cyrilzakka/clinical-trials huggingface dataset:
Maudsley Model of Anorexia Nervosa Treatment for Adolescents and Young Adults (MANTR-a)

The aim of this study is to test effectiveness of a new treatment program for adolescents and young adults within the age of 14-21 suffering from AN (MANTR-a) compared to treatment as usual (TAU).

Anorexia nervosa (AN) is a serious mental illness which leads untreated to aggravation of symptomatology and chronification. Among all mental illnesses, AN has the highest mortality rate, which is about 5.1 per 1000 people per year. High drop-out rates (up to 40%) or small treatment motivation constrains treatment success. Since the onset of AN is mainly in adolescence, it is important to start with therapy as early as possible and establish an effective single-setting treatment program for this age group to prevent chronification.

MANTR-a (Maudsley model of anorexia nervosa treatment for adolescents) is an innovative, theory-based, tailored treatment program which combines a cognitive behavioural approach with motivational interviewing. The main focus of the treatment program is the transformation maintaining factors of AN, like personality aspects, pro-anorexic beliefs, emotion regulation strategies, thinking styles and obstructive behaviour from caregivers.

The aim of this study is the examination ot the effectiveness of the MANTR-a treatment program for adolescents and young adults. Therefore we compare MANTR-a (intervention group) with treatment as usual (control group). Assessments will be conducted before treatment (T0, baseline), after six months (T1), after 12 months (T2) and after 18 months (T3, follow-up) via questionnaires, interviews and neuropsychological measurements. Process evaluation takes place after every session. Each group consists of female adolescents and young adults within the age of 14-21 suffering from AN (ICD-10: F50.0, F50.1), resulting in an overall sample size of 100.

The long-term goal of the study is to provide an evidence-based outpatient treatment for children and adolescents with AN in order to prevent a chronic course of the disease.

Eligibility Criteria:
Inclusion Criteria:

* ICD-10 diagnosis of anorexia nervosa (F50.0) or atypical anorexia nervosa (F50.1).

Exclusion Criteria:

* life-threatening AN requiring immediate inpatient treatment as defined by NICE (2017)
* insufficient cognitive ability
* insufficient knowledge of German language to understand the treatment
* severe mental or physical illness that needs treatment on its own (e.g. psychosis)
* substance abuse
* pregnancy
A Study of Tirzepatide (LY3298176) in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Overweight (SURMOUNT-CN)

This is a study of tirzepatide in Chinese participants without Type 2 Diabetes who have obesity or overweight.

The main purpose is to learn more about how tirzepatide affects body weight.


Eligibility Criteria:
Inclusion Criteria:

* Have a BMI ≥28 kilogram/square meter (kg/m²), or ≥24 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
* Have a history of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Have Diabetes Mellitus
* Have a self-reported change in body weight \>5 kg within 3 months prior to screening
* Have obesity induced by other endocrinological disorders
* Have had a history of chronic or acute pancreatitis
* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years
* Have any lifetime history of a suicide attempt
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
Progression of Sub-Clinical Atherosclerosis

To determine the rate of progression of sub-clinical cardiovascular disease as measured in carotid intimal medial thickness over a period of 8 to 10 years.

BACKGROUND:

Strong associations exist between cardiovascular events and increased carotid artery wall intima-media thickness (IMT) as measured non-invasively by carotid ultrasound. Carotid IMT is accepted as a surrogate marker of sub-clinical cardiovascular disease.The study will determine the rate of progression of sub-clinical cardiovascular disease (change in IMT) over a period of 8 to 10 years.

DESIGN NARRATIVE:

The study will determine the rate of progression of sub-clinical cardiovascular disease (change in intimal medial thickness {IMT}) over a period of 8 to 10 years. Imaging and IMT measurements of approximately 2800 to 3000 members of the Framingham Offspring cohort having had baseline IMT measurements at their 1995-98 clinic visit will be repeated in 2005-2007. The principal aims of the project are to study the primary hypotheses that: 1. Interim exposure to traditional cardiovascular risk factors measured over 50 years is positively associated with the progression rate of carotid IMT. 2. Baseline carotid IMT and cumulative exposure to cardiovascular risk factors 20 years before the baseline visit are a better predictor of progression of sub-clinical disease after 8 to 10 years than the interim exposure to risk factors. 3. Novel risk factors such as C-reactive protein and homocysteine affect progression of carotid atherosclerosis more than traditional risk factors. This study will add a phenotypic marker of site-specific change in sub-clinical cardiovascular disease to the Framingham Study database. This complements ongoing research on the progression of sub-clinical cardiovascular disease and its associations with family history of premature cardiovascular events and genomic markers

Eligibility Criteria:
No eligibility criteria
Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids

The primary objective of this study is to investigate the uptake/gastrointestinal absorption of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and Cmax, as well as any adverse events are recorded.

As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure cholesterol and related lipids.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-65
* healthy, good physical condition

Exclusion Criteria:

* Pregnancy or breast-feeding
* Gastrointestinal conditions
* Acute or chronic liver disease
* Acute or chronic kidney disease
* Acute or chronic cardiovascular disease
* Allergy or Intolerance to gluten
* Allergy or Intolerance to fish or shellfish
* Use of medications (e.g., anticoagulants/ blood thinners such as warfarin; blood lipid-lowering agents such as statins)
* Use of Fish oil supplements
* Use of any form of nicotine or tobacco
* Alcohol and substance abuse history
* Participation in another investigational study
After Discharge Management of Low Income Frail Elderly

The purpose of this study is to determine whether comprehensive post-hospitalization interdisciplinary care management can be an effective care delivery model to improve outcomes in low-income frail elderly.

This randomized trial will test the effectiveness of improved clinical practice through comprehensive care management in elderly patients with chronic illness and functional impairment discharged from an acute care hospital. For the intervention group, patient care will be coordinated by a nurse care manager who will perform a comprehensive in home assessment and provide patient education and self management support. The care manager will work with an interdisciplinary team (IT) to develop and implement a plan of care. Evidence based care plans will be implemented in collaboration with the patient, the primary care physician (PCP), the local Area Agency on Aging (AAoA), and other community social agencies. The care manager will provide frequent patient follow up across all providers to ensure integration of medical and social issues. Control patients will be referred to the local AAoA with no IT follow up. Although control patients will receive, through the AAoA, referrals for care and psychosocial support, the absence of a care manager and IT will, we expect, result in functional decline, lower quality of life, and higher health care costs.

The intervention (n=265) and control (n=265) groups will be compared at 1 year on a profile of health and well being using a multiple endpoint global hypothesis testing strategy. The global measure will be comprised of the following 5 domains: function, institutionalization, quality of life, quality of medical management, and quality of self management. Priority populations identified by AHRQ who are targeted in this study include the elderly, patients with chronic illnesses, low income (dual eligible), and patients with disabilities. This study also includes minorities, women, and patients who live in the inner city. Future economic analyses of benefits (for which alternative funding is currently being sought) will inform policy makers about funding care management in AHRQ priority populations.

Eligibility Criteria:
Inclusion Criteria:

* \> 65 years old
* Confirmed or probable dual eligible
* Have at least one chronic illness (chronic obstructive pulmonary disease \[COPD\], diabetes, stroke/atrial fibrillation, ischemic heart disease, hypertension, congestive heart failure \[CHF\], osteoporosis, osteoarthritis) and at least 1 impaired activity of daily living (ADL) 11 or 2 impaired instrumental activities of daily living (IADLs)
* Be discharged home or to a skilled nursing facility (or acute rehabilitation) for a maximum of 8 weeks before being discharged to home

Exclusion Criteria:

* Enrolled in this health system's care management program
* Chemically dependent
* Those with a Mental Status Questionnaire score \> 5
* Diagnosed psychosis
* Dialysis
* Terminal diagnosis/hospice
The Effect of Neuromuscular Training Program in Futsal Players

Despite its popularity, there has been limited research on futsal, possibly due to the lack of financial interest in the game, and most of these research articles have addressed game analysis and/or physiological demands on players during match playing and training. For this reason, our aim is to evaluate the effectiveness of an 8-week neuromuscular training program on performance, physical fitness and injury risk in university futsal players.

Futsal, known as five-on-five indoor soccer, is a team sport officially authorized by FIFA and is becoming more and more popular all over the world. Futsal is among the 10 risky sports with the highest traumatic injuries. Futsal-induced traumas cause undesirable consequences such as accelerated osteoarthritis, different types of injuries in the muscle-tendon region, ligament injuries, cartilage injuries, loss of physical activity and higher repetitive injuries. Activities that result in a higher level of fitness can significantly reduce the likelihood of injury and serve as a useful tool for athletes' professional careers and post-career periods.

Neuromuscular control, which is considered a critical component of motor skills, is defined as the ability to keep the body's center of gravity within the base of support. It can be categorized as static or dynamic balance and may be the most modifiable risk factor for the prevention of knee injuries. Interventions targeting neuromuscular control include dynamic lower extremity alignment during landing from a jump, shock absorption, muscle recruitment patterns; and gains improvement in balance through plyometric, strengthening, balancing, endurance and stability exercises. Neuromuscular training program can improve neuromuscular control, which can lead to improvement in balance and joint stability.

In our study, it was aimed to evaluate the effectiveness of an 8-week neuromuscular training program on performance, physical fitness and injury risk in university futsal players.

Eligibility Criteria:
Inclusion Criteria:

* Playing in Istanbul Medipol University futsal team
* 2 days a week, 2 hours training for futsal or 1 game a week and 2 hours a week, 2 days a week

Exclusion Criteria:

* History of lower extremity injury or surgery within 6 months prior to the test
* Injury three months before the study,
* Failure to heal or complete rehabilitation of previous injury,
* Physical or mental conditions that prevent them from participating in technical and tactical futsal training and/or experimental training programs
* Two or more missed training sessions
Natural History of Levodopa-Induced Dyskinesia (LID)

Levodopa is the main drug treatment for Parkinson's disease. Levodopa can cause unwanted and uncontrolled movements called dyskinesias (LID). The severity of these movements can range from subtle to extremely debilitating. These movements may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the occurrence rate of LID range from 12 % to 100% after one year of levodopa treatment. These estimates used reporting mechanisms such as self-report and doctor-reported. These reporting mechanisms are not reliable. We will use an objective measure of dyskinesia in the first 5 years of treatment for Parkinson's disease. The purpose of this protocol is to use an objective measure to estimate dyskinesia onset.

Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. Current estimates of the prevalence of LID widely range from 12 % to 100% affected after one year. The purpose of this study is to estimate the median onset time of levodopa induced dyskinesia in newly treated Parkinson's disease patients. All participants will complete seven overnight visits at the OCTRI Inpatient unit over 5 years. During the next day, participants will complete a mental task while standing on a force plate for one minute every half hour until the end of the study. A levodopa IV infusion will occur from 0900 to 1100.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease
* At least 21 years of age
* Levodopa treatment that will be orally initiated no more than 1 month after the screening visit for the study.

Exclusion Criteria:

* Unable to stand for 1 minute intervals
* Sensory deficits in the feet
* Significant cognitive impairment
* Unstable medical or psychiatric conditions (including hallucinations)
* History of dopamine receptor blocking medications (Haldol, Orap, Zyprexa)
Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy with histology were performed within 7 days.The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity index (CDAI), respectively. The Mayo endoscopy score was evaluated. UC patients whose Mayo endoscopy score was 2 or 3 were divided into the active UC group.

CD patients whose CDAI \>150 were divided into the active CD group.

Eligibility Criteria:
Inclusion Criteria:

* Patients whom possible UC or Crohn disease was suspected

Exclusion Criteria:

* other autoimmune diseases
* acute or chronic renal failure
* chronic heart diseases
* liver cirrhosis
* cancer
* acute or chronic infections
* ischemic colitis
* infectious colitis
Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia

This study evaluates the addition of tobramycin inhalation treatment to standard intravenous therapy in the treatment of ventilator associated pneumonia.

Rationale: Approximately 9-27% of mechanically ventilated patients in the intensive care unit (ICU) develop ventilator-associated pneumonia (VAP). Patients in whom VAP develops have a higher mortality rate up to 50%, stay longer in the intensive care unit (ICU), and require more resources than those without the disease. Despite the availability of modern ICU care and modern antibiotics, the overall clinical cure rate after 72 hours of antibiotic treatment for VAP is only 40%. The cure rate for Pseudomonas aeruginosa is even lower. It is unclear why VAP cure rates are so low. The ATS guidelines recommend IV antibiotic treatment (IV AB), especially directed against gram-negative microorganisms. However, the relatively poor response rates seen with intravenous therapy of VAP and the emergence of MDR organisms makes new treatment options desirable. The ATS/IDSA VAP guidelines recommend that "adjunctive therapy with an inhaled aminoglycoside or polymyxin (colistin) for MDR Gram-negative pneumonia should be considered, especially in patients who are not improving". It is therefore necessary to investigate whether adjunctive therapy with inhalation Tobramycin could ameliorate prognosis. The recommendations by the Society of Infectious Diseases Pharmacists are similar.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation 48 hours or more
* New or progressive radiologic pulmonary infiltrate

Together with at least two of the following three criteria (\< 24 h):

* temperature \>38°C
* leukocytosis \>12,000/mm3 or leucopenia \<4,000/mm3
* purulent respiratory secretions

Exclusion Criteria:

* patients with allergy to tobramycin
* pregnancy
* expected to die within 72 hours after enrollment
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).


Eligibility Criteria:
Inclusion Criteria:

Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)

* Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Eastern Cooperative Oncology Group (ECOG) ≤2
* Life expectancy \> 1 year
* Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
* Prescribed a minimum of six cycles of platinum-based chemotherapy
* Adequate organ function as defined below:

  1. Hemoglobin \> 9 g/dL
  2. Leukocytes \>1,500/mcl
  3. Absolute Neutrophil Count \> 1,000/mcL
  4. Platelets \> 125,00/mcL
  5. total bilirubin Within normal institutional limits
  6. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal
  7. Serum creatinine \< 1.5 mg/dL.

Exclusion Criteria:

* Prior history of any cancer (other than non-melanoma skin cancer)
* Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
* Prior severe head injury
* Has a history of dementia or other neurodegenerative disorders
* Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
* Presence of known brain metastases
* Has an active infection requiring treatment
* Known immunosuppressive disease
* Has active systemic autoimmune diseases such as lupus
* Receipt of systemic immunosuppressive therapy
* Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
* Pregnant of breastfeeding.
Retrospective Comparative Study of Routine Lower Neck CT in the Staging and Diagnosis of Lung Cancer Across Two Cohorts

This is a study comparing routine inclusion of the lower neck in initial CT thorax in patients with suspected lung cancer to not including it. The study aims to assess whether such an intervention reduces the number of invasive investigations required to achieve a final diagnosis and clinical stage and whether it improves the detection of cervical lymph nodes involvement by lung cancer.

Two practices currently exist regarding the role of lower neck CT in patients with suspected lung cancer but with little evidence for either. Routine lower neck CT is potentially associated with benefits of higher detection of neck lymphadenopathy leading to better staging, less invasive procedure with positive implications for patients experience and care. The potential harms are delay in diagnosis due to false positive findings and radiation exposure. There is limited evidence in this area so this study will potentially provide evidence to inform health policy decisions based on the risk benefit balance.

This is a retrospective comparative study to assess the real-life impact of routine lower neck CT on the diagnostic and staging work up of patients with suspected lung cancer across two cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age \> 18 years
* Pathologically confirmed primary lung cancer
* Intrathoracic N2 and or N3 disease on CT defined as lymph node with short diameter \> 10 mm

Exclusion Criteria:

* None
Brief Group Psychotherapy for Anxiety and Depression

The present work aims to develop a randomized clinical trial with a sample of 100 patients diagnosed with anxiety and depression in primary care. All participants are tested by several self-reports related to emotional disorders in a repeated measures design, pre and post treatment. It is our aim this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment in Primary Care. In addition, emotional regulation will be assessed and examined as a key factor in the clinical improvement.


Eligibility Criteria:
Inclusion Criteria:

* Anxiety
* Depression

Exclusion Criteria:

* Severe mental disroders
* Drug abuse
* Suicidal ideation/severe depression