cyrilzakka/clinical-trials huggingface dataset:
Thoracic Sympathetic Ganglion Block Inadvertent Spread

This study wants to identify the incidence of inadvertend intercostal or epidural spread of thoracic sympathetic block

Clinically, sympathetic blocks (SB) have been used widely to relieve the symptoms of SMP or to differentiate between SMP and sympathetically independent pain. In order to an SB has a diagnostic value, it requires the successful disturbance of the sympathetic activity for a proper duration of time.

For the diagnosis of SMP using an SB, it is essential achieving complete interruption of the sympathetic activity while preserving the sensory and motor function. The sympathetic trunk at lumbar region runs on the anterolateral surface of the vertebral column from L1 to L4 levels, and deep to the medial aspect of the psoas major muscle. Therefore, the investigators can hardly find epidural contrast spread during lumbar SB due to an anterior location of lumbar sympathetic ganglion to the lateral vertebral body. However, frequent psoas muscle injection can be encountered due to a close proximity of lumbar sympathetic ganglion.

In contrast to lumbar sympathetic ganglion, the thoracic sympathetic ganglion is not separated from somatic nerves by muscles and connective tissue. Moreover, the upper thoracic ganglion runs on the posterior surface of vertebral column with close proximity to adjacent epidural region.

This difference of thoracic sympathetic ganglion leads to a frequent epidural and intercostal spread if the investigators perform thoracic SB. Such spread to epidural and intercostal space lowers the diagnostic value of thoracic SB. In addition, serious adverse outcome can be encountered if neurolytic agent is injected into epidural or intercostal space for the purpose of thoracic sympathectomy. Considering the diagnostic value and safety of thoracic SB, evaluation of actual incidence of occurrence of intercostal and epidural spread is important.

Eligibility Criteria:
Inclusion Criteria:

* complex regional pain syndrome
* lymphedema after breast cancer surgery

Exclusion Criteria:

* coagulopathy
* infection
* previous spine fusion at thoracic level
Safety of Xeloda in Solid Tumours

The primary objective of this study is to observe safety and tolerability of Xeloda as used in medical practice, alone and in combination with docetaxel.


Eligibility Criteria:
Inclusion Criteria:

Metastatic Breast Cancer:

* women \>=18 years of age
* Patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
* Previous therapy should have included an anthracycline.
* Patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
* Female patients with histopathologically proven metastatic breast cancer
* Adequate bone marrow, liver, renal and cardiac functions

Colon Cancer:

* Patients \>18 years of age
* Patients with histologicaly confirmed colon cancer
* Patients with potential curative tumor resection within 8 weeks before enrolment in the study
* Patients previously not treated with chemiotherapy

Exclusion Criteria:

Metastatic Breast Cancer:

* Patients previously treated with docetaxel (Taxotere) or capecitabine (Xeloda)
* Patients with contraindications for any of study drugs as listed in approved SmPC

Colon Cancer:

* Patients previously treated with chemiotherapy
* Patients with contraindications for study drug as listed in approved SmPC
Clinicopathological Aspects of Acute Appendicitis in Patients Above Age of Thirty at Sulaimani Emergency Hospital

Aims of this study are :

* Estimate the incidence of A.A. in patients above age of 30 y in 4 age groups .
* Correlate between different clinical aspects and histopathological results.
* Determine rate of negative appendectomy in those patients.

Acute appendicitisis the clinical condition which refer to inflammation of the vermiform appendix1. It is the most common abdominal emergency2,3,4 .it accounts for more than 40,000 hospital admissions in England every year 5 . Approximately 8% of the population in Western countries would have appendicitis during their life 6 .In the United States, the estimated incidenc of acute appendicitis is 11 cases per 10,000 population 5 . However, in South Africa, the incidencewas estimated to be less than 9 per 100,000 6 .Appendectomy is considered the most common emergency surgical procedure worldwide6,8 ,9. The cause of acute appendicitis is unknown but it is multifactorial; luminal obstruction , dietary and familial factors have been suggested 5 . Fecoliths are the most common cause of obstruction. It was demonstrated that the mean duration of abdominal pain in patients with gangrenous appendix is 46.2 hours and 70.9 hs for perforated 7 .

The peak incidence of acute appendicitis is at the age of 10 to 30 years 6,10. There are special features for appendicitis according to age 1. A.A is primarily a disease of the younger population, with only 5-10% of cases occurring in elderly people, but the incidence of acute appendicitis in elderly began to increase with the increase in life expectancy14. Older patients with acute abdominal pain are high-risk patients, unlike their younger counterparts15 . Morbidity and mortality rates are greater in elderly due to atypical presentations and delay in diagnosis leading to increase rate of perforation and intra-abdominal infection.. They need to be clinically evaluated by experienced surgeons within a narrow time margin14,15.

Eligibility Criteria:
Inclusion Criteria:

* patients above age of thirty appendectomy done for them

Exclusion Criteria:

* patients less than thirty years conservative mangement
Lipoic Acid Supplementation in IVF

Alpha-Lipoic Acid (ALA) is a natural molecule that can make a significant contribution to the success of embryo implantation phase, because it exerts, directly or indirectly, an immunomodulatory activity. ALA has the ability to regenerate antioxidants molecules that facilitate embryo implantation, and to stimulate the production of local mediators useful for implantation. This study is a prospective clinical trial and aims to evaluate the reproductive outcomes of Italian couples following oocyte donation fresh cycles when receiving per os tablets of lipoic acid. Indeed, the control group had only the standard treatment (vaginal progesterone), whereas the study group, in addition to that, received ALA (300 mg, 2 times per day) by oral route, from the day of donors oocyte pick up until the pregnancy test. If the childbearing occurred, treatment continued until the 8th week of pregnancy. Primary outcome of the study is the implantation rate while the positive hCG rate, the clinical pregnancy rate, the miscarriage rate and the live-birth rate are secondary outcomes .


Eligibility Criteria:
Inclusion Criteria:

Donors:

* Proof of fertility;
* ⩽32 years old
* BMI \<30 kg/m2
* Regular menstrual cycles of 25-33 days
* Two normal ovaries based on transvaginal scan findings.

Recipients:

* Women with infertility problems
* ⩽50 years old,
* BMI \<34 kg/m2

Exclusion Criteria:

Donors:

* Polycystic ovaries
* Endometriosis
* Gynaecological or medical disorders.

Recipients:

* Endocrinologic problems
* Medication for chronic illness
* Azoospermic partner that require TESE
* Sperm donation cycles
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.


Eligibility Criteria:
Inclusion criteria:

1. Aged 2 months (42 through 98 days) at the time of enrollment.
2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3. In good health as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.

Exclusion criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S pneumoniae.
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies \[eg, Synagis\]).
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA

This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere, MA, and its effect on participating students with regard to BMI, cognitive, and quality of life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Two sessions will be held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program participation on child BMI, quality of life, and executive function.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the BOKS program
* Participating school
* Age 5-14

Exclusion Criteria:

* No valid consent
* Not enrolled in BOKS
Multifocal Brain Magnetic Stimulation in Chronic Ischemic Stroke

Transcranial magnetic stimulation for post-stroke upper-body motor deficits.

This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved.

This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years;
* Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --

Exclusion Criteria:

* History of seizure;
* Epileptogenic activity (indicative of increased risk of seizures) on EEG;
* Any active unstable medical condition;
* Pregnancy;
* Schizophrenia, bipolar disorder, alcoholism, or substance abuse;
* Medications which in the investigator's clinical judgment significantly lower the seizure threshold;
* Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.;
* Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study.
* Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study
* Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination:
* National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction.
* Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm.
* Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm.
* Any condition that precludes a high quality brain MRI scan.
A Feasibility Study of an Emotion-Focused Mindfulness Group

Living with symptoms of mental illness is associated with psychosocial impairment as it can affect someone's ability to work, their relationships and level of functioning. This also has high economic costs on a societal level. It has been shown that an increase in self-compassion may result in a secondary benefit of reducing psychological distress, which could offer substantial benefits. There is little empirical data on Emotion Focused Mindfulness (EFM) interventions for the population we are studying. This study aims to address this gap in the literature and practice, thus advancing the field.

Study Design

The proposed study is a non-controlled, open-label, repeated measures intervention study. It is a two year feasibility study.

Procedure:

Recruitment

Participants will be recruited through the Mount Sinai Academic Family Health Team. Patients who experience symptoms of depression and/or anxiety, may be referred by any member of the family health team, self-referrals through the family health team will also be accepted. Patients will be screened for eligibility for the EFM Group by the group facilitators. Patients may participate in the EFM group and refuse to participate in the research study.

When patients agree to participate in the group intervention, patients will then be asked about interest in participating in this research. Group facilitators will provide details about the study. Interested patients are given the consent form to review. The group facilitator leaves the room and the research associate will then come into the room to obtain written consent.

Intervention

The group will run for 8-weeks. Each group session is 2 and a half hours. Half way through the intervention there will be a 5 hour retreat on the weekend. A typical group format includes 20-40 minutes of meditation, followed by 10 minutes of independent journaling. Then group members will have time to report on recollections from meditation and facilitators will provide feedback. There is a break and the second part of the group focuses on a didactic teaching topic. Topics change each week. EFM groups will run between September 2016 and June 2018.

Eligibility Criteria:
Inclusion Criteria:

Must be patient of Mount Sinai Academic Family Health Team

* Adults over the age of 18 years
* Symptoms of depression and anxiety as identified by the patient and/or family physician
* Sufficient English language skills to participate in the group (based on assessment of group facilitators)
* Committed and willing to engage in the group work, such as listening to others, speaking in front of others (based on assessment of group facilitators)

Exclusion Criteria: (each based on assessment by group facilitators)

* Active suicidality
* Severe depression
* Possible alcohol abuse
* High tendency to dissociate
* Personality style that may disrupt group formation processes, participation in interpersonal group processes, and/or developing a meditation practice
The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis

The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated informed consent form
2. Good general health
3. Male or female subjects aged \>21 years old
4. Availability for the 9 week duration of the study
5. Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth (potential target teeth) demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental X-ray.
6. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method (Oral or parenteral hormonal contraceptive; Intrauterine device; barrier and spermicide) of birth control during the study.

Exclusion Criteria:

1. An existing aggressive periodontitis.
2. Presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study.
3. Presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed.
4. Soft or hard tissue tumours of the oral cavity.
5. Presence of dental implant adjacent to target tooth.
6. Presence of more than 2 adjacent periodontal pockets on the same potential target tooth.
7. Periodontal pockets of more than 9 mm in depth, and/or with class 2 or 3 furcation involvement, on the potential target tooth.
8. Systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
9. History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
10. Subjects taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
11. Subjects treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration.
12. Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis, abscesses and related oral pathologies.
13. The presence of any medical or psychiatric condition that in the opinion of the investigator could affect the successful participation of the subject in the study.
14. Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
15. Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
Effects of Daily Almond Intake as a Preload Before Meals Versus as a Snack Among Korean Adults

The study was conducted to investigate the effects of daily almond intake based on the timing of almond consumption (i.e., almond consumption as a preload or between-meal snack) on body composition, lipid profile, and oxidative and inflammation indicators among young Korean adults.

The current study was conducted to investigate the effects of daily almond intake on body composition, lipid profile, and oxidative and inflammation indicators among young Korean adults based on the timing of almond consumption. Participants were randomly assigned to one of three groups: (1) a pre-meal group (PM; n = 58) in which participants were instructed to consume 56 g of almonds per day as a preload when having regular meals; (2) a snack group (SN; n =55) in which participants were instructed to consume 56 g of almonds between meals as snacks; and (3) a control group (CL; n = 56) in which participants were provided high-carbohydrate iso-caloric control food. The three-day diet records, including two consecutive weekdays and one weekend day, were done once before the trial and twice during the trial. Body composition was assessed through multi-frequency whole-body bioimpedance measurement using InBody 620 (Biospace Co., Ltd, Seoul, Korea).After a 12-hour fast, blood samples were taken at the baseline time point (week 0) and at weeks 8 and 16 by standard venipuncture. The serum total cholesterol and triglycerides levels were measured by the enzymatic-colorimetric method using a Cobas 8000 c702 chemistry analyzer (Roche Diagnostics; Mannheim, Germany). HDL cholesterol and LDL cholesterol levels were determined via homogeneous enzymatic colorimetry.

Eligibility Criteria:
Inclusion Criteria:

* non-smokers
* age 20-39 yr
* Male and Female non-smokers
* BMI 17-30 kg/m2
* under Korean habitual diet

Exclusion criteria:

* any diseases
* any weight change 6 mo before the study
* \>2 times/wk nut consumption
* frequent alcohol consumption
* any use of nutrient supplements
* erratic exercise habits
* women who were with irregular menses, taking birth control pills, pregnant or lactating
Effects of Training in a Virtual Environment in Chronic Stroke Patients

The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group, 20 each one.

The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients. It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty chronic stroke patients are randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions. The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).

Eligibility Criteria:
Inclusion Criteria:

* hemiparetic status resulting from a single stroke at least 6 months earlier;
* the ability to walk 10 m independently with or without an assistive device;
* the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
* the absence of serious visual impairment or a hearing disorder;
* power of at least grade 3 in the hemiplegic lower extremity;
* able to understand and follow simple instructions.

Exclusion Criteria:

* a Montreal Cognitive Assessment (MoCA) score of \< 20;
* severe dementia or aphasia;
* hemispatial neglect, ataxia or any other cerebellar symptom;
* inability to stand without minimal assist;
* Impaired vision
* Uncontrollable medical complications
* participation in other studies or rehabilitation programs