cyrilzakka/clinical-trials huggingface dataset:
A Compassionate-focused Intervention for Older People with Bipolar Disorder

The aim of this study is to determine whether it is feasible to deliver a 9-session compassionate-focused therapy for older people with bipolar disorder. Participants will be asked to complete baseline measures and at post-intervention follow-up (12 weeks and 24 weeks) to understand any potential clinical benefits of the therapy.

The present study will evaluate the feasibility of a compassionate-focused intervention targeting rumination that is specifically tailored for older people with bipolar disorder. In addition to evaluating its feasibility, the study will also investigate whether there are any clinical benefits associated with the intervention, namely, any potential reductions in negative rumination and feelings of guilt and shame. To date, there has been no research evaluating the feasibility of this type of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60 years and above.
* Have a nominated healthcare professional (i.e. GP/Care Coordinator)
* Meet the criteria for a diagnosis of bipolar disorder I or II according to the MINI.
* Score of \>57 on Ruminative Response Scale (RRS)
* Be able to provide written informed consent.
* Be able to speak sufficient English to engage in the assessments and intervention.

Exclusion Criteria:

* Currently in an episode of mania or hypomania according to the MINI.
* Experiencing 'severe depression' according to the Hamilton Depression Rating Scale, which equates to a score of over 24.
* MoCA score of \<22 to exclude for moderate and severe cognitive impairment.
* Currently receiving psychological therapy.
Evaluation of Global Smart Drinking Goals Initiative

This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.

This study will evaluate effects of a multi-component, population-level intervention on alcohol use and related harms in six intervention cities relative to six matched comparison cities. The trial is expected to expand to nine intervention and nine comparison cities in 2018. Intervention components include screening and brief interventions by health providers, other evidence-based interventions (e.g., enforcement of drink-driving or underage drinking laws), and novel or partially tested interventions that warrant further evaluation. Key outcomes of interest include alcohol-related harms such as alcohol-related motor vehicle crashes and fatalities, heavy/binge drinking, underage drinking, and drinking and driving.

Multiple years of pre- and post-intervention survey data will be collected from cross-sectional samples of adults and youth in each city to assess intervention effects on harmful alcohol use. Multiple years of archival data will also be collected from each city to assess intervention effects on alcohol-related harms such as motor vehicle crashes and fatalities, violence and unintentional injuries. Multi-level analyses will be conducted with data for the total sample of 18 cities and for each pair of cities to determine whether the overall goal of reducing harmful alcohol use by at least 10% is achieved.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years old
* Parental consent is be required if under 18 years old

Exclusion Criteria:

* Institutionalized individuals
Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT

To investigate the diagnostic value of ultralow-dose computed tomography in the detection of pulmonary nodules and lung parenchym alterations (e.g. emphysema) compared to standard-dose-CT.


Eligibility Criteria:
Inclusion Criteria:

* planned normal dose-CT by clinical indication at our institution
* obtained informed consent

Exclusion Criteria:

* planned lowdose-CT by clinical indication at institution
* no informed consent obtained
* age \< 18 years
* pregnancy
The Effect of Ketone Ester Supplementation and Ketogenic Diet on Brain Plasticity in Overweight/Obese Adults

This project comprises an initial crossover placebo-controlled neurophysiological study to ascertain the effect of acute ketone ester ingestion on motor cortex plasticity, followed by a second 2-week intervention study aimed to compare the effect of a ketogenic diet versus ketone ester supplementation on motor cortex plasticity, resting brain function and structure, and metabolic and neuroendocrine responses.

The study initially makes a bold attempt to explore whether the ketone supplementation would induce improvements in the overweight/ obese population's brain health via altering motor cortex plasticity, brain function and structure, and metabolic and neuroendocrine pathways. The study's aims include:

* assessing changes in brain plasticity associated with excessive body weight and/or obesity.
* evaluating the potential of ketone monoester supplementation in enhancing brain plasticity.
* evaluating the potential of ketone monoester supplementation in correcting impaired brain plasticity due to excessive body weight.
* evaluating the impact of short-term ketogenic dieting and ketone monoester supplementation on brain plasticity.
* investigating structural and functional brain adaptations to short-term ketogenic dieting and ketone supplementation.
* assessing the relationship between changes in brain plasticity and the brain's structural and functional adaptations and changes in circulating levels of brain-derived neurotrophic factors and key central acting hormones (i.e., insulin and leptin) due to ketogenic dieting and ketone monoester supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \> 25 and \< 35 kg/m2 (overweight/obese group) or BMI \> 18.5 and \< 25 kg/m2 (healthy weight group);
* Right-handed.

Exclusion Criteria:

* Presenting any established counter indication for transcranial magnetic stimulation;
* Currently taking any medication affecting the central or the peripheral nervous system;
* Suffering from any psychiatric, neurologic, cardiovascular, or metabolic disease, including type 1 and type 2 diabetes mellitus;
* Undertaking surgery in the past six months;
* Engaged in resistance training.
* Pregnancy;
* Breastfeeding;
* Being amenorrhea.
Real-world Incidence Proportion of Hepatic Toxicity and All Adverse Drug Reactions (ADRs) in Japanese Patients Receiving Daclatasvir (DCV) Trio Therapy

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan


Eligibility Criteria:
Inclusion Criteria:

* Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration

Exclusion Criteria:

* Patients who use the DCV Trio off label
Feasibility of Delivering an Avatar Life-review Intervention to Support Patients With Active Cancer

The objective of the study is to determine the feasibility and acceptability of an integrated art and technology, storytelling, life review platform for patients with active cancer. The VoicingHan project is an avatar storytelling platform designed for patients with advanced cancer receiving palliative care at Virginia Commonwealth University's Massey Cancer Center. VoicingHan supports terminally ill patients by using oral storytelling as an artistic medium to facilitate patients' interactive performances. Movement-based, creative expression has been shown to reduce stress and depression. By projecting movement-based actions onto an avatar, this can serve as a tool to express emotional distress, address satisfaction with care, and view cancer in a different light.

Life reviews have been used in palliative care to help individuals integrate memories into a meaningful whole, providing a balanced view of the past, present and future. Life review is also an evaluative process, enabling participants to examine how memories contribute to the meaning of their life.

VoicingHan, the software program that will be used in this study, provides an illusion that the Avatar is speaking, allowing users to observe their stories in real time, potentially encouraging deeper reflection and memory retrieval. The technology uses motion capture (MoCap) to translate human movement into a digital platform. MoCap offers several advantages: lightweight, sensitive to minute movement, and user-friendly.

Patients will select avatars from different age groups during their sessions, allowing them to retrieve specific, positive memories of different lifetime periods and facilitating a more candid autobiographical memory. Creative expression may serve as a vehicle for patients with a life limiting illness in finding purpose and creating a sense of meaning. The integration of art and technology into a storytelling, life-review platform through means of engaging the physical, psychological, and spiritual domains will support patients to contemplate their own mortality.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older
* Patient participants must have metastatic or locally recurrent cancer
* Participants must be able to understand English
* Participants must be ambulatory
* Ability and willingness to sign a written informed consent document

Exclusion Criteria:

* Participants who cannot understand written or spoken English
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients

To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical Center Hospital. Retrospective data will be collected regarding morbidly obese patients who have undergone cesarean section and patients will be recruited to have the intervention (negative-pressure wound therapy) applied and outcomes will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean section at Albany Medical Center Hospital
* Current BMI greater than or equal to 40

Exclusion Criteria:

* Current BMI less than 40
* current skin or soft tissue infection
* skin or soft tissue disorder
* allergy to silver
Hyaluronic Acid Effect on Xenogenic Bone Healing

The aim of this study is to test the hyaluronic acid hydrogel impact on the healing acceleration of xenogenic bone substitutes used in ridge preservation.

Following tooth extraction, bone particles are mixed with the hyaluronic acid gel and grafted in the tooth socket. at the implant placement phase, a cone beam computer assisted tomography file is recorded in order to compare it with the baseline and a biopsy to evaluate the histological consequences.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of tooth extraction and willing to receive dental implants in the extraction site
* Presence of two mono radicular teeth in need of extraction

Exclusion Criteria:

* Patients with systemic diseases
* Patients under 8 years and above 60 years.
* Presence of endodontic or periodontal lesion in the extraction sites
Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Children and adolescents between the ages of 10-16 years. Subjects cannot turn 17 years and 11 months before the end of treatment (52 weeks) - Diagnosis of type 2 diabetes mellitus and treated for at least 30 days with: diet and exercise alone, diet and exercise in combination with metformin monotherapy, diet and exercise in combination with metformin and a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin, diet and exercise in combination with a stable (Stable is defined as basal insulin adjustments up to 15%) dose of basal insulin - HbA1c: 7.0-11% (inclusive) if diet and exercise treated or 6.5-11% (inclusive) if treated with metformin as monotherapy, basal insulin as monotherapy or metformin and basal insulin in combination - Body mass index (BMI) above 85% percentile of the general age and gender matched population Exclusion Criteria: - Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin and/or basal insulin within 90 days prior to screening - Recurrent severe hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated above 99th percentile for age and gender in children - Known or suspected abuse of alcohol or drugs/narcotics
Identification of Diagnostic And Prognostic Biomarkers From Amyotrophic Lateral Sclerosis (ALS) Skin and Adipose Samples

The purpose of the project is to obtain skin and adipose tissue samples from patients with ALS to develop new diagnostic and prognostic markers of the disease. These samples will be obtained when percutaneous endoscopic gastrostomy (PEG) is performed as part of their standard of care. Skin and adipose tissue samples will also be obtained from disease control subjects who require a PEG as part of their standard of care.

Subjects who are undergoing a percutaneous endoscopic gastrostomy (PEG) tube insertion as part of their standard of care will be asked if a skin and adipose sample may be collected for research during the procedure. After a participant has signed the informed consent, the sub-investigator from the Department of Gastroenterology will collect a skin and adipose sample during the procedure. Individuals with a diagnosis of definite ALS and disease controls (i.e. stroke, head and neck cancer, spinal cord injury, etc.) will be included in this study.

The coded skin and adipose sample will be taken to the Carolinas Neuromuscular/ALS Research Laboratory in the Cannon Research Center for processing. The skin and adipose will be separated from each other and divided into halves. Each half of skin and adipose will be submerged in preservative and either shipped to ALS-TDI or retained at -80°C in the Carolinas Neuromuscular/ALS Research Laboratory. The research staff at the Carolinas Neuromuscular/ALS-MDA Center will be responsible for shipping the sample to the ALS-TDI for either RNA isolation using the Qiagen RNAEasy kit (Qiagen) or for purification of protein. Subsequently, gene expression profiling on Affymetrix Genechips or Mass Spec based proteomics on a Thermo Orbitrap LC-MS/MS instrument will be performed, respectively. The discovery effort (if all participants are working at capacity) should not take more than 12 months.

In addition to the above procedures, a member of the study team will review the medical chart to obtain additional information on the participant's medical and family history. For ALS patients, past ALSFRS-R scores or FVC scores will be provided to the "ALS-TDI Skin and Adipose Biomarker Study" to enhance the usefulness of the information for research.

Samples will not be stored with any patient identifiers. Samples will be retained and continued to be studied as new techniques become available. Data from the study may be published in scientific journals. Publications will not include any patient identifiers.

Eligibility Criteria:
Inclusion Criteria:

* for ALS patients, subjects must be diagnosed with definite ALS according to the El Escorial Criteria (EEC)
* all subjects must be diagnosed with a condition requiring PEG (percutaneous endoscopic gastrostomy) tube insertion
* subjects must be older than 18 years of age

Exclusion Criteria:

* children 18 years old and younger
Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).

120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.


Eligibility Criteria:
Inclusion Criteria:

* distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
* \>18 years and \<65 years
* address in Oslo municipality

Exclusion Criteria:

* multitrauma
* previous fracture same wrist
* multiple injuries on the same side
* not competent to consent
* dementia / nursing home patient
* substance abuse
* foreign / tourists
* median nerve compression requiring emergency surgery
* pathological fracture
* open fracture
* congenital malformations that make it difficult to interpret data
* patient does not want surgical treatment
* not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
* more than 10 days after injury
Anesthetics and Auditory, Visceral, and Heat Evoked Potentials

The aim of the present study is to investigate and quantify the influence of commonly used anesthetics on auditory and pain evoked potentials.

During surgery patients are exposed to different auditory and sensory stimuli. In this study we investigate the influence of different anesthetics to alertness and nociception. In addition to auditory stimuli (AEP as a measure of sedation), Contact Heat Evoked Potential Stimuli (CHEPS), and esophageal evoked potentials from the lower 1/3 of the esophagus are measured to quantify the effects of anesthetics. 60 Volunteers are enrolled into this study. For each drug, three different levels are measured:

* level 1 no medication
* level 2 low dose of medication
* level 3 light sedation dose (volunteer responds to command)

Four drugs are measured in the study:

propofol, sevoflurane, S-ketamine and remifentanil.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

* drugs that effect the central nervous system
* neurological or psychiatric diseases
* contraindications against propofol, sevoflurane, S-ketamine or remifentanil
* any damages or loss of hearing
* heartburn or any stomach diseases
CYP2D6 Genotype on the Clinical Effect of Tamoxifen

The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA).


Eligibility Criteria:
Inclusion Criteria:

* The patient must sign the informed consent form.
* The patient must sign the informed consent of genotype screening test.
* The patient must be between 18 years old and 45 years old who can make a decision independently.
* Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.(The type of mastectomy performed, number of axillary nodes removed, number of axillary nodes found positive, and tumor size must be included on the CRFs. For patients who have more than one discrete tumor masses should be measured and reported on the CRFs.)
* Patients must be within 3 months after the last cycle of chemotherapy.
* Patients must have the history of normal menstruation prior to the start of chemotherapy.
* Stage I, II or III
* Woman, less than or equal to 45 years of age
* The test result of the estrogen receptor is positive.
* WHO performance status 0, 1 or 2.
* Patients who were treated with cytotoxic chemotherapy in pre or post surgery. Permissible prior chemotherapy; currently locally available and approved standard chemotherapy in the adjuvant or neoadjuvant setting: e.g., AC(Doxorubicin/cyclophosphamide) followed by taxane, AC(Doxorubicin/cyclophosphamide), TA(Docetaxel/ Doxorubicin), FAC(5-fluorouracil/ doxorubicin / cyclophosphamide) or others.
* Adequate hematological function defined by hemoglobin 10g/dl, neutrophil count 1.5 X 10 9/L and platelets 100 X 10 9/L.
* Adequate hepatic function defined by AST and ALT 2.5 X upper limit of normal. Alkaline phosphatase 5 X upper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine \< 175 mmol/L.

Exclusion Criteria:

* The test result of the estrogen receptor is negative or unknown.
* Patients with the history of hysterectomy or oophorectomy.
* Sarcomas or squamous cell carcinomas of the breast are not eligible.
* Patients with malignancies(other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell/squamous cell carcinoma of the skin.
* Investigational drugs given within the previous 4 weeks.
* Patients with thrombocytopenia (platelets \< 100 X 10 9/L or on anti-coagulant therapy(contra-indicated due to risk of bleeding with i.m. injection of Zoladex).
* Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior chemotherapy.
* Patients who are pregnant or lactating are ineligible.
Parotid-sparing IMRT for Nasopharyngeal Cancer

In the treatment of nasopharyngeal cancers, to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

The purpose of this study was to determine the feasibility in delivering induction chemotherapy and concomitant chemotherapy with IMRT in the treatment of locally advanced nasopharyngeal cancers and to determine the incidence of high grade (≥G2) subjective xerostomia at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* nasopharyngeal cancers

Exclusion Criteria:

* Patients \<16 years old or with a previous malignancy other than non-melanomatous skin cancer were excluded