cyrilzakka/clinical-trials huggingface dataset:
AISTCM-Outcome Measurement of Acute Ischemic Stroke With Traditional Chinese Medicine

The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and to observe its safety.

The purpose of this study is to determine whether Traditional Chinese Medicine (TCM) is able to improve the outcome of acute ischemic stroke and safety.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke diagnosis by CT/MRI scan
* Yin pattern of Traditional Chinese Medicine Theory
* 40-85 years old
* Total anterior circulation infarcts (TACI), partial anterior territory cerebral infarction (PACI), lacunar anterior circulation infarcts (LACI) type under Oxfordshire Community Stroke Project (OCSP) standard
* NIHSS \>=4;
* Glasgow coma scale (GCS) \>=7;
* Modified Rankin Scale less than 2 degrees before onset of this stroke
* Informed consent signed by patient or his/her family

Exclusion Criteria:

* Hemorrhagic stroke;
* Coma, GCS\<=7;
* Cerebral hernia;
* Serious heart, liver, lung, kidney functional failure;
* Gastrointestinal (GI) bleeding;
* Thrombolysis drugs or surgery was administrated to the patient;
* Not cooperative with physician;
* Psychological disorder;
* Already taken part in other clinical drug trial within the past 3 months
An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery

This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. This trial will also assess safety (side effects).

This research trial will involve all available subjects who received treatment in DURECT Protocol C803-017. All subjects will have the same follow-up safety assessments performed. No experimental treatment will be given in this trial. Subjects, Investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have provided written consent to participate in the trial prior to any trial procedures and understand that they are free to withdraw from the trial at any time.
* Participants must be able to read and understand the consent form, complete trial-related procedures, and communicate with the trial staff.
* Participants must have participated in DURECT Protocol C803-017 and received SABER™-Bupivacaine or SABER™-Placebo approximately 18 months before enrolling in this trial.

Exclusion Criteria:

* Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.
Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit

Objective: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation for heavy smokers who are willing to quit.

Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers, were willing to quit, and attending an academic outpatient clinic in Western Switzerland. Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever cravings appear; control group) or to use NNS at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM) during the first three weeks of use. Self reported abstinence from smoking at six months was confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect GLS regression was used to calculate the mean difference of daily doses between groups controlling for lack of independence between measures from the same individual.


Eligibility Criteria:
Inclusion Criteria:

* Highly dependent smokers in the stage of preparation according to Prochaska and Di Clemente's stages of change model

Exclusion Criteria:

* History of myocardial infarction in the preceding 3 months
* Pregnancy or breast-feeding
* Use of any form of smokeless tobacco or other nicotine replacement therapy
A One-Day ACT Workshop for Emotional Eating

Emotional eating is a behaviour that has been linked to weight concerns, mental health concerns, and disordered eating. Effective interventions have been developed to treat emotional eating, however these exist solely in the context of promoting weight loss. Emotional eating is not exclusive to those who struggle with weight and thus interventions are needed that target those who engage in emotional eating regardless of their weight status. The present study aims to do so through the implementation of a one day Acceptance and Commitment Therapy (ACT) workshop for emotional eaters.

Emotional eating is defined as increased food consumption in response to negative emotions, and has been linked to weight concerns, mental health concerns, and disordered eating behaviours. Effective interventions have been developed that address emotional eating, namely to improve weight loss. Such interventions are based in Acceptance and Commitment Therapy (ACT), which encourages tolerance of internal cues, such as emotions, and external cues, such as food.

Emotional eating, however, is not exclusive to those who struggle with their weight. Many individuals maintain a normal weight despite engaging in emotional eating. These individuals still consume an excess of high calorie (for which they somehow eventually compensate), high fat, and high sugar foods as part of their emotional eating. Unhealthy dietary habits such as these have been shown to be associated with an increased risk of all-cause mortality, as well as health concerns including diabetes and cardiovascular disease. Individuals with normal weight are not eligible for ACT programs described above, despite the increased risk of health concerns associated with emotional eating.

The present study aims to test the feasibility and acceptability of a one-day ACT workshop to reduce emotional eating and improve health that is not focused on weight loss as its primary outcome, and rather targets all individuals who engage in emotional eating.

Eligibility Criteria:
Inclusion Criteria:

* Engaging in emotional eating as per a DEBQ-EE score of 3.25 or higher
* Being over the age of 18

Exclusion Criteria:

* Not meeting the DEBQ-EE 3.25 or higher inclusion criteria
* Being under the age of 18
Brain Stimulation And Group Therapy to Improve Gesture and Social Skills in Psychosis (BrAGG-SoS)

Randomized, double-blind, placebo-controlled clinical trial testing the effects of 10 sessions of continuous theta burst stimulation and the effects of 16 sessions of social cognitive remediation therapy on gesture performance and nonverbal communication skills in schizophrenia

The study focuses on nonverbal communication skills in schizophrenia. The trial will test, whether the combination of noninvasive brain stimulation and group psychotherapy will improve gesture performance and thus nonverbal communication in schizophrenia

Eligibility Criteria:
Inclusion Criteria:

* Right-handed subjects
* Ability and willingness to participate in the study
* Ability to provide written informed consent
* Informed Consent as documented by signature
* schizophrenia spectrum disorders according to Diagnostic and statistical manual version 5 (DSM-5)

Exclusion Criteria:

* Substance abuse or dependence other than nicotine
* Past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, M. Parkinson, M. Huntington, dystonia, or severe head trauma with subsequent loss of consciousness.
* Epilepsy or other convulsions
* History of any hearing problems or ringing in the ears
* Standard exclusion criteria for cerebral magnetic resonance imaging scanning and transcranial magnetic stimulation (TMS); e.g. metal implants, claustrophobia
* Patients only: any transcranial magnetic stimulation (TMS) treatment in the past 3 months
* Patients only: any cognitive remediation therapy in the past 2 years
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Effect of Prophylactic Clip Application for the Prevention of Postpolypectomy Bleeding in Pedunculated Colonic Polyps

Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Preventive methods such as endoloop and epinephrine injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no randomized controlled study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So the investigators designed a randomized controlled trial to confirm the efficacy of application of prophylactic clip in the prevention of postpolypectomy bleeding in large polyps.

Patients who had pedunculated colorectal polyps with heads larger than 10 mm and stalks larger than 5 mm in diameter were included. In clip group, hemoclips were applied to the base of the stalk, followed by conventional snare polypectomy. In conventional group, conventional snare polypectomy was done without any preventive management. Immediate and delayed bleeding complications were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion Criteria:

* bleeding tendency, poor preparation, sessile polyp
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

This is an interventional, placebo-controlled, randomized, double-blinded, dose comparison, phase I/II study of Galnobax® in subjects with diabetic foot ulcers. Additionally the effect of dosage and frequency of application will also be studied . The total trial duration per subject is 25 weeks which comprises of 1 week for screening, 12 weeks of treatment and 12 weeks of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 95 years, inclusive, with Type 1 or Type 2 diabetes undergoing therapy for glycemic control
* Subjects having below knee ulcer of at least 4 week and maximum of 52 weeks duration which is a full thickness ulcer without exposure of bone, muscle, ligaments, or tendons
* Ulcer should be clinically non-infected
* Ulcer area (length x width) measurement between 1.5 cm2 and 10 cm2, inclusive and post debridement ulcer area less than or equal to 12 cm2.
* Full-thickness ulcer of Grade 1 or Grade 2 as per Wagner's classification system
* Recently debrided ulcer (2 weeks prior to screening) and post debridement ulcer free of necrotic debris, foreign bodies, sinus tracts, tunneling, and undermining, comprised of healthy vascularized tissue as determined by the Investigator
* Inability to perceive 10 grams pressure using Semmes-Weinstein 5.07 monofilament in the peri-ulcer area
* Ankle Brachial index between 0.7 and 1.2

Exclusion Criteria:

* Actively infected ulcers with or without purulent discharge, ulcers with exposed bone or associated with osteomyelitis.
* Subjects having cellulitis, ischemic or gangrenous ulcers in the opinion of the Investigator
* Glycosylated hemoglobin (HbA1C) \>12%
* Diagnosed and/ currently unstable hypotension, heart block, cardiac failure, and other cardiac complications
* Subject diagnosed with cancer undergoing chemotherapy
* Revascularization surgery 4 weeks prior to signing the ICF
* Renal failure as defined by serum creatinine \>3.0 mg/dL or renal insufficiency requiring frequent dialysis
* Poor nutritional status as measured by serum albumin \<3.0 g/dL
* Active Charcot or other structural deformity that would prevent adequate off-loading of the study foot
Stereotactic Radiosurgery and Systemic Dose Chemotherapy for Locally Advanced Lung Cancer

This is a pilot study looking at using stereotactic radiosurgery and full dose chemotherapy to treat stage II and III lung cancer that is not amendable to surgical resection.

Current standard of care for treatment of locally advanced (unresectable stage II and all of stage III) non-small cell lung cancer (NSCLC) is chemo-radiation which consists of 7 weeks of radiation and chemotherapy given at a reduced dose (as opposed to systemic dose when chemotherapy given by itself). While outcomes have improved over time they remain humbling, with current approaches associated with overall poor results both in terms of local (30% of patients have local failure) and distant control (40% of patients have distant failure) with a median overall survival of 17 months.

This study is evaluating treatment with full dose chemotherapy and stereotactic body radiotherapy (SBRT). SBRT uses high doses of radiation in a very precise and conformal manner, the number of treatments are much reduced versus conventional radiation (SBRT would be able to be completed in 2 weeks or less). The biologically effective dose of SBRT is much higher than that of conventional radiation; despite being a shorter number of treatments the effective radiation dose is higher. SBRT would be completed in 2 weeks and since radiation would be completed in a shorter time span, would allow patients to have higher (systemic) chemotherapy doses.

The purpose of this study is to explore SBRT in addition to systemic doses of chemotherapy in the treatment of locally advanced NSCLC.

Eligibility Criteria:
Inclusion criteria:

* Nonsmall cell lung cancer (NSCLC) (any histology)
* unresectable stage II
* Stage III
* Tumor less than 8 cm
* Karnofsky performance scale (KPS) of 50 or better
* Three or fewer mediastinal or hilar lymph nodes

Exclusion criteria

* Small cell lung cancer (SCLC)
* Stage I and stage IV patients
* Stage II patients eligible for surgical resection
* Concurrent severe disease that the treating physician feels will interfere with therapy this can include significant cardiovascular or pulmonary disease.
* KPS 40 or less (bed bound)
* Tumor size greater than 8 cm
* Inability to safely treat target lesions (at discretion of treating physician, this would most likely be secondary to not being able to place fiducial markers for tracking)
* Four or more medisatinal or hilar lymph nodes
Safety of Cardiac Pacemakers in 3 Tesla MRI

To evaluate short-term and long-term effects by MR imaging at 3T on the technical and functional status of cardiac pacemakers.

Recently, a shift could be observed from cardiac pacemakers being an absolute contraindication to being a relative contraindication for MR imaging at 1.5 Tesla, depending on a patient-per-patient risk-benefit-evaluation, which includes an urgent clinical need for MR imaging (other imaging modalities non-conclusive) and co-morbidities (especially cardiac co-morbidities). At the same time, MR imaging at 3 Tesla is evolving from a research application only to an important imaging modality today.

Using the improved signal-to-noise-ratio, high field MR-Systems with a field strength of 3 Tesla offer a variety of diagnostic advantages to 1.5 Tesla systems. These advantages lead to a higher sensitivity and specificity in diagnosing, foremost neurological, disorders.

In this study, we evaluate the safety of MR imaging of the brain in patients with cardiac pacemakers at 3T.

Eligibility Criteria:
Inclusion Criteria:

* Urgent need for an MRI examination
* Stable pacemaker physical parameters

  * Battery voltage \> 2.7 V
  * Battery impedance \< 2000 Ohm
  * Battery estimated remaining lifetime \> 6 months
  * Lead impedances 200-2000 Ohm
* Stable pacing parameters

  * Pacing capture threshold \<2.5V at a pulse duration of 0.4ms
  * Sensing \> 5mV
* Minimum 3 months since pacemaker and lead implantation

Exclusion Criteria:

* History of ventricular tachycardia (VT) or ventricular fibrillation
* Unstable angina
* Myocardial infarction within the previous 3 months
* Cardiothoracic surgery within the previous 3 months
* Presence of an abdominal pacemaker with lead length \> 70 cm
* Presence of MRI incompatible bioimplants or other MRI incompatible materials
Effects of Dry Needling on Muscle Function in Patients With Hip Osteoarthritis

The aim of this study was to assess the effects of dry needling technique on muscle strength and muscle length in patients with hip osteoarthritis at short term.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed medically with a X-Ray test
* American College of Rheumatology Criteria

Exclusion Criteria:

* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
* Vascular or neurological disease.
* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
* Fear of needles
Registeranalysis for the Examination of NOMI

The registry includes patients undergoing cardiovascular and thoracic surgery at the Saarland University Medical Center, Homburg/Saar, Germany. This study is a monocentric, retrospective study investigating the development of NOMI and outcome of patients.

All data were acquired from the hospital electronic health record and the picture archiving computer system (PACS).

NOMI was suspected if the following clinical signs occured:

new onset of oliguria (urine output \<0.5 mL/kg/hour for at least 6 hours) or anuria, abdominal distention with decreased or absent bowel sounds, elevated serum lactate levels \>5.0mmol/L or metabolic acidosis (base excess \<-5mmol/L).

In accordance to the definition of cardiogenic shock angiography was performed in patients with a systolic blood pressure \>90 mmHg and a cardiac index \>1.8 L/minute/m².

Eligibility Criteria:
Inclusion Criteria:

* The investigators include anonymous data from patients with cardio-thoracic surgery

Exclusion Criteria:

* None
PAIN-LESS: Understanding and Alleviating Pain for Cancer Patients in Academic and Community Hospitals

This study will increase knowledge of patient preferences for pain treatments, and improve the ability to meet patients pain management needs. This study will assess patient attitudes towards underutilized treatments and identify technologies to increase awareness of such treatments. This study also demonstrate the feasibility of using the Penn Cancer Network in future clinical and cancer control research and better understand how to effectively raise patients awareness of supportive cancer services.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older; Have a primary diagnosis of cancer;
* Have a Karnofsky functional score of 60 or greater (i.e. ambulatory);
* Understand written English;
* Verbally indicate to the RA/RN that they feel physically well enough to complete a survey at the time of approach;
* Report experiencing nonzero pain (on a scale of 0-10) in the last seven days

Exclusion Criteria:

* An inability to understand the requirements of the survey
Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis

As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait disorders are amongst the symptoms of MS. Balance disorders and the falls caused by them are the most frequent problems which result in disability of MS patients, with 75% of all patients being affected during the course of disease. When considering previous studies carried out on physiotherapy and rehabilitation practices in the light of balance disorders and other related problems faced by MS patients, it can been that various physiotherapeutic approaches are applied with varying follow-up times and in the form of hospital sessions, home sessions, or group training. Posture and balance problems in MS patients are tried to be solved through long-lasting treatment sessions using traditional methods of physiotherapy, where less patient participation is observed. Fatigue, psychological impairment, and insufficient motivation are other aspects which influence the success of treatment and which need to be addressed in MS patients. In contrast to traditional methods of physiotherapy applied in form of long-lasting treatment sessions, technology-supported rehabilitation approaches have emerged in recent years. It can be seen that different systems have started to be employed in the physiotherapy of many chronic diseases, either alone or in company with traditional methods. Even though the clinical use of these systems is becoming widespread, there are certain gaps in terms of the systems' impacts, comparative advantages, or cost effectiveness. Keeping this in mind, the purpose of this study is to investigate and compare the impacts of 'Nintendo Wii Fit' and 'Balance Trainer', as two of the technologic methods with therapeutic impact which have started to be used for different diagnosis groups in recent years, on the balance and posture parameters of MS patients, with the ultimate aim to introduce a whole new point of view to traditional physiotherapy and rehabilitation studies.


Eligibility Criteria:
Inclusion Criteria:

* . Participants who were ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses or worsening in the last 3 months, with an EDSS between 2.5-6 and aged between 25 to 60 years

Exclusion Criteria:

* physical activity more than 150 minutes per week, were pregnant, had blurred vision, had psychiatric problems, or severe cognitive impairment.