cyrilzakka/clinical-trials huggingface dataset:
Visual Observation Scale for the Upper Limb During Walking in Patients After Stroke.

For several years now, it has been demonstrated that the upper limb plays an important role in the function of an efficient and balanced gait pattern in healthy adults. After a stroke, the reduced muscle strength has a clear influence on the gait pattern, but also on the active movement possibilities of the upper limb. However, the role of the upper limb during gait is not sufficiently explored in the literature. The gold standard for motion analysis is a 3D analysis performed with infrared cameras capturing reflective markers during gait. Unfortunately, it is not possible for all people after a stroke to undergo this examination. On the one hand, patients must already have a certain degree of independence with regard to gait. On the other hand, not all centers have access to this expensive accommodation. There are some validated observation scales for people after stroke to describe the gait based on a 2D video image. This method is much more accessible and can be applied by any therapist. However, to date there has been little attention paid to the upper limb in these observation scales. Therefore, analogous to the observation scales for gait, an observation scale for the upper limb during gait was set up. The use of this scale can add value to the rehabilitation of people after a stroke.

* The treatment team will receive information about the patient's complete movement pattern.
* The arm will be more prominent when setting rehabilitation goals related to gait. This can lead to a positive effect on the gait pattern itself, but also to more attention being paid to the arm, which has a more difficult recovery than the leg after a stroke.

The aim of the current study will be

* to determine the inter and intra tester reliability of this visual observation scale
* to investigate if the results of the visual observation scale correlate to a 3D assessment performed in a subgroup of participants

Patients will be walking for 4x10 m. During this walking a 2D video recording in the frontal (back and front view) and sagittal plane (left and right sided view) will be performed.

Supervision of therapist during walking is allowed. Therapist cannot help the patient during walking.

This images will be used to score the visual observation scale (G.A.I.T) and the additional observation scale developed for this study.

In a subgroup of participants from the Ghent University Hospital, a 3D assessment will be made on an instrumented treadmill (GRAIL, Motek), which will be used as a golden standard to compare with.

Additional clinical parameters will be investigated to describe the study group.

Eligibility Criteria:
Inclusion Criteria:

* All stroke patients who are able to walk with or without the use of a unilateral walking device (stick, tripod) for at least 10 m.
* Normal ambulation prior to stroke.
* Unilateral stroke.

Exclusion Criteria:

* Other neurologic conditions.
* Orthopedic conditions that influence gait.
* Visual impairments that impede independent walking.
* Cerebellar stroke
What Influences Patient Outcome in Obstructive Airway Disease?

The aim of this observational study is to utilise the established record linkage data available in Tayside to investigate hospital admissions, exacerbations and mortality in COPD.


Eligibility Criteria:
Inclusion Criteria:

* Data collected through TARDIS database

Exclusion Criteria:

* History of asthma or malignancy. Less than 50 years of age
Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. However, operative pain was still an important factor, which might contribute to several post-operative complications.

In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory drugs and opioid agents, or patient-controlled analgesia for post operative pain control. However, some side effects were observed occasionally.

The role of acupuncture in post-operative pain control was frequently discussed in recent research. The main mechanisms of acupuncture in pain control were (1) to stimulate the release of endogenous opioid and (2) to block TRPV1 receptor.

The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the first clinical trial investigated the role of acupuncture in post-operative pain control for traditional thoracotomy patients. However, there was no further research about the role of acupuncture applied to minimal invasive thoracoscopic surgery.

Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order to deliver a safe and effective way in pain control, and to save medical cost and promote quality of patient care.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 20-year-old
* Both male and female patients
* Nationality: Republic of China (R.O.C., Taiwan)
* Who received thoracoscopic surgery for benign lung tumor/disease, metastatic lung tumor, primary lung cancer, mediastinal tumor

Exclusion Criteria:

* Abnormal function of coagulation
* Platelet count less than 20 x 10\^3/mm\^3
* International normalized ratio (INR) more than 2.5
* Severe comorbidity, for example central vascular, cardiovascular disease, liver/renal failure
* Who would not cooperate in access, or express appropriately
Effect of Aging & Obesity With Exercise Intervention

Obesity leads to a vicious circle that increases intramuscular fat, insulin resistance, promotes muscular dysfunction resulting in increased muscle fat accumulation. The study of muscle function and intramyocellular lipids is insufficient for obesity. Particularly, the study of mechanisms in muscle function and intramyocellular lipids is few nationally and internationally.

This study is prospective study. The goal of this study is

1. To examine the distribution and contractile properties (cross-sectional area, maximal force, specific force, maximal shortening velocity) of single muscle fiber sex/Myosin heavy chain (MHC) type-related differences, by extracting a single muscle fiber from the vastus lateralis in young men and women.
2. To examine the effects of intramyocellular lipids on physical activity ability, muscle dysfunction, and metabolic disorders in relation to aging and obesity.
3. To examine the effects of intramyocellular lipids on physical activity ability, muscular dysfunction, and metabolic disorders after 12 weeks resistance exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Young men: Age (20-35 yrs), BMI (19-23 Kg/m2)
* Young women: Age (20-35 yrs), BMI (19-23 Kg/m2)
* Elderly women: Age (65-80 yrs), BMI (19-23 Kg/m2)
* Elderly obese women: Age (65-80 yrs), BMI ( \>25 Kg/m2)
* Subjects who can agree voluntarily.

Exclusion Criteria:

* Acute coronary syndrome.
* Uncontrolled hypertension.
* Subjects who took drugs which can affects neuromuscular system.
* Severely impaired cognition
* Subjects who cannot agree voluntarily
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy

This study aims to demonstrate the preventive effect of compression therapy using surgical gloves in chemotherapy-induced peripheral neuropathy. Patient-reported outcome measures (PROMs) are utilized for comparing the change in neuropathic pain between intervention and control groups. Among the PROMs, the neurotoxicity component of the functional Assessment of Cancer Therapy-taxane (FACT-Tax) is used for good and poor outcomes between baseline and post-chemotherapy in paclitaxel-treated breast cancer patients.

Chemotherapy-induced peripheral neuropathy (CIPN) is associated with side effects of taxanes, including paclitaxel. The common side effect may adversely affect the quality of life. However, no treatment for CIPN can be strongly recommended. Therefore, prevention is important. Cryotherapy, compression therapy, and exercise therapy can be considered for prevention, but no definitive recommendations are available. Studies with wider sample sizes are needed to confirm the efficacy and the preventive methods are complex for application. The study use surgical gloves for compression therapy to reduce discomfort and increase compliance with the procedure.

Patients with stage II-III breast cancer who receive paclitaxel chemotherapy for at least 12 weeks in six academic hospitals in South Korea will participate in the study. The study design is a multicenter, open-label, randomized controlled trial. The patients are randomly assigned to intervention or control groups. Intervention patients will wear two-layer of normal-sized surgical gloves on both hands during chemotherapy infusion. The primary outcome is to demonstrate the preventive effect of compression therapy using surgical gloves as measured by the change in the neurotoxicity of FACT-Tax questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 19 years, under 70 years old
* Stage II-III breast cancer
* No distant metastasis
* Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel for at least 12 weeks
* Signed informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%)

Exclusion Criteria:

* Recurred breast cancer
* Patients who have previously received treatment that could cause neuropathy; taxane or platinum-based chemotherapy, antitubulins, proteasome inhibitors
* Known history of neuropathy
* Chronic kidney disease
* Raynaud's phenomenon
* Peripheral vascular disease; peripheral arterial ischemia
* Cold intolerance
* Allergy in natural rubber latex or surgical gloves
* Patients who have dermatitis, wound, or musculoskeletal problems in hand at enrollment
* Current use medications which may mitigate chemotherapy-induced peripheral neuropathy; duloxetine, gabapentin/pregabalin, Baclofen-amitriptyline-ketamine (BAK; topical amitriptyline, ketamine, ±baclofen), oral cannabinoids, tricyclic antidepressants, ganglioside-monosialic acid
Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemic

This is a Multicenter, Randomized, Double-Blind, Placebo-Parallel-Controlled, Phase II Clinical Stud to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with Hyperlipidemic.


Eligibility Criteria:
Inclusion Criteria:

1. Regularly taking any moderate-intensity or higher dose\* of statin stabilization therapy for ≥4 weeks at screening:

   1. ASCVD risk is ultra-high risk Fasting LDL-C ≥ 1.4 mmol/L;
   2. ASCVD risk very high risk Fasting LDL-C ≥1.8 mmol/L;
   3. ASCVD risk is intermediate or high risk Fasting LDL-C ≥ 2.6 mmol/L.
2. Any other condition that is not met at screening Regularly taking any moderate intensity and higher dose\* statin stabilization therapy for ≥4 weeks;

   a) Fasting LDL-C ≥ 2.6 mmol/L.
3. Fasting triglycerides ≤ 5.6 mmol/L.

Exclusion Criteria:

1. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%).
2. eGFR \<30ml/min/1.73m2 at the screening visit.
3. CK \>5times ULN at the screening visit.
Pharmacokinetics and Relative Bioavailability Study

A Single-Dose Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules

Pharmacokinetics And Relative Bioavailability Study Of Tolterodine From Two Microspheres In Powder Blend Extended Release Formulations Compared To The Commercial Extended Release Capsules

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

Exclusion Criteria:

* Evidence or history of clinically significant diseases
WHO Checklist- Based Infection Prevention Guidelines in Mulago Hospital

This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days .

To determine the level of compliance with WHO checklist-based infection prevention guidelines following caesarean delivery in Mulago National Referral Hospital, Kawempe.

To determine the association between compliance with WHO checklist-based infection prevention guidelines and surgical site infection following caesarean delivery in Mulago Hospital, Kawempe.

This prospective cohort study will assess all mothers undergoing elective and emergency caesarean delivery in the labour ward theatre at Mulago National Referral Hospital based temporarily at Kawempe Hospital. Mothers will be recruited into the study systematically over a period of 3 months and follow-up daily until discharge or 30 days of in-hospital stay for the purpose of documentation of surgical site infection. Data will be collected using the checklist expansion for antisepsis and infection control questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Mothers undergoing elective and emergency caesarean deliveries in Mulago National Referral Hospital, Kawempe in labour suite and gynaecology theatre.

Exclusion Criteria:

* Patient who is unconscious and unknown patient
ERG/EOG Study in AMD Patients Treated With Ranibizumab

This is an open-label study assessing electrophysiologic testing of the retina with Electoretinogram (ERG) /Electrooculogram (EOG) tests in patients with exudative age-related macular degeneration (AMD). The standard FDA-approved treatment for wet AMD is ranibizumab (Lucentis). This study focuses on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \>55 years
* Patients to be included in the study must have AMD with choroidal neovascularization
* BCVA between 20/20 - 20/400
* Lesion size less than or equal to 12 MPS disc areas

Exclusion Criteria:

* Prior treatment with an anti-VEGF agent within 6 months of enrollment in this study
* Pregnancy (positive pregnancy test)
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* Media insufficient to obtain a view
* Other causes of CNV not related to AMD
* Active ocular or peri-ocular infection
* Ocular surgery within 1 month prior to the study
The Effect of Exercise Dosage on Physical Function, Cognition and Disability Following Critical Illness

Survival following a critical illness continues to improve with ongoing developments in medical management, however evidence shows that this patient group is at a high risk of suffering long term disability. The objectives are to determine if there is a link between the amount of exercise performed in intensive care on the presence of delirium, long term cognition and disability whilst ensuring that patient reported outcomes correlate with actual measured results, and to obtain information on recovery from patients and/or relatives to determine themes.

Survival from a critical illness is increasing, however the long term effect on patient's quality of life and the ability for patients to return to pre-illness function is unfavourable. Exercise in the ICU has been proven to be safe and effective, with decreases in length of stay and improvements in physical and psychosocial function seen in multiple studies. At present, the investigators are unsure on the most effective way to exercise this patient group in relation to duration, type, intensity and frequency.

The investigators aim to link the presence of delirium during an ICU admission, disability-free survival and quality of life obtained from telephone follow-up six months following ICU discharge with the amount of exercise performed during their ICU stay to determine a relationship. Additionally, in a small group of participants, the investigators will measure cognitive and physical function to ensure that the patient reported data accurately reflects their true functional level, while allowing patients and/or relatives, next of kin or carers to provide information regarding their recovery through an interview process.

The measure of physical function and disability (via the WHODAS and Euro Qol Group Health Survey (EQ5D)) obtained during telephone interview of the 500 patients enrolled in the PREDICT study will be correlated with the amount of exercise they performed whilst in Intensive Care obtained from the medical records. The presence of delirium will also be obtained from the medical records and linked with the amount of exercise performed to determine if a link is present. A sub-set of this population (40) will be invited at the 3-month follow up phone call of the PREDICT study to have a physiotherapist visit them to assess their cognitive and physical function and interview them and/or their relatives, next of kin or carer to determine themes of the recovery process following critical illness.

Eligibility Criteria:
Inclusion Criteria:

- ICU patients who have been invasively mechanically ventilated for over 24 hours

Exclusion Criteria:

* Patients aged less than 18 years old
* A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. Traumatic Brain Injury, Subarachnoid Haemorrhage, stroke or hypoxic brain injury after cardiac arrest)
* Second or subsequent admission to ICU during a single hospital admission
* Death is deemed imminent and inevitable
* Participants who do no not speak English
A Trial on Metacognitive Training for Depression (D-MCT)

The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention.

Despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. While in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. A main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals).

Metacognitive Training for Depression (D-MCT) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. The training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.

Aim of the present randomized-controlled trial is to investigate the efficacy of D-MCT as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (Positivity Training, PT). Based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to D-MCT or PT. Blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). Primary outcome parameter is severity of depressive symptoms measured with the HDRS total score (17-item version). Secondary outcome measures are self-assessed depression (BDI), dysfunctional beliefs (DAS), metacognitions (MCQ), self-esteem (RSE), and quality of life (WHOQOL-BREF).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depression according to DSM-IV (MINI Interview)
* Diagnosis of Dysthymia according to DSM-IV (MINI Interview)

  * DSM-IV = The Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text Revision (American Psychiatric Association, 2000)

Exclusion Criteria:

* Lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to DSM-IV (MINI Interview)
* Current substance dependency according to DSM-IV (MINI Interview)
Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes

Vitamin D deficiency is widespread throughout the world, and the deficiency has been associated with several chronic diseases, such as cardiovascular diseases and diabetes. In Nordic countries, like in Finland, there is a particular variation in vitamin D status, and during wintertime, when there is no exposure to ultraviolet-B light from the sun, serum concentrations of vitamin D decrease substantially. In Finland, some 40% of middle-aged men and one third of women also have some degree of impairment of glucose metabolism.

The purpose of this trial is to investigate the effects of two different daily doses of vitamin D on glucose metabolism in men 60 years of age or older and who are vitamin D deficient, have a high body mass index and at least two characteristics of cardio-metabolic syndrome.

Altogether 102 subjects with low serum calcidiol (\<60 nmol/L) will be recruited and randomized to one of the three groups: 1) 40 µg/d vitamin D3, 2) 80 µg/d vitamin D3 or 3) placebo. The supplementation period will last for 6 months from September 2011 to March 2012.

The main hypotheses of the trial are: (1.) Vitamin D supplementation will improve glucose and insulin metabolism in people with a low baseline vitamin D status, in a dose-dependent manner. (2.) Vitamin D supplementation will have an effect on the expression of genes involved in glucose and insulin metabolism and inflammation. (3.) Vitamin D supplementation will have an effect on epigenetic changes in key genes participating in vitamin D metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Serum calcidiol \<75 nmol/L
* Body mass index 25-35 kg/m2
* Impaired fasting glucose or impaired glucose tolerance (fasting glucose 5.6-7.0 mmol/L or 2h oral glucose tolerance test glucose 7.8-11.0 mmol/L)

Exclusion Criteria:

* Any chronic disease and condition, which may hamper to follow the intervention protocol (such as alcohol abuse)
* Any chronic disease or therapy which may mask or interact with the investigated effects (such as diabetes or systemic corticosteroid therapy)
* Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis)
* Use of supplements yielding vitamin D over 20 µg/d and unwillingness to discontinue the use.