cyrilzakka/clinical-trials huggingface dataset:
Long Term Effects of Erythropoietin in Patients With Moderate to Severe Traumatic Brain Injury

Traumatic brain injury is catastrophic event that commonly require treatment in an intensive care unit. Management is mainly supportive aiming at avoiding hypoxia, hypotension, hypoglycaemia and increased intracerebral pressure. Thus far efforts to find a specific pharmacologic therapies have been disappointing. Recently it was demonstrated that recombinant erythropoietin has been found to decrease mortality at six months from injury but without significantly improving functional neurological outcome (GOSe). Whether this survival benefit of EPO is sustained beyond 6 months is unknown.

In the current study survival data will be collected centrally and patients alive or person responsible will be invited to participate in an evaluation of neurological function and quality of life. Factors associated with time to death as well as factors associated with long term quality of life will be determined with statistical methods.

Aim: In this post hoc study of a RCT the primary aim is to determine the effect of EPO compared to placebo in improving outcome, including survival, neurological function and quality of life two years after the conclusion of the EPO-TBI study (two to seven years after moderate or severe TBI occurring in individual patients).

Design: A long term follow-up study of a prospective, multi-centre, double blind, phase III, randomised controlled trial.

Methods: Survival status at the time when this follow-up trial is executed will obtained in all patients. Time from injury will vary between 2 to 7 years depending on when the patient was enrolled. This information will obtained from hospital notes, national register offices and/or national statistical bureaus. Since the trial was an international RCT, strategies may vary and will take into account local circumstances. Local plans will be developed by the local principal investigators and approved by the management committee.

Data includes

* Survival status at long term follow up (alive/dead)
* Time from injury to assessment (days)
* If the patients is deceased, time of death and time from injury in days

Quality of life assessment

Patients (or a proxy - generally a close family member) who are alive at 2-7 years after randomisation will be interviewed by trained assessors. The same contact person as used in the primary trial will be contacted primarily. Consent will be obtained for the conduction for long term assessment. Assessors will use a standardized structured telephone questionnaires to determine GOSE and QOL. Neurological outcomes will then be defined as favourable (GOSE 5 to 8; moderate disability and good recovery) or unfavourable (GOSE 1 to 4; death and severe disability). Data include:

* Time of assessment
* Time from injury in days
* Follow-up GOSE
* Follow-up EQ-5D
* Follow-up SF-12

Eligibility Criteria:
Inclusion Criteria:

* Participation in the EPO-TBI study without withdrawal of informed consent.

Exclusion criteria:

* Failure to to consent for the conduction of the follow-up assessment.
Radiation Therapy and Intratumoral Autologous Dendritic Cells in Soft Tissue Sarcomas (STS)

The purpose of this study is to determine if injection of the participant's our own immune related white blood cells (called dendritic cells) into their tumor will strengthen their immune system to fight against their cancer.


Eligibility Criteria:
Inclusion Criteria:

* Intermediate or High grade (AJCC 7th edition Grade 3 and 4 or Grade 2 and 3 of a 3 tier system) STS as determined by local pathology diagnostic biopsy specimen review
* Musculoskeletal tumor in extremities, trunk or chest wall
* Primary tumor or isolated locally recurrent tumor greater than 5 cm in diameter as measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1
* Clinical Stage T2N0M0 (AJCC 7th edition)
* Age ≥18 years at time of consent
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0 or 1
* Patient's written study specific, Institutional Review Board (IRB) stamped informed consent.
* Adequate organ function (measured within a week prior to beginning treatment for Arm B and within 2 weeks of beginning treatment for Arm A): white blood count (WBC) \> 3,000/mm³ and absolute neutrophil count (ANC) \>1500/mm³; Platelets \> 100,000/mm³; Hematocrit \> 25%; Bilirubin \< 2.0 mg/dL; Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min
* Radiation Oncologist must confirm that a 2-3 cm strip of skin can be spared from RT.

Exclusion Criteria:

* Retroperitoneal or Head and Neck primary locations
* Gastrointestinal stromal tumor (GIST)
* Demonstrated metastatic disease
* Contraindication to resection
* Prior RT if the current tumor is locally recurrent after prior resection
* Concurrent treatment with any anticancer agent other than RT as dictated by the protocol
* Prior chemotherapy for the pre-surgical treatment of the primary tumor (neoadjuvant chemotherapy)Bleeding/coagulation disorder
* Human Immunodeficiency Virus (HIV) infection or other primary immunodeficiency disorder
* Ongoing systemic therapy with immunosuppressant drugs (e.g. corticosteroids, azathioprine, cyclosporin, methotrexate)
* Steroid therapy within 4 weeks of first DC administration
* Any serious ongoing infection
* Pregnant or lactating women. Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment).
Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 6-12 years, inclusive.
* Subjects meeting the DSM-IV criteria for primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
* Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to Screening visit.

Exclusion Criteria:

* Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
* Diagnosed with or history of a tic disorder or Tourette's syndrome.
* History of seizure disorder.
* The presence of a known medical condition that would preclude the use of methylphenidate.
* A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease.
* ALT (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) at Screening.
* A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
* Subjects who have participated in an investigational trial within the past 4 weeks (28 days)
* Subjects who are currently taking antidepressants or other psychotropic medication.
* Subjects who have initiated psychotherapy during the three months prior to randomization.
* Subjects with a positive urine drug screen.
* Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate.

Other protocol-defined inclusion/exclusion criteria may apply
Phytosterols, Ezetimibe, and Cholesterol Metabolism

Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-controlled crossover trial the effects of placebo, ezetimibe treatment and ezetimibe plus phytosterol treatment will be measured.

The investigators will perform a randomized, placebo-controlled crossover feeding study in 25 subjects with greater than ideal levels of LDL cholesterol who do not require anti-cholesterol drug treatment. Subjects will consume a baseline diet provided by a feeding center that is deficient in phytosterols for three periods of 21 days separated by 7-day washout periods. Treatments will be given in random order During period B placebo phytosterols and placebo ezetimibe will be given; during period C placebo phytosterols and active ezetimibe will be given; during period A active phytosterols and active ezetimibe will be given. Study endpoints are fecal cholesterol excretion and percent cholesterol absorption determined by gas chromatography/mass spectrometry and circulating LDL cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any race or ethnicity between 18 to 80 years of age;
* Body mass index between 20 - 35 kg/m2;
* LDL-cholesterol between 130 - 189 mg/dL based on the average of duplicate screening measures. If the two LDL-C levels differ by more than 30 mg/dL, a third test will be scheduled with all three results averaged;
* Free of chronic disease;
* Willing to eat only the foods that are provided by the Center during the diet periods;
* Willing to abstain from the consumption of alcohol for 48-hours prior to blood draw days;
* Willing to drink no more than 5 cups of caffeine-containing beverages a day.

Exclusion Criteria:

* Age \< 18 or \> 80 years;
* Based on duplicate screening laboratory values: 1)LDL-C \>=190 mg/dL; 2)TG \>=250 mg/dL;3)blood pressure \>= 160 mm Hg systolic or 95 mm Hg diastolic;
* Documented presence of atherosclerotic disease;
* Diabetes mellitus;
* Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease;
* Body mass index \> 35;
* For women, pregnancy, breast feeding or postpartum \< 6 months;
* For women, peri-menopausal;
* For women, sexually active but not practicing effective birth control methods;
* History of drug or alcohol abuse;
* History of depression or mental illness requiring treatment or medication within the last 6 months;
* multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence;
* Chronic use of over-the-counter medication which would interfere with study endpoints including laxatives and antacids;
* Lifestyle or schedule incompatible with the study protocol;
* Planned continued use of dietary supplements through the study trial;
* Taking any lipid-lowering, or other medications known to affect blood cholesterol.
An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

To investigate safety and efficacy of varenicline tartrate in helping people quit smoking


Eligibility Criteria:
Inclusion Criteria:

* Current cigarette smokers between the ages of 18 and 75 years, who are motivated to stop smoking

Exclusion Criteria:

* Patients currently suffering from depression, or have been diagnosed with depression in the last 12 months, or subjects with past or present history of psychosis, panic disorder, or bipolar disorder
* Any subject with known severe chronic obstructive pulmonary disease (COPD)
EMERGE Mothers and Kids

The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.

The primary objectives of the EMERGE Mothers and Kids follow up study are:

1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 10 years post the index pregnancy;
2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;
3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;
4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the original EMERGE trial and consenting to further follow up.

Exclusion Criteria:

* EMERGE trial participants who did not provide consent for further follow up studies.
Dornase Alpha for the Treatment of COVID-19

In this study, the effectiveness of the Dornase Alpha treatment, which is known to reduce the viscosity of respiratory secretions, will be investigated in new diagnosed and severe COVID-19 patients separately.

Recent studies confirmed the role of immune hyperactivation in the pathogenesis of COVID-19. Immune cells, especially neutrophils, infiltrate pulmonary capillaries that cause acute fibrin deposition and extravasation into the alveolar space. This excessive accumulation of neutrophils constitutes NETs which makes the mucus thick and viscous. The highly viscous mucus lowers the patient's respiratory function and impairs ventilation supporting NETs may play a major role in the disease. As a mechanism, double-stranded DNA constitutes the backbone of NETs and Dornase alfa promotes the clearance of NETs from plasma neutralization. Endogenous Deoxyribonucleases (DNases), which physiologically break up this extracellular DNA, may become overwhelmed by a massive influx of NETs. Clinically, recombinant human DNase I (rhDNase, Dornase Alfa) has the identical primary amino acid sequence with the native human enzyme and has been approved for the management of cystic fibrosis. Daily administration of dornase alfa is effective in the treatment of cystic fibrosis patients improving pulmonary functions. The similarity of mucus secretions in COVID-19 and cystic fibrosis patients by the means of NETs makes Dornase alfa as a therapeutic option in COVID-19.

Progressive COVID-19 pneumonia may be mortal if it is not treated early, causing respiratory failure. The most important factor leading to respiratory failure is hyaline membrane formed by a neutrophil trap that develops in the cavities of the alveoli. Dornase Alpha is thought to have an important contribution by the lysis of this hyalen membrane. In this study, it is aimed to evaluate the effectiveness of Dornase Alpha treatment in case of early and late use in COVID-19 disease.

Patients diagnosed with COVID-19 PCR and / or radiological-clinical findings is included in the study, and this treatment is carried out in 2 patient groups in comparison with the control groups. The groups are:

1. Newly Diagnosed Patient Group I. Dornase Alpha treated group ii. Control group
2. Patient Group Monitored by Mechanical Ventilation I. Dornase Alpha treated group ii. Control group

Eligibility Criteria:
Inclusion Criteria:

* Being 18 or older
* Approving the Informed Consent Form
* Being diagnosed with COVID-19 with PCR and / or radiological clinical findings
* Hospitalization indication according to Ministry of Health criteria

Exclusion Criteria:

* Pregnant and / or breastfeeding women.
* Any known allergy to Dornase Alpha
* Being involved in another drug study
* Previously diagnosed with chronic lung disease
SBRT Versus Conventional Fractionated Radiotherapy for Vertebral Metastases

Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months. Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. This project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.

Vertebral metastases are events that affect the quality of life of tumor patients, and are often accompanied by severe pain at the site of metastasis and even by the risk of compression fracture. For vertebral metastases who are not yet at risk of vertebral instability fracture, a moderate dose (30Gy/10F) external radiation therapy is the most widely used treatment technique. Previous studies have shown that 60-80% of patients could achieve pain relief with moderate doses of radiation therapy, with median pain control duration of approximately 4 months.

Stereotactic Radiation Therapy (SBRT) is currently the most advanced radiation therapy technique. It enables focused radiation therapy with small fields through stereotactic techniques. In June 2021, Zhongnan Hospital of Wuhan University introduced the True Beam radiotherapy system, which has a higher treatment rate compared to conventional radiotherapy equipment, while It is the most reliable vehicle to achieve SBRT.

Therefore, this project proposes to treat vertebral metastases from non-small cell lung cancer using SBRT technology on the True Beam radiotherapy system to compare its efficacy with conventional external irradiation technology in terms of pain relief as well as local control.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed stage IV non-small cell lung cancer.
* General condition score ≤ 2.
* With vertebral metastases combined with painful symptoms.
* Absence of neurological symptoms due to vertebral metastases, such as dyskinesia, defecation or urination abnormalities.
* No previous radiation treatment of any kind to the vertebral body.
* The metastatic vertebra has not been treated surgically
* Vertebral stability score (SINS) ≤ 12
* Patient life expectancy of more than 6 months.

Exclusion Criteria:

* Small cell cell lung cancer or large cell carcinoma
* General condition score \>2, intolerant of radiotherapy.
* Comorbid neurological symptoms such as dyskinesia, abnormal bowel movements or urination
* Metastatic vertebrae that have received radiotherapy or surgical intervention
* Vertebral stability score (SINS) \>12
* Patient life expectancy of less than 6 months
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any investigational product against COVID-19 (based on anamnesis)
3. Subjects who have history of COVID-19 (based on anamnesis or other examinations).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. The result of RT-PCR test for SARS-CoV-2 is positive.
6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
7. Abnormality hematology and biochemical test results (for main study subset).
8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
11. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
13. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
14. Subjects plan to move from the study area before the end of study period.