cyrilzakka/clinical-trials huggingface dataset:
CHANGE Feasibility Study

The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.


Eligibility Criteria:
Inclusion Criteria:

1. Meet current cochlear implant indications at the implanting centre
2. In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 \& 500Hz in the ear to be implanted.
3. Fluent speaker in the local language used to assess clinical performance
4. Eighteen years of age or older at the time of implantation with no upper age limit

Exclusion Criteria:

1. Evidence of hearing loss prior to 5 years of age.
2. Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
3. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
4. Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
5. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
6. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
7. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
8. Active middle-ear infection,
9. Tympanic membrane perforation
10. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
11. Unwillingness or inability of the candidate to comply with all investigational requirements.
12. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
13. Patients with recurrent episodes of bacterial meningitis.
FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients

This study is conducted to assess the effectiveness of functional electrical stimulation Vs limb loading exercises on hand grip strength,dexterity and function in patients with subacute cervical spinal cord injury.

Spinal cord injury (SCI) is based on the concept that rehabilitative training recruits neuronal systems spinal cord injury that remain intact after the injury to take over the impaired function.Working in the field of rehabilitation of the spinal cord injured, presents many challenges. Every patient presents a new and specific challenge. The tetraplegics more so than the paraplegics as the result of loss of active function of their upper extremities in addition to loss of function in the trunk and lower extremities. This study will be conducted to assess the effects of functional electrical stimulation versus limb loading exercises on hand grip strength,dexterity and function in patients with subacute spinal cord injury.

trength,dexterity and function in patients with subacute spinal cord injury. The study will be randomized clinical trial. Participants will be randomly allocated in to two groups each group will have ten participants.. This study will be conducted in two Hospitals in Punjab pakistan. The group A Will receive functional electrical stimulation .The group B will receive upper limb loading exercises .Both groups will be given 30-45 min session 5 days per week for 8 weeks. The outcomes will be measured before and after giving treatment by using modified Action Research Arm Test (ARAT),Hand held dynamometry , Nine-Hole Peg Test (9HPT). The results will be calculated by using SPSS 23 version . Statistical tests will be applied according to the normality of the data either it will be parametric or non-parametric.

Eligibility Criteria:
Inclusion Criteria:

* Patients with incomplete SCI at neurological level C5-T1 in subacute stage.
* Medically stable
* Able to tolerate the Functional Electrical stimulation without sustained autonomic dysreflexia
* A score greater than 16 in mini-mental test

Exclusion Criteria:

* Patients taking long term steroids
* patient having pre-existing injury on upper limb or hand
* Patients have had Previous participation in experimental trial for spinal cord injury
* Patients using Currently cardioactive medications
* Individuals who has had Tendon transfers, implanted devices bladder stimulation, chronic intrathecal infusions
* Individuals with Bleeding disorders.
* Amputation of any digit on target hand
Ovarian Reserve in Patients With Psoriasis

Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Autoimmune diseases including psoriasis are linked to premature ovarian reserve. This study aims to measure serum hormones including FSH,LH,E2,PRL and AMH (indicators of ovarian reserve) in women with and without psoriasis.

Psoriasis is a common autoimmune disease. It affects women of all ages including reproductive years. Almost 75% of patients are diagnosed before the age of 40. There is also increased evidence on autoimmune disease and their link to premature ovarian failure.Ovarian reserve is important for the reproductive period. The measurements of serum hormones including follicle stimulating hormone (FSH),luteinizing hormone (LH),prolactin (PRL), estradiol (E2) and anti-mullerian hormone (AMH) will give us an idea about the ovarian reserve. The investigators aim is to measure ovarian reserve parameters in patients newly diagnosed with psoriasis and to compare them to healthy controls. Serum FSH,LH,E2,PRL and AMH will be measured on the 3rd day of the cycle.The serum hormone levels will be compared between women with psoriasis and women without psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Reproductive age group women: 18-40 years
* Women diagnosed with psoriasis (case group)
* Women without psoriasis (control group)

Exclusion Criteria:

* Women with PCOS (polycystic ovary syndrome)
* history of ovarian surgery
* Body mass index (BMI) over 30
* Women with other autoimmune diseases including Hashitomo thyroiditis
* Women with family history of premature ovarian insufficiency (POI)
* Women with infertility
* Psoriasis using systemic drugs including steroids and immunosuppressive therapy.
Database of Patients Treated With Respiratory Support

An observatory of patients registered in 22 local homecare associations in France, for respiratory diseases, with annual data update. Demographic and clinical data are registered rendering possible extraction of clinical and prognostic data.

Patients on treatment for respiratory failure and for sleep apnoea are registered on entry into treatment with recording of clincal and demographic data. Data available on age, sex, region, respiratoy function, blood gases, smoking status and some bilogical data

Eligibility Criteria:
Inclusion Criteria:

* requiring respiratory support
Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity.

Understanding the functioning of human neurons has always been a key element, especially with regard to the translation of the inputs they receive into actions that determine human behavior. However, the vast majority of studies have been performed in animal models due to the difficulty in maintaining neuronal functions ex vivo. Recently, techniques have been illustrated that allow us to obtain slices of brain tissue removed during neurosurgical interventions. The patch-clamp and HD-MEA (high density - microelectrodes array) techniques, used until now for animal samples, can allow us to study the functioning of the neural cells that make up these slices. Furthermore, the exploration of the functioning of the aforementioned cells in pathological conditions can open the field for further therapeutic perspectives.


Eligibility Criteria:
Inclusion Criteria:

* patients with a brain/cerebellum primary or secondary tumor for whom at least partial resection has been planned.

Exclusion Criteria:

* patients with a brain/cerebellum primary or secondary tumor for whom a biopsy has been planned
Fluorouracil and Leucovorin and/or Levamisole After Surgery In Treating Patients With Dukes' B Or Dukes' C Colon Cancer

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Leucovorin may help fluorouracil kill more tumor cells. Biological therapies, such as levamisole, may interfere with the growth of tumor cells and slow the growth of solid tumors. It is not yet known whether fluorouracil is more effective when given together with leucovorin and/or levamisole after surgery in treating colon cancer.

PURPOSE: This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole, or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes' B or Dukes' C colon cancer.

OBJECTIVES: I. Compare, in a Phase III setting, disease-free survival and overall survival of patients who have undergone potentially curative resection of Dukes' B or C carcinoma of the colon randomly assigned to adjuvant therapy with 5-fluorouracil/leucovorin vs. 5-fluorouracil/levamisole vs. 5-fluorouracil/leucovorin/levamisole.

OUTLINE: Randomized study. Arm I: Single-agent Chemotherapy with Drug Modulation. 5-Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590. Arm II: Single-agent Chemotherapy with Drug Modulation plus Biological Response Modifier Therapy. 5-FU; with CF; plus Levamisole, LEV, NSC-177023. Arm III: Single-agent Chemotherapy plus Biological Response Modifier Therapy. 5-FU; plus LEV.

PROJECTED ACCRUAL: 1,800 evaluable patients will be accrued over about 3 years; an additional 2 years will be required before final analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria
A Study of a Bivalent Influenza Peptide Conjugate Vaccine in Healthy Adults

This is a first in man study evaluating the tolerability and immunogenicity of BIPCV/IMX (V512) at increasing concentrations of influenza viral peptides A/M2+B/HA0 peptides and IMX, a saponin-based adjuvant.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good physical health
* Subject is not in the category of individuals recommended by the CDC to receive influenza vaccine for the upcoming 2 influenza seasons
* Subject agrees not to seek vaccination with licensed influenza vaccines during the study
* Female subjects agree to use acceptable birth control for 6 weeks prior to first dose of vaccine until 1 month post Dose 3

Exclusion Criteria:

* Subject has a history of allergic reaction to the vaccine components
* Subject has has a fever within 3 days of screening
* Subject had a vaccination with an inactive virus within 14 days of Dose 1
* Subject had a vaccination with a live virus within 30 days of Dose 1
Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis

The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.

A total target sample size of 40 adults with MS and 40 adults without MS will be recruited. The 40 adults without MS will undergo the two baseline testing sessions only for the first phase of the study. 20 of those individuals with MS will be randomly selected to undergo the intervention phase of the study.

The research design will include two groups, the intervention and control group. Both groups will undergo a screening process, two baseline testing sessions, and be randomly assigned to one of the two groups. The duration of the study is 6 weeks in length for a total of 18 training sessions. The intervention group participants will undergo gait training with a specific concomitant cognitive task (dual-task) for a total walking time of 20 minutes and with rest breaks the total session time is \~60 minutes with a physical therapist. The control group will undergo gait training, but without the cognitive task. Feedback from the therapist will be provided to each participant concerning gait mechanics and ways to improve gait regardless of group membership.

Outcome measures data will be collected twice at baseline, once at mid-intervention, once at post-intervention, and once at one-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Ability walk independently with or without an assistive device
* Independent and community-dwelling
* No history or presence of other clinically significant musculoskeletal, cardiovascular, respiratory, or neurologic disease.
* Definite diagnosis of MS \[Expanded Disability Status Scale (EDSS) ≤6.5\]
* Relapse free for the past 30 days and not currently receiving or will receive any rehabilitation services during the study.

Exclusion Criteria:

- Participants experiencing a true relapse or exacerbation of their symptoms (\>24 hours duration in the absence infection or fever, or and ambient increase in body temperature) during the study will be excluded from the study.
Serum Regucalcin Level and Chronic Hepatitis B

This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Chronic hepatitis B (CHB) infection continues to be an important health problem due to its high morbidity and mortality. For this reason, it is very important to determine the appropriate timing to start antiviral therapy in patients with CHB infection and to evaluate the stage of liver fibrosis in the treatment follow-up. Liver biopsy is the gold standard for detecting liver fibrosis. Although it is generally accepted to be a safe procedure, it can cause some serious complications. For this reason, in recent years, many studies have been conducted on new noninvasive tests in the evaluation of liver fibrosis. One of them is the serum regucalcin level. Studies have shown that serum regucalcin levels increase in liver damage, but there is no study in the literature comparing liver fibrosis and serum regucalcin levels in CHB infection. This study, it was aimed to investigate the relationship between serum regucalcin level and liver fibrosis level in patients with CHB infection.

Eligibility Criteria:
Inclusion Criteria:

* Being followed up with a diagnosis of chronic hepatitis B
* Not having a known history of liver disease who applied to our outpatient clinic for other reasons
* Having a liver biopsy
* ≥18 years

Exclusion Criteria:

* \<18 years
Exploring the Influence of Trptophan on the Treatment of Pouchitis

Patients with a pouch frequently suffer from chronic inflammation of the intestinal tract, called pouchitis. Pouchitis is routienly treated with repeated courses of antibiotics and probiotics, which does not stop the inflammation from recurring and exposes the patients to the risk of developing antibiotic -resistant pouchitis. Experimental data suggest that the effectiveness of the antibiotic and probiotic treatment can be prolonged by high consumption of trypotophan, an aminoacid present in everyday food. The Try Pro Pouch study aims to compare the consumption of high amounts of tryptophan against placebo in patients with pouchitis.

Participants with chronic pouchitis receive either a weight adapted supplement containing etiher trypotophan or a placebo after completing the standard treatment with antibiotics or probiotics for their pouchitis. Endoskopy will be performed, stool and blood will be sampled, symptoms will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Pouchitis (PDAI \>= 7)
* indication for the application of antibiotics and probiotics
* Age \>=18 years
* Informed consent

Exclusion Criteria:

* major surgery planned druing the intervention
* high risk for malnutrition (NRS 2002 \>=3/ BMI \<18,5 kg/m\^2)
Use of Procalcitonin, a Blood Test to Guide Antibiotic Therapy for Sepsis in Adults

Trial design:

Randomised controlled, two-arm, parallel, clinical trial to assess the efficacy and safety of sequential daily procalcitonin assessments to guide de-escalation of empirical antibiotic therapy in adult patients with sepsis.

Trial settings Trial site is Chattogram Medical College Hospital (CMCH), Bangladesh. CMCH is tertiary care hospital with undergraduate and postgraduate teaching facilities. This tertiary hospital receives referrals from urban and rural areas of southern Bangladesh and has basic facilities for intensive care and haemodialysis.

Trial Participants:

Male or female hospitalised patients, 16-65 years of age, with confirmed or suspected sepsis Patients (Total 532) will be 1:1 randomised to either:

* Intervention arm: daily measurement of serum procalcitonin concentrations to guide de-escalation of antibiotics (Intervention arm: 266), or
* Control arm: standard of practice to guide de-escalation of antibiotics without procalcitonin assessments (Control arm: 266).

Patients will be followed-up until ICU discharge and/or hospital discharge with an additional follow-up at 28 days after discharge.

Funder: Wellcome Trust of Great Britain

Grant reference number from Wellcome Trust: 220211/A/20/Z


Eligibility Criteria:
Inclusion Criteria:

* Participant, legally authorised person/ legal guardian willing and able to give informed consent for participation in the trial.
* Male or Female, aged 16 to 65 years
* Suspected or proven bacterial infection
* A positive sepsis screening National Early Warning Score (NEWS) equal or greater than 5 (Table 1 or at least one criterion with a score of 3.
* Intention to start parenteral antibiotic therapy
* Within 24 hours of hospital admission

Exclusion Criteria:

* Patients with suspected/documented tuberculosis, parasitic infection (including malaria or visceral leishmaniasis), or viral infections (i.e., COVID-19, dengue, HIV)
* Pregnancy
* Intended for a short stay in ICU or general ward (such as post-operative)
* Patients requiring a predefined long course of antibiotic therapy (such as endocarditis, osteomyelitis, lung abscess, liver abscess, septic arthritis)
* Immunocompromised patients, including as severe neutropenia (\< 500 cells/ml), transplant recipients, on prolonged corticosteroid treatment, chemotherapy or disease modifying immunomodulatory medications
* More than 48 hours of parenteral antibiotic use
* Surgical patients, including patients with a surgical septic source or patients requiring source control, i.e. abscess drainage
* Moribund patients or patients receiving end of life care
* Previous enrolment in PROCALBAN
* Conditions accompanied with a systemic inflammatory state, including pancreatitis, cardiogenic shock, severe trauma
The Comparison of Incidence and Risk Factors of Postoperative Delirium in Elderly Patients After Lower Extremity Surgery

The aim of this study is to compare the risk factors and the incidence of delirium following orthopedic surgery under the general or regional anesthesia in elderly patients.

One hundred twenty elderly patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery were enrolled into the study. Patients were allocated into two groups to receive regional anesthesia (group R, n=50) or general anesthesia (group G, n=70). Hemodynamic and blood parameters, potential risk factors of delirium including age, sex, duration of surgery, the type of anesthesia, coexisting disease, smoking and amount of drug used delirium tests (CAM and DRS-R-98), hospital stay and costs were recorded for all patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I-III,
* 120 patients aged ≥65 years scheduled for total hip or knee arthroplasty and femur fracture surgery

Exclusion Criteria:

* Exclusion criteria were patient refusal, abuse of alcohol and/or drugs
* Hypersensitivity to local anesthetics
* Vertebral abnormality
* Previous lumbar vertebra surgery
* Coagulation disorder
* Infection (systemic or local)
* Cerebrovascular disease
* Neurosurgery
* Vascular surgery
* Frequent use of analgesic drug
* ≥5 drugs per day and psychiatric medication
Intervention for Emotions in Caregivers of Dementia

This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes).

A dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) program can be developed to address EE in caregivers, such as (1) reduce caregivers' EE, (2) reduce caregivers' depressive symptoms, (3) reduce the behaviorally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and (4) improve caregivers' perceived stress from PLwD's BPSD.

Eligibility Criteria:
Inclusion Criteria:

* with a high level of expressed emotion as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C);(Kavanagh et al., 1997; Van Humbeeck et al., 2002; Yu et al., 2016)
* provides care at least 4 hours per day;(Moon \& Adams, 2013)
* consent to participate, and
* no acute psychiatric illness.

Exclusion Criteria:

* with a low level (scored lower than 35 on FAS-C) of expressed emotion
* do not provide consistent or sufficient care (fewer than 4 hours per day) to PLwD
* do not consent to participate;
* with comorbid acute psychiatric illness.