cyrilzakka/clinical-trials huggingface dataset:
A Trial of Negative Ion Generation Versus Light-Emitting Diode Phototherapy for Seasonal Affective Disorder (SAD)

This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.

This is a randomized, controlled clinical trial comparing an inactivated negative ion generation (placebo condition) and light-emitting photodiode therapy (active condition), for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. Exclusion criteria included any other current treatment for SAD, as well as bipolar disorder, type 1, a chronic psychotic disorder, or a substance use not if full remission for at least one year. The trial has a 1 week baseline phase and subjects were seen weekly during a 4 week treatment phase. The study was double-blind. The study was conducted at 8 sites in the US, Canada and The Netherlands.

Eligibility Criteria:
Inclusion Criteria:

* Seasonal Affective Disorder
* Age 18 to 65

Exclusion Criteria:

* Psychotropic medication treatment
* History of light treatment for SAD
* History of mania or psychosis
Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting

Women with chronic medical conditions have been found in multiple studies to use birth control less often compared to women without chronic medical conditions. The investigators hypothesized that approaching women with chronic medical conditions who were admitted to the hospital and having a bedside conversation about pregnancy intention and counseling regarding birth control usage along with offering to start birth control before discharge would increase the use of birth control in this population. As a separate intervention, the investigators hypothesized that having a brief conversation with the participants and then giving them a flyer that recommended talking with their doctor about birth control could also increase the use of birth control in this population.


Eligibility Criteria:
Inclusion Criteria:

* Currently admitted to the hospital
* Has one or more qualifying chronic medication conditions listed in their chart (hypertension, obesity with BMI\>35, diabetes, current or history of breast cancer, rheumatoid arthritis, sickle cell disease, or lupus)

Exclusion Criteria:

* Currently pregnant
* Using surgical or non-surgical contraception
* Immediately post-partum or admitted to the gynecology service
* Non-English speaking
* Non-verbal or too ill to consent
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia
* PANSS-T of at least 70 at screening and baseline

Exclusion Criteria:

* Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
* DSM-IV diagnosis of psychiatric disorder other than schizophrenia
A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUGANO) Primary Efficacy Will be Determined at Week 56

This is a phase 3 randomized, double -masked study comparing the efficacy of EYP-1901 against Aflibercept.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated or treatment naïve patients with a documented diagnosis of wAMD in the study eye, with onset of disease that began at any time prior to the Screening Visit.
* Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score between 78 to 35 letters (approximately 20/32 to 20/200 Snellen equivalent) in the study eye at the Screening Visit and on Baseline (Day 1).
* For previously-treated subjects, must have been treated with at least 2 anti-VEGF IVT injections (i.e., aflibercept 2 mg, aflibercept 8 mg, bevacizumab, ranibizumab, or faricimab) in the previous 6 months for wAMD per standard of care in the study eye prior to the Screening Visit.

Exclusion Criteria:

* Subfoveal fibrosis, atrophy, or scarring in the center subfield.
* BCVA using ETDRS charts \<20 letters (20/400 Snellen equivalent) in the fellow eye.
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women aged 18 to 49 years
* Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1
* Must be sexually active and at risk for becoming pregnant.

Exclusion Criteria:

* Planned use of any other form of birth control other than the test article.
* Depression requiring hospitalization or associated with suicidal ideation within the last 3 years.
* High blood pressure (defined as elevated sitting blood pressure: \> 140/90 mm Hg).
Prolonged Pulsatile Kisspeptin Administration in Hypogonadotropic Hypogonadism

The goal of this study is to develop novel treatments for patients with a condition called hypogonadotropic hypogonadism (HH) through the use of exogenous kisspeptin.

* Assignment: Each study subject will serve as their own control. The order of kisspeptin doses will be randomized within each set/exposure.
* Delivery of Interventions:

  * Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories. Subjects will also wear a gonadotropin releasing hormone (GnRH) pump prior to the inpatient study visit.
  * On the day of the inpatient study, the subjects will

    * Undergo q10 min blood sampling for 6 hours,
    * Receive kisspeptin intravenous (IV) boluses from hour 6 to hour 44 (20 boluses total),
    * Undergo q10 min blood samplings for another 6 hours,
    * Receive a single GnRH IV bolus at hour 51.

Eligibility Criteria:
Inclusion/exclusion criteria:

* Age 18 years and older,
* Confirmed diagnosis of HH with

  * Low testosterone or estradiol,
  * Low or low-normal gonadotropin levels,
  * Thyroid stimulating hormone (TSH) and prolactin within the reference range,
  * Absence of abnormal pituitary or hypothalamic findings on Magnetic resonance imaging (MRI),
* All other medical conditions stable and well controlled,
* No prescription medications known to affect reproductive endocrine function for at least 2 months or for 5 half-lives of the drug (whichever is shorter) except for medications used to treat the subject's reproductive condition,
* No history of a medication reaction requiring emergency medical care,
* No illicit drug use,
* No excessive alcohol consumption (\<10 drinks/week),
* Normal blood pressure (BP), (systolic BP \< 140 mm Hg, diastolic \< 90 mm Hg),
* White blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
* Prolactin below 110% of the upper limit of the reference range,
* Hemoglobin

  * Women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
  * Men: on adequate testosterone replacement therapy: normal male reference range,
* Blood urea nitrogen (BUN), creatinine, aspartate aminotransferase (AST), alanine transaminase (ALT) not elevated,
* For women,

  * Negative serum human chorionic gonadotropin (hCG) pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration),
  * Not breastfeeding and not pregnant.
High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Gastroscopy Sedated by Propofol

Hypoxia is the most common adverse events during sedated gastroscopy. In present study, high-flow nasal cannula oxygenation will be utilized in order to reduce the hypoxia. At the same time the feasibility and safety will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing gastroscope
* age over 18 years old
* Signed informed consent form

Exclusion Criteria:

* Coagulation disorders or a tendency of nose bleeding;
* An episode/exacerbation of congestive heart failure (CHF) that requires a change in medication, diet or hospitalization from any cause in the last 6 months;
* Severe aortic stenosis or mitral stenosis;
* Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months;
* Acute myocardial infarction in the last 6 months;
* Acute arrhythmia (including any tachycardia - or bradycardia) with hemodynamic instability;
* Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy);
* Increased intracranial pressure;
* ASA \>III;
* Mouth, nose, or throat infection;
* Fever, defined as core body temperature \> 37.5oC ;
* Pregnancy, breastfeeding or positive pregnancy test
* Emergency procedure
Optimal Intravesical Lidocaine Volume for Pain Relief During Office Intra-detrusor Onabotulinum Toxin a Injections

The purpose of our study is to evaluate the efficacy and safety of different volumes of bladder-numbing medication for pain relief at the time of office bladder Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

The volume of 2% intravesical lidocaine solution and efficacy for pain relief at the time of office intradetrusor Botox A injection has not been well studied. Studies evaluating intravesical lidocaine show that it is not sufficiently absorbed by human bladders to achieve serum toxicity levels and only provides superficial local anesthetic effect. Experts agree that intravesical local anesthetic can be given in the office, with approximately 30 to 40 mL of 2% lidocaine instilled via catheter into the bladder for about 20 minutes before injection. However, there is little evidence regarding this strategy, and future research would help standardize recommendations.

The purpose of our study is to evaluate the efficacy and safety of higher volume pre-procedure intravesical lidocaine solution for pain at the time of intradetrusor office Botox injections. This is a randomized prospective, double-blind superiority trial comparing 200 ml 2% lidocaine versus 30 ml 2% lidocaine for office Botox injections.

Eligibility Criteria:
Inclusion Criteria:

* Adult female, \>18 years, English-speaking (surveys utilized are not validated in all languages)
* Able to provide informed consent
* Indications: Refractory urge urinary incontinence, Refractory urinary urgency and frequency, Neurogenic bladder (without sensory deficit)

Exclusion Criteria:

* Untreated urinary tract infection at the time of procedure
* Contra-indication to Botox
* Contraindication to intravesical lidocaine
* Inability to provide informed consent
* Pregnancy, breast-feeding, intending to become pregnant within 6 months of treatment
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or metastatic breast cancer.The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-70 years old
* ECOG 0-1
* Expected lifetime more than 12 weeks

Exclusion Criteria:

* Pregnancy
* Brain Metastasis,
* Severe Infection
Effect of Ethnicity on Changes in VO2max and Cardiac Output in Response to Short-Term High Intensity Interval Training

The purpose of this study was to determine if ethnicity alters training responsiveness to a low dose of high intensity interval training in inactive women.

Prior to the session, women completed a 4-minute warmup at 10 % PPO. Each subject completed 9 sessions of HIIT over a 3-week period which consisted of eight to ten 1-minute bouts of cycling at 85% PPO with 75-second recovery between bouts at 10 % PPO. This protocol is well-tolerated in inactive individuals. Continuously during each session, heart rate was monitored using telemetry. On days 1, 3, 6, and 9 of training, the physical activity enjoyment scale (PACES) was completed. VO2max and cardiac output max were assessed prior to training, as well as post.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Between the age of 18-45
* Healthy and non-obese (BMI \< 30 kg/m2)
* Perform less than 150 minutes per week of exercise in the last 12 months
* 100% Caucasian or 100% Hispanic

Exclusion Criteria:

* Injured
* Obese
* Active
* Mixed ethnicity
Compare the Pharmacokinetic of K-877 Controlled Release (CR) and Immediate Release (IR) Tablets in Healthy Adults.

A study to compare the pharmacokinetics of 3 types of K-877 controlled release tablets with a current normal K-877 tablet in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check-in assessments.
* Subject has a supine blood pressure (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (males) or 50 mm Hg diastolic (females). If the initial blood pressure is out of range, blood pressure may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
* Subject has a supine pulse rate (as measured at Screening during the collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute. If the initial pulse rate is out of range, the pulse rate may be repeated after the subject has maintained a rested position in a quiet environment for at least 10 minutes.
* Subject does not meet any exclusion criteria outlined in the clinical study protocol.
Perımenopausal Women's Attıtudes Towards Menopause and Spırıtual Well-Beıng

Menopause; cessation of menstruation due to cessation of follicular activity is the transition from the reproductive period to non-reproductive life. Considering that the average life expectancy is increasing, women spend most of their lives in the menopausal period. Women who have a positive attitude towards menopause have a positive body image, experience less depressive experiences, and the severity of menopause symptoms decreases. It has also been assumed that spiritual well-being is effective in reducing the severity of menopause symptoms and anxiety, supporting positive body image, and coping with losses.

Baduanjin exercise is a type of body mind exercise. It increases the production of life energy and distributes it to different aspects of the body.

It is thought that the baduanjin body-mind exercise to be applied to perimenopausal women will have positive effects on the spiritual well-being of menopausal women and their attitudes towards menopause. Thus, it is expected that women's transition and adaptation to the menopause process will be easier.

This study will be carried out as a pre-test - post-test randomized controlled experimental study. The population of the research consists of female patients between the ages of 45-55 who are registered to a family health center located in a provincial center in the north of Turkey. Women who are in the perimenopausal period and meet the inclusion criteria according to the Staging of Reproductive Aging in Women (STRAW) criteria will be included in the study. The random.org program will be used to unbiasedly assign 60 women who meet the research criteria to the experimental and control groups.

The menopause adaptation program will be applied to the intervention regimen. This program, which will be applied to the experimental group, was prepared based on the Meleisin Transition theory. Since women's menopause is a transition process, the transition theory was preferred. Within the scope of the program, the experimental group will be given online menopause health education for the first 6 weeks and baduanjin exercise will be taught. For the next 8 weeks, individuals will be asked to practice the baduanjin exercise 3 times a week. Online consultation will be provided during this period.

The study will be completed in 14 weeks in total. No intervention will be applied to the control group. The study will be terminated after the post-test data is collected. Data will be collected using the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ, Spirituality Index of Well-Being Scale).

Eligibility Criteria:
Inclusion Criteria:

* Being in the perimenopausal period
* Being between the ages of 40-55
* Having entered menopause naturally
* Volunteering to participate in research

Exclusion Criteria:

* Having a physical problem that prevents exercise
* Being on hormone therapy
* Not having a menstrual period for more than 8 months
* Not using a smartphone
Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease

This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol. No investigational treatments or standard treatments will be administered on this protocol.

Background:

* Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
* Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.

Objectives:

-To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.

Eligibility:

-Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.

Design:

* The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
* Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
* Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.

Eligibility Criteria:
* ELIGIBILITY CRITERIA:

Patients of any age who were previously enrolled on a CCR protocol.

Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.

CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.

Patient or Legally Authorized Representative (LAR)/guardian is able to provide informed consent.
Study of Hepatic Arterial Infusion to Treat Biliary Tract Carcinomas

This Phase II clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (HAI) of Oxaliplatin and Fluorouracil in Patients with Unresectable Biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have histologically or cytologically confirmed Biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer without evident liver metastasis.
* Patient must have locally advanced disease that is unresectable after review by the Hepatobiliary Surgery service
* Patient's Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Hemoglobin \>= 90g/L
* Total bilirubin =\< 2 X institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normality
* Creatinine =\< 1.5 X institutional upper limit of normal
* Albumin \>= 30g/L
* Patient must be able to understand and willing to sign a written informed consent document

Exclusion Criteria:

* Patients who have had prior chemotherapy and other antitumor therapy treatment
* Patient who is receiving any other investigational agents
* Patient who have evident distant (M) disease;
* Patient who have a diagnosis of hepatic encephalopathy
* Patients who have a diagnosis of sclerosing cholangitis.
* Patients who have a diagnosis of Gilbert's disease.
* Patients who have clinical ascites
* Patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements
* No other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years
* Patient who is pregnant or lactating
* Patient Allergic to Iodine contrast medium
* Uncontrolled severe coagulation disorders (INR \< 1.5 in patients not on warfarin therapy)