cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an On-Demand Humidifier on Neuromuscular Patients Requiring Mechanical Ventilation

Monocenter study to determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient's perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 of age; \< 85 years of age
2. Participants with a neuromuscular disorder who:

   1. Require 24 hour mechanical ventilation in some form through tracheostomy, mask or mouth piece
   2. Can be ambulatory for at least a few hours during the day while using a heat and moisture exchange device (HME) or no humidification
   3. Can part of the day use a heated pass-over humidification system while on their ventilator (overnight, for example).
3. Able to provide feedback/articulate via some form of communication
4. Patients using a Trilogy ventilator
5. Invasively ventilated patients that are willing to use a HME device on their way to participate in the study (from home to hospital).
6. Patients that are willing to participate and are able to consent and sign the informed consent form. (Patients with the functional capacity for medical decision-making).

Exclusion Criteria:

1. Clinically unstable, i.e.,

   1. Acute respiratory failure
   2. Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
   3. Uncontrolled cardiac ischemia or arrhythmias
   4. Any participant determined as inappropriate for the study by the Principal Investigator
2. Patients suffering from metastatic or terminal cancer
3. Patients lacking the functional capacity for medical decision-making.
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD).

This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine Research Institute (NHTMRI).

Study design: Randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

- 1. Age from 18-65 years. 2. Cases with NAFLD suspected by abdominal ultrasound or CT. 3. Negative viral hepatitis markers (Hepatitis B surface Antigen \&Hepatitis C virus Antibody).

4. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4\<14.6KPa). 7. Hepatic steatosis \> 5% with MRI-PDFF.

Exclusion Criteria:

* 1. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).

  2. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).

  3. Child-Pugh score \> 7. 4. Cirrhotic patients diagnosed by fibroScan (F4\>14.6KPa) 5. Calculated Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73m2. 6. Pregnancy. 7. Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003).

  8. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.
A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure

Heart failure is a common and serious condition. Despite rapid advancements in heart failure treatment, the prognosis remains severe. Smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme Q10 and selenium-may reduce the risk of complications associated with heart failure. The DANUTRIO-HF trial will investigate whether these supplements can make a difference for individuals with heart failure. The study will assign approximately 4,044 patients from across Denmark to either coenzyme Q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.

This investigator-initiated, pragmatic, registry-based, double-blinded, placebo-controlled, 2x2 factorial, individually randomized trial aims to evaluate the efficacy of daily intake of the nutritional supplements coenzyme Q10 versus placebo, and selenium versus placebo, in preventing heart failure hospitalizations and cardiovascular death in heart failure patients. The trial plans to randomize approximately 4,044 participants in an event-driven design. Participants will be identified through the Danish Administrative Health Registries, which will also serve as the primary source for data collection. Contact with potential participants will be made via the mandatory Danish electronic letter system. No scheduled in-person visits are required in the main study, and all study interventions will be mailed to participants.

A substudy involving up to 600 participants will assess the effects of coenzyme Q10 and selenium on functional capacity, treatment compliance, biochemical biomarkers, and cardiac function and structure. This group will attend two in-person visits for additional evaluations, including echocardiography, blood sampling, and a 6-minute walk test at baseline and at the 1-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged ≥ 18 years.
* Registered with a heart failure diagnosis (ICD-10: I50) as a primary discharge diagnosis in The Danish National Patient Registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after HF diagnosis.
* Informed consent form has been signed and dated.

Exclusion Criteria:

* Use of vitamin K-antagonist
* Registered with a cancer diagnosis (C00-C97 not C44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in The Danish National Patient Registry.
Coached or Non-Coached Weight Loss Intervention

To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and provide informed consent
* 18-65 years old
* Self-report of good health (physical and mental)
* Not diagnosed with diabetes
* Overweight or obesity (BMI ≥ 27)
* Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females
* Not 6 months postpartum
* Not planning to become pregnant in the next 5 months.

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent
* Currently pregnant or ≤ 6 months postpartum
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data E.g., evidence of an eating disorder, major chronic condition
Geriatric Assessments in Senior Adults With Multiple Myeloma

This study will evaluate the prevalence of geriatric syndromes in older adults with multiple myeloma, examine relationships between baseline geriatrics syndromes and initial treatment selection, and examine risk of functional decline.

Relationship between baseline geriatric questionnaires and initial treatment selection in older adults with newly diagnosed multiple myeloma.

Feasibility of subjects completing the CARG geriatric assessments at baseline, 3 months and 6 months.

Comorbidities or dependence in IADLs at baseline predict decline in functional status at 6 months of follow-up in older adults with newly diagnosed multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have a diagnosis of multiple myeloma by IMWF criteria: diagnosis must have occurred within 3 months of study enrollment.
* Patient must be ≥ 65 years of age.
* Patient's life expectancy must be ≥ 6 months.
* Patient must be willing to complete follow-up assessments.
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patient must not have a diagnosis of smoldering myeloma.
* Patient must not have concomitant amyloidosis.
Turkish Version of the Kinesthetic and Visual Imagery Questionnaire

Imagery is determined with two strategies to mentally simulate the movements: visual and kinesthetic imagery. Visual motor imagery (VMI) is associated with spatial coordinates of a movement in the environment and through this speciality VMI applies mainly to the imagery of moving objects or to movement of another person in the imagined environment, although imagine of own movement is also possible. Kinesthetic motor imagery depends on dynamic relationship among the individual, the movement and the environment and it should be determined by the nature of the task, the environment and individual characteristics and also requires "feel" the movement.

The aim of this study is to translate this questionnaire into Turkish and the translation in terms of its internal consistency, test-retest reliability.


Eligibility Criteria:
Inclusion Criteria:

* ages between 18-65 years, healthy volunteers, with no limitation in mobility or movement disorder, with no chronic pain

Exclusion Criteria:

* refuse to attend to the study, neurological conditions
Renal Regional Oxygen Saturation During Transcatheter Aortic Valve Implantation

This prospective observational study evaluates the association of peri-procedural changes in renal regional oxygen saturation and post-procedural acute kidney injury in patients undergoing transcatheter aortic valve implantation.

This prospective observational cohort study evaluated the association of renal regional oxygen saturation, measured during transcatheter aortic valve implantation, and post-procedural acute kidney injury. Renal regional oxygen saturation is measured using near-infrared spectroscopy on the skin surface over the kidneys.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>= 20 years old) undergoing transcatheter (transfemoral) aortic valve implantation

Exclusion Criteria:

* Emergent procedure
* Pre-procedural severe renal impairment (eGFR \< 30 mL/min/1.73 m2)
* Pre-procedural hemodialysis
* Distance from skin to renal capsule \> 4 cm
* Pre-procedural mechanical ventilation
* Refuse to participate
The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

Goal-directed therapy (GDT) has been applied to various clinical settings and has been widely researched recently as a method for perioperative management of patients. Radical cystectomy is a complex surgical procedure in which the bladder is removed, followed by urinary diversion. It is an extensive and time-consuming intervention and has high probability of fluid imbalance and bleeding during surgery. We hypothesized that the application of GDT in these patients would improve clinical postoperative outcomes. Therefore, we will attempt to evaluate improvement of postoperative outcomes after applying GDT protocol based on changes in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open radical cystectomy
* Patients with American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* Significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate \<60 ml/min)
* Congestive heart failure (New York Heart Association scores ≥3), Left Ventricular Ejection Fraction \< 35%
* Arrhythmia
* Coagulopathy (PT INR \>1.5)
HuMax-CD4 in Non-Cutaneous T-Cell Lymphoma

The purpose of this study is to assess the safety and efficacy of treatment of non-cutaneous T-cell lymphoma with treatment with CD4.

The study is closed and all subjects have completed treatment.

The study is to evaluate the safety and efficacy of Humax CD4 with CHO vs CHO alone in subjects with non-cutaneous T cell lymphoma. The primary efficacy will be evaluated by time to relapse.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic biopsy of non cutaneous T Cell lymphoma with positive phenotype
* Relapsed or refractory to minimum of one course of chemotherapy
* Study is closed to enrollment.
Effect Of HCP On Nutrition, Physical Activity And Body Mass Index

The goal of this clinical trial is to test effectiveness of "The Healthy Choices Program, in adolescents. The main question\[s\] it aims to answer are:

1. Effectiveness of Healthy Choices on Body Mass Index
2. Effectiveness of Healthy Choices on Health Attitude, Nutrition and Physical Activity Knowledge
3. Effectiveness of Healthy Choices on Fruit,vegetable, water consumption

In our study, a quasi-experimental design with a pre-test and post-test control group was used. This study was carried out between May 2022 and January 2023. 150 adolescents in the 5th, 6th and 7th grades of two secondary schools in Istanbul were included in the study. One of the schools was designated as the intervention group (n=75) and the other as the control group (n=75). Six sessions of training were given to the intervention group. Data were collected using the Descriptive Characteristics Form, Healthy Habits Questionnaire, Adolescent Attitude Scale, Adolescent Physical Activity Knowledge Scale, Adolescent Nutrition Knowledge Scale and Physical Activity Questionnaire. Chi-square test, t test, Mann-Whitney U test, Wilcoxon test were used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adolescents in 6th, 7th and 8th grades

  * Adolescents without mental disabilities
  * Families and adolescents who agree to participate in the study

Exclusion Criteria:

* Families and adolescents who did not agree to participate in the study were not included in the study.
Gender Stigma Consciousness and Surgical Training

Previous investigations have focused on challenges that surgeons face once they have entered into practice. We have yet to explore difficulties in the training environment, and whether these have an effect on professional development. In this study, we investigate how certain environmental factors can affect skill acquisition for the resident surgeon. Our trial tests whether psychosocial constructs affect task-performance. This study is a multi-center endeavor with the University of North Carolina-Chapel Hill, the University of Washington, and UPMC. Over an 12 month period, residents will be asked to complete surveys and a laparoscopic skills assessment, which will be administered after residents are randomized to an intervention or control arm. The intervention arm will be asked to read an article that is meant to trigger psychosocial constructs that we hypothesize will affect skill performance. The control arm will receive a neutral article prior to completing the laparoscopic skills assessment.


Eligibility Criteria:
Inclusion Criteria: Categorical General surgery residents who completed undergraduate medical education in the United States

Exclusion Criteria: Residents who have completed graduate medical education training in a subspecialty prior to their general surgery residency.
Nevirapine Levels and Fluconazole

Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.


Eligibility Criteria:
Inclusion Criteria:

1. HIV-infected patients \>15 years of age,
2. naïve to antiretroviral therapy,
3. were initiated with a NVP-based ART regimen,
4. used NVP 200-mg once-daily lead-in dose, prior to escalation to 200 mg twice daily.

Exclusion Criteria:

1. creatinine level was higher than 2.0 mg/ml
2. liver aminotransferase enzyme was higher than five times of upper normal limit
3. receiving a medication that has drug-drug interactions with NVP or FLU
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* solid cancer patient
* age of 20-65 years old
* subjects who scored =4 or \>4 on the Brief Fatigue Inventory
* subjects with informed consent

Exclusion Criteria:

* metastatic cancer(stage IV)
* with psychotic symptoms such as delusion and hallucination or with suicidal risk
* with delirium or dementia
* current medication of cognitive enhancer or psychostimulant uncontrolled medical illness
* current medications that are contraindicated or not recommended for co-administration with modafinil
Long-term Use of Sonias Combination Tablets in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety and efficacy of long-term use of Sonias Combination Tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

This a special drug use surveillance on long-term use of pioglitazone/glimepiride combination tablets (Sonias Combination Tablets) designed to investigate the frequency of adverse drug reactions in patients with type 2 diabetes mellitus in the routine clinical setting.

The usual adult dosage is one tablet of Sonias administered orally once daily before or after breakfast (15 mg/1 mg or 30 mg/3 mg of pioglitazone/glimepiride).

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus for whom a physician has concluded that combination therapy with pioglitazone hydrochloride and glimepiride is appropriate and for whom long-term treatment with Sonias Combination Tablets is considered necessary

Exclusion Criteria:

* (1) Patients with cardiac failure or a history of cardiac failure (2) Patients with serious hepatic or renal impairment (3) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (4) Patients with severe infection, severe trauma, or pre- and post-operative patients (5) Patients with gastrointestinal disorders such as diarrhea and vomiting (6) Pregnant or potentially pregnant women (7) Patients with a history of hypersensitivity to the ingredients in Sonias Combination Tablets or sulfonamides
Bardet Beidle Syndrome in a Syrian Adolescent : a Rare Case Report

Bardet-Biedl Syndrome (BBS) is an uncommon genetic disorder that affects multiple organs. and presents with a variety of characteristics. It is caused by a dysfunction in the cilia. We present a case of bradet-biedl syndrome presenting with intellectual disabilities, post-axial polydactyly, gingival hyperplasia, and a significant family history of scleroderma. The diagnosis was determined based on clinical physical examination findings. The patient is undergoing treatment with Thyroxine. Although medical staff are incapable of treatment, systems support adjust the overall well-being and quality of life for individuals with Bardet-Biedl syndrome and their families.

Bardet-Biedl Syndrome (BBS) is a rare genetic disorder that affects multiple organ systems presents with a variety of characteristics . It is caused by a dysfunction in the cilia The disorder is autosomal recessive and has a prevalence rate of 1 per 160000 live births in Europe. The primary manifestations include central obesity, post-axial polydactyly, retinal dystrophy, hypogonadism, learning difficulties, and renal malformations . Secondary manifestations include diabetes, brachydactyly, syndactyly, strabismus, cardiac problems, speech difficulties, and ataxia .The diagnosis of BBS requires the presence of four primary features or three primary features and two secondary features , a new paper suggests that modified criteria for diagnosis can be at a moderate level of confidence if it includes at least 2 primary criteria . In this paper, we describe an adolescent male with a unique presentation of BBS. To the best of our knowledge, this is the first case in Syria described in the literature

Eligibility Criteria:
Inclusion Criteria:

* any person

Exclusion Criteria:

* any person
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Inadequate blood sugar control

Exclusion Criteria:

* Previous treatment for diabetes
* Current treatment with other medications to lower blood sugar
* Major heart, liver or kidney problems
* Women who are pregnant or breastfeeding