anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nebivolol
Trial phase: Not Applicable
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: No
Participants at risk: 11
Group description: Nebivolol: Subject will take nebivolol daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Adult renal transplant recipients, men and women between 18 and 75 years of age, inclusive.
Patients must be > 3 months post-transplant.
Patients must have stable renal function (stable renal function will be defined as those patients without infection or hospitalization [for any reason] over the past 30 days, and patients with < 20% change in their serum creatinine over the past 30 days.
Patients receiving corticosteroids must be receiving a daily dose of < 7.5 mg of prednisone (or therapeutic equivalents based on glucocorticoid equivalency scale).
All eligible patients must be receiving antihypertensive medication management which must include metoprolol tartrate or metoprolol succinate.
Patients may be on more than one medication to control their hypertension. Use of any other FDA-approved antihypertensive agent is permitted.
All eligible patients will either be at goal blood pressure (<120/80 mmHg) or have Pre-hypertension (<140/90 mmHg) or Stage I hypertension (<160/100 mmHg) at the time of study inclusion.
Patients who are able to comprehend and satisfactorily comply with protocol requirements.
Patients who signed the written informed consent given prior to entering any study procedure.

Exclusion Criteria:

Patients with Stage II/uncontrolled hypertension (>159/99 mmHg).
Patients with an easily identifiable etiology for fatigue (i.e. anemia, iron-deficiency, poor sleep patterns, etc.).
Patients who have a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety and efficacy during the course of the trial (i.e. arrhythmia).
Patients with any current malignancy, or any clinically significant hematological, endocrine, cardiovascular, hepatic, gastrointestinal or neurological disease (including any form of epilepsy). If there is a history of such disease but the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.
Patients who are judged by the investigator to be unable or unlikely to follow the study protocol and complete all scheduled visits.
Patients with any contraindications to beta blocker therapy as listed in the package labeling for both metoprolol succinate and nebivolol.
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants received elagolix 200 mg twice a day for 3 months.
Eligibility criteria:
Inclusion Criteria:

Subject is a pre-menopausal female 20 to 49 years of age.

Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:

At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
Subject has a history of regular menstrual cycles between 24 to 35 days.
Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.

Exclusion Criteria:

Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.

Subject has a history of clinically significant condition(s) including but not limited to:

Endometriosis
Epilepsy or seizures
Type 1 diabetes
Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Participants received elagolix 300 mg twice a day for 3 months
Eligibility criteria:
Inclusion Criteria:

Subject is a pre-menopausal female 20 to 49 years of age.

Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:

At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
Subject has a history of regular menstrual cycles between 24 to 35 days.
Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.

Exclusion Criteria:

Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.

Subject has a history of clinically significant condition(s) including but not limited to:

Endometriosis
Epilepsy or seizures
Type 1 diabetes
Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Participants received elagolix 100 mg twice a day (BID) for 3 months.
Eligibility criteria:
Inclusion Criteria:

Subject is a pre-menopausal female 20 to 49 years of age.

Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:

At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
Subject has a history of regular menstrual cycles between 24 to 35 days.
Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.

Exclusion Criteria:

Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.

Subject has a history of clinically significant condition(s) including but not limited to:

Endometriosis
Epilepsy or seizures
Type 1 diabetes
Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Intervention: Elagolix
Trial phase: Phase 2
ATC code: H01CC03 | H01CC53
SMILES: COc1cccc(-c2c(C)n(Cc3c(F)cccc3C(F)(F)F)c(=O)n(C[C@H](NCCCC(=O)O)c3ccccc3)c2=O)c1F
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Participants received elagolix 600 mg once a day for 3 months.
Eligibility criteria:
Inclusion Criteria:

Subject is a pre-menopausal female 20 to 49 years of age.

Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:

At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
Subject has a history of regular menstrual cycles between 24 to 35 days.
Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.

Exclusion Criteria:

Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.

Subject has a history of clinically significant condition(s) including but not limited to:

Endometriosis
Epilepsy or seizures
Type 1 diabetes
Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Intervention: Lorazepam
Trial phase: Phase 4
ATC code: N05BA06 | N05BA56
SMILES: O=C1Nc2ccc(Cl)cc2C(c2ccccc2Cl)=NC1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 400
Group description: Lorazepam 4mg/4ml

Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery
Eligibility criteria:
Inclusion Criteria:

patients > 18 years admitted to the Day-Case Surgery Department Erasmus MC

Exclusion Criteria:

insufficient command of the Dutch language
ophthalmology surgery
Extracorporeal Shock Wave Lithotripsy (ESWL)-, Gastrointestinal endoscopic intervention, Botox-, Abortion and Pain treatment
Use of psychopharmaceuticals
Contra-indication of lorazepam use
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 400
Group description: NaCl 0.9% 4ml

NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery
Eligibility criteria:
Inclusion Criteria:

patients > 18 years admitted to the Day-Case Surgery Department Erasmus MC

Exclusion Criteria:

insufficient command of the Dutch language
ophthalmology surgery
Extracorporeal Shock Wave Lithotripsy (ESWL)-, Gastrointestinal endoscopic intervention, Botox-, Abortion and Pain treatment
Use of psychopharmaceuticals
Contra-indication of lorazepam use
Intervention: MESALAMINE
Trial phase: Phase 1
ATC code: A07EC02
SMILES: Nc1ccc(O)c(C(=O)O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 59
Group description: MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
Eligibility criteria:
Inclusion Criteria:

Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period.

Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:

Male, or
Non-pregnant, non-lactating female
Females must be at least 90 days post-partum or nulliparous.

Exclusion Criteria

A history of current or recurrent disease that could affect the colon. This includes gastrointestinal disease, peptic ulceration, gastrointestinal bleeding, celiac disease, lactose intolerance, ulcerative colitis, Crohn's disease, or Irritable Bowel Syndrome. Subjects who have a history of chronic constipation, which is physician diagnosed and treated, will also be excluded from the study (frequency of bowel movements >48 hours between samples).
A history of current or relevant serious, severe, or unstable (acute or progressive) physical or psychiatric illness.
A history of gastrointestinal surgery performed within the past 12 months prior to the first dose of investigational product, with the exception of an appendectomy.
A history of or current clinically relevant moderate or severe renal or hepatic impairment.
A history of asthma or bronchospasm associated with the use of 5-ASA or other non-steroidal anti-inflammatory drugs.
Known or suspected intolerance or hypersensitivity to the investigational product or amoxicillin, closely related compounds, or any of the stated ingredients
A history of, or current, pancreatitis
Intervention: Naldemedine
Trial phase: Phase 2
ATC code: A06AH05
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CC(C(=O)NC(C)(C)c1nc(-c3ccccc3)no1)=C2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received 0.1 mg naldemedine orally once daily for 28 days.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms
Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion Criteria:

Evidence of clinically significant gastrointestinal disease
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation
Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Intervention: Naldemedine
Trial phase: Phase 2
ATC code: A06AH05
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CC(C(=O)NC(C)(C)c1nc(-c3ccccc3)no1)=C2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants received 0.2 mg naldemedine orally once daily for 28 days.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms
Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion Criteria:

Evidence of clinically significant gastrointestinal disease
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation
Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Intervention: Naldemedine
Trial phase: Phase 2
ATC code: A06AH05
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CC(C(=O)NC(C)(C)c1nc(-c3ccccc3)no1)=C2O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Participants received 0.4 mg naldemedine orally once daily for 28 days.
Eligibility criteria:
Inclusion Criteria:

Subjects aged 18 years or older at time of informed consent with non-malignant chronic pain experiencing opioid-induced constipation
Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms
Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion Criteria:

Evidence of clinically significant gastrointestinal disease
History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation
Severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation
Intervention: Bepotastine besilate
Trial phase: Phase 4
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 1.5% bepotastine besilate, drops, twice per day, for two weeks

bepotastine besilate, 1.5%: Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
Eligibility criteria:
Inclusion Criteria:

Moderate to severe allergic subjects (≥ 2.5 on a 0.0 to 4.0 itching scale AND

> grade 2.0 bulbar redness using validated (Efron) scale)

Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB).
Can comply with instillation of study drug
Must be able to comply with the visit schedule and other requirements of the study.

Exclusion Criteria:

Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions.
Active inflammation of the cornea, iris, anterior chamber
Active or suspected herpetic eye disease (simplex, vaccinia, varicella)
Active or suspected mycobacterial or acanthamoeba infection
Active for suspected fungal disorders of the eye
Persistent and significant dry eye syndrome
Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components
Pregnancy or breast-feeding
Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study.
Participation in any other study within 30 days of this study.
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 4
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: treatment with 0.2 % loteprednol etabonate, drops, four times per day

Loteprednol etabonate: Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
Eligibility criteria:
Inclusion Criteria:

Moderate to severe allergic subjects (≥ 2.5 on a 0.0 to 4.0 itching scale AND

> grade 2.0 bulbar redness using validated (Efron) scale)

Must be able to understand and sign an informed consent form that has been approved by the Institutional Review Board (IRB).
Can comply with instillation of study drug
Must be able to comply with the visit schedule and other requirements of the study.

Exclusion Criteria:

Subjects who use daily wear (5-7 days / week, 6-16 hours/day)25 disposable soft hydrogel or silicone hydrogel contact lenses will be included in the study if they have been consistently wearing the same brand and have been using the same care solution for one month or longer. They will be asked to not wear their soft contact lenses to the eligibility visit (three days of no lens wear) and be willing to discontinue lens wear during the two weeks of the study because of the incompatibility of medicated eye drop instillation with contact lens wear and the potential confounding effect of contact lenses and care solutions.
Active inflammation of the cornea, iris, anterior chamber
Active or suspected herpetic eye disease (simplex, vaccinia, varicella)
Active or suspected mycobacterial or acanthamoeba infection
Active for suspected fungal disorders of the eye
Persistent and significant dry eye syndrome
Known allergy, contraindications or hypersensitivity to loteprednol, bepotastine, or its components
Pregnancy or breast-feeding
Use of topical eye drops, topical or systemic antihistamines, topical, nasal or systemic corticosteroids, immunosuppressive or immunomodulating agents, decongestants, aspirin, or non-steroidal antiinflammatory (NSAIDs) during the two weeks prior to the study.
Participation in any other study within 30 days of this study.