cyrilzakka/clinical-trials huggingface dataset:
Transcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence

This is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of TTNS versus a sham intervention. Both interventions will be performed by participants in their homes after standardized instruction. The primary outcome is a comparison of the mean change in OAB-q scores before and after treatment between the intervention and control groups. Changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. Intention to treat analysis will be performed.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 episodes urgency incontinence on 3-day voiding diary
* Duration of symptoms ≥ 3 months
* Off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks
* No known neurologic disease
* Ability to complete home sessions and clinic follow up
* Ability to complete voiding diaries
* Internet access and proficiency
* English or Spanish-speaking

Exclusion Criteria:

* Pregnant
* Known or suspected urinary retention
* Symptomatic urinary tract infection unresolved at the time of randomization
* Recurrent urinary tract infection (≥ 3/12 months)
* Bladder pain syndrome
* Known or suspected advanced (stage III or IV) pelvic organ prolapse
* Neurogenic bladder
* Current or prior bladder malignancy
* Current or previous use of bladder Botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation
* Pacemaker or other implantable device
* Disease affecting lower extremities
* Bilateral metallic lower limb implant
* Incarceration
Perceptions of Burden in Patients With Late-Stage Cancer and Their Caregivers

RATIONALE: Gathering information over time about patients' sense of being a burden on their caregiver, and caregivers' sense of burden on themselves, may help doctors learn more about the desire to die in patients with late-stage cancer.

PURPOSE: This clinical trial is studying perceptions of burden in patients with late-stage cancer and their caregivers.

OBJECTIVES:

Primary

* To measure psychosocial correlates of desire for hastened death (DHD) and change in DHD in patients with late-stage cancer by examining the relationship among a patient's perception of being a burden, their caregiver's perceptions of the patient's burdensomeness, and DHD changes over time.

Secondary

* To identify coping and personality factors in both caregivers and patients that may be related to the patients' DHD and changes in their DHD.

OUTLINE: Patients and caregiver dyads complete questionnaires at baseline, 2 months, and 4 months. The dyads complete demographic questionnaire, the Hospital Anxiety and Depression Scale (HADS), the Beck Hopelessness Scale (BHS), the Dyadic Adjustment Scale (DAS), and the Life Orientation Test-Revised (LOT-R). Patients also complete the Schedule of Attitudes Toward Hastened Death (SAHD), the Brief Coping Orientation to Problems Experienced (Brief COPE), the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), and the Caregiver Demands Scale (CDS). Caregivers also complete the Katz Index of Independence in Activities of Daily Living (IADL).

Patients' medical charts are reviewed for stage and node status at primary diagnosis, previous oncology surgeries, previous adjuvant treatments, treatment at time of recurrence, disease free interval, site of metastasis, and response to current treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria

  * Patient with a diagnosis of cancer

    * Confirmed late-stage disease refractory to standard primary therapy
    * Reside with a non-paid primary caregiver
    * Receiving care at the Cancer Institute of New Jersey
  * Caregiver

    * Must be at least 18 years old

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 4 months
* No documented or observable cognitive (e.g., dementia) or psychiatric (e.g., psychosis) problems that would interfere with study participation
* Able to read and write English (patient and caregiver)

PRIOR CONCURRENT THERAPY:

* Not specified
Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage

The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).

The study hypothesized that administration of Deproteinised Calf Blood Serum Injection would alleviate PHE and secondary brain injury, thus improving clinical outcomes in patients with ICH. The investigators will enroll 60 acute supratentorial ICH patients. Patients will be assigned randomly to receive either Deproteinised Calf Blood Serum Injection or placebo treatment, which is blinded to evaluator and patients. All patients in the study will receive standard care treatment and clinical, diagnostic, laboratory, safety, and follow-up evaluations. Blood will be drawn and brain MRI will be done in different time course. Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Stroke impact scale , Glasgow Coma Scale ,Barthel index score and modified Rankin scale assessments, will be done periodically until 90 days after onset.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)
2. Bleeding into deep gray matter (basal ganglionic and thalamus), and the amount of bleeding between 5 and 30 ml;
3. Age between 18 and 80 years;
4. Presentation within 48 hours of symptom onset, and NCCT at 24 hours need to be done in patients presenting within 24 hours of symptom onset in order to exclude hematoma expansion.
5. Informed consent by patients or relatives.

Exclusion Criteria:

1. Â secondary ICH (secondary to trauma, tumor, vascular malformations, ischemic stroke hemorrhagic transformation, etc.);
2. Glasgow Coma Score of 3-8 at admission;
3. Parenchymal hemorrhage with ventricle involved;
4. Patients with hematoma expansion; .
5. Planned surgery within 3 days of symptom onset;
6. Incompletely absorbed brain hematoma previously;
7. Prestroke modified Rankin score(mRS)\>1;
8. Patients with hemorrhagic disease or coagulation disorders;
9. Patients with severe liver and renal insufficiency;.
10. Patients with severe heart failure or other serious systemic diseases;
11. Patients with malignant tumors or ongoing anti-tumor therapy;
12. Patients with a history of dementia or mental disorders;
13. Pregnant or lactating women or those who has a recent fertility plan;
14. Any contraindications to MRI(such as cardiac pacemakers and other metal implants, claustrophobia);
15. Any other neuroprotective has been applied before randomization;
16. Terminal patients whose life expectancy \<90 days;
17. Patients participating in other clinical trials 30 days prior to randomization.
Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty

Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II were included in this randomized study who were divided into the study group of 30 patients who had been transfused autologous blood and the control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 grams of intravenous tranexamic acid. This study was conducted through the laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for both groups in the pre-operative and the post-operative period and the assessment of the amount of transfused blood units in both groups.

A total of 60 patients were included in this randomized study that were divided into a study group of 30 patients, who had been transfused autologous blood and a control group of 30 patients who had been transfused only allogeneic blood. Parenteral iron preparation was given to all patients of the study group after each donation. Intraoperatively all patients of the study group received 2 g of intravenous TXA.

This study was conducted through laboratory analysis of hemoglobin and hematocrit values during blood donation and for both groups in the preoperative and the postoperative period and the assessment of the amount of transfused blood units in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Elective revision total hip replacement surgery was performed in 60 patients aged between 60 and 75 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm.

Exclusion Criteria:

* This study excluded cases of revision total hip arthroplasty (RTHA) for infection or fractures as well as early revisions for dislocations secondary to implant malposition. Preoperative autologous blood donation was not done in patients with cardiac decompensation, severe hemodynamic problems, respiratory insufficiency, severe defect of central nervous system, active infection, blood disease or coagulopathies.
Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers

The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Eligibility Criteria:
Inclusion Criteria:

* Obese, otherwise healthy females
* Post menopausal or infertile
* Weight ≥ 50 kg
* BMI ≥ 32 and ≤ 45 kg/m2

Exclusion Criteria:

* Use of weight loss agents in the past month
* History of eating disorder
* History of diabetes or other endocrine disorder
* History of gastric bypass
* Current smokers
* Unstable body weight during the past 3 months
SIMPLIFY the Hand Hygiene Procedure - Three Steps Versus Six Steps for Performing Hand Hygiene (SIMPLIFY Study)

Hand hygiene is one of the most important measures to prevent healthcare associated infections. A hand hygiene technique consisting of three steps may be superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique. Therefore, the aim of this study is to compare compliance with hand hygiene indications and technique between a 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Hand hygiene is one of the most important measures to prevent transmission of pathogens between healthcare workers and patients, and ultimately, healthcare-associated infections. However, compliance with both hand hygiene indications and technique (outlining the steps for applying hand rub to ensure coverage of all surfaces of the hands) remains insufficient at most institutions worldwide. It was previously demonstrated that a hand hygiene technique consisting of three steps is superior to the 6-step technique outlined by the World Health Organization (WHO) in terms of compliance with both indications and technique in a single center study. Furthermore, the 3-step technique was non-inferior regarding microbiological efficacy in two experimental studies and during daily clinical practice. To further investigate the external validity and generalizability of these findings to different settings, this study compares both compliance with hand hygiene indications and technique between the 3-step and the 6-step technique for applying hand rub in an international multicenter cluster randomized trial.

Eligibility Criteria:
Inclusion Criteria:

Health Care Workers (HCW) working at the randomized wards during the pre-defined timeframe

Exclusion Criteria:

Individuals, who are no HCWs
Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS)

The aim of this study is to compare the efficacy of analgesic methods after Caesarean Section before and after Post Caesarean Acute Pain Service establishing.


Eligibility Criteria:
Inclusion Criteria:

* Caesarean Section performed from October 2009 to October 2011 (study period)
* completed "Evaluation of postoperative analgesia after Caesarean Section" form.

Exclusion Criteria:

* Not completed "Standard Evaluation of postoperative analgesia after Caesarean Section" form.
Safety Study of Adjuvant Gemcitabine Started One Week After Laparoscopic Distal Pancreatectomy for Adenocarcinoma

We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

Gemcitabine-based chemo¬therapy remains the cornerstone for treatment of locally advanced or metastatic pancreatic cancer. Other novel chemotherapeutic combinations have been investigated in clinical trials, but the overall conclusions are that these agents have failed to improve outcomes. Our hypothesis is that nodal and hematologic micrometastasis make pancreas cancer a systemic problem at the time of surgery. Waiting the traditional six weeks to begin adjuvant therapy allows this very aggressive cancer to metastasize while the patient is waiting to begin therapy. This leads to the increased incidence of locoregional recurrence and poor prognosis. We believe that laparoscopic distal pancreatectomy for cancer allows quicker recovery and significantly reduces the chances of postoperative wound breakdown. This will shorten the wait time required to begin adjuvant therapy to one week after surgery thereby combating the micrometastasis unseen at the time of surgery. Prognosis for patients with pancreatic cancer will therefore improve along with decreasing the incidence of locoregional recurrence.

Methods: We will perform a prospective, non-randomized phase II study with patients undergoing laparoscopic distal pancreatectomy for pancreatic adenocarcinoma at Johns Hopkins Hospital. Gemcitabine will be given as a single-agent chemotherapy regimen one week following laparoscopic distal pancreatectomy according to the protocol designed by our medical oncologist. Six cycles of gemcitabine will be given. The patients will be followed in the medical oncology clinic weekly. Our Primary outcome variable will be all cause postoperative morbidity. Our sample size will be small (6-10 patients) as this is a Phase II study. Early termination rules include development of prohibitive toxicity or death. Our endpoints are an improvement in overall survival, quality of life, progression free survival, or disease free survival. Exclusion criteria will include patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients older than 18 with clinical diagnosis of distal pancreas adenocarcinoma

Exclusion Criteria:

* Patients with T4 or M1 disease, R2 resection margin, preoperative therapy, or if adjuvant therapy status was unknown.
Study on Patterns of Care in Mild Asthmatic Patients

The PRIME study is an observational, Real World Evidence study designed to collect the type of treatments that are currently prescribed to patients with mild asthma and to collect relevant clinical data that could reflect the control of the disease over a 6-month observational period according to the standard clinical practice.

Outpatients attending the hospital clinics/study centres will be recruited. Patients with mild asthma treated by Step 1 or step 2 treatments according to GINA report will be recruited. A total of approximately 1200 patients will be enrolled. Patients will be followed-up during a 6-month observational period according to standard practices.

Eligibility Criteria:
Inclusion Criteria:

* Adult subject (aged ≥ 18 years) up to 75 years
* Subject with confirmed asthma diagnosis
* Subject in treatment for mild asthma with Step 1 or Step 2 according to GINA report
* Subject with written privacy and study informed consent

Exclusion Criteria:

* Subject enrolled in experimental (interventional) clinical trials, or receiving experimental treatments in the prior 3 months
* Known pregnant or breast-feeding subject
* Subject unable to understand and autonomously fill in questionnaires
* Subject unable to use electronic devices to fill in e-diary, or without compatible electronic devices with access to the Internet
* Subject who had asthma exacerbation(s) in the past 4 weeks prior to study entry
* Subject with confirmed Chronic Obstructive Pulmonary Disease
A Dangerous Triad in Ageing and in Chronic Obstructive Pulmonary Disease (COPD) - Reduced Muscle Mass, Impaired Muscle Function and Malnutrition

The investigators have taken part in the development of simple muscle function tests and studied physical training and energy turnover in patients with chronic obstructive pulmonary disease, COPD. The investigators have found that muscle wasting in COPD is related to poor prognosis and that physical training might lead to improved, less energy-demanding muscle function. Elderly subjects also suffer from muscle wasting that leads to frailty, poor autonomy and, secondarily, fractures. In the planned study the investigators will validate simple muscle function tests (hand grip strength, heel rise test, voluntary quadriceps muscle strength, 30 m walking test and balance tests) in both groups by relating them to an involuntary, magnet stimulated, test of quadriceps force, HRQL, tests of body composition (impedance, DXA) and recordings of physical activity. The relation between food intake, systemic inflammation, muscle mass and function will be analysed.

The study has been ethically approved and started in COPD patients and will be expanded to a representative sample of elderly.

Simple, evaluated muscle function tests applied in primary care may be used for early detection of muscle dysfunction in COPD patients and elderly so that early intervention against impaired muscle function can be started. Analyses of food intake and of inflammatory markers might identify factors of special importance for muscle dysfunction, which eventually might lead to improved dietary therapy and pharmacological interventions.


Eligibility Criteria:
Inclusion Criteria:

* Women and men between 65 and 81 years of age, randomly selected from the national registration, are invited to take part in the study.
* Patients referred to the outpatient clinic of the lung unit at Sahlgrenska University Hospital with a diagnosis of COPD are asked for participation.
* Inclusion criteria for COPD patients:
* Clinical diagnosis of COPD
* FEV% \< normal value minus 2 SD
* Smoking history; 10 pack years or more

Exclusion Criteria:

* Any specific muscular disease
* Severe disease or handicap making investigations impossible
* Exclusion criteria for COPD patients:
* Any specific muscular disease
* Any co-existing serious disease
The Avastin vs Visudyne for Neovascular AMD Study

The object of the study is to compare the treatment effect of bevacizumab (Avastin), an antibody targeting vascular endothelial growth factor, with verteporfin photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration, the leading cause of vision severe loss in the Western world.

Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. Current treatment options have up until now been limited to photodynamic therapy (PDT) where a photosensitizing agent in combination with laser is used to occlude the pathologic vessels. Anti-VEGF agents have recently become available making them a potentially attractive treatment alternative for neovascular AMD. We will compare the effect intravitreally administered bevacizumab with conventional PDT in a prospective, randomized and controlled trial including 100 patients (50 patients receiving either treatment regimen). Non-treated patients will receive either sham-injection or sham-PDT. The primary endpoint of the study is the amount of patients losing less than 15 letters on the ETDRS visual acuity chart. The study will go on for 2 years with an interim report after 1 year.

Eligibility Criteria:
Inclusion Criteria:

* patients with subfoveal neovascular AMD with either classic/predominantly classic or small occult lesions
* visual acuity \>=0.1

Exclusion Criteria:

* patients with subfoveal neovascular AMD with minimally classic lesions or large occult lesions
* subfoveal hemorrhage (\>1DA) or fibrosis
* patients previously treated for neovascular AMD in the study eye
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter 4

The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a permanent or temporary risk of Pulmonary Embolism.
* Patient must provide informed consent At least one of the following conditions -
* Proven PE
* Recurrent PE despite adequate
* Contraindication to anticoagulation
* Inability to achieve/maintain therapeutic anticoagulation
* Iliocaval DVT
* Large, free-floating proximal DVT
* Massive PE treated with thrombolysis/thrombectomy
* Chronic PE treated with thrombectomy
* Protection during thrombolysis for iliocaval DVT
* PE with limited cardiopulmonary reserve
* Poor compliance with anticoagulation medication
* High risk of injury worsening on anticoagulation
* Multi-trauma patient with high risk of PE
* Surgical patients at high risk of PE
* Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up

Exclusion Criteria:

* Age \<18 years old
* Patient has any one of the following conditions:

  * Renal vein thrombosis
  * IVC thrombosis extending to the renal veins
  * Duplicate IVC
  * Gonadal vein thrombosis
  * Requires supra-renal placement
* Vena cava diameter of 17-28mm
* Uncontrolled infectious disease
* Risk of aseptic PE
* Uncontrolled coagulopathy
* Existing inferior vena cava filter implant
* Life expectancy less than 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Condition that inhibits radiographic visualization of the IVC
* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
* Known hypersensitivity to contract which cannot be pretreated
* Access vessels preclude same insertion of delivery system
* Participation in another drug or device trial
* Unable or unwilling to cooperate with study procedures or required follow-up visits