cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of Albumin-bound Paclitaxel/granulocyte-based Therapy for Recurrent/metastatic Breast Cancer

The goal of this clinical trial is to learn if Albumin-bound Paclitaxel/Granulocyte drug can treat patients with recurrent/metastatic breast cancer. The main questions it aims to answer are:

To verify the safety of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

To evaluate the efficacy of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

To detect the pharmacokinetic behavior of Albumin-bound Paclitaxel/Granulocyte drug in patients with recurrent/metastatic breast cancer.

In this open, single-armed study, selected patients with recurrent/metastatic breast cancer confirmed by Histopathology will be received Albumin-bound Paclitaxel/Granulocyte-based therapy. The granulocyte will be separated by blood cell separator, and will be cultured in the GMP laboratory to make Albumin-bound Paclitaxel/Granulocyte drug. Then the drug will be infused intravenous into patients.

Eligibility Criteria:
Inclusion Criteria:

* Female, aged ≥ 18 years old; Obtain an informed consent form voluntarily signed by the patient themselves; Recurrent/metastatic advanced breast cancer patients (refer to TNM standard); Patients who have received standard first-line treatments and expected survival time ≥ 3 months; EOCG score ≤ 2 and KPS≥ 70 points; Liver, kidney and bone marrow functions are basically normal; Patients of childbearing age need to take appropriate protective measures before enrollment and after treatment 3 months.

Exclusion Criteria:

* Individuals who have received other anti-tumor treatment within 4 weeks prior the enrollment; Patients with history of allergy to paclitaxel, albumin naproxen, ibuprofen, trimethoprim and ampicillin; Positive blood pregnancy test; Patients who required anti coagulant therapy; Patients with active infectious diseases or a history of bone marrow or organ transplantation
Acute Effects of Whole Body Vibration for Individuals With Parkinson Disease

This is an exploratory study to assess the impact of whole body vibration on backward walking speed in people with Parkinson disease.

This study will provide valuable information towards the relationship between backward walking using the 3-minute backward walk test and whole body vibration (WBV). The 3MBWT has shown to have diagnostic accuracy for fall prediction in older adults. The 3MBWT has been found to be feasible within the acute stroke population. In a study, the 3MBWT revealed that in the geriatric population a score of more than 4.5 seconds were likely to report a fall history. Gait parameters including a decrease in gait velocity (p\<0.01) have been found to worsen while performing dual tasks (serial-7 subtraction) in individuals with PD. Research has shown when compared to other cognitive tests, the "serial sevens" tests increased the time required to perform the Timed Up and Go in individuals with PD.

This study will use a control group performing mid-squats on level ground and an intervention group performing mid-squats on a WBV machine. Each group will perform 5 sets of mid-squats for 60 seconds with a 60 second rest period between each set. Pre and post testing will involve three trials of the 3MBWT.

The purpose of this study is to determine the immediate impact of WBV on backward walking velocity in individuals diagnosed with PD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Parkinson disease (PD)
* classified Hoehn and Yahr stages I - IV
* ability to walk independently for at least 5 minutes
* alert and oriented to person, place and time
* Age between 40-85 years old

Exclusion Criteria:

* Deep-Brain Stimulation surgery less than 24 months prior to the start of the study
* physician changes in Deep-Brain Stimulation parameters during the study
* acute orthopedic injury or surgery that could impact gait
* a neurological condition other than PD
Health Evaluation And Learning for Total Parenteral Nutrition (TPN) at Home Patient Registry

The HEALTH Registry is a prospective, observational, non-interventional registry study of patients receiving home parenteral nutrition therapy in the US for a variety of indications.

The objective of the HEALTH Patient Registry is to establish and track therapy utilization and outcomes of patients receiving home parenteral nutrition therapy. Data collected will include information on patient safety, clinical outcomes, resource utilization and health-related quality of life (QOL). The goals of this Registry include:

* To better understand the patients and populations requiring HPN in the U.S.
* To measure clinical outcomes associated with HPN
* To identify areas for focused quality improvement interventions
* To provide opportunity for resource allocation identification and improvement

Eligibility Criteria:
Inclusion Criteria:

* Patient of any age, gender, and indication referred to Coram/CVS Specialty Infusion Services to receive HPN in an alternate site of care, such as the home or infusion suite
* Patient must be managed by Coram/CVS Specialty Infusion Services
* The patient or the patient's caregiver must be willing to receive care and comply with the teaching and training necessary to administer treatment

Exclusion Criteria:

* Patient is unable to start, or stops receiving HPN
* Patient is NOT managed by Coram/CVS Specialty Infusion Services
* A patient and/or a patient's insurance will not cover cost of HPN therapy with Coram/CVS, or a patient elects not to start treatment
Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island

Cardiovascular disease (CVD) is the second leading cause of death in France and the leading cause of death on Reunion Island. Some modifiable risk factors for cardiovascular diseases are well identified and can be easily modulated, in particular by hygiene and dietetic measures (tobacco, sedentary lifestyle). Other risk factors such as high blood pressure, diabetes or dyslipidemia can also be pharmacologically modulated. On the other hand, there is a cardiovascular risk factor that we do not know how to modulate: a high level of lipoprotein (a) (Lp (a)), whose regulation remains largely unknown.

High plasma levels of Lipoprotein (a) remain a major risk for the development of cardiovascular disease and its clinical complications, which no drug can currently reduce. Understanding the biological and genetic determinants modulating Lp (a) levels remains a major challenge for treating subjects with hyper Lp (a). Several individuals and possibly Reunion families have been detected as having abnormally high rates of apo (a)

Thanks to the link between cardiovascular clinical picture, Lp (a) concentration and other biological markers, the study should allow a better understanding of the mechanisms underlying the cardiovascular risk in order to offer advice. prevention and care of at-risk subjects screened; or even avenues for adapted genetic counseling (DNA sequencing).

At the genetic level, several hypotheses could be explored making it possible to link the expression of the apo (a) protein to the genotype, in particular the presence of mutations in the gene, in the promoter region, polymorphisms, or epistatic regulation.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Lp (a)\> 200 nmol / L OR member of family of a patient with Lp (a)\> 200 nmol / L
* be affiliated or beneficiary of a social security scheme
* signed consent

Exclusion Criteria:

* Refusal to participate
Endostatin in Treating Patients With Advanced Refractory Solid Tumors

RATIONALE: Endostatin may stop the growth of solid tumors by stopping blood flow to the tumor.

PURPOSE: Phase I trial to study the effectiveness of endostatin in treating patients who have advanced refractory solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and Phase II dose of endostatin in patients with advanced refractory solid tumors. II. Determine the qualitative and quantitative nature of the toxicities encountered with endostatin in this patient population. III. Evaluate the basic pharmacokinetics and metabolism of endostatin by measurement of plasma levels by EIA and mass spectrometry in this patient population. IV. Investigate the relationship between pharmacokinetic parameters and toxicity in this patient population. V. Evaluate biologic evidence of angiogenesis inhibition in patients receiving endostatin.

OUTLINE: This is a dose escalation study. Patients receive endostatin IV over 1 hour daily for 28 days, followed by 1 week of rest. Patients receive subsequent courses of daily therapy in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of endostatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities.

PROJECTED ACCRUAL: Approximately 30-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced refractory solid tumor for which no curative therapy exists Bidimensionally measurable or evaluable disease accessible to biopsy No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 OR Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Other: No serious active infection Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
Basel Long COVID-19 Cohort Study and Digital Long COVID Substudy

The Basel Long COVID Cohort Study (BALCoS) is a registry-based cohort study that focuses on the patients' present health status, symptoms, the course of these symptoms, and potential mechanisms involved. The project aims to investigate proposed mechanisms behind Post COVID-19 condition (PCC), including a) autoimmunity, b) chronic inflammation, c) genetics, d) coagulation disorders, and e) psychosocial factors. Patients in the cohort can also join the Digital Long COVID Study (DiLCoS), a single-arm, cohort-based proof-of-feasibility study that is part of the larger BALCoS. DiLCoS is a intervention substudy designed to evaluate whether doing exercises delivered via a smartphone app (referred as digital intervention) can help with PCC. The digital intervention is a 12-week program that includes different kinds of exercises like breathing exercises, relaxation techniques, and tips on managing fatigue and other symptoms. It also teaches patients how to monitor their activities and energy levels, and provides psychological exercises to cope with negative thoughts and pain. Patients in the cohort complete a set of assessments that include the collection of sociodemographic and clinical data, biomarkers, neurocognitive testing, psychometric questionnaires, and measures of physical performance, and provide consent that their data from routine clinical care can be used for the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with PCC will be included. PCC will be defined as:
* History of confirmed or suspected SARS CoV-2 infection
* Symptoms usually start within 3 months from the onset of acute SARS CoV-2 infection with symptoms and effects that last for at least 2 months
* Symptoms cannot be explained by an alternative diagnosis
* signed informed consent is required

Additional Inclusion Criteria for participtation in DiLCoS:

* A smartphone with a compartible-operating system
* Separate signed informed consent is required

Exclusion Criteria:

* Age \<18 years
* Lack of consent to participate in the study
* Language barriers (lack of sufficient knowledge of German)
* Lack of general understanding of study procedures
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Patients between 40 and 80 years of age with controlled COPD.
* Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
* Body mass index (BMI) must be within the range of 18 to 32 kg/m2

Exclusion Criteria:

* Participation in any interventional clinical investigation with 4 weeks of study start
* Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
* Past medical personal or close family history of clinically significant ECG abnormalities
* Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
* A known hypersensitivity to the drug.
* History of immunocompromise, including a positive HIV test result.
* History of drug or alcohol abuse within 12 months of study start
* Any condition that may compromise patient safety
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)

To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients


Eligibility Criteria:
Inclusion Criteria:

* Single or bilateral lung transplant recipients
* Confirmed RSV infection
* Greater than 90 days post current lung transplant
* Rejection free for a minimum of 30 days

Exclusion Criteria:

* Known viral, bacterial, or fungal respiratory co-infection at the time of RSV diagnosis
* Bronchiolitis obliterans syndrome (BOS) Grade 3 or any BOS with FEV1 that has not been stable for at least 3 months
* Use of alemtuzumab within 9 months prior to screening, anti-thymocyte globulin (ATG) within 90 days of screening or prednisone or equivalent as maintenance therapy
* Active treatment for acute graft rejection
Dental Plaque Microbiota in Caries-free and Caries-active Children

Dental caries is a polymicrobial infection originally thought to be caused by Streptococcus mutans and Lactobacilli. However, unprecedented developments in modern molecular techniques have demonstrated that several microbial species are associated with the disease in addition to streptococci and lactobacilli. Dental caries initiation and progression is a dynamic process in which demineralization of the tooth structure, as a result of acid production from acidogenic bacteria (due to carbohydrate metabolism) is being counteracted by the remineralization of the tooth surface by strong alkali production by certain bacteria in the dental biofilm. The aim of the present study is to identify the different microbiota in the oral biofilm using new laboratory techniques as well as the levels of salivary proteins in caries-free compared with caries active Arab children.

The objective of this study will be to investigate the dental plaque's microbial diversity using Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technology in the mixed dentition as well as the levels of salivary proteins in caries-free compared with caries active Arab children. The study protocol was approved by the Health Science Center Ethical Committee at Kuwait University.

One hundred 6-9 year-old children with caries active and caries-free status will be recruited from randomly selected public schools in Kuwait. After DNA purification from supragingival plaque samples, HOMINGS will be performed. To get an insight into the host factors involved in this complex interplay between the host and the bacteria, stimulated saliva from the study subjects will be analyzed by proteomics. For children in both groups supragingival plaque samples will be collected from the buccal and lingual surfaces of all teeth. After preparing the samples, the aliquots of purified DNA samples will be shipped to The Forsyth Institute for Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) protocol.

Eligibility Criteria:
Inclusion Criteria:

* Arab 6-9 year old children
* Healthy
* Caries free, dmft/DMFT=0
* Caries Active: dmft/DMFT\>5

Exclusion Criteria:

* Children with a systemic disease or any drug use that could affect the microflora of the oral cavity or the salivary gland functions
* History of salivary gland diseases
* Those who received antibiotic therapy during the last 3 months
* Children with severe localized or generalized periodontitis.
Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.


Eligibility Criteria:
Inclusion Criteria:

Normal

* Able and willing to provide consent.
* Able and willing to complete required exams.

Corneal conditions

* Able and willing to provide consent.
* Able and willing to complete required exams.
* History of refractive surgery, contact lens, dry eye or keratoconus.

Exclusion Criteria:

Normal

* History of refractive surgery, contact lens, dry eye or pathology.
* Blepharitis or meibomitis
* Unable to complete required exams.

Corneal conditions

• Unable to complete required exams.
Mobile After-Care Support App: Pilot RCT

The overall aim of this program of research is to refine and test the feasibility and acceptability of a newly developed mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder. The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of the app. To achieve the specific aims, the investigators will conduct a pilot randomized clinical trial (n = 60), with two treatment arms: MACS vs. a mobile app attention control condition.


Eligibility Criteria:
Inclusion Criteria:

* recently hospitalized
* DSM-5 criteria for psychotic-spectrum disorder based on structured clinical interview
* 18 years or older
* prescribed antipsychotic medication upon discharge
* ability to speak and read English

Exclusion Criteria:

* substance use disorders at severe level
* planned discharge to supervised living setting or participation in formal outpatient adherence programs
* pregnancy or other medical condition contraindicating use of antipsychotic medications
Clinical Study on Auricular Points Sticking Plus Chinese Medication for Hot Flashes in Breast Cancer Women

Object:The aim of this study was to investigate the effectiveness of sticking and massaging auricular points for the management of hot flashes in postoperative breast cancer patients.

Patients and Methods A randomized controlled trial is conducted by comparing effectiveness of sticking and massaging auricular points relieving hot flashes in women with breast cancer versus placebo auricular points. A total of 92 women(still recuiting) with breast cancer, who were under hormonal therapy were randomly assigned and the allocation ratio was 1:1. Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments.

The primary outcome was hot flash score(HFS)at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes.The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric Scale(GCS)and Menopause Quality of Life scales(MenQoL)as well as serum estradiol(E2), follicle-stimulating hormone(FSH) and beta-endorphin(β-EP).Expectation and satisfaction of treatment effect and safety were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Primary breast cancer after surgical treatment, pathologically diagnosed malignant breast epithelial tumors (breast cancer), immunohistochemistry showed pathological type of estrogen receptor (ER) and / or progesterone receptor (PR) positive.
* Participants should be currently receiving endocrine therapy with oral administration of SERMS(selective estrogen receptor modulators) only.
* Participants should be suffered from perimenopausal symptoms,which is the sudden onset of facial skin flushing, sweating, began from chest and neck,often lasts a few seconds to several minutes and then subsided after center body temperature drops, the associated symptoms of heart palpitations, anxiety, impatience and even a sense of panic, and even wake up at night. The interval between the two attacks is more than 10 minutes.
* Hot flashes occurs during endocrine therapy of breast cancer
* KPS score \>60 score \>2 and ECOG
* Hot flashes (greater than or equal to 3 times the number of hot flashes per day)
* Symptoms persist for more than 2 weeks

Exclusion Criteria:

* Participants who have uncontrolled diabetes, hyperthyroidism and hypertension and in patients with pheochromocytoma
* Abnormal blood routine, liver and kidney damage (the index is greater than 1.2 times the upper limit of normal value)
* Pregnant or lactating women, persons with mental disorders
* Participants with other cancers
* Participants are participating in other clinical trials
* Current chemotherapy treatment period has not yet completed
* Taking corticosteroids or sex hormone treatment.
A Study on the Efficacy and Safety of Benzonatate Soft Capsules for Improving Adult Cough Symptoms

The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms.

The purpose of this study is evaluate the efficay and safety of benzonatate soft capsules for improving adult cough symtoms. The study was designed to be randomized, double-blind, placebo-controlled.Subjects were randomly assigned to the benzonatate soft capsule group and the placebo group on a 1:1 basis。According to the regulatory requirements, 200 cases were planned to be included. Considering that poor efficacy of the placebo control group might lead to shedding, a 10% increase in shedding was achieved, and 220 cases were finally determined, with 110 cases in each group.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 75 years of age;
2. the onset time is more than 3 days and less than 8 weeks;
3. dry cough, the total score of cough symptom in day and night is greater than 4;
4. Willing to sign informed consent.

Exclusion Criteria:

1. allergic person or known to the test drug containing ingredients (including benzo, soybean oil, glycerin, gelatin) allergy;
2. the cough symptoms are caused by bronchial asthma, tuberculosis, pneumoconiosis, bronchiectasis, tumor and other diseases that have been clearly diagnosed.
3. coughers caused by drugs;
4. respiratory depression or airway obstruction;
5. patients with uncontrolled diabetes or hypertension;
6. having difficulty in swallowing or affecting drug absorption, such as active peptic ulcer and acute gastritis;
7. patients with severe hematopoietic system, nervous system, mental illness (including alcohol and substance abuse) or immunodeficiency diseases;
8. laboratory examination results are abnormal with clinical significance, among which: A.C r is higher than normal value; B.A LT and/or AST\>2 times normal value upper limit (ULN).
9. women during pregnancy or lactation or women who are preparing for pregnancy or lactation during the trial;
10. in the first 3 months of screening, any other experimental drug treatment was accepted;
11. Failure to comply with test plans or other conditions that other researchers believe is not appropriate for the group.