anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nikethamide
Trial phase: Phase 1 | Phase 2
ATC code: R07AB02 | R07AB52
SMILES: CCN(CC)C(=O)c1cccnc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 3
Group description: NiCord: NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.

The primary safety objective was to assess the acute toxicity associated with the infusion of omidubicel within 24 hours post-infusion.

Part 2: The primary efficacy objective of Part 2 was to assess the cumulative incidence of donor-derived neutrophil engraftment by Day 42 following transplantation of single unit omidubicel.
Eligibility criteria:
Inclusion Criteria:

Must be 2 - 45 years of age and at least 10 kg
Must have clinically severe SCD (SS, SC or SBeta0 Thal) or thalassemia major and be eligible for myeloablative SCT
Must have two partially HLA-matched CBUs for part 1; and one partially HLA-matched CBU for part 2
Back-up autologous stem cells harvested from bone marrow
Adequate Karnofsky Performance score or Lansky Play-Performance scale
Sufficient physiological reserves
Signed written informed consent

Exclusion Criteria:

HLA-matched related donor able to donate
Severe alloimmunization with inability to guarantee a supply of adequate PRBC donors
Prior allogeneic hematopoietic SCT within the last 12 months or reduced-intensity transplant within the past 6 months
Human immunodeficiency virus (HIV) infection
Active or uncontrolled infection
Pregnancy or lactation
Intervention: PBT-1033
Trial phase: Phase 2
SMILES: CN(C)Cc1ccc2c(Cl)cc(Cl)c(O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: PBT2: 250mg capsules administered orally once per day for 26 weeks
Eligibility criteria:
Inclusion Criteria:

Patients who:

Provide signed informed consent in accordance with local regulations.
Have Huntington disease including clinical features of HD and a CAG repeat number ≥ 36.
Have a Total Functional Capacity between 6 and 13, inclusive.
Have cognitive impairment as demonstrated by a MoCA score of ≥ 12.
Are ≥ 25 years of age.
If taking tetrabenazine, have been on a stable dose for at least 3 months.
If female, are either a) of childbearing potential and compliant in using adequate birth control or b) not of childbearing potential.
If male, is either a) of reproductive potential and compliant in using adequate birth control or b) not of reproductive potential.
Have a study partner who is willing to provide consent and spends on average at least two hours a day for at least four days a week with the patient, is fluent in the English language, and who agrees to attend certain study visits and provide accurate information about the patient.
Are able to swallow oral capsules.

Are fluent in the English language for the administration of rating scales and have sufficient visual, hearing and motor skills to complete procedures.

Exclusion Criteria:

Patients who:

Have an allergy to PBT2 or its excipients.
Have other known primary neurodegenerative disorders associated with dementia.
Have known dementia syndromes due to non-primary CNS disease.
Have another condition that in the investigator's judgment is resulting in clinically significant cognitive impairment.
In the opinion of the investigator, have any clinically significant uncontrolled medical or psychiatric illness, including history of seizures.
Have clinically significant cardiovascular, hepatic, renal, pulmonary, metabolic or endocrine disease that, in the opinion of the investigator, would interfere with an individual's participation in the study.
Have a calculated creatinine clearance at Screening of <50mL/min.
Have a history of malignancy diagnosed within 2 years of Screening.
Are pregnant or lactating females.
Intervention: Ranolazine
Trial phase: Not Applicable
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.

Ranolazine: 1000mg, two times a day, 12 hour intervals
Eligibility criteria:
Inclusion criteria:

Male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - Aortic or Tricuspid or Pulmonary valves
Patients who are not previously on Ranolazine
Do not have a history of arrhythmia and are not on any antiarrhythmic therapy
Patients with QTc on a 12 lead EKG of less than or equal to 460 ms
Patients with estimated Glomerular Filtration Rate (GFR) greater than 30 mL/min/1.73 m2 on the initial lab work
Available at least 48 hours before surgery

Exclusion criteria:

Patients who are not undergoing above surgeries
Patients undergoing surgery for mitral valve replacement/repair
Patient with cirrhosis
Pregnant patients
Patients with chronic atrial fibrillation
Patients who had prior adverse drug reactions or allergies to Ranolazine
Patients who are already taking Ranolazine prior to the study
Patient who are reported HIV Positive (as there are antiretroviral drug interactions)
Patients who are on drugs listed in Appendix A prior to the study
Intervention: Unii-Y4069R7J86
Trial phase: Phase 2
SMILES: CNC(=O)COc1cccc(Nc2ncc(F)c(Nc3ccc4c(c3)NC(=O)C(F)(F)O4)n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: R343 2mg, 2 puffs bid

R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid
Eligibility criteria:
Inclusion Criteria:

Clinical history of asthma
Ability to perform spirometry

Exclusion Criteria:

Chronic obstructive pulmonary disease or bronchiectasis
Upper or lower respiratory infection
Intervention: Unii-Y4069R7J86
Trial phase: Phase 2
SMILES: CNC(=O)COc1cccc(Nc2ncc(F)c(Nc3ccc4c(c3)NC(=O)C(F)(F)O4)n2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: R343 1mg, 1 puff bid

R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid
Eligibility criteria:
Inclusion Criteria:

Clinical history of asthma
Ability to perform spirometry

Exclusion Criteria:

Chronic obstructive pulmonary disease or bronchiectasis
Upper or lower respiratory infection
Intervention: Mapracorat
Trial phase: Phase 3
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 245
Group description: Mapracorat ophthalmic suspension, 3%,

Mapracorat: 1 drop of study medication into the study eye QID for 14 days
Eligibility criteria:
Inclusion Criteria:

Subjects who are candidates for routine, uncomplicated cataract surgery.
Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
Presence of active external ocular disease: infection or inflammation of the study eye.
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
Intervention: Prasugrel
Trial phase: Phase 1
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy males, as determined by medical history and physical examination.
Are between the ages of 20 and 45 years, inclusive.
Have a body mass index (BMI) of 19 kg/m^2 to 27 kg/m^2, inclusive, at screening.

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 60 days from a clinical trial involving an investigational drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Have known allergies to prasugrel or related compounds.
Are persons who have previously completed or withdrawn from this study or any other study investigating prasugrel.
Self-reported history of significant bleeding from trauma (for example, prolonged bleeding after tooth extraction).
History of major surgery within 3 months of screening or planned surgery within 14 days after the last day of dosing.
Have a platelet count of <100,000/(cubic millimeters) mm^3 at the time of screening.
Have tested positive for fecal occult blood at screening.
Have significant prolongation of prothrombin time (PT) or activated partial thromboplastin time (APTT) at screening.
Have a clinically significant abnormality following the investigator's review of the physical examination, electrocardiogram (ECG)and clinical (safety) laboratory tests at screening.
Personal or first-degree family history of coagulation or bleeding disorders (that is, hematemesis, melena, severe or recurrent epistaxis, hemoptysis, gastrointestinal ulcers, hemorrhage, clinically overt hematuria or intracranial hemorrhage) or reasonable suspicion of vascular malformations, for example, cerebral hemorrhage, aneurysm or premature stroke (cerebrovascular accident [CVA] <65 years of age).
Have significant active hematological disease and/or whole blood donation of more than 400 mL within the last 2 months and component blood donation within the last month.
Volunteers who have an average weekly alcohol intake that exceeds 21 units per week or volunteers unwilling to adhere to study alcohol restrictions during the study (1 unit = 360 mL of beer; 150 mL of wine; 45 mL of distilled spirits).
Intervention: Mapracorat
Trial phase: Phase 3
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 240
Group description: Mapracorat ophthalmic suspension, 3%,

Mapracorat: 1 drop of study medication into the study eye four times daily (QID) for 14 days
Eligibility criteria:
Inclusion Criteria:

Subjects who are candidates for routine, uncomplicated cataract surgery.
Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
Presence of active external ocular disease: infection or inflammation of the study eye.
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
Intervention: Retapamulin
Trial phase: Not Applicable
ATC code: D06AX13
SMILES: [H][C@@]12C(=O)CC[C@]13CC[C@@H](C)[C@@]2(C)[C@H](OC(=O)CS[C@@H]1C[C@H]2CC[C@@H](C1)N2C)C[C@@](C)(C=C)[C@@H](O)[C@@H]3C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: twice daily topical application of clobetasol propionate foam 0.05% for 14 days and Retapamulin 1% ointment for 5 days
Eligibility criteria:
Inclusion Criteria:

Male or female subjects at least 18 years of age with a clear diagnosis of moderate-to-severe hand or hand/foot dermatitis.
Subjects must be in general good health as confirmed by a medical history.
Subjects must be capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
At the Baseline Visit, Subjects must have a Physician's Global Assessment (PGA) of at least 3 (moderate severity).
Subject must be willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up period periods and comply with all study requirements.
If a subject is a female of childbearing potential she must have a negative urine pregnancy test prior to study treatment initiation and must agree to use an approved method of birth control during the study period (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrhea for at least one year) or surgically sterile (tubal ligation and/or hysterectomy) females are categorized as non-childbearing potential.

Exclusion Criteria:

Non-English speaking subjects
Females who are pregnant, breast feeding, or attempting to conceive.
Subjects with a history of known or suspected intolerance to any of the excipients of retapamulin 1% ointment or clobetasol propionate 0.05% foam.
Subjects who have used any topical corticosteroids, topical antibiotics, topical immunosuppressants, other topical therapies (tar, calcineurin inhibitors), or phototherapy (PUVA, UVB) within eight weeks of the Baseline Visit.
Subjects who have used any systemic corticosteroids, systemic antibiotics, or systemic immunosuppressants therapies within eight weeks of the Baseline Visit.
Subjects with any overt signs of skin atrophy, telangiectasias, and/or striae in the target area(s).
Subjects with any active skin malignancy.
Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study period.
Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment for atopic dermatitis.
Intervention: Diethylcarbamazine
Trial phase: Phase 4
ATC code: P02CB02
SMILES: CCN(CC)C(=O)N1CCN(C)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: diethylcarbamazine 8 mg/kg single oral dose

Diethylcarbamazine: single dose
Eligibility criteria:
INCLUSION CRITERIA (SCREENING):

A subject will be eligible for participation in the screening portion of this protocol if all of the following criteria apply:

male or non-pregnant and not breastfeeding female subjects,
age 20-60 years (per participant self-report)
resident of Akonolinga
Loa microfilaremia from 20 to 5000 mf/mL from the prior screening in the village or did not participate in the prior screening
consent to a blood draw to screen for infection with Loa loa
must be willing to have blood samples stored

EXCLUSION CRITERIA (SCREENING):

A subject will not be eligible for participation in the screening portion of this study if any of the following conditions apply:

Known to be pregnant (by history) or breastfeeding
Chronic medical conditions, including but not limited to diabetes, renal or hepatic insufficiency, immunodeficiency, psychiatric disorder, seizure, that in the investigators judgments are deemed to be clinically significant
History of hypersensitivity reaction to DEC or IVM

INCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will be eligible for participation in the interventional portion of the study only if all of the following additional inclusion criteria apply:

Loa loa microfilaremia between 20 and 2,000 mf/mL blood drawn between 11:30 am and 2:30 pm measured within 30 days prior to the baseline visit
The subject agrees to storage of samples for study

EXCLUSION CRITERIA (INTERVENTIONAL STUDY):

A subject will not be eligible to participate in the interventional portion of the study if any of the following conditions are fulfilled at the time of enrollment:

Pregnancy (by serum or urine beta-HCG) or breastfeeding
Chronic kidney or liver disease
Hgb < 10 gm/dL
Filarial infection other than Loa loa or M. perstans (O. volvulus, or W. bancrofti)
Use of DEC or IVM within the past 6 months
Use of immunosuppressive therapies, including steroids, within the past month
Any condition that in the investigator s opinion places the subject at undue risk by participating in the study

EXCLUSION OF CHILDREN AND PREGNANT WOMEN:

Pregnant women and children (the age of consent in Cameroon is 20 years of age) will be excluded from this study since it involves administration of medications contraindicated in pregnancy and more than minimal risk with no prospect of direct benefit, respectively.
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 295
Group description: 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

None
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 248
Group description: 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

None
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 257
Group description: 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

None
Intervention: Ketorolac
Trial phase: Not Applicable
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 94
Group description: Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)

Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure
Eligibility criteria:
Inclusion Criteria:

Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
Gestational age less than or equal to 11+6, confirmed by ultrasound
Eligible for suction curettage according to PPLM protocols
Choice of local anesthesia

Exclusion Criteria:

Choice of IV sedation for pain control
Hypersensitivity to NSAIDs or lidocaine
Contraindications to NSAIDs:

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

NSAIDs taken < 8 hours prior to procedure
Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
Long-term narcotic use
Unable or unwilling to complete required study procedures
Previous participation in the study
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 94
Group description: Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.
Eligibility criteria:
Inclusion Criteria:

Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
Gestational age less than or equal to 11+6, confirmed by ultrasound
Eligible for suction curettage according to PPLM protocols
Choice of local anesthesia

Exclusion Criteria:

Choice of IV sedation for pain control
Hypersensitivity to NSAIDs or lidocaine
Contraindications to NSAIDs:

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

NSAIDs taken < 8 hours prior to procedure
Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
Long-term narcotic use
Unable or unwilling to complete required study procedures
Previous participation in the study
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Nebivolol: 5 mg tablet to be taken by mouth once per day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >125 mmHg and <160 mmHg and/or diastolic >80 mmHg and <100 mmHg.
All of the women in the study will be postmenopausal and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
Candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Exclusion Criteria:

Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits).
Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication and aspirin) medications will not be eligible.
Fasting plasma glucose >126 mg/dL.
Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.
Use of hormone replacement therapy.
In hypertensive subjects, a seated systolic blood pressure >160 mmHg or a seated diastolic blood pressure >100 mmHg will be excluded.