cyrilzakka/clinical-trials huggingface dataset:
A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy

This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy.

Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor.

All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.


Eligibility Criteria:
INCLUSION CRITERIA:

* patients with prostate cancer who have just undergone prostatectomy,
* high risk of their cancer recurring (High risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.)

EXCLUSION CRITERIA:

* Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
* Prior radiation therapy
* Patients receiving any concurrent therapy for cancer. This includes alternative therapies
* Patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids.
* History of a malignancy other than prostate cancer
* Peripheral neuropathy \>/= Grade 2
* Psychological, familial, sociological or geographical conditions which do not permit treatment and/or medical follow-up required to comply with the study protocol
* Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).
Mehri Turki Webbed Neck Classification

This study aims to identify all types of congenital neck deformities called " webbed neck ". Through a literature survey, the researcher selected 27 articles describing the surgical treatment of the webbed neck, but without considering the varieties of this deformity. For this reason, the researcher studied all the reported cases from which she developed a classification containing 4 types of webbed necks allowing the use of the most suitable technique to enhance the surgical outcomes.

Through a literature survey of 27 selected articles (from PubMed database and clarivate web of science). The publication years ranged from 1937 to 2020 and the number of patients reported to have undergone surgery was 78 patients.

The webbed neck is a noticeable congenital deformity mainly observed in Turner syndrome. It consists of a bilateral fold extending from the mastoid to the acromion with several distinctions as described in Mehri Turki's webbed neck classification as follows:

Type 1: The fold is maintained by a fibrotic band and the posterior skin is abnormally hairy with a low hairline placement.

Type 2: There is no fibrotic band and the hair abnormality exists as in Type 1

Type 3: There is a fibrotic band and a low posterior hairline but the posterior skin is hairless

Type 4: The fold is maintained by a fibrotic band without hair abnormality

It appears that according to the type of webbed neck, the surgical approach and surgical steps and technique will be adapted to what will be corrected. This classification is therefore crucial to guide surgeons towards the most suitable technique allowing the best results.

Eligibility Criteria:
Inclusion Criteria:

* Articles with a detailed description of the surgical technique
* Articles reporting post-operative results
* Articles written in English or French

Exclusion Criteria:

* Articles with incomplete descriptions of the webbed neck
* Articles without iconography
A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

The purpose of this study is to determine the efficacy and safety of topiramate compared with placebo in obese, Type 2 diabetic patients on a controlled diet.

Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate in obese, diet-controlled, type 2 diabetic patients. Patients are randomized to receive either topiramate or placebo. After a 5 week pre-enrollment phase followed by a 6 week run-in phase, patients in the topiramate group start an 8-week titration phase to reach the assigned dose of topiramate, either 96 or 192 mg daily. Treatment continues for 1 year. Assessments of effectiveness include percent change in body weight, hemoglobin type A1c \[HbA1c\] levels, Body Mass Index \[BMI\], the numbers and proportion of 5% and 10% weight loss responders, glucose tolerance, waist and hip circumferences, changes in the mass of left ventricle of the heart, blood pressures, and fasting lipid profiles. Safety evaluations, including incidence of adverse events, vital signs, clinical laboratory values, and electrocardiograms \[ECGs\], are monitored throughout the study. The study hypothesis is that topiramate, combined with controlled diet, will be effective in weight reduction and controlling blood sugar level and is well tolerated. During the initial 8 weeks, the oral doses of either a matching placebo or topiramate will be gradually increased to the target doses (96 milligrams\[mg\] or 192mg daily); the dose will be maintained for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \>= 27 and \< 50
* Diagnosis of Type 2 diabetes according to either Swedish guideline or the American Diabetes Association (ADA) criteria
* HbA1c \<10.5% at enrollment
* No previous oral antidiabetic medication or insulin therapy
* Stable body weight
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

* Known contraindication or hypersensitivity to topiramate
* Fasting plasma glucose (FPG) \>= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, Visit 4 (Week 0)
* HBA1c of \>10.5% at enrollment
* History of severe recurrent hypoglycemic episodes prior to study entry
* Use of any systemic corticosteroids within 30 days of enrollment
* Diagnosed Type 1 diabetes
* History of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones
China Collaborative Study on Epidemiology of Acute Kidney Injury

Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital. AKI has become a huge medical burden in China. Little information is available about this disease burden in our country. The investigators aimed to evaluate the burden of AKI and to analyze the related risk factors.

The investigators launch a nationwide of all patients, who were admitted to hospital from 2011-2016. Patients were diagnosed on the basis of changes in serum creatinine by the laboratory information system. The investigators assessed rates of AKI according to the criteria of 2012 Kidney Disease Improving Global Outcomes (KDIGO).

Eligibility Criteria:
Inclusion Criteria:

* The patients diagnosed on the basis of changes in serum creatinine according to the criteria of 2012 Kidney Disease Improving Global Outcomes(KDIGO)

Exclusion Criteria:

* Serum creatinine record less than two times during hospitalization
* Patients being diagnosed with End-stage kidney disease (chronic kidney disease stage 5)
* Nephrectomy
* Kidney transplantation
* Peak serum creatinine of less than 53µ mol/L
* Serum creatinine decrease after amputation
Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System

The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT ABBREVO® Continence System in women undergoing Mid-urethral sling surgery for Stress Urinary Incontinence (SUI).


Eligibility Criteria:
Inclusion Criteria:

Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:

1. Stress urinary incontinence symptoms
2. Diagnostic evaluation, a positive cough stress rest, to confirm diagnosis of stress urinary incontinence.
3. Female subjects ≥ 21 years of age requiring treatment of SUI
4. Desired surgical correction of stress urinary incontinence using synthetic sub-urethral vaginal slings
5. Planned surgery for primary stress incontinence without concomitant prolapse surgery
6. Patient able and willing to participate in follow-up
7. Subject or authorized representative has signed the approved informed consent

Exclusion Criteria

Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:

1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires
2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product
3. History of previous synthetic, biologic or fascial sub-urethral sling
4. Pregnancy or plans for future pregnancy
5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.
6. Current genitourinary fistula or urethral diverticulum
7. Reversible cause of incontinence (i.e. drug effect)
8. Contraindication to surgery
Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer

RATIONALE: Aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. It is not yet known what effect aromatase inhibitor therapy has on blood vessel function.

PURPOSE: This clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.

OBJECTIVES:

* Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative).

* Group 1 (hormone receptor-positive): Patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity.
* Group 2 (hormone receptor-negative): Patients do not receive adjuvant treatment.

Endothelial function is measured in both groups at baseline and at follow up by the room temperature peripheral arterial tonometry (RT-PAT) index using the EndoPAT method.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Ductal carcinoma in situ (DCIS) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer
* May not have had a prior mastectomy with requirement for mastectomy of the contralateral breast
* No requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection
* Hormone receptor status meeting 1 of the following criteria:

  * Hormone receptor negative and not eligible for aromatase inhibitor therapy (AI)
  * Hormone receptor positive and are not receiving an AI

PATIENT CHARACTERISTICS:

* Postmenopausal
* No known or symptomatic coronary artery disease
* No significant co-morbidities, including any of the following conditions:

  * Active renal or hepatic disease
  * Known uncontrolled and/or untreated peripheral arterial disease
  * Uncontrolled and/or untreated hypertension
  * Uncontrolled and/or untreated diabetes
  * Uncontrolled and/or untreated hyperlipidemia

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* More than 7 days since prior hormone replacement therapy or hormone-based contraception
* More than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease
* More than 12 months since prior and no concurrent chemotherapy for this disease
* No prior bilateral mastectomy
Trial of AEO in New Glioblastoma (GBM)

This is a multicenter, Phase 2, Proof-of-concept study in subjects with newly diagnosed glioblastoma multiforme (GBM).

All subjects will receive standard of care therapy for the treatment of their GBM and any Anti-Epileptic Drug (AED) deemed necessary for their surgical resection of the GBM. Patients who are taking concomitant AEDs will be eligible for the study. Treatment with Anhydrous Enol-Oxaloacetate will be added to the Standard of Care.

This study is testing adjuvant Anhydrous Enol-Oxaloacetate (AEO) in GBM, an orally active drug candidate which in animal studies has demonstrated decreased tumor growth rate and increased survival.

Currently, the multidisciplinary Standard of Care treatment for Glioblastoma multiforme includes maximal surgical resection of the tumor followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy.This study will treat newly diagnosed GBM patients by adding Anhydrous Enol-Oxaloacetate treatment to their current Standard of Care.

In the body, Anhydrous Enol-Oxaloacetate (AEO) converts into "Oxaloacetate", a metabolite important for many biochemical reactions in the body. On a cellular level, oxaloacetate treatment has been found to modify cancer metabolism in GBM cells, reversing the "Warburg Effect", reducing glycolysis and reducing lactate production. In animals, oxaloacetate treatment has increased survival and reduced tumor growth of implanted GBM tumors.

In other animal studies, oxaloacetate has also shown to have neuo-protective effects including positive effects on seizure development.

.

Eligibility Criteria:
Inclusion Criteria:

* • Histopathologic diagnosis of glioblastoma multiforme

  * Standard of care maximal feasible surgical resection of the glioma
  * Post-operative pre-enrollment MRI-Note: measurable disease is not required
  * Concomitant anti-epileptic drugs
  * Hemoglobin \>9 g/dL
  * Platelets \>100,000/microliter (mcL)
  * \<3.0 Upper Limit of Normal Range (ULN) for Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and/or Alkaline Phosphatase
  * \<2.0 Upper Limit of Normal Range (ULN) for serum creatinine
  * Karnofsky performance status \>70
  * Mentally competent to follow study procedures
  * Male and female patients of childbearing potential must agree to use a dual method of contraception (a highly effective method of contraception in conjunction with barrier contraception) consistently and correctly from the first dose of study drug until 90 days after the last dose of study drug
  * Able to answer questions on the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire
  * Subject is willing and able to give informed consent and to follow instructions as per the protocol

Exclusion Criteria:

* • Concomitant treatment with carmustine wafers or tumor-treating electric fields (TTFields)

  * QT Interval corrected with the fridericia formula (QTcF) \>480ms
  * Significant concurrent illness / disease
  * Predicted life expectancy \< 6 months from date of randomization
  * Pregnancy
  * Enrollment in another clinical trial during the course of the study
Results of Rotator Cuff Repair

The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.

There is a higher risk of rotator cuff tears following dislocation when the individual is greater than 40 years old. Rotator cuff tears after dislocation of the shoulder are more of a challenge to repair particularly if there is a delay in diagnosis. Clinical experience would suggest that rotator cuff repair within the first month of injury allows for better results in acute rotator cuff tears without shoulder dislocation. There are no reported results for rotator cuff repairs following shoulder dislocation and timing of repair. If we find that early repair provides better results this will be important for Primary Care Providers and Emergency Department physicians to refer these patients early for evaluation and subsequently earlier treatment.

Eligibility Criteria:
Inclusion Criteria:

* age 35 years or older with acute rotator cuff tear following documented shoulder dislocation requiring reduction, subjects sustained acute rotator cuff tear following shoulder dislocation that was treated surgically with open and/or arthroscopic technique between January 1, 2001 and June 1, 2011, surgical intervention within 6 months of dislocation, minimum follow up time of one year from surgery.

Exclusion Criteria:

* rotator cuff tears without shoulder dislocation, known previous rotator cuff disease, history of other trauma to the shoulder, inability to provide informed consent, other suspect pathology (ie: tumor, infection).
Mindfulness, Breast Cancer and Psycho-Immune Dysregulation

The purpose of this study is to evaluate the benefits of a Mindfulness Based Stress Reduction (MBSR) program for psycho-immune dysregulation in women newly diagnosed with breast cancer compared to women with breast cancer completing an attention control condition (health education classes). Women will be randomized to either the MBSR or health education classes. They will complete psychometric instruments evaluating psychological outcomes and will provide blood samples for immune outcomes. They will also provide saliva samples for cortisol diurnal rhythm determination. Measures will be done longitudinally pre and post MBSR or health education program. It is hypothesized that MBSR participants will exhibit improved psychological and immunological outcomes over time, as compared to women randomized to the health education classes.

The Mindfulness-Based Stress Reduction (MBSR) program is designed to cultivate conscious awareness (i.e., mindfulness) of one's experience in a non-judgmental or accepting manner (Kabat-Zinn, et al., 1990). Mindfulness programs may facilitate recovery from cancer. However, most prior mindfulness investigations for women with breast cancer focused on cancer survivors, well beyond the acute period of cancer diagnosis and treatment. Moreover, few of these studies evaluated immune measures with relevance to cancer.

Women diagnosed with early stage breast cancer (Stages 0, 1, 2, and 3) will be enrolled. Eligible women will be identified after completion of their breast surgery and when surgical pathology reports are available. Women will complete psychometric instruments and study questionnaires. They will provide blood for immune measures and saliva for cortisol diurnal rhythm. Measures will be done at five separate time points. These are pre-, mid-, and completion of either the MBSR or the attention control program, as well as at 1- and 6-months post-program. Demographic information and information about health behaviors will be collected by self-report. Wrist actigraphy for an additional assessment of sleep quality will be done in an exploratory manner. Hierarchical linear modeling will be used to compute multilevel model for change, based on full maximum likelihood estimation (Raudenbush, S. W., and A. S. Bryk. 2002). Hierarchical linear modeling will be applied to examine intra-individual and inter-individual differences in initial status (baseline) and trajectories of change over time.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Early Stage Breast Cancer

Exclusion Criteria:

* Prior training in MBSR,
* Recurrent breast cancer,
* Metastatic breast cancer,
* Other cancers (except basal cell carcinoma),
* Immune-based disease,
* Psychoses,
* Cognitive dysfunction,
* Unable to read or write English,
* History of substance abuse,
* Use of immune-altering medications
Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes

This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.

Diet plays a crucial role in maintaining overall health, and changes in dietary patterns are increasingly recognized as major contributors to chronic disease development. Inadequate dietary intake and poor diet quality have been linked to increased risks of cardiometabolic diseases and disruptions in gut microbiota composition. However, most studies investigating these associations have been conducted on Western populations, and there is a lack of research focusing on Asian populations. Given the genetic, metabolic, and dietary differences between Western and Asian populations, examining these associations in an Asian population is essential for a deeper understanding of population-specific risk factors and health outcomes. Therefore, there is an urgent need to assess the associations between dietary intake, cardiometabolic health, and gut microbiota composition in Asian population.

This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.

Findings from this study will offer valuable insights into the relationship between diet, cardiometabolic health, and the gut microbiota in this population. In addition, this research may identify specific dietary patterns or nutrients that offer greater benefit for cardiometabolic and gut health. In turn, these findings can contribute to the improvement of current dietary guidelines aimed at promoting better cardiometabolic and gut microbiota outcomes for the broader Singaporean population.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give informed consent
2. Adults 21-80 years old
3. English-literate
4. Have venous access sufficient to allow for blood sampling as per the protocol
5. No drastic change of diet for the past 1 year
6. If taking medication, has been consistently taking antihypertensive/cholesterol-lowering/type-2 diabetic medication for more than 5 years prior to starting the study.

Exclusion Criteria:

1. Taking dietary supplements and fermented foods, which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics, yogurt, kimchi) 2 months before starting the 1st study visit only.
2. Taking dietary supplements or medications, which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), tryptophan, 5-hydroxytryptophan or melatonin supplementations) 1 month before starting the study.
3. Taking dietary supplements which may impact the eye outcomes (e.g. Vitamin A, vitamin A-containing multivitamin) 2 months before starting the study.
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women

We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.

We asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.

Eligibility Criteria:
Inclusion Criteria:

* Stress urinary incontinence

Exclusion Criteria:

* language other than english