cyrilzakka/clinical-trials huggingface dataset:
Obstructive Sleep Apnea Syndrome In Patients Treated For Cancer Of The Upper Aerodigestive Tract

Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

The patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy)

Prospective open-label, non-randomized, monocentric, cohort study, to assess the prevalence and severity of sleep apnea syndrome in patients treated for cancer of the upper aerodigestive tract.

Patients are included in the study when they are hospitalized for panendoscopy. Thereafter, it takes about 1 month to start any treatment. The duration of treatment is estimated at about 5 months (the longest regimen would be induction chemotherapy followed by surgery and adjuvant complementary treatment). After which the patient follows a usual course of care including, at the end of the treatment of his cancer of the upper aerodigestive tract, screening for obstructive sleep apnea syndrome at 3 months and 6 months (Epworth score and ventilatory polygraphy).

Eligibility Criteria:
Inclusion Criteria:

* macroscopic lesion suggestive of a cancerous tumour of the upper aerodigestive tract (oral cavity, oropharynx, larynx, hypopharynx, cavum, cervical lymph node metastases with an occult primary cancer)
* awaiting anatomopathological confirmation

Exclusion Criteria:

* history of cancer of the upper aerodigestive tract
* history of known obstructive sleep apnea syndrome
* cancer of the thyroid, salivary glands, nose and paranasal sinuses
* patients under guardianship or curatorship
L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain

The aim of this study is to quantitatively characterize the effects of L-menthol as a topical counter-irritant on cutaneous pain and hyperalgesia provoked by topical application of the TRPA1-agonist trans-cinnamaldehyde (CA) in healthy human volunteers.

This study is designed as an experimental model in healthy humans.

Eligibility Criteria:
Inclusion Criteria:

* 18 healthy men and women aged 18-50 years willing to abstain from alcohol, nicotine, caffeine and pain medication 24 hours before experimental sessions

Exclusion Criteria:

* Pregnancy
* Skin disorders (e.g. contact eczema)
* Chronic pain conditions
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)

This is a prospective, single-arm study to investigate the efficacy and safety of the combination of fixed low-dose eltrombopag plus recombinant human thrombopoietin (rhTPO) as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) patients during the COVID-19 pandemic.

Eltrombopag, a small molecule agonist of thrombopoietin receptor (TPO-RA), was recommended as the subsequent treatment for ITP patients, which also already showed robust efficacy.Recombinant human thrombopoietin (rhTPO) is a full-length glycosylated-TPO produced by Chinese hamster ovary cells, which showed its effectiveness in ITP in a variety of studies.

Both eltrombopag and rhTPO demonstrated good safety in ITP patients. Because of their non-immunosuppressive nature, both of them serve as a reasonable choice during the global COVID-19 pandemic.

Since they increase the number of platelets through different mechanisms, and previous studies demonstrated that they might exert synergic effect. The investigators hypothesized that the combination of these two agents could be a promising option for treatment of corticosteroid-resistant or relapsed ITP patients.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)
2. Subject has signed and provided written informed consent.
3. Fertile patients must use effective contraception during treatment and observational period
4. Negative pregnancy test

Exclusion Criteria:

1. Have an impaired renal function as indicated by a serum creatinine level \> 2.0 mg/dL
2. Have an inadequate liver function as indicated by a total bilirubin level \> 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level \> 3×upper limit of normal
3. Have a New York Heart Classification III or IV heart disease
4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
5. Have active hepatitis B or hepatitis C infection
6. Have a HIV infection
7. Have active infection requiring antibiotic therapy within 7 days prior to study entry
8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
9. Previous splenectomy
10. Had previous or concomitant malignant disease
11. Not willing to participate in the study.
12. Expected survival of \< 2 years
13. Intolerant to murine antibodies
14. Immunosuppressive treatment within the last 2 weeks
15. Connective tissue disease
16. Autoimmune hemolytic anemia
17. Patients currently involved in another clinical trial with evaluation of drug treatment
Turkish Version of the Hand20 Questionnaire With Carpal Tunnel Syndrome

The questionnaire will be investigated by administering the Hand-20 questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire to patients with carpal tunnel syndrome, one week apart.

Questionnaires, which are used to express the perception of difficulty and hand functionality during daily living activities of individuals with carpal tunnel syndrome, and most importantly, which are easy to administer, should be preferred in order to plan a patient-specific treatment program with these results. Self-administered questionnaires showing the physical dimension of recovery are effective and sensitive to change.

Hand20 is a short, easy-to-understand and visual questionnaire used to evaluate disorders caused by upper extremity pathologies, developed by Suzuki et al. in 2010 and proven to be valid in upper extremity diseases by Töre et al. In this questionnaire consisting of 20 questions, the answer to each question is graded between 0 and 10 (0: No restrictions, 10: Impossible). The best score is 0, the worst score is 100.

Boston carpal tunnel syndrome questionnaire (BKTSA) will be used to evaluate the functionality level and symptom severity of the patients. In this questionnaire, which consists of 2 parts: symptom severity and functional capacity, a separate average score will be calculated for each part by dividing the total score obtained by the number of questions. An increased score indicates decreased functional capacity and increased symptom severity.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 25-60 years
* Patients diagnosed with carpal tunnel
* Patients who volunteered for treatment

Exclusion Criteria:

* Patients who do not agree to volunteer
* Patients who have undergone surgery from the wrist region
Evaluation of Deterioration in Body Posture of Older Patients During Gait Compared to Stance

The goal of this observational study is to analyze how spinal alignment changes when walking compared to standing still in adults aged 50 to 80 years who have sagittal imbalance. The main questions we aim to answer are:

1. Do patients with radiological parameters indicative of sagittal imbalance experience a statistically significant deterioration in sagittal balance during walking compared to a control group?
2. Do radiographs taken after six minutes of walking provide comparable results to dynamic measurements during the walking test?
3. Do patients with a greater deterioration in sagittal balance during walking show poorer clinical self-assessment scores?
4. Is there a significant correlation between parameters obtained using established diagnostic methods and the degree of sagittal balance deterioration during walking?

Participants will be divided into two groups: patients with radiological indicators of sagittal imbalance and a control group of healthy individuals with back pain of similar age. Participants will:

1. Complete questionnaires about their back pain and mobility.
2. Have X-ray images taken of their spine before and after walking for six minutes.
3. Undergo muscle strength tests and gait analysis using motion capture and electromyography (EMG) to monitor muscle activity while walking.


Eligibility Criteria:
Inclusion Criteria:

* Pelvic incidence-lumbar lordosis deficit (PI-LL) greater than 10 or sagittal vertical axis (SVA) greater than 4 centimeters
* The main symptom is low back pain
* Age between 50-80 years.

Exclusion Criteria:

* Symptoms of spinal stenosis
* Previous instrumented spinal surgery
* Cobb angle greater than 30°
* Symptoms of hip or knee arthrosis
* Symptoms of vascular intermittent claudication
* Cardio-pulmonary disease that lowers the patient's physical capability
* Neuromuscular disease
Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain

Low back pain (LBP) is a significant health issue. It impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses. To find out what changes occurred after the application of two exercise modalities \[Conventional Exercise (CE) and Laser-Guided Exercise (LGE)} and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with NSCLBP.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female ages between 18 and 45 years (11).
* Patients diagnosed with nonspecific low back pain (11).
* patients with pain intensity of "3" or greater on numeric pain rating scale

Exclusion Criteria:

* Patients with neurological symptoms.
* Patients diagnosed with fatigue syndrome
* Females having pregnancy
* History of low back surgery
Peripheral Artery Disease in Vastmanland

The main purposes of this study are:

* to describe the prevalence and degree of reduced left ventricular function and hypertrophy in patients with peripheral arterial disease in comparison to controls from the general population,
* to evaluate factors of importance to left ventricular dysfunction and hypertrophy in patients with peripheral arterial disease, and
* to assess the impact of cardiac function and left ventricular hypertrophy on long-term prognosis in patients with peripheral artery disease.

Left ventricular dysfunction is often a consequence of coronary heart disease (CHD). CHD is prevalent among patients with peripheral artery disease. However, there is limited data regarding left ventricular morphology and function in those patients. In the cross-sectional part of this study we will describe the prevalence of reduced cardiac function and left ventricular hypertrophy in a cohort of patients with peripheral artery disease. The patient outcomes will be compared to control subjects randomly selected from the general population in a case-control design. Further, clinical and genetic determinants of cardiac dysfunction in the patient cohort will be identified. In the longitudinal part of the study, the impact of cardiac function and morphology on cardiovascular mortality and morbidity will be evaluated in the cohort.

Eligibility Criteria:
Inclusion Criteria:

Fulfillment of at least one of the following criteria:

* ankle-brachial-index (ABI) \<= 0.9, or
* stenosis of \> 30% of the internal carotid artery, or
* symptoms typical for claudication and corresponding stenotic findings on the ultrasound examination.

Exclusion Criteria:

* age less than 18 years
* severly impaired communication capabilities
Use of Music and Voice Stimulus on Coma Patients

Objectives: (1) To check music and voice message influence on vital signs and facial expressions of patients in physiological or induced comas; (2) To connect the existence of patient's responsiveness with the Glasgow Coma Scale or with the Ramsay Sedation Scale.

Method: This was a randomized controlled clinical trial with 30 patients, from two Intensive Care Units, being divided in 2 groups (control and experimental). Their relatives recorded a voice message and chose a song according to the patient's preference. The patients were submitted to 3 sessions for 3 consecutive days.

The relatives elaborated a voice recorded message and choose a music according to the patient preference, which were recorded in the same Compact Disc. Two identical CD's were made at the same recorded time; one with and another one without stimulus in order to make the random division of the groups. The patients were evaluated according to one of the Scales; they used earphones. During the sessions, the data relating to the vital signs and the face expression were recorded in a data collection instrument.

Eligibility Criteria:
Inclusion Criteria:

* To be in coma;
* To be evaluated according to one of the Scales and to have a score in the study range: in physiological comas, score between 3 to 8 Glasgow Coma Scale (GCS); in induced coma, one of the last two scores of Ramsay Sedation Scale (RSS), R5 or R6;
* To have hearing function preserved according to family;
* To have written consent from the family or responsible party for the patient's participation in the research.

Exclusion Criteria:

* Score between 9 to 15 in GCS or scores R1, R2, R3 or R4 in RSS
Preclinical Research of mμSORS for Noninvasive Blood Glucose Detection

This is a single-center, open-label, prospective study. Blood glucose was measured at different time points during oral glucose tolerance testing in patients with type 2 diabetes mellitus, using both venous plasma and multi-channel microspatial offset Raman scattering spectroscopy (mμSORS). Venous plasma glucose was set as gold standard.The two measurements were collected synchronously so as to calculate the mean absolute relative difference (MARD) and the consensus error grid (CEG). Accuracy of non-invasive blood glucose testing by mμSORS will be validated. MARD for two measurement methods in different blood glucose ranges and the safety outcomes of mμSORS such as adverse events will also be assessed.

In order to clinically verify the accuracy and safety of non-invasive blood glucose measurement by the mμSORS technology, and to explore the feasibility of non-invasive detection in multi-indicators of mμSORS, this study will conduct an oral glucose tolerance test on patients with type 2 diabetes. There will be 12 collection points of blood samples as follows: 0-min and post glucose-load 15-min，30-min，45-min，60-min，75-min，90-min，105-min，120-min，135-min，150-min， and 180-min. Approximately 4ml of whole blood was collected at each time point for venous plasma glucose and serum insulin measurement. The blood glucose value measured by mμSORS will be obtained synchronously at the above 12 time points.

Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects with type 2 diabetes mellitus;
* 2. Age ≥ 18 years;
* 3. There are no scars, obvious pigmentation and other factors that interfere with the detection of the palm skin to be tested;
* 4. Fully understand the nature, significance, possible benefits, possible inconveniences or potential risks of this research, and should also understand the research procedures, be willing to complete the entire research process, and provide written consent form.

Exclusion Criteria:

* 1. Type 1 diabetes, monogenic diabetes, pancreatic damage, or secondary diabetes of other causes should be excluded;
* 2. Severe structural heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA≥III); acute myocardial infarction within 12 months before enrollment; history of severe liver or kidney dysfunction(MDRD eGFR\< 60 ml/min/1.73m2); and mental disorders, etc.;
* 3. With a history of acute complications of diabetes within 3 months before enrollment; or severe chronic complications of diabetes;
* 4. Alcohol dependency or drug abuse;
* 5. Those who have participated in clinical trials of other drugs within 3 months before screening (since the last visit of the previous trial);
* 6. Pregnancy or lactation period;
* 7. Difficulty in venous blood collection or blood-injection-injury phobia;
* 8. Other circumstances that the investigator considers inappropriate to participate in the study.
Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment

The goal of this clinical trial is to learn about the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers who live in settings with mild iodine deficiency.

The main questions it aims to answer are:

1. What are the effects of iodine-containing multiple micronutrient supplements provided to breastfeeding mothers on infant development, as measured by electroencephalography/visual evoked potentials?
2. What are the effects of iodine-containing multiple micronutrient supplements on breast milk concentrations of iodine, and infant iodine and thyroid status?
3. How do iodine and iron interact with each other to affect thyroid function in the mother during lactation?

Participants will be randomized to receive a daily multiple micronutrient tablet containing iodine (UNIMAPP) for 6 months postpartum, or routine postnatal care per Ethiopia Ministry of Health. Mothers will provide a breast milk sample and drop of blood at 3 and 6 months postpartum. Infants will provide a urine sample and drop of blood, and have a neurodevelopmental assessment at 3 and 6 months.

Researchers will compare the groups that received the iodine-containing micronutrient supplement with the group that received routine care (IFA) and see if there were any benefits on infant development and iodine and thyroid status in the mother and baby.


Eligibility Criteria:
Inclusion Criteria:

* Intention to breast feed at least 3 months
* Birth weight \>2000g

Exclusion Criteria:

* Intention to primarily feed by alternative sources (formula, animal milk)
* Multiple pregnancy
* Infant with major congenital anomalies
* Infants with severe morbidity or developmental disorder
* Mother with HIV or chronic renal disease
* Plan to move out of study catchment area
* Does not agree to follow up or EEG/VEP
Blister Packaging Medication to Increase Treatment Adherence and Clinical Response

This quantitative, interview-based study will determine if increased prescription medication adherence via blister pack administration will reduce suicide related behavior among the high risk population of patients discharged from a psychiatric inpatient unit. The aims of the project are to determine whether blister packaging medication significantly increases treatment adherence and if blister packaging significantly decreases intentional self-poisoning behavior (i.e., suicide attempts and completions). By tracking former psychiatric inpatients for 12 months post-discharge and obtaining monthly medication adherence ratings, we will determine if blister packaging (BP) medications leads to better adherence than dispensing as usual (DUA). The psychiatric patients we will be recruiting have been diagnosed with, major affective disorder, bipolar affective disorder, post-traumatic stress disorder, or schizophrenia (or any combination of these diagnoses). By tracking former psychiatric patients for 12 months post-discharge and obtaining monthly reports (self-report and medical record review) of suicide-related behaviors, we will determine if patients in the BP condition have less intentional self-poisoning behavior than those in the DAU condition.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* diagnosed with major affective disorder,
* bipolar affective disorder,
* post-traumatic stress disorder, or
* schizophrenia (or any combination of these diagnoses)
* under voluntary status at some point during admission
* currently prescribed medications
* deemed capable of managing their own medications after discharge
* not currently active duty in any branch of the military
* able to correctly answer questions verifying they understand the consent form
* English-Speaking

Exclusion Criteria:

* Under the age of 18
* Not under voluntary status at some point during admission
* Not currently prescribed medications
* Not able to manage their own medications after discharge
* Non-English-speaking
* Currently active duty in any branch of the military
* Inability to correctly answer questions indicating comprehension of information on the consent form
Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.

Postoperative pain in children is still one of the most under diagnosed and under treated medical problems. It affects post-surgery recovery, mortality and morbidity, limits mobility. Untreated pain not only causes child's suffering but can decrease the pain threshold in the future or lead to the development of chronic pain. Postoperative analgesia has been traditionally based on opioids but as their use can be associated with adverse effects prolonging hospital stay and affecting recovery current guidelines focus on multimodal approaches involving numerous analgesics with different mechanism of action. Growing evidence suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids. Lidocaine has been proved to have analgesic and anti-inflammatory properties. It is also a potent peripheral nervous system modulator inhibiting peripheral and central sensitization. The studies performed in adult population have proved the efficacy of systemic lidocaine in postoperative pain treatment. It is an effective adjunct that reduces opioids consumption and facilitates pain management. As such lidocaine infusion has been included in postoperative pain management guidelines for adults. Studies on children population have promising results but high quality randomized controlled trials are still missing.

The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane) in reducing opioids consumption and facilitating postoperative pain control in children undergoing laparoscopic appendectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 months and 18 year-old
2. Patients with American Society of Anaesthesiologists physical status (ASA) class 1/1E, 2/2E, 3/3E
3. Patients undergoing laparoscopic appendectomy

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of lidocaine
2. Patients with American Society of Anaesthesiologists physical status (ASA) IV or more.
3. Severe cardiovascular disease
4. Preoperative bradycardia
5. Preoperative atrioventricular block
6. Renal failure
7. Chronic treatment with analgesics
8. Parents' refusal