cyrilzakka/clinical-trials huggingface dataset:
A Study of Anti-VEGFR2 AK109 in Subjects With Advanced Solid Tumors

This is a first in human(FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and anti-tumor activity of AK109, an anti-VEGFR2 monoclonal antibody, as a single agent in adult subjects with advanced solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Have signed written informed consent form voluntarily.
* Histologically or cytologically documented advanced solid tumor that is refractory/relapsed/intolerant to standard therapies, or for which no effective standard therapy is available, or subject refuses standard therapy.
* Have radiologically measurable disease based on RECIST 1.1
* ECOG of 0 or 1.
* Estimated life expectancy of ≥3 months.
* Adequate organ function.
* Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.

Exclusion Criteria:

* have been diagnosed other advanced tumors within 2 years before the first use of the study drug, except for the cured localized tumors.
* with active central nervous system metastasis, cancerous meningitis, or spinal cord compression.
* Prior use of any anti-VEGF or anti-VEGFR antibodies.
* Receipt of anti-tumor treatment, other study drug, major surgery, or serious infection within 4 weeks prior to C1D1 (Cycle 1 Day1, the first dose of study drug).
* Have received central venous catheterization within 7 days prior to C1D1.
* Severe or uncontrolled cardiovascular and cerebrovascular diseases.
* Uncontrolled hypertension.
* have a high risk of bleeding.
* Uncontrolled gastrointestinal diseases.
* Uncontrolled pleural/pericardial or peritoneal effusion.
* Have occurred any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 monthsprior to C1D1.
* With cirrhosis of Child-Pugh B or C.
* Active or unstable viral hepatitis; or active tuberculosis.
* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
* received live vaccines prior 30 days within the first dose.
* take apart in other clinical studies at the same time.
* known to be allergic to any component of AK109, other monoclonal antibodies or any therapeutic protein.
* mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.
* Any treatment risk or condition that interferes with the study by the investigator judged.
A Study of the Efficacy and Safety of Antiwei Granules in the Treatment of Common Cold

To further evaluate the efficacy and safety of Antiwei granule in the treatment of common cold (wind-cold syndrome)


Eligibility Criteria:
Inclusion Criteria:

1. It met the diagnostic criteria of common cold in western medicine;
2. In accordance with the TCM syndrome differentiation standard of wind-cold syndrome;
3. Male and female patients aged 18 to 65 years;
4. The disease duration at enrollment was ≤48 h;
5. At enrollment, 37.3 ° C ≤axillary temperature \< 38.5 ° C;
6. Informed consent was obtained voluntarily.

Exclusion Criteria:

1. Complicated with influenza, pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute pharyngeal conjunctivitis, acute viral or herpetic pharyngitis, acute viral or herpetic laryngitis;
2. Patients who had been infected with 2019-ncov in the past and still had symptoms such as cough and fatigue for nearly 3 months after the antigen turned negative;
3. Primary ciliary dyskinesia syndrome, other acute onset nasal diseases (such as allergic rhinitis, chronic rhinitis, acute and chronic sinusitis, etc.), previous nasal surgery or radiotherapy of the nasopharynx with nasal mucosal dysfunction；
4. Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease, interstitial lung disease, etc.), asthma, and tuberculosis;
5. White blood cell count \>12.0×10\^9/L or \<3.0×10\^9/L , And/or neutrophil percentage \>80%;
6. Aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × ULN, or serum creatinine ≥ ULN, judged by the investigator to be clinically significant；
7. Combined with other serious primary diseases of the heart, brain, lung, liver, kidney or blood system, such as unstable control/serious complications of diabetes, viral hepatitis, hemophilia, or mental disorders;
8. Patients who had been treated with Chinese and western drugs for the relief of common cold and its symptoms after the onset of the current illness, including but not limited to antibiotics, antiviral, antihistamine, steroids, decongestants, antipyretic and analgesic, antitussive and expectorant drugs etc;
9. Those who were allergic to the known composition of the investigational drug or to emergency medication, or emergency drug contraindication population;
10. The participants (and their partners) had planned pregnancy or were unwilling to take appropriate contraceptive measures from enrollment to 1 month after the end of the trial, or were pregnant or lactating;
11. Suspected or true history of alcohol or drug abuse;
12. Participants who had participated in another clinical trial within 1 month before enrollment;
13. Persons deemed unsuitable for clinical trial by the investigator (e.g., athletes or persons not eligible for enrollment for other reasons).
Structured EDucation for Rehabilitation in Intermittent Claudication

A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost physical function through exercise rehabilitation. Supervised exercise programmes can markedly improve walking capacity, but these are resource intensive, National Health Service provision is limited, and patients cite accessing services as a barrier to participation.

Increasing walking activity via a structured education programme might be a pragmatic solution for improving walking capacity, health and wellbeing in patients with IC; however, further research is needed to substantiate this. Hence, the aim of this project is to develop a pragmatic education programme to increase walking in these patients and to collect data on its feasibility to inform the development of a definitive trial investigating clinical and cost effectiveness.

Focus groups will be conducted to inform the development of the education programme. Programme components will be theoretically-underpinned and evidence-based. The development of the programme will be an iterative process involving pilot work, feedback, evaluation, and revision. The programme will then be assessed in a randomised controlled pilot study with 6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain preliminary data of its impact on important outcomes (daily steps/physical activity, walking capacity, quality of life, illness perceptions).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>18 years with intermittent claudication due to peripheral arterial disease
* Stable disease for \>3 months
* Able to provide consent
* Able to read and speak English to a level allowing satisfactory completion of written questionnaires and to participate in the education intervention

Exclusion Criteria:

* Previous endovascular/surgical interventions
* Scheduled endovascular/surgical intervention
* Critical limb ischaemia
* Those whose function is uniquely impaired, e.g. wheelchair-bound patients and patients with lower-extremity amputation(s)
* Presence of contraindications to exercise or co-morbidities that limit exercise performance to a greater extent than the intermittent claudication (e.g. severe arthritis)
* Major surgery, myocardial infarction or stroke/transient ischemic attack in the previous 6 months
* Patients who already perform greater than 30 min of structured exercise three times weekly (self-reported)
Plant-based Diets and Risk of Cancer in the Adventist Health Study-2

The Adventist Health Study-2 is a long-term study, exploring the links between lifestyle, diet, and disease outcomes among Seventh-day Adventists. More than 96,000 church members from the U.S. and Canada are participating in the current study, AHS-2, conducted by researchers at the Loma Linda University School of Public Health.

The Adventist Health Study-2 (AHS-2) is a large national cohort of 96,000 Seventh-day Adventists in the U.S. and Canada. The study is searching for associations between diet and risk of common and medium frequency cancers (breast, prostate, colorectal, lung, uterus, pancreas, melanoma of skin). This cohort is unusual in that about half are vegetarian, many eat soy at Asian levels, and many have very low or absent dairy intake while others eat normal amounts of dairy. Thus observations on these people, many of whom have contrasting dietary habits, may provide insights about diet and cancer, so supporting dietary changes that could be readily adopted by many.

Eligibility Criteria:
Inclusion Criteria:

* Member of a Seventh-day Adventist church \>30 years of age Ability to read English Live in the US or Canada

Exclusion Criteria:

* Less than 30 years of age
* Church members who did not complete the baseline questionnaire.
* Incarcerated or institutionalized people
* Non-English speakers
Urinary Retention After Vaginal Delivery With Epidural Anesthesia.

The investigators intend to compare the rate of urinary retention among female patients after vaginal delivery under epidural anesthesia, depending on bladder catheterization type, either by a foley catheter inserted adjacent to epidural anesthesia or intermittent catheterization applied every 4 hours during labor.

An explanation about the study will be delivered to each participant and each participant will sign a confirmed consent. Patients will be randomized between 2 groups of treatment: 1. intermittent catheterization applied every 4 hours during labor. 2. foley catheter inserted adjacent to epidural anesthesia.

In patients with a foley catheter, the catheter will be removed soon after delivery. Participants will be followed by a clinician post labor. An abdominal US will be performed either 4 hours after delivery or after the participant urinates to check the bladder volume.

Patient information including demographic information, information regarding the patient's pregnancy and delivery will be collected from the patient's electronic record.

Eligibility Criteria:
Inclusion Criteria:

* Female patients in labor designated for vaginal delivery with epidural anesthesia.

Exclusion Criteria:

* Patients with neurological problems including gestational diabetes.
* Patients either designated for elective cesarean delivery or emergent cesarean delivery.
Effect of Wearable Hip-Assist Robot on Reduction of Cardiopulmonary Metabolic Efficiency in Healthy Adults

The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).

The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).

Metabolic energy expenditure and muscle fatigue are measured simultaneously.

Eligibility Criteria:
Inclusion Criteria:

* Elderly adults over age 65
* Those without a history of central nervous system disease

Exclusion Criteria:

* Those who have problems with walking due to problems such as visual field defects or fractures
* A person whose height is less than 140 cm or not more than 185 cm
* Body mass index BMI (body mass index) based on 35 or more obese
* Those with a cognitive problem that are difficult to understand and participate fully in this study
* Those who are at risk of falling when walking with serious dizziness
Phase 1 Study of CT-996 in Overweight/Obese Participants and Patients With Type 2 Diabetes Mellitus

A study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 in overweight/obese participants and participants with T2DM.

A multi-center, randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of CT-996 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Participants 18-65 years old, inclusive
* BMI of 25 - 40, inclusive
* Stable body weight for two months

Exclusion Criteria:

* History of significant medical conditions and malignancy
* Uncontrollable hypertension
* History of alcoholism or drug addiction within 1 year prior to Screening
* Current or recent participation in an investigational clinical trial
VEGF Gene Transfer for Critical Limb Ischemia

The purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using Vascular Endothelial Growth Factor (VEGF) or placebo in patients with moderate to high-risk Critical Limb Ischemia (a condition in which there is poor blood circulation in the leg). This trial will assess whether VEGF improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.)

VEGF is DNA, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. Once the DNA is in the leg, it directs the cells of the artery wall to increase its production of VEGF, which has been shown to cause new blood vessels to grow. This experimental therapy is designed to grow new blood vessels around blockages in the leg arteries.

The total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. Following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. There is no charge for any testing or office visits required by the study.

This study has been approved by the Food and Drug Administration (FDA).


Eligibility Criteria:
Inclusion Criteria:

* Be at least 21 years old
* Have critical limb ischemia
* Have severe blockages in at least one artery in the affected leg as demonstrated by an angiogram
* Have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely decreased blood flow
* Agree to participate in follow-up.

Exclusion Criteria:

* Have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in situ carcinoma) within the last 5 years
* Be pregnant or lactating
* Have a history of alcohol or drug abuse within 3 months of screening
* Have advanced (Rutherford Category 6) critical limb ischemia, characterized by extensive tissue loss or gangrene
* Have osteomyelitis
* Have undergone successful aortic or lower extremity surgery, angioplasty, or lumbar sympathectomy within the 2 months preceding screening
* Be a suitable candidate for surgical or endovascular revascularization in the limb in which treatment is proposed
* Subjects in whom arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder
Effectiveness of a Public Campaign to Increase Stroke Awareness in Reducing Prehospital Delay

The starting hypothesis is that a multilevel educational campaign, specifically developed for the local community, can increase public stroke awareness and reduce pre-hospital delay.

The effectiveness of such intervention will be evaluated according to a cluster randomized, stepped wedged design. The clusters are the four communities of the Area Vasta Emilia Nord, AVEN (Parma, Piacenza, Modena e Reggio Emilia). As analysis Units, we will consider the patients consecutively admitted to the six participating hospitals throughout the study period, for suspected stroke or transitory ischemic attack (TIA).

After a baseline 3 month period, the educational campaign will be sequentially launched in the four communities over four 3 month periods, according to a computer-generated list. The comparison will be the"usual care".

Primary outcome measures: The proportion of patients arriving at the Emergency Department (ED) with suspected stroke or TIA within two hours.

Secondary outcome measures: the proportion of patients with confirmed stroke or TIA diagnosis; the proportion of ischemic stroke patients evaluated for recominanat Tissue Plasminogen Activator (rTPA) therapy; the proportion of patients treated with rTPA; time interval between arrival at the ED and CT scan; for patients treated with rTPA, time interval between arrival at the ED and therapy initiation (door to needle time); death and disability (assessed as modified Rankin Score 3-5) at 1 and 3 month from stroke onset.

Eligibility Criteria:
Inclusion Criteria:

* Patients consecutively admitted to the six participating hospitals for suspected stroke or transitory ischemic attack (TIA), defined as abrupt onset of focal or generalized neurologic deficit of vascular origin.

Exclusion Criteria:

* No information available on the time of stroke onset.
* No informed consent from patient or caregiver
Incidence and Risk Factors of Ocular Complications Among Patients With Homocystinuria

Background: Cysteine beta-synthase (CBS) deficiency, often known as classic homocystinuria (HCU), is an uncommon inborn mistake in methionine metabolism. Developmental delay, intellectual incapacity, skeletal and vascular symptoms, and ocular abnormalities are possible main clinical characteristics.

Objective: This study sought to describe the ocular anomalies that King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia, HCU patients presented with between 2018 and 2022.

This retrospective research included 6 HCU patients. Demographic and clinical characteristics of patients as age, gender, comorbidities were collected. Relevant clinical and ophthalmic assessments, like visual acuity, fundus examination findings, complications and type of surgery were also reported

Eligibility Criteria:
Inclusion Criteria:

* All patients from all age groups who were diagnosed with homocystinuria between 2018 and 2022 were included, regardless of whether the diagnosis was made biochemically (by exhibiting hyperhomocysteinaemia and hypermethioninaemia) or genetically (by discovering biallelic pathogenic mutations in the CBS gene)

Exclusion Criteria:

* Patients with incomplete investigations for various reasons
Analysis of Dendritic Phenotype and Function of Patients Receiving VEGF-Trap on VGFT-ST-0202

RATIONALE: Studying the dendritic cells in samples of blood from patients with cancer receiving aflibercept may help doctors learn about the effect of aflibercept on dendritic cells.

PURPOSE: This laboratory study is evaluating dendritic cells in patients with advanced solid tumors or non-Hodgkin lymphoma receiving aflibercept on clinical trial VGFT-ST-0202.

OBJECTIVES:

* Evaluate the effect of in vivo aflibercept on the presence of different populations of dendritic cells (DC) and immature cells (ImC) in the peripheral blood of cancer patients by characterizing the time course (kinetics) of the improvement in antigen presenting cell (APC) phenotype (decline in DC/ImC ratio) occurring early and late after aflibercept administration.
* Evaluate the effect of aflibercept administration on DC function based on ability to stimulate antigen specific proliferative (allogeneic and tetanus toxoid) and cytolytic T cell responses (influenza) by characterizing the time course (kinetics) of the improvement in APC function occurring early and late after aflibercept administration.
* Explore the relationship of baseline aflibercept level and host APC phenotype.

OUTLINE: This is a multicenter study.

Patients undergo phlebotomy and blood collection at baseline and on days 15, 29, and 57. Samples are analyzed for dendritic cell phenotype, subpopulations, maturation status, and function in terms of ability to activate autologous T cells.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced solid tumor or non-Hodgkin lymphoma and enrolled on clinical trial VGFT-ST-0202
* Hemoglobin ≥ 10 g/dL
* Willing to undergo phlebotomy

Exclusion Criteria:

* none listed

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Clinical Observation of Long-term Efficacy and Safety of Glycyrrhizic Acid Preparation in the Therapy of Autoimmune Liver Disease

This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

This study was a retrospective clinical observation cohort study. All patients with autoimmune liver disease treated with glycyrrhizic acid preparations in the Department of Liver Diseases, Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, were enrolled. Clinical follow-up data including demographics, hematuria, and liver and kidney were collected. Functional, electrolyte blood glucose, PTA, erythrocyte sedimentation rate, serum AFP and other clinical biochemical indicators and autoantibodies, special proteins and liver imaging (liver ultrasound) examination. The clinical effect of glycyrrhizic acid preparation for the treatment of autoimmune liver disease for 144 weeks and the safety during treatment were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients with autoimmune liver disease: All enrolled autoimmune liver diseases meet the diagnostic criteria of China's Consensus on Diagnosis and Treatment of Autoimmune Liver Disease (2015);
* 2) no hormones and / or immunosuppressants and other liver protection drugs;
* 3) Sign the written informed consent form.

Exclusion Criteria:

* 1) Combine other hepatitis virus (HCV, HDV) infections;
* 2) viral liver disease;
* 3) HIV infection;
* 4) long-term alcohol abuse and / or other liver damage drugs;
* 5) mental illness;
* 6) Evidence of liver tumors (liver cancer or AFP \> 100 ng/ml);
* 7) decompensated cirrhosis;
* 8) Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up;
* 9) There are hormones and / or immunosuppressants and other liver protection drugs.