cyrilzakka/clinical-trials huggingface dataset:
The Characteristics of Regional Bone Quality in the Cervical Vertebrae Considering BMD

Data of CT images and the femoral neck BMD were obtained from 99 patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months) from April 2009 to December 2014. There were 52 females and 47 males. The mean age was 63.7 year (female: 63.4 years, male: 64.1; range 32-86 years). The patient was excluded who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass. Patients were divided into three groups according to femoral neck BMD (Group A, T-score ≥-1; Group B, -2.5\<T-score\<-1.0; Group C, T-score≤-2.5). Group A had normal BMD patients, Group B had lower normal patients including osteopenic patients and Group C presented osteoporotic patients. The mean HU numbers of cortical bone area in the vertebral canal (cHU, the medial wall of the lateral mass), the posterior wall of transverse foramen (fHU), the medial (mHU), lateral wall (lHU) and trabecular area of pedicle (pHU) were measured on the axial CT images in clinical images.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent the cervical CT and BMD simultaneously (the gap of both studies was within 6 months)

Exclusion Criteria:

* Who had any destructive pathology or severe spondylosis in the cervical pedicle and the cervical lateral mass.
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopa

This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease
* Patients with L-dopa induced dyskinesia for at least 3 months
* Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum

Exclusion Criteria:

* History of severe allergy to food or drugs
* Very low or high body weight.
* Prior surgery for Parkinson's Disease
* Smokers

Other protocol-defined inclusion/exclusion criteria may apply
a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.

Background: Using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers.

Methods: The investigators designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence.

Eligibility Criteria:
Inclusion Criteria:

* Planned for major surgery
* At risk for pulmonary complications

Exclusion Criteria:

* Planned thoracic surgery .
* Unscheduled surgery (i.e., urgent, or emergent surgeries)
Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease

The investigator aim to identify the role of inorganic pyrophosphate and other anti-calcifying molecules in vascular disease in children with chronic kidney disease, with a view to developing therapeutic approaches aimed at limiting the onset of vasculopathy.

The study of pro- and anti-calcifying molecules in children with chronic kidney disease will be carried out using dosages made on serum in comparison with the dosage of these same molecules in control children matched according to age and sex. without chronic kidney disease. An evaluation of vascular function by clinical (auscultation, palpation) and ultrasound techniques (measurement of intima-media thickness and measurement of pulse wave velocity) will also be carried out in children with chronic kidney disease and compared to norms of children without chronic kidney disease. These evaluations aim to improve understanding of the pathophysiology of vascular calcification and thus open up therapeutic perspectives in these children.

Eligibility Criteria:
Inclusion Criteria:

All groups :

* Minor patients (\<18 years)
* Patients of both sexes
* Informed patients and parents who have signed the informed consent form
* Patients affiliated to social security

Control group :

- Patients with no particular pathology undergoing surgery and receiving a preoperative check-up

CKD groups :

* Patients on dialysis for more than 3 months, regardless of technique
* Kidney transplant patients
* Patients with CKD, whatever the cause

Exclusion Criteria:

* Progressive cancer or kidney disease
* Treatments that may modify PPi concentration (e.g. bisphosphonates)
Effect of Noise Blocking During General Anesthesia on Postoperative Pain

To investigate the effect of noise blocking during general anesthesia on postoperative pain in patients undergoing laparoscopic abdominal surgery. The aim of this study was to determine whether noise blocking can reduce postoperative pain, analgesic use, and its possible effects on intraoperative electrocorticogram.


Eligibility Criteria:
Inclusion Criteria:

* ASA Classification ⅰ-ⅲ
* Patients undergoing elective laparoscopic abdominal surgery under general anesthesia
* Voluntarily accept PCIA and signed informed consent

Exclusion Criteria:

* Patients with previous severe disease
* Patients with hearing abnormalities
* Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
* Patients with chronic preoperative pain and/or long-term analgesic use
* Patients who could not cooperate with the study for any reason
Mensenchymal Stem Cell (MSC) Included in OrthADAPT Membrane for Rotator Cuff Tears Repair

Surgical reconstructive procedures for rotator cuff tears present a number of limitations. The few studies in which the repair integrity is evaluated, have shown the existence of a high rate of reruptures in spite of the fact that the functional results obtained short-term are satisfactory. Morphologic analysis from the sutures, after different follow-up periods, has not shown satisfactory results.

Thus, the purpose of the current study was to test the hypotheses that mesenchymal stem cells (MSCs) included in a membrane into rotator cuff tears improves, the radiograms and the function compared to cell-free tendon defect treatment.

The investigators will include: Patients with massive tears from the supraspinatus tendon, in which reconstructive surgery is indicated. Patients will be randomly stratified into two groups.

The first group will receive autologous MSCs transplantation included in a collagen type I membrane (OrthADAPT) and the second group will serve as cell-free controls.

The surgical procedure will be performed by arthroscopic and/or combined technique: arthroscopic subacromial decompression and mini-open rotator cuff repair. The OrthADAPT-cells composite will be put on the sutured area. The radiograms and function will be assessed by independently observers, who will no have knowledge of the study group from which they will have been obtained.

Eligibility Criteria:
Inclusion Criteria:

* Subject providing informed consent.
* Comprised subject male/female aged 55-80.
* Subject has a supraspinatus tendon rupture.
* Subject has an unilateral injury.
* Rupture is enough to need medical assistance.
* Subject has an conventional medical treatment fail at least 3 months.
* Subject has a "reparable" injury according to Goutallier´s criteria.

Exclusion Criteria:

* Subject has a prior clinical history of arthritis, diabetes or inflammatory disease.
Studying DNA in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer

RATIONALE: Studying tissue and blood samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is evaluating DNA to see how well it predicts response to treatment in patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.

OBJECTIVES:

* To determine if DNA methylation patterns and expression of differentially methylated genes taken before chemotherapy can predict patient outcome with regard to progression-free survival.
* To evaluate whether DNA methylation can predict response assessed by RECIST criteria and CA 125 response.
* To evaluate the specificity and sensitivity of predicting methylation changes in tumor from the changes at the corresponding CpG islands in plasma.

OUTLINE: Tumor samples are collected at the time of initial laparotomy and blood is drawn prior to surgery for DNA methylation and biomarker studies.

Changes in DNA methylation will be examined globally using DNA methylation hybridization to microarrays and methylation specific PCR, as well as expression of genes shown to be differentially methylated.

Eligibility Criteria:
1. Clinically suspected FIGO stages Ic-IV epithelial ovarian cancer that are about to undergo surgery for confirmatory biopsy and attempted cytoreductive surgery
2. Given written informed consent
3. Female and \>18 years of age
Middle Meningeal Artery (MMA) Embolization Compared to Traditional Surgical Strategies to Treat Chronic Subdural Hematomas (cSDH)

Chronic Subdural Hematoma (cSDH) is a common hematologic problem particularly in older patients. The purpose of this study is to evaluate the safety and efficacy of middle meningeal artery (MMA) embolization compared to traditional surgical strategies for patients presenting with chronic subdural hematoma (cSDH). Although MMA embolization is minimally-invasive procedure that is routinely used for the treatment of tumors or vascular formations (1), this study investigates the use of an established procedure for a new disease state.

The purpose of the research study is to evaluate the safety and efficacy of a new, less-invasive procedure to treat chronic subdural hematoma (cSDH). A subdural hematoma occurs when blood collects on the brain's surface beneath the skull. Subdural hematomas can be life-threatening. They usually result from a head injury. This study will compare the new procedure to conventional surgical treatment of chronic subdural hematoma (cSDH). The new procedure is called middle meningeal artery embolization (MMA).

Current or conventional treatment of chronic subdural hematoma (cSDH) involves surgery (burr hole drainage and craniotomy) to access and remove the cause of the bleeding that is causing the subdural hematoma.

The new procedure, MMA embolization, involves guiding a catheter that is inserted into a blood vessel to the area of the brain that is supplying blood to the subdural hematoma. Particles or a special type of glue will be released to stop the bleeding that is causing the subdural hematoma. This technique has been used to treat other brain conditions, for example, (to treat tumors or malformation of blood vessels).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Participant or Surrogate must be English speaking
* Subjects must have a diagnosis of chronic or acute-on subdural hematoma based on brain imaging, as documented by an
* One or more symptoms attributable to chronic SDH including headache cognitive impairment, gait instability, seizure, or mild focal neurologic deficit.
* In opinion of Investigator or the subject's referring physician, the subject has failed conservative management.

Exclusion Criteria:

* The Subdural hematoma is causing mass effect significant enough to cause marked or progressive neurologic impairment
* Any requirement for urgent surgical evacuation is necessary
* Life expectancy is less than 6 months in the opinion of the subject's primary physician
* Markedly tortuous vasculature precluding safe endovascular access, as assessed on angiogram
* Acute subdural hematomas
* Health insurance doesn't cover MMA embolization or performing Surgeon and follow up visits are considered out of network.
* Pregnancy
Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan Women

Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle- income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.

The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).

We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent for participation in the trial
* Female aged 18-49 years
* Moderate anemia (Hb \<110 g/L, but not severely anemic with Hb \<80 g/L) • Iron deficient (ZnPP \>40 mmol/mol haem)
* Anticipated residence in the study area for the study duration

Exclusion Criteria:

* Major chronic infectious disease (e.g., HIV infection);
* Major chronic non-infectious disease (e.g., Type 2 diabetes, cancer);
* Chronic medications;
* Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
* COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
* MenACWY vaccine in the past
* Typhoid vaccine in the past
* Pregnant (confirmed by rapid test during screening) or lactating.
* Malaria (confirmed by rapid test) à study start will be postponed
A Clinical Trial of the Efficacy and Safety of Levilimab (BCD-089) in Patients With Severe COVID-19

The objective: to study the efficacy and safety of levilimab in subjects with severe COVID-19.

This study is multicenter, comparative, randomized, double-blind, placebo controlled clinical trial with adaptive design. Females and males, aged 18 years and older, admitted to hospital with severe COVID-19 pneumonia on SOC therapy will receive either levilimab 324 mg s/c or placebo s/c. In case of no clinical improvement is observed, investigator can administer a rescue therapy - open label LVL 324 mg s/c. The outcomes will be assessed up to day 60. Results of interim analysis of safety and efficacy data of first 60 enrolled subjects will be submitted for independent DMC review and decision about changes to the protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent (subject; legally authorized representative) or signed conclusion of panel of independent medical doctors
2. Males and non-pregnant females aged 18 years or older at the IC date
3. Positive test for SARS-CoV2 nucleic acid (RNA) at the IC date
4. Admitted as inpatient to a hospital with radiologically confirmed pneumonia
5. Severe form of COVID-19.
6. Subjects meeting any of the following criteria:

   * Total respiratory rate \> 30 breaths per minute
   * SpO2 ≤ 93%
   * PaO2 /FiO2 ≤ 300 mmHg
   * Chest imaging (X-ray, CT, US) showed lesion progression within 24-48 hours \>50%
   * Decrease of consciousness level, Psychomotor agitation/irritability
   * Hemodynamically unstable (systolic blood pressure \<90 mmHg or diastolic blood pressure \< 60 mmHg or urine output \< 20 ml/h)
   * Arterial lactate \> 2 mmol/l
   * qSOFA (quick sequential organ failure assessment score) \> 2. Subjects meeting three following criteria: Low blood pressure (SBP ≤ 100 mmHg); High respiratory rate (≥ 22 breaths/min); Altered mentation (Glasgow Coma Scale ≤ 14)

Exclusion Criteria:

1. Critical COVID-19. Subjects meeting any of the following:

   * Respiratory failure and requiring invasive mechanical ventilation (tracheal intubation)
   * Septic shock
   * Multiple organ failure
2. Life expectancy \< 24h, in the opinion of the investigator,
3. Unlikely to remain at the investigational site beyond 48 hours
4. Use of other monoclonal antibodies for COVID-19 treatment
5. Current treatment with immunosuppressive agents (including corticosteroids)
6. Participating in other drug clinical trials at the IC date or within 60 days after randomization (participation in COVID-19 anti-viral trials may be permitted if approved by Sponsor)
7. Laboratory values:

   * ALT / AST \> 10 ULN at screening
   * Platelets \< 50х109/l at screening
   * Absolute Neutrophil Count \< 1х109/l at screening
8. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
9. Confirmed active tuberculosis
10. History of allergic reaction to monoclonal antibodies
11. Pregnancy or breastfeeding
12. Any illness or laboratory findings that, in the opinion of the study investigator, might pose an additional risk to the patient by their participation in the study,
A Study of WD-890 in Participants With Moderate-to-Severe Plaque Psoriasis

Th purpose of the study is to evaluate the dose response of WD-890 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

The total duration of this study is up to 24 weeks which includes a screening period of less than or equal to (\<=) 4 weeks, a 16-week treatment period, and a 4-week safety follow-up period. Aged 18 to 70 years (inclusive) were enrolled in this study. Participants were randomized to receive WD-890 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participant aged 18 to 70 years(inclusive)at the time of informed consent.
* Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.

  ≥10% of BSA involvement at screening visit and randomization;
* Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization

Exclusion Criteria:

* Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)
* Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted
* Class III or IV congestive heart failure by New York Heart Association Criteria
* Participant with a history of chronic bacterial infections (e.g., chronic pyelonephritis, chronic bronchiectasis, or chronic osteomyelitis).
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion

In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.

Although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. This is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication.

The "Unified Airways" concept considers the upper and lower airways as one unified airway. In recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms.

Conditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. Together will these mechanisms lead to a worsening of the asthmatic disease.

The aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. The primary outcome variable is improvement in asthma symptomatology. The secondary outcome variables are improvement in nasal blockage.

Eligibility Criteria:
Inclusion Criteria:

* asthma (according to British Thoracic Society guideline)
* \>18 years

Exclusion Criteria:

* pregnancy
* systemic disease with nasal manifestations
* cancer of the nose
* currently receiving cancer therapy
* previous nose surgery