cyrilzakka/clinical-trials huggingface dataset:
Long-term Safety and Efficacy of Adipose-derived Stem Cells to Treat Complex Perianal Fistulas in Patients Participating in the FATT-1 Randomized Controlled Trial

The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial \[ClinicalTrials.gov identifier: NTC00475410\], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (ASC)and/or fibrin glue.

Complex perianal fistulas are a source of great distress for suffers. Treatment options are limited and surgery is often associated with incontinence and recurrence.

The biological properties of stem cells derived from adult tissues make them candidates for the treatment of pathologies requiring tissue regeneration or in diseases where the healing process is altered.

This study aims to evaluate the safety and efficacy of patients having participated within a preceding multicenter, placebo-controlled, phase 3 study \[ClinicalTrials.gov identifier: NTC00475410\]. The present extension aims to collect safety and efficacy data for up to 12 month from initial administration.

Fistula closure is defined as absence of suppuration through the external orifice with complete re-epithelization of the external orifice and absence of collections \>2cm directly related to the fistula tract treated, as measured by MRI.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 dose of the treatment assigned in the FATT-1 trial
* Informed consent

Exclusion Criteria:

* Other experimental drugs other than Cx401 during the follow-up period
Whey vs Casein to Combat Post-inflammatory Protein and Muscle Waste in Acute Disease

This study compares three different protein supplements (casein, whey and leucine-enriched whey) and their effect on post-inflammatory muscle waste in a model of acute disease. Each test person will undergo all three interventions.

It is believed that leucine is the primary driver of muscle protein synthesis and therefore we hypothesize that leucine-enriched whey and whey are superior to casein in combating post-inflammatory muscle waste, because of its higher leucine content (16%, 11% and 9% leucine, respectively).

Background:

Acute illness is accompanied by infection/inflammation, anorexia and immobilization all contributing to muscle loss, making nutritional supplement optimization an obvious target for investigation and eventually clinical intervention. In the clinical setting large heterogenicity among patients complicates investigations of muscle metabolism during acute illness. Therefore we introduce a disease model by combining "Inflammation + 36 hour fast and bedrest". Inflammation/febrile illness will be initiated by using the well-established "human endotoxemia model" with a bolus injection of Escherichia coli lipopolysaccharide (LPS), known to cause inflammation comparable with the initial phase of sepsis. The amino acid leucine has shown to be particularly anabolic in performance sports, but little is known about its potential beneficial effects during acute illness. Leucine is a powerful activator of muscle protein synthesis and it seems that protein supplements with the highest leucine content elicit a greater increase in protein synthesis than those with a smaller fraction of leucine.

The protein supplements used most in hospitals contain casein derived protein, which has a much lower leucine content than the whey protein compounds typically used in performance sports.

This study compares three different protein supplements.The study is an open, randomized crossover trial. Laboratory technicians, test subjects and investigators will be blinded.

Interventions:

I. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Casein (9% leucine) II. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Whey (11% leucine) III. LPS (1 ng/kg as bolus) + 36 h fasting + 36 h bedrest + Leucine-enriched whey (16% leucine)

The test objects will be given 0,6 g protein/kg, 1/3 as a bolus and 2/3 as sipping over a period of 3,5 hour. Muscle metabolism will be investigated by phenylalanine tracer using the forearm model and total protein metabolism using a carbamide tracer. Through muscle biopsies intracellular signalling pathways will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Male
* Age between 20-40
* BMI between 20-30
* Normal health examination and blood samples
* Written informed consent

Exclusion Criteria:

* Immobilisation of an extremity, unless a doctor has declared it fully rehabilitated.
* Allergy against lidocain or latex.
* The use of anabolic steroids
* Disease like: Diabetes, epilepsia, infection, cardiovascular disease.
Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

The purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study.

The goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering PRIME (Pharmacist Reconciliation to Improve Medication Management in the Elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of PRIME for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Diagnosed with any stage breast, GI or lung cancer
* Panning to receive first-line chemotherapy at MGH
* Verbal fluency in English

Exclusion Criteria:

* Unwilling or unable to participate in the study
* Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
The Correlation Between COVID-19 and Dysphagia in Adults With Swallowing Disorders

This study aims to investigate the correlation between COVID-19 and dysphagia in adults. The population of the study consisted of those who applied to Bezmialem University, Department of Otorhinolaryngology, Dysphagia Outpatient Clinic with the complaint of dysphagia. Patients older than 18 years of age, suffering from dysphagia and not having mental retardation were included in the study. Patients who did not have swallowing difficulties and refused to participate in the study were excluded.

Coronavirus Disease 2019 (COVID-19) is characterized by involvement in multiple tissues and organs throughout the body. Conditions related to COVID-19 itself or its treatment are known to be associated with swallowing function. Our study aimed to investigate the correlation between COVID-19 and dysphagia in adults who applied to our dysphagia outpatient clinic. Patients over the age of 18, who applied to the dysphagia outpatient clinic were included in our study. Patients' demographic and COVID-19 information were recorded. Swallowing impairment of the patients was evaluated with the fiberoptic endoscopic swallowing study (FEES). FEES was scored with the Penetration-Aspiration Scale (PAS). Eating Assessment Tool-10 (EAT-10) questionnaire was used to examine how the quality of life of the patients was affected by swallowing difficulties. Oral motor dysfunction (OMD) evaluation was performed by the clinician.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years of age
* Suffering from dysphagia
* Not having mental retardation

Exclusion Criteria:

* Patients who did not have swallowing difficulties
* Refused to participate in the study
Comparison of Sensimed Triggerfish With Goldmann Applanation Tonometry and Perkins Tonometry

This prospective, crossover study is designed to correlate SENSIMED Triggerfish® (TF) continuous IOP monitoring with conventional 24 h intraocular pressure profiles in glaucoma patients. There are two control measurements: The GAT/Perkins profile in the same eye in the second night and the GAT/Perkins profile in the same night in the fellow eye. Therefore, each eye serves as test eye and also as control for the second test eye.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to comply with the study procedure
* Patient must be ≥ 18 years old
* Diagnosis of primary open angle glaucoma (EGS criteria)
* Similar behaviour of IOP in both eyes in former IOP profiles
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Visual Acuity of 20/200 or better in both eyes
* Ability of subject to understand the character and individual consequences of the study
* For women with childbearing potential, adequate contraception

Exclusion Criteria:
Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children

This study will evaluate the long-term effects of a prenatal and early childhood home nurse visitation program for socially disadvantaged women and their children.

Nearly half a million children are born each year to single, low-income mothers. Children born to socially disadvantaged mothers are more likely to experience chronic health problems, encounter child abuse and neglect, and receive insufficient health care. Home visitation by nurses during pregnancy and early childhood may prevent a wide range of health and developmental problems in children born to women who are either teenagers, unmarried, or of low economic status.

This study is associated with a home nurse visitation program that first began with 400 socially disadvantaged pregnant women between the years of 1977 and 1980 in an upstate New York semi-rural county. Participants in the original study were randomly assigned to participate in the home nurse visitation program or receive comparison services from pregnancy until the child's second birthday. Participants assigned to receive comparison services were provided with free transportation for prenatal and child care, as well as sensory and developmental screening for the child. Participants assigned to the home nurse visitation program were visited at home by a nurse 9 times during pregnancy and 23 times during the child's first 2 years of life. A follow-up study concluded that the home nurse visitation program reduced the number subsequent pregnancies, use of welfare, child abuse and neglect, and criminal behavior on the part of the socially disadvantaged mothers for up to 15 years after the birth of their first child.

This follow-up study will determine whether a home nurse visitation program has continued long-term effects on a child's health and development, 27 years later. Specifically, this study will evaluate whether the nurse-visited young adult offspring differ from the comparison group in their economic productivity; rates of child abuse and neglect; criminal behavior; mental health; abuse of substances; use of welfare, foster care, and healthcare in relation to government expenditures; and quality of their partnered relationships. Participants within the nurse-visited program group will be compared with each other to determine whether certain characteristics or factors, such as genetic vulnerabilities, environmental risks, or a history of child abuse, make someone less likely to benefit from a home nurse visitation program.

Eligibility Criteria:
Inclusion Criteria:

* Offspring of mothers who had participated in Elmira, N.Y. randomized clinical trial of prenatal and infant/toddler home visiting by nurses.
* Participants needed to be at least 27 years of age.
Volumetric Monitoring in Major Lung Surgery

The hypothesis of this observational single-center clinical study was to explore the volumetric hemodynamic monitoring in the perioperative period in major and risky thoracic intervention. The investigators monitored the changes in the volumes of blood in the central vessels and heart chambers as well as a volume of fluid in pulmonary tissue (i. e. extravascular lung water).

The goal of this observational study is to investigate into changes in volumetric hemodynamic parameters obtained with a technique of transpulmonary indicator dilution after major thoracic intervention, including pneumonectomy and lobar resections. The important parameters of hemodynamics were monitored throughout the intervention and 48 hrs postoperatively, including extravascular lung water index, global end-diastolic volume index, etc.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age above 18 and below 80
* Confirmed malignant bronchial neoplasm or
* Destructive pulmonary infection

Exclusion Criteria:

* Pregnant
* Severe pulmonary hypertension
* Pulmonary tuberculosis
* Severe occlusive atherosclerosis of lower extremities
Mitochondrial Function in Circulating Cells and Muscle Tissue

The main goal of this project is to determine whether mitochondrial function in circulating cells is related to that measured in the muscle fibers of the same subjects.

Data from human and animal models strongly suggests that reduced tissue mitochondrial function can be an early marker for detection of dysfunctional metabolism. It is unclear if tissue mitochondrial dysfunction can be detected using less invasive methodology. In this project, the investigators plan to study mitochondrial bioenergetics in circulating cells and paired muscle biopsies in two metabolic disparate groups of women; healthy lean vs. overweight/obese with/without insulin resistant women of similar age. Women of similar age that are either healthy lean or overweight/obese with/without insulin resistance will be recruited to participate in one study that includes a blood draw and a muscle biopsy. Mitochondrial function in circulating blood cells and muscle tissue will be determined. The association between circulating blood cells and muscle tissue mitochondria respiration will be determined for the two groups combined, and differences between groups will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 25-35 years of age
* Either healthy lean (BMI\<25) or insulin resistant and obese (BMI \>30)

Exclusion Criteria:

* Medication that can affect study outcomes, as determined by the principal investigator, including anti-diabetic medication
* Chronic diseases, acute inflammation, chronic renal failure (glomerular filtration rate \<45), or heart problems
Screening and Management of High-risk Populations of Stroke in Dehui City

This epidemiological survey is to analyze the prevalence rate of stroke and exposure rate of risk factors in sampling population aged 40 years and over (born before December 31,1975) in Dehui City, to provide scientific basis for pertinent prevention and control of stroke in Jilin Province, and to provide valuable data for the high-risk groups to carry out regular follow-up and standardized management.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years and over in Dehui City
* Willing to participate in the study and follow-up visits
* Signed an informed consent

Exclusion Criteria:

* Life expectancy\<3 years
* Unwilling to participate in the study and follow-up visits
* Living away from Dehui City over 6 months
* Unable to cooperate with examination and questionnaire due to mental disease
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

This was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus long-acting beta agonist (LABA).

Subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2:

* Placebo inhaled once daily
* CSJ117 0.5 mg inhaled once daily
* CSJ117 1.0 mg inhaled once daily
* CSJ117 2.0 mg inhaled once daily
* CSJ117 4.0 mg inhaled once daily
* CSJ117 8.0 mg inhaled once daily

The study included:

* A screening period of approximately 2 weeks
* A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period)
* A double blinded treatment period of 12 weeks
* A follow-up period of up to 12 weeks, study drug free, following the last dose of study treatment.

Patients who successfully completed 12 weeks of treatment in this study could be offered participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed asthma
* Male and female patients aged ≥18 and ≤75 years
* Patients who have been treated with medium or high dose ICS plus LABA with up to 2 additional controllers
* Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal
* A positive reversibility test
* ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.

Exclusion Criteria:

* Patients who have a cigarette smoking history of greater than 10 pack years or current smokers
* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and until 12 weeks after last study drug treatment
* Patients with a history of immunodeficiency disease or hepatitis B, untreated and not cured hepatitis C or HIV.
Brief Title: a Clinical Study to Assess Gingivitis

The objective of this learning clinical study is to evaluate the effects of formulation chemistry on gingivitis.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with 10-70 % bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.

Exclusion Criteria:

* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.
Incidence and Risk Factors of Parastomal Bulging in Patients With Ileostomy or Colostomy

The purpose of this study is to use routinely-collected health data from registers to examine the incidence of parastomal bulging (PB) at different time points in the first year after surgery for ileostomy or colostomy. Additionally, the purpose is to investigate risk factors for development of PB.

Parastomal bulging (PB) in patients with ileostomy and colostomy in the Capital Region of Denmark up to one year after surgery is the primary outcome in this study. The investigators will use a register-based study design to evaluate routinely-collected health data from the Danish Stoma Database Capital Region (DSDCR). Incidence of PB one year post surgery and at different points of follow-up during the first year will be investigated using survival analysis. Potential risk factors will be investigated controlling for potential confounders. In order to include relevant variables on lifestyle, comorbidity, and physical status, data from the DSDCR will be linked to data from the Danish Anaesthesia Database.

Eligibility Criteria:
Inclusion Criteria:

* Subject is registered in the Danish Stoma Database Capital Region
* Is registered as having either ileostomy, jejunostomy, sigmoidostomy, or transversostomy

Exclusion Criteria:

* Patients with urostomy or unknown stoma type
Interaction of Chronic Sleep Restriction and Circadian Misalignment on Sleep and Neuro-cognitive Performance

The primary objectives of the proposed experimental and modeling efforts are to quantify the influences of acute sleep deprivation (short-term homeostatic), chronic sleep restriction (long-term homeostatic), circadian rhythmicity, and their interactions on neurocognitive performance and to develop a new model of sleep homeostasis that can predict the effects of chronic sleep restriction. This model will be based on the underlying neuroanatomy and neurophysiology. This new model will facilitate optimization of human performance in operational settings, such as are seen in military operation and other work environments.

This protocol involves a baseline period consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours. This is followed by a forced desynchrony regimen spanning 21 calendar days and consisting of 12 cycles ("days") of a 42.85-hour wake:bedrest schedule. In each 42.85 hour cycle, there are 32.85 hours of scheduled wakefulness and 10 hour sleep opportunities. This will allow assessment of the independent contributions of circadian phase and homeostatic sleep pressure on sleep and neurobehavioral performance. This forced desynchrony regimen is followed by 10 recovery days consisting of 14 hours of wakefulness and 10 hour nocturnal sleep episodes each 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years old
* Medically healthy

Exclusion Criteria:

* Sleep disorder
* Psychiatric illness
* Chronic medical condition
* No prescription or Non-prescription medications