cyrilzakka/clinical-trials huggingface dataset:
Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxanes Chemotherapy in Breast Cancer

Precision Acupuncture in the Treatment of Peripheral Neuropathy After Taxane Chemotherapy in Breast Cancer

Associated peripheral neuropathy in breast cancer patients has a significant impact on their quality of life and treatment compliance. Many studies have shown that acupuncture has a certain therapeutic effect on peripheral neuropathy. Studies have shown that taxane induced peripheral neuropathy in breast cancer is related to genetic factors. Based on SNPs related to peripheral neuropathy, this study screened SNPs related to peripheral neuropathy caused by taxane drugs, and established a prognostic model.

Eligible patients diagnosed with stage I, II or IIIA breast cancer and experiencing peripheral neuropathy for at least 2 weeks were assessed by the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group-Neurotoxicity，FACT/GOG-Ntx) and the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale(EORTC QLQ-CIPN20). Likert level 5 and level 4 scores were used for all items in the above two scales. The investigators will temporarily divide the study into a group, and the investigators will increase the group if necessary. Laboratory personnel were blinded to all clinical and outcome data.

Eligibility Criteria:
Inclusion Criteria:

1. The patient was at least 18 years old and had reported grade 1 or higher neuropathic symptoms for more than 2 weeks;
2. Patients were screened for eligibility by the investigator prior to enrollment, including verification of baseline neuropathic symptoms.
3. Patients had a diagnosis of stage I, II, or IIIA breast cancer;
4. Have completed at least 2 weeks of chemotherapy;
5. Higher scores indicate more severe symptoms;
6. Voluntarily participate in the clinical trial and sign the informed consent form after informed consent (patients voluntarily accept the treatment and give informed consent);
7. Eastern Cooperative Oncology Group (ECOG ) score of physical condition (0-1);
8. Patients with previous local recurrence were eligible;
9. The basic indexes were consistent, and the blood routine and ECG were normal.

Exclusion Criteria:

1. patients with needle phobia;
2. Low platelet count (\<50 000); co-morbidity with a bleeding disorder; comorbidity with thyroid dysfunction; pregnancy; haemoglobin levels \<10 g/dl and haematocrit \<30; anaemia on active pharmacological treatment or receiving blood transfusion or steroids;
3. having metastatic or recurrent disease, history of preexisting peripheral neuropa- thy prior to chemotherapy, uncontrolled seizure disorder, unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
4. Being pregnant or nursing, or having used acupuncture for peripheral neuropathy within 6 months prior to study entry;
5. Life expectancy \<6 months;
6. Lymphedema of limbs;
Cataract Surgery Technique and Ocular Clarity

The goal of this study is to study the restoration of quality of vision, expressed as straylight, in the immediate period after cataract surgery with two different phacoemulsification technologies.

Cataract is an opacification of the lens. With cataract surgery, the lens is surgically removed after which a clear artificial intraocular lens is implanted. For patients, it is important that they regain functional vision as quickly as possible after surgery as a limited vision may increase the risk of falling and increases the dependency on other people. Surgical removal of the lens is done with a phacoemulsification system. Differences between phacoemulsification systems are the used pump type, the way the needle oscillates, and the fluid dynamics of the system. It is unknown whether any of the available systems offer an advantage on the amount of corneal oedema that develops after surgery and, therefore, results in a more rapid restoration of functional vision.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cataract in both eyes,
* Having consented to and is planned to undergo cataract surgery in both eyes,
* Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
* A targeted refractive error of emmetropia,
* Corneal astigmatism of ≤1.5 D,
* Age of at least 18 years,
* Willing and able to participate in both preoperative and postoperative examinations, and
* Agreeing to sign the informed consent form.

Exclusion Criteria:

* Insufficient understanding of the Dutch language to comply with study procedures,
* Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
* Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
* Subjects with an increased risk of complicated cataract surgery:
* Lens subluxation or (phaco)iridodonesis,
* Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
* History of ocular trauma,
* Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
* A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.
The Energy Cost of 1-Hour Football Training

This study aims at investigating the energy expenditure following a single Football trainning session in middle aged males. The participants will perform a soccer training session \[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design.

Football is an intermittent sport with frequent activity changes and a high number of explosive movements. As a result, both mitochondrial and the non-mitochondrial energy sources (phosphagens, lactic acid system) are heavily utilized during football practice and games, which may contribute to the rise of oxygen consumption following exercise (EPOC) compared with cardiovascular-type exercise, where VO2 can reach a steady state.However, it is observed that there is a methodological limitation in the determination of total energy expenditure during and after football training and specifically in overwight middle-aged participans with metabolic syndrome.

Twenty overweight middle-aged males with mtabolic syndrome will perform a soccer training session \[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Anthropometric, biochmeistry indicators, metabolic, blood pressure, physical activity and performance measurements will be measured at baseline. Global positoning system and accelerometry devices will be used to measure the distance and intensity of football trianing. The metabolic cost will be estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Free of musculoskeletal injuries
* No use of ergogenic supplements or medication
* Free of chronic diseases
* age of 40-60 years
* BMI\>25
* Metabolic syndrome

Exclusion Criteria:

* Musculoskeletal injury
* Use of alcohol, caffeine and any type of ergogenic supplements or medication during the course of the study
Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography

The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.


Eligibility Criteria:
Inclusion Criteria:

* Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria:

* Weight \> 300 lb
Effects of an Intervention on Improving Midlife Women's Menopause-related Symptoms

This study was an experimental study with repeated measures. Study aims were to examine the effects of pelvic floor muscles training (PFMT) combined with yoga on improving genitourinary/climacteric symptoms, the pelvic floor muscles strength, and health-related quality of life (HRQL). Study participants were assigned to the intervention group or comparison group. Data analyses were based on the information obtained from 91 midlife women with a mean age of 56.6 years. Information related o the pelvic floor muscles strength was only obtained from 45 women. Descriptive statistics were used to represent study participants' individual characteristics, genitourinary/climacteric symptoms, the pelvic floor muscles strength, and HRQL. Paired t tests, independent t tests, and Generalized Estimating Equation (GEE) procedures were used to examine the intervention effects.

This study was an experimental study with repeated measures. Study aims were to examine the effects of PFMT combined with yoga on improving genitourinary/climacteric symptoms, the pelvic floor muscles strength, and HRQL. Study participants were randomly assigned to the intervention group or comparison group. All study participants received an educational section (a discussion section and an abbreviated practice section) and related educational materials. The intervention group attended on-site group practice sessions and performed individual home-based practice. The comparison group performed individual home-based practice only. Data analyses were based on the information obtained from a sample of midlife women with a mean age of 56.6 years. Relevant information was mainly collected by a structured questionnaire. Information related to the pelvic floor muscles strength was only obtained from 45 women in the intervention group by using the FemiScan pelvic floor therapy system. Descriptive statistics were used to represent study participants' individual characteristics, genitourinary/climacteric symptoms, the pelvic floor muscles strength, and HRQL. Paired t tests, independent t tests, and GEE procedures were used to examine the intervention effects.

Eligibility Criteria:
Inclusion Criteria:

* Women who experienced ≥1 genitourinary symptoms.

Exclusion Criteria:

* Being pregnancy or breastfeeding, experiencing iatrogenic menopause (e.g., surgery, chemotherapy or radiation related), maintaining regular PFMT and/or yoga practices, using oral contraceptive or psychiatric medications, and having physical weakness/limitation or major cognitive impairment.
Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.

Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Overt biopsy-proven diagnosis of cervical cancer, at any stage;
* Signed written informed consent to personal data treatment for research purposes

Exclusion Criteria:

* Age \<18 years old;
* Uncertain diagnosis of cervical cancer;
* MRI scan not according the standard acquisition protocol (ESUR guidelines);
* Patients candidate to non-standard treatments;
* Refusal to sign the written informed consent to personal data treatment for research purposes
The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels

Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve. In prior studies, tubal ligation has been shown to have an adverse effect on ovarian reserve. One theory postulated for this effect is that the ovarian circulation is disrupted by the procedure, leading to altered hormone production. In this prospective cohort study, the investigators plan to analyze the rates of AMH decline by comparing the following contraceptive methods: tubal ligation, Essure placement, and levonorgestrel intrauterine devices (IUDs).

Anti-mullerian hormone (AMH) has been shown to be a reliable marker of ovarian reserve because levels demonstrate a consistent age-related decline and do not fluctuate throughout the menstrual cycle. In prior studies measuring markers other than AMH, tubal ligation has been shown to have an adverse effect on ovarian reserve.

The primary aim of this study will be to compare the rates of anti-mullerian hormone (AMH) decline following tubal ligation, Essure placement, and levonorgestrel IUDs, and then identifying any and all differences that these specific contraceptive methods have on the changes of AMH rates over time. The secondary aim will focus on analyzing the various types of tubal ligation methods (i.e. coagulation, ligation, clips, bands, etc.) to see if different techniques result in any difference in the rate of AMH decline. The hypothesis is that tubal ligation will result in an accelerated rate of AMH decline as compared to other long-term or permanent contraceptive methods.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Female
* Age 25-40
* Electing one of the following contraceptive methods: tubal ligation, Essure, levonorgestrel IUD
* Ability to understand study procedures and to comply with them for the entire length of the study
* Willingness to comply with follow-up visit requirements

Exclusion Criteria:

* Age \<25 or \>40 at initiation or completion of the study
* Prior oophorectomy or salpingectomy
* Prior surgery of the ovaries or fallopian tubes
* Prior ovarian, uterine, or fallopian tube cancers
* Prior ovarian, uterine, or fallopian tube radiation exceeding \>200rads
* Prior platinum-based or alkalizing chemotherapy
* Current cancer (any form)
* Current pregnancy
* Allergy to any of the components of the selected devices (titanium, rubber, nickel, plastic, silicone)
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
* Inability or unwillingness of a potential participant to give written informed consent
* Inability for the potential participant to consent for herself
Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction

The purpose of this study is to compare two different soft tissue allografts, double bundle tibialis anterior allograft or quadruple bundle hamstring allograft, used in repairing a torn anterior cruciate ligament (ACL) of the knee.


Eligibility Criteria:
Inclusion Criteria:

* ACL injury is the primary limitation to activities of daily living.

Exclusion Criteria:

* Multiple current ligamentous injuries to the knee.
* Revision reconstruction of the ACL.
* Uncorrected instability of the ACL on the opposite knee.
LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia

This randomized controlled trial is aimed to compare the efficacy between Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD) regarding the ability and duration to produce complete regression for cases with atypical endometrial hyperplasia.

Up to 25% of cases with endometrial cancer and atypical hyperplasia occur in premenopausal women. The progressively increasing trend of delay in first conception increases such patients who wish to have children.3 The recommended treatment for EH without atypia is primarily hormonal, whereas the preferred treatment for EH with atypia is hysterectomy given the significant risk for both concurrent and subsequent development of endometrial carcinoma. A dilemma results when EH with atypia is diagnosed in women who wish to retain fertility or declining doing hysterectomy due to concomitant medical morbidities. In these women, a trial of hormone therapy can be considered.4,5 In recent years, progestin therapy has been successfully used to treat selected women with endometrial cancer and atypical hyperplasia who desire to preserve fertility or having severe medical co-morbidities precluding (immediate) surgery. The most common progestin regimens include Megestrol acetate (MA) and the levonorgestrel intrauterine system (LNG-IUD).5-7

Eligibility Criteria:
Inclusion Criteria:

All cases with evidence of atypical endometrial hyperplasia declining doing hysterectomy

Exclusion Criteria:

* Cases with evidence of associated endometrial cancer.
* Cases with simple hyperplasia without atypia.
* Patients failed to collect at least 2 endometrial samples during treatment course.
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides

Clinical Phase I/II study to investigate the feasibility and tolerability of synthetic adjuvant peptide immunisation in combination with immune adjuvants (granulocyte macrophage colony stimulating factor; Montanide ISA-51) in patients with advanced renal cell cancer (RCC).


Eligibility Criteria:
Inclusion Criteria:

* Advanced renal cell carcinoma clinical stage T3 or T4, N0, M0
* N+, M0
* M1 (after complete metastasectomy)
* ECOG performance status 0 or 1
* age \>18 years
* at least 4 weeks since last administration of radiation- or chemotherapy
* Serum levels of bilirubin \<2 mg/dl, creatinine\<2mg/dl

Exclusion Criteria:

* detectable distant metastasis in radiological imaging (M1)
* patients unable to consent
* severe cardiopulmonary disorder (NYHA \>= 3)
* presence of secondary malignancy
* Immunosuppressive medication (last application of glucocorticoids \> 4 weeks)
* seizure
* pregnancy
* simultaneous participation in other active or passive immunisation treatment
Activity and Fatigue of the Respiratory Muscles and Pulmonary Characteristics in Post-Polio Patients

Background: Early diagnosis of respiratory impairment in Post-Polio (PPS) patients may delay respiratory decline and future need of invasive respiratory aids.

Objectives: To compare pulmonary function measures, maximal respiratory pressure and activity levels and fatigue of respiratory muscles between patients with PPS and healthy controls.

Design: Cross-sectional study. Setting: Hadassah physical medicine and rehabilitation department, Jerusalem. Patients: Patients with PPS (N=12; 6 males; age 62.1±11.6 years) able to walk for 6 minutes without human assistance; age-matched healthy subjects (N=12; 4 males; age 62.2±6.5 years).

Intervention: None. Measurements: A body plethysmograph was used to quantify forced expiratory volume in the first second of a forced expiratory maneuver, vital capacity, slow vital capacity, Residual Volume (RV), Total Lung Capacity (TLC), and Thoracic Gas Volume (TGV). Also, RV to TLC ratio is calculated. A manometer was used to measure Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP). A spirometer was used to measure Maximal Voluntary Ventilation (MVV). Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing MVV.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with post-polio syndrome
* Able to walk for 6 minutes, with or without walking aids and orthotics but without human assistance

Exclusion Criteria:

* Any neurological or orthopedic condition, unrelated to post-polio syndrome
Follow up and Observation of Charcot Marie Tooth Disease in Families

The study is aimed to test the hypothesis that there is anticipation in CMT


Eligibility Criteria:
Inclusion Criteria:Patients with Genetically confirmed CMT 1a disease -

Exclusion Criteria:

-
The Effect of Vitamin D Supplementation on Glucose Metabolism in Non-Diabetic African American Adults

Type 2 diabetes is more common among African Americans than Caucasians. African Americans are also at a higher risk for lower levels of vitamin D compared to other ethnic groups. The investigators don't yet know if there is a connection between not having enough vitamin D and type 2 diabetes in African Americans. Researchers have found that the less vitamin D Caucasians had the higher the chance they would have type 2 diabetes but it is less clear if this is the case for African Americans. The investigators want to better understand how vitamin D status and diabetes risk are linked in African Americans. Also, the investigators want to see if supplementation with vitamin D will improve your blood pressure, blood sugar, \& insulin. All of these are in some way related to diabetes. The investigators want to measure changes in blood sugar \& blood pressure in people who do not have diabetes with the hope of learning new information to help treat those that do have diabetes.

The investigators hypothesize that vitamin D status is related to diabetes risk measured by hemoglobin A1c (a test of glucose level over time), fasting glucose and insulin in non-diabetic African American adults and that body weight status may affect vitamin D status in response to vitamin D supplements compared to placebo.

Participants will be randomly assigned to receive either a 60,000 IU vitamin D3 supplement every four weeks or an inactive placebo. All investigators and the participants will be blinded to the assignment group of each participant until all testing is completed.

Eligibility Criteria:
Inclusion Criteria:

* African American by self-report
* In good health

Exclusion Criteria:

* Diagnosis of diabetes
* Health problems/medication affecting calcium and/or vitamin D metabolism
* Current use of vitamin/mineral/herbal/nutritional supplements
* Inability to swallow pills
* Pregnancy