cyrilzakka/clinical-trials huggingface dataset:
Mini-trampoline Intervention vs. Nordic Walking: Balance, Fitness and Neuropsychological Effects

The effects of mini-trampoline training on balance, cardiorespiratory fitness, strength and neuropsychological parameters in an overweight or obese population are unknown. The aim of this 2-arm randomized controlled trial is to compare the effects of a 12-week mini-trampoline training and a 12-week nordic walking training on balance, fitness and strength in overweight/obese individuals.

A growing body of literature suggests, that obesity is not only associated with medical conditions such as diabetes, but also linked to altered gait, impaired balance and a greater likelihood of falls. Weight reduction has been shown to improve balance controle. Methods to increase physical activity are largely not accepted in this population and those which conserve the musculoskeletal system are rare. Physical activity has been shown to influence mood, quality of life and eating behavior. Mini-trampoline training has been shown to enhance stability and increase fitness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55 years
* Body Mass Index ≥25 kg/m2
* ≤ 1h regular exercise/ physical activity per week

Exclusion Criteria:

* cardiovascular or other chronic diseases not permitting sports participation
* inability to follow the procedures of the study (e.g. due to dementia)
* neurological disorders limiting balance or medications impairing balance
* hypertensive blood pressure not permitting exercise (\>180/100 mmHg)
* medication: beta-blocking agents which reduce cardiac adaption abilities to exercise
* known pregnancy with contraindications for exercise according to the guidelines of the American College of Obstetricians and Gynecologists
Comparison of Glycemic Control With Smartphone Application

The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.

The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.

Eligibility Criteria:
Inclusion Criteria:

* Adult type 2 diabetes mellitus patients (≥ 18years of age) whose HbA1c is ≥8% on insulin.
* At least three months of daily home glucose monitoring before including in the study
* Willing to provide consent to participate in the study4. Uses a smartphone with cellular network and willing to and has ability to learn and use the Vivo vitals application on it.

Exclusion Criteria:

* Patients who have Gestational diabetes or type 1 diabetes
* Patients who have been admitted to the hospital in the last month for more than 3 days.
* Patients who have adrenal disorders or taking exogenous glucocorticoids.
* Patients who are mentally incompetent, having uncontrolled psychiatric conditions, inmates.
* Patients with active malignancies including those on treatment
Linearity and Non-linearity of Cerebral Autoregulation

Injured brain tissue supplied by a disturbed state of cerebral autoregulation (CA) is at risk of secondary ischemia, e.g. in patients with stroke, subarachnoid hemorrhage, intracerebral hemorrhage or bacterial Meningitis. Up to now, there is lack of a simple and easy to perform bed side test that would allow for to intervene when CA failure is indicated. For this purpose, we explore the dynamics of the interplay between blood pressure and cerebral blood flow velocity using transcranial Doppler ultrasound (or near infrared spectroscopy derived haemoglobin concentration changes) as a measure of CA. To describe these dynamics different mathematical models are used, but they all still need validation and proof of concept because these dynamics are poorly understood with respect to the factors which influence the composition of the mathematical models.

Objectives: To what amount is CA disturbed in the different stroke subgroups ? Is a disturbed CA a risk factor of poorer outcome ?

We investigate which factors determine the dynamics of CA under the assumption that disturbed dynamics of the relation blood pressure (BP) - cerebral blood flow velocity CBFv) indicate a disturbed CA. Factors to be considered relevant are BP, blood carbon dioxide (CO2) concentration (measured as endtidal CO2 concentration), autonomic nervous system function such as heart rate, pulse pressure amplitude and baroreflex sensitivity, movement or psychological tasks, and in the patients the kind and the severity of the underlying disease. Via different mathematical models the effects of these variables on CBFv as the Output function is evaluated. The most frequently used approach is the use of Transfer functions.

In the registry will include the patients with acute strokes hospitalized at our stroke center. We will include every stroke patient with any Kind and severity of stroke syndromes who gives informed consent and who has a so called temporal ultrasound window to insonate the middle cerebral artery. BP will be measure noninvasively by a Finapres device. Items registered are Age, gender, cerebrovascular risk factors, temperature, mean BP and ist variability on days 1-3, stroke classification using TOAST, Perfusion Computed Tomography and MRI, and at the time of the simultaneous recordings of CBFv and BP the endtidal CO2, mean BP, mean pulsatility index, and after Transfer function analysis coherence, gain and Phase in different frequency ranges

Eligibility Criteria:
Inclusion Criteria:

* every typ of ischemic stroke of any severity
* presence of a "temporal bone window"

Exclusion Criteria:

* Age \< 18 years,
* pregnancy
* no informed consent.
* absence of a "temporal bone window"
New Serum Biomarkers for Monitoring Early Diagnosis of Ovarian Cancer Recurrence

In this study, mass spectrometry was used to analyze immune inflammation-related protein complexes, post-translational modified glycopeptide omics and tumor-related metabolomics in serum, respectively, in order to find potential metabolic small molecule biomarkers or marker profiles that can be used for early diagnosis of cancer recurrence.

Time cohort study: patients with confirmed ovarian epithelial cancer at different time cutoff points before treatment, after surgery, during chemotherapy, and after chemotherapy, until clinically confirmed patients relapse. At least 50 patients are expected to be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Female
* A diagnosed patient with epithelial ovarian cancer
* Age ≤ 70

Exclusion Criteria:

* Male
* Suffering from other malignant tumors
* Non-compliant patient
* Age above 70
Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments.

Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty.
2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).
3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.
4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).
5. Referral and attendance of medical rehabilitation post-discharge.

Exclusion Criteria:

1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).
2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).
3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.
4. Cognitive impairment defined as \<20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of \<24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.
The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting

Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site.

Forty individuals (19 males and 21 females; age range: 18-35 years) were enrolled in the study. Based on the remaining tissue at donor site after free gingival graft harvesting, individuals were divided into two groups: 1.0-1.9 millimeter (mm) remaining tissue at donor site after harvesting (n = 20), 2-2.9 mm remaining tissue at donor site after harvesting. Tissue filling in defect area from three points (mesial, central and distal) was measured at various time-points (baseline, post-operative 1, 3, 6 months).

Eligibility Criteria:
Inclusion Criteria:

* All individuals received oral hygiene instructions and full-mouth scaling was performed. -They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush
* Individuals were re-evaluated at 8 weeks after initial therapy, and only full mounth plaque score and full mounth bleeding score \<15% were enrolled to the surgical procedure
* mucogingival defects which for soft tissue graft application were indicated
* For Less than 2 mm group, between 2.5 and 3.4 mm palatal thickness at each measurement points before graft harvesting
* For 2 mm or more group, between 3.5 and 4.4 mm palatal thickness at each measurement points before graft harvesting.

Exclusion Criteria:

* periapical or palatal pathologies,
* absence teeth from canine to first molar,
* excessive forces including mechanical forces from orthodontics and occlusion,
* systemic diseases that would contraindicate for periodontal surgery or interfere with tissue healing, chronic high-dose steroid therapy, radiation or immunosuppressive therapy, pregnancy, lactation, smoking, or allergy or sensitivity to any drug
* Study participants had no history of drug therapy known to interfere with healing and to cause gingival enlargement
* Individuals who had complication such as bleeding, necrosis and delay healing during or after surgery were excluded from the study.
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Primary Objectives:

* Myocarditis CTCAE version 5.0 grade ≥ 3
* Ventricular tachycardia (≥ 30 seconds)
* Advanced atrioventricular block
* Incident heart failure event
* Cardiovascular mortality
* Non-fatal sudden cardiac arrest
* Acute coronary syndrome
* Pericarditis
* Pericardial tamponade

Secondary Objectives:

* Time from symptom onset to diagnosis of major adverse cardiovascular events
* Time from symptom onset to diagnosis of myocarditis
* Initial hospitalization duration for the adverse cardiovascular event from primary endpoint
* Peak biomarker levels including troponin T, troponin I, creatine kinase, and creatine kinase myocardial band
* Percentage of patients with negative workup for myocarditis
* Percentage of patients requiring major cardiac testing including echocardiograms, cardiac magnetic resonance imaging, and/or invasive heart catheterization
* Duration of interruption and/or discontinuation of immune checkpoint inhibitor therapy
* Cancer progression free survival
* Time to next cancer therapy

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient ≥18 years old
* Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic
* Willingness to provide informed consent

Exclusion Criteria:

* Troponin T not available at screening or prior to randomization
* Inability to comply with planned study procedures
* Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment
* Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study
* Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
Trastuzumab Plus Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab plus carboplatin and paclitaxel in treating patients who have advanced non-small cell lung cancer.

OBJECTIVES: I. Assess the toxicity of monoclonal antibody HER2 with carboplatin and paclitaxel in patients with HER2 positive non-small cell lung cancer. II. Determine median time to progression and one year freedom from progression in this patient population. III. Evaluate one year survival rate and overall objective response rate in this patient population.

OUTLINE: Patients receive paclitaxel IV over 3 hours immediately followed by carboplatin IV over 30 minutes immediately followed by monoclonal antibody HER2 IV over 30-90 minutes on day 1. Patients also receive monoclonal antibody HER2 on days 8 and 15. Treatment is repeated every 3 weeks for 6 courses. After 6 courses of treatment, patients may receive monoclonal antibody HER2 weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years and once a year thereafter until disease progression or death.

PROJECTED ACCRUAL: A total of 22-44 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Recurrent AND/OR Stage IIIB with pleural or pericardial effusion OR Stage IV Must have at least one bidimensionally measurable lesion Must be HER2 positive (1-3+) Brain metastases allowed, if symptoms controlled and not requiring steroids Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for NSCLC Endocrine therapy: No concurrent steroids Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: No uncontrolled angina pectoris and arrhythmias No myocardial infarction within past 3 months No uncompensated congestive heart failure Ejection fraction at least 45% Other: No active infections Not pregnant or nursing Fertile patients must use effective contraception HIV negative No other active malignancies No evidence of peripheral sensory neuropathy of at least grade 2
The Role Of Nitazoxanide, Interferon Alfa And Ribavirin In Treatment Of Hepatitis C Infected Type 2 Diabetic Patients

The purpose of this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country like Pakistan, the standard treatment of hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in efficacy to peginterferon and also cost effective.

After taking proper informed consent from patients, patients who fulfill the research criteria are randomized into 2 groups (control/study). Patients in both groups will be treated with conventional interferon alfa and Ribavirin.Those in study group will be given tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C Virus(PCR)RNA, Liver function tests, complete blood count will be done.

Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C genotype 3a
* Hepatitis C Virus(PCR)RNA Detected
* Alanine transaminase \>60
* Diabetic HbA1c\<8
* BMI\>23

Exclusion Criteria:

* Previously treated Hepatitis C patients
* Pregnant females
* Decompensated liver disease,Child class B OR above
* Thyroid disease,Thyroid stimulating hormone\>10,0.05
* Absolute neutrophil count\<1500,Platelets\<80,000,Hb\<10g Female,\<11g Male
* Severe cardiac disease,New York Heart Association2
* Moderate to severe depression assessed by Beck Depression Inventory scale
Temporomandibular Joint Problems and Core Stabilization

This study aimed to investigate the relationship between temporomandibular joint problems, head posture, tongue strength, and endurance with core stabilization.

This cross-sectional study was conducted on university students aged 18-31 between September 2022 and February 2023. In the evaluation of the students were used that the Fonseca's Anamnestic Questionnaire for temporomandibular joint dysfunction, Research Diagnostic Criteria for Temporomandibular Disorders Examination Form for maximum pain-free mouth opening, presence of sound in temporomandibular joint movements, and palpation parameters of temporomandibular joint and surrounding muscles, Craniovertebral Angle for forward head posture, and Iowa Oral Performance Instrument for tongue strength and endurance. In addition, the Trunk Flexor Endurance Test and Biering Sorenson Test were used for static endurance of the core muscles, and Sit-ups Test and Modified Push-ups Test were used for dynamic endurance of the core muscles.

Eligibility Criteria:
Inclusion Criteria:

* University students aged 18 and 31 who agreed to participate in the study
* signed the Informed Consent Form were included.

Exclusion Criteria:

* having a non-reducible disc problem,
* having surgery related to spine, abdomen and/or TMJ problem,
* history of trauma, cancer,
* presence of neurological problems, congenital anomaly, musculoskeletal problems, systemic disease, facial paralysis,
* receiving any treatment related to the spine and TMJ in less than six months.
Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects

The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* use of any prescript medication
* chronic hiccups
* pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases.
* pre-existent lung disease
* pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
* pregnancy, breast feeding
* upper airway / esophageal pathology
* phrenic nerve lesions
* any metals in body (pacemaker, splinters, metal stiches)
Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease

Recommendations for cardiovascular rehabilitation (CVR) encourage exercise training, primarily involving the aerobic system, to allow patients to regain independence in daily activities. However, the lactic anaerobic process is also involved during these activities (stair climbing, carrying loads, etc.). Hence there is a major interest in accurately assessing patients' anaerobic capacities in order to tailor suitable exercise programs. However, there are no functional tests specifically dedicated to the evaluation of lactic anaerobic metabolism and adapted to people with coronary disease. The investigators offer a dedicated test, the short and fast test (SFST), which can be applied in current clinical practice and has already been evaluated in a population of healthy subjects. The purpose of this project is to evaluate the safety, feasibility and validity of SFST in a population of patients with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

- Patient who has given oral consent Adult patient (male or female) with coronary artery disease without heart failure referred for rehabilitation program Left ventricular ejection fraction (Simpson method) \> 45%.

Exclusion Criteria:

* Protected adult
* Patient not affiliated to a national health insurance scheme
* Pregnant or breastfeeding woman
* Orthostatic hypotension
* Severe obstructive heart disease
* aortic valve narrowing
* Progressive severe cardiac rhythm or conduction disorders not requiring a device, detected during the initial stress test.
* intracavitary cardiac thrombus
* severe pulmonary arterial hypertension (systolic pulmonary hypertension \>70mmHg)
* recent venous thromboembolic history (last 3 months)
* heart transplantation
* associated medical condition that can predominantly impair functional and respiratory capacities (examples: unstabilized metabolic disorders such as progressive renal failure, significant asthenia related to a severe unstabilized condition such as neoplasia, systemic disease, chronic obstructive pulmonary disease...)
* physical impairments of the lower limbs hindering the test, whether neurological (central or peripheral), arterial (in particular, arteriopathy of the lower limbs with systolic index \< 0.6) or orthopedic (degenerative or inflammatory rheumatism)
* Treatment with Corticosteroids, Anabolics, or L-Carnitine.