cyrilzakka/clinical-trials huggingface dataset:
Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis

The primary aim of our study is to evaluate the presence of stress urinary incontinence in postmenopausal patients with and without osteoporosis, determine its impact on quality of life, and explore its relationship with sarcopenia.

One hundred postmenopausal women, aged 50-75, who applied to the Physical Therapy and Rehabilitation outpatient clinic at Beylikdüzü State Hospital and have Dual-X-ray Absorptiometry (DXA) measurements taken within the last 6 months, including both osteoporotic and non-osteoporotic patients, will be included in the study. Sociodemographic data such as age, gender, height, weight, and BMI will be recorded. DXA results, including femoral neck and L1-L4 T-scores and BMD values, will be obtained. Patients will be asked about osteoporosis treatment, presence of fecal incontinence, constipation, and medication use. Stress urinary incontinence will be determined through a questionnaire, and its impact on quality of life will be assessed using the Incontinence Quality of Life Scale. In the second phase, sarcopenia will be evaluated according to the Asian Working Group for Sarcopenia (AWGS) criteria by assessing skeletal muscle mass (via bioelectrical impedance analysis), handgrip strength, and the 5-times sit-to-stand test.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with DXA measurements performed within the last 6 months.
* Based on DXA measurements:

Femoral neck and L1-L4 T-scores of -1 and above will be included in the control group (non-osteoporotic).

Femoral neck and L1-L4 T-scores of -2.5 and below will be included in the osteoporosis group.

* Aged 50-75 years

Exclusion Criteria:

* Refusal to participate in the study.
* History of neurological diseases, infections, surgeries, or trauma that could cause urinary incontinence or muscle loss.
* Presence of psychiatric disorders.
* Cognitive impairments.
* Use of medications that could affect the study results.
Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients with peripheral neuroectodermal tumors, Ewing's sarcoma, Wilms' tumor, or bone cancer.

OBJECTIVES: I. Determine the response rate and event-free survival of patients with peripheral primitive neuroectodermal tumors or Ewing's sarcoma treated with cyclophosphamide, doxorubicin, vincristine, etoposide, and ifosfamide, followed by surgery (if feasible) and radiotherapy. II. Determine the response to a uniform treatment regimen in order to clarify whether these disease categories each have a different prognosis.

OUTLINE: Patients are stratified according to disease category (primitive neuroectodermal tumor vs Ewing's sarcoma). Patients receive treatment on regimen A as outlined below during courses 1-3 and 6 and regimen B as outlined below during courses 4, 5, and 7 in the absence of disease progression or unacceptable toxicity. Each course lasts 3-4 weeks. Patients without metastatic disease after completion of course 3 undergo complete tumor resection, if feasible. Patients achieving complete response with or without microscopic residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3 weeks. Patients with gross residual disease after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3.6 weeks. Regimens A and B are defined below: Regimen A: Patients receive cyclophosphamide IV over 6 hours on days 1 and 2, doxorubicin IV continuously and vincristine IV continuously on days 1-3, and vincristine IV on day 9. Regimen B: Patients receive etoposide IV over 1 hour, followed immediately by ifosfamide IV over 1 hour on days 1-5. Patients are followed monthly for 18 months and then every 6 months for 18 months.

PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study within 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor, including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron microscopy, and/or chromosomal analysis may be required to rule out other small round cell neoplasms

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Not specified
Accelerated Partial Breast Irradiation Versus Standard or Hypofractionated Whole-Breast Irradiation, in Early Breast Cancer, After Breast-conserving Surgery

Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.

There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.

The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.

Eligibility Criteria:
Inclusion Criteria:

* Information to the patient and signed informed consent;
* Women aged ≥50 years
* Breast conserving surgery
* Pathologic tumor size \< 3 cm (maximum microscopic diameter of the invasive component)
* Invasive adenocarcinoma (except classic invasive lobular carcinoma)
* Unifocal disease
* Histopathologic grades I or II
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Lymphovascular invasion absent
* Negative axillary lymph nodes
* Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
* No prior breast or mediastinal radiotherapy
* No hematogenous metastases

Exclusion Criteria:

* Previous malignancy (except non-melanomatous skin cancer)
* Mastectomy
* Classical-Type Invasive Lobular Carcinoma
* Neoadjuvant chemotherapy
* Human Epidermal growth factor Receptor-type 2 positive (HER2+)
* Triple-negative breast cancers
* Intravascular lymphoma present
* Contraindications to radiotherapy.
* No geographical, social or psychologic reasons that would prevent study follow
Smoking Cessation Intervention After Stroke or Transient Ischaemic Attack.

Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Patients with stroke or transient ischemic attach should receive advise on smoking cessation. It is however unknown if an intensive smoking cessation program is better than ordinary advise on smoking cessation during hospitalisation for stroke or transient ischemic attack.

The aim of the study was to assess if an intensive smoking cessation program made more patients stop smoking after stroke or transient ischemic attack.

Patients with stroke or transient ischemic attack are admitted to the department of neurology at Odense University hospital. Patient who are smokers on admission and age \< 76 years, inhabitants in Funen County and with symptoms developed before admission will be offered participation in the study unless they have severe stroke, stroke more than 3 weeks before admission, other severe disease or unable to participate.

Study participants will be randomised to either usual short advise on smoking cessation or an intensive smoking cessation program. All participants will be followed-up for 6 months with regard to smoking habits.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 76 years
* Inhabitant in Funen County
* Acute stroke or transient ischemic attack
* Symptoms with onset before admission
* Current smoker on admission

Exclusion Criteria:

* Severe stroke
* Current stroke onset more than 3 weeks before admission
* Other severe disease
* Unable to participate
Evaluation of an Universal Surgical Device for Mandibular Reconstruction.

Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity.

Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide.

The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.


Eligibility Criteria:
Inclusion Criteria:

* Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment
* Patients insured under the French social security system
* Free and informed consent

Exclusion Criteria:

* Lateral mandibular reconstruction without symphysis reconstruction
* Legally incompetent
* Inclusion in another protocol of research , involving mandibular reconstruction
* Pregnant or breastfeeding women
NIV for Hypercapnic Respiratory Failure: AVAPS vs S/T BIPAP

The goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. The investigators will compare AVAPS and BIPAP S/T and hypothesize that AVAPS will result in a decreased length of stay in the ICU or on telemetry. Currently, noninvasive ventilation is the standard of care for hypercapnic respiratory failure. However, the most effective mode for patients with hypercapnic respiratory failure is unclear.

1. Overall Study Design and Plan

This is a single center, randomized trial that will include a total of 100 adult subjects aged 18 or older with hypercapnic respiratory failure of all etiologies (i.e. "all comers"). The investigators will randomize patients in a single-blinded (patient blinded) fashion to BIPAP S/T or AVAPS during the duration of their hospitalization. The investigators will assess ABG at baseline, 1 hour after initial placement on BIPAP S/T or AVAPS, and between hours 24-48 of use. The investigators will record the pre-NIV pH and PaCO2, post-NIV pH and PaCO2, length of hospital stay in the medical ICU or telemetry unit, days on NIV, need for intubation (if occurred), transition to medical ICU care in patients who were initially admitted to telemetry, and in-hospital mortality. All collected laboratory data are already done as part of usual care for all patients placed on NIV when a patient is on the telemetry unit or medical ICU. The groups will undergo stratified randomization based on whether they are initially admitted to medical ICU or medical telemetry. Patients from medical ICU or telemetry units will be randomized to one of the following arms:

Arm 1: AVAPS mode Arm 2 2: BIPAP S/T mode

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form directly by the patient; consent can also be obtained via a legal patient representative/health care proxy/surrogate
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or older
4. Diagnosed with hypercapnic respiratory failure on admission (ABG)
5. Admitted to Lenox Hill Hospital medical intensive care unit or telemetry unit
6. Requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure

Exclusion Criteria:

1. Patients who require ventilation at predetermined tidal volumes
2. Patients who require rapid and frequent IPAP adjustments to maintain a consistent tidal volume
3. Age less than 18 years of age
4. Currently intubated
5. Chronic tracheostomy
6. Pregnancy
7. Hypotension
8. Epistaxis (nosebleed)
9. Untreated pertussis
10. Acute sinusitis or Otitis media
11. Patients at risk of aspirating gastric contents
12. Patients with lack of spontaneous respiratory drive
13. Patients with the inability to maintain a patent airway or adequately clear secretions
14. Prisoners or other institutionalized individuals
Racial Differences: Nitric Oxide(NO) and Endothelin-1(ET-1) in Preeclampsia (PreE)

The goal of this study is to examine the activation of markers of endothelial and cardiovascular dysfunctions, from women with high-risk pregnancies. Information from this study will hopefully provide enough information to determine a link between race, the advent of high risk pregnancies and cardiovascular markers. With this information it might be possible to intervene with approved pharmacological treatments.


Eligibility Criteria:
Inclusion Criteria:

* African-american or Caucasian
* Pregnant
* Between ages of 18 - 40 years of age

Exclusion Criteria:

* Presence of a disease or condition which is not preeclampsia
* Drug or alcohol abuse during pregnancy
* Obesity
Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer

The purposes of this study are :

* to investigate the safety and clinical efficacy of sole therapy with DLBS1425 in suppressing disease-(tumour) progression in subjects with advanced/metastatic breast cancer; and
* to determine the minimal effective and safe dose of DLBS1425 in the therapy of advanced/metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with Stage IIIB or IV breast cancer who have failed with or refuse to receive standard chemotherapies
* Subjects with the expression of ER/PR negative; or positive ER/PR expression but have failed with or refuse to receive hormonal therapy
* Either + or - expression of HER-2/neu gene
* ECOG status = 0-2
* At least have 1 evaluable and measurable metastatic lesion as defined by RECIST criteria
* Adequate haematological, liver, and renal function
* At least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy
* At least 4 weeks has elapsed since surgical biopsy / major surgery

Exclusion Criteria:

* Allergic to the trial product
* Any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation
* Concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease
Optimal Bupivacaine Dose for Initiation of Labor Epidural Techniques

To estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor.

The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required to achieve initial effective comfort in 90% of patients (ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; we hypothesize that we will be able to determine the ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses.

Eligibility Criteria:
Inclusion Criteria:

1. Parturient with no major co-morbidities
2. Singleton, vertex gestation at term (37-42 weeks)
3. Less than or equal to 5 cm dilation
4. Desire to receive epidural labor analgesia
5. Numerical Rating Scale greater or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.

Exclusion Criteria:

1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
2. Any contraindication to the administration of an epidural technique
3. History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. history of uterine rupture). NB: Exception-trial of labor after cesarean delivery (TOLAC) will be eligible.
5. Evidence of anticipated fetal anomalies
Prospective Bone Marrow Biopsy Safety and Efficacy Study

Bone marrow biopsy is a frequently performed procedure to diagnose and evaluate hematologic diseases. It is estimated that over 700,000 bone marrow procedures (BMP's) are performed annually in the U.S. Most of them are performed by practicing hematologists/oncologists in their offices or hospitals. However, a significant number are performed by hematologists-in-training (H-I-T's) in teaching hospitals. However, the incidences of complications associated with bone marrow biopsy are largely unknown. This study has two goals:

1. The first goal is to objectively determine by CT and clinical assessment, the actual risk to patients of the bone marrow biopsy and the rate of pelvic injury in an unselected group of hematology patients requiring a bone marrow biopsy, as performed by hematologist-in-training.
2. The second goal is to determine the quality of bone marrow biopsies obtained, using the lateral angulation technique.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have a hematological or oncological condition which requires a bone marrow aspiration and biopsy procedure, and no alternative procedures are available for diagnosis, staging, monitoring or follow up of their disease.
2. Subjects must be able to understand the risks/benefits and provide written informed consent to participate in the study, and be willing to participate in all required study activities for the duration of the study.
3. Subjects must be 40 years of age or older.

Exclusion Criteria:

1. Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
2. Psychiatric or cognitive illness or recreational drug/alcohol abuse that, in the opinion of the investigator would effect subject safety and/or compliance.
3. Patients with uncontrolled bleeding disorders.
4. Pregnant and lactating females (due to radiation exposure during the CT scans).
Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study

This study examines the effect of a five-year multifactorial lifestyle intervention in the Oslo diet and antismoking study on long-term cancer risk. In 1972-1973, 1232 men with high cardiovascular risk profile were randomised to intervention including cholesterol lowering diet, weight loss and antismoking advice, or control (1:1). This study examines the effect of the intervention on 43-year cancer incidence and mortality.

The Oslo diet and antismoking study showed that a 5-year lifestyle intervention reduced the long-term risk of coronary events and mortality. The lifestyle risk factors for cancer are partly similar to those for coronary heart disease, e.g. smoking, high body weight, unfavourable diet. The investigators therefore expect that the intervention has an effect on cancer risk in the long term.

In this follow-up study, the investigators analyse the association between the intervention, and cancer incidence and mortality drawn from the Cancer Registry of Norway and the Norwegian Cause of Death Registry from the time of randomisation in 1972/3 until the end of 2015.

Eligibility Criteria:
Inclusion Criteria:

* participated in screening of coronary risk factors, into which all men born in 1923-1932 and living in Oslo were invited in 1972-1973
* being in the upper quartile of a coronary risk score based on blood pressure, serum total cholesterol concentration and cigarette smoking

Exclusion Criteria:

* serum total cholesterol level above 9.0 mmol per Liter
* having a healthy diet, based on a short dietary history
* self-reported cardiovascular disease or diabetes
* previous history of cancer
Prediction and Close Monitoring of Postoperative Recurrence by Intestinal Ultrasound After Ileocecal Resection in Crohn's Disease Patients

Crohn's disease (CD) is an inflammatory bowel disease causing chronic transmural inflammation followed by intestinal complications including strictures and penetrating lesions such as fistulas and abscesses. 30-50% of the CD patients will require surgery during the course of their disease. Unfortunately, resection is not curative and endoscopically recurrent lesions (i.e. endoscopic recurrence) are observed in 65-90% of patients within 12 months, and in 80-100% within 3 years after the operation. Eventually 15-20% of patients will require new surgery within 5 years. Close monitoring for postoperative recurrence is therefore needed to perform early intervention and prevent clinical recurrence and need for re-surgery. Endoscopy is the gold standard to assess postoperative disease recurrence however it's limited by its invasiveness. Cross sectional imaging is known for accurate detection of postoperative recurrence. Intestinal ultrasound (IUS) of the colon and (neo)terminal ileum correlates well with CT, MRE and colonoscopy findings in the postoperative setting. IUS is non-invasive, cheap, readily available and may show early, signs of disease recurrence. Therefore it could be a useful tool to predict endoscopic recurrence at 6 months.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Crohn's disease
* undergoing ICR (or re-resection)
* ≥16 years of age

Exclusion Criteria:

* \<16 years of age
* Inability to give informed consent
* Ongoing gastroenteritis
* Deviating stoma
* (Sub)total colectomy
* Obesity (BMI \>35 kg/m²)
* Insufficient visualization of the anastomosis AND the neo-terminal ileum at baseline IUS