cyrilzakka/clinical-trials huggingface dataset:
SREBP1 as a Potential Biomarker Promotes Cell Proliferation and Invasion in Thyroid Cancer

In this study, the investigators detected the expression of SREBP1 in thyroid cancer tissues, explored the biological functions of SREBP1 in thyroid cancer cells.

qRT-PCR and immunohistochemistry were used to detect the expression of SREBP1 in 96 pairs thyroid cancer tissues and the adjacent normal tissues. The following methods, including the MTS, colony-forming assay, flow cytometry and hoechst staining were used to detect the biological function of thyroid cancer cells based on SREBP1 interference or not.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of thyroid cancer Reciving thyroidectomy surgery No experience of radiation therapy Nice treatment compliance and follow-up regularly

Exclusion Criteria:

Prior history of malignancy ; Radiotherapy history, chemotherapy history; Serious concomitant diseases ; Chronic renal insufficiency and liver dysfunction
Deep Brain Stimulation Effects on Weight Change and Metabolic Rate

This study focuses on lateral hypothalamic area (LHA) deep brain stimulation (DBS) for severe obesity. In a previous pilot study, three subjects were implanted with a DBS electrode into the LHA under an Investigational Device Exemption (IDE) and IRB approved study at West Virginia University. That study demonstrated the safety of DBS of the LHA in these patients. These patients, who met the enrollment criteria of having prior placement of LHA DBS in accordance with previous study protocol, were eligible for this study with a goal of determining optimal DBS settings.

The goal of this study was to investigate changes in Resting Metabolic Rate (RMR) at different settings during stimulation of the LHA with DBS and to find the optimal setting for increasing the RMR in two patients that previously were implanted. Although 3 subjects had undergone placement of the DBS electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.

Each subject utilized the metabolic chambers and Deltatrac II Metabolic Carts (SensorMedics Corporation, Anaheim, California or Datex-Ohmeda, Helsinki, Finland) at Pennington Biomedical Research Center (PBRC), in Baton Rouge, Louisiana to objectively measure the correlation of their metabolic rate to various novel settings on the DBS for a one week period.

The schedule for the metabolic testing included: Day 0 baseline overnight chamber with no stimulation. Days 1-4 Resting metabolic rate (RMR) will be performed hourly with variable LHS DBS settings. The settings will be changed approximately every 15 minutes after the DBS settings are changed. Day 4 overnight chamber at ideal metabolic rate setting. After RMR test on Day 4, the subject will have a dual-energy x-ray absorptiometry (DXA) scan performed to assess body composition.

Subjects were also be seen in clinic as often as every month but no less than every 3 months to assess changes in weight until the study ended.

Eligibility Criteria:
Inclusion Criteria:

* Prior placement of LHA DBS in accordance with previous study protocol

Exclusion Criteria:

* Not a participant of the original LHA DBS study
* Prior brain surgery, excluding the placement of LHA DBS
* Taking medications with a recognized adverse event of weight change.
* Diagnosis of a neurological disorder, such as multiple sclerosis or stroke.
* Concurrent use of weight-loss prescription drug therapy or the use of over- the-counter weight loss preparations.
* Unable to participate in scheduled study visits
Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk

The aim of this study is to reveal how different forms of milk casein, lactose and moderate breakdown of proteins affect the symptoms that may arise from milk and markers of inflammation in volunteers receiving symptoms from milk. Research hypotheses are: 1) Protein hydrolyzed milk is as tolerated or better tolerated than A2 milk, and 2) Lactose is the main causative agent of stomach symptoms in milk-sensitive individuals.


Eligibility Criteria:
Inclusion Criteria:

* Perceive disturbing gut symptoms from regular milk
* Commits to the research diet for the whole research period
* Age: 18-65
* BMI: 18.5-30
* Healthy (normal kidney, liver and thyroid function and self-reported)

Exclusion Criteria:

* Milk allergy
* Regular medication (other than contraceptives) or medication affecting the gut
* Recent course of antibiotics (\< 3 months prior the study)
* Pregnancy or lactation
* Diagnosed bowel disease
Dialectical Behavior Therapy for Adolescents with Fetal Alcohol Spectrum Disorders Feasibility Trial

The purpose of this study is to test the feasibility of dialectical behavior therapy for adolescents (DBT-A) with fetal alcohol spectrum disorders (FASD). In partnership with a community mental health practice, Genesee Valley Psychology (GVP), two cohorts of five adolescents with FASD and their caregivers will participate in an already existing comprehensive DBT-A program (including individual therapy, group skills training, and 24/7 phone coaching). This program has been adapted for neurodivergent teens, including the development of trainings for mental health clinicians on FASD. The aim of the current study is to assess the acceptability of DBT-A from the perspective of teens, caregivers, and clinicians. Additionally, barriers and facilitators of implementing DBT-A with teens with FASD, as well as the feasibility of the research protocol will be assessed to inform later larger-scale trials.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

For adolescents:

* Ages 14-17 years
* Have a diagnosis of FASD under any diagnostic criteria
* Residing in the state of New York
* Willing and able to attend group sessions virtually
* Have one of the following:

  1. A diagnosis of disruptive mood dysregulation disorder, borderline personality disorder, or multiple other serious mental health diagnoses
  2. A history of multiple psychiatric hospitalizations and/or recurring presentation at psychiatric emergency rooms
  3. A score of 7+ on the McLean screening instrument (MSI; instrument attached and included in eligibility screen)
* Have functional deficits in three of five problem areas:

  1. Emotional dysregulation
  2. Impulsivity (including avoidance)
  3. Interpersonal challenges
  4. Teenager and family challenges
  5. Reduced awareness and focus
* Access to the internet and device with Zoom capabilities

For caregivers:

* Parent or legal guardian of an adolescent (ages 14-17 years) with an FASD diagnosis
* Residing in the state of New York
* Willing and able to attend group sessions virtually
* Access to the internet and device with Zoom capabilities

For clinicians:

* Employee of GVP
* Administered DBT-A to teens with FASD as part of this study

Exclusion Criteria:

* • Adolescent, caregiver, or clinician has insufficient proficiency in English

  * Primary psychotic disorder
  * Ongoing substance/drug dependence or eating disorder at such a level that would impede engagement with DBT modalities (i.e. if an individual requires detoxification or hospitalization for stabilization)
  * Adolescent or caregiver has a moderate to severe intellectual disability (IQ \< 51)
Home-based Progressive Resistance Exercise to Enhance Physical Performance of Older Adults With Possible Sarcopenia

The overall aim of the proposed project is to improve muscle strength in older adults with possible sarcopenia by promoting home-based progressive resistance exercise. The target population for health talks is community-dwelling older adults. A Three monthly home-visits and weekly phone calls will be made. A waitlist randomised controlled trial will be conducted to evaluate effectiveness, and qualitative feedback will be collected from participants. A pilot study will be conducted first.


Eligibility Criteria:
The inclusion criteria are:

* Aged 65-89;
* Possible sarcopenia (defined by AWGS 2019);
* No cognitive impairment (Abbreviated Mental Test score ≥8); and
* No communication problems.

The exclusion criteria are:

* having engaged in a structured exercise programme in the past 6 months or planning to do so within the intervention period;
* mobility-limiting injury of the hands or lower limbs, surgery or hospitalisation within the intervention period;
* contraindications such as musculoskeletal/cardiorespiratory disorders, or any advanced diseases that inhibit them from exercising.
Clinical Evaluation of Florbetapir in Primary Progressive Aphasia

The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

This study is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures

Exclusion Criteria:

* Clinically significant cardiovascular disease
* clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Pregnant
* Breastfeeding
* Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
* History of relevant severe drug allergy or hypersensitivity
* Patients who have received an investigational medication under an FDA Investigational New Drug (IND) protocol within the last 30 days.
SpeakFree Heat and Moisture Exchanger (HME)

The purpose of the study is to evaluate the new Blom-Singer SpeakFree disposable hands free valve heat and moisture exchanger (HME). The investigators will compare the SpeakFree to other modalities of stomal occlusion (digital occlusion and digital depression of an HME) for patients who communicate with a voice prosthesis as determined by patient preference and satisfaction. In addition, the investigators will compare the SpeakFree to other modalities of stomal occlusion as determined by objective measures of speech and voice parameters (maximum phonation time, syllables per breath, minimum/maximum phonation pressures, and a clinician rating of voice quality using a visual analog scale).


Eligibility Criteria:
Inclusion Criteria:

* Participants who have undergone a total laryngectomy who have and use a voice prosthesis as their primary form of communication for at least 3 months prior to study enrollment.
* Participants must have had at least 2 voice prosthesis management visits from a speech pathologist at the University of Miami prior to study enrollment.
* Participants must have fully healed suture lines.
* Participants must demonstrate fluent tracheoesophageal speech (i.e., maximum phonation time of at least 5 seconds during 3 consecutive trials)
* Current HME use for a minimum of 1 month
* Participants willing to complete the survey and provide a signed Informed Consent Form
* Males and non-pregnant females over the age of 18

Exclusion Criteria:

* Participants who do not have a voice prosthesis.
* Participants who have dysarthria.
* Participants who are currently receiving treatment for head and neck cancer.
* Participants who have an underlying neurologic condition potentially impacting speech.
Caffeine for Apnea of Prematurity (CAP)

At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity.

Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.


Eligibility Criteria:
Inclusion Criteria:

* birthweight 500 to 1250 grams
* postnatal age day 1 to day 10
* infant considered a candidate for methylxanthine therapy by clinical staff

Exclusion Criteria:

* dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
* unlikely to comply with long-term follow-up
* prior treatment with a methylxanthine
Women's Activity and Lifestyle Study in Connecticut

Despite an increase in longevity, surviving ovarian cancer often brings an array of unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to test whether exercise compared with attention control has a beneficial impact on quality of life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Currently, the American Cancer Society recommends a physically active lifestyle for cancer survivors to increase disease-free survival from cancer and other chronic diseases, and to improve quality of life. Studies of a strong benefit of physical activity on improving QOL following other types of cancer treatment, e.g., breast cancer, are well documented in the literature; yet very few studies of physical activity and QOL after a diagnosis of ovarian cancer have been published. Therefore, clinical trials of exercise on common physical and psychological consequences of ovarian cancer and its treatments are warranted.

The primary aims of our study are to examine, in 230 women who have completed treatment for Stage I-IV ovarian cancer, the impact of a moderate-intensity aerobic exercise intervention vs. attention control on:

* Quality of Life
* Body Composition (weight, BMI, total and % body fat, waist and hip circumference)
* Hormones possibly associated with physical activity and ovarian cancer prognosis (insulin, IGF-I, IGF-II, IGF binding protein-3, CRP, leptin, estrone, estradiol, free estradiol, and sex-hormone binding globulin, osteopontin, MIF, prolactin, and CA-125)
* Cardiorespiratory Fitness - an objective measure of functional capacity and adherence to exercise.

Hypotheses: Women randomized to exercise will experience improvements in quality of life, body composition, hormone levels, and cardiorespiratory fitness compared to women randomized to usual care.

Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* stage I-IV ovarian cancer
* less than 76 yrs of age

Exclusion Criteria:

* exercising
Exercise and GLP-1 RA on Insulin Secretion

The purpose of this study is to determine the effect of endurance exercise on insulin secretory capacity, alone or in addition to treatment with the glucagon-like-peptide receptor agonist semaglutide, in patients with type 2 diabetes.

The effects of endurance exercise alone or in addition to treatment with glucagon-like- peptide receptor agonists on insulin secretory capacity, will be determined in patients with type 2 diabetes.

Included patients will be randomized to either 12 weeks of endurance exercise training 3 times a week or therapeutical treatment with semaglutide for 3 months followed by 12 weeks of endurance exercise training 3 times a week. Insulin secretory capacity will be determined by hyperglycemic clamp method before and after.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* BMI 28-35
* Moderately preserved insulin secretory capacity (determined by glucagon test)

Exclusion Criteria:

* Insulin treatment
* Hypertension grade 3
* Heart disease
* Medical history with pancreatitis
* Diagnosed with neuropathy
* Excessive alcohol consumption
* Any condition that would interfere with the protocol.
BEMER in the Treatment of Pain in Fibromyalgia.

Fibromyalgia is one the most common causes of chronic pain syndromes in women. It causes considerable costs in primary health care setting as well as specialized medical care sector.Electrotherapy and exercise therapy has shown to have short-term pain relieving effects in randomized controlled trials (RCT) among fibromyalgia patients. However, there is sparse knowledge about the effects of long-term RCTs in the treatment of pain in fibromyalgia, as there are no publications about cost-effectiveness analysis of such treatments.

The aim of this study is to investigate whether the BEMER electromagnetic field therapy device has beneficial long-term effects in the treatment of pain, and whether it improves fibromyalgia patients' quality of life. In addition, this study investigates whether the BEMER device treatment is cost-effective in the treatment of fibromyalgia patients.

The participants of this study are working age female patients from the Central Finland Health Care District, and who have been treating because of severe pain. After eligibility has been assessed by health-related questionnaire and clinical examination, the participants will be randomly assigned into the treatment or control group. Treatment group patients will receive the loan activated BEMER-care unit, while controls will receive inactivated sham BEMER-unit. All participants will use the device regularly on a daily bases over three months. After one month treatment break, the treatment group will become a control group and control group will become a treatment group according cross-over design principle. Switching the groups will take place by changing the BEMER devices during the break. Throughout the study, both participants and researchers are unaware whether the participants are using activated or inactivated BEMER-devices. The research will be carried out and coordinated by Central Finland Central Hospital, and the research project will take place between September 2014 and June 2018.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fibromyalgia
* chronic persistent moderate or severe pain for more than 12 months
* average minimum pain intensity of 5 in the scale of 0 to 10 during the last 7 days
* age between 18 and 60 years
* female gender

Exclusion Criteria:

* an inflammatory rheumatic disease
* some other chronic pain disease as fibromyalgia
* psychiatric illness
* addiction to opiates
* substance abuse
* smoking
* a person with disability
* pregnancy and breast-feeding
Heart Function in Rheumatoid Arthritis and Ankylosing Spondylitis Pre and Post-TNF Blocker

The purpose of this study is to determine possible alterations in cardiac function in patients with Rheumatoid Arthritis and Ankylosing Spondylitis under anti-TNF therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis eligible to receive TNF blockers
* Diagnosis of Ankylosing Spondylitis eligible to receive TNF blockers

Exclusion Criteria:

* Clinical heart failure
* Chagas'disease
* Stable or unstable angina
* Past history of myocardial infarct
* Systemic árterial hypertension (grade 3)
* Valvulopathy
* Chronic kidney disease
Interpersonal Psychotherapy for Maternal Depression

Depression related to pregnancy frequently presents postpartum depression, which has deteriorating and lasting negative effects, not only on infant and child well being but also on mother's and father's mental health (Nancy K et al 2009). It is therefore important to introduce interventions aiming to improve mental health of mothers that could minimize the risk of diseases, and have positive effect child's on physical and psychological developmental wellbeing.

Therefore, this project has been designed to assess the effectiveness of Interpersonal Psychotherapy for Postnatal Depression in Pakistan.

Prevalence of depression in the postnatal period is 10% to 17 % in western world ( O 'Hara and Swain 1996; Josseffson et al 2001; Yoshida et al 2001) and 23% to 36% in the developing world (Rahman et al 2003; Patel et al 2002; Husain et al 2006).

In developed countries, studies indicate that maternal depression is associated with long-term emotional, cognitive and behavioral problem in children. There is evidence of link between maternal psychopathology to physical health of child. Research evidence also indicates that long-term negative impact of postnatal depression is on the mother's mental health, on infant's development and on the marital relationship (Reay, Fisher, Robertson, Adams and Owen 2005).

because of high prevalence of maternal depression in low income countries like Pakistan, the present study is designed to test the effectiveness of Interpersonal Psychotherapy for women with maternal depression. The participants will be recruited from Civil hospital Karachi and also from three different communities. total 50 participants will be recruited and randomized to 2 groups: either intervention or TAU group. Assessment will be done on baseline, after completion of intervention and 3 months after completion of intervention. Assessment will include Edinburg Postnatal depression scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Rosenberg Self Esteem scale. Participants in intervention group will receive 12 sessions of Interpersonal Psychotherapy (IPT)

Eligibility Criteria:
Inclusion Criteria:

* Mothers age 18 years and above older with child below 3 years of age
* Meet the criteria for mild to moderate depressive symptoms on (EPDS (cut off score above 10) and
* Were resident of trial catchment area were included in the study.

Exclusion Criteria:

* Mothers who were suffering from severe depression, with diagnosed learning or physical disability or
* Any major psychiatric illness other than maternal depression, with Alcohol and substance dependent or
* Actively suicidal were excluded from the study.
Long-term Follow-up of RESTORE Study

The RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898).

The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion.

Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in and not withdrawn from the original RESTORE study