anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tenalisib
Trial phase: Phase 1
SMILES: CC[C@H](Nc1ncnc2[nH]cnc12)c1oc2ccccc2c(=O)c1-c1cccc(F)c1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: A single dose of RP6530 following fast condition

RP6530: Single oral dose
Eligibility criteria:
Inclusion Criteria:

Healthy male volunteers; aged 18 to 45 years;
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
Non- smokers or ex-smokers;
Able to give informed consent.

Exclusion Criteria:

Subjects with evidence or history of clinically significant disease;
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
Subjects who have received any investigational drug in the previous 28 days;
Subjects participated in a study with PI3k inhibitors at least once in past year;
Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.
Intervention: Tenalisib
Trial phase: Phase 1
SMILES: CC[C@H](Nc1ncnc2[nH]cnc12)c1oc2ccccc2c(=O)c1-c1cccc(F)c1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: A single dose of RP6530 following fed condition

RP6530: Single oral dose
Eligibility criteria:
Inclusion Criteria:

Healthy male volunteers; aged 18 to 45 years;
Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
Non- smokers or ex-smokers;
Able to give informed consent.

Exclusion Criteria:

Subjects with evidence or history of clinically significant disease;
Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
Subjects who have received any investigational drug in the previous 28 days;
Subjects participated in a study with PI3k inhibitors at least once in past year;
Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.
Intervention: Loratadine
Trial phase: Phase 4
ATC code: R06AX13
SMILES: CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Interleukin 1: 17 CH Interleukin 4: 17-27 CH Interleukin 5: 17 CH Interleukin 6: 17 CH Interleukin 10: 17 CH Interleukin 12: 9 CH Interleukin 13: 17 CH Tumor Necrosis Factor Alpha: 17 CH Transforming Growth Factor Beta: 5 CH Pulmo histaminum: 15 CH SNA-HLA-II: 18 CH

Impregnated on lactose saccharose globules (380 mg/capsule)

2LALERG: Homeopathic drug
Eligibility criteria:
Inclusion Criteria:

Age ≥18 years, male and female
Woman of childbearing age using effective contraceptive means
Patient having the faculties to understand and respect the constraints of the study
Symptomatic since at least two seasons and confirmed by positive skin test and/or the presence of IgE for grasses (prick test defined as positive if higher than or equal to half the negative control; IgE positive if at least class 3 (≥ 3.5 kU / L); these tests must have been performed at the latest at the first screening visit
Signature of the Informed Consent Form

Exclusion Criteria:

Pregnant woman or woman wishing to become pregnant
Breastfeeding woman
Patient with an acute exacerbation of allergic rhinitis
Patient with uncontrolled asthma
Immunotherapy received within the last two years
Patient with a known lactose intolerance
Patient who participated in a clinical study in the previous three months
Patient who is not sufficiently motivated to engage on a follow-up period of 6 months or more, unable to complete the patient diary, or likely to travel or to move before the end of the study,
Patient taking nasal or bronchial inhaled corticosteroids on a long term basis (intermittent consumption during the season is permitted provided it is mentioned in the patient's records)
Intervention: Iron sucrose
Trial phase: Phase 4
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Iron sucrose 200mg for 5 doses

Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
Eligibility criteria:
Inclusion Criteria:

All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months

Exclusion Criteria:

Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.
Intervention: Perampanel
Trial phase: Phase 4
ATC code: N03AX22
SMILES: N#Cc1ccccc1-c1cc(-c2ccccn2)cn(-c2ccccc2)c1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: During the Titration Period, participants received perampanel 2 mg/day and were up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants received the last dose they achieved at the end of the Titration Period and continued receiving this dose once daily for up to Week 36. At the discretion of investigators, dose adjustments were allowed based on the participant's clinical response and tolerability.
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)

Exclusion Criteria:

Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
Presence of previous history of Lennox-Gastaut syndrome
Presence of nonmotor simple partial seizures only
Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Visit 1 (Week 0)
Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
Participant who is participating in other intervention clinical trial
Intervention: Prochlorperazine
Trial phase: Phase 3
ATC code: N05AB04
SMILES: CN1CCN(CCCN2c3ccccc3Sc3ccc(Cl)cc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously

Compazine: Compazine 10mg with diphenhydramine 25 mg IV
Eligibility criteria:
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria

Age 18 to 65 years who present to the ED with complaint of a headache
Temperature less than 100.4 F
Diastolic blood pressure less than 104 mm Hg
Normal neurologic exam and normal mental status

Exclusion Criteria

Pregnant or breastfeeding
Meningeal signs are present
Acute angle closure glaucoma is suspected
Head trauma within the previous two weeks
Lumbar puncture within the previous two weeks
Thunderclap (rapid) onset of the headache
Weight more than 150 kg or less than 40 kg
Known allergy to diphenhydramine
Known allergy to ondansetron. (Zofran)
Known allergy to Compazine
Known allergy to Ketamine
History of schizophrenia or bipolar disorder
History of intracranial hypertension
Is a prisoner
Patient declined informed consent
Non-English speaking patient
Attending provider excludes patient
Elderly patients with dementia
Patients with severe headaches that diminish their decision making capability will not be able to participate
Intervention: Alisporivir
Trial phase: Phase 3
SMILES: C/C=C/C[C@@H](C)[C@@H](O)[C@H]1C(=O)N[C@@H](CC)C(=O)N(C)[C@H](C)C(=O)N(CC)[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@H](C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 164
Group description: All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
Eligibility criteria:
Inclusion Criteria:

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Exclusion Criteria:

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.
Intervention: Alisporivir
Trial phase: Phase 3
SMILES: C/C=C/C[C@@H](C)[C@@H](O)[C@H]1C(=O)N[C@@H](CC)C(=O)N(C)[C@H](C)C(=O)N(CC)[C@@H](C(C)C)C(=O)N[C@@H](C(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@H](C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](CC(C)C)C(=O)N(C)[C@@H](C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 397
Group description: All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
Eligibility criteria:
Inclusion Criteria:

Provides written informed consent before any assessment is performed
Is male or female aged ≥18
Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
Has achieved SVR24
Is able to comply with the visit schedule

Exclusion Criteria:

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Use or planned use to start a new course of hepatitis C therapy.
No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: oral misoprostol given 25 mcg every 2 hours
Eligibility criteria:
Inclusion Criteria:

Pregnant Female Patients greater than or equal to 18 years of age
Induction of labor for a single live intrauterine pregnancy
Greater than or equal to 37 weeks gestational age
Cephalic presentation
20 minute reassuring fetal heart rate (reactive nonstress test (NST))
Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

Previous uterine scar
Contraindication to vaginal delivery
Patients with preeclampsia
Grand multiparty - greater than or equal to 5 live births or stillbirths
Premature rupture of membranes
Suspected intrauterine growth restriction
Fetal anomalies
Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: vaginal misoprostol given 25 mcg every 4 hours
Eligibility criteria:
Inclusion Criteria:

Pregnant Female Patients greater than or equal to 18 years of age
Induction of labor for a single live intrauterine pregnancy
Greater than or equal to 37 weeks gestational age
Cephalic presentation
20 minute reassuring fetal heart rate (reactive nonstress test (NST))
Bishop score based on sterile vaginal exam of less than or equal to 6, for which the cervical dilation is less than or equal to 2 cm.
Equal to 3 or less uterine contractions over 10 minutes

Exclusion Criteria:

Previous uterine scar
Contraindication to vaginal delivery
Patients with preeclampsia
Grand multiparty - greater than or equal to 5 live births or stillbirths
Premature rupture of membranes
Suspected intrauterine growth restriction
Fetal anomalies
Contraindication to misoprostol (history of allergy to prostaglandins, glaucoma)
Intervention: HALOBETASOL PROPIONATE
Trial phase: Phase 2
ATC code: D07AC21
SMILES: CCC(=O)OC1(C(=O)CCl)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 62
Group description: Cream

Ultravate Cream: Cream
Eligibility criteria:
Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA (Body Surface Area) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA (Investigators Global Assessment) score of 3 or 4. (The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.)
If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization.
Subject is willing to comply with study instructions and return to the clinic for required visits.

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Intervention: HALOBETASOL PROPIONATE
Trial phase: Phase 2
ATC code: D07AC21
SMILES: CCC(=O)OC1(C(=O)CCl)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: Cream

Ultravate Cream: Cream
Eligibility criteria:
Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Subject is willing to comply with study instructions and return to the clinic for required visits.

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Intervention: Regorafenib
Trial phase: Phase 2
ATC code: L01EX05 | L01XE21
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)c(F)c2)ccn1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Regorafenib monotherapy at an initial dose of 160 mg once daily orally (21 days on, 7 days off treatment)
Eligibility criteria:
Inclusion Criteria:

Metastatic colorectal cancer with histological proof
Measurable disease according RECIST 1.1
Age ≥ 70 years
ECOG ≤ 1
Biological values Haemoglobin ≥ 9 g/dL, PNN ≥ 1500/mm3, platelets≥ 100 000/mm3, bilirubin ≤ 1,5N, ASAT, ALAT et PAL ≤ 2,5N (≤ 5N if hepatic metastases), lipase ≤1,5N, TP≥ 70%, Creatinine clairance ≥ 30 mL/min
Patient without response to 5FU chemotherapy or anti-vegf treatment or anti EGFR treatment (if RAS wild-type), in progression during this treatment or treatment stopped because of toxicities
Geriatric Questionnaires answered
Life-expectancy ≥ 3 months
Informed Consent Signed

Exclusion Criteria:

Not able to swallow tablets (crushed tablets are not allowed)
Previous treatment with regorafenib or other multikinase treatment
Other cancer during the last 5 years, excepted in-situ cervix cancer, skin cancer non melanoma and cancer of the bladder curatively treated
Radiotherapy: with extended fields in the last 4 weeks, with limited fields in the last 2 weeks previous inclusion
Toxicity > grade 1 not resolved with previous treatment
Major surgery in the 28 days before the inclusion
Non cicatrized injury, ulcer or bone fracture
Congestive Cardiac insufficiency classe >2 (NYHA)
Unstable angor in the last 3 months
Myocardial Infraction in the 6 months before inclusion
HTA not controlled
Pheochromocytome
Arterial or venous thromboembolism in the past 6 months
Infection of grade > 2
VIH infection
B or C hepatitis necessiting a specific treatment
Cirrhosis
Suspicion of brain metastasis or brain metastasis
Haemorraghe ofgrade >3 in the last weeks
Symptomatic Pulmonary fibrosis
Proteinuria > grade 3
Malabsorption
Allergy know to the treatment or to one similar treatment or to one treatment component
Systemic anti-cancer drug during the study or the the last 4 weeks
Concomitant treatment with CYP3A4 inhibitor or inductor or with UGT1A9 inhibitor
Social, psychological or medical condition which can interfere with the study participation
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Participants received Brand Name Travoprost one drop once daily for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Be apt to give consent
Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

Angle closure glaucoma or having benefited from a peripheral iridotomy
Known allergies to travoprost or to one of the ingredients
Current usage of other glaucoma drops other than travoprost
Current usage of topical corticosteroids
Pregnancy
Breast feeding
Monophthalmic
Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
Active intraocular inflammation
Ocular surface disease that interferes with accurate measuring of the intraocular pressure
Any clinically significant ocular disease that could interfere with the study
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Participants received Generic Travoprost one drop once daily for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Be apt to give consent
Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

Angle closure glaucoma or having benefited from a peripheral iridotomy
Known allergies to travoprost or to one of the ingredients
Current usage of other glaucoma drops other than travoprost
Current usage of topical corticosteroids
Pregnancy
Breast feeding
Monophthalmic
Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
Active intraocular inflammation
Ocular surface disease that interferes with accurate measuring of the intraocular pressure
Any clinically significant ocular disease that could interfere with the study
Intervention: Glycerin
Trial phase: Phase 4
ATC code: A06AG04 | A06AX01
SMILES: OCC(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1370
Group description: Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.

Glycerin Suppository: 30min before ESWL
Eligibility criteria:
Inclusion Criteria:

any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
at least 18 years old
provides informed consent

Exclusion Criteria:

readmitted to the hospital during the enrollment of the study
contraindications to ESWL
suspected or established malignancy
pancreatic ascites
receiving NSAIDs within 7 days
contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
presence of coagulopathy or received anticoagulation therapy within 3 days
acute pancreatitis within 3 days
known active cardiovascular or cerebrovascular disease
pregnant or breastfeeding women
without a rectum (ie, status post-total proctocolectomy)