cyrilzakka/clinical-trials huggingface dataset:
Family Functioning and Adverse Side Effects of Family-based Therapy for Anorexia Nervosa

The study examines potential adverse side effects on family functioning and parent-child relationships of standard treatment family-based therapy (FBT) for anorexia nervosa (AN) in children and youths.

Background:

Family-based treatment (FBT) for anorexia nervosa (AN) in children and youth has contributed significantly to the treatment of a disorder that has otherwise had a poor prognosis. Focus in FBT is on empowering parents to take full control over their child's nourishment. However, many parents are concerned how FBT might affect the relationship with their child as parents assume a double role of insisting on eating and weight gain, while at the same time providing emotional support, when this distresses the child. Moreover, FBT may have a "blind eye" to psychological difficulties with e.g. emotion regulation and interpersonal challenges, and thus inadvertently exacerbating them while focusing narrowly on eating and weight gain.

Aim:

The aim of the study is to quantitatively investigate side-effects of FBT by:

1. Assessing average changes as well as variations across families from start of FBT, after 3 months, and at end of FBT in four domains: perceived parental stress level and family function, emotion regulation ability and perceived attachment to parents.
2. Qualitatively describe the lived experience of young persons as well as parents going through FBT.
3. Based on the results of a) and b) to generate hypotheses on which additions and / or alterations to treatment that may mitigate potential adverse side effects of FBT- treatment. These modifications to FBT will be tested in a future clinical trial.

Exploratively, we will investigate whether level of family functioning at three months of FBT predicts changes in the four above mentioned domains at end of treatment (EOT), thus identify early in treatment the families at risk of adverse side-effects of FBT.

Methods:

Family functioning, parental stress level and attachment perception are measured with questionnaires only. Emotion regulation is measured with questionnaires and the Tangram Puzzle Task. The qualitative section of the study consists of interviews at end of treatment and will be conducted in a co-operation with the Danish patient organization Eating Disorders and Self Harm.

The project is a sub study to the larger study investigating response to treatment of eating disorders in youth: Effectiveness of Family-based Intervention in a Child and Adolescent Mental Health Service (CAMHS) for Children and Adolescents With Eating Disorders (VIBUS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of F50.0 or F50.1 first time of treatment with family-based treatment living with a minimum of one parent informed consent from young person and parents

Exclusion Criteria:

* non Danish-speaking
National Survey of Workplace Violence

China has witnessed a surge in violence against medical personnel, including widely reported incidents of violent abuse, riots, attacks, and protests in hospitals, but little is known about the definite prevalence of workplace violence against physicians of obstetrics and gynecology in China. The aim of this study is to analyze prevalence of workplace violence against physicians of obstetrics and gynecology in China. A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.

A random sampling will be performed in all 32 provinces, municipality or autonomous regions in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and the sample size under the condition of simple random sampling is 600 persons. If the homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3, the sample size of every level needs is 1800. Considering 10% population refusing to be surveyed, in all mainland of China, three levels of hospitals will include at least 6000 physicians who accept survey.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old
* Belonging to and registered at specific hospital
* Active employment in obstetrics, reproduction, or gynecology
* Signed an approved informed consents

Exclusion Criteria:

* Not meeting all the inclusion criteria
* Not completing the whole questionnaire
Catechin Mouth-washing for Removal of Intraoral Bacteria

The Purpose of this study is to evaluate the effects of catechin mouth-washing on the removal of intraoral bacteria in the elderly

Catechins are the major components of tea flavonoids and recent in vitro experimental studies have revealed that tea catechin extracts induce bactericidal effects. However, a limited number of studies have been conducted on the clinical effects of tea catechin against bacterial infection and also the effects in the elderly is unclear. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of catechin mouth washing on oral pathogenic bacterial detected in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* aged over 65 years
* detected oral pathogenic bacterium and revalidated during the wash-out period
* without antibacterial medicine, other mouth-washing remedies during the study
* Obtained written informed consent before participation

Exclusion Criteria:

* possessing some infectious diseases in need of therapy
* possessing tea or catechin allergy
* diagnosed as inadequate for other reasons to participate the study by principal investigator
Myo-inositol Versus Clomiphene Citrate in PCOS

Specific aim: To compare inositol and the golden standard first line treatment of ovulation induction, namely clomiphene citrate.


Eligibility Criteria:
Inclusion Criteria:

* Rotterdam criteria for PCOS (cf. the recent ESHRE guidelines): at least 2 out of 3 criteria should be fulfilled: irregular cycle (shorter than 21 days or longer than 35 days); clinical (modified Ferriman-Gallwey score ≥ 6) or biochemical signs (elevated free testosterone) of hyperandrogenism (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx); PCO ovaries on ultrasound (www.eshre.eu/Guidelines-and- Legal/Guidelines/Polycystic-Ovary-Syndrome.aspx): multiple small cysts (≥ 20 per ovary and/or an ovarian volume ≥ 10 ml, measured with a probe \>8 MHz) in both ovaries.
* A first treatment cycle, possibly combined with intra uterine insemination (IUI) and this for (one of) the following reasons: mild male factor (as defined by each local center) endometriosis AFS score 1 or 2
* Use of own or donor sperm.

Exclusion Criteria:

* Tubal factors
* Uterine factors
* Endometriosis AFS score 3 or 4
* Moderate to severe male factor (as defined by each local center)
* BMI \> 35
The Effect of Degree of Rice-polishing on Glycaemic Response

To investigate the effects of rice polishing on glycaemic and insulinaemic response in healthy Chinese male volunteers.

There will be a total of 8 test session. Each session will last for 3.5 hours. At each test session, volunteers will be served with test meal and blood will be collected. After an overnight fast, subjects will visit the research center. Two fasting capillary blood samples will be collected via fingerprick. Following the fasting samples, subject will consume the test meals. Further blood samples will be collected at 15, 30, 45, 60, 90, 120, 150, 180 minutes after the ingestion of test meal. These samples will be used to analyses for whole capillary blood glucose. At every 30 minute interval, samples will be collected for analysis of capillary plasma insulin.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Chinese ethnicity
* Age ≥21 and ≤ 60 years
* Body mass index between 18.5 to 25 kg/m2
* Normal blood pressure =\<140/90 mmHg
* Fasting blood glucose \<6.0 mmol/L
* In general good health

Exclusion Criteria:

* Current smoker
* Have any metabolic diseases (such as diabetes, hypertension etc)
* Do not have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)
* Have medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics)
* Have intolerances or allergies to any foods
* Currently partake in sports at the competitive and/or endurance levels
* Intentionally restrict food intake
Octabaix Intervention Study

Objective: To determine the effectiveness of an individual multifactorial intervention on falls and undernutrition risk in very older people in the community.

Design: Randomized, controlled trial.

Method: Three hundred and twenty eight people born in 1924, after recruitment will be followed for a three year period. Subjects received two in-home visits from a trained nurse or physicians who assessed falls and nutritional risk factors using an algorithm.

The intervention consisted of recommendations to the subject and their primary physician, and other providers, telephone calls, and exercise and nutritional plan. Control subjects received a general primary care assessment.

Measurements: the primary outcome were rate of falls and rate of undernourished risk. Secondary outcomes included different geriatrics characteristics.The outcomes of this study will provide important new information to reduce the incidence of falls and the risk of undernutrition of this population by intervention. Significant differences are not expected according to social-demographics sex and other factors, but they are expected by other obtained factors and indices that could allow to detection of octogenarian people with great risk of deterioration in just a short time.

Eligibility Criteria:
Inclusion Criteria:

* Subjects born in 1924 of one of the 7 participating health centers and noninstitutionalized

Exclusion Criteria:

* Institutionalized
Sufentanil for Anesthesia Induction in Continuous Remifentanil Anesthesia

The appropriate management of postoperative pain is recognized as an important clinical challenge with implications beyond humanitarian issues. Evidence shows that effective postoperative analgesia is associated with physiological benefits to the patient, shortened length of hospital stay and lower rates of in-hospital complications, such as pneumonia, delirium and persistent pain after surgery. However, despite the availability of several analgesic drugs and strategies the prevention and treatment of postoperative pain is often suboptimal. Remifentanil is a potent short acting opioid commonly used in continuous infusion for anesthesia for several surgical procedures. Remifentanil has been extensively advocated as a means to provide quick patient awakening in the immediate postoperative period with a very low risk of respiratory depression. Yet it does not provide residual analgesia and postoperative pain is a major concern. In order to overcome this limitation, practicing anesthesiologists frequently give patients a single dose of Sufentanil, a long acting opioid, during the induction of anesthesia where Remifentanil will be used in continuous infusion. However the effectiveness of this strategy still lacks evidence from controlled clinical trials.

We propose the current randomized clinical trial to assess the analgesic effectiveness of Sufentanil administered as a single dose during the induction of anesthesia for the management of postoperative pain in patients undergoing open abdominal surgery performed with continuous infusion of Remifentanil.

Eligibility Criteria:
Inclusion Criteria:

* Physical status (American Society of Anesthesiologists) 1, 2 or 3
* Age 18 years and older
* Patients selected for open Abdominal surgery under general total intravenous anesthesia

Exclusion Criteria:

* Physical status (American Society of Anesthesiologists) 4
* Patients undergoing other anesthesia technic (subarachnoid, epidural, nerve block, etc)
* History of anaphylactic reaction after use of tramadol, dipyrone, propofol, rocuronium, dexamethasone, sufentanil, remifentanil or morphine
* Chronic uso of drugs that are associated with major increases in the activity of P450 isozymes (Carbamazepine, phenobarbital, rifampin, tobacco, phenytoin, Hypericum perforatum)
* Previous History of Drug addiction
* alcoholism
Salbutamol Tolerance Onset

Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* 18 to 65 years of age
* non smoker
* beta agonist naive for at least 14 days
* baseline FEV1 at least 70% predicted
* no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1

Exclusion Criteria:

* poorly controlled asthma
* pregnant or lactating women
Neurological Blood-based Biomarkers and Cognitive Disorders in Critically Ill Survivors.

Cognitive disorders are common after intensive care. Currently, their diagnosis is based on clinical tests. The investigators plan to study the relationship between different neurological blood biomarkers (cytokines, S100β protein, neuron specific enolase, total Tau protein and neurofilament light chain) and the occurrence of cognitive disorders during the three months following intensive care discharge.


Eligibility Criteria:
Inclusion Criteria:

* Anticipated ICU stay of at least 7 days for sepsis, acute respiratory distress syndrome, severe burns
* French speaking

Exclusion Criteria:

* hearing loss or blindness
* mental retardation
* known cognitive disorders or dementia
* ICU admission for neurological disease
* refusal
Evaluation of the Effectiveness and Safety of ABAStroke

The aim of the project is to confirm the effectiveness and safety of the ABAStroke technology, which uses the principles of Applied Behavior Analysis (ABA) in the rehabilitation of cognitive deficits in patients after strokes. The study is comparative in nature, where a group of 100 patients will be included in this randomized study, divided equally into a study group and a control group. The purpose of the study is also to demonstrate that this non-invasive new rehabilitation technology based on the ABAStroke computer software supports the process of rehabilitation in the field of cognitive functions together with standard pharmacological therapy, including the possibility of using rehabilitation (as recommended by researchers and other doctors conducting rehabilitation of a patient after a stroke brain). ABAStroke can lead to improved cognitive functions (such as abstraction, short-term memory, visuospatial functions, executive functions, language, verbal fluency, allopsychic orientation, and attention) and is delivered via a mobile device app that can be used at home.


Eligibility Criteria:
Inclusion Criteria:

1. Men and/or women between the ages of 18 and 70
2. Condition after an ischemic or hemorrhagic stroke that occurred within the last 6 months before the start of the study.
3. MoCA score \>14 and \<26 points.
4. Signing of the informed consent form by each study participant.

Exclusion Criteria:

1. Vision disorders of various etiologies, which, in the opinion of the researcher, prevent the efficient use of a device using electronic displays.
2. Psychotic episodes and/or manic episodes and/or severe depression (Beck score 26 or higher) in the past year.
3. History of alcohol abuse or physical dependence on opioids in the past 2 years.
4. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social circumstances) that could affect the patient's ability to attend scheduled appointments and use the investigational technology as determined by the investigator.
5. MoCA score \<15 or \>25 points.
6. Treatment of procognitive drug therapy in the last 6 months before inclusion in the study:

nootropics (pro-cognitive): cerebrolysin, citicoline, vinpocetine, nicergoline, piracetam, Gingo Biloba preparations, lecithin, cholinesterase inhibitors: donepezil, rivastigmine, galantamine, NMDA receptor antagonist: memantine.
AI Screening for Diabetic Retinopathy

The increasing prevalence of diabetes mellitus represents a major health problem, especially since around 40% of diabetic patients develop diabetic retinopathy, which severely impairs vision and can lead to blindness. This development could be prevented by annual check-ups and timely referral for treatment. However, there are major differences in the quality of examinations and bottlenecks in examination appointments. A solution to the problem could be the use of artificial intelligence (AI), especially deep learning. Initial studies have shown that deep learning algorithms can be used successfully to detect diabetic retinopathy. However, it remains to be clarified whether the use of AI can achieve a sufficiently high level of accuracy in the detection of retinopathies. Therefore, in the present study, the positive predictive value (PPV), the negative predictive value (NPV), the sensitivity (SEN) and the specificity (SPEZ) of the AI algorithm 'MONA-DR-Model' in the detection of diabetic retinopathy should be measured. In addition, it is to be examined how well the classification into mild and severe retinopathy corresponds and how well this new examination method is accepted by the patients.

As part of the study, a 45-degree fundus image is taken for each eye and patient using the 'Crystalvue NFC 600'. The fundus photographs are then analyzed using the 'MONA-DR-Mode'l and classified as "diabetic retinopathy according to AI present (K+)" or "diabetic retinopathy according to AI absent (K-)". These classifications are compared with the results ("diabetic retinopathy according to the doctor present (A+)" or "diabetic retinopathy according to the doctor absent (A-)") of the examinations routinely provided for in the Disease Management Program (DMP) diabetes mellitus type 2 by resident ophthalmologists who work in the period 6 months before and after the fundus photography in the West German Centre of Diabetes and Health (WDGZ) were compared. All patients with the assessment "diabetic retinopathy according to AI present (K+)" or discrepancies with the ophthalmological DMP examination in the outpatient environment are offered a routine appointment at the Marienhospital. There, an eye examination is then carried out by an ophthalmologist and, without knowledge of the previous findings, a reassessment and classification as "diabetic retinopathy according to the doctor present (A+)" or "diabetic retinopathy according to the doctor absent (A-)" is carried out by the AI.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus
* Diabetes duration ≥ 5 years
* Age \> 18 years old
* Patient is able to give informed consent
* Fluent in written and spoken German, or interpreter present

Exclusion Criteria:

* History of laser treatment
* Contraindication to the fundus imaging systems used in the study
Experimental and Clinical Studies of Retinal Stimulation

The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.

The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.

Eligibility Criteria:
Inclusion Criteria:

* Must be implanted with an Argus II Retinal Prosthesis system.
* Have 5 or more electrodes that create a perception with stimulation.
* Must be willing and able to comply with the protocol testing requirements.

Exclusion Criteria:

* Subjects participating in another investigatory drug or device study
* Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
Analgesic Effect of Adductor Canal Block With and Without Dexamethasone for Knee Arthroscopy

The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal block with and without dexamethasone when added to bupivacaine on the duration of postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery using Numeric Rating Score (NRS).

Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion of any signs of toxicity or nerve injury, the patients operations were done under spinal anesthesia. Patients were allocated into one of 2 groups (30 patients per group).

I. Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml normal saline.

ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).

Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively for 24 h.

Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia. Time to first request for analgesia \& total dose of rescue analgesia were be recorded.

10. Satisfaction score will be measured on a linear numerical scale; ranging from 0 = complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like nausea, vomiting, bradycardia, hypotension will be also documented. The time to first analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative, 6, 12, 18, and 24 h postoperative from zero to 5.

Eligibility Criteria:
Inclusion Criteria:

* Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction

Exclusion Criteria:

* patient refusal
* drug allergy
* failed procedure
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.

Objectives:

* To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.
* To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (\< 2 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 21 y/o
* IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model
* Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
* Solid nodules or part-solid nodules with solid component \>=8mm
* CT scan with nodule of concern performed within 60 days of enrollment

Exclusion Criteria:

Pure ground glass nodule or subsolid nodule with solid component \<8mm

* Currently on therapy for any cancer
* History of primary lung cancer within the last 5 years
* Multiple nodules highly suspicious for metastatic disease
* Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
* Pregnant women
* Prisoners
* Inability to provide informed consent
* Serologic evidence of active fungal infection