cyrilzakka/clinical-trials huggingface dataset:
Mild Therapeutic Hypothermia for Patients With Acute Coronary Syndrome and Cardiac Arrest Treated With PCI

Mild Therapeutic Hypothermia for Patients with Acute Coronary Syndrome and Cardiac Arrest Treated with Percutaneous Coronary Intervention (UNICORN) study is designed to determine whether mild therapeutic hypothermia (MTH) applied in patients with acute coronary syndromes (ACS) and cardiac arrest treated with percutaneous coronary intervention (PCI) is associated with better clinical outcomes as compared with therapy without MTH.

The UNICORN study is a multi-center, international, observational, phase IV clinical trial which is aimed to investigate whether MTH applied in patients with ACS and cardiac arrest treated with PCI is associated with better clinical outcomes as compared with therapy without MTH. This trial will provide important information regarding the impact of MTH in unconscious with a score of ≤8 on the Glasgow Coma Scale on admission to the hospital after out-of-hospital cardiac arrest (OHCA) with diagnosed or presumed ACS and shockable initial rhythm.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Survivor of OHCA
* Sustained return of spontaneous circulation (ROSC) for more than 20 minutes after resuscitation
* Unconsciousness with a score of ≤8 on the Glasgow Coma Scale after ROSC
* Shockable initial rhythm
* Diagnosis or suspicion of ACS

Exclusion Criteria:

* Unwitnessed OHCA
* Obvious or suspected pregnancy
* Known serious infection/sepsis before OHCA
* Known bleeding diathesis
* Confirmed or suspected internal bleeding
* Confirmed or suspected acute stroke
* Confirmed or suspected cerebral injury
* Known serious neurological dysfunction (CPC≤4) before OHCA
* Known serious disease making 180 days of survival unlikely
* Hemodynamic instability with systolic blood pressure \<65 mmHg despite treatment
* Time delay from ROSC to MTH induction \> 240 min.
* Asystole or pulseless electrical activity (PEA) as the initial rhythm
* Initial body temperature \<30°C
D-Cycloserine Augmentation of Exposure and Response Prevention Treatment for Obsessive-Compulsive Disorder

We propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.

Exposure and response prevention (ERP) has proven efficacy for OCD treatment in adults. Yet, ERP does not help all individuals, and those who benefit often remain somewhat symptomatic. Behavioral models for OCD treatment are based on two components. First, fears are acquired by the development of an association between a neutral stimulus and an aversive stimulus such the former acquires the aversive properties of the latter. The neutral stimulus is then designated as a conditioned stimulus (CS), and the original aversive stimulus is called an unconditioned stimulus (UCS). Second, the acquired fears can be unlearned through presentation of the CS in the absence of the UCS, a process known as extinction. On a neural level, ERP incorporates similar mechanisms to those involved in fear conditioning. Antagonists at the glutamatergic NMDA receptor, which is involved in learning and memory, block both fear learning and extinction. D-Cycloserine (DCS), a partial agonist at the N-methyl-D-aspartate (NMDA) glutamate receptor subtype, augments learning in animals and humans. Clinical application in animals and humans suggest that DCS facilitates the fear extinction process when taken prior to exposure to feared stimuli. An initial trial in acrophobic adults provided support for acute DCS dosing as facilitating extinction to fear. Given that ERP is based on extinction, it follows that DCS may augment ERP therapy providing enhanced treatment effects. With this in mind, we propose to undertake an initial study of DCS to determine whether it has any short-term clinical benefits when added to standard ERP therapy in adults with OCD.

Eligibility Criteria:
Inclusion Criteria:

1. a principal diagnosis of OCD assigned at pre-treatment, derived from the ADIS-IV, with a clinical severity rating of 4 or above;
2. 18-65 years of age; and,
3. an IQ of ³ 80.

Exclusion Criteria:

1. positive diagnosis of schizophrenia, other psychotic disorder, pervasive developmental disorder, organic brain syndrome, or mental retardation;
2. do not speak English;
3. are unwilling to attend twice weekly sessions; or,
4. is pregnant, breast feeding a child, or attempting to become pregnant (see below rationale)
Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer

RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

OBJECTIVES:

* To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
* To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.

OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.

Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Eligibility Criteria:
Inclusion Criteria:

-All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.

Exclusion Criteria:

* Inability to provide informed consent
* Minors
* Pregnant women
A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures

A two arm, randomized, double-blind study comparing zonisamide with placebo. The zonisamide arm will consist of 100 subjects and the placebo arm of 50 subjects. Study medication will be administered as an add-on treatment to the subject's current 1 or 2 anti-epileptic (AEDs).


Eligibility Criteria:
Key Inclusion Criteria:

1. Capable of maintaining a seizure daily diary or who have access to a caregiver who is prepared to complete this on the patient's behalf.
2. Able to complete the questionnaires used in this study.
3. Localization related epilepsy, with simple and/or complex partial seizures with or without secondary generalized seizures as defined by the International League Against Epilepsy (ILAE) criteria.
4. Have at least one well documented seizure in the 4 weeks preceding the Randomisation Visit (Visit 2) and are deemed to require additional AED medication.
5. Receiving at least one, but not more than two other marketed AEDs as concomitant medication, and the dosage should be stable for at least four weeks before the Screening Visit.

Key Exclusion Criteria:

1. Seizures attributed to metabolic causes (e.g., electrolyte disturbances, hyperglycaemia).
2. Seizures which could be attributed to use of a drug.
3. Presence of primary generalised epilepsies or seizures, such as absences, myoclonic epilepsies, Lennox-Gastaut syndrome.
4. A history of eating disorders or a body weight below 40 kg.
5. A history of blood dyscrasias.
6. A history of renal stones or having risk factors for nephrolithiasis such as a family history of nephrolithiasis or hypercalciuria.
7. An increased risk factor for rhabdomyolysis such as uncontrolled hypothyroidism, personal or family history of muscle disorders.
8. Taking concomitant medication associated with nephrolithiasis and medications increasing the risk of rhabdomyolysis.
9. Taking rifampicin or drugs with anticholinergic effects.
10. Taking carbonic anhydrase inhibitors or topiramate.
11. A history of pancreatitis.
12. A history of Stevens Johnson Syndrome.
13. Elevated levels of serum creatinine \>165 Umol, or known severe hepatic impairment to the extent that the protocol dose titration schedule cannot be followed.
Ultrasound Guided Percutaneous Cholecystostomy.

Surgical cholecystostomy has proven value in the management of both inflammatory and obstructive biliary tract disease

The etiology of biliary obstruction can be benign or malignant. Benign disease, such as calculi, strictures, or pancreatitis, can be common causes in adult patients \[5\], whereas benign strictures including posttransplant anastomotic strictures and strictures secondary to hepatic artery insufficiency, stone disease, infection, and iatrogenic causes can be seen in children \[6\]. Obstruction can also be seen in the setting of biliary tract abnormalities, such as biliary atresia in neonates and symptomatic choledochal cysts, autoimmune pancreatitis, and sclerosing cholangitis in older children \[7\]. Biliary obstruction secondary to neoplasm commonly occurs with pancreatic cancer, cholangiocarcinoma, or metastases in adult patients and biliary rhabdomyosarcoma or neuroblastoma in younger patients \[8\].

The question remains as to whether all patients undergoing PCT drainage require a definitive cholecystectomy. Previous publications have suggested that there is a reluctance to use PCT in older and comorbid patients due to concerns of potentially committing such patients to an interval surgical procedure for which they may not be suitable.

Eligibility Criteria:
Inclusion Criteria:

* Pyocele of the gallbladder
* Mucocele of the gallbladder
* Perforated gallbladder
* Malignant causes of gallbladder obstruction

Exclusion Criteria:

* Uncontrolled bleeding disorders
Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases

This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.


Eligibility Criteria:
Inclusion Criteria:

* patients with ulcerative colitis or crohn's disease
* treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab
* active disease ( HBI \> 5 for CD patients or SCCAI\> 6 for UC patients)
* patients treated with infliximab only at the time of loss of response

Exclusion Criteria:

* Patients with CD with ano perineal lesions and without luminal activity
* patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate
* patients with acute severe flare (HBI\>12 for CD patients and Lichtiger score \> 10 for UC patients)
* pregnant female
* patients with anal disease alone
Metabolism and Pharmacokinetics of [14C]-BI 409306 After Administration as Oral Solution in Healthy Male Volunteers

The aim of this study is to assess the mass balance recovery from excreta of carbon 14 labelled BI409306 (\[14C\] BI 409306) in healthy, CYP2C19 genotyped subjects and to provide plasma, urine and faecal samples for metabolite profiling and structural identification.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male genotyped as CY2C19 poor metabolizer (PM) or extensive metabolizer (EM) according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Pulse Rate), 12-lead ECG (Electrogardiogramm), and clinical laboratory tests. PM is defined as carrier of two non-functional alleles \*2 and \*3 of the CYP2C19 gene (diplotypes \*2/\*2; \*2/\*3; \*3/\*3). EM is defined as carrier of two functional alleles of the CYP2C19 gene (absence of \*2, \*3, \*17; diplotype \*1/\*1).
2. Age of 30 to 65 years (incl.).
3. BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.).
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
5. A history of regular bowel movements (averaging 1 or more bowel movements per day; subjects with regular bowel movements of \>3 per day will be excluded).
6. Subjects who are sexually active must use, with their partner, 2 approved methods of highly effective contraception from the time of IMP administration until 90 days after the last dose of IMP.

Exclusion criteria:

1. Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogramm) is deviating from normal and judged as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. Any significant history of ocular or eye disease.
6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)
7. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Evaluation of the Stability of Implants With Two Different Surface Treatments

The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.

The selected patients will be randomly divided into two groups by computer-generated list. The control group will receive implant surface treated by acid etching and test group receive implants with hydrophilic surface (Test). Both the test and the control group will undergo the same pre-surgical, surgical and post-surgical protocols.

The evaluation of the implant will be done by the analysis of resonant frequency wich will be performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden) immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th, 8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on these dates will be measured on a scale from 0 to 100. The smartpeg be used with special developed Healing without the use of pillars or intermediaries.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had lost teeth in the posterior maxilla (region of premolars and molars, can be interspace or free end) in need of restoration with implant-supported prostheses
* Able to understand and sign a waiver of informed free consent
* Good oral hygiene
* The receiving implant sites must have at least 3 months of healing after tooth extraction, proper height and width to install an implant of 4.3 mm in diameter and 10 mm of high.

Exclusion Criteria:

* Patients requiring implants in the mandible or anterior maxilla (bone type I and II), or to submit any of the following conditions: general contraindications for surgical procedures, uncontrolled diabetes, severe bruxism or clenching, pregnant and lactating women, active periodontal disease, smoking and use of alcohol or drugs
* Patients who underwent radiotherapy near the buccal cavity regions chemotherapy and those who use or have recently used bisphosphonates, such as alendronate.
Turkish Version of Infant Movement Motivation Questionnaire

Purpose: It is the examination of the Infant Movement Motivation Questionnaire of the validity and reliability of Turkish.

Pretest: Participants were informed about the aims of the study and fill in a consent form. They filled in a paper version of the Turkish translation of the Infant Movement Motivation Questionnaire. The parents had to answer questions about the content and meaning of the IMMQ items and sociodemographic.

Validation Study: Participants were informed about the aims of the study and filled in a consent form. The questionnaires of the survey filled in at the early intervention center. About 30 minutes were needed to answer the 27 questions of the IMMQ, Ages and Stages Questionnaire, and sociodemographic.

The period when human life activity most intense is the first years of life. Different practices such as voicing, speaking, sitting, walking, mental skills, communication, socializing acquire new skills. Infant Movement Motivation Questionnaire(IMMQ) 27-item scale that questions babies' discovery, activity, motivation, and adaptation skills in daily life activities through the parent. The scale was developed in 2012 by Samantha Doralp. As the scale provides information about how babies spend their time in their natural environment and the personal characteristics of babies, it was decided to carry out a validity and reliability study in the Turkish language, considering the early use of support programs in clinical use. The development of this scale shows the first step in understanding the role of baby characteristics in the movement development of babies in the first year of life. A good understanding of the link between baby characteristics and motor development can have a significant impact on planning interventions and can have a significant impact in ensuring that a particular environment is optimally tailored to the child's use and needs.

Eligibility Criteria:
• Volunteers who have babies with typical development between 0-12 months

Exclusion Criteria:

* Parents of babies with a neurological diagnosis
* Parents of babies with vision, hearing loss
* Parents of babies with a genetic and metabolic diagnosis
Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)

The diagnosis of depressed left ventricular ejection fraction (dLVEF) (EF\<50%) depends on golden standard ultrasound cardiography (UCG). A wearable synchronized phonocardiography (PCG) and electrocardiogram (ECG) device can assist in the diagnosis of dLVEF, which can both expedite access to life-saving therapies and reduce the need for costly testing.

The synchronized PCG and ECG is wirelessly paired with the WenXin Mobile application, allowing for simultaneous recording and visualization of PCG and ECG. These features uniquely enable this device to accumulate large sets of acoustic data on patients both with and without heart failure(HF).

This study is a Case-control study. In this study, the investigators seek to develop an artificial intelligence (AI) analysis system to identify dLVEF (EF\<50%) by PCG and ECG. All adults (aged ≥18 years) planned for UCG were eligible to participate (inpatients and outpatients). Specifically, the investigators will attempt to develop machine learning algorithms to learn synchronized PCG and ECG of patients with dLVEF. Then we use these algorithms to identify dLVEF subjects. The investigators anticipate to demonstrate the wearable cardiac patch with synchronized PCG and ECG can reliably and accurately diagnose dLVEF in the primary care setting.

Eligibility Criteria:
Inclusion Criteria:

* Attendance at RuiJin hospital for UCG
* Signed dated informed consent
* Commit to follow the research procedures and cooperate in the implementation of the whole process research
* UCG has been completed
* Age ≥ 18
* At least 8 consecutive cycles of sinus rhythm can be recorded

Exclusion Criteria:

* Patients with pacemakers
* Complete left bundle branch block or block or QRS wave widening\>120ms
* Left chest skin damaged or allergic to patch
* Refusal to participate
Thyromental Height Test as a New Method for Prediction of Difficult Intubation in Obese Patients

The main objective of this trial is to assess the clinical usefulness of thyromental height test (TMHT) in prediction of difficult intubation in obese patients scheduled for elective surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation in obese patients.

Successful and fast intubation are crucial for the safety of general anaesthesia. Failed intubation and acute hypoxia remain among the major contributing factors of anaesthesia related deaths. Difficult intubation prevalence in literature is very inconsistent and varies between 1.5-20% of cases in general population, to even 50% in obese Thai population.

Obesity remains a challenging problem in perioperative care. It is assumed that the airway access may be restricted due to anatomic changes resulting from excess body weight. There are factors like diagnosed obstructive sleep apnoea or large neck circumference that also relate to occurrence of difficult intubation in obese patients.

There is a number of anthropometric scales and tests used for predicting difficult intubation in obese patients. However, none of them appears to be sensitive and specific enough to effectively predict difficult intubation.

Recently, simple and non-invasive test predicting difficult intubation was introduced-thyromental height test (TMHT). It shows promise as a more effective substitution for frequently cited anthropometric measures. It is based on the height between the anterior border of the thyroid cartilage and the anterior border of the mentum, measured while the patient lies in the supine position with closed mouth.

The main objective of this trial is to assess the clinical usefulness of TMHT in prediction of difficult intubation in obese patients scheduled for elective surgical procedures. The secondary aim is to evaluate usefulness of other commonly used predictive tests associated with difficult intubation in obese patients.

Eligibility Criteria:
Inclusion Criteria:

* qualification for elective surgical procedures, requiring general anaesthesia, direct laryngoscopy and intubation
* consent for participation in the trail
* age ≥18 years
* BMI ≥30 kg/m2

Exclusion Criteria:

* BMI ≤30 kg/m2
* patients overweight due to ascites or tumor
* emergency procedures
* visible anatomic abnormalities
* patients scheduled for awake fibreoptic intubation
* intubation failure
* lack of consent for participation in the trail
Developing a Curriculum to Teach Laparoscopic Colorectal Surgery

Although a significant amount of work has been done to validate simulators as viable systems to teach technical skills outside the operating room, the next necessary step is to integrate simulator training into a comprehensive curriculum. The purpose of this study is to develop and validate a comprehensive ex-vivo curriculum for laparoscopic colorectal surgery. This curriculum will include training on a virtual reality simulator, cognitive training and cadaver lab training. The investigators will assess the effectiveness of the curriculum by conducting a randomized single blinded controlled trial. The investigators will be comparing the technical performance of curricular trained and non-trained residents in the operating room, during a procedure on a patient. The investigators hypothesize that surgical residents who participate in the curriculum will have superior technical proficiency and cognitive knowledge relating to performing laparoscopic colorectal surgery compared to conventionally trained residents.


Eligibility Criteria:
Inclusion Criteria:

* resident in general surgery
* post graduate year (PGY) 2 or higher
* performed less than 10 laparoscopic colorectal procedures independently