individual athlete.

Eligibility Criteria:
Inclusion Criteria:

* Included in competitive play
* Is a professional athlete or participates in organized professional sports activities

Exclusion Criteria:

* Present injuries
* Recreational athletes
* Any other significant diseases
Comparison of Two Biphasic Insulin Regimens

Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices

A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.

Eligibility Criteria:
Inclusion Criteria:

* regular attendees of Outpatient Clinic of the Diabetes Centre of the 1st Department of Internal Medicine of University Hospital in Thessaloniki Greece
* The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin
* baseline HbA1c\<7%

Exclusion Criteria:

* the presence of type 1 Diabetes Mellitus
* stage 4 Chronic Kidney Disease
* use of antidiabetic medications other than insulin and metformin
* major cardiovascular event during the last six months
* acute illness and hospitalization during the last two weeks
* pregnancy
* absence of good metabolic control assessed with self-monitoring of blood glucose during the week before entering the study (\>20% of the measurements \<80mg/dl or \>130mg/dl)
* inability of the patients to understand the study procedures and sign the consent form
Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)

The aim of this study is to adapt and validate to the Spanish the European Quality Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically ill and dying patients in the ICU.

The aim of this study is to adapt and validate a Spanish-language version of the European Quality Questionnaire (EuroQ2). Using a forward-backward translation methodology, we will translate the EuroQ2 into Spanish and will evaluate its psychometric characteristics in a clinical sample of 200 family members responsible for making medical decisions for patients who are discharged from the ICU or who died in the ICU. Cronbach's alpha values, confirmatory factor analysis (CFA) will be evaluated in order to know the reliability, construct validity, and convergent validity.

Eligibility Criteria:
Inclusion Criteria:

* Family members of patients admitted to the ICU for 48 hours or more.
* Family members responsible for patient decision making in the ICU who consent participate.

Exclusion Criteria:

* Family members younger than 18 years,
* Family members not able to read or write Spanish
Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty

The study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group).

Sensory innervation of the hip region involves branches of the lumbar plexus and sacral plexus. Effective post operative analgesia can be approached by blocking the lumbar plexus at the level of the quadratus lumborum muscle. Quadratus lumborum block has several approach methods (anterior, lateral, posterior, and intramuscular). Anterior quadratus lumborum block also known as transmuscular QL block or QL3, the local anaesthetic (30ml of bupivacaine 0.375%) is injected between the psoas major muscle (PM) and the quadratus lumborum muscle (QL). Therefore, the anterior quadratus lumborum block may generate analgesia from T10 to L4 covering the sensory innervation of the hip region.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists physical status \|-\|\|\| , scheduled to undergo unilateral hip replacement via lateral approach.

Exclusion Criteria:

* patient refusal.
* History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension.
* coagulation disorders.
* History of allergy to the study medication.
* Infection overlying the injection site.