cyrilzakka/clinical-trials huggingface dataset:
Sleep Subtypes in Adolescent Depression

The purpose of this study is to compare sleep neurophysiology and behavior in adolescents with MDD with hypersomnia (MDD-HYP) and insomnia (MDD-INS) with healthy controls (HC). In addition, the investigators will test the efficacy of a simple behavioral sleep restriction on mood and sleep in their sample.

The World Health Organization has identified depression as the leading cause of burden of disease amongst young people. Subjective sleep complaints are often a core symptom of depression and highly prevalent with 60-90% of depressed adolescents suffering from disrupted sleep. This sleep disruption often takes the form of insomnia (e.g., difficulty falling or staying asleep, or waking too early) or hypersomnia (prolonged sleep episodes or excessive daytime sleepiness). The aim of the trial is to examine the efficacy of a simple behavioral sleep restriction two weeks in duration on mood and sleep in adolescents ages 14 to 17 years with and without major depressive disorder. During this period sleep is objectively measured using actigraphy and monitor mood using self-report. The results of the study will inform whether a simple behavioral sleep restriction beneficially impacts mood and sleep.

Eligibility Criteria:
Inclusion Criteria:

- This study will recruit adolescents (ages 14 to 17 years) with major depressive disorder (MDD) with insomnia (MDD-INS) and with hypersomnia (MDD-HYP) and age and gender matched controls (HC).

Inclusion Criteria:

Key inclusion criteria for MDD Hypersomnia Group:

* MDD as determined through the MINI-KID
* Determination of hypersomnia as defined by excessive daytime sleepiness, or long sleep duration.
* Written informed consent

Key inclusion criteria for MDD Insomnia Group:

* MDD as determined through the MINI-KID
* Determination of insomnia as defined by the insomnia severity index
* Written informed consent

Exclusion Criteria:

* Key exclusion criteria for all three groups include:

  * Current or lifetime experience of frank psychosis or mania
  * Presence of suicidal intent representing imminent risk as indicated during clinical interview
  * Medical or neurological condition that could impact brain functioning
  * History of physical brain injury or blow to the head resulting in loss of consciousness greater than 5 minutes
  * Do not meet criteria for substance or alcohol dependence in the last three months
  * Presence of an organic sleep disorder (e.g., narcolepsy, sleep apnea)

Additional exclusion criteria for healthy control group:

* Presence of psychiatric disorder
* Self-reported disrupted, short or ill-timed sleep

Additional exclusion criteria for MDD-INS and MDD-HYP:

• No sleep difficulties
Assessment of Stuttering Severity in Adults and Adolescences in Conversational and Narrative Contexts

The aim of this study is to assess stuttering severity in both narration and conversation in adults and adolescences in order to determine which situation is more stressful so that more reliable and accurate measures for diagnosis can be done. Also this study will help in determining the best line of management of stuttering.

Stuttering is a speech disorder in which the flow of speech is disrupted by involuntary repetitions and prolongations of sounds, syllables, words or phrases as well as involuntary silent pauses or blocks.

In the world, approximately 1% of the adult population suffer from stuttering. Stuttering has severe impact on the overall quality of the person's life such as anxiety, stress, shame, low self-esteem and negative affectivity .It also affects his educational attainment, his attractiveness and work life as he avoids employment.

Stuttering varies in severity, frequency and duration from situation to situation. So its dynamics are best understood within discourse contexts that involve interactions with other people. Clinicians typically rely on spontaneous conversational samples for analyzing speech disfluencies. They have good validity, but the use of a more structured form of speech may allow for more efficient, reliable elicitation of stuttering related behaviours and better understanding of the nature of stuttering.

Narration offers a more structured context than conversation because storytellers must weave together information about the characters, the circumstances and actions. Also, narration often contains more complex language than conversation and put the whole responsibility on the speaker for planning and conveying the information to the listener, compared to conversation where two or more speakers co-construct the stream of topics and comments. Thus, narration places more linguistic, cognitive and communicative demands on speakers than does conversation.

A research was done on six adult participants and showed that some of them stuttered more during conversation and others stuttered more during narration.

Eligibility Criteria:
Inclusion Criteria:

1. Age :11-50
2. Gender : both sex will be included in the study
3. IQ \>85
4. No previous therapy

Exclusion Criteria:

* 1. Presence of any other speech, language, physical or neuropsychatric disorders.
Dual Task in Duchenne Muscular Dystrophy

This study was planned to determine the effects of the dual-task performance of children with DMD with motor dysfunction and varying degrees of cognitive impairment compared to their healthy peers, to compare the dual-task performance of children with different functional levels, and to determine the relationship between parameters that may affect dual-task performance.

Children who are at least 6 years old and who can walk 10 meters independently, whose Duchenne's muscular dystrophy (DMD) diagnosis has been confirmed as a result of genetic testing, will be included in the study. To determine dual-task performance, the 10-meter Walk Test will be performed with additional motor and cognitive tasks. Functional level (Brooke Lower Extremity Functional Classification), ambulation level (North Star Ambulation Rating), muscular performance and functions (6 Minute Walk Test), balance (Pediatric Berg Balance Scale and four square step test), fear of falling (Fear of Falling Questionnaire), gait (Gait in DMD Assessment Scale, Gait Quality and Independence Classification Scale in DMD, and Functional Evaluation Scale for Duchenne Muscular Dystrophy-Gait Domain (FES-DMD-GD)), cognitive level (Modified Mini-Mental State Test (MMDT)), independence and activity limitation (Pediatric Functional Independence Measure (WeeFIM) and ACTIVLIM), quality of life (The Pediatric Quality of Life Inventory (PedsQL)-Neuromuscular Module Turkish version PedsQL-3.0 Neuromuscular Module) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with DMD by a pediatric neurologist,
* Must be at least 6 years old and have the ability to walk 10 meters independently,
* Being able to cooperate with the instructions given by the physiotherapist,
* Not having undergone surgery in the last 6 months and not having any injuries,

Exclusion Criteria:

* Failure to cooperate with the physiotherapist who made the evaluations,
* Have had any injury and/or surgery in the last 6 months,
* Children without consent will not be included.
Measuring rTMS-induced Neuroplasticity With EEG Steady-state Visual-evoked Potentials

The goals of this study are to 1) use EEG steady-state visual evoked potentials as a noninvasive measure of the neuroplasticity induced by repetitive transcranial magnetic stimulation (rTMS), 2) use visual contrast detection paradigms as a behavioral measure of rTMS effects, and 3) to investigate how visual spatial attention augments or suppresses the neuroplastic impact of rTMS. Participants will observe visual stimuli on a screen while allocating their attention to different parts of the visual field and making responses when they observe changes in the visual stimuli. rTMS is performed to visual cortex using MRI-retinotopy neuronavigation. Then the visual task paradigm is performed again.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18 to 65
* Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
* Left- or Right-handed
* No current or history of neurological disorders
* No seizure disorder or risk of seizures

Exclusion Criteria:

* Those with a contraindication for MRIs (e.g. implanted metal)

  * Any unstable medical condition
  * History of head trauma with loss of consciousness
  * History of seizures
  * Neurological or uncontrolled medical disease
  * Active substance abuse
  * Diagnosis of psychotic or bipolar disorder
  * Currently taking medications that substantially reduce seizure threshold (e.g., bupropion, olanzapine, chlorpromazine, lithium)
  * Currently pregnant or breastfeeding
Protein Concentrations in Yogurt and Satiety, Food Intake and Glycemia in Healthy Men

This study compared the effects of dairy products, including milk and yogurt, with different amounts of proteins on responses of appetite, glucose and insulin and on food intake at a meal served 120 minutes later in healthy adult male individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-30 years
* Body mass index: 20 and 24.9 kg/m2

Exclusion Criteria:

* Breakfast skippers,
* Smokers,
* Dieters,
* Individuals with lactose-intolerance or who are allergic to milk,
* Individuals with gastrointestinal problems and
* Individuals with diabetes or other metabolic diseases
Severe Complications After Gastrectomy for Esophagogastric Junction and Gastric Cancer

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications. This is a retrospective cohort study.

Gastrectomy is the main treatment for gastric and Siewert type II-III esophagogastric junction (EGJ) cancer. This surgery is associated with significant morbidity. The aim of the present study is to identify the predictors of postoperative morbidity and to evaluate long term survival according to complications.

This was a retrospective cohort study. The investigators included patients treated with gastrectomy for gastric or EGJ cancers at a single center. Severe morbidity was defined as Clavien-Dindo score ≥3.

The following factors are analyzed: age, sex, comorbidity, American Society of Anesthesiologists (ASA) physical status, tobacco and alcohol consumption, body mass index (BMI), hematocrit, serum albumin level, tumor location, the use of preoperative chemotherapy, laparoscopic or open surgery, total or subtotal gastrectomy, duodenal stump closure, multi-organ resection, lymphadenectomy, reconstruction method, T status, lymph node metastasis, and resection margin. The T stage was grouped by T1-T2 and T3-T4 for analysis. Patients will be followed for 5 years after surgery for survival analysis. A multivariate analysis is performed to identify predictors of overall and severe morbidity; and predictors of long-term survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with a gastrectomy for gastric cancer or esophagogastric cancer.
* Confirmed adenocarcinoma histology.

Exclusion Criteria:

* Histology different from adenocarcinoma.
Physical Activity in Patients With Systemic Lupus Erythematosus

Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients.

Objective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it.

Method. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients.

Expectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of systemic lupus erythematosus
* Of legal age
* Residents in Spain
* Who sign the informed consent document.

Exclusion Criteria:

* Patients dependent in the development of activities of daily living.
* Unable to ambulate without the help of third parties.
* Who have undergone surgery in the last 6 months.
Safety and Efficacy of Zicronapine in Patients With Schizophrenia

To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment.

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited.

Thus, present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, non-acute patients with schizophrenia will be randomised to blinded treatment with either zicronapine or a standard antipsychotic treatment for 24 weeks. The safety (with focus on metabolic parameters) and efficacy of zicronapine will be evaluated in comparison to risperidone.

Eligibility Criteria:
Inclusion Criteria:

* The patient meets the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* The patient is a man or woman, ≥18 and ≤65 years old
* The patient has a PANSS total score ≥60 and ≤100 (extremes included) at screening and baseline

Exclusion Criteria:

* The patient has a current, predominant Axis I psychiatric disorder other than schizophrenia as defined in the DSM-IV-TR
* The patient has a current diagnosis or a history of substance dependence (except nicotine) or substance abuse (except cannabis) according to the DSM-IV-TR criteria ≤6 months prior to screening
* The patient is at significant risk of harming him/herself or others according to the investigator's judgement (assisted by the assessment of suicidal ideation and behaviour using the C-SSRS)
* The patient is resistant to antipsychotic treatment according to the investigator's judgement or has been treated with clozapine ≤3 months prior to screening
* The patient has experienced an acute exacerbation requiring hospitalisation ≤3 months prior to screening or between screening and baseline
* The patient has been treated with risperidone or paliperidone ≤6 months prior to screening

Other inclusion and exclusion criteria may apply.
Shift Characteristics Affect Handover Duration and Rates.

The primary aim of our study was to analyze the independent factors affecting handover duration in Emergency Department. The secondary aim was to identify the factors affecting Emergency Department handover rates.

The primary aim in this study was to analyze the independent factors affecting handover duration in Emergency Department. Our secondary aim was to identify the factors affecting the Emergency Department handover rates. To better analyze independent variables, we dichotomized the data. First, we dichotomized handover duration into two groups according to the median handoff time of 20 minutes. Second, we divided handover rates into two groups using the median rate of handovers per shift, which was 3.87%.

Eligibility Criteria:
Inclusion Criteria:

The day and night shift handover , which are the interactive, verbal, bedside, and face-to-face interactions between the outgoing and incoming medical staff, were included.

Exclusion Criteria:

Handover locations other than bedside (n=3), handover methods except verbal communication (by paper (n=2)), and the use of information technology (n=1) were excluded to standardize the procedure.
Foot Reflexology on Premenstrual Syndrome

: Premenstrual Syndrome (PMS) is a set of physical, emotional and behavioral symptom that start during the week preceding menstruation and are alleviated when the menstrual flow begins. Reflexology is one of the most popular complementary therapies

This study was aimed to determine the effect of foot reflexology in the treatment of premenstrual syndrome. Subjects and methods: Fifty volunteer, single females with premenstrual syndrome (PMS) were selected randomly from outpatient clinic of obstetrics and gynecology at Kasr El Ainy University Hospital, Faculty of Medicine, Cairo University to share in this study, their age ranged from 18 to 25 years old and their body mass index (BMI) did not exceed 30kg/m2, the participants were assigned into two groups of equal numbers. The group (A) received therapeutic foot reflexology with dietary modification 3 times/week for8 weeks, while the group (B) received dietary modifications only for 8 weeks. All subjects in both groups were assessed through the visual analogue scale (VAS) for pain and Premenstrual Daily Symptoms Questionnaire for (PMS) related symptoms. Results: The results of the present study revealed that there was statistically significant improvement in both pain and premenstrual related symptoms in group (A) than in group (B).

Eligibility Criteria:
Inclusion Criteria:

* their age ranged from 18 to 25 years old
* their body mass index (BMI) did not exceed 30kg/m2

Exclusion Criteria:

* Rheumatoid arthritis
* Bronchial asthma
* depression
* anxiety
Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

The purpose of the investigators' study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).

Our previous studies showed that radiofrequency ablation (RFA) was as effective as liver resection for small hepatocellular carcinoma (HCC), but the recurrence rates after RFA were relatively high. Adjuvant therapies maybe reduce the recurrence rate. Phase 1 and 2 studies showed that thalidomide was a safety and effective treatment for HCC, especially for small HCC with liver cirrhosis. So we proposed that low-dose thalidomide adjuvant therapy will improve the disease progress free survivals and overall survivals after RFA for HCC.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 75 years, who refused surgery or first recurrence after hepatectomy
* A solitary HCC 3.1-7.0cm in diameter, or 2-3 lesions, sums of diameters ≤ 7.0cm
* Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US
* No extrahepatic metastasis
* No imaging evidence of invasion into the major portal/hepatic vein branches
* No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
* A platelet count of \> 40,000/mm3
* No previous treatment of HCC except liver resection

Exclusion Criteria:

* Patient compliance is poor
* Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis \& T1). Any cancer curatively treated \> 3 years prior to entry is permitted
* History of cardiac disease:

  * congestive heart failure \> New York Heart Association (NYHA) class 2
  * active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted)
  * cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, \*calcium channel blocker or digoxin
  * uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs)
* Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
* Known history of human immunodeficiency virus (HIV) infection
* Known Central Nervous System tumors including metastatic brain disease
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
* Distantly extrahepatic metastasis
Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer

The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.

To determine the clinical activity of 177Lu -J591 for the treatment of patients with metastatic, androgen-independent prostate cancer.

Patients will receive a single dose of J591 (total antibody of 20 mg) consisting of antibody chelated with 177Lu at a dose of 65 or 70 mCi/m2 with a specific activity of 12-15 mCi/mg plus non-radiolabeled antibody.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of prostate adenocarcinoma.
* Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
* Progressed following discontinuation of anti-androgen therapy, if received.
* Serum testosterone \< 50 ng/ml

Exclusion Criteria:

* Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
* Use of PC-SPES within 4 weeks of treatment.
* Use of red blood cell or platelet transfusions within 4 weeks of treatment.
* Use of hematopoietic growth factors within 4 weeks of treatment.
* Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
* Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
* Prior radiation therapy encompassing \>25% of skeleton.
* Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
* Active angina pectoris or NY Heart Association Class III-IV.
* History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
* Prior monoclonal antibody therapy with the exception of ProstaScint®
* Prior investigational therapy (medications or devices) within 6 weeks of treatment.
* Known history of HIV