cyrilzakka/clinical-trials huggingface dataset:
Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands

Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.

20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (\> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

Eligibility Criteria:
Inclusion Criteria:

* Must be ≥22 years of age
* Competent and willing to provide written, informed consent to participate in the study
* Willing to comply with study protocol requirements

For subjects with Essential Tremor:

* A diagnosis of essential tremor
* A tremor severity score of 2 or above in the dominant hand/arm as measured by one of the TETRAS upper limb postural tremor items
* No significant alcohol intake within 8 hours prior to study visits

For subjects with Parkinson's Disease:

* Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
* Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry

Exclusion Criteria:

* Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
* Suspected or diagnosed epilepsy or other seizure disorder
* Any skin condition at the stimulation site that in the investigator's opinion should preclude participation in this study
* Diagnosed with peripheral neuropathy affecting the tested upper extremity
* Presence of any other neurodegenerative disease other than essential tremor or Parkinson's Disease
* Subjects unable to communicate with the investigator and staff
* Any health condition or concomitant medication that in the investigator's opinion should preclude participation in this study
* Pregnancy or anticipated pregnancy during the course of the study
* Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
* Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor
The Outcome of Abdominoplasty After Massive Weight Loss

The primary aim of this study is to compare early surgical complications after abdominoplasty performed by plastic and general surgeons. Secondary aims were to assess whether specific guidelines might have impact on the rate of complications. The hypothesis is that general surgeons have more complications.

Bariatric surgery has gained widespread acceptance and 6,800 patients are yearly operated in Sweden. Approximately 30 % of these patients require abdominoplasties for functional disabilities being a total of 2,300 patients. Today the plastic surgeons of the departments of Plastic and Reconstructive Surgery do not have the capacity to accommodate this demand. A Department of General Surgery started to perform abdominoplasties.

This is a retrospective cohort study. Charts were retrieved from 69 consecutive patients operated by general surgeons at Capio S:t Görans Hospital, Stockholm, Sweden (group A) from 13th of May to 19th of December 2011. Charts from 70 consecutive patients operated by plastic surgeons at the Department of Plastic and Reconstructive Surgery, Karolinska University Hospital, Stockholm, Sweden (group B) were studied from 14th of January 2010 to 7th of December 2012. Collected data consist of patient demographics, operation methods, and complications observed at 30 days' follow-up. The outcome of a third group of about 70 patients operated between 22th of January 2013 to 3th of June 2014 at S:t Görans Hospital (group C) are compared to the outcome of groups B and A. Guidelines for the surgical technique as well as pre-and postoperative care were refined between the operations of group A and C.

Statistics Anova and regression analysis will be applied. And for dichotomous data Chi-Square test and Fischers exact test will be calculated. Power was calculated with the test of proportion for two independent groups and 5 per cent significance.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal skin ptosis \> 3 cm
* Weight stability \> 6 months
* Smoke free \> 6 weeks prior to surgery
* BMI ≤28 or a significant weight reduction equivalent to 80 per cent of excess weight

Exclusion Criteria:

* Weight instability
* Smoking
* BMI \>35
* Psychological imbalance or psychiatric non-treated diseases
* Advanced cardio-vascular diseases
Feasibility of Internet Group CBT-I for Gyn Oncology Patients

The goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting.

Secondary objectives:

1. To compare insomnia symptoms before and after intervention.
2. To evaluate any changes in quality of life symptoms while undergoing the intervention.
3. To evaluate the duration of symptoms improvement after the intervention is complete.

This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.

Eligibility Criteria:
Inclusion Criteria:

1. English-speaking women greater than 18 years old who present to UC Davis Comprehensive Cancer Center for treatment or surveillance of gynecologic cancer
2. Must have access to internet
3. Be able to connect via secure web-based platform
4. Be able to complete online questionnaires
5. Moderate or severe insomnia
6. Have access to a mobile device or computer

Exclusion Criteria:

1. Participants without ability to connect with both audio and visual through secure web-based platform
2. Participant is currently taking sleep medication prescribed by their provider for sleep disturbance or insomnia - Patients taking over the counter medications or supplements are eligible
3. Participants with remote history of insomnia, but not currently having symptoms of insomnia
4. Have other reasons for poor sleep
Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers

The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration of a novel selective alpha2c adrenoceptor antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741 affects connectivity between brain areas in rest, as measured using fMRI, and cognitive performance in the sample under investigation.


Eligibility Criteria:
Inclusion Criteria:

* good command of English language
* right handedness
* normal or corrected-to-normal vision

Exclusion Criteria:

* personal history or active presence of psychiatric conditions
* usage of psychotropic medication within the past 3 months
* pregnancy or breast-feeding status
* systolic blood pressure \< 90 mmHg or \> 140 mmHg at screening visit
* diastolic blood pressure \< 50 mmHg or \> 90 mmHg at screening visit
* resting heart rate \< 45 beats/minute or \> 100 beats/minute at screening visit
* active presence of medical condition at physical examination
* history of major traumatic brain injury
* any other contraindication to MRI of the brain
* use of psychoactive substances incl. alcohol in 24 hours prior to test session
Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors

RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting. It may also help improve mental health, quality of life, and immune function in patients receiving chemotherapy.

PURPOSE: This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors.

OBJECTIVES:

Primary

* Compare the effect of mindfulness relaxation vs relaxing music vs standard symptom management education on conditioned and nonconditioned nausea and vomiting in patients with newly diagnosed solid tumors undergoing chemotherapy.

Secondary

* Compare mental health (anxiety, depression, and distress), quality of life (cancer-related symptoms, fatigue, sleep, and pain), and immune function in patients receiving these interventions.

OUTLINE: This is a multicenter study comprising a pilot phase followed by a randomized phase. (Pilot phase completed as of 3/10/2012.)

* Pilot phase: Patients undergo mindfulness relaxation (MR) therapy comprising listening to instructions on breathing techniques and other mind and body relaxation practices on compact disc for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment. (Pilot phase completed as of 3/10/2012.)
* Randomized phase: Patients are randomized to 1 of 3 treatment arms.

  * Arm I: Patients undergo MR therapy as in the pilot phase.
  * Arm II: Patients listen to relaxing music (with no instructions on relaxation techniques) for 30 minutes before and during each chemotherapy session AND at least once daily for the entire duration of chemotherapy treatment.
  * Arm III: Patients receive standard symptom management education. In both phases, nausea and vomiting, mental health (anxiety, depression, and distress), and quality of life (cancer-related symptoms, fatigue, sleep, and pain) are assessed at baseline, periodically during treatment, and then at 3 months.

Patients are followed annually for up to 5 years for survival.

PROJECTED ACCRUAL: A total of 474 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

1. are \>/= 18 years of age
2. are anticipated to undergo at least four cycles of chemotherapy treatment
3. have had no previous treatment with chemotherapy
4. have no evidence of distant metastatic disease
5. can read/speak in English or Spanish
6. have no known psychotic diagnosis
7. have an expected survival of at least 6 months

Exclusion Criteria:

1. have a known psychotic diagnosis
2. will undergo an undefined number of chemotherapy regimens
Pulse Sequence Development on 3T Magnetic Resonance Imaging/Spectroscopy

The purpose of this study is to find ways to improve the appearance of tumours or markers that indicate the presence of tumours in Magnetic Resonance Imaging (MRI). Although based on the same technology, there are many ways to obtain images using MRI. The type of image that will be produced by the scanner depends on the instructions sent to the machine. These instructions tell different components of the machine when to turn on and off and all together are called a pulse sequence. These pulse sequences can get quite lengthy and intricate and small changes in them can produce considerable changes in the resulting image. the aim of this protocol is to alter existing pulse sequences to improve image appearance. This protocol will involve only healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult

Exclusion Criteria:

* subject under 18 years of age
* subject pregnant, or may be pregnant
Anterolateral Versus Posterior Approach for Total Hip Arthroplasty After Displaced Femoral Neck Fracture

There are two surgical approaches (incision types) used by surgeons who do total hip replacements. The purpose of this study is to determine which type of surgical approach (incision type) produces the best results for patients who have a total hip replacement.

Null Hypothesis : There is no difference in complication rate, functional outcome, surgical time, or blood loss when comparing outcomes in patients receiving THA to hemiarthroplasty or ORIF for femoral neck fractures.

Patients undergoing Total hip Arthroplasty following displaced femoral neck fracture, will be consented and randomized to one of two surgical approaches ( anterior or posterior).

Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* Age 65 years or older
* Acute, femoral neck fracture

Exclusion Criteria:

Cognitive impairment

* Active Infection
* Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease)
* Limited life expectancy
* Pathologic fracture (tumor)
* Acetabular fractures
Cytisine Pharmacokinetics and Dose Response (C-DRAKS 3 and C-DRAKS 4)

A number of pharmacotherapies are available for smoking cessation in New Zealand including nicotine replacement therapy, bupropion, an antidepressant medication and varenicline. Of these, varenicline is the most effective, but also the most expensive. Varenicline acts like nicotine and stimulates nicotine receptors in the brain, but to a lesser extent, and simultaneously block nicotine binding to its receptors and thus reduces the rewarding effects of cigarette smoking. Cytisine (Tabex® and Desmoxan®) is a plant alkaloid and also acts in a similar way to varenicline but is significantly cheaper. It has been used for more than 50 years in some parts of eastern and central Europe as an aid to quit smoking, but is not approved for use in many countries such as New Zealand, Australia, the UK or the US. Randomised, placebo-controlled trials have shown that cytisine is more effective than placebo and nicotine replacement therapy (NRT)for smoking cessation. However there is a paucity of pre-clinical data on cytisine. In particular, there are limited data on the pharmacokinetic and the dose response characteristics of cytisine. Furthermore, the current dosing regimen recommended by the manufacturer is complex and has no clear basis in empirical research.

Complexity of dosing has been shown to be a key factor in determining adherence. Therefore, a simpler regimen would likely maximise the effectiveness of treatment through improved adherence to the treatment regimen. The investigators therefore propose to undertake two studies to investigate the influence of dose, dosing frequency and dosing duration on the pharmacokinetics and tolerability of cytisine and cigarette craving in smokers.

see above

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age,
* be able to provide written consent,
* have no significant medical or psychiatric disorder (see below under exclusion criteria)
* smoke at least 10 cigarettes a day

Exclusion Criteria:

* they are pregnant or breastfeeding,
* they are current users of NRT products,
* they are current users of non-NRT smoking cessation therapies (e.g. bupropion \[Zyban®\], clonidine, nortriptyline, or varenicline \[Champix®\]),
* they are enrolled in another smoking cessation programme (concurrent referral to a face-to-face provider from Quitline is acceptable) or other cessation study
* they have had a heart attack, stroke, or severe angina within the past three months,
* they have uncontrolled high blood pressure (\> 150 mmHg systolic, \> 100 mmHg diastolic),
* they have phaeochromocytoma,
* they have been diagnosed with epilepsy
* they suffer from significant mental health problems
* they have severe renal impairment
* they are taking medications which are significantly affected by cessation of smoking (e.g. warfarin, olanzapine, clozapine, therophylline, etc.)
Augmenting Urinary Reflex Activity: Study 3

AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.


Eligibility Criteria:
Inclusion Criteria:

* Participant has exited the AURA-2 clinical investigation.
* Participant has an implanted Amber UI system.
* Consents to participation.

Exclusion Criteria:

* Participant has withdrawn from AURA-2 clinical investigation.
* Participant is pregnant.
* A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).
Etoricoxib Versus Gabapentin for Knee Arthroscopy

To determine that when administered as part of a multimodal analgesic regimen, use of the new COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).

Background: Post-discharge pain remains a significant problem after many ambulatory surgery procedures. Both etoricoxib and gabapentin have been used to prevent postoperative pain; however their relative efficacy in the post-discharge period is not known. We hypothesized that daily use of etoricoxib would offer advantages over gabapentin as part of a multimodal analgesic regimen in the perioperative period due to its pharmacokinetic profile.

Methods: Seventy-five healthy outpatients undergoing elective ambulatory knee arthroscopy were randomly assigned to receive identical-appearing capsules containing either a placebo, gabapentin (1.2g, or etoricoxib 120 mg, 30-90 min before skin incision and at 08H00 on the first, second, and third postoperative days. Post-discharge pain was treated with "rescue" dipyrone syrup (500 mg). Pain intensity (as assessed using a 100 visual analog scale), dipyrone usage, and the incidence of nausea and vomiting, sedation and anxiety were recorded at specific time intervals in the postoperative period. The recovery of functional activity was assessed at 96 h after surgery using a validated questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Elective ambulatory knee arthroscopy

Exclusion Criteria:

* History of clinically-significant cardiovascular,pulmonary,hepatic,renal, neurologic, psychiatric or metabolic disease
* Patients chronically receiving pain killers
The Maximum Tolerated Dose of Mesenchymal Stem Cells From Umbilical Cord

The aim of this study was to evaluate the maximum tolerated dose of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of human knee OA

This is a single-centre, quadruple blined, randomized controlled trail with a total of 9 knee osteoarthrits patients as participants, who will be randomly assigned into high dose group, moderate dose group or low dose group. The participants in the high dose group will receive the treatment of high dose MSCs (1×10\^8cells/3mL) anticular injection.The dose of the MSCs in medium dose group is 5×10\^7cells/3mL, and the dose in the low dose group is 1×10\^7cells/3mL. Unexplained local and systemic symptoms will be assessed to determine the the maximum tolerated dose of mesenchymal stem cells in anticular injection.

Eligibility Criteria:
Inclusion Criteria:

① K / L score of 2-3; ② chronic knee pain; ③ no local or systemic infection; ④ without obvious contraindication of the joint puncture from hematology and biochemical tests; ⑤ informed consent. -

Exclusion Criteria:

① older than 75 years old or less than 18 years old, or without full capacity for civil conduct; ② HIV, hepatitis virus or syphilis virus infection or their serology is positive; ③ BMI index is greater than 30; ④ congenital or acquired knee deformity; ⑤ pregnant or lactating women; ⑥ tumor patients; ⑦ immunodeficiency patients; ⑧ intra-articular drug injection history within 3 months; ⑨ participating in other clinical trials; ⑩ other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.-
Comparison of the Efficacy of Ticagrelor Combined With ASA to ASA Alone in Patients With Stroke

Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA.

Cerebrovascular disease is the main cause of death and severe long-term disability worldwide. Antiplatelet drugs are the main drugs for ischemic stroke and TIA. Cyclooxygenase inhibitor acetylsalicylic acid (ASA) has always been the most widely studied antiplatelet therapy. The studies of acrates of aliscon body evaluated the efficacy and safety of ticagrelor monotherapy in preventing major vascular events in patients with AIS or TIA. The results showed that the number of patients with endpoint events in ticagrelor group was less than that in ASA group, However, it has not been proved that ticagrelor monotherapy is better than ASA. The purpose of this study is to prove that ticagrelor is better than ASA. The study will be designed as a randomized, double-blind, placebo-controlled, parallel grouping study and conducted in multiple centers to ensure the representation of multiple countries, races and races, so as to ensure that the results of the study can be widely applied.

Eligibility Criteria:
Inclusion Criteria:

1. Over 40 years old
2. Acute ischemic attack
3. Symptoms occurred within 24 hours after randomization

Exclusion Criteria:

1. Dual antiplatelet therapy with ASA and P2Y12 inhibitors is needed
2. Antiplatelet agents other than ASA
3. Anticoagulant therapy
4. Have any atrial fibrillation / flutter
5. Renal failure requiring dialysis
6. During pregnancy or lactation
Longitudinal Geriatric Assessment to Optimize Outcomes of Older Patients With Muscle-Invasive Bladder Cancer After Radical Cystectomy

This single arm pilot study will evaluate the feasibility and acceptability for perioperative Comprehensive Geriatric Assessment (CGA) and CGA-directed supportive and restorative care for patients with muscle-invasive bladder cancer who are planned to undergo preoperative chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Males and females age ≥ 65 years
* Diagnosis/disease status
* Histologically proven muscle-invasive bladder cancer (MIBC) without metastatic disease.
* Patients planning to undergo neoadjuvant chemotherapy and radical cystectomy for MIBC.
* Treatment with investigational systemic therapy is permitted if participants will be receiving chemotherapy as part of their treatment plan

Exclusion Criteria:

* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
* Any other known invasive malignancy within previous 2 years with the following EXCEPT: low grade prostate cancer on active surveillance, chronic lymphocytic leukemia CLL on surveillance / observation, non-melanoma skin cancers