cyrilzakka/clinical-trials huggingface dataset:
Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30

Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70/30 in healthy subjects The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between dosing. The planned trial duration for each subject is about 12 to 36 days.

Eligible subjects will undergo two 24-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or post-menopausal female subjects. Post-menopausal state is defined as no menses for 12 months without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (\>= 25.8 IU/L).
* Age between 18 and 55 years, both inclusive.
* Body Mass Index (BMI) between 18.5 and 29.0 kg/m\^2, both inclusive.
* Fasting plasma glucose concentration \<= 100 mg/dL.
* Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to Investigational Medicinal products ((IMP(s)) or related products.
* Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomization in this trial.
* Any history or presence of clinically relevant comorbidity, as judged by the investigator.
* Systolic blood pressure \< 95 mmHg or \>140 mmHg and/or diastolic blood pressure \< 50 mm Hg or \> 90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
* Pulse rate at rest outside the range of 50-90 beats per minute.
Changes in Function of the Upper Limb With Physiotherapy

This paper describes a pilot clinical study designed to compare changes in ROM, muscle strength and functional recovery of the upper limb during the inpatient treatment period of burn injury.

Patients with burns can face challenges throughout their recovery, including contractures and a reduced range of motion (ROM) in the upper limb (UL), upper and lower limb impairment. Restoring range of motion, muscle strength, and mobility is essential to reduce scarring formation and contractures. The study included 17 patients with unilateral or bilateral superficial, deep partial and full thickness burns to the upper limbs, with or without burns to the upper body, covering 10% or more of the total body surface area

Eligibility Criteria:
Inclusion Criteria:

* patients aged 18-69 years
* had burns on the upper limb(s) with or without burns on the upper body
* burns involving ≥ 10% total body surface area (TBSA) with the presence of deep partial thickness or full thickness burns
* who agreed to take part in the study

Exclusion Criteria:

* inability to perform or understand tests
* other injuries (fractures, brain injury)
* central and peripheral nervous system disorders
* amputation
* with burns on the head, hands, feet, and genital area
Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.

This study will be conducted to evaluate the outcomes of action observation therapy on fine motor skills of affected upper limb among patients with chronic stroke.

The data for study will be collected for the duration of 5 months, data will be collected at 1st, 4th, 8th, 12th and then at 16th week of follow up. It is a Randomized Control Trial. Patients will be selected by Consecutive Sampling from Ittefaq Hospital Trust, Lahore. All patients were right handed prior to stroke. Screening tools used will be Canadian Neurological Scale, the Mini-Mental State Examination (MMSE), the Bell Barrage test, and the ideomotor apraxia test (SpinnlerRognoni).Tests for assessment will be Fugl-Meyer test (FM) (of the upper limb), Frenchay Arm test (FAT), Box and Block test (BBT), Modified Ashworth Scale (AS) and Functional Independence Measure Motor items (FIMM). The SPSS version 21 will be used for analyzing data. The descriptive data will be expressed in Frequency and Percentages, while within the group differences will be measured by Mixed Model Anova.

Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke,
* Enrolled 6 months after the event onset with ischemia or primary hemorrhage.
* All patients were right handed prior to stroke.

Exclusion Criteria:

* Posterior circulation infarction,
* Subarachnoid hemorrhage,
* Severe forms of neglect and anosognosia (number of errors in Bell Barrage test≥15)
* Impaired comprehension (Token test score ≤ 17)
* History of endogenous depression or serious psychiatric disorders, and
* Severe visual deficits (restricting the access to visual stimuli).
Effects of Neuromuscular Blocking Agents (NMBA) on the Alteration of Transpulmonary Pressures at the Early Phase of Acute Respiratory Distress Syndrome (ARDS)

Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:

* reduction of the consumption of oxygen linked to ventilatory workload;
* increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
* anti-inﬂammatory effect contributing to a reduction in pulmonary inﬂammation and improvement in oxygenation,
* reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.

The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.


Eligibility Criteria:
Inclusion Criteria:

* Early (\< 48H) Severe ARDS: PaO2 / FiO2 ratio \< 150 with PEEP \>= 5 cmH20

Exclusion Criteria:

Age \< 18 ans Patient already under continuous infusion NMBA. Known NMBA Allergy or intolerance Contra-indication to introduction of nasogastric tube
G-CSF in Decompensated Cirrhosis: an Open Label Trial

Globally, cirrhosis is the fifth commonest cause of mortality. Its natural history is typified by an initial, largely asymptomatic, "compensated" phase followed by "decompensation" due to complications of raised portal pressures and hepatocellular dysfunction.

Currently the only definitive treatment option for cirrhosis is liver transplantation which is limited in its applicability due to donor shortage, exorbitant costs and lack of widespread availability. The need for long term immunosuppression and its attendant complications are a further drawback. The ability of stem cells to differentiate into multiple cellular lineages makes one speculate that they can be used for tissue repair and regeneration when tissue-resident stem cells become overwhelmed. Bone marrow derived stem cells have amazing plasticity. They can "home" to the liver in response to injury and help in liver regeneration by trans-differentiation, cell fusion and augmentation of tissue- resident stem cell mediated repair. Two methods are available for the mobilisation of stem cells from the bone marrow to the liver. One involves the administration of cytokines like granulocyte-colony stimulating factor (G-CSF) and the other is the isolation of stem cells from the marrow followed by their injection into the hepatic artery or portal vein after purification. The latter is probably more cumbersome and may be potentially risky due to the underlying coagulation abnormalities in cirrhotic patients .

G-CSF has been shown to mobilise bone marrow stem cells and even increase survival in patients of severe alcoholic steatohepatitis and ACLF. There is conflicting evidence on the role of G-CSF in decompensated cirrhosis with some studies showing improved survival while others have shown a lack of clinical or biochemical benefit. Many of these studies have used a single course of G-CSF. Verma et al, in a recent study published in 2018, elegantly demonstrated the beneficial effect of multiple courses of G-CSF in improving mortality and transplant free survival in decompensated cirrhotics.

The investigators too speculate that multiple cycles of G-CSF could result in better outcomes in decompensated cirrhosis by causing more prolonged and sustained stem cell homing to the liver. Thus, this study is being undertaken to further evaluate the safety and efficacy of multiple cycles of G-CSF in decompensated cirrhotics.


Eligibility Criteria:
Inclusion Criteria:

* Decompensated Cirrhosis of liver irrespective of etiology

Exclusion Criteria:

* Acute on chronic liver failure (fulfilling either APASL or CANONIC criteria of ACLF)
* Splenic diameter of more than 18 cm
* Concomitant HCC or other active malignancy
* Upper gastrointestinal bleeding in the previous 7 days
* Portal vein thrombosis
* Severe renal dysfunction as defined by creatnine \> 1.5mg/dl
* Severe cardiac dysfunction
* Uncontrolled diabetes (Hb A 1c ≥ 9) or diabetic retinopathy
* Acute infection or disseminate intravascular coagulation
* Active alcohol abuse in last 3 months
* Known hypersensitivity to G-CSF
* HIV co-infection
* Pregnancy
* Refusal to give informed consent
Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

The main purpose of this study is to determine the treatment effects and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* Provided informed consent
* Ability to read and write in Portuguese
* Ability to use a computer and/or smartphone, and the internet
* History of cancer
* Having completed primary cancer treatment (survivors who are on hormone and/or other long-term maintenance therapy agencies are eligible to participate)
* Subclinical or significant symptoms of insomnia (ISI scores\&gt;=8)
* Ongoing sleep medication accepted if the dosage has been stable during the last 4 weeks

Exclusion Criteria:

* Age ≤ 18 years
* Another unstable condition (e.g., sleep, psychiatric or medical condition)
* Pregnancy or breastfeeding
* Concurrent CBT-I
* Habitual night shift, or rotating shift-workers
Trial Applying Policy to Eliminate or Reduce Inappropriate Narcotics in the General-population

To assess the effectiveness of a government-led population-based opioid intervention on discontinuation of opioid medication in community-dwelling adults with chronic non-cancer pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults registered to receive pharmaceutical benefits in Manitoba, who are aged 18 years and over and who have received ≥90 days supply of opioids in the 6 months prior to the trial will be included. This will ensure chronic use and episodic use of opioids will be included.

Exclusion Criteria:

* People receiving palliative care, people with cancer, and people who receive opioids in hospital. People with dementia (identified by having received a prescription for memantine or a cholinersterase inhibitor in the previous 12 months) will be excluded.
Harmonics-based in Vivo Optical Virtual Biopsy

The research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy.

In the research, the investigators use the Cr:forsterite laser as the light source, and utilize the nonlinear optical microscopic system to observe human skin via in vivo detection. In this study, images of human skin tissue will be acquired by virtual section to truly evaluate the feasibility of this system in clinical application.

This research intends to conduct the following research:

1. To study the feasibility of this technology to observe melanin in the skin: As melanin is THG-bright, the technology will help to explore the distribution and change of melanin in the skin.
2. To study the capability of this technology in the early diagnosis of skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma: By obtaining skin images of healthy and diseased patients, we can establish an image database of normal and cancerous skin in different atages, and evaluate the efficacy of this technology for early diagnosis of skin malignancy in the future.
3. To study the ability of this technology to observe and analyze the degree of skin aging: Optical sectioning of human skin in a non-invasive in vivo manner can be used to detect the microscopic changes of skin aging and solar damage, and to find out the indicators of skin aging, so as to be used in the future to assist the therapeutic analysis of anti-skin aging treatment.
4. To study the ability of this technology to observe peripheral vasculopathy and molecular changes of microvascular structures in diabetic patients: Perform microscopic imaging on healthy and diabetes patients' skin to observe effects of structures and molecules in their skin, such as peripheral vasculopathy in diabetic patients, and the status of disease parameters, with a view to find the cause of peripheral vascular lesions and other biological information.

Eligibility Criteria:
Inclusion Criteria:

1. healthy volunteers of different skin colors and different ages
2. patients with suspected melanoma
3. patients with suspected basal cell carcinoma or squamous cell carcinoma
4. patients with diabetes mellitus

Exclusion Criteria:

1. volunteers have infectious disease
2. volunteers' skin have been infected with ulceration
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD\], who complete at least 78 weeks of the Phase 3 study while on study medication, are eligible for enrollment. Subjects will be treated for 52 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. The primary efficacy outcome assessment is a measure of cognition (ADAS-Cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and biomarkers of AD and neurodegeneration will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
* Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.

Exclusion Criteria:

* Significant worsening of medical conditions that may preclude completion of this study.
* Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
* Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
* Subject taking any prohibited medications per protocol.
Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism

The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.


Eligibility Criteria:
Inclusion Criteria:

* Male ages 18-68 years diagnosed as having testosterone deficiency with clinical symptoms
* A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart)

Exclusion Criteria:

* Abnormal prostate as evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, or elevated levels of prostate specific antigen (PSA \> 4ng/ml) or a maximum urine flow rate of less than 12 ml/sec(of a urine volume greater than 150ml) (and/or an International Prostate Symptom Score IPSS score \>19)
* Hematocrit \> 50%
* Major psychiatric illness
* Unable to understand the protocol or to give informed consent
* Use of paroxetine and clomipramine
* Active alcoholism
* History of drug abuse within the past five years;
* Use of drugs that might interfere with the results of the study (e.g., antiandrogen, estrogens or P 450 enzyme inducers, barbiturates);
* BMI \< 18 or \> 30 according to Chinese BMI references;
* Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known skin intolerance to alcohol;
* Prolactin \> 40 mcg/L;
* Untreated severe obstructive sleep apnea;.
* Uncontrolled or poorly controlled heart failure
Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant

RATIONALE: Studying samples of semen from cancer survivors in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This phase I research study is looking at the presence of donor-derived DNA in semen samples form cancer survivors who underwent donor stem cell transplant.

OBJECTIVES:

* To examine semen samples from male survivors of allogeneic hematopoietic stem cell transplantation for the presence of donor-derived DNA.

OUTLINE: Semen samples are collected and assessed by flow cytometry and PCR. DNA samples are compared to previously analyzed DNA extracted from survivor and donor. Samples are also analyzed for sperm concentration, motility, morphology, and viability.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Disease in remission
* More than 365 days since prior allogeneic hematopoietic stem cell transplantation with history of full donor engraftment
* Stable complete donor chimerism

PATIENT CHARACTERISTICS:

* Able to consent and willing to provide a semen sample
* Survivors who present for long-term follow-up appointments in the adult and pediatric stem cell transplant clinic at Vanderbilt University Medical Center
* No known history of infertility or azospermia

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No history of testicular irradiation ≥ 200 cGy
Non-influenza Etiologies of Acute Respiratory Illness in Southeast Asia

Acute respiratory infection (ARI) constitutes a leading cause of morbidity, hospitalization and mortality worldwide. The most common etiologic agents of ARI's, especially in children, are viruses.

The study objective is to determine the viral and bacterial etiologies of ARIs in patients with lower respiratory tract infection in South East Asia.

This is a laboratory based surveillance study, in which the archival specimens from hospitalized patients will be tested for respiratory pathogens other than influenza viruses Standard descriptive statistics will be used to present the findings

This study will test 1400 specimens from 1200 patients at the following laboratories:

* National Hospital of Pediatrics, Hanoi
* National Institute of Infectious and Tropical Diseases, Hanoi
* Siriraj Hospital, Bangkok
* National Institute of Health Research and Development, Jakarta
* Hospital for Tropical Diseases, HCMC
* Children Hospital #1, Ho Chi Minh City
* Children Hospital #2, Ho Chi Minh City
* Queen Sirikit National Institute of Child Health

Eligibility Criteria:
Inclusion Criteria:

* Adequately stored respiratory specimens obtained from hospitalized patients suspected of lower respiratory tract infection and were tested for influenza.

Exclusion Criteria:

* Specimens stored at insufficient temperature
* Specimen volume is insufficient
* No demographic data available
* Specimen unsuitable for testing for other technical reasons
Web-based CBT for Insomnia Patients With Fibromyalgia

Researchers are evaluating if cognitive behavioral therapy for insomnia delivered over the internet will help with fibromyalgia symptoms.

The investigators are studying the effect of an internet-based cognitive behavioral therapy for insomnia, compared with usual care in fibromyalgia patients. Fibromyalgia patients will consent to study, and a determination made if the patients meet criteria. If eligible, qualifying patients will be randomized, and begin participation in randomized intervention. During participation on the study subjects will complete surveys at set intervals.

Eligibility Criteria:
Inclusion Criteria:

* Meets diagnostic criteria for fibromyalgia
* Has insomnia
* Have internet access and a device that can access the web-based program.

Exclusion Criteria:

* Active sleep disorder which is not treated (obstructive sleep apnea, obesity hypoventilation syndrome)
* Active psychiatric disorder (Bipolar affective disorder, anxiety, depression, schizophrenia) which is not optimally managed.
* Chronic fatigue syndrome
* Morbid obesity
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3

Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Florida Medicaid
* Not initiated the HPV vaccine series at the start of the study period.

Exclusion Criteria:

* Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast
* Pregnant
* Not enrolled in Florida Medicaid