cyrilzakka/clinical-trials huggingface dataset:
Computerized Olfactory Test - Alzheimer Disease Mild Stage

This study evaluates the effectiveness of the smell tests that are used in early diagnosis of mild dementia.

For twenty years research has shown a strong link between olfactory disorders and Alzheimer's disease. The focus is on the very early alteration of the olfaction which acts as a harbinger of the disease since it is detectable in its asymptomatic phase. In addition, olfactory involvement is a precursor to the transformation of mild cognitive impairment into MA. Indeed the anatomical structures the first lesions are located in the transentorhinal region of the temporal lobe and entorhinal phase, before progressing towards the limbic system, which will mark the clinical appearance of the first signs of AD.

In literature, it has been shown that there was no olfactory test that is recognized as a gold standard in the scientific community due to a lack of homogeneity of the tools used, their availability and their validity depending on the culture. Moreover, of all the tests currently available, none are specific to neurodegenerative diseases.

Very recent studies show that there is also a strong preference for imaging tools or biomarkers in the detection of AD, but it appears that the olfactory disorders are well before these markers. It has been shown that an identification test is comparable in predictive accuracy to neuroimaging and cerebrospinal fluid sampling.

This study will therefore focus on the calibration and validation of a computerized olfactory test for the diagnosis of Alzheimer's disease and based the recommendations of professionals so as to promote the effective use of this test in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Being 60 years old and over
* The participants enrolled in the control group must have a score of the Mini-Mental State Exam test greater than or equal to 28.
* The participants enrolled in the intervention group must have a diagnosis of Alzheimer's disease, and the score of the Mini-Mental State Exam test should be between 20 and 27

Exclusion Criteria:

* Presenting an unstable, acute or current psychiatric or physical condition that is severe enough to prevent the participant from participating in the study, as determined by the investigator.
* Having an uncorrected major visual or hearing impairment or anosmia (total olfaction loss).
Establishing Automatic Method of Counting and Classify Bone Marrow and Peripheral Blood Cells

Counting and classification of blood cells in a bone marrow smear and peripheral blood smear are essential to clinical hematology. To this date, this procedure has been carried out in a manual manner in the great majority of clinical settings. There is often inconsistency in the counting result between different operators largely due to its manual nature. There has not been an effective and standard method for blood smear preparation and automatic counting and classification. The recent advent of deep neural network for medical image processing introduced new opportunities for an effective solution of this long-standing problem. Numerous results have been published on the effectiveness of convolutional neural network in clinical image recognition task.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have suspected or confirmed hematological diseases and receive bone
* marrow or peripheral blood cell morphological examination in National Taiwan University Cancer Center
* Patients who are aged more than 20 y/o

Exclusion Criteria:

•Patients who are not willing to sign informed consents
Botulinum Toxin Injection in the UES for R-CPD

The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection).

This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
3. Between 18 and 65 years old
4. Inability to belch, which is bothersome enough to consider treatment, with or without any of the concomitant symptoms (bloating, flatulence, gurgling noises, etc)
5. Typical findings on high resolution impedance manometry with belch provocation test (Karlien Raymenants et al, DDW 2023)

Exclusion Criteria:

1. Participant has a history of surgery in the upper GI tract, that might interfere with the belch reflex (such as anti-reflux surgery)
2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial, to be decided at the discretion of the investigator.
4. If applicable: Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive
5. Participation in another interventional Trial with an investigational medicinal product (IMP) or device
6. \>65 years old; \< 18 years of age
Simulated Clinical Use Testing On Safety Lancets (Test B)

A simulated clinical use testing on the HTL-Strefa's safety lancets

This study aims to evaluate the safety of the use of the safety lancets: Haemolance Plus, Prolance and MediSafe Solo in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.

The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.

Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:

* evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
* evaluators will be United States (US) residents
* evaluators can read, write, and speak English
* evaluators are at least 18 years old
* evaluators are able to understand and provide signed consent for the study
* evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
* evaluators have no concerns about the ability to perform the simulated skin pricking.

Exclusion Criteria:

Individuals will be excluded if:

* They do not routinely use safety lancets to collect capillary blood samples,
* They cannot read, write, and speak English,
* They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
* They have participated in a product evaluation
A Study of Xeloda (Capecitabine) in Combination With Oxaliplatin in Patients With Metastatic Colorectal Cancer.

This single arm study will investigate possible pharmacokinetic interactions between Xeloda and oxaliplatin, and assess whether the pharmacokinetics of Xeloda and/or oxaliplatin is influenced by the addition of Avastin. All subjects will provide samples for pharmacokinetic analysis during the first 3 cycles of treatment. In cycles 1 and 2 patients will receive a treatment regimen containing Xeloda (1000mg/m2 bid) and oxaliplatin (130mg/m2 iv) and in cycle 3 Avastin (7.5mg/kg iv) will be added to the regimen. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* adenocarcinoma of colon or rectum, with metastatic or locally advanced disease.

Exclusion Criteria:

* previous systemic treatment for advanced or metastatic disease;
* previous treatment with oxaliplatin or Avastin.
Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder

The purpose of this study is to determine the effectiveness and tolerability of atomoxetine (Strattera) in adult patients with generalized social anxiety disorder (an anxiety disorder characterized by a fear of interpersonal interactions).

Controlled studies show that approximately 50% of patients with generalized social anxiety disorder(GSAD)will respond to treatment with available pharmacotherapeutic agents such as SSRI's. This still leaves 50% that respond partially or not at all. Those who do respond, often experience adverse events (e.g., sexual dysfunction), which leads them to discontinue treatment. Thus, there is a strong rational for identifying alternatives to SSRI's that are effective with fewer side effects (or with a different side-effect profile, that features less sexual dysfunction)for the treatment of GSAD. Available data demonstrate that sustained-release venlafaxine, a dual reuptake inhibitor, is also effective for GSAD.(Stein et al., 2005). It is unclear from these studies whether serotonin reuptake is integral to efficacy for social anxiety disorder, or whether norepinephrine reuptake will convey similar efficacy. Atomoxetine (Strattera)an inhibitor of the presynaptic norepinephrine transporter, is an ideal candidate to address both these issues.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women, ages 18-65, in good general health
* Meet DSM-IV criteria for Social Anxiety Disorder

Exclusion Criteria:

* Pregnant or breastfeeding
* Narrow angle glaucoma
* Any uncontrolled medical condition or any medical condition which would represent a contraindication to atomoxetine (Strattera) pharmacotherapy (e.g., hepatic insufficiency, untreated hypertension, untreated cardiovascular or cerebrovascular disease)
* Any concomitant non-psychotropic medications that the physician determines are a contraindication to atomoxetine (Strattera) pharmacotherapy (e.g., Albuterol, various pressor agents)
* Bipolar disorder, or any psychotic or organic mental disorder or dementia
* Current substance abuse or dependency
* Current active suicidal ideation
* Current use of herbal psychoactive treatments such as St. John's Wort
* Concurrent psychotropic medication is not permitted for 2 weeks prior to randomization (4 weeks in the case of fluoxetine) or at any point thereafter.
* Receipt of formal psychotherapy concurrently
* Inability, in the investigator's opinion, to comply with study procedures or assessments
Treatment of Unilateral Posterior Cross Bite in Children

Rapid maxillary expansion and quad-helix are two well established appliances in dentistry used for posterior cross bite treatment. This study aims to compare this two different appliances in patients in their early mixed dentition, regarding treatment effects of the extra oral soft tissue but also dental and skeletal effects, if the children experience any pain and discomfort during treatment and the study also aims to make a cost minimization analysis. Comparison of these different treatments are barely made and no randomized controlled trial is yet published. No study has evaluated the difference of subjective experience during these two treatments. After this study we will know which one of these two appliances are the most effective, regarding cost minimization and treatment result but we are also able to put it in relation to the patients subjective experience


Eligibility Criteria:
Inclusion Criteria:

* Children in the early mixed dentition
* Unilateral posterior cross bite including the first permanent molar

Exclusion Criteria:

* No ongoing sucking habits
* Craniofacial syndroms
* Earlier Orthodontic treatments
* Not able to independently understand and answer the questionnaires
Treatment With Synthetic ACTH in High Risk Patients With Membranous Nephropathy

The purpose of this study is to determine whether treatment with long-acting synthetic adrenocorticotropic hormone is in the treatment of patients with idiopathic membranous nephropathy and high for renal failure.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven idiopathic membranous nephropathy.
* Nephrotic syndrome: proteinuria \> 3.5 g/day and serum albumine \< 30 g/l
* Normal or mildly impaired renal function (eGFR \> 60 ml/min, MDRD formula)
* High risk for renal failure: beta-2-microglobulin excretion \> 500 ng/min
* Relative contra-indication for cyclophosphamide treatment:

  * fertility and wish for (future) family expanding
  * high age ( \> 60 years)
  * former cyclophosphamide treatment
  * intolerance to cyclophosphamide

Exclusion Criteria:

* Clinical,biochemical or histological signs of any underlying systemic disease
* Any infectious disease (including latent tuberculosis and/or latent amoebiasis)
* Active gastric or duodenal ulcers
* Pregnancy, lactation, inadequate contraceptives
* Clinical signs of renal vein thrombosis
* Asthma and /or any allergic conditions or hypersensitivity reactions
* Allergic reaction to synthetic ACTH in the past
Breast Cancer - Navigate - Prospective Cohort

The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.

TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.

Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Diagnosed with non-metastatic breast cancer (stages I-III)
* An order placed for a post-operative chemotherapy cycle by a NM clinician
* Not have initiated a recommended post-operative chemotherapy cycle at the time of study enrollment
* Completed surgery for breast cancer
* First-time diagnosis of breast cancer
* Established care at Northwestern Medicine
* English-speaking as the navigation website is not yet available in other languages
* Access to internet on a smart phone or computer/tablet
* Any ethnic background
* We will only consider patients that sign an informed consent form

Exclusion Criteria:

* Men will be excluded because the navigation website only contains content and resources for women. Men also make up less than 1% of all breast cancer diagnoses and the Breast Cancer-Navigate app/website content was developed for female breast cancer patients.
* Diagnosis of additional, life-threatening condition (e.g., end-stage renal disease, heart failure) which can interfere with timely planned adjuvant chemotherapy treatment for cancer.
S4 :Trial Of Fully Closed-Loop Ventilation In ICU.

Preliminary study to compare IntelliVent-ASV to conventional modes used from intubation to extubation or death in ICU patients requiring mechanical ventilation measuring duration of mechanical ventilation in order to design a multicenter large trial.


Eligibility Criteria:
Inclusion criteria:

- Unselected ICU patients invasively ventilated for less than 24 hours, with an expected duration of MV longer than 48 hours.

Exclusion criteria:

* broncho-pleural fistula
* dyshemoglobulinémia
* moribund patient
* do-not-resuscitate order
* chronic respiratory failure requiring long term ventilation,
* patient ventilated more than 24 hours before admission,
* pregnancy,
* age below 18 years,
* protected patients,
* patient already participating in the study,
* Cheynes-Stockes breathing.
* Included patients with a treatment withdrawal decision within 24 hours after inclusion will be excluded,
* patients transferred to another ICU,
* patients needing ECMO, patients randomized to IntelliVent having less than 20% of time in IntelliVent-ASV.
Evaluation of the ScalpelCric Set and Comparison With Two Further Techniques of Cricothyrotomy

During a cannot ventilate cannot intubate situation surgical airway is the last rescue option. Especially in the prehospital setting the airway management seems to be more difficult than in a hospital setting. Nearly all emergency physicians have a limited experience with cricothyrotomy and it is a unclear what method should be taught for this lifesaving procedure, due to lack of data in humans. The aim of this study is to compare the performance of medical personnel (medical students, paramedics, trainee anaesthetists and consultants) in establishing an emergency surgical airway on a plastic laryngeal model and in a porcine laryngeal model using the Scalpel Bougie technique, the Seldinger technique and the common surgical technique.

Furthermore the investigators want to elucidate whether the training of the 3 techniques has an influence in the decision making of the preferred technique in a subsequently simulated cannot ventilate cannot intubate scenario.

The investigators plan to recruit medical students (University Mainz), paramedics (employed in ambulance and rescue helicopter), trainee anaesthetists and consultants of the department of anesthesiology from the university hospital Mainz. After written informed consent the participants have to complete an pre-study questionnaire, than the participants get an information sheet about the 3 techniques and the investigators show the participants a short video demonstrating the different techniques. All participants have the opportunity to practice one insertion with each method on a plastic laryngeal model.

After that the participants have to perform each technique on the plastic model and the investigators measure the time from initially handling equipment to the final end-point, which the investigators take as a successful placement of the endotracheal tube verified by a fiberoptic position check.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* German language in speaking and writing
* Capability of giving consent

Exclusion Criteria:

* Participants unwilling or unable to give informed consent
Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
* American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI
* Intact spinal reflexes below the level of SCI
* At least 1-year post-SCI
* At least 22 years of age
* Willing to use medically acceptable methods of contraception, if female and of child-bearing potential

Exclusion Criteria:

* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of enrollment
* History of chronic and/or treatment resistant urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Untreated clinical diagnosis of depression
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in another interventional clinical trial
* Presence of conditions or disorders which require MRI monitoring
* A history of coagulopathy or other significant cardiac or medical risk factors for surgery
* Current use of a ventilator
* Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
* History of frequent hypotension characterized by light headedness, or loss of consciousness
* History of frequent hypertension characterized by headache, or bradycardia
* History of frequent, severe, autonomic dysreflexia
* Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Risk Factors for Co-existence of Cervical Elongation in Uterine Prolapse

The presence of co-existence of cervical elongation in women of uterine prolapse may decrease the patients' satisfaction of uterine-preservation surgery for uterine prolapse, and additional surgery, such as Manchester surgery, may be needed to solve the problem.Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.

Purpose:

Thus the aim of this study is to investigate the risk factors of co-existence of cervical elongation in uterine prolapse.

Patients and Methods:

Between January 1994 and October 2014, all women underwent vaginal total hysterectomy in a medical center were enrolled in this study. Medical records were reviewed. Cervical elongation is defined as the presence of cervical length \>3.38 cm or cervix to corpus ratio \>0.79.

Expected Results:

The investigators will get the risk factors of co-existence of cervical elongation in uterine prolapse, and the result should be helpful for preoperative consultation, especially for uterine-preserving pelvic floor reconstruction surgery.

Eligibility Criteria:
Inclusion Criteria:

* All women with uterine prolapse underwent vaginal total hysterectomy
* \> 20 years old.

Exclusion Criteria:

* nil