cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation

The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.

Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.

Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.

All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy \>= 1 month;
* Is receiving a regular dose of opioids for the control of pain;
* Has a diagnosis of opioid induced constipation;
* Is on a stable laxative regimen.

Exclusion Criteria:

* Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;
* Has evidence of current fecal impaction;
* Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;
* Has a body weight less than 27 kg
* Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
Role of Nerve Mobilizations in Decreasing Pain and Disability Among Patients With Cervical Radiculopathy

Objective of the study is to find out the effectiveness of nerve mobilization in patients with cervical radiculopathy. It is a single blinded randomized controlled trial using non-probability convenient sampling. Data is collected from University Physical therapy and Rehabilitation Clinic, University of Lahore, Pakistan.

Alternate hypothesis: There is a significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.

Null hypothesis: There is no significant role of nerve mobilizations in decreasing pain and disability among patients with cervical radiculopathy.

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It will be a prospectively registered, parallel designed, randomized controlled trial with concealed allocation, conducted in University Physical Therapy and Rehabilitation Clinic, Lahore, Pakistan. Patients who met the eligibility criteria will be informed about the aim of the study. All eligible participants who will agree to participate in the study signed the consent form. Eligibility of the participants will be determined by the two members of the research team before the randomization. After baseline assessment, eligible patients will be randomly assigned (in a 1:1 ratio) into two groups (Group A and Group B). Randomization will be done by one of the research team members using fish bowl method. Randomization assignments will be kept in opaque, sealed envelopes and unsealed by the researchers after baseline testing. Outcome assessor will be masked to group allocation and patients will be instructed not to talk about the content of their exercise program during the post intervention visit and could contact their therapists in case of any problems during trial participation. Help of female physiotherapist will be taken for the female patients. The sample size was calculated as 76 participants (38 per group), allowing statistical power of 80%, an alpha level of 5% and attrition rate of 20% having mean difference of 1.1 and SD of 1.48 and 1.63.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with age between 20 to 45 years
* Patients having pain for more than 4 months
* Patients having positive upper limb neurodynamic test
* Patient with positive spurling test.

Exclusion Criteria:

* Patients with trauma of upper limb and cervical spine
* Dizziness
* Upper limb circulatory disturbance
* Malignancy
* Patients with bilateral symptoms
Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging

This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).

Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* DES in proximal coronary vessel segments

Exclusion Criteria:

- Any conditions that may interfere with the safety or efficacy of CCTA
Changes in Quadriceps Muscular Activity in Patients After Total Knee Arthroplasty Compared to Healty Subjects

During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle.The aim of the study is to investigate differences in quadriceps neuromuscular activity in the acute phase after surgery.

During Total Knee Arthroplasty (TKA), joint undergo considerable stress, which causes neuromuscular activation deficits of the quadriceps femoris muscle. The current phenomenon depends on a complex mechanism called Arthrogenic Muscle Inhibition (AMI). AMI has been studied only in sub-acute and chronic phase after TKA due to the invasive procedures employed in order to evaluate it; However, clinical observation and experimental studies suggest presence of this phenomenon also in the first postoperative days. The aim of the study is to investigate differences in quadriceps neuromuscular activity, in acute phase.

The study is a prospective observational study.15 healthy subjects and 15 patients scheduled for TKA will be recruited. Patients will be asked to perform three isokinetic taks in the same standardized biomechanical context in order to evaluate changes in quadriceps neuromuscular activity after surgery as primary outcome. Secondly, correlation between primary aim and pain perceived by the patient will be investigated. Moreover, patient's functional ability will be assessed using the Timed Up and Go Test (TUG). Data will be recorded the day before TKA, at one and three days after surgery.

At the end of data acquisition, normality and homogeneity of demographic variables will be assessed. Differences in the outcome measures will be investigated with the t student test (or with the related non-parametric tests) and by means of the mixed models repeated measures ANOVA test. Linear regression will be applied to evaluate any correlation between outcomes.

Eligibility Criteria:
Inclusion Criteria:

* age: over 18 years.
* subjects eligible for TKA.

Exclusion Criteria:

* QAB (quadriceps activation battery) \< 6 the day before the operation
* neurological or musculoskeletal diseases (different from the causes that which led the patient to the TKA), which may interfere with the quadriceps muscle activation or with motor performance of the subject.
* Uncooperative subjects.
Sub-Occipital MIT With and Without HR Agonist Contraction of Hamstrings in Neck Pain Patients With Hamstring Tightness

Hamstrings and Sub occipital muscles are part of the superficial back line of the myofascial chain which connects the neck to the lower extremity and the soft tissue in the cervical spine links the dura and sub occipital muscle fascia. Increased tension in one or other part of this myofascial chain disturbs the whole superficial back line and compromises the flexibility. The objective of this study is to determine the Effects of Sub-Occipital Muscle Inhibition technique (MIT) with and without Hold Relax (HR) Agonist Contraction of Hamstrings on Pain, Disability and Craniovertebral angle in Neck pain patients with Hamstring Tightness. This study will be a randomized controlled trial and will be conducted in Physiotherapy center of AL-Mahmood Welfare Foundation Sahiwal. This study will be completed in time duration of 10 months after the approval of synopsis and consecutive sampling technique will be used. A sample size of 34 will be randomly assigned into two groups. Group A will be given Sub Occipital Muscle Inhibition treatment while Group B will be given Sub occipital Muscle Inhibition and Hold Relax Agonist Contraction of hamstring. Each group will be given three sessions per week. Data will be collected from all participants before first session of treatment and after 6th session of treatment by using Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), Cervical Range of motion (CROM), Craniovertebral Angle (CVA) and Active knee extension (AKE) test measurement.


Eligibility Criteria:
Inclusion Criteria:

Age 25-40 years Both Genders ( Male and Female) Neck Pain on NPRS ≥5 NDI score ≥14 ( Moderate disability) Active knee extension lag ≥30 and considered as tight hamstrings

Exclusion Criteria:

Acute Low back or Neck pain History of lumbar and cervical herniated disc and spinal stenosis History of cervical spine surgery and Trauma History of vascular disease in head and neck Progressive neurological deficit or Inflammatory condition ( such as peripheral neuropath, rheumatoid arthritis) History of abdominal or pelvic surgery in last 6 months
The Effect of Acupuncture Protocol Involving in Weizhong (BL4) and Huantiao (GB30) Points in Treating Ankylosing Spondylitis

The purpose of this study is to evaluate the effect of acupuncture protocol involving in Weizhong (BL4) and Huantiao (GB30) points in treating ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

* Eligible adult (≥18 years of age) patients
* had a diagnosis of AS for at least 3 months defined as definite by the 1984 modified New York criteria
* Eligible patients also had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of ≥4 (0-10 cm scale)
* A visual analogue scale (VAS) score for total back pain of ≥4 (0-10 cm scale)

Exclusion Criteria:

* Had received prior Acupuncture therapy
* With complete ankylosis of the spine, defined as the presence of bridging syndesmophytes at all intervertebral levels of the cervical and lumbar spine on lateral view spinal radiographs
Postural Analysis During Dental Surgery

Background: Attention and awareness towards MSDs in the dental profession has increased considerably in recent years. From recent literature reviews, it is learned that prevalence of MSDs in dentists is 64-93%. It has been seen that the use of magnification systems not only improves the operator's visual capabilities, but also allows for a more correct posture, and to prevent the onset of back and neck disorders.

Purpose and methods: Evaluate dentist posture during extraction of third lower molars depending on whether the operator uses the naked eye, surgical loupes or surgical microscope systems. Data will be evaluated through the index RULA (rapid upper limb assesment) to define whether there is a change in exposure to the risk of MSDs (Muskoloskeletal disease) and using fiducial markers for the movement analysis of the operator during the procedure.

Study design: randomized controlled clinical trial. Purpose: Evaluate dentist posture during extraction of third lower molars depending on whether the operator uses the naked eye, surgical loupes or surgical microscope systems. Methods: Data will be analysed through the index RULA (rapid upper limb assesment) to define whether there is a change in exposure to the risk of MSDs (Muskoloskeletal disease).

Posture assessment will be based on 3-D data of the upper body, which can discriminate spatial displacements up to 2mm in translation and 1 degree in rotation.

The surgical intervention will be performed under local anesthesia (mepivacaine 20 mg/ml with adrenaline 1:100000) and by the use of microscope (OPMI Movena S7) or surgical loupes or no magnifying system.

During this session the following data will be collected for the study:

1. Demographic data (baseline)
2. Medical and dental history
3. Parameters related to the lower third molar
4. Radiographic tests
5. Marker operator position
6. Pre- and postoperative photographs

Each patients will be recalled for follow-up visits at 7 days. During this session will be carried out the removal of stitches and data will be recorded as follows:

1. VAS pain and trismus.
2. Number of painkillers taken
3. Control photographs
4. Posse Scala

Eligibility Criteria:
Inclusion Criteria:

* patients elements 38 or 48 in dysodontiasis requiring a complex extraction
* able to sign informed consent

Exclusion Criteria:

* general contraindication to surgical treatment
* pregnancy
* lactation
* age under 18 years
The Significance of Glucose Intolerance in the Pathogenesis of Idiopathic Axonal Polyneuropathy

The purpose of this study is to determine whether impaired glucose handling (abnormality in the way the body processes blood sugar) can cause a neuropathy (damage to the nerves).

Neuropathy of undetermined etiology is a common disease that usually starts at the sixth to seventh decades. It can cause significant pain and disability. Previous studies have demonstrated increased prevalence of abnormal glucose handling, when these patients were tested with oral glucose tolerance test (OGTT). On the other hand, many of the neuropathy patients suffer from pain and depression and obesity; and abnormal OGTT in these patients may be the result of these factors. We assume that if abnormal handling of blood sugar is the cause of neuropathy, these patients may have evidence of damage to other organs (like eyes and kidneys) as a result of abnormal blood sugar. In a pilot study, we will determine the incidence of subtle damage to kidneys, eyes and also look for other factors associated with abnormal glucose handling in patients with neuropathy and abnormal OGTT and compare it to age matched controls with normal OGTT.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria (for the subjects) will include peripheral neuropathy, age more than 50 years, and a negative workup for neuropathy (aside from an abnormal OGTT). Age matched controls will have no history of diabetes or baseline retinal disease . A workup to rule out other causes of peripheral neuropathy, and an OGTT, will be performed prior to participation in the study.

Exclusion Criteria:

Patients with abnormal OGTT in the diabetic range will not be included.
Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain

The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with Acute low back pain

This study is a randomized, double-blind, active- and placebo-controlled, parallel, phase II study to evaluate efficacy and safety of NVP-1203 in patients with Acute low back pain

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
* 19 Years and older
* A patient has symptom of acute low back pain

Exclusion Criteria:

* Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
* Inadequate subject for the clinical trial by the investigator's decision
Hand Grasping Techniques on Eliciting the Grasp Reflex in Patients With Dementia

In this study, the investigators will determine the difference between the two techniques used to elicit the grasp response in patients with frontal lobe dysfunction, primarily in dementia patients versus control patients.

The goal of this project is to determine the optimal technique to elicit the grasping response in patients with dementia or suspected frontal lobe dysfunction. The proposed study is to perform two techniques to elicit grasp response in patients with dementia or suspected frontal lobe dysfunction and observe the presence or absence of the response and prominence of the response on a proposed rating scale. Future goals will be aimed at aiding clinicians in refining their clinical techniques to be more sensitive for diagnosing frontal lobe dysfunctions.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to sign informed consent or have a surrogate present to sign the consent
2. Age 18 or above
3. Patients are diagnosed with dementia, Alzheimer's disease, or frontal lobe dysfunction
4. Medications are to remain stable during the course of the study except for emergency modifications.

Exclusion Criteria:

1. Inability to obtain informed consent from patient or surrogate
2. Unable to follow commands.
3. Physical restrictions (i.e. spasticity of hands/arms, upper extremity amputation)
4. Other comorbidities such as muscular diseases, hepatic encephalopathy, renal failure, down syndrome, NPH, depression, and cerebral palsy.
Effect of Different Concentrations of Lidocaine in Relieving Pain in Wide Awake Hand Surgery Using Tumescence

Lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of procedures. This has been quite popular especially in wide awake surgery of the hand with no tourniquet. However, the appropriate lidocaine concentration is yet to be established. This randomized control trial will study the minimum effective lidocaine concentration in hand surgery using the tumescent technique.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 16 to 60 years of either gender
2. Patients with post burn/post traumatic contractures involving fingers \& palm
3. Patients with nerve injury or flexor/extensor tendons injury distal to mid forearm.

Exclusion Criteria:

1. Patients with history of ischemic heart disease, chronic liver disease (ALT/AST 40 IU/L), renal disease (creatinine 13mg/dl), bleeding disorder, peripheral arterial disease \& peripheral neuro3pathy .
2. Surgical site infection .
3. History of allergic hypersensitivity to epinephrine or lidocaine.
Registration Study of Amyotrophic Lateral Sclerosis (ALS) in Mainland China

A multi-center registration study of natural history and clinical characteristics of ALS in mainland China

Amyotrophic lateral sclerosis (ALS) is a rapidly progressive neurodegenerative disease of unknown etiology that is currently incurable. This study is a national multi-center registration study. The study collects general information of ALS patients including medical history, disease characteristics, clinical treatment data, and patient information for different visits in different centers. The aim of the study is: a) describe the distribution of ALS in mainland China(explore the differences in the number of ALS at different times, different regions, and different populations) and further find the reasons that affect the distribution of ALS, b) study the development of ALS in mainland China and the corresponding changes in the characteristics of the disease, c) explore factors that influence the prognosis of ALS.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to EI Escorial diagnostic criteria
* Age: 18-70 years

Exclusion Criteria:

* Refuse to cooperate or reject the informed consent
Post-operative Dental Pain Study Comparing Analgesic Efficacy

GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.
Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol.

Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone.

The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Completes the qualifying clinical study final visit
* In the opinion of the principal investigator (PI), has been generally compliant with study requirements during the qualifying study, or must be considered eligible to enroll in PIPF-012 by the InterMune medical monitor
* Is able to provide informed consent and comply with the requirements of the study

Exclusion Criteria:

* Is pregnant or lactating
* Has known hypersensitivity to any of the components of the study drug
* Starts participation in another interventional clinical trial between the end of participation in the qualifying InterMune clinical trial and entry into PIPF-012
* Receives concomitant and/or excluded medications as defined in the protocol
* Permanently discontinues study drug during the qualifying study for any reason before study completion