cyrilzakka/clinical-trials huggingface dataset:
Is Sphenopalatine Ganglion Block Treatment Effective on Postspinal Headaches

This study evaluates effect of sphenopalatine ganglion block in post dural puncture headache. Half of participants will receive standard supportive treatment and other half of patients will be performed sphenopalatine ganglion block.

Spinal anesthesia is known subarachnoid block also commonly used regional anesthesia technic. Spinal anesthesia is frequently performed in obstetric patients undergoing cesarian section, which has several advantages including less deep vein thrombosis incidence, low opioid requirement, early mobilization and early lactation also has some complications too. Postdural headache is one of the most known complications of spinal anesthesia.

The etiology of the postspinal headache remains unclear. Severeness of the symptoms and amount of the cerebrospinal fluid leakage have been found positive correlating. The cerebrospinal fluid supports brain with it's mass effect. When a leakage of the fluid occurs, support of the brain decreases and pain sensitive structures of the brain gets more sensitive. In this condition 5 th 9th and 10 th cranial nerves, falks cerebelli, tentorium and blood vessels are affected most. Decreased cerebrospinal fluid volume causes decreased brain volume and compensatory mechanisms lead to cerebral venous dilatation. Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline. Epidural blood patch is the gold standard for the treatment . However epidural blood patch is an invasive technic and has some complications such as dural puncture, infection and neurologic trauma.

Sphenopalatine ganglion is one of the four parasympathetic thin ganglion in skull. Parasympathetic fibers innervates cerebral and meningeal blood vessels which cause vasodilatation and stimulate nociceptor activation on meninges. Consequently headache is related with sensory cortex.

Transnasal SPG block is performed successfully in chronic pain syndromes including migraine, cluster headaches and atypic face pain. Likewise the SPG block is performed in acute treatment of postspinal headache. However gold standard of the treatment is epidural blood patching which is interventional and has many risks. Several studies enrolled limited participants offer SPG block primarily in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Patients who was diagnosed for postdural puncture headache after cesarian section
* Patients who is fluent speaking and writing in turkish

Exclusion Criteria:

* Refusal to participate in the study
* Patients who was known lidocaine sensitivity
* Patients with severe nasal septum deviation
Walking Strategies in Usual Locomotion of Lower Limb Amputees

Amputation is a life-altering event with an immediate and obvious effect on daily life activities and quality of life. Asymmetrical movements of the lower limbs and compensatory strategies during walking are associated with an elevated risk for developing deleterious secondary health conditions. It is well established that therapeutic gait training methods are effective in reducing spatiotemporal gait deviations and improving functional mobility. However, the littérature does not clearly indicate the best time to perform a gait training or which gait parameters predict it.

The main aim of this study is to determinate the walking strategies of lower limb amputees in several locomotion tasks on daily life. Then, the investigators study the evolution of these walking strategies after a gait training and over time.

Quantified gait analyses are included in the practice for consultations to monitor orthopaedic devices, and are specific to the study for the rehabilitation stay (V2 and V3).

The subjects in the control group will be recruited from among the carers of patients undergoing rehabilitation and from among volunteers recruited by means of posters in the establishments of the HOPALE Foundation in Berck.

Once the eligibility criteria have been checked, a quantified gait analysis and functional tests will be carried out: the 6-minute walk test (T6M) and the Time Up and Go test (TUG). They will complete a single visit lasting approximately 1 hour and 30 minutes.

Eligibility Criteria:
Inclusion Criteria (Amputees patients):

* Major amputation of the lower limb,
* Unilateral amputation,
* Aged 18 or over,
* Mobility level equal to or greater than 2 (according to Medicare Functional Classification Levels),
* Subject who has given his or her free and informed consent.

Non-inclusion Criteria (Amputees patients):

* Definitive apparatus less than one month old,
* Contraindications for walking,
* Presence of a major neurocognitive disorder reported in the medical record (as mentioned in the DMS-5): acquired, significant and progressive reduction in abilities in one or more cognitive domains, significant enough to no longer be able to perform activities of daily living alone (loss of autonomy)
* Cognitive disorders reported in the medical file,
* Subject under guardianship, curatorship or protective measure,
* Pregnant or lactating woman.

Inclusion Criteria (Healthy volunteers):

- Able to walk 50m alone.

Non- Inclusion Criteria (Healthy volunteers):

* Contraindication to effort,
* Cognitive disorders known by the subject, causing difficulties in performing tasks related to activities of daily living
* Any history of neurological or orthopedic origin likely to limit the quality of walking,
* Notion of trauma on the musculoskeletal system less than 3 months (sprain type, muscle injury, etc.),
* Subject under guardianship, curatorship or protective measure,
* Pregnant or lactating woman.
Quality Control of CE-Certified Phonak Hearing Aids - 2016_05

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants to grant quality control prior to product launch. The aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Eligibility Criteria:
Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders
Pelvic Floor Muscles and Success in the Surgical Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse

The aim of the study is evaluation of the efficiency of pelvic floor muscles in the context of surgical outcomes in the treatment of stress urinary incontinence and pelvic organ prolapse.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal and postmenopausal women
* stress urinary incontinence
* pelvic organ prolapse

Exclusion Criteria:

- previous surgical interventions due to stress urinary incontinence or pelvic organ prolapse
Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients

This is a double-blind, randomized controlled study evaluating the efficacy and safety of HGXJT in combination with ICI-based standard treatment in lung cancer patients with bone metastases. Enrolled participates will randomly receive HGXJT or placebo during the first 4-6 cycles of ICI-based standard treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with non-small cell lung cancer diagnosed by histopathology or cytopathology.
2. Presence of bone metastases.
3. EGFR/ALK gene wild type.
4. No prior treatment with PD-1 inhibitors (combination or monotherapy)
5. Those who have not received prior antitumor therapy or have not received further antitumor therapy after failure of first-line antitumor therapy.
6. PS score (ECOG) ≤ 2 points
7. Normal hepatic and renal function.

   Normal hepatic function: total serum bilirubin level ≤ 1.5 times of the upper limit of normal value(ULN), serum serum aspartate aminotransferase(AST) \& alanine aminotransferase(ALT) ≤ 2.5 times ULN

   Normal renal function: serum creatinine ≤ 1.5 mg/dl (133 μmol/L) and/or creatinine clearance ≥ 60 ml/min.
8. Presence of at least one assessable lesion.
9. Signed informed consent, patient willing to accept this regimen, able to adhere to the medication, and good compliance.

Exclusion Criteria:

1. Unable to complete the baseline assessment form
2. Combination of other serious illnesses, including uncontrolled active infection, severe electrolyte disturbances, and significant bleeding tendencies.
3. Pregnant or lactating women.
4. Combined autoimmune diseases, hematologic disorders, or long-term use of hormones or immunosuppressive drugs.
5. Combination of other uncontrolled tumors.
6. Combination of severe brain or mental illness that affects the patient's ability to self-report.
7. Combined organ transplant history (including bone marrow autotransplantation and peripheral stem cell transplantation).
8. Those who are legally incompetent and whose medical or ethical reasons affect the continuation of the research.
Analysis of Cerebral Correlates of Pedophilia With Neuroimaging Techniques

The main objective is to identify cerebral correlated of pedophilia using neuroimaging techniques.


Eligibility Criteria:
Inclusion Criteria (for patients):

* Diagnosis of pedophilia
* Male
* Age between 18 and 65
* Informed consent signed

Inclusion Criteria (for healthy patients):

* Male
* Age between 18 and 65
* Informed consent signed

Exclusion Criteria (for patients):

* IQ \<70
* Ongoing treatment with cyprostrerone acetate or GnRH agonist or antidepressant treatment (5HT reuptake inhibitor)
* Ongoing detention

Exclusion Criteria (for healthy patients):

* psychiatric disorders
* IQ\<70
* Sexual disorders
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the percentage of participants who achieve different thresholds in fasting TG. Another objective is to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).

This will be a multi-center, randomized, double-blind, placebo-controlled study in approximately 152 participants with hypertriglyceridemia (triglycerides \> 150 milligrams per deciliter \[mg/dL\]) and established or at increased risk for atherosclerotic cardiovascular disease, and/or with severe hypertriglyceridemia. The study will have an up to 8-week screening period, a 53-week treatment period, and a 13-week post-treatment follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years at the time of informed consent
2. Fall into at least 1 of the following groups (a or b):

   1. Hypertriglyceridemia with fasting TG ≥ 150 mg/dL (1.69 millimoles per liter \[mmol/L\]) and \< 500 mg/dL (5.65 mmol/L) with either clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or at increased risk for ASCVD
   2. Severe hypertriglyceridemia with fasting TG ≥ 500 mg/dL (5.65 mmol/L).
3. Participants must be on standard-of-care (SOC), lipid-lowering medications per local guidelines.
4. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria:

1. Diabetes with any of the following:

   1. Newly diagnosed within 12 weeks of screening
   2. Hemoglobin A1C (HbA1c) ≥ 9.5% at Screening
   3. Change in basal insulin regimen \> 20% within 3 months prior to Screening
   4. For participants with type 1 diabetes: episode of diabetic ketoacidosis, or ≥ 3 episodes of severe hypoglycemia within 6 months prior to Screening
2. Acute coronary syndrome or stroke/transient ischemic attack (TIA) within 6 months prior to Screening
3. Major surgery, peripheral revascularization, or non-urgent percutaneous coronary intervention (PCI) within 3 months prior to Screening, or upcoming planned major surgery or major procedure (e.g., arterial revascularization) during the course of the study
4. Active pancreatitis within 4 weeks prior to Screening
Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.

A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women ≥ 18 years of age
* Gestational age between 14 and 26 weeks confirmed by ultrasound
* Currently smoking ≥ 5 cigarettes per day

Exclusion Criteria:

* Abnormal liver function tests
* History of or current seizure disorder or closed head injury with loss of consciousness
* Known hypersensitivity to bupropion
* Any psychiatric disorder requiring psychotropic medication
* Current anorexia or bulimia
* Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks
* Major Depressive Disorder or current suicidal risk
* Use of any illicit substances since receiving knowledge of pregnancy
* Regular use of alcohol (\>1 drink/week on average)
* Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus
* Twins or other multiple gestation
* Fetal abnormality on the 14 week ultrasound
* Plans to deliver at a hospital other than Memorial Hermann
* Inability to communicate with research staff or make study visits due to lack of phone or transportation access
* Participation in another clinical study which may affect study outcomes
* Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)
Nursing Care With Patients With Venous Leg Ulcers

Aims are:

* develop an Internet-based education programme about venous leg ulcer nursing care (ELC)
* evaluate the clinical, cognitive and economical outcomes of education programme

Research questions are:

1. What are the cognitive outcomes of ELC (perceived knowledge, attitudes towards venous leg ulcer nursing care, theoretical knowledge level and practical knowledge)?

Hypotheses for research question 1 are:

1. Nurses using the ELC will have better knowledge (perceived, practical and theoretical knowledge) than those who will not use the ELC.
2. Nurses using the ELC will have more positive attitudes towards venous leg ulcer nursing care than those who will not use the ELC.

2. What are the clinical outcomes of ELC (ulcer healing, ulcer size, treatment supplies)?

Hypotheses for research question 2 are:

1. Ulcer healing progresses better among patients who are taken care by nurses using the ELC.
2. Ulcer sizes will be 10 % smaller among the patients cared for nurses using the ELC.
3. Nurses using the ELC will use mire adequate treatment supplies than those who will not use the ELC.

3. What are the economical outcomes (treatment time and supply usage) of ELC?

Hypothesis for research question 3 is:

1. The economical expenditures will be lower among nurses using the ELC.

The ultimate aim is to promote evidence-based nursing care among patients with venous leg ulcer.

The study takes place in home-care in two Finnish municipality, which are similar size and staff structure and working ideology are basically the same.

Enrolment of participants has started with information occasion in both municipalities in June 2014. Nurses were asked to fill the Patients Clinical Situation Questionnaire, handouts and forms for informed consent were delivered. (Figure 1) All eligible nurses and patients will be identified with Patient Clinical Assessment. The sample size was determined with power analysis and the result was that 200 nurses are needed in the intervention group and 100 nurses in the comparison group.

Eligibility Criteria:
Inclusion criteria for nurses:

1. Working in municipality home-care
2. Permanent attachment or three months or longer temporary post in municipality home-care
3. Working in home-care area where patients with chronic leg ulcer are taken care during the study

Exclusion criteria for nurses:

1. Working in other place than home-care There are no other exclusion criteria.

Inclusion criteria for patients to observation are:

1. Home health-care patient aged 60 or over
2. Venous leg ulcer diagnosis
3. Chronic ulcer in the lower leg without diagnosis

Exclusion criteria for patients:

1. An ulcer with other diagnosis than venous leg ulcer diagnosis There are no other exclusion criteria for patients.
The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients

This study prospectively uses the biased coin technique to investigate the effect of concomitant administration of remifentanil on the 95% effective dose of intravenous remimazolam (Effective dose 95 \[ED95\]) required for loss of consciousness during anesthesia induction. .


Eligibility Criteria:
Inclusion Criteria:

* The adult patients who are scheduled to surgery under general anesthesia

Exclusion Criteria:

* Severe obesity (BMI \> 30 kg/m2)
* Allergy to remimazolam or remifentanil
* Under conditions which make it difficult to respond to the investigator's verbal commends like hearing impairment, etc.
* Patients with general conditions are more than ASA class III
* Patients with brain disease (dementia, cerebral infarction, etc.)
Clinical Study of Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Knee Osteoarthritis

Umbilical cord blood mononuclear cells contain hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), endothelial progenitor cells and other pluripotent stem cells, as well as immature immune cells, which can differentiate into chondrocytes, hematopoietic, epithelial, endothelial and nerve cells. It gives the ability to promote wound healing and vascular microcirculation reconstruction, and has the potential to treat many diseasesHowever, clinical studies on cord blood mononuclear cells in knee osteoarthritis have not been reported in the literature. Therefore, this study aims to explore the safety and effectiveness of cord blood mononuclear cells in the treatment of patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥30 years old, ≤75 years old, no gender limit;
* Meet the KOA diagnostic criteria in the "Classification Criteria for Knee Osteoarthritis" revised by the American College of Rheumatology (ACR);
* According to the X-ray K-L grading and evaluation standard, it is at level II-III;
* Continuous pain for at least 6 months;
* No local or systemic infection;
* There is no obvious contraindication for articular cavity puncture in hematology and biochemical testing;
* Subjects and their families understand the clinical trial protocol and agree to participate in the trial, voluntarily and sign an informed consent form;

Exclusion Criteria:

* Age\<30 years old;
* Tumor diseases;
* Severe kidney, lung or liver damage;
* Blood diseases include anemia and thrombocytopenia;
* Type I diabetes;
* Severe effusion;
* Contracture or instability of the knee joint, with an axial deformity greater than 10°;
* Infectious arthritis or skin disease;
* Inject corticosteroids and immunosuppressants into the knee joint within 2 months;
* Suffer from mental illness and poor compliance;
* Cases that the investigator thinks are not suitable for inclusion in the group.