cyrilzakka/clinical-trials huggingface dataset:
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy

The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm Embolization System used to embolize intracranial aneurysms

The following parameters will be evaluated as part of this study:

* Aneurysm morphology
* Aneurysm size
* For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)
* Size of the embolization device(s) used in the procedure
* Intra-procedural assessment of aneurysm occlusion and flow stasis
* Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and other scores as appropriate)
* Aneurysm occlusion durability
* Recanalization rate
* Device-related changes in Modified Rankin Scale from baseline
* Complications/adverse events
* Rebleed/new bleed

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Must sign and date an IRB/EC-approved written informed consent prior to initiation of any study procedures

Exclusion Criteria:

* Must not have clinical or angiographic evidence of vasospasm
* Must not have lesion with characteristics unsuitable for endovascular treatment
* Must not have neurologic or psychiatric conditions, which preclude ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule
* Must not be concurrently involved in another investigational or post-market study
* Must not have received any investigational device for treatment of the target intracranial aneurysm prior to entry into this trial
Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

The frequency of femoral nerve block and adductor canal block for analgesia after TKA(total knee arthroplasty) increases with the use of ultrasonography in regional anesthesia. In this study, we aimed to compare the effects of femoral nerve block and adductor canal block on postoperative analgesia in patients undergoing unilateral knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* ASA(American Society of Anesthesiologists) Classification I-II
* Age: \<55 years
* Unilateral total knee arthroplasty

Exclusion Criteria:

* Does not approve the study
* Pregnant
* Emergency
* ASA III-IV
* History of local anesthetic allergy
* Infection in the block area
* Coagulation disorder
* Morbid obesity (body mass index\> 40 kg / m²)
* Severe organ failure
* Previous neurological deficit
* Psychiatric disease
* History of chronic pain
Urinary Incontinence in Women From Amapa

The investigators aim to study the prevalence of urinary incontinence in women who live in the riverside community in the state of Amapa (The Bailique Island) and compare it to the prevalence of urinary incontinence in women who live in the urban region -Macapa-the capital city of the Amapa State - Brazil.

The study aims to compare urinary complaints of women belonging to two different groups: women who live in a riverside area of the Amapa State-the Bailique Island, which is about 12 hours by boat from the state capital city and compare them to those of the women who live in the urban region -Macapa (the capital city of the Amapa State). The main goals are: to describe the clinical features of the women in the study, assess probable risk factors concerning the urinary incontinence, make physical gynecological exam as well as urodynamic studies in the patients who have urinary complaints and use a life quality questionnaire with those patients (Kings Health Questionnaire).

Cross and prevalence Study, followed by case series. Cohort study between the two populations. The riverside group with 120 interviews and the urban group with 260 interviews, where the sample calculation was based on the population of each region and the incidence of urinary incontinence checked through a pilot study.

After reading and signing an informed consent, interviews with women aged 20 years or over and non-pregnant are hold so as to identify those who have complaints about urinary incontinence, socio-economic data and risk factors. In patients who complain about urinary incontinence, gynecological exams are performed in order to assess genital prolapse and urodynamic studies are made as to confirm urinary incontinence and life quality questionnaire. All the data will be encoded in the database and analyzed through statistics programs and a comparison between the two groups (urban and riverside) will be made.

Eligibility Criteria:
Inclusion Criteria:

* women aged 20 or over
* living either in the urban area or in the riverside

Exclusion Criteria:

* women under 20 and
* pregnant
ECoG BMI for Motor and Speech Control

Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.

ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With this ECoG-based neural interface, study patients will undergo training and assessment of their ability to control a complex robotic system and to determine if ECoG brain signals can be used to produce speech.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21
2. Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy.
3. Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living.
4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
5. Must live within a two-hour drive of UCSF

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Inability to understand and/or read English
3. Inability to give consent
4. Dementia, based on history, physical exam, and MMSE
5. Active depression (BDI \> 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.)
6. History of suicide attempt or suicidal ideation
7. History of substance abuse
8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure
9. Inability to comply with study follow-up visits
10. Any prior intracranial surgery
11. History of seizures
12. Immunocompromised
13. Has an active infection
14. Has a CSF drainage system or an active CSF leak
15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition
16. Has an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump, or presence of any head or neck metallic foreign bodies
17. Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum iridium, nichrome)
A New Surgical Treatment Technique "Aspiration and Percutaneous Capsulotomy" for Digital Mucous Cyst

Digital mucous cysts (DMCs) are a benign rubbery cystic lesion which usually involve the dorsal or lateral side of DIP joint (digital interphalangeal joint) or proximal nail fold. The most successful treatment way is surgical management. However, which may cost time, require expertise, may cause infection, prolong wound healing and sometimes may lead to the joint movement limitation. The investigator bring this new technique: percutaneous capsulotomy for digital mucous cysts, which is easy and quick, last but not least, low recurrence rate.

Participant

Between 2016 and 2017, 50 participants with DMCs in Taipei veteran general hospital were included in this study. According to the clinical assessment at OPD(out participants department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including participant's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment. After explaining to participants about the treatment choice (surgical excision, aspiration of cystic contents, and our needle assisted percutaneous capsulotomy for mucous cyst) and participants agreed with accepting needle assisted percutaneous capsulotomy, they were selected for accepting our needle assisted percutaneous capsulotomy for mucous cyst.

Surgical capsulotomy procedure.

The surgical procedure for DMCs was using a 18G needle performing aspiration first and then cutting the stalk tract by the needle tip for capsulotomy. All procedure were done with local anesthesia. After operation, the investigator asking participants using dressing to pressure the wound about 10 minutes to stop bleeding. Later on, the wound was covering with antimicrobial ointment (neomycin) and simple dressing. Educating participants from water for 24 hrs.

Clinical assessments

The investigator evaluating participant's prognosis by VAS, the improvement of fingernail deformity, the participants' subjective satisfaction and the recurrences was evaluating during follow-ups. This clinical study's approval was obtained from Association of IRB, Taipei veteran general hospital.

Eligibility Criteria:
Inclusion Criteria:

* According to the clinical assessment at OPD(out patient department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including pateint's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment

Exclusion Criteria:

* autoimmune disease related diffused arthritis, age younger than 20 year-old, severe painful deformity of the involved joint.
Tolerability and Efficacy of CD+A Compared to AQ+SP for the Treatment of P.Falciparum Malaria in Rwandan Children

In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded.

Between 2001 and 2006, as an interim strategy, Rwanda chose amodiaquine+ sulfadoxine-pyrimethamine (AQ+SP) as the first line anti-malaria treatment. Although the clinical response to this combination was relatively good in 2001, since then its efficacy has steadily declined: in 2002 the proportion of successful treatment (recorded at 28 days and PCR-unadjusted) was 83 % (Rwagacondo et al., 2003) and in 2003 it was 74% (Karema et al., 2006). Different artemisinin-based combination treatments (ACTs) such as amodiaquine+artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPPQ) and artemether-lumefantrine (ALN) have been tested in the past few years as possible alternatives to AQ+SP (Fanello et al., 2006; Karema et al., 2006).

Chlorproguanil-dapsone (also known asLapDap) is an antifolate combination similar to sulfadoxine/pyrimethamine (SP) but for two important features: (1) it is rapidly eliminated and therefore exerts less selective pressure for resistance-conferring parasite mutations than does SP (Winstanley et al., 1997; Nzila et al., 2000b) and (2) it is active against the SP-resistant forms of the parasite that are found in Africa (Mutabingwa et al., 2001a,b; Kublin et al., 2002). Moreover, a pediatric course of treatment of LapDap is estimated to cost $0.15 (Mutabingwa et al., 2001b), making it orders of magnitude less expensive than any marketed antimalarial drug other than chloroquine and SP.

In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up until day 28 after treatment. Adverse events, clinical and parasitological outcomes were recorded.

Based on the results of all trials carried out by the NMCP, The Rwandan Ministry of Health has now changed the first line to artemether-lumefantrine (ALN), Coartem®. The drug arrived in the country in October 2006.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-59 months;
* Weight ≥5 kg;
* Monoinfection with P. falciparum;
* Parasite density between 2,000-200,000/µL;
* Fever (axillary body temperature =\>37.5C) or history of fever in the preceding 24 hours;
* Packed Cell Volume (PCV) \>21%.

Exclusion Criteria:

* Severe malaria;
* Mixed malaria infection;
* Any other concomitant illness or underlying disease;
* Known allergy to the study drugs being used in this trial;
* Clear history of adequate antimalarial treatment in the previous 72 hours.
Evaluation of Blood Platelet Indices,Platelet Aggregation in the Activity of IBD Patients on Biological Treatment

ulcerative colitis and Crohn's disease, the two major forms of inflammatory bowel disease, are chronic, idiopathic, relapsing inflammatory conditions of the gastrointestinal tract. The mechanism is multifactorial and may result from the combined interaction of environmental, genetic, epithelial barrier defects, dysregulated immune responses, and microbial factors

Histopathological examinations play a role in the diagnosis and management of UC, but they are costly and invasive. So, non-invasive inflammatory biomarkers of IBD, such as the WBCS, ESR and CRP are used in clinical practice .

Platelets play a critical role in blood hemostasis so impaired platelet activation may cause persistent mucosal inflammation. Many studies have demonstrated that patients with IBD may have increased risks of venous thrombosis. Thrombosis is a major cause of morbidity and mortality in IBD.

Platelet to lymphocyte ratio can be easily calculated from CBC can serve as useful biomarkers for predicting mucosal inflammation in UC.

Current disease management guidelines were focused on the use of anti-inflammatory agents, aminosalicylates, and corticosteroids. However, some patients are still refractory to these therapies.

Biological therapy has revolutionized the management of inflammatory bowel disease in the last few years. There available biologic medicines are infliximab, adalimumab, golimumab, vedolizumab, and ustekinumab. Biological therapy brought a better control of inflammatory bowel diseases. Its use requires specific care before the beginning and during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. All patients diagnosed with inflammatory bowel disease ulcerative colitis or crohn's disease
2. All IBD patients received biological treatment
3. All IBD patients controlled with conventional treatment

Exclusion Criteria:

1. IBS patients
2. IBD Patients with: a) another autoimmune disease like ITP and SLE B) Bleeding tendency as hemophilia or thrombophilia C) Previous thrombotic events or on anticoagulants or antiplatelet drugs D) With another comorbidity as liver cell failure, respiratory failure, renal failure and cardiac failure
Sympatholysis in Chronic Kidney Disease

The purpose of this study is to find out why patients with chronic kidney disease (CKD) have poor exercise capacity and what causes an increase in blood pressure during exercise (i.e. increased adrenaline levels, or decreased ability of blood vessels to dilate).

Patients with chronic kidney disease (CKD) suffer from exercise intolerance and poor physical capacity which contributes to increased cardiovascular risk in this patient population. Prior studies have shown that CKD patients have an exaggerated increase in blood pressure (BP) during both static and rhythmic exercise. Such abnormal hemodynamic responses to exercise can contribute to poor physical capacity and abnormal muscle blood flow during exercise in these patients. The goals of this project are to investigate the mechanisms and potential therapies targeting the abnormal hemodynamic response during exercise in CKD by examining the roles of impaired vasodilation, and exaggerated vasoconstriction.

Eligibility Criteria:
Inclusion Criteria:

* Veterans with Stages III and IV Chronic Kidney Disease (CKD)
* Kidney transplant recipients with varying degrees of kidney function
* Veterans 18-75 years old, without kidney disease, as study controls
* Exercise less than 20 minutes twice per week
* Willing and able to cooperate with the protocol

Exclusion Criteria:

* Severe CKD (estimated glomerular filtration rate (eGFR) \< 15 cc/minute)
* Metabolic alkalosis (serum bicarbonate \> 28 meq/L)
* Ongoing drug or alcohol abuse
* Diabetic neuropathy
* Any serious systemic disease that might influence survival
* Severe anemia with hemoglobin (Hbg) level \< 10 g/dL
* Clinical evidence of congestive heart failure or ejection fraction below 35%
* Symptomatic heart disease determined by prior electrocardiogram, stress test, and/or history
* Treatment with central alpha agonists (clonidine)
* Uncontrolled hypertension with blood pressure (BP) greater than 170/100 mmHg
* Low blood pressure with BP less than 100/50 mmHg
* Pregnancy or plans to become pregnant
* Current treatment with monoamine oxidase inhibitors (MAOIs)
* Inability to exercise on a stationary bicycle
Reducing Obesity Using Social Ties Program

This trial aims to test the feasibility and acceptability of addressing interpersonal barriers to weight-related behavior change. Specifically, the study will test if, by including up to two friends, family members, or co-workers in a lifestyle intervention for weight loss, the person enrolled in the study loses more weight than someone whose friends, family members, or co-workers were not invited to participate.

The investigators will evaluate whether the ROBUST intervention not only addresses individual-level behaviors (i.e., healthy eating, increased physical activity) but also:

1. reduces social undermining as well as changes perceived health norms by activating communal coping - a behavioral process that involves thinking, communicating, and acting as if a health risk (i.e., Type 2 diabetes) is shared; and
2. dampens the harmful effects of increased interpersonal conflict on weight by teaching participants how to induce a positive affect and self-affirming mindset

Participants in the control arm will receive the same number of lifestyle sessions as those randomized to the social network intervention.

Participants will:

1. Be randomly assigned to either the study group, which is asked to invite up to two friends or family members to join them at three coaching sessions, or the group that does not invite anyone.
2. Receive 15 coaching sessions over 24 weeks.
3. Complete an online questionnaire about eating and physical activity habits, confidence in developing healthier habits, mood, and health habits of twelve of their closest friends and family members.
4. Complete a 3-day weekly food log and wear a provided Fitbit for at least 9 hours daily.
5. The invited friends and family members will also be asked to complete a brief questionnaire about their eating and physical activity habits when they start and end the study.

Eligibility Criteria:
Inclusion Criteria:

* Index Participant:

  1. Black race or Hispanic ethnicity
  2. Male or Female 18 years of age or older
  3. Calculated BMI \> 30kg/m2 from objectively measured height and weight by study staff
  4. Access \& willingness to use program food intake app via home computer or a smartphone
  5. Ability to identify at least one adult social network member who will participate in the study
* Social Network Member:

  1. Male or Female 18 years of age or older
  2. Access to the internet or a smartphone

Exclusion Criteria:

* Index Participant:

  1. Active enrollment in a weight-loss program, use of weight-loss medications, or planning weight-loss surgery
  2. Advanced medical illness, dementia, hospitalization, injury, or pregnancy that inhibits regular physical activity
  3. Contraindications to exercise based on the Physical Activity Readiness Questionnaire or lack of clearance from a health care provider
  4. Unresolved Food insecurity
  5. Speaks a language other than English or Spanish
* Social Network Member:

  1. Speaks a language other than English or Spanish
Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)

The overall aim is to evaluate the impact of the use of two different guidelines for monitoring labor progress, the WHOs LCG versus standard care, on neonatal and maternal outcomes. The hypothesis is that the use of LCG will reduce adverse neonatal outcomes and decrease the number of intrapartum Cesarean sections compared with standard care.

Secondly, other perinatal interventions and complications will be compared between the LCG and standard care groups, as well as economic considerations. This will be investigated using a multicenter, stepped-wedge cluster randomized trial design.

In addition, the project will explore a series of quantitative and qualitative research questions to gain in-depth knowledge about experiences and perceptions about childbirth and the use of LCG. These research questions will be investigated using questionnaires, focus group and individual interviews with providers, partners and women that have gone through childbirth.

Study Title

Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? A stepped-wedge cluster randomized trial (PICRINO).

Primary Objectives

To compare two different guidelines for monitoring labor progress, the the World Health Organization (WHO)'s Labour Care Guide (LCG) with standard care, and evaluate:

Adverse neonatal outcome, a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score \<7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.

The rate of intrapartum cesarean section.

Secondary Objectives

Secondary outcomes will be a composite of severe neonatal outcomes including five-minute Apgar score \<4, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures and meconium aspiration syndrome and other relevant neonatal outcomes.

Obstetric outcomes will be mode of delivery, oxytocin use, postpartum hemorrhage, perineal laceration (grade II-IV), duration of labor, women´s and partner´s experiences of childbirth, healthcare providers experiences of and compliance to LCG and economic considerations.

Study Design

A multicenter, stepped-wedge cluster randomized trial.

Study Population

All women in active labor at participating delivery units in Sweden.

Power analysis

With significance level 0.05, the power to detect the anticipated risk reduction (20%) would be \>0.999.

Study Duration

2023-2025

Eligibility Criteria:
Inclusion Criteria:

-All women in active labor

Exclusion Criteria:

-No exclusion criteria