cyrilzakka/clinical-trials huggingface dataset:
Effects of a Dietary Supplement on Markers of Glucose Control and Quality of Life

This study is a double-blind, randomized, two-arm, placebo-controlled trial of apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio (i.e. The Center for Applied Health Sciences). Subjects will attend four study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work \[also HgA1c, insulin\], background baseline diet). Over the next 12 weeks, subjects will attend Visits 2-4, wherein assessments of serum glucose, insulin, HOMA-IR, 2-hour glucose tolerance test (GTT), HgA1c, C-reactive protein, adiponectin, ferritin, waist circumference, quality of life questionnaire, and various visual analog scales for appetite, satiety, and cravings will be made.


Eligibility Criteria:
Inclusion Criteria:

Provide voluntary signed and dated informed consent. Be in good health as determined by medical history and routine blood chemistries.

Age between the ages of 21 and 65 (inclusive). Body Mass Index of 18.5-34.99 (inclusive). Body weight of at least 120 pounds. Fasting blood sugar of 100-125 (inclusive) OR HgA1c of 5.7-6.4% (inclusive). Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic bloodpressure \< 90 mm Hg.

Normal seated, resting heart rate (\<90 per minute). Willing to duplicate their previous 24-hour diet, refrain from caffeine for 12 hrs and exercise for 24 hr prior to each trial, and fast for 10 hours prior each of the treatments.

Exclusion Criteria:

History of unstable or new-onset cardiovascular or cardiorespiratory disease. History of diabetes, or other endocrine disorder. Fasting blood sugar of \> 125 mg/dL or HgA1c of \> 6.4%. History of use of medications or dietary supplements known to affect glycemia or insulinemia.

History of hyperparathyroidism or an untreated thyroid disease. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).

Prior gastrointestinal bypass surgery (Lapband), etc. Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).

Chronic inflammatory condition or disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).

Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of- Analysis.

Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.

Any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
Communication by Brain - Computer Interface in Amyotrophic Lateral Sclerosis:Feasibility Study

ALS is a severe progressive neurodegenerative disease characterized by degeneration motor neurons leading to death in 3 to 5 years. Gradually in time, the patient deprived of all motor skills as well as the possibility of communication written and oral developing a state close Locked In Syndrome (LIS). The main objective is to establish the feasibility of brain-computer interface using the pathological condition, with dependent disabled subjects as a means of communication.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* have a diagnosis of ALS suspected, possible, probable with EMG
* be able to follow the study process and to comply with the schedule of visits upon entry into the study
* understand the purpose of the study
* expressing P300 wave in the conditions of the study

Exclusion Criteria:

* have a mental illness or clinical dementia defined clinically significant may hinder the patient's ability to follow the procedures of the study
* have a significant history of photosensitive epilepsy
* have a history of allergy to the gel used for the electrodes
* Major protected by law (guardianship, curators)
* have uncorrectable visual disorders
* not being able to maintain a sitting position and focus on a computer screen for more than 30 min.
Efficacy of Å6 in Ovarian Cancer Patients Following First-Line Chemotherapy and a Rising CA125 Levels

The purpose of this study is to determine whether injections of Å6 are effective in treating ovarian cancer patients who have completed first-line therapy and currently have no detectable cancer but have experienced a doubling of CA 125 levels.


Eligibility Criteria:
Inclusion Criteria:

* Females ≥18 years of age
* Histologically or cytologically documented primary epithelial ovarian carcinoma, cancer of the Fallopian tube, or primary peritoneal carcinoma
* Completion of first-line chemotherapy
* Clinical remission as a result of chemotherapy
* History of normal CA125 level after initial course of therapy
* CA125 serum level has shown 2 consecutive rises based on 3 consecutive samples which are mutually \>= 28 days apart, provided that:

  1. the 3rd sample is above the institution's ULN, and
  2. the 3rd sample is confirmed by a 4th sample which is likewise higher than the 2nd sample value and is above the institution's ULN
* No clinically evident disease progression, as assessed by history, physical examination, computed tomographic (CT) scan, or magnetic resonance imaging (MRI)
* ECOG Performance Status of 0 or 1
* No clinically significantly abnormal clinical laboratory tests or concomitant illnesses
* Ability and willingness to self-administer subcutaneous injections
* Although pregnancy is extremely unlikely in this patient population because of the disease and prior treatment, patients who have the potential to become pregnant must have a negative pregnancy test and must agree to practice an effective method of contraception throughout the trial.

Exclusion Criteria:

* Persistent adverse events due to agents administered more than 4 weeks earlier
* More than 1 course of previous chemotherapy for the qualifying cancer
* Disease requiring chemotherapy or radiotherapy
* Ascites
* Recent history of active infection, gastrointestinal bleeding, thromboembolic disorders, or anticoagulation
OPsumit USers Registry

Prospective observational drug registry developed to characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.


Eligibility Criteria:
Inclusion Criteria:

Patients newly treated with Opsumit defined as a new user of therapy, initiated ≤ 30 days prior to enrollment visit.

Signed ICF

Exclusion Criteria:

Previous user of Opsumit defined as patient who initiated therapy \>30 days prior to enrollment.

Patients enrolled in any ongoing clinical trials
Prevalence of IR in Overweight and Obese Adolescents

The aim of this study is to determine the prevalence of Insulin Resistance (IR) among overweight and obese adolescents using HOMA-IR scores and identify lifestyle risk factors in the IR and Non-IR group.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents of ages ≥ 10-≤18 years, of both sexes who are Overweight (BMI \> 85th percentile) or Obese (BMI \> 95th percentile).

Exclusion Criteria:

* Obesity due to Secondary causes as Cushing disease or hypothyroid patients, and any other patients with Chronic illness.
Influence of Episodic Memory on Healthy Eating

The present research project investigates if recall of recent eating episodes enhances consumption of fruits and vegetables

Episodic memory is the capacity to remember past autobiographic events, including eating episodes. Recalling a previous meal decreases the amount eaten in a subsequent snack occasion.

Recall of recent eating episodes could alert individuals about the relationship between their eating behaviour and wellbeing. This is supported by the observation in slimming trials that participants who keep a food diary lose more weight than those who do not record their intake.

Lab experiments have focused on the effect of eating episodic memory on later intake of unhealthy food. However, less is known about the effect on intake of healthy food. Increasing consumption of food that contains nutritious elements like fruit could protect against chronic disease. If eating episodic memory would increase intake of healthy food, this would benefit individuals' health.

The aim of the present between-subjects experiment is to test the influence of memory of recent eating episodes on fruit and vegetable consumption. The interest is to assess differences in amount of fruit/vegetables eaten in each of two conditions: (i) after a recall of eating episodes of the day before and (ii) after recall of activities of the day before excluding eating episodes. The hypothesis is that fruit/vegetable consumption after recalling eating episodes would be higher than after recalling non-eating related activities.

The project will consist of four individual studies varying weight status of participants and test food: i) Female with healthy weight, and fruit as test food; ii) Female with healthy weight, and vegetable as test food; iii) Female with unhealthy weight, and fruit as test food; and iv) Female with unhealthy weight, and vegetable as test food.

Eligibility Criteria:
Inclusion criteria:

* Age 18-25 years old
* Body mass index within ranges of healthy weight and overweight or slight obesity (18.5 to 24.9 and 25.0 to 34.9 kilograms divided by squared height)

Exclusion criteria:

* Fruit hypersensibility
* Vegetable hypersensibility
* Chronic ill health
Early Predictors of Necrotizing Enterocolitis in Neonates

The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of non-invasive measures as well as biochemical markers to identify neonates early in the disease process. Thus, the investigators aim to identify infants with NEC prior to the onset of symptoms to institute or test treatments in the long term to prevent the progression of the disease in these infants.

The study will enroll premature, low birth weight infants in the Neonatal Intensive Care Units (NICU). Potential study subjects will be identified upon delivery, or transfer to the NICU, and notification by the neonatology service. Infants born at less than 30 weeks gestational age, birth weight less than or equal to 1500 grams will be eligible for enrollment in the study. The purpose of the study designed is to compare the splanchnic tissue oxygenation index and gut inflammatory biomarkers of patients with any stage of NEC with healthy controls. Since we will not be able to determine which patients will develop NEC a priori, we will anticipate enrolling up to 450 neonates to identify 15 neonates with NEC.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at ≤30 weeks gestational age and/or
* Infants with a birth weight ≤1500 grams

Exclusion Criteria:

* gestational age at birth greater than 30 weeks
* obvious dysmorphic syndromes
* any abdominal wall defect including omphalocele or gastroschisis
* any known intestinal atresia
* complex cardiac abnormalities
* any known lethal chromosomal abnormalities
Construct Validity and Reliability SCUES

The aim of the study was to determine construct validity, discriminant validity and intra- and interrater reliability of the Selective Control of the Upper Extremity Scale (SCUES).

This study included children diagnosed with unilateral cerebral palsy. Children's upper extremity-selective motor controls were evaluated by video recording. Manual Ability Classification System and Taylor Hand Function Test were used to determine upper extremity functions

Eligibility Criteria:
Inclusion Criteria:

* Ages between 3-18 years
* Diagnosed as Cerebral Palsy (Hemiplegia)

Exclusion Criteria:

* Participants with an unstable situation regarding their tonus-regulating medications
* Participants had a botulinum toxin injection within the last 6 months, or any surgical correction within the last year
Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin

The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy suggests a role for IMA as a potential biomarker for abnormal placental development related to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent pregnancy loss (RPL).

Ischemia-modified albumin (IMA) measured by the albumin cobalt binding test is a relatively new biomarker in the identification of myocardial ischemia. Experimental studies have shown that pregnancies normally develop in a relatively hypoxic intrauterine environment, and the subsequent reperfusion and oxidative stress is important for physiological trophoblast development. The finding that maternal serum IMA levels are raised so early in pregnancy provides further support for IMA as a potential marker for abnormal placental development that may be related to early pregnancy loss. In this study, we aimed to evaluate maternal circulating IMA levels in women with RPL by comparing them with healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* first trimester pregnancy
* absence of fetal cardiac activity
* absence of fetal pole
* history of two or more unexplained first trimester miscarriages
* no live births
* apparently healthy women attending for antenatal care in the first trimester with at least one previous uneventful natural pregnancy

Exclusion Criteria:

* pre-existing diabetes or vascular disease were excluded
* diagnosis of chromosomal, anatomic, endocrinologic and autoimmunologic etiology of recurrent pregnancy loss
* Women with multiple pregnancy
* any major or minor fetal anomaly
* current smokers
A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

The study is to understand whether distribution of two different supplies of nicotine patches through a telephone quitline has an effect on quit rates. The two different supplies are four vs. eight (in two separate four-week mailings) weeks of nicotine patches. The hypothesis is that eight weeks will be slightly more efficacious but four weeks will be more cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* All callers to the Colorado QuitLine who report currently smoking 16-20 cigarettes
* who enroll in QuitLine services
* who do not require physician approval to obtain nicotine replacement therapy
* who are willing to receive the nicotine patch

Exclusion Criteria:

* Contraindications to receiving the nicotine patch through the QuitLine without physician approval include: history of hearth disease (heart attack, chest pain, or coronary artery disease), high blood pressure, pregnancy, skin conditions such as difficult to manage psoriasis or eczema, or history of a local reaction to the nicotine patch
* those who do not complete the call in English
Physical Therapy Using Virtual Reality/Augmented Reality

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality (VR) headset, Augmented Reality (AR) Headset) are more effective than the standard of care (i.e., no technology-based distraction) for improving clinical outcomes in patients requiring acute rehabilitation due to deconditioning and surgery. Measures will include include range of motion, gait progression, strength progression, time to first out of bed, time to first step.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-99
* Diagnosis need for physical rehabilitation

Exclusion Criteria:

* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems
* Patients whose children are clinically unstable or require urgent/emergent intervention
* Patients who clinically unstable or requires urgent/emergent intervention
Assessing Cervical Dystonia

The study involves the use of a novel, non-invasive, monitoring device to measure the response to treatment with botulinum toxin injections in 24 (16 Intervention and 8 control) patients with cervical dystonia. A baseline assessment, prior to botulinum treatment,will be structured around validated clinical rating scales for cervical dystonia and questionnaires and the performance of simple neck movements, and will be undertaken while the patient wears a movement sensor attached to the head with an elastic strap. The same assessments will be undertaken at 0, 3, 6, 9 and 12 weeks following treatment to assess response. The patients' treatment will not be affected by their participation in the research. The device readings will then be compared with the clinical ratings to establish whether it might be used as a more sensitive measure of treatment response than clinical assessment alone. This will help clinicians to plan and execute botulinum injections more effectively in future


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants aged 18 years or older (no upper age limit) and willing and able to provide informed consent.
* Participant is able and willing to comply with the follow-up schedule and protocol.
* Participants diagnosed with cervical dystonia.
* Participant has previously received botulinum toxin therapy for cervical dystonia without adverse side effects OR is naïve to botulinum toxin therapy but is suitable to participate in the investigator's opinion

Exclusion Criteria:

* -Participated in another clinical investigation within 30 days.
* Allergy to device components or botulinum toxin.
* Medical co-morbidities that preclude botulinum toxin therapy.
* Patient is incapable of understanding or responding to the study
LAT for Oligoprogressive NSCLC Treated With First-line OSImertinib

To determine whether in patients with EGFR mutated advanced NSCLC and osimertinib as first-line treatment, the (repeated) use of LAT to ≤ 3 OP lesions and continuation of first-line osimertinib, improves the median progression-free survival by more than 3 months (i.e. PFS2-PFS1 = \>3 months).

The (repeated) use of LAT to ≤ 3 OP lesions with continuation of first-line osimertinib, is endorsed by international guidelines (NCCN, ESMO).

In this phase IIb prospective non-randomized observational trial, we want to document the benefit of LAT in this patient cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥ 18 years of age
2. Established histological diagnosis of advanced NSCLC, not suitable for radical treatment, with an EGFR actionable mutation receiving first-line targeted TKI therapy with osimertinib
3. Initial radiologically confirmed response (at least stable disease) to osimertinib assessed 3 months post commencing osimertinib according to RECIST criteria v1.1.
4. Confirmed OPD defined as ≤ 3 intra- and extracranial sites of progressive disease. OP may be defined as progression of an individual metastasis according to RECIST or on 2 consecutive imaging studies at least 2 months apart with a minimum of 5mm increase in size from baseline or an unambiguous development of a new metastatic lesion with a grand total of 3 lesions. All sites must be visible, imaging defined targets, not previously treated with radiation or radiofrequency and suitable for treatment with LAT as determined by the local multi-disciplinary team (MDT).
5. Adequate baseline organ function to allow LAT to all the OP targets.
6. Predicted life expectancy ≥ 6 months
7. Karnofsky Index ≥ 60% and ECOG 0-2
8. Provision of written informed consent
9. Female participants must be surgically sterile or postmenopausal if SBRT is planned to the abdominal area or must agree to use effective contraception during the period of therapy.

Exclusion Criteria:

1. \> 3 sites of progressive disease
2. Oligoprogressive metastases not amenable to LAT
3. Radiotherapy or radiofrequency ablation near the OP lesion prior to the inclusion in the LAT-FLOSI study
4. Co-morbidities considered clinically precluding the safe use of LAT
5. Any psychological, sociological or geographical issue potentially hampering compliance with the study
6. Pregnancy
Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

This study evaluates treatment effect of Cervical Collar (CC) in moderate obstructive sleep apnea.The investigators believe that stabilization of the neck by using a CC during sleep helps sustain airway patency. This would mean preventing collapse of airways during sleep.

The study is a randomized, open, parallel-group intervention study. The two treatment groups are:

A. Patients with moderate OSA are treated with lifestyle advice (n = 50) B. Patients with moderate OSA are treated with CC and lifestyle advice (n = 50).

Moderate and severe obstructive sleep apnea (OSA) is strongly associated with cardiovascular diseases, diabetes and also with occupational and traffic accidents due to fatigue and daytime sleepiness. Treatment of moderate OSA is usually by a mandibular advancement device (MAD) and in sometimes even Continuous Positive Airway Pressure (CPAP). MAD and CPAP treatment effectiveness is impeded by limited compliance with long term treatment. Knowledge about mechanical barriers in upper respiratory tract has triggered interest in finding a new treatment method that may prevent collapse of airways during sleep. The investigators believe that stabilization of the neck by using a cervical collar (CC) during sleep helps sustain airway patency. This would mean improved oxygen saturation in the blood and a reduction of daytime fatigue in patients with OSA.

Eligibility Criteria:
Inclusion Criteria:

* Moderate obstructive sleep apnea (AHI 15-30)
* BMI \<35
* Age 18-75
* Signed Informed Consent

Exclusion Criteria:

* Ongoing or planned pregnancy during intervention
* Whiplash injury or other neck pain
* Rheumatic diseases
* Dementia
* Active alcohol or drug abuse \<2 back in time
* Treatment with sleeping pills or other sedatives
* Cannot wear CC for any reason
* Pregnant or lactating women
* Not expected to be able to comply with nighttime breathing registration/treatment due to medical and/or psychological conditions.