cyrilzakka/clinical-trials huggingface dataset:
Interest of Intravaginal Electro-stimulation at Home by GYNEFFIK® Compared to Usual Care in Incontinent Patients With Prior Perineal Reeducation

The aim of this study is to assess the benefit of GYNEFFIK®, a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK® electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained.


Eligibility Criteria:
Inclusion Criteria:

* out-patient over 18 years old, having understood and signed the Informed Consent Form
* seen for urinary stress incontinence or urinary mixed incontinence (with a major stress incontinence part) troubles
* spontaneously asking for help
* who can be followed for a long time

Exclusion Criteria:

* Urinary Incontinence (UI) found out during medical interviewing without spontaneous complaint
* Urinary troubles due to neurological pathology (stroke, multiple sclerosis, ...)
* UI due to congenital malformation
* UI having led to surgery
* UI treated in the last 6 months
* UI within 24 weeks of Past Partum
* Pelvic surgery within 12 months
* On-going inflammatory or infectious neoplastic disease
* Perineal hypoesthesia
* Local conditions prohibiting the use of an intra-vaginal device (vaginal atrophia, continuous metrorrhagia, vaginal prolapse \> 2°, ...)
* Pacemaker use
* Women of child bearing potential without effective method of contraception or planning to get pregnant in the next 12 months
* Intravaginal contraception
* Mental impairment or inability to understand or follow study instructions
* Patient who may not come back to the study visits
* Patient already enrolled for another study or having been enrolled in another clinical study in the past 3 months
Field Evaluations of Innovative Tools for Vector-borne Disease Control in Conflict-affected Communities

The aim of this study is to determine the effectiveness of a new spatial repellent (called Mesh) at repelling multiple disease vectors and, reducing clinical malaria rates in temporary shelters and camp settings. The design of the study will be a two-armed cluster randomised trial.

By conducting the research in challenging camp settings in the north of Nigeria, the MENTOR Initiative aims to determine whether Mesh can be effective in harsh camp conditions where communities are living in conflict area temporary shelters.


Eligibility Criteria:
Inclusion Criteria:

* Shelters with 1 or more children from 6-10 years old
* Shelters with an adult/head of the household

Exclusion Criteria:

* Shelters without children from 6-10 years old
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.

OBJECTIVES:

* Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma.
* Assess other intermediate markers of immune response in patients treated with this regimen.
* Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen.

OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels.

Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma

  * Unresectable disease
* No known uncontrolled CNS metastases

  * CNS metastases allowed only if recently irradiated or known to be controlled

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin at least 8 g/dL
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Absolute lymphocyte count at least 1,000/mm\^3

Hepatic:

* Total bilirubin no greater than 1.5 mg/dL OR
* Conjugated bilirubin no greater than 0.3 mg/dL
* AST no greater than 2.5 times upper limit of normal

Renal:

* Creatinine no greater than 2 mg/dL

Cardiovascular:

* No myocardial infarction within the past 6 months
* No uncontrolled hypertension, angina, or congestive heart failure

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study
* No known intolerance to acetaminophen
* No primary or secondary immunodeficiency
* No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* At least 1 month since prior topical, systemic, or inhaled corticosteroids
* No concurrent topical, systemic, or inhaled corticosteroids

Radiotherapy:

* See Disease Characteristics

Surgery:

* Not specified
Gastric pH in Intubated Children

Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk

Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction


Eligibility Criteria:
Inclusion Criteria:

* age \> 1 / \<= 16 years
* ASA class I or II
* elective surgery requiring general anaesthesia using tracheal intubation

Exclusion Criteria:

* disease or dysfunction of gastrointestinal tract
* chronic diseases or conditions not compatible with ASA class I or II
The Effects of Automatic Gas-Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries

In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries.

In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries. This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Aged between18-73

Exclusion Criteria:

* heart failure
* liver disease
* lung disease
* kidney disease
Computer-Based Auditory Rehabilitation

Hearing in noisy environments is a perceptual problem that is ubiquitous in modern industrialized societies. This particular listening context offers a particular challenge to individuals living with hearing impairment (30 million in US alone) even after treatment with hearing aids or cochlear implants. The ability of the brain to extract regularities from the environment and suppress distracting information can be improved with intensive cognitive training. The investigators will test whether the hearing in noise abilities of adults living with hearing impairment can be improved with a cognitive training paradigm.

Hearing impairment (HI) represents the most common cause of moderate to severe disability in the world, with an estimated prevalence of 636 million individuals (30 million in the US alone). Amplification devices (i.e., hearing aids) are commonly used to compensate for HI stemming from acoustic trauma, ototoxic insult, normal aging or other sources of cochlear degeneration. The chief complaint of individuals with HI is hearing in the types of noisy environments that characterize most work, educational, and social situations. Unfortunately, hearing aids do not completely address the perceptual impairments in these situations. That is because the difficulties that individuals with HI have hearing in noise result from the reduced salience of cues that are used to sort out auditory scenes. Making sounds louder improves audibility, but does not afford adaptation of the brain to the abnormal coding of sensory information by the damaged cochlea. The investigators will test whether the hearing in noise abilities of adults living with hearing impairment can be improved with a cognitive training paradigm.

Eligibility Criteria:
Inclusion Criteria:

* Binaural sensorineural hearing impairment
* Use of binaural hearing aids
* Native English Speaker

Exclusion Criteria:

* Significant cognitive impairment
* Significant motor impairment
* History of neurological disease/head trauma
* Use of psychotropic and thyroid medications
Prospective Cohort Study of 4,837 Post-myocardial Infarction Patients (Alpha Omega Cohort)

The Alpha Omega Cohort is a prospective study of 4,837 state-of-the-art drug-treated Dutch patients aged 60-80 years who had a clinically diagnosed myocardial infarction up to 10 years before enrolment. During the first 40 months of follow-up, patients took part in an experimental study of low doses n-3 fatty acids (Alpha Omega Trial, ClinicalTrials.gov NCT00127452). At baseline (2002-2006), data on medical history, medication use, diet, lifestyle and other factors were collected by means of questionnaires. Patients were physically examined by trained research nurses and blood samples were obtained. Follow-up for vital status and cause-specific mortality is ongoing. The trial was approved by a central medical ethics committee (Haga Hospital, The Hague, The Netherlands) and all patients provided written informed consent.

Details are reported in publications.

Eligibility Criteria:
The Alpha Omega Cohort is a prospective cohort study. The cohort originated from the Alpha Omega Trial, a 40-month intervention study of low doses of n-3 fatty acids (in margarine spreads) and cardiovascular events (NCT00127452). The in/exclusion criteria were defined for the Alpha Omega Trial.

Inclusion criteria:

* Men and women
* Aged 60 through 80 y
* Verified clinically diagnosed myocardial infarction up to 10 y before entry into the study
* Written informed consent

Exclusion criteria:

* Living in a nursing home or other institution
* Participation in another scientific study
* Habitual margarine intake \< 10 g per day
* Habitual fish intake \> 150 g per day
* Habitual alcohol intake \> 6 drinks per day
* Use of fish oil capsules or other supplements containing omega-3 fatty acids
* Presence of cancer with \< 1 y of life expectancy
* Cognitive impairment, as indicated by the Mini Mental State Examination (score \<= 21)
* Unintended weight loss \> 5 kg in the past year
* Lack of facilities for cooled margarine storage at home
* Inability or unwillingness to comply with study procedures
Evaluation of the BunnyLens TR Intraocular Lens

With age, a human crystalline lens opacifies (cataract) disabling the eye in generating a clear, well contrasted image. The only therapeutic solution to this problem is surgical replacement of the crystalline lens with an intraocular lens (cataract surgery).

In addition to the cataract, the person might suffer from pre-existing cormeal astigmatism. In cases of severe corneal astigmatism, the standard IOL might not provide the optimal result, and additional surgical procedures as Incisional Keratotomy or Limbal Relaxing Incisions might be required.

BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.

The BunnyLens TR IOL is designed for micro-incision cataract surgery (MICS), through 1.8mm incisions.

The aims of this study are to:

* Demonstrate a reduction in refractive cylinder compared to pre-operative corneal astigmatism
* Exceed monocular best corrected distance visual acuity results provided in ISO guidelines.

The reduction in refractive cylinder compared to pre-operative corneal astigmatism will be assessed using pre- and postoperative subjective refraction evaluation. Units of the measurement: diopters.

Monocular best corrected distance visual acuity will be assessed using ETDRS charts. Units of the measurement: logMAR.

There are no complications related to the BunnyLens TR implantation beyond those that might be expected in standard cataract surgery. The complications will be reported using Ocular condition forms included in the CRFs.

Eligibility Criteria:
Inclusion Criteria:

* Between 40 and 80 years of age, of either gender and any race;
* Have preoperative corneal astigmatism of \>= 2 Dpt as determined by IOL Master keratometry;
* Have regular, bowtie shaped corneal astigmatism. Corneal topography printout should be approved and signed by cornea specialist.
* Anterior chamber depth is between 2.5 to 3.8 mm
* Axial length is between 22 to 26 mm
* are willing and able to understand and sign an informed consent;
* have age related cataracts that require extraction followed by implantation of a posterior chamber intraocular lens (IOL) and used as an on-label procedure;
* are able to obtain pupil dilation \>=4.0 mm.

Exclusion Criteria:

* Following disease(s)/condition(s): choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, microphthalmos, proliferative diabetic retinopathy, corneal dystrophy, optic nerve atrophy, uncontrolled glaucoma or glaucoma treated by 3 or more medications, uncontrolled systemic disease or any ocular condition, that by opinion of investigator would compromise the refractive outcome or potential of the eye to achieve good vision.
* High intraocular pressure (above 25mmHg)
* Previous intraocular or corneal surgery;
* Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
* Current rigid contact lens usage (within 3 months prior to the preoperative biometry reading)
The Reverse Barrel™ VRD Intracranial Aneurysm Trial

The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.


Eligibility Criteria:
Summary Inclusion Criteria:

1. Male or female ≥18 years old.
2. A wide neck, intracranial, bifurcating or branch aneurysm with a neck ≥4 mm or a dome-to-neck ratio \<2, including non-de novo aneurysms where no stent was utilized.
3. Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).
4. Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.
5. Subject is eligible to undergo a procedure with the use of contrast media.
6. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
7. Subject has given written informed consent.
8. Life expectancy \> 12 months.

   -

Summary Exclusion Criteria:

1. Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.
2. Subject is currently undergoing radiation therapy.
3. Subject has known allergies to nickel-titanium metal.
4. Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.
5. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
6. Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).
7. Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
8. Subject is currently participating in another clinical research study.
9. Subject has had a previous intracranial stenting procedure associated with the target aneurysm.
10. Subject is unable to complete the required follow-up.
11. Subject is pregnant or breastfeeding.(Females of childbearing potential must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
12. Subject has participated in a drug study within the last 30 days.
13. Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.
14. Extradural aneurysms.

    -
Does Post Operative Pancreatic Fistula, After Left Sided Resections, Heal Faster After the Introduction of a Pancreatic Stent?

Dividing pancreas when performing left-sided resections opens the risk for leakage from the divided end of the pancreas. Pancreatic juices could have a severe effect on surrounding abdominal tissues with abscess formation producing systemic inflammation and potential lethal bleeding. Proper drainage of pancreatic juices is the primary treatment. Effective drainage reduces healing time. A pancreatic stent could theoretically improve the drainage of pancreatic juice into the duodenum and by this shorten the healing time still further.

Pre operative prophylactic stenting of the pancreas before division of the parenchyma has not shown a positive effect on fistula formation.

In an open randomized multicenter clinical trial we want to test the hypothesis that a reduced fistula healing time, in left sided pancreatic resections, could be reduced by introducing a pancreatic stent when on post operative day 3 or later a B och C fistula (according to the International Study Group on Pancreatic Fistula, ISGPF) is diagnosed by randomizing between pancreatic stent with drains versus only drains.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Left sided or distal pancreatic resection
* Grade B or C fistula on postoperative day 3 or later

Exclusion Criteria:

* Do not want to participate in study
* Can not read patient information in swedish
* The papilla can not be endoscopically reached
Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)

The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.


Eligibility Criteria:
Inclusion Criteria:

* Age between 16 and 30 years
* First episode psychosis diagnosis according to DSM-5 criteria

Exclusion Criteria:

* Lees of 16 years or more than 30 years
* Not fulfilling DSM-5 criteria for first episode psychosis
* Any treatment with the psychologist or the psychiatrist of the team
Frequency Effect of STN-DBS Through the Dual System on FOG in PD

We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS.

The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. After four weeks, the investigators will check the UPDRS part I, II, IV, FOG-Q, and PDQ-39 values at each frequency, including the proportion of use of two frequencies.

Eligibility Criteria:
Inclusion Criteria:

* patients with PD who are aged 30 years or older
* patients with bilateral STN-DBS
* patients who have a FOG at their med "off" state in outpatient clinic or hospitalization, or UPDRS part II FOG subscore above 1

Exclusion Criteria:

* patients without FOG
* patients who have undergone DBS
* patients who have had previous brain surgery
* patients who have undergone reoperation of DBS
* patients who underwent unilateral DBS
* patients with cognitive impairment (MMSE \<18)
Observational Study Regarding the Necessity of Inclusion of Foot Arch State Together With the Angiosome Theory Within the Wound, Ischemia and Foot Infection Classification (WIfI) to Enhance the Predictability of Wound Healing and Decision Making

This study aims to assess the complete healing or healing progress of foot ulcer within 1 year Where the patients will be classified according to foot arch state together with the angiosome theory and the WIFI clinical stage to reflect the the necessity of inclusion of foot arch state together with the angiosome theory within the WIFI classification to enhance the predictability of wound healing and decision making

Patients will be classified according to their WIFi stages into 3 groups and each group will be furtherly classified according to the patient's angiography of foot arch (whether by CT angiography or direct angiography) into:

Type 1: patent foot arch Type 2: partially occluded foot arch which is divided into whether Type 2a: patent dorsal tributary of foot arch Type 2b: patent lateral tributary of foot arch Type 3: totally occluded foot arch is divided into whether. Type 3a: totally occluded foot arch with anterior tibial artery inflow. Type 3b: totally occluded foot arch with posterior tibial artery inflow.

During follow-up assessments, wound is classified to be within: anterior tibial artery, posterior tibial artery or both territories.

Wound healing states are often classified based on the progression of the healing process into each of the following categories such as:

1. Complete Healing: Wound closure with the restoration of tissue integrity and absence of signs of infection.
2. Partial Healing: Significant improvement but not complete closure; may involve reduction in wound size and improved tissue viability.
3. Worsening: Increase in wound size or signs of infection which may necessitates performing major amputation.

Eligibility Criteria:
Inclusion Criteria:

* diabetic foot in the form of gangrene, or a lower limb ulceration \>2 weeks duration.

Exclusion Criteria:

1. Age below 18 years old.
2. Critically ill patients
3. Patients with acute ischemia
4. patients with pure venous ulcer
5. patients with ulcer due to rheumatological disease
6. The patient has known sensitivity to heparin.
7. The patient has comorbid conditions that may limit their ability to comply with the follow-up requirements
8. The patient has an untreatable allergy to radiographic contrast material.
9. Patient refusing consent