cyrilzakka/clinical-trials huggingface dataset:
Tandospirone Citrate in the Treatment of Patients With Generalized Anxiety Disorder

The purpose of this study is to evaluate the efficacy and safety of comparative high dose Tandospirone Citrate in the treatment of patients with generalized anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Male or female
* Diagnosed with GAD according to DSM-IV
* HAMA score≥17
* Provide with written informed consent
* Agree to be washed-out for two weeks if receiving SSRI, SNRI or NASA.

Exclusion Criteria:

* Serious suicidal tendency
* The score of the sixth item of HAMA ≥3
* The score of HAMD ≥21
* Pregnant or lactating women
* History of allergic or hypersensitivity to tandospirone
* Serious or unstable cardiac, renal, neurologic, cerebrovascular, metabolic, or pulmonary disease
* Secondary anxiety disorders
* Drug or alcohol dependence within 1 year
* Patients currently taking benzodiazepine drugs
* Drivers and dangerous machine operators
* Participated in other clinical studies in the last 30 days
* Patients with clinically significant ECG or laboratory abnormalities
* Patients with a history of epilepsy
* Patients with abnormal TSH concentration
Automatic Diagnosis of Spinal Stenosis on CT

MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis.

MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis. It would be a time-saving workflow if the software can assist the radiologists to detect and locate the suspected lesion.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* with radiologists' CT reports on cervical, thoracic and lumbar stenosis

Exclusion Criteria:

* not applicable (only specific levels with extensive infections, fractures, tumor, high-grade spondylolisthesis would be excluded for analysis).
Randomized Clinical Trial to Evaluate the Effect of Dapagliflozin in Patients with Diabetic Macular Edema

The purpose of this clinical study is to explore the efficacy of dapagliflozin as an adjunct to intravitreal anti-vascular endothelial growth factor (anti-VEGF) for enhanced reduction of retinal thickness and vision improvement in patients with diabetic macular edema. The main question the study aims to answer is: Does dapagliflozin reduce the thickness of the macula when combined with the standard of care intravitreal anti-VEGF therapy more than the intravitreal anti-VEGF therapy alone?

Some evidence in the literature suggests that sodium glucose co-transporter 2 (SGLT2) inhibitors may be beneficial in reducing diabetic macular edema. The objective of this clinical trial is to investigate the efficacy and safety of dapagliflozin when combined with intravitreal aflibercept injections in the management of patients with type II diabetes mellitus and center-involved diabetic macular edema (ci-DME). This randomized, double-blind, parallel group, active control design, clinical trial, is investigating the effect of oral dapagliflozin 10 mg given once daily in addition to intravitreal aflibercept versus intravitreal aflibercept alone on reducing macular central subfield thickness (CST) and improving visual acuity in diabetic patients with ci-DME.

Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes mellitus (DM) adult patients, on premixed insulin and metformin, who are diagnosed with center-involved diabetic macular edema (ci-DME)

Exclusion Criteria:

* Patients below 18 years old
* Patients with type I diabetes mellitus (Insulin dependent diabetes mellitus IDDM)
* Pregnant and lactating women
* Patients with other causes of macular edema such as retinal vein occlusion
* Patients who had previous macular laser treatment in the affected eye
* Patients who had previous peripheral panretinal photocoagulation laser (PRP) treatment in the affected eye during the past 6 months
* Patients who had been treated with intravitreal anti-VEGF injections in the affected eye during the past 6 months
* Patients who had myocardial infarction within 3 months of recruitment
* Patients who had stroke within 3 months of recruitment
* Patients with severe hepatic impairment of Child-Turcotte-Pugh class C
* Patients treated with antidiabetic drugs thiazolidinediones (TZD) (rosiglitazone and pioglitazone)
* Patients already on SGLT2 inhibitor drugs (dapagliflozin, canagliflozin, or empagliflozin) before recruitment
* Patients on topical prostaglandin analogs (e.g., latanoprost, travoprost, ioprost, and tafluprost)
* Patients diagnosed with ocular surface infections until treated
Masculine Norms and Skin Care Knowledge, Attitudes, and Behaviors

Examining whether men with greater Avoidance to Femininity subscores using the Male Role Norms Inventory - Short Form will demonstrate differences in skin care knowledge, attitudes, and behaviors, compared to men with lower subscores.

This purpose of this study is to examine whether a man's adherence to traditional masculine norms correlates with his skin care attitudes or behaviors. A stronger understanding of these associations may enable dermatologists to better understand their patient's perception of skin care. The utility of this knowledge lies in creating outreach interventions and informing risk stratification. The study also seeks to determine whether skin care knowledge varies by adherence to masculine norms. This knowledge can be used to guide patient education in a clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 or older
* Subjects identity as Male
* Reside in the United States
* Able to complete an online survey published in English

Exclusion Criteria:

- Subjects who do not meet the inclusion criteria - Subjects who have previously completed the study
Cognitive Training Through Gaming and Walking

This pilot study estimates the preliminary efficacy of a walking regime with or without a gamified inhibitory control training app (PolyRules!) on cognitive outcomes among healthy adults.

This pilot study examines the preliminary efficacy of combining a walking regimen with gamified inhibitory control training (PolyRules!), compared to walking alone, on cognitive outcomes among healthy adults (ages 18 and over). Participants (n=30) will first be asked to wear a Fitbit for one week to capture baseline activity. Participants will then be randomized to (1) walking alone regimen or (2) walking + gamified inhibitory control training for three weeks. Cognitive assessments will be conducted at enrollment and at the end of the 4-week study protocol. The primary outcome is performance changes in attention and inhibitory control \[Cancellation task, Flanker task, and Rule Set task\]; And working memory capacity \[N-Back task, Letter-Numbers task, and Corsi task\]. Engagement and adherence will be operationalized as the frequency and duration of cognitive training passively recorded on the PolyRules! app and frequency and duration of walking as monitored by Fitbit data. Qualitative indicators will also be collected via semi-structured interviews to capture participants' satisfaction, perceived benefits of- and/or barriers to engaging with the cognitive training and/or walking regimens.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, write, and speak English with acceptable visual and auditory acuity, as the app is only available in English
* Able and willing to walk independently with or without walking aids
* Able and willing to engage in 30 minutes of walking daily
* Able and willing to wear a fitness tracking device (e.g. Fitbit)
* Not currently engaging in a daily walking regimen of 30 minutes or more a day

Exclusion Criteria:

* Visual impairments that would preclude participants from using the app
* Undergoing active cancer treatment
* Diagnosis of peripheral neuropathy, severe musculoskeletal or neurodegenerative disease (e.g. dementia, multiple sclerosis, Parkinson's disease, Huntington's disease, etc.)
* Taking medications that may affect cognitive function
* Pacemaker, implantable cardiac defibrillator, neuro-stimulation devices, cochlear implants, implantable hearing aids, or other electronic medical equipment
A Comparative Study of Subjects Past Their Final Follow-ON Visit

A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.

A comparative study to follow subjects who received stem cell therapies three, five, seven, nine, and thirteen years after their follow-on visit. Subjects will be selected from a pool of previous Interdisciplinary Stem Cell Institute trial participants.

Subjects will be followed during the study depending on the initial visit for this trial. The time point at which they are followed will depend on the subject's injection date in the previous trial. Depending on the subjects first treatment date (Day of injection) in the previous Interdisciplinary Stem Cell Institute (ISCI) cardiovascular clinical trial, subjects may be eligible for one to four study visits in this trial. Those who do not have a three, five, seven, nine or eleven year visit may receive informed consent at the year thirteen visit. Thus, subjects can be enrolled and consented at any visit if the previous eligible visit was missed.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age and older
* Provide written informed consent
* Have been previously enrolled or currently participating in an investigator-initiated cardiovascular trial at ISCI (In cases where participants are currently enrolled in another clinical trial they are still able to participate concurrently in this trial).

Exclusion Criteria:

* Have known, serious radiographic contrast allergy, which cannot be managed with premedication only if able to undergo MRI or CT.
* Have a history of drug or alcohol abuse within the past 24 months
Effects of T-bet B Cells in Persistent Virus Control After Discontinuance of NAs in CHB Patients

The immune mechanism of the nucleos(t)ide analogs (NAs) in inhibiting HBV replication effectively while having a low sustained virus control rate after drug withdrawal is unclear. B cell immunity and antibody response are the keys to prevent HBV reinfection and keep the virus under control. T-bet+ B, which can be regulated by IL-21, is a newly discovered major effector B cell in protection of pathogens and it is a main subtype of HBsAg-specific B cells. Thus, we suspect that T-bet+ B may play a role in ongoing controlling of the virus after withdraw of NAs in CHB patient. Based on our previous studies on CHB immunity, we use the RNAseq analyse, flow cytometry, and Elispot assay to analyze the frequency, function, and phenotype of B cells in CHB patients with different profiles after withdraw of NAs.


Eligibility Criteria:
Inclusion Criteria:

18 to 70 years old, no gender restriction, serum HBsAg positive than 6 months, can understand and sign informed consent, good compliance.

Exclusion Criteria:

coinfected with other hepatotropic virus such as hepatitis C virus,hepatitis D -virus,hepatitis E and hepatitis A etc; coinfected with HIV, markers such as ceruloplasmin, anti-nuclear antibodies and anti-mitochondrial antibodies for co-existent autoimmune and metabolic liver diseases were positive, with hepatocellular carcinoma(HCC) with uncontrollable extrehepatic disease, received glucocorticoid or other immune inhibitor therapy, pregnancy
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)

Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination

In France, 1 couples out of 5 consults for suspected infertility. Hysterosalpingography is the first line diagnostic examination in this course and can sometimes be therapeutic. This gynecological examination is invasive in nature, this exam requires an administration of iodinated contrast product by the endocavitary route.

Hysterosalpingography is the most painful examination in this treatment path and pain's assessment is classified as strong by the French National Authority for Health (Haute Autérité de Santé) and anxiety-inducing. For these patients, drug analgesic treatments remain ineffective or contraindicated in outpatient mode. Ionizing irradiation is a constraint that makes hypnosis unsuitable.

Several studies show the contribution of a virtual reality headset in reducing pain and anxiety by inducing patients in an hypnotic environment. This tool standardizes interventions based on changes in consciousness. It is an easy-to-use, non-drug analgesia with few side effects and inexpensive.

The environment offered by this medical device is based on evidence to peacefully escort patients on a journey of natural elements. Calm music is made up of key elements of musical therapy. A medical anesthesiologist and hypnotherapist wrote the hypnotic induction. And, the voice is the one of an experienced sociologist in practice. A simple meditation modeled on heart synchronization sets a persistent goal during this immersion.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* patients with a prescription for hysterosalpingography
* patients able to answer the questionnaire independently (French-speaking or understanding French)
* informed consent, signed by the patient
* patients benefiting from a social security scheme or benefiting through a third party

Exclusion Criteria:

* patients with a contraindication to virtual reality headset.
* refusal to participate in the study
* Contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection)
* patient under guardianship, curatorship or subordination
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition

This study will enrol participants aged 12 years or older with a body weight \>= 40 kilograms (kg) diagnosed with PNH who have not been previously treated with complement inhibitor therapy. Approximately 50 participants will be treated with Crovalimab for at least 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>= 40 kg at screening.
* Willingness and ability to comply with all study visits and procedures.
* Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.
* LDH Levels \>= 2x the ULN at screening.
* Participants who have at least four transfusions during 12 months prior to screening (documented in the medical record).
* Presence of one or more of the following PNH-related signs or symptoms within 3 months of screening.
* Vaccination against Neisseria meningitidis serotypes A, C, W, and Y \< 3 years prior to initiation of study treatment (Day 1)
* Vaccination against Haemophilius influenzae type B and Streptococcus pneumonia according to national vaccination recommendations.
* For participants receiving other therapies (e.g., immunosuppressants, corticosteroids): stable dose for \>= 28 days prior to screening and up to the first drug administration.
* Adequate hepatic and renal function.
* Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 46 weeks (approximately 10.5 months) after the final dose of crovalimab.
* Platelet count \>=30,000 cubic millimeter (mm\^3) at screening
* ANC \> 500/μl at screening

Exclusion Criteria:

* Current or previous treatment with a complement inhibitor.
* History of allogeneic bone marrow transplantation.
* History of Neisseria meningitidis infection within 6 months prior to screening and up to first drug administration.
* Known or suspected immune or hereditary complement deficiency.
* Known HIV infection with CD4 count \< 200 cells per microlitre (cells/µl) within 24 weeks prior to screening.
* Infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 28 days prior to screening and up to the first drug administration, or oral antibiotics within 14 days prior to screening and up to the first drug administration.
* Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration.
* Presence of fever (\>= 38˚C) within 7 days before the first drug administration.
* Splenectomy \< 6 months before screening.
* History of malignancy within 5 years prior to screening and up to the first drug administration.
* Pregnant or intending to become pregnant during the study or within 46 weeks (10.5 months) after the final dose of study treatment.
* Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever is greater.
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease.

After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

* Male or female ≥ 18 years
* Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
* Must meet a determined average minimum number of daily stools or rating of abdominal pain over a 7 day period
* Subject must have failed or experienced intolerance to at least one of the following: budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine, 6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

* Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, microscopic colitis, radiation colitis or diverticular disease-associated colitis
* Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures, abscesses, short bowel syndrome; or other disease complications for which surgery might be indicated or could confound the evaluation of efficacy
* Intestinal resection within 6 months or any intra-abdominal surgery within 3 months prior to the Screening Visit
* Ileostomy or a colostomy
* Subject has a history of any clinically significant medical condition that, in the investigator's opinion, would prevent the subject from participating in the study.
Calcium Absorption in Postmenopausal Thai Women

Adequate calcium absorption is essential for reducing one's risk of developing osteoporosis. However, postmenopausal Thai women consume diets which are habitually low in calcium due to lactose intolerance and dietary patterns which typically do not include milk-based products. The primary goal of this study is to measure the fractional calcium absorption from milk and a commonly ingested green leafy vegetable (cassia) in postmenopausal Thai women with habitually low calcium intakes. The secondary objective is to determine associations between calcium absorption and biomarkers which impact vitamin D status and bone metabolism.

Postmenopausal Thai women (n=22) will be recruited from the community surrounding Bangkok and Nakhon Pathon, Thailand. They will be invited to participate in an isotope study comparing the fractional calcium absorption from milk and cassia. Upon arrival, a fasting blood sample will be drawn on the morning of the absorption study to analyze serum markers of vitamin D and bone metabolism (25-hydroxy vitamin D \[25OHD\], parathyroid hormone \[PTH\], and beta-crossLaps) and to determine their impact on calcium absorption. Following this blood draw, women will receive a stable calcium isotope (42Ca) intravenously. Then for breakfast and lunch respectively, the women will be randomly assigned to orally ingest a stable calcium isotope from either the milk (44Ca) or cassia (43Ca) test meals. On day two, women will receive a breakfast, snack, and lunch meal. Urine samples will be collected over the entire 28 hour period and the 24-hr urine collection will be used to measure urinary calcium concentration and to calculate fractional calcium absorption.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* At least 3 years postmenopausal

Exclusion Criteria:

* Diagnosed gastrointestinal or metabolic diseases known to interfere with calcium absorption and metabolism
* Women taking medications (including thiazide diuretics, hormonal replacement therapy, etc.) within two months prior to the study
* Women taking dietary supplements within two months prior to the study
Customized Multiple Orbital Wall Decompression for Sight-threatening Graves's Ophthalmopathy

Graves' orbitopathy (GO) is an disfiguring and disabling autoimmune condition. Sight-threatening GO is an most severe form and occurs in about 5% of patients with Graves' disease. It can cause blurred vision, color vision and vision function damage, and affects the quality of life. The goal of this retrospective cohort study is to propose a customized orbital decompression algorithm for patients with sight-threatening Graves'ophthalmopathy and to explore the therapeutic effect of customized orbital decompression in sight-threatening patients.


Eligibility Criteria:
Inclusion Criteria:

* Sight-threatening patients undergoing interdisciplinary discussion and orbital decompression operation.
* The sight-threatening GO refer to those with DON, exposure keratitis or corneal breakdown.
* DON was diagnosed according to the following clinical findings including optic nerve head edema, visual field defect, impaired color vision, afferent pupil defect, retinal folds, radiologic evidence of apical optic nerve compression or globe subluxation.
* Diagnosis of exposure keratitis or corneal breakdown was made based on physical exam signs, e.g. microepithelial defects, abrasion or ulcer. A minimum follow-up of 12 months was required for inclusion.

Exclusion Criteria:

* Patients were excluded if exophthalmos, rather than acute visual loss, was the indication for surgery.
* Cases with a history of previous ocular surgery, glaucoma, and visual defects from other ocular conditions were excluded from the study.