cyrilzakka/clinical-trials huggingface dataset:
Factors Affecting Weight Gain in Women Receiving Adjuvant Chemotherapy for Breast Cancer

RATIONALE: Chemotherapy may affect various factors that can lead to weight gain.

PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.

OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include: Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin, insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or expenditure (oral intake, physical activity, and resting metabolic rate) Psychological factors (depression and quality of life) II. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.

III. Assess the impact of chemotherapy on bone marrow density in these patients.

PROTOCOL OUTLINE:

Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits): (i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during these visits include evaluation of blood for hormones, growth factors, and leptin; body composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan; and evaluation of resting metabolic rate and daily energy expenditure by a single administration of doubly labeled water at visits "a" and "b" during data collection timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer, dietary intake, physical activity, depression, and quality of life are also administered at the three timepoints.

PROJECTED ACCRUAL:

A total of 140 patients will be accrued for this study within 1-2 years.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven newly diagnosed stage I, II, or resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines alone No concurrent participation in dietary and/or exercise weight loss programs --Patient Characteristics-- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No physical or mental disability that would preclude completing questionnaires No prior or concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism
Effects of Lee Silverman Voice Treatment BIG on Dynamic Balance in Parkinson's Patients

To determine the effects of Lee Silverman Voice Treatment BIG on dynamic balance in Parkinson's patients

This study will be conducted to compare the effects of Lee Silverman Voice Treatment BIG and conventional physiotherapy on dynamic balance in patients of PD. Patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation center, National Hospital Lahore. Dynamic gait index will be used as data collection tool to test dynamic balance of patients. Patients will be allocated to intervention groups by randomization. After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.

Eligibility Criteria:
Inclusion Criteria:

* Stage I, II, III Parkinson's patients on Hoehn \&;Yahr classification
* Able to walk without assistive devices
* Stable medication 4 weeks prior to and during study

Exclusion Criteria:

* Patients with depression or dementia
* Disabling bradykinesia to make sure patients are efficient to engage and cooperate in conventional physical therapy
Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis

To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
2. Patient capable of complying with study requirements
3. Signed informed consent by patient

Exclusion Criteria:

1. Scheuermann's disease
2. Infection or malignancy
3. Primary abnormalities of bones (e.g. osteogenesis imperfecta)
4. Primary muscle diseases, such as muscular dystrophy
5. Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
6. Spinal cord abnormalities with any neurologic symptoms or signs
7. Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
8. Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
9. Patients requiring anterior release or instrumentation
10. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
11. Pregnancy
12. Patient cannot follow study protocol, for any reason
13. Patient cannot or will not sign informed consent
Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit

Exclusion Criteria:

* Patients on a ketogenic diet
* Seizures too close together to accurately count
* Pseudoseizures
* Status epilepticus 1 month prior Visit 1
* Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.
Clinical Trial of a New Device for Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

Compartment syndrome remains a very serious complication of lower extremity trauma and/or procedural cases that involved lower or upper extremity surgery. This condition results in muscle death, chronic pain, infection, and possible amputation. Early diagnosis is essential to institute interventions to avoid complications. Unfortunately, the subjective pain of the patient remains the mainstay for diagnosis. A method or device is needed that would improve the investigator's ability to diagnose this potentially devastating condition. The purpose of this trial is to evaluate the safety and functionality of MY01, an investigational device that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. This is a single centre, non-randomized, non-controlled, unblinded, prospective trial of the MY01 device. A cohort of 25 participants will be prospectively enrolled to document the performance of the device.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 16-65.
* Fracture of the tibia, foot, forearm, femur, or humerus that is felt by the surgeon to have a reasonable indication that elevated intracompartmental pressure could occur in the patient.
* Planned admission to hospital (to enable monitoring of compartment pressures)
* Provision of informed consent to participate.

Exclusion Criteria:

* Frankly contaminated or infected wounds or fractures.
* Clinical suspicion of acute compartment syndrome requiring urgent fasciotomy at time of presentation to study center.
* Current or pre-existing neuropathy in the study limb.
* Pregnant women.
Effects of Acupuncture on Ovarian Function and Pregnancy Outcomes in Women With Decreased Ovarian Reserve

The randomized, placebo-controlled multicenter trial is conducted in three centers in China. After screening and obtaining the signed informed consent, the participants are randomly divided into two groups: acupuncture group and sham acupuncture group.


Eligibility Criteria:
Inclusion Criteria:

1. Infertile women older than 18 years and younger than 40 years to undergo fresh IVF or self-pregnant;
2. AMH\<1.1 ng/ml；
3. total AFC\< 7；
4. 10 U/L\<FSH\< 25IU/L,或FSH/LH\>2.6；
5. had a history of low ovarian response once, and the number of eggs obtained in IVF was less than 3 （at least two of the 2）3）4）5 ）items are required）；
6. Willing to accept randomized grouping, treatment arrangement and follow-up, and signing informed consent.

Exclusion Criteria:

Patients who met any of the following conditions were not included:

1. Severe abnormality of uterine cavity caused by adenomyosis, uterine fibroids, endometrial polyps, tuberculosis of the reproductive system, endometritis, abnormal endometrial thickness (HCG day of the previous IVF cycle is less than 7mm or greater than 14mm);
2. Patients with other endocrine diseases, such as thyroid disease, hyperprolactinemia, insulin resistance, diabetes, adrenal disease, etc., and poor control of hormone levels in the last 3 months;
3. Clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome, etc.;
4. Untreated hydrosalpinx;
5. Body mass index (BMI) higher than 28 kg/m;
6. The male or female chromosome abnormality;
7. People with previous history of acupuncture sickness;
8. Those who have previously participated in the study or are currently receiving acupuncture treatment.
Burn-out Among Chinese Anaesthesiologist After COVID-19 Pandemic Peak and Its Protective Factor： a National Survey

The investigators proposed a national representative survey to collect data of socio-demographic characteristics, level of exposure to COVID-19, depression，anxiety， ptsd， burnout and resilience of working anaesthesiologists across mainland China for the following purpose

1. Explore the current burn-out rate of Chinese anaesthesiologists and compared it with data acquired in 2015；
2. Explore the perceived covid-19 exposure of COVID-19 among Chinese anaesthesiologist.
3. Explore rate of burnout, anxiety, depression, PTSD symptoms experienced by the participants
4. Explore the protective psychosocial characteristics of burnout. (resilience)
5. See whether covid-19 exposure contribute to higher burn out rate.


Eligibility Criteria:
Inclusion Criteria:

working anaesthesiologist in mainland China

Exclusion Criteria:

-
Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether giving chemotherapy in addition to standard therapy is a more effective treatment for lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard therapy given with or without combination chemotherapy in treating patients with non-small cell lung cancer.

OBJECTIVES: I. Assess whether the addition of cisplatin-based chemotherapy to standard treatment improves survival in patients with non-small cell lung cancer.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo primary surgery, radical radiotherapy, radiotherapy with surgery, or best supportive care. Arm II: Patients undergo treatment as in arm I. Beginning within 10 weeks after surgery or radical radiotherapy or as soon as possible after diagnosis, patients receive 1 of the following regimens: Regimen A: Patients receive cisplatin IV on day 1 followed by vindesine on days 1 and 8. Regimen B: Patients receive mitomycin, ifosfamide, and cisplatin on day 1. Regimen C: Patients receive mitomycin, vinblastine, and cisplatin on day 1. Regimen D: Patients receive vinorelbine on days 1 and 8 and cisplatin on day 1. Treatment in all 4 regimens repeats every 3 weeks for 3 courses. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,800 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer being treated with primary surgery, radical radiotherapy, surgery plus radiotherapy, or best supportive care

PATIENT CHARACTERISTICS: Age: Adult Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No inadequate renal function Other: No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer Must be fit enough to receive therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radical radiotherapy allowed Surgery: See Disease Characteristics Prior surgery allowed
Evaluation of the Ability of Newly Developed Adhesives to Absorb Moisture

The aim of this evaluation is to investigate the ability of newly developed adhesive patches to absorb moisture.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have intact skin on the area used in the evaluation
4. Have an abdominal area accessible for application of test product (assessed by investigator)
5. Negative pregnancy test for fertile women
6. Signed document claiming use of safe contraceptives for fertile women

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemo-therapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigator)
5. Participating in interventional clinical investigations or have previously participated in this evaluation. Exception: Participation in other Coloplast sponsored clinical investigations or evaluations is accepted under the circumstances that the subject has paused the activities in the investigation/evaluation and are otherwise complying with the inclusion and exclusion criteria of this (CP284) Evaluation
Effect of Age on Treatment Decision-Making in Elderly Patients With Acute Myeloid Leukemia

Patients aged ≥70 years with acute myeloid leukemia (AML) have a poorer prognosis than those aged 60 to 69 years. The poor outcome is the result of treatment-related toxicity in elderly patients, owing to comorbidities, the greater possibility of other hematopoietic disorders, and a biologically poor risk prognosis. Anthracycline- and cytarabine-based therapy, administered for 3 and 7 days respectively (3 +7), remains the standard induction therapy for this patient population. This approach improved survival compared with supportive care (median, 5 vs. 3 months) for adults aged ≥ 65 years. However, the overall view has been that the results of intensive chemotherapy in elderly patients remain poor. Although complete remission (CR) rates of 40% to 80% can be achieved in highly selected populations, long-term survival has been poor. Furthermore, most clinical trials have only enrolled patients with an adequate performance status (PS).

Prognostic models have been developed from clinical trial data to predict the outcomes for older patients. However; each model relies on chronologic age. Age is a surrogate measure for both changes in tumor biology and patient characteristics. Understanding which patients are likely to benefit from intensive therapies versus low-intensity therapies or supportive care is critical. The definition of "fit" to undergo intensive induction therapy has not been established, and the therapeutic choice is mainly determined by physician and patient decision. In older patients, low-dose cytarabine (LD-AraC) has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that could have an improved side effect profile and, in some cases, bioavailability might offer future improvement for this patient population. In this setting, the investigators have tended to consider, since 2007, patients aged ≥70 years as potential candidates for alternative lower intensity therapy (LD-AraC, hypomethylating agents) even when they presented in good physical condition.

The investigators goal was to determine whether age ≥ 70 years could represent a useful and simple cut off for treatment decision-making in clinical practice and whether low-intensity therapy could be an alternative therapeutic approach to intensive chemotherapy even for patients aged ≥ 70 years who were theoretically "fit" (WHO /ECOG/ PS of ≤ 2).


Eligibility Criteria:
Inclusion Criteria:

* Are at least 70 years of age
* Have a diagnosis of AML according to World Health Organization (WHO) classification
* Provide signed, written informed consent

Exclusion Criteria:

* Patients with acute promyelocytic leukemia
* Have an ECOG score ≥2
Phase II Trial of Thalidomide Combined With Concurrent Chemoradiotherapy in Esophageal Cancer

The purpose of this study is to down-regulate VEGF expression in esophageal cancer patients by thalidomide, so to improve their chemoradiotherapy effect. Patients with esophageal cancer receiving chemoradiotherapy were divided into different sub-group according to dynamic change of their VEGF level,and those showed increased or unchanged VEGF were added thalidomide at random. Efficacy and side effect of thalidomide combined with chemoradiotherapy were evaluated, and at the same time, activity of thalidomide on esophageal cancer and its clinical safely were assessed.

Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-72Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.

Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 25 mg/m2/d, d1-4; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.

Administration of thalidomide: Determine serum VEGF level of the esophageal cancer patients 3-4 weeks after the beginning of radiotherapy, those whose VEGF level, compared with that before radiotherapy, increased or unchanged will be divided into two groups: one is given thalidomide concurrent with the following chemoradiotherapy, 100mg/d at bedtime for the initial week, and if no moderate above side effect occurred 200mg/d from the next week till the end of chemoradiotherapy; the other received concurrent chemoradiotherapy only.

VEGF determination: Peripheral venous blood samples will be taken in one week before, 3-4 weeks during, and in one week after radiotherapy respectively. The serum VEGF will be determined by the double antibody sandwich ELISA.

Eligibility Criteria:
Inclusion Criteria:

* cytologically or histologically confirmed esophageal carcinoma
* age of 20 -80
* Karnofsky performance status ≥ 70
* no treatments prior to enrollment
* at least one measurable lesion on CT, MRI or esophageal barium exam
* normal functions of heart, lung, liver, kidney and bone marrow
* blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
* informed consent signed

Exclusion Criteria:

* prior treatments of chemotherapy or irradiation
* poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable
* contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis
* participating in other clinical trials
* pregnancy, breast feeding, or not adopting birth control
* drug or alcohol addiction, uncontrolled epileptic seizure, or psychotic with no ability of self control
* coexisted morbidities that investigators believed not suitable for chemoradiation
Knowledge and Attitude of Dialysis Center Medical Staff Towards Living Kidney Donation

The goal of this cross-sectional study is to learn about the level of knowledge and attitudes of medical staff working in dialysis centers about living kidney donations. The main questions it aims to answer are:

* What is the level of knowledge of dialysis center medical staff regarding living kidney transplantations?
* How much time does the staff have for educating the patients about living kidney donations? Participants will be asked to answer a self-report questionnaire along with two standardized tools.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary consent to participate in the study.
* Communicative knowledge of the Polish language.
* Each potential participant will receive comprehensive information about the purpose and course of the study before participating in the study and will consent to the study.
* Dialysis station employee: doctor, nurse.

Exclusion Criteria:

* no consent
* no communicative knowledge of the Polish language
* not working in dialysis center currently
Intra-individual Reproducibility in Nerve Block Duration

An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.

An interventional randomized controlled crossover trial, with the purpose to elucidate the reproducibility in nerve block duration on 20 healthy volunteers in Denmark.

There will be two trial arms:

1: Day one; Right side low dose nerve block and left side high dose nerve block. Repeated after 24 hours. Day three; Left side low dose nerve block and right side high dose nerve block. Repeated after 24 hours

2: Day one; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours

All volunteers will receive two peripheral nerve blocking catheters adjacent to the common peroneal nerve and will be treated two times on each side with Lidocaine 0.5% 5 mL and 10 mL.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years
2. ASA classification ≤ II

Exclusion Criteria:

1. Allergy to local anaesthetics
2. Body weight 40 kg
3. Possible peripheral nerve injury or disease, including polyneuropathy and diabetes
4. Enrolment or recent participation in studies that may interfere with this study
5. Habitual use of any kind of analgesic medications
6. Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion.
7. Pregnancy or breastfeeding