cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder

Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together.

Pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women.

Surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies.

This may be because of higher awareness among women and cost of and morbidity after surgery.

The conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback.

The outcome was up to 35\~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies.

Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.).

At the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

* Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device
Effects of Pilates Training on Physical Performance of Cricketers

This study is designed to evaluate the effectiveness of Pilates training improves physical fitness of cricket players.

During the modern times, researchers have notably increased their knowledge, grounded on literature, with regards to the relationship between core stability and athletic performance. Number of research studies have also been completed that underline the benefits of core stability training on injury prevention or performance, but in combination with other training modalities such as speed, power, strength and agility. Although several studies have investigated core stability benefits in athletes but there are very limited studies have presented the role of Pilate training in increasing the core strength and stability of cricket players in order to maximize their performance in the game. This study will contribute in describing the effects of Pilate training in cricket players.

Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study. Active Male cricketers. Had practiced for at least 2 years Age group of 19-30 Players with normal BMI (ranging in between 18.5 to 24.9)

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study. History of metabolic diseases.

History of recent fractures. Players taking substance inhibited (in and out of the competition) by WADA Had extreme discomfort on contracting the abdominal muscles.

Were spin bowlers.
Effect of Ruxolitinib on Tumor Infiltrating Myeloid Cells

Ruxolitinib will be dispensed to patients candidate to prostatectomy immediately after histological diagnosis of prostate adenocarcinoma. The treatment will be given for 28 days followed by a prostatectomy thereafter.

Tumor material and blood samples will be analysed before, during and after the treatment with Ruxolitinib.

Patients with suspected localized prostate cancer will undergo biopsies spotting different prostate sites, as per standard clinical practice. Patients with histologically confirmed prostate adenocarcinoma and candidate for prostatectomy, after signing the Informed Consent Form, will receive Ruxolitinib for 4 weeks (the time normally elapsing between histological diagnosis and surgery) and will thereafter undergo prostatectomy.

Remaining biological material from the diagnosis and the prostatectomy will be sent to the Molecular Oncology Laboratory for molecular analysis.

In addition, blood samples will be drawn before, during Ruxolitinib treatment (Week 2), at the end of treatment (Week 4), and after prostatectomy (Week 5), to assess the frequency and subtype of immune subsets and the circulating levels of cytokines and secreted.

Patients will be monitored for occurrence of adverse events/surgical complications during treatment and up to 4 weeks after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years
* Histological diagnosis of prostate adenocarcinoma
* Stage ≥T2b for which surgery is indicated
* No distant metastasis (M0)
* NLR ≥3 in the blood or NLR ≥3 in the tumor biopsies or a percentage of MDSCs ≥ 30% in the tumour biopsies
* PS (ECOG scale) 0-1
* Adequate hepatic function: ALT and ASAT ≤ 2.5 x ULN, Bilirubin ≤ 1.5 ULN (exception if Gilbert's syndrome ≤ 2.5 x ULN)
* Adequate renal function: calculated creatinine clearance ≥ 50 ml/min according to the formula of Cockcroft-Gault
* Hemoglobin ≥ 10 g/dl, leukocyte count ≥ 4.0 x 103/µl, platelet count ≥ 200 x 103/µl
* Informed Consent as documented by the patient's signature

Exclusion Criteria:

* No history of coagulation disorders and normal INR
* Significant cardiovascular disorders in the last 12 months
* Other clinically significant concomitant disease states which in the opinion of the Investigator may represent contraindications to study participation
* Known or suspected non-compliance
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Ongoing treatment with strong CYP3A4 inhibitors or dual CYP2C9 and CYP3A4 inhibitors
Matched Unrelated Donor Transplant for Metastatic Renal Cell Carcinoma

The purpose of this study is to find out what effects (good and bad) a stem cell transplant from an unrelated donor will have for patients with kidney cancer that has spread to other parts of the body (metastasized).

Standard treatment for kidney cancer that has spread to other parts of the body may include immunotherapy (a therapy that uses the body's natural immune system to fight cancer) and cytokines (proteins found in the body). If these treatments are not successful at controlling the cancer then chemotherapy or thalidomide are used. Chemotherapy and thalidomide will not cure kidney cancer but they may control the disease in some patients.

In some patients, transplants are now proposed for study. Stem cells (from bone marrow or the bloodstream) are normally used to treat cancers of the blood, not kidney cancer. Since researchers are still learning about using stem cell transplants for kidney cancer, the study is considered a research study. Patients participating in this study will receive smaller doses of chemotherapy drugs to prepare them for the transplant than patients who have a standard transplant. This type of transplant is called a "reduced intensity" transplant. A reduced intensity transplant uses the cell-killing activity of the transplanted donor stem cells to attack the recipient's cancer cells. This is called graft-versus-tumor-effect (GVT). Previous studies have shown that GVT may be greater if the donor is not related to the recipient.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic (stage IV) renal cell carcinoma (RCC) predominately clear cell type
* Prior nephrectomy
* Available HLA-matched (8/8, 7/8) unrelated donor
* At least one prior immunotherapy; or immunotherapy + chemotherapy; or targeted therapy, for metastatic RCC.
* Adequate organ function

Exclusion Criteria:

* Prior allogeneic stem cell transplantation
* RCC with histology other than clear cell type
* History or presence of brain metastasis
Clinical Trial to Assess the Preventive Effects of Cetylpyridinium Chloride on Sarcopenia

This study is to assess the impact on the prevention of sarcopenia after taking cetylpyridinium chloride targeting the patients of pre-sarcopenia or sarcopenia over the age of 60

75 people that meet the inclusion criteria on screening test are assigned to one of three groups by randomization. They take the medication for four weeks under doubleblind. Two study groups take cetylpyridinium chloride of 1.5mg, 4.5mg daily for four weeks. Control group takes the placebo for the same period. The main outcome variables are measured and compared respectively in baseline, immediately after dosing end and two weeks, four weeks after the end of administration. Finally cetylpyridinium chloride is verified whether it has a preventive effect on sarcopenia and set an appropriate dose.

Eligibility Criteria:
Inclusion Criteria:

* Pre-sarcopenia A. Reduced skeletal muscle mass (appendicular skeletal muscle mass/height2) M \< 7.0kg/m2, F \< 5.7kg/m2

Exclusion Criteria:

* History of stroke or spinal cord injury
* Artificial joint
* Acute disease or unstable chronic disease
* Phenylketonuria
* History of myocardiac infarction
* Allergic contact dermatitis
* History of drug/alcohol addiction, habitual smoker
Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults

The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.


Eligibility Criteria:
Inclusion Criteria:

* male and female aged 18-75 years;
* BMI between 19 and 30 kg/m2,
* LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,
* stabilized hypercholesterolemia (since more than 3 months),
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
* used to consume dairy products,
* for female: effective contraceptive methods used,
* agreeing to a written informed consent

Exclusion Criteria:

* plasma triglycerides (TG) levels \> 350 mg/dL (4 mmol//L),
* any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,
* known allergy or hypersensitivity to milk proteins,
* systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,
* subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* diabetic subjects (type I and type II),
* any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
* for female subject: pregnancy, breast feeding or intention to become pregnant during the study,
* for female subject: subject likely to change her contraceptive method during the study,
* active heavy cigarette smokers (reported more than 20 cigarettes / day),
* subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study
Knack Technique in Post-menopausal Women With Stress Urinary Incontinence

To determine the Effects of pelvic floor muscle exercise with and without Knack Technique in post-menopausal women with stress urinary incontinence


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women
* Multiparous women
* Previous history of vaginal deliveries
* Women with mild to moderate stress or mixed incontinence (with predominance of SUI) via the 3 incontinence questions (3IQ)
* Able to have a gynecological examination

Exclusion Criteria:

* Symptoms of overactive bladder alone
* Previous participation in a pelvic floor re-education program and/or previous pelvic floor surgery or currently receiving other treatment for urinary incontinence.
* Loss of stools or mucus
* Active urinary or vaginal infection in the past 3 months
Comparison of Biomarkers Based on Fine-Needle Aspiration in Women at Increased or Normal Risk of Breast Cancer

RATIONALE: Examining biomarkers in fine-needle aspiration specimens from women at risk for breast cancer may improve the ability to detect breast cancer cells early and plan effective treatment.

PURPOSE: Screening trial to compare specific biomarkers based on fine-needle aspiration specimens from women at increased or normal risk of breast cancer.

OBJECTIVES:

* Compare specific biomarkers, including cellular morphology (cytology), proliferation index (Ki-67), p53 expression, and LOH in chromosome 9p at locus DS9157, in fine needle aspirate specimens from women at increased vs normal risk of breast cancer.
* Determine whether these specimens are adequate to perform the biomarker assays and whether this technique could be used in the general outpatient setting.
* Determine whether biomarker levels in these patients are concordant or discordant with individual clinical risk of breast cancer.
* Determine whether 1 or more biomarkers can distinguish high-risk from control patients.
* Correlate specific biomarkers and changes in biomarker levels with pathologic diagnosis from the breast biopsy.

OUTLINE: Patients undergo fine needle aspiration of normal appearing breast tissue prior to the beginning of elective surgery. Specimens are analyzed for the presence of specific biomarkers.

PROJECTED ACCRUAL: Approximately 156 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Increased risk of breast cancer as determined by 1 or more first-degree relatives (mother, sister, or daughter) with a history of breast cancer OR a personal history of atypical hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ of the breast OR
* No increased risk of breast cancer as determined by a lack of the above conditions
* Scheduled to undergo elective breast surgery for removal of a mammographic lesion or palpable breast lump
* No prior bilateral mastectomy or bilateral breast irradiation
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 30 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No active invasive malignancy in any site except basal cell or squamous cell skin cancer
* No significant medical or psychiatric problems that would preclude study
* No evidence of excessive use of narcotics or drug dependency

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
Naturalistic Study to Evaluate the Utilization of Care Services Associated to the Diagnostic Process of Any Kind of Epilepsy

Naturalistic, multicentre, epidemiological study to evaluate the care services used during the process of diagnosis of any kind of epilepsy. Data about services since first seizure until confirmed diagnosis will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes 16 years old or older, being diagnosed of any kind of EPILEPSY (criteria ILAE) and with diagnosis being confirmed by a Neurologist over the last 6 months and with write informed consent.

Exclusion Criteria:

* Patients with epilepsy diagnosis confirmed by a Neurologist over the last 6 months before the study or with incapacity to fulfill the requirements of the study.
Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment

The objective of this study is to demonstrate that there is a benefit in switching chronic schizophrenic patients from conventional antipsychotic to olanzapine in terms of efficacy, neurological safety and patient's outcome.


Eligibility Criteria:
Inclusion Criteria:

Schizophrenic patient meeting the DSM-IV diagnostic criteria more than one year ago and treated with antipsychotic for at least 1 year.

Outpatient (or patient admitted to hospital for social or logistic reasons).

Patient receiving a stable dose of the same conventional antipsychotic for at least 8 weeks before visit 1.

Patient presenting a PANSS score equal or greater than 49 at Visit 2.

Patient considered by the investigator as possible candidates for a switch, owing to inadequate efficacy or poor safety of the current treatment.

Exclusion Criteria:

Patient presenting a schizophreniform or a schizo-affective disorder according to the DSM-IV diagnostic criteria, or any other disorder from Axis I of the DSM-IV, or a disorder from Axis II (limit personality), substance dependence or substance abuse.

Administration of an atypical antipsychotic drug during the 8 weeks preceding V1.

History of resistance to antipsychotic drugs

Hospitalization in a psychiatric unit or in a psychiatric emergency department within the 8 weeks preceding the beginning of the study.

Presence of serious unstable disease, such as a fatal outcome or hospitalization in an intensive care unit, is foreseeable within a period of 6 months.
A Study to Evaluate Guideline Adoption Through Quality Improvement Project (QIP) in Pulmonary and Critical Care Medicine (PCCM) Department

This is a cluster randomized controlled trial with PCCM department in each site being the cluster. Fifty-four sites' PCCM departments will be randomized to the QIP arm versus control arm in 2:1 allocation ratio. The QIP arm will perform QIP intervention. The control arm will not receive intervention and continue with usual care.

The primary endpoints of this study are molecular testing rate of non-small cell lung cancer (NSCLC) prior to the first systematic anti-tumor therapy, and adjuvant or first line targeted therapy treatment rate in actionable oncogenic alterations (AGA) NSCLC.

Approximately 1728 patients from 54 sites will be enrolled (about 30 NSCLC \[20%-30% squamous cases\] and 2 extensive-stage small-cell lung cancer \[ES-SCLC\] patients in each site). Patients in the QIP arm will be enrolled after about 3-month QIP intervention. Patients in the control arm will be enrolled as soon as the trial starts. Data on lung cancer diagnosis and treatment pattern will be collected.

Eligibility Criteria:
1. Cluster 1.1 Cluster inclusion criteria 1.1.1 PCCM department in Tier 3 hospital. 1.1.2 PCCM department's standardized construction certification is "qualified ".

   1.1.3 PCCM department who want to improve lung cancer healthcare quality and agree to participate in study.

   1.2 Cluster exclusion criteria 1.2.1 PCCM department does not carry out anti-tumor treatment for lung cancer. 1.2.2 PCCM department participant in other lung cancer quality improvement study.
2. Individual Patient 2.1 Individual inclusion criteria 2.1.1 Pathology diagnosed NSCLC or ES-SCLC. 2.1.2 No prior systematic anti-tumor therapy, or prior adjuvant and neo-adjuvant therapies, definitive radiation/chemoradiation are permitted as long as treatment was completed at least 12 months prior to the development of recurrent disease.

2.1.3 Performance score (PS) 0-2. 2.1.4 Life expectancy \>12 weeks. 2.2 Individual exclusion criteria 2.2.1 Have a plan to transfer to other hospitals to receive anti-tumor therapy within 3 months after signing the ICF.

2.2.2 Participating in another interventional clinical study.
Dexmedetomidine in Children Having Transthoracic Echocardiography

Sedation Techniques for children undergoing transthoracic echocardiography (TTE).

The goal in this study is to determine if there is a significant difference in the quality of sedation between two standard sedation techniques and between two doses of dexmedetomidine for children undergoing (TTE).

Eligibility Criteria:
Inclusion Criteria:

* Outpatients scheduled to receive sedation for transthoracic echocardiography
* Subject must be a candidate for both types of anesthetic and both doses of dexmedetomidine
* Must be 3 months to 36 months of age

Exclusion Criteria:

* The subject has a history of cardiac conduction system disease (e.g. 1st or 2nd degree AV block) or channelopathy (e.g. long QT).
* The subject is taking digoxin, alpha-adrenergic or beta-adrenergic agonist or antagonist (e.g., clonidine, propranolol, albuterol), anti-arrhythmic medications, or vasodilators (e.g. ACE inhibitors)
* The subject has received a dose of any other sedative within 48 hours.
* The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
* The subject is allergic to or has a contraindication to any of the drugs used in the study.
* The subject has previously been treated under this protocol.
* The subject has severe coarctation of the aorta (risk of exaggerated vasoconstriction)
* The subject has Moyamoya disease (risk of recurrent stroke)
Radiation Therapy Plus Chemotherapy in Treating Patients With Pancreatic Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy combined with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of brachytherapy followed by external-beam radiation therapy plus chemotherapy in treating patients who have pancreatic cancer that cannot be removed surgically.

OBJECTIVES:

* Determine the response/remission rate, survival, and degree of local control from interstitial colloidal phosphorus P32 followed by external beam radiotherapy and chemotherapy in patients with unresectable pancreatic cancer.

OUTLINE: Patients are stratified according to prior therapy (yes vs no).

Patients receive dexamethasone intratumorally, then macroaggregated albumin and interstitial phosphorus P32 intratumorally. Most patients receive a second course of this brachytherapy.

Patients then proceed to chemoradiotherapy beginning 7-14 days after brachytherapy. Radiotherapy is administered 5 days a week for 6.4 weeks. Fluorouracil IV is administered every other day for 4 doses during weeks 1 and 2.

Patients are followed monthly for 1 year then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven unresectable adenocarcinoma of the pancreas limited to the head, body, or tail of the pancreas

  * Diameter no greater than 5 cm
  * Volume no greater than 66 mL
* No ascites (with or without tumor cells)
* No endoscopically proven tumor penetration of duodenum or stomach

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Hematopoietic:

* WBC at least 3,000/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

* No hepatic disease
* At least 50% uptake of technetium-sulfur colloid in normal liver if cirrhosis suspected
* No vascular occlusion of portal system

Renal:

* Creatinine no greater than 1.5 mg/dL
* BUN no greater than 25 mg/dL

Other:

* No Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* If prior chemotherapy, test dose of colloidal phosphorous P32 administered prior to attempted treatment

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy to pancreas, liver, or upper gastrointestinal tract

Surgery:

* No complete surgical resection
* No splenectomy