cyrilzakka/clinical-trials huggingface dataset:
The Effect Of Vestibular Rehabilitation On Kinesiophobia And Balance With Individuals Who Has Vestibular Hypofunction

Vestibular hypofunction is a disease which emerge through a partial or total loss on a vestibular organ or vestibular nerve. It can be seen unilateral or bilateral. Aim of the study is to examine effects of vestibular rehabilitation on kinesiophobia, quality of life, dynamic vision acuity and balance. The study was conducted with patients diagnosed with vestibular hypofunction. 30 patients who are in the ages between 18 and 65 have participated in the study. Exercise programs has given to patients to do at home. Patients were observed every two weeks in the hospital. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backwards both open and closed eyes, and walking on tandem both open and closed eyes. Exercise program was applied for 8 weeks. Before and after the treatment, Tampa Kinesiophobia Scale, World Health Organization Quality of Life Scale-Short form in Turkish, Dynamic Visual Acuity Test, Balance Tests, Unterberger Test, Visual Analog Scale to measure dizziness and fatigue, for verticality and horizontality perception Subjective Visual Vertical and Subjective Visual Horizontal tests have been applied. As a result of the study, statistical correlations have been found except semi-tandem posture test with eyes open and Romberg's test both with eyes open and closed. It can be said that vestibular rehabilitation has improved quality of life, balance, dynamic vision acuity and overcame kinesiophobia on the patients.

Vestibular rehabilitation consisted of a total of 4 sessions, rearranged every 15 days. These exercises were prepared gradually to increase the vestibulo-ocular reflex and vestibulospinal reflex. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. The therapist gave the patients a home exercise program. It was emphasized that the exercises should be applied as 10 repetitions. After the session, the exercises shown to the patients were explained in written form and given as home exercises. They were also asked to do home exercises 3 times a day, 10 repetitions, for 15 days. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with vestibular hypofunction diagnosed by videonystagmography test
* Patients aged between 18-65 years.

Exclusion Criteria:

* Patients with visual impairment and neurological involvement
* Individuals with wavy vertigo
* Ataxia, or other lesions causing oscillopsia
* Dementia
* Patients with severely limited mobility and unable to walk without using a walker, cane, or orthosis.
Using Social Media to Enhance the Impact of the Teen Outreach Program

The investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program.


Eligibility Criteria:
Inclusion Criteria:

* boys and girls club member in metro Denver, age 14-18

Exclusion Criteria:

* non-english speaking
Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone.

The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

Patients with oligometastatic squamous cell carcinoma were enrolled and 2:1 randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy (radiotherapy, surgery, radiofrequency/microwave ablation, etc.) or PD-1 inhibitor +/- chemotherapy alone. Different local therapy techniques are allowed to be used on different lesions in the same patient.All suspected malignant lesion should be included in local treatment planning in principle.

The primary end point was progression-free survival (PFS). The second end points included overall survival, side effects and local control.

Eligibility Criteria:
Inclusion Criteria:

* 1. ≥18 years old; 2. ECOG 0-1; 3. Esophageal squamous cell carcinoma 4. ASTRO/ESTRO defined genuine oligometastatic disease and consistent with: i. ≤4 distant metastases, ii. ≤3 metastatic lesions within a single organ, iii. maximum diameter of each metastatic lesion ≤5cm; 5. ≥1 pathologically diagnosed metastases

Exclusion Criteria:

* 1. History of disseminated metastases or ASTRO/ESTRO defined induced oligometastatic disease 2.Esophageal perforation/hemorrhage 3.Progression disease after PD-1 inhibitor treatment 4.In-field recurrence 5.Intolerance to chemotherapy or immunotherapy 6.lung V20\>25%
C-11 Choline PET-CT Scan in Finding Metastases in Patients With Newly Diagnosed High-Risk Prostate Cancer

RATIONALE: New diagnostic procedures, such as C-11 choline PET-CT scan, may be effective in finding cancer that has spread to the bone and lymph nodes in patients with prostate cancer.

PURPOSE: This clinical trial is studying how well C-11 choline PET-CT scan works in finding metastases in patients with newly diagnosed high-risk prostate cancer.

OBJECTIVES:

Primary

* To determine the sensitivity and specificity of PET-CT scan using C-11 choline in detecting bone and lymph node metastases in patients with newly diagnosed high-risk adenocarcinoma of the prostate.

Secondary

* To perform semi-quantitative analysis of tracer uptake using standard uptake values and qualitative analysis using pure visual analysis.
* To develop an algorithm that includes the routine use of C-11 choline PET-CT scan for the staging of patients with prostate cancer at high risk of metastatic disease.
* To determine whether the presence of C-11 choline PET-CT scan positivity in these patients is predictive of outcomes, including biochemical relapse-free survival, time to development of clinically apparent metastases, time to local failure, and overall survival.
* To obtain tissue specimens from these patients for correlative studies and further evaluation.
* To obtain information regarding the feasibility and characteristics of C-11 choline PET-CT scan after androgen suppression.

OUTLINE: Patients undergo CT scan of the abdomen and pelvis with IV contrast and a bone scan. Patients also undergo a C-11 choline PET-CT scan\*. In the case of any positive scan, patients undergo a needle biopsy. If the biopsy is negative for metastatic disease or if the biopsy is positive for metastatic disease in a draining lymph node region, patients receive radiotherapy and hormonal (antiandrogen) therapy. If the biopsy is positive for metastatic disease at any other site, patients receive hormonal therapy alone.

NOTE: \*The first 10 patients enrolled on the study who have a positive PET-CT scan and positive biopsy undergo a second PET-CT scan at 6 months after the initial PET-CT scan.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Prior negative prostate biopsy allowed
* High-risk disease, as defined by one of the following:
* PSA ≥ 20 ng/mL
* Gleason score ≥ 8
* Digital rectal examination revealing ≥ T2c disease (tumor involving more than one half of one lobe of the prostate)
* Creatinine \< 2.0 mg/dL
* Able to tolerate PET scan, CT scan, and bone scan
* Able to tolerate IV and oral contrast
* Willing to undergo biopsy of positive findings on PET-CT scan, CT scan, or bone scan

Exclusion Criteria:

* Other cancer within the past 5 years (except for nonmelanoma skin cancer)
* No prior radiotherapy, hormonal therapy, surgery (other than biopsy), or cryotherapy for prostate cancer Prior transurethral resection of the prostate allowed
PROstaTE Cancer Treatment and Obesity in Zoladex-Astrazeneca Treated Patients

The reports on relationship of obesity and biochemical or clinical recurrence of prostate cancer are controversial. Several reports have shown that obesity is associated with increased risk of biochemical or clinical failure after radical prostatectomy. Other prospective studies have shown no adverse effect of obesity on long-term outcomes after prostatectomy. Limited reports are available on the impact of obesity on prostate cancer progression after radiotherapy. Primary: to assess percentage recurrence rate among normal weight and overweight or obese prostate cancer patients treated by adjuvant Zoladex therapy. Secondary: to determine the Quality of Life differences among normal and overweight or obese prostate cancer patients by a Quality of Life questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven prostate cancer patients being on adjuvant Zoladex treatment after primary therapy or on adjuvant therapy without primary curative therapy

Exclusion Criteria:

-Prostate cancer patients refractory to hormonal therapy, not agreeing to participate, allergy against treatment
The Personal Concerns Inventory Study (PCI)

Services for people with personality disorders are challenged by how to engage clients in therapy. High non-completion rates have major cost-efficiency implications, but more worrying is that drop-out may be associated with negative outcomes for clients. The investigators have developed a motivational intervention that helps people focus on their valued and attainable life goals and consider how therapy could help with goal attainment.One way to improve retention in treatment is to deliver pre-therapy motivational preparation interviews. The primary aim of our proposed research is to gather information to determine whether a randomised controlled trial of a goal-based motivational intervention is feasible in a community personality disorder treatment service.

The investigators aim to work with community adults with personality disorder. Referrals to Nottinghamshire NHS Trust's community personality disorder service will be eligible for inclusion. After initial assessment for suitability for the service, patients will be randomised to receive the motivational interview plus treatment as usual or treatment as usual only. The investigators aim to recruit 100 participants over 1½ years. The comparison is between a motivational intervention called the Personal Concerns Inventory plus treatment as usual and and treatment as usual only in the client preparation phase. The feasibility measures are (1) the recruitment rate to a goal-based motivational interview plus treatment as usual or treatment as usual only, and (2) the acceptability of the intervention to clients and therapists. The investigators will also develop measures to assess the processes by which the intervention may have an effect, and assess the cost of the intervention compared with treatment as usual.

Eligibility Criteria:
Inclusion Criteria:

* Referred to the Nottinghamshire Personality Disorder and Development Network
* Opted to attend group sessions within the Nottinghamshire Personality Disorder and Development Network
* Aged 18 or over.
* Proficiency in spoken English
* Capacity to provide valid informed consent

Exclusion Criteria:

* Currently enrolled in another trial
Remicade Safety Line (Study P03236)(COMPLETED)

The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.

This study used a non-probability sampling method.

Eligibility Criteria:
Inclusion Criteria:

* Patients with active rheumatoid arthritis confirmed with adequate clinical response(ACR) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab.

Exclusion Criteria:

* As per Summary of Product Characteristics (SmPC)
Investigating Accelerated Learning in Healthy Subjects

The purpose of this study is to investigate whether it is possible to accelerate learning and improve associative memory performance in healthy subjects, by (1) applying transcranial Direct Current Stimulation (tDCS) during a verbal paired-associate learning task and by (2) optimizing the learning method with repeated retrieval practice.

Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. Previous research has also emphasized the importance of repeated retrieval practice as a way to accelerate learning and enhance associative memory performance. Therefore, this study will examine the effect of repeated retrieval practice on associative memory performance by using two versions of an associative memory task.

To investigate whether it is possible to accelerate learning and improve associative memory using tDCS and repeated retrieval practice, the performance in a Verbal Paired-Associate memory task during the first visit and 1 week after will be compared for four study groups. The first group will get active tDCS during a version of the verbal paired-associate learning task with repeated retrieval practice. The second group will get active tDCS during a version of the verbal paired-associate learning task without repeated retrieval practice. The third group will get sham tDCS during a version of the verbal paired-associate learning task with repeated retrieval practice and the fourth group will get Sham tDCS during a version of the verbal paired-associate learning task without repeated retrieval practice.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-35 years
* Native English Speaker

Exclusion Criteria:

* History of severe head injuries,epileptic insults, or heart disease
* Severe psychiatric disorders and severe untreated medical problems.
* Acquainted with the foreign language used in the learning task
* Contraindications for tDCS (pregnant women, implanted devices)
A Genome-Wide Association Study for Neonatal Diseases

This is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (NEC) using genome-wide association study (GWAS) and enterotype investigation. We hypothesize that specific genetic factors and microbiome could predispose preterm neonates for the development of NEC.

NEC is the most frequently encountered surgical emergencies and a life-threatening disease that predominantly affects preterm neonates. The incidence is estimated to be 7-10% in ver low birth weight (VLBW) neonates (Lin and Stoll, 2006; Neu and Walker, 2011). However, a significant proportion of affected neonates (20-30%) develops severe progressive disease with intestinal necrosis and complications resulting in gut perforation and peritonitis which require urgent surgical intervention (surgical cases) (Sharma et al., 2006). The mortality rate of surgical cases is high (25-50%), and may increase to 100% in patients with pan-necrosis of the bowel. Those neonates who survived often suffer severe morbidity, including short bowel syndrome, parenteral nutrition-associated cholestasis, poor physical growth and neurodevelopmental impairment (Neu and Walker, 2011; Salhab et al., 2004). However, the etiology and pathophysiology of NEC remain incompletely understood. The current knowledge has directed towards multiple predisposing factors which include prematurity, immature gut mucosa and host defense immunity, formula milk feeding and altered microbial colonization in the gut resulting in excessive inflammatory response, leading to irreversible intestinal cell death and gut necrosis (Neu and Walker, 2011; Chan et al., 2013). To date, no genetic risk markers or biomarkers are available for reliable prediction of neonates who are at high risk of developing NEC. Besides host genetic factors, gut bacteria have been reported to predispose neonates to disease risk (Mai et. al., 2011; Neu and Pammi, 2018).

In this study, we shall conduct a GWAS on Chinese preterm neonates for identification of genetic risks for NEC and determine gut microbiome structure (enterotype) of NEC.

Eligibility Criteria:
Inclusion Criteria:

Chinese infants admitted in the neonatal unit (NNU)

Exclusion Criteria:

Refuse consent for study
52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes,
* Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1,
* HbA1c \>6.5% and ≤10.0%

Exclusion Criteria:

* Type 1 diabetes,
* history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,
* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
Patterns of ABL Mutation in Asian With Imatinib Resistant Chronic Myeloid Leukemia and Ph Positive Acute Lymphocytc Leuekmia Patients (AMICA)

The purposes of this study are to investigate the patterns of BCR-ABL mutations in CML and Ph positive ALL patients with imatinib resistance during the year of 2001-2009 in Asian institutes.

Awareness of the significance of BCR-ABL mutations is generally low across Asia. This is partly due to historical limitations in capabilities for mutation testing. While numerous mutation studies have been done in non-Asian populations, there are very few published reports on mutations in Asians. CML management in Asia therefore continues to be largely intuitive.

Anecdotal reports, suggest that there may differences in the presence or absence of mutations at the time of initial diagnosis and their occurrence during imatinib treatment. At present, however, we have no comprehensive formal knowledge of the actual nature of mutations in Asians. There are moves towards the establishment of CML registries that will capture the pattern of mutations among Asian patients.

In recent years, several laboratories in the region have been performing mutation analysis. However, no systematic evaluation of or report on these data has been undertaken. This study therefore intends to collect documented mutation data in Asian CML and Ph positive ALL patients from identified Asian institutes. While this is a retrospective, cross-sectional analysis of mutation information, the study will provide the first comprehensive formal report on mutations in Asian CML and Ph positive ALL patients. The collecting information has the potential better to inform the clinical management of CML and Ph positive ALL in Asia according to the mutation result and possibly future research in these patients.

Eligibility Criteria:
Inclusion Criteria:

* All mutation data from CML and Ph positive ALL patients who developed imatinib resistance during the year 2001-2009

Exclusion Criteria:

* Mutation data from CML and Ph positive ALL patients who, in addition to imatinib, received other therapy. Follow up mutation report after second generation TKI therapy.
Methadone Patient Access to Collaborative Treatment

The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.

It will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.

This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:

AIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.

AIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.

AIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.

Eligibility Criteria:
Inclusion Criteria:

* Staff providing methadone treatment services at the enrolled opioid treatment programs

Exclusion Criteria:

* Patients receiving methadone treatment at the enrolled opioid treatment programs
Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Based on the overwhelming positive response to this survey and the large number of patients being treated with PD-1/PD-L1 therapy in the UPMC system, the investigators are proposing a trial that will randomize patients who have disease stability to stop treatment at 1 year or continue treatment until disease progression. The investigators anticipate that the results of this study will answer questions regarding the optimal duration of treatment. therapy.

Within the UPMC system, approximately 2,300 patients received PD-1/PD-L1 therapy for a variety of advanced solid tumors within the past year. It is anticipated that this number will increase as the clinical indications for treatment with these agents also increase. The investigators conducted a survey of 60 Medical Oncologists within the UPMC system regarding their interest in a trial that will attempt to address the question of optimal length of PD-1/PD-L1 treatment. Fifty-two (86.7%) physicians indicated that they would participate in a clinical trial that had a primary goal of determining whether it was feasible to stop immunotherapy after 1 year of treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients must have an advanced solid tumor malignancy (specifically NSCLC, bladder, HNSCC, renal, melanoma, cervical, Merkel cell, MMR/MSI \[colon, rectal, cholangio, esophageal, ovarian, uterine\], anal, gastric and GE junction, hepatocellular, triple negative breast cancer) that is being treated with a PD-1/PD-L1 inhibitor including pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab according to standard of care treatment.
* Patients who initially started treatment with another agent in combination with the PD-1/PD-L1 inhibitor, i.e. chemotherapy, ipilumumab, are eligible.
* Patients must have at least stable disease as evidenced by scans performed within 6 weeks of randomization.
* Signed Informed consent allowing randomization to stopping immunotherapy at 1 year ± 6 weeks versus continued treatment beyond 1 year.
* Patients can have measurable or non-measurable disease per RECIST v1.1.
* Patients cannot be enrolled in a clinical trial.

Exclusion Criteria:

* Patients with documented progressive disease prior to randomization.
* Patients with an immune-related toxicity preventing the continuation of treatment beyond 1 year at the treating physician's discretion.