cyrilzakka/clinical-trials huggingface dataset:
Sleep Restriction and Parental History of Hypertension

The purpose of this study is to research the effects of partial sleep deprivation (sleep restriction) in a group of individuals whose parents have high blood pressure compared to a group of individuals whose parents have normal blood pressure.


Eligibility Criteria:
Inclusion Criteria

* Healthy adults aged 18-35 years
* Absence of any significant medical or psychiatric disease (as per the investigators' judgment)
* Nonsmoker
* Nonpregnant
* History of normal sleep duration (reported average sleep duration between 7-9 hours/night and no habitual napping)
* Both biological parents with medical records from Mayo Clinic or Rochester Epidemiology Project
* Ability to understand study procedures and to comply with them for the entire length of the study
* Ability to understand English and provide informed consent

Exclusion Criteria

* Age \<18 or \>35 years
* Body mass index \<18.5 or ≥30 kg/m2
* Pregnant or lactating
* Unable to determine history of hypertension in participant's biological parents or subject being adopted
* Use of tobacco, vaping, marijuana products or other drugs
* Excessive caffeine consumption (\>400 mg/day)
* Excessive alcohol consumption (\>7 drinks/week for women, \>14 drinks/week for men)
* Office systolic/diastolic blood pressure (SBP/DBP) ≥130/80 mmHg
* Daytime ambulatory SBP/DBP ≥130/80 mmHg
* Fasting glucose ≥126 mg/dl
* Glomerular filtration rate \<60 mL/min/BSA
* History of significant medical or psychiatric disorders (as per the investigators' judgment)
* Regular use of prescription medications other than contraceptives
* Use of melatonin supplements or any other over-the-counter sleep aid
* Moderate-to-severe sleep disordered breathing (apnea/hypopnea index, AHI ≥15) or mild sleep disordered breathing (AHI 5-15) with daytime sleepiness (Epworth Sleepiness Scale \>10)
* Moderate-to-severe insomnia (Insomnia Severity Index \>14)
* Restless leg syndrome (as per the Cambridge-Hopkins questionnaire)
* Excessive daytime sleepiness (Epworth Sleepiness Scale \>15)
* Extreme chronotype (Morningness-Eveningness Questionnaire \>69 or \<31)
* Night shift work
* Habitual high levels of physical activity (\>3000 MET×minutes/week)125
* Ongoing participation in other research studies (as per the investigators' judgment)
* Any other medical, geographic, or social factor making study participation impractical
* Not English-speaking and/or inability to provide informed consent
* Exclusionary for blood draws: hemoglobin \<11.6 g/dL in women / \<13.2 g/dL in men; participants with measured hemoglobin levels below these thresholds will be allowed to continue participate in study tests and procedures not involving blood draws.
Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* Nulliparous women
* gestational age \>=37.0 weeks
* Bishop score \<=6
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure

Exclusion Criteria:

* Multiple pregnancy
* Placenta previa
The Effect of Combined Thermal and Electrical Muscle Stimulation (cTEMS) on Obesity

Objective:

It is unclear whether prolonged electrical muscle stimulation can improve cardiorespiratory fitness and reduce body fat in obese subjects. The purpose of this study is to investigate the effect of prolonged combined thermal and electrical muscle stimulation (cTEMS) on peak oxygen consumption (VO2 peak) and body composition. We will also investigate the biochemical effects and the resultant lipolysis-related gene expression changes in adipocytes.

Methods:Eleven obese (BMI≥30) individuals will receive cTEMS in three 60-minute sessions per week for 8 weeks. Activity levels and dietary habits will be kept unchanged and controlled with an accelerometer and nutritional questionnaire. Before and after the stimulation period, functional capacity are assessed by VO2 peak, and body composition was assessed by dual-energy X-ray absorptiometry and bioelectrical impedance analyses. Lipolytic activity will be determined in abdominal adipose tissue by 24 hours of microdialysis on a sedentary day, and adipose tissue biopsies will be taken for the gene expression analysis.


Eligibility Criteria:
Inclusion Criteria:

* Obese (Body mass index; BMI ≥ 30 kg/m2),
* sedentary subjects (\< 20 minutes of exercise \< 3 days per week).
* Other inclusion criteria were age between 30 and 70 years and
* the ability to undergo exercise testing.

Exclusion Criteria:

* Pacemaker or implanted defibrillator,
* regular medication,
* cardiovascular disease,
* pulmonary disease,
* extensive dermatological disease or other primary diseases;
* pregnant women;
* and individuals who abuse alcohol or drugs were excluded from the study
Predictive Factors in Response to Inhaled Corticoids in Chronic Cough

The hypothesis is that a high fractional exhaled nitric oxide can predict the response to inhaled corticoids in chronic cough.


Eligibility Criteria:
Inclusion Criteria:

* chronic cough

Exclusion Criteria:

* active smoker
* treated by corticoids during the previous month
* use of angiotensin-converting-enzyme inhibitor
RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.

Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.

Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in \~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Eligibility Criteria:
Inclusion Criteria:

* biliary atresia

Exclusion Criteria:

* \<100 days at portoenterostomy
* no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
* anu contra-indications to corticosteroids
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.

Our studies will systematically investigate and establish evidence on whether Cone-beam computed tomography (CBCT) of the temporal bone could be used in the diagnosis and treatment of otosclerosis and in the post-operative follow-up after stapedotomy.

Cone-beam CT has a high resolution and a low effective radiation dose to the patient when compared to conventional CT-scans. Surgical treatment of otosclerosis is primarily by stapedotomy. The decision of surgical treatment is currently based on the history, clinical examination, and audiological tests, but stapes fixation can only be confirmed per-operatively.

This protocol includes the following overall aims for the following studies:

* To establish the diagnostic precision of clinical CBCT in diagnosing otoslcerosis, i.e., the sensibility and specificity for our scanning protocols (n=50).
* To determine if CBCT can support the clinicians' decision making in the diagnosis of otosclerosis (n=100).
* To assess the value of CBCT in the planning of stapes surgery. Two groups will be established: CBCT-based pre-operative planning (e.g., prothesis parameters and anatomic landmarks) and no-planning (standard treatment). Patients will be allocated by 1:1 randomization (n=75).
* To assess the value of CBCT in the post-operative follow-up of 2-3 weeks, 2-3 months, and 12 months. Follow-up includes a clinical examination, audiometry, CBCT (block-randomized), and patient questionnaires (audiometry and patient questionnaire not at the "2-3 weeks" control) (n=75).
* To assess the value of pre-preoperative CBCT on post-surgical result at follow up (2-3 weeks, 2-3, months and 12-months) (n=75).

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years of age).
* Referred to our department suspected for otosclerosis.
* Consents to participation in the project.

Exclusion Criteria:

* A history of surgical treatment for otosclerosis (ipsilateral ear).
* A history of tympanoplasty type 2-4 (ipsilateral ear).
* Other competing middle-ear diseases (ipsilateral ear).

Inclusion and exclusion criteria for patients enrolled for post-surgical follow-up are the same as above in addition to:

Exclusion:

- Intraoperative findings not supporting otosclerosis.
Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery

Breast cancer patients often have perioperative emotional disorders such as anxiety and depression, which can lead to poor quality of recovery.This study aims to determine whether ketamine could improve the quality of recovery in breast cancer patients. Meanwhile, it will show if ketamine could improve anxiety, depression, postoperative pain and fatigue.This trial also will bring great concerns on patients' mental health perioperatively and explore the measures to improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologists Grade I-II
2. Patients undergoing elective breast cancer surgery under general anesthesia

Exclusion Criteria:

1. Unstable hypertension, history of heart disease
2. Hepatic or renal dysfunction
3. Patients undergoing chemotherapy before surgery
4. Have a history of chronic pain or chronic use of analgesic
5. Have mental illness or can't cooperate with investigators
6. Have a history of ketamine allergy
The Effect of Long-Chain Polyunsaturated Fatty Acids on Cognitive Performance and Mood

The study investigates whether dietary intake of omega-3 long-chain polyunsaturated fatty acids affects learning and mood of healthy young adults.

The long-chain polyunsaturated fatty acids (LCPUFA) EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid) of the omega-3 series and AA (arachidonic acid) of the omega-6 series are building blocks of all cell membranes and are found in high concentrations in retina and brain. Food sources of LA and ALA are vegetable oils, nuts and seeds. Since low conversion rates from ALA to DHA are a characteristic of human metabolism, adequate dietary provision with the long-chained omega-3 molecules depends primarily on individual eating habits. While AA is abundant in meat and dairy products, EPA and DHA are found in noteworthy concentrations only in certain species of fatty fish, such as salmon or mackerel.

The study investigates whether participants receiving an omega-3 supplement over a period of 4 month, perform better on a series of cognitive tests, than the participants allocated to the placebo group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy young adults

Exclusion Criteria:

* Coagulation disorder
Morphology Effects of Extended Wear Hearing Instrument

The lyric hearing device is a commercially available device produced by Sonova, and designed to be used for extended periods of time. We further want to investigate the morphology of the tissue around the device at different periods of time after the device has been fitted and used for a while.

An initial imaging of the tissue will be taken for baseline measurements. Questionnaires will also be used to assess patients satisfaction with the device and cognitive abilities.

If the person seems to be a good candidate for the study, the Audiologist could discuss with the patient the time involved in the study and arrange an appointment with the patient if interested.

A series of appointments are designed to follow up the patient's development with the device at determined times during the process. On the first appointment the patient will be consented prior to any tests or health services given.

The first and last appointments are the longest ones with a duration of about 1 and a half hours for questionnaires, medical history, and device fitting. Additionally, all appointments include measurement of ear canal relative humidity which should take a total of 30 minutes and imaging of the area to determine thickness and blood flow in the tissue surrounding the device. Follow-up appointments with the Audiologist will take 45 minutes for all basic procedures. The Lyric device is used commercially and Audiologist can provide it to patients already, but the purpose of this study is to use a pioneer technique with a device that looks inside the ear canal in the same way as a regular used speculum to look at details of the tissue around the device to see if any changes occur due to extended wear of the Lyric hearing aid device.

The complete study per person will be completed in about six months. An Audiologist will perform all the audiology testing plus the ear canal humidity measurements and his/her time will be covered by the sponsor (a total of 9 hours per patient). The Lyric devices will be provided on loan by the sponsor as well as the equipment and software needed to make the ear canal humidity measurements. The imaging measurements will be conducted by the Audiologist trained in using the handheld device.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients in the USC Otolaryngology Clinic who are determined to be candidates for a Lyric extended wear hearing aid device by their treating Audiologist (in general people with mild to moderate hearing loss may be eligible).

Exclusion Criteria:

* Patients in the USC Clinic who are determined by the Audiologist not to be good candidates for the Hearing aid extended wear device (in general, people with severe hearing loss are not eligible).
Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.

To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* have ocular health within normal limits.
* have blood (hematology, blood chemistry) and urine analysis within normal limits.
* have a body weight within 15% of ideal weight

Exclusion Criteria:

* have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol;
* have any active systemic or ocular disorder other than refractive disorder.
* have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the Investigator's opinion could affect ophthalmic drop absorption.
* have a history of chronic alcohol consumption.
* consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at Visit 1 or anticipated use during the study.
* have a history of tobacco, nicotine, or nicotine containing product use within the last year prior to Visit 2;
* have significant weight change (over 10 pounds) within the 60 days prior to Visit 2;
* have blood donation or equivalent blood loss of 450 ml or more, within 60 days prior to Visit 2;
* have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg);
* have intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859 (NCT00870467))

The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.

This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).

Eligibility Criteria:
Inclusion Criteria:

* The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.

Exclusion Criteria:

* Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.
Envafolimab as First-line Treatment of Aged Patients in Advanced NSCLC

Explore the efficacy and safety of Envafolimab in first line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression, view to providing better treatment options for elderly patients with high PD-L1 expression and improving the survival and prognosis of patients .


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent.
* Age strictly at least 70 years.
* Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of locally advanced (stage IIIb/IIIc), metastatic, or relapsing (stage IV) according to the American Joint Committee on Cancer Staging Handbook.
* Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region.
* No previous systemic chemotherapy for lung cancer.
* PD-L1≥50% in tissue samples detected by immunohistochemistry.
* PS 0 or 1.
* Life expectancy sup 12 weeks.
* Normal hematologic function.

Exclusion Criteria:

* EGFR-sensitive mutations or ALK rearrangements
* Previous treatment with immune checkpoint inhibitors
* Presence of symptomatic brain metastases；
* Chinese patent medicine with anti-lung cancer indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for the local use of pleural effusion control) for systemic treatment；
* Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ；
* Concurrent administration of one or several other antitumor therapies；
* Concurrent participation in another clinical trial；
* Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial；
* Systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initial administration；
* Contraindication to the study drugs；
* Has not fully recovered from toxicity and/or complications caused by any intervention prior to the commencement of treatment (i.e., grade 1 or baseline, excluding fatigue or hair loss);
* A history of human immunodeficiency virus (HIV) infection;
* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);
* Active HCV infected;
* Recent vaccination within 30 days before the first administration (cycle 1, day 1);
* Other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).
Clinical Trial of Ultra-high Dose Methylcobalamin for ALS

To examine the clinical efficacy and safety of ultra-high dose (50mg, im, twice a week) methylcobalamin in retarding the progression of symptoms in amyotrophic lateral sclerosis (ALS) patients, we enroll ALS patients diagnosed by Updated Awaji Criteria within 12 months after the clinical onset. First they are followed for 12 weeks with Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) scores, and only those who exhibit drops of 1-2 points are allowed to enter into the test period. A total of 128 patients are randomized and the half having placebo. They are blindly evaluated for drops of ALSFRS-R in 16 weeks, as the primary outcome. After this, all subjects receive methylcobalamin.


Eligibility Criteria:
Inclusion Criteria:

Treatment and OLE Phase:

* ALS patients within 12 months after clinical onset at the entry
* Diagnosed based on updated Awaji criteria: definite, probably or laboratory supported probable
* Decline of ALSFRSR being 1 or 2 during observation period of 12 weeks
* Japanese Clinical Severity Scale 1 or 2
* Those who can visit the participating medical centers

Tsunagi Phase:

- The subjects for the Tsunagi phase are patients with ALS who are continuing the administration of this drug at the time of approval, and have obtained consent for the transition to the Tsunagi phase.

Exclusion Criteria:

Treatment and OLE Phase:

* Those who have tracheostomy
* Those who had NIPPV
* %FVC\<60%
* Those who have Chronic Obstructive Pulmonary Disease (COPD)
* Those who have symptoms and signs of B12 deficiency
* Those who had edaravone less than 4 weeks prior to entry
* Those who changed the schedule and dosing of riluzole
* Those who have dementia
* Those who have the possibility of pregnancy
* Those who have serious respiratory or cardiac diseases
* Those who have malignancies
* Those who participated other clinical trials within 12 weeks
* Those who have allergies to B12 and related compounds

Tsunagi Phase:

Not applicable.
Ginger Capsules for the Chronic Treatment of Obesity

Regarding its complex pathogenesis and clinic-epidemiological meaning, different strategies are needed for the treatment of obesity. Ginger is the rhizome of a plant with thermogenic and anti-inflammatory effects, and may be a promising alternative as add-on strategy in the treatment for obesity. The primary objective of the current study is to assess whether consumption of ginger as an add-on strategy to restrictive diet is effective to reduce fat body percentage, increase basal metabolic rate and improve loss weight.

The secondary objectives are:

* to assess the effect of nutritional intervention in quality of diet and weight loss.
* to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in overweight subjects.

Overweight individuals will be interviewed at baseline and after 30, 60, 90, 120, 150 and 180 days from baseline. The following measures will be assessed: body composition (fat body% and free fat body%), anthropometric measures (height, weight, body mass index, waist circumference and abdominal circumference), blood pressure, basal metabolic rate, behavioral symptoms, binge eating (binge eating scale) and peripheral biomarkers. Behavioral symptoms will be assessed using the following self-reported questionnaires: Beck Depression Inventory (depression symptoms), Beck Anxiety Inventory (anxiety symptoms), Medical Outcomes Study 36 - Item Short - Form Health Survey (quality of life) and Perceived Stress Scale (stress).

Enrolled participants will receive restrictive diet calculated on individual requirements aiming at the loss from two to four kilogram per month in addition to capsules of ginger or placebo, as follows:

* Group 1 will receive vials containing 90 capsules of 200mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months in addition to restrictive diet.
* Group 2 will receive vials containing 90 capsules of 200mg of placebo (cellulose) to be taken three times a day for six months in addition to restrictive diet.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-60 years old;
* Body mass index 25-35 kg/m².

Exclusion Criteria:

* Pregnant or lactating women;
* Abuse of alcohol or drugs;
* Hypersensitivity to ginger;
* Other endocrine disease;
* Women in use of insulin or anti-inflammatory and antidepressants drugs.