cyrilzakka/clinical-trials huggingface dataset:
Quantitative Study on HRCT Phenotype of COPD

To explore the HRCT phenotype of the combined COPD assessment staging system

HRCT can be rapidly and safely deployed has enabled COPD research to move beyond FEV1 by facilitating and amplifying clinical phenotyping measurements, providing quantitative information, and detecting significant responses to therapy even in the absence of significant FEV1 improvements.

We explore the HRCT phenotype of the combined COPD assessment staging system,and found that:

1. Airway remodeling occurs in COPD patients. CT shows varying degrees of bronchial wall thickness, area increasing and emphysema as the new GOLD classification Group A-D arising.
2. The GOLD Combined assessment staging system helps doctors choose an individualized treatment for the COPD patients

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 80 (including 40 and 80)
2. It meets the diagnostic criteria for COPD
3. No language communication barriers, or the family members who know the condition can complete the questionnaire on behalf of the patient, and the data are reliable;
4. Voluntarily agree to participate in this study

Exclusion Criteria:

1. Older than 80 or younger than 40
2. Pregnant women
3. Complicating with other lung diseases, such as asthma, pneumonia, bronchiectasis, lung abscess, interstitial lung disease, confirmed and suspected lung cancer of lung shadow, active pulmonary tuberculosis, etc
4. Previous lung surgery
5. Cognitive dysfunction
6. Unable to cooperate with lung function test.
A Randomized Controlled Trial Comparing the Effect of Pelvic Floor Muscle Training

Aim: To determine the effects of pelvic floor muscle training (PFMT) in women with a single delivery route. Pregnancy and delivery route alter the pelvic floor muscle strength and are considered risk factors for urinary incontinence and genital dystopias. Methods: A Randomized controlled clinical trial with two hundred ninety-seven women aged 35 to 45 years old were selected for functional assessments of their pelvic floors by vaginal digital palpation and perineometry. One hundred sixty-five (69.7%) exhibited muscle strength deficits and were included in the clinical trial. The participants were distributed into two groups based on the delivery route (A, vaginal delivery and B, cesarean delivery) and were then randomly subdivided into Groups A1 (n = 44) and B1 (n = 42), who performed PFMT, and Groups A2 (n = 39) and B2 (n = 40), who did not undergo muscle training. The PFMT involved perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions. The functional assessment of pelvic floor by vaginal digital palpation and perineometry was performed after 15 sessions of pelvic´s floor muscles training. The statistical analysis was performed using the Mann-Whitney and Z tests at a 5% level of significance.


Eligibility Criteria:
Inclusion Criteria:

* age between 35 and 45 years old, obstetric antecedent of a single delivery route (i.e., vaginal or abdominal), and regular menstrual cycles for six months prior to the initial interview.

Exclusion Criteria:

* women who had complaints or clinical manifestations suggestive of urinary incontinence, intense pelvic or vaginal pain, past histories of physical therapy for pelvic floor strengthening, correction of genital prolapse, myomectomy, (total or subtotal) hysterectomy, morbidities such as diabetes and arterial hypertension, or body mass indices (BMIs) that were determined during the physical examination to be equal to or higher than 30 kg/m2.
IRESSA™ (Gefitinib) in Breast Cancer Patients

This is a phase II trial to assess whether IRESSA™ (gefitinib) has anti-tumour efficacy in patients with breast cancer. The trial proposes to enter 27 patients who have acquired resistance to tamoxifen and 27 patients with ER negative tumours. However for each of these two types of patients recruitment will stop after 14 patients have been entered in order to confirm that IRESSA™ (gefitinib)has anti-tumour efficacy. If no patient out of 14 in a group has shown clinical benefit (ie an objective response (CR or PR) or stable disease (SD) for at least 24 weeks) then a clinical benefit rate of \>20% can be ruled out with \>95% certainty. If one or more of the objective response or stable disease (\> 24 weeks) has been seen in the first 14 patients recruited in a group then recruitment to that group will recommence to a total of 27 patients. If 14 patients are entered into an arm but not all 14 patients are available for final analysis and the toxicity/safety and tolerability profile of the therapy is acceptable and documented and a clinical benefit is seen in the patients, enrolment of additional patients beyond the initial 14 may be made based on overall clinical assessment.


Eligibility Criteria:
Inclusion Criteria:

* histological or cytological confirmation of breast cancer that is either

  * a primary tumour in a patient unfit for or who has declined surgery
  * advanced (locally or metastatic) disease
* acquired resistance to tamoxifen or ER negative tumour
* at least one measurable or assessable lesion
* WHO performance status 0 - 2
* life expectancy of 12 weeks or more

Exclusion Criteria:

* more than one previous chemotherapy regimens for advanced disease
* prior anthracycline chemotherapy (\> 250 mg/m2 adriamycin)
* radiotherapy completed within 14 days prior to Day 1 of treatment
* incomplete healing from prior oncologic or other major surgery
* signs of neurological symptoms consistent with spinal cord compression
* any evidence of clinically active interstitial lung disease (patients with chronic stable
Prehabilitation Prior to Surgery for Kidney Tumors

The goal of this clinical trial is to examine if one month of general health optimization before surgery for kidney tumors can help participants recover more quickly from surgery.

The optimization process is called prehabiliation, and will last one month. It consists of

1. A comprehensive health assessment
2. Assisted smoking cessation
3. A home exercise program.

The investigators will compare an intervention group receiving one month of prehabilitation with a control group receiving the standard of care.

Some of the main questions the investigators want to answer are

* Are participants in the intervention group more satisfied with their quality of recovery after surgery?
* Do participants in the intervention group maintain more of their physical abilites compared to the control group?


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
* Clinical Frailty Scale 3-6

Exclusion Criteria:

* It is determined by an attending physician, or at a multi-disciplinary team-conference, that a 2-4 week postponement of surgery will not be beneficial for the participant.
* Participant does not understand Danish og English
Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms

The purpose of this study is to determine if soy-derived phytoestrogens (naturally occurring compounds similar to estrogen) can prevent bone loss and other menopausal symptoms in women who have recently gone through menopause.

Study hypothesis: Tablets of high-dose, purified soy phytoestrogens spare the normally occurring spinal bone loss and improve biological and other emotional changes of menopause.

The risks of bone loss and osteoporosis increase significantly after menopause. Although hormone therapy (HT) can spare menopausal women from bone loss and other menopausal symptoms, Women's Health Initiative (WHI) findings indicate significant potential health risks associated with HT. This has prompted women to switch from HT to naturally occurring compounds similar to estrogen, such as those derived from soy, in the hope that estrogens from plant sources can provide benefits while sparing adverse effects caused by prescribed estrogens. However, the long-term efficacy and safety of plant estrogens are unknown. This study will evaluate the effectiveness of treatment using purified soy isoflavones, a dietary source of phytoestrogens, in preventing bone loss, menopausal symptoms, and other changes associated with estrogen deficiency in young menopausal women. The "Soy Phytoestrogens As Replacement Estrogen (SPARE)" study will provide a foundation of knowledge from which menopausal women and their doctors can begin to make more informed decisions regarding HT and other treatment options.

Enrollment into the study will occur over 3 years, with each participant taking part in the study for a total of 2 years. Participants will be randomly assigned to one of two groups; the first group will receive a 200 mg dose of soy isoflavones daily and the second group will receive placebo daily. There will be 10 study visits: screening, study entry, randomization at Month 1, six follow-up visits at Months 2, 4, 8, 12, 16, 20, and a final visit at the end of active participation at Month 24. At each study visit, participants will have blood drawn, provide urine samples, answer questionnaires, and have mammograms and bone density tests.

Eligibility Criteria:
Inclusion Criteria

* Absence of menstrual period for 12 months but not more than 5 years, or absence of menstrual period for 6 to 12 months and follicle stimulating factor (FSH) greater than 40 IU/L

Exclusion Criteria

* Treatment with estrogens, progesterone, raloxifene, or tamoxifen
* Treatment with bisphosphonates, calcitonin, fluoride, or systemic corticosteroids
* Use of soy/herbal supplements, including DHEA, within 3 months prior to study entry
* Use of antibiotics in the month prior to study entry
* Use of prescription medication to treat hot flashes
* Chemical menopause, including post-chemotherapy
* Hyperthyroidism
* Hypothyroidism
* Uncontrolled diabetes
* Malabsorption syndromes or other chronic diseases
* Body mass index (BMI) less than 20 or greater than 32
* Bone mineral density (BMD) T-score below -2.0 in lumbar spine or femoral neck
The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

This study is a single-center, prospective, group-controlled clinical trial, aiming to clarify the relationship between the depth of dissection and scar formation in the treatment of early gastric cancer by ESD, and to provide high-quality evidence-based medicine for the treatment of early gastric cancer.

This project intends to compare the scar size of ESD for early gastric cancer with different peeling depths, explore the relationship between ESD peeling depth, scar formation and gastric function, and clarify the differential impact of different peeling depths on the prognosis of patients. We plan to provide evidence for guidelines of early gastric cancer ESD treatment based on the related data. In further, the project show insight into a more effective clinical technique which profit patients better prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old and younger than 75 years old.
* Early gastric cancer (T1a stage) diagnosed by gastroscopy or ultrasonography, differentiated and no ulcer; or early gastric cancer (T1a stage), differentiated with ulcer, lesion diameter \<3cm; or early gastric cancer (T1a stage), undifferentiated and No ulcer, lesion diameter \<2cm.
* Pathological diagnosis of gastric cancer.
* No further treatment is required.
* Patients diagnosed for the first time without other serious gastrointestinal diseases.

Exclusion Criteria:

* Those who did not comply with the test requirements, obviously violated this protocol, or switched to other protocols in the middle of treatment.
* Advanced gastric cancer; or undifferentiated gastric cancer lesions \> 2 cm in diameter; or differentiated gastric cancer with ulcer lesions \> 3 cm in diameter.
* Coagulation disorders.
* Serious heart, liver, kidney and other diseases, can not tolerate ESD treatment.
* Patients with gastric cancer complications such as gastrointestinal bleeding and perforation that need emergency treatment.
* Patients with distant metastasis.
* Patients with other tumors, patients with a history of malignant tumors (except early carcinoma in situ.
* The patient himself requests to withdraw from the trial.
* The researcher believes that the patient is not suitable to participate in this study.
Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study

The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.

Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (ART) (7, 8).

Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance
3. Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
4. Have capacity for informed consent
5. HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation

Exclusion Criteria:

1. Pregnancy
2. Prisoners
3. Discretion of IOR or clinician
Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring

This is a two-cohort, crossover pilot study to determine interstitial glucose levels coincident with the consumption of a novel carbohydrate blocking supplement.

This two-cohort study will evaluate a novel supplement developed for metabolic support using measures of glycemic variability, fasting glucose, and fasting insulin. In the first cohort, over the course of two weeks, these endpoints will be determined by continuous glucose monitoring (CGM) and blood/urine analyses in healthy adults using a carbohydrate blocking supplement (CBS). Following an interim analysis, the CBS will be evaluated for an additional two months in healthy volunteers using the same measures outlined above.

Eligibility Criteria:
Inclusion Criteria:

If female, negative pregnancy test

* Body mass index (BMI) ≤ 32
* HbA1C ≤ 6.4% at screening
* Fasting blood glucose level ≤ 125 mg/dL at screening
* \[COHORT 1 ONLY\] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), food journaling, consumption of a standardized, high carbohydrate meal daily, CGM device application, and phlebotomy
* \[COHORT 2 ONLY\] Willing and able (in the opinion of the investigator) to comply with all study requirements, including swallowing size 00 capsules (approximately 23 mm long and 8.5 mm diameter), CGM device application, and phlebotomy
* Signed informed consent, HIPAA Authorization, and Confidentiality Agreement

Exclusion Criteria:

* Pregnancy within the last 60 days or currently breastfeeding
* Existence of any medical condition, significant disease or disorder, or surgery within the past 12 months that may, in the judgment of the medical provider, put the participant at risk, or affect study results, procedures or outcomes
* Existence of any medical concerns, or any finding that may, in the judgment of the staff medical provider, put the participant at risk, or affect study results, procedures or outcome
* \[COHORT 1 ONLY\] Sensitivity or allergy to gluten, sugar, peanuts, apples, strawberries, dairy, or orange juice
* Known or suspected allergy or sensitivity to essential oil, fatty oils, cellulose, or botanical products
* Currently following a ketogenic or medically prescribed diet, or have followed a ketogenic or medically prescribed diet within the last 3 months
* Arterial hypertension ≥140/90 mmHg.
* HbA1c ≥ 6.5% at screening
* Fasting blood glucose \> 125 mg/dL at screening
* Current or previous participation in any other clinical trial within the last month
* History of smoking or vaping within the last 3 months
Intravital Microscopy (IVM) in Patients With Peritoneal Carcinomatosis (PC)

This study will investigate the tumor-associated vasculature of patients with peritoneal carcinomatosis, or cancer that spreads along the inner abdominal lining. The investigators will use a technology known as intravital microscopy (IVM) in order to visualize in real-time the tumor-associated vessels of peritoneal disease. The IVM observations may determine if an individual patient's tumor vessels would be amenable to receiving systemic therapy, based on the functionality of the vessels.

Primary objective(s): To determine the feasibility and clinical utility of performing HIVM in patients with peritoneal carcinomatosis during standard course of treatment (cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, or CRS-HIPEC).

Secondary objective(s):

1. Compare the microscopic observation of the tumor-associated vessels with normal tissue (peritoneal surface) in each individual subject.
2. Correlate the microscopic observations of the tumor-associated vessels with pathologic grade of tumor implants.
3. Correlate the microscopic observation of the microvasculature with tumor-specific and overall survival.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age.
2. Have an ECOG Performance Status of ≤ 2. Refer to Appendix C.
3. Have measurable disease in the peritoneum by direct visualization (visible lesion typically \> 0.5 cm in maximal diameter).
4. Carcinomatosis that meets indications for CRS-HIPEC.
5. Subject must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
6. A negative skin-prick test to fluorescein.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations.
2. Renal dysfunction as defined as a GFR \< 45.
3. Liver dysfunction as defined by Child-Pugh score \> 5, or LFT's 1.5x above normal range.
4. Any known allergy or prior reaction to fluorescein or ICG or a positive skin prick test to fluorescein.
5. Pregnant or nursing female subjects, determined preoperatively with a urine pregnancy test.
6. Unwilling or unable to follow protocol requirements.
7. Any condition which in the Investigators' opinion deems the patient unsuitable (e.g., abnormal EKG).
8. Any condition that excludes CRS-HIPEC as the standard of care for the patient.
Effect of Treatment With Stress-Doses Glucocorticoid in Patients With Acute Respiratory Distress Syndrome (ARDS)

The purpose of this study is to see if stress doses of hydrocortisone improve early outcome in patients who are in early stage of ARDS and with relative adrenal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* within the first 3 days of onset of clinically definite ARDS confirmed by AECC criteria in 1994
* 18 to 85 year old

Exclusion Criteria:

* pregnancy or lactation
* tumor or other immunologic disease
* immunosuppressive drug used
* bone marrow or lung transplantation
* primary or secondary disease of adrenal gland
* hormone used within 3 months
* refusing conventional therapy
* be in other clinical tests within 30 days
Case Management Study to Reduce Health Care Utilization for Frequent Hospital Care Users

The purpose of this study is to identify persons with high risk of frequent hospital admissions and by counselling by one in depth interview followed by frequent telephone contacts improve their quality of life and reduce their healthcare utilization.

Participants are identified by administrative data and a model predicting high risk of future healthcare utilization. Participants are invited to the study by mail. After informed consent participants are randomized to either active treatment or control 3:1. Active patients have an in depth interview with a specially trained nurse. Further counselling by telephone weekly for 6-9 months.

Quality of Life is measured by SF-36 every 3 months for one year both in active participants and in controls.

Eligibility Criteria:
Inclusion Criteria:

* Patient \> 18 years
* Recent history of contact with hospital
* Anticipated sustained high visit frequency

Exclusion Criteria:

* Dementia (ICD10: F00-F03 or F051)
* Psychoses (ICD10: F20-F29)
* Drug abuse (ICD10: F10-F19)
* Metastases (ICD10: C77-C80)
* Hearing impairment or language difficulties
* Life expectancy \< 1 year No telephone
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-60
* Patients with a diagnosis of multiple sclerosis

Exclusion Criteria:

* Patients with a history or presence of chronic disease of the immune system other than MS
* Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply