anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Piflufolastat F 18
Trial phase: Phase 3
SMILES: O=C(O)CC[C@H](NC(=O)N[C@@H](CCCCNC(=O)c1ccc([18F])nc1)C(=O)O)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 208
Group description: Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
Eligibility criteria:
Inclusion Criteria:

Male >/= 18 years of age
Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy

Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of:

Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (American Urological Association [AUA]); or
Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (American Society for Therapeutic Radiology and Oncology [ASTRO]-Phoenix)
Negative or equivocal findings for prostate cancer on conventional imaging performed as part of standard of care workup within 60 days prior to Day 1
Life expectancy ≥6 months as determined by the investigator
Able and willing to provide informed consent and comply with protocol requirements

Exclusion Criteria:

Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives prior to Day 1
Ongoing treatment with any systemic therapy (e.g. ADT, antiandrogen, GnRH, LHRH agonist or antagonist) for prostate cancer
Treatment with ADT in the past 3 months of Day 1
Receipt of investigational therapy for prostate cancer within 60 days of Day 1
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
Intervention: Minoxidil
Trial phase: Phase 3
ATC code: C02DC01 | D11AX01
SMILES: Nc1cc(N2CCCCC2)nc(N)[n+]1[O-]
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: The patients applied 1 mL of solution at morning and evening intervals to the thinning hair areas of the scalp for 36 weeks

Topical Minoxidil 5%: Use Minoxidil 5% solution every day in scalp hair loss areas for 9 months
Eligibility criteria:
Inclusion Criteria:

Men 18 to 50 years old
Written consent
Normal general health status
Men who have a presentation of androgenetic alopecia (Norwood II - V).

Exclusion Criteria:

Use of any topical product in the target region interfering with the study product in the last three months
Within the past 6 months receiving of chemotherapy/cytotoxic agents
Clinical diagnosis of alopecia areata or other non-AGA forms of alopecia
Uncontrolled hypertension
Any dermatological disorders in the scalp, such as fungal or bacterial infections, eczema, atopic dermatitis, seborrheic dermatitis, psoriasis, sun damage, skin cancer
Hormonal diseases such as thyroid disorders, diabetes and, ...
Smokers
Liver and kidney disease
History of hair transplants
History of surgical correction of hair loss on the scalp
Subject having dyed, bleached hair or, with a permanent wave prior to study start.
No written consent
Intervention: Zuranolone
Trial phase: Phase 3
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Participants received SAGE-217 matching placebo capsules (single-blind), orally, once daily prior to Day 1 (Days -2 and -1) followed by self-administration of SAGE-217, 30 mg capsules, orally, once daily for 12 days. Thereafter participants received SAGE-217, 30 mg capsules, orally, once daily, 30 minutes prior to lights out (PSG) on Days 13 and 14 (double-blind). Thereafter participants self-administered SAGE-217 matching placebo capsules (single-blind), orally, once daily on Days 15 to 21.
Eligibility criteria:
Inclusion Criteria:

Participant had a diagnosis of MDD as diagnosed by structured clinical interview for diagnostic and statistical manual of mental disorders, fifth edition, clinical trials version (SCID-5-CT), with symptoms that have been present for at least a 4-week period.
Participant had a diagnosis of Insomnia that is confirmed at screening based on the diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) diagnostic criteria using the SCID-5-CT.
Participant had an Insomnia Severity Index (ISI) score greater than or equal to (>=) 15 (moderate to severe insomnia).
Participant had a Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥28 prior to dosing and a Hamilton Rating Scale for Depression (HAM-D) total score of ≥20.

Exclusion Criteria:

Participant had attempted suicide associated within the current episode of MDD.
Participant had onset of the current depressive episode during pregnancy or 4 weeks postpartum, or the participant had presented for screening during the 6-month postpartum period.
Participant had a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
Participant had a medical history of seizures.
Participant had active psychosis per Investigator assessment.
Intervention: Nabilone
Trial phase: Phase 3
ATC code: A04AD11
SMILES: CCCCCCC(C)(C)c1cc(O)c2c(c1)OC(C)(C)C1CCC(=O)CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Assessment of long-term efficacy and safety of nabilone 0.25 mg - 2 mg

Nabilone 0.25 mg: capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
Eligibility criteria:
Inclusion Criteria:

In order to be eligible for participation in the study, subjects must meet all inclusion criteria:

In order to be eligible for the study, patients must have completed the double-blind phase of the NMS-Nab trial as responders within the last 2 months.
For patients that completed NMS-Nab Study over 2 months prior to the Screening / Baseline Visit, and meet all other inclusion criteria, eligibility should be discussed on a case-by-case basis.
Only patients without a drug-related serious adverse event (SAE) or (drug-related) moderate or severe AE during the NMS-Nab Study can be included in the study
Patients must be able and willing to provide written informed consent prior to any study related procedure being performed. Patients with a legal guardian should be consented according to local requirements.
Patients must be willing and able to take oral medication and able to comply with the study specific procedures.
The patient is in good health as determined by medical examination and based on the investigator's judgement

Exclusion Criteria:

Patients with any of the following characteristics will be excluded from entering the study:

Patients with PArkinson´s Disease (PD) who have not participated in the randomized double-blind phase of the previous NMS-Nab Study.
Patients that experienced a drug-related SAE or had a (drug-related) moderate or severe AE during the NMS-Nab Study will be excluded in the study.
Patients who are unable or unwilling to comply with the study procedures in the investigator´s opinion.
Patients with any clinically significant or unstable medical or surgical condition at the Screening / Baseline Visit that may preclude safety and the completion of the study participation (based on the investigator's judgement).
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
Eligibility criteria:
Inclusion Criteria:

American society of Anesthesiology (ASA) status of I-III
Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

Exclusion Criteria:

Patient not willing to be a part of the study
Patients were aged <60 or >75 years
Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance
Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]
Patients who had recently received a sedative or opioid drug
Patients with a MoCA (Montreal Cognitive Assessment) score <26
Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: The Control Group will receive placebo infusion of normal saline.
Eligibility criteria:
Inclusion Criteria:

American society of Anesthesiology (ASA) status of I-III
Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

Exclusion Criteria:

Patient not willing to be a part of the study
Patients were aged <60 or >75 years
Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance
Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]
Patients who had recently received a sedative or opioid drug
Patients with a MoCA (Montreal Cognitive Assessment) score <26
Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study
Intervention: Dexmedetomidine
Trial phase: Phase 2
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 19
Group description: 2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion

dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Eligibility criteria:
Inclusion Criteria:

children affected by behavior disorders who underwent EEG procedure with sedation
written informed consent

Exclusion Criteria:

ASA > 2
hypersensitivity of active substance
therapy with beta blockers or digoxin, arrhythmia
Intervention: Bisoprolol
Trial phase: Phase 4
ATC code: C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 22
Group description: bisoprolol 2.5 mg was given to patients of bisoprolol group 2 hours preoperative
Eligibility criteria:
Inclusion Criteria:

patients who underwent functional endoscopic sinus surgery
ability to swallow tablets

Exclusion Criteria:

suspected difficult airway
basal HR <60/min.
chronic cardiovascular or cerebrovascular disease
bronchial asthma or COPD
DM
bleeding disorders
anemia (Hb level< 10 gm/dl)
renal or hepatic insufficiency
psychiatric disorders
chronic treatment by BBs, gabapentin or drugs that affect coagulation
acute nasal infection
allergy/contraindications to any of the study's drugs.
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Has a 2-year history of seasonal allergic rhinitis
Has a positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
Is in good health and free of any unstable, clinically-significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria:

Women who are pregnant or breastfeeding
Women of childbearing potential who are not using an acceptable form of birth control
Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn, or nedocromil
Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study, or required treatment which might interfere with the study
Is on immunotherapy with the exception of maintenance therapy
Has a clinically significant upper respiratory or sinus infection
Has used an investigational drug within the previous 30 days
Has nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow
Has a history of multiple drug allergies or an allergy to antihistamines or corticoids
Has dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
Has rhinitis medicamentosa
Is using of any chronic medication which could affect the course of seasonal allergic rhinitis
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 3
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received dimethyl fumarate 120 mg capsules BID, orally for 7 days followed by 240 mg capsules, BID, orally for 95 weeks and peginterferon beta-1a matching placebo SC injection Q2W for up to 96 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
Must have an EDSS score between 0.0 and 5.0.
Must have a body weight of ≥30 kg
Must have experienced ≥1 relapse in the 12 months prior to randomization (Day 1), or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or ≥2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event.

Key Exclusion Criteria:

Participants having primary progressive, secondary progressive, or progressive RMS.
Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.
History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study
Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Oxygen
Trial phase: Phase 3
ATC code: V03AN01
SMILES: O=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Control group will receive 100% oxygen, inhalation therapy for a duration of 2 hours via an FDA-approved mask breathing circuit.

Oxygen: A total of three inhalation treatments with 100% oxygen (6 total exposure hours) over one week with 2 or 3 days between each session.
Eligibility criteria:
Inclusion Criteria:

Patients must be diagnosed with CRPS based on the revised International Association for the Study of Pain criteria.
Duration of disease must be at least 6 months.
Written informed consent.

Exclusion Criteria:

Patients who had no subjective benefit from ketamine infusions, as determined by interview during the recruitment process.
Patients taking more than 60mg of morphine equivalents or more daily for an alternative chronic pain condition.
Patients with both coronary artery disease (as determined by cardiac catheterization) and a functional status of less than 4 metabolic equivalents. The limited functional status must be secondary to cardiopulmonary symptoms (angina, dyspnea on exertion). Patients with coronary artery disease and a limited functional status (<4 METS) secondary to chronic pain can be included.
Patients with congestive heart failure of any etiology that are NYHA Class III or IV
Patients with moderate or severe pulmonary hypertension as determined by echocardiogram or right heart catheterization.
Patients with intraocular surgery within the past 14 days
Patients with worker's compensation claims and active litigation.
Patients who have been diagnosed with COPD.
Patients who use home oxygen therapy for any condition.
Diagnosis of Alcohol Use Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Illicit drug use within the past three months (not including marijuana).
Pregnant patients or patients with upcoming planned pregnancy.
Intervention: CID 118984462
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCNC(=O)CCC(NC(=O)CCCCCCCCCCCCCCC(=O)O)C(=O)O)C(=O)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 360
Group description: Insulin degludec administered SC once a day. Doses were individualized and titrated according to protocol-defined targets.

The starting dose of insulin degludec was 10 IU/day ideally at bedtime, titrated to a fasting blood glucose (FBG) <90 milligram per Deciliter (mg/dL), following a treat-to-target (TTT) algorithm based on the last 3 FBG values.
Eligibility criteria:
Inclusion Criteria:

Participants must:

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
Be of stable weight (± 5%) for at least 3 months before screening
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Exclusion Criteria:

Participants must not:

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level >3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if their ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate <45 mL/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin, or metformin plus an SGLT-2 inhibitor during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
Intervention: Loratadine
Trial phase: Phase 2
ATC code: R06AX13
SMILES: CCOC(=O)N1CCC(=C2c3ccc(Cl)cc3CCc3cccnc32)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Take treatment daily for 7 days.

Loratadine: 10 mg in a capsule

Placebo: Administered via capsule
Eligibility criteria:
Inclusion Criteria:

Diagnosis of neutropenia
Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month
Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI)

Exclusion Criteria:

Other sources of chronic pain
Previously tried loratadine for 7 consecutive days or more for bone pain
Allergy to loratadine
Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment.
Eligibility criteria:
Inclusion Criteria:

Participant must be age-eligible in the feeder study at the time of signing the informed consent.
Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Exclusion Criteria:

Medical reasons not to start the next treatment cycle in the respective feeder
Pregnancy
Intervention: Lurasidone
Trial phase: Phase 4
ATC code: N05AE05
SMILES: [H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Open-label treatment with lurasidone within the dose range of 20-60 mg daily

Lurasidone: Participant will have an open label trial of lurasidone for eight weeks.
Eligibility criteria:
Inclusion Criteria:

Bipolar I disorder, bipolar II disorder or other specified bipolar disorder
Currently in a major depressive episode and moderately depressed
Age 18-50 years old
Patients on psychiatric medications will not be benefitting from those medications
Females of childbearing potential must be willing to use an acceptable form of birth control throughout the study

Exclusion Criteria:

Diagnosis of schizophrenia or other psychotic disorders, recent alcohol or substance use disorder, recent anorexia or bulimia nervosa
Previous failed trial of lurasidone, or had intolerable side effects of lurasidone
Significant active physical illness
Actively suicidal
ECT within the past 6 months
Recent pregnancy, abortion or miscarriage or plans to conceive during the study; currently lactating
Metal in the body that is not MRI compatible
Current, past or anticipated exposure to radiation
Currently taking an anticoagulant medication