cyrilzakka/clinical-trials huggingface dataset:
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>= 18 years of age;
* chronic renal anemia;
* continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
* regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
* significant acute or chronic bleeding.
Epidemiology and Prognosis of ARDS After Pulmonary Resection Surgery

The improvement in ARDS mortality over the last 20 years seems to be largely explained by the reduction of mechanical ventilation-induced injury (VILI). VILI is essentially related to volotrauma closely associated with "strain" and "stress". The pulmonary stress corresponds to the transpulmonary pressure (alveolar pressure - pleural pressure), and the strain to the change in lung volume related to the functional residual capacity (FRC) of the injured lung at PEEP = 0. The volotrauma corresponds therefore to the generalized excess of stress and strain on the injured lung.

The initial therapeutic strategy consists in protective ventilation with a tidal volume of 6 ml/kg of theoretical ideal weight (predicted by height), associated with a high respiratory rate between 25 and 30 cycles per minute to control PaCO2 (\< 50 mmHg), apply a high positive expiratory pressure PEEP according to FiO2, maintain a plateau pressure (PP) lower than 30 cmH20, reduce instrumental dead space, use curarization, recruitment maneuvers such as alternate prone, improve ventilation-perfusion adequacy using inhaled NO.

As a last resort, extracorporeal oxygenation by veno-venous ECMO is a device to supplement respiratory function by improving oxygenation and ensuring decarboxylation. Veno-venous ECMO is indicated in severe ARDS with PaO2/FiO2 \< 80 mmHg and/or when mechanical ventilation becomes unsafe due to increased plateau pressure despite optimized ARDS management including high PEEP levels, curarization and prone position.

After lung resection surgery, the incidence of ARDS is 2-8% and its prognosis remains more poor, despite advances in management, with a mortality of up to 60%. Risk factors include intraoperative vascular filling, type of pulmonary resection, and predicted postoperative respiratory function. Early support with VV ECMO is vital in some patients to treat severe hypoxemia, due to variable surgical reduction of lung parenchyma depending on carcinological involvement or initial lung pathology. ). There are very few data concerning these patients with pulmonary resection. The primary objective of this study is to describe the prevalence of ARDS and the risk factors for its occurrence after pulmonary resection surgery. The secondary objective is to compare the ventilation parameters (especially motor pressure) in patients with reduced lung parenchyma in ARDS under VV ECMO with those who did not use VV ECMO assistance.


Eligibility Criteria:
Inclusion criteria:

- Patient hospitalized following ARDS after thoracic resection surgery

Exclusion criteria:

- Refusal to participate after receiving the information letter
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.


Eligibility Criteria:
Inclusion criteria:

* Naturally postmenopausal women of any age with at least one ovary
* Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
* Stable, monogamous heterosexual relationship for at least one year
* Willing to discuss sexual issues
* Willing to engage in sexual activity at least once a month
* Normal Pap smear
* Normal mammogram
* Normal uterine lining
* Able to comply with daily use of handheld data entry device

Exclusion criteria:

* Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
* Partner with inadequately treated organic or psychosexual dysfunction
* Sexual function impaired by psychiatric disorder
* Sexual function impaired by gynecological disorder
* Major Depression
* Suicidal behavior or ideation
* Major life stress that could impair sexual function
* Substance abuse
A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)

This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.


Eligibility Criteria:
Inclusion Criteria:

* Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
* Patient has in the study eye, 20/40 - 20/160 vision
* Patient has Type 1 or Type 2 diabetes
* Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control

Exclusion Criteria:

* Patient has had any active ocular infection in either eye
* Patient has intraocular pressure \> 22 mmHg or a diagnosis of glaucoma
* Patient has cystoid macular edema in the study eye
* Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
* Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
* Patient has an HbAIc value \> 10% at Visit 1
* Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months
* Patient has a history of cancer within 5 years prior to signing informed consent
* Patient has clinically-relevant chronic renal failure
* Patient has high blood pressure
* Patient has coronary heart disease
* Patient has known allergies to steroids
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C, Genotype 1 or 4
* HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
* Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
* Naive to prior anti-HCV therapy

Exclusion Criteria:

* Infected with HCV other than Genotype 1 or 4
* Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Use of hematologic growth factors within 90 days prior to study randomization
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis

The aim of this study is to determine the safety and efficacy of a topical natural health product in comparison to placebo for the treatment of herpes labialis.


Eligibility Criteria:
Inclusion Criteria:

* Female and male, in good health, 18 years of age or older,
* With history of recurrent herpes labialis with at least twice a year during the past twenty-four months,
* Agreeing not to take another treatment against cold sore, nor anti-inflammatory, antibiotics and steroids,
* Cooperating in the study, able to be monitored at each visit, aware of the demands and duration of the controls, thus allowing perfect adherence to the established protocol,
* Must be willing and able to participate and to provide written informed consent,
* Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.

Exclusion Criteria:

* Volunteers who refuse to introduce the product to be tested in its routine,
* With a history of hypersensitivity to the type of product to be tested (e.g., products that contain essential oil),
* Who have a history of eczema, topical dermatitis, psoriasis or significant skin anomalies on the areas to be tested,
* Who suffer from a serious illness or health problem or a critical or progressive disease,
* Who have taken prescription or over the counter medication that could affect skin characteristics or could bias the study (i.e. antibiotics, antihistamines, anti-inflammatories...) within 7 days prior to study beginning,
* Who have recently acquired or who currently have significant skin pigmentation, who frequent tanning salons or foresee exposure to the sun during the study,
* Who abuse alcohol, drugs and/or tobacco,
* Female subjects who are pregnant, breastfeeding or expecting to become pregnant during the study.
Analysis of Plasma Tumor DNA in Lung Cancer Patients

The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in \<50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility Criteria:
Inclusion Criteria:

* Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
* Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
* Patients must have given written informed consent

Exclusion Criteria:

* Patients who refuse the blood samplings
Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

PRIMARY OBJECTIVE:

I. To decrease the length of invasive mechanical ventilation (MV) and rate of 30-day mortality from CRS due to SARS-CoV-2.

SECONDARY OBJECTIVES:

I. To decrease the rates of intensive care unit (ICU) transfer. II. To decrease the rate of invasive mechanical ventilation (MV). III. To decrease the length of ICU stay. IV. To decrease the rate of tracheostomy. V. Safety and efficacy of tociluzumab. VI. Biomarker assessment for response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive tocilizumab intravenously (IV) every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.

ARM II: Patients receive standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration \[FDA\] approved)
* Should be hospitalized and exhibit at least one of the following predictors of mortality

  * Age \>= 65 years
  * Current smoker (smoked \>= 100 cigarettes in life and actively smoking)
  * Chronic obstructive pulmonary disease (COPD)
  * Diabetes
  * Hypertension
  * Coronary artery disease
  * Cerebrovascular accident (CVA)
  * Chronic renal disease (creatinine of \>= 2 mg/dl)
  * Cancer
  * Patients that have C-reactive protein (CRP) \>= 10 mg/L
  * D-dimer \>= 0.5 mg/L
  * Procalcitonin \>= 0.5 mg/L
  * Lactate dehydrogenase (LDH) \>= upper limit of normal (ULN)
* Patients or authorized family member willing to sign informed consent to participate in this study

Exclusion Criteria:

* Pregnant or lactating women
* Hypersensitivity to tocilizumab
* Patients or authorized family member unwilling to sign informed consent to participate in this study
* Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)
The Effect of Preoperative Turning in Bed and Mobilization Training on the Postoperative First Mobility

The purpose of this study is to examine the effect on the first mobility of inside bed rotation and mobilization training to patients who will be lumbar disc surgery.

The purpose of this study is to examine the effect on the first mobility of inside bed rotation and mobilization training to patients who will be lumbar disc surgery. This study Is a randomized controlled clinical trial. The sample of this study consisted of 40 operated with the diagnosis lumbar disc herniation patients that 19 of which were intervention and 21 of which were control patients between January- November 2019. The patients were taken to the table randomization method in the study. While the patients receiving control treatment received routine clinical care, the patients in the intervention group received in- bed rotation and mobilization training with planned training with planned training one day before the operation.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18,
* Being literate in Turkish,
* Being in the ASA(American Society of Anesthesiologists) 1,2 and 3 classification,
* Having surgery for the first time due to lumber disc herniation and volunteering to participate in the research.

Exclusion Criteria:

* Having a mental or physical disability to prevent in-bed rotation and mobilization training to be given before surgery,
* to get a score above 16 from the Observer Mobility Scale before surgery.
Evaluation of an Intensive Inpatient Psychotherapy Treatment for Severely and Early Traumatized Children (MOSES)

Evaluation of longitudinal treatment effects applying an intensive psychotherapeutic intervention for inpatients (age of participants: 6-13 years) with a multi-method-approach to address the complex nature of severe childhood trauma. (Chronic Post-Traumatic Stress Disorder)

Severe adversity and trauma in early childhood have been associated with a highly increased risk for a variety of psychiatric disorders, lasting into adulthood. This increased risk is accompanied by a set of biological changes ranging from changes in cortical thickness to endocrinological changes. At a behavioral level, children with complex PTSD (developmental trauma disorder) show severe and long-lasting negative effects. Such children exhibit a wide range of symptoms: affect dysregulation, attention difficulties, impairment in interpersonal relationships, aggressive and dissociative behaviour, disturbances of cognition. Corresponding alterations in neural networking and brain development are well studied. Although evidence-based treatment approaches for children with non-complex PTSD exist, complex-traumatized children have no well-evaluated treatments. Furthermore, early intervention can prevent the chronification and exacerbation of symptoms and promote social adaptation and participation.The following topics will be addressed: (1) brain development (Multimodal MRI (mMRI) including anatomical (T1-MPRAGE, T2-FLAIR, DTI-Diffusion Tensor Imaging) and functional MRI measurements (resting-state functional MRI, task fMRI (presenting affective pictures according to the International Affective Picture System, IAPS), EEG); (2) alterations in neuroendocrinological systems involved in stress regulation (Cortisol, Oxytocin, Vasopressin); (3) behavioral symptoms; (4) cognitive functioning; (5) attachment representations of children and their primary caregivers;

Eligibility Criteria:
Inclusion Criteria:

* Severe early traumatization with experiences of violence, neglect, abuse and chronic symptoms related to complex PTSD.

Exclusion Criteria:

* Autism spectrum disorder
* Addiction disorder
* Mental disability (IQ \< 85)
* Endangerment to themselves or others
Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy

This study aims to evaluate the effectiveness of prewarming methods in preventing intraoperative hypothermia in patients undergoing HoLEP surgery. Designed as a randomized controlled study, patients who receive prewarming will be compared with those in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18 years and older
* Patients undergoing HoLEP surgery under general anesthesia
* Patients who consent to participate in the study

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Patients unable to read, understand, or sign the informed consent form.
* Hemodynamically unstable patients.
* Patients with a preoperative or intraoperative body temperature \>37°C.
Effects of Perturbation Therapy and Trunk Control Training

A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. Trunk control plays a vital role in various aspects of daily life, including balance, walking, and overall functional abilities. Children with cerebral palsy (CP), who experience limitations in their ability to move, often expend more energy compared to their healthy peers.

This study will be randomized clinical trial used to compare the effects of Perturbation and trunk control training in children with Cerebral Palsy. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre-assessment will be done using Berg balance scale, functional Independent measures and TUG test as objective measurements. Subjects in one group will be treated using Perturbation therapy and the other one will be treated with Trunk control training. Both groups had three treatment sessions per week, for 4 weeks, and the total time for every session was about 30-45 minutes. A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. On the other hand, "mechanical perturbations" physically displace the body segments, potentially leading to a shift in the overall center of mass or actual imbalance. Even small displacements of a single body segment, like the head, can elicit minor muscle responses throughout the body

Eligibility Criteria:
Inclusion Criteria:

* Kids that suffer from cerebral palsy.
* Ages span from 5 to 10 years.
* Both males and females were represented.
* During the preceding half-year, there was no orthopedic surgery or spasticity-reduction intervention.
* No significant lower limb muscular contraction

Exclusion Criteria:

* Individuals suffering from sensory, proprioceptive, cognitive, and perceptual impairments, as well as those with contractures.
* Any neurological disease that impairs balance, including orthopedic disorders
* Individual experiencing seizures and has undergone any prior surgical treatments.
* Uncorrected visual issues
A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health

The aim of this analysis was to compare gingivitis- and plaque-reduction efficacy from randomized controlled trials (RCTs) up to six months long evaluating oscillating-rotating, sonic, and manual toothbrushes


Eligibility Criteria:
Subjects were excluded from this study for the following reasons;

* pregnancy,
* rampant caries,
* severe periodontitis,
* at discretionary of the Principal Investigator.
Characterization of the Neo-squamous Epithelial Barrier

To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.

The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).

Mucosal impedance will be measured by an endoscopic probe. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.

Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 18-90) who underwent an ablative program for BE

Exclusion Criteria:

* Patients that have not achieved complete remission of intestinal metaplasia.
* Patients unable to consent.
* Pregnant women