cyrilzakka/clinical-trials huggingface dataset:
Cost-effectiveness Analysis and Conditional Response to the Effect of Positional Devices in Obstructive Sleep Apnea

The objectives of this study are:

* To assess the effectiveness and cost-effectiveness of a vibrating positional device (NightBalance, Philips) in the treatment of positional obstructive sleep apnea compared to conventional CPAP treatment.
* To investigate whether a positional device (NightBalance, Philips) avoids supine position after a period of use of the device without actively using the device for a subsequent period of time.

Non-inferiority clinical trial open to patients and investigators, multicenter, randomized and controlled to treatment with positional device (PD) and CPAP to evaluate the effectiveness of treatment of positional obstructive sleep apnea with a PD (NightBalance, Philips) compared to CPAP after 6 months of continuous treatment (first phase) and the permanence of such efficacy after subsequent discontinuation of treatment (second phase).

An initial respiratory polygraphy will be performed in all patients and the sleep study will be repeated at 6 months with PD and CPAP. After its withdrawal, in those patients who respond, the respiratory polygraphy will be repeated at one week and one month.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Signed informed consent.
* Diagnosis of POSA by respiratory polygraphy with the following criteria:

  * AHI ≥ 15/h or AHI ≥ 10/h and AHI \<15/h with an Epworth \>10
  * AHI ns \<10/h (\<5/h in mild OSA).
  * AHI is at least twice the AHI in ns
  * Time in supine \>20%.
  * Valid recording time\>4h

Exclusion Criteria:

* Treatment of OSA with CPAP or DAM in the previous month or treatment with surgery for OSA at any time.
* Presence of other sleep disorders or central sleep apnea (central AHI \>50% of total AHI).
* Severe cardiovascular, neuromuscular or pulmonary pathology or chronic home oxygen use.
* Poorly controlled arterial hypertension or refractory arterial hypertension.
* Condition that makes it difficult or impossible to change position during sleep.
* Epworth scale score ≥ 16.
* Professional driver, heavy machinery operator or shift worker.
* Pregnancy.
* Treatment with medication that may interfere with alertness or drowsiness such as: sedative antidepressants, hypnotics, opioids, anticonvulsants or central nervous system stimulants.
Effect of Liquid Volume and the Amount of Incorporated Gas Into a Carbohydrate/Protein Beverage on Satiety

Liquid foams can be formed by trapping pockets of gas in a beverage. The primary objective of this study is to test the individual contribution, and possible interaction, of the liquid volume and gas to liquid volume ratio (i.e. %overrun (%OR, defined as 100 x \[gas volume/liquid volume\]) of a beverage to its satiating properties.

It is not known how the liquid and gas volumes of a liquid foam contribute to its satiating properties and how and if these factors interact. The best way to assess these parameter combinations and their interactions is to use a special statistical approach named "Response Surface Methodology" (RSM). The current study therefore has a Central Composite Design with 9 foams differing in liquid volume and in ratio of gas to liquid volume (%overrun, which is defined as 100 x gas volume/liquid volume).

Each subject will be appointed to a single parameter combination and receives this parameter combination twice, separated by a one-week wash-out period.

On both test days subjects' self-assessment of feelings of satiety and physical discomfort will be recorded during 4 hours post-consumption of the treatment using Electronic Visual Analogue Scale.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 21 and 32 kg/m²
* Apparently healthy: measured by questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eat 3 meals a day, no vegetarian.
* Reported intense sporting activities below 10h/w
* Reported alcohol consumption below 14 units/w (female volunteers) or below 21 units/w (male volunteers)

Exclusion Criteria:

* Dislike, allergy or intolerance to test products or indicating to be unable to consume 514 ml of aerated test product
* Any food allergy, or dislike or intolerance with the foods supplied during the study
* Eating disorder (measured by SCOFF questionnaire, 2 or more"yes" responses) High or very high restrained eaters (measured by questionnaire; score of 15 or higher, Polivy et al. 1978)
* Reported medical treatment that may affect eating habits/satiety
* Reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 6 months ago) or wish to become pregnant during the study
Inflammatory Markers for Postoperative Complications in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Infective complications after cancer surgery had a significant impact on disease-free and overall survival. Postoperative inflammatory markers have been proven useful in predicting infective complications. However, it remains unknown whether these markers can predict postoperative infection in patients receiving cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) which causes the systemic inflammatory response syndrome. Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis were assessed for postoperative complications. Patients were divided into two groups according to the presence of infective complications. Presence of abscess, positive blood, surgical site, urine or sputum cultures, or clinical signs and symptoms with comparable radiologic findings were defined as infective complications. Retrospectively, C-reactive protein (CRP), neutrophil-to-lymphocyte ratio, white blood cell count, platelet count, mean platelet volume, platelet-to-lymphocyte ratio, albumin were collected from preoperative day and postoperative days (POD) 0-14.


Eligibility Criteria:
Inclusion Criteria:

* Between September 2014 and April 2017, all patients who underwent cytoreductive surgery and HIPEC for peritoneal carcinomatosis

Exclusion Criteria:

* A Patient treated the dexmedetomidine.
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers

This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* BMI 18-30 kg/m2
* body weight \> 50 kg

Exclusion Criteria:

* no history of sleep disorder
* no concurrent medications
* no alcohol use
* no medical issues
* no smoking
Long-term Outcomes of Pregnant Women With PAH

The investigators intend to explore the characteristics and outcomes of pregnant women with PAH during different pregnancies and to provide applicable evidence for clinical practice.

Pulmonary arterial hypertension (PAH) is a fatal disease with progressive vascular resistance that leads to the loss of right heart function. Avoiding pregnancy is essential for PAH women. In recent years, maternal mortality in pregnant women with PAH has decreased mostly due to emerging advanced therapies for PAH and the progress in high-risk pregnancy management. Nevertheless, the maternal death rate in parturients with PAH remains high; therefore, contraception is still recommended for women diagnosed with PAH. However, some women develop this condition during pregnancy. With the two-child policy, families in China are allowed to have a second child. As a result, the number of PAH diagnoses during pregnancy may increase with the general increase in the number of pregnant women. Additionally, some patients develop PAH only during their second pregnancy. In order to investigate the incidence and clinical characteristics of pregnant women diagnosed with PAH during different pregnancies, this observational study aimed to analyze perinatal and pregnancy clinical data, to compare the perinatal status and maternal and infant outcomes of the first and second pregnancies complicated with PAH, establishing a clinical basis for the prenatal consultation, diagnosis, and treatment of pregnant women with PAH.

Eligibility Criteria:
Inclusion Criteria:

PAH was screened by Doppler echocardiography first. Echocardiographic criteria for the diagnosis of PAH included tricuspid regurgitation velocity \>2.8 m/sec, with extra more than one additional echocardiographic sign

Exclusion Criteria:

Cases of PH diagnosed before pregnancy, secondary to chronic lung disease, and left heart disease, as well as right ventricular outflow tract obstruction and congenital pulmonary stenosis.
The Superficial Lesions in the Peri-auricular Region

Superficial lesions on and around the ear are uncommon with many differential diagnoses and different characteristic histopathologic features. The purpose of this study was to describe a series of peri-auricular superficial lesions and characterize the distinctive types of these lesions.

Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated. Data were retrieved, reviewed, and analyzed. The primary analysis outcome measures were patient history (age, gender, complaint, medical advice clinic, and associated medical diseases), lesions examination (site, laterality, clinical presentation, and the number of lesions). Also, the needed investigations for diagnosis, type of intervention, postoperative patient satisfaction were evaluated. Evaluation of the patients' follow up was done.

Eligibility Criteria:
Inclusion Criteria:

* Patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) operated during the period extending between 2017 and 2019
* Available full demographic, clinical and histopathological data

Exclusion Criteria:

* deep lesions involving parotid or parapharyngeal space
* Missed demographic, clinical and histopathological data
Kidney Injury Severity and COVID-19

The authors hypothesize that the SARS-CoV-2 virus can affect the kidneys, causing them to be damaged. The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

In December 2019, an outbreak of the 2019 novel coronavirus disease (COVID-19) caused by the SARS coronavirus 2 (SARS-CoV-2) occurred in Wuhan, China. It has spread rapidly to other areas in China and worldwide. The most common manifestations of COVID-19 included fever, dry cough, dyspnea, myalgia, fatigue and radiographic evidence of pneumonia. Complications (acute respiratory distress syndrome, shock, acute cardiac injury, secondary infection, and acute kidney injury) and death may occur in severe cases. Recent reports showed that extrapulmonary symptoms (intestinal symptoms in 10-20% of patients) and renal failure in some patients may be associated with the interaction of the virus with angiotensin-converting enzyme 2 (ACE-2) receptors in other organs. It was suggested that ACE-2 expression in the kidneys can be the cause of kidney injury occurring in a number of patients with SARS-CoV-2.However, ACE-2 is not the only possible cause of kidney injury - sepsis-related cytokine storm can also lead to damage of kidney parenchyma.

The present study aims to explain the mechanisms of kidney injury in patients diagnosed with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Pneumonia confirmed by CT scans

Exclusion Criteria:

* a history of chronic renal failure;
* a history of kidney transplantation;
* intake of substances with a history of renal toxicity (no later than a month before inclusion);
* patients with a single kidney;
* refusal of the patient to participate in the study;
* absence of SARS-CoV-2 virus smear from the nasopharynx in PCR.
A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART

To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity.

Patients receive oral thalidomide in a blinded, placebo-controlled study. \[AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.\]

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection.
* CD4+ cell count between 300 and 500 cells/mm3.
* HIV-1 RNA \< 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry \[AS PER AMENDMENT 11/25/98:
* Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test\].
* Established B cell lines \[deleted AS PER AMENDMENT 11/25/98\].
* Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses.
* Life expectancy \> 6 months \[deleted AS PER AMENDMENT 11/25/98\].

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Active opportunistic infection or HIV-related malignancy \[HIV-related malignancy deleted AS PER AMENDMENT 11/25/98\].
* Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.

Concurrent Medication:

Excluded:

* Other investigational HIV-drugs.
* Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.

Patients with the following prior conditions are excluded:

History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.

Prior Medication:

Excluded:

* Previous immunization with pneumococcal polysaccharide vaccine \[or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine\].
* Tetanus toxoid booster within 5 years \[deleted AS PER AMENDMENT 11/25/98\].
* Other investigational HIV-drugs within 6 weeks of enrollment.
* Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment.

Risk Behavior:

Excluded:

Active drug or alcohol abuse.

Required:

Effective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. \[AS PER AMENDMENT 11/25/98:

* On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.\]
Multiparametric Imaging in Multiple Myeloma

Patients with Multiple Myeloma will undergo single timepoint Positron Emission Tomography imaging with intravenously injected C11 Methionine to detect viable lesions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Myeloma with symptomatic bone or soft tissue disease
* Eastern Cooperative Oncology Group status 0 to 2
* Life expectance \>= 12 weeks
* Ability to understand and willingness to sign informed consent
* Tissue sampling with genotype data planned within 3 months of C11 positron emission tomography (PET) imaging

Exclusion Criteria:

* Pregnant or breast feeding
* Claustrophobic reactions and unable to lie still on a bed inside the PET scanner for 60 minutes
* Research related radiation exposure exceeding 50 millisieverts
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma

This study will combine cabozantinib with pemetrexed to treat patients with non-small cell lung cancer, urothelial cancer and advanced malignant mesothelioma. This study will test the safety of both drugs used together and see what effect (good or bad) it has no participants and their cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced NSCLC, urothelial cancer or malignant mesothelioma.
* 18 years or older.
* At least one prior chemotherapy before entering in this trial.
* Not pregnant or breastfeeding.

Exclusion Criteria:

* Prior treatment with cabozantinib.
* Currently receiving cancer treatment (last dose 2 weeks prior to enrollment in study).
* History of bleeding disorder/bleeding history within 12 weeks before first study treatment dose.
Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease

To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in patients with PD treated with Duodopa®. This is in search for an optimal diet that will accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and thus improve motor function and quality of life.

A prospective single-blind-crossover study in patients with PD regularly treated with Duodopa® (LICG) in which three different diets will be given. Diet A: Low fat western diet - traditional low-fat Western diet; a normal diet according to the recommendations of health organizations in which proteins consumed throughout the day, high-protein meal at noon and in the evening.

Diet B: Equal protein redistribution diet (EPRD) - proteins consumption is controlled and equally distributed over six meals throughout the day to minimize motor fluctuations.

Diet C: Protein redistribution diet (PRD) in which proteins are consumed in the morning prior to connection to the pump and in the evening after disconnecting from the . Carbohydrates and fats will be consumed during the day.

Following recruitment and study initiation patients will consume diet A for 3 weeks. Patients will then be randomized into either diet B or diet C for 3 additional weeks. At completion of this period patients will consume diet A for 2 weeks ("wash-out" period) and will then be "crosseovered" to get the third diet (B or C).

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Duodopa at least three months and are stable on medical therapy
* Patients should be not demented, able to fill diaries and to sign an informed consent

Exclusion Criteria:

* Severe dementia
* Inability to fill out diaries
* Unstable mediated condition
* Chronic renal failure
Response to Rotavirus Vaccine in Infants in Ho Chi Minh City in Vietnam

The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam.

The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.

This study will be an open single arm, single centre, interventional study conducted in Ho Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between 8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be requested to bring the infants 2-3 days following each Rotarix vaccination to receive the standard EPI vaccinations. The infants will then be under passive and active surveillance for rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post vaccination and at 6, 12 and 18 month old visits will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations.
* Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months.
* Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies.

Exclusion Criteria:

* Refusal of consent.
* Parent/ guardian under the age of 18.
* Premature (i.e. gestation period \<37 weeks).
* Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations.
* History of hypersensitivity to any components of the vaccine or adverse vaccine event.
* History of intussusception or congenital malformation of the gastrointestinal tract in the child that is likely to predispose child to intussusception.
* History of severe combined immunodeficiency disease (SCID), acquired immune deficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) positivity, or other known immunodeficiency syndromes that may place the child at risk during immunisation.
Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin

The study consists of measurement of antidepressant-induced excessive sweating and its treatment with an experimental medication, terazosin (approved for hypertension), that will be added to the antidepressant. This study is for people who take an antidepressant due to a depressive disorder. This is an open-label study (no placebo group) that will last 5 weeks, with one week of baseline measurement and four weeks of treatment with the study medication. The study is based on the hypothesis that terazosin will be effective in reducing the severity of excessive sweating caused by antidepressant treatment, and will have minimal side-effects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 75 years
2. Clinical diagnosis of a Depressive disorder (Diagnostic and Statistical Manual of Mental Disorders - IV-TR)
3. Presence of excessive sweating by self-report
4. The excessive sweating started after initiation of an antidepressant and, if treatment with the antidepressant was interrupted, did not persist for more than 4 weeks during that interruption
5. Treatment with the antidepressant is deemed to be clinically necessary due to substantial benefit from this antidepressant, and failure to respond to or tolerate an alternative
6. Excessive sweating has persisted for at least 4 weeks prior to baseline assessment
7. The excessive sweating is rated by the patient as at least moderately bothersome.
8. Episodes of excessive sweating occur at least twice a week for last 4 weeks

Exclusion Criteria:

1. Presence of another known disease that could potentially cause excessive sweating
2. Failure to respond to antiadrenergic (reducing activity of the sympathetic nervous system) treatment in the past
3. Blood pressure less than 110 mm Hg systolic at the screening or baseline visits
4. Orthostatic hypotension by history or on assessment at the screening or baseline visits (defined as a decrease of 10 mm Hg or greater after standing for 2 minutes).
5. Current antihypertensive treatment
6. History of significant cardiac disease, including coronary artery disease
7. Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
8. History of priapism (persistent and painful erection)