cyrilzakka/clinical-trials huggingface dataset:
The Association Between Obesity-Related Indicators and Adverse Outcomes in Ischemic Stroke Patients

The study population comprised patients experiencing acute first-ever ischaemic stroke, with diagnostic criteria established in accordance with the International Classification of Diseases, Ninth Revision. All subjects presented rigorous neuroimaging evidence, including head computed tomography and/or magnetic resonance imaging, which underwent review by two or more experienced neuroradiologists. Adverse outcomes were characterized as compliant endpoint events, encompassing mortality and recurrences. The primary outcome was adverse outcomes and the secondary outcome was recurrence-free survival (RFS).

Clinical data for the derivation cohort were acquired from three medical facilities: Tongji Hospital Sino-French New City Branch in Caidian District, Tongji Hospital Qiaokou Branch in Hankou District, and Tongji Hospital Optics Valley Branch in Wuhan East Lake High-Tech Development Zone. The clinical data were sourced from the electronic medical records of Tongji Hospital, the largest healthcare facility in the Hubei region of China. Its comprehensive electronic medical record system comprises over 60 million medical records spanning from 1980 to the present. We retrospectively gathered information on patients admitted for acute first-ever ischaemic stroke between January 2012 and January 2022. The following individuals were excluded from the study: 1) Those under 18 years of age; and 2) Pregnant women.

The variables gathered included the primary test parameters of patients within 24 hours of admission, encompassing age, gender, smoking and alcohol consumption status, arterial blood pressure, fat-related indicators, comorbidities, and the primary treatments administered within the initial 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* We retrospectively gathered information on patients admitted for acute first-ever ischaemic stroke between January 2012 and January 2022.

Exclusion Criteria:

1. Those under 18 years of age; and 2) Pregnant women.
Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.


Eligibility Criteria:
Inclusion Criteria:

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria:

* contraindications according to SPC
Using the Movement and Electromyographical Analyses to Assess the Muscle Spasticity

This study intends to use an dynamometer and surface electromyography to objectively and quantitatively measure the corresponding force and electromyography signal generated when the hand joint receives stretching by doing circular motion, and further explore the differences and relationships of existing muscle spasm classification, kinetic and kinematic data, upper extremity performance, activity of daily life. In addition, to investigate the differences of kinetic and kinematic data between stroke patient and healthy participants during doing hand circular motion activity.

Purpose 1 : To collect upper limb muscle activity parameters of healthy adults and stroke patients to establish a database of doing hand circular motion activity.

Purpose 2 : To test the reliability of this refined muscle testing by collecting the muscle activity during hand circular motion activity.

Purpose 3 : To compare the results of the EMG signal strength with other evaluation methods such as the modified Ashworth scale and dynamometer to understand the relationship between the EMG signal and each evaluation results.

Purpose 4 : To compare the differences in electromyographic signals, muscle strength, and joint angle between healthy adults and stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 65 years old
* with the clinical diagnosis of stroke
* Mini-mental state examination (MMSE) score ≥ 25 points

Exclusion Criteria:

* pain, subluxation or related medical history of shoulder, elbow, and wrist joints within six months
* surgery on shoulder, elbow or wrist
* with muscle or nerve disorders or diseases that significantly affect the performance of the upper extremities
Effect of Drainage of Subglottic Secretions on Pneumonia Acquired Under Mechanical Ventilation

The purpose of this study is to determine whether drainage of subglottic secretions is effective to reduce the incidence of pneumonia acquired under mechanical ventilation in ICU's patients.

Nosocomial infection represent a major problem in hospitals. In intensive care units, ventilator-associated pneumonia (VAP) is associated with an increase in morbidity and mortality. Incidence of VAP is high, 20 to 30% of patients under mechanical ventilation (MV) for more than 48 hours. In the pathogenesis of VAP, two processes are considered essential for its development: bacterial colonization of the oropharynx and tracheobronchial tract, followed by aspiration of contaminated secretions into the lower airways. It has been shown that pooled secretions above inflated endotracheal tube cuffs may be source of aspiration and can be a cause of VAP. Several studies have suggested that recurrent aspiration of subglottic secretions can be prevented by intermittent drainage of subglottic secretions. Nevertheless, recent CDC guideline reported that there was not enough evidence to conclude on the efficacy of such intervention.

During the study, patients, in both groups, will be intubated with the same device permitting subglottic drainage (HiLo Evac endotracheal tube). The daily screening of VAP will be performed until the 28th days of mechanical ventilation without occurrence of VAP. The follow-up of each patient will be realized until the ICU's discharge.

Comparison: The incidence of VAP will be compared between two groups: one group with intermittent drainage of subglottic secretions and the other one without this intervention.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients expected to require MV more than 48 hours

Exclusion Criteria:

* patients already intubated for more than 12 hours
* patients intubated with another tube than the HiLo Evac tube
* patients admitted for cardiac arrest
* patients admitted for self poisoning
* patients admitted with tracheotomy
* patients already included in an another clinical trial
Olanzapine vs. Comparator and Placebo in the Treatment of Patients With Bipolar I Disorder

The goals of this study are:

A. To determine whether olanzapine can help patients with bipolar disorder who currently have mild to moderate mania.

B. To assess the safety of olanzapine and any side effects that might be associated with it, as well as the quality of life and functioning of patients treated with olanzapine.

C. To assess how olanzapine compares to divalproex.


Eligibility Criteria:
Inclusion Criteria:

* You must be 18 to 65 years old.
* You must have a diagnosis of bipolar I disorder and must be experiencing a manic or mixed (symptoms of mania and depression occurring together) episode.
* You must be able to visit the doctor's office as scheduled for 15 weeks.
* All female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception.

Exclusion Criteria:

* You have rapid cycling bipolar disorder, or are having hallucinations or delusions, or are feeling suicidal.
* You are pregnant or breastfeeding
* You have a history of: inadequately controlled diabetes; heart disease; narrow angle glaucoma; low white blood cell or platelet count; have a positive test result for human immunodeficiency virus (HIV+); or any other serious, unstable illnesses as judged by the study physician.
Clozapine Induced Weight Gain

Clozapine is prescribed to patients with psychosis in whom other treatments have not worked. Research has shown, however, that clozapine may be associated with weight gain and abnormal blood sugar levels in some patients. There is strong evidence to suggest that genetic variation between individuals plays an important role in the development of these side effects in response to the medication. Our research aims to evaluate the effects of two genes and the blood level of clozapine on side-effects such as weight changes and blood sugar levels in patients receiving clozapine treatment. From out-patient clinics in Cwm Taf UHB, the investigators aim to recruit 160 patients who are taking clozapine; collect information/ measurements from recruits relating to size/ weight/ BMI, risk of diabetes and blood samples to measure markers of blood sugar, fat/lipids, clozapine and its breakdown products, blood cells and variants of two specific genes. From this information the investigators will be particularly interested to understand if there is any association between the variation in these two genes with weight gain or changes in blood sugar, in patients taking clozapine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* Taking/compliant with clozapine antipsychotic medications.
* Patients meeting the ICD-10 criteria for a diagnosis of schizophrenia, schizoaffective or borderline personality disorders.

Exclusion Criteria:

* History of current alcohol/illicit substance dependency.
* Unable/ unsuitable to complete the study protocol e.g. acutely ill, suicidal or aggressive patients.
* Unable to consent to the study.
Effect of CBD on the Brain

This proposal focuses on the therapeutic relevance of the endocannabinoid (eCB) system for the treatment of Fragile-X syndrome (FXS), the primary hereditary cause of autism spectrum disorder (ASD). Although most individuals with FXS have moderate to severe intellectual disability (ID), caregivers are mainly concerned about aggressive behavior and anxiety problems, hallmark features of the condition. Concurrent lines of evidence suggest that targeting the endocannabinoid (eCB) system by administration of cannabidiol (CBD) could upregulate GABAergic functions and correct inhibitory deficits presumed responsible for the neuropsychiatric phenotype of FXS. However, the eCB system and its effect on the brain remains unexplored in FXS patients. This clinical trial aims to define the therapeutic relevance of the eCB system for FXS using a multimodal neuroimaging approach to finely characterize the acute effects of oral CBD on the principal inhibitory neurotransmitter system (GABA) in a large cohort of FXS patients.


Eligibility Criteria:
Inclusion Criteria:

Eligibility criteria for FXS participants will include:

* age between 7 and 55 years, molecular diagnosis of FXS,
* intelligence quotient (IQ) \<70,
* aberrant behavior questionnaire score (ABC-C) \> 20,
* \<3 psychoactive drugs, drug stable for \> 3 months.

Eligibility criteria for the control group:

* 18 and 55 years old,
* be in good general health, with no history of neurological or psychiatric disorders.

Eligibility Criteria for all Participants:

* A minimum weight of 60 kg;
* no history of liver problems (A complete blood profile to measure liver enzyme levels (bilirubin, aspartate aminotransferase (AST), argininosuccinate lyase (ASL), alanine transaminase (ALT), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT)) will be obtained before randomization for all participants).

Exclusion Criteria:

* The presence of an absolute contraindication to the use of TMS and MRI / MRS (ie presence of metal in the head).
* Individuals with ALT / ASL levels greater than 3 times the upper normal baseline, or if bilirubin exceeds 2 times the upper baseline,
Treatment of the Face and Neck With Lower Ulthera System Energy Settings

Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This trial is a prospective, single-site, double-blinded, randomized, split-face design. Subjects will be randomized to one of three treatment groups, receiving treatment using different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity on the face and neck

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the face or neck.
* Excessive skin laxity on the face or neck.
* Significant scarring in areas to be treated.
* Open wounds or lesions in the area to be treated.
* Severe or cystic acne on the area to be treated.
Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")

The purpose of this study is to evaluate the safety, efficacy, and side effects of the CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal pleural surface.

The proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with CryoSpray at dye marked metastatic foci.

Initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. If necessary, dosimetry changes may occur after 3 subjects are treated and observed. It is unknown if dosimetry will need to be increased to enhance effectiveness. The PI may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. If disease exists bilaterally, only one side will be sprayed.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Deemed a candidate for cryotherapy based on physician physical or medical history review
* Deemed operable based on institutional criteria
* Able to sign informed consent
* Documented lung or other visceral cancer with pleural involvement.
* WBC \> 4,000/mm3, platelets \>100,000mm3
* Physically well enough to undergo moderate sedation and pleuroscopy
* Female patients must be HCG negative
* There should be direct evidence of disease progression despite treatment in previously treated patients

Exclusion Criteria:

* Pregnant or nursing
* Planning to sire a child while enrolled in the study
* Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
* Refusal or inability to give consent.
* Concurrent chemotherapy.
* Medical contraindication or potential problem that would preclude study participation
* Concurrent participation in other experimental studies
* Uncontrolled coagulopathy or bleeding diathesis
* Serious medical illness, including:
* Uncontrolled congestive heart failure
* Uncontrolled angina
* Myocardial infarction
* Cerebrovascular accident within 6 months prior to study entry
Genetics of Symptomatology and Treatment Response in Psychotic Major Depression

We hope to learn more about the biology of psychiatric illness with the hope of improving the diagnosis and treatment of such psychiatric conditions as major depression.

From the blood sample you donate, the researchers will obtain DNA. This DNA will be used to search for DNA markers related to the underlying biology of psychiatric illness and how this might explain the symptoms of these disorders. Research using DNA is an important way to try to understand human disease and/or the role genes play in disease. In effect, part of your blood sample will be used to attempt to understand how genetic factors contribute to the symptoms of such psychiatric conditions as major depression.

Eligibility Criteria:
Inclusion Criteria:

1. You are currently experiencing symptoms that are consistent with an episode of major depression without symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
2. You are currently experiencing symptoms that are consistent with an episode of major depression with symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or
3. You have been diagnosed with either schizophrenia or schizoaffective disorder, or
4. You are a volunteer without a history of psychiatric illness (a healthy control subject).
Outcomes and Clinical Applications of Thin Free Flaps for Soft Tissue Defects

Flap coverage is often required to achieve primary wound closure and to achieve a good functional result. Free flap has gain popularity over random flap in soft tissue reconstruction to achive maximal cosmetic and functional outcome. Advances in reconstructive techniques have widened the application of free flap tissue transfer for repair of head and neck defects and have resulted in improved quality of life and both functional and aesthetic outcomes. Interference of high technology like CT Angio and Duplex ultra sound makes perforator detection more easy and more accurate. Fasciocutaneous free flaps raised in the traditional sub or supra-fascial planes can sometimes be thick and bulky. Elevating thin flaps has long been a goal of reconstructive surgeons. Thin flaps have numerous advantages in reconstruction. Thin flap is required in aesthetically significant areas, such as in fascial and hand reconstruction. In addition to their aesthetic importance, thin flaps are frequently required due to functional considerations. In head and neck reconstruction, bulky flaps may interfere with smooth swallowing and cause airway obstruction. In adition resurfacing of joint exposure require thin flap to maintain maximum joint function. Donor site shows better outcomes with thin free flap due to preservation of deep fatty layer that decrease the incidence of donor site neuroma and better countour when application of skin graft.


Eligibility Criteria:
Inclusion Criteria:

* All patients with soft tissue defects in different body regions who are prepared for free flap surgery. All patients under 65 year of age and above 5 years of age.

Exclusion Criteria:

* Patient who is not indicated for free flap. Patient above 65 year of age and below five year of age. Severely ill patient or with vascular problem or unfit for surgery.
Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir

The primary objective of this trial is to investigate the effect of food and of gastric pH increase on the relative bioavailability of faldaprevir.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy condition
An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia


Eligibility Criteria:
Inclusion Criteria:

* Must have completed Study 111-301
* Female \>= 10 years old or who have begun menses must have a negative pregnancy test at the Baseline Visit and be willing to have additional pregnancy tests during the study
* If sexually active, willing to use a highly effective method of contraception while participating in the study
* Are willing and able to perform all study procedures
* Parent(s) or guardian(s) are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any research-related procedure. Also, subjects under the age of majority are willing and able to provide written assent (if required by local regulations or the IRB/IEC) after the nature of the study has been explained and prior to performance of any research-related procedure. Subjects who reach the age of majority in their country while the study is ongoing will be asked to provide their own written consent again upon reaching the legal age of majority.

Exclusion Criteria:

* Permanently discontinued BMN 111 or placebo prior to completion of the 111-301 study
* Have a clinically significant finding or arrhythmia on Baseline ECG that indicates abnormal cardiac function
* Evidence of decreased growth velocity (\<1.5 cm/year) as assessed over a period of at least 6 months or of growth plate closure (proximal tibia, distal femur) through bilateral lower extremity X-rays.
* Require any investigational agent prior to completion of study period
* Current therapy with medications known to alter renal function
* Pregnant or breastfeeding or plan to become pregnant during study
* Concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason.
* Have a condition or circumstance that, in the view of the investigator, places the subject at high risk for poor treatment compliance or for not completing the study.
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.


Eligibility Criteria:
Inclusion Criteria:

* A history of dry eye (based on the date of initial dry eye symptoms)
* Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
* Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion Criteria:

* History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
* Use of ophthalmic cyclosporine within 45 days of Visit 1.
* Use of any topical ophthalmic steroid within 2 weeks of Visit 1.
* Have worn contact lenses or anticipate using contact lenses during the study.
* Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
* Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma

The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.

A prospective, randomized, single-blind, positive control design was used to study primary open-angle glaucoma. Eligible subjects were screened and randomly assigned to the experimental group and the control group.

Eligibility Criteria:
Inclusion Criteria

* Patients with a clinical diagnosis of primary open-angle glaucoma (POAG) who could undergo minimally invasive glaucoma surgery (MIGS) as judged by the investigator.
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)

To investigate the efficacy and safety of AK106-001616 in patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA (class I to III)
* Stable dose of methotrexate (at least 12 weeks)

Exclusion Criteria:

* Pregnant or breastfeeding
* Abnormal screening laboratory test values considered to be clinically significant