cyrilzakka/clinical-trials huggingface dataset:
Colvera for Detection of Disease Recurrence

To compare the sensitivity and specificity estimates of Colvera with that of a commercially available CEA test for detection of recurrent disease in CRC subjects who are undergoing surveillance for recurrence.

This is an observational, prospective comparison study, where blood is collected for assay of methylated BCAT1 and IKZF1 DNA and CEA, from subjects who have undergone curative treatment for primary CRC of stages II and III (AJCC) and who are in remission and scheduled for follow-up radiological imaging as part of their surveillance program for recurrence. Participation is for one visit only as part of each subject's surveillance-monitoring schedule. Two K2-EDTA blood tubes and two PAXgene™ tubes will be collected Any evidence of methylated BCAT1 and/or IKZF1 DNA in blood represents a Colvera "positive" result. CEA levels of 5ug/L or higher will represent a "positive" result. Sensitivity and specificity of the Colvera and CEA test will be estimated and compared in a paired fashion in each case where recurrence status has been investigated and determined by the site clinical management team. Blood testing shall be performed and analyzed by qualified staff blinded to clinical status. This is a cross-sectional observational non-significant risk study, and test results will not be used for clinical management, i.e. there will be no interventions in subjects consenting to participate in this Research Study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older, and capable and willing to provide informed consent.
2. Subject has undergone curative treatment for primary CRC of stages II and III (AJCC).
3. Subject has no clinical evidence of disease (NED) (after initial treatment)
4. Subject has concluded course of initial treatment for primary CRC (i.e. end of surgery, chemotherapy and/or radiotherapy)
5. Subject is willing/able to provide a blood sample

Exclusion Criteria:

1. Subject has evidence of residual disease.
2. Subject has other organ cancer at the time of recruitment.
3. Subject has prior history of recurrent CRC.
4. Subject has concurrent serious non-neoplastic illness that makes enrollment impractical or clinically inappropriate.
5. Subject is receiving chemo- or radiotherapy at the time of blood collection, or between blood collection and radiological imaging.
Mechanical Ventilation- Weaning and Thoracic Impedance Tomography

The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.

This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned.

The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods


Eligibility Criteria:
Inclusion Criteria:

* age≥18 years
* duration of controlled mechanical ventilation≥ 24 h
* temperature≤ 39°C
* hemoglobin≥ 6 g/dl
* ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O
* ability of the patient to breathe spontaneously
* informed consent

Exclusion Criteria:

* patient participated in another interventional trial within the last four weeks before enrollment
* peripheral neurological disease associated with impairment of the respiratory pump
* muscular disease associated with impairment of the respiratory pump
* unstable thorax with paradoxical chest wall movement
* planned surgery under general anesthesia within 72 hours
* difficult airway or intubation
* existing tracheotomy at ICU admission
* expected survival\<72 hours
* home mechanical ventilation or on chronic oxygen therapy
* suspected or confirmed pregnancy
A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma

This trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS）detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of subcranial hematoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years old
2. Unilateral subcranial hemorrhage confirmed by cranial CT

Exclusion Criteria:

1. Bilateral subcranial hemorrhage
2. Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT
3. Obvious skull fracture in the location of hemorrhage on cranial CT
Health-Related Quality of Life in Children and Adolescents With Clubfoot

This prospective cohort study aims to evaluate the health-related quality of life (HRQoL) in children aged 2 to 15 years with congenital clubfoot, treated primarily according to the Ponseti method. The study will assess HRQoL using the Pediatric Quality of Life Inventory (PedsQL 4.0) and clinical outcomes using the PBS Clubfoot Score (PBS). Participants will be followed for 2 and 5 years to evaluate changes in HRQoL and clinical function. The primary objective is to understand the long-term impact of clubfoot and its treatment on patients' physical, emotional, and social well-being.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 15 years diagnosed with congenital clubfoot.
* Undergoing treatment or follow-up at Drammen Hospital.
* Both unilateral and bilateral cases included.
* Written informed consent from parents or legal guardians.

Exclusion Criteria:

* Concurrent severe medical or psychological conditions affecting outcomes.
* Lack of written informed consent.
* Incomplete or missing data for PedsQL or PBS assessments.
Impact of a Multimodal Prehabilitation Program Before Robotic-assisted Radical Prostatectomy.

The aim of the study is to verify whether a multimodal prehabilitation programme prior to robotic radical prostatectomy contributes to a faster recovery of quality of life after surgery, to better functional results (including erectile function and continence) and to less perioperative anxiety.

Single center randomized clinical trial including prostate cancer patients undergoing robotic-assisted radical prostatectomy at the Hospital Clínic de Barcelona. Patients will be randomized into two groups, one receiving multimodal prehabilitation and the other a control group. Multimodal prehabilitation consists of improving the functional and mental capacity of an individual to cope with a significant stressor, in this case surgery. The design of our prehabilitation program, lasting 4 weeks prior to surgery, consists of three parts; physical state, nutritional state and mental health. In the case of physical condition, a series of supervised and "home-based" exercises (aerobic and functional) will be carried out in addition to specific pelvic floor exercises. The nutritional status will be evaluated by a nutritionist. Diet guidelines will be given and if there are deficiencies they will be supplemented. Regarding mental health, a visit will be made with a psychologist and group and online therapies will be offered. The outcomes will be evaluated before starting the prehabilitation program, at the end of it (just before surgery) and at 4, 8 and 16 weeks after surgery. The outcomes include variables on physical, nutritional and mental state, health-related quality of life (HRQoL), and continence and erectile function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with localized prostate cancer
* Candidates to robotic radical prostatectomy

Exclusion Criteria:

* Non-localized prostate cancer
* Previous history of pelvic radiotherapy or pelvic surgery
* Failure to consent,
* Unwillingness to participate
* Anticipated failure to adhere to the program sessions.
A Research Study Looking at the Comparability (Bioequivalence) of Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

The study will look at how two different forms of semaglutide reach and stay in the blood after injection. None of the two forms of semaglutide have been approved by the authorities to treat obesity, but it has been approved as a treatment for diabetes mellitus. Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance. Participants will get the medicine as an injection under the skin of the belly using a pen-injector. The type of pen-injector is different for the two forms of semaglutide. The study staff will teach participants how to inject the medicine. Participants will take an injection once a week and will get a total of 21 injections of study medication. The study will last for about 27-30 weeks. Participants will have 25 study visits with the study doctor. For 2 of the visits, participants will stay in the clinic for 3 days and 2 nights. Participants may have to stop the study if the study doctor thinks that there are risks for their health. Women cannot take part if they are pregnant, breast-feeding or planning to become pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive)
* Body weight between 70.0 and 130.0 kg (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Inability or unwillingness to perform self-injection
Comparison of Two Novel Indirect Laryngoscopes to the Macintosh Laryngoscope in Patients With Cervical Spine Immobilization.

It is essential that anaesthetists successfully perform orotracheal intubation in scenarios in which intubation is potentially more difficult, such as where the neck is immobilized.

The Airtraq® Laryngoscope and the CMAC are new intubating devices. They are designed to provide a view of the glottis without alignment of the oral, pharyngeal and tracheal axes.

These devices may be especially effective in situations where intubation of the trachea is potentially difficult.

The efficacy of these devices in comparison to the traditional Macintosh laryngoscope in situations where the cervical spine is immobilized is not known.

The investigators aim to compare the performances of the Airtraq® Laryngoscope and the CMAC to that of the Macintosh laryngoscope, the gold standard device, in patients in which the cervical spine has been immobilized by means of a Manual in-line stabilization of the spine.

Hypothesis: The primary hypothesis is that, in the hands of experienced anaesthetists, time to intubation would be shorter using the indirect laryngoscopes, than using the Macintosh laryngoscope in simulated difficult laryngoscopy.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 - 3
* Aged 18 - 85 years
* Written informed Consent
* No relevant drug allergies
* Mallampatti 1 - 2.

Exclusion Criteria:

* Patients unable to cooperate with airway assessment (2)
* Patients with predicted difficult intubation

  * Mallampatti III or IV
  * Thyromental distance \< 6cm
  * Mouth opening \< 3.5 cm
  * Cervical spine disease
  * Anteriorly protruding incisors
  * Poor Dentition (2)
  * Tumours, polyps or foreign bodies in the upper airway (2)
  * Patients with documented difficult airways (2).
  * Patients with history of or risk factors for gastric regurgitation (i.e. require rapid sequence induction of anaesthesia)
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.

To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).


Eligibility Criteria:
Inclusion Criteria:

* subjects over 18 years,
* subject about having a chest pain of coronary syndrome,
* subject about not having received heparin or LMWH

Exclusion Criteria:

* subject minor
* subject without informed consent,
* subject after receiving an anticoagulant treatment,
* transplanted heart, kidney or liver
"Assessing the Impact of Personalized Music Playlists on Procedural Anxiety and Crown Preparation Performance Among Young Dentists: a Randomized Controlled Trial"

The objective of this study was to evaluate the effectiveness of personalized music playlists in reducing procedural anxiety among young dentists performing crown preparations for porcelain-fused-to-metal (PFM) crowns.

A randomized controlled trial with a parallel-group design was conducted at the Department of Prosthodontics, School of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, from April 12th, 2024, to October 11th, 2024. A total of 64 young dentists (20-30 years old) were randomly assigned to two groups: the experimental group (Group A), which listened to personalized music during the procedure, and the control group (Group B), which received no music. Anxiety was measured using the State-Trait Anxiety Inventory (STAI) before and after the procedure. Physiological parameters, including heart rate and respiratory rate, were also monitored. The preparation was evaluated based on a structured scoring rubric, assessing critical parameters. The scoring was conducted by two experienced prosthodontists who were blinded to the participant's group allocation. Statistical analysis was performed using SPSS version 25.0.0, with a p-value of \<0.05 considered statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Young dentists 20-30 years.
* Recently graduated from dental school. (graduated within the last 1-3 years.)
* No hearing impairments or known psychiatric disorders.

Exclusion Criteria:

* Dentists with previous experience in anxiety management techniques.
* Those who have already participated in similar studies.
Chlamidia Antibodies Test for Tubal Factor Screening

The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for screening of tubal factor in patients who undergo artificial insemination.


Eligibility Criteria:
Inclusion Criteria:

* Age \< 38 years
* FSH \< 12.
* Treatment intrauterine insemination

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease
* Severe male factor
* Policystic ovarian syndrome
* Previous abdominal or uterine surgery
* Prevous abdominal or genital infections
* Uterine myomas
* Hidrosalpinx
* Uterine congenital abnormalities
In-Vivo Assessment of Silver Biomaterial Nano-Toxicity 32 Ppm

The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old without debilitating chronic disease or history of cardiovascular event.

Exclusion Criteria:

* Women physically capable of becoming pregnant, who are not using 2 barrier methods of birth control;
* Any female who is nursing;
* History of heavy metal allergy;
* History of asthma or Chronic Obstructive Pulmonary Disease;
* History of renal impairment;
* Symptoms of active upper respiratory disease at time of consent;
* Smoking more than 5 cigarettes or equivalent and not able to stop for 48 hours;
* Ability to discontinue chronic medications or nutraceuticals for 20 days or 5 half-lives of the agent, whichever is longer.
50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia

This trial attempts to investigate whether the dosage (frequency) has an effect on the treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST, while the other half will be recruited to 50 Hz MST.

Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT).Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects. Though high dose (frequency) MST is gaining popularity, there is no evidences supporting its superiority over low dose (frequency) MST either on efficacy, safety, or seizure quality.

Eligibility Criteria:
Inclusion Criteria:

1. DSM-5 diagnosis of schizophrenia;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the positive and negative syndrome scale (PANSS)\[20\] score ≥ 60;
4. informed consent in written form.

Exclusion Criteria:

1. diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. other conditions that investigators consider to be inappropriate to participate in this trial.
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
ATP Level and Cough Sensitivity to ATP in Subjects With Refractory Chronic Cough

This is a prospective case - control study to investigate ATP level in induced sputum and cough sensitivity to ATP in subjects with refractory chronic cough. 60 refractory chronic cough and 30 matched healthy controls were recruited. Medical history records, cough severity assessment, induced sputum for ATP measurement, ATP evoked cough and capsaicin evoked cough were completed. The difference of sputum ATP level between patients and control and the correlation between sputum ATP level and cough sensitivity to ATP were analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Chronic cough as sole symptom lasting ≥6 months;
2. No potential causes were identified after full investigations or cough persisted after treatment trials directed to potential causes;
3. Cough Visual Analogue Score ≥30mm.

Exclusion Criteria:

1. Current or recent smokers (\<6 months abstinence) , those with \>20 pack-year smoking history;
2. With a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) ratio \<60%;
3. With a history of upper respiratory tract infection or significant change in pulmonary status within 4 weeks.
A Study to Investigate the Glucose Lowering Effects of Dextromethorphan Alone or in Combination With Sitagliptin in Subjects With Type 2 Diabetes Mellitus (T2DM) After an Oral Glucose Tolerance Test

The study has a randomized, double-blind, placebo-controlled, double dummy and eight-way cross-over design. Males with T2DM on a stable metformin monotherapy will be screened for participation in the study. Eligible subjects will be randomized to receive DXM 30 mg, DXM 60 mg, DXM 90 mg alone or in combination with sitagliptin 100 mg, sitagliptin 100 mg alone, or placebo (for DXM and sitagliptin) on in total eight treatment days. An OGTT will be started 1 hour after study drug administration and blood glucose will be measured over the next 4 hours. There will be a 3 to 14-day washout period between doses.

This study is performed to determine the optimal dose of DXM that, compared to placebo, decreases glucose excursions following an OGTT. Doses of 30 mg, 60 mg and 90 mg DXM were chosen. Since DXM 60 mg was effective in the previous study in increasing insulin secretion, this dose will be kept. A lower dose (30 mg) will be given to see whether effects on insulin secretion are present also at lower doses and then translate into a BG lowering action. A higher dose (90 mg) will be added to see whether this way an effect on glucose excursion reduction occurs following an OGTT, (like previously demonstrated with 270 mg DXM) that can be related to an increase of insulin secretion.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated written informed consent obtained before any study-related activities
2. Male subjects with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening
3. Medical history without major pathology (with the exception of type 2 diabetes)
4. On a stable regimen of metformin monotherapy for at least 3 months
5. Aged between 45 and 70 years of age, both inclusive
6. Body mass index (BMI) between 25 and 35kg/m2, both inclusive

Exclusion Criteria:

1. Subjects with type 1 diabetes, MODY or secondary forms of diabetes such as due to pancreatitis
2. History of pancreatitis
3. Current or previous treatment with insulin therapy
4. Treatment with any hypoglycemic medication other than metformin within the three months prior to screening
5. Mean QTc\> 450 msec
Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age

To determine the Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age.

Our study will compare the Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age as in our population compliance with oral medication is better among patients, and is socially and culturally more acceptable.

Eligibility Criteria:
Inclusion Criteria:

* Age:02 to 05 Years of Age
* both genders will be included.
* patients diagnosed with allergic rhinitis.

Exclusion Criteria:

* patients older than 05 years of age
* a positive history of HIV,TB,Immune deficiency.
* any nasal structural abnormality i.e.polyps,deviated nasal septum.
* history of frequent nasal bleeding,epistaxis.
* concomitant asthma.