cyrilzakka/clinical-trials huggingface dataset:
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents

Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a limited number of reports on the management of occluded SEMS with various results. The aim of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent ERBD after the occlusion of initial SEMSs.

Endoscopic placement of self-expandable metallic stents (SEMSs) is the mainstay of palliative measures for alleviating obstructive jaundice secondary to advanced cholangiocarcinoma. Previous meta-analysis showed no significant difference in stent patency between covered and uncovered SEMS, which are currently available. However, information on secondary SEMS insertion is still scarce, and there has been no prospective trial comparing efficacy of secondary stenting between covered and uncovered SEMS for the management of occluded metal stent in malignant biliary obstruction. Previously, only two small retrospective studies addressed this issue. Given the absence of prospective trial on re-intervention for occluded SEMS in malignant biliary obstruction, we aimed to prospectively compare the efficacies and complication rates of secondary ComVi stent (cSEMS) and uSEMS for the management of such condition.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SEMS occlusion, which was inserted either endoscopically or percutaneously, for the relief of malignant nonhilar biliary obstruction
* Patients in whom the above SEMS had been inserted for no less than 7 days
* Patients with one of the following:

  1. cholangitis (as defined by fever, tenderness in the right upper quadrant or epigastrium, and/or a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion)
  2. a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion
* Patients in whom the cause of initial ERBD occlusion was identified, such as tumor overgrowth, ingrowth, and/or sludge
* Age ≥ 20 years

Exclusion Criteria:

* Unable to give informed consent
* Patients with sepsis and/or shock not responding to medical treatment or Eastern Cooperative Oncology Group (ECOG) Performance Status 4
* Patients with estimated survival \< 4 weeks
* Patients who had undergone curative or palliative surgical intervention
* Hilar or perihilar biliary obstruction
* Patients who had undergone endoscopic nasobiliary drainage,plastic stent insertion, or percutaneous transhepatic biliary drainage prior to second SEMS insertion
* Covered SEMS as initial SEMS
* Migration or food impaction as the cause of initial SEMS occlusion
Safety and Efficacy Studies of rHSA/GCSF Fusion Protein For Injection to Treat Neutropenia

Safety and efficacy studies of rHSA/GCSF fusion protein for injection in treatment of neutropenia induced by chemotherapy of cancer patients.

A dosage climbing for the safety and efficacy studies for the neutropenia induced by chemotherapy cancer patients Repeat-dose studies for the safety and efficacy studied for the neutropenia.

Eligibility Criteria:
Inclusion Criteria:

- chemotherapy induced neutropenia

Exclusion Criteria:

- treated with other biological drugs or other neutropenia therapy drugs
Endothelial Function, Arterial Stiffness and Components

Specific Aim: Compare the endothelial function, arterial stiffness and components of metabolic syndrome of childhood Acute Lymphoblastic Leukemia (ALL) survivors to healthy sibling controls. Plan: A cross sectional study comparing ALL survivors to sibling controls including measures of endothelial function and arterial stiffness obtained form a peripheral artery tonometry device, height, weight, waist circumference, fasting lipid, glucose and insulin.


Eligibility Criteria:
Inclusion Criteria:

Survivor:

Inclusion

1. Ages 8-28 (8 is chosen as lower age limit because developmental understanding will allow survivor to follow instructions for procedures, 28 is chosen as upper limit to include age ranges seen for treatment in the pediatric program)
2. Off therapy for at least 6 months and not more than 10 years (6 months

Inclusion

1. Biological sibling
2. Ages 8-28 (when more than one sibling is available the one closest in age will be chosen.))

Exclusion Criteria:

1. Uncontrolled medical conditions that could interfere with participation or interpretation of results
2. History of relapsed ALL or history of bone marrow transplantation
A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media

Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.

Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 \[30 cases in each group\]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3.

Outcomes:

1. Improvement of hearing
2. Closure of tympanic perforation
3. Recurrence of disease
4. external ear canal stenosis

Tools for measurement of outcomes \[before and after surgery\]:

1. Pure tone audiometry
2. Impedance audiometry
3. Otoendoscopy
4. External ear canal dimensions

Eligibility Criteria:
Inclusion Criteria:Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain -

Exclusion Criteria:1. atticoantral otitis media 2. Specific otitis media 3. Sensorineural hearing loss 4. Fixed/Dislocated ossicular chain 5. Uncorrectable disease focus in nose/throat 6. Chronic otitis media in active phase 7. Chronic otitis media with complications 8. Extensive unresectable tympanosclerosis

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Cross Body vs Sleeper Stretch on Pain, Range of Motion and Functional Performance in Cricket Bowlers.

The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive sleeper stretch in a side lying position. Group B will receive cross-body stretch will be done in sitting position

The objective of the study is to determine the comparison of sleeper stretch and cross body stretch on pain, range of motion and functional performance in cricket bowlers with GIRD. The study is randomized and single-blinded. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Subjects in Group A will receive sleeper stretch in a side lying position. Group B will receive cross-body stretch will be done in sitting position. A universal goniometer, Upper limb functional index (UEFI) scale and Numeric pain rating scale (NPRS) will be used at the baseline and after the completion of treatment at 6 weeks.

The data will be analyzed by SPSS, version 25. Statistical significance is P=0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 30years,
* Both male and female,
* \>10% IR deficit,
* \>25% IR deficit related to contralateral limb,
* Athletes one year of regular practice,
* Lift off test for shoulder internal rotation positive.

Exclusion Criteria:

* Non players,
* Any nerve lesions of upper limb,
* Players with history of shoulder pain or fracture or dislocation in less than twelve months
Effectiveness of Cognitive Stimulation Treatment in Patients With Parkinson's Disease

The goal of this observational study is to evaluate the relationship between GBA mutation and cognitive stimulation treatment response in patients with Parkinson's disease. The main questions it aim to answer are: • assess whether the GBA mutation is associated with greater or lesser response to cognitive training treatment compared to a control group of PD patients without genetic mutations. • investigate the effect of cognitive stimulation program on behavioural aspects as secondary consequence induced by the possible improvement of cognitive abilities following treatment.

Participants will be undergo to: - a neuropsychological evaluation describing their cognitive profile; - a genetic investigation and finally included in a cognitive stimulation programs according to regular clinical practice. Researchers will compare PD patients with GBA mutation and patients without genetic mutation to evaluate the effectiveness of cognitive stimulation treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's disease according to the Gelb et al. criteria;
* Patients who have carried out genetic screening for MP;
* Patients who have a raw score in the range 15.50 to 22.23 at Montreal cognitive assessment (MoCA);
* Patients who have signed the informed consent and the Privacy Policy;
* Patients who are included in cognitive stimulation programs according to regular clinical practice.

Exclusion Criteria:

* Patients with the initial suspicion of MP that during the diagnostic work-up they were suffering from a different pathology;
* Patients who have refused consent to participate in the study;
* Patients with a diagnosis of MP and cognitive profile of dementia;
* Patients undergoing deep brain neurostimulation (DBS-STN) treatment. Patients treated with DBS-STN were excluded because such treatment involves a surgical procedure whose effects on cognitive functioning could represent an interfering variable.
Connect to Protect Partnerships for Youth Prevention Interventions: Phase II

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such Adolescent Trials Network (ATN) research activities.

This phase will describe specific locations within high-risk areas where youth, ages 12-24, spend time. HIV risk behaviors, social networking patterns and HIV prevalence among youth at these venues will be assessed by administering anonymous computerized interviews to eligible and willing youth. This information will be shared with community partners during scheduled working group meetings.

This is Phase II of a three stage project whose overall goals are to develop viable community-based HIV prevention interventions and to form and maintain the necessary community collaborations to support such ATN research activities.

During this phase, each ATN site will gather additional information within high-risk areas and solicit community partner input to ultimately pinpoint the specific locations where at-risk youths, ages 12-24, may be recruited for interventions. This will be done by the following methods:

Venues will be identified by HIV+ youth at the ATN site by participation in an anonymous computerized interview. Site staff will then perform brief venue interviews (BVIs) at selected venues to assess the potential yield of youths 12-24 years old. Community partners will also provide the site staff with information on known high-risk venues. High-risk venues will further be identified by the results of anonymous computerized interviews and HIV assays obtained from eligible and willing youth participants at the venues. The interviews will gather information on HIV risk behaviors, social networking patterns and HIV prevalence among youths at these venues. This information will be shared with community partners during scheduled working group meetings.

Eligibility Criteria:
Inclusion Criteria:

Index Subjects:

* Documented HIV-infection
* Acquisition of HIV after age 9 years
* Verbal confirmation of 12-24 years of age
* Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
* Ability to understand and willingness to provide informed consent/assent

BVI subjects:

* Youths who appear to be 12-24 years old

HIV Serosurvey subjects at the venues:

* Verbal confirmation of 12-24 years of age
* Verbal report of having engaged in sexual activity (vaginal, anal and/or oral sex) within the past 12 months
* Ability to understand and willingness to provide informed consent/assent

Exclusion Criteria:

* Visibly distraught and/or emotionally unstable (i.e. depressive mood, exhibiting manic, suicidal or violent behavior, etc.)
* Visibly intoxicated or under the influence of psychoactive agents
* Clinically presents as acutely ill
Neural Computations of Goal-directed Decision-making

The purpose of this research is to better understand how the human brain accomplishes the cognitive task of making goal-directed decisions. These investigations are critical to better understand human cognition and to design treatments for disorders of decision making and performance monitoring.

Flexible goal-directed decision-making is a core aspect of higher-order adaptive biological intelligence. A number of psychiatric disorders involve impairments in goal-directed decision-making, yet the current lack of even a basic understanding of how goal-directed action selection is implemented at the neuronal level in humans hinders the ability to pinpoint these neuropsychiatric dysfunctions. In particular, it is completely unknown how goals, and the stimuli and actions that need to be selected from in order to pursue them, are represented at the level of single neurons, nor how goals get selected from available possible goals.

The study experiments utilize the rare opportunity to record in-vivo from human single neurons simultaneously in multiple brain areas in patients undergoing treatment for drug resistant epilepsy. The study will utilize a combination of (i) in-vivo recordings in awake behaving humans assessing decision making accuracy and ability through choice ratings, (ii) computational analysis and modeling.

These techniques will be applied to characterize the functional contribution of human ventromedial prefrontal (vmPFC), dorsal anterior cingulate (dACC) and pre-supplementary motor area (pre-SMA) in these processes. Investigators will first test the longstanding proposal never tested at the neuronal level in humans that the value of stimuli is especially represented by neurons in vmPFC, while the value of actions are more represented by neurons in dorsal cortical areas such as the pre-SMA. Investigators will then address how goals themselves are represented. In the real world, animals including humans need to select a goal before any action is performed. Thus, there is a hierarchical process of goal selection followed by action selection. Investigators hypothesize that the vmPFC plays a specific role in goal-valuation and selection, while neurons in dorsomedial areas including pre-SMA and dACC will play more of a role in valuing and selecting the actions that implement the chosen goal.

The expected outcome of this work is a comprehensive understanding of the functions of the human PFC in goal-directed decision-making at cellular resolution while shedding light on the neural mechanisms of goal-representation and selection which hitherto has been virtually unstudied.

Eligibility Criteria:
Inclusion Criteria:

* Intractable epilepsy, undergoing invasive monitoring
* Age ≥13
* Full Scale Intelligence Quotient \> 70
* Ability to comprehend and perform simple behavioral tasks by pressing buttons on laptop computer in response to questions

Exclusion Criteria:

* Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain
A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir

This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.

Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.

Eligibility Criteria:
Inclusion Criteria

You may be eligible for this trial if you:

* Are HIV-positive.
* Are 13 years of age or older.
* Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.
* In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.
* Have the written consent of a parent or legal guardian if you are under age 18.
* Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).
* Are willing to complete the 48-week study.

Exclusion Criteria

You will not be eligible for this trial if you:

* Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.
* Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.
* Have had certain types of hepatitis in the past 6 months.
* Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.
* Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.
* Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease

The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.

Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic PD confirmed by a movement disorders neurologist
* a Mini-Mental Status Examination (MMSE)\[13\] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam
* functional visual acuity for recognizing the laser beam on the rolling walker
* FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)
* ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.

Exclusion Criteria:

* diagnosis of a gait disorder other than Parkinson's disease
Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

Total anomalous pulmonary venous connection (TAPVC) is a complex congenital heart disease, requiring surgical repair. Pulmonary venous obstruction (PVO) is the major complication, with limited effective reinterventions and poor outcomes. This trial aims at investigating that postoperative anticoagulant management reduce the incidence of PVO.

Total anomalous pulmonary venous connection (TAPVC) is a complex congenital heart disease, with all the pulmonary veins connecting to the right heart system through collateral vessels, accounts for about 3% of congenital heart disease. Pulmonary venous obstruction (PVO) is a major complication, with limited effective reinterventions and poor outcomes. The major challenge for surgical repair of TAPVC is to lower the incidence of PVO.

Previous studies in our center showed the abnormal coagulation function, such as elevated International Normalized Ratio (INR), and decreasing of prothrombin activity, are associated with a higher rate of PVO. Some researches suggested that postoperative application of anticoagulants might reduce the incidence of PVO, however, the evidences are still limited. This trial will randomize patients to receive either conventional postoperative management or continuous infusion anticoagulant (Heparin) until the removal of deep vein catheter. The primary endpoint will be incidence of PVO, days of chest drainage more than 40ml/d, and mortality rate. Secondary endpoints including readmission, functional capacity assessment, quality of life and incidence of complications will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* 1. Infants and neonates who are diagnosed with TAPVC
* 2. Infants and neonates who undergo initial surgical repair for TAPVC

Exclusion Criteria:

* 1. Concommitant diagnosis including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia or transposition of the great arteries.
* 2. Older than 1-year-old.
Effects of Muscle Energy Technique in Knee Osteoarthritis Patients

To determine the effectiveness of muscle energy technique along conventional physical therapy after mesenchymal stem cell transplantation in knee Osteoarthritis patients regarding Pain, range of motion, functional disability and quality of life.

Mesenchymal stem cells (MSCs) replacement is a regenerative therapeutic procedures for the early treatment of cartilaginous defects in knee osteoarthritis. MSCs may improve symptoms and function in osteoarthritic joints but also decrease inflammation and induce cartilage healing by differentiating into chondrocytes, osteoblasts and indicating appropriate extracellular matrix proteins (i.e. collagen I and II) through the secretion of cytokines, chemokines, and growth factors from MSCs.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Age \> 40 years
* Knee osteoarthritis patients undergone mesenchymal stem cell transplantation.

Exclusion Criteria:

* History of recent or past septic arthritis
* Patients with neurological deficit
* Uncontrolled diabetes
* Malignancy
* Vascular insufficiency