cyrilzakka/clinical-trials huggingface dataset:
Recovery From Psychosis in Schizophrenia - The Impact of Cognitive-Behavioral Therapy

This study examines the impact of Cognitive-Behavior Therapy (CBT) on symptoms, physiological arousal, stressors, and the ways to deal with them in individuals with schizophrenia and related disorders. The primary aim of this study is to investigate the role cognitive coping strategies play in mediating the link between stress, physiological arousal, and psychotic symptoms in individuals with schizophrenia during recovery from psychosis.

This study examines the mechanisms of recovery from psychosis. Specifically, the study aims to evaluate the putative impact of enhancing cognitive coping strategies via Cognitive-Behavior Therapy for psychosis (CBTp) on subjective stress, autonomic regulation (physiological arousal), and psychotic symptoms in individuals with schizophrenia and related disorders. As part of the study, participants will be randomized to receive up to 26 weekly sessions of CBTp (over 30 weeks) or "treatment as usual". Research evaluations will completed at baseline, and after 10, 20 and 30 weeks. The study outcome measures include psychotic symptoms as measured by clinical interviews, along with ambulatory measures of autonomic regulation and self-reports of psychotic experiences during daily functioning using mobile devices (i.e., Palm computers).

Eligibility Criteria:
Inclusion Criteria:

* Males and females between ages 18-50.
* Have capacity to give informed consent.
* English speaking.
* Have a DSM-IV diagnosis of schizophrenia, or schizoaffective disorder, or schizophreniform disorder.
* Presence of active psychosis as indexed by ratings ≥3 on any hallucinations and delusions items of the Scale for Assessment of Positive Symptoms (SAPS).

Exclusion Criteria:

* Lacks capacity to give informed consent.
* Diagnosis of mental retardation (IQ \< 80).
* Have history of neurological disorders or medical conditions known to seriously affect the brain.
* Have history of cardiac conditions or hypertension; current use of anti-cholinergic, beta-blockers, anti-histamine, or anti-hypertensive medication; abnormalities on ECG.
* Have used street drugs within the past 4 weeks.
The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection

To compare the eradication success rate between 10-days sequential therapy and 7-days tailored therapy based on H. pylori culture and antimicrobial susceptibility testing.

As increasing antimicrobial resistance in Korea, the effectiveness of empirical Helicobacter pylori (H. pylori) therapies have been declined. Recently, 10-day sequential therapy was not sufficient to overcome tough situation for H. pylori eradication.

Thus, in this study, the investigators evaluated the efficacy of H. pylori eradication between a 7 days tailored therapy (7 day PPI based triple therapy, bismuth quadruple therapy or moxifloxacin contained triple therapy) for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the 10 day sequential therapy for the first eradication of H. pylori infection, and the investigators analyzed the prevalence of the antibiotic resistance in the tailored therapy group.

Eligibility Criteria:
Inclusion Criteria:

* The patients who proved H. pylori infection following three methods

  1. positive rapid urease test (CLOtest)
  2. histologic evidence of H. pylori by modified Giemsa staining
  3. positive Urea breath test
* Male and female Korean Adult (Aged ≥ 18 years)

Exclusion Criteria:

* Patients who received eradication therapy for H. pylori infection, previously
* H. pylori eradication failure because of poor compliance
* the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
* Advanced gastric cancer or other malignancy
* Abnormal liver function or liver cirrhosis
* Abnormal renal function or chronic kidney disease
* Other severe concurrent diseases
* Previous allergic reactions to the study drugs
* Pregnant or lactating women
Exercise and Diet for Pediatric Obesity

The coronavirus disease (COVID-19), is a communicable pandemic disease as stated by the world health organization (WHO), which has been affecting the world since December 2019. COVID-19 infected children develop the signs and symptoms of the disease, which can be exaggerated or life-threatening when associated with comorbidities like; obesity, sickle cell anemia, immune disorders, chromosomal abnormalities, chronic respiratory or cardiac problems, and congenital malformations.3 It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop obesity. It is a major health concern in this pandemic situation, which can be addressed and treated with the use of appropriate physical training and proper dietary habits.

Children confirmed with COVID-19 infection have some systemic illness, that might lead to children with obesity. They are advised to perform regular physical training and consume a proper diet to prevent and treat negative consequences. Therefore, different obesity management and weight reduction protocols are developed to control and prevent health problems and socio-economic issues associated with obesity. The management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, there is a need for an elaborative trial in this field. Hence, the aim of this trial was to investigate and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low protein diet in community-dwelling COVID-19 infected children with obesity.

Eligibility Criteria:
Inclusion Criteria:

* Positively diagnosed COVID-19 children
* age group of 5 - 12 years
* Body mass index (BMI) between 85th to 99th percentiles

Exclusion Criteria:

* history of physical training,
* taking medications,
* recent surgeries,
* fractures and joint problems in the lower extremity,
* cardiac and respiratory problems,
* neurological issues,
* major psychiatric problems,
* other systemic diseases,
* contraindications for physical training and family with food restrictions
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus

The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females aged 18-60 years
* Normal weight, at least 50 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease
* Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study
* Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
* Known hypersensitivity to the active substance(s) or the excipient of the drug
* Pregnant or lactating females
Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study

The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children.

The main questions it aims to answer are:

* How differ the cortisol level between groups?
* How change the cortisol level over time?
* Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.

For expectant parents, the birth of a child is often a stressful situation. In the case of a premature birth, the psychological stress is usually increased because the parents frequently could not prepare for the birth. Therefore, the researcher would like to investigate this stress of fathers of newborn children.

For this purpose, the stress hormone cortisol in the fathers' hair will be analysed and questionnaires on the fathers' mental health will be collected. Subsequently, the differences between fathers of prematurely born and of maturely born children will be compared.

The investigators will do the analyses at three time points: the first time point will be at the first week after birth, the second three months and the third six months after birth. At six months of the infant's age, additionally the paternal sensitivity will be measured.

The compared groups will differ with respect to gestational age: Group 1 includes preterm infants with a gestational age below 32 weeks and a birth weight \<1500 grams (very low birthweight infants), group 2 preterm infants with a gestational age between 32 0/7 to 36 6/7 (moderate and late preterm infants) and group 3 consists of mature infants (over 37 weeks gestational age).

Eligibility Criteria:
Inclusion Criteria:

* Premature or mature infant (22 0/7 to 42 0/7 weeks of gestation)
* For mature infants (37 0/7 to 42 0/7 weeks of gestation) undisturbed neonatal period
* No severe malformations or genetic diseases of the newborn child
* Sufficient knowledge of German of the father
* written consent of the custodial parents

Exclusion Criteria:

* adoptive or foster paternity
* hair length below 3 cm at the posterior vertex region of the back of the father's head
* endocrine disorders, especially of the adrenocortical system (e.g. Cushing syndrome, adrenal insufficiency)
* taking steroidal medications or other drugs that affect the activity of the hypothalamic-pituitary-adrenocortical system
* paternal psychological or severe physical illness
Effect of Weight Loss on Brain Insulin Sensitivity in Humans

Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c \<6.5%
* Age between 40 and 75 years
* No intake of antidiabetic drugs or drugs for weight reduction
* no steroid intake
* Stable medication over 10 weeks before the start of the study

Exclusion Criteria:

* Persons who wear non-removable metal parts in or on the body.
* Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
* Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
* Persons with hearing impairment or increased sensitivity to loud noises
* People with claustrophobia
* Minors or non-consenting subjects are also excluded
* Subjects with an operation less than 3 months
* Simultaneous participation in other studies
* Neurological and psychiatric disorders
* Subjects with hemoglobin Hb \<11 g / dl
* Hypersensitivity to any of the substances used
Effect of Ginger Supplement on Non-alcoholic Fatty Liver

The hypothesis of this study was that ginger supplement consumption can be introduced as a new therapeutic strategy for non-alcoholic fatty liver disease through the improved body antioxidant activity, reduced levels of inflammation and insulin resistance. A randomized double-blind study was designed to evaluate this hypothesis in order to examine the effectiveness of ginger supplement in patients with non-alcoholic fatty liver disease.


Eligibility Criteria:
Inclusion Criteria:

* presence of steatosis on ultrasound examination
* high concentration of liver enzyme (alanine aminotransferase (ALT) greater than normal range of 1.5 times)

Exclusion Criteria:

* various types of hepatitis
* diabetes mellitus
* cancer inherited disorders affecting liver condition (storage disorders of iron, copper, and others)
* non-treated hypothyroidism
* using alcohol
* consumption of phenytoin amoxyfan and lithium
* using minerals multivitamin supplements such as vitamin E, vitamin D, supplements made from Silybum marianum extract like livergol
* weight loss surgery in the last year or strict diets to weight loss in the past three months pregnancy
* lactation
* autoimmune diseases
Myofascial Release of the Pectoral Fascia

Neck-shoulder pain is among the most common health care problems, especially in office workers and females. Forward shoulder posture (FSP) is a common postural deviation and known risk factor for the development of neck-shoulder pain and pathology. Common approaches for reducing FSP include stretching and performing manual techniques to increase the length and extensibility of the scapular protractors, and strengthening the scapular retractors. Myofascial release (MFR) is a group of manual techniques that elongate and soften restricted fascia, however, the effects of myofascial release to the pectorals on FSP are currently unknown. The objectives of this study are to determine the impact of 4-minutes of MFR on: 1) FSP, 2) pectoral length, 3) muscle activity of the upper, middle, and lower trapezius and pectoralis major, 4) scapular retractor to protractor ratio of activity, and 4) movement performance compared to a soft-touch control. We hypothesize that MFR will: 1) decrease FSP, 2) increase pectoral length, 3) increase upper, middle, and lower trapezius activity and decrease pectorals major activity, 4) increase the scapular retractor to protractor ratio of activity, and 4) improve movement performance.


Eligibility Criteria:
Inclusion Criteria:

* have 1 cm of anterior deviation of the acromion process (forward shoulder posture)
* right handed

Exclusion Criteria:

* recent history (\<6 months) of neck, shoulder, or upper back pain
* recent history (\<6 months) of neck, shoulder, or upper back injury/pathology
* history of orthopaedic or neurological disorders
Altering Multitasking Behavior Using Low Current Brain Stimulation

This study is designed to investigate multitasking deficits, with a particular interest in reducing costs related to dual-tasking (dividing attention between tasks) and task-switching (switching between tasks) using noninvasive brain stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to participate in non invasive brain stimulation research
* Must be a fluent English speaker
* Must be at least 18 years old
* Must be right-handed
* Must have normal or corrected-to-normal vision

Exclusion Criteria:

* Any history of complications with non invasive brain stimulation research
* Any metallic implants in head
* Any implanted internal or external electrical stimulation device
* Any adverse reaction to tDCS or other forms of low current brain stimulation
* Any history of seizure
* Any history of head injury
* Any illness that caused brain injury
* Any other brain-related condition
* Any diagnosis of neurological or psychiatric disorder
* A sensitive scalp
Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Mycobutin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

* Patients need to be administered Mycobutin® in order to be enrolled in the surveillance.

Exclusion Criteria:

* Patients not administered Mycobutin®.
Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching
* Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment\*

  * retention at 2 hr: \>60% or
  * retention at 4 hr: \>10% \*Based on International consensus on gastric scintigraphy

Exclusion Criteria:

* Gastric outlet, small bowel, or colon obstruction.
* Small bowel malrotation
* Inflammatory bowel disease
* Contraindication for surgical implantation of GES
* Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc.
* Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease.
* Significant coagulopathy
* Non-ambulatory patients: bed-ridden, nursing home resident, etc.
* Pregnancy
* Unable to give own informed consent
* Prisoners
Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients of age 18 years or above
* Patients diagnosed with stage 1 or stage 2 essential hypertension
* Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

* Secondary hypertension or severe hypertension
* Clinically significant cardiovascular disease or heart failure
* Clinical significant respiratory disease that would prohibit the use of a beta blocker
* A medical contraindication to discontinuing a current antihypertensive therapy
* History of Type 1 diabetes mellitus
* History of Severe Mental Illness except mild depression
Honey and a Mixture of Honey, Beeswax and Olive Oil-propolis Extract in Treatment of Chemotherapy-induced Oral Mucositis

Although, oral mucositis has been studied for many years, no available treatment has been shown to be effective in preventing or treating mucositis. Based on the observations that honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial and wound healing effects, the present study aims at evaluation of the effect of topical application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as natural products, in treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia (ALL). This is a randomised controlled clinical trial in which eligible patients were randomly assigned into three equal treatment groups. Group 1 received 15 gm honey applied topically to the affected oral mucosa three times daily. Group 2 received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (HOPE) applied topically to the oral mucosa three times daily. Group 3 served as control and received a 7.5% benzocaine gel applied to the areas of ulcers three times daily.

All patients with ALL during the consolidation phase of treatment, and with chemotherapy-related oral mucositis grades 2 and 3 were candidates for this trial.Exclusion criteria included the presence of any of the following: (1) coexisting diabetes mellitus, (2) administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study, (3) presence of neutropenia (absolute neutrophilic count \[ANC\] ≤ 1500/mm3), (4) presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more. The primary outcome measure was the "recovery time", defined as the number of days from initiation of treatment to when complete healing of all ulcers occurred.

Eligibility Criteria:
Inclusion Criteria:

* All patients with ALL during the consolidation phase of treatment, and
* with chemotherapy-related oral mucositis grades 2 and 3

Exclusion Criteria:

1. coexisting diabetes mellitus,
2. administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study,
3. presence of neutropenia (absolute neutrophilic count \[ANC\] ≤ 1500/mm3),
4. presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more)
Liver CT Dose Reduction With Deep Learning Based Reconstruction

A deep learning-based de-noising (DLD) reconstruction algorithm (ClariCT.AI) has the potential to reduce image noise and improve image quality. This capability of the CliriCT.AI program might enable dose reduction for contrast-enhanced liver CT examination. In this prospective multicenter study, whether the ClariCT.AI program can reduce the noise level of low-dose contrast-enhanced liver CT (LDCT) data and therefore, can provide comparable image quality to the standard dose of contrast-enhanced liver CT (SDCT) images will be evaluated.

The aim of this study is to compare image quality and diagnostic capability in detecting malignant tumors of LDCT with DLD to those of SDCT with MBIR using the predefined non-inferiority margin.

A deep learning-based de-noising (DLD) reconstruction algorithm (ClariCT.AI) has the potential to reduce image noise and improve image quality. This capability of the CliriCT.AI program might enable dose reduction for contrast-enhanced liver CT examination. In this prospective multicenter study, whether the ClariCT.AI program can reduce the noise level of low-dose contrast-enhanced liver CT (LDCT) data and therefore, can provide comparable image quality to the standard dose of contrast-enhanced liver CT (SDCT) images will be evaluated.

The aim of this study is to compare image quality and diagnostic capability in detecting malignant tumors of LDCT with DLD to those of SDCT with MBIR using the predefined non-inferiority margin.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-year-old and 85 years old
* patients referred to the Radiology department to perform contrast-enhanced liver CT under the suspicion of focal liver lesions

Exclusion Criteria:

* patients with estimated glomerular filtration rate \< 60 mL/min/1.73m2
* previous history of severe adverse reaction to iodinated contrast media.