cyrilzakka/clinical-trials huggingface dataset:
Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)

Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.

In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.

This study aims to analyse the shape of the different components of the intracranial pressure waves (P1, P2, and P3) when the patient is flattened to determine an index to define the level of cerebral compliance.

Eligibility Criteria:
Inclusion Criteria:

* Continuous intracranial pressure monitoring
* Sedated patient on mechanical ventilation

Exclusion Criteria:

* Craniectomy
* Major hemodynamic failure
Study of the Molecular Mechanisms Underlying the Cross-neutralizing Capacity of AS04-adjuvanted HPV Vaccine (Cervarix®) in Comparison With the Aluminiumhydroxyphosphate Sulphate Adjuvanted HPV Vaccine (Gardasil®)

Six identical female twins aged 9-13 years will participate. One sib of each twin pair will be given Cervarix according to the 0, 1, 6 month vaccination scheme, while the other sib will be given Gardasil according to the 0, 2, 6 month vaccination scheme. Three blood samples will be taken (the first prior to vaccine administration, the second and third 7 days after dose 2 and 3, respectively). The blood samples will be used to determine: 1) the magnitude the anti-HPV 16 and anti-HPV-18 antibody responses, 2) as well as the cross-reactive pattern of these responses towards related, non-vaccine HPV strains (HPV-31 and -33, and HPV-45). 3) plasmablast isolated from blood taken 7 days after the 3rd dose in the first place (and eventually after the 2nd dose also) will be examined for for the usage of VDJ and VJ segments in the immunoglobulin heavy (VH) and light (VL) heavy and light chains. Gene useg in B cells induced by Cervarix and Gardasil will be compared. Finally the cross-reactive potential of monoclonal antibodies obtained by eukaryotic expression of a series of heavy (VH) and light (VL) chains from single ASC isolated after the 3rd dose of a three-dose schedule of either Cervarix or Gardasil will be examined.

The duration of the study is approximately 187 days. Five study visits will take place, over a time period of 6.5 months, followed by a telephone call after 12 months.

The purpose of the study is to learn more about the molecular mechanisms underlying the cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted HPV vaccine (Gardasil®).


Eligibility Criteria:
Inclusion Criteria:

* Six homozygous twins in good health, without preceding sexual activity (virgin). Subjects have a negative pregnancy test on the day of vaccination and have agreed to continue abstinence during the entire study period and for two months after completion of the vaccination series.

Exclusion Criteria:

* Subjects are not participating in any other clinical trials and have not been vaccinated previously against HPV and have not had an administration of MPL or AS04 in the past.
Contoura vs Wavefront Optimized Ablation

To evaluate the efficacy, safety and accuracy of Contoura topography-guided LASIK \& PRK in comparison to Wavefront optimized LASIK \& PRK in virgin eyes with astigmatism.

In Upper Egypt, The second principal cause of blindness was uncorrected refractive errors accounting for 16% of sample population. It was reported that astigmatism (defined as cylinder power \> 0.5 D) was the most common refractive errors in children and adults followed by hyperopia and myopia.

Laser vision correction has been established over the last 2 decades as a safe and effective intervention to treat refractive errors, being one of the main techniques practiced globally.

However, many subjects after LASIK had uncorrected distance visual acuity (UDVA) greater than 1.0, they complain about poor night vision, glare, and double vision. As studies have shown that every 1° deviation of the astigmatic axis could result in loss of correction of 3.3%. Even residual astigmatism less than 0.50D could have an actual impact on visual quality.

Excimer laser ablation used in the correction of refracted errors especially astigmatism may reduce quality of vision, and that is attributed to the induced optical aberrations. The most prevalent of these optical aberrations is the spherical aberration.

Among multiple sophisticated profiles that developed to optimize visual outcomes, wavefront optimized profile which compensate for corneal curvature to reduce spherical aberration.

The topographic guided profiles which consider the shape of the anterior corneal surface. Contoura topography guided ablation corrects astigmatic power and axis to create a more uniform, aberration-free cornea.

Treating astigmatism can be challenging as the conventional patterns of Excimer laser treatment of astigmatism is known to be less predictable than that of spherical refractive errors.

Eligibility Criteria:
Inclusion Criteria:

* Astigmatism (up to 5.0 diopters) or less.
* Central corneal thickness (CCT) of 500 microns or more
* Estimated Residual stromal bed thickness (RSB) of 280 microns or more
* Subject has provided written informed consent

Exclusion Criteria:

* Keratoconus
* Abnormal topography
* previous ocular trauma or eye surgery
* pre-existing diseases of the vitreous, macula, or optic nerve that can affect visual outcome
* patients with uveitis and anterior segment pathology
* patients with corneal pathology or Severe dry eye
* pregnancy or breast-feeding females
* uncontrolled vascular or autoimmune disease
Pathogenesis of Functional Hypothalamic Amenorrhea

This is a randomized pilot study of the use of cognitive behavior therapy versus observation to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.

The study enrollment was completed in 2003. The study results are being analyzed.

Eligibility Criteria:
Inclusion Criteria:

* women with functional hypothalamic amenorrhea
* day awake / night asleep schedule

Exclusion Criteria:

* eating disorders, depression, excessive exercise or any other cause of amenorrhea and anovulation other than functional hypothalamic amenorrhea
* weight loss greater than 10 pounds when amenorrhea developed
* running more than 10 miles per week or exercising more than 10 hours per week
Medical Telephone Triage of Emergency Calls for Thoracic Pain

Thoracic pain is the main symptom of acute coronary syndrome (ACS), urgent and serious illness. Whereas hospital mortality decreased until reaching 10%, out-of-hospital mortality remains high: half of the deaths occur during the first two hours. The benefit of an early diagnosis of ACS in term of morbidity and mortality is well established. Identification of the coronary origin of a thoracic pain by the telephone triage physician of the pre-hospital emergency service (SAMU) leads to the sending of a physician staffed ambulance (UMH) and is thus a key element of the prognosis.

The aim of the study is to build a telephone predictive score of ACS at the triage of calls for non traumatic thoracic pain. The separate analysis of the questionnaires by sex will authorize the validation of a unique score or two distinct scores for men and women.

In France, approximately 30% of the calls for thoracic pain associated with an ACS do not benefit from the sending of an UMH. Our assumption is that this situation could be improved if telephone triage physicians were guided by recommendations or consensual algorithms of decision. The telephone triage doctor will manage a single questionnaire with the patient, with demographic and simple clinical data. The construction of the score will be done by the analysis of these data confronted with the final diagnosis (effective ACS or not). The effective existence of an ACS among patients with thoracic pain will be affirmed by an expert committee after collection of the intra-hospital patient's data and the follow-up at one month.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting a non-traumatic chest pain.
* Call to the telephone triage center in first (direct call from the patient) or second intention (call of another person before the patient)

Exclusion Criteria:

- Inability to speak directly to the patient
Neurocognition and Work Productivity in Major Depressive Disorder (MDD)

This study will investigate the relationships between subjective cognitive complaints, neurocognitive deficits, and work productivity in participants with Major Depressive Disorder (MDD), before and after 8 weeks of treatment with an antidepressant medication. Our hypothesis is that, in working participants with MDD of at least moderate severity, neurocognitive deficits will predict poorer work functioning and productivity.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Major Depressive Disorder as per DSM-IV-TR
2. Current employment of at least 15 hours per week
3. Baseline score of 23 or greater on the Montgomery-Asberg Depression Rating Scale, indicating at least moderately severe depression
4. Baseline score of 6 or greater on the British Columbia Cognitive Complaints Inventory, indicating at least moderate subjective cognitive complaints
5. Competency to give informed consent

Exclusion Criteria:

1. Current receipt of short-term or long-term disability benefits from employer
2. Serious suicidal risks as judged by the investigators
3. Other DSM-IV-TR diagnoses:

   1. organic mental disorders
   2. active substance abuse/dependence, including alcohol
   3. schizophrenia, paranoid or delusional disorders, or other psychotic disorders
   4. (as primary diagnosis:) panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, or post-traumatic stress disorder
   5. bipolar disorder
   6. bulimia nervosa or anorexia nervosa
4. Serious illness that is not stabilized, including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease
5. Regular/current use of other psychotropic drugs and/or herbaceuticals
6. Use of fluoxetine within 5 weeks of Visit 1, monoamine oxidase inhibitors within 14 days of Visit 1, and other antidepressants within 7 days of Visit 1 (all to ensure adequate drug washouts prior to neurocognitive assessment)
7. Previous treatment with desvenlafaxine
8. Treatment-resistance in the current episode, as defined by failure (i.e., lack of clinically significant response) of 2 or more antidepressants given at therapeutic doses for at least 6 weeks
9. Any history of treatment with electroconvulsive therapy
10. Initiation of formal psychotherapy (e.g., cognitive-behavioural therapy or interpersonal psychotherapy) with 2 months of Visit 1, or plans to start such psychotherapy during this study
11. Current use of any other form of treatment for depression
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification.

Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed.

Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:

1. ≥75 years of age OR
2. \<75 years of age with at least 1 of the following:

i. Poor performance status (ECOG) score of 2-3.

ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:

1. Left ventricular ejection fraction (LVEF) ≤50%.
2. Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
3. Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
4. Chronic stable angina or congestive heart failure controlled with medication.

iii. Liver transaminases \>3 × upper limit of normal (ULN).

iv. Other contraindication(s) to anthracycline therapy (must be documented).

v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization.

Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas ≥30 mL/min.

Exclusion Criteria:

Candidate for intensive remission induction chemotherapy at the time of enrollment.

Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators.

Known extramedullary central nervous system (CNS) AML.

Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

Prior treatment with decitabine or azacitidine.

Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.

Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.

Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.

Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring \>2 liters per minute (LPM) oxygen.
Changes in Circulatory I-FABP in Elderly Persons in Daily Life

The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in elderly volunteers following the combination of moderate physical activity and a standard meal.


Eligibility Criteria:
Inclusion Criteria:

1. Age 75 years or older (both sexes)
2. Participating in the Embrace project.

Exclusion Criteria:

1. Previous gastrointestinal resections
2. Chronic inflammatory gastrointestinal disease
Noninvasive Neuromodulation in the Management of Post-COVID Musculoskeletal Pain

Brief Summary:

The post-Covid syndrome is a problem that affects a significant number of people in the world. Among the most common symptoms is pain, and although there is no specific data on neuropathic pain and Covid, due to under-diagnosis, they may be closely related.

Non-invasive neuromodulation acts on the Central Nervous System through the bioelectrical stimulation of nervous tissue and modulation of the system nervous, and can be useful in acute, chronic and musculosqueletal pain, and in symptoms such as stress, anxiety and sleep disturbances.

The objective of this clinical trial is to assess the efficacy of non-invasive neuromodulation in the treatment of post-Covid musculoskeletal pain. Subjects will be randomly divided into two groups: an experimental group in which non-invasive neuromodulation will be applied and a sham group to which it will be applied off. The variables to be studied before, during and after treatment will be neuropathic pain with the DN4 questionnaire, pain intensity with the EVA scale, sleep quality with the Pittsburgh Sleep Quality Index, level of stress and anxiety with the HADS questionnaire and quality of life with the SF12.


Eligibility Criteria:
Inclusion Criteria:

* Positive result in PCR or antigen test for detecting COVID-19 in the last 3 months.
* Present musculoskeletal pain in the last 3 months.
* Age between 18 to 65 years old.
* Score equal or superior to 4 in DN4 scale.

Exclusion Criteria:

* Present musculoskeletal pain of traumatic origin or known cause
* Present musculoskeletal pain with more than 3 months of evolution.
* Pregnant women
* Present of vascular alterations, malignancy, thrombophlebitis or fever.
The Effect of Hippotherapy Applied on Different Seating Surfaces in Children With Special Needs

The effect of hippotherapy, which will be applied to children with special needs in a single session, on sitting balance and walking speed under the supervision of a physiotherapist was investigated. 30 randomly selected children with special needs between the ages of 3-18 who were referred to the Gebze Equestrian Training Center were included in the study. The children were randomly divided into 3 groups: 10 in the saddle, 10 naked (direct contact with the horse), and 10 in the hippotherapy group, in which a cloth of different texture was placed on the horse. Each group did a 30-minute hippotherapy session in the manege area. Before the application, the sitting balance of the children was evaluated by playing the Nintendo Wii Balance Platform and the Basic Balance Game. In addition, 10 m walking test was applied for walking speed. These assessments were repeated after the 30-minute session. It was checked whether the application had an effect on balance and walking speed. Comparisons between the groups were made and it was examined which application was more effective on balance and walking speed.


Eligibility Criteria:
Inclusion Criteria:

* Having a child with special needs between the ages of 3-18,
* Children with a diagnosis of Cerebral Palsy (CP) have a level of 1 and 2 according to the Gross Motor Function Classification System,
* Ability to understand simple commands,
* Ability to sit unaided for at least 10 seconds,

Exclusion Criteria:

* Presence of clinical conditions that may pose an obstacle
* Lack of cooperation
* Presence in another study performed at the same time as the study
* Lack of family approval.
Engaging Sexual and Gender Minority Cigarette Smokers Into Social Media-based Treatment

This research study will evaluate the preliminary efficacy of Pride Posts Plus, a social media-based smoking cessation treatment. A pilot randomized trial (N=120) will compare Pride Posts Plus, which includes a gamification element, to Pride Posts (without gamification) and to a usual care treatment. Participants will be adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be treatment engagement, a quit attempt (y/n), and thoughts about tobacco abstinence at 3 and 6 mos.

Participants (N=136) will be randomized to one of three conditions: (1) Pride Posts, a Facebook-delivered smoking cessation intervention (including daily posts, and weekly live group sessions, tailored to sexual and gender minority (SGM) adults; (2) Pride Posts Plus, the Facebook-delivered smoking cessation intervention plus a gamification element, or (2) a usual care condition which includes referral to smokefree.gov, a federally-developed web-based intervention which includes similar digital treatment elements. All participants will have access to up to six months of nicotine replacement therapy (NRT).

Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to provide biochemical verification of smoking status using a portable carbon monoxide measurement tool. All intervention and assessment procedures will be conducted digitally.

Eligibility Criteria:
Inclusion Criteria:

* Daily smoker
* Self-identify as sexual and/or gender minority
* Interested in quitting in next 6 months
* 6 months of Facebook experience
* English-speaking

Exclusion Criteria:

* Contraindications to nicotine replacement therapy
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes

Eligibility Criteria:
Inclusion Criteria:

1. Both males and females will be enrolled and must be at least 18 years of age and under age of 90
2. Patients with a documented history of IPMN by any imaging method.
3. All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
4. Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
5. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Exclusion Criteria:

1. Patient under the age of 18 and over the age 90
2. Contraindications to LINFU® as determined by study investigators:

   1. Patient with uncorrectable coagulopathy
   2. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
   3. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
3. Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure
4. Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
5. Pregnant females will be excluded
6. Patient that is unable to provide informed consent
7. Patient with known allergy to the microbubble contrast agent or secretin

Study Design Overview: