cyrilzakka/clinical-trials huggingface dataset:
The Short-Term MBT Project

The study will evaluate the benefitial and harmful effects of short-term (20 weeks) compared to long-term (14 months) mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder.

Psychotherapy for borderline personality disorder is often lengthy and resource-intensive. Mentalization-based therapy is an example of an evidence-based treatment that currently has empirical support as an 18-months outpatient program for borderline personality disorder. However, this duration is rarely available, and the long and costly treatment combined with a highly prevalent disorder result in insufficient access to evidence-based care.

The trial is an investigator-initiated, single-centre, assessor-blinded, randomized clinical superiority trial of short-term (20 weeks) compared to long-term (14 months) outpatient mentalization-based therapy for borderline personality disorder or subthreshold borderline personality disorder. Participants will be recruited from the Outpatient Clinic for Personality Disorders at Stolpegaard Psychotherapy Centre, Mental Health Services, Capital Region of Denmark. Participants will be assessed at trial intake using the Mini International Neuropsychiatric Interview and the Structured Clinical Interview for DSM-5 Personality Disorders. Participants will be included if they meet a minimum of four DSM-5 criteria for borderline personality disorder. Participants will be assessed blind to treatment allocation at baseline, and at 8, 16, and 24 months after randomization.

The primary outcome is severity of borderline symptomatology assessed using the Zanarini Rating Scale for Borderline Personality Disorder interview. Secondary outcomes include self-harm incidents, functional impairment (Work and Social Adjustment Scale), quality of life (Short-Form Health Survey), and global functioning (Global Assessment of Functioning scale). Psychiatric symptoms (Symptom Checklist 90) will be included as an exploratory outcome. Measures of personality functioning, attachment, group alliance, borderline symptoms and mentalization skills will be included as predictor and mediator variables.

Eligibility Criteria:
Inclusion Criteria exclusive to the Outpatient Clinic

* Age \>18 years
* Personality disorder(s) considered to be primary diagnosis/diagnoses

Inclusion Criteria exclusive to the trial:

* A minimum of four DSM-5 criteria for borderline personality disorder
* Written informed consent

Exclusion Criteria exclusive to the Outpatient Clinic:

* Possibility of a learning disability (IQ\<75)
* A diagnosis of schizotypal personality disorder or antisocial personality disorder
* Presence of a comorbid psychiatric disorder that requires specialist treatment elsewhere
* Current (past 2 months) substance dependance including alcohol
* Concurrent psychotherapeutic treatment outside the clinic

Exclusion Criteria exclusive to the trial:

- Lack of informed consent
Acupuncture Needling on Connective Tissue by Ultrasound

The purpose of this study is to investigate the effect of acupuncture needling on connective tissue using ultrasound techniques both in animals and in humans.


Eligibility Criteria:
* Healthy Humans
* No bleeding disorders
* No anticoagulant therapy
* Cannot be pregnant
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss

This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject is aged 6 months to 21 years inclusive.
* Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
* Subject is scheduled to receive a chemotherapy regimen that includes a cumulative cisplatin dose of ≥ 200 mg/m2.
* Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000 Hz, in both ears and does not have a history of sensorineural hearing loss.

Exclusion Criteria:

* Subject has middle ear effusion upon clinical examination.
* Subject has a history of central nervous system radiotherapy that encompasses all or part of the cochlea or will receive such radiation therapy during the course of the study.
* Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
* Subject is currently participating on a separate otoprotection clinical study.
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis

The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill all of the following items

  * Patients with primary osteoporosis
  * Patients who have existing 1-4 vertebral fractures
  * Patients with back pain persisting for one week or more
  * Postmenopausal women between 46 and less than 80 years of age
Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40 in Vitrectomy

Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia in vitrectomy. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire in vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients (20-80 years old) scheduled for vitrectomy surgery undergoing general anesthesia.
2. ASA 1-3

Exclusion Criteria:

1. Patients with allergy to anesthetic agents
2. Anticipated difficult airway
3. BMI \> 30 kg/m2
4. Chronic obstructive pulmonary disease
5. Heart failure 6. Unstable angina
Assessment of Brain Cognitive Impairment in Breast Cancer

To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.

Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary stage I-II breast cancer.
* Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
* No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
* Eastern Cooperative Oncology Group score of 0-1 points.
* Can understand and complete various scales.
* Right handedness.
* Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.
* Sign the informed consent and voluntarily participate in this clinical observation.

Exclusion Criteria:

* Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.
* Current or former epilepsy, dementia, or learning disabilities.
* Past psychiatric history.
* Past history of malignancy.
* MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
Use of Teach Back to Improve Comprehension of Discharge Instructions for Emergency Patients With Limited Health Literacy

The purpose of this study was to determine whether use of teach-back discharge instructions improve patient satisfaction and patients' self-reported and objective comprehension of discharge instructions in the emergency department when compared to standard discharge instructions.


Eligibility Criteria:
Inclusion Criteria:

* patients being discharged from the emergency department
* A score of 6 or less on the Rapid Estimate of Adult Literacy in Medicine, Revised (consistent with Limited Health Literacy)

Exclusion Criteria:

* aphasia,
* non-English speaking,
* mental handicap,
* psychiatric chief complaint,
* too high acuity per physician,
* insurmountable communication barrier,
* evaluations for sexual assault,
* clinical intoxication.
Impact of the Sustained Viral Response of Chronic Hepatitis c After Treatment With Direct Action Antivirals

The purpose of this study is to evaluate the evolution of liver injury with fibrosis data obtained using non-invasive serological markers in patients who achieved SVR after treatment with direct-acting antivirals.

This open study includes patients with chronic hepatitis C who received treatment with the new direct-acting antivirals between November 1, 2014 and December 31, 2017, who achieved a sustained viral response at week 12.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic liver disease caused by virus C.
* Have received treatment with the new DAAs between November 1, 2014 and December 1, 2017.
* Patients diagnosed with advanced fibrosis and liver cirrhosis. Advanced fibrosis was defined as a Fibroscan\> 10 kPa, an APRI index\> 1.5 and / or a FIB-4 index\> 3.25. For its part, cirrhosis was defined such as a Fibroscan\> 12.5 kPa and / or presence of esophagogastric varices in the endoscopic study and / or data portal hypertension ultrasound.

Exclusion Criteria:

* Coinfection by virus B or HIV.
* Development of HCC before or during treatment.
* Abuse of alcohol intake or addiction to parenteral drugs.
* Liver disease of non-viral etiology (autoimmune, toxic, metabolic).
An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients

This was an observational, single arm, multicentric study conducted for the adjustment of treatment strategy and its monitoring using high-frequency and high-dosage administration of interferon-beta (Rebif) in MS subjects. Study focussed on assessment of the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects.

Treatment of MS, which progresses to attacks or episodes, with interferon-beta has established itself as therapy of the first choice. On the basis of different studies, the hypothesis was substantiated that the effectiveness is dependent on dose and application frequency. These realizations justify the use of high-dose interferon-beta not only in subjects in the initial stages of disease, but also in those subjects, who have a progressing disease activity even in the advanced stage, if other therapies fail. For achieving maximum benefit for the subject, an optimum therapy is imperative. The therapy plan (Immunomodulatory Therapy) of "MS Therapy Consensus Group" (MSTKG) is being widely used. In the article: "Optimising lmmunomodulatory Therapy for MS Patients" that appeared in the "International Journal of MS care" in the year 2002, a simple 9-scale model" is proposed that defines four areas respectively: not conspicuous, conspicuous, alarming and measures are necessary, in the three areas: attacks/episodes, disease progression and magnetic resonance tomography (MRT). The modification of an existing therapy, such as modifying the application plan, increasing the dosage, or substance change is recommended, if 'conspicuousness' is shown in all three areas, two areas are shown as 'alarming' or an area is shown as 'action necessary'. The decision for a therapy adjustment with the help of the "three scale model" should not happen solely on the results of the MRT. The model in the study involved attack or episode pertaining to: frequency, degree of severity, ability of involution and the response to a cortisone pulse therapy.

OBJECTIVES

* To assess the effectiveness and safety of existing immunomodulatory basis therapy in MS subjects
* To identify candidates suitable for possible therapy adjustment

Eligibility Criteria:
Inclusion Criteria:

* Subjects with clinically ensured diagnosis of a MS and history of attacks or episodes
* Subjects who were on one of the permitted basis therapies at least since 6 months
* Subjects with existing systemic concurrent diseases (e.g.diabetes, heart, liver, kidney diseases) should be monitored very carefully.

Exclusion Criteria:

* Subjects with secondary progressive course of the MS without attacks or episodes, pregnant or nursing subjects as well as subjects with history of contraindications
Double Blind Comparative Study of TAK-875

The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* The participant is an outpatient.
* The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

* The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
* The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Screening for CRC Using a Mixed Strategy of Sigmoidoscopy and Colonoscopy in Average-Risk Population According to Age

BACKGROUND: Primary screening with sigmoidoscopy would miss a substantial proportion of advanced proximal neoplasia (APN), but screening with universal colonoscopy is costly. The aim of this study is to assess the efficacy of mixed strategy which uses sigmoidoscopy for younger patients and colonoscopy for older patients.

MATERIALS and METHODS: We analyzed an established database containing consecutive average-risk adults aged 50 or older who underwent screening colonoscopy as part of health check-up. We assessed the efficacy of mixed screening strategy using colonoscopy for persons aged at and above a certain cut-off age and sigmoidoscopy for persons aged below that age. Those who underwent sigmoidoscopy initially would be referred for subsequent colonoscopy if distal sentinel lesion was detected.

Because the prevalence of proximal colon cancer and APN was higher in older patients15, a greater proportion of advanced colonic neoplasia or cancer would be missed if colonoscopy was not performed for older patients. So if we develop a mixed strategy to offer sigmoidoscopy for younger patients and reserve colonoscopy for older patients, we might be able to detect more APN with fewer colonoscopic procedures. We aimed to determine an optimal cut-off age and choose an appropriate distal sentinel lesion for subsequent colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Only asymptomatic ethnic Chinese subjects aged 50 years or older who underwent total colonoscopy were included in this study

Exclusion Criteria:

* Persons with symptoms indicative of colorectal cancer, such as hematochezia, body weight loss, development of persistent abdominal pain or rectal pain, and a change in bowel habit, were excluded from this study. Other exclusion criteria were: (1) past history of CRC, colon polyps, or inflammatory bowel disease; (2) a history of screening tests, including FOBT, sigmoidoscopy, colonoscopy, or barium studies within 5 years; (3) any first degree relative(s) with colon cancer; (4) criteria for hereditary nonpolyposis colorectal cancer, familial adenomatous polyposis, or other polyposis syndrome; (5) obvious anemia with hemoglobin level less than 10g/dl; (6) incomplete examination of entire colon, including poor colon preparation and failure to reach cecum.
Comparison Between the Oro-Helical Length Technique and the 7-8-9 Rule in Determination of the Ideal Endotracheal Tube Insertion Depth in Neonates

This study was conducted on neonates needing intubation; Group A,: the ETT insertion depth was estimated according to the OHL method. Group B,: the ETT insertion depth was estimated according to the 7-8-9 method.


Eligibility Criteria:
Inclusion Criteria:

* • Full term and preterm neonates who were admitted to NICU and needing endotracheal intubation for invasive mechanical ventilation or administration of surfactant.

  * Delivery room intubations were not included as infants are not routinely weighed prior to resuscitation at our hospital. However, infants intubated in the delivery room who were subsequently intubated in the NICU were eligible for inclusion in our study.

Exclusion Criteria:

- 1. Major upper or lower airway anomalies. 2. Infants with craniofacial, vertebral anomalies. 3. Significant congenital anomalies including cardiac, abdominal or respiratory.

4. Neonates those whose parents declined consent were excluded from the study.
Autoimmune Diabetes: Markers of the Disease and Treatment of Latent Autoimmune Diabetes in Adults (LADA)

Autoimmunity is the main cause of diabetes type 1 and an important factor as cause of Latent Autoimmune Diabetes in Adults (LADA). Recently, research has found that being deficient of T-reg cells is an important cause of autoimmunity. The study hypothesis are:

1. Patients with newly found diabetes type 1 have less T-reg than healthy.
2. Patients with newly found diabetes type 1 have less T-reg than patients with long duration of the illness.
3. The number of T-reg is negative associated with HLA-risk-haplotype.
4. The number of T-reg is negative associated with LADA.
5. Differences relating to inflammatory cytokines will be seen among patients with newly found diabetes type 1, but not among others.

Research has worked out that b-cells are being destroyed by cytokines released from inflammatory cells. One hypothesis in that T-reg is a cause of autoimmunity, and that T-reg concentrations are low in patients with newly diagnosed diabetes type 1.

Blood samples will be taken from 10 patients with newly diagnosed type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA) and type 1 diabetes older than 10 years and the same amount of samples from healthy, age- and sex-matched blood donors. Markers of autoimmune diabetes will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed diabetes type 1
* LADA
* diabetes type 1 older than 10 years

Exclusion Criteria:

* none
Tofacitinib Bioequivalence Study Comparing Tablets And Capsules

The overall aim of the study is to establish bioequivalence between commercial tofacitinib tablet formulations with the tofacitinib capsule formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including oral temperature, BP and PR measurement, 12 Lead ECG and clinical laboratory tests.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
Premedication Simethione Improves Visibility During Bowel Cleansing for Colonoscopy

To evaluate the efficacy, visibility of low volume polyethyleneglycol-simeticone (2-LPEG-S) for colonoscopy.

In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 2 L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to simeticone plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients are between 18-65 years old
* undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up

Exclusion Criteria:

* suspected gastrointestinal obstruction or perforation
* severe acute inflammatory bowel disease
* toxic megacolon
* ileus or gastric retention, ileostomy,
* hypersensitivity to any of the ingredients
* pregnancy and lactation and/or at a risk of becoming pregnant
Cardiac Arrhythmias in Epilepsy: the CARELINK-study

Patients with difficult-to-treat epilepsy ("refractory epilepsy") are at high risk of sudden death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of time, the frequency of clinically relevant arrhythmias appeared much higher in two small observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients at high risk of cardiac arrhythmias, so that we can timely institute preventive measures (e.g. pacemaker implantation).


Eligibility Criteria:
Inclusion Criteria:

* Drug-resistant focal epilepsy: failure of adequate trials of two tolerated and appropriately chosen and used antiepileptic drug (AED) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom \[16\]
* ≥ 1 complex partial and/or generalized tonic clonic seizure/month as indicated by history taking
* If female, not pregnant
* Aged 18 to 60 years
* Able to undergo the study procedure as judged by the treating physician.

Exclusion Criteria:

* Clinical suspicion of seizure-induced asystole (e.g. seizures with sudden flaccid falls)
* Reveal implantation (either present or in the past)
* Known clinical relevant structural cardiac disease
* Hereditary syndromes that increase the risk of cardiomyopathy (e.g. Marfan's disease)
* ECG findings suggestive of arrhythmias without proper cardiac evaluation to in- or exclude this possibility. According to European Society of Cardiology (ESC) guidelines on syncope the following ECG findings will be used: bifascicular block and other intraventricular conduction abnormalities, asymptomatic inappropriate sinus bradycardia (\<50 bpm), sinoatrial block or sinus pause ≥3s in the absence of negative chronotropic medications, non-sustained VT, pre-exited QRS complexes, prolonged or short QT interval, Brugada pattern, pattern suggestive of arrhythmogenic right ventricular cardiomyopathy.
* Pacemaker
* Use of beta blockers or other anti-arrhythmic/anti-arrhythmogenic medication
* Previous diagnosis of psychogenic non-epileptic seizures
* Patients who live alone and are not able to recall their seizures