cyrilzakka/clinical-trials huggingface dataset:
CCEF in the Treatment of Acute VFFs: Randomized Controlled Trial

in recent years the search for therapeutic protocols that could enhance the VFFs healing, thus reducing bed rest-related complications and improving the quality of life of osteoporotic patients. In this context, biophysical stimulation with Capacitively Coupling Electric Fields (CCEF) together, antiresorptive therapy, vitamin D supplementation, and analgesic drugs could play a central role.

CCEF is a non-invasive type of biophysical stimulation used to enhance fracture repair and spinal fusion. Positive effects of CCEF have been reported in osteoporotic vertebral fractures to resolve chronic pain and in postoperative pain, disability, and quality of life after spinal fusion In a preliminary observational study, Piazzolla et al. showed a significantly faster VBME resolution and back pain improvement in patients suffering from VFFs.

Between January 2015 and December 2020, patients referring to the spine centres participating in this multicentre randomized controlled trial with acute VFFs type OF1 or OF2 were included in the present study. Ethical clearance was obtained from our centre's clinical research ethics, as per the 1964 Declaration of Helsinki, and all patients gave informed consent before enrolment in the study.

Eligibility Criteria:
Inclusion Criteria:

* male and female;
* years≥ 60 years old;
* BMI ≤ 35 kg/cm2;
* fracture site between T10 and L3;
* pain at the VCF level;
* low back pain onset within twenty days;
* VBME\>60% in MRI at baseline;
* VBME in a maximum of two vertebral bodies.

Exclusion Criteria:

* posterior wall /pedicle injury;
* previous vertebroplasty/ kyphoplasty;
* history of spine infection or tuberculosis;
* history of malignant tumours that could spread to the spine;
* concomitant rheumatoid arthritis or spondylarthritis;
* scoliosis ≥ 40° according to Cobb;
* thoracolumbar kyphosis\>20° or thoracic kyphosis\>70°;
* any contraindication to MRI;
* use of biomedical devices.
Safety and Immunogenicity Study of GSK Biologicals' Seasonal Influenza Candidate Vaccine (GSK2321138A)

This study is designed to assess the safety and immunogenicity of a GSK Biologicals' investigational vaccine GSK2321138A in adults 18 years old and older. This study is also designed to assess the lot-to-lot consistency of vaccine GSK2321138A. The blinding will be double blind for all groups except for the GSK2604409A Group which will be open.


Eligibility Criteria:
Inclusion Criteria:

* A male or female 18 years of age or older at the time of the first vaccination
* Subjects who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject.
* Healthy subjects or those with chronic well-controlled disease as established by physical examination before entering into the study.
* Female subjects of non-childbearing potential may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:
* - has practiced adequate contraception for 30 days prior to vaccination,
* - and has a negative urine pregnancy test on the day of vaccination,
* and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of the study vaccine or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
* Administration of an influenza vaccine during the 6 months preceding entry into the study.
* Planned administration / administration of a vaccine not foreseen by the study protocol within 30 days before vaccination and up to Day 21.
* Any contra-indication to intramuscular administration of the influenza vaccines.
* History of hypersensitivity/anaphylaxis to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Any administration of a long-acting immune-modifying drug within 3 months before study start, or planned administration during the study period.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Acute disease and/or fever at the time of enrolment.
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
* History of chronic alcohol consumption and/or drug abuse.
* Any condition which, in the opinion of the investigator, prevents the subject from participating in the study
* Pregnant or lactating female.
A Cryotherapy With Tranexamic Acid Versus Normal Saline in the Treatment of Melasma

This study aimed to evaluate the effectiveness of a precision cryotherapy via boosting mode combined with tranexamic acid versus normal saline in the treatment of melasma. Eighteen patients aged 25 to 60 years diagnosed with epidermal-typed melasma sized equal to or more than 2 cm on both cheeks were included. The patients were treated with a precision cryotherapy via boosting mode combined with tranexamic acid and normal saline on each side of cheek for 4 times every 1 week. Then, they were follow up at 1 and 3 months after the last treatment. Subjective assessment of physician and patient improvement were evaluated. Moreover, Melasma Area and Severity Index (MASI), melanin and erythema index using Mexameter were also recorded.

TargetCool via boosting mode combined with tranexamic acid versus normal saline were studied in patients diagnosed with epidermal-typed melasma.

Eligibility Criteria:
Inclusion Criteria:

* The patients diagnosed with epidermal-type melasma sized equal to or more than 2 cm on both sides of cheeks
* Fitzpatrick skin type II-IV

Exclusion Criteria:

* Pregnant or lactation
* Subjects who have been treated with any kind of energy-based device 6 months prior to the inclusion
* Subjects who have been treated with topical or oral treatment for melasma 6 months prior to the inclusion
* Subjects who allergy to cryotherapy such as cryoglobulinemia, cold urticaria, and abnormal cold tolerance
* Subjects with abnormal sensation such as diabetes mellitus
* Active skin infections
* History of hypertrophic scars or keloids History of hypertrophic scars or keloids
Effects of Pesticide Exposure on Neurodevelopment/Growth/Respiratory Health

Exposure and health study of pesticide and allergen exposures to pregnant women and children. Intervention study is planned after assessment is completed.

Exposure assessment and pathway analysis of organophosphate pesticides to low income pregnant women and children living in the Salinas valley of California. Health study investigating neurodevelopment, growth, and asthma in children.

Eligibility Criteria:
* Female, at least 18 years of age.
* Live in Salinas valley in California.
* Pregnant.
* Medical eligible.
Can Simple and Inexpensive Techniques Enhance Patient Comfort

This research study compares two methods of performing colonoscopy without sedation. The standard method is to insert the colonoscope without adding any water to the colon, and when colonic spasms occur during the examination, waiting for the spasms to subside before continuing with the insertion of the colonoscope. The study method involves putting 200 ml (7 oz) of warm water through the colonoscope into the colon at the beginning of the examination, and when colonic spasms occur during the examination, putting 30 ml (1 oz) of warm water into the spastic area(s) to relax the colonic spasms.

The purpose of the study is to conduct a RCT study to determine the effectiveness of loading the sigmoid colon with warm water and warm water irrigation for dealing with colonic spasms in enhancing patient abdominal comfort during unsedated colonoscopy. The specific aim is to compare Study Treatment of warm water loading and irrigation when spasms occur with Control Treatment of no water loading and waiting for spasms to subside. The proportion of patients complaining of abdominal discomfort and their discomfort score are the primary outcome variables. The secondary outcome variables and co-variables described below will be recorded in a prospective manner to ensure completeness of data collection. In preliminary clinical observation at VA Sepulveda ACC, 25 to 30% of VA patients accept colonoscopy without sedation. The goal of this study is to find ways of further reducing discomfort associated with unsedated colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female
* Adult patients 18 years old in need of colonoscopy for screening or follow up of colonic polyps, and willing to consent to be randomized.

Exclusion Criteria:

* Patients receiving outpatient prescription narcotic treatment \[more likely to have discomfort response even with sedation (42)\].
* Patients who report excessive anxiety \[pre-endoscopy appointment, single question asking how anxious the patient generally is, four point scale (1 = not at all, 2 = slightly, 3 = moderately, 4 = excessively\].
* Excessive anxiety is significantly correlated with lack of cooperation during colonoscopy and high dissatisfaction score after the procedure (43).
* Patients with moderate to severe abdominal discomfort, unable to provide informed consent, have a poor bowel preparation (discolored rectal output or feces filled rectal vault), and those who decline to participate, will also be excluded.
A Dose Evaluation Study of the Effect of Plug Placement on the Efficacy and Safety of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to determine the effect of plug placement on the efficacy, safety and duration of effect of the L-PPDS (latanoprost punctal plug delivery system).


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years old
* Diagnosis of bilateral open angle glaucoma or ocular hypertension
* Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria:

* Any significant vision loss in the last year
* No contact lens use for the length of the study
* Abnormal eye lids, eye infection or diseases to the eye
* Recent eye surgery
* Uncontrolled medical conditions
A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China

A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.

This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC). Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient greater than or equal to 18 years of age with diagnosis of RA (Rheumatoid Arthritis) and no history of chronic arthritis before age 16.
2. Patient meets the requirements for treatment with adalimumab per the local product label.
3. Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic\* DMARD (Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (\*rituximab may not have been used in the past 104 weeks before the Baseline visit).
4. Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.

Exclusion Criteria:

1. Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit.
2. Prior clinically active TB (tuberculosis): if patient has had prior clinically active TB, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study.
3. Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
4. Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical judgment.
Exploring the Relationship Between L-dopa Responsiveness and Small Intestinal Microbiome in Parkinson's Disease

The investigators hypothesize that small intestinal (SI) microbiome biomarkers predict the responsiveness to oral levodopa/carbidopa in people with Parkinson's disease (PwPD). The investigators will analyze the bacterial species and function of bacterial pathways influencing the responsiveness of PwPD to oral L-dopa. The investigators will pursue this goal using a reliable capsule system (SIMBA capsule, Nimble Science, Calgary, AB) that suitably captures SI luminal fluid for multi-omics analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females aged 50-85 years old at time of on-site visit. (ages 81-85 will be assessed on a per case basis by the principal investigator)
2. Signed Informed consent.
3. Willing \& able to comply with study procedures (including SIMBA capsule ingestion) and have study assessments performed.
4. Able to swallow a size-00 capsule (25mm length) in OFF state.
5. Diagnosis of idiopathic PD (Clinically Probable PD), including documented levodopa responsiveness.
6. Treatment with an immediate release levodopa formulation during the day at a stable dose for at least 2 months prior to enrollment.

Exclusion Criteria:

1. Any risk of capsule non-excretion related to intercurrent gastrointestinal conditions.
2. Use of any medications in the week prior to the on-site study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function.
3. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration, e.g., SDQ score \> 4.
4. Any concomitant or previous treatment (\<2 months from on-site study visit) with significant anti-inflammatory or immune suppressant medication, e.g., DMARDs, biologicals or systemic corticosteroids, except non-chronic PRN use of an NSAID and/or 5-ASA (mesalazine) treatment.
5. Active cancer within 5 years.
6. Clinically significant immune deficiency (according to Investigator's judgement).
7. Antibiotic use (except for local use), ≤12 weeks prior to on-site study visit, or Fecal Microbiota Transplantation anytime in medical history.
8. Use of prebiotics, or probiotics ≤2 weeks prior to the on-site study visit.
9. Dementia in medical history.
10. Insulin-dependent diabetes mellitus.
11. Current Psychosis episode by clinical judgement based on anamnesis.
12. Pregnancy.
13. Alcohol or drug abuse.
14. Deep brain stimulation or Duodopa/Lecigon treatment.
Prognostic Factors Affecting Survival of Gastric GIST

Gastrointestinal stromal tumor (GIST) is the most common non-epithelial mesenchymal tumor of the gastrointestinal tract. Surgical treatment is the only curative therapy for primary localized GIST. This study aimed to identify the clinicopathological characteristics of gastric GISTs and to study the predictive factors for recurrence in Tunisian patients.

The prognosis of gastric GIST depends on various tumor factors with the most important being the mitotic index and tumor necrosis. Imatinib therapy has revolutionized the treatment of advanced GIST.

They have been the subject of much controversy in terms of their histogenesis, classification, treatment and prognosis. GISTs are histologically similar to smooth muscle and nerve tumors such as leiomyomas, leiomyosarcomas or schwannomas. Currently they are well characterized with the recent discovery of the C-KIT gene mutation and the expression by tumor cells of the C-KIT protein.

Moreover, the discovery of this receptor is at the origin of the introduction of a "targeted therapy": an anti-tyrosine kinase molecule having revolutionized the therapeutic management of these tumors. However, the standard curative treatment of GIST remains complete surgical resection with negative margin from the tumor.

Eligibility Criteria:
Inclusion Criteria: patient having gastric GIST

-

Exclusion Criteria:

* patient operated for other gastric tumors
The Efficacy of Maternal Sound for Pediatric Patients Undergoing Cardiac Surgery

A newborn's recognition and preference for their mother's voice occurs early in life, very likely during fetal development. Maternal voice stimuli undergo a unique form of cerebral processing that lends support for the existence of neurophysiologic mechanisms that reflect a child's preference for his/her mother's voice. This study aims to evaluate and compare the effect t of maternal sound listening in children undergoing cardiac surgery on stress response and physiological parameters.

Children (4 to 8 years) undergoing repair of Atrial Septal Defect (ASD). Patients will be randomized into two equal groups (30 in each group) (control group and maternal sound group); in control group patients listened to a blank CD, while in maternal sound group patients listened to a recorded CD where the mother singing the most popular songs their children like or telling a story to their children. Baseline stress markers (blood glucose and plasma cortisol) sampled the morning before scheduled operation. A interview with the patients and their parents before operation to collect the questionnaire regarding patient's characteristic (age, sex, weight and height), patient's clinical data (medical diagnosis and American Society of Anesthesiologists physical status) and haemodynamic data (blood pressure, heart rate, oxygen saturation on room air, temperature). In addition, the researcher interviewed with the mothers to record on one CD their voice while they are singing the most popular songs their children like or telling a story to their children to help them to sleep to be used during intra-operative period in maternal sound group.

Eligibility Criteria:
Inclusion Criteria:

* Age range 4-8 years
* Elective cardiac surgery
* Atrial Septal Defect (ASD) repair with Cardiopulmonary bypass

Exclusion Criteria:

* Previous cardiac surgery
* Diabetes mellitus
* Hearing impairment
* Psychiatric illness
* Neurological illness.
CLL Empirical Antibiotic Regimen

The purpose of this study is to evaluate whether patients with previously untreated, early stage CLL respond to empirical broad spectrum antibiotics and therefore test the hypothesis that occult bacterial infections are involved in the induction and maintenance of CLL.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* ECOG performance status of 2 or less.
* CLL with a diagnostic score of 4 or 5.
* Clinical stage A disease.
* No disease progression over a minimum of 1 month prior to commencement of therapy.
* Less than 2 adverse prognostic factors.
* Absence of adverse cytogenetics.
* Expected survival \> 6 months.
* Able to give informed consent.
* No clinical evidence of active infection at the time of study entry.
* No known allergy to any of the study medications.
* Renal and liver function tests within normal limits.

Exclusion Criteria:

* Disease progression during screening period.
* Known positivity for HIV types 1 or 2.
* Active infection at the time of screening.
* Pregnancy or lactation.
* Females of childbearing potential† and males not willing to practice an effective method of contraception whilst receiving the antibiotic regimen and for 4 weeks after the last dose.
* Concomitant medication likely to produce serious interaction with study drugs including warfarin type oral anticoagulants and anti-epileptics.
Virtual Reality (VR) to Improve Quality of Life in Patients Diagnosed With Neurological Disorders

Participants with neurological disorders will be recruited to complete sessions of virtual reality (VR) immersion. VR has been shown to have therapeutic benefit in certain patient populations and requires further clinical study to determine the extent to which VR can be used to rehabilitate and reduce symptom burden. This study seeks to pilot newly developed VR methods and collect preliminary data in order to support research grants and inform larger clinical trials. Additionally, this proposed study will explore the tolerability and preliminary efficacy of Virtual Reality (VR), specifically to determine whether VR can acutely reduce the severity of symptom burden caused by neurological disorders.


Eligibility Criteria:
Inclusion Criteria:

* 18-79 years of age
* Has been diagnosed by a clinician as having MS
* Able to commit to the designated period of testing
* Able to understand the informed consent process and provide consent to participate in the study
* Capacity to complete study procedures as determined by screening personnel
* A Brief Pain Inventory interference score of at least 3 or more.
* SDMT Z-Score \> -3.0
* WRAT4 Standard Score \> or = 85

Exclusion Criteria:

* Visual, auditory, and motor deficits that would prevent full ability to understand study
* Visual, auditory, and motor deficits that would prevent full ability to operate VR equipment
* Uncontrolled epilepsy
* Current diagnosis of vertigo
* Uncontrolled mood disorders
* History of Psychosis or Schizophrenia
* Expanded Disability Status Scale (EDSS) Score greater than 6.5
* Unable to tolerate or manipulate VR treatment procedures (as evidenced by VR capability assessment)