cyrilzakka/clinical-trials huggingface dataset:
NAC Vs Placebo on Opioid Use for Hysterectomy

This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.


Eligibility Criteria:
Inclusion

* Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
* 18 years of age and older

Exclusion

* Less than 40kg in weight
* Unable to provide written, informed consent
* History of an adverse or anaphylactoid reaction to acetylcysteine
* Active asthma, wheezing, or using inhaled bronchodilators
* Non-English speaking
* Insulin dependent diabetes if D5W is required
* Blood clotting disorders
Congenital Syphilis Prospective Cohort With Retrospective Evaluation

Syphilis is an infectious disease caused by Treponema pallidum. In children, there are two different forms of this disease; acquired syphilis and congenital syphilis, which results from transplacental transmission of spirochetes.

The worldwide incidence of congenital syphilis has increased in past years, probably due to inadequate control of pregnant women and lack of early diagnose and treatment in acute infected adults.

This infection can have numerous and non-specific manifestations at all stages, and may simulate other diseases, which can delay diagnose if not suspected.

A high number of newborns can be asymptomatic, so diagnose is confirmed or discharged by serologic testing after 6 to 10 months of age.

This study will observe the clinical presentation and the laboratory of patients with CS treated.


Eligibility Criteria:
Inclusion Criteria:

* Infants with reactive VDRL /RPR of mothers with positive serology without confirmed treatment or incomplete.
* Patients with compatible clinical signs of syphils.

Exclusion Criteria:

* Patients with diagnosis of acquired syphilis
* Patients whose medical records are missing
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and \< 50 years
* Important essential tremor (bilateral postural and/or action tremor since more than one year)
* Normal physical and neurological examination, except for essential tremor
* Insufficient efficiency of usual essential tremor's treatment
* No treatment altering the cortical excitability
* Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential

Exclusion Criteria:

* Cervical tremor
* Current neurological or psychiatric illness other than essential tremor
* Individual who is on medication which is known to lower seizure threshold
* Previous history of seizure(s), malaise or current active epilepsy
* Contraindication for MRI or TMS study
* Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control
* Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent
* Simultaneous participation in another clinical trial
* Patients who are not enrolled at social security
Buprenorphine for Treatment of Neonatal Abstinence Syndrome in Infants With In Utero Exposure to Benzodiazepines

The opioid neonatal abstinence syndrome (NAS) is a condition of withdrawal symptoms after utero exposure to opioids. Sublingual buprenorphine shows promise as a new treatment in NAS. This trial will investigate the safety and tolerability of sublingual buprenorphine in infants exposed to both opioids and benzodiazepines in utero or with exposure of opioids in those who are breastfeeding.

Infants with in utero exposure to opioids often require therapy with morphine for an extended period. In a clinical trial, sublingual buprenorphine reduced this treatment period by \~30%. However, infants with both opioid and benzodiazepine exposure were not included in the trial. This study will test the safety and tolerability of sublingual buprenorphine in infants with in utero exposure to benzodiazepines or who are breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 37 weeks gestation
2. Exposure to opioids in utero
3. Demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment
4. Exposure to benzodiazepines in utero and/or receiving breast milk. Benzodiazepine use is defined as maternal use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother 30 days prior to birth.

Exclusion Criteria:

1. Major congenital malformations and/or intrauterine growth retardation defined as birth weight \<2200 gm
2. Medical illness requiring intensification of medical therapy. This includes, but is not limited to suspected sepsis requiring antibiotic therapy.
3. Hypoglycemia requiring treatment with intravenous dextrose
4. Bilirubin \>20 mg/dL (The need for phototherapy is not exclusionary)
5. Seizure activity or other neurologic abnormality
The Impact of an Epidural Ropivacaine-Neostigmine Injection for Perineal Analgesia at the End of Labor.

Perineal pain after childbirth occurs in the majority of women (with or without episiotomy). Perineal pain can become source of chronic pain in 9%-12% of the cases. Neostigmine a cholinesterase inhibitor at a dose of 500µg combined with Sufentanil or Ropivacaine (=local anaesthetic) is an analgesic. The goal of this study is to examine the effect of the use of epidural Neostigmine for perineal analgesia at the end of the labor on acute pain and on the development of chronic pain post partum.

The goal of epidural analgesia during labour is to obtain an analgesia with a minimum of "motor block". Absence of motor block at the time of the childbirth allows to decrease the rate of instrumentation (forceps, vacuum extractor). When the parturient approach complete cervical dilatation (8-10 cm), the anaesthetist must perform a last epidural injection for perineal analgesia. Generally a local anaesthetic is used (ex : Ropivacaine). Adjuvant can be associated to local anaesthetic (Sufentanil, Clonidine and more recently Neostigmine) to maximize local anaesthetic without increasing motor block.

Neostigmine, a cholinesterase inhibitor, increase concentration of acetylcholine on synaptic level and stimulate analgesic mechanisms mediated by this acetylcholine on dorsal horn of spinal cord.

Perineal pain after childbirth appears in most of the women with or without episiotomy. (Mac Arthur Am J Obst. Gynecol. 2004). This perineal pain can become source of chronic pain in 9%-12% of the cases. Neostigmine, a cholinesterase inhibitor at the dose of 500µg, combined with Sufentanil or Ropivacaine (=local anaesthetic) has an analgesic effect.

The goal of this study is to examine the effect of epidural Neostigmine for perineal analgesia at the end of the labour and on the development of chronic pain post-partum.

Inclusion criteria : any parturient of 18-45 years, normal pregnancy, at full term and having an effective epidural anaesthesia during labour.

Exclusion criteria : multiple pregnancy, obstetric pathology, refusal of participation.

Randomisation : 2 groups of 30 patients

Method :

Installation of the epidural catheter :

- Injection of Ropivacaïne + Sufentanil

Perineal analgesia :

* Ropi Group : epidural injection of Ropivacaine
* Neostigmine Group : epidural injection of Ropivacaine and Neostigmine

Evaluation of VAS, vital signs of parturient and fetal heart rate, instrumentation rate.

Evaluation of immediate post-partum pain (48hours) and use of analgesic medication in the ward.

Evaluation of chronic pain after 10 days and 1 month.

Eligibility Criteria:
Inclusion Criteria:

* any parturient of 18-45 years
* normal pregnancy
* at full term
* having an effective epidural anesthesia during labor

Exclusion Criteria:

* multiple pregnancy
* obstetric pathology
* refusal of participation
Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma

The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the SLT.

The selective laser trabeculoplasty (SLT) is the laser treatment of choice for treating glaucoma. A There is however a controversy regarding the use of drops post-treatment. Indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae "cleaning". Others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from with primary open-angle glaucoma.
* Patients with IOP \> 21 mmHg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment.
* Patients \> 18 years old, able to consent.
* Patients consenting to the trial.

Exclusion Criteria:

* Patients suffering from chronic glaucoma other than primary open-angle glaucoma
* Patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the SLT
* Patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month.
* Patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae.
* Monophthalmic patients.
* Patients who already underwent a glaucoma treatment to the eye requiring treatment.
* Patients who already underwent a glaucoma treatment using SLT or ALT (Argon laser trabeculoplasty)
* Patients who underwent cataract surgery in the past 3 months.
* Pregnant patients.
Disability Among Adults With Asthma

To identify risk factors for work disability among adults with asthma treated by pulmonary and allergy specialists.

BACKGROUND:

Disability among those with asthma is common and costly. Little is known about the causes of disability in asthma; experience with other chronic diseases suggests that illness severity alone does not adequately predict disability. There is a theoretical and experimental basis upon which to postulate that other variables, including factors such as job flexibility, asthma self-efficacy, social supports, and cigarette smoking may be predictors of disability in asthma. The study helped to explain the inter-relationships among illness severity, other co-factors and disability in asthma, addressing a major research gap.

DESIGN NARRATIVE:

The study was a cross-sectional survey, including retrospective work history data. A random sample was conducted of 40 board certified pulmonologists in Northern California enrolling persons with asthma. Pulmonologists maintained a log of all persons meeting a clinical definition of asthma presenting to their offices for treatment over a one month period. A total of 601 subjects with any history of laborforce participation were interviewed by a trained survey worker in order to assess severity of disease using a severity scale based on symptoms, medications, and past-asthma history. The computer-assisted, telephone-administered interviews used established survey instruments to assess psychosocial variables, smoking exposure and work history.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Treatment of Ocular Graft-versus-Host Disease (GVHD) With Topical Loteprednol Etabonate 0.5%

The purpose of this research is to:

1. Evaluate the safety and efficacy of a steroid eye drop (Lotemax) in patients who have been diagnosed with graft-versus-host disease (GVHD), which is a complication that may occur after bone marrow transplant where the newly transplanted material attacks the patient's body and may cause eye dryness.
2. Assess the safety and efficacy of Lotemax in decreasing the eye's reaction to the process in GVHD before the patient undergoes bone marrow transplant.
3. Compare how well Lotemax works in decreasing the process in GVHD with an immunosuppressive eye drop (Restasis), which has been commonly used in the treatment of this condition.

Allogeneic bone marrow or peripheral stem cell transplantation result in Graft-versus-Host disease. Ocular symptoms may be the first presentation of GVHD and may be seen in the absence of systemic manifestations. GVHD is categorized into acute and chronic forms as defined by 100 days after the transplant. Acute GVHD is characterized by dermatitis, hepatitis, and enteritis. Chronic GVHD involves the skin, mouth, liver, gastrointestinal tract, lungs, and eyes. Ocular GVHD is a common cause of dry eye symptoms in patients who have undergone bone marrow transplant (BMT), and can be defined as ocular surface disease in the context of GVHD. Dry eyes develop in 76% of acute GVHD patients and between 62.5% and 81.8% of chronic GVHD patients. Current treatment for ocular GVHD includes topical cyclosporine 0.05% (Restasis, Allergan). Topical loteprednol etabonate 0.5% (Lotemax, Bausch and Lomb) has been shown to be safe and efficacious in treatment of inflammatory ocular disorders, but has not been prospectively studied in ocular GVHD.

2. Hypothesis: We anticipate that topical loteprednol etabonate 0.5% will be safe and efficacious in treatment of ocular GVHD patients, and would add to the armamentarium of therapeutics for this disease. Further, by following the natural progression of the disease prior to a patient's Bone Marrow Transplant (BMT), we may elucidate a new standard of care for these patients - one that involves referral to an ophthalmologist before ocular GVHD symptoms arise.

Eligibility Criteria:
Inclusion Criteria:

Scheduled for allogenic bone marrow transplant

Exclusion Criteria:

Allergic reaction to loteprednol or cyclosporine, previous allogenic transplant
Sympathetic Overactivity in Essential Hypertension

The primary objective of the study is whether subjects with hypertension and proteinuria display increased sympathetic nerve activity compared to hypertensive subjects without proteinuria and normotensive controls.


Eligibility Criteria:
Inclusion Criteria:

* Normotension or hypertension

Exclusion Criteria:

* Pregnant and nursing women
* Myocardial infarction, clinical signs of coronary heart disease
* Severe depression
A Study of LY900014 in Healthy Chinese Participants

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy native Chinese males or females
* Female participants:

  * Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study.
  * Women not of child-bearing potential who are infertile or post-menopausal
* Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
* Are nonsmokers
* Have a fasting plasma glucose value \>71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]) and \<108 mg/dL (6.0 mmol/L)

Exclusion Criteria:

* Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product
* Have previously completed or withdrawn from this study or any other study investigating LY900014
* Have known allergies to LY900014 or any components of the formulation
* Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study.
* Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days.
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Headless Screw Fixation for Metacarpal Fractures in Adults.

The goal of this study is to evaluate results of intramedullary screw fixation of metacarpal fractures while summarizing the pearls and pitfalls to maximize successful surgical outcomes in adults, Metacarpal fractures are third most common upper extremity fractures, Intramedullary screw Fixation is a fixation option that offers rigid stability, early active range of motion, and simplicity of insertion,


Eligibility Criteria:
Inclusion Criteria:

* Adult patients.
* Metacarpal shaft fractures.
* Simple fractures.
* Recent fractures within 1-2 weeks.
* Isolated metacarpal fractures.

Exclusion Criteria:

* Pediatric fractures with open physis.
* Head-splitting fractures and Metacarpal basal fractures.
* Compound fracture increasing risk of infection.
* medical illness or mental disorders affecting the follow-up examination.
* Association with other fractures fixed by methods that limit early range of motion.
* pathologic fractures.
A Clinical Study About Improvement of Chronic Fatigue After Taking Red Ginseng

The purpose of this study is to verify the efficacy of taking red ginseng for chronic fatigue patient.

Verify the efficacy and safety after taking red ginseng for chronic fatigue syndrome or idiopathic chronic fatigue patient. They were verified through not only survey like VAS change about fatigue, fatigue severity scale, Chalder fatigue severity questionnaire, SRI-short form , BDI , ISI EQ-5D-5L, ginseng subjective symptoms questionnaire but also an anti-oxidant test and a salivary cortisol test after 6 weeks after taking red ginseng or placebo drugs.

Eligibility Criteria:
Inclusion Criteria:

1. At least 19 years of age, but below 65 years of age
2. A subject who appear repetitive or continuous fatigue of unknown cause.
3. A subject who has not abnormal findings of blood pressure, complete blood cell count(Hb, Hct, WBC, glucose), biochemical examination(AST, ALT, creatinine), thyroid gland function test(TSH, FT4), Urine test(Urine glucose, Urine protein), Chest X-ray, and ECG for causing fatigue
4. A subject who voluntarily agrees to participate and signs after listening to explanation for purpose and characteristic about this clinical trial

Exclusion Criteria:

1. A subject who has history or PI for chronic fatigue
2. A subject who takes this drug in 2 weeks : antidepressant drug, anti-anxiety drug,sleeping pill, an antihistamine etc.
3. Pregnant, lactating women or a subject who has plan pregnancy.
4. A subject who receive medical treatment or takes dietary supplement(vit B,C etc) for chronic fatigue in 2 weeks.
5. A subject who has night duty, shift work or heavy work
6. A subject who is judged as being not fit by a specialist
GotNet Study, The Gothenburg Nurse-led Tight Control Study

Purpose: To compare a nurse-led clinic including person-centered care and tight control with "care as usual" in patients with rheumatoid arthritis (RA) and moderate/ high disease activity.

Project description: Study population: Patients with RA, 18-80 yrs old, with moderate/ high Disease Activity Score of 28 joints (DAS28 \> 3.8) and disease duration \> 2 yrs in a 6-month randomized controlled study with a 6 month open follow-up. Intervention group (N=60): Nurse-led visits every 6th week, with structured person-centered care and evaluation of disease activity. If disease remission is not reached, pharmacological treatment including both short-term (intra-articular and oral steroids) and long-term alterations (DMARDs and biologics) is modified according to a predefined algorithm. The control group (N=60) is treated according to "care as usual" with visits to physician every 6th month. Outcome measures: Primary outcome measure is change in Diseases Activity Score (DAS). Secondary outcomes are quality of life, self-efficacy, disability, emotional well-being, pain, fatigue, sleep and satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 and \<80 years of age
* Signed and dated informed consent form before the start of any specific protocol procedures
* Fulfill the 1987 ACR criteria or the 2010 ACR/EULAR criteria for RA with disease duration of \>2 years
* Moderate to high disease activity (DAS28 \>3.8)
* ≥2 swollen joints

Exclusion Criteria:

* Diagnosis of any other inflammatory arthritis
* History of chronic infection, recent serious or life-threatening infection within 6 months
* Concurrent malignancy, a history of malignancy or current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease