cyrilzakka/clinical-trials huggingface dataset:
KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING

Titanium pistons cause MRI artifacts that prevent interpretation of the vestibule. This disadvantage is not present on CT but the vestibule is not visible. Hence the interest in creating a model with 6 reference cuts in order to position the utricle and the saccule in the vestibule in CT. Furthermore, the scanner has fewer contraindications, greater availability and a shorter examination time than MRI.

The aim of the study is to analyze six normal sections chosen as reference in histology, high resolution T2 MRI and CT in order to compare them with precise topographical landmarks to position the posterior membranous labyrinth in CT. Then, apply the investigators' observations to cases of operated otosclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years old) and minors (≥ 6 years old)
* Subject having received an MRI of the internal ear canals from the HUS between 01/01/2018 and 01/01/2021 or a CT scan of the rocks between 07/01/2015 and 01/01/2021
* Normal MRI or CT on the side opposite the pathology.
* Normal tonal audiogram on the side opposite the pathology (peripheral facial paralysis assumed to be cold for MRI and petrous fracture for CT).
* Subject who has not expressed his opposition, after information, to the reuse of his data for the purposes of this research.
* Holders of authority who have not expressed their opposition, after information, to the reuse of their child's data for the purposes of this research

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Holders of parental authority who have expressed their opposition to the reuse of their child's data for the purposes of this research
* Imaging with artifacts
* Absence of pure-tone audiogram or its abnormality on the side of the ear studied
* Any malformation or pathology of the vestibule on imaging on the side of the ear studied
* Subjects under guardianship or curatorship
Lung Ultrasound to Detect Pulmonary Complications in Critically Ill Parturients

This study aims at describing the frequency, timing and type of pulmonary complications detected with lung ultrasound in critically-ill parturients in admitted to a high-dependency unit in Freetown, Sierra Leone.

Rationale: The three big 'killers' in parturients, peripartum hemorrhage, sepsis and pre-eclampsia all predispose to pulmonary complications. These complications affect management before, during and after the primary obstetric problem has been solved. A timely diagnosis and thorough follow-up of pulmonary complications may benefit parturients. Lung ultrasound (LUS) is a point-of-care imaging bedside tool increasingly used in the critical care setting that may prove useful in parturients.

Objective: To describe frequency, timing and type of pulmonary complications detected with LUS in critically ill parturients in a high-dependency unit (HDU), and to determine the association with outcome.

Hypotheses: Pulmonary complications detected by LUS are frequent in parturients admitted to a HDU in a resource-limited setting, and are associated with hospital mortality.

Study design: A prospective observational study. Study population: Critically ill parturients admitted to the HDU of the Princess Christian Maternity Hospital (PCMH) in Freetown, Sierra Leone.

Sample size: No formal sample size calculation is performed. Based on current rates of admissions to the HDU of the PCMH the investigators expect to perform LUS in at least 125 patients.

Methods: A trained physician performs all 12-region LUS investigations. LUS is performed at admission, after 24 and 48 hours, and when a patient's respiratory condition deteriorates. LUS findings are reported using a standardized semi-quantitative visual LUS scoring method.

Main study parameters/primary endpoints: The proportion of critically ill parturients admitted to the HDU of the PCMH with pulmonary complications detected by LUS, including interstitial syndrome, pulmonary consolidation, and pleural effusion.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the HDU of the PCMH during the study period
* Verbal informed consent of the patient or his/her formal representative

Exclusion Criteria:

* Lung ultrasound not feasible, e.g., due to electricity breakdown, or absence of the trained sonographer.
Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)

This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and reliever therapy (SMART) versus its competitive alternatives.

The aims of this study are:

* To estimate the relative effectiveness of each one of the alternatives in the management of patients with moderate to severe asthma through a systematic review for the following outcomes:

  * Cumulative incidence of asthma severe exacerbations symptoms
  * Safety of each alternative (frequency of adverse events and complications due to the medications)
* To estimate the direct medical costs of treating with each pharmacologic alternative: Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting inhaled beta 2 agonist plus inhaled corticosteroids.
* To create a decision analysis model (decision tree) that allows comparisons between the alternatives on expected values and costs.
* To calculate the average and incremental cost-effectiveness ratios.
* To carry out a sensitivity analysis to test de robustness of the cost-effectiveness results allowing for reasonable changes in expected values and costs.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe asthma.
Effect of Transcutaneous Acupoint Electrical Stimulation (TAES) on Postoperative Cough in Lung Cancer

Observation and exploration of the improvement in cough symptoms in postoperative lung cancer patients with Transcutaneous Acupoint Electrical Stimulation (TAES), the change in Cough Symptom Score (CSS) compared to baseline, the change in Visual Analog Scale (VAS) score for cough symptoms compared to baseline, the change in total score of Leicester Cough Questionnaire-Mandarin Chinese version (LCQ-MC) compared to baseline, and overall evaluation of treatment effectiveness by patients. A total of 120 postoperative lung cancer patients with cough were strictly selected according to the inclusion/exclusion criteria and treated and followed up according to the research plan requirements. Clinical observation forms were completed and clinical data were recorded in the database. Statistical analysis was performed on relevant clinical observation indicators to report research results and write related papers.

To obtain sufficient evidence from evidence-based medicine, prospective, random, blind, and controlled clinical trials are adopted to evaluate the effectiveness and safety of TEAS in treating postoperative cough in lung cancer patients. This study aims to provide a potential non-pharmacological treatment option for postoperative cough patients with lung cancer, improve the quality of life of postoperative lung cancer patients, identify the population that is more likely to benefit from TEAS treatment and provide a solid scientific basis and guidance for personalized acupuncture treatment for postoperative cough in lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old - Surgery performed under general anesthesia for radical resection of lung cancer or lung cancer resection combined with lymph node dissection.
* Pathological confirmation of primary lung cancer after surgery.
* Duration of persistent dry cough after lung surgery ≥2 weeks.
* Consciousness, ability to express opinions clearly, and voluntary signing of informed consent.

Exclusion Criteria:

* Patients diagnosed with acute respiratory system diseases within 1 month.
* Patients diagnosed with pneumonia based on chest X-ray.
* Patients with a history of asthma or tuberculosis.
* Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection, coagulation disorders (hypercoagulable state or bleeding tendency), or other severe systemic diseases.
* Patients who have used steroid drugs within the past 3 months.
* Patients who have taken angiotensin-converting enzyme inhibitors (ACEIs) within the past 6 months.
* Patients with surgical incisions, skin allergies, wounds, or infections in the treatment area.
* Patients who cannot tolerate transcutaneous acupoint electrical stimulation or withdraw during the procedure.
* Patients with contraindications to transcutaneous electrical stimulation or implanted electrophysiological devices.
* Patients who are pregnant or breastfeeding.
Sonographic Study of Hip Joint in Hockey Players

The aim is to determine whether the game of ice hockey has an effect on structural changes in the hip joint. The parameter to be investigated will be the increased frequency of structural changes of the hip joint in ice hockey players compared to a control group. Participants in the study will undergo MSK sonographic examination of both hip joints followed by functional hip mobility testing. The functional testing consists of three tests. Data will be processed in MS Office in MS Word, and the resulting data will be subject to statistical evaluation.

The examined hip joint structure will be examined monographically and simultaneously using functional tests, the Patrick test, a passive test of the range of motion in the hip joint to external and internal rotation in the joint, FADDIR test. Approximately 20 probands will be enrolled in the study based on voluntary participation from a group of players of the Charles University hockey team Prague, who have a valid medical examination with no restrictions on eligibility for selected sporting activities. The second group will consist of approximately 20 additional probands from the U20 age group of ice hockey players enrolled voluntarily with a valid medical examination with no restrictions on eligibility for the selected sporting activities. In addition, approximately 20 volunteers of the same age range will be included in the study and form the control group. In total, there will be approximately 60 participants in the study.

The conditions for inclusion in the first and second test groups will be an age range of 19-28 years, playing ice hockey for 6 years at least three times a week in the standard training regime of Czech ice hockey clubs. The player must be a registered player, i.e. his/her health condition must be suitable for ice hockey. The exclusion criteria for the test group will be persons outside the defined age limit with acute or chronic illnesses for any reason and persons with post-traumatic hip and pelvic conditions.

The inclusion criteria for the third control group will be the same age range of 19-28 years and no acute, especially infectious, diseases and persons with post-traumatic hip and pelvic conditions. This will be a normal recreational sporting population with no registration affiliation in any sport.

Eligibility Criteria:
Inclusion Criteria:

* a valid medical examination with no restrictions on eligibility for selected sports activities
* playing ice hockey from the age of 6 at least three times a week in the standard training regime of Czech ice hockey clubs
* registered player, i.e. his/her health must be fit to play ice hockey.

Exclusion Criteria:

* persons outside the defined age limit
* with acute or chronic illnesses for any reason
* persons with post-traumatic hip and pelvic conditions
Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection

The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.

High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.

To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.

Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.

In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 45-85 years old;
2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit;
3. Written informed consent obtained.

Exclusion Criteria:

1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
3. Staged procedure for polypectomy or biopsy of known unresected lesions
4. Previous surgical resection of colon
5. Personal history of colorectal cancer
6. Personal history of familial polyposis syndrome
7. Personal history of inflammatory bowel disease
8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
9. Pregnancy
10. Unable to obtain informed consent
The Vestibular Socket Therapy : A Novel Concept for Immediate Implant Placement in Defective Fresh Extraction Sites

This article aims to provide a non- staged treatment protocol to placing dental implants in compromised fresh sockets in the aesthetic zone.

This is a site-specific therapy uses study a slowly resorbing regenerative barrier (shield) to augment any thin or deficient labial plate of bone, enhances the overlying soft tissue quality and quantity at the same time with implant fixture placement using a computer-guided surgical template.

Eligibility Criteria:
Inclusion Criteria:

* A hopeless single tooth in the maxillary anterior region
* Sufficient apical bone to allow adequate anchorage/primary stability of the implant
* had natural teeth present adjacent to the tooth being replaced

Exclusion Criteria:

* Presence of acute infection
* Impossibility of reaching adequate implant primary stability in the native
* Smokers of \> 10 cigarettes
* Antitumor chemotherapy or radiotherapy in the previous year
Cord Milking and Activity Of The Immune System In Preterm Infants

In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself.

In preterm infants the starting point of the level of the IgG's is lower from the level of term infants.

Delayed cord clamping /milking it was prooved in many researches as benificial in terms of : levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord clamping /milking cause to less fever disease or hospitalization it the neonats.

In this study we come to a prove that if we miking the cord in preterm infats we will increse the level of IgG .

Eligibility Criteria:
Inclusion Criteria:

* PRETERM INFANS BETWEEN 24+0/7 TO 36

  * 6/7 WEEKS.
  * NEWBORN FOR MOTHER WHO AGREE TO PARTICIPATE IN THE RESEARCH WHO DELIVER IN NORMAL DELIVERY / PLANED OR URGENT CESARIAN DELIVERY

Exclusion Criteria:

* INTRA UTERINE GROWTH RESTRICTION, INFANT UNDER 10% TO AGE OF PREGNANCY.
* MOTHER WHO IS NOT WILLING TO PARTICIPATE IN RESEARCH.
* NEONATES TO MOTHER WHOM SUSPECTED TO BE IMMUNO- COMPROMISED OR HAVING INFECTION AROUND DELIVERY.
A Study of AK-01 (LY3295668) in Solid Tumors

This two-part study consists of a phase 1 dose escalation study in participants with locally advanced or metastatic solid tumors, and a phase 2 portion in up to 3 groups with either small cell lung cancer, breast cancer and/or one other solid tumor type.


Eligibility Criteria:
Inclusion Criteria:

* Have received at least 1 but no more than 4 prior systemic therapies
* Have adequate organ function
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have estimated life expectancy greater than or equal to (≥)12 weeks
* Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
* Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
* Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
* Male participants must use a barrier method of contraception during the study and for the following 3 months

Phase 1

* Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)

Phase 2

* Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
* Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:

  * Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy
  * Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
  * Triple negative breast cancer (TNBC) and failed standard therapy
  * Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy
  * Other solid tumor type that has been approved by the sponsor

Exclusion Criteria:

* Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
* Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)
Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis

Hypothesis: Basal insulin analogs with continuous 24-hour delivery of insulin improve glycemic control during the first year of treatment of children/adolescents with type 1 diabetes mellitus (T1DM)by preserving endogenous insulin production and a close to normal balance of the GH-IGF-axis.

This a randomized, open-label, parallel-group trial of 120 children, 7 - 17 years of age, newly diagnosed with T1DM. The investigators will investigate whether the use of long-acting basal insulin analogs Lantus (Glargine) or Levemir (Detemir) during the first year of treatment results in improved glycemic control (HbA1c) compared with Insulatard (NPH insulin) when given in a meal insulin therapy regimen with rapid acting Novorapid (insulin aspart). The investigators will explore possible mechanisms of action by determining remaining endogenous insulin production and changes in the GH-IGF-axis. The investigators will also assess changes in body composition and evaluate quality of life in each treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes and novel to insulin therapy
* Age 7 - 17 years
* Informed consent

Exclusion Criteria:

* Moderate to severe ketoacidosis (pH\<7.2 and/or standard bicarbonate \<10 mmol/l)
* Suspected non-type 1
* IA2 and GAD65: all-antibody negative
* Celiac disease or other chronic disease
* Hypothyroidism, if not well controlled
* Syndromes
* Previous anorexia nervosa
* Neuro-psychiatric disease
* Malignancy
FOCUS Fatigue Outcome in Copaxone USers

* The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.
* Secondary outcome measures are:disability, relapse rate, quality of life and depression.


Eligibility Criteria:
Inclusion Criteria:

* relapsing-remitting Multiple Sclerosis (MS),
* at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,
* ambulant patients i.e disability score EDSS MAX 5,5,
* clinically stable MS
* relapse free and steroid free at least 30 days prior to start copaxone treatment

Exclusion Criteria:

* hypersensitivity to glatiramer acetate or mannitol,
* pregnancy,
* fertile female not willing to use effective contraception,
* previous treatment with copaxone

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.