cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%.

Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* photographically and histologically proven thoracic esophageal squamous carcinoma
* stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by AJCC(2002)
* radiochemotherapy indication
* measurable tumor
* adequate hematologic, hepatic and renal function
* Karnofsky performance status ≥70
* age more than 18years and less than 70 years

Exclusion Criteria:

* pregnancy and lactation
* significant neurologic disease
* severe liver and renal malfunction,and Significant medical illness
* previous chemotherapy, radiotherapy or immunotherapy
* esophagus hemorrhage and esophagus perforation features
Endothelial Microparticles in Systemic Sclerosis Pulmonary Hypertension

Systemic sclerosis (SSc, also known as scleroderma) is a disease characterized by fibrosis of the skin and organs, inflammation, and an abnormal endothelial cell lining inside of vessels. A common and deadly complication of SSc is pulmonary hypertension (PH), which is an abnormal elevation in the blood pressure within the lung blood vessels. Early identification and treatment of PH is important in SSc, and no clinical factors can predict which patients will develop PH with acceptable accuracy. A potential marker of PH in SSc is the presence of increased amounts of endothelial microparticles (EMPs), which are substances circulating in the blood that were released from damaged vessel wall endothelial lining. A main goal of this study is to investigate if there is a difference in EMP levels between SSc patients with and without PH. The investigators will also use human endothelial cells in a lab environment to test whether these EMPs isolated from SSc patients are actually causing damage to the vessel lining. Lastly, the investigators will investigate the potential benefit of a medication used after transplant, mycophenolate mofetil (MMF). This will be done by causing damage to isolated human endothelial cells and treating them with MMF. The main goal of this portion of our study is to see if EMP levels are reduced when cells are treated with MMF. Overall, the investigators anticipate the following outcomes of this study: 1) use EMP levels to differentiation patients with SSc who have PH from those without PH, 2) use EMPs to understand how endothelial damage occurs in SSc, and 3) use EMPs to help us develop new treatments for patients with vascular diseases.


Eligibility Criteria:
For systemic sclerosis subjects:

Inclusion Criteria:

* Age \>18 years
* Meet American College of Rheumatology criteria for systemic sclerosis

Exclusion Criteria:

* Chronic kidney disease (estimated creatinine clearance \<50mL/min)
* Uncontrolled hypertension (diastolic blood pressure\>120mmHg)
* Acute coronary syndrome within the past 6 months
* Chronic obstructive pulmonary disease
* Diabetes mellitus
* Hemolytic anemia
* Active tobacco abuse

For healthy control subjects:

Inclusion Criteria:

* Age\>18 years
* Age- and sex-matched to SSc patients

Exclusion criteria:

* Coronary artery disease
* Uncontrolled hypertension (diastolic blood pressure\>120mmHg)
* Chronic obstructive pulmonary disease
* Chronic kidney disease
* Diabetes mellitus
* Hemolytic anemia
* Active tobacco abuse
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pozelimab in Combination With Cemdisiran in Healthy Adult Volunteers

The primary objective of the study is to evaluate the safety and tolerability of ascending doses of subcutaneous (SC) pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart.

The secondary objectives of the study are:

* To assess the concentration-time profiles of total pozelimab, total complement component 5 (C5), cemdisiran, and cemdisiran metabolite(s) following single ascending doses of SC pozelimab and SC cemdisiran when administered on the same day or sequentially 28 days apart
* To assess the pharmacodynamic (PD) profile of ascending doses of SC pozelimab and SC cemdisiran, as well as when administered on the same day or sequentially 28 days apart
* To assess the immunogenicity of pozelimab and cemdisiran


Eligibility Criteria:
Key Inclusion Criteria:

1. Has a body mass index less than 30 kg/m2 at the screening visit
2. Judged to be in good health as defined in the protocol
3. Is in good health based on laboratory safety testing obtained at the screening visit NOTE: Subject with a history of Gilbert's disease can be enrolled in the study
4. Willing to undergo vaccination against Neisseria meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit
5. Must have two negative COVID-19 tests taken 48 hours apart and within 7 days prior to study drug administration

Key Exclusion Criteria:

1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the subject by study participation
2. Hospitalization (\>24 h) for any reason within 30 days of the screening visit
3. Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
4. Is positive for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), hepatitis C antibody and positive for qualitative (ie, detected) HCV RNA test at the screening visit
5. Within the previous 2 months of the screening visit has a history of bacterial, protozoal, parasitic or viral infection (including COVID-19) and/or persistent chronic or active recurring infection which requires treatment with antibiotics, antivirals, or antifungals
6. Known or suspected COVID-19 disease
7. Known allergy or intolerance to penicillin class antibiotics or macrolides

NOTE: Other protocol-defined Inclusion/ Exclusion criteria apply
A Study to Assess Benign Joint Hypermobility Syndrome in Children With a History of Wheezing or Asthma

The purpose of this study is to assess benign joint hypermobility syndrome (BJHS) in children with a history of wheezing or asthma. BJHS is a common syndrome of joint and connective tissue laxity without any other rheumatologic disease. This assessment will be performed by using either method below depending upon if the child has a history of wheezing or severe asthma:

1. Determine the correlation, if there is an increased rate of BJHS in children with a history of wheezing as well as if there is an increased history of wheezing in children with BJHS; or
2. Determine asthma control, lung function and asthma exacerbations (a flare up or acute worsening of symptoms) in children with BJHS compared to children with asthma without BJHS, to assess if it BJHS is associated more with children with severe asthma.


Eligibility Criteria:
Inclusion Criteria:

* All children ages 6-16 with a history of wheezing or asthma

Exclusion Criteria:

* For subjects with a history of Wheezing: History of chronic lung disease or prematurity, chronic aspiration, congenital anomalies of the upper and lower airway, primary ciliary dyskinesia, cystic fibrosis, history of heart failure, immune deficiency, or any inflammatory arthritis.
* For Subjects with a history of Asthma: current acute respiratory exacerbation, history of chronic lung disease of prematurity, chronic aspiration, congenital anomalies of the upper or lower airway, primary ciliary dyskinesia, cystic fibrosis, restrictive lung disease, history of heart failure, immune deficiency, or inflammatory arthritis.
Naltrexone in Treatment of Cocaine Dependence - 5

The purpose of this study is to determine the efficacy of naltrexone in the treatment of cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2) decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in treatment.

Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating cocaine dependence in a patient sample that initiated the study while in an inpatient setting and were then followed-up for 3 months as outpatients.

Eligibility Criteria:
Inclusion Criteria:

1. Meet DSM-III-R criteria for cocaine dependency,
2. 18 to 65 years of age,
3. capable of understanding the study,
4. voluntarily signed consent,
5. male or non-pregnant female using approved form of birth control.

Exclusion Criteria:

1. abnormal liver function tests (SGOT, SGPT, or GGT greater than twice the normal values),
2. opioid use within the last 7 days,
3. use of neuroleptics,
4. having a severe acute medical problem,
5. unable to complete psychiatric rating scales, or
6. judged by the investigator to be unlikely to comply with the study protocol
Pelvic Floor Function After Vaginal and Cesarean Delivery Among Egyptian Women

A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section

A cross sectional study for assessment of pelvic floor functions after 6 months to 4 years after normal vaginal delivery or Cesarean section Four separate entities were evaluated using internationally recognized and validated questionnaires:

1. Pelvic organ prolapse evaluated using the Pelvic Organ Prolapse Distress Inventory
2. Urinary functions were evaluated using the International Consultation on Incontinence Questionnaire Short Form
3. Fecal incontinence was evaluated using Wexner Fecal Incontinence Score
4. Sexual functions were evaluated using female sexual function index

Eligibility Criteria:
Inclusion Criteria:

* primiparity,
* singleton pregnancy
* cephalic presentation
* term delivery (38-42 weeks).

Exclusion Criteria:

* Women with operative vaginal delivery (vacuum extraction or forceps delivery)
* women who had another delivery between the time of first one and time of evaluation
* women with neurological diseases
* women with vascular diseases and Diabetes Mellitus
EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase

The primary objective of this study is to describe the percentage of patients with HER2-positive and Triple Negative tumour underwent neoadjuvant treatment in clinical practice during the past 5 years out of total number of patients who underwent neoadjuvant treatment, regardless molecular subtypes. Secondary objectives The secondary objectives which are limited to molecular subtypes of study interest, HER2-positive and Triple Negative tumours, are follow reported:

* To perform a descriptive analysis on neoadjuvant treatment choice according to molecular subtype and initial staging;
* To perform a descriptive analysis on clinical and tumour pathological characteristics according to molecular subtypes and initial staging;
* To perform radiological response descriptive analysis achieved with neoadjuvant therapy according to treatment and instrumental examination type (for example: breast MRI, breast ultrasound or mammography);
* To perform a descriptive analysis of surgical procedures for both, the breast and the axilla, according to radiological tumour response, initial staging and molecular subtypes;
* To perform a descriptive analysis on therapies performed in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes;
* To describe and to analyse the eligibility criteria evolution in neoadjuvant treatment setting during the last 5 years;
* To perform a descriptive analysis on pathological complete response (cPR) according to neoadjuvant treatment, molecular subtypes and initial staging;
* To evaluate disease-free survival (DFS) according to pCR and molecular subtypes;
* To evaluate overall survival (OS) according to pCR and molecular subtypes.


Eligibility Criteria:
Inclusion Criteria:

* For primary endpoint assessment we calculated the percentage of HER2 positive and Triple Negative patients who underwent neoadjuvant treatment in the past 5 years in each site. For this aim all patients with early breast cancer diagnosis who underwent neoadjuvant treatment during the study time, ranging from 01/01/2016 to 01/01/2021, will be included if they had:
* Histological diagnosis of infiltrating breast cancer performed by breast and/or axillary nodes biopsy;
* Age ≥ 18 years at the time of disease onset;
* Absence of secondary lesions, i.e. initial disease stage I, II or III;
* Known status of ER, PgR, HER-2 and Ki67.

Exclusion Criteria:

* Documented distant disease at onset diagnosis or within 3 months from breast surgery;
* Prior neoadjuvant hormonal treatment exposure;
* Prior diagnosis of primary breast cancer or second primitive tumour starting from different organ
A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics

Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.

ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.

The primary objective of this trial is to explore the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to investigate the pharmacokinetics with single and multiple doses of ALTN from 5mg/d,10mg/d,16mg/d,12mg.

Eligibility Criteria:
Inclusion Criteria:

1. late malignant tumor patients diagnosed with the pathological and/or cytological;
2. lack of the standard treatment or treatment failure;
3. 18-65years, ECOG:0-1,Expected survival period \>3 months;
4. stop medicine \> 30 days if any other chemotherapy drugs be used.
5. HB≥90g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT ≥100×109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR≥60ml/min,TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF≥LLN.
6. Female should be agreed to use contraceptive during the study and after 6 months (such as intrauterine device(IUD), the pill or a condom); The serum or urine pregnancy test negative before take ALTN, and is out of non-lactation period. Male should be agreed to use contraceptive during the study and after the period of 6 months.
7. Volunteer, informed consent form (ICF) signed, compliance.

Exclusion Criteria:

1. Subject was diagnosed with other malignant tumors previously or meanwhile;
2. Participated in other clinical trials in four weeks;
3. Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection);
4. Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient;
5. Hypertension
6. Urine protein: ++, and urinary in 24 hours \> 1.0g;
7. Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy;
8. Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder;
9. With artery/venous thrombotic before oral ALTN;
10. With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment;
11. With Abnormal thyroid function;
12. With history of psychiatric drugs abuse or a mental disorder;
13. Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers);
14. Have immunodeficiency history;
15. According to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial.
Intravenous Lidocaine in the Prevention of Postoperative Vomiting in Elective Tonsil Surgery

There some evidence regarding the effect of lidocaine for the prevention of nausea and vomiting in adults.

The investigators want to know whether with intravenous lidocaine a adjunct for general anesthesia for children between 2 and 12 years who are undergoing tonsillectomy, with or without adenoids has the same effect.

Eligibility Criteria:
Inclusion Criteria:

* Children between 2 and 12 years
* ASA I or II
* Programmed for elective tonsillectomy with or without adenoidectomy under general anesthesia

Exclusion Criteria:

* Obesity, defined as body mass index (BMI) ≥ 95th percentile for age and sex.
* Use of antiemetic drugs during the 24 hours before surgery.
* Gastroesophageal reflux.
* History of allergy to any of the drugs used in the study.
* Down Syndrome.
Whole Body Vibration in Children With Cerebral Palsy

Some positive effects of whole body vibration applications in reducing spasticity, improving walking ability, and increasing walking speed have been reported in children with CP, but the evidence is not strong enough. Therefore, this study was planned to evaluate the effect of whole body vibration treatment on spasticity, gait, balance, and motor performance in children with spastic CP. This study hypothesis that whole body vibration provides an additive improvement on spasticity, balance, gait and motor performance.

Participants will be evaluate at baseline, after the conventional physiotherapy program, and after whole body vibration training program. During this period, the participants who were recruited whole body vibration training program, whole body vibration will be applied in addition to conventional physiotherapy sessions comprised 45 min, 2 days a week, during 8 week.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with spastic diplegic CP in GMFCS levels I and II, CFCS level I and MACS levels I and II
* Aged 6-17 years
* Ability to cooperate with the evaluations
* Walking independently with or without an orthosis (without any support)

Exclusion Criteria:

* Having a recent injury affecting the lower extremities
* Having undergone any surgery or Botulinuim Toxin application within the last six months
* Having severe cardiopulmonary or systemic problems
* Having uncontrolled seizures, visual or hearing problems preventing the evaluations
Choline Nutrition in Children With Cystic Fibrosis (CF)

Cystic Fibrosis (CF) is a complex disease with a wide range of clinical problems. Despite enzyme replacement therapy, children with cystic fibrosis (CF) may still have problems absorbing some nutrients. Detailed studies of the nutrient status of children with CF and have found low amounts of choline, an essential dietary nutrient, and altered levels of some amino acids in almost all patients. Choline is an essential dietary nutrient that is important in many important body functions, which include proving a source of methyl groups, the structure of cell membranes and in acetylcholine. Most choline is present in our diets in a fat known as phosphatidylcholine. Research studies have shown that children with cystic fibrosis do not absorb fat, including phosphatidylcholine very well. In previous studies, we showed that choline provided as a dietary supplement for 2 weeks improved choline status in children with cystic fibrosis.

The purpose of this research is to find out if choline supplements over a longer duration of 6 months will improve and maintain normal choline status in children with CF.

This is a prospective study involving 34 children attending an outpatient clinic for children with CF. After enrollment, subjects will be followed for 9 months with each child serving as their own control in a repeated measures design.

Chart data, height, weight, pulmonary function, dietary intake and a venous blood and urine sample will be collected at enrollment then every 3 months for 9 months. Choline supplementation will be from enrollment for 6 months, with follow up at 3 months post supplementation. To avoid additional hospital visits and blood draws, and to co-ordinate with pulmonary function, hematology, clinical chemistry tests as part of clinical care, each subject will be seen at routine scheduled clinic appointments, which are every 3 months.

The objectives are to

1. determine if supplementation with choline for 6 months corrects biochemical markers of choline deficiency and improves indices of reduced methylation capacity (including methionine, SAM, SAM/SAH) and redox status (GSH/GSSG) based on measures of blood and urine
2. determine whether or not choline supplementation decreases plasma pro-inflammatory mediators
3. determine if choline supplementation improves the low n-6 and n-3 fatty acids levels in children with CF,
4. explore if choline supplementation has the potential to have clinical relevance in reducing recurrent inflammation, and improve pulmonary function and/or reduce liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Children with Cystic Fibrosis of known genotype.

Exclusion Criteria:

* No hospitalizations within the previous month
* not receiving parenteral nutrition
* FEV1 \> 50% at enrollment
* BMI and weight for age z-scores \> 5th percentile
* non smokers
* no asthma
* not taking any lipid supplement or other agent designed to effect glutathione status.
Uric Acid Levels and Endothelial Functions

Uric acid is a risk factor for coronary artery disease (CED) in postmenopausal women but the association with inflammation and coronary microvascular endothelial dysfunction is not well-defined. The aim of this study was to determine the relationship of serum uric acid, inflammatory markers and CED.


Eligibility Criteria:
Inclusion Criteria:

* Referred to Mayo Clinic for cardiac catheterization
* Postmenopausal

Exclusion Criteria:

* History of percutaneous coronary intervention
* Coronary artery bypass graft surgery
* Unstable angina pectoris
* Valvular heart disease
* Peripheral vascular disease
* Known congestive heart failure
Varenicline (Champix®) Special Investigation (Regulatory Post Marketing Commitment Plan)

The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).

The subjects have been retreated with varenicline within 52 weeks, and subjects have been enrolled to varenicline Drug Use Investigation protocol A3051109.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects intend to quit tobacco use who are prescribed varenicline (Champix®) by their Physicians
* Subjects who are prescribed varenicline (Champix®) for the second time within 52 weeks of initial treatment.

Exclusion Criteria:

Non-participants of varenicline (Champix®) Drug use Investigation protocol A3051109.