cyrilzakka/clinical-trials huggingface dataset:
Long Term Clinical Outcome of Single Open Door Laminoplasty With Preservation of Unilateral Muscular Ligament Complex

To collect and measure the preoperative and postoperative clinical data of the patients undergoing single open-door expansive laminoplasty with preservation of musclar ligament complex through posterior cervical approach in our hospital and summarize the long-term clinical effect and postoperative imaging changes and analyze the long-term clinical effect of this operation

Objective: To collect and measure the preoperative and postoperative clinical data of the patients undergoing single open-door expansive laminoplasty with preservation of musclar ligament complex through posterior cervical approach in our hospital. To summarize the long-term clinical effect and postoperative imaging changes and to analyze the long-term clinical effect of this operation on cervical spondylosis. To provide scientific basis for clinical work and theoretical research in the future.

This study was a retrospective study, and the medical records of posterior cervical open-door expansive laminoplasty with musclar ligament complex preservation in the orthopedics department of our hospital from 2006 to 2017 were collected, and the patients with complete diagnosis and treatment data were selected for analysis and research.The preoperative and postoperative changes of the patients were studied by combining the patient's case and imaging examination (MR, CT, X plain film) and other diagnosis and treatment data.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70, gender unlimited;
2. The patient was diagnosed with cervical spondylosis and met the indications of posterior cervical laminoplasty;
3. Basis of serious diseases of heart, brain, lung, kidney or other important organs, preoperative ASA score I-II;
4. Agree to participate in the study and sign the informed consent；

Exclusion Criteria:

1. Preoperative ASA score ≥III;
2. One-stage combined anterior and posterior surgery of cervical spine;
3. Correction of cervical deformity;
4. Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations;
5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;
6. People with mental disorders, alcohol dependence or drug abuse history;
7. women in the period of lactation and pregnancy;
8. People with allergic constitution or previous allergies to a variety of drugs;
9. Other researchers consider it inappropriate to participate in this study
DDI Study With Multiple-dose LX4211 and Single Dose Rosuvastatin

This study will be conducted as a single-center, open-label, 2-period, single-sequence, drug-drug interaction study to assess the effects of multiple-dose LX4211 400 mg (2 × 200-mg tablets qd × 7 days) on the PK of single-dose rosuvastatin (1 × 10-mg tablet) in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥18 to ≤55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mmHg; diastolic blood pressure, 50-90 mmHg; heart rate, 45-100 bpm
* Body mass index (BMI) ≥18 and ≤32 kg/sq m
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
* Use of any medications or supplements/supratherapeutic doses of vitamins within 14 days prior to the first dose administration and throughout the duration of the study
* Receipt of any investigational agent or study drug within 30 days prior to Screening
* Receipt of any protein- or antibody-based therapeutic agents within 3 months prior to Screening
* Prior exposure to LX4211
* Use of tobacco, smoking cessation products, or products containing nicotine within 3 months prior to Screening and for the duration of the study
* History of any serious adverse reaction or hypersensitivity to any inactive component of LX4211 or rosuvastatin
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211 or rosuvastatin
* History of any major surgery within 6 months or anticipated surgery prior to Day
* History of any clinically significant hypoglycemia or hyperglycemia
* History of renal disease, or significantly abnormal kidney function test at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
* History of any active infection within 14 days prior to Day 1
* History of alcohol or substance abuse within 2 years prior to Screening
* Positive hepatitis panel
* Donation or loss of \>500 mL of blood or blood product within 3 months prior to Screening
* Women who are breastfeeding or are planning to become pregnant during the study, or women who have a positive serum pregnancy test
* Positive urine glucose at Screening
* Positive urine screen for drugs of abuse and cotinine at Screening, Day -1, or Day 13
* Inability or difficulty swallowing whole tablets
* Unable or unwilling to cooperate with the Investigator for any reason
Gene Expression, Immunological Status and Metabolome in Glioma Patients

Study on glioma patients treated with brain surgery is focusing on the analysis of their transcriptome expression profile measured in two immune cell populations, CD4+ T cells and CD56+ NK cells. The results of analysis will be compared to the reference data of healthy population. Furthermore, the metabolomic and immunological status will also be monitored and compared to healthy group reference data, before and after the surgery\*. With comparative crossomics analysis the investigators intend to possibly identify new diagnostic and prognostic biological markers for the relapse of the disease. The results are expected to convey a deeper insight into pathophysiology of the glioma as well as into the mechanisms of the current surgical therapy.

\* The healthy reference data have been published in collaborative efforts of BTC, UMC and NIB (Gruden et al. 2012).


Eligibility Criteria:
Inclusion Criteria:

* malignant glioma = glioblastoma (WHO IV) patients

Exclusion Criteria:

* pregnancy
* metastases
Combined Treatment for Patients With Comorbid Substance Use Disorders and Post-traumatic Stress Disorder (PTSD): an Integration of Cognitive-behavioral Treatment (CBT) and Trauma-focused Structured Writing Therapy

This study is a randomized controlled trial comparing two treatments for patients with comorbid substance use disorder (SUD) and post-traumatic stress disorder (PTSD) conducted within two different routine clinical settings for the treatment of SUD, namely (a) a day-care and inpatient setting and (b) an outpatient setting. Participants will be randomly assigned to either (1) a combination of cognitive-behavioral treatment (CBT) for SUD and trauma-focused structured writing therapy, or (2) CBT for SUD alone. Randomization will take place separately for each setting. It is expected that the combined treatment is significantly more effective in reducing symptoms of SUD as well as PTSD than CBT for SUD alone. Outcome measures will be assessed at pre-treatment, post-treatment as well as 3 months, 6 months and 12 months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of substance abuse or substance dependence according to DSM-IV
* Diagnosis of PTSD according to the DSM-IV or subthreshold PTSD (at least one re-experiencing symptom plus either three avoidance/numbing or two hyperarousal symptoms are present)
* 18 years or older
* Sufficient fluency in Dutch or English to complete treatment and research procedures

Exclusion Criteria:

* Severe psychiatric problems that may interfere with study participation or that require more intensive clinical care than can be offered in the present study (e.g., dementia, psychotic symptoms, depression with suicidal ideation, manic episode and borderline personality disorder)
* Receiving concurrent psychotherapy
* Participants using tranquilizers are required to terminate medication use before inclusion
* Participants using anti-depressant medication are required to stabilize medication use before inclusion.
SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition.
* Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion Criteria:

* Use of any b-blocking agent, including eye-drops.
* Use of oral GCS as maintenance treatment.
* Known or suspected hypersensitivity to study therapy or excipients.
* A history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
Study of AS1411 in Advanced Solid Tumours

A Phase I open label study of AS1411 in advanced solid tumours. Objectives include determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain preliminary evidence of clinical and biological responses to AS1411 therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced solid tumours that were refractory to conventional/standard treatment
* Age \>/ 18 years
* ECOG performance status \</ 2 (Karnofsky \>/60%
* Life expectancy \>/ 8 weeks
* Adequate organ and marrow function

Exclusion Criteria:

* Radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for nitrosourea or mitomycin C
* Lack of recovery from adverse events (AEs) caused by agents administered before study entry; current use of other investigational agent(s)
* Uncontrolled brain metastases including a need for corticosteroid therapy
* Pregnancy
* Uncontrolled intercurrent illness
* Psychiatric illness/social situations that could limit compliance
Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis

The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.

A pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with Oral Defense Toothpaste.

In this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. The first arm (test arm) will receive Oral Defense Toothpaste and be required to brush three times per day, for 8 days. The second arm (control arm) will receive Crest Toothpaste and be required to brush three times per day, for 8 days. Patients in the control arm will be provided Magic Mouth Rinse, if needed. Healing of oral mucositis lesions will be evaluated at days 1 and 8. Quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 receiving chemotherapy
* Mucositis lesions not exceeding grade 2

Exclusion Criteria:

* Patients receiving high load chemotherapy
* Patients receiving radiation therapy
* Patients receiving oral antivirals, oral antifungals or oral antibacterials
* Patients experiencing oral candidiasis
Mobile Interpretation Bias Modification Clinical Trial

The Mobile-Interpretation Bias Modification clinical trial aims to examine the efficacy of a brief mobile phone delivered interpretation bias modification to reduce anxiety sensitivity cognitive concerns and suicidal ideation in National Guard Personnel. The investigators propose a randomized controlled trial testing the efficacy, acceptability, and usability of M-IBM with a sample of 114 National Guardsmen with current suicidal ideation and elevated anxiety sensitivity cognitive concerns. Participants will complete assessments, receive assistance on installing M- IBM on their phone, complete an M-IBM intervention session, and complete post-intervention assessments. Baseline measures of psychopathology, and usability/acceptability of M-IBM will be obtained during the initial session. In addition, 1-month, and 3-month follow-ups would be scheduled to examine changes in psychopathology. The investigators hypothesize that those randomized to M-IBM will experience reductions in anxiety sensitivity cognitive concerns, suicidal ideation. In addition participants will find M-IBM acceptable and easy to use.


Eligibility Criteria:
Inclusion Criteria:

* Elevated ASCC (\>2) and include only Guard members who also have current SI (\> 0) .
* Ownership of a smartphone

Exclusion Criteria:

* those determined by military or study personnel to be actively psychotic, manic, or imminently suicidal and in need of emergency services
Retrospective Observational Registry of Patients With Atrial Fibrillation From Vigo´s Health Area

Registry of all consecutive patients with atrial fibrillation from Heath Area of Vigo, since 2013 to 2020, in order to study therapy, mortality, cardiovascular complications and bleeding events.

Retrospective observational registry of patients diagnosed of atrial fibrillation between 2013 and 2020. Clinical, analytical and echocardiographic data will be recorded, as well as therapeutic prescription information. Data on mortality and cardioembolic and hemorrhagic events will be collected during follow-up. The aim is to study the prevalence and incidence of atrial fibrillation, the anticoagulant treatment according to cardioembolic risk, the thromboembolic events and hemorrhagic events, the risk of mortality (Cardiovascular, Non-Cardiovascular), the contemporary management (Rhythm control versus frequency control strategy), and other complications, such as heart failure, acute coronary syndrome or cancer.

Eligibility Criteria:
Inclusion Criteria:

* All patients with confirmed diagnoses of atrial fibrillation by ECG.

Exclusion Criteria:

* None
Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study

Rationale: Iron deficiency and zinc deficiency, are of public health significance in sub-Saharan Africa. An estimated 50% of children (5-14 years) in developing countries suffer from anaemia, half of which is estimated iron deficiency anaemia. Interventions have been designed and implemented over the years towards solving hunger and anaemia especially among school age children. One of such interventions is School Feeding Programme (SFP) which is common in both developing and industrialized countries. SFP has been part of the Ghanaian educational system for well over 40 years, albeit on small scale. The main stay of the programme that makes it distinguishable from other past and existing school feeding programmes is its reliance on locally produced and available foods, such as cowpeas. Legume staples like cowpea have been identified to be important sources of protein and non-heme iron to rural populations of developing countries like Ghana. The problem however is the low bioavailability of these micronutrients from these legumes.

Objective: To assess the efficacy of iron fortified cowpea based meal (Tubani) in improving iron status of primary school children in rural northern Ghana Study design: A randomized double blind parallel design will be conducted. One group will receive iron fortified Tubani with NaFeEDTA and the other group will receive unfortified Tubani.

Study population: Two hundred and forty apparently healthy pupils in lower primary school will participate. The participating schools have a school feeding programme currently in operation.

Intervention (if applicable): Children will be fed Tubani containing 10mg of fortification iron (in the form of NaFeEDTA) three times in a week for six months. Weight, height and blood samples will be measured at baseline and after six months of intervention. Participants will be treated against intestinal parasites before start of intervention and halfway through the intervention.

Main study parameters/endpoints: The main study endpoint is iron-deficiency anaemia (IDA). IDA will be defined as concurrent anaemia and iron deficiency. Whole blood will be collected for the analysis of Hb, serum ferritin (SF), serum transferring receptor (sTfR) and C-reactive protein (CRP). Anemia will be defined as a hemoglobin concentration \<115 g/L, and iron deficiency will be defined as an SF concentration \<12 µg/L.

Venipunctures occasionally lead to bruises or small local inflammation which usually disappear within one week. To minimize this risk, blood collection will be performed by a trained and experienced phlebotomists. Written informed consent will be obtained from all subjects.


Eligibility Criteria:
Inclusion Criteria:

* Children 6-12 years old
* Regularly attending school, in grades 1-3
* Apparently healthy, free of chronic illnesses and not taking chronic medication.
* No medication nor supplemental iron at time of entry into the study
* Informed consent obtained from at least one parent or guardian

Exclusion Criteria:

* Children with severe anemia (Hb\<70 g/l).
Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods

This clinical trial studies how well an educational intervention works in increasing knowledge about prostate cancer in high-risk neighborhoods. Learning about prostate cancer and the pros and cons of screening for prostate cancer may increase knowledge about prostate cancer while decreasing anxiety and concerns about prostate cancer screening.

PRIMARY OBJECTIVES:

I. To identify neighborhoods with disproportionately high rates of advanced prostate cancer and describe patient- and neighborhood-level risk factors associated with the high-risk neighborhoods.

II. To develop, using a mixed methods approach, a targeted educational intervention about prostate cancer for men who live in high risk neighborhoods.

III. To test the impact of the targeted intervention on levels of knowledge, anxiety, and informed decision making about prostate cancer (PCa) screening.

IV. To observe the rates of PCa screening in the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Focus groups consisting of men who live, work, or worship in the 4 predetermined neighborhoods
* Currently reside in one of the four selected high risk neighborhoods

Exclusion Criteria:

• Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen \[PSA\] or digital rectal examination \[DRE\]) within the past 12 months
Improving Patient-Centered Care Delivery Among Patients With Chronic Obstructive Pulmonary Disease

This study involves development and testing of a patient and family-centered transitional care program for patients who are hospitalized with Chronic Obstructive Pulmonary Disease (COPD) exacerbations. The study intervention includes tailored services to address individual patients' biopsychosocial needs, starting early during hospital stay and continuing for 3 months post hospital discharge.

The study hypothesis is that compared to usual care, the study intervention will : a) Improve patient health- related quality of life and survival, and reduce use of hospital and emergency room visits; b) result in improved patient experience, self- confidence, and self-care behaviors; c) result in improved family caregivers coping skills, self-confidence, and problem solving skills to address patient barriers to care and treatment.

This study evaluates using a randomized controlled trial design the impact of a patient and family-centered transitional care program named the BREATHE program. The BREATHE program stands for 'Better Respiratory Education and Treatment Help Empower'. The BREATHE program offers the following:

1. Individualized transition support services to help ensure that the patient (and family caregiver if available) are prepared for discharge, understand the discharge plan of care, and receive post discharge follow up to help meet their needs
2. Tailored COPD self-management education and support program that starts during the hospital stay and continues post discharge in the community setting
3. Facilitated access to community based services.

The intervention is delivered by a new team member called "COPD Nurse Transition Guide". The new team member works with both the hospital and outpatient care teams, is a registered nurse with homecare services experience, and have received additional training in COPD self-management and motivational interviewing. The nurse meets participants in the hospital and then follows up with them via home visits and phone calls.The intervention involves both patients and family caregivers (if available), is literacy adapted, and follows a tailored approach based on patient needs, priorities, and preferences.

Eligibility Criteria:
Inclusion criteria:

* Admitted to the hospital with a diagnosis of an acute COPD exacerbation; OR has a previous COPD diagnosis\* AND receiving treatment to control COPD symptoms - (e.g. nebulizer treatment, prednisone course, ...) in the current hospitalization
* Age \> 40 and \>10 pack-yrs smoking
* English speaking
* Anticipated discharge back to home (rather than to Hospice or long term nursing home placement)

Exclusion criteria:

* Severe cognitive dysfunction
* Terminal illness (less than 6 months life expectancy) that is non-COPD related
* Homeless (no home address)
Exploring Cancer Evolution, Prognostic and Predictive Biomarkers in EGFR-mutant NSCLC

To investigate genomic architecture, cancer evolution and their relationship with clinical outcomes in EGFR-mutant NSCLC.

EGFR mutations are detected in about 50% of East Asian NSCLC and 10% of Western NSCLC. EGFR-mutant NSCLC harbors distinct genomic architecture including high ITH, early diversification, genome instability, low background mutation rates. But despite its high ITH, EGFR-mutant NSCLC usually have better prognosis than NSCLC with other driver mutations even without the application of targeted therapies, indicating that EGFR mutations may have distinct impacts on cancer evolution. This study intends to investigate the genomic architecture, cancer evolution trajectories and their relationship with clinical outcomes in EGFR-mutant NSCLC, and to identify prognostic and predictive biomarkers for this population that could potentially guide therapeutic decisions and improved clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Histologically or cytologically confirmed non-small-cell lung cancer
3. ECOG PS=0-2
4. EGFR mutations confirmed by tissue or peripheral blood
5. Can provide tumor tissue samples (fresh or archived)
6. The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent

Exclusion Criteria:

1. History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
2. Unable to provide sufficient tumor tissue for analysis.
3. Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class \>= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.
4. Subjects who are deemed unable to comply with the study requirements or complete the study.