cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Effectiveness and Safety of Amberen and Smart B by Women With Climacteric Syndrome

To evaluate effectiveness and safety of combined use of dietary supplements Amberen and Smart B by women with a typical (without complications) form of climacteric syndrome, with mild to moderate symptoms.

1. To evaluate effectiveness of combined use of dietary supplements Amberen and Smart B (vs placebo) by women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause in regards to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions;
2. To evaluate safety of combined use of dietary supplements Amberen and Smart B (vs placebo) by women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause, lasting no less than 1 year in regards to vasomotor, endocrine-metabolic, and neuro-psychological dysfunctions;
3. To develop recommendations for combined use of dietary supplements Amberen and Smart B for women with a typical (without complications) form of climacteric syndrome, with mild to moderate vegetative symptoms during perimenopause and menopause (menopausal for at least 1 year).

Eligibility Criteria:
Inclusion Criteria:

* Female patients, 42-60 years of age;
* Patient with diagnosis of "climacteric syndrome", in typical or non-complicated form, mild or moderate vegetative symptoms during menopause i.e. absence of menstrual period for at least 1 year;
* Ability to read and understand informed consent form for the study's participation;
* Patients without risk factors and changes in the breast tissue based on the mammogram;
* Patients with medical history of risk factors without changes in the breast tissue;
* Ability to adhere to the conditions of the study.

Exclusion Criteria:

* Presence of female reproductive system cancers (breast cancer, cervical cancer etc.);
* Presence of extragenital oncological conditions, except those in complete remission for 5 years or more;
* Conditions requiring emergency or planned hospitalization in the next 6 months;
* Presence of hormonally-active extragenital endocrine diseases (thyroid, adrenal, pituitary, hypothalamus);
* Surgical interventions done on sex organs or breasts, 1 year or less prior to the screening;
* Any surgeries done less than 3 months prior to the screening;
* Patients receiving HRT;
* Psychiatric conditions;
* Diabetes;
* Total ovariectomy
* Patients taking any other dietary supplements that can affect climacteric syndrome within the last month before enrolling in the study

  * High risk of non-compliance
Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

This is a pilot randomised controlled trial investigating the use of an adjustable compression garment in the treatment of patients with Breast Cancer related upper limb Lymphoedema. This study will be conducted as part of a MSc qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place in the Physiotherapy Department of Sligo University Hospital (formerly Sligo General Hospital). The study will be conducted in conjunction with Sligo University Hospital and it has attained ethical approval through the relevant University Hospital Ethics Committee.

The experimental group will receive 5 treatments followed by a final assessment on the 6th visit over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes. They will then put on an Adjustable Compression sleeve (Juzo varocare adjustable compression system). Patients will be re-measured before the fourth treatment and again on session 6. At this point patients will receive a standard arm compression sleeve. This will be worn in alternation with their adjustable compression sleeve over the following 6 months. Patient will have their limb volume re-measured at the 6 month review.

The control group will receive 5 treatments followed by a final assessment on the 6th visit over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes. They will then have their arm wrapped in Coban compression bandaging which will stay on until their next treatment. This will occur twice weekly for a period of 3 weeks. Patients will be Re-measured before the fourth treatment and again on session 6. At this point they will attend occupational therapy where they will receive 2 standard arm compression sleeves. The patient wears 1 sleeve every day over the following 6 months. Patient will have their limb volume re-measured at the 6 month review.

Eligibility Criteria:
Inclusion Criteria:

* Upper limb lymphoedema (secondary to breast cancer) diagnosed by a consultant
* Aged \> 18 years.
* Males and females.
* Stage 2 Lymphoedema.
* \>10% volume difference between upper limbs.
* Cognitive ability to understand the programme.

Exclusion Criteria:

* Involvement in other studies or rehabilitation programmes.
* Active infection disease progression.
* Congestive Cardiac Failure.
* Non-English speakers.
* Under 18's.
* Poor cognition for treatment compliance or consent.
* Pregnant, or currently breast feeding.
Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders

Randomized controlled trial (RCT) comparing youth diagnosed with major depressive disorder treated with online mindfulness-based cognitive behavioural therapy vs. standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health. N = 168 subjects will consist of youth from First Nations background (18-30 yrs) and youth from all other ethnic backgrounds stratified to two intervention groups and two wait-list control groups consisting of 50% First Nations youth and 50% youth of all other ethnic backgrounds.

A high proportion (70%) of mental health problems appear before 25 yrs. and can become become long-standing, significant disorders that impair all life domains. Early signs of disorder left untreated is an acute problem for Canadian youth as 15-25 yrs is the most likely age-strata for diagnosable psychiatric disorders, substance dependencies and suicide. Progress in youth treatments that engage the tendencies of youth to respond to online internet contact are likely to be especially strategic.

In this randomized controlled trial (RCT) diagnosed depressed youth are treated with online mindfulness-based cognitive behavioural therapy (MB-CBT) and standard psychiatric care or just standard psychiatric care (as wait-list controls). Eligible subjects will be recruited from the wait-lists of the Centre for Addiction and Mental Health (CAMH), and from community-based practices and clinics proximal to CAMH. The consented 168 subjects will be from First Nations background (18-30 yrs) and from all other ethnic backgrounds, stratified into two intervention groups and two wait-list control groups.

Primary outcome is self reported depression using the Beck Depression Inventory II while secondary outcomes include self reported anxiety (Beck Anxiety Inventory), depression (Quick Inventory of Depressive Symptomatology, 24-item Hamilton Rating Scale for Depression (HRSD-24)), pain (Brief Pain Inventory) mindfulness (Five-Facet Mindfulness Questionnaire) and intervention costs.

If hypotheses are confirmed that youth can be effectively treated with online MB-CBT at reduced costs, effective treatment can be delivered to greater numbers with less geographic restriction.

Eligibility Criteria:
Inclusion Criteria

* 18-30 yrs
* First Nations background or other ethnicity
* BDI-II at mild-moderate levels (i.e., BDI-II score ≥ 14 and \< 29 )
* diagnosis of major depressive disorder
* fluent in english
* diagnosis by a CAMH physician and diagnosis confirmed by a MINI International Neuropsychiatric Interview

Exclusion Criteria

* \< 18 yrs and \> 30 yrs
* BDI-II in severe range ≥ 29 or \< 14
* does not qualify for diagnosis of major depressive disorder or diagnosis not confirmed by MINI International Neuropsychiatric Interview
Motivational Program for Smokers Enrolled in a Methadone Maintenance Program

RATIONALE: Stop-smoking programs may help patients stop smoking and prevent cancer from forming.

PURPOSE: This clinical trial is studying how well a motivational program works in helping smokers enrolled in a methadone maintenance program quit smoking.

OBJECTIVES:

* Determine the efficacy of a brief motivational intervention on smoking cessation in smokers enrolled in a methadone maintenance program.

OUTLINE: Patients are assigned to 1 of 2 groups.

* Group 1: Patients undergo assessment at baseline and at 1, 3, and 6 months.
* Group 2: Patients receive a brief motivational intervention at the time of their baseline assessment and undergo assessment as in group 1.

All patients will be offered a 2- to 3-month supply of nicotine patches.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must be currently enrolled in a methadone maintenance program
* Smokes at least 10 cigarettes a day

PATIENT CHARACTERISTICS:

* Not pregnant
* No concurrent medical condition that precludes the use of nicotine patches

PRIOR CONCURRENT THERAPY:

* No concurrent use of other nicotine replacement therapy
Gingival Crevicular Fluid Alkaline Phosphatase as Skeletal Growth Indicator

Determination of the pubertal growth spurt in Egyptian female patients using gingival crevicular fluid alkaline phosphatase

assessment of the pubertal growth spurt in growing Egyptian female patients by using a simple, quick and easy method, through taking a gingival crevicular fluid alkaline phosphatase sample and measuring its concentration. Comparing the concentration of GCF ALP to the standardized middle phalanax of the middle finger MP3 we can predict if it can be an accurate and reliable method as skeletal growth indicator.

Eligibility Criteria:
Inclusion Criteria:

1. Gender: only female subjects will be included.
2. Age between 7-16 years old
3. Intermediate or late mixed dentition and permanent dentition
4. Good general health with absence of any nutritional problems or bony disease
5. No usage of any anti-inflammatories or antibiotics in the month preceding the study
6. Fully erupted upper and lower central incisors for sample collection
7. Good gingival and periodontal health as indicated by Probing depth (PD) values that should not exceed 3 mm for the whole dentition.
8. Willingness to participate in the study and sign the informed consent form

Exclusion Criteria:

1. Male adolescent subjects
2. Periodontal and /or gingival disease
3. Systemic and/or bone disease

3. Growth abnormality
Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke

The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

Abstract

Objective: The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.

Background:

Method: The investigators will study 50 patients with stroke consecutively admitted to a designated stroke rehabilitation unit in the Oklahoma City VA Medical Center. All patients will receive their daily 3-hours conventional therapy, plus an hour of either exoskeleton or over-ground gait training 3 times per week for 60 minutes. Patients were assigned to either the experimental (exoskeleton) or the control (over-ground) groups by computer-generated randomization. This is an open-label pragmatic trial, where neither the patients nor the clinicians could be masked to the intervention. Institution review board (IRB) approval will be obtained for the protocol. The demographic data to be collected includes: age, gender, race/ethnicity, stroke onset to admission, stroke types (ischemic/hemorrhagic), and stroke severity (on the National Institute of Health Stroke Severity \[NIHSS\] scale. Admission and discharge total Functional Independence Measure (FIM), spasticity and depression scores, ambulation velocity over 2-minutes (2-MWT) in feet/minute, and discharge disposition. The intervention is Indego® exoskeleton. The primary outcome measures were: changes in the FIM, depression and spasticity scores. The secondary outcome measure was discharge disposition. Continuous variables were analyzed using Students t-test, ordinal variables were analyzed using Mann-Whitney, and the nominal variables were analyzed using Chi-square analyses.

Eligibility Criteria:
Inclusion Criteria:

1. All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
2. Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
3. Depressed patients will be included in the study
4. Patients able to stand alone
5. Patients able to provide a written informed consent, from cognitively intact patients (admission Mini Mental Scale Examination \[MMSE\] greater than or equal to 21).

Exclusion Criteria:

1. Aphasic patients unable to communicate
2. Confused patients
3. Patients medically unstable
4. Patients unable to stand alone
5. Refusal to provide written informed consent
Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy

To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.

Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs

Eligibility Criteria:
Inclusion Criteria:

1. Patients American Society of anesthesiologists' physical status (ASA) I to II.
2. Aged 18 to 50 years.
3. Both sexes.

Exclusion Criteria:

* Spinal malformation
* Recurrent LDH
* Multi segment LDH
* Patients younger than 18 years or older than 50 years
* Patients with hypersensitivity to one of the used drugs
A Multifaceted Intervention to Improve Bleeding Management Among Patients Using Oral Anticoagulants (IMPACT-BLEEDING)

Prospective, cluster randomized trial including expected 168 patients with chronic use of oral anticoagulation (OAC) suffering major bleeding. Randomization will be performed stratified by geographic region (Southern/Southeastern Brazil versus other Brazilian regions).

The Group 1 in this trial will consist of a multifaceted bundle of instructions to sites about optimal management of bleeding, including transfusion thresholds and when indicated; laboratory assessment of coagulation when indicated; reversal agents when indicated, and tailored approach to restarting of oral anticoagulation and dosing adjustments among patients after bleeding episode. This bundle will be based on a society guideline on bleeding management from the American College of Cardiology. The Group 2 will be randomized to the standard of care. Standard of care will be left to the discretion of the sites (clusters) participating in the study. All sites, including those from the control group, will be encouraged to follow local policies of blood product utilization and bleeding management.

Eligibility Criteria:
Inclusion criteria

* Age ≥ 18 years;
* Patients using chronic OAC (that is, for 30 or more consecutive days) due to AF/flutter, VTE or other clinical indication and presenting with a major bleeding episode according to the definition of the International Society of Thrombosis and Hemostasis (ISTH). Exclusion criteria
* Patients with limitation to follow-up;
* Patients with do not resuscitate order at time of enrolment.
Development of a Musculoskeletal Model of the PIP Joint

The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger tip. The outcome following replacement surgery of this joint is considered unsatisfactory. In order to improve these outcomes, it would be helpful to understand the geometry of the joint, how it moves and the forces that are involved. This can be achieved using computer models that model the bones and the soft tissues - musculoskeletal models. In order to make these models as representative as possible, they should be generated using anatomical data.

Data will initially be extracted from patients' existing magnetic resonance imaging (MRI) and computed tomography (CT) scans. This will enable the computer model to begin being constructed. In parallel to the model initialisation, anatomical and motion data of the PIP joint of healthy volunteers will be collected. The necessary data will be collected using CT and MRI scans, as well as optical motion tracking methods. These data will then be used to populate the musculoskeletal model.

Once the model is constructed, it will be used to simulate the motion of the joint and look at the effect of a simulated PIP joint replacement. This information should then provide insight as to how PIP joint replacements might be improved in future.


Eligibility Criteria:
Inclusion Criteria:

* In general good health
* University of Southampton members of staff
* Over 18 years old and able to provide informed consent
* No known problems relating to the PIP joint

Exclusion Criteria:

* Volunteers involved in other studies concerned with the function and anatomy of the PIP joint which would have adverse effects on this study and/or the study in which they are currently involved.
* Those undergoing treatment related to the PIP joint
* No metallic object should be present in the scanner and therefore those with any implanted metallic devices, or other devices which may cause or be caused adverse effects (e.g. metal plate, pacemaker)
Effect of Community Social Mobilization for the Prevention of HIV in Young South African Women

The overall purpose is to assess whether a community social mobilization (CSM) program focused on young men ages 18-35 years of age changes gender norms in the community. The secondary purpose is to determine if there is a combined effect of CSM and HPTN 068 (Conditional Cash Transfers) on HIV and HSV-2 incidence. The goal of the mobilization activities is to engage young men around the issues of gender norms, intimate partner violence and HIV risk and to encourage them to take action to protect young women and reduce HIV risk in their communities.


Eligibility Criteria:
Inclusion Criteria:

Quantitative Work

* Men and women ages 18-35 years
* Have lived in study area continuously for the past 12 months
* Able and willing to provide informed consent

Qualitative Work

* Men and women ages 18-99 years
* A community member, CAT member or community mobilizer
* Able and willing to provide informed consent
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study

To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.

Primary objective:

1. Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old

Secondary objectives:

1. Rate of sobriety maintenance for 1 year after enrollment
2. Re-infection rate with HCV over 1 year after enrollment
3. Re-admission rates for detox
4. Cravings

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 30
* Successfully detoxed at PHBH from opioids
* Agree to participate in a closely monitored program
* Positive HCV VL \> 5,000 on two tests
* Minimum one follow-up visit after discharge from PHBH to be enrolled
* Any genotype
* APRI less than 1 and Fibrosure less than 0.45
* Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret
* Treatment naïve for HCV
* Signed informed consent

Exclusion Criteria:

* Cirrhosis
* Co-infection with HIV or HBV
* Inability to comply with treatment or follow up
* Renal failure with GFR less than 50 mL/min5\*
* Any prior treatment for HCV
* Diabetes with HgA1c more than 8.0
* Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:

  * ALT/AST \> 10x normal value,
  * WBC with ANC \< 1500 cell/ul,
  * Hemoglobin \< LLN,
  * Treatment for cancer or lymphoma in the past 5 years,
  * Hemoglobin A 1C \> 8%.
* Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.
* Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres
Interval-training in Type 2 Diabetics

Interval training is superior to continuous training for improving glycemic control, hereunder glycemic variability and -spikes. However, the underlying mechanisms and the clinical impact is at present unknown.

The overall objective of this project is to determine the mechanisms underlying aeroic interval-training-induced reductions in glycemic variability and -spikes, and the impact on levels of systemic inflammation in type 2 diabetes patients. It is hypothesized that aerobic interval training reduces glycemic variability and -spikes more than continuous training due to larger improvements in both peripheral insulin sensitivity and the mass action effect of glucose. Moreover, it is hypothesized that these reductions in glycemic variability and -spikes also reduces systemic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* BMI \>18 but \<40 kg/m2

Exclusion Criteria:

* Pregnancy
* Smoking
* Contraindication to increased levels of physical activity
* More than moderate levels of physical activity (\>90 min/week) of maximally moderate intensity
* Insulin dependence
* Thyroid, liver, lung, heart or kidney disease, with the need for treatment