cyrilzakka/clinical-trials huggingface dataset:
Mental Health in Refugees and Asylum Seekers

The objective of this study is to investigate a stepped and collaborative care model (SCCM) for adolescent and adult refugees suffering from depression living in Germany.

A prospective, cluster-randomized intervention study, conducted in seven German cities and comprising a total of 476 patients, should compare effectiveness and efficiency of this SCCM as compared to a 'Treatment as Usual' (TAU) condition. The fundamental principle of the examined care model is to provide patients with mild and moderate depression with accessible and affordable treatments, which are located outside the usual psychiatric-psychotherapeutic institutions (e.g. peer-to-peer-approaches or smartphone based interventions).

The acquired insights from the stepped care model, as well as concerning the individual low barrier interventions for adolescents and adults, can be used immediately for benefitting the provision of care of refugees but also for improving care of other communities with lacking access to health care systems. The generated disease figures from the nationwide screening process can be utilized directly to manage the provision of mental health fostering offers for refugees by federal institutions and social health insurance companies.

In both treatment arms (SCCM and TAU) and independent of intervention form participants will be assessed at four time periods after the initial screening process: Baseline (T1), after week 12 (T1), after week 24 (T2), after week 48 (T3).

Following clinical measurement tools will be used at all time periods:

* Refugee Health Screener (RHS-15)
* Patient Health Questionnaire (PHQ-9)
* Patient Health Questionnaire-Adapted (PHQ-A) \*
* Montgomery-Åsberg Depression Scale (MÅDRS)
* Mannheimer Modul Ressourcenverbrauch (MRV)
* Brief Resilience Scale (BRS)
* General Self-Efficacy Scale (GSE)
* World Health Organization Quality of Life (WHOQOL-BREF)
* Child \& Adolescent Trauma Screening (CATS)\*

Following clinical measurement tools will be used at Baseline (T1):

* Demographics / Migration Questionnaires
* M.I.N.I. International Neuropsychiatric Interview
* M.I.N.I. KID International Neuropsychiatric Interview\*
* Harvard Trauma Questionnaire (HTQ)

Following clinical measurement tools will be used at Baseline (T0) and after Post-Intervention (T1):

* Cultural Differences Subscale
* Credibility / Expectancy Questionnaire

Following clinical measurement tools will be used at Baseline (T0), after Post-Intervention (T1) and Follow-Up 1 (T3):

- Strengths and Difficulties Questionnaire (SDQ)

\*Adolescents only

Eligibility Criteria:
Inclusion Criteria:

* Obtained a statutory health insurance
* Approved residence status as a refugee, asylum seeker or asylee
* Mother tongue in Arabic or Farsi/Urdu or speaks English or German fluently
* Age between 16-65 years
* Participants shows relevant depressive symptoms measured by the PHQ-9 or PHQ-A

Exclusion Criteria:

* An existing schizophrenia or degenerative disorder
* Missing informed consent
* Possible suicidality
* Uncertain residence status
Patients Undergoing Total Intracorporeal or Extracorporeal Anastomosis After Segmental Resection for Deep Endometriosis

Impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis undergoing either a totally intracorporeal or extracorporeal procedure

Surgery is the treatment of choice for deep endometriosis with bowel involvement and endometriosis nodules will be treated by segmental resection and subsequent anastomosis packing. Anastomosis packing with a totally intracorporeal approach may be a successful solution to reduce some of the complications after discoid or segmental resection with conventional laparotomic approach for extracorporeal anastomosis.

Setting up the colorectal anastomosis with a totally intracorporeal approach represents a surgical method that has been recently introduced but is already approved in terms of safety and reproducibility. However, experience with this technique is currently limited and there is no established consensus regarding patient suitability or data on longer-term outcomes. New studies are therefore needed to further validate the technique and to fully assess its long-term benefits resulting in increased quality of life for operated patients or to identify any associated complications.

The aim of the study is therefore to describe the impact on the quality of life (in terms of functional recovery and gastrointestinal symptoms) of segmental resection surgery in patients with intestinal endometriosis who underwent either a totally intracorporeal or extracorporeal procedure. In addition, the aim is to detect any differences in the duration of the operating time, compare the duration of the postoperative hospital stay and determine the success rate of the totally intracorporeal procedure

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 54 years of age
* Diagnosis, by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected intestinal involvement
* Intraoperative indication for segmental resection for intestinal endometriosis
* Obtaining informed consent for study participation and data processing

Exclusion Criteria:

* Patients with a known concomitant inflammatory bowel syndrome (inflammatory bowel syndrome)
* Patients undergoing emergency/emergency surgery
The Effect of the Glycemic Load of Meals on the Cognition and Mood of Older Adults

A lower rather than a higher glycemic load (GL) meal has been shown to benefit cognition and mood, however, the data in older adults and those most prone to cognitive dysfunction, is limited and conflicting. One explanation is that the GL of a meal may interact with a person's pre-existing glucose tolerance (GT).

As older adults have a higher incidence of glucose tolerance and are more likely to experience memory problems the present study considers the interaction between the GL of meal in those with better or poorer GT.

The population studied will not have a history of diabetes or dementia. A battery of cognitive tests will be administered after meals sweetened with one of three sugars known to vary in the rate that they release glucose into the blood stream.

On day one subjects will take an oral glucose tolerance test and will then be divided into four groups depending on their glucose tolerance (how long values remain raised) and the tendency for values to subsequently fall to low values.

On a second occasion 155 healthy older adults, aged 45-80 years, will be randomly assigned to receive either a glucose, sucrose or isomaltulose based meal. All meals are matched on macronutrient composition and differ only in glycemic load. Cognitive performance and mood will be assessed 30, 105 and 180 minutes after breakfast. Measures of memory, attention, reaction times and mood will be taken.

The response to the three meals will be contrasted in those with different glucose profiles on day one

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of 45 to 80 years

Exclusion Criteria:

* Type 1 or type 2 diabetes
* Dementia
* Liver disease
* Gastro-intestinal problems
Frequency Analysis of the Ultrasound Images in Rotator Cuff Tendon

Previous studies used spatial frequency analysis of tendon ultrasound images and considered that the parameters can reflect the micro-structure of the tendon. In this study, we try to recruit and analysis the rotator cuff tendon in healthy adults with different ages and different equipment to explore the the normal range and differences of spatial frequency parameters. The hypotheses of this study are (1) the young and the elderly would have significantly different spatial frequency value; and (2) there would be significant different results between different equipment.

Tendons are hierarchical fibrous tissues. The speckle signals of ultrasonic images have parallel stripes arranged along the long axis of the tendon, reflecting the arrangement of collagen fiber bundles in the tendon. The micro-structure of tendons can be quantified by analyzing the speckle pattern of ultrasonic images. A research team used fast Fourier transform to convert ultrasound images of tendons into two-dimensional spatial frequency spectra, and used linear discriminate analysis to calculate multiple spatial frequency parameters. The results indicated that there were 5 parameters with the highest accuracy in discriminating Achilles tendinopathy. There is a significant difference in the spectrum frequency parameters of whether the tendon was loaded and whether there was a tendinopathy tendon. Past studies using spatial frequency analysis in patients with shoulder pain, and they found that there was no significant difference between the asymptomatic control group and shoulder pain patients. The risk factors of rotator cuff tendon injury is related advanced age, dominant hand, and repeated overhead activities. Therefore, in this study, we will recruit participants of different ages and investigate the results of spatial frequency analysis of bilateral shoulders ultrasound images. The aim of this study is to know whether these factors may affect the micro-structure of the rotator cuff tendons and establish the reference norm of spatial frequency analysis parameters in those without obvious tendon degeneration or injury. In addition, we aim to compare the differences between spectrum analysis parameters with several instruments by using different ultrasonic equipment. This study could provide a reference for the clinical application of spatial frequency analysis in tendon ultrasound images.

Eligibility Criteria:
Inclusion Criteria:

* (1) age between 20-40 or age over 60;
* (2) no bilateral shoulder pain or discomfort within six months;
* (3) no past diagnosis in shoulder or upper extremities.

Exclusion Criteria:

* (1) fracture of upper extremities before;
* (2) be diagnosed as neck radiculopathy, central nervous system lesion of brain, or peripheral nervous system lesion of upper extremities;
* (3) rheumatoid arthritis or autoimmune disease;
* (4) have received any shoulder injection or surgery;
* (5) tendon tear in shoulder sonograms.
Experience of Adolescents With Anorexia Nervosa Towards Antidepressants

The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

In our adolescent psychiatric unit, antidepressant's prescription is common during the care pathway for adolescents with anorexia nervosa.

The literature highlights a paradox between scientific data and clinical practice, based on expert consensus. There are a very few qualitative studies in this subject and none of them concern adolescents.

The purpose of this qualitative study is to explore the experience and opinion of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 12 to 25
* Suffering from anorexia nervosa \[according to DSM-5 criteria\]
* Has been prescribed for a type of SSRIs antidepressant (still ongoing or interrupted at the time of the interview)
* Non-opposition to the study

Exclusion Criteria:

* Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia nervosa
* Body Mass Index \< 15
* Prescribed for another antidepressant than SSRIs
Ultrasound-Guided Adductor Canal Block for Total Knee Arthroplasty Surgery

The ultrasound-guided selective blockade of the saphenous nerve in the adductor canal provides effective analgesia and reduces postoperative pain in patients undergoing arthroscopic medial meniscectomy. Selective blockade of the saphenous nerve in the adductor canal provides effective analgesia without quadriceps muscle weakness. It has been shown that the adductor canal block (ACB) block increases the spread of local anesthetics in a distal and proximal way. Therefore, the proximal spread of local anesthetics may cause possible quadriceps weakness. The distal spread of local anesthetics may increase analgesic effect via sciatic nerve. The different volumes for ACB is a topic of discussion. The aim of this study is to compare the different volumes of US-guided ACB performing for postoperative analgesia management after total knee arthroplasty surgery.

Knee arthroplasty is one of the most common orthopedic procedures. Patients may complain severe pain due to the surgical trauma and the prosthesis. Opioid agents are commonly used for analgesia management. However, opioids have adverse effects such as nausea, vomiting, sedation and respiratory depression. Peripheral nerve blocks such as femoral block, adductor canal block (ACB) may be performed to reduce opioid consumption and opioid-related side effects.

Selective blockade of the saphenous nerve in the adductor canal for knee surgery provides effective analgesia without quadriceps muscle weakness. This is an important advantage of ACB since it there is no motor blockade in the postoperative period. Blocking of the motor branches leads to delaying of the mobilization and it increases the patient's falling risk. ACB, targets the saphenous nerve and the vastus medialis branch which are the two largest sensorial nerves of the femoral nerve that innervates the knee. ACB blocks the articular branches of the obturator nerve at the same time. Since the ACB is performed at the distal site of thigh it does not target majority of the efferent branches of the quadriceps muscle, therefore the strength of this muscle may not be affected. ACB is usually performed with a volume of 10-30 ml and studies may be needed including different volumes to understand its effectiveness.

The aim of this study is to compare the different volumes (20 ml, 30 ml, and 40 ml) of US-guided ACB for postoperative analgesia management after total knee arthroplasty. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), motor blockage, the first mobilization time, and adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II-III
* Scheduled for total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* history of bleeding diathesis
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who do not accept the procedur
Alcohol, Behavior, and Brain Imaging

To evaluate the relationship of extraversion to both the acute subjective and behavioral effects of alcohol, and the neural reactivity to the anticipation of reward.


Eligibility Criteria:
Inclusion Criteria:

* 21-29 years old
* 7-30 alcoholic drinks per week (as reported on PHQ or TLFB)
* At least one binge episode (4 for females/5 for males) per month
* No 'flushing' reaction to alcohol
* Females must be on birth control or in the beginning of follicular phase (1-14 days after start of menstruation)
* BMI 19-26
* High school education or greater, fluent in English
* No night shift work
* No current or past year Axis I psychiatric disorder including drug/alcohol dependence
* No current psychopharmacological treatment
* No lifetime ADHD or prescription for ADHD medication
* No abnormal EKG, cardiovascular illness, high blood pressure
* No medical condition or pharmacological treatment for which alcohol is contraindicated
* Not pregnant, lactating, or planning to become pregnant
* Smoke \<6 cigarettes per day
* No previous participation in studies that have used the Stop Task (except IDAC) o Previous Stop Task studies: GOI, CAP, STEM, JAM, MACI, PAC, CAM
Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury

Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides. Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy. There are currently no studies to construct a model for predicting the risk of D-AKI associated with aminoglycosides. Therefore, the study aimed to develop a model to predict the risk of D-AKI that could be used in clinical practice. Clinical data of inpatients treated with aminoglycosides at the First Affiliated Hospital of Shandong First Medical University from January 2018 to December 2020, were collected. The primary endpoint was D-AKI, defined according to the 2012 Global Outcomes for Kidney Disease Improvement (KDIGO). Patient clinical information, including demographic information, admission and discharge information, disease history, medication information, and laboratory tests, was obtained through an in-hospital electronic medical record system. Independent risk factors associated with D-AKI will be screened by univariate and multifactorial analyses. Covariates with significant differences (P \< 0.05) were included in logistic regression models. The models were evaluated by the area under the curve (AUC) of the receiver operating characteristic curve (ROC) obtained by ten-fold cross-validation. Future studies are needed to test the application of this model in clinical practice to determine whether D-AKI in this setting can be predicted and mitigated.


Eligibility Criteria:
Inclusion Criteria:

* All inpatients who used aminoglycosides during hospitalization
* Hospital stay ≥ 48h
* Age ≥18 years
* There are two or more blood creatinine tests during hospitalization

Exclusion Criteria:

* Hospital stay \< 48h
* Age \<18 years
* Glomerular filtration rate (GFR) \< 30ml/min/1.73m2 within 48 hours after admission
* AKI was diagnosed on admission
* Less than two Scr test results during hospitalization
* The Scr values were always lower than 40 μmol/L during hospitalization
* Cases with incomplete medical history information
Effects of Otago-based Multicomponent Exercise on Sarcopenia in Pre-Frailty Older Adults in Nursing Homes: a Randomized Controlled Trial

The objective of this clinical trial is to understand the efficacy of a targeted exercise program (Otago exercise program+Strength training) in elderly people with prefrailty and sarcopenia. The trial aims to answer the following main questions:

* Is OEP+ST effective in elderly people with prefrailty and sarcopenia?
* In what areas did participants improve during the OEP+ST intervention?

Researchers will randomly assign participants to an experimental group (OEP+ST) and a control group (daily care only) for comparison to see the effects of this intervention.

Participants in the EG group will:

* Exercise 3 times a week for 1 hour each time (including 10 minutes of warm-up, 40 minutes of exercise and 10 minutes of stretching) At the same time, it is necessary to walk for 30-40 minutes three times a week. It lasts for three months.
* Test and record their condition (including frailty, body composition, physical function, quality of life) before and after the experiment.


Eligibility Criteria:
Inclusion Criteria:

* Participants were diagnosed with pre-existing frailty (Fried score 1-2); At the same time, they were also diagnosed with sarcopenia (according to AWGS Asian Sarcopenia Diagnostic Criteria 2019 edition: Grip strength: male \< 28kg, female \< 18kg; SMI: Male \< 7.0kg/m2, female \< 5.4kg/m2; Walking speed ≤1.0 m/s; 5 sit-up test times ≥12s); Simple mental status examination (MMSE score ≥21); There are no absolute contraindications to physical exercise (chest pain, chest tightness, palpitations, dyspnea, syncope, high fever, severe cough, severe diarrhea, gross hematuria, radiating pain in waist and legs, fracture, etc.).

Exclusion Criteria:

* Uncontrolled high blood pressure. Coronary artery disease. Rheumatoid arthritis. Type 2 diabetes. Respiratory diseases and lung diseases. Are taking or have used antibiotics and/or antifungal therapy in the past 4 weeks.

Unwillingness to stick to a prescribed schedule.
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste

The objective of this study was to evaluate the anti-plaque efficacy of the Anacor prototype dentrifice as compared to commercial control products following a single use of the dentrifice.

The widespread successful use of triclosan as an anti-inflammatory and anti-bacterial agent is well documented. The standard dentrifice has demonstrated a robust anti-plaque and anti-inflammatory effect providing multiple benefits. There is a clear value to identify additional agents with the same dual action with a comparable or an enhanced level of efficacy. This study examined the anti-plaque efficacy following a single use of the prototype dentifrice.

Eligibility Criteria:
Inclusion Criteria:

* Must be between ages 18 to 65 years inclusive
* Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present
* Must give written informed consent
* Be in good general health
* Must discontinue oral hygiene for 24-hours after initial appointment
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental visits/procedures
* Advanced periodontal disease
* 5 or more decayed, untreated dental sites
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of drugs that can affect salivary flow
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxen), unless approved by the study medical staff
* Pregnant or breastfeeding
* Participation in another clinical study in the month preceding this study
* Allergic to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
* History of allergic reaction to any anti-inflammatory agents
Mirtazapine for Chronic Insomnia in Older Adults

Insomnia is highly prevalent in the older adult population. The pharmacolgical management of chronic insomnia includes benzodiazepines and Z-drugs (zolpidem, zopiclone). Although these drugs are indicated for insomnia, they are not without side effects. These drugs are associated with cognitive impairment, rebound insomnia, falls and addiction. Mirtazapine has a hypnotic and sedative effect related to the blocking of histamine-1 receptors. No clinical trials has evaluated the efficacy and safety of mirtazapine for insomnia in the older population.

The goal of the study is to assess the efficacy and safety of mirtazapine compared to a placebo in older adults with chronic insomnia.

This prospective double-blind placebo controlled trial will be conducted in adults 65 years and older with chronic insomnia. The treatment group will receive mirtazapine 7.5 mg at bedtime for 28 days and the control group will receive a matching placebo for 28 days. The sample size for the pilot study will be 60 subjects, 30 subjects in the treatment group and 30 subjects in the control group. The efficacy of mirtazapine will be measured using the Insomnia Severity Index and the Pittsburgh Sleep Quality Index. Safety will be monitored during the study


Eligibility Criteria:
Inclusion Criteria:

* Age 65 years and older
* A report of sleep initiation or maintenance problems
* An adequate opportunity and circumstances to sleep,
* To have at least one daytime consequence in relation to sleep complaint.
* Sleep disorder and daytime consequences occur at least 3 times a week.
* Duration of sleep disorder and daytime consequences for at least 3 months
* Sleep complaint cannot be explained by a sleep disorder other than chronic insomnia.

Exclusion Criteria:

* Contrindication to mirtazapine
* Use of drug for insomnia
* Cognitive Behavioural Therapy for insomnia
* Use of Melatonin
* Active psychiatric illness
* Parkinson's disease
* Major Neurocognitive disorders
* More than one fall in the last 3 months