cyrilzakka/clinical-trials huggingface dataset:
Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

Chronic conditions such as stroke are associated with physical disability and an economic burden for the family and the society. A medical approach is often not sufficient to address the bio-psychological process of chronic disease. Behavioural medicine approaches are often needed to improve the treatment outcomes. Those approaches have often successfully been used together with physical activity to change health behaviour in inactive individuals and in pain management. In this project the combined approach of behavioural medicine principles and physical training will be tried on patients who have had a stroke one year ago where it has yet only been used scarcely. As the study focus on the individuals' ability to function and be active the primary outcome measure is disability. The aim of the study are in a randomized controlled study evaluate if a high intense functional exercise program as an group intervention under three months can influence functional, psychosocial, anthropometric and biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome variables will be analyzed:

1. level of physical activity, motor function and balance
2. depression and health-related quality of life
3. body mass index (BMI), metabolic risk profile, inflammation status
4. number of falls, fall-related self-efficacy and outcome expectations

Hife include functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. All exercise shall be performed in weight-bearing positions, eg squats and walking over obstacles. HIFE are performed twice a week during 1 h. for three months in a group with 6-7 seven patients with stroke. Two physiotherapists lead the group and one physiotherapist select exercises for each participant according to their functional deficits. The exercises will be progressively increased in load and difficulty.

Eligibility Criteria:
Inclusion Criteria:

* Patient with first-ever stroke in the age of 65-65 years getting their stroke at least one year ago and living in the community.

Exclusion Criteria:

* Other illness or disability that have an impact on the activity level and participation in tests beside problems after stroke.
Study on OsseoSpeed™ TX Narrow Implants in the Upper Jaw in a Chinese Population

The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.


Eligibility Criteria:
Inclusion criteria:

1. Provision of informed consent
2. Aged 20-75 years at enrollment
3. History of edentulism in the study area of at least two months
4. Neighboring tooth/teeth to the planned crown(s) must have natural root(s)
5. Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
6. Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
7. Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

1. Unlikely to be able to comply with study procedures, as judged by the investigator
2. Uncontrolled pathologic processes in the oral cavity
3. Known or suspected current malignancy
4. History of radiation therapy in the head and neck region
5. History of chemotherapy within 5 years prior to surgery
6. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
7. Uncontrolled diabetes mellitus
8. Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
9. Smoking more than 10 cigarettes per day
10. Present alcohol and/or drug abuse
11. Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
12. Previous enrollment in the present study
13. Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
Cyberknife After Breast Conservative Surgery

Accelerated partial breast irradiation with CyberKnife (CK-APBI) is a promising innovative approach for early breast cancer after conservative surgery, for addressing the need of a radiotherapy target only to the surgical cavity in selected patients, exceeding the limits of other PBI/APBI.

The large majority of local recurrences in breast cancer after breast conserving treatment are close to the original tumor site. This evidence suggested to restrict the radiotherapy target to the surgical cavity in selected patients. Consequently, shorter fractionation strategies focused only on tumor bed with a small cuff of surrounding subclinical disease, i.e. accelerated partial breast irradiation (APBI), were developed. Stereotactic radiotherapy was thought, consisting of a short course of intense treatment focused on the target tissue. There is very little experience with CiberKnife for early breast cancer until now.

This study is a prospective non-randomized study designed to assess the acute, sub-acute, late toxicity, cosmesis and globally the feasibility of CyberKnife (CK-APBI). From June 2013 to June 2018 we are going to enroll 80 patients considered eligible for the present study. All patients will be followed for at least 2 years. A first enrollment of 20-25 patients is scheduled as first assessment.

Breast magnetic resonance imaging (MRI) will be aided to mammography and ultrasound examination for confirming the best selection of patients.

For the assessment of acute toxicity, cosmetic results by three different observers (physician, patient, external observer), medium term and late toxicity, patients were evaluated and the results recorded immediately before and after radiotherapy, then after 1 month, three, six, nine, and twelve, and twenty-four months. The toxicity will be correlated to the main radiotherapy treatment dosimetry and delivery recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients were ≥45 years of age with stage I-IIA histologically confirmed breast carcinoma, with tumor-free (at least 2 mm or more) inked histologic margins at surgical resection.

Exclusion Criteria:

* Invasive lobular or multicentric carcinoma;
* Extensive associated non-invasive ductal carcinoma (synchronous or previous); peritumoral vascular invasion (\>3 vessels);
* BRCA mutation carriers,
* \>4 involved axillary lymph nodes,
* Distant metastasis,
* Non-epithelial malignancies of the breast,
* Synchronous contralateral invasive carcinoma,
* Paget disease,
* History of previous malignancy (except non-melanoma skin cancers and in situ oral cavity and cervix carcinoma);
* Further exclusion criteria were pregnancy, collagen vascular disease, aesthetic additive prostheses, severe cardiac, pulmonary and liver diseases, infectious, psychiatric illness compromising the correct acquisition of informed consent.
Biomarkers and Cardiac CT

Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the identification of these patients remains a clinical challenge.

One promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred from the Cardiology clinic for routine CCTA.

Exclusion Criteria:

* Pregnancy
* Severe renal insufficiency
* Severe allergy to contrast medium
* Inability to obtain informed consent
* Age below 18 years
Rocuronium and Supramaximal Stimulation

To shorten induction time, some anesthesiologist gives a priming dose of muscle relaxant before starting Neuromuscular Transmission monitor (NMT). To properly evaluate neuromuscular function during the surgury, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, The investigators designed this study to find out.

The NMT monitor module automatically determines the current needed for the supramaximal stimulus, and maintains this current throughout the procedure.

The supramaximal current is the current above which there is no increase in the evoked muscle response. At this stimulus current, all motor units are firing in response to nerve stimulation. According to previous studies, the current was significantly increased in the presence of edema and peripheral neuropathy. In this study, the route of administration, dosage, dosage regimen, and treatment period are basically the same as the investigators anesthesia department's routine procedure for general anesthesia. The difference will be the time the investigators set between the priming dose to final dose of rocuronium is 2 minutes. The investigators use 2 minutes as the peak effect of rocuronium is 105±36S.

To properly evaluate neuromuscular blockade during the surgery, baseline supramaximal stimulation of the monitored nerve is mandatory. Not knowing if the priming dose of muscle relaxant affects the supramaximal stimulation current setting, the investigators designed this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving general anesthesia and use rocuronium for induction

Exclusion Criteria:

* Muscular disease
* Peripheral neuropathy
* Difficult airway or difficult mask ventilation
* Allergy to study related medication
* Pregnant woman
* \< 20-year-old or \> 65-year-old
* BMI \<18.5 or BMI\>24.9
Critical Periods of Exercise

Early childhood (\~3-7 years of age) is an important window for determining body composition trajectory and may be a critical period for the development of tissue partitioning patterns that influence obesity risk. As adiposity accelerates during this critical period, deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of tissue mass accrued in early childhood has implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting energy expenditure.

The interplay between fat and bone deposition represents a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly the phenotype underlying obesity and diabetes risk may be determined by the differentiation of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development. In vitro studies demonstrate transdifferentiation under the influence of specific external stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass accrual in adulthood, even when the stimulus is later removed (animals are no longer exercising). Children's early experiences (engagement in physical activity vs. sedentary behavior) may 'environmentally induce' alterations in body composition and predispose individuals to obesity throughout life.

Aim 1. To examine the associations between body composition via DXA and objectively-measured physical activity/inactivity.

1. Hypothesis 1.1: There is a positive association between physical activity and bone mass.
2. Hypothesis 1.2: There is a positive association between sedentary behavior and total fat mass.

   Aim2. To examine the associations between adipose tissue distribution via MRI and objectively-measured physical activity/inactivity.
3. Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.
4. Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue.


Eligibility Criteria:
Inclusion Criteria:

* children aged 3 to 7 years
* healthy, not under the care of a doctor
* not taking medications known to alter body composition or metabolism
A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B \~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B \~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)

Eligibility Criteria:
Inclusion Criteria:

1. Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
2. Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender;
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0\~1;
4. The expected survival time is at least 12 weeks;
5. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
6. Subject has adequate organ and bone marrow function
7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug Sets, etc.); women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Exclusion Criteria:

1. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
2. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
3. Women during pregnancy or lactation;
4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
5. Patients with history of severe cardiovascular and cerebrovascular diseases.
6. Patients with active infection and currently requiring intravenous anti-infective treatment
Total Knee Arthroplasty With and Without Tourniquet: Comparative Study

Tourniquet use during total knee arthroplasty (TKA) improves visibility and reduces intraoperative blood loss. However, tourniquet use may also have a negative impact on early recovery of muscle strength and lower extremity function after TKA.Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B

This study started on March 2016 and ends on October 2018. Seventy Patients are involved in this study and were divided into two groups; Group A (35) patients were treated with TKA with pneumatic thigh tourniquet. Group B (35) patients were treated with TKA without tourniquet. All patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment so they are candidates for primary TKA. The two groups are matched related to age and gender. Selection of patients into two groups done randomly with regard of odd number for group A and even number for group B. All patients were followed for a period of two weeks until removal of skin sutures for the following parameters:

Amount of blood transfusion done at and after surgery. Amount of blood drained postoperatively through suction drain. Occurrence of postoperative wound hematoma. VAS (Visual analogue score) for thigh pain at 1st day and (2) weeks postoperatively.

Clinical DVT.

Eligibility Criteria:
Inclusion Criteria:

* patients were suffering from severe knee osteoarthritis and they failed to respond to conservative treatment

Exclusion Criteria:

* Hb less than 12.
* D.M.,Blood dyscrasia.
* Any evidence of infection by screening test ESR and CRP. ,
* BMI more than 30.
Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant

The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.

We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized. Patients will receive two different doses of the blocker and the effect will be measured with oral glucose tolerance tests. The study is a randomized placebo-controlled study.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* informed consent
* age 18-70, for females only postmenopausal

Exclusion Criteria:

* heart disease
* anxiety disorder
* antidiabetic treatment other than metformin
* adrenergic blockers
* ulcus
* allergy to any component in the capsules
Dry Needling and Manipulation vs. Mobilization, Exercise and Interferential Electrotherapy for Shoulder Impingement (Subacromial Pain Syndrome)

The purpose of this research is to compare two different approaches for treating patients with shoulder impingement (subacromial pain syndrome): electric dry needling and spinal manipulation versus impairment-based mobilization, exercise, and interferential electrotherapy. Physical therapists commonly use all of these techniques to treat shoulder impingement (subacromial pain syndrome). This study is attempting to find out if one treatment strategy is more effective than the other.

Patients with shoulder impingement (subacromial pain syndrome) will be randomized to receive 2 treatment sessions per week for up to 6 weeks (up to 12 sessions total) of either: (1) electric dry needling and spinal manipulation or (2) impairment-based mobilization, exercise and interferential electrotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Adult over the age of 18 years old that is able to read, write and speak English
2. Primary complaint of anterolateral shoulder pain lasting longer than 6 weeks
3. One or more of the following special tests:

   1. Positive Neer Impingement test-i.e. pain with passive overpressure at full shoulder flexion with the scapula stabilized.
   2. Positive Hawkins-Kennedy test-i.e. pain with passive internal rotation at 90° of shoulder and elbow flexion
4. Pain with ONE or more of the following active movements and resisted isometric tests

   1. Pain with active shoulder elevation
   2. Pain with resisted shoulder external rotation at 90 deg of abduction
   3. Pain with resisted shoulder abduction in Empty Can Test positon - i.e. 90 deg of shoulder abduction, 30 deg of horizontal adduction (i.e. in scapular plane) and full internal rotation (i.e. thumb down)

Exclusion Criteria:

1. Report of red flags to manual physical therapy to include: severe hypertension, infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
2. History of shoulder injection within the past 3 months.
3. History of shoulder dislocation, subluxation, fracture, adhesive capsulitis, or cervical, thoracic or shoulder surgery.
4. Isolated acromioclavicular joint pathology (i.e. the only location of symptoms is localized specifically with one finger directly over the acromioclavicular joint and nowhere else, and reproduced only with acromioclavicular palpation by the examiner.)
5. Evidence of cervical radiculopathy, radiculitis or referred pain from the c-spine
6. Full-thickness rotator cuff tears (evidenced by MRI and/or positive lag signs)
7. Baseline SPADI of not less than 20%
8. History of breast cancer on involved side.
9. Prior treatments (eg. Acupuncture, physical therapy, chiropractic, dry needling, massage therapy, injections) to the involved limb over past 3 months.
10. Pending litigation for an injury.
11. Psychiatric disorders or cognitively impaired
12. Pregnancy
Topical Lidocaine After Arthroscopy on Knee

More than half of the patients suffer from intensive pain 1-2 days after arthroscopy in the knee. Walking function and physical activities are affected by this intensive pain although local anaesthetic is given in the joint and soft tissue.

The patients are often discharged on the same day as the arthroscopy takes place depending on their ability to walk with or without assistive technology.

It is a well-known fact that the patient is given a dose of morphine, analgesics or an ice pack on a painful knee to reduce pain intensity. The aim of the project is to study whether pain intensity and analgesics can be additionally reduced by giving local anaesthetic by means of an adhesive tape placed on the skin instead of giving morphine, analgesics or ice pack on a painful knee.

The researchers plan to include a cohort of 180 patients: 60 patients having a meniscus sutured, 60 patients having meniscus tissue removed surgically, 60 patients having mucous fold removed surgically.

This study is planned to be a pilot study in order to complete a future large medical science study.


Eligibility Criteria:
Inclusion Criteria:

* Planned resection of meniscus (DS832, DM232)
* Planned meniscus suture (DS832)
* Planned plica resection (DM659)
* Patients \>=18 years and \<50 years
* Statement of consent
* Tolerance to Lidocaine (analgesics)

Exclusion Criteria:

* Type 1 diabetes or type 2 diabetes
* Allergic to Lidocaine (analgesics)
* Heart disease, liver disease, kidney disease
* BMI \>=35
* Unability to read or speak Danish
* Rheumatoid arthritis or other degenerative diseases in joint, bone structure or cartilage
* Insufficient coagulation
* Medication of morphine pre-operatively
* Pregnant and nursing women