cyrilzakka/clinical-trials huggingface dataset:
First Experimental Study of Transference Work - In Teenagers (FEST-IT)

The First Experimental Study on Transference work - In Teenagers (FEST-IT) will be a randomized clinical trial, which will be designed to explore effects of transference work in dynamic psychotherapy in adolescents with major depressive disorder (MDD). The design of the study is a so-called dismantling design, in which a single component is added and/or varied to an existent treatment method (psychodynamic psychotherapy). Thus, the efficiency of a specific technique (transference interventions) can be identified.

The primary hypothesis is that the transference group may have a more favorable course over time than will the comparison group.

The second hypothesis is that patients with a history of low Quality of Object Relations score and/or personality disorders-might benefit more from therapy with transference work than from therapy without.

The third hypothesis is that female adolescents may have better treatment effect of transference work than male adolescents.

The effect of transference interventions in depressed adolescents and the moderator moderating effect of quality of object relations, personality disorder and gender will be explored. Methods and study design: The First Experimental Study of Transference Work-In Teenagers (FEST-IT) will be a randomized clinical trial with a dismantling design. The study is aimed to explore the effects of transference work in psychodynamic psychotherapy for adolescents with depression. One hundred patients ages 16 to 18 years old will be randomized to one of two treatment groups, in both of which general psychodynamic techniques will be used. The quality of adolescents' relationships will be a central focus of the study.The patients will be treated over 28 weeks with either a moderate level of transference intervention or no transference intervention. Follow-up will be at 1 year after treatment termination.

Gender personality disorder (PD) and quality of object relations (QOR) will be the preselected moderators.

The object of this clinical trial is to explore the effect of transference interventions in psychodynamic psychotherapy in adolescents with a major depressive disorder. Using a randomized and dismantling design, we hope that the study will add more specific knowledge to the evidence base.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 16 - 18 years

Exclusion Criteria:

* Pervasive developmental disorder,
* psychosis, or substance abuse
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy

Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.

This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).


Eligibility Criteria:
Inclusion Criteria:

* Women with no sign of breast cancer as controls
* Non-pregnant and non-lactating
* Ability to understand and willingness to sign a written consent

Exclusion Criteria:

* Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.)
* Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
* Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study.
* Women with history of breast disease, previous breast surgery, or breast implants.
* Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years.
* Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients

A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard care with a fixed pressure Continuous Positive Airway Pressure (CPAP) device and compared to a less aesthetically pleasing CPAP device without technologies (AutoCPAP, SensAwake™, ThermoSmart™) in patients previously diagnosed with moderate-severe obstructive sleep apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years with moderate-to-severe OSA (Apnea Hypopnea Index equal to or greater than 10 per hour).
* Successful titration Polysomnography (PSG).
* Fluency in both written and spoken English.

Exclusion Criteria:

* Participants prescribed and fitted with any PAP device in the past 2 years.
* Contraindicated for CPAP or AutoCPAP therapy.
* Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
* Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
* Previous surgery for OSA or snoring or any surgery of the mouth, nose, sinuses or airways.
* If SensAwake™ or ThermoSmart™ was disabled on the treatment arm (or conversely) during the study protocol.
* If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
* If the physician objects to their patient taking part in the study.
Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study

The aim of the LedRad LTE study is to determine the current complaints, late side effects and satisfaction of patients who were treated with radiotherapy for Ledderhose disease at least two years ago.


Eligibility Criteria:
Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago
Effects of Board Games on Balance in Association With Cognition in Community-Dwelling Elderly.

As age progress incidence of fall increases. Cognitively impaired patients have poor balance and they are more prone to falls. Balance and cognitive functions are co-related in middle-aged and community-dwelling elderly. In fact age-related cognitive decline as the brain ages it has exceptional neuroplasticity. To maintain balance and prevent falls various cognitive processes are required. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. Cognitive training using simple games might improve the elements of balance and gait, and prevent falls.

In fact age-related cognitive decline, as the brain ages, it has exceptional neuroplasticity. This can be achieved by cognitive training which consists of domain-specific task completion or exercises to promote neurogenesis in that domain. Cognitive training is an approach towards enhancing neural plasticity by focusing on and training cognitive domains for balance improvement. Board games can be used as tools for cognitive training as they have the means to restore and form motor skills, cognitive functioning, and logical and spatial thinking. A board game is a generic term for a game played by placing, moving or removing pieces on a board and that utilizes a game format in which pieces are moved in particular ways on a board marked with a pattern. As a tool, board games can improve comprehension and cognitive functioning among participants.

As per a study, computer-based cognitive training by simple games such as Road Tour, Jewel Diver, and Sweep Seeker improved visuospatial memory, speed of processing and inhibition which in turn improved balance and gait, and prevented falls in community-dwelling elderly but as per the author's access, there's lack of standardization in terms of types of cognitive training program intended to improve balance in the elderly population by using simple board games. Hence, the author established the research question of whether is this technique effective in the elderly population in terms of its effects on cognition and balance to prevent falls. This study will provide insight to the clinician on whether board games-based cognitive training improves balance and prevents fall risk in the elderly population.

Eligibility Criteria:
Inclusion Criteria:

* Males and Female participants aged 60 years or older.
* Score of 26 or more on the Mini-Mental State Examination (MMSE)
* At least one self-reported fall within the last 2 years or (BBS) score less than 52 and more than 41.
* Subjects who are willing to commit to the time commitments required by the program.

Exclusion Criteria:

* Those who will not meet the inclusion criteria.
* Presence of any physical limitation that may limit hand movement.
* Presence of a severe walking or balance impairment For Example; (Amputation, or Fracture at that time.)
* Self-reported presence of vertigo
* Any visual disease
* Currently using psychotropic medications.
* Presence of any neurological disorder
The Effects of Cilnidipine on Metabolic Syndrome Improvement

Abnormalities of glucose, insulin and lipoprotein metabolism are common in patients with hypertension, and these metabolic abnormalities are reported to be related to insulin resistance. Therefore, whenever treating such patients, antihypertensive agents that may have the added effect of improving insulin resistance should be selected. CinalongTM (Cilnidipine) is expected to improve metabolic syndrome as well as insulin resistance by its dual effects on L and N-type calcium (Ca) channels. In this study, the researchers investigate the effects of CinalongTM on insulin resistance and other metabolic related factors.

* Multi-center, randomized, prospective, double blind, active control, parallel study
* Superiority study (Treatment group - Cilnidipine/Control group - Nifedipine)
* Measure the effects of Cinalong(TM) after 3 month and 12 month-application

Eligibility Criteria:
Inclusion Criteria:

1. Men or women, 30-65 years of age having essential hypertension with metabolic syndrome
2. At Screening and Visit 1, blood pressure should be: sitting systolic blood pressure (SiSBP) \>=140 mmHg or sitting diastolic blood pressure (SiDBP)\>= 90 mmHg and two or more of the following criteria should apply.

   * Abdominal obesity: waist circumference \>= 90 cm in men and \>= 80 cm in women
   * Hypertriglyceridemia:. \>=150 mg/dl (1.695 mmol/l)
   * Low HDL cholesterol: \< 40 mg/dl (1.036 mmol/l) in men and \< 50 mg/dl (1.295 mmol/l) in women
   * High fasting glucose: \>= 110 mg/dl (6.1 mmol/l)

Exclusion Criteria:

1. Secondary hypertension
2. Malignant hypertension
A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method

The goal of this project is to develop a new noninvasive ultrasound based technique, called vibro-acoustic analysis (VAA), for evaluation of infant bone health with particular application in assessment of bone health in premature infants who are at risk for bone disease.

With increased survival of very low birth weight and premature infants over recent decades, bone assessment has become especially vital with the recognition of metabolic bone disease (MBD) of prematurity. Bone assessment became especially vital during last decades with the growing emphasis on metabolic bone disease of prematurity and low-birth-weight infants. Statistics shows that up to 50% of low birth weight and preterm newborns are likely to develop metabolic bone disease. Currently, no screening test has been shown to provide both sensitive and specific evidence of developing MBD over the first several weeks of life in the premature infants. Therefore, there is a need for a non-invasive tool for evaluation of infant bone health. This study will be conducted on premature infants at risk for MBD at multiple time points during their growth, with full term infants as controls. vibro-acoustic analysis (VAA) measurements will be done on the tibia. VAA measurements for the premature infants will be compared to those of full term infants. Performance of VAA in identifying osteopenia and its ability to monitor the response to treatment will be evaluated. The investigators will use an ultrasound system that has been used in the pilot study and employ a transducer with a smaller footprint for pediatric application.

Eligibility Criteria:
Inclusion Criteria:

* Full term newborns, approximately equal number of male and female newborn, age \<28 days.
* Preterm infants, approximately equal number of male and female preterm infants with gestational age at birth \<37 weeks or birth weight \<1500 grams.

Exclusion Criteria:

* Infants currently requiring continuous cardiovascular medication infusions, including but not limited to, dopamine, epinephrine, milrinone, and dobutamine (may have received these medications in the past.
* Infants with major congenital anomalies that may affect bone health or structure.
* For full term infants, infants with a history of intrauterine growth restriction or who are small for gestational age (\<10th percentile for weight) at birth.
Anticipatory & Preventive Team Care (APTCare): At Risk Patients of Family Health Networks

The University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of preventive care for frail patients at risk of functional decline. At risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse practitioners and a pharmacist. In collaboration with the family physician, they develop an individualized care plan, a treatment and management road plan, for each patient, which they implement over the study period of one approximately year. The objective of the study is to compare the effectiveness of the model of care that includes the nurse practitioners and pharmacist against standard care in preventing functional decline, to determine the acceptability of this model of care to patients, their caregivers and the medical team, and to evaluate the cost implication of the program.


Eligibility Criteria:
Inclusion Criteria:

* 50 years and over
* 'At Risk' by having one or more of the following: a. Visits to emergency dept within the past 6 months; b. Admission to hospital for a medical problem in past 6 months; c. High service use profiles; d. Polypharmacy; e. Other high risk factors
* Capable of giving informed consent
* Able to use the Care Companion technology

Exclusion Criteria:

* Cognitive impairment such that they cannot give informed consent
* Unable or unwilling to use the telehomecare equipment
* Unlikely to tolerate the intensive intervention
* Language or cultural barriers
* Being acutely ill or having an unstable condition on entry to the study
High-density EEG in Neurological Disorders

The purpose of the study is to use a new method of high-density electroencephalogram (HD-EEG) recording to map brain areas important for movement, sensation, language, emotion, and cognition.

This study will measure brain waves using high-density EEG. Participants will be asked wear a cap with electrodes attached to it. During the recording, participants may be asked to rest, sleep, or complete a task. The tasks involve viewing pictures, answering questions, speaking, or moving an arm or leg. Recordings generally last between 60-120 minutes.\*

Eligibility Criteria:
Inclusion Criteria:

* Able to perform the tasks
* Able to give own consent

Exclusion Criteria:

* Any neurologic or psychiatric diagnosis such as stroke, tumor, or psychosis judged to interfere with high-density EEG.
Absorption of Peptides, Fluid, and Electrolytes in Patients With an Ileostomy

Clinical trial, active comparator, cross over, randomised. In total, 12 adults with an ileostomy will be randomised to a sequential 4 weeks intervention with different qualities and sources of protein wish 2-week washout periods. Primary outcome: Ileostomy output.

Patients with an ileostomy may be dehydrated and have nutritional deficiencies secondary to malabsorption of fluid, electrolytes, and nutrients. In this randomised, double blinded, crossover intervention study we aim to investigate how different protein sources affect intestinal absorption in patients with an ileostomy and intestinal insufficiency. Three oral solutions with different protein sources (hydrolysed whey, whey, and casein) will be administered in three different four-week intervention periods. The results will facilitate improved counselling and treatment of patients with an ileostomy.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old), male or female patients with an ileostomy and intestinal insufficiency
* Episodical or chronic sodium depletion defined by two urine samples with sodium levels ≤ 20 mmol/L, sampled with at least 28 days apart
* Six months or more after most recent bowel surgery
* If inflammatory bowel disease, no clinical signs of activity (any treatment allowed except systemic steroids \> 10 mg/day)

Exclusion Criteria:

* Parenteral nutrition or intravenous fluid support ≥ 4000 mL/month
* Ongoing infection (C-reactive protein above 8 mg/L or core temperature \>38.0°C)
* Self-reported intolerance to dairy products, including lactose intolerance
* Inability to understand Danish or the trial procedures
* Known or anticipated pregnancy
* Known severe renal insufficiency (eGFR \< 20 mL/min)
* Known diabetes mellitus (HbA1c ≥ 48 mmol/mol (6.5%))
* Pacemaker, cochlear implants, or other electrical implants excludes the participants from BIA-measurements and measurements of GITT with 3D-Transit capsules, but not the remaining investigations
* Known intestinal stenosis or parastomal hernia excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
* Abdominal diameter \> 140 cm, or planned MR scan four weeks following participation excludes measurements of GITT with 3D-Transit capsules, but not the remaining investigations
Serum Potassium as a Predictor of Clinical Outcomes in an Older Patient Cohort With Chronic Postsurgical Pain

Perioperative serum potassium in patients over 65 impacts recovery, quality of life and physical functioning. While perioperative serum potassium is an important preoperative risk factor for poor surgical outcomes in older adults, the relationship between perioperative serum potassium and postsurgical pain in this population has not been investigated. The investigators hypothesized that preoperative serum potassium would be associated with greater odds of postsurgical chronic pain.

This study is a secondary interim analysis of 'Perioperative Database of Chinese Elderly Patients,' an ongoing prospective observational cohort study that began in 2020 at the muti-center in China with the primary aim of complications in older adults before and after surgery. The investigators described the demographics, comorbidities, and assessment scores as n (percentage) or mean (SD), as appropriate. Unadjusted bivariate analyses included t-test or χ2 test to compare differences between minimal pain and intrusive pain at 3 months after surgery based on demographics, preoperative status, baseline pain status and perioperative serum potassium. The investigators then created a logistic regression model with the outcome of persistent pain at 3 months after surgery and serum potassiumas the main predictor, adjusting for baseline pain, surgery type and surgery part and frailty status based on the hypothesis and association. The investigators also tested for the interaction between baseline pain and serum potassiumas.

Eligibility Criteria:
Inclusion Criteria:

* Geriatric surgical patients ≥65 years old
* Diagnosis of Chronic postsurgical pain (CPSP) CPSP was made based on the guidelines of the International Society for Pain (CPSP: ICD-11) as follows: Chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. The pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). Other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. Dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain.

Exclusion Criteria:

* Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery.
* patients who did not agree to participate in the study were excluded in all groups.
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma

The purpose of this trial is to study the benefits of giving chemotherapy to women after they have had surgical resection of their primary disease and have no evidence of disease remaining(known as adjuvant therapy). The major objective of this study is to determine the progression free survival. The goal is to prevent relapse or recurrence of their uterine leiomyosarcoma.

Patients with a diagnosis of early-stage uterine leiomyosarcoma have a 70% chance of relapse or recurrence of their disease. Patients enrolled in this trial will receive 4 cycles of gemcitabine and docetaxel followed by 4 cycles of adriamycin. Following completion of chemotherapy, they will be have repeat imaging at regular intervals to monitor for disease recurrence along with periodic clinical evaluations.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* high risk uterine LMS, FIGO stage I or II
* pathology review of LMS high grade and /or mitotic rate greater than or equal to 5 mitoses/10 hpf
* no longer than 12 weeks from surgical resection of cancer
* no evidence of residual disease
* ECOG 0 or 1
* ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000
* creatinine ≤ 1.5 x institutional upper limits of normal
* adequate liver function
* neuropathy (sensory and motor) ≤ CTC grade 1
* negative pregnancy test
* signed consent

Exclusion Criteria:

* patients with other invasive malignancies
* prior therapy with gemcitabine or docetaxel or doxorubicin
* hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
* women who are breast feeding
* cardiac ejection fraction \<50%
* prior pelvic irradiation
* treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents