anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: Saline vehicle intradermally injected into the other forearm
Eligibility criteria:
Inclusion Criteria:

Healthy volunteers between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arm.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Use of anti-depressants, anti-psychotics, and illicit drugs.
Known history of neuropathy, uremia, uncontrolled thyroid disease, and diabetes mellitus.
Use of Botulinum toxin in the last year.
Known allergies to Botox.
Pregnant women. (Women of child bearing potential will undergo an human chorionic gonadotrophin (hCG) pregnancy test before Botox application).
Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
Infection at the injection site.
Cardiovascular disease.
Neuromuscular disorder (e.g., amyotrophic lateral sclerosis, myasthenia gravis, or Lambert-Eaton syndrome).
Compromised respiratory function.
Dysphagia.
History of urinary tract infection.
History of urinary retention.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.
Screening laboratory result indicating HCV GT3 infection.

Chronic HCV infection, defined as one of the following:

Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or
A liver biopsy consistent with chronic HCV infection; or
Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.
Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).
Documented as noncirrhotic.

Exclusion Criteria:

Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could have precluded adherence to the protocol in the opinion of the investigator.
Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus Ab (HIV Ab).
Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.
Any cause of liver disease other than chronic HCV infection.
Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.
History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.
Previous use of any anti-HCV treatment.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female (of nonchildbearing potential, practicing total abstinence, sexually active with female partners only, or using allowed contraceptive methods) at least 18 years of age at time of screening.
Screening laboratory result indicating HCV GT3 infection.

Chronic HCV infection, defined as one of the following:

Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening; or
A liver biopsy consistent with chronic HCV infection; or
Abnormal alanine aminotransferase (ALT) levels for at least 6 months before screening.
Hepatitis C virus treatment-naïve (i.e., participant had never received any anti-HCV treatment).
Documented as noncirrhotic.

Exclusion Criteria:

Female who was pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner was pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could have precluded adherence to the protocol in the opinion of the investigator.
Positive test result at screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus Ab (HIV Ab).
Hepatitis C virus genotyping performed during screening indicated co-infection with more than one HCV genotype.
Any cause of liver disease other than chronic HCV infection.
Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493/ABT-530, SOF, or DCV.
History of severe, life-threatening, or other significant sensitivity to any excipients of the study drug.
Previous use of any anti-HCV treatment.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind [DB] treatment period)
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2) infection.
Chronic HCV infection.
Subject must be HCV treatment-naïve (subject had never received a single dose of any approved or investigational regimen) or had failed prior interferon (IFN) or pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Subject must be non-cirrhotic.

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label [OL] treatment period)
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2) infection.
Chronic HCV infection.
Subject must be HCV treatment-naïve (subject had never received a single dose of any approved or investigational regimen) or had failed prior interferon (IFN) or pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN therapy.
Subject must be non-cirrhotic.

Exclusion Criteria:

History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype.
Intervention: Hydroxyurea
Trial phase: Phase 2
ATC code: L01XX05
SMILES: NC(=O)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Initiate hydroxyurea at 10 mg/kg daily and escalate hydroxyurea dose by 5 mg/kg/day every 8 weeks up to a maximum dose of 35 mg/kg/day if blood counts meet escalation criteria.

Hydroxyurea: Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the AdultsQLTM 3.0 Sickle Cell Disease Module after 6 months at MTD, compared to entrance scores
Eligibility criteria:
Inclusion Criteria:

Diagnosis of HbSC disease
Score of 80 or lower on the AdultQLTM 3.0 Sickle Cell Disease Module, or any disease related complication, including, but not limited to, one or more pain events per year, proliferative sickle retinopathy, avascular necrosis, cholelithiasis, or any thrombotic event. If the subject has a score >80, they may still enroll on the trial, and be analyzed for secondary endpoints. They will be excluded from analysis of the primary endpoint.

Exclusion Criteria:

Failure to meet inclusion criteria
Hydroxyurea usage in the last 3 months.
Chronic RBC transfusion therapy
Packed red blood cell transfusion in the last 3 months (temporary exclusion).
Pregnancy, or refusal to use medically effective birth control if female and sexually active.
Current phlebotomy therapy
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.

Aspirin: If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.
Eligibility criteria:
Inclusion Criteria:

All patients, 18+ years of age, scheduled at WVU Medicine Center for Joint Replacement for a History and Physical visit to undergo a total hip or knee surgery.
Primary replacements and revisions.
Weight bearing as tolerated postoperatively.

Exclusion Criteria:

History of DVT/PE
History of hypercoagulable disorder
Currently on other blood thinning medication with the exception of aspirin (Plavix, Coumadin, xarelto, pradaxa, lovenox, heparin, other Factor Xa inhibitors).
Patients less than 18 years of age.
Intervention: GABAPENTIN ENACARBIL
Trial phase: Not Applicable
SMILES: CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: open-label single arm study

Horizant, 600 mg oral once daily at 5 pm for 360 days.

Horizant: Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.

Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360).
Eligibility criteria:
Inclusion Criteria:

Adult patients with diagnosis of RLS for more than one year.
Patients who are on DA therapy for 6 months or longer.
Patients who developed Augmentation (on stable dose of DA) lasting for 3 months or longer.
Augmentation severity rating scale of 5 to 15.
Both males and females
Age range = 18-85 year

Exclusion Criteria:

Known Hypersensitivity to Horizant or Gabapentin products
Peripheral neuropathy
Radiculopathy
Peripheral vascular disease
Uremia [abnormal blood urea nitrogen (BUN) or Creatinine on Comprehensive Metabolic Panel (CMP)]
Anemia
Patients who are currently pregnant
Patients who currently take opioids, lithium, anti-nausea medications (e.g. metoclopramide), dopaminergic antagonists (e.g. Haloperidol), 1st generation antihistamines (e.g. diphenhydramine, pseudoephedrine), anti-psychotic medications and iron therapy.
Subjects with impaired decision making capability.
Intervention: Pibrentasvir
Trial phase: Phase 3
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
Chronic HCV infection
Subject must be HCV treatment-naïve or have failed prior HCV treatment
Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease

Exclusion Criteria:

Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530
Intervention: Lovastatin
Trial phase: Phase 4
ATC code: C10AA02 | C10BA01
SMILES: [H][C@@]12C(=C[C@H](C)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Subjects will receive the Parent Implemented Language Intervention (PILI) in combination with study medication Lovastatin.

Lovastatin: Once per day dosing
Eligibility criteria:
Inclusion Criteria:

Documentation of a full mutation with absence or deficient FMRP levels.
Males and females ages 10 through 17 years
Willingness of potential study participant as well as a parent or caretaker to participate in the protocol.
Speech is the primary means of communication with three-word or longer utterances used on a daily basis.
Intelligence quotient (IQ) ≤70 as measured by the Leiter- R.
Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative qualitative serum β-human chorionic growth hormone (β-HCG) or urine pregnancy test collected at the initial screening visit.

Exclusion Criteria:

Persons who do not speak English.
Changes in any medications (including investigational medications) within the last month (4 weeks). All concomitant medications must have been on a stable course for at least 4 weeks prior to enrollment into the study and maintain stability throughout the course of the study.
Changes in behavioral therapy or educational programming during the study. This does not include scheduled school holidays.
Have any disease or condition (medical or surgical) at screening that might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems; or other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the investigational product, or would place the subject at increased risk.
Patients who, in the opinion of the investigator, are unsuitable in any other way to participate in this study, including being unable to comply with the requirements of the study or displaying clinically significant abnormalities in safety assessments at screening.
Patients on prohibited medications
History of recurrent status epilepticus.
Inability to withhold grapefruit and grapefruit juice from diet during the entire clinical trial.
Subjects unwilling to abstain from alcoholic beverages during the trial.
Subjects who are actively suicidal.
Intervention: Halodrol
Trial phase: Not Applicable
SMILES: CC12C=CC(O)C(Cl)=C1CCC1C2CCC2(C)C1CCC2(C)O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Based upon the preliminary studies that assessed the duration of the antimicrobial effects of Halo as reported in the preliminary studies and feasibility, subjects assigned to both study arms will be asked to spray the product intra-orally 3 times daily (Three sprays per use, total = 9 sprays per day).

Halo Oral Spray: Three sprays per use, total = 9 sprays per day
Eligibility criteria:
Inclusion Criteria:

Signed informed consent
Ages between 18-45 years, inclusive
Non-tobacco/nicotine use (at least 3 months)
BMI of 17-35 kg/m2 inclusive
Able to comply with all study procedures and follow-up
Healthy on the basis of screening medical exam, blood chemistries, hematology, and serum pregnancy tests for females (at screening )
Non-pregnant or breast-feeding

Exclusion Criteria:

History of current use of narcotics, or recreational drug use.
Use of > 7 alcoholic beverages in 1 week
Any acute illness such as asthma, cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal (including eating disorder), endocrine/metabolic, neurologic, dermatologic, or psychiatric disease.
Treatment with another investigational product in the past 30 days
Immunocompromised status including HIV by history
Use of any other intra-oral product (especially antiseptic).
Intended use of mouthwash during study duration
Laboratory (screening) of creatinine > 1.5 X ULN, hemoglobin < 10.5 g/dL, platelet count ≤ 99,000/mm3, absolute neutrophil count ≤1200/ mm3, serum glucose ≥ 150 mg/dl (Subject can enroll prior to receiving lab results. Subject will be contacted if lab results are an exclusion and discontinue from study)
Use of any systemic antibiotic or antifungal within 30 days of screening
Prior or current history of seasonal allergies, chronic sinusitis or rhinitis
Allergy to any component of Halo
Oral lesions
Dentures
Dental Treatment currently in progress (implants, root canals, complex restorative procedures)
Intervention: Imatinib Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Single dose of imatinib 600mg po
Eligibility criteria:
INCLUSION CRITERIA:

Age greater than or equal to 18 years old and less than or equal to 65 years
Loa loa microfilaremia >500 MF/mL and <2500 MF/mL at screening visit.
Subject has the capacity to understand the potential risks and benefits and consents to protocol indicated blood draws and follow up visits.

EXCLUSION CRITERIA:

Women under 45 years of age, or over 45 years of age with a menstrual period in the preceding 12 months.
Currently breastfeeding
Currently taking daily medications
Known chronic medical conditions, including but not limited to diabetes, renal failure, liver disease, seizure disorder, HIV, malignancy, psychiatric disorder, or any conditions which within the investigators judgement are deemed to be clinically significant.
W. bancrofti serologic positivity against Wb123
O. volvulus serologic positivity against Ov16
HIV by history or clinical signs of HIV/AIDS (e.g. oral thrush, oral/skin lesions of Kaposi s sarcoma, etc.)
Any of the following lab abnormalities: Creatinine >1.5, Platelets <100,000/mL, Hemoglobin <12g/dL, alanine aminotransferase or aspartate aminotransferase >60 U/L, total bilirubin >1.7mg/dL, absolute neutrophil count equal to or less than 1500/mm(3).
Any condition that, in the opinion of the PI, may substantially increase the risk of participation, including any contraindication to imatinib.
Intervention: Bivalirudin
Trial phase: Not Applicable
ATC code: B01AE06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(=O)O)NC(=O)CNC(=O)[C@H](CC(N)=O)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](N)Cc1ccccc1)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily

(dexlan+amox+clar+metr)+(dexlan+amox): a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily
Eligibility criteria:
Inclusion Criteria:

Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

previous H pylori-eradication therapy
ingestion of antibiotics or bismuth within the prior 4 weeks
patients with allergic history to the medications used
patients with previous gastric surgery
the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
pregnant women