cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Electromagnetic Navigation System Assisted Percutaneous Endoscopic Lumbar Decompression

There is a shallow learning curve with TELD (transforaminal endoscopic lumbar discectomy). The aim of this study is to assess the safety and efficacy of TELD assisted by electromagnetic navigation for treating lumbar disc herniation (LDH).


Eligibility Criteria:
Inclusion Criteria:

1. age≥18 and ≤80 years;
2. typical clinical symptoms and consistent imaging evidence of mono-radiculopathy LDH; or single level LSS combined with disc herniation
3. recalcitrant pain despite proper conservative therapy (including analgesics, NSAIDs, corticoids infusion under CT guidance and physical therapy) for at least 3 months before surgery and/or neurological deficit in the territory of the irritated nerve root
4. VAS pain ≥ 6/10
5. Absence of significant instability;

Exclusion Criteria:

1. serious underlying disease or mental illnesses
2. severe central stenosis, cauda equina syndrome, spinal instability, active infection, and serious calcified fragments
3. previous lumbar treatment with spinal surgery, ozone intervention, or radiofrequency ablation
4. unwilling or unable to participate in treatment and complete follow-up
5. Multi-level disc pathology
6. MRC paresis \<4/5
7. Pregnancy
8. participation in another clinical trial
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure

This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females.
* Non-smokers
* Agree to remain in the clinic for the time defined in the protocol.
* Normal ECG.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Risk factors for precipitation of angle closure glaucoma or elevated IOP.
* Inability to refrain from use of contact lenses during the study days, if correction is required.
* Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
* Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
A Study on Eradication Rate of Triple Therapy According to Treatment Period and CYP2C19 Polymorphisms in H.Pylori Patients

This study compared efficacy and safety of basic triple therapy according to treatment period. This study evaluated Effect of CYP2C19 genetic polymorphisms on the efficacy

This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID on the first line eradication treatment of H.pylori according to treatment period.

Participants are defined as persons who have endoscopically confirmed on gastric or duodenal ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the UBT test. For 7 days or 10 days Participants treated as basic triple therapy including Noltec(Ilaprazole) 10mg, Clapaxine(Clarithromycin) 500mg and Pamoxin Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test at 49±5days from the first day dosing. The investigators would point out the impact of CYP2C19 genotypes on Clarythromycin-based first-line and rescue therapies.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have endoscopically confirmed on gastric, duodenal ulcer(including scar) or gastritis confirmed to be H.pylori positive patients in the biopsy and UBT test.
* Subject who fully understands conditions of clinical trial.
* Subject who agrees to participate and spontaneously sign the ICF

Exclusion Criteria:

* Known hypersensitivity to any component of ilaprazole, Amoxicillin and Levofloxacin
* Subjects who are taking contraindicated medications for experimental and concomitant drug.
* Patients with abnormal levels in the laboratory tests Total Bilirubin, Creatinine\> 1.5 times upper limit of normal AST, ALT, Alkaline phosphatase, BUN\> 2 times upper limit of normal Administrated of PPI, antibiotic medication within 4 weeks prior to commencement of the study.
* Pregnant and/or lactating women
* Reproductive aged women not using contraception
* Uncontrolled diabetics
* Uncontrolled hypertension
* Uncontrolled liver dysfunction
* Alcoholics
* Subjects with a history of digestive malignancy within 5 years
* Subjects with a history of gastrectomy or esophagectomy Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption.
* Subjects participating in a clinical trial before another trial wihin 30 days
* Inconsistence judged subject by researcher
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control

The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection
* Patients scheduled for surgery at the JRSC or MSK Monmouth
* Previously enrolled patients \> 6 months from contralateral mastectomy

Exclusion Criteria:

* Patients who are non-English speaking
* Patients having any immediate breast reconstructive procedure
* Patients are having bilateral mastectomy
* Patients who report a baseline pain score \> 3, unrelated to a breast procedure
* Patients who take long acting opioid medication use
* Patients will be excluded if they are having their mastectomy performed with tumescence
* Patients weighing \< 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose
* Patients within 6 months of previous enrollment for surgery for contralateral mastectomy
Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Primary Objective:

* To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.

Secondary objectives:

* To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal
* To assess the general safety of 35-mg risedronate administered once weekly.


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main Inclusion/Exclusion criteria are listed hereafter:

Inclusion criteria:

* Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH \>40 mIU/mL and estradiol \<20 pg/mL.
* Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
* Lumbar spine BMD mean value \> 0.772g/cm2 (Hologic) or \>0.880 g/cm2 (Lunar).

Exclusion criteria :

* Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (\<0.637 g/cm2 \[Hologic\]) or \<0.694 g/cm2 \[Lunar\]) as determined by dual-energy x-ray absorptiometry (DXA)
Couple-based Intervention on Quality of Life in HIV Male Serodiscordant Couples

This study aims to provide preliminary evidence of the efficacy of couple-based intervention over usual care in HIV serodiscordant couples in China. The investigators hypothesize that couple-based intervention would be more effective than usual care concerning both partners' quality of life and relationship satisfaction. The investigators also pilot the feasibility, acceptability, and appropriateness of the intervention content and implementation.

HIV serodiscordant couples in the intervention arm will receive three sessions of dyadic intervention. In contrast, couples in the control arm will receive usual care.


Eligibility Criteria:
The inclusion criteria for couples will be: (a) both partners are males, (b) both partners age over 18, (c) both partners report being a couple for at least three months, (d) one partner is HIV positive and the other partner is HIV-negative (i.e., serodiscordant couples), and (e) both partners are willing to participate.

The exclusion criteria for couples will be: (a) either partner cannot complete the assessment due to a low education level or physical or psychological constraint, and (b) either partner has been diagnosed with another life-threatening disease (e.g., cancer).
Postoperative Neurocognitive Dysfunction: Is There Any Place for Emergency Agitation: A Prospective Cohort Trial

Perioperative neurocognitive disorders (PND) have been studying by clinicians, particularly by anesthesiologists, pretty long, however the most inspiring advancements were achieved during the last few decades. The most recent classification of PND which includes cognitive decline diagnosed before operation (described as neurocognitive disorder); any form of acute event (postoperative delirium) and cognitive decline diagnosed up to 30 days after the procedure (delayed neurocognitive recovery) and up to 12 months (postoperative neurocognitive disorder) was proposed in 2017. However at will one can notice at least one uncertainty that pertinent to the definition of delirium, emergency delirium and not mentioned in the classification discussed agitation.

The objective of the study is to determine if there is a difference between emergence agitation and emergence delirium.


Eligibility Criteria:
Inclusion Criteria:

* Age from 45 to 74 years
* Undergoing elective orthopedic surgery
* Provide written informed consent to participate in the PoD trial

Exclusion Criteria:

* Undergoing emergent/urgent surgery
* Montreal Cognitive Assessment \< 18 points
* History of mental disorders according ICD-11
* Treated with at least one psychotropic drug
* Patients with neuromuscular disease
* Inability to undergo preoperative assessment for any reason
* Previously enrolled in PoD trial
A Facebook Intervention for Young Sexual and Gender Minority Smokers

The 2-year research plan will test the Put It Out Project (POP) in a pilot randomized trial (N=120) compared to TSP and two historical control conditions. Participants will be young adults who smoke, identify as sexual or gender minorities, and use Facebook. The primary outcome will be biochemically verified 7-day abstinence from smoking at 3 and 6 months. Secondary outcomes will be a quit attempt (y/n), stage of change, and thoughts about tobacco abstinence at 3 and 6 mos.

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use, tailored to SGM young adults; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 90 days of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments will occur at baseline, 3, and 6 months follow-up. Assessments will include measures on smoking, thoughts about abstinence, and SGM identity experiences. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.

Eligibility Criteria:
Inclusion Criteria:

* read English
* between 18 and 25 years of age
* indicate they use Facebook "most" (≥ 4) days per week
* have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
* identifies as SGM

Exclusion Criteria:

* do not read English
* are not between 18 and 25 years of age
* indicate they do not use Facebook "most" (≥ 4) days per week
* have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
* does not identify as SGM
Does Elective Amniocentesis Change Vaginal Microbiome?

the aim of this study is to check if elective amniocentesis change vaginal microbiome


Eligibility Criteria:
Inclusion Criteria:

* pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant.

Exclusion Criteria:

* infection in the Uterus
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients

Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed.

In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (\<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA is positive
* Genotype 6
* Treatment naive
* Raised ALT

Exclusion Criteria:

* Active substance abuse
* Poorly controlled psychiatric disease
* HBsAg positive
* Anti-HIV positive
* Suffering from other significant concurrent medical conditions including chronic liver diseases
Allergic Rhinitis Changes the Sinus Microbiome

The investigators hypothesize that treatment with QNASL will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 18 and 55 years of age.
2. Two year history of seasonal allergic rhinitis.
3. Positive skin test to grass and/or tree antigen.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Subjects treated with systemic steroids during the previous 30 days.
4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
7. Subjects treated with immunotherapy and are escalating their dose.
8. Subjects on chronic anti-asthma medications.
9. Subjects with polyps in the nose or a significantly displaced septum.
10. Upper respiratory infection within 14 days prior to study start.
A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants

The purpose of the study is to assess the safety and tolerability of JNJ-72537634 compared with placebo in healthy participants after administration of single and multiple day doses.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of at least 50 kilogram (kg)
* Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening
* Be healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant
* Have normal bowel movements, ranging from 1 to 3 times daily to every other day and have normal consistencies according to the Bristol Stool Scale, ranging from 3 to 5 at admission
* All women of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on day of admission

Exclusion Criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* Has an active systemic or GI acute or chronic infection as determined by appropriate clinical screening and laboratory tests
* If female, has a positive serum pregnancy test at screening, a positive urine pregnancy test at admission, or is lactating prior to study enrollment
* An active cigarette smoker or has quit cigarette smoking within the previous 6 months
* Has a positive urine toxicology screen at screening or at admission for substances of abuse including but not limited to: barbiturates, benzodiazepines, tetrahydrocannabinol (THC), cocaine, opiates, methamphetamines, tricyclic antidepressants (TCA), methadone, 3,4-methylenedioxymethamphetamine (MDMA), oxycodone, and amphetamines
Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes

DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316), or follow-up without screening (N=315). All have access to cardiovascular prevention according current guidelines. The main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients 55 to 75 years old had type-2 diabetes and at least two of the following cardiovascular risk factors:

  * urinary albumin excretion \> 30 mg/L or \> 30 mg/24 hours,
  * treated or untreated hypertension,
  * treated or untreated lipid abnormality,
  * peripheral arterial disease,
  * history of transient ischemic accident,
  * tobacco consumption
  * familial history of premature cardiovascular disease.

Exclusion Criteria:

* History of myocardial infarction, coronary artery disease, or stroke,
* Previous positive stress test or myocardial perfusion imaging,
* Negative stress test or myocardial perfusion imaging within the last three years
Early Vision Screening in High-risk Children

To evaluate the effect of early vision screening with automated photorefraction device in high risk children

Pre-term, low-birth-weight, and development delay are well-known risk factors related to higher incidence of high refractive error and strabismus, which can potentially lead to amblyopia and is regarded as amblyopia risk factors. This project is a cross-sectional controlled study. Our study includes high-risk group and normal group. High-risk group includes children with birth history of pre-term, low-birth-weight and the diagnosis of development delay in FEMH. Normal group enrolled age-matched children without those risk factors. Vision screening by FDA-approved photorefraction device as well as comprehensive ophthalmic exams for definite diagnosis will be performed on the high-risk group and the normal group.

Eligibility Criteria:
Inclusion Criteria:

* High risk group: children with gestational age less than 36weeks, birth weight less than 2500g and children diagnosed as develop delay
* Normal group: children with normal birth history and normal development

Exclusion Criteria:

* Children with known ophthalmic diseases
* Children with congenital systemic diseases
The Impact of Communication With Healthcare Providers Via WeChat on Survival Outcomes for Lung Cancer Patietns

The use of smartphone-based WeChat applications offers significant advantages in cancer patient education, rehabilitation monitoring, and postoperative symptom management. Through the WeChat platform, patients can access health education materials, engage in online consultations, and interact with doctors and other patients at any time. This ongoing education and psychological support help alleviate patient anxiety and improve their quality of life. This study aims to conduct a prospective observational study in our hospital to explore the impact of WeChat communication on the prognosis of patients with different histological types and stages of lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* (1) Lung cancer patients receiving treatment at Shanghai Pulmonary Hospital (2) ECOG performance status of 0-2 (3) No other serious internal medical conditions (such as severe heart failure, hypertensive crisis, diabetic ketoacidosis, severe liver or kidney impairment, etc.) (4) No history of other malignant tumors in the past 5 years, and no detection of other tumor history during follow-up after lung cancer diagnosis (5) Relevant pathological results

Exclusion Criteria:

* (1) Patients refused enrollment in this study; （2）Patients refused follow-up.